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Confidential Draft Submission No. 3 confidentially submitted to the Securities and Exchange Commission on December 16, 2014

This draft registration statement has not been publicly filed with the Securities and Exchange Commission, and all information herein remains strictly confidential.

Registration No. 333-            

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM F-1

REGISTRATION STATEMENT

Under

The Securities Act of 1933

 

 

MESOBLAST LIMITED

(Exact name of Registrant as specified in its charter)

 

 

 

Australia		2836		Not Applicable
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

Silviu Itescu

Chief Executive Officer and Executive Director

Level 38

55 Collins Street

Melbourne 3000

Australia

Telephone: +61 (3) 9639-6036

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

 

Mesoblast, Inc.

Level 3

505 5th Avenue

New York, NY 10017

(212) 880-2060

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

 

Jeffrey D. Saper, Esq.     Steven V. Bernard, Esq.     Megan J. Baier, Esq.     Wilson Sonsini Goodrich & Rosati, P.C.     650 Page Mill Road     Palo Alto, CA 94304		Peter T. Howard General Counsel and Corporate Executive Level 38 55 Collins Street Melbourne 3000 Australia		Ian Davis John Steven Minter Ellison Level 23, Rialto Towers 525 Collins Street Melbourne 3000 Australia		Thomas J. Ivey, Esq. Mark J. Leemen, Esq. Skadden, Arps, Slate, Meagher & Flom LLP 525 University Avenue #1400 Palo Alto, CA 94301

 

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

 

 

CALCULATION OF REGISTRATION FEE

 

Title of each class of securities to be registered(1)		Proposed maximum aggregate offering price(2)(3)		Amount of registration fee
Ordinary shares, no par value		US$		US$

(1)	American depositary shares issuable upon deposit of the ordinary shares registered hereby will be registered under a separate registration statement on Form F-6 (Registration No. 333-            ). Each American depositary share represents              ordinary shares.

(2)

Includes (a) all ordinary shares that may be purchased by the underwriters pursuant to an over-allotment option, and (b) all ordinary shares initially offered and sold outside the United States that may be resold from time to time in the United States either as part of their distribution or within 40 days after the later of the effective date of this Registration Statement and the date the shares are first bona fide offered to the public. The shares are not being registered for the purpose of sales outside the United States.

(3)	Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933.

 

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said Section 8(a) may determine.

 

 

 

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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED DECEMBER 16, 2014

Prospectus

             American Depositary Shares

representing ordinary shares

 

Mesoblast Limited

 

 

This is an initial public offering in the United States of American depositary shares, or ADSs, representing ordinary shares of Mesoblast Limited, or Mesoblast. Mesoblast is offering              ADSs. Each ADS represents              ordinary shares, no par value, deposited with JPMorgan Chase Bank, N.A., as depositary. The estimated initial public offering price will be between US$         and US$         per ADS.

Our ordinary shares currently trade on the Australian Securities Exchange under the symbol “MSB.” On December 12, 2014, the closing price for our ordinary shares was A$4.24. We intend to apply to list our ADSs on the                  under the symbol “            ”.

 

 

Investing in our ADSs involves a high degree of risk. See “Risk Factors” beginning on page 13.

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

 

		Per ADS				Total
Initial public offering price		US$				US$
Underwriting discounts and commissions		US$				US$
Proceeds before expenses, to us		US$				US$

We have granted the underwriters the right to purchase up to an additional              ADSs from us at the public offering price less the underwriting discounts and commissions.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed on the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the ADSs to purchasers on or about                     , 2015.

 

 

 

J.P. Morgan		Credit Suisse
Piper Jaffray

                    , 2014

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TABLE OF CONTENTS

 

		Page
The Offering			9
Summary Consolidated Financial and Operating Data			11
Risk Factors			13
Forward-Looking Statements			52
Use of Proceeds			54
Price Range of Our Ordinary Shares			55
Exchange Rate Information			56
Dividends and Dividend Policy			57
Capitalization			58
Dilution			59
Selected Consolidated Financial Data			61
Management’s Discussion and Analysis of Financial Condition and Results of Operations			63
Business			80
Management			127
Principal shareholders			144
Related Party Transactions			146
Description of Share Capital			147
Description of American Depositary Shares			154
Shares Eligible For Future Sale			165
Taxation			167
Underwriting			176
Expenses Relating to This Offering			180
Legal Matters			181
Experts			181
Enforcement of Civil Liabilities			181
Where You Can Find More Information			182
Index to consolidated financial statements			F-1

 

 

You should rely only on the information contained in this prospectus and any related free-writing prospectus that we authorize to be distributed to you. We have not, and the underwriters have not, authorized any person to provide you with information different from that contained in this prospectus or any related free-writing prospectus that we authorize to be distributed to you. This prospectus is not an offer to sell, nor is it seeking an offer to buy, these securities in any state where the offer or sale is not permitted. The information in this prospectus speaks only as of the date of this prospectus unless the information specifically indicates that another date applies, regardless of the time of delivery of this prospectus or of any sale of the securities offered hereby.

No action is being taken in any jurisdiction outside the United States to permit a public offering of the ADSs or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of the prospectus applicable to that jurisdiction.

Until                     , 2015 (the 25^th day after the date of this prospectus), all dealers that buy, sell or trade in our ADSs, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to their unsold allotments or subscriptions.

 

 

 

 

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STATISTICAL AND OTHER INDUSTRY AND MARKET DATA

This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosure contained in this prospectus and we believe these industry publications and third-party research, surveys and studies are reliable.

TRADEMARKS

We own or have rights to trademarks and trade names that we use in connection with the operation of our business, including our corporate name, logos, product names and website names. Other trademarks and trade names appearing in this prospectus are the property of their respective owners. Solely for your convenience, some of the trademarks and trade names referred to in this prospectus are listed without the ^® and ^TM symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks and trade names.

CONVENTIONS THAT APPLY TO THIS PROSPECTUS

Except where the context requires otherwise and for purposes of this prospectus only:

 

•

“ADSs” refers to our American depositary shares, each of which represents ordinary shares, and “ADRs” refers to the American depositary receipts that evidence our ADSs.

 

•

“Mesoblast,” “we,” “us” or “our” refer to Mesoblast Limited and its subsidiaries.

 

•

“A$” or “Australian dollar” refers to the legal currency of Australia.

 

•

“IFRS” refers to the International Financial Reporting Standards as issued by the International Accounting Standards Board, or IASB.

 

•

“GAAP” refers to the Generally Accepted Accounting Principles in the United States.

 

•

“FDA” refers to the United States Food and Drug Administration.

 

•

“NIH” refers to the United States National Institutes of Health.

 

•

“US$” or “U.S. dollars” refers to the legal currency of the United States.

 

•

“U.S.” or “United States” refers to the United States of America.

Unless otherwise indicated, the consolidated financial statements and related notes included in this prospectus have been presented in Australian dollars and also comply with IFRS, which differs in certain significant respects from GAAP. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Certain Differences Between IFRS and GAAP.”

This prospectus contains translations of certain Australian dollar amounts into U.S. dollars at specified rates solely for the convenience of the reader. Unless otherwise stated, the translation of Australian dollars into U.S. dollars has been made at the exchange rate as quoted by the Board of Governors of the Federal Reserve System on June 30, 2014, which was A$1.00 to US$0.9427. We make no representation that the Australian dollar or U.S. dollar amounts referred to in this prospectus could have been converted into U.S. dollars or Australian dollar, as the case may be, at any particular rate or at all. See “Risk Factors—Risks Related to Ownership of Our ADSs, Our Trading Market and This Offering—We are subject to risk associated with currency fluctuations, and changes in foreign currency exchange rates could impact our results of operations.” On October 31, 2014, the exchange rate was A$1.00 to US$0.8791.

 

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RISK FACTORS

You should carefully consider the risks described below and all other information contained in this prospectus before making an investment decision. If any of the following risks actually occur, our business, financial condition and results of operations could be materially and adversely affected. In that event, the trading price of our ADSs could decline, and you may lose part or all of your investment. This prospectus also contains forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including the risks described below and elsewhere in this prospectus.

Risks Related to Our Financial Position and Capital Requirements

We have incurred operating losses since our inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future. We may never achieve or sustain profitability.

We are a clinical-stage biotechnology company and we have not yet generated significant revenues. We have incurred net losses during most of our fiscal periods since our inception. As of June 30, 2014, we had a comprehensive loss of A$87.6 million (or US$82.6 million). Our net loss for the year ended June 30, 2014 was A$81.0 million (or US$76.4 million). We do not know whether or when we will become profitable. To date, we have not generated any revenues from the sale of products. Our losses have resulted principally from costs incurred in our manufacturing and clinical development activities.

We anticipate that our expenses will increase in the future as we move toward commercialization, including the scaling up of our manufacturing activities. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To achieve and maintain profitability, we must successfully develop our product candidates, obtain regulatory approval, and manufacture, market and sell those products for which we obtain regulatory approval. If we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for our product candidates in those markets. We may not succeed in these activities, and we may never generate revenue from product sales that is significant enough to achieve profitability. Our failure to become or remain profitable would depress our market value and could impair our ability to raise capital, expand our business, discover or develop other product candidates or continue our operations. A decline in the value of our company could cause you to lose part or all of your investment.

We have never generated any revenue from product sales and may never be profitable.

Our ability to generate revenue and achieve profitability depends on our ability, either alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize our product candidates. We do not anticipate generating revenues from product sales for the foreseeable future, and we may never generate product sales. Our ability to generate future revenues from product sales depends heavily on our success in a number of areas, including:

 

•

completing research and preclinical and clinical development of our product candidates;

 

•

seeking and obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies;

 

•

establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand for our product candidates, if approved;

 

•

launching and commercializing product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales force, marketing and distribution infrastructure;

 

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•

obtaining market acceptance of our product candidates and stem cell therapy as a viable treatment option;

 

•

addressing any competing technological and market developments;

 

•

obtaining and sustaining an adequate level of reimbursement from payors;

 

•

identifying and validating new stem cell therapy product candidates;

 

•

negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;

 

•

maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;

 

•

attracting, hiring and retaining qualified personnel; and

 

•

implementing additional internal systems and infrastructure, as needed.

Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency, or the EMA, or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.

Even if this offering is successful, we will require substantial additional financing to achieve our goals, and our failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

Our operations have consumed substantial amounts of cash since inception. As of June 30, 2014, our cash and cash equivalents were A$196.4 million (or US$185.1 million). We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future in connection with our planned research, development and product commercialization efforts. In addition, even if this offering is successful, we will require additional financing to achieve our goals and our failure to do so could adversely affect our commercialization efforts. We anticipate that our expenses will increase substantially if and as we:

 

•

continue the research and clinical development of our product candidates, including our MSC-100-IV and MPC-150-IM (Class II-IV) product candidates;

 

•

initiate and advance our product candidates into larger and more expensive clinical studies, including a Phase 3 clinical trial for our MPC-06-ID and MPC-25-Osteo product candidates;

 

•

seek to identify, assess, acquire, and/or develop other product candidates and technologies;

 

•

seek regulatory and marketing approvals in multiple jurisdictions for our product candidates that successfully complete clinical studies;

 

•

establish collaborations with third parties for the development and commercialization of our product candidates, or otherwise build and maintain a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

 

•

further develop and implement our proprietary manufacturing processes in both planar technology and our bioreactor programs and expand our manufacturing capabilities and resources for commercial production;

 

•

seek coverage and reimbursement from third-party payors, including government and private payors for future products;

 

•

make milestone or other payments under our agreements pursuant to which have licensed or acquired rights to intellectual property and technology;

 

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•

seek to maintain, protect and expand our intellectual property portfolio; and

 

•

seek to attract and retain skilled personnel.

If we were to experience any delays or encounter issues with any of the above, including clinical holds, failed studies, inconclusive or complex results, safety or efficacy issues, or other regulatory challenges that require longer follow-up of existing studies, additional major studies, or additional supportive studies in order to pursue marketing approval, it could further increase the costs associated with the above. Further, the net operating losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic collaborations or partnerships, or marketing, distribution or licensing arrangements with third parties, we may be required to do so at an earlier stage than would otherwise be ideal and/or may have to limit valuable rights to our intellectual property, technologies, product candidates or future revenue streams, or grant licenses or other rights on terms that are not favorable to us. Furthermore, any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

Risks Related to Clinical Development and Regulatory Review and Approval of Our Product Candidates

Our product candidates are based on our novel MLC technology, which makes it difficult to accurately and reliably predict the time and cost of product development and subsequently obtaining regulatory approval. At the moment, no stem cell products have been approved in the United States.

We have not commercially marketed, distributed or sold any products. The success of our business depends on our ability to develop and commercialize our lead product candidates. We have concentrated our product research and development efforts on our MLC platform, a novel type of stem cell therapy. Our future success depends on the successful development of this therapeutic approach. There can be no assurance that any development problems we experience in the future related to our MLC platform will not cause significant delays or unanticipated costs, or that such development problems can be solved. We may also experience delays in developing sustainable, reproducible and scalable manufacturing processes or transferring these processes to collaborators, which may prevent us from completing our clinical studies or commercializing our products on a timely or profitable basis, if at all.

In addition, the clinical study requirements of the FDA, the EMA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential product candidates. The regulatory approval process for novel product candidates such as ours can be more expensive and take longer than other, better known or extensively studied pharmaceutical or other product candidates to develop. In addition, adverse developments in clinical trials of cell therapy products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any of our product candidates. At the moment, no other stem cell products have been approved in the United States, which makes it difficult to determine how long it will take or how much it will cost to obtain regulatory approvals for our product candidates in either the United States or elsewhere.

We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies.

We have never obtained regulatory approval for a product. We must conduct extensive testing of our product candidates to demonstrate their safety and efficacy, including both preclinical animal testing and human clinical trials, before we can obtain regulatory approval to market and sell them. Conducting such testing is a

 

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lengthy, time-consuming, and expensive process and there is a high rate of failure. Our current and completed preclinical and clinical results for our product candidates are not necessarily predictive of the results of our ongoing or future clinical trials. Promising results in preclinical studies of a product candidate may not be predictive of similar results in humans during clinical trials, and successful results from early human clinical trials of a product candidate may not be replicated in later and larger human clinical trials or in clinical trials for different indications. If the results of our or our collaborators’ ongoing or future clinical trials are negative or inconclusive with respect to the efficacy of our product candidates or if we or they do not meet the clinical endpoints with statistical significance or if there are safety concerns or adverse events associated with our product candidates, we or our collaborator may be prevented or delayed in obtaining marketing approval for our product candidates.

We may encounter substantial delays in our clinical studies.

We cannot guarantee that any preclinical testing or clinical trials will be conducted as planned or completed on schedule, if at all. A failure can occur at any stage of testing. Events that may prevent successful or timely commencement, enrollment or completion of clinical development include:

 

•

delays in raising, or inability to raise, sufficient capital to fund the planned trials;

 

•

delays by us or our collaborators in reaching a consensus with regulatory agencies on trial design;

 

•

changes in trial design;

 

•

inability to identify, recruit and train suitable clinical investigators;

 

•

inability to add new clinical trial sites;

 

•

delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations, or CROs, and clinical trial sites;

 

•

delays in obtaining required Institutional Review Board, or IRB, approval at each clinical trial site;

 

•

delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials;

 

•

imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites;

 

•

failure by CROs, other third parties or us or our collaborators to adhere to clinical trial requirements;

 

•

failure to perform in accordance with the FDA’s current Good Clinical Practices, or cGCP, or applicable regulatory guidelines in other countries;

 

•

delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;

 

•

delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;

 

•

delays caused by clinical trial sites not completing a trial;

 

•

failure to demonstrate adequate efficacy;

 

•

occurrence of serious adverse events in clinical trials that are associated with the product candidates that are viewed to outweigh its potential benefits;

 

•

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; or

 

•

disagreements between us and the FDA or other regulatory agencies interpreting the data from our clinical trials.

 

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Delays, including delays caused by the above factors, can be costly and could negatively affect our or our collaborators’ ability to complete clinical trials for our product candidates. If we or our collaborators are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval and/or will not be able to commercialize our product candidates.

We may find it difficult to enroll patients in our clinical trials, especially for indications such as aGVHD which are designated as orphan or niche markets, which could delay or prevent development of our product candidates.

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates as well as completion of required follow-up periods. In general, if patients are unwilling to participate in our stem cell therapy trials because of negative publicity from adverse events in the biotechnology or stem cell industries or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting patients, conducting trials and obtaining regulatory approval for our product candidates may be delayed. More specifically, certain of our product candidates, including MSC-100-IV for aGVHD, target indications with relatively small patient populations, which can prolong the clinical trial timeline for the regulatory process if sufficient patients cannot be enrolled in a timely manner. As a result, we or our collaborators generally will have to run multi-site and potentially multi-national trials, which can be time consuming, expensive and require close coordination and supervision. If we have difficulty enrolling a sufficient number of patients or otherwise conducting clinical trials as planned, we or our collaborators may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.

In addition, our planned clinical trials targeting more prevalent indications, such as our product candidates for CDLBP, MPC-06-ID, and CHF, MPC-150-IM, may require the recruitment of several thousand patients. If there are delays in accumulating the required number of trial subjects or, in trials where clinical events are a primary endpoint, there may be delays in completing the trial. These delays could result in increased costs, delays in advancing development of our product candidates, including delays in testing the effectiveness, or even termination of the clinical trials altogether.

Patient enrollment and completion of clinical trials are affected by factors including:

 

•

size of the patient population, particularly in orphan diseases;

 

•

severity of the disease under investigation;

 

•

design of the trial protocol;

 

•

eligibility criteria for the particular trial;

 

•

perceived risks and benefits of the product candidate being tested;

 

•

proximity and availability of clinical trial sites for prospective patients;

 

•

availability of competing therapies and clinical trials;

 

•

efforts to facilitate timely enrollment in clinical trials;

 

•

patient referral practices of physicians;

 

•

ability to monitor patients adequately during and after treatment; and

 

•

the degree of treatment effect in event-driven trials.

Once enrolled, patients may choose to discontinue their participation at any time during the trial, for any reason. Participants also may be terminated from the study at the initiative of the investigator, for example if they experience serious adverse clinical events or do not follow the study directions. If we are unable to maintain an adequate number of patients in our clinical trials, we may be required to delay or terminate an ongoing clinical trial, which would have an adverse effect on our business.

 

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We may participate in multinational clinical trials, which present additional and unique risks.

We plan to seek initial marketing approval for our product candidates in the United States and in select non-U.S. jurisdictions such as Canada. Conducting trials on a multinational basis requires collaboration with foreign medical institutions and healthcare providers. Our ability to successfully initiate, enroll and complete a clinical trial in multiple countries is subject to numerous risks unique to conducting business internationally, including:

 

•

difficulty in establishing or managing relationships with physicians and CROs;

 

•

different standards for conducting clinical trials and resulting patients;

 

•

our inability to locate qualified local consultants, physicians and partners;

 

•

the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatments; and

 

•

differing genotypes, average body weights and other patient profiles within and across countries from our donor profile may impact the optimal dosing or may otherwise impact the results of our clinical trials.

Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates, or limit the scope of any approved indication or market acceptance.

Participants in clinical trials of our investigational stem cell products may experience adverse reactions or other undesireable side effects. While some of these can be anticipated, others may be unexpected. We cannot predict the frequency, duration, or severity of adverse reactions or undesireable side effects that may occur during clinical investigation of our product candidates. If any of our product candidates, prior to or after any approval for commercial sale, cause adverse events or are associated with other safety risks, a number of potentially significant negative consequences could result, including:

 

•

regulatory authorities may suspend (e.g., through a clinical hold) or terminate clinical trials;

 

•

regulatory authorities may deny regulatory approval of our product candidates;

 

•

regulators may restrict the indications or patient populations for which a product candidate is approved;

 

•

regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a risk evaluation and mitigation strategy, or REMS, in connection with approval, if any;

 

•

regulatory authorities may withdraw their approval, require more onerous labeling statements or impose a more restrictive REMS than any product that is approved;

 

•

we may be required to change the way the product is administered or conduct additional clinical trials;

 

•

patient recruitment into our clinical trials may suffer;

 

•

our relationships with our collaborators may suffer;

 

•

we could be required to provide compensation to subjects for their injuries, e.g., if we are sued and found to be liable or if required by the laws of the relevant jurisdiction or by the policies of the clinical site; or

 

•

our reputation may suffer.

There can be no assurance that adverse events associated with our product candidates will not be observed, even where no prior adverse events have occurred. As is typical in clinical development, we have a program of ongoing toxicology studies in animals for our other clinical-stage product candidates and cannot provide assurance that the findings from such studies or any ongoing or future clinical trials will not adversely affect our clinical development activities.

 

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We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized. In addition, regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. If we elect or are forced to suspend or terminate a clinical trial for any of our product candidates, the commercial prospects for that product as well as our other product candidates may be harmed and our ability to generate product revenue from these product candidates may be delayed or eliminated. Furthermore, any of these events could prevent us or our collaborators from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these product candidates either by us or by our collaborators.

Several of our product candidates treat patients who are extremely ill, and patient deaths that occur in our clinical trials could negatively impact our business even if they are not shown to be related to our product candidates.

We are developing MPC-150-IM, which will focus on Class IV CHF, MSC-100-IV, which will focus on steroid-refractory aGVHD and MPC-CBE, which will focus on bone marrow transplants after high dose chemotherapy. These patients who receive our product candidates are very ill due to their underlying diseases.

Generally, patients remain at high risk following their treatment with our product candidates and may more easily acquire infections or other common complications during the treatment period, which can be serious and life threatening. As a result, it is likely that we will observe severe adverse outcomes during our Phase 3 trial for these product candidates, including patient death. If a significant number of study subject deaths were to occur, regardless of whether such deaths are attributable to our product candidates, our ability to obtain regulatory approval for the applicable product candidate may be adversely impacted and our business could be materially harmed.

The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming, and unpredictable. If we or our collaborators are unable to obtain timely regulatory approval for our product candidates, our business may be substantially harmed.

The regulatory approval process is expensive and the time and resources required to obtain approval from the FDA or other regulatory authorities in other jurisdictions to sell any product candidate is uncertain and approval may take years. Whether regulatory approval will be granted is unpredictable and depends upon numerous factors, including the discretion of the regulatory authorities. For example, governing legislation, approval policies, regulations, regulatory policies, or the type and amount of preclinical and clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It is possible that none of our existing or future product candidates will ever obtain regulatory approval, even if we expend substantial time and resources seeking such approval.

Further, regulatory requirements governing stem cell therapy products in particular have changed frequently and may continue to change in the future. For example, in November 2014, Japan’s parliament enacted new legislation to promote the safe and accelerated development of treatments using stem cells. The new Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, or PMD Act, establishes a framework for expedited approval in Japan for regenerative medical products. As this is a new regulation, it is not clear yet what impact it will have on the operation of our business. Any regulatory review committees and advisory groups and any contemplated new guidelines may lengthen the regulatory review process, require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions. As we advance our product candidates, we will be required to consult with these regulatory and advisory groups, and comply with applicable guidelines. If we fail to do so, we may be required to delay or

 

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discontinue development of our product candidates. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a product candidate to market could decrease our ability to generate sufficient revenue to maintain our business.

Our product candidates could fail to receive regulatory approval for many reasons, including the following:

 

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we may be unable to successfully complete our ongoing and future clinical trials of product candidates;

 

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we may be unable to demonstrate to the satisfaction of the FDA or other regulatory authorities that a product candidate is safe, pure, and potent for any or all of a product candidate’s proposed indications;

 

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we may be unable to demonstrate that a product candidate’s benefits outweigh the risk associated with the product candidate;

 

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the FDA or other regulatory authorities may disagree with the design or implementation of our clinical trials;

 

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the results of clinical trials may not meet the level of statistical significance required by the FDA or other regulatory authorities for approval;

 

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the FDA or other regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

 

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a decision by the FDA, other regulatory authorities or us to suspend or terminate a clinical trial at any time;

 

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the data collected from clinical trials of our product candidates may be inconclusive or may not be sufficient to support the submission of a biologics license application, or BLA, or other submission or to obtain regulatory approval in the United States or elsewhere;

 

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the inability to obtain sufficient quantities of the product candidates for use in clinical trials;

 

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our third party manufacturers of supplies needed for manufacturing product candidates may fail to satisfy FDA or other regulatory requirements and may not pass inspections that may be required by FDA or other regulatory authorities;

 

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the failure to comply with applicable regulatory requirements following approval of any of our product candidates may result in the refusal by the FDA or similar foreign regulatory agency to approve a pending BLA or supplement to a BLA submitted by us for other indications or new product candidates; and

 

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the approval policies or regulations of the FDA or other regulatory authorities outside of the United States may significantly change in a manner rendering our clinical data insufficient for approval.

We or our collaborators may gain regulatory approval for any of our product candidates in some but not all of the territories available and any future approvals may be for some but not all of the target indications, limiting their commercial potential. Regulatory requirements and timing of product approvals vary from country to country and some jurisdictions may require additional testing beyond what is required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other countries or by the FDA. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.

Even if we obtain regulatory approval for a product candidate, our products will be subject to ongoing regulatory scrutiny.

Any of our product candidates that are approved in the United States will continue to be subject to ongoing regulatory requirements relating to the quality, identity, strength, purity, safety, efficacy, testing, manufacturing, marketing, advertising, promotion, distribution, sale, storage, packaging, pricing, import or export, record-keeping and submission of safety and other post-market information for all approved product candidates, including both federal and state requirements in the United States. In particular, as a condition of approval of a

 

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BLA, the FDA may require a REMS, to ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. Moreover, regulatory approval may require substantial post-approval (Phase 4) testing and surveillance to monitor the drug’s safety or efficacy. Delays in the REMS approval process could result in delays in the BLA approval process. In addition, as part of the REMS, the FDA could require significant restrictions, such as restrictions on the prescription, distribution and patient use of the product, which could significantly impact our ability to effectively commercialize our product candidates, and dramatically reduce their market potential thereby adversely impacting our business, results of operations and financial condition. Post-approval study requirements could add additional burdens, and failure to timely complete such studies, or adverse findings from those studies, could adversely affect our ability to continue marketing the product.

Any failure to comply with ongoing regulatory requirements, as well as post-approval discovery of previously unknown problems, including adverse events of unanticipated severity or frequency, or with manufacturing operations or processes, may significantly and adversely affect our ability to generate revenue from our product candidates, and may result in, among other things:

 

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restrictions on the marketing or manufacturing of the product candidates, withdrawal of the product candidates from the market, or voluntary or mandatory product recalls;

 

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costly regulatory inspections;

 

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fines, warning letters, or holds on clinical trials;

 

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refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our collaborators, or suspension or revocation of BLAs;

 

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product seizure or detention, or refusal to permit the import or export of products; and

 

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injunctions or the imposition of civil or criminal penalties by FDA or other regulatory bodies.

If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our business and our operating results will be adversely affected.

The FDA’s policies, or that of the applicable regulatory bodies in other jurisdictions, may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we or our collaborators are not able to maintain regulatory compliance, are slow or unable adopt new requirements or policies, or effect changes to existing requirements, we or our collaborators may no longer be able to lawfully market our product, and we may not achieve or sustain profitability, which would adversely affect our business.

Ethical and other concerns surrounding the use of embryonic stem cell-based therapy may negatively affect regulatory approval or public perception of our non-embryonic stem cell product candidates, which could reduce demand for our products or depress our share price.

The use of embryonic stem cells, or ESCs, for research and therapy has been the subject of considerable public debate, with many people voicing ethical, legal and social concerns related to their collection and use. Our cells are not ESCs, which have been the predominant focus of this public debate and concern in the United States and elsewhere. However, the distinction between ESCs and non-ESCs, such as our MLCs, is frequently misunderstood by the public. Negative public attitudes toward stem cell therapy could also result in greater governmental regulation of stem cell therapies, which could harm our business. The use of these cells could give rise to ethical and social commentary adverse to us, which could harm the market demand for new products and depress the price of our ordinary shares. Ongoing lack of understanding of the difference between ESCs and non-ESCs could negatively impact the public’s perception of our company and product candidates and could negatively impact us.

 

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Additional government-imposed restrictions on, or concerns regarding possible government regulation of, the use of stem cells in research, development and commercialization could also cause an adverse effect on us by harming our ability to establish important partnerships or collaborations, delaying or preventing the development of certain product candidates, and causing a decrease in the price of our ordinary shares or by otherwise making it more difficult for us to raise additional capital. For example, concerns regarding such possible regulation could impact our ability to attract collaborators and investors. Also, existing and potential government regulation of stem cells may lead researchers to leave the field of stem cell research altogether in order to assure that their careers will not be impeded by restrictions on their work. This may make it difficult for us to find and retain qualified scientific personnel.

Fast track designation by the FDA may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in the United States.

If a drug is intended for the treatment of a serious or life-threatening condition or disease and the applicable nonclinical or clinical data demonstrate the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure that the FDA would decide to grant it. We may in the future seek fast track designation for our product candidates as appropriate in the United States. For any product candidate that receives fast track designation, we may not experience a faster development, review or approval process compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

Orphan drug designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed.

A product candidate that receives orphan drug designation can benefit from potential commercial benefits following approval. Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is intended to treat a rare disease or condition, defined as affecting a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the European Union, or EU, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 10,000 persons in the EU. Currently, this designation provides market exclusivity in the U.S. and the European Union for seven years and ten years, respectively, if a product is the first such product approved for such orphan indication. This market exclusivity does not, however, pertain to indications other than those for which the drug was specifically designated in the approval, nor does it prevent other types of drugs from receiving orphan designations or approvals in these same indications. Further, even after an orphan drug is approved, the FDA can subsequently approve a drug with similar chemical structure for the same condition if the FDA concludes that the new drug is clinically superior to the orphan product or a market shortage occurs. In the EU, orphan exclusivity may be reduced to six years if the drug no longer satisfies the original designation criteria or can be lost altogether if the marketing authorization holder consents to a second orphan drug application or cannot supply enough drug, or when a second applicant demonstrates its drug is “clinically superior” to the original orphan drug.

Our MSC-100-IV product candidate has received orphan drug designation for the treatment of aGVHD by the FDA. If we seek orphan drug designations for this or other product candidates in other indications or in other jurisdictions, such as for MSC-100-IV in the EU, we may fail to receive such orphan drug designations and, even if we succeed, such orphan drug designations may fail to result in or maintain orphan drug exclusivity upon approval, which would harm our competitive position.

 

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Breakthrough therapy designation by the FDA may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in the United States.

We have in the past and may in the future apply for breakthrough therapy designation for our product candidates, as appropriate, in the United States. A breakthrough therapy is defined as a product that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and for which preliminary clinical evidence indicates substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs and biologics that have been designated as breakthrough therapies, interaction and communication between the FDA and the applicant can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Products designated as breakthrough therapies by the FDA may, in some cases, also be eligible for accelerated approval.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our products or product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree. In any event, the receipt of a breakthrough therapy designation for a product or product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures and, in any event, does not assure ultimate approval by the FDA. We have in the past been denied breakthrough designation for certain of our product candidates. In addition, even if one or more of our products or product candidates does qualify as a breakthrough therapy, the FDA may later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

We may face competition from biosimilars due to changes in the regulatory environment.

We may face competition from biosimilars due to the changing regulatory environment. In the United States, the Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products that are demonstrated to be “highly similar,” or biosimilar, to or “interchangeable” with an FDA-approved innovator (original) biological product. This new pathway could allow competitors to reference data from innovator biological products already approved after 12 years from the time of approval. In his proposed budget for fiscal years 2014 and 2015, President Obama proposed to cut this 12-year period of exclusivity down to seven years. The President has also proposed to prohibit additional periods of exclusivity due to minor changes in product formulations, a practice often referred to as “evergreening.” In Europe, the European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In Europe, a competitor may reference data from biological products already approved, but will not be able to get on the market until ten years after the time of approval. This 10-year period will be extended to 11 years if, during the first eight of those 10 years, the marketing authorization holder obtains an approval for one or more new therapeutic indications that bring significant clinical benefits compared with existing therapies. In addition, companies may be developing biosimilars in other countries that could compete with our products. If competitors are able to obtain marketing approval for biosimilars referencing our products, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

Risks Related to Our Strategic Alliances

We are substantially dependent on the expertise of Teva and JCR to develop and commercialize our product candidates in certain indications. If we fail to maintain our current strategic relationships with Teva and JCR, our business, commercialization prospects and financial condition may be materially adversely affected.

We have entered into agreements with Cephalon, Inc. (a wholly owned subsidiary of Teva), or Cephalon, and JCR under which Teva and JCR are responsible for certain development and commercialization activities related to our product candidates. Teva is responsible for Phase 3 trials, and for the commercialization (excluding manufacturing) of certain of our stem cell product candidates in specified indications, namely in the

 

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cardiovascular, central nervous system and bone marrow transplant fields. Currently, we are collaborating with Teva, and Teva has commenced a Phase 3 trial for our MPC-150-IM product candidate for CHF. JCR is responsible for the development and commercialization of JR-031 for the treatment of aGVHD in the Japanese market. The prospects for these product candidates to be successfully developed and commercialized depend on the expertise, development and commercial skills, and financial strength of Teva and JCR.

Our collaborations with Teva or JCR may not be successful, and we may not realize the expected benefits from such collaborations, due to a number of important factors, including but not limited to the following:

 

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Teva or JCR may terminate their agreement with us as described below prior to completing development or commercialization of our product candidates, in whole or in part, adversely impacting our potential approval and revenue from licensed products;

 

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the timing and amount of any payments we may receive under these agreements will depend on, among other things, the efforts, allocation of resources, and successful commercialization of the relevant product candidates by Teva or JCR, as applicable, under our agreements;

 

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the timing and amounts of expense reimbursement that we may receive are uncertain; or

 

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Teva or JCR may change the focus of their development or commercialization efforts or pursue or emphasize higher-priority programs.

In particular, with the exception of the cardiovascular field, in which Teva is obligated to conduct and fund the Phase 3 clinical trial in CHF at least through the first interim analysis, Teva has the right to terminate their agreement with us upon advance notice to us. JCR has the right to terminate their agreement with us upon advance notice to us.

A failure by Teva or JCR to successfully develop our product candidates which are covered by the collaboration, or commercialize such, or the termination of our agreement with Teva or JCR, as applicable, may have a material adverse effect on our business, results of operations and financial condition.

We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates in a timely and cost-effective manner or at all, and our business could be substantially harmed.

We have relied upon and plan to continue to rely upon third-party entities, including CROs, academic institutions, hospitals and other third-party collaborators, to monitor, support, conduct and/or oversee preclinical and clinical studies of our current and future product candidates. We rely on these parties for execution of our nonclinical and clinical studies, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.

If any of our relationships with these third-parties terminate, we may not be able to enter into arrangements with alternative parties or do so on commercially reasonable terms. In addition, these parties are not our employees, and except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our on-going nonclinical and clinical programs. If third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Third parties may also generate higher costs than anticipated. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

Switching or adding additional third parties involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result,

 

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delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with these third parties, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

Our existing product development and/or commercialization arrangements, and any that we may enter into in the future, may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.

We are a party to, and continue to seek additional, collaboration arrangements with other biopharmaceutical companies for the development and/or commercialization of our current and future product candidates. We may enter into new arrangements on a selective basis depending on the merits of retaining certain development and commercialization rights for ourselves as compared to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate, both in the United States and internationally. To the extent that we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to negotiate, document and implement, and we cannot guarantee that we can successfully maintain such relationships or that the terms of such arrangements will be favorable to us. If we fail to establish and implement collaboration or other alternative arrangements, the value of our business and operating results will be adversely affected.

We may not be successful in our efforts to establish, implement and maintain collaborations or other alternative arrangements if we choose to enter into such arrangements. The terms of any collaboration or other arrangements that we may establish may not be favorable to us. The management of collaborations may take significant time and resources that distract our management from other matters.

Our ability to successfully collaborate with any future collaborators may be impaired by multiple factors including:

 

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a collaborator may shift its priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;

 

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a collaborator may cease development in therapeutic areas which are the subject of our strategic alliances;

 

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a collaborator may change the success criteria for a particular program or product candidate thereby delaying or ceasing development of such program or candidate;

 

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a significant delay in initiation of certain development activities by a collaborator will also delay payments tied to such activities, thereby impacting our ability to fund our own activities;

 

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a collaborator could develop a product that competes, either directly or indirectly, with our current or future products, if any;

 

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a collaborator with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;

 

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a collaborator with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

 

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a collaborator may exercise its rights under the agreement to terminate our collaboration;

 

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a dispute may arise between us and a collaborator concerning the research or development of a product candidate or commercialization of a product resulting in a delay in milestones, royalty payments or termination of a program and possibly resulting in costly litigation or arbitration which may divert management attention and resources;

 

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a collaborator may not adequately protect or enforce the intellectual property rights associated with a product or product candidate; and

 

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•

a collaborator may use our proprietary information or intellectual property in such a way as to invite litigation from a third party.

Any such activities by our current or future collaborators could adversely affect us financially and could harm our business reputation.

Risks Related to Our Manufacturing and Supply Chain

We have no experience manufacturing our product candidates at a commercial scale and we are in the process of establishing a new manufacturing facility and processes for clinical supply for our MSC product candidates. We may not be able to manufacture our product candidates in quantities sufficient for development and commercialization if our product candidates are approved, or for any future commercial demand for our product candidates.

We have manufactured clinical quantities of our MPC product candidates in our manufacturing facilities, owned by Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., collectively referred to as Lonza. With respect to MSCs, successful clinical production of MSCs was established prior to our acquisition of the MSC assets. We are now establishing MSC production in a new facility in Singapore. We do not have any direct experience in manufacturing commercial quantities of any of our product candidates. The production of any biopharmaceutical, including stem cells, involves complex processes and protocols. We cannot provide assurance that such production efforts will enable us to manufacture our product candidates in the quantities and with the quality needed for clinical trials and any resulting commercialization. If we are unable to do so, our clinical trials and commercialization efforts, if any, may not proceed in a timely fashion and our business will be adversely affected. If any of our product candidates are approved for commercialization and marketing, we may be required to manufacture the product in large quantities to meet demand. Producing product in commercial quantities requires developing and adhering to complex manufacturing processes that are different from the manufacture of a product in smaller quantities for clinical trials, including adherence to additional and more demanding regulatory standards. Although we believe that we have developed processes and protocols that will enable us to consistently manufacture commercial-scale quantities of product, we cannot provide assurance that such processes and protocols will enable us to manufacture our product candidates in quantities that may be required for commercialization of the product with yields and at costs that will be commercially attractive. If we are unable to establish or maintain commercial manufacture of the product or are unable to do so at costs that we currently anticipate, our business will be adversely affected.

Further, we are currently finalizing the development of 3-dimensional, or 3D, bioreactor based production for MLCs, the goal of which is to allow us to produce our products at commercial scale. There is no guarantee that we will successfully complete this process, due to multiple factors, including the failure to produce sufficient quantities and the inability to produce cells that are equivalent in physical and therapeutic properties as compared to the products produced using our current two-dimensional, or 2D, manufacturing processes. In the event our transition to 3D manufacturing is unsuccessful, we may not be able to produce our products in a cost-efficient manner and our business may be adversely affected.

We rely on Lonza as our sole supplier and manufacturer of certain of our product candidates. Our business could be harmed if Lonza fails to provide us with sufficient quantities of these product candidates or fails to do so at acceptable quality levels or prices.

We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture our MPC product candidates for use in the conduct of our clinical trials, and we currently lack the resources and the capability to manufacture any of our product candidates on a clinical or commercial scale. As a result, we currently depend on Lonza to manufacture our MPC product candidates. Relying on Lonza as our sole source to manufacture our MPC product candidates entails risks, and Lonza may:

 

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cease or reduce production or deliveries, raise prices or renegotiate terms;

 

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be unable to meet any product specifications and quality requirements consistently;

 

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delay or inability to procure or expand sufficient manufacturing capacity, which may harm our reputation or frustrate our customers;

 

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not have the capacity sufficient to support the scale-up of manufacturing for our product candidates;

 

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have manufacturing and product quality issues related to scale-up of manufacturing;

 

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experience costs and validation of new equipment facilities requirement for scale-up that it will pass on to us;

 

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fail to comply with cGMP and similar foreign standards;

 

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lose its manufacturing facility in Singapore, stored inventory or laboratory facilities through fire or other causes, or other loss of materials necessary to manufacture our product candidates;

 

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experience disruptions to its operations by conditions unrelated to our business or operations, including the bankruptcy or interruptions of its suppliers;

 

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experience carrier disruptions or increased costs that it will pass on to us;

 

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failure to secure adequate supplies of essential ingredients in our manufacturing process;

 

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experience failure of third parties involved in the transportation, storage or distribution of our products, including the failure to deliver supplies it uses for the manufacture of our product candidates under specified storage conditions and in a timely manner; and

 

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appropriate or misuse our trade secrets and other proprietary information.

Any of these events could lead to delays in the development of our product candidates, including delays in our clinical trials, or failure to obtain regulatory approval for our product candidates, or it could impact our ability to successfully commercialize our current product candidates or any future products. Some of these events could be the basis for FDA or other regulatory action, including injunction, recall, seizure or total or partial suspension of production.

In addition, the lead time needed to establish a relationship with a new manufacturer can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new manufacturer. We are in the process of transferring our manufacturing from Lonza’s U.S. facility to Lonza’s Singapore facility and expanding our manufacturing collaborations in order to meet future demand and to provide back-up manufacturing options, which also involves risk and requires significant time and resources. Our future collaborators may need to expand their facilities or alter the facilities to meet future demand and changes in regulations. These activities may lead to delays, interruptions to supply, or may prove to be more costly than anticipated. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and financial condition.

We may not be able to manufacture or commercialize our product candidates in a profitable manner under our relationship with Teva or otherwise.

We intend to implement a business model under which we control the manufacture and supply of our product candidates through our product suppliers, including Lonza. For example, under our collaboration with Teva, we are obligated to supply our product candidates subject to that collaboration at our expense. In return, we are paid a transfer price equal to an escalating double-digit percentage of Teva’s net sales price for our product candidates. We and the suppliers of our product candidates, including Lonza, have no experience manufacturing our product candidates at commercial scale. Accordingly, there can be no assurance as to whether we and our suppliers will be able to scale-up the manufacturing processes and implement technological improvements in a manner that will allow the manufacture of our product candidates in a cost effective manner. Our collaborators’ inability to sell our product candidates at a price that exceeds our cost of manufacture by an amount that is profitable for us, will have a material adverse result on the results of our operations and our financial condition.

Our or our collaborators’ ability to identify, test and verify new donor tissue in order to create new master cell banks involves many risks.

The initial stage of manufacturing involves obtaining MLC-containing bone marrow from donors, for which we currently rely on Lonza. MLCs are isolated from each donor’s bone marrow, and expanded to create a master cell bank. Each individual master cell bank comes from a single donor. A single master cell bank can source

 

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many production runs, which in turn can produce up to thousands of doses of a given product, depending on the dose level. The process of identifying new donor tissue, testing and verifying its validity in order to create new master cell banks and validating such cell bank with the FDA and other regulatory agencies is time consuming, costly and prone to the many risks involved with creating living cell products. There could be consistency or quality control issues with any new master cell bank. Although we believe we and our collaborators have the necessary know-how and processes to enable us to create master cell banks with consistent quality and within the timeframe necessary to meet projected demand and we have begun doing so, we cannot be certain that we or our collaborators will be able to successfully do so, and any failure or delays in creating new master cell banks will have a material adverse impact on our business, results of operations, financial conditions and growth prospects and could result in our inability to continue operations.

We and our collaborators depend on a limited number of suppliers for our product candidates’ materials, equipment or supplies and components required to manufacture our product candidates. The loss of these suppliers, or their failure to provide quality supplies on a timely basis, could cause delays in our current and future capacity and adversely affect our business.

We and our collaborators depend on a limited number of suppliers for the materials, equipment and components required to manufacture our product candidates and the product candidates themselves. We rely exclusively on Lonza to supply certain of our product candidates. In addition, we rely on third parties to provide various “devices” or “carriers” for some of our programs (e.g., the catheter for use with MPC-150-IC, the collagen sponge used in spinal fusion, and the hyaluronic acid used for disc repair). The main consumable used in our manufacturing process is our media, which currently is sourced from fetal bovine serum, or FBS. This material comes from limited sources, and as a result is expensive. As a result, we or our collaborators may not be able to obtain sufficient quantities of our product candidates or other critical materials equipment and components in the future, at affordable prices or at all. A delay or interruption by our suppliers may also harm our business, and operating results. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we or our collaborators may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our and our collaborators’ dependence on single-source suppliers exposes us to numerous risks, including the following:

 

•

our or our collaborators’ suppliers may cease or reduce production or deliveries, raise prices or renegotiate terms;

 

•

we or our collaborators may be unable to locate suitable replacement suppliers on acceptable terms or on a timely basis, or at all; and

 

•

delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors for future needs.

We and our collaborators and Lonza are subject to significant regulation with respect to manufacturing our product candidates. The Lonza manufacturing facilities on which we rely may not continue to meet regulatory requirements or may not be able to meet supply demands.

All entities involved in the preparation of therapeutics for clinical studies or commercial sale, including our existing manufacturers, including Lonza, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical studies must be manufactured in accordance with current Good Manufacturing Practice, current Good Laboratory Practice, and cGCP and other international regulatory requirements. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale as well as the conduct of laboratory and clinical processes and procedures related thereto. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our product candidates.

 

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We, our collaborators, or suppliers must supply all necessary documentation in support of a BLA on a timely basis and must adhere to current Good Laboratory Practice and current Good Manufacturing Practice regulations enforced by the FDA and other regulatory agencies through their facilities inspection program. Lonza and other suppliers have never produced a commercially approved cellular therapeutic product and therefore have not obtained the requisite regulatory authority approvals to do so.

Before we can begin commercial manufacture of our products for sale in the United States, we must obtain FDA regulatory approval for the product, in addition to the approval of the processes and quality systems associated with the manufacturing of such product, which requires a successful FDA inspection of the facility handling the manufacturing of our product, including Lonza’s manufacturing facilities. The novel nature of our product candidates creates significant challenges in regards to manufacturing. For example, the U.S. federal and state governments and other jurisdictions impose restrictions on the acquisition and use of tissue, including those incorporated in federal Good Tissue Practice regulations. We may not be able to identify or develop sources for the cells necessary for our product candidates that comply with these laws and regulations. Further, we may be required to conduct additional clinical trials using 3D manufacturing processes before we receive regulatory approval.

In addition, the regulatory authorities may, at any time before or after product approval, audit or inspect a manufacturing facility involved with the preparation of our product candidates or raw materials or the associated quality systems for compliance with the regulations applicable to the activities being conducted. Although we oversee each contract manufacturer involved in the production of our product candidates, we cannot control the manufacturing process of, and are dependent on, Lonza for compliance with the regulatory requirements. If Lonza is unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect our business, results of operations and financial condition. If Lonza fails to maintain regulatory compliance, the FDA or other applicable regulatory authority can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new drug product or biologic product, withdrawal of an approval, or suspension of production. As a result, our business, financial condition, and results of operations may be materially harmed.

We will rely on third parties to perform many necessary services for the commercialization of our product candidates, including services related to the distribution, storage and transportation of our products.

We will rely upon third parties for certain storage, distribution and other logistical services. In accordance with certain laws, regulations and specifications, our product candidates must be stored and transported at low temperatures within a certain range. If these environmental conditions deviate, our product candidates’ remaining shelf-lives could be impaired or their efficacy and safety could become adversely affected, making them no longer suitable for use. If any of the third parties that we intend to rely upon in our storage, distribution and other logistical services process fail to comply with applicable laws and regulations, fail to meet expected deadlines, or otherwise do not carry out their contractual duties to us, or encounter physical damage or natural disaster at their facilities, our ability to deliver product to meet commercial demand may be significantly impaired.

Product recalls or inventory losses caused by unforeseen events may adversely affect our operating results and financial condition.

Our product candidates are manufactured, stored and distributed using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as strict company and government standards for the manufacture, storage and distribution of our product candidates, subjects us to risks. For example, during the manufacturing process we have from time to time experienced several different types of issues that have led to a rejection of various batches. Historically, the most common reasons for batch rejections include major process deviations during the production of a specific batch and failure of manufactured product to meet one or more specifications for cell count, viability and appearance. While product candidate batches released for the use in clinical trials or for

 

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commercialization undergo sample testing, some latent defects may only be identified following product release. In addition, process deviations or unanticipated effects of approved process changes may result in these product candidates not complying with stability requirements or specifications. The occurrence or suspected occurrence of production and distribution difficulties can lead to lost inventories, and in some cases product recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays, substantial expense, lost sales and delays of new product launches. In the event our production efforts require a recall or result in an inventory loss, our operating results and financial condition may be adversely affected.

Risks Related to Commercialization of Our Product Candidates

Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients and healthcare payors.

Even when product development is successful and regulatory approval has been obtained, our ability to generate significant revenue depends on the acceptance of our products by physicians, payors and patients. Many potential market participants have limited knowledge of, or experience with, stem cell-based products, so gaining market acceptance and overcoming any safety or efficacy concerns may be more challenging than for a more traditional therapies. Our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful. Such efforts to educate the marketplace may require more resources than are required by the conventional therapies marketed by our competitors. We cannot assure you that our products will achieve the expected market acceptance and revenue if and when they obtain the requisite regulatory approvals. Alternatively, even if we obtain regulatory approval, that approval may be for indications or patient populations that are not as broad as intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. The market acceptance of each of our product candidates will depend on a number of factors, including:

 

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the efficacy and safety of the product candidate, as demonstrated in clinical trials;

 

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the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any warnings that may be required on the label;

 

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acceptance by physicians and patients of the product as a safe and effective treatment;

 

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the cost, safety and efficacy of treatment in relation to alternative treatments;

 

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the continued projected growth of markets for our various indications;

 

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relative convenience and ease of administration;

 

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the prevalence and severity of adverse side effects; and

 

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the effectiveness of our, and our collaborators’, sales and marketing efforts.

Market acceptance is critical to our ability to generate significant revenue. Any product candidate, if approved and commercialized, may be accepted in only limited capacities or not at all. If any approved products are not accepted by the market to the extent that we expect, we may not be able to generate significant revenue and our business would suffer.

If, in the future, we are unable to establish our own sales, marketing and distribution capabilities or enter into licensing or collaboration agreements for these purposes, we may not be successful in independently commercializing any future products.

We have no sales and marketing infrastructure and, as a company, have limited sales, marketing or distribution experience. Commercializing our product candidates, if such product candidates obtain regulatory approval, would require significant sales, distribution and marketing capabilities. Where and when appropriate, we may elect to utilize contract sales forces or distribution collaborators to assist in the commercialization of our product candidates. If we enter into arrangements with third parties to perform sales, marketing and distribution

 

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services for our product candidates, the resulting revenue or the profitability from this revenue to us may be lower than if we had sold, marketed and distributed that product ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute any future products or may be unable to do so on terms that are favorable to us. We may have little control over such third parties, and any of these third parties may fail to devote the necessary resources and attention to sell, market and distribute our current or any future products effectively.

To the extent we are unable to engage third parties to assist us with these functions, we will have to invest significant amounts of financial and management resources, some of which will need to be committed prior to any confirmation that any of our proprietary product candidates will be approved. For any future products for which we decide to perform sales, marketing and distribution functions ourselves, we could face a number of additional risks, including:

 

•

our inability to recruit and retain adequate numbers of effective sales and marketing personnel or to develop alternative sales channels;

 

•

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products;

 

•

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more diversified product lines; and

 

•

unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing organization.

We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully, than we do.

The biopharmaceutical industry is highly competitive and subject to rapid change. The industry continues to expand and evolve as an increasing number of competitors and potential competitors enter the market. Examples of potential competitors for our Tier 1 products include, but are not limited to, Novartis Pharmaceuticals and Servier Laboratories for CHF; Johnson & Johnson, Pfizer, Inc. and ISTO Technologies for CDBLP; and Amgen Inc., Pfizer, Inc. and Johnson & Johnson for aGVHD. Many of our competitors, potentially including the aforementioned, have significantly greater development, financial, manufacturing, marketing, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and in manufacturing pharmaceutical products. Recent and potential future merger and acquisition activity in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds that could make our product candidates obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing our product candidates or competitors to our product candidates before we do. Specialized, smaller or early-stage companies may also prove to be significant competitors, particularly those with a focus and expertise in the stem cell industry and/or those with collaboration arrangements and other third party payors. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. If we are not able to compete effectively against potential competitors, our business will not grow and our financial condition and results of operations will suffer.

Our marketed products may be used by physicians for indications that are not approved by the FDA. If the FDA finds that we marketed our products in a manner that promoted off-label use, we may be subject to civil or criminal penalties.

Under the Federal Food, Drug and Cosmetic Act, or FDCA, and other laws, if any of our product candidates are approved by the FDA, we would be prohibited from promoting our products for off-label uses. This means, for example, that we would not be able to make claims about the use of our marketed products outside of their

 

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approved indications, and we would not be able to proactively discuss or provide information on off-label uses of such products, with very specific and limited exceptions. The FDA does not, however, restrict physicians from prescribing products for off-label uses in the practice of medicine. Should the FDA determine that our activities constituted the promotion of off-label use, the FDA could bring action to prevent us from distributing those products for the off-label use and could impose fines and penalties on us and our executives. In addition, failure to follow FDA rules and guidelines relating to promotion and advertising can result in, among other things, the FDA’s refusal to approve a product, the suspension or withdrawal of an approved product from the market, product recalls, fines, disgorgement of money, operating restrictions, injunctions or criminal prosecutions.

If we or our collaborators fail to obtain and sustain an adequate level of reimbursement for our products by third-party payors, sales and profitability would be adversely affected.

Our and our collaborators’ ability to commercialize any products successfully will depend, in part, on the extent to which coverage and reimbursement for our products and related treatments will be available from government healthcare programs, private health insurers, managed care plans, and other organizations. Additionally, even if there is a commercially viable market, if the level of third-party reimbursement is below our expectations, our revenue and profitability could be materially and adversely affected.

Third-party payors, such as government programs, including Medicare in the United States, or private healthcare insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for medical products and services, and many third-party payors limit coverage of or reimbursement for newly approved healthcare products. Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors, including the third-party payor’s determination that use of a product is:

 

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a covered benefit under its health plan;

 

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safe, effective and medically necessary;

 

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appropriate for the specific patient;

 

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cost-effective; and

 

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neither experimental nor investigational.

A current trend in the U.S. healthcare industry as well as in other countries around the world is toward cost containment. Large public and private payors, managed care organizations, group purchasing organizations and similar organizations are exerting increasing influence on decisions regarding the use of, and reimbursement levels for, particular treatments. In particular, third-party payors may limit the covered indications. Cost-control initiatives could decrease the price we might establish for any product, which could result in product revenue and profitability being lower than anticipated.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or other regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution expenses. Interim reimbursement levels for new drugs, if applicable, may also be insufficient to cover our and any collaborator’s costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Furthermore, reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis. Our existing or future collaborators, if any, may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals which could adversely affect our revenues and profits. In many countries, products

 

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cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect our sales and profitability. In the event that countries impose prices which are not sufficient to allow us or our collaborators to generate a profit, our collaborators may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect sales and profitability.

Due to the novel nature of our stem cell therapy and the potential for our product candidates to offer therapeutic benefit in a single administration, we face uncertainty related to pricing and reimbursement for these product candidates.

Our target patient populations may be relatively small, and as a result, the pricing and reimbursement of our product candidates, if approved, must be adequate to support commercial infrastructure. If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and sell our product candidates will be adversely affected. The manner and level at which reimbursement is provided for services related to our product candidates (e.g., for administration of our product to patients) is also important. Inadequate reimbursement for such services may lead to physician resistance and adversely affect our ability to market or sell our products.

Price controls may be imposed in foreign markets, which may adversely affect our future profitability.

In some countries, particularly EU member states, Japan, Australia and Canada, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, revenues or profitability could be adversely affected.

If the market opportunities for our product candidates are smaller than we believe they are, our revenues may be adversely affected and our business may suffer. Because the target patient populations of certain of our product candidates are small, we must be able to successfully identify patients and achieve a significant market share to maintain profitability and growth.

Certain of our research and product development focuses on treatments for small patient populations, including orphan or niche markets. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are based on estimates. These estimates may prove to be incorrect and new studies may change the estimated incidence or prevalence of these diseases. The number of patients in the United States, Europe and elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business.

 

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We are exposed to risks related to our international operations, and failure to manage these risks may adversely affect our operating results and financial condition.

We and our subsidiaries operate out of Australia, the United States, Singapore and Switzerland, and we have a collaborator, JCR, with rights to develop and distribute products based on our MSC technology in Japan. Our primary manufacturing collaborator, Lonza, serves us primarily out of their facilities in Singapore, and through contractual relationships with third parties, have access to storage facilities in the U.S., Europe, Australia and Singapore. As a result, a significant portion of our operations are conducted by and/or rely on entities outside the markets in which our products are sold, and, accordingly, we import a substantial number of products into such markets. We may, therefore, be denied access to our customers or suppliers or denied the ability to ship products from any of these sites as a result of a closing of the borders of the countries in which we sell our products, or in which these operations are located, due to economic, legislative, political and military conditions in such countries. If any of our product candidates are approved for commercialization, we may enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions. We expect that we will be subject to additional risks related to entering into international business relationships, including:

 

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unexpected changes in tariffs, trade barriers and regulatory requirements;

 

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economic weakness, including inflation, or political instability in particular foreign economies and markets;

 

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logistics and regulations associated with shipping cell samples and other perishable items, including infrastructure conditions and transportation delays;

 

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potential import and export issues with the U.S. Customs and Border Protection and similar bodies in other jurisdictions;

 

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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

 

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workforce uncertainty in countries where labor unrest is more common than in the United States;

 

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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

 

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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

Use of animal-derived materials could harm our product development and commercialization efforts.

Some of the manufacturing materials and/or components that we use in, and which are critical to, implementation of our technology involve the use of animal-derived products, including FBS. Suppliers or regulatory changes may limit or restrict the availability of such materials for clinical and commercial use. While FBS is commonly used in the production of various marketed biopharmaceuticals, the suppliers of FBS that meets our strict quality standards are limited in number and region. As such, to the extent that any such suppliers or regions face an interruption in supply (for example, a new occurrence of so-called “mad cow disease”), it may lead to a restricted supply of the serum currently required for our product manufacturing processes. Any restrictions on these materials would impose a potential competitive disadvantage for our products or prevent our ability to manufacture our cell products. The FDA has issued regulations for controls over bovine material in animal feed. These regulations do not appear to affect our ability to purchase the manufacturing materials we currently use. However, the FDA may propose new regulations that could affect our operations. Our inability to develop or obtain alternative compounds would harm our product development and commercialization efforts. There are certain limitations in the supply of certain animal-derived materials, which may lead to delays in our ability to complete clinical trials or eventually to meet the anticipated market demand for our cell products.

 

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If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liability as a result of the human clinical use of our product candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

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decreased demand for our products, even if such products are approved;

 

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injury to our reputation;

 

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withdrawal of clinical trial participants;

 

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costs to defend the related litigations;

 

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a diversion of management’s time and our resources;

 

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substantial monetary awards to trial participants or patients;

 

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product recalls, withdrawals, or labeling, marketing or promotional restrictions;

 

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increased cost of liability insurance;

 

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loss of revenue;

 

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the inability to commercialize our product candidates; and

 

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a decline in our ordinary share price.

Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop. Additionally, our insurance policies have various exclusions, and we may be subject to a product liability claim for which we have no coverage or reduced coverage. Any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Risks Related to Our Intellectual Property

We may not be able to protect our proprietary technology in the marketplace.

Our success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others. We rely upon a combination of patents, trade secret protection, and confidentiality agreements to protect the intellectual property of our product candidates. Patents might not be issued or granted with respect to our patent applications that are currently pending, and issued or granted patents might later be found to be invalid or unenforceable, be interpreted in a manner that does not adequately protect our current product or any future products, or fail to otherwise provide us with any competitive advantage. As such, we do not know the degree of future protection that we will have on our proprietary products and technology, if any, and a failure to obtain adequate intellectual property protection with respect to our product candidates and proprietary technology could have a material adverse impact on our business.

 

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Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to patent technology in jurisdictions with significant or otherwise relevant commercial opportunities or activities. However, patent protection may not be available for some of the products or technology we are developing. If we must spend significant time and money protecting or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business, results of operations and financial condition may be harmed.

The patent positions of biopharmaceutical products are complex and uncertain.

The scope and extent of patent protection for our product candidates are particularly uncertain. To date, our principal product candidates have been based on specific subpopulations of known and naturally occurring adult stem cells. We anticipate that the products we develop in the future will continue to include or be based on the same or other naturally occurring stem cells or derivatives or products thereof. Although we have sought and expect to continue to seek patent protection for our product candidates, their methods of use and methods of manufacture, any or all of them may not be subject to effective patent protection. Publication of information related to our product candidates by us or others may prevent us from obtaining or enforcing patents relating to these products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, any of our issued patents may be declared invalid. If we fail to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete with our product candidates. We may also face competition from companies who develop a substantially similar product to our other product candidates that may not be covered by any of our patents.

Many companies have encountered significant problems in protecting and enforcing intellectual property rights in foreign jurisdictions. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology and pharmaceutical patents. The legal systems of certain countries do not favor the enforcement of patents and other intellectual property rights, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business. We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These products may compete with our current or future products, if any, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

 

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We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

We maintain certain of our proprietary know-how and technological advances as trade secrets, especially where we do not believe patent protection is appropriate or obtainable, including, but not exclusively, with respect to certain aspects of the manufacturing of our products. However, trade secrets are difficult to protect. We take a number of measures to protect our trade secrets including, limiting disclosure, physical security and confidentiality and non-disclosure agreements. We enter into confidentiality agreements with our employees, consultants, outside scientific collaborators, contract manufacturing partners, sponsored researchers and other advisors and third parties to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection, or failure to adequately protect our intellectual property could enable competitors to develop generic products or use our proprietary information to develop other products that compete with our products or cause additional, material adverse effects upon our business, results of operations and financial condition.

We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our licensors.

We may be forced to litigate to enforce or defend our intellectual property rights against infringement by competitors, and to protect our trade secrets against unauthorized use. In so doing, we may place our intellectual property at risk of being invalidated, unenforceable, or limited or narrowed in scope and may no longer be used to prevent the manufacture and sale of competitive product. Further, an adverse result in any litigation or other proceedings before government agencies such as the United States Patent and Trademark Office, or the USPTO, may place pending applications at risk of non-issuance. Further, interference proceedings, derivation proceedings, entitlement proceedings, ex parte reexamination, inter partes reexamination, inter partes review, post-grant review, and opposition proceedings provoked by third parties or brought by the USPTO or any foreign patent authority may be used to challenge inventorship, ownership, claim scope, or validity of our patent applications. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential and proprietary information could be compromised by disclosure during this type of litigation.

Intellectual property disputes could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and/or management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our ADSs and ordinary shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of litigation proceedings more effectively than we can because of their greater financial resources and personnel. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to conduct our clinical trials, continue our internal research programs, in-license needed technology or enter into strategic collaborations that would help us bring our product candidates to market. As a result, uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

 

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Recent patent reform legislation and court decisions could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. The USPTO has and continues to develop and implement regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act. The full effect of these changes are currently unclear as the USPTO has not yet adopted all pertinent final rules and regulations, the courts have yet to address these provisions and the applicability of the Leahy-Smith Act and new regulations on specific patents, including our patents discussed herein, have not been determined and would need to be reviewed. Accordingly, it is not yet clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. As a result, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents, all of which could have a material adverse effect on our business and financial condition.

On June 13, 2013, the U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., held that isolated DNA sequences are not patentable because they constitute a product of nature. The Supreme Court did not address stem cells in particular, and as a result, it is not yet clear what, if any, impact this recent Supreme Court decision or future decisions will have on the operation of our business.

If third parties claim that intellectual property used by us infringes upon their intellectual property, commercialization of our product candidates and our operating profits could be adversely affected.

There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biopharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights, or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against us or any third-party proprietary technologies we have licensed. Any such claims could also be expensive and time consuming to defend and divert management’s attention and resources, and could delay or prevent us from commercializing our product candidates. Our competitive position could suffer as a result. Although we have reviewed certain third-party patents and patent filings that we believe may be relevant to our product candidates, we have not conducted a freedom-to-operate search or analysis for our product candidates, and we may not be aware of patents or pending or future patent applications that, if issued, would block us from commercializing our product candidates. Thus, we cannot guarantee that our product candidates, or our commercialization thereof, do not and will not infringe any third party’s intellectual property.

If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity of our product candidates, our business may be materially harmed.

Depending on the timing, duration and specifics of FDA marketing approval of our product candidates, if any, one of the U.S. patents covering each of such approved product(s) or the use thereof may be eligible for up to five years of patent term restoration under the Hatch-Waxman Act. The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA approved product. Patent term extension also may be available in certain foreign countries upon regulatory approval of our product candidates, including by the EMA in the EU or the PMDA in Japan. Nevertheless, we may not be granted patent term extension either in the United States or in any foreign country because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than we request. In addition, if a patent we wish to extend is owned by another party and licensed to us, we may need to obtain approval and cooperation from our licensor to request the extension.

If we are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product will be shortened

 

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and our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially.

Risks Related to Our Business and Industry

If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.

We are highly dependent on members of our executive management, particularly Silviu Itescu, our Chief Executive Officer. Dr. Itescu was an early pioneer in the study and clinical development of stem cells and is globally recognized in the field of regenerative medicine. The loss of the services of Dr. Itescu or any other member of the executive management team could impede the achievement of our research, development and commercialization objectives. We do not maintain “key person” insurance for any of our executives or other employees.

Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

Our employees, principal investigators, consultants and collaboration partners may engage in misconduct or other improper activities, including noncompliance with laws and regulatory standards and requirements and insider trading.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards we have established, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of activity relating to pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation, or, given we are a listed company in Australia, and will be a listed company in the United States following the completion of this offering, breach of insider trading laws. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

We may acquire other companies or assets which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results.

We have in the past and may in the future seek to acquire businesses, products or technologies that we believe could complement or expand our product offerings, enhance our technical capabilities or otherwise offer growth opportunities. For example, we acquired Osiris in 2013, which we are still working to integrate into our business. The pursuit of potential acquisitions may divert the attention of management and cause us to incur

 

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various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies successfully, or effectively manage the combined business following the acquisition. We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

 

•

incurrence of acquisition-related costs;

 

•

diversion of management’s attention from other business concerns;

 

•

unanticipated costs or liabilities associated with the acquisition;

 

•

harm to our existing business relationships with collaborators as a result of the acquisition;

 

•

harm to our brand and reputation;

 

•

the potential loss of key employees;

 

•

use of resources that are needed in other parts of our business; and

 

•

use of substantial portions of our available cash to consummate the acquisition.

In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results arising from the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our business, results of operations and financial condition may be adversely affected.

We and our collaborators must comply with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.

We and our collaborators are subject to various federal, state and local environmental laws, rules and regulations, including those relating to the discharge of materials into the air, water and ground, the manufacture, storage, handling, use, transportation and disposal of hazardous and biological materials, and the health and safety of employees with respect to laboratory activities required for the development of products and technologies. In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources.

We work with outside scientists and their institutions in developing product candidates. These scientists may have other commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to leverage our discovery platform.

We work with scientific advisors and collaborators at academic research institutions in connection with our product development. These scientific advisors serve as our link to the specific pools of trial participants we are targeting in that these advisors may:

 

•

identify individuals as potential candidates for study;

 

•

obtain their consent to participate in our research;

 

•

perform medical examinations and gather medical histories;

 

•

conduct the initial analysis of suitability of the individuals to participate in our research based on the foregoing; and

 

•

collect data and biological samples from trial participants periodically in accordance with our study protocols.

These scientists and collaborators are not our employees, rather they serve as either independent contractors or the primary investigators under research collaboration agreements that we have with their sponsoring

 

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academic or research institution. Such scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for another entity arises, we may lose their services. It is also possible that some of our valuable proprietary knowledge may become publicly known through these scientific advisors if they breach their confidentiality agreements with us, which would cause competitive harm to our business.

If our ability to use cumulative carry forward net operating losses is or becomes subject to certain limitations or if certain tax incentive credits from which we benefit expire or no longer apply to us, our business, results of operations and financial condition may be adversely affected.

We are an Australian company subject to Australian corporate taxation. As of June 30, 2014, we had net operating losses carried forward of A$146.8 million. These losses may be available for use, once we are in a tax profitable position. These losses were incurred in different jurisdictions and can only be offset against profits earned in the relevant jurisdictions. Tax losses are able to be carried forward at their nominal amount indefinitely in Australia and in Singapore, and for up to 20 years in the U.S. as long as certain conditions are met. In order to use these tax losses, it is necessary to satisfy certain tests and, as a result, we cannot assure you that the tax losses will be available to offset profits if and when we earn them. Our carry forward net operating losses in the U.S. first start to expire in 2032. In addition, we are eligible for certain research and development tax incentive refundable credits in Australia, which credits increase our available cash flow, and we currently project to benefit from these incentives in future taxable years. There can be no assurances that we will continue to benefit from these incentives or that such tax incentive credit programs will not be revoked or modified in any way in the future. If these incentives are revoked or modified or if we are no longer eligible for such incentives, our business, results of operations and financial condition may be adversely affected.

Taxing authorities could reallocate our taxable income within our subsidiaries, which could increase our consolidated tax liability.

We conduct operations in multiple tax jurisdictions and the tax laws of those jurisdictions generally require that the transfer prices between affiliated companies in different jurisdictions be the same as those between unrelated companies dealing at arms’ length, and that such prices are supported by contemporaneous documentation. While we believe that we operate in compliance with applicable transfer pricing laws and intend to continue to do so, our transfer pricing procedures are not binding on applicable tax authorities. If tax authorities in any of these countries were to successfully challenge our transfer prices as not reflecting arms’ length transactions, they could require us to adjust our transfer prices and thereby reallocate our income to reflect these revised transfer prices, which could result in a higher tax liability to us, and possibly interest and penalties, and could adversely affect our business, results of operations and financial condition.

The pharmaceutical industry is highly regulated and pharmaceutical companies are subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act.

Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include:

 

•

the federal Anti-Kickback Statute which prohibits, among other things, the knowing and willful payment of remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by the federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients);

 

•

federal False Claims Act which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to the federal government (e.g., Medicare and Medicaid) or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government;

 

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•

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HIPAA imposes civil and criminal liability for the wrongful access and disclosure of protected health information;

 

•

the federal Physician Payments Sunshine Act, created under Section 6002 of the Patient Protection and Affordable Care Act, as amended, the ACA, requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, those physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members;

 

•

the FDCA, which, among other things, regulates the testing, development, approval, manufacture, promotion and distribution of drugs, devices and biologics. The FDCA prohibits manufacturers from selling or distributing “adulterated” or “misbranded” products. A drug product may be deemed misbranded if, among other things, (i) the product labeling is false or misleading, fails to contain requisite information or does not bear adequate directions for use; (ii) the product is manufactured at an unregistered facility; or (iii) the product lacks the requisite FDA clearance or approval;

 

•

the U.S. Foreign Corrupt Practices Act, or FCPA, which prohibits corrupt payments, gifts or transfers of value to non-U.S. officials; and

 

•

non-U.S. and U.S. state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

The federal false claims laws have been interpreted to apply to arrangements between pharmaceutical manufacturers and a variety of health care professional. Although the federal Anti-Kickback Statute has several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and prosecutors have interpreted the federal healthcare fraud statutes to attack a wide range of conduct by pharmaceutical companies. In addition, most states have statutes or regulations similar to the federal anti-kickback and federal false claims laws, which apply to items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the payor. Administrative, civil and criminal sanctions may be imposed under these federal and state laws.

Further, the ACA, among other things, amended the intent standard under the Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the ACA makes clear that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal False Claims Act. Any violations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition.

A failure to adequately protect private health information could result in severe harm to our reputation and subject us to significant liabilities, each of which could have a material adverse effect on our business.

Throughout the clinical trial process, we may obtain the private health information of our trial subjects. There are a number of state, federal and international laws protecting the privacy and security of health information and personal data. As part of the American Recovery and Reinvestment Act 2009, or ARRA, Congress amended the privacy and security provisions of HIPAA. HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans, collectively referred to as covered entities. The HIPAA amendments also impose compliance obligations and corresponding penalties for non-compliance on individuals and entities that provide

 

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services to healthcare providers and other covered entities, collectively referred to as business associates. ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement authority to state attorneys general. The amendments also create notification requirements for individuals whose health information has been inappropriately accessed or disclosed: notification requirements to federal regulators and in some cases, notification to local and national media. Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of Health and Human Services, or HHS. Most states have laws requiring notification of affected individuals and state regulators in the event of a breach of personal information, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significant data security requirements, such as encryption or mandatory contractual terms to ensure ongoing protection of personal information. Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance. The EU’s Data Protection Directive, Canada’s Personal Information Protection and Electronic Documents Act and other data protection, privacy and similar national, state/provincial and local laws may also restrict the access, use and disclosure of patient health information abroad. We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate problems caused by such breaches.

Our operations are subject to anti-corruption laws, including Australian bribery laws, the United Kingdom Bribery Act, and the FCPA and other anti-corruption laws that apply in countries where we do business.

Anti-corruption laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under these anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws or other laws including trade related laws. If we are not in compliance with these laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of these laws by respective government bodies could also have an adverse impact on our reputation, our business, results of operations and financial condition.

Risks Related to Ownership of Our ADSs, Our Trading Market and This Offering

The market price and trading volume of the ADSs may be volatile and may be affected by economic conditions beyond our control.

The market price of the ADSs may be highly volatile and subject to wide fluctuations. In addition, the trading volume of the ADSs may fluctuate and cause significant price variations to occur. If the market price of the ADSs declines significantly, you may be unable to resell your ADSs at or above the offering price, if at all. We cannot assure you that the market price of the ADSs will not fluctuate or significantly decline in the future.

Some specific factors that could negatively affect the price of the ADSs or result in fluctuations in their price and trading volume include:

 

•

results of clinical trials of our product candidates;

 

•

results of clinical trials of our competitors’ products;

 

•

regulatory actions with respect to our products or our competitors’ products;

 

•

actual or anticipated fluctuations in our quarterly operating results or those of our competitors;

 

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•

publication of research reports by securities analysts about us or our competitors in the industry;

 

•

our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;

 

•

fluctuations of exchange rates between the U.S. dollar and the Australian dollar;

 

•

additions to or departures of our key management personnel;

 

•

issuances by us of debt or equity securities;

 

•

litigation involving our company, including: shareholder litigation; investigations or audits by regulators into the operations of our company; or proceedings initiated by our competitors or clients;

 

•

strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;

 

•

the passage of legislation or other regulatory developments affecting us or our industry;

 

•

fluctuations in the valuation of companies perceived by investors to be comparable to us;

 

•

changes in trading volume of ADSs on the                     and of our ordinary shares on the ASX;

 

•

sales or perceived potential sales of the ADSs or ordinary shares by us, our directors, senior management or our shareholders in the future;

 

•

short selling or other market manipulation activities;

 

•

announcement or expectation of additional financing efforts;

 

•

terrorist acts, acts of war or periods of widespread civil unrest;

 

•

natural disasters and other calamities;

 

•

changes in market conditions for biopharmaceutical stocks; and

 

•

conditions in the U.S. or Australian financial markets or changes in general economic conditions.

An active trading market for the ADSs may not develop in the United States and the trading price for our ordinary shares may fluctuate significantly.

Our ADSs began trading on the over-the-counter market in 2005. Since trading began on this market, our ADSs have not traded on many days and the highest trading volume recorded in a single day was 24,000 ADSs. If an active public market in the United States for the ADSs does not develop after this offering, the market price and liquidity of the ADSs may be materially and adversely affected. While we have applied for the listing of the ADSs on the                     , a liquid public market in the United States for the ADSs may not develop or be sustained after this offering. The initial public offering price for the ADSs will be determined by negotiation among us and the underwriters, and the price at which the ADSs are traded after this offering may decline below the initial public offering price, which means you may experience a decrease in the value of your ADSs regardless of our operating performance or prospects. In the past, following periods of volatility in the market price of a company’s securities, shareholders often instituted securities class action litigation against that company. If we were involved in a class action suit, it could divert the attention of senior management and, if adversely determined, could have a material adverse effect on our results of operations and financial condition. Investors purchasing the ADSs in this offering will suffer immediate and substantial dilution.

The public offering price for the ADSs will be substantially higher than the net tangible book value per share of our outstanding ordinary shares immediately after this offering. If you purchase ADSs in this offering, you will incur substantial and immediate dilution in the net tangible book value of your investment. Net tangible book value per ordinary share represents the amount of total tangible assets less total liabilities, divided by the number of ordinary shares, respectively, then outstanding. To the extent that performance rights and options that are currently outstanding are exercised or converted, there will be further dilution in your investment. We may

 

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also issue additional ordinary shares, performance rights, options and other securities in the future that may result in further dilution of your ordinary shares. See “Dilution” for a calculation of the extent to which your investment will be diluted.

The dual listing of our ordinary shares and the ADSs following this offering may adversely affect the liquidity and value of the ADSs.

Following this offering and after the ADSs are listed on the             , our ordinary shares will continue to be listed on the ASX. We cannot predict the effect of this dual listing on the value of our ordinary shares and ADSs. However, the dual listing of our ordinary shares and ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the development of an active trading market for the ADSs in the United States. The price of the ADSs could also be adversely affected by trading in our ordinary shares on the ASX.

We are subject to risks associated with currency fluctuations, and changes in foreign currency exchange rates could impact our results of operations.

Historically, a substantial portion of our operating expenses has been denominated in U.S. dollars and our main currency requirements are the Singaporean dollar, U.S. dollars and Australian dollars. Approximately 45% of our cash and cash equivalents as of June 30, 2014 were denominated in U.S. dollars and 55% were denominated in Australian dollars. 12% of the Australian dollar balance is subject to forward contracts to purchase U.S. dollars at a predetermined rate in the future. After allowing for financial derivative contracts, at the year ended June 30, 2014, we held 51% of our cash and cash equivalents in U.S. dollars and 49% in Australian dollars. Because our functional currency is the Australian dollar, changes in the exchange rate between the Australian dollar and the U.S. dollar could materially impact our reported results of operations and distort period-to-period comparisons. For example, a significant portion of our research and clinical trials are undertaken outside of Australia. As such, payment will be made in various non-Australian dollar currencies, and may exceed the budgeted expenditure if there are adverse currency fluctuations against the Australian dollar.

Further, any significant change in the value of the Australian dollar may have a material adverse effect on the value of, and any dividends payable on, our ADSs in U.S. dollars. More specifically, if we decide to convert our Australian dollars into U.S. dollars for the purpose of making payments for dividends on our ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar against the Australian dollar would have a negative effect on the U.S. dollar amount available to us. To the extent that we need to convert U.S. dollars we receive from our initial public offering into Australian dollars for our operations, appreciation of the Australian dollar against the U.S. dollar would have an adverse effect on the Australian dollar amount we would receive from the conversion. Consequently, appreciation or depreciation in the value of the Australian dollar relative to the U.S. dollar would affect our financial results reported in U.S. dollar terms without giving effect to any underlying change in our business or results of operations. As a result of such foreign currency fluctuations, it could be more difficult to detect underlying trends in our business and results of operations.

Future sales of our ordinary shares or ADSs, or the perception that such sales may occur, could depress the price of our ADSs.

After the completion of this offering, we expect to have             ordinary shares outstanding, including the shares underlying the ADSs we are selling in this offering, almost all of which may be resold in the public market immediately after this offering. We, all of our directors, our chief executive officer, and our chief financial officer have each signed lock-up agreements for a period of 180 days following the date of this prospectus, subject to extension in the case of an earnings release, material news or a material event relating to us. See “Underwriting.”

The underwriters may, in their sole discretion and without notice, release all or any portion of the ordinary shares subject to lock-up agreements. As restrictions on resale end, the market price of our ADSs could drop significantly if the holders of these ordinary shares sell them or are perceived by the market as intending to sell them. These factors could also make it more difficult for us to raise additional funds through future offerings of our ordinary shares, ADSs or other securities.

 

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As a foreign private issuer, we are permitted and expect to follow certain home country corporate governance practices in lieu of certain             requirements applicable to domestic issuers and we are permitted to file less information with the Securities and Exchange Commission than a company that is not a foreign private issuer. This may afford less protection to holders of our ADSs.

As a “foreign private issuer,” as defined in Rule 405 under the Securities Exchange Act of 1933, as amended, or the Securities Act, whose ADSs will be listed on the             , we will be permitted to, and plan to, follow certain home country corporate governance practices in lieu of certain             requirements. For example, we may follow home country practice with regard to certain corporate governance requirements, such as the composition of the board of directors and quorum requirements applicable to shareholders’ meetings. This difference may result in a board that is more difficult to remove and less shareholders approvals required generally. In addition, we may follow home country practice instead of the              requirement to hold executive sessions and to obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions or private placements of securities. The above differences may result in less shareholder oversight and requisite approvals for certain acquisition or financing related decisions. Further, we may follow home country practice instead of the              requirement to obtain shareholder approval prior to the establishment of amendment of certain share option, purchase or other compensation plans. This difference may result in less shareholder oversight and requisite approvals for certain company compensation related decisions. A foreign private issuer must disclose in its annual reports filed with the Securities and Exchange Commission, or SEC and the             , the requirements with which it does not comply followed by a description of its applicable home country practice. The Australian home country practices described above may afford less protection to holders of the ADSs than that provided under the              rules.

Further, as a foreign private issuer, we are exempt from certain rules under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that impose disclosure requirements as well as procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as a company that files as a domestic issuer whose securities are registered under the Exchange Act, nor are we generally required to comply with the SEC’s Regulation FD, which restricts the selective disclosure of material non-public information. Accordingly, the information may not be disseminated in as timely a manner, or there may be less information publicly available concerning us generally than there is for a company that files as a domestic issuer.

We are an emerging growth company and our election to adopt the reduced disclosure and governance requirements applicable to emerging growth companies may make the ADSs less attractive to investors and, as a result, adversely affect the price of the ADSs and result in a less active trading market for the ADSs.

We are an “emerging growth company” as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. For example, we have elected to rely on an exemption from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act relating to internal control over financial reporting, and we will not provide such an attestation from our auditors until such an attestation is required. We have also elected to rely on an exemption that permits an emerging growth company to include only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations disclosure, and we have therefore only included two years of audited financial statements and related management’s discussion and analysis of financial condition and results of operations in this prospectus.

We may avail ourselves of these disclosure exemptions until we are no longer an emerging growth company. We cannot predict whether investors will find the ADSs less attractive because of our reliance on some or all of these exemptions. If investors find the ADSs less attractive, it may adversely impact the price of the ADSs and there may be a less active trading market for the ADSs.

 

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We will cease to be an emerging growth company upon the earliest of:

 

•

the last day of the fiscal year in which the fifth anniversary of the completion of this offering occurs;

 

•

the date on which we are deemed to be a large accelerated filer, which means, among other things, the market value of our ordinary shares held by non-affiliates exceeds US$700 million as of the end of the second quarter of such fiscal year;

 

•

the last day of the fiscal year in which we have total annual gross revenues of at least US$1 billion; and

 

•

the date on which we have issued more than US$1 billion in non-convertible debt securities in any rolling three-year period.

If we fail to establish and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.

Section 404(a) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires that, beginning with our annual report for the year ending June 30, 2016, our management assess and report annually on the effectiveness of our internal controls over financial reporting and identify any material weaknesses in our internal controls over financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act requires our independent registered public accounting firm to issue an annual report that addresses the effectiveness of our internal controls over financial reporting, we have opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to comply with SEC rules that implement Section 404(b) of the Sarbanes-Oxley Act until such time as we are no longer an emerging growth company.

Our first Section 404(a) assessment will take place beginning with our annual report for the year ending June 30, 2016. As of the date of this filing, we have not designed and implemented controls to maintain appropriate segregation of duties in our manual and computer based business processes which could have a pervasive impact over the preparation of the financial statements. Specifically, we have limited accounting personnel to enable effective segregation of duties to allow for appropriate monitoring of financial reporting matters and internal control over financial reporting. Consequently we have determined there is a material weakness in the internal control over financial reporting. This material weakness did not result in material adjustments to the financial statements, however there is a reasonable possibility that a material misstatement of the annual financial statements would not have been prevented or detected on a timely basis due to the failure to design and implement appropriate segregation of duty controls.

In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal controls over financial reporting, we will need to expend significant resources and provide significant management oversight. We have commenced the process of reviewing and improving our internal controls over financial reporting for compliance with Section 404(a) of the Sarbanes-Oxley Act. We have made efforts to improve our internal controls and accounting policies and procedures, including hiring new accounting personnel and engaging external temporary resources. Implementing any appropriate changes to our internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns. These changes may not, however, be effective in maintaining the adequacy of our internal control.

If either we are unable to conclude that we have effective internal controls over financial reporting or, at the appropriate time, our independent auditors are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal controls over financial reporting as required by Section 404(b) of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, the price of the ADSs could decline and we may be subject to litigation or regulatory enforcement actions. In addition, if we are unable to meet the requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to remain listed on                     .

 

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We will incur significant increased costs as a result of operating as a company whose ADSs are publicly traded in the United States, and our management will be required to devote substantial time to new compliance initiatives.

As a company whose ADSs will be publicly traded in the United States, we will incur significant legal, accounting, insurance and other expenses that we did not previously incur. In addition, the Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform and Consumer Protection Act and related rules implemented by the SEC and             , have imposed various requirements on public companies including requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives, and we will need to add additional personnel and build our internal compliance infrastructure. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. These laws and regulations could also make it more difficult and expensive for us to attract and retain qualified persons to serve on our board of directors, our board committees or as our senior management. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of the ADSs, fines, sanctions and other regulatory action and potentially civil litigation.

ADS holders may be subject to additional risks related to holding ADSs rather than ordinary shares.

ADS holders do not hold ordinary shares directly and, as such, are subject to, among others, the following additional risks.

 

•

As an ADS holder, we will not treat you as one of our shareholders and you will not be able to exercise shareholder rights, except through the American depositary receipt, or ADR, depositary as permitted by the deposit agreement.

 

•

Distributions on the ordinary shares represented by your ADSs will be paid to the ADR depositary, and before the ADR depositary makes a distribution to you on behalf of your ADSs, any withholding taxes that must be paid will be deducted. Additionally, if the exchange rate fluctuates during a time when the ADR depositary cannot convert the foreign currency, you may lose some or all of the value of the distribution.

 

•

We and the ADR depositary may amend or terminate the deposit agreement without the ADS holders’ consent in a manner that could prejudice ADS holders.

You must act through the ADR depositary to exercise your voting rights and, as a result, you may be unable to exercise your voting rights on a timely basis.

As a holder of ADSs (and not the ordinary shares underlying your ADSs), we will not treat you as one of our shareholders, and you will not be able to exercise shareholder rights. The ADR depositary will be the holder of the ordinary shares underlying your ADSs, and ADS holders will be able to exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the deposit agreement relating to the ADSs. There are practical limitations on the ability of ADS holders to exercise their voting rights due to the additional procedural steps involved in communicating with these holders. For example, holders of our ordinary shares will receive notice of shareholders’ meetings by mail and will be able to exercise their voting rights by either attending the shareholders meeting in person or voting by proxy. ADS holders, by comparison, will not receive notice directly from us. Instead, in accordance with the deposit agreement, we will provide notice to the ADR depositary of any such shareholders meeting and details concerning the matters to be voted upon at least 30 days in advance of the meeting date. If we so instruct, the ADR depositary will mail to holders of ADSs the notice of the meeting and a statement as to the manner in which voting instructions may be given by holders as soon as practicable after receiving notice from us of any such meeting. To exercise their voting rights, ADS holders must then instruct the ADR depositary as to voting the ordinary shares represented by their ADSs. Due to these procedural steps involving the ADR depositary, the process for exercising voting rights may take longer for ADS holders than for holders of ordinary shares. The ordinary shares represented by ADSs for which the ADR depositary fails to receive timely voting instructions will not be voted.

 

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We may be or become classified as a passive foreign investment company, which could result in adverse U.S. federal income tax consequences to U.S. holders of our ADSs or ordinary shares.

Based on our business projections and the anticipated composition of our income and assets for the current and future years, we do not expect that we will be a “passive foreign investment company,” or PFIC, for the taxable year ending June 30, 2015. However, if there is a change in the type or composition of our gross income, or our actual business results do not match our projections, it is possible that we may become a PFIC in future taxable years. We will be a PFIC for any taxable year if either: (i) 75% or more of our gross income for the taxable year is passive income (such as certain dividends, interest, rents or royalties and certain gains from the sale of shares and securities or commodities transactions, including amounts derived by reason of the temporary investment of funds raised in offerings of our ordinary shares or ADSs), or (ii) the average percentage value of our gross assets during the taxable year that produce passive income or are held for the production of passive income is at least 50% of the value of our total assets. For purposes of the PFIC asset test, passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing, debt instruments or bank deposits that is readily convertible into cash. If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC income and asset tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income. Investors should be aware that our gross income for purposes of the PFIC income test depends on the receipt of Australian research and development tax incentive credits and other revenue, and there can be no assurances that such tax incentive credit programs will not be revoked or modified, that we will continue to conduct our operations in the manner necessary to be eligible for such incentives or that we will receive other gross income that is not considered passive for purposes of the PFIC income test. The value of our assets for purposes of the PFIC asset test will generally be determined by reference to our market capitalization, which may fluctuate. The composition of our income and assets will also be affected by how, and how quickly, we spend the cash raised in this offering. Under circumstances where our gross income from activities that produce passive income significantly increases relative to our gross income from activities that produce non-passive income or where we decide not to deploy significant amounts of cash for active purposes, our risk of becoming classified as a PFIC may substantially increase. Since a separate factual determination as to whether we are or have become a PFIC must be made each year (after the close of such year), we cannot assure you that we will not be or become a PFIC in the current or any future taxable year. If we are treated as a PFIC for any taxable year, then U.S. holders generally would be subject to adverse U.S. federal income tax consequences (regardless of whether we continued to be a PFIC) unless a U.S. holder makes a “mark-to-market” election or a “Qualified Electing Fund” election. We intend to provide U.S. holders with the information necessary to make and maintain a “Qualified Electing Fund” election if we are treated as a PFIC for any taxable year. See “Taxation—Default PFIC Rules.”

We have never declared or paid dividends on our ordinary shares, and we do not anticipate paying dividends in the foreseeable future. Therefore, you must rely on price-appreciation of our ADSs for a return on your investment.

We have never declared or paid cash dividends on our ordinary shares. For the foreseeable future, we currently intend to retain all available funds and any future earnings to support our operations and to finance the growth and development of our business. Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to compliance with applicable laws and covenants under current or future credit facilities, which may restrict or limit our ability to pay dividends, and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant. We do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future. As a result, a return on your investment in our ADSs will likely only occur if our ADS price appreciates. There is no guarantee that our ADSs will appreciate in value after this offering or even maintain the price at which you purchase the ADSs. You may not realize a return on your investment in our ADSs and you may even lose your entire investment in our ADSs.

 

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You may not receive distributions on our ordinary shares represented by the ADSs or any value for such distribution if it is illegal or impractical to make them available to holders of ADSs.

While we do not anticipate paying any dividends on our ordinary shares in the foreseeable future, if such a dividend is declared, the depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of our ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to holders of ADSs. We have no obligation to take any other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have a material adverse effect on the value of your ADSs.

Our management has discretion as to the use of the net proceeds from this offering, and such use may not produce income or increase the market price of our ADSs.

We intend to use the net proceeds of this offering to among other things, continue the research and clinical development of our product candidates; seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; establish collaborations with third parties for the commercialization of our product candidates, or otherwise build and maintain a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval, and for which we have maintained commercial rights; further develop and implement our proprietary manufacturing processes and expand our manufacturing capabilities and resources; make milestone or other payments under our agreements pursuant to which have licensed or acquired rights to intellectual property and technology; and for working capital and other general corporate purposes. However, our management will have considerable discretion in the application of the net proceeds received by us. For more information, see “Use of Proceeds.” You will not have the opportunity, as part of your investment decision, to assess whether proceeds are being used appropriately. You must rely on the judgment of our management regarding the application of the net proceeds from this offering. The net proceeds may be used for corporate purposes that do not improve our efforts to maintain profitability or increase our ADS price. Moreover, the net proceeds from this offering may be placed in investments that do not produce income or that lose value.

If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the market price and trading volume of our ordinary shares and/or ADSs could decline.

The trading market for our ordinary shares and ADSs will be influenced by the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts may discontinue research on our company, to the extent such coverage currently exists, or in other cases, may never, publish research on our company. If no or too few securities or industry analysts commence coverage of our company, the trading price for our ordinary shares and ADSs would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our ordinary shares or ADSs or publish inaccurate or unfavorable research about our business, the market price of our ADSs would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our ordinary shares and/or ADSs could decrease, which might cause our price and trading volume to decline.

You may be subject to limitations on transfers of your ADSs.

Your ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deems it advisable to do so

 

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because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason.

U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of senior management and the experts named in this prospectus.

Several of our officers, directors and the experts named in this prospectus are non-residents of the United States, and a substantial portion of the assets of such persons are located outside the United States. As a result, it may be impossible to serve process on such persons in the United States or to enforce judgments obtained in U.S. courts against them based on civil liability provisions of the securities laws of the United States. Even if you are successful in bringing such an action, there is doubt as to whether Australian courts would enforce certain civil liabilities under U.S. securities laws in original actions or judgments of U.S. courts based upon these civil liability provisions. In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in Australia or elsewhere outside the U.S. An award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered and is intended to punish the defendant. The enforceability of any judgment in Australia will depend on the particular facts of the case as well as the laws and treaties in effect at the time. The United States and Australia do not currently have a treaty or statute providing for recognition and enforcement of the judgments of the other country (other than arbitration awards) in civil and commercial matters.

As a result, our public shareholders may have more difficulty in protecting their interests through actions against us, our management, our directors than would shareholders of a corporation incorporated in a jurisdiction in the United States.

Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares or ADSs.

We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Australian Corporations Act 2001, or the Corporations Act. Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting power in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares. This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ opportunity to sell their ordinary shares and may further restrict the ability of our shareholders to obtain a premium from such transactions. See “Description of Share Capital—Change of Control.”

Our Constitution and Australian laws and regulations applicable to us may adversely affect our ability to take actions that could be beneficial to our shareholders.

As an Australian company we are subject to different corporate requirements than a corporation organized under the laws of the United States. Our Constitution, as well as the Corporations Act, set forth various rights and obligations that apply to us as an Australian company and which may not apply to a U.S. corporation. These requirements may operate differently than those of many U.S. companies. You should carefully review the summary of these matters set forth under the section entitled, “Description of Share Capital” as well as our Constitution, which is included as an exhibit to this registration statement to which this prospectus forms a part, prior to investing in the ADSs.

 

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FORWARD-LOOKING STATEMENTS

This prospectus includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “could,” and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. Forward-looking statements include, but are not limited to, statements about:

 

•

the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development programs;

 

•

our ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials;

 

•

our ability to advance our manufacturing capabilities;

 

•

the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any;

 

•

the commercialization of our product candidates, if approved;

 

•

regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies;

 

•

the potential for our product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths;

 

•

the potential benefits of strategic collaboration agreements and our ability to enter into and maintain established strategic collaborations;

 

•

our ability to establish and maintain intellectual property on our product candidates and our ability to successfully defend these in cases of alleged infringement;

 

•

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

 

•

estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

 

•

our financial performance;

 

•

our use of proceeds from this offering;

 

•

developments relating to our competitors and our industry;

 

•

the pricing and reimbursement of our product candidates, if approved; and

 

•

other risks and uncertainties, including those listed under the caption “Risk Factors.”

You should read thoroughly this prospectus and the documents that we refer to herein with the understanding that our actual future results may be materially different from and/or worse than what we expect. We qualify all of our forward-looking statements by these cautionary statements. Other sections of this prospectus include additional factors which could adversely impact our business and financial performance. Moreover, we operate in an evolving environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

 

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This prospectus also contains third-party data relating to the biopharmaceutical market in Australia that includes projections based on a number of assumptions. The biopharmaceutical market may not grow at the rates projected by market data, or at all. The failure of this market to grow at the projected rates may have a material adverse effect on our business and the market price of our ADSs. Furthermore, if any one or more of the assumptions underlying the market data turns out to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this prospectus relate only to events or information as of the date on which the statements are made in this prospectus. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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USE OF PROCEEDS

We anticipate that the net proceeds from this offering will be approximately US$            , or approximately US$             if the underwriters exercise their option to purchase additional shares in full, at an assumed initial public offering price of US$             per ADS (the midpoint of the price range set forth on the cover page of this prospectus), after deducting underwriting discounts and commissions and estimated offering expenses payable by us. A US$1.00 increase (decrease) in the assumed initial public offering price of US$             per ADS would increase (decrease) the net proceeds of this offering by US$             million, after deducting underwriting discounts and commissions.

The principal purposes of this offering are to increase our financial flexibility, create a U.S. public market for our ADSs in addition to our existing Australian public market thereby enhancing our access to public equity markets.

We currently intend to use the net proceeds from this offering as follows:

 

•

approximately $         million to fund the clinical development of our Tier 1 product candidates;

 

•

approximately $         million to fund the clinical development of our Tier 2 product candidates;

 

•

approximately $         million to further develop and implement our proprietary manufacturing processes and expand our manufacturing capabilities and resources, including, but not limited to, finalizing the development and implementation of the 3D bioreactor-based manufacturing of our products, finalizing the development of our proprietary FBS-free media, and expansion of the scale of manufacturing to support commercial production of our products at our collaborator Lonza; and

 

•

the remainder for general and administrative expenses (including personnel-related costs), working capital and other general corporate purposes, including funding general corporate overhead and the costs of operating as a public company.

This expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions. We have not determined the amounts we may spend on any of the items listed above or the timing of these expenditures.

As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. We may find it necessary or advisable to use the net proceeds from this offering for other purposes, and we will have broad discretion in the application of net proceeds. Although we may use a portion of the net proceeds of this offering for the acquisition or licensing, as the case may be, of additional technologies, other assets or businesses, we have no current understandings, agreements or commitments to do so.

As of June 30, 2014, our cash and cash equivalents were A$196.4 million (or US$185.1 million). Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments.

 

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PRICE RANGE OF OUR ORDINARY SHARES

The following tables present, for the periods indicated, the high and low market prices for our ordinary shares reported on the ASX under the symbol “MSB” for the periods indicated in Australian dollars and U.S. dollars. U.S. dollar per ordinary share amounts have been translated into U.S. dollars at a rate of A$1.00 to US$0.9427 based on the certified foreign exchange rates published by the Board of Governors of the Federal Reserve System on June 30, 2014.

 

		Price per ordinary share (A$)								Price per ordinary share (US$)
Period		High				Low				High				Low
Annual:
Fiscal Year Ended June 30, 2010			2.26				0.78				2.13				0.74
Fiscal Year Ended June 30, 2011			9.95				1.72				9.38				1.62
Fiscal Year Ended June 30, 2012			10.04				5.44				9.46				5.13
Fiscal Year Ended June 30, 2013			7.49				4.22				7.06				3.98
Fiscal Year Ended June 30, 2014			6.80				4.18				6.41				3.94
Quarterly:
Fiscal Year Ended June 30, 2013:
First Quarter Ended September 30, 2012			7.37				5.52				6.95				5.20
Second Quarter Ended December 31, 2012			6.88				4.22				6.49				3.98
Third Quarter Ended March 31, 2013			7.49				5.17				7.06				4.87
Fourth Quarter Ended June 30, 2013			6.43				5.14				6.06				4.85
Fiscal Year Ended June 30, 2014:
First Quarter Ended September 30, 2013			6.22				5.19				5.86				4.89
Second Quarter Ended December 31, 2013			6.80				5.37				6.41				5.06
Third Quarter Ended March 31, 2014			6.13				5.15				5.78				4.85
Fourth Quarter Ended June 30, 2014			5.45				4.18				5.14				3.94
Fiscal Year Ended June 30, 2015:
First Quarter Ended September 30, 2014			5.88				3.64				5.54				3.43
Most Recent Six Months:
Month ended June 30, 2014			4.99				4.18				4.70				3.94
Month ended July 31, 2014			4.68				3.91				4.41				3.69
Month ended August 31, 2014			5.13				3.91				4.84				3.69
Month ended September 30, 2014			5.88				4.25				5.54				4.01
Month ended October 31, 2014			4.38				3.64				4.13				3.43
Month ended November 30, 2014			4.32				3.91				4.07				3.69

 

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EXCHANGE RATE INFORMATION

The Australian dollar is convertible into U.S. dollars at freely floating rates. There are no legal restrictions on the flow of Australian dollars between Australia and the United States. Any remittances of dividends or other payments by us to persons in the United States are not and will not be subject to any exchange controls.

The table below sets forth for the periods identified the number of U.S. dollars per Australian dollar as quoted by the the Board of Governors of the Federal Reserve System. These rates are provided solely for your convenience and are not necessarily the exchange rates that we used in this prospectus or will use in the preparation of our periodic reports or any other information to be provided to you. We make no representation that any Australian dollar or U.S. dollar amounts could have been, or could be, converted into U.S. dollars or Australian dollars, as the case may be, at any particular rate, the rates stated below, or at all. For information on the effect of currency fluctuations on our results, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

Period		Period end(1)				Average				High				Low
Year Ended:
June 30, 2010			0.8480				0.8820				0.9369				0.7751
June 30, 2011			1.0732				0.9905				1.0970				0.8380
June 30, 2012			1.0236				1.0323				1.1026				0.9453
June 30, 2013			0.9165				1.0272				1.0591				0.9165
June 30, 2014			0.9427				0.9186				0.9705				0.8715
Month Ended:
June 30, 2014			0.9427				0.9365				0.9430				0.9250
July 31, 2014			0.9301				0.9389				0.9488				0.9301
August 31, 2014			0.9344				0.9309				0.9352				0.9263
September 30, 2014			0.8737				0.9042				0.9376				0.8737
October 31, 2014			0.8791				0.8781				0.8904				0.8675
November 30, 2014			0.8524				0.8644				0.8737				0.8520

 

(1)	For the fiscal years, determined by averaging daily closing exchange rate. Monthly and interim period averages are calculated using the average of the daily rates during the relevant period.

 

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DIVIDENDS AND DIVIDEND POLICY

Since our inception, we have not declared or paid any dividends on our shares. We intend to retain any earnings for use in our business and do not currently intend to pay cash dividends on our ordinary shares. Dividends, if any, on our outstanding ordinary shares will be declared by and subject to the discretion of our board of directors, and subject to Australian law.

Any dividend we declare will be paid to the holders of ADSs, subject to the terms of the deposit agreement, to the same extent as holders of our ordinary shares, to the extent permitted by applicable law and regulations, less the fees and expenses payable under the deposit agreement. Any dividend we declare will be distributed by the depositary bank to the holders of our ADSs. Cash dividends on our ordinary shares, if any, will be paid in U.S. dollars. See “Description of American Depositary Shares.”

 

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of June 30, 2014. Our capitalization is presented on:

 

•

an actual basis; and

 

•

an as adjusted basis to reflect the issuance and sale of              ordinary shares in the form of ADSs by us in this offering and our receipt of the estimated net proceeds from such issuance and sale in this offering, each based on an assumed initial public offering price of US$             per ADS (the midpoint of the price range set forth on the cover page of this prospectus), after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

You should read this table in conjunction with our consolidated financial statements and the related notes thereto included elsewhere in this prospectus and the information under “Selected Consolidated Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

		As of June 30, 2014
		Actual(1)								As adjusted
		US$				A$				US$		A$
		(in thousands)
										(unaudited)
Cash and cash equivalents			185,141				196,394
Liabilities:
Non-current liabilities			268,595				284,921
Current liabilities			40,230				42,675
Total liabilities			308,825				327,596
Equity:
Issued capital (321,640,094 ordinary shares (no par value) issued as of June 30, 2014, and 316,468,901 ordinary shares (no par value) issued as of June 30, 2013)			638,290				677,087
Reserves			69,209				73,416
Accumulated losses			(168,541	)			(178,785	)
Total equity			538,958				571,718
Total capitalization			847,783				899,314

 

(1)

A US$1.00 increase (decrease) in the assumed initial public offering price of US$             per ADS would increase (decrease) total cash and cash equivalents, equity and total capitalization by US$             million, after deducting the estimated underwriting discounts and commissions payable by us and assuming no exercise of the underwriters’ option to purchase additional ADSs.

The table above excludes the following shares:

 

•

the exercise of outstanding employee options and loan funded share plan shares outstanding at June 30, 2014 to purchase 17,549,542 fully paid ordinary shares issuable upon at a weighted average exercise price of A$5.82 per ordinary share.

 

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DILUTION

As of June 30, 2014, our net tangible book value was A$(0.37) (or US$(0.35)) per ordinary shares and              per ADS. Net tangible book value per ordinary share represents total tangible assets minus total liabilities divided by the total number of ordinary shares outstanding. Dilution is determined by subtracting net tangible book value per ordinary share from the assumed public offering price per ordinary share.

Without taking into account any other changes in net tangible book value after June 30, 2014, other than giving effect to our sale of              ADSs in the offering at an assumed initial public offering price of US$         per ADS (the midpoint of the price range set forth on the cover page of this prospectus) and after deducting underwriting discounts and commissions and estimated expenses of the offering payable by us, but without taking into account any other changes in such net tangible book value after June 30, 2014, the net tangible book value per ordinary share would increase to US$         per ordinary share (or US$         per ADS), or US$         per ordinary share (or US$         per ADS) if the underwriters’ over-allotment option is exercised in full. This represents an immediate increase in net tangible book value of US$         per ordinary share (or US$         per ADS) to our existing shareholders (or US$         per ordinary share (or US$         per ADS) if the underwriters’ over-allotment option is exercised in full), and an immediate dilution of US$         per ordinary share (or US$         per ADS) to purchasers of ADSs in the offering (or US$         per ordinary share (or US$         per ADS), if the underwriters’ over-allotment option is exercised in full).

The following table illustrates this dilution on a per ordinary share basis and a per ADS basis assuming that all ADSs are exchanged for ordinary shares:

 

		Per ordinary share		Per ADS
Assumed initial public offering price
Net tangible book value as of June 30, 2014
Increase attributable to the sale of the ADSs
Pro forma net tangible book value after this offering
Dilution to purchasers of ADSs in the offering

A US$1.00 increase (decrease) in the assumed public offering price of US$         per ADS would increase (decrease) our pro forma net tangible book value after giving effect to the offering by US$         per ordinary share and US$         per ADS, respectively, and the dilution in pro forma net tangible book value per ordinary share and per ADS to new investors in this offering by US$         per ordinary share and US$         per ADS, respectively, assuming no change to the number of ADSs offered by us as set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions.

The following table summarizes, on a pro forma basis as of June 30, 2014, the differences between our existing shareholders as of such date and the new investors with respect to the number of ordinary shares purchased from us, the total consideration paid and the average price per ordinary shares paid at an assumed initial public offering price of US$         per ADS (the midpoint of the price range set forth on the cover page of this prospectus) before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

Ordinary shares purchased

Total consideration

Average price per share

Average price per ADS

Number

Percent

Amount

Percent

(in millions, except percent and per share data)

Existing shareholders

%

US$

%

Purchasers of ordinary shares

Total

100.0

%

100.0

%

 

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A US$1.00 increase (decrease) in the assumed initial public offering price of US$         per ADS would increase (decrease) total consideration paid by new investors, total consideration paid by all shareholders and the average price per ADS paid by all shareholders by US$         million, and US$        , respectively, assuming no change in the number of ADSs sold by us as set forth on the cover page of this prospectus and without deducting underwriting discounts and commissions.

The number of ordinary shares to be outstanding following the offering is based on 317,155,094 fully paid ordinary shares outstanding at June 30, 2014, and excludes:

 

•

the exercise of outstanding employee options and loan funded share plan shares outstanding at June 30, 2014 to purchase 17,549,542 fully paid ordinary shares issuable upon at a weighted average exercise price of A$5.82 per ordinary share.

To the extent all options outstanding at June 30, 2014 are exercised, the number of ordinary shares to be outstanding immediately following the offering would increase to              and the total consideration would increase to US$        . Our existing shareholders would hold              ordinary shares or     % of the number of ordinary shares outstanding immediately following the offering for which they paid US$         or     % of the total consideration. The purchasers of ADSs in the offering would hold     % of the number of ordinary shares outstanding immediately following the offering and would experience immediate dilution in net tangible book value of US$         per ordinary share (or US$         per ADS). In addition, we may in the future elect to raise additional capital as a result of favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities could result in further dilution to our shareholders. See “Risk Factors—Risks related to Ownership of Our ADSs, Our Trading Market and This Offering—An active trading market for the ADSs may not develop in the United States and the trading price for our ordinary shares may fluctuate significantly.”

 

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SELECTED CONSOLIDATED FINANCIAL DATA

The following selected consolidated financial data presented below as of and for the years ended June 30, 2014 and 2013 has been derived from our audited consolidated financial statements included elsewhere in this prospectus. Historical results are not necessarily indicative of results to be expected in the future and the results for the year ended June 30, 2014 are not necessarily indicative of the results that may be expected for any other period. The summary consolidated financial data should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes thereto included elsewhere in this prospectus.

Our financial statements are presented in Australian dollars and have been prepared in accordance with IFRS. Solely for the convenience of the reader our consolidated financial statements as of and for the year ended June 30, 2014 have been translated into U.S. dollars at a rate of A$1.00 to US$0.9427, based on the certified foreign exchange rates published by the Board of Governors of the Federal Reserve System on June 30, 2014, the last business day of our year ended June 30, 2014. Such convenience translation should not be construed as a representation that the Australian dollar amounts have been or could be converted into U.S. dollars at this rate, any particular rate or at all.

 

		Year ended June 30,
		US$ 2014				A$ 2014				A$ 2013
		(in thousands, except per share information)
Consolidated Income Statement Data:
Revenue:
Commercialization revenue			15,470				16,410				18,260
Interest revenue			9,022				9,570				10,526
Revenue from continuing operations			24,492				25,980				28,786
Other income:
Research & development tax incentive			8,103				8,595				5,924
Release of excess provision for services			2,379				2,524				—
Other income			10,482				11,119				5,924
Total revenue from continuing operations			34,974				37,099				34,710
Expenses from continuing operations:
Research and development			(52,136	)			(55,305	)			(47,835	)
Manufacturing commercialization			(26,026	)			(27,608	)			(23,230	)
Management and administration			(25,040	)			(26,562	)			(22,840	)
Finance costs			(4,081	)			(4,329	)			—
Other expenses			(4,005	)			(4,248	)			(883	)
Total expenses from continuing operations			(111,288	)			(118,052	)			(94,788	)
Loss before income tax			(76,314	)			(80,953	)			(60,078	)
Income tax expense			(5	)			(5	)			(1,585	)
Loss attributable to the owners of Mesoblast Limited.			(76,319	)			(80,958	)			(61,663	)
Losses per share from continuing operations attributable to the ordinary equity holders of the Group:
Basic—losses per share(1)			(23.89	)			(25.34	)			(21.06	)
Diluted—losses per share(1)			(23.89	)			(25.34	)			(21.06	)

 

(1)	Please refer to Note 20 to our consolidated financial statements and the related notes thereto included elsewhere in this prospectus for a calculation of basic and diluted losses per share.

 

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		As of June 30,
		US$ 2014				A$ 2014				A$ 2013
Consolidated Balance Sheet Data:
Cash and cash equivalents			185,141				196,394				315,309
Total current assets			192,074				203,749				331,844
Total assets			847,783				899,314				883,712
Total current liabilities			40,230				42,675				50,588
Total liabilities			308,825				327,596				253,446
Net assets			538,958				571,718				630,266
Equity:
Issued capital (321,640,094 ordinary shares (no par value) issued as of June 30, 2014, and 316,468,901 ordinary shares (no par value) issued as of June 30, 2013)			638,290				677,087				654,458
Reserves			69,209				73,416				73,635
Accumulated loss			(168,541	)			(178,785	)			(97,827	)
Total equity			538,958				571,718				630,266

 

		Year ended June 30,
		US$ 2014				A$ 2014				A$ 2013
Cash Flow Data:
Net cash (outflows) in operating activities			(77,170	)			(81,861	)			(54,081	)
Net cash (outflows) in investing activities			(38,471	)			(40,809	)			(5,042	)
Net cash inflows by financing activities			2,291				2,430				169,349

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with “Selected Consolidated Financial Data,” and our consolidated financial statements included elsewhere in this prospectus. We present our consolidated financial statements in Australian dollars and in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board, or IFRS.

The statements in this discussion regarding industry outlook, our expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described in “Risk Factors” and “Forward-Looking Statements” in this prospectus. Our actual results may differ materially from those contained in or implied by any forward-looking statements.

Solely for the convenience of the reader, certain Australian dollar amounts as of and for the year ended June 30, 2014 have been translated into U.S. dollars at the rate at June 30, 2014, of A$1.00 to US$0.9427. These translations should not be considered representations that any such Australian dollar amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Our fiscal year ends each year on June 30. Reference to a year relates to the fiscal year, ended in June 30 of the year indicated, rather than the calendar year, unless indicated by a specific date. “FY2014” refers to the year ended June 30, 2014 and “FY2013” refers to the year ended June 30, 2013.

Overview

We are a global leader in the field of regenerative medicine. We have leveraged our proprietary technology platform, which is based on specialized cells known as MLCs to establish what we believe to be the most advanced regenerative medicine product portfolio in the industry. Over 6,000 doses of our MLC-based product candidates have now been administered to over 1,300 patients, including in multiple completed Phase 2 trials where our product candidates have achieved statistically significant results in treated patients across multiple indications. Based on those clinical results, we now have five product candidates that are in active Phase 3 trials or are Phase 3-ready. We believe we are well positioned to have the first allogeneic stem cell products approved in Japan and the United States.

We have incurred net losses during most of our fiscal periods since our inception. As of June 30, 2014, we had a comprehensive loss of A$87.6 million (or US$82.6 million). Our net loss for the year ended June 30, 2014 was A$81.0 million (or US$76.4 million).

Mergers and Acquisitions

On October 11, 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture-expanded mesenchymal stem cells, or MSCs, for A$134.3 million in cash, securities and contingent consideration. See Note 12 to our consolidated financial statements and the related notes thereto included elsewhere in this prospectus for more information regarding the acquisition consideration. We believe the acquisition is complementary to our business in its nature with many commercial and strategic benefits. The acquired assets included:

 

•

MSC-100-IV for aGVHD;

 

•

broadened late-stage clinical programs in other strategic areas of focus, including Crohn’s disease and acute myocardial infarction, or AMI;

 

•

long-term clinical data from over 1,000 patients treated with MSCs, including safety, efficacy and repeat dosing data; and

 

•

MSC-focused intellectual property and know-how.

 

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Financial Overview

We have incurred significant losses since our inception. We anticipate that we may continue to incur significant losses for the foreseeable future. There can be no assurance that we will ever achieve or maintain profitability. We have never generated any sales revenues ourselves or royalty revenues from sales of our products by our collaborators and we may never be profitable.

We expect our future capital requirements will continue as we:

 

•

continue the research and clinical development of our product candidates, including our MSC-100-IV and MPC-150-IM (Class II-IV) product candidates;

 

•

initiate and advance our product candidates into larger and more expensive clinical studies, including a Phase 3 clinical trial for our MPC-06-ID and MPC-25-Osteo product candidates;

 

•

seek to identify, assess, acquire, and/or develop other product candidates and technologies;

 

•

seek regulatory and marketing approvals in multiple jurisdictions for our product candidates that successfully complete clinical studies;

 

•

establish collaborations with third parties for the development and commercialization of our product candidates, or otherwise build and maintain a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

 

•

further develop and implement our proprietary manufacturing processes in both planar technology and our bioreactor programs and expand our manufacturing capabilities and resources for commercial production;

 

•

seek coverage and reimbursement from third-party payors, including government and private payors for future products;

 

•

make milestone or other payments under our agreements pursuant to which we have licensed or acquired rights to intellectual property and technology;

 

•

seek to maintain, protect, and expand our intellectual property portfolio; and

 

•

seek to attract and retain skilled personnel.

We expect that our Research and development and Management and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our products and to continue as a going concern. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates.

Revenue from Continuing Operations

We derive revenue from continuing operations as follows:

Commercialization Revenue. Commercialization revenue refers to upfront and milestone payments received under development and commercialization agreements.

In the year ended June 30, 2011, we received upfront payments of US$130.0 million under a development and commercialization agreement, or the DCA, with Teva. See “Business—Our Strategic Alliances—Teva/Cephalon, Inc.—Cardiovascular, Neurological and Bone Marrow Collaboration.”

 

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Revenues from such non-refundable, up-front payments are initially reported as deferred revenues on the consolidated balance sheet and are recognized in revenue as earned over the estimated development period. As management cannot readily estimate the costs required to complete the development program pursuant to the DCA, management has concluded that the revenue is earned over the estimated development period of MPC-150-IM. Therefore, revenues are being recognized on straight line basis over the development period of this product candidate. If we were to shorten or lengthen the development period then we would be required to change the amount of revenue we recognize.

Interest Revenue. Interest revenue is accrued on a time basis by reference to the principal outstanding and at the effective interest rate applicable.

Other Income. Other income primarily comprises tax incentive payments from the Australian Government’s Innovation Australia Research and Development Tax Incentive Plan for research and development activities conducted in Australia in relation to our qualifying research that meets the regulatory criteria. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than A$20.0 million. The commercialization revenue is not subject to inclusion in the determination of the annual aggregate turnover measure. Eligible companies can receive a refundable tax offset for a percentage of their research and development spending. Up to June 30, 2014, the rate of the refundable tax offset was 45% after that date the rate is 43.5%.

Other income also includes a gain from the release of an excess provision following the settlement of a dispute with a service provider.

Expenses from Continuing Operations

Research and Development. Research expenditure is recognized as an expense as incurred. Our Research and development expenses consist primarily of:

 

•

salaries and related overhead expenses for personnel in research and development functions;

 

•

fees paid to consultants and CROs, who perform research on our behalf and under our direction;

 

•

costs related to laboratory supplies used in our research and development efforts;

 

•

costs related to the creation and maintenance of our intellectual property portfolio;

 

•

rent and utility costs for our research and development facilities; and

 

•

costs related to share-based incentives granted to personnel in research and development functions.

Acquired in-process research and development is capitalized as an asset and is not amortized but is subject to impairment review.

Manufacturing Commercialization. Manufacturing commercialization expenditure is recognized as an expense as incurred. Our manufacturing commercialization expenses consist primarily of:

 

•

salaries and related overhead expenses for personnel in manufacturing functions;

 

•

fees paid to our contract manufacturing organizations, which perform process development on our behalf and under our direction;

 

•

costs related to laboratory supplies used in our manufacturing development efforts; and

 

•

costs related to share-based incentives granted to personnel in manufacturing functions.

Management and Administration. Management and administration expenses consist primarily of salaries and related costs for employees in executive, corporate and administrative functions. Other significant Management and Administrative expenses include legal and professional services, rent and depreciation of leasehold improvements, insurance and information technology services.

 

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Finance Costs. Finance costs relate to the unwinding of contingent consideration items pertaining to the MSC assets of Osiris. We did not have any borrowings outstanding as of June 30, 2014.

Other Expenses. Other expenses are comprised of unrealized foreign exchange losses on our U.S. dollar deposits plus realized losses on any foreign currency payments to our suppliers. Any unrealized foreign exchange gains on our U.S. dollar deposits or realized gains on any foreign currency payments to our suppliers would be included in Other Income. There were no gains recorded for the year ended June 30, 2014 and 2013.

Results of Operations

Comparison of Our Results for the Year Ended June 30, 2014 with the Year Ended June 30, 2013

The following table summarizes our results of operations for the years ended June 30, 2014 and 2013, together with the changes in those items in dollars and as a percentage:

 

		For the year ended June 30,												Australian Dollar Change				% Change
		US$ 2014				A$ 2014				A$ 2013
		(in thousands, except per share data)
Consolidated Income Statement Data:
Revenue:
Commercialization revenue			15,470				16,410				18,260				(1,850	)			(10	%)
Interest revenue			9,022				9,570				10,526				(956	)			(9	%)
Revenue from continuing operations			24,492				25,980				28,786				(2,806	)			(10	%)
Other income:
Research and development tax incentive			8,103				8,595				5,924				2,671				45	%
Release of excess provision of services			2,379				2,524				—				2,524				NM
Other income			10,482				11,119				5,924				5,195				88	%
Total revenue from continuing operations			34,974				37,099				34,710				2,389				7	%
Expenses from continuing operations:
Research and development			(52,136	)			(55,305	)			(47,835	)			(7,470	)			16	%
Manufacturing commercialization			(26,026	)			(27,608	)			(23,230	)			(4,378	)			19	%
Management and administration			(25,040	)			(26,562	)			(22,840	)			(3,722	)			16	%
Finance costs			(4,081	)			(4,329	)			—				(4,329	)			NM
Other expenses			(4,005	)			(4,248	)			(883	)			(3,365	)			381	%
Total expenses from continuing operations			(111,288	)			(118,052	)			(94,788	)			(23,264	)			25	%
Loss before income tax			(76,314	)			(80,953	)			(60,078	)			(20,875	)			35	%
Income tax expense			(5	)			(5	)			(1,585	)			1,580				100	%
Loss attributable to the owners of Mesoblast.			(76,319	)			(80,958	)			(61,663	)			(19,295	)			31	%
Loss per share from continuing operations attributable to the ordinary equity holders of Mesoblast:
Basic—losses per share			(23.89	)			(25.34	)			(21.06	)			(4.28	)			20	%
Diluted—losses per share			(23.89	)			(25.34	)			(21.06	)			(4.28	)			20	%

 

*	NM = not meaningful

 

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Revenue from Continuing Operations

Revenues were A$26.0 million for the year ended June 30, 2014, compared to A$28.8 million for the year ended June 30, 2013, a decrease of A$2.8 million. The following table shows movement within revenue for the years ended June 30, 2014 and 2013, together with the changes in those items:

 

		For the year ended June 30,												Australian Dollar Change				% Change
		US$2014				A$2014				A$2013
Revenue:
Commercialization revenue			15,470				16,410				18,260				(1,850	)			(10	%)
Interest revenue			9,022				9,570				10,526				(956	)			(9	%)
Revenue from continuing operations			24,492				25,980				28,786				(2,806	)			(10	%)

The A$1.9 million decrease in commercialization revenue from FY2014 to FY2013 is based on the increase in the estimated development period of the upfront milestone payment from Cephalon, Inc. (a wholly-owned subsidiary Teva).

The A$1.0 million decrease in interest revenue is due to a decline in market interest rates over the period, and a move towards investing in shorter term deposits. We have also held a higher ratio of U.S. dollars to Australian dollars in FY2014 compared with FY2013, which decreased revenue as yields on U.S. dollar bank accounts were lower than yields on Australian dollar bank accounts.

Other Income

Other income was A$11.1 million for the year ended June 30, 2014, compared to A$5.9 million for the year ended June 30, 2013, an increase of A$5.2 million. The following table shows movement within other income for the years ended June 30, 2014 and 2013, together with the changes in those items:

 

		For the year ended June 30,												Australian Dollar Change				% Change
		US$2014				A$2014				A$2013
Other income:
Research and development tax incentive scheme			8,103				8,595				5,924				2,671				45	%
Release of excess provision of services			2,379				2,524				—				2,524				NM
Other income			10,482				11,119				5,924				5,195				88	%

 

* NM = not meaningful

The A$2.7 million increase in research and development tax incentive, from A$5.9 million for the year ended June 30, 2013 to A$8.6 million for the year ended June 30, 2014, is due to additional research and development tax incentive income being received in FY2014 for qualifying research and development. The change in estimate was due to the fact that research and development tax incentives were estimated based on the level of qualifying research and development expenditures made during the year, which was higher than estimated.

Of the A$8.6 million research and development tax incentive recorded in other income for the year ended June 30, 2014, A$3.4 million relates to the incentive we received from the Australian Government for the year ended June 30, 2013 following a change in the original assessment. The change in estimate was due to the fact that the research and development tax incentives were introduced in 2011 and were dependent on the level of qualifying research and development expenditure and, as such, consecutive risk adjustments were made in the estimate in the year ended June 30, 2013 until we became familiar with the relevant regulations.

Other income includes a one-time release of a provision regarding a dispute with a service provider that has been settled during FY2014. A provision of A$8.4 million had been taken up in 2010 and, on finalization of this matter in April 2014, the excess provision of A$2.5 million was recorded as other income.

 

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Research and Development

Research and development expenses were A$55.3 million for the year ended June 30, 2014, compared to A$47.8 million for the year ended June 30, 2013, an increase of A$7.5 million. The A$7.5 million net increase in Research and development expenses reflects the clinical development of the MSC assets acquired from Osiris, the clinical advancement of our MPC programs as they transition to late-stage development, and our continued investment in resources to execute our late-stage clinical programs.

Approximately one third of the increase (or A$2.5 million) in Research and development expenses for the year relates to the advancement of our Tier 1 products, and in particular the clinical programs for aGVHD and Crohn’s Disease. These programs form part of our new MSC-100-IV product portfolio acquired from Osiris. The expenses for our Tier 1 product MPC-06-ID for the treatment of CDLBP are consistent with the prior year, while Research and development expenses for the MPC-150-IM product for CHF are funded by our collaborators, Teva (NYHA Class II/III) and the NIH (NYHA Class IV).

Tier 2 and pipeline product development expenses in FY2014 increased by A$1.1 million compared to FY2013. The expenses in this category include significant expenditures on patient recruitment, which we undertook during FY2014 for our three programs within the MPC-300-IV product, in particular, the treatment of glucose control in patients with type 2 diabetes, diabetic nephropathy and rheumatoid arthritis.

Also included in Tier 2 expenses were costs for the ongoing Phase 2 trial in Europe for the treatment of heart attacks (product MPC-25-IC), and the completion of the Phase 2 program for lumbar spinal fusion (product MPC-25-Osteo). Expenses for both of these products were relatively constant between FY2014 and FY2013, decreasing by only A$0.3 million.

Product development support expenses in FY2014 across all programs increased by A$2.8 million compared to FY2013, primarily reflecting the costs of the additional resources required to run the MSC-100-IV product late-stage programs acquired during FY2014, together with increased development costs for our MPC-06-ID product for chronic low back pain as we progress to Phase 3 clinical development.

Also included in Research and development expenses are intellectual property portfolio costs, which have risen in FY2014 by A$1.4 million compared with FY2013. This reflects the purchase of MSC patent families from Osiris.

We expect that our Research and development expenses will continue to increase as we continue to fund our programs through to market. We believe these increases will likely include increased costs related to the hiring of additional personnel in research and development functions, increased costs paid to consultants and CROs, and increased costs related to laboratory supplies.

Manufacturing Commercialization

Manufacturing Commercialization expenses were A$27.6 million for the year ended June 30, 2014, compared with A$23.2 million for the year ended June 30, 2013, an increase of A$4.4 million. A$3.6 million of the A$4.4 million net increase in Manufacturing Commercialization expenses is attributable to production of MSC-100-IV. This also includes the purchase of MSC master cell banks from Lonza, as well as review and transfer of the MSC production process from the Lonza facility in the U.S. to the facility in Singapore.

In support of MSC production and our ongoing transition from research grade production to commercial production, the manufacturing department has grown in employees from six as of June 30, 2013 to twelve as of June 30, 2014, resulting in a A$0.8 million increase in salaries, share-based compensation and associated expenses for FY2014.

We are also continuing to invest in bioreactor manufacturing processes. During FY2013, this development work was partially funded by a third party supplier in anticipation of future work being carried out with such supplier, hence our expenses were relatively low compared to the work performed. During FY2014 the funding from the third party supplier decreased and the arrangement will be completed by December 2014.

 

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In addition to the above, we continue to invest cash to (i) further establish our manufacturing processes in Lonza’s Singapore facility, (ii) produce MPCs and MSCs to support clinical trial activities, (iii) optimize clinical production processes, including transitioning away from bovine serum, and (iv) continue bioreactor manufacturing development.

We expect that our Manufacturing Commercialization expenses will continue to increase as we ramp up our manufacture in anticipation of commercial and clinical demands, and further invest in bioreactor manufacturing development. We believe these increases will likely include increased costs related to the hiring of additional personnel in manufacturing functions, increased costs paid to consultants and contract manufacturing organizations.

Management and Administration Expenses

Management and administration expenses were A$26.5 million for the year ended June 30, 2014, compared with A$22.8 million for the year ended June 30, 2013, an increase of A$3.7 million. The A$3.7 million increase in Management and administration expenses is primarily the result of additional costs incurred as a result of the increased head count of 116 staff at June 30, 2014 compared with 75 at June 30, 2013, such as rent costs due to increased office space, information technology support and general compliance.

We expect that our Management and administration expenses will continue to increase as our product candidates develop towards commercialization. These increases will likely include increased costs related to the hiring of additional personnel in management and administrative functions, as well as increased costs paid to consultants, and associated administrative costs.

Finance Costs

Finance costs of A$4.3 million in FY2014 represent the change in fair value of contingent consideration financial liabilities pertaining to the acquisition of the MSC assets of Osiris. These costs are currently a non-cash item. On successful achievement of agreed milestones, the costs will be payable in cash or shares at our discretion. On successful achievement of commercialization of any MSC-based product, product royalties will be funded from the profits generated.

We expect that these Finance costs will continue to increase as we continue to develop towards commercialization of the MSC-based products as the discounting of the contingent consideration unwinds with time and/or achievement of milestones.

Other Expenses

Other expenses were A$4.2 million for the year ended June 30, 2014, compared with A$0.9 million for the year ended June 30, 2013, an increase of A$3.3 million. This increase is attributable to foreign exchange losses on revaluation of foreign currency denominated monetary assets and liabilities, mostly due to the appreciation of the Australian dollar relative to the U.S. dollar during the second half of FY2014.

We expect that Other expenses will continue to fluctuate as a result of the movement in the Australian dollar to U.S. dollar exchange rate going forward.

Net Operating Losses

As of June 30, 2014, we had net operating losses carried forward of A$146.8 million. These losses may be available for use, once we are in a taxable profit position. These losses were incurred in different jurisdictions and can only be offset against profits earned in the relevant jurisdiction. Further, in order to use these tax losses, it is necessary to satisfy certain tests and, as a result, we cannot assure you that the tax losses will be available to offset profits if and when we earn them.

 

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Liquidity and Capital Resources

Sources of Liquidity

We have incurred losses from operations since our inception in 2004 and as of June 30, 2014, we had an accumulated deficit of A$178.8 million. We expect that the net proceeds from this offering and our existing cash and cash equivalents will be sufficient to fund our current operations through at least the next twelve months. We expect that our Research and development and Management and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

From our inception through June 30, 2014, we have funded our operations principally with A$677.1 million in proceeds received from the sale of our ordinary shares and the receipt of US$130 million upon signing a development and commercialization agreement with Cephalon, Inc. (a wholly-owned subsidiary Teva) during the financial year ended June 30, 2011. As of June 30, 2014, we had cash and cash equivalents of A$196.4 million (or US$185.1 million). Cash in excess of immediate requirements is invested primarily in money market funds in order to maintain liquidity and preserve capital.

Cash Flows

The following table sets forth the significant sources and uses of cash for the periods set forth below:

 

		Year ended June 30,
		US$2014				A$2014				A$2013
		(in thousands)
Consolidated Cash Flow Data:
Net cash outflows in operating activities			(77,170	)			(81,861	)			(54,081	)
Net cash outflows in investing activities			(38,471	)			(40,809	)			(5,042	)
Net cash inflows by financing activities			2,291				2,430				169,349
Net (decrease) / increase in cash and cash equivalents			(113,350	)			(120,240	)			110,226

Cash Flows From Operating Activities. Net cash used in operating activities was A$81.9 million for the year ended June 30, 2014, compared to A$54.1 million for the year ended June 30, 2013. The change from FY2014 to FY2013 primarily reflects the increasing clinical development and manufacturing expenditures as we advance our late stage programs, with five Phase 3 or Phase 3-ready programs, and the acquisition of the MSC assets acquired from Osiris. This resulted in an increase in payments to suppliers and employees of A$38.6 million to A$106.3 million in FY2014 from A$67.7 million in FY2013. We received A$9.3 million from the Australian Government’s Innovation Australia Research and Development Tax Incentive Program for research and development activities conducted in Australia in FY2014 compared to A$Nil in FY2013. Our interest received also increased by A$2.3 million to A$12.6 million in FY2014 from A$10.3 million in FY2013 due to a number of our term deposits invested in FY2013 maturing in FY2014. Income tax refunded decreased by A$0.8 million to A$2.5 million in FY2014 from A$3.3 million in FY2013.

Cash Flows from Investing Activities. Net cash used in investing activities was A$40.8 million for the year ended June 30, 2014, compared to A$5.0 million for the year ended June 30, 2013. In FY2014, we used A$35.6 million to pay for the acquisition of MSC assets from Osiris; we paid A$1.7 million in rental deposits as security for the sublease agreement for our Melbourne and New York offices, and we used A$1.9 million for fixed assets primarily for plant and equipment for the progression of our clinical trials and computer equipment for our expanding staff. We used A$1.5 million for the payment of financial derivatives, A$0.5 million for the payment of licenses and we received a repayment of loans from employees of A$0.3 million. In FY2013, we used A$1.5 million to pay for in-process research & development, and we paid A$1.2 million for fixed assets primarily plant and equipment for the progression of our clinical trials and computer equipment for our expanding staff. We used A$2.2 million for the payment of financial derivatives and A$0.1 million for the payment for licenses.

Cash Flows from Financing Activities. Net cash provided by financing activities was A$2.4 million for the year ended June 30, 2014, compared to A$169.3 million for the year ended June 30, 2013. This decrease was due

 

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to the fact that in FY2013, we received A$164.4 million of proceeds from the issuance of ordinary shares from a private placement to institutional investors in March 2013. There was also a decrease of A$2.8 million in FY2014 due to a reduction in the number of options exercised.

Operating Capital Requirements

To date, we have not generated any revenues from our product sales. We do not know when, or if, we will generate any revenue from our product sales. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize one or more of our cell-based product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our cell-based product candidates, and begin to commercialize any approved products either directly ourselves or through a collaborator or partner. We are subject to all of the risks incident in the development of new cell-based products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Upon the completion of this offering, we expect to incur additional costs associated with operating as a U.S. public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.

We expect that our Research and development and Management and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our ordinary shares. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

Contractual Obligations and Commitments

The following table summarizes our significant contractual obligations and commercial commitments at June 30, 2014:

 

		Total				Within one year				Later than one year but no later than three years				Later than three years but no later than five years				Later than five years
		(A$ in thousands)
Operating leases			19,502				2,814				5,635				5,932				5,121
Total Commitments			19,502				2,814				5,635				5,932				5,121

We lease various offices under non-cancellable operating leases expiring within 1 to 7 years. The leases have varying terms, escalation clauses and renewal rights. On renewal, the terms of the leases are renegotiated.

In addition to the obligations in the table above, as of June 30, 2014 we also had the following significant contractual obligations described below.

 

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Contingent Liabilities

We will be required to make a milestone payment to Central Adelaide Local Health Network Incorporated, or CALHNI, of US$0.25 million on completion of each Phase 3 (human) clinical trial and US$0.35 million on each FDA marketing approval for products in the orthopedic field. We will pay CALHNI a commercial arm’s length royalty based on net sales by us of licensed products in the orthopedic field each quarter.

We may also be required to pay consideration to CALHNI upon successful completion of subsequent clinical milestones in fields other than orthopedic. These payments are not included in the table above due to the uncertainty of their timing.

Capital Commitments

We did not have any commitments for future capital expenditure outstanding as at June 30, 2014.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, other than operating leases as mentioned above, as defined under SEC rules.

Certain Differences Between IFRS and GAAP

IFRS differs from GAAP in certain respects. Management has not assessed the materiality of differences between IFRS and GAAP. Our significant accounting policies are described in Note 21 to our consolidated financial statements and the related notes thereto included elsewhere in this prospectus.

Quantitative and Qualitative Disclosure About Market Risk

The following sections provide quantitative information on our exposure to interest rate risk, share price risk, and foreign currency exchange risk. We make use of sensitivity analyses which are inherently limited in estimating actual losses in fair value that can occur from changes in market conditions.

Interest Rate Risk

We are not exposed to typical interest rate risk, which is the impact of interest rates on the cost of servicing and repaying debt. Our exposure to interest rate arises through movements in regards to interest income we earn on our deposits. The interest income derived from these balances can fluctuate due to interest rate changes. This interest rate risk is managed by spreading the maturity date of our deposits across various periods. We ensure that sufficient funds are available, in at-call accounts, to meet our cash flow requirements.

Share Price Risk

We have a contractual obligation to Osiris that may require us to issue shares if certain conditions within the contractual arrangement are triggered. A lower share price will require a greater number of securities to be issued in the year ended June 30, 2015. We can elect to make payment in cash, or cash and shares, for this arrangement should we elect to do so. See “Business—Osiris Acquisition—Continuing Obligations.”

Foreign Currency Exchange Risk

We have certain clinical, regulatory and manufacturing activities which are being conducted internationally. Our primary currency exposure is the clinical trial activities which are occurring in the United States of America and manufacturing activities occurring in Singapore. As a result of these activities, we have foreign currency amounts owing primarily in U.S. dollars and Singapore dollars, as well as some smaller amounts in various other currencies. These foreign currency balances give rise to a currency risk, which is the risk of the exchange rate moving, in either direction, and the impact it may have on our financial performance.

 

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We manage the currency risk by evaluating the trend of the relevant foreign currency rates, or FX rates, to the Australian dollar and making decisions as to the levels to hold in each currency by assessing our future activities which will likely be incurred in those currencies. We engage professional advice when considering forward foreign exchange contracts.

As of June 30, 2014, we held 45% of our cash in U.S. dollars, and 55% in Australian dollars. 12% of the Australian dollars balance is subject to forward contracts to purchase U.S. dollars at a predetermined rate in the future. After allowing for these derivative contracts, we held effectively 51% U.S. dollars and 49% Australian dollars as of June 30, 2014. We have entered these financial derivative contracts to take advantage of enhanced interest rates yields available on Australian dollar deposit when compared to U.S. dollar deposits. We sell U.S. dollars and buy Australian dollars from the bank at a pre-agreed FX rate and agree to then sell those Australian dollars and buy U.S. dollars from the bank on maturity also at a pre-agreed rate. As these FX rates are known at the outset, there is no currency risk.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we have prepared in accordance with IFRS. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in our consolidated financial statements appearing elsewhere in this prospectus, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.

Revenue Recognition

Revenues comprise the fair value of the consideration received or receivable.

Commercialization Revenue

Development and commercialization revenue generally includes non-refundable up-front license and collaboration fees; milestone payments, the receipt of which is dependent upon the achievement of certain clinical, regulatory or commercial milestones; as well as royalties on product sales of licensed products, if and when such product sales occur; and revenue from the supply of products.

Where such arrangements can be divided into separately identifiable components (each component constituting a separate earnings process), the arrangement consideration is allocated to the different components based on their relative fair values and recognized over the respective performance period in accordance with IAS 18 Revenue. Where the components of the arrangement cannot be divided into separate units, the individual deliverables are combined as a single unit of accounting and the total arrangement consideration is recognized over the estimated collaboration period. Such analysis requires considerable estimates and judgments to be made by us, including the relative fair values of the various elements included in such agreements and the estimated length of the respective performance periods.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, within current liabilities. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, within non-current liabilities.

 

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Cephalon Arrangement

In December 2010, we entered into a development and commercialization agreement, or the DCA, with Cephalon, Inc., now a wholly-owned subsidiary of Teva, which allows for Teva to obtain world-wide rights to commercialize specific products based on our proprietary adult stem cell technology platform. As part of the DCA, we received US$130 million as a non-refundable up-front payment.

Further payments of up to US$1.7 billion may be received on achievement of certain regulatory milestones with respect to each product Teva may choose to commercialize. The milestones are based on approvals of the product for treatment in various territories. We would also be entitled to receive future royalty payments for supply of commercialized product as a percentage of net sales. No such payments have been received.

We analyzed the arrangement to determine whether the components which include a license, participation in a joint steering committee, a development program, and manufacturing and supply services, can be separated or must be treated as a single transaction in assessing revenue recognition criteria.

As our obligations in relation to the joint steering committee and the development program are substantive and cannot be readily separated from the initial license transfer, we have not accounted for the license as a separate component. As management cannot readily estimate the costs required to complete the development program, due to significant uncertainties relating to success of the development program, revenue has been recognized on a straight line basis over the estimated development period of MPC-150-IM. If we were to shorten or lengthen the development period then we would be required to change the amount of revenue we recognize.

For FY2014 and FY2013, we recognized A$16.4 million and A$18.3 million of revenue, respectively, being the amortization of the initial payment over the estimated development program term. No revenue has been recognized for any future development milestones or royalties specified in the agreement as we cannot reliably estimate whether we would become entitled to such payments.

JCR Arrangement

In October 2013, we acquired all of Osiris’ culture-expanded, MSC-based assets. These assets included assumption of a collaboration agreement with JCR, a research and development oriented pharmaceutical company in Japan. Revenue recognized under this model is limited to the amount of cash received or for which we are entitled, as JCR has the right to terminate the agreement at any time.

Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. With respect to the First JCR Field, we are entitled to payments when JCR reaches certain development and commercial milestones and to escalating double-digit royalties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to a double digit profit share. Royalty revenue is recognized upon the sale of the related products provided the Group has no remaining performance obligations under the arrangement.

Government Grant Revenue

Revenue from government grants is recognized in the consolidated income statement on a systematic basis over the periods in which the entity recognizes as expense the related costs for which the grants are intended to compensate in accordance with IAS 20 Accounting for Government Grants and Disclosure of Government Assistance.

The Australian Government replaced the research and development tax concession with the research and development tax incentive from July 1, 2011. The provisions provide refundable or non-refundable tax offsets.

The research and development tax incentive applies to expenditure incurred and the use of depreciating assets in an income year commencing on or after July 1, 2011. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than A$20 million. Eligible companies can receive a refundable tax offset for a percentage of their research and development spending. Up to June 30, 2014 the rate of the refundable tax offset was 45%, after that date the rate is 43.5%.

 

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Our research and development activities are eligible under an Australian government tax incentive for eligible expenditure from July 1, 2011. Management has assessed these activities and expenditure to determine which are likely to be eligible under the incentive scheme. At each period end, management estimates and recognizes the refundable tax offset available to us based on available information at the time.

The receivable for reimbursable amounts that have not been collected is reflected in trade and other receivables on our consolidated balance sheets.

Business Combinations

We record business combinations in accordance with IFRS 3 Business Combinations.

IFRS 3 Business Combinations requires that the acquisition of business be accounted for under the acquisition method of accounting. The definition of a business in IFRS 3 Business Combinations is: a business consists of inputs and processes applied to those inputs that have the ability to create outputs.

The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments or other assets are acquired. The consideration transferred for the acquisition of a business comprises the fair values of the assets transferred, the liabilities incurred and the equity interests issued by us. The consideration transferred also includes the fair value of any asset or liability resulting from a contingent consideration arrangement. Acquisition-related costs are expensed as incurred. Identifiable assets acquired and liabilities and contingent liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date.

The excess of the consideration transferred over the fair value of the net identifiable assets acquired is recorded as goodwill. If those amounts were to be less than the fair value of the net identifiable assets acquired and the measurement of all amounts has been reviewed, the difference would be recognized directly in the consolidated income statement as a bargain purchase.

Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate is determined based on required rates of returns of comparable companies (having regards to their stage of development, their size and number of projects) and the indicative rates of return required by suppliers of venture capital for investments with similar technical and commercial risks.

In October 2013 we acquired the MSC business of Osiris. In accordance with the guidance in IFRS 3 Business Combinations management determined that, although no equity interests were acquired, the asset purchased in this acquisition did constitute a business under the definition.

In accordance with IFRS 3 Business Combinations the acquisition method of accounting was used to account for the business combination. An independent valuation expert provided the fair value of the consideration paid and assets transferred, the liabilities incurred and the equity interests issued by us.

The purchase agreement also included a component of contingent consideration which was made up of certain pre-determined milestone and royalties. At acquisition this contingent consideration was recognized as a financial liability at its fair value which was provided by an independent valuation expert. See Notes 5 and 12 of our consolidated financial statements and the related notes thereto included elsewhere in this prospectus for more information regarding the contingent consideration. This financial liability is subsequently remeasured to fair value with changes in fair value recognized in the consolidated income statement.

We recognized goodwill on acquisition which was the excess of the consideration transferred over the fair value of the net identifiable assets acquired.

An independent valuation expert calculated all valuations on the basis of fair value less costs to sell by using the income approach.

 

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Goodwill

We have recognized goodwill as a result of two separate acquisitions. Goodwill of US$118.4 million was recognized on acquisition of Angioblast Systems Inc. in 2010 and US$13.9 million was recognized on the acquisition of assets from Osiris in 2013. In both cases the goodwill recognized represented excess in the purchase price over the net identifiable assets and in-process research and development acquired in the transaction. We have a single operating unit and all goodwill has been allocated to that unit.

The goodwill resulting from these acquisitions is tested for impairment in accordance with IAS 36 Impairment of Assets which requires testing be performed at any time during an annual period, provided the test is performed at the same time every year. We test for impairment annually on May 31. Additionally, assets must be tested for impairment if there is an indication that an asset may be impaired. The recoverable amounts of our assets and cash-generating units have been determined based on fair value less costs to sell calculations, which require the use of certain assumptions. See Note 6 of our consolidated financial statements and the related note thereto included elsewhere in this prospectus for more information regarding the assumptions used in determining the fair value less costs to sell.

In-Process Research and Development

IFRS requires that acquired in-process research and development be measured at fair value and carried as an indefinite life intangible asset subject to impairment reviews. We have recognized in-process research and development as a result of two separate acquisitions. In-process research and development of US$387.0 million was recognized on the acquisition of Angioblast Systems Inc. in 2010 and US$126.7 million was recognized on the acquisition of assets from Osiris in 2013.

All in-process research and development recognized on our balance sheet is a result of a business acquisition and is considered to be an indefinite life intangible asset on the basis that it is incomplete and cannot be used in its current form. Indefinite life intangible assets are not amortized but rather are tested for impairment annually at May 31 of each year in accordance with IAS 36 Impairment of Assets which requires testing annually, or whenever there is an indication that an asset may be impaired.

In-process research and development will continue to be tested for impairment until the related research and development efforts are either completed or abandoned. Upon completion of the related research and development efforts, management determines the remaining useful life of the intangible assets and amortizes them accordingly. In order for management to determine the remaining useful life of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the product life cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and various other relevant factors.

In the case of abandonment, the related research and development efforts are considered impaired and the asset is fully expensed.

Impairment of Assets

Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested annually for impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

We impair assets in accordance with IAS 36 Impairment of Assets. IAS 36 Impairment of Assets outlines that an impairment loss must be recognized if an asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and its value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from other assets or groups of assets (cash-generating units). The recoverable amounts of our assets and cash-generating units have been determined based on fair value less costs to sell calculations, which require the use of certain assumptions. See Note 6 of our consolidated

 

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financial statements and the related note thereto included elsewhere in this prospectus for more information regarding the assumptions used in determining the fair value less costs to sell.

Management maintains internal valuations of each asset annually (or more frequently should indicators of impairment be identified) and valuations from independent experts are requested periodically, within every three year period. The internal valuation are continually reviewed by management and consideration is given as to whether there are indicators of impairment which would warrant impairment testing.

The impairment testing completed at May 31, 2014 showed the recoverable amount of our cash generating unit, including goodwill and in-process research and development, exceeded the carrying amounts, and therefore no impairment was identified.

Investments and Other Financial Assets

We invest our cash in term deposits and other similar low risk products. We classify investments as either a cash equivalent or a short-term investment in accordance with IAS 7 Statement of Cash Flows. For a deposit to be classified as a cash equivalent it should be held for the purpose of meeting short-term cash commitments rather than for investment or other purposes and IAS 7 outlines that:

 

•

It must be readily convertible to a known amount of cash (qualifies when it has a short maturity, of say, 3 months or less from the date of acquisition);

 

•

It must be subject to insignificant risk of change of value.

We review the terms and conditions of each deposit to determine if it is a cash equivalent in accordance with IAS 7.

Deposits with maturity dates between 3 months and 12 months are classified as short term investments. The carrying amount of short-term investments approximates fair value due to the short maturities of these instruments, and there are no unrealized gains or losses associated with these instruments. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset and liability.

Fair Value Measurements

For financial instruments that are measured on the balance sheet at fair value, IFRS 7 requires disclosure of the fair value measurements by level of the following fair value measurement hierarchy:

 

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Level 1: The fair value of financial instruments traded in active markets (such as publicly traded derivatives, and trading and available-for-sale securities) is based on quoted market prices at the end of the reporting period. The quoted market price used for financial assets held by the Group is the current bid price. These instruments are included in level 1.

 

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Level 2: The fair value of financial instruments that are not traded in an active market (for example, foreign exchange contracts) is determined using valuation techniques which maximize the use of observable market data and rely as little as possible on entity-specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2.

 

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Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for provisions (contingent consideration).

Our level 3 assets and liabilities consist of a contingent consideration provision related to the acquisition of Osiris Therapeutics, Inc’s MSCs business. Level 3 assets and liabilities were 99.6% and 0% of total assets and liabilities measured at fair value as of June 30, 2014 and 2013, respectively. There were no transfers between any of the levels for recurring fair value measurements during the year.

 

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The following table summarizes the assumptions, techniques, and significant unobservable inputs used in level 3 fair value measurements:

 

Description

Fair value as of June 30, 2014

Valuation technique

Unobservable Inputs*

Range of inputs (weighted average)

Relationship of unobservable inputs to fair value

Contingent consideration provision

86,249

Discounted cash flows

Risk adjusted discount rate

11%-13% (12.5%)

A change in the discount rate by 0.5% would increase/decrease the fair value by 3%

Expected unit revenues

n/a

a 10% increase in the price assumptions adopted would increase the fair value by 5%

 

*	There were no significant inter-relationships between unobservable inputs that materially affect fair values.

Net Deferred Tax Assets

We record deferred tax assets if, based upon the available evidence, it is more likely than not that we will recognize some or all of the deferred tax assets. We have had a history of net losses since inception, and as a result, we have not recognized our net deferred tax assets due to our plans to centralize intellectual property and therefore taxable temporary differences will not be available to offset the deferred tax assets. If circumstances change and we determine that we will be able to realize some or all of these deferred tax assets in the future, we will record an adjustment for the recognition of deferred tax assets.

Currently, our pipeline is at various stages of development and our intangible intellectual property assets are held by a number of our entities across multiple jurisdictions. We are seeking to centralize our intellectual property in Singapore where our manufacturing plant is located and are currently contemplating the steps to achieve this objective.

As required under IFRS, we do not recognize the impact of any potential future corporate re-organizations to remeasure our deferred tax liabilities until they are in place. Our deferred tax liabilities are measured at the relevant rate in the relevant jurisdiction at each balance date. Any potential future changes arising from a re-organization could be material to our future operations.

Accrued Research and Development and Manufacturing Commercialization Expenses

As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. Examples of estimated accrued expenses include fees paid to:

 

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CROs in connection with clinical studies;

 

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investigative sites in connection with clinical studies;

 

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vendors in connection with preclinical development activities; and

 

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vendors related to product manufacturing, process development and distribution of clinical supplies.

 

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We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical study milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly. To date, there have been no material differences from our estimates to the amount actually incurred.

Jumpstart Our Business Startups Act of 2012

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, or the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to foreign issuer companies. We have irrevocably elected to avail ourselves of this extended transition period and, as a result, we will not adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if as an “emerging growth company” we choose to rely on such exemptions, we may not be required to, among other things, (i) provide an auditor’s attestation report on our systems of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non- emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation. These exemptions will apply until we no longer meet the requirements of being an “emerging growth company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of US$1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than US$1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

 

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BUSINESS

Overview

We are a global leader in the field of regenerative medicine. We have leveraged our proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, or MLCs, to establish what we believe to be the most advanced regenerative medicine product portfolio in the industry. Over 6,000 doses of our MLC-based product candidates have now been administered to over 1,300 patients, including in multiple completed Phase 2 trials where our product candidates have achieved statistically significant results in treated patients across multiple indications. Based on those clinical results, we now have five product candidates that are in active Phase 3 trials or are Phase 3-ready. We believe we are well positioned to have the first allogeneic stem cell products approved in Japan and the United States.

Our deep understanding of the fundamental mechanisms of action of MLCs and our proprietary manufacturing processes have been leveraged to create a portfolio of independent, non-interchangeable MLC-derived product candidates. Each of our product candidates has its own distinct technical characteristics, target indications, individual reimbursement strategy, separate commercialization potential, and unique partnering opportunities.

We have focused on significantly advanced stages of diseases where specific subpopulations of patients have high unmet medical needs, providing accelerated development pathway opportunities and the potential for attractive pricing. Our goal is to first gain broad acceptance of any approved products as treatment options for severely ill patients, then expand the applications of such products over time to broader patient populations.

We expect a number of important clinical milestone events to occur over the next 12 to 24 months for our most advanced product candidates, including:

 

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At the end of the first quarter 2015, we expect to announce 24-month results from the already completed Phase 2 trial of our Tier 1 product candidate MPC-06-ID for CDLBP, demonstrating whether the treatment benefit seen at 12 months persists for 24 months. We believe evidence of sustained clinical treatment effect for 24 months should support attractive pricing and reimbursement, and our ability to enter into a commercial partnership.

 

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At the end of the first quarter 2015, we expect to announce three month and six-month results from the Phase 2 trial of our Tier 2 product candidate MPC-300-IV for diabetic kidney disease. Positive results will cause us to elevate this product candidate to Tier 1, and we believe will facilitate discussions with the FDA on progressing to an adaptive Phase 2b/3 clinical trial design.

 

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During the third quarter 2015, we expect to announce three-month and six-month results from the Phase 2 trial of our Tier 2 product candidate MPC-300-IV for rheumatoid arthritis. Positive results will cause us to elevate this product candidate to Tier 1, and we believe would also allow the product candidate to be advanced into Phase 3 and facilitate potential strategic partnering discussions.

 

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During the second half 2015, we expect that our licensee, JCR, will receive a response to its request for approval for its aGVHD MSC-based product (JR-031). JCR filed for marketing approval in Japan in September 2014 and was granted orphan drug priority review. If successful, JR-031 will be the first allogeneic cell-based product approved in Japan and we will be the recipient of a revenue stream tied to resulting JCR sales under our agreement with JCR.

 

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During the first quarter 2016, we expect to announce the results of the first interim analysis of safety and efficacy from the Phase 3 trial of our Tier 1 product candidate MPC-150-IM for CHF. This will include six-month results for surrogate parameters of heart failure. We believe that positive results from this interim analysis will reinforce and validate the Phase 3 trial design assumptions that we made based on our Phase 2 trial results.

 

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During first half 2016, we expect to announce the results from the Phase 3 trial of our Tier 1 product candidate MSC-100-IV for aGVHD. We believe that positive results will support filing a BLA in second half 2016.

 

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In mid-2016, we expect to announce the results of an interim analysis from two simultaneous Phase 3 trials of our Tier 1 product candidate MPC-06-ID for CDLBP. Enrollment for these trials is expected to begin in early 2015. This analysis will be based on approximately one-third of the total patients recruited across both trials. Full top-line results from both trials are expected in mid-2017.

Proprietary Platform and Scalable Manufacturing

MLCs are present around blood vessels in all tissues, where they can respond to signals associated with tissue damage. This response includes the secretion of a variety of biomolecules that affect various reparative and immunomodulatory mechanisms responsible for maintaining tissue health. Understanding the mechanisms of action by which these biomolecules induce tissue restoration has broad applicability in treating diseases for which current standards of care are inadequate or for which no approved therapy currently exists. Each of our MLC-based product candidates has been optimized through proprietary manufacturing processes to release certain biomolecules implicated in the mechanisms of action thought to modify outcomes in a specific target disease state.

MLCs have two additional, distinct characteristics that, when combined with our proprietary manufacturing processes, enable allogeneic or “off-the-shelf” use of our product candidates. First, we have developed proprietary methods that enable the isolation of MLCs from healthy donors and their large-scale expansion while maintaining their ability to produce key biomolecules associated with tissue health and repair. In addition, unlike other categories of stem cells, MLCs are “immune privileged” in that they do not express specific cell surface co-stimulatory molecules that would otherwise initiate an immune response when administered to unrelated patients. These characteristics allow us to produce large quantities of off-the-shelf MLC-based product candidates from a few donors for use in thousands of unrelated recipients, with consistent, well-defined therapeutic properties, batch-release criteria and established potency assays, all with accompanying manufacturing and distribution economies-of-scale.

We have developed multiple distinct product candidates derived from our MLC platform by applying an approach that we refer to as “Product-by-Process,” or PBP, in which we modify the manufacturing, formulation, dosage and route of administration for each product to optimize an MLC-derived product for a specific target condition. For example, products for treating systemic inflammatory or immunologic conditions are delivered intravenously, while products for tissue repair and regeneration are delivered locally, and differences in formulation give rise to distinct disc repair and spinal fusion product candidates. This allows for the development of independent, non-interchangeable products, each of which has distinct pricing and strategic partnering opportunities. We have also established what we believe to be a leading intellectual property position covering compositions, uses and methods of manufacturing of MLCs, which we believe provides us with substantial competitive advantages for the commercial development of regenerative medicine products.

Lead Product Candidates

We have prioritized our portfolio into tiers based on stage of development, largest market opportunities and anticipated time to market. Tier 1 programs represent our lead programs where we focus the majority of our time and resources. Tier 2 programs are also in development and may advance to Tier 1 depending on the merit of newly generated data, market opportunity or partnering options. Additionally, we have a significant pipeline of earlier-stage programs.

We expect a number of important clinical milestone events to occur over the next 12 to 24 months for our most advanced product candidates in both Tier 1 and Tier 2. In 2015, we expect to report data from three Phase 2 trials and for JCR, our partner in Japan, to receive a response to its request for approval for its aGVHD MSC-based product. In 2016, we expect to report data from three Phase 3 trials and to submit a BLA for approval for one product candidate in the U.S.

For each product candidate, we evaluate whether to pursue development and commercialization on our own or with a strategic collaborator who can provide the appropriate resources and expertise to maximize each opportunity. Teva is our global collaborator for the late-stage clinical development and commercialization of certain cardiovascular, central nervous system and bone marrow transplant fields, and recently initiated a large Phase 3 trial with 1,730 patients for our product candidate MPC-150-IM for CHF. JCR is our collaborator in Japan for the treatment of acute graft versus host disease, or aGVHD.

 

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A summary of our Tier 1 and Tier 2 programs, our most advanced product candidates, and their corresponding stage of development and our strategic collaboration status are captured in the tables below.

Tier 1 Programs

 

Product Candidates		Programs		Collaborator/ Geographic Rights		Stage of Development		Anticipated Milestones
MPC-06-ID		CDLBP		Proprietary (Global)		•    Phase 2 trial completed •    End-of-Phase 2 FDA meeting in June 2014		•    Additional data on 24-month effect from Phase 2 trial at end of first quarter 2015 •    Phase 3 interim analysis results in mid-2016 •    Phase 3 top-line data in mid-2017
MPC-150-IM		Class II/III CHF		Teva (Global)		•    Phase 2 trial completed •    Phase 3 trial enrollment ongoing		•    First Phase 3 interim analysis for safety and efficacy results in first quarter 2016 •    Phase 3 trial complete in 2018
MPC-150-IM		Class IV CHF		Teva (Global)		•    Phase 2a trial completed •    Enrollment ongoing for additional Phase 2 trial		•    Initiate Phase 2b trial in the first quarter 2015, funded by the NIH •    Phase 2b trial results expected in early 2017
MSC-100-IV		Acute steroid-refractory GVHD		Proprietary (North America)		•    Conditionally approved in Canada for pediatric use •    U.S. Phase 3-ready		•    Pediatric launch in Canada 2016 •    Initiate U.S. Phase 3 trial (pediatric) by end of 2014; top-line data by first half 2016; BLA filing in second half 2016
JR-031		Acute GVHD		JCR (Japan)		•    JCR filed for marketing approval (Japan) in September 2014		•    JCR filing currently under priority regulatory review by the PMDA

 

All time periods refer to calendar year periods.

Tier 2 Programs

 

Product Candidates		Programs		Collaborator/ Geographic Rights		Stage of Development
MPC-300-IV		Diabetic kidney disease		Proprietary		•    Phase 2 trial ongoing •    3-month and 6-month top-line data at end of first quarter 2015
		Rheumatoid arthritis (biologic refractory)		Proprietary		•    Phase 2 trial ongoing •    First cohort enrollment complete; actively enrolling second cohort •    3-month and 6-month top-line data in third quarter 2015
MPC-25-IC		Acute cardiac ischemia		Teva		•    Phase 2 trial ongoing
MPC-25-Osteo		Spinal fusion		Proprietary		•    Phase 2 trial completed •    Phase 3 trial design ongoing
MPC-CBE		Bone marrow transplantation		Teva		•    Phase 3 trial ongoing
MSC-100-IV		Crohn’s disease (biologic refractory)		Proprietary		•    Phase 3 trial ongoing*

 

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All time periods refer to calendar year periods.

*	An additional Phase 3 program will be necessary before applying for market approval.

Our Competitive Strengths

We have a leadership position in regenerative medicine due to our MLC platform, broad portfolio of product candidates targeting attractive markets, stem cell manufacturing capabilities, intellectual property portfolio, key strategic alliances and experienced management team.

Disruptive technology platform

Our proprietary MLC platform allows us to develop product candidates that have the potential to significantly improve the treatment of a number of serious and debilitating conditions due to the MLCs’ ability to secrete biomolecules that induce tissue repair through multiple diverse mechanisms. Regenerative medicines aim to restore affected cells and tissues, and therefore may have broad applicability in treating diseases where current standards of care are often inadequate or where no approved therapy currently exists.

Our MLC platform has two additional technical advantages that are not shared by other cell types. The first is that we use proprietary processes to isolate MLCs from a few healthy donors and significantly expand them in culture, while maintaining their innate therapeutic characteristics. The second is that MLCs do not materially activate the immune system. Together, these two unique characteristics enable MLCs to be used as allogeneic, off-the-shelf therapies that can be developed from a small number of donors and administered to many patients, with batch-to-batch consistency, commercial scale capabilities and predictable therapeutic properties, all without any material immune responses in patients.

Broad portfolio of distinct late-stage product candidates

While all of our product candidates are based on our MLC platform, our PBP approach allows for the development of distinct, non-interchangeable products, each of which can attract exclusive pricing and partnering opportunities. Using this approach, we have created a broad portfolio of product candidates that target a wide range of diseases, including five Phase 3 or Phase 3-ready product candidates, and potentially the first culture-expanded allogeneic stem cell products to be approved in Japan and the United States. We have an extensive patient safety data file on our MLC-based product candidates.

Target markets with high unmet needs

Our strategy is to develop product candidates that target significantly advanced stages of certain diseases where specific sub-populations have high unmet needs. These include moderate to severe CDLBP, chronic CHF and aGVHD, as well as additional indications targeted by our Tier 2 programs. As a result, we will potentially benefit from accelerated development pathways and attractive pricing and reimbursement. As any of our products get market approval and acceptance in the medical community, we believe we will have the opportunity to expand over time into broader patient populations with less severe stages of a targeted disease.

Scalable manufacturing capabilities

We have developed proprietary manufacturing processes that we expect will enable production at commercial scale with reproducibility and batch-to-batch consistency, supported by robust quality assurance procedures and lot release assays. Our manufacturing processes have met stringent criteria required by international regulatory agencies, including the FDA. We have built an internal team with significant experience in the production of cell therapy products and the commercial production of approved biopharmaceuticals.

We have established a strategic alliance with Lonza, a global leader in biopharmaceutical manufacturing, which includes exclusive access to their large-scale biologics production facility in Singapore, a major international hub for biopharmaceutical development and manufacturing, for cell therapy products. Our exclusive long-term access to this Singapore facility allows us to utilize our proprietary manufacturing processes in a controlled environment.

 

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Intellectual property leadership

We have a large patent portfolio of issued and pending claims covering compositions of matter and methods of use for MLCs, irrespective of the tissue source for donated MLCs (e.g., our patents cover MLCs from bone marrow, adipose, placenta, umbilical cord and dental pulp tissues). Our patents also cover elements of our manufacturing processes. As of November 2014, we have 67 patent families, including more than 572 patents or patent applications. We maintain trade secrets covering a significant body of know-how and proprietary information related to our core product candidates and technologies. As a result, we believe we have a leading intellectual property position in the MLC space, that provides us with substantial competitive advantages for the commercial development of regenerative medicine products.

Strategic alliances

We have established strategic relationships with several industry leaders to support the development and potential commercialization of our product candidates. Our collaborators provide clinical development, manufacturing and commercial capabilities as well as financial support to enhance the potential for the success of our product candidates, which mitigates our capital obligations and commercial risk.

Teva is our global collaborator for the late-stage clinical development and commercialization of certain cardiovascular, central nervous system and bone marrow transplant fields, and recently initiated a large Phase 3 trial with 1,730 patients for our product candidate MPC-150-IM for CHF. JCR is our collaborator in Japan for the treatment of aGVHD. Lonza is our collaborator for cell therapy manufacturing. Our relationship with the Singapore Economic Development Board, or EDB, provides us with various financial incentives associated with our activities in Singapore.

Experienced management team

Our CEO, Dr. Silviu Itescu, is a pioneer in the study and clinical development of stem cells, and a globally recognized leader in the field of regenerative medicine. Our broader management team, through prior employment at leading drug development companies and regulatory agencies, has substantial experience in the clinical development, manufacturing, regulatory management and commercialization of biopharmaceuticals.

Our Strategic Alliances

We have established strategic alliances to provide clinical development and manufacturing and commercial capabilities, which mitigates our capital obligations and commercial risk. Key terms of these strategic alliances are summarized below. We will evaluate and, where appropriate, enter into additional collaborations with biopharmaceutical or other organizations to further advance our product candidate portfolio and to gain access to scientific expertise or funding support.

Teva/Cephalon, Inc.—Cardiovascular, Neurological and Bone Marrow Collaboration

In December 2010, we entered into a development and commercialization agreement, or DCA, with Cephalon, Inc., now a wholly-owned subsidiary of Teva. We refer in this discussion to Cephalon and Teva together as Teva. Under the DCA, which will continue in existence for so long as Teva or its affiliates or sublicensees are developing any product covered by the DCA, we and Teva are collaborating to develop certain MPC-based product candidates, including MPC-150-IM for CHF. The collaboration is limited to certain specified indications within cardiovascular, central nervous system, and BMT. Teva has the right and responsibility to fund late-stage clinical development (Phase 2b and Phase 3 clinical trials) and to commercialize certain of our product candidates for specified indications throughout the world. The most advanced of the programs is our CHF program, and Teva recently initiated a large Phase 3 trial in this indication with approximately 1,730 patients for our product candidate MPC-150-IM.

In conjunction with signing the DCA, Teva has paid us US$130 million and purchased A$197 million of our ordinary shares. Under the DCA, Teva has agreed to pay us up to an additional US$1.7 billion in milestone payments for certain of our product candidates that are approved in specified indications in certain major

 

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jurisdictions. In addition, Teva agreed to pay us escalating double-digit revenue share of its world-wide net sales of certain of our product candidates.

In September 2013, we and Teva amended the DCA. As a result of the amendment, the ongoing Phase 3 clinical trial for MPC-150-IM in CHF, which Teva is conducting and funding, now includes two interim analyses of efficacy and/or safety. Subject to the trial reaching specified enrollment rates, Teva is obligated to conduct and fund the Phase 3 clinical trial for CHF at least until the first interim analysis is completed.

All activities under the DCA are overseen by a joint steering committee with an equal number of representatives appointed by us and Teva. Generally, we are responsible for development costs for product candidates through Phase 2a clinical studies, except that Teva is obligated to reimburse us for a certain portion of our costs related to the development of such product candidates for the central nervous system field. Generally, Teva is responsible for development costs beyond Phase 2a clinical studies. We are the exclusive supplier for each of our product candidates for development and commercialization activities for the specified indications. Teva is responsible for obtaining and maintaining regulatory approvals as well as for all commercialization costs.

During the term of the DCA, we and Teva agreed to mutual non-compete with respect to stem cell therapeutic products in the specified indications. However, any entities that we may acquire or may acquire us may continue any existing competing activities subject to certain requirements to keep those activities separate from our collaboration with Teva, and in such circumstances, Teva would have the right to take over sole control of the development of our covered product candidates for the specified indications under the DCA.

With the exception of the cardiovascular field, in which Teva is obligated to conduct and fund the Phase 3 clinical trial in CHF at least through the first interim analysis, Teva has the right to terminate the DCA upon advance notice to us. We have the right to terminate the DCA in the event Teva materially breaches the DCA and has not cured within certain time periods, except that once Teva has received regulatory approval for any covered product in any of the U.S., the EU or Asia, we may not terminate with respect to that same geographic location.

JCR Pharmaceuticals Co., Ltd—Hematological Malignancies and Hepatocytes Collaboration in Japan

In October 2013, we acquired all of Osiris Therapeutics, Inc.’s business and assets related to culture expanded MSCs. These assets included assumption of a collaboration agreement with JCR, or the JCR Agreement, which will continue in existence until the later of 15 years from the first commercial sale of any product covered by the agreement and expiration of the last Osiris patent covering any such product. JCR is a research and development oriented pharmaceutical company in Japan. Under the JCR Agreement, JCR has the right to develop our MSCs in two fields for the Japanese market: exclusive in conjunction with the treatment of hematological malignancies by the use of HSCs derived from peripheral blood, cord blood or bone marrow, or the First JCR Field; and non-exclusive for developing assays that use liver cells for non-clinical drug screening and evaluation, or the Second JCR Field. Under the JCR Agreement, JCR obtained rights in Japan to our MSCs, for the treatment of aGVHD. JCR also has a right of first negotiation to obtain rights to commercialize MSC-based products for additional orphan designations in Japan. We retain all rights to those products outside of Japan.

The Japanese Pharmaceuticals and Medical Devices Agency granted JR-031 orphan drug status in December 2013, and, as a result, it will be subject to a priority review. JCR filed for approval in September 2014. JCR is currently expanding its manufacturing facility in preparation for commercial launch. JR-031 has the potential to be the first culture-expanded allogeneic stem cell product to be approved in Japan.

Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. With respect to the First JCR Field, we are entitled to payments up to US$6.5 million in the aggregate when JCR reaches certain development and commercial milestones and to escalating double-digit royalties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, we are entitled to a double digit profit share.

Intellectual property is licensed both ways under the JCR Agreement, with JCR receiving exclusive and non-exclusive rights as described above from us and granting us non-exclusive, royalty-free rights (excluding in

 

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the First JCR Field and Second JCR Field in Japan) under the intellectual property arising out of JCR’s development or commercialization of MSC-based products licensed in Japan.

JCR has the right to terminate the JCR Agreement for any reason, and we have a limited right to terminate the JCR Agreement, including a right to terminate in the event of an uncured material breach by JCR. In the event of a termination of the JCR Agreement other than for our breach, JCR must provide us with its owned product registrations and technical data related to MSC-based products licensed in Japan and all licenses of our intellectual property rights will revert to us.

Lonza—Manufacturing Collaboration

In September 2011, we entered into a manufacturing services agreement, or MSA, with Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., collectively referred to as Lonza, a global leader in biopharmaceutical manufacturing. Under the MSA, we pay Lonza on a fee for service basis to provide us with manufacturing process development capabilities for our product candidates, including formulation development, establishment and maintenance of master cell banks, records preparation, process validation, manufacturing and other services.

Under the MSA, as long as we continue to meet certain annual spending commitments with respect to activities in Singapore, Lonza agreed not to supply third parties with allogeneic cell therapy products from Singapore, including from its existing biologics production facility, subject to certain exceptions. During the term of the MSA, we will have access to this facility, which allows us to utilize our proprietary manufacturing processes in this controlled environment.

We have agreed to order a certain percentage of our clinical requirements and commercial requirements from Lonza. Lonza has agreed not to manufacture or supply commercially biosimilar versions of any of our product candidates to any third party, during the term of the MSA, subject to our meeting certain thresholds for sales of our products.

We can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for our product candidates. In return if we exercise this option, we will purchase agreed quantities of our product candidates from this facility. We also have a right to buy out this manufacturing facility at a pre-agreed price two years after the facility receives regulatory approval.

The MSA will expire on the later of December 31, 2020 or the three year anniversary of the date of the first commercial sale of product supplied under the MSA, unless it is sooner terminated. We have the option of extending the MSA for an additional 10 years, followed by the option to extend for successive three-year periods subject to Lonza’s reasonable consent. We may terminate the MSA with two years prior written notice, and Lonza may terminate with five years prior written notice. The MSA may also terminate for other reasons, including if the manufacture or development of a product is suspended or abandoned due to the results of clinical trials or guidance from a regulatory authority. In the event we request that Lonza construct the manufacturing facility described above, neither we nor Lonza may terminate before the third anniversary of the date the facility receives regulatory approval to manufacture our product candidates, except in certain limited circumstances. Upon expiration or termination of the MSA, we have the right to require Lonza to transfer certain technologies and lease the Singapore facility or the portion of such facility where our product candidates are manufactured, subject to good faith negotiations.

We currently rely, and expect to continue to rely, on Lonza for the manufacture of our product candidates for preclinical and clinical testing, as well as for commercial manufacture of our product candidates if marketing approval is obtained.

Singapore Economic Development Board (EDB)—Singapore Operations

In May 2014, the Economic Development Board of Singapore, or EDB, granted us certain financial incentives tied to revenues generated by our Singapore operations, among other things. These incentives include two separate 15-year periods (each broken into five-year increments) of potential incentives, one related

 

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primarily to non-manufacturing activities and the other related to manufacturing activities. We will be eligible for these incentives if we meet certain investment or activity thresholds in Singapore, including employment levels, amounts of business or manufacturing related expenses, and the performance of various services including business development, planning, manufacturing, intellectual property management, marketing and distribution. For example, in order to obtain full financial benefits from the EDB for our manufacturing-related incentives, we must manufacture at least 50% of the global volume of our first three commercial products in Singapore (subject to certain exceptions), and we would be required to construct and operate a manufacturing facility in Singapore, and hire and maintain a specified number of professionals (including supply chain personnel) in connection with the operation of that facility. The activities under our MSA with Lonza could be used to fulfill all or part of the requirements to obtain the EDB financial incentives.

Stem Cell Therapeutics

We are a global leader in the development of regenerative medicine product candidates due in large part to the therapeutic and commercial advantages offered by our MLSC-based platform.

Introduction to Mesenchymal Lineage Stem Cells

Stem cells can be characterized as either embryonic or adult in origin. Embryonic stem cells, or ESCs, are pluripotent, and differentiate during embryonic and fetal development into all specialized tissues in the body, including nerve, muscle, skin, blood, and bone. ESCs and the related induced-pluripotent stem cells have two characteristics that complicate use as therapeutic products. First, ESCs have a relatively high proliferative capacity that can give rise to certain cancers called teratomas. Further, ESCs are not immune privileged, meaning they can activate the immune system of any treated patient. In contrast, we develop products based on MLCs, which are adult stem cells that play an important role in tissue repair and organ maintenance throughout life, have less proliferative potential, are more restricted in their differentiation properties, and to date have not been shown to cause teratomas. The number and quality of MLCs progressively decline with advancing age, which we believe may be associated with the development of degenerative conditions. As such, we obtain our MLCs from young, healthy adults.

MLCs are present around blood vessels in all tissues where they can respond effectively to various signals associated with tissue damage. This response includes the secretion by MLCs of a variety of biomolecules, including growth factors, cytokines, chemokines and immunomodulatory biomolecules, that affect various reparative mechanisms associated with the maintenance of tissue health. The coordinated beneficial effects of these biomolecules on damaged tissues include:

 

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Blood vessel function and regeneration. MLCs play a central role in the maintenance, repair and regeneration of blood vessels. This is achieved in large part through the secretion of growth factors which act on neighboring endothelial cells to promote blood vessel regeneration and function.

 

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Tissue repair. MLCs represent a key cellular constituent of stem cell niches in multiple adult tissues such as the bone marrow, heart and brain where they facilitate endogenous tissue repair by multiple mechanisms, including promotion of survival and function of mature cells within a given tissue or of the endogenous stem cells with which they are associated in niches within these tissues. This is achieved by secretion of a broad repertoire of bioactive molecules, including chemokines, growth factors and enzymes, that promote survival and proliferation together with remodeling of the extracellular matrix of the tissue.

 

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Immunomodulation. Located at the interface between the circulation and the tissues, MLCs play a physiological role in modulating immune responses via their ability to alter the effector functions of extravasated white blood cells by up-regulation of a battery of secreted immunomodulatory proteins.

There are two subcategories of MLCs: mesenchymal precursor cells, or MPCs, and mesenchymal stem cells, or MSCs, which while similar, have subtle, different functional characteristics that are considered when determining which cell type to use when developing a product for a targeted disease.

 

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Mechanisms of Action Underpin Product Development

The unique combination of properties based on secretion of diverse biomolecules underscores the importance of MLCs as a platform for the development of cell based regenerative medicine therapies.

Our lead MLC products have been optimized through proprietary manufacturing processes to release certain biomolecules implicated in the mechanisms of action by which the MLC product is thought to modify outcomes for each specific target condition for which it is being developed. Examples of these biomolecules as they relate to characterization of our products are as follows:

 

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MPC-06-ID: this product candidate is designed for local delivery to degenerating intervertebral discs and to allow our MLCs to secrete biomolecules involved in enhanced migration and proliferation of intervertebral disc progenitor cells, and in enhanced proteoglycan and collagen synthesis in the disc nucleus and annulus. These biomolecules include Angiopoietin-1 and transforming growth factor beta, or TGF-beta.

 

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MPC-150-IM: this product candidate is designed for local delivery to damaged heart muscle and to allow our MLCs to secrete biomolecules involved in enhanced myocardial neovascularization, cardiomyocyte survival, cardiomyocyte precursor migration and proliferation, and reduction in fibrosis and myocardial scar. These biomolecules include stromal cell-derived factor 1, or SDF-1, Angiopoietin-1, vascular endothelial growth factor, or VEGF, hepatocyte growth factor, or HGF, and matrix metalloproteinases, or MMPs.

 

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MSC-100-IV, JR-031 and MPC-300-IV: these product candidates have been designed for intravenous delivery in systemic conditions of excessive inflammation, and to allow our MLCs secrete biomolecules involved in immunomodulation, particularly prostaglandin E2, or PGE2, and indoleamine 2, 3-dioxygenase, or IDO, in response to activation by pro-inflammatory cytokines such as tumor necrosis factor-alpha, or TNF-alpha, and interleukin-1, or IL-1. Release of immunomodulatory biomolecules by these MLC products acts to polarize pro-inflammatory M1 monocytes to anti-inflammatory M2 monocytes, and to switch activated T helper cells 1 and 17, or Th1 and Th17, respectively, to Th2 cells and FOXP3 T regulatory cells.

 

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MPC-25-Osteo: This product is designed to allow our MLCs secrete biomolecules involved in osteoblast migration and bone vasculature, both features of new bone formation; these biomolecules include various bone morphogenic proteins, or BMPs, and VEGF.

While our MLCs play very active roles in tissue repair, our products have what we believe to be a uniquely extensive safety profile. We have an extensive patient safety data file on our MLC-based product candidates as a result of having now treated over 1,340 patients. Over 1,100 patients have received our MSC products, having received multiple exposures exceeding 6,000 doses. Over 240 subjects have received single doses of MPC products, which entered clinical development several years after MSCs.

Allogeneic, Off-the-Shelf, Commercially Scalable Products

Our proprietary MLC-based products have two distinct technical properties that enable their use for allogeneic purposes, meaning cells from one donor can be expanded to treat many unrelated recipients.

 

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Expansion. We have developed proprietary methods that enable the large scale expansion of our MLCs while maintaining their ability to produce key biomolecules associated with tissue health and repair. This allows us to produce a cellular product with consistent, well-defined therapeutic properties, batch release criteria and established potency assays, all with accompanying manufacturing economies of scale.

 

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Immune Privilege. Unlike other categories of stem cells, including ESCs and tissue specific adult stem cells such as hematopoietic stem cells, or HSCs, MLCs are immune privileged, meaning they do not express specific cell surface co-stimulatory molecules involved in initiating and facilitating general immune responses. Additionally, MLCs release various biomolecules involved in the inhibition of immune responses.

 

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In contrast, autologous stem cell products, which are produced from the patient’s own stem cells, require individual product regulatory testing and do not benefit from manufacturing economies of scale. Moreover, autologous therapies are vulnerable to significant patient-to-patient variability, resulting in a corresponding variability in the results derived from clinical use.

Despite these weaknesses, many autologous products have been advanced into clinical trials by academic and industry developers, who may understand the therapeutic potential of MLCs, but who may not have the requisite intellectual property or manufacturing capabilities and infrastructure needed to facilitate cost-effective allogeneic product development.

Our Product Candidates

We have prioritized our therapeutic programs into tiers based on stage of development, largest market opportunities and nearest term revenue potential. Tier 1 programs represent our lead programs where we focus the majority of our time and resources. Tier 2 programs are continually evaluated, and we may advance these programs into Tier 1 depending on merit of clinical data generated, market opportunity or collaboration opportunity. These product candidates will be discussed in detail below. We are developing additional product candidates that have the potential to advance into Tier 1 and Tier 2 going forward.

We expect a number of important clinical milestone events to occur over the next 12 to 24 months for our most advanced product candidates in both Tier 1 and Tier 2. In 2015, we expect to report data from three Phase 2 trials and for JCR, our partner in Japan, to receive a response to its request for approval for its aGVHD MSC-based product. In 2016, we expect to report data from three Phase 3 trials and to submit a BLA for approval for one product candidate in the U.S.

 

 

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Tier 1 Programs

MPC-06-ID for the Treatment of Chronic Discogenic Low Back Pain

Overview

MPC-06-ID is our proprietary Phase 3-ready product candidate for the treatment of CDLBP caused by DDD. MPC-06-ID consists of a unit dose of 6 million MPCs administered with hyaluronic acid, or HA, and is injected by syringe directly into a targeted damaged disc.

In CDLBP, damage to the disc is the result of a combination of factors related to aging, genetics, and micro-injuries, which compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage to the disc also results in an inflammatory response with ingrowth of nerves that results in chronic pain. The combination of anatomic instability and nerve ingrowth results in CDLBP and functional disability.

With respect to mechanisms of action in CDLBP, extensive studies have established that MLCs secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MLCs have also been shown to produce anti-inflammation factors. These effects together offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy, and improving disc stability, while also reducing inflammation and pain.

Market Opportunity

Over four million patients in the U.S. alone suffer from CDLBP. After failure of conservative measures (medication, injections, physical therapy, etc.), there is no treatment that prevents progression of disc degeneration, reduces pain and improves function over a sustained period of 6 to 12 months. When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means, major invasive surgery such as spinal fusion is the only remaining option.

All therapies for progressive, severe and debilitating pain due to degenerating intervertebral discs treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying cause of the disease. Surgical intervention is not always successful in addressing the patient’s pain and functional deficit. Physicians estimate that 40% of surgically treated patients eventually fail. Total costs of low back pain are estimated to be between US$100 billion and US$200 billion annually with two thirds of attributed to patients’ decreased wages and productivity.

As a result, we believe that the most significant unmet need and commercial opportunity in the treatment of CDLBP is a therapy that has the ability to reverse, halt or slow the progression of the disease. MPC-06-ID is being developed to target the population of patients suffering from moderate to severe chronic low back pain due to moderately degenerated discs. The target patient population has exhausted conservative treatment options, may have failed epidural steroid injections to alleviate pain and has no treatment option other than invasive and costly surgical interventions.

Current Status and Anticipated Milestones

We originally filed an investigational new drug, or IND, application to begin a Phase 2 trial for CDLBP in 2011. In September 2014, after an end of Phase 2 meeting with the FDA where full 12 month results were presented, we amended the IND and filed our Phase 3 clinical study protocol. We expect this Phase 3 program to be actively enrolling during the first quarter of 2015.

At the end of the first quarter 2015, we expect to announce 24-month results from the already completed Phase 2 trial. These results will demonstrate whether the treatment benefit seen at 12 months persists for 24 months. We believe that evidence of sustained clinical treatment effect for 24 months should support attractive pricing and reimbursement, and our ability to enter into a commercial partnership.

 

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Enrollment of two simultaneous Phase 3 trials is expected to begin in early 2015 and will take approximately 18 months to complete, meaning by mid-2016. We expect to announce the results of an interim analysis based on approximately one-third of the total patients recruited across both trials in mid-2016. Top-line data from both trials are expected in mid-2017.

Phase 2 Clinical Trial

The primary objective of our Phase 2 study was to evaluate the safety of MPCs in CDLBP. Secondary objectives were to evaluate efficacy parameters such as radiographic, low back pain, function/disability, medication usage, work status and quality of life improvement measures. Patients were evaluated at 1, 3, 6 and 12 months after treatment with longer term follow-up evaluations continuing at 24 and 36 months. Full 6 and 12 month data are now available.

Eligible subjects were at least 18 years of age with chronic lumbar back pain for 6 months or greater duration due to moderate DDD in one lumbar vertebral level between L1 and S1. Subjects had to have failed at least 3 months of non-operative management with exposure to physical therapy. The study evaluated intra-discal injection of two separate doses: 6 million MPCs, which is MPC-06-ID, and 18 million MPCs with both MPC doses administered with HA, and compared to saline (placebo control) or HA alone (vehicle control) injection. 100 subjects across 15 sites were randomized with 20 receiving saline, 20 receiving HA, 30 receiving MPC-06-ID with HA, and 30 receiving 18 million MPCs with HA. The mean duration of DDD in these patients was approximately 6 years. Baseline pain, function scores, and radiographic scores were similar among all groups.

Phase 2 Clinical Trial Results

With respect to the primary endpoint, allogeneic MPC treatment, including MPC-06-ID, was well tolerated with the most frequently reported adverse event, back pain, occurring across all patient groups.

With respect to secondary efficacy endpoints, the FDA has provided guidelines to developers of restorative or replacement disc therapies on how to evaluate patient response, utilizing a composite endpoint based on clinical differences in both pain and function from baseline. This composite-based endpoint for FDA approval is different than has been used by pharmacologic agents developed solely for palliative improvement in symptoms, such as analgesics, where short term improvement in mean pain scores between groups is sufficient to support a label for short term pain reduction. We believe that achieving success in long-term improvement of both pain and function will support a broad label for disc restoration and reimbursement from payors.

We have utilized this composite-based endpoint and associated guidelines, among other measures, in the evaluation of our Phase 2 results.

 

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Improvement in chronic low back pain: At 12 months, 69.2% of the MPC-06-ID group, 61.5% of the 18 million MPC group, 31.3% of the saline group, and 35.3% of the HA group had achieved at least 50% reduction in back pain, as measured by visual analog scale, or VAS (p = 0.036 across all four groups). Both MPC dose groups had a statistically significant greater proportion of patients with 50% or more reduction in back pain from baseline compared to the pooled controls (MPC-06-ID: p=0.009, 18 million: p=0.038). Statistical significance denotes the mathematical likelihood that the results observed are real and not due to chance. In addition, a significantly greater proportion of patients in both MPC dose groups achieved minimal or no residual back pain at 12 months compared to pooled controls (MPC-06-ID: 52%, 18M: 42%, pooled controls: 18%, p=0.009 and p=0.05, respectively).

 

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MPC groups have a greater proportion of patients with at least a 50% improvement in back pain or minimal/no residual back pain at 12 months relative to controls

 

 

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Improvement in function: Both MPC dose groups had a greater proportion of patients with a minimally important clinical difference, or MICD, of 30% or more improvement in function from baseline compared to control groups, as measured by Oswestry Disability Index, or ODI, (MPC-06-ID: 58%, 18 million 62%, saline 44%, HA 41%, p=0.174 across all four groups). A greater proportion of MPC-treated patients achieved minimal or no residual functional disability at 12 months than controls (MPC-06-ID: 36.0% and 18 million MPC: 38.5%, compared to pooled controls: 18.2%, p=0.14 and p=0.14, respectively).

 

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Reduced need for additional surgical and non-surgical interventions: MPC-treated patients had a significantly reduced need for additional interventions at the treated disc level, including surgical intervention (spinal fusion, discectomy or artificial disc replacement) or injection (epidural steroid injection, rhizotomy or transforaminal injections), than saline controls. By 12 months, 25% of patients in the saline control group had undergone an additional intervention, compared with 10% of patients in the HA control group, 6.9% of patients in the MPC-06-ID group and only 3.3% of patients in the 18 million MPC-treated group. By Kaplan-Meier analysis of time to a first additional treatment intervention, treatment with either MPC-06-ID or 18 million MPC significantly reduced the need for additional interventions compared with saline treatment (p=0.024 and p=0.010, respectively).

 

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Improved disc stability: In patients with early disc degeneration (Pfirrmann MRI degenerative grades below 5), increased translational movement of the disc is a potential indicator of instability associated with early disc degeneration and annular fissures seen on MRI and pathologic examination. At 12 months, MPC-treated patients demonstrated a significant reduction in radiographically-determined translational movement of the disc, suggesting a treatment effect on disc degeneration, anatomy, and improved disc stability. The 18 million MPC group had a mean translational movement of only 1.3%, the MPC-06-ID group 2.0%, the HA group 2.5%, and the saline group 3.5% (p=0.021 between groups).

 

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Overall treatment success: Based on precedent and FDA feedback from our end-of-Phase 2 meeting, a composite endpoint requiring at least a 50% improvement in low back pain, 15 point improvement in ODI and no treatment intervention (surgical or injection) was established as sufficient to meet FDA’s requirements for approval. Utilizing this FDA recommended composite endpoint in a post-hoc analysis of Phase 2 data, separation between treatment and control arms was first seen at 3 months, maximal at 6 months, and sustained for at least 12 months. More specifically, the MPC-06-ID group, the 18 million MPC group, the HA control and the saline control groups had 44.0%, 42.3%, 17.6% and 12.5% of subjects meet the treatment success criteria at both 6 and 12 months, respectively. The

 

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MPC-06-ID group composite endpoint was statistically superior to the saline control group (p=0.006) and near superior to the HA control group (p=0.054) while the 18 million MPC group was also superior to the saline control group (p=0.020).

MPCs Demonstrate Significant Improvement in Overall

Treatment Success Compared to Saline Controls

 

This sustained treatment effect suggests a disc regenerative mechanism of action rather than a simple analgesic effect, which we believe would have been noted within the first month and would not have been sustained without repeated treatment. We believe the ability to meet this composite endpoint at both 6 and 12 months would demonstrate a robust and durable benefit for the patient rather than a transient or temporary response.

Phase 3 Design

Based on an end-of-Phase 2 meeting with the FDA, we intend to initiate two concurrent Phase 3 clinical trials that will use a composite primary end point of pain relief and improved function, consisting of a 50% reduction in lower back pain as measured by VAS and a 15 point improvement in ODI, with no intervention at both 6 and 12 months. Our Phase 3 trial will evaluate the same approach but will also add an arm to evaluate a 6 million MPC dose alone. The studies will be double-blinded, and include approximately 330 patients each. The study is planned to be international in scope including sites in the U.S., Australia, Canada and potentially Europe. Total recruitment time is expected to be approximately 18 months, with 12 months of follow-up. An interim analysis by an independent statistician will be performed when the first 150 patients across both trials have completed 12 months of follow-up to ensure the assumptions underlying the trial size is correct.

MPC-150-IM for the Treatment of Class II, III and IV Congestive Heart Failure (CHF)

Overview

MPC-150-IM for the treatment of chronic CHF is our product candidate partnered with Teva. MPC-150-IM consists of 150 million MPCs administered by direct cardiac injection in patients suffering from chronic heart failure and progressive loss of heart function following damage to the heart muscle caused by a heart attack, coronary artery disease, hypertension or genetic factors.

MPCs release a range of factors when triggered by specific receptor-ligand interactions within damaged tissue. It is believed that the factors released from the MPCs induce functional cardiac recovery by simultaneous activation of multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in cardiac scarring and fibrosis, and regeneration of heart muscle through activation of tissue precursors.

 

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Our unit dose of 150 million cells was based on multiple large preclinical animal studies in ischemic and non-ischemic heart failure models which identified an optimal cell dose above 110 million, and a Phase 2 dose-ranging study in patients with heart failure of either ischemic or non-ischemic etiology which identified the 150 million dose as the most effective for both improvement in left ventricular volumes and in prevention of heart failure related hospitalizations or death.

Market Opportunity

CHF is a chronic condition characterized by an enlarged heart and insufficient blood flow to the organs and extremities of the body. The condition progresses over time and can be caused by many factors that put an excess demand on the heart muscle, including high blood pressure, incompetent valves, infections of the heart muscle or valves, or congenital heart problems.

The American Heart Association reports 5.1 million adults in the United States with diagnosed CHF, or about 2% of the adult population, with 825,000 new cases diagnosed each year. CHF prevalence is expected to grow 46% by 2030, affecting more than 8 million Americans. The estimated annualized cost for CHF care in the United States is approximately $32 billion, and is projected to grow to approximately $77 billion by 2030.

Heart failure is classified in relation to the severity of the symptoms experienced by the patient. The most commonly used classification system for severity of heart failure, established by the New York Heart Association, or NYHA, is as follows:

 

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Class I (mild): patients experience no or very mild symptoms with ordinary physical activity

 

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Class II (mild): patients experience fatigue and shortness of breath during moderate physical activity

 

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Class III (moderate): patients experience shortness of breath during even light physical activity

 

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Class IV (severe): patients are exhausted even at rest

Risk for recurrent heart failure-related hospitalizations and death increases progressively with increase in left ventricular volumes, reduction in ejection fraction, and progression in NYHA grade. About 40% of all heart failure patients have a low ejection fraction (<35-40%), NYHA Class II/III CHF, and are at considerable risk of repeated hospitalizations and death despite maximal drug therapy.

Subjects with NYHA Class III/IV disease represent approximately 39% of the CHF population and are considered to have advanced CHF. Importantly, we believe patients with advanced or Class III/IV disease continue to represent the greatest unmet medical need despite recent advances in new therapeutic agents for heart failure. In contemporary studies, Class III/IV heart failure patients, characterized by heart failure hospitalizations in the previous 12 months, severely impaired baseline cardiac function, increased systolic and diastolic volumes, and elevated B-type natriuretic peptide, or BNP, levels, have been reported to have an incidence of death or cardiovascular hospitalization approaching 50% over a median period of 16.6 months.

The definitive method of treating end-stage disease currently is a heart transplant or implanting a mechanical assist device. Although there are many patients awaiting a transplant, due to limited supply there were only 2,378 transplants performed in the United States in 2012.

Recently, results from our Phase 2 trials in patients with Class II/III CHF and in patients with Class III/IV CHF requiring assisted mechanical assist devices have shown that our MPCs appear to have the greatest efficacy in patients with the most advanced CHF. We believe that targeting this patient population can provide us with the shortest Phase 3 program, the fastest time to market, with the most unmet need, and the opportunity for the most attractive pricing.

Current Status and Anticipated Milestones

The Phase 3 trial is actively enrolling patients with NYHA Class II/III disease. The enrollment criteria for this trial, including a heart failure hospitalization within the previous 9 months and high BNP levels, are expected to result in enrichment for patients at higher risk of recurrent hospitalizations and death. This trial design is based

 

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on the results from our completed Phase 2 trial for MPC-150-IM for the treatment of NYHA Class II/III CHF. We expect database lock for the first interim analysis will occur towards the end of 2015. During first quarter 2016, we expect to announce the results of the first interim analysis of safety and efficacy from the Phase 3 trial of our Tier 1 product candidate MPC-150-IM for CHF. We believe that positive results from this interim analysis will reinforce and validate the Phase 3 trial design assumptions that we made based on our Phase 2 trial results. A subsequent second interim analysis of the primary endpoint will be used for possible resizing or early trial termination, with those results expected in early 2017. We expect that our Phase 3 trial will be complete in 2018.

A Phase 2b trial in patients with end-stage or advanced heart failure whose circulation is supported mechanically by a left ventricular assist device, or LVAD, is planned to begin the first quarter 2015 and will be funded by the NIH. We expect that results from this trial will be available in early 2017. This trial will be conducted by a multi-center team of researchers within the NIH-funded Cardiothoracic Surgical Trials Network, or CSTN, led by Icahn School of Medicine at Mount Sinai, New York. This trial is based on preliminary results obtained from a pilot trial testing a single 25 million low dose MPC injection in this same patient population, being conducted and reviewed by the same investigator group.

Completed Phase 2 Trials

Phase 2 Trial in NYHA Class II/III CHF Patients.

The primary objective of the Phase 2 study was to evaluate the safety and tolerability of 3 increasing doses (25, 75, or 150 million cells) of MPCs in patients with heart failure due to left ventricular systolic dysfunction of either ischemic or non-ischemic etiology. The secondary objective was to explore functional efficacy by using major adverse cardiac events, or MACE, data, imaging, and other surrogates for clinical events. Patients were allocated sequentially to 1 of 3 dosing cohorts with randomization to receive either endomyocardial injections of MPCs or mock mapping/ injection procedures (control). An additional time-to-first event analysis of heart failure-related MACE, or HF-MACE, was performed. HF-MACE was defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events.

We hypothesized that the greatest benefit would be seen at the highest dose, since in multiple large animal studies in heart failure of either ischemic and non-ischemic etiology, the greatest cardiac recovery was seen with a single MPC injection in the 110-225 million dose range, delivered by either of two different endomyocardial catheter systems. Safety and MACE endpoints were evaluated for up to 3 years for all patients. Surrogate efficacy endpoints were evaluated at baseline, 3, 6 and 12 months, except for single-photon emission computed tomography and radionuclide angiography, or MUGA, which were only performed at baseline and 6 months.

Patients with NYHA Class II or III heart failure who had a left ventricular ejection fraction, or LVEF, of less than 40% by baseline screening echocardiogram were recruited for the study and were enrolled at 6 sites. All patients were between 20 and 80 years old, had either non-ischemic or ischemic cardiomyopathy that was not amenable to percutaneous intervention or surgery, and were on a prescribed regimen of maximal tolerated heart failure medications. Key exclusion criteria included acute myocardial infarction within 30 days, sustained ventricular tachycardia, unstable angina, or the presence of a left ventricular thrombus.

Patients were randomized to either an injection of 25, 75 or 150 million MPC by endomyocardial catheter or scripted mock injections (control group) while in the catheterization laboratory. MPCs were administered into the left ventricle (approximately 15-20 injections of 0.2ml/injection) using the J&J Myostar™ injection catheter and NOGASTAR™ Mapping Catheter system that identifies viable/hibernating myocardium based on electrical voltage, theoretically making targeting of healthy but at risk tissue easier. This catheter has the largest safety profile (with use in over 1000 patients) and was the most acceptable catheter to the FDA for initiating Phase 3 studies.

Pilot Phase 2a Trial in Patients With Advanced Heart Failure Requiring Mechanical Support

A multi-center, randomized, double-blind, sham-procedure controlled trial is evaluating 30 patients 2:1 randomized to endomyocardial injection of 25 million MPCs or medium (control) during LVAD implantation for either bridge-to-transplant or as a destination therapy. The primary safety endpoint is incidence of infectious

 

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myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization (90 days post-randomization). The key efficacy endpoints are functional status and ventricular function, while temporarily weaned from LVAD support (90 days post-randomization). Patients are followed until transplant or 12 months post-randomization, whichever comes first. The two treatment groups were similar with respect to baseline characteristics. The mean age was 57.4 years (±13.6) and 83.3% were male. The mean LVEF was 18.1% (± 4.3), 36.7% had ischemic cardiomyopathy, and all patients were implanted with HeartMate II^® LVADs (Thoratec Corp.), 66.7% of which were implanted for destination therapy indication.

Phase 2 Trial Results

Phase 2 Trial in NYHA Class II/III CHF Patients

Overall, results obtained in patients with CHF showed positive effects on clinical outcomes, including left ventricular remodeling and functional exercise capacity. The 150 million cell dose showed greatest threshold benefit for reducing HF-MACE long-term. More specifically:

 

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Endomyocardial injections of MPCs in patients with chronic heart failure were feasible and safe. The incidence of adverse events was similar across all groups.

 

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Treatment of patients with MPCs was not associated with a clinically significant immune response.

 

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At 6 and 12 months, there was an improvement in the 75 million and 150 million doses for left ventricular end systolic volume, or LVESV, and left ventricular end diastolic volume, or LVEDV, in MPC-treated patients compared with controls;

 

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The 150 million cell dose showed the greatest effect compared to controls for LV remodeling (LVESV and LVEDV both p<0.02) at month 6 post treatment and functional exercise capacity as measured by six minute walk test (6MTW: p=0.062) at month 12 post treatment.

 

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As a post-hoc blinded analysis, over 36 months of follow up, the 150 million cell dose was associated with a significantly greater probability of remaining free of HF-MACE events compared to the control group (0% versus 33% HF-MACE by Kaplan-Meier, p=0.025 by log-rank). The 25 and 75 million doses were not statistically different than controls with respect to this measure.

HF-MACE by Kaplan-Meier Curve-36 Months Post-Treatment

 

 

 

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A second post hoc blinded analysis was undertaken at 36 months comparing the 150 million cell dose versus placebo in 18 Class II/III CHF patients who met criteria for advanced heart failure, notably a baseline LVESV >100ml as a surrogate for significant myocardial contractile abnormality. This analysis was assessed against a comparison of the 150 million cell dose versus placebo in 12 Class II/III CHF patients with baseline LVESV <100ml.

This analysis demonstrated that:

 

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all of the HF-MACE events over 36 months of follow-up were exclusively in the placebo-treated controls with advanced heart failure; more specifically, among 18 Class II/III CHF patients with baseline LVESV >100 ml, 5/7 (71%) placebo-treated versus 0/11 150 million MPC-treated experienced one or more HF-MACE events over 36 months; none of 12 placebo or 150 million MPC-treated Class II/III patients with baseline LVESV <100ml had any HF-MACE events;

 

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control patients with advanced heart failure (baseline LVESV > 100 ml) were the fastest progressors over 6 months in terms of significant worsening in LVESV and LVEDV volumes, and loss of ejection fraction, or LVEF; and

 

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the 150 million MPC dose had the greatest magnitude of cardioprotective effect on LVESV (p<0.02), LVEDV (p<0.03) and LVEF (p<0.05) in Class II/III patients with the greatest baseline LV contractile abnormality over a 6 month follow up period (i.e. those with baseline LVESV > 100 ml)

Comparison of All Subjects versus Subjects With LVESV > 100 mL

 

Entire Cohort Baseline to Month 6

Change LVESV > 100 mL Baseline to Month 6

Control (n=15)

MPC-IM-150 (n=15)

Change Relative to Control

Control (n=7)

MPC-IM-150 (n=11)

Change Relative to Control

P-values

LVESV

+20

-7

-27

+46

-8

-54

<0.02

LVEDV

+20

-10

-30

+41

-10

-51

<0.03

LVEF

-2.3

+0.6

+2.9

-6.4

+1.7

+8.1

<0.05

 

A p-value is a probability, ranging in value from 0 to 1, which indicates the likelihood that the results of a study are different between treatment and control groups. The lower the p-value, the harder it would be to see the results by chance alone. P-values below 0.05 are typically referred to as statistically significant.

 

 

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Pilot Phase 2a Trial Results in Patients With Advanced Heart Failure Requiring Mechanical Support

The preliminary results of this trial were presented at the American Heart Association Scientific Sessions 2013 and published in Circulation in June 2014.

To date, no patients developed a primary safety event at the trial’s 90-day primary endpoint, nor during the 12-month follow-up period. At the 90 day primary endpoint analysis of the trial, there were three deaths (30%) in the control group and none in the MPC group. Six MPC patients (30%) died over the 12 months.

At the 90-day primary end-point analysis of the trial, 50% of MPC treated patients were able to successfully tolerate weaning off of LVAD support for 30 minutes compared to 20% in the control group. Eighty-five percent (85%) of MPC patients tolerated one or more temporary LVAD weans over the 12 month follow-up period, compared to 40% of control patients.

Based on these results, the posterior probability that a single injection of the 25 million low-dose of MPCs increased the likelihood of successful weaning is 93%. The duration of temporary LVAD wean, for those who tolerated it, was greater in MPC than control patients at each time point.

 

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This trial has to date demonstrated feasibility and safety, and suggested that a single low-dose MPC injection improved cardiac function and had an early benefit on survival. We hypothesize that a higher MPC dose may further enhance the ability to wean LVAD recipients off support, and may show a more prolonged survival benefit.

12 Month Survival in the MPC and Control Groups

 

Ongoing Phase 3 Clinical Trial of MPC-150-IM In Class II/III Patients With CHF

The Phase 3 trial is being conducted by our partner Teva and is actively enrolling in the United States. The clinical protocol was designed after consultation with both the FDA and the European Medicines Agency. The Phase 3 trial design is a double-blinded, 1:1 randomized, sham-procedure-controlled study evaluating a single dose of 150 million MPCs, delivered via endomyocardial injection catheter to the left ventricle, in NYHA Class II/III heart failure patients with an ejection fraction of less than 40%, high BNP levels, and a heart failure-related hospitalization within the past nine months. We expect physicians to favor enrollment of late stage CHF patients in this trial.

An internal review of baseline characteristics of the first 25 patients showed that 90% had LVESV >100ml. Because the Phase 2 trial described above showed that MPC-150-IM most effectively improved outcomes in more advanced heart failure patients, or those with baseline LVESV>100ml, we believe that the enrollment criteria for our ongoing Phase 3 trial should enable selection of a target patient population that is well-suited to respond to MPC-150-IM. Moreover, we believe that this target patient population represents a major unmet medical need at high risk of rapid progression, meaning that if successful in this difficult-to-treat population, MPC-150-IM should be well-positioned for attractive reimbursement.

The primary efficacy endpoint of the trial is a time-to-first-event analysis of HF-MACE, defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events. These non-fatal decompensated heart failure events require use of intravenous diuretics during an in-hospital stay or during an outpatient visit. Adjudication of HF-MACE will be performed by an independent, blinded clinical endpoint committee. The trial is an event-driven trial. The trial aims to enroll approximately 1,730 patients and will include two interim analyses of efficacy and/or safety.

Database lock in preparation for the first interim analysis is expected to be performed toward the end of 2015. A second interim analysis is planned for potential resizing, or for early termination based on futility.

Phase 2b Trial of MPC-150-IM in Patients With Advanced Heart Failure Requiring Mechanical Support

A 120-patient trial, to be conducted by the NIH-funded CSTN, will evaluate the effects of a single injection of MPC-150-IM into the hearts of patients with advanced heart failure. This is a prospective, multi-center, double-blind, 2:1 randomized, single dose cohort, sham procedure controlled trial to evaluate the safety and efficacy of injecting a dose of 150 million MPCs into the native myocardium of LVAD recipients. Patients with

 

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advanced CHF, implanted with an FDA-approved LVAD as either bridge-to-transplant or destination therapy may be eligible to participate in the trial. All patients will be followed until 12 months post randomization.

The primary objectives of this trial are to evaluate the safety and efficacy of injecting 150 million MPCs into the native myocardium of LVAD recipients. The primary efficacy endpoint of this study is survival over 12 months, and the co-primary endpoint is functional status, while temporarily weaned from LVAD support, over the 12 months post randomization. Functional status is defined by the ability to tolerate wean from LVAD support to low flow for 30 minutes. Secondary endpoints will include physiological parameters (which include echocardiography assessment of cardiac function and remodeling) and neurocognitive assessments.

CSTN is currently completing submissions and interactions with the FDA and Health Canada. Recruitment is expected to be completed by the second half 2015, and results are expected second half 2016.

MSC-100-IV/JR-031 for the Treatment of acute Graft versus Host Disease (aGVHD)

Overview

MSC-100-IV is our product candidate for the treatment of aGVHD following allogeneic BMT. Available data from clinical dose ranging studies identified an effective dose to be 2 x 10⁶ hMSC/kg, body weight, to be administered twice weekly for four weeks after diagnosis of aGVHD. For the U.S. market, the unit packaging is 100 million cells/bag for intravenous infusion. JR-031 for the treatment of aGVHD is our licensed product candidate that JCR is currently developing in Japan.

In a BMT, donor cells attack the recipient, aGVHD. The donor T-cell mediated inflammatory response involves secretion of TNF-alpha and INF-gamma, resulting in activation of pro-inflammatory T-cells and tissue damage in the skin, gut and liver which is often fatal.

MSC-100-IV was developed to counteract the inflammatory processes by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of endogenous anti-inflammatory cells to involved tissues.

Currently there are no approved therapies for steroid-refractory patients with aGVHD in the U.S., and off-label options have demonstrated mixed efficacy with high toxicity. As such, we believe there is a significant need for effective treatment with a favorable risk/benefit profile.

MSC-100-IV is the world’s first conditionally approved allogeneic stem cell therapeutic having received conditional approval in Canada, and is the only stem cell therapeutic designated by the FDA as both an orphan drug and fast track product candidate. MSC-100-IV has been used for the treatment of aGVHD in children in the U.S., Canada and several European countries under an expanded access program, or EAP. This program enrolled more than 240 patients suffering from steroid-refractory aGVHD.

Market Opportunity

According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%. The cost of treating patients with steroid-refractory aGVHD, who represent approximately 50% of all cases, is around US $325,000 per patient.

The aGVHD market requires a small, targeted commercial footprint. The target audience for aGVHD will primarily be board-certified in hematology-oncologists who perform hematopoietic stem cell transplants. In the U.S., there are approximately 75 centers that perform pediatric transplants, with 50% of all transplants occurring at approximately 15 centers. Similarly, there are approximately 110 centers that perform adult transplants with half of those transplants occurring at approximately 20 centers.

 

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Current Status and Anticipated Milestone

Japan. Our licensee, JCR, filed for regulatory approval for its aGVHD MSC based product (JR-031) in Japan in September 2014 and was granted orphan drug priority review. During the second half of 2015, we expect JCR will receive a response to its request for approval for its JR-031. If successful, JR-031 will be the first allogeneic cell-based product approved in Japan.

U.S. For the pediatric indication, we expect to initiate a Phase 3 trial by the end of 2014, to report top-line results of this Phase 3 trial during first half 2016, and to make our BLA filing during second half 2016. During the conduct of our pediatric Phase 3 trial, we expect to have discussions with the FDA regarding the trial design for a potential Phase 3 trial to support approval of this product for adults with liver or gut aGVHD.

Rest of the World. MSC-100-IV has received conditional approval for the treatment of pediatric aGVHD from Health Canada in Canada, and we expect to launch in Canada in mid-2016. We expect to seek EU approval after the results of our Phase 3 (pediatric) trial are released.

Completed Clinical Trials/EAP

Pediatric Population

Since 2008 we have conducted an expanded access program, or EAP, called Protocol 275, for a group of pediatric patients with steroid refractory, or SR, aGVHD. An EAP provides investigational therapy to patients outside of a clinical trial in a country that has not received marketing approval for the product candidate being evaluated. It is intended for the treatment of serious or life-threatening conditions for which there is no available alternative treatment and where there is existing evidence of safety as well as signals of efficacy in order to establish that the patient may benefit from the therapy. An EAP may be offered on an individual basis or for a group of patients. Although some of our EAP participants previously participated in controlled clinical trials, none of the patients in our EAP are currently participating in our controlled clinical trials and the EAP itself is not a controlled trial.

Our Protocol 275 includes defined eligibility and treatment plan, controlled data and safety collection and pre-specified endpoints and data analysis. All trial components are designed to assure the conduct is consistent and data are valid for interpretation. It is an open label program with single arm design so all patients enrolled receive the treatment.

Over 240 pediatric patients with SR-aGVHD have been treated on this protocol. As such, we believe that the results from the Protocol 275 EAP provide us with valuable data which may support possible product approval. The results of the first 75 patients from Protocol 275 were published in 2013, and additional analysis of data from the first 160 patients has recently been completed. Use of MSC-100-IV resulted in a clear, significant survival benefit among responding pediatric BMT recipients with SR-aGVHD. Of the 160 children treated, 64% achieved a response at day 28 to MSC-100-IV. Among responders, 81% were alive at day 100, compared to 39% survival at 100 days among non-responders (p<0.0001, log rank test). Day 28 response to MSC-100-IV was a significant predictor of improved day 100 survival (p<.001). The EAP protocol for MSC-100-IV represents the largest prospective program of its kind in pediatric patients with SR-aGVHD.

 

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In this Protocol 275 the FDA has acknowledged that the results from MSC-100-IV treatment provide a substantial safety experience and likely evidence of a treatment effect. The FDA has also acknowledged that given the prior results with mesenchymal lineage stem cells in this indication, and the unmet medical needs, that a randomized controlled study is neither feasible or ethical. However, given the number of additional therapies received by many of the EAP patients (often 2-4 prior therapies), additional data in the absence of confounding additional therapies has been requested by the FDA. We expect to provide this additional data through a single-arm, open-label Phase 3 study of 60 pediatric patients with SR-aGVHD. These patients will not receive other line therapies thus allowing the treatment effect of MSC-100-IV to be clearly observed. The FDA has indicated that should this trial meet its designated endpoints, which is not guaranteed, the resulting data from this trial will be the basis for an accelerated approval pathway.

 

Adult Population

Protocol 280 was a Phase 3 trial conducted between 2006 and 2009 in 260 adult (n=232) and pediatric patients (n=28) with Grades B-D steroid-refractory aGVHD. This trial included patients with skin, liver and lower GI complications. This trial had a rigorous primary endpoint of complete and durable response, meaning complete resolution of all clinical signs of aGVHD that had to be maintained for at least 28 consecutive days (durable complete response, or DCR). Additional efficacy endpoints included overall response for each organ at day 28 and day 100; survival at 100 and 180 days post first infusion; time to complete response; and cumulative steroid usage. Overall, treatment with MSC-100-IV was safe and resulted in improved clinical responses, particularly in patients with generally more serious visceral organ involvement. Overall clinical response correlated with improved survival, as was also demonstrated in the ongoing pediatric EAP.

In the per-protocol population (those receiving at least 6 infusions and without major protocol violations or violations of inclusion/exclusion criteria, n=179), MSC-100-IV outperformed placebo on the primary endpoint, with a DCR rate of 40% versus 28% (p=0.087), but did not reach statistical significance. In the pre-specified subgroup analysis MSC-100-IV treated patients showed significant improvements in overall response rates in the difficult to treat liver and lower GI aGVHD subgroup: in subjects with liver aGVHD, MSC-100-IV improved day 100 overall response to 76% versus 47% in controls (p=0.039, n=61); for subjects with lower-GI aGVHD, MSC-100-IV improved day 100 overall response to 82% versus 64% in controls (p=0.015, n=174).

 

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The incidence of adverse events observed in this study were what would otherwise be expected for patients recovering from HSCT and battling steroid refractory GVHD, with no difference reported between the MSC-100-IV and placebo treatment groups overall, and with most treatment-emergent adverse events deemed to be unrelated to treatment (78.5% and 81.5% in MSC-100-IV and placebo treatment groups, respectively). Variance in response by subgroup is illustrated below.

Phase 3 Trials

During the conduct of our open-label study of approximately 60 children, we expect to have discussions with the FDA regarding the trial design for a potential Phase 3 trial to support approval of this product for adults with liver or gut aGVHO.

Tier 2 Programs

MPC-300-IV for the Treatment of Diabetic Kidney Disease

Overview

MPC-300-IV for the treatment of diabetic kidney disease, including diabetic nephropathy, is our proprietary Tier 2 product candidate, consisting of up to 300 million MPCs delivered intravenously.

The aberrant activation of the immune system that occurs in type 2 diabetes patients is associated with inflammation of fat tissues, resistance to the effects of insulin in the fat tissues, poor glucose control, and ultimately microvascular and macrovascular damage involving the kidneys, heart and eyes. We are developing a high-dose product for intravenous administration to target the polyvascular complications of patients with type 2 diabetes, including diabetic nephropathy.

Market Opportunity

While all classes of current anti-diabetic agents are effective at improving glucose control, they are not effective in preventing or potentially reversing end-organ complications in type 2 diabetes, a complication that affects approximately 40 to 50% of the over 20 million people in the U.S. with diabetes. More specifically, in 2011, approximately 115,000 new patients started treatment for end-stage kidney disease, involving either dialysis or a transplant, diabetes being the major cause. To the extent MPC-300-IV can be shown to be effective in this population, additional applications would be possible for the over 20 million people in the U.S. who have chronic kidney disease.

Current Status and Anticipated Milestones

Our Phase 2 trial of MPC-300-IV for the treatment of diabetic kidney disease is ongoing. We expect to announce three-month and six-month results of a placebo-controlled, dose-ranging study (2 doses) in 30 grade 3b diabetic nephropathy patients at the end of first quarter 2015. Both treatment cohorts have completed dosing and

 

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are being followed up per protocol. We expect that a positive treatment effect evident at three or six months following a single intravenous injection of MPC-300-IV will enable discussion of adaptive Phase 2b/3 clinical trial designs with the FDA, and may enable us to elevate this product candidate to Tier 1.

Phase 2 Design

The first complication of type 2 diabetes we are evaluating is diabetic kidney disease, also known as diabetic nephropathy. The ongoing study enrolled type 2 diabetic patients with moderate to severe renal impairment (i.e. Stage 3b-4 chronic kidney disease) in a randomized, placebo-controlled Phase 2 trial in Melbourne, Australia to evaluate the effects over three months of a single infusion of MPCs versus placebo in 30 subjects with type 2 diabetes and stage 3b-4 chronic kidney disease.

MPC-300-IV for the Treatment of Rheumatoid Arthritis (RA) (Biologic Refractory)

Overview

MPC-300-IV is a proprietary Phase 2 product candidate being developed for biologic-refractory rheumatoid arthritis, or RA. The product candidate is being evaluated at both 1 and 2 million cell/kg dose(s) via intravenous infusion.

Market Opportunity

RA is a disease that affects approximately 1.3 million people in the U.S., and is responsible for approximately 250,000 hospitalizations and 9 million physician visits per year in the U.S. If left untreated, RA can lead to joint destruction, deformity, disability, and decreased quality of life. Existing biologic therapies have made major inroads to the treatment of RA, often by targeting single pathways of inflammation in a disease that is driven by multiple inflammatory cytokine pathways. Despite the variety of options currently available, approximately one third of patients either do not respond or cannot tolerate these therapies, or lose efficacy over time. There is therefore a segment of the population who would benefit from an alternative therapeutic approach.

Current Status and Anticipated Milestones

Our Phase 2 trial of MPC-300-IV for the treatment of biologic refractory RA is ongoing. We expect to announce three-month and six-month results from this Phase 2 placebo-controlled, dose-ranging study for all 48 treated patients in this study. The first treatment cohort has been fully enrolled, and the second dose cohort is currently enrolling. We expect to announce three-month and six-month results from the Phase 2 trial for this product during the third quarter 2015. We expect that a positive treatment effect evident at three or six months following a single intravenous injection of MPC-300-IV will enable discussion of Phase 3 clinical trial designs with the FDA, and we believe it will facilitate discussions with potential strategic partners.

Ongoing Phase 2 Trial

We initiated a Phase 2 trial to evaluate the safety, tolerability and effectiveness of a single intravenous infusion of two MPC dose levels a single intravenous infusion of its MPCs for the treatment of active RA in patients who have failed at least one TNF-alpha inhibitor. This randomized, double-blind placebo-controlled sequential dose escalation trial is currently enrolling, with recruitment already completed for 24 patients in cohort 1 who received a single dose of 1 million MPCs per kg. These patients continue to be followed-up, while patients in the second cohort receive an MPC dose of 2 million per kg completed. The results of the Phase 2 program will guide the future direction of this program.

MPC-25-IC for the Treatment of Acute Cardiac Ischemia

Overview

MLCs release factors that induce functional cardiac recovery by simultaneous regeneration of endogenous vascular network formation as well as of endogenous cardiomyocytes or cardiomyocyte precursors. When injected into ischemic myocardium, MLCs are very potent inducers of large caliber arteriogenesis compared to

 

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only small vessel angiogenesis obtained with hematopoietic stem cells which only give rise to the endothelium of capillaries. Based on this mechanism, and positive results of a sheep intracoronary preclinical study, we commenced the Phase 2 Allogeneic MPC Infusion in myoCardial Infarction, or AMICI trial, of MPC-25-IC, the first clinical study to evaluate an allogeneic cellular therapy for AMI delivered by intracoronary infusion.

Market Opportunity

The majority of heart attack patients undergo angioplasty and stent procedures successfully. However, a high risk subset of patients progress over the ensuing two years to develop heart failure despite maximal therapy. For these patients, a therapy that can protect at-risk heart muscle cells from dying by delivery via intra-coronary administration at the time of the angioplasty, could prevent this major complication.

Current Status

Our Phase 2 trial for MPC-25-IC for the treatment of acute myocardial infarction is ongoing.

Phase 2 Design

The AMICI trial is a prospective, randomized, placebo-controlled, double blind clinical trial that will analyze the effect of intracoronary infusion of MPCs in patients with an ST-elevation myocardial infarction of the anterior wall. The therapy will be initiated directly following revascularization of the left anterior descending artery, along with standard therapies for AMI. Up to 225 patients with a first anterior wall AMI will be enrolled. After successful revascularization, the patients will be 1:1:1 randomized to receive 12.5 or 25 million MPC or placebo via intracoronary infusion. The primary safety endpoint is defined as the occurrence of major adverse cardiac events, or MACE, at 30 days follow up. The secondary efficacy endpoint is defined as reduction in the left ventricular end-systolic volume. Additional efficacy parameters from cMR and echocardiography will also be evaluated. The Phase 2a/2b trial is actively recruiting in Europe, Australia, and New Zealand.

MPC-25-Osteo for Spinal Fusion

Overview

MPC-25-Osteo for spinal fusion is a proprietary Phase 3-ready product candidate. All doses of MPC-25-Osteo for the treatment of spinal fusion consist of 25 million MPCs delivered on a collagen sponge to the disk space.

Market Opportunity

According to Millennium Research Group, or MRG, in the U.S. there were approximately 392,000 thoracolumbar spinal fusion procedures performed in 2012 of which lumbar fusion procedures form a significant part. MRG estimates the overall worldwide market for bone graft substitutes to be nearly $1.6 billion in 2012 with the majority of bone graft revenues, approximately 70%, coming from spinal fusion procedures.

Current Status

Our Phase 2 trial for MPC-25-Osteo for the treatment of spinal fusion is completed and our Phase 3 trial design is ongoing. We view MPC-25-Osteo as a potential collaboration or partnership opportunity.

Phase 2 Design

We conducted a 24 patient Phase 2 study of MPCs (implanted into intervertebral disc space) undergoing 1 or 2-level lumbar interbody fusion via posterior procedures (TLIF, PLIF). Patients were randomized to 25 million MPC dose (n=8), 75 million MPC dose (n=8) or autograft from the hip (n=8).

Phase 2 Top Line Results

Treatment with MPC-25-Osteo was equivalent to hip autograft, the gold standard for this procedure, at 12 months in terms of fusing the spinal segment, reducing pain and improving function, without the need for a

 

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second surgical procedure to harvest the patient’s own bone, which can cause blood loss, infection and chronic pain at the bone harvest site.

Importantly, there were no cell-related serious adverse events such as excessive bone formation or nerve compression, which have been reported with other biologic therapies in lumbar spinal fusion.

Phase 3 Design

We have had an end-of-Phase 2 meeting with the FDA, and as a result of that meeting there is a consensus regarding the scope and design of a Phase 3 program using MPC-25-Osteo for the treatment of lumbar spinal fusion. While we prepare this product for Phase 3, we intend to continue our analysis of strategic options for the development and distribution of this product, which include a potential collaboration or partnering options.

MPC-CBE for the Treatment of Bone Marrow Transplant (BMT)

Overview

MPC-CBE for BMT is a proprietary Phase 3 product candidate. All doses of MPC-CBE for the treatment of BMT consist of hematopoietic stem cells expanded ex vivo by incubation with MPCs, administered intravenously.

Market Opportunity

BMT is the primary treatment option for many patients who have undergone treatment for advanced blood cancers, such as acute myeloid leukemia. At present, approximately 30,000 allogeneic BMTs are performed globally. The vast majority of these transplants use adult donor sources.

We believe the number of BMTs performed could be significantly increased if there was a safe alternative to the existing donor match material used to treat these patients. Our Phase 3 clinical trial using MPCs to expand hematopoietic precursors from cord blood for transplantation in cancer patients is ongoing. If this product is successful, it has the potential to increase the total number of unrelated donor transplants, and provide therapy for patients with malignant diseases for which transplantation is the only option for a potential successful treatment. We expect to complete our Phase 3 trial for BMT in 2018. This product falls under the Teva collaboration.

Current Status

Our Phase 3 trial for MPC-CBE for the treatment of BMT patients is ongoing.

 

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Phase 2 Design

A 24 patient Phase 2 trial was conducted where patients were given MPC-expanded cord blood cells. Targeted patients were adults with hematologic cancers.

 

 

Phase 2 Top-Line Results

MPC-expanded cord blood significantly improved engraftment. Median time to neutrophil engraftment was 15 versus 24 days with unexpanded cord blood. Median time to platelet engraftment was 42 days for patients receiving MPC-CBE versus 49 days with expanded cord blood.

Ongoing Phase 3 Trial

A 240 patient Phase 3 study comparing patients receiving a cord blood unit expanded with our MPCs (MPC-CBE) (active arm) versus patients receiving an unexpanded cord blood unit (control arm), in evaluating reconstitution of bone marrow after high-dose chemotherapy is ongoing. Primary endpoint is time to neutrophil and platelet recovery.

 

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MSC-100-IV for the Treatment of Crohn’s Disease (Biologic Refractory)

Overview

MSC-100-IV for the treatment of Crohn’s disease refractory to steroids and immune suppressants is a proprietary product candidate currently being evaluated in a Phase 3 trial. All doses of MSC-100-IV for the treatment of Crohn’s disease consist of 100 to 200 million MSCs delivered intravenously in a multiple dose regime. An additional pivotal Phase 3 program will be needed for approval.

MSC-100-IV has demonstrated immunomodulatory properties to regulate T-cell mediated inflammatory responses by inhibiting T-cell proliferation and down-regulating the production of the pro-inflammatory cytokines, including tumor necrosis factor-alpha, or TNF-alpha, and interferon gamma. More critically, MLCs have been shown to be capable of effective down-regulation of Th17 cells, reduction in IL-17 levels, and induction of FoxP3 regulatory T cells. These inflammatory pathways are acknowledged to be central to the pathogenesis of Crohn’s disease and other inflammatory conditions.

Market Opportunity

Crohn’s Disease, or CD, is a chronic inflammatory disorder of the gastrointestinal tract, characterized by periods of remission and symptomatic relapse. The burden of CD is substantial, accounting for more than 1 million cases in the seven major pharmaceutical markets in 2012.

The U.S. has the highest prevalence of the disease, with more than 600,000 people afflicted and approximately 20,000 new cases diagnosed each year. Of the 600,000 U.S. patients, studies have shown that approximately 8-20% are unresponsive, resistant or intolerant to existing treatments, which include corticosteroids, immunosuppressants and biologics. The global CD therapeutics market was estimated to be worth $4.4 billion in 2012.

A treatment to induce rapid remission is highly needed, particularly in high-risk patients such as those with biologic-resistant disease and those with fistulas, a complication of CD which occurs in 20-40% of patients and often requires invasive surgical procedures.

Current Status

Our Phase 3 trial for MSC-100-IV for the treatment of CD is ongoing.

Clinical Data and Design

We conducted a 9 patient pilot Phase 1/2 study in 2006, where there was a statistically significant decrease in mean Crohn’s Disease Activity Index, or CDAI, scores of 105 points (reduced from 341 to 236) in MSC-100-IV treated patients by day 28 post-treatment, compared to control (p=0.004). The CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease.

Based on those results, a 330 patient Phase 3 multi-centered, double-blind, randomized, placebo-controlled was initiated in 2007. The focus of this trial is on the safety and efficacy of MSC-100-IV in moderate to severe CD in patients who are refractory to steroid, immunosuppressant and biologic therapy. The primary endpoint is the proportion of patients experiencing disease remission within 28 days of treatment, compared to those patients receiving placebo, as defined by an absolute CDAI score below 150.

An interim analysis in 2009 suggested that one of the doses reached statistical significance for disease remission in the targeted population. As a result of that analysis, enrollment was restarted in 2010 utilizing only the best-performing (but undisclosed) dose and placebo.

This trial is ongoing, and when complete, we will evaluate whether the primary endpoint of day 28 remission in biologic-refractory patients has been achieved, whether there is evidence of efficacy in high-risk groups such as those with fistulizing disease and multi-drug refractory patients, and whether maintenance dosing can result in longer duration of effect.

 

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Manufacturing and Supply Chain

Overview

Our manufacturing strategy for our cellular product candidates focuses on the following important factors: (i) clear product delineation to protect pricing and partner markets by creating distinct products using discrete manufacturing processes, culture conditions, formulations, and/or dose regimens; (ii) designing commercial scale-up and supply to meet increasing demand; (iii) implementing efficiencies and yield improvement measures to reduce cost-of-goods; (iv) maintaining regulatory compliance with best practices; and (v) establishing and maintaining multiple manufacturing sites for product supply risk mitigation.

The stem cell manufacturing and distribution process generally involves five major steps:

 

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Procure bone marrow—acquire bone marrow from healthy adults with specific FDA-defined criteria, which is accompanied by significant laboratory testing to establish the usability of the donated tissues;

 

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Create master cell banks—isolate MLCs from the donated bone marrow and perform a preliminary expansion to create master cell banks. Each individual master cell bank comes from a single donor.

 

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Expand to therapeutic quantities—expand master cell banks to produce therapeutic quantities, a process that can yield thousands of doses per master cell bank, with the ultimate number depending on the dose for the respective product candidate being produced;

 

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Formulate, package and cryopreserve; and

 

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Distribution—with the exception of procurement and creation of master cell banks, our manufacturing is conducted in Lonza’s Singapore facility, and products will be frozen, then shipped to Lonza or other storage sites in the U.S. and other jurisdictions via cryoshippers. Those distribution centers then send the products on to treatment centers in cryoshippers. Treatment centers either move the products into their own freezers, or receive the cryoshipper in “real time” and product stays in the cryoshipper until thawed for patient use within a well-defined window. We intend to continue utilizing this approach in the future, except that we intend to settle on a new network of distributors in various regions.

Our Tier 1 product candidates are manufactured in two-dimensional, or 2D, planar, 10-layer cell factories, using media containing fetal bovine serum, or FBS.

The relatively small patient numbers and orphan drug designation for MSC-100-IV for aGVHD led us to believe that 2D manufacturing will provide commercial cost of goods for this product candidate if fully approved. We also believe that 2D manufacturing is commercially feasible for Phase 3 trial supply and the initial launch of MPC-06-ID for CDLBP.

However, to build up commercial scale-up and supply for secondary indications for MSC-100-IV, for MPC-150-IV for CHF, and for full market supply of MPC-06-ID, we are transitioning the manufacturing processes to three-dimensional, or 3D, bioreactors with greater capacity to improve efficiency and yields, with resulting lower-cost of goods.

Our manufacturing activities have met stringent criteria set by international regulatory agencies, including the FDA. By using well-characterized cell populations, our manufacturing processes promote reproducibility and batch-to-batch consistency for our allogeneic cell product candidates. We have developed robust quality assurance procedures and lot release assays to support this reproducibility and consistency.

Key Manufacturing Activities

The following represent current key manufacturing activities:

 

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Establishment of production in Lonza’s Singapore facility: historically, all of our product candidates were produced in a Lonza plant in Maryland, United States. We are still transitioning our production to Lonza’s Singapore facility, but we have produced product from this facility that has been released for clinical use. We are currently finalizing the process for producing MSC-100-IV for aGVHD, which we expect to result in clinical products being made by the end of 2014.

 

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Introduction of defined media: we have developed a proprietary FBS-free media, and that greatly enhances the yields achieved in production. We have made substantial progress in this development effort, and once complete, we intend to conduct “comparability” studies to illustrate that products produced with this media are equivalent to those produced using FBS based media.

 

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Establishment of 3D bioreactor production: we have made significant advances in the development of 3D bioreactor processes. We have conducted successful production runs in our facilities at a 50 liter scale, our targeted commercial volume for production. When finalized, our proprietary 3D bioreactor process will be transferred to Lonza to be used solely for our clinical and commercial production. We expect to evaluate products produced in 3D bioreactors in later stages of our Phase 3 clinical trials, which will serve as FDA required comparability studies to 2D if successful.

While we remain confident in our ability to deliver successful outcomes from each of these activities, any unexpected issues or challenges faced in doing so could delay our programs or prevent us from continuing our programs.

Intellectual Property

We have a large patent portfolio of issued and pending claims covering compositions of matter, uses for our MLC cell-based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our manufacturing processes, with over 67 patent families, including more than 572 patents or patent applications as of November 2014.

One of our major objectives is to continue to protect and expand our extensive estate of patent rights and trade secrets, which we believe enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary technologies, and support our corporate strategy to target large, mature and emerging healthcare markets for our exploratory therapeutic product candidates.

More specifically, our patent estate includes issued patent and patent applications in major markets, including, but not limited to, the United States, Europe and Japan. The patents that we have obtained, and continue to apply for, cover MLC technologies and product candidates derived from these technologies, irrespective of the tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp.

These patents cover, among other technology areas, a variety of MLCs (including MPCs and MSCs), and the use of MLC for expansion of hematopoietic stem cells, or HSCs. Among the indication-specific issued or pending patents covering products derived from our MLCs are those which provide commercial support for our Tier 1 product candidates: CDLBP, CHF and aGVHD. We also have issued and pending patents covering all of our Tier 2 and pipeline indications, including inflammatory bowel disease (e.g., Crohn’s disease), type 2 diabetes and its complications, rheumatoid arthritis, neurologic diseases, eye diseases and orthopedic diseases.

Our patent portfolio also includes issued and pending coverage of proprietary manufacturing processes that are being used with our current two-dimensional manufacturing platform as well as the 3D bioreactor manufacturing processes currently under development. These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, aggregates minimization, cryopreservation, release testing and potency assays. In addition, we maintain as a trade secret, among other things, our proprietary FBS-free media used in our 3D bioreactor manufacturing processes.

We maintain trade secrets covering a significant body of know-how and proprietary information relating to our core product candidates and technologies. We protect our confidential know-how and trade secrets in a number of ways, including requiring all employees and third parties that have access to our confidential information to sign non-disclosure agreements, limiting access to confidential information on a need-to-know basis, maintaining our confidential information on secure computers, and providing our contract manufacturers with certain key ingredients for our manufacturing process.

In addition, in many major jurisdictions there are other means that may be available to us by which we would be able to extend the period during which we have commercial exclusivity for our product candidates,

 

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which include, but are not limited to the exclusive right to reference our data, orphan drug exclusivity and patent term extensions.

As part of our strategy, we seek patent protection for our product candidates and technologies in major jurisdictions including the United States, Europe, Japan, and Australia and file independent and/or counterpart patents and patent applications in other jurisdictions globally that we deem appropriate under the circumstances, including China, Taiwan, India, Canada, Hong Kong, Israel, Korea, New Zealand, and Singapore.

We recently strengthened and extended the coverage of our MLC patent portfolio by acquiring the MSC assets of Osiris in October 2013. These assets included a significant number of new patent families. As a result, our current patent portfolio now includes 67 patent families. Over the past year alone, we have been granted an additional 14 new patents including two Japanese patents, five United States patents, two Chinese patents, and five in other jurisdictions. As of October 20, 2014, our worldwide patent portfolio includes the following:

 

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101 patents or patent applications are related to specific compositions-of-matter or methods of purifying our MLCs as follows:

 

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63 patents or patent applications that we own related to MPC compositions of matter or methods of purifying MPCs. This portion of the current portfolio will, if the existing applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, include patent coverage until approximately 2026 (worldwide, excluding possible patent term extensions);

 

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7 patents or patent applications that we own related to MSC compositions of matter or methods of purifying MSCs. This portion of the current portfolio will, if the existing applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, include patent coverage until approximately 2019 (worldwide, excluding possible patent term extensions);

 

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31 patents or patent applications that we have in-licensed from the NIH related to dental pulp stem cells, or DPSCs. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2024 (worldwide, excluding possible patent term extensions);

 

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337 patents or patent applications are related to specific therapeutic applications of our MLC-based product candidates broken down as follows:

 

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74 patents or patent applications that we own related to therapeutic applications of our MLC-based products for treatment of immunologic/inflammatory disorders (including RA, Crohn’s disease, Type 2 diabetes and complications thereof, and asthma). This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2035 (worldwide, excluding possible patent term extensions).

 

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65 patents or patent applications that we own related to therapeutic applications of our MLC-based products for treatment of cardiovascular disorders (including CHF and acute myocardial infarction and ischemic stroke). This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2024 (worldwide, excluding possible patent term extensions).

 

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59 patents or patent applications that we own related to therapeutic applications of our MLC-based products for treatment of orthopedic disorders. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2032 (worldwide, excluding possible patent term extensions).

 

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85 patents or patent applications that we own related to therapeutic applications of our MLC-based products for oncology/hematology (including GVHD and bone marrow transplantation).

 

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This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2030 (worldwide, excluding possible patent term extensions).

 

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54 patents or patent applications that we own related to other therapeutic applications of our MLC-based products (including treatment of CNS disorders, genetic disorders and eye diseases). This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2032 (worldwide, excluding possible patent term extensions).

 

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38 patents or patent applications that we own related to cell manufacturing or production. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2035 (worldwide, excluding possible patent term extensions).

 

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134 patents or patent applications are related to complementary technologies and additional product candidates as follows:

 

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62 patents or patent applications that we own related to cell-based complementary technologies supporting our cell-based pipeline and lifecycle management. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2030 (worldwide, excluding possible patent term extensions);

 

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25 patents or patent applications that we own related to compositions of matter comprising improved forms of SDF-1 or uses thereof. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2032 (worldwide, excluding possible patent term extensions);

 

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47 patents or patent applications that we have exclusively licensed from the Trustees of Columbia University in relation to uses of various factors derived from MLCs or other biological agents for treatment of cardiovascular diseases or other fibrotic conditions. This portion of the current portfolio, if the existing patent applications are issued, and the appropriate maintenance, renewal, annuity, or other governmental fees are paid, will include patent coverage until approximately 2023 (worldwide, excluding possible patent term extensions);

We anticipate filing additional patent applications covering our product candidates and other cellular products under development, and core technologies such as manufacturing.

Our policy is to patent the technology, inventions and improvements that we consider important to the development of our business, only in those cases in which we believe that the costs of obtaining patent protection is justified by the commercial potential of the technology and associated product candidates, and typically only in those jurisdictions that we believe present significant commercial opportunities to us. In those cases where we choose neither to seek patent protection nor protect the inventions as trade secrets, we may publish the inventions so that it defensively becomes prior art in order for us to secure a freedom to operate position and to prevent third parties from patenting the invention.

We also seek to protect as trade secrets our proprietary and confidential know-how and technologies that are either not patentable or where we deem it inadvisable to seek patent protection. To this end, we generally require all third parties with whom we share confidential information and our employees, consultants and advisors to enter into confidentiality agreements prohibiting the disclosure of confidential information. These agreements with our employees and consultants engaged in the development of our technologies require disclosure and assignment to us of the ideas, developments, discoveries and inventions, and associated intellectual property rights, important to our business. Additionally, these confidentiality agreements, among others, require that our employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology.

 

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License Agreements

Central Adelaide Local Health Network Incorporated—Mesenchymal Precursor Cell Intellectual Property

In October 2004, we, through our wholly-owned subsidiary, Angioblast Systems Inc., now Mesoblast, Inc., acquired certain intellectual property relating to our MPCs, or Medvet IP, pursuant to an Intellectual Property Assignment Deed, or IP Deed, with Medvet Science Pty Ltd, or Medvet. Medvet’s rights under the IP Deed were transferred to Central Adelaide Local Health Network Incorporated, or CALHNI, in November 2011. In connection with our use of the Medvet IP, we are obligated to pay CALHNI, as successor in interest to Medvet, (i) certain aggregated milestone payments of up to US$2.5 million and single-digit royalties on net sales of products covered by the Medvet IP, for cardiac muscle and blood vessel applications and bone and cartilage regeneration and repair applications, subject to minimum annual royalties beginning in the first year of commercial sale of those products and (ii) and single-digit royalties on net sales of the specified products for applications outside the specified fields. Additionally, we are obligated to pay CALHNI a double-digit percentage in the teens of any revenue that we receive in exchange for a grant of a sublicense to the Medvet IP in the specified fields. Under the IP Deed, we also granted to Medvet a non-exclusive, royalty-free license to the Medvet IP for non-commercial, internal research and academic research.

Case Western Reserve University—Mesenchymal Stem Cell Intellectual Property

In October 2013, our wholly owned subsidiary, Mesoblast International Sàrl, acquired certain MSC-based assets from Osiris including a technology transfer and license agreement between Osiris and Case Western Reserve University, or CWRU. Pursuant to the technology transfer and license agreement, or CWRU Agreement, we (i) were assigned certain patent rights relating to MSCs, or CWRU Assigned Patents, and (ii) obtained an exclusive, worldwide, sublicensable license to (A) information and know-how relating to MSCs, or CWRU Technology, and (B) certain patents relating to (x) MSCs, or CWRU Licensed Patents, and (y) the CWRU Assigned Patents, to the extent the CWRU Assigned Patents are not owned by us (collectively, with the CWRU Technology and CRWU Licensed Patents, the CWRU Licensed Technology and Patents).

CWRU retained a right to use the CWRU Licensed Technology and Patents for nonclinical research, testing or educational purposes, including research funded by a commercial entity unless the commercial entity obtains a license or ownership of the research results. Under the CWRU Agreement, we are obligated to pay single-digit royalties on net sales of product covered by the CWRU Licensed Patents and a double-digit percentage of royalties received from a sublicensee of the CWRU Licensed Patents. Additionally, we are obligated to pay single-digit royalties on products covered by certain of the CWRU Assigned Patents. The royalties that we are obligated to pay to CWRU on sales of products are not due for an initial period of sales of each such product, and are subject to a reduction in the event we have to pay royalties to a third party for the sale of those products. The royalties that we owe under the CWRU License on sales of products will also be reduced for costs arising from an infringement suit against us by a third party based on sales of covered products and for costs arising from any suit we file against a third party to protect any intellectual property right granted under the CWRU Agreement. Our payment obligations under the CWRU Agreement are subject to a minimum annual payment.

Either we or CWRU may initiate a suit based on the infringement of the CWRU Licensed Technology and Patents. In the event CWRU notifies us that a third party desires to obtain a sublicense to the CWRU Licensed Technology and Patents in a field that we are not practicing, we are obligated to negotiate in good faith a sublicense with the third party subject to certain limitations that protect our commercial interests.

The CWRU Agreement continues until at least expiration of all of the patents within the CWRU Licensed Technology and Patents, unless the CWRU Agreement is terminated at an earlier time. The last patent in this portfolio expires in July 2020. We have a right to terminate the CWRU License upon advance written notice to CWRU. CWRU has a more limited right to terminate the CWRU License that includes a right to terminate the CWRU License in the event we have materially breached the CWRU License and have not cured the breach within a specified time period.

 

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Osiris Acquisition—Continuing Obligations

In October 2013, we and Osiris entered into a purchase agreement, or the Osiris Purchase Agreement, under which we acquired all of Osiris’ business and assets related to culture expanded MSCs. Pursuant to the Osiris Purchase Agreement, we also agreed to make certain milestone and royalty payments to Osiris pertaining to MSC-100-IV for the treatment of aGVHD and Crohn’s disease. Each milestone payment is for a fixed dollar amount and may be paid in cash or our ordinary shares, at our option. The maximum amount of future milestone payments we may be required to make to Osiris is US$50 million. Any ordinary shares we issue as consideration for a milestone payment will be subject to a contractual one year holding period, which may be waived in our discretion. In the event that the price of our ordinary shares decreases between the issue date and the expiration of any applicable holding period, we will be required to make an additional payment to Osiris equal to the reduction in the share price multiplied by the amount of issued shares under that milestone payment. This additional payment can be made either wholly in cash or 50% in cash and 50% in our ordinary shares, in our discretion. In December 2013, as consideration for one of these milestone payments, we issued 2,948,729 ordinary shares to Osiris. Such ordinary shares are subject to a contractual holding period, which is set to expire on December 18, 2014, which we may waive in our discretion. We have also agreed to pay varying earnout amounts as a percentage of annual net sales of acquired products, ranging from low single-digit to 10% of annual sales in excess of US$750 million. These royalty payments will cease after the earlier of a ten year commercial sales period and the first sale of a competing product.

Competition

The biotechnology and pharmaceutical industries are highly competitive and are characterized by rapidly advancing technologies and a strong emphasis on proprietary products. Any product candidates that we and our collaborators successfully develop and commercialize will compete with existing products and new products that may become available in the future.

We believe that we are a leader in the development of regenerative medicine products, and that we do not have any direct competitors which are currently capable of operating at a similar scale to develop products based on stem cells. As a result, we believe our competition is more indirect and general in nature, and falls into two broad categories:

 

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Biopharmaceutical companies who may develop their own approach to regenerative medicine. As adult stem cell therapies advance in human clinical trials and potentially gain market approvals, we expect larger biotechnology and pharmaceutical companies may become more interested in regenerative medicine. Certain of these companies, including Celgene Corporation and Johnson & Johnson, have filed patent applications relating to the use of genetically modified cells to treat disease, disorder or injury. In the future, large biopharmaceutical companies may decide to significantly increase their efforts to internally develop their own approaches, or acquire other companies or technologies, in the field of regenerative medicine.

 

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Biopharmaceutical companies who may develop competing products using other technologies. Products developed using our MLC platform technology will face competition in the market, including from products which have been developed using traditional biotechnology and pharmaceutical approaches. This includes both products that are already approved and distributed, as well as products currently under development or those that will begin development in the future.

We believe that a number of our potential competitors, particularly large biopharmaceutical companies, have significantly greater financial resources and general expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Our market has been characterized by significant consolidation by pharmaceutical and biotechnology companies, which is likely to result in even more resources being concentrated among a smaller number of our potential competitors.

 

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Government Regulation

We are developing cellular therapy product candidates. All of our product candidates are regulated as biological products by the FDA. Within the FDA, the Center for Biologics Evaluation and Research, or CBER, regulates biological products. In the United States, biological products are subject to federal regulation under the FDCA, the Public Health Service Act, or PHS Act, and other federal, state, local and foreign statutes and regulations. Both the FDCA and the PHS Act, as applicable, and their corresponding regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution, import, export, reporting, advertising and other promotional practices involving drugs and biological products. Before clinical testing of a new drug or biological product may commence, the sponsor of the clinical study must submit an application for investigational new drug exemption, or IND, to FDA, which must include, among other information, the proposed clinical study protocol. To obtain marketing authorization once clinical testing has concluded, a BLA must be submitted for FDA approval. The process of obtaining regulatory authorizations and approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources and we may not be able to obtain the required regulatory approvals.

U.S. Product Development Process

The process required by the FDA before a biological product may be marketed in the U.S. generally involves the following:

 

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completion of nonclinical laboratory studies, meaning in vivo or in vitro experiments in which an investigational product is studied prospectively in a test system under laboratory conditions to determine its safety, must be conducted according to FDA’s cGLP regulations, as well as, in the case of nonclinical laboratory studies involving animal test systems, in accordance with applicable requirements for the humane use of laboratory animals or other applicable regulations;

 

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submission to the FDA of an application for an IND, which must become effective before human clinical studies may begin;

 

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performance of adequate and well-controlled human clinical studies according to the FDA’s cGCPs and any other applicable regulatory requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed product for its intended use;

 

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submission to the FDA of a BLA for marketing approval demonstrating the safety, purity and potency of the product which must be supported by substantial evidence from adequate and well-controlled clinical investigations;

 

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, purity and potency;

 

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potential FDA inspection of the nonclinical and clinical study sites that generated the data in support of the BLA; and

 

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FDA review and approval of the BLA.

Human testing of a biological product candidate is preceded by preclinical testing, including nonclinical laboratory studies in which the product candidate is studied prospectively in a test system under laboratory conditions to determine its safety. A test system may include any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. Nonclinical laboratory studies that support research or marketing applications must be done in accordance with FDA’s cGLP regulations.

The clinical study sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA

 

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as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical study on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical study can begin. The FDA may also impose clinical holds on a product candidate at any time during clinical studies due to safety concerns or non-compliance. If the FDA imposes a clinical hold, studies may not recommence unless FDA removes the clinical hold and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will not arise that suspend or terminate such studies.

Clinical studies involve the administration of the biological product candidate to subjects under the supervision of qualified investigators, generally physicians not employed by or under the study sponsor’s control. Clinical studies are conducted under protocols detailing, among other things, the objectives of the clinical study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical study will be stopped if certain adverse events, or AEs, should occur. Each new protocol and certain amendments to the protocol must be submitted to the FDA. Clinical studies must be conducted and monitored in accordance with the FDA’s cGCP regulations and guidance, including the requirement that written informed consent to participate in the study be obtained from all participants. Further, each clinical study must be reviewed and approved by an independent Institutional Review Board, or IRB, at or servicing each institution at which the clinical study will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the risks to individuals participating in the clinical studies are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent document that must be signed by each clinical study subject or his or her legal representative and must monitor the clinical study until completed.

Human clinical studies are typically conducted in three sequential phases that may in some cases overlap or be combined:

 

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Phase 1. The biological product is initially introduced into a small number of human subjects. In the case of cellular therapy products, the initial human testing is conducted in patients with the disease or condition targeted by the biological product candidate. Phase 1 studies are intended to determine the metabolism and pharmacologic actions (including adverse reactions), the side effects associated with increasing doses, and, if possible, to gain early evidence of on effectiveness. The information obtained in Phase 1 should be sufficient to permit the design of well-controlled, scientifically valid Phase 2 studies.

 

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Phase 2. Controlled clinical studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study, to assess side effects and risks, and

 

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Phase 3. Assuming preliminary evidence suggesting effectiveness has been obtained, controlled studies are conducted in a larger group of subjects to gather additional information about effectiveness and safety in order to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Post-approval clinical studies, sometimes referred to as Phase 4 clinical studies, may be conducted after initial marketing approval. In some cases FDA may require a Phase 4 study to be performed as a condition of product approval. Sponsors also can voluntarily conduct Phase 4 studies to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. FDA regulations extend to all phases of clinical development, and apply to sponsors and investigators of clinical studies. FDA oversight includes inspection of the sites and investigators involved in conducting the studies.

Concurrent with clinical studies, companies usually complete additional animal studies and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.

 

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The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things; the sponsor must develop methods for testing the identity, purity and potency of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

U.S. Review and Approval Processes

After the completion of clinical studies of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product. The BLA must include results of product development, laboratory and animal studies, human studies, information on the manufacture and composition of the product, proposed labeling and other relevant information. In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a substantial user fee. PDUFA also imposes an annual product fee for biologics and an annual establishment fee on facilities used to manufacture prescription biologics. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, an application fee is not assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

Within 60 days following submission of the application, the FDA reviews the BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any marketing application that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviews the application to determine, among other things, whether the proposed product is safe and potent, or effective, for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, potency and purity. The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS; the FDA will not approve the application without a REMS, if required.

Before approving a BLA, the FDA will typically inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical studies were conducted in compliance with IND study requirements and cGCP requirements. To assure cGMP and cGCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.

Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and deny approval. Data obtained from clinical studies

 

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are not always conclusive and the FDA may interpret data differently than we interpret the same data. If the agency decides not to approve the marketing application, the FDA will issue a complete response letter that usually describes all of the specific deficiencies in the application identified by the FDA. Additionally, the complete response letter may include recommended actions that the applicant might take to place the application in a condition for approval. Such recommended actions could include the conduct of additional studies. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. In addition, the FDA may require post-approval clinical studies, sometimes referred to as Phase 4 clinical studies, designed to further assess a product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

One of the performance goals agreed to by the FDA under the PDUFA is to complete its review of 90% of standard BLAs within 10 months from filing and 90% of priority BLAs within six months from filing, whereupon a review decision is to be made. The FDA does not always meet its PDUFA goal dates and its review goals are subject to change from time to time. The review process and the PDUFA goal date may be extended by three months if the FDA requests or the application sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date.

Post-Approval Requirements

Maintaining substantial compliance with applicable federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Rigorous and extensive FDA regulation of biological products continues after approval, particularly with respect to cGMP. We will rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of any products that we may commercialize. Manufacturers of our products are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation. Other post-approval requirements applicable to drug and biological products, include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements, reporting of adverse effects, reporting updated safety and efficacy information, and complying with electronic record and signature requirements. After a BLA is approved, the product also may be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of drug and biological products.

We also must comply with the FDA’s advertising and promotion requirements, such as those related to direct-to-consumer advertising, the prohibition on promoting products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label use”), industry-sponsored scientific and educational activities, and promotional activities involving the internet. Discovery of previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity. Sanctions authorized under FDA’s legal authorities

 

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could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties. Violations of the FDCA may serve as a basis for the refusal of, or exclusion from, government contracts, including federal reimbursement programs, as well as other adverse consequences including lawsuits and actions by state attorneys general. Any agency or judicial enforcement action could have a material adverse effect on us. Drug and biological product manufacturers and other entities involved in the manufacture and distribution of approved drug or biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market. In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

U.S. Patent Term Restoration and Marketing Exclusivity

Depending upon the timing, duration and specifics of the FDA approval of the use of our product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an new drug application, or NDA, or BLA plus the time between the submission date of an NDA or BLA and the approval of that application. Only one patent applicable to an approved product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.

Under the Hatch-Waxman Amendments, a drug product containing a new chemical entity as its active ingredient is entitled to five years of market exclusivity, and a product for which the sponsor is required to generate new clinical data is entitled to three years of market exclusivity. A drug or biological product can also obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.

The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. However, complexities associated with the larger, and often more complex, structure of biological products, as well as the process by which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.

A reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product. On April 10, 2013, President Obama released his proposed budget for fiscal year 2014 and proposed to

 

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cut this 12-year period of exclusivity down to seven years. He also proposed to prohibit additional periods of exclusivity for reference biologics due to minor changes in product formulations, a practice often referred to as “evergreening.” The first biologic product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against other biologics submitted under the abbreviated approval pathway for the lesser of (i) one year after the first commercial marketing, (ii) 18 months after approval if there is no legal challenge, (iii) 18 months after the resolution in the applicant’s favor of a lawsuit challenging the biologics’ patents if an application has been submitted, or (iv) 42 months after the application has been approved if a lawsuit is ongoing within the 42-month period.

Government Regulation Outside of the U.S.

In addition to regulations in the U.S., we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of our products. In particular, we view the EU and Japan as important jurisdictions for our business. The EU has vested centralized authority in the EMA and Committee on Proprietary Medicinal Products to standardize review and approval across EU member nations. Any product candidates we seek to commercialize in the EU are subject to review and approval by the EMA. In Japan, the Pharmaceuticals and Medical Device Agency, or PDMA, a division of the Ministry of Health, Labour and Welfare, or MHLW, regulates the development and commercialization of medical therapies. Recently, Japan’s parliament enacted new legislation to promote the safe and accelerated development of treatments using stem cells. The new Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, or PMD Act, took effect in November 2014 in Japan. The PMD Act establishes a framework for expedited approval in Japan for regenerative medical products such as ours. Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical studies or marketing of the product in those countries. Certain countries outside of the U.S. have a similar process that requires the submission of a clinical study application much like the IND prior to the commencement of human clinical studies. In the EU, for example, a clinical trial application, or CTA, must be submitted to each country’s national health authority and an independent ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical study development may proceed.

The requirements and process governing the conduct of clinical studies, product licensing, coverage, pricing and reimbursement vary from country to country. In all cases, the clinical studies are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

To obtain regulatory approval of an investigational biological product under EU regulatory systems, we must submit a marketing authorization application, or MAA. The application used to file the BLA in the U.S. is similar to that required in the EU, with the exception of, among other things, country-specific document requirements. The EU also provides opportunities for market exclusivity. For example, in the EU, upon receiving marketing authorization, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application. During the additional two-year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity. Products receiving orphan designation in the EU can receive 10 years of market exclusivity, during which time no similar medicinal product for the same indication may be placed on the market. An orphan product can also obtain an additional two years of market exclusivity in the EU for pediatric studies. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications.

The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the U.S. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such

 

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condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to 10 years of market exclusivity for the approved therapeutic indication. The application for orphan drug designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if:

 

•

The second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;

 

•

The applicant consents to a second orphan medicinal product application; or

 

•

The applicant cannot supply enough orphan medicinal product.

For other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical studies, product licensing, coverage, pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the availability of coverage and adequate reimbursement from third-party payors. Third-party payors include government programs such as Medicare or Medicaid, managed care plans, private health insurers, and other organizations. These third-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they determine that the product or therapy was not medically appropriate or necessary. Third-party payors may attempt to control costs by limiting coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drug products for a particular indication, and by limiting the amount of reimbursement for particular procedures or drug treatments.

The cost of pharmaceuticals and devices continues to generate substantial governmental and third party payor interest. We expect that the pharmaceutical industry will experience pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative proposals. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Adequate third-party

 

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reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Some third-party payors also require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, these requirements or any announcement or adoption of such proposals could have a material adverse effect on our ability to obtain adequate prices for our product candidates and to operate profitably.

In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. There can be no assurance that our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available or that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our product profitably.

Healthcare Reform

In the U.S. and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs. In the U.S., the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the Medicare Modernization Act, changed the way Medicare covers and pays for pharmaceutical products. The Medicare Modernization Act expanded Medicare coverage for drug purchases by the elderly by establishing Medicare Part D and introduced a new reimbursement methodology based on average sales prices for physician administered drugs under Medicare Part B. In addition, this legislation provided authority for limiting the number of drugs that will be covered in any therapeutic class under the new Medicare Part D program. Cost reduction initiatives and other provisions of this legislation could decrease the coverage and reimbursement rate that we receive for any of our approved products. While the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the Medicare Modernization Act may result in a similar reduction in payments from private payors.

In March 2010, the President signed into law the ACA, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers and impose additional health policy reforms. Among other things, the ACA revises the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states. Further, the new law imposes a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance have also been enacted, which may affect our business practices with healthcare practitioners and a significant number of provisions are not yet, or have only recently become, effective. Although it is too early to determine the full effect of the ACA, the new law appears likely to continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, on August 2, 2011, the President signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

 

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These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

We expect that the ACA, as well as other healthcare reform measures that have been and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product, and could seriously harm our future revenue. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

In addition, different pricing and reimbursement schemes exist in other countries. In the European Community, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may be marketed only once a reimbursement price has been agreed upon. Some of these countries may require, as condition of obtaining reimbursement or pricing approval, the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.

Other Healthcare Laws and Compliance Requirements

In the U.S., the research, manufacturing, distribution, sale and promotion of drug products, including biologics, and medical devices are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, divisions of the U.S. Department of Health and Human Services, including the Office of Inspector General and the Centers for Medicare and Medicaid Services, the U.S. Department of Justice, state Attorneys General, and other state and local government agencies. For example, sales, marketing and scientific/educational grant programs must comply with fraud and abuse laws such as the federal Anti-Kickback Statute, as amended, the federal False Claims Act, as amended, and similar state laws. Pricing and rebate programs must comply with the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the Veterans Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal and state consumer protection and unfair competition laws.

The federal Anti-Kickback Statute prohibits any person, including a prescription drug manufacturer (or a party acting on its behalf), from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce or reward either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. The term “remuneration” has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value. Although there are a number of statutory exception and regulatory safe harbors protecting certain business arrangements from prosecution, the exception and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from federal Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the recently enacted ACA, which, among other things, amends the intent requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the ACA provides that the government may assert that a

 

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claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (discussed below) or the civil monetary penalties statute, which imposes fines against any person who is determined to have presented or caused to be presented claims to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Additionally, many states have adopted laws similar to the federal Anti-Kickback Statute, and some of these state prohibitions apply to the referral of patients for healthcare items or services reimbursed by any third-party payor, including private payors, and in at least some cases, these state laws do not contain safe harbors.

The federal False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal government recovery. In recent years, the number of suits brought by private individuals has increased dramatically. In addition, various states have enacted false claims laws analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare program. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The False Claims Act has been used to assert liability on the basis of inadequate care, kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price, improper use of Medicare numbers when detailing the provider of services, improper promotion of off-label uses (i.e., uses not expressly approved by FDA in a drug’s label), and allegations as to misrepresentations with respect to the services rendered.

Our future activities relating to the reporting of discount and rebate information and other information affecting federal, provincial, state and third party reimbursement of our products, and the sale and marketing of our products and our service arrangements or data purchases, among other activities, may be subject to scrutiny under these laws. We are unable to predict whether we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the cost of defending such claims, as well as any sanctions imposed, could adversely affect our financial performance. Also, the Health Insurance Portability and Accountability Act of 1996, or HIPAA, created several new federal crimes, including healthcare fraud, and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

In addition, we may be subject to, or our marketing activities may be limited by, data privacy and security regulation by both the federal government and the states in which we conduct our business. For example, HIPAA and its implementing regulations established uniform federal standards for certain “covered entities” (healthcare providers, health plans and healthcare clearinghouses) governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health information. The American Recovery and Reinvestment Act of 2009, commonly referred to as the economic stimulus package, included expansion of HIPAA’s privacy and security standards called the Health Information Technology for Economic and Clinical Health Act, or HITECH, which became effective on February 17, 2010. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”—independent contractors or agents of covered entities that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

There are also an increasing number of state “sunshine” laws that require manufacturers to make reports to states on pricing and marketing information. Several states have enacted legislation requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state,

 

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make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. In addition, beginning in 2013, a similar federal requirement began requiring manufacturers to track and report to the federal government certain payments and other transfers of value made to physicians and other healthcare professionals and teaching hospitals and ownership or investment interests held by physicians and their immediate family members. The federal government will disclose the reported information on a publicly available website beginning in 2014. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. If we fail to track and report as required by these laws or otherwise comply with these laws, we could be subject to the penalty provisions of the pertinent state and federal authorities.

Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, exclusion from participation in government healthcare programs, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of premarketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-approval requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

Employees

As of June 30, 2014, we had 116 full-time employees, 84 of whom are based in the United States, 26 of whom are based in Australia, including our CEO and certain executive team members, and 5 of whom are based in Singapore. We had 75 and 63 full-time employees as of June 30, 2013 and June 30, 2012, respectively. We have no collective bargaining agreements with our employees. We have not experienced any work stoppages to date and consider our relations with our employees to be good. The composition of our employee base breaks down as follows:

 

 

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Facilities

We lease approximately 11,150 square feet of office space in Melbourne, Australia, where our headquarters are located. We currently pay approximately A$695,000 per year for this lease, which expires in April 2020. We also lease approximately 31,000 square feet in New York City, where significant development and commercial activities are conducted. We currently pay US$955,000 per year for this lease, which expires in May 2021. We also lease laboratory space in Singapore. We pay A$17,200 per month for this lease, which expires in January 1, 2015. We are currently in the process of extending this lease. All of our manufacturing operations are currently located at Lonza’s manufacturing facilities. See “Business—Manufacturing and Supply Chain.”

Legal Proceedings

From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not presently party to any legal proceedings that, in the opinion of our management, would reasonably be expected to have a material adverse effect on our business, financial condition, operating results or cash flows if determined adversely to us. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

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MANAGEMENT

Directors and Senior Management

The table below sets forth the certain information relating to our directors and senior management as of the date of this prospectus.

 

Name		Age		Position
Silviu Itescu		57		Executive Director and Chief Executive Officer
Paul Hodgkinson		46		Chief Financial Officer
Peter Howard		46		Corporate Executive and General Counsel
Sue MacLeman		50		Head of Commercial
John McMannis		59		Head of Manufacturing
Michael Schuster		37		Investor Relations
Paul Simmons		57		Head of Research
Donna Skerrett		55		Chief Medical Officer
Darin Weber		46		Head of Regulatory & Quality Management
Brian Jamieson		70		Chairman of the Board of Directors
William Burns		67		Director
Donal O’Dwyer		61		Director
Eric Rose		63		Director
Michael Spooner		57		Director
Ben-Zion Weiner		69		Director

Senior Management

Silviu Itescu, MBBS (Hons), FRACP, FACP, FACRA, helped form Mesoblast in 2004 and has served on our board of directors as Executive Director and Chief Executive Officer since July 2004. Prior to forming Mesoblast, Dr. Itescu formed Angioblast Systems, Inc. in 2001, which was acquired by Mesoblast in 2010. He has been a faculty member of Columbia University in New York, the University of Melbourne and Monash University.

We believe Dr. Itescu is qualified to serve as a member of our board of directors because he has consulted for various international pharmaceutical companies, has been an adviser to biotechnology and health care investor groups, and has served on the board of directors of several publicly listed life sciences companies.

Paul Hodgkinson, MA (Hons) FCA, has served as our Chief Financial Officer since June 2014. Mr. Hodgkinson has 16 years of international pharmaceutical experience in the areas of finance, strategic planning, business development and licensing, manufacturing and supply chain, and procurement. From 2011 through 2014, Mr. Hodgkinson served as the Country Chief Financial Officer for the Novartis Australia and New Zealand, or ANZ, group of companies and divisions, which was comprised of Alcon, Sandoz, and the Novartis Vaccines and Diagnostics, Consumer Health, Animal Health, and Pharmaceuticals divisions. From 1998 to 2006, Mr. Hodgkinson held a number of leadership roles with AstraZeneca in the United Kingdom, including Global Licensing Finance Director, before serving as Chief Financial Officer for AstraZeneca Australia from 2006 through 2011. Mr. Hodgkinson is a member of the Institute of Chartered Accountants in Australia, is a Fellow of the Institute of Chartered Accountants of England and Wales and has a masters in engineering from Cambridge University. He has also undertaken executive leadership programs at the Harvard Business School and INSEAD.

Peter Howard, BSc, LLB (Hons), has served as our General Counsel and Corporate Executive since July 2011. Peter Howard has been integrally involved with Mesoblast since its inception in 2004, when he played a critical role in the corporate structuring and listing of Mesoblast on the Australian Securities Exchange, or ASX. More generally, Mr. Howard has extensive experience with many biopharmaceutical firms and major research institutions, covering public listings, private financings, strategic, licensing, intellectual property and mergers and acquisition activities. He has done so in several roles, including as a partner at a major law firm, entrepreneur, director and senior executive.

 

 

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Sue MacLeman, BPharm, MMktg, MLaw, FACPP, FAICD, has served as our global Head of Commercial since January 2014 and served as Senior Vice President Corporate ( 2011-2013). Mrs. MacLeman has more than 20 years of experience as a pharmaceutical executive and has held roles in corporate, medical, marketing, business development and sales management roles at Schering-Plough Corporation (now Merck) ( 1991-1994), at Amgen Inc. (1993-1996), and at Bristol-Myers Squibb Company (1996-2002). Mrs. MacLeman also served as Chief Executive Officer at EQiTX Ltd (2004-2006), Benitec Biopharma Ltd (2007-2010), Progen Pharmaceuticals Ltd (2010-2011) and in the past served as a board member of AusBiotech Ltd, EQiTX Ltd, Benitec Biopharma Ltd and is currently a non-executive director at Reproductive Health Sciences Ltd. Before her work in the pharmaceutical industry, Mrs. MacLeman worked in various hospitals roles including as a pharmacist and as an executive (1985-1991). Mrs. MacLeman has been a member of the Pharmaceutical Industry Council since 2007 and a member of the Australian Government Pharmaceutical Working Group since 2007. In 2011, Mrs. MacLeman was appointed to the Victorian Biotechnology Advisory Council.

John McMannis, PhD has served as our Head of Manufacturing since 2011. Dr. McMannis has 27 years of experience in clinical cellular therapy trials in both academic and commercial environments. Before joining Mesoblast, Dr. McMannis served at the University of Texas MD Anderson Cancer Center as a Professor of Medicine from 1999 to 2011, and as the Director of the Cell Therapy Laboratory from 1999 to 2011, and as the Technical Director of the Cord Blood Bank from 2008 to 2011. Before his tenure at the University of Texas MD Anderson Cancer Center, Dr. McMannis was a Senior Director Technical Affairs at the Immunotherapy Division of Baxter and Therapy Scientist at COBE BCT (now Terumo BCT). Dr. McMannis has served on the scientific advisory boards at BioSafe SA, Biolife Solutions, Inc., and General Electric and on the board of directors for the American Association of Blood Banks, or AABB, and the National Marrow Donor Program, or NMDP, which operates the “Be the Match” donor program.

Michael Schuster, MBA has been with Mesoblast for the last ten years and has served as our Head of Investor Relations and New Product and Technology Evaluation since 2013. Prior to that, Mr. Schuster was Executive Vice President of Global Therapeutic Programs from 2010 to 2013 and was the Director of Business Development and Vice President of Operations from 2004 to 2010. Mr. Schuster has been the head of Mesoblast’s investor relations outreach program since 2013 and was part of the founding executive team at both Mesoblast Limited and Angioblast Systems, Inc. Mr. Schuster holds an undergraduate degree in science from Tufts University, a master’s degree in Immunology & Microbiology from New York Medical College, and a MBA from Fordham University in New York.

Donna Skerrett, MD has served as our Chief Medical Officer since 2011, and she previously held roles at Mesoblast in Clinical and Regulatory Affairs since 2004. Dr. Skerrett has 20 years of combined experience in transfusion medicine, cellular therapy, and transplantation. Prior to joining Mesoblast, Dr. Skerrett was Director of Transfusion Medicine and Cellular Therapy at Weill Cornell Medical Center in New York from 2004 to 2011, and she served as Associate Director of Transfusion Medicine and Director of Stem Cell Facilities at Columbia University’s New York-Presbyterian Hospital from 1999 to 2004. She has been an advisor to the New York State Department of Health on the Progenitor Cell Committee since 1989 and has been Chair of the Governor’s Council on Blood and Transfusion Services since 2007.

Paul Simmons, PhD has served as our Head of Research and New Product Development since 2011. Dr. Simmons has nearly 30 years of experience in stem cell research, especially research in basic hematopoiesis and in precursor cells for the stromal system of the bone marrow, and served as President of the International Society of Stem Cell Research, or ISSCR, from 2006 to 2007. Prior to joining Mesoblast, Dr. Simmons held the C. Harold and Lorine G. Wallace Distinguished University Chair at the University of Texas Health from 2008 to 2011 and served as the inaugural Professor and Director of the Centre for Stem Cell Research at the Brown Foundation Institute of Molecular Medicine from 2006 to 2011. Dr. Simmons is, or has served as, an associate editor, a member of the editorial board, or a reviewer on multiple scientific and medical journals including Experimental Hematology, Cytotherapy and Stem Cell Research, Cell Stem Cell, Stem Reports, Science and Nature.

 

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Darin Weber, PhD has served as our Head of Regulatory Affairs since June 2011 and Head of Quality Management since October 2012. Dr. Weber has 18 years of experience in cellular and tissue-based regenerative medicine products and serves on the United States Pharmacopeia Expert Committee and on committees within the International Society for Cellular Therapy and Alliance for Regenerative Medicine. Before joining Mesoblast, Dr. Weber worked as a senior consultant at Biologics Consulting Group, Inc. from February 2004 to May 2011. Prior to that, Dr. Weber worked at the FDA Center for Biologics Evaluation and Research as a regulatory management officer from 1996 to 1998, as a regulatory review officer from 1998 to 2003, and as the Chief of the Cellular Therapy Branch in the Office of Cellular, Tissue and Gene Therapies from 2002 to 2004. During his employment with the FDA, Dr. Weber held a Commission in the United States Public Health Service Commissioned Corps, with a rank of Lieutenant Commander at the conclusion of his service.

Directors

Brian Jamieson, FCA, has served on our board of directors as Chairman since 2007. Mr. Jamieson was Chief Executive of Minter Ellison Melbourne and a partner of the Minter Ellison Revenue Group from 2002-2005. He retired as Chief Executive of Minter Ellison Melbourne on December 31, 2005. Prior to joining Minter Ellison, Mr. Jamieson was Chief Executive Officer at KPMG Australia from 1998-2000, Managing Partner of KPMG Melbourne and Southern Regions from 1993-1998 and Chairman of KPMG Melbourne from 2001-2002. He was also a KPMG Board Member in Australia, and a member of the USA Management Committee. Mr. Jamieson is Chairman of Sigma Pharmaceuticals Limited and a Non-Executive Director of the Tatts Group Limited and OZ Minerals Limited. He is also a director and Treasurer of the Bionic Ear Institute. He is a fellow of the Institute of Chartered Accountants in Australia.

We believe Mr. Jamieson is qualified to serve as a member of our board of directors because he has over 30 years of experience in providing advice and audit services to a diverse range of public and large private companies.

William Burns, BA, has served on our board of directors since March 2014. Mr. Burns has spent his entire management career at the Beecham Group and F. Hoffmann-La Roche Ltd. He was Chief Executive Officer of Roche Pharmaceuticals from 2001 through 2009, when he joined the board of directors of F. Hoffmann-La Roche Ltd. until he retired in 2014. Mr. Burns has also served on the board of directors of Roche Holdings AG from 2010 through 2014, Chugai Pharmaceutical Co. and Genentech from 2002 to 2014, and Crucell from 2010 through 2011. Mr. Burns is also a member of the oncology Advisory Board of the Universities of Cologne/Bonn. Mr. Burns is currently the Chairman of the board of directors of Biotie Therapies Corp. and is a non-executive director of Shire PLC. In October 2014 Mr. Burns was appointed a trustee of the Institute of Cancer Research, London, UK.

We believe Mr. Burns is qualified to serve as a member of our board of directors because of his extensive experience in the pharmaceuticals industry, specifically as a member of the board of directors of other pharmaceutical companies.

Donal O’Dwyer, BE, MBA, has served on our board of directors since 2004. Mr. O’Dwyer has over 25 years of experience as a senior executive in the global cardiovascular and medical devices industries. From 1996 to 2003, Mr. O’Dwyer worked for Cordis Cardiology, the cardiology division of Johnson & Johnson’s Cordis Corporation, initially as its president (Europe) and from 2000 as its worldwide president. Prior to joining Cordis, Mr. O’Dwyer worked for 12 years with Baxter Healthcare, rising from plant manager in Ireland to president of the Cardiovascular Group, Europe, now Edwards Lifesciences. Mr. O’Dwyer is a qualified civil engineer, has an MBA and is on the board of directors of a number of companies including Cochlear Limited, Atcor Medical Holdings Ltd and Fisher & Paykel Healthcare Ltd.

We believe Mr. O’Dwyer is qualified to serve as a member of our board of directors because of his extensive experience in the cardiovascular and medical devices industries.

Eric Rose, MD, has served on our board of directors since 2013. Dr. Rose is currently Chairman and Chief Executive Officer of SIGA Technologies and Executive Vice President, Life Sciences at MacAndrews & Forbes,

 

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Inc., the holding company of Ronald O. Perelman. From 2008 through 2012, Dr. Rose served as the Edmond A. Guggenheim Professor and Chairman of the Department of Health Evidence and Policy at the Mount Sinai School of Medicine. From 1994 through 2007, Dr. Rose served as Chairman of the Department of Surgery and Surgeon-in-Chief of the Columbia Presbyterian Center of New York Presbyterian Hospital. From 1982 through 1992, he led the Columbia Presbyterian heart transplantation program in the United States. Dr. Rose currently sits on the board of directors of ABIOMED.

We believe Dr. Rose is qualified to serve on our board of directors because of his years of experience as a surgeon, researcher and businessman.

Michael Spooner, BCom, ACA, MAICD, has served on our board of directors since 2004. During this period he has filled various roles including as Chairman from the date of our IPO in 2004 until 2007, Chair of the Audit and Risk Committee as well as a member of our Remuneration Committee. Over the past several years Mr. Spooner has served on the board of directors in various capacities at several Australian and international biotechnology companies, including BiVacor Pty Ltd (2009-2013), Advanced Surgical Design & Manufacture Limited (2010-2011), Peplin, Inc. (2004-2009), Hawaii Biotech, Inc. (2010-2012), Hunter Immunology Limited (2007-2008), and Ventracor Limited (2001-2003). Prior to returning to Australia in 2001, Mr. Spooner spent much of his career internationally where he served in various roles including as a partner to PA Consulting Group, a UK based management consultancy and a Principal Partner and Director of Consulting Services with PricewaterhouseCoopers (Coopers & Lybrand) in Hong Kong. In addition Mr. Spooner has owned and operated several international companies providing services and has consulted to a number of U.S. and Asian public companies.

We believe Mr. Spooner is qualified to serve on our board of directors because of his business experience and relationships with investment firms and business communities worldwide.

Ben-Zion Weiner, BSc, MSc, PhD, has served on our board of directors since 2012. Prior to joining Mesoblast, Dr. Weiner spent 37 years at Teva until he retired in 2012. During his tenure at Teva, he served as the Vice President of Research and Development from 1986 to 2002, the Global Vice President of Global Products from 2002 to 2006, and the Chief R&D Officer from 2006 to 2012. Dr. Weiner is currently on the board of directors at Novaremed Ltd., the scientific advisory board at E-QURE Corp. and Breed IT, Corp. and has in the past served on the board of directors at Geffen Biomed Investments Ltd (2010-2013), XTL Biopharmaceuticals Limited (2012-2013) and Breed IT, Corp.

We believe Dr. Weiner is qualified to serve on our board of directors because of his experience in our industry and prior board service.

There are no family relationships among any of our directors and senior management. The business address of each of our directors and senior management is Mesoblast Limited, Level 38, 55 Collins Street, Melbourne 3000, Australia.

Board of Directors

Our board of directors currently consists of seven members, including our Chief Executive Officer. We believe that each of our directors has relevant industry experience. The membership of our board of directors is directed by the following requirements:

 

•

our Constitution specifies that there must be a minimum of 3 directors and a maximum of 10, and our board of directors may determine the number of directors within those limits;

 

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it is the intention of our board of directors that its membership consists of a majority of independent directors who satisfy the criteria for independence recommended by the ASX’s Corporate Governance Principles and Recommendations;

 

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the chairperson of our board of directors should be an independent director who satisfies the criteria for independence recommended by the ASX’s Corporate Governance Principles and Recommendations; and

 

 

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•

our board of directors should, collectively, have the appropriate level of personal qualities, skills, experience, and time commitment to properly fulfill its responsibilities or have ready access to such skills where they are not available.

Our board of directors is responsible for, and has the authority to determine, all matters relating to our corporate governance, the policies, practices, management and operation. The principal roles and responsibilities of our board of directors are to:

 

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facilitate board of directors and management accountability to our company and its shareholders;

 

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ensure timely reporting to shareholders;

 

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provide strategic guidance to us, including contributing to the development of, and approving, the corporate strategy;

 

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oversee management and ensure there are effective management processes in place;

 

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monitor:

 

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organizational performance and the achievement of our strategic goals and objectives;

 

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financial performance including approval of the annual and half-year financial reports and liaison with our auditors;

 

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progress of major capital expenditures and other significant corporate projects including any acquisitions or divestments;

 

•

compliance with our code of conduct;

 

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progress in relation to our diversity objectives and compliance with its diversity policy;

 

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review and approve business plans, the annual budget and financial plans including available resources and major capital expenditure initiatives;

 

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approve major corporate initiatives;

 

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enhance and protect the reputation of the organization;

 

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oversee the operation of our system for compliance and risk management reporting to shareholders; and

 

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ensure appropriate resources are available to senior management.

Committees

To assist our board of directors with the effective discharge of its duties, it has established a Nomination and Remuneration Committee, an Audit and Risk Management Committee and a Science and Technology Committee. Each committee operates under a specific charter approved by our board of directors.

Nomination and Remuneration Committee. The members of our Nomination and Remuneration Committee are Messrs. Jamieson, O’Dwyer (Chairman) and Spooner, all of whom are independent, non-executive directors. The remuneration committee is a committee of our board of directors, and is primarily responsible for making recommendations to our board of directors on:

 

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Board appointments;

 

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Non-executive director fees;

 

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The executive remuneration framework;

 

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Remuneration of executive directors, including the CEO and other key executives;

 

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Short-term and long-term incentive awards; and

 

 

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•

Share ownership plans.

The committee’s objective is to ensure remuneration policies are fair and competitive and in line with similar industry benchmarks while aligned with our objectives. The remuneration committee seeks independent advice from remuneration consultants as and when it deems necessary. See “Management—Remuneration.”

Audit and Risk Management Committee. The members of our Audit and Risk Management Committee are Messrs. Jamieson, O’Dwyer and Spooner (Chairman), all of whom are independent, non-executive directors. This committee will oversee, review, act on and report on various auditing and accounting matters to our board of directors, including the selection of our independent accountants, the scope of our annual audits, fees to be paid to the independent accountants, the performance of our independent accountants and our accounting practices. In addition, the committee will oversee, review, act on and report on various risk management matters to our board of directors.

The effective management of risk is central to our ongoing success. We have adopted a risk management policy to ensure that:

 

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appropriate systems are in place to identify, to the extent that is reasonably practical, all material risks that we face in conducting our business;

 

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the financial impact of those risks is understood and appropriate controls are in place to limit exposures to them;

 

•

appropriate responsibilities are delegated to control the risks; and

 

•

any material changes to our risk profile are disclosed in accordance with the our continuous disclosure policy.

It is our objective to appropriately balance, protect and enhance the interests of all of our shareholders. Proper behavior by our directors, officers, employees and those organizations that we contract to carry out work is essential in achieving this objective.

We have established a code of conduct, which sets out the standards of behavior that apply to every aspect of our dealings and relationships, both within and outside Mesoblast. The following standards of behavior apply:

 

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patient well-being;

 

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comply with all laws that govern us and our operations;

 

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act honestly and with integrity and fairness in all dealings with others and each other;

 

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avoid or manage conflicts of interest;

 

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use our assets properly and efficiently for the benefit of all of our shareholders; and

 

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seek to be an exemplary corporate citizen.

Science and Technology Committee. The members of the Science and Technology Committee are Messrs. Itescu, Rose (Chairman), Burns and Weiner. The Science and Technology Committee is a committee of our board of directors, and is primarily responsible for making recommendations to our board of directors pertaining to our strategic direction and investment in research and development and technology, by:

 

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identifying areas and activities that are critical to the success of our regenerative medicine discovery, development and licensing efforts;

 

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evaluating the effectiveness of our regenerative medicine development and licensing strategies and operations;

 

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keeping our board of directors apprised of this evaluation process and findings;

 

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making appropriate recommendations to our board of directors on modifications of strategies and operations; and

 

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identifying additional areas of focus as appropriate.

 

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Remuneration

Directors’ Fee Structure

We have six non-executive directors, three based in Australia, one in the United States, one in Switzerland and one in Israel. Non-executive director fees are paid with due consideration to the Australian regulations with consideration made to the time commitment required of each director. They have been set at market rates for our industry and size of company in order to attract those directors who have considerable expertise both in our industry and in the Australian capital markets.

Non-executive directors receive fixed fees for their services as a director, plus any applicable compulsory superannuation.

Non-executive directors receive a letter of appointment covering the key terms of their appointment to our board of directors. Non-executive directors are not entitled to retirement allowances, in line with guidance from the ASX Corporate Governance Council. Superannuation contributions, required under the Australian superannuation guarantee legislation, continue to be made.

Structure of the Board and Directors Fees

In line with our growth, our board of directors made the decision to expand the skillset of our board of directors by obtaining new members. To ensure it could attract new high caliber members, our board of directors, through its Nomination and Remuneration Committee, commissioned Towers Watson to perform a market benchmarking exercise in October 2012.

Towers Watson benchmarked us against companies of comparable size and complexity, with a particular focus on companies with a comparable market capitalization because we do not currently derive significant revenue, but are well capitalized. Our size, profile and international operations brings with it governance and regulatory complexity (as does the business in which we operate) which has a direct bearing on the scope and complexity of the non-executive director roles. In addition, other large Australian healthcare companies were referenced.

As a result of that benchmarking exercise, directors’ fees were reset to align with the median reported fees payable to the Chairman, non-executive directors, the chair of our board of director committees, and committee members.

Since that review, effective on November 1, 2013, non-executive directors were allocated a 2.6% increase to their board of director fees only. Committee membership fees were held constant. Fees are paid as follows, and statutory superannuation is paid in addition to the fees below as applicable (all amounts are in Australian dollars):

 

		From November 1, 2013 to Current																From November 1, 2012 to October 31, 2013
Position		Board of Directors				Audit and Risk Committee				Nomination and Remuneration Committee				Science & Technology Committee*				Board of Directors				Audit and Risk Committee				Nomination and Remuneration Committee				Science & Technology Committee
Chair			328,230				25,000				20,000				20,000				320,000				25,000				20,000				20,000
Member			128,250				12,500				10,000				10,000				125,000				12,500				10,000				10,000

 

*	The Science and Technology Committee was established in October 2013.

Maximum Annual Fee Pool (Non-Executive Directors)

The maximum annual fee pool for non-executive directors currently available is A$1,250,000 which was approved by shareholders at the annual general meeting held on November 15, 2013. Prior to that, the aggregate of non-executive directors’ fees was most recently approved by shareholders on February 9, 2011, in response to the appointment of an additional director to our board of directors.

At the annual general meeting on November 15, 2013, our directors considered that the aggregate amount of directors’ fees to be paid out of company funds by way of remuneration to non-executive directors for their

 

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services as our non-executive directors should be increased from the current aggregate maximum of A$1,000,000 previously approved by shareholders, to an aggregate maximum sum of A$1,250,000, being an increase of A$250,000 or 25%. This increase was to allow specifically for the addition of Dr. Eric Rose to our board of directors in April 2013, and to ensure we had capacity within our non-executive directors fee pool to appoint any further directors to our board of directors should this be in our best interest at a future time.

Since then, (in March 2014) Mr. William Burns joined our board of directors which further strengthened the skills, expertise, and diversity of our board of directors.

Performance Review

During the year our board of directors conducted a self-review of its performance and its operations as whole. The review was conducted internally using questionnaires and interviews between the Chairman and each individual director.

CEO Remuneration

Silviu Itescu is our CEO and founder and serves on our board of directors. Our CEO is our single largest shareholder and has been since our inception in 2004.

Our CEO’s remuneration is comprised of the following components:

 

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Fixed remuneration, comprising base salary and statutory superannuation; and

 

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Performance based remuneration, comprising short-term incentives up to a maximum entitlement of 100% of fixed remuneration, based on business and individual performance.

Our board of directors periodically reviews our CEO’s remuneration package including the remuneration mix and has determined that at this stage in our development he has sufficient exposure to our shares to ensure that his personal interests are closely aligned to the creation of long-term shareholder value. Our board of directors believes that the current remuneration package offers an appropriate balance between fixed and performance-based pay and does not believe that the inclusion of a further long-term share-based incentive will offer material additional benefit to us at this time.

Since June 30, 2014, a benchmarking study on CEO remuneration was performed by an independent service provider. The findings of this exercise show our CEO’s overall remuneration package resides between the 25th percentile and the median of the comparison group. The comparison group included Australian-based companies with a similar market capitalization to ours, of between A$1 billion to A$1.5 billion.

Fixed Remuneration

Our CEO’s annual fixed pay pursuant to his contract of employment dated April 1, 2014 is A$960,000 plus statutory superannuation. This reflected a 2.6% increase on the prior year, an amount chosen with reference to the adjustments provided to other employees and our CEO’s contract of employment which called for a minimum increase of CPI. Our CEO’s new contract of employment has been amended during the year to remove the requirement of a minimum increase linked to CPI.

Performance-Based Incentives

In order to align our CEO with our shorter-term success and the achievement of milestones which are designed to ultimately lead to long-term shareholder wealth, our CEO has 50% of this total remuneration package at risk, and is paid subject to meeting annual key performance indicators, or KPIs. These KPIs are set by our board of directors, with reference to the upcoming strategic milestones needed to be achieved in order for us to grow and set the foundation for long-term shareholder wealth.

At the end of the financial year our board of directors assesses the overall performance of our company, and our CEO’s individual performance against the set KPIs. The achievement of these KPIs is always assessed in the

 

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context of total corporate performance against budget which ensures cost control is always part of the performance framework and is regularly measured and reported.

Our board of directors approved the following KPIs for the CEO in the following performance categories for the financial year ended June 30, 2014:

 

KPI		Percentage				Achievement
Clinical Trial Management: regulatory and enrollment targets			30				Achieved
Completion of Osiris asset acquisition and integration			25				Achieved
Company performance versus budget, together with specific strategic and capital market initiatives			27.5				Partially achieved
Manufacturing achievements			12.5				Achieved
Develop and implementation of a product focused organization structure			5				Achieved

While the specific details of these milestones are commercially sensitive and therefore are not disclosed, our board of directors has approved areas of focus within the KPI categories:

 

•

Clinical trial management: Specific emphasis was placed on receiving regulatory approval to commence certain clinical trials, as well as continued recruitment progress across all of our clinical programs.

 

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Completion of Osiris asset acquisition & integration: Emphasis was placed on the integration of the assets, including intellectual property, as well as receiving greater clarity from a regulatory perspective on the path to approval of certain programs.

 

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Manufacturing achievements: Focus has been placed on the improvement/development of our manufacturing processes to ensure scalability, supply and yield. Additionally, a strategic relationship formed with the Singapore Economic Development Board supporting our manufacturing operations.

For the financial year ended June 30, 2014, the total performance assessment of the achievement of the above KPIs was 87.5% of the target/maximum short-term incentive.

Non-CEO Executive Remuneration

Closely supporting our CEO in the execution of our strategy is our executive team, which consists of ten people, as of June 30, 2014, who report to our CEO. Our executive team is currently located across both the United States and Australia.

Our executive team remuneration packages are designed to be competitive in each of the jurisdictions in which they are based, with close alignment across the team where skillsets and experience are similar, to ensure cohesion.

Remuneration Structure

The aim of our executive remuneration structure is to ensure the remuneration package reflects the skills, responsibilities and experience of our people. It is also designed to align the achievement of our goals that are ultimately set to achieve long-term shareholder value. We are committed to adhering to appropriate corporate governance standards for executive (including the CEO) remuneration, having regard to the ASX Corporate Governance Principles and Recommendations and relevant stakeholder bodies, together with mindfulness of the industry and environment we are operating within.

Our remuneration arrangements for our executive team (excluding the CEO whose details are discussed above) are comprised of both fixed and performance-based remuneration. The fixed remuneration component allows us to recruit and retain highly specialized experts in a small and competitive market. The at-risk components of short-term incentives, or STIs, and long-term incentives, or LTIs, seek to reward our executives for achieving the short-term operational objectives that are essential to reaching our long-term objective of creating regenerative medicine therapies for major unmet clinical needs.

 

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When conducting our annual executive remuneration review, the Nomination and Remuneration Committee considers the following:

 

•

our operational performance and current financial position;

 

•

the achievement of our strategic goals for the year; and

 

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the individual performance of our executive team members.

The Nomination and Remuneration Committee benchmarks the various components of our executive remuneration to packages paid by other publicly listed companies in our peer group, incorporates compensation data from recruitment processes and an international life sciences survey, and considers recommendations from our CEO (other than for his own salary). From time to time the Nomination and Remunerations Committee engages the services of outside compensation consultants.

As approximately 75% of our employees are in the United States, it is critical that our approach to remuneration in that market is appropriate and competitive, to ensure we can hire and retain the key individuals we need to give us the best opportunity for success.

The typical target remuneration mix of our executive team (excluding the CEO) approximates 40% fixed and 60% performance-based. Of the 60% performance-based remuneration, 40% relates to LTIs and 20% STIs.

Fixed Remuneration

Fixed remuneration consists of base salary, and in keeping with local market practices our Australian executives receive employer superannuation contributions, up to the statutory limits, and our United States executives receive medical and insurance benefits.

Performance-Based Remuneration

Our performance-based remuneration components consist of at-risk of STIs and LTIs. Annual STI and LTI grants are determined each year by the CEO together with the Nomination and Remuneration Committee, with regard to both individual performance and overall corporate performance. STI and LTI recommendations are then subject to approval by our board of directors.

Short-Term Incentives (STIs). Our approach to STI setting is influenced by the fact that we are in development state and are pre-revenue, as follows:

 

•

We set STIs at a smaller proportion of our total target remuneration than LTIs to conserve cash outflow; and

 

•

We measure performance against the following:

 

•

achievement of individual KPIs;

 

•

key corporate and budgetary milestones; and

 

•

achievement of strategic goals.

All of the factors lead to long-term shareholder value creation.

Individual’s KPIs for the executive team are closely aligned to our strategy and objectives, and our CEO’s own KPIs. This ensures that by their achievement they will contribute to the overall corporate goals.

STI allocations for the executive team start with an assessment of overall company performance against key milestones, strategic goals and budget performance. The STIs are then adjusted up or down based on each executive’s operational ability to contribute to our goals and their individual performance against their own individual KPIs. For the 2013/14 financial year, executive STI allocations were between 82.5% and 100% of target. STIs are paid in cash.

 

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The following table outlines a summary of our 2014 Short-Term Incentive Plan, or STIP:

 

What is the 2014 STIP?		An incentive plan under which eligible employees are (subject to satisfaction of specified performance measures) granted a cash amount, which is based on a percentage range of each participant’s fixed remuneration (determined according to role and ability to influence our performance is assessed against a combination of company and individual measures.
When is the 2014 STIP grant paid to eligible employees?		The STIP amount will be paid to each participant who satisfies applicable performance measures in August 2014, following assessment of performance against the applicable measures during the 2013/14 performance period.
Who participates in the 2014 STIP?		All employees hired on or before March 31, 2014 are eligible for consideration. Employees hired during the year are recognized on a pro-rata basis.
Why does our board of directors consider the 2014 STIP an appropriate incentive?		The STIP is a globally recognized form of reward for management, aimed at ensuring focus and alignment our goals and strategy. Based on both company and individual measures, and in conjunction with other factors, our board of directors believes that it helps encourage and reward high performance.
What are the performance conditions under the 2014 STIP?		Individual performance is measured against the achievement of individual KPIs, key corporate and budgetary milestones and achievement of strategic goals all of which lead to long-term shareholder value creation.
What is the relationship between our performance and allocation of STIs?		At the end of the financial year our board of directors assesses our overall company performance based on the achievement of our CEO’s KPIs. This assessment will adjust how much of our bonus pool is eligible for allocation. For example, if we achieve an 85% company performance assessment, then 85% of the total bonus pool will be available for allocation to individual employees. The executives evaluate individual performance contributions and make recommendations of the bonus amount each employee should receive based on the bonus pool they have available for allocation and with reference to individual target bonus opportunities.
What is the period over which our performance is assessed?		The assessment period is the financial year preceding the payment date of the STIP (July 1 through June 30).

Long-Term Incentives (LTIs). As a biotechnology company which is still in the clinical trial development stage, we aim to conserve our cash resources in order to fund our programs, therefore we place significant weight on the LTI component of our remuneration mix. This focuses our executives on the value creation that occurs as our products move through development process and ultimately to therapeutic treatment.

 

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In designing a LTI mechanism which aims to reward and retain talent across our locations, and considering 84 of our employees are based in the United States, we seek to balance:

 

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Australian practice and governance expectations, where LTI are expected to have performance hurdles other than price and employment milestones alone;

 

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United States practices, where options are a widely distributed remuneration component, typically issued without a price premium, performance hurdles or milestones, and which vest on a more regular basis (e.g. rolling monthly basis);

 

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A strong preference for a single reward mechanism to maintain executive cohesion and teamwork; and

 

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Alignment with driving shareholder value.

In view of the points outlined above our approach is to issue LTIs to executives that are time based. They are issued at a premium to the actual share price on the day they are issued. It is our belief that this approach is the appropriate one for us at this stage as we believe that the addition of performance hurdles to our LTI program would make it problematic for us to attract and retain the people we need, particularly in the United States, and would ultimately be negative for our company. This is an area we continue to review and assess on an ongoing basis.

In Australia, LTIs consist of limited recourse of our loan-funded shares pursuant to the rules of the Loan-funded Share Plan, or LFSP. Outside Australia, LTIs consist of options over our ordinary shares under the rules of the Employee Share Ownership Plan, or ESOP. Both the ESOP and LFSP were approved by shareholders at the annual general meeting held in November 2013. Both plans operate in a similar manner, with the shares/options typically having a purchase/exercise price premium applied, three-year vesting schedules and a five-year life.

Executive LTI allocations are determined with consideration to the nature of the role within our organization, market value of LTI allocations for comparable roles, previous grants made and the remuneration mix described above where a modified Black-Scholes calculation is used to determine the value of the option.

Shares issued in the LFSP are issued as new equity, and we do not buy shares on-market under this plan in an effort to conserve cash.

Summary of the key features of the ESOP and LFSP (collectively, the LTI Plans):

 

Why does our board of directors consider the LFSP/ESOP an appropriate long-term incentive?		The Plans are designed to reward participants for our performance and to align long-term interests of shareholders, participating employees and us, by linking a significant proportion of at-risk remuneration to our future performance, currently assessed over a three-year period from the date of grant of the shares.
In what circumstances are LTI entitlements forfeited?		The LTI will be forfeited upon cessation of employment prior to the conclusion of the performance period in circumstances where a participant is a bad leaver as defined in the Plan rules, or breaches any term of the Loan Agreement in the case of the LFSP. Otherwise a leaver may retain vested Loan Funded Shares or Options subject to repayment of the Loan or exercising the option within 60 days of cessation of employment or within a longer period if so determined by our board of directors.

 

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What are the performance conditions under the LTI scheme?		Shares and options are issued at a 10% premium above the volume weighted average share price calculated at grant date. In addition participants have to remain in employment with us for the LTIs to vest.
Why did our board of directors choose the above performance conditions/hurdles?		High volatility makes it difficult to set meaningful performance hurdles other than price premiums, and applying such hurdles may have a severe impact on the competitiveness of remuneration.
What is the relationship between our performance and allocation of shares/options?		Equity-based remuneration is an integral part of remuneration in the biotechnology industry as they reward share price growth and seek to conserve cash. Our board of directors believes that share price growth is an appropriate measure of success as it is the prime driver of investment in the biotechnology sector, and is simply and clearly rewarded using equity-based remuneration.
What is the maximum number of shares/options that may be granted to a participant to the LTI scheme?		The maximum number of shares or options that may be granted is determined by the level of equity based remuneration applicable to each applicant.
When do the shares/options vest?		Shares/options vest in three equal tranches, one year, two years and three years after the date of grant, provided performance conditions are met.
Is the benefit of participation in the LTI scheme affected by changes in the share price?		Yes, participants in the both the ESOP and LFSP will be affected in the same way as all other shareholders by changes in our share price. The value participants receive through participation in the Plans will be reduced if the share price falls during the performance period and will increase if the share price rises over the performance period.

Australian Loan Funded Share Plan (LFSP):

 

What is the LFSP?		An incentive plan under which eligible employees are granted our limited recourse, interest free, loan-funded ordinary shares. Vesting of the LFSP shares is contingent on our achieving certain performance hurdles over a set performance period.
Who participates in the LSFP?		All of our eligible Australian based employees who are in positions to influence achievement of our long-term outcomes and where warranted by market practice for attraction and retention.
What are the key features of the LTI scheme?		Loan funded shares are issued with a price per shares that is typically 10% higher than the volume weighted average share price calculated at grant date. The Loan-Funded shares are subject to a Loan Agreement between the participant and us. Once all conditions are met and the participant no longer has any outstanding obligations pursuant to the Loan Agreement, the loan funded shares revert to being fully paid ordinary shares.

 

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How are shares provided to participants under the Loan-Funded scheme?		Shares issued in the LFSP are issued as new equity and we do not buy shares on-market under this plan in an effort to conserve cash.

ESOP:

The ESOP operates as a traditional option plan, and is used for non-Australian based employees:

 

What is the ESOP?		An incentive plan under which eligible employees are granted options over our ordinary shares. Vesting and exercise of the ESOP options is contingent on the us achieving certain performance hurdles over a set performance period.
Who participates in the ESOP?		All of our international (non-Australian based) employees, who are in positions to influence achievement of our long-term outcomes and where warranted by market practice for attraction and retention.
What are the key features of the ESOP?		Options are issued with an exercise price at a percentage premium above the volume weighted average share price calculated at grant date. High volatility makes it difficult to set meaningful performance hurdles and applying such hurdles may have a severe impact on the competitiveness of remuneration
How are shares provided to participants under the ESOP?		Shares are issued to the participant upon the holder exercising their option and paying the exercise price to us (once all vesting conditions are satisfied).

Employment Agreements

The employment of our CEO is formalized in a contract of employment, the key terms of which are as follows:

 

Name		Term		Notice Period				Termination Benefit
Silviu Itescu		Initial term of 3 years commencing April 1, 2014, and continuing subject to a 12 months’ notice period			12 months			12 months base salary

On termination of employment, key management personnel are entitled to receive their statutory entitlements of accrued annual and long service leave, together with any superannuation benefits.

There is no entitlement to a termination payment in the event of resignation or removal for misconduct.

The employment of the executive team is also formalized in employment contracts. Five of the executive team have employment contracts with initial terms ranging from 15 months to three years, with notice periods ranging from six to twelve months. The remaining five members have continuous employment contracts with no fixed term and notice periods ranging from “at will” to twelve months. Four contracts have contractual CPI increases—there are no other contractual increases in remuneration.

 

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Remuneration Details

Details of the remuneration of our individual directors for the year ended June 30, 2014 are set out below (amounts are presented in Australian dollars):

 

		Short-Term Benefits												Post- Employment Benefits				Long- Term Benefits				Share- Based Payments				Other				Total
		Salary and Fees				Cash Bonus(3)				Non-Monetary Benefits				Super- annuation				Long- Service Leave				Options				Termination Benefits
Silviu Itescu			960,000				840,000				—				17,775				—				—				—				1,817,775
William Burns(1)			44,145				—				—				—				—				—				—				44,145
Brian Jamieson			325,547				—				—				17,775				—				—				—				343,322
Donal O’Dwyer			159,667				—				—				14,769				—				—				—				174,436
Michael Spooner			162,167				—				—				15,000				—				—				—				177,167
Ben Zion-Weiner			134,667				—				—				—				—				—				—				134,667
Eric Rose(2)			142,167				—				—				—				—				—				—				142,167
Total directors 2014			1,928,360				840,000				—				65,319				—				—				—				2,833,679

 

(1)	William Burns joined our board of directors on March 6, 2014.

(2)	Eric Rose joined our board of directors on April 15, 2013.

(3)	STI payable for the year ended June 30, 2014, accrued and not yet paid. This represents 87.5% of target bonus, and therefore an amount of A$120,000 (12.5%) was forfeited.

Details of the remuneration of our individual directors for the year ended June 30, 2013 are set out below (amounts are presented in Australian dollars):

 

		Short-Term Benefits(1)												Post- Employment Benefits				Long- Term Benefits				Share- Based Payments				Other				Total
		Salary and Fees				Cash Bonus(2)				Non-Monetary Benefits				Super- annuation				Long- Service Leave				Options				Termination Benefits
Silviu Itescu			936,000				795,600	(3)			—				16,470				—				—				—				1,748,070
Brian Jamieson			286,667				—				—				16,470				—				5,032				—				308,169
Donal O’Dwyer			146,667				—				—				13,200				—				—				—				159,867
Michael Spooner			149,167				—				—				13,425				—				—				—				162,592
Ben Zion-Weiner			117,249				—				—				—				—				—				—				117,249
Eric Rose (from April 15, 2013)			26,042				—				—				—				—				—				—				26,042
Total directors 2013			1,661,792				795,600				—				59,565				—				5,032				—				2,521,989

 

(1)	Short-term benefits may include amounts paid to superannuation at the election of the individual;

(2)	Our CEO cash bonus is 85% of his target bonus. The amount of bonus forfeited during the year as a result of performance targets not being met is therefore 15%.

(3)	Accrued but not paid as at June 30, 2013.

Performance-Based Remuneration

Performance-based remuneration consists of STIs and LTIs. The relative proportions of remuneration that are linked to performance and those that are fixed, for key management personnel, are as follows:

 

		Fixed Remuneration %								At-Risk STI %								At-Risk LTI %
Name		2014				2013				2014				2013				2014				2013
Silviu Itescu			54				54				46				46				0				0

 

 

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The proportion of at-risk performance remuneration that was awarded and forfeited during the year is as follows:

 

		At-Risk STI
Name		Awarded %				Forfeited %
Silviu Itescu (2014)			87.5				12.5
Silviu Itescu (2013)			85				15

Remuneration Consultants

During the year ended June 30, 2014, the Nomination and Remuneration Committee of our board of directors engaged Towers Watson, to provide a report on non-executive directors’ fees, including equity components, for appropriately similar companies both in Australia and the United States. They were paid A$13,000 for providing this report. Their report did not include any remuneration recommendations within the meaning of section 9B of the Corporations Act, and consequently they are not considered to be remuneration consultants in relation to Mesoblast as defined by section 9 of the Corporations Act.

Share Based Compensation

There were no grants of share options made to key management personnel, including to our directors, in either the current or prior financial year. There has been no modification to any terms and conditions of share-based payment transactions during the current and prior financial year.

Details of options over our ordinary shares provided as remuneration to each director and member of key management personnel for the current and prior financial years are set out in the tables below:

Remuneration Values

The following table provides the remuneration values:

 

		Remuneration consisting of options(1)				Value of options granted(2)				Value of options exercised(3)				Value of options lapsed(4)
Brian Jamieson (2014)			—				—			A$	583,950				—
Brian Jamieson (2013)			1.6	%			—				—				—

 

(1)	The percentage of the value of remuneration consisting of options, based on the value of options expensed during the year in accordance with AASB2 Share-based payments.

(2)	The accounting value at grant date of options that were granted during the year as part of remuneration, determined using Black-Scholes valuation model and in accordance with AASB2 Share-based payments.

(3)	The intrinsic value at exercise date of options that were exercised during the year, having been granted as part of remuneration previously.

(4)	The intrinsic value at lapse date of options that lapsed during the year because a performance condition was not met, but valued as if the performance condition had been met.

Number of Options

The following table provides the number of options:

 

		No. of options granted during the year				No. of options vested during the year				No. of options lapsed during the year
Brian Jamieson (2014)			—				—				—
Brian Jamieson (2013)			—				75,000				—

There were no options granted under the ESOP that vested and/or forfeited during the current financial year.

 

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Shares provided on exercise of remuneration options:

 

2014		No. of options exercised during the year				No. of our ordinary shares issued				Exercise Date		Value per share at exercise date (closing price)				Exercise price per option
Brian Jamieson			75,000				75,000			September 2, 2013		A$	5.65			A$	1.73
Brian Jamieson			75,000				75,000			December 13, 2013		A$	5.58			A$	1.73

Options Granted as Remuneration

The following table presents options and loan-funded shares that have been granted over unissued shares during or since the end of the year, to any of our directors or any of our five most highly remunerated officers (excluding directors), as part of their remuneration. Included in these options are options granted as remuneration to our officers who are among the five highest remunerated officers and the group (other than directors), but are not key management persons and hence are not disclosed in the remuneration report:

 

Name of Officer

Issue Date

Exercise Price

Number of shares, under option or loan-funded

Silviu Itescu

—

—

—

Peter Howard(1)

December 11, 2013

A$

5.92

200,000

Michael Schuster(1)

September 3, 2013

A$

5.92

200,000

Donna Skerrett(1)

September 3, 2013

A$

5.92

200,000

Darin Weber(1)

September 3, 2013

A$

5.92

200,000

 

(1)	Five most highly remunerated officers, but not designated key management personnel.

 

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PRINCIPAL SHAREHOLDERS

The following table sets forth information regarding the beneficial ownership of our ordinary shares at September 30, 2014 by:

 

•

each of our directors and senior management; and

 

•

each person known by us to own more than 5% of our ordinary shares.

We have determined beneficial ownership in accordance with the rules of the SEC. Except as indicated in the footnotes below, we believe, based on the information furnished to us, that the persons named in the following table have sole voting and investment power with respect to all ordinary shares that they beneficially own, subject to applicable community property laws.

The percentage ownership of each listed person before this offering is based upon 317,211,029 ordinary shares outstanding at September 30, 2014. As of December 11, 2014, we had 19 holders of record in the United Sates, which represented approximately 18.3% of our ordinary shares outstanding. The percentage ownership of each listed person after the offering is based upon                  ordinary shares outstanding immediately after the closing of this offering, including the ordinary shares identified in the immediately preceding sentence plus the ordinary shares to be sold by us in this offering.

In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person, we deemed outstanding ordinary shares subject to options held by that person that are currently exercisable or exercisable within 60 days of September 30, 2014. We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person.

The underwriters have an option for a period of 30 days from the date of this prospectus to purchase up to an additional              ADSs from us at the initial public offering price less the underwriting discounts and commissions.

Unless otherwise indicated, the principal address of each of the shareholders below is c/o Mesoblast Limited, Level 38, 55 Collins Street, Melbourne 3000, Australia.

 

		Shares beneficially owned before offering								Shares beneficially owned after offering (assuming no exercise of the over-allotment option)
Name		Number				%				Number		%
5% or Greater Shareholders:
M&G Investment Group(1)			36,782,943				11.60	%
Cephalon, Inc.(2)			55,785,806				17.59	%
Silviu Itescu(3)			68,244,642				21.51	%
Capital Research Global Investors(4)			21,770,000				6.86	%
Thorney Holdings(5)			18,029,407				5.68	%
Directors and officers:
Silviu Itescu(3)			68,244,642				21.51	%
William Burns			—				*
Brian Jamieson(6)			535,000				*
Paul Hodgkinson			—				*
Eric Rose			—				*
Donal O’Dwyer(7)			1,104,727				*
Ben-Zion Weiner			—				*
Michael Spooner			985,606				*
All directors and officers as a group (8 persons)			70,864,975				22.27	%

 

*	Less than 1% of the outstanding ordinary shares.

 

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(1)	Includes shares owned indirectly through custodial accounts, over which shares M&G Investment Group retains voting and dispositive power. The address for M&G Investment Group is Laurence Pountney Hill, London EC4R 0HH, United Kingdom.

(2)	The address for Cephalon Inc. is 41 Moores Road, Frazer, PA 19355.

(3)	Includes (a) 67,751,838 ordinary shares owned by Dr. Itescu and (b) 487,804 ordinary shares owned by Josaka Investments Pty Ltd., the trustee of Dr. Itescu’s self-managed superannuation fund.

(4)	Includes shares owned indirectly through custodial accounts, over which shares Capital Research Global Investors retains voting and dispositive power. The address for Capital Research Global Investors is 333 South Hope Street, Los Angeles, California, 90071.

(5)	Includes shares owned indirectly through custodial accounts, over which shares Thorney Holdings retains voting and dispositive power. The address for Thorney Holdings is 55 Collins Street, Level 39, Melbourne, Victoria 3000, Australia.

(6)	Includes (a) 185,000 ordinary shares owned by Mr. Jamieson, (b) 200,000 ordinary shares owned by Mr. Jamieson through Bond Street Custodians Limited, and (c) 150,000 ordinary shares subject to options exercisable within 60 days of September 30, 2014 held by Mr. Jamieson.

(7)

Includes (a) 300,000 ordinary shares owned by Mr. O’Dwyer, (b) 5,000 ordinary shares owned by Dundrum Investments Ltd. as trustee for the Dundrum Superannuation Fund, and (c) 799,727 ordinary shares subject to options exercisable within 60 days of September 30, 2014 held by Dundrum Investments Ltd. Mr. O’Dwyer and his spouse are sole shareholders of Dundrum Investments Ltd.

 

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RELATED PARTY TRANSACTIONS

Other than compensation arrangements which are described under “Management—Remuneration” or as disclosed below, from July 1, 2011 to September 30, 2014 we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) key management personnel and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.

Teva/Cephalon

In December 2010, we entered into a development and commercialization agreement, or DCA, with Cephalon, Inc., now a wholly-owned subsidiary of Teva, and one of our largest equity holders. See “Principal Shareholders.” In this section, we refer to Cephalon and Teva together as Teva. In September 2013, we and Teva amended the DCA. See “Business—Our Strategic Alliances—Teva/Cephalon, Inc.—Cardiovascular, Neurological and Bone Marrow Collaboration” for a description of the DCA, as amended.

In December 2010, we also entered into a subscription deed with Teva, or the Deed. Pursuant to the Deed, for so long as Teva holds at least 10% of our outstanding ordinary shares, in connection with any future placements of our ordinary shares or issues of ordinary shares on the conversion of convertible securities, Teva has the right to subscribe, on the same terms and at the same time, for additional ordinary shares that would result in Teva maintaining its same percentage ownership in Mesoblast immediately before and after the issuance. Teva’s subscription right does not apply to issuances made (i) under an option plan or pursuant to remuneration arrangements for employees or directors, (ii) under a dividend reinvestment plan or (iii) pursuant to an acquisition agreement. Teva’s subscription right is conditioned upon the ASX granting a waiver of Listing Rule 6.18, which restricts options from being exercisable over a percentage of an ASX listed company’s capital.

Loan-Funded Share Plan

Our Loan-funded Share Plan, or LFSP, is our incentive plan under which eligible employees are granted limited recourse, interest free, loan-funded ordinary shares of Mesoblast. Vesting of the LFSP shares is contingent upon our achievement of certain performance hurdles over a certain period. As of September 30, 2014, we had A$33.4 million of loans outstanding under the LFSP. During the three year period from July 1, 2011 through September 30, 2014, the largest amount outstanding under the LFSP was A$33.4 million. See “Management—Remuneration—Non-CEO Executive Remuneration—Performance-Based Remuneration—Long-Term Incentives (LTIs)—Australian Loan Funded Share Plan (LFSP)” for a more detailed description of the LFSP.

Indemnification Agreements and Directors’ and Officers’ Liability Insurance

Under our Constitution, to the extent permitted by the Corporations Act we may indemnify or insure any person who is or has been our or any of our subsidiaries’ officer, which indemnity or insurance policy may be in such terms as the directors approve and, in particular, may apply to acts or omissions prior to or after the time of entering into the indemnity or policy.

We have entered into deeds of indemnity, insurance and access, or Deeds, with each director.

Under the Deeds, we indemnify (to the maximum extent permitted under Australian law) each director and certain officers against all liabilities incurred by the director as an officer of us (or a controlled entity of us) and any and all legal costs incurred by that director or officer in defending an action for a liability incurred by the director as an officer of us (or a controlled entity of us). The Deeds provide that the indemnities are unlimited as to amount, and are continuing and irrevocable. Also under the Deeds, we must obtain insurance during each director’s period of office and for a period of seven years after a director ceases to hold office.

 

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DESCRIPTION OF SHARE CAPITAL

General

The following description of our ordinary shares is only a summary. We encourage you to read our Constitution, which is included as an exhibit to this registration statement, of which this prospectus forms a part.

We are a public company limited by shares registered under the Corporations Act by the Australian Securities and Investments Commission, or ASIC. Our corporate affairs are principally governed by our Constitution, the Corporations Act and the ASX Listing Rules. Our ordinary shares trade on the ASX, and we are applying to list the ADSs on the                 .

The Australian law applicable to our Constitution is not significantly different than a U.S. company’s charter documents except we do not have the concept of or a limit on our authorized share capital, the concept of par value is not recognized under Australian law and as further discussed under “—Our Constitution.”

Subject to restrictions on the issue of securities in our Constitution, the Corporations Act and the ASX Listing Rules and any other applicable law, we may at any time issue shares and grant options or warrants on any terms, with the rights and restrictions and for the consideration that our board of directors determine.

The rights and restrictions attaching to ordinary shares are derived through a combination of our Constitution, the common law applicable to Australia, the ASX Listing Rules, the Corporations Act and other applicable law. A general summary of some of the rights and restrictions attaching to our ordinary shares is set forth below. Each ordinary shareholder is entitled to receive notice of, and to be present, vote and speak at, general meetings.

Changes to Our Share Capital

As of June 30, 2013, we had 313,148,901 fully paid ordinary shares outstanding. As of June 30, 2014, we had (i) 317,155,094 fully paid ordinary shares outstanding and (ii) outstanding employee options and loan funded share plan shares to purchase an aggregate of 17,549,542 ordinary shares at a weighted average exercise price of A$5.82.

During the last three years, the following changes have been made to our ordinary share capital:

 

•

On March 14, 2013, we issued 26,970,979 ordinary shares to institutional investors in a private placement in Australia and certain other countries. Consideration per share was A$6.30;

 

•

On October 29, 2013, we issued 70,164 ordinary shares as consideration for the acquisition of certain assets from Provasculon, Inc. Consideration per share was A$5.96; and

 

•

On December 18, 2013, we issued 2,948,729 ordinary shares to Osiris Therapeutics, Inc. as consideration for taking delivery of the assigned and other assets pursuant to the purchase agreement for the acquisition of the entire culture expanded mesenchymal stem cell assets of Osiris Therapeutics, Inc. Consideration per share was A$5.69.

In addition, we issued the following fully-paid ordinary shares upon exercise of employee options over the past three years:

 

•

987,300 ordinary shares in the year ended June 30, 2014;

 

•

2,552,816 ordinary shares in the year ended June 30, 2013; and

 

•

3,279,848 ordinary shares in the year ended June 30, 2012.

 

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Our Constitution

Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or purposes of Mesoblast. Our Constitution is subject to the terms of the ASX Listing Rules and the Corporations Act. It may be modified or repealed and replaced by special resolution passed at a meeting of shareholders, which is a resolution passed by at least 75% of the votes cast by shareholders (including proxies and representatives of shareholders) entitled to vote on the resolution.

Under Australian law, a company has the legal capacity and powers of an individual both within and outside Australia. The material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a definitive statement of the rights and liabilities of our shareholders. Our Constitution is filed as an exhibit to the registration statement, of which this prospectus forms a part.

Directors

Interested Directors

Except as permitted by the Corporations Act and the ASX Listing Rules, a director must not vote in respect of any contract or arrangement in which the director has any direct or indirect material personal interest or any lesser interest according to our Constitution. Such director must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being considered.

A director is said in our Constitution to be liable to account to us for any profits derived in respect of a matter in which the director has a material interest unless the director:

 

•

declares the Director’s interest in the matter as soon as practicable after the relevant facts come to the Director’s knowledge; and

 

•

does not contravene our constitution or the Corporations Act in relation to the matter.

Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of certain interests and prohibits directors of companies listed on the ASX from voting on matters in which they have a material personal interest and from being present at the meeting while the matter is being considered. In addition, unless a relevant exception applies, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision of financial benefits (including the issue by us of shares and other securities) to our directors, including entities controlled by them and certain members of their families.

Borrowing Powers Exercisable by Directors

Pursuant to our Constitution, our business is managed by our board of directors. Our board of directors has the power to raise or borrow money, and charge any of our property or business or any uncalled capital, and may issue debentures or give any other security for any of our debts, liabilities or obligations or of any other person, in each case, in the manner and on terms it deems fit.

Retirement of Directors

Pursuant to our Constitution, one-third of our directors, other than the director who is the Managing Director (or the director appointed as “Managing Director” by the directors and, typically, our chief executive officer), must retire from office at every annual general meeting. If the number of directors is not a multiple of three, then the number nearest, to but not exceeding, one-third must retire from office. The directors who retire in this manner are required to be the directors or director longest in office since last being elected. A director, other than the director who is the Managing Director, must retire from office at the conclusion of the third annual general meeting after which the director was elected. Retired directors are eligible for a re-election to the board of directors.

 

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A director who is appointed during the year by the other directors only holds office until the next general meeting at which time the director may stand for election by shareholders at a general meeting.

In addition, provisions of the Corporations Act apply where at least 25% of the votes cast on a resolution to adopt our remuneration report (which resolution must be proposed each year at our annual general meeting) are against the adoption of the report at two successive annual general meetings. Where these provisions apply, a resolution must be put to a vote at the second annual general meeting to the effect that a further meeting, or a spill meeting, take place within 90 days. At the spill meeting, the directors in office when the remuneration report was considered at the second annual general meeting (other than the Managing Director) cease to hold office and resolutions to appoint directors (which may involve re-appointing the former directors) are put to a vote.

Voting restrictions apply in relation to the resolutions to adopt our remuneration report and to propose a spill meeting. These restrictions apply to our key management personnel and their closely related parties. See “Rights and Restrictions on Classes of Shares—Voting Rights” below.

Pursuant to our Constitution, no person is eligible to be elected as a director unless a notice of the director’s candidature is given to us at least 35 business days (30 business days for a meeting shareholders have requested directors to call) before the meeting. This restriction does not apply to a retiring director or to the election of a director previously appointed by the directors during the year.

Share Qualifications

There are currently no requirements for directors to own our ordinary shares in order to qualify as directors.

Rights and Restrictions on Classes of Shares

Subject to the Corporations Act and the ASX Listing Rules, the rights attaching to our ordinary shares are detailed in our Constitution. Our Constitution provides that any of our ordinary shares may be issued with preferred, deferred or other special rights, whether in relation to dividends, voting, return of share capital, payment of calls or otherwise as our board of directors may determine from time to time. Subject to the Corporations Act and the ASX Listing Rules, any rights and restrictions attached to a class of shares, we may issue further shares on such terms and conditions as our board of directors resolve. Currently, our outstanding share capital consists of only one class of ordinary shares.

Dividend Rights

Our board of directors may from time to time determine to pay dividends to shareholders. All unclaimed dividends may be invested or otherwise made use of by our board of directors for our benefit until claimed or otherwise disposed of in accordance with our Constitution.

Voting Rights

Under our Constitution, each shareholder present at a meeting in person or by proxy or representative has one vote determined by a show of hands at a meeting of the shareholders. On a poll vote, each such shareholder shall have one vote for each fully paid share and a fractional vote for each share that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid to such date on that share. Shareholders may vote by proxy, but not electronically. Under Australian law, shareholders of a public listed company are not permitted to approve corporate matters by written consent. Our Constitution does not provide for cumulative voting.

Note that ADS holders may not directly vote at a meeting of the shareholders but may instruct the depositary to vote the number of deposited ordinary shares their ADSs represent.

 

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There are a number of circumstances where the Corporations Act or the ASX Listing Rules prohibit or restrict certain shareholders or certain classes of shareholders from voting. For example, key management personnel details of whose remuneration are included in our annual remuneration report and their closely related parties are prohibited from voting on the resolution that must be proposed at each annual general meeting to adopt our remuneration report, as well as any resolution to propose a spill meeting. An exception applies to exercising a directed proxy which indicates how the proxy is to vote on the proposed resolution on behalf of someone other than the key management personnel or their closely related parties; or that person is chair of the meeting and votes an undirected proxy where the shareholder expressly authorizes the chair to exercise that power. Key management personnel and their closely related parties are also prohibited from voting undirected proxies on remuneration related resolutions. A similar exception to that described above applies if the proxy is the chair of the meeting.

Right to Share in Our Profits

Subject to the Corporations Act and pursuant to our Constitution, prior to our liquidation, our shareholders are entitled to participate in our profits only by payment of dividends. Our board of directors may from time to time determine to pay dividends to the shareholders; however, no dividend is payable except in accordance with the thresholds set out in the Corporations Act.

Rights to Share in the Surplus in the Event of Liquidation

Our Constitution provides for the right of shareholders to participate in a surplus in the event of our liquidation.

Redemption Provisions

There are no redemption provisions in our Constitution in relation to ordinary shares. Under our Constitution and subject to the Corporations Act, any preference shares may be issued on the terms that they are, or may at our option or at the option of the holder be, liable to be redeemed.

Sinking Fund Provisions

Our Constitution allows our directors to, at their discretion, set aside any sums they think proper out of our profits as reserves, which may be applied for any proper purpose.

Liability for Further Capital Calls

According to our Constitution, our board of directors may make any calls from time to time upon shareholders in respect of all monies unpaid on partly paid shares respectively held by them, subject to the terms upon which any of the partly paid shares have been issued. Each shareholder is liable to pay the amount of each call in the manner, at the time and at the place specified by our board of directors. Calls may be made payable by installment.

Provisions Discriminating Against Holders of a Substantial Number of Shares

There are no provisions under our Constitution discriminating against any existing or prospective holders of a substantial number of our ordinary shares.

Variation or Cancellation of Share Rights

The rights attached to shares in a class of shares may only be varied or cancelled by a special resolution of shareholders, together with either:

 

•

a special resolution passed at a separate meeting of members holding shares in the by those members class; or

 

•

the written consent of members with at least 75% of the votes in the class.

 

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General Meetings of Shareholders

General meetings of shareholders may be called by our board of directors or, under the Corporations Act, by a single director. Except as permitted under the Corporations Act, shareholders may not convene a meeting. Under the Corporations Act, shareholders with at least 5% of the votes that may be cast at a general meeting may call and arrange to hold a general meeting. The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that may be cast at a general meeting or at least 100 shareholders who are entitled to vote at the general meeting. Notice of the proposed meeting of our shareholders is required at least 28 days prior to such meeting under the Corporations Act.

Foreign Ownership Regulation

There are no limitations on the rights to own securities imposed by our Constitution. However, acquisitions and proposed acquisitions of shares in Australian companies may be subject to review and approval by the Australian Federal Treasurer under the Foreign Acquisitions and Takeovers Act 1975, or the FATA, which generally applies to acquisitions or proposed acquisitions:

 

•

by a foreign person (as defined in the FATA) or associated foreign persons that would result in such persons having an interest in 15% or more of the issued shares of, or control of 15% or more of the voting power in, an Australian company; and

 

•

by non-associated foreign persons that would result in such foreign person having an interest in 40% or more of the issued shares of, or control of 40% or more of the voting power in, an Australian company.

The Australian Federal Treasurer may prevent a proposed acquisition in the above categories or impose conditions on such acquisition if the Treasurer is satisfied that the acquisition would be contrary to the national interest. If a foreign person acquires shares or an interest in shares in an Australian company in contravention of the FATA, the Australian Federal Treasurer may order the divestiture of such person’s shares or interest in shares in Mesoblast. The Australian Federal Treasurer may order divestiture pursuant to the FATA if he determines that the acquisition has resulted in that foreign person, either alone or together with other non-associated or associated foreign persons, controlling Mesoblast and that such control is contrary to the national interest.

Ownership Threshold

There are no provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. The Corporations Act, however, requires a substantial shareholder to notify us and the ASX once a 5% interest in our ordinary shares is obtained. Further, once a shareholder has (alone or together with associates) a 5% or greater interest in us, such shareholder must notify us and the ASX of any increase or decrease of 1% or more in its interest in our ordinary shares. Upon becoming a U.S. listed public company, our shareholders will also be subject to disclosure requirements under U.S. securities laws.

Issues of Shares and Change in Capital

Subject to our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time issue shares and grant options or warrants on any terms, with preferred, deferred or other special rights and restrictions and for the consideration and other terms that the directors determine. Our power to issue shares includes the power to issue bonus shares (for which no consideration is payable to Mesoblast), preference shares and partly paid shares.

Subject to the requirements of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, including relevant shareholder approvals, we may consolidate or divide our share capital into a smaller or larger number by resolution, reduce our share capital (provided that the reduction is fair and reasonable to our shareholders as a whole, does not materially prejudice our ability to pay creditors and obtains the necessary shareholder approval) or buy back our ordinary shares including under an equal access buy-back or on a selective basis.

 

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Change of Control

Takeovers of listed Australian public companies, such as Mesoblast, are regulated by the Corporations Act, which prohibits the acquisition of a “relevant interest” in issued voting shares in a listed company if the acquisition will lead to that person’s or someone else’s voting power in Mesoblast increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below 90%, subject to a range of exceptions.

Generally, a person will have a relevant interest in securities if the person:

 

•

is the holder of the securities;

 

•

has power to exercise, or control the exercise of, a right to vote attached to the securities; or

 

•

has the power to dispose of, or control the exercise of a power to dispose of, the securities (including any indirect or direct power or control).

If, at a particular time, a person has a relevant interest in issued securities and the person:

 

•

has entered or enters into an agreement with another person with respect to the securities;

 

•

has given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in relation to the securities;

 

•

has granted or grants an option to, or has been or is granted an option by, another person with respect to the securities, and the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised; or

 

•

the other person is taken to already have a relevant interest in the securities.

There are a number of exceptions to the above prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the more significant exceptions include:

 

•

when the acquisition results from the acceptance of an offer under a formal takeover bid;

 

•

when the acquisition is conducted on market by or on behalf of the bidder under a takeover bid and the acquisition occurs during the bid period;

 

•

when shareholders of Mesoblast approve an acquisition that would otherwise breach the prohibition, by resolution passed at general meeting;

 

•

an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had voting power in Mesoblast of at least 19% and, as a result of the acquisition, none of the relevant persons would have voting power in Mesoblast more than three percentage points higher than they had six months before the acquisition;

 

•

as a result of a rights issue;

 

•

as a result of dividend reinvestment schemes;

 

•

as a result of certain underwriting arrangements;

 

•

through operation of law;

 

•

an acquisition that arises through the acquisition of a relevant interest in another company listed on the ASX, certain other Australian financial markets or a foreign stock exchange approved in writing by ASIC;

 

•

arising from an auction of forfeited shares; or

 

•

arising through a compromise, arrangement, liquidation or buy-back.

 

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A formal takeover bid may either be a bid for all securities in the bid class or a fixed proportion of such securities, with each holder of bid class securities receiving a bid for that proportion of their holding. Under our Constitution, a proportionate takeover bid must first be approved by resolution of our shareholders in general meeting before it may proceed.

Breaches of the takeovers provisions of the Corporations Act are criminal offenses. In addition, ASIC and, on application by ASIC or an interested party, such as a shareholder, the Australian Takeover Panel have a wide range of powers relating to breaches of takeover provisions, including the ability to make orders canceling contracts, freezing transfers of, and rights (including voting rights) attached to, securities, and forcing a party to dispose of securities including by vesting the securities in ASIC for sale. There are certain defenses to breaches of the takeover provisions provided in the Corporations Act.

Access to and Inspection of Documents

Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our registers on the payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial records and other documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books.

 

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DESCRIPTION OF AMERICAN DEPOSITARY SHARES

American Depositary Receipts

JPMorgan Chase Bank, N.A., as depositary will issue the ADSs which you will be entitled to receive in this offering. Each ADS will represent an ownership interest in                      shares which we will deposit with the custodian, as agent of the depositary, under the deposit agreement among ourselves, the depositary and yourself as an ADR holder. In the future, each ADS will also represent any securities, cash or other property deposited with the depositary but which they have not distributed directly to you. Unless certificated ADRs are specifically requested by you, all ADSs will be issued on the books of our depositary in book-entry form and periodic statements will be mailed to you which reflect your ownership interest in such ADSs. In our description, references to American depositary receipts or ADRs shall include the statements you will receive which reflect your ownership of ADSs.

The depositary’s office is located at 4 New York Plaza, Floor 12, New York, NY, 10004.

You may hold ADSs either directly or indirectly through your broker or other financial institution. If you hold ADSs directly, by having an ADS registered in your name on the books of the depositary, you are an ADR holder. This description assumes you hold your ADSs directly. If you hold the ADSs through your broker or financial institution nominee, you must rely on the procedures of such broker or financial institution to assert the rights of an ADR holder described in this section. You should consult with your broker or financial institution to find out what those procedures are.

As an ADR holder, we will not treat you as a shareholder of ours and you will not have any shareholder rights. Australian law governs shareholder rights. Because the depositary or its nominee will be the shareholder of record for the shares represented by all outstanding ADSs, shareholder rights rest with such record holder. Your rights are those of an ADR holder. Such rights derive from the terms of the deposit agreement to be entered into among us, the depositary and all registered holders from time to time of ADSs issued under the deposit agreement. The obligations of the depositary and its agents are also set out in the deposit agreement. Because the depositary or its nominee will actually be the registered owner of the shares, you must rely on it to exercise the rights of a shareholder on your behalf. The deposit agreement and the ADSs are governed by New York law. Under the deposit agreement, as an ADR holder, you agree that any legal suit, action or proceeding against or involving us or the depositary, arising out of or based upon the deposit agreement or transactions contemplated thereby, may only be instituted in a state or federal court in New York, New York, and you irrevocably waive any objection which you may have to the laying of venue of any such proceeding and irrevocably submit to the exclusive jurisdiction of such courts in any such suit, action or proceeding.

The following is a summary of what we believe to be the material terms of the deposit agreement. Notwithstanding this, because it is a summary, it may not contain all the information that you may otherwise deem important. For more complete information, you should read the entire deposit agreement and the form of ADR which contains the terms of your ADSs. You can read a copy of the deposit agreement which is filed as an exhibit to the registration statement of which this prospectus forms a part. You may also obtain a copy of the deposit agreement at the SEC’s Public Reference Room which is located at 100 F Street, NE, Washington, DC 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-732-0330. You may also find the registration statement and the attached deposit agreement on the SEC’s website at http://www.sec.gov.

Share Dividends and Other Distributions

How will I receive dividends and other distributions on the shares underlying my ADSs?

We may make various types of distributions with respect to our securities. The depositary has agreed that, to the extent practicable, it will pay to you the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, after converting any cash received into U.S. dollars (if it determines such

 

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conversion may be made on a reasonable basis) and, in all cases, making any necessary deductions provided for in the deposit agreement. The depositary may utilize a division, branch or affiliate of JPMorgan Chase Bank, N.A. to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. Such division, branch and/or affiliate may charge the depositary a fee in connection with such sales, which fee is considered an expense of the depositary. You will receive these distributions in proportion to the number of underlying securities that your ADSs represent.

Except as stated below, the depositary will deliver such distributions to ADR holders in proportion to their interests in the following manner:

 

•

Cash. The depositary will distribute any U.S. dollars available to it resulting from a cash dividend or other cash distribution or the net proceeds of sales of any other distribution or portion thereof (to the extent applicable), on an averaged or other practicable basis, subject to (i) appropriate adjustments for taxes withheld, (ii) such distribution being impermissible or impracticable with respect to certain registered ADR holders, and (iii) deduction of the depositary’s and/or its agents’ expenses in (1) converting any foreign currency to U.S. dollars to the extent that it determines that such conversion may be made on a reasonable basis, (2) transferring foreign currency or U.S. dollars to the United States by such means as the depositary may determine to the extent that it determines that such transfer may be made on a reasonable basis, (3) obtaining any approval or license of any governmental authority required for such conversion or transfer, which is obtainable at a reasonable cost and within a reasonable time and (4) making any sale by public or private means in any commercially reasonable manner. If exchange rates fluctuate during a time when the depositary cannot convert a foreign currency, you may lose some or all of the value of the distribution.

 

•

Shares. In the case of a distribution in shares, the depositary will issue additional ADRs to evidence the number of ADSs representing such shares. Only whole ADSs will be issued. Any shares which would result in fractional ADSs will be sold and the net proceeds will be distributed in the same manner as cash to the ADR holders entitled thereto.

 

•

Rights to receive additional shares. In the case of a distribution of rights to subscribe for additional shares or other rights, if we timely provide evidence satisfactory to the depositary that it may lawfully distribute such rights, the depositary will distribute warrants or other instruments in the discretion of the depositary representing such rights. However, if we do not timely furnish such evidence, the depositary may:

 

•

sell such rights if practicable and distribute the net proceeds in the same manner as cash to the ADR holders entitled thereto; or

 

•

if it is not practicable to sell such rights by reason of the non-transferability of the rights, limited markets therefor, their short duration or otherwise, do nothing and allow such rights to lapse, in which case ADR holders will receive nothing and the rights may lapse.

We have no obligation to file a registration statement under the Securities Act in order to make any rights available to ADR holders.

 

•

Other Distributions. In the case of a distribution of securities or property other than those described above, the depositary may either (i) distribute such securities or property in any manner it deems equitable and practicable or (ii) to the extent the depositary deems distribution of such securities or property not to be equitable and practicable, sell such securities or property and distribute any net proceeds in the same way it distributes cash.

 

•

Elective Distributions. In the case of a dividend payable at the election of our shareholders in cash or in additional shares, we will notify the depositary at least 30 days prior to the proposed distribution stating whether or not we wish such elective distribution to be made available to ADR holders. The depositary shall make such elective distribution available to ADR holders only if (i) we shall have timely requested that the elective distribution is available to ADR holders, (ii) the depositary shall have

 

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determined that such distribution is reasonably practicable and (iii) the depositary shall have received satisfactory documentation within the terms of the deposit agreement including any legal opinions of counsel that the depositary in its reasonable discretion may request. If the above conditions are not satisfied, the depositary shall, to the extent permitted by law, distribute to the ADR holders, on the basis of the same determination as is made in the local market in respect of the shares for which no election is made, either (x) cash or (y) additional ADSs representing such additional shares. If the above conditions are satisfied, the depositary shall establish procedures to enable ADR holders to elect the receipt of the proposed dividend in cash or in additional ADSs. There can be no assurance that ADR holders generally, or any ADR holder in particular, will be given the opportunity to receive elective distributions on the same terms and conditions as the holders of shares.

If the depositary determines in its discretion that any distribution described above is not practicable with respect to any specific registered ADR holder, the depositary may choose any method of distribution that it deems practicable for such ADR holder, including the distribution of foreign currency, securities or property, or it may retain such items, without paying interest on or investing them, on behalf of the ADR holder as deposited securities, in which case the ADSs will also represent the retained items.

Any U.S. dollars will be distributed by checks drawn on a bank in the United States for whole dollars and cents. Fractional cents will be withheld without liability and dealt with by the depositary in accordance with its then current practices.

The depositary is not responsible if it decides that it is unlawful or not reasonably practicable to make a distribution available to any ADR holders.

There can be no assurance that the depositary will be able to convert any currency at a specified exchange rate or sell any property, rights, shares or other securities at a specified price, nor that any of such transactions can be completed within a specified time period. For further information about the general sale and/or purchase of securities see https://www.adr.com.

Deposit, Withdrawal and Cancellation

How does the depositary issue ADSs?

The depositary will issue ADSs if you or your broker deposit shares or evidence of rights to receive shares with the custodian and pay the fees and expenses owing to the depositary in connection with such issuance. In the case of the ADSs to be issued under this prospectus, we will arrange with the underwriters named herein to deposit such shares.

Shares deposited in the future with the custodian must be accompanied by certain delivery documentation and shall, at the time of such deposit, be registered in the name of JPMorgan Chase Bank, N.A., as depositary for the benefit of holders of ADRs or in such other name as the depositary shall direct.

The custodian will hold all deposited shares (including those being deposited by or on our behalf in connection with the offering to which this prospectus relates) for the account of the depositary. ADR holders thus have no direct ownership interest in the shares and only have such rights as are contained in the deposit agreement. The custodian will also hold any additional securities, property and cash received on or in substitution for the deposited shares. The deposited shares and any such additional items are referred to as “deposited securities”.

Upon each deposit of shares, receipt of related delivery documentation and compliance with the other provisions of the deposit agreement, including the payment of the fees and charges of the depositary and any taxes or other fees or charges owing, the depositary will issue an ADR or ADRs in the name or upon the order of the person entitled thereto evidencing the number of ADSs to which such person is entitled. All of the ADSs issued will, unless specifically requested to the contrary, be part of the depositary’s direct registration system, and a registered holder will receive periodic statements from the depositary which will show the number of ADSs registered in such holder’s name. An ADR holder can request that the ADSs not be held through the depositary’s direct registration system and that a certificated ADR be issued.

 

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How do ADR holders cancel an ADS and obtain deposited securities?

When you turn in your ADR certificate at the depositary’s office, or when you provide proper instructions and documentation in the case of direct registration ADSs, the depositary will, upon payment of certain applicable fees, charges and taxes, deliver the underlying shares to you or upon your written order. Delivery of deposited securities in certificated form will be made at the custodian’s office. At your risk, expense and request, the depositary may deliver deposited securities at such other place as you may request.

The depositary may only restrict the withdrawal of deposited securities in connection with:

 

•

temporary delays caused by closing our transfer books or those of the depositary or the deposit of shares in connection with voting at a shareholders’ meeting, or the payment of dividends;

 

•

the payment of fees, taxes and similar charges; or

 

•

compliance with any U.S. or foreign laws or governmental regulations relating to the ADRs or to the withdrawal of deposited securities.

This right of withdrawal may not be limited by any other provision of the deposit agreement.

Record Dates

The depositary may, after consultation with us if practicable, fix record dates for the determination of the registered ADR holders who will be entitled (or obligated, as the case may be):

 

•

to receive any distribution on or in respect of shares,

 

•

to give instructions for the exercise of voting rights at a meeting of holders of shares, or

 

•

to pay the fee assessed by the depositary for administration of the ADR program and for any expenses as provided for in the ADR,

 

•

to receive any notice or to act in respect of other matters,

all subject to the provisions of the deposit agreement.

Voting Rights

How do I vote?

If you are an ADR holder and the depositary asks you to provide it with voting instructions, you may instruct the depositary how to exercise the voting rights for the shares which underlie your ADSs. As soon as practicable after receiving notice of any meeting or solicitation of consents or proxies from us, the depositary will distribute to the registered ADR holders a notice stating such information as is contained in the voting materials received by the depositary and describing how you may instruct the depositary to exercise the voting rights for the shares which underlie your ADSs, including instructions for giving a discretionary proxy to a person designated by us. For instructions to be valid, the depositary must receive them in the manner and on or before the date specified. The depositary will try, as far as is practical, subject to the provisions of and governing the underlying shares or other deposited securities, to vote or to have its agents vote the shares or other deposited securities as you instruct. The depositary will only vote or attempt to vote as you instruct. Holders are strongly encouraged to forward their voting instructions to the depositary as soon as possible. Voting instructions will not be deemed to be received until such time as the ADR department responsible for proxies and voting has received such instructions notwithstanding that such instructions may have been physically received by the depositary prior to such time. The depositary will not itself exercise any voting discretion. Furthermore, neither the depositary nor its agents are responsible for any failure to carry out any voting instructions, for the manner in which any vote is cast or for the effect of any vote. Notwithstanding anything contained in the deposit agreement or any ADR, the depositary may, to the extent not prohibited by law or regulations, or by the requirements of the stock exchange on which the ADSs are listed, in lieu of distribution of the materials provided to the depositary in connection with any meeting of, or solicitation of consents or proxies from, holders of deposited securities,

 

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distribute to the registered holders of ADRs a notice that provides such holders with, or otherwise publicizes to such holders, instructions on how to retrieve such materials or receive such materials upon request (i.e., by reference to a website containing the materials for retrieval or a contact for requesting copies of the materials).

There is no guarantee that you will receive voting materials in time to instruct the depositary to vote and it is possible that you, or persons who hold their ADSs through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote.

Reports and Other Communications

Will ADR holders be able to view our reports?

The depositary will make available for inspection by ADR holders at the offices of the depositary and the custodian the deposit agreement, the provisions of or governing deposited securities, and any written communications from us which are both received by the custodian or its nominee as a holder of deposited securities and made generally available to the holders of deposited securities.

Additionally, if we make any written communications generally available to holders of our shares, and we furnish copies thereof (or English translations or summaries) to the depositary, it will distribute the same to registered ADR holders.

Fees and Expenses

What fees and expenses will I be responsible for paying?

The depositary may charge each person to whom ADSs are issued, including, without limitation, issuances against deposits of shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the ADSs or deposited securities, and each person surrendering ADSs for withdrawal of deposited securities or whose ADRs are cancelled or reduced for any other reason, US$5.00 for each 100 ADSs (or any portion thereof) issued, delivered, reduced, cancelled or surrendered, as the case may be. The depositary may sell (by public or private sale) sufficient securities and property received in respect of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.

The following additional charges shall be incurred by the ADR holders, by any party depositing or withdrawing shares or by any party surrendering ADSs or to whom ADSs are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the ADSs or the deposited securities or a distribution of ADSs), whichever is applicable:

 

•

a fee of US$1.50 per ADR or ADRs for transfers of certificated or direct registration ADRs;

 

•

a fee of up to US$0.05 per ADS for any cash distribution made pursuant to the deposit agreement;

 

•

a fee of up to US$0.05 per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision);

 

•

a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such holders or by deducting such charge from one or more cash dividends or other cash distributions);

 

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•

a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the US$0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those holders entitled thereto;

 

•

stock transfer or other taxes and other governmental charges;

 

•

cable, telex and facsimile transmission and delivery charges incurred at your request in connection with the deposit or delivery of shares;

 

•

transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities;

 

•

in connection with the conversion of foreign currency into U.S. dollars, JPMorgan Chase Bank, N.A. shall deduct out of such foreign currency the fees, expenses and other charges charged by it and/or its agent (which may be a division, branch or affiliate) so appointed in connection with such conversion; and

 

•

fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement.

JPMorgan Chase Bank, N.A. and/or its agent may act as principal for such conversion of foreign currency. For further details see https://www.adr.com.

We will pay all other charges and expenses of the depositary and any agent of the depositary (except the custodian) pursuant to agreements from time to time between us and the depositary. The charges described above may be amended from time to time by agreement between us and the depositary.

Our depositary has agreed to reimburse us for certain expenses we incur that are related to establishment and maintenance of the ADR program upon such terms and conditions as we and the depositary may agree from time to time. The Depositary may make available to us a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as we and the Depositary may agree from time to time. The depositary collects its fees for issuance and cancellation of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions, or by directly billing investors, or by charging the book-entry system accounts of participants acting for them. The depositary will generally set off the amounts owing from distributions made to holders of ADSs. If, however, no distribution exists and payment owing is not timely received by the depositary, the depositary may refuse to provide any further services to holders that have not paid those fees and expenses owing until such fees and expenses have been paid. At the discretion of the depositary, all fees and charges owing under the deposit agreement are due in advance and/or when declared owing by the depositary.

The fees and charges you may be required to pay may vary over time and may be changed by us and by the depositary. You will receive prior notice of the increase in any such fees and charges.

Payment of Taxes

ADR holders must pay any tax or other governmental charge payable by the custodian or the depositary on any ADS or ADR, deposited security or distribution. If an ADR holder owes any tax or other governmental charge, the depositary may (i) deduct the amount thereof from any cash distributions, or (ii) sell deposited securities (by public or private sale) and deduct the amount owing from the net proceeds of such sale. In either case the ADR holder remains liable for any shortfall. Additionally, if any taxes or other governmental charges (including any penalties and/or interest) shall become payable by or on behalf of the custodian or the depositary with respect to any ADR, any deposited securities represented by the ADSs evidenced thereby or any distribution

 

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thereon, such tax or other governmental charge shall be paid by the holder thereof to the depositary and by holding or having held an ADR the holder and all prior holders thereof, jointly and severally, agree to indemnify, defend and save harmless each of the depositary and its agents in respect thereof. If any tax or governmental charge is unpaid, the depositary may also refuse to effect any registration, registration of transfer, split-up or combination of deposited securities or withdrawal of deposited securities until such payment is made. If any tax or governmental charge is required to be withheld on any cash distribution, the depositary may deduct the amount required to be withheld from any cash distribution or, in the case of a non-cash distribution, sell the distributed property or securities (by public or private sale) to pay such taxes and distribute any remaining net proceeds or the balance of any such property after deduction of such taxes to the ADR holders entitled thereto.

By holding an ADR or an interest therein, you will be agreeing to indemnify us, the depositary, its custodian and any of our or their respective officers, directors, employees, agents and affiliates against, and hold each of them harmless from, any claims by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced rate of withholding at source or other tax benefit obtained.

Reclassifications, Recapitalizations and Mergers

If we take certain actions that affect the deposited securities, including (i) any change in par value, split-up, consolidation, cancellation or other reclassification of deposited securities or (ii) any distributions of shares or other property not made to holders of ADRs or (iii) any recapitalization, reorganization, merger, consolidation, liquidation, receivership, bankruptcy or sale of all or substantially all of our assets, then the depositary may choose to, and shall if reasonably requested by us:

 

•

amend the form of ADR;

 

•

distribute additional or amended ADRs;

 

•

distribute cash, securities or other property it has received in connection with such actions;

 

•

sell any securities or property received and distribute the proceeds as cash; or

 

•

none of the above.

If the depositary does not choose any of the above options, any of the cash, securities or other property it receives will constitute part of the deposited securities and each ADS will then represent a proportionate interest in such property.

Amendment and Termination

How may the deposit agreement be amended?

We may agree with the depositary to amend the deposit agreement and the ADSs without your consent for any reason. ADR holders must be given at least 30 days notice of any amendment that imposes or increases any fees or charges (other than stock transfer or other taxes and other governmental charges, transfer or registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or otherwise prejudices any substantial existing right of ADR holders. Such notice need not describe in detail the specific amendments effectuated thereby, but must identify to ADR holders a means to access the text of such amendment. If an ADR holder continues to hold an ADR or ADRs after being so notified, such ADR holder is deemed to agree to such amendment and to be bound by the deposit agreement as so amended. Notwithstanding the foregoing, if any governmental body or regulatory body should adopt new laws, rules or regulations which would require amendment or supplement of the deposit agreement or the form of ADR to ensure compliance therewith, we and the depositary may amend or supplement the deposit agreement and the ADR at any time in accordance with such changed laws, rules or regulations, which amendment or supplement may take effect before a notice is given or within any other period of time as required for compliance. No amendment, however, will impair your right to surrender your ADSs and receive the underlying securities, except in order to comply with mandatory provisions of applicable law.

 

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How may the deposit agreement be terminated?

The depositary may, and shall at our written direction, terminate the deposit agreement and the ADRs by mailing notice of such termination to the registered holders of ADRs at least 30 days prior to the date fixed in such notice for such termination; provided, however, if the depositary shall have (i) resigned as depositary under the deposit agreement, notice of such termination by the depositary shall not be provided to registered holders unless a successor depositary shall not be operating under the deposit agreement within 60 days of the date of such resignation, and (ii) been removed as depositary under the deposit agreement, notice of such termination by the depositary shall not be provided to registered holders of ADRs unless a successor depositary shall not be operating under the deposit agreement on the 120^th day after our notice of removal was first provided to the depositary. After termination, the depositary’s only responsibility will be (i) to deliver deposited securities to ADR holders who surrender their ADRs, and (ii) to hold or sell distributions received on deposited securities. As soon as practicable after the expiration of six months from the termination date, the depositary will sell the deposited securities which remain and hold the net proceeds of such sales (as long as it may lawfully do so), without liability for interest, in trust for the ADR holders who have not yet surrendered their ADRs. After making such sale, the depositary shall have no obligations except to account for such proceeds and other cash.

Limitations on Obligations and Liability to ADR holders

Limits on our obligations and the obligations of the depositary; limits on liability to ADR holders and holders of ADSs

Prior to the issue, registration, registration of transfer, split-up, combination, or cancellation of any ADRs, or the delivery of any distribution in respect thereof, and from time to time in the case of the production of proofs as described below, we or the depositary or its custodian may require:

 

•

payment with respect thereto of (i) any stock transfer or other tax or other governmental charge, (ii) any stock transfer or registration fees in effect for the registration of transfers of shares or other deposited securities upon any applicable register and (iii) any applicable fees and expenses described in the deposit agreement;

 

•

the production of proof satisfactory to it of (i) the identity of any signatory and genuineness of any signature and (ii) such other information, including without limitation, information as to citizenship, residence, exchange control approval, beneficial ownership of any securities, compliance with applicable law, regulations, provisions of or governing deposited securities and terms of the deposit agreement and the ADRs, as it may deem necessary or proper; and

 

•

compliance with such regulations as the depositary may establish consistent with the deposit agreement.

The issuance of ADRs, the acceptance of deposits of shares, the registration, registration of transfer, split-up or combination of ADRs or the withdrawal of shares, may be suspended, generally or in particular instances, when the ADR register or any register for deposited securities is closed or when any such action is deemed advisable by the depositary; provided that the ability to withdraw shares may only be limited under the following circumstances: (i) temporary delays caused by closing transfer books of the depositary or our transfer books or the deposit of shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes, and similar charges, and (iii) compliance with any laws or governmental regulations relating to ADRs or to the withdrawal of deposited securities.

The deposit agreement expressly limits the obligations and liability of the depositary, ourselves and our respective agents, provided, however, that no such disclaimer of liability under the Securities Act of 1933 is intended by any of the limitations of liabilities provisions of the deposit agreement. In the deposit agreement it provides that neither we nor the depositary nor any such agent will be liable if:

 

•

any present or future law, rule, regulation, fiat, order or decree of the United States, Australia or any other country, or of any governmental or regulatory authority or securities exchange or market or

 

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automated quotation system, the provisions of or governing any deposited securities, any present or future provision of our charter, any act of God, war, terrorism, nationalization or other circumstance beyond our, the depositary’s or our respective agents’ control shall prevent or delay, or shall cause any of them to be subject to any civil or criminal penalty in connection with, any act which the deposit agreement or the ADRs provide shall be done or performed by us, the depositary or our respective agents (including, without limitation, voting);

 

•

it exercises or fails to exercise discretion under the deposit agreement or the ADR including, without limitation, any failure to determine that any distribution or action may be lawful or reasonably practicable;

 

•

it performs its obligations under the deposit agreement and ADRs without gross negligence or willful misconduct;

 

•

it takes any action or refrains from taking any action in reliance upon the advice of or information from legal counsel, accountants, any person presenting shares for deposit, any registered holder of ADRs, or any other person believed by it to be competent to give such advice or information; or

 

•

it relies upon any written notice, request, direction, instruction or document believed by it to be genuine and to have been signed, presented or given by the proper party or parties.

Neither the depositary nor its agents have any obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities or the ADRs. We and our agents shall only be obligated to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities or the ADRs, which in our opinion may involve us in expense or liability, if indemnity satisfactory to us against all expense (including fees and disbursements of counsel) and liability is furnished as often as may be required. The depositary and its agents may fully respond to any and all demands or requests for information maintained by or on its behalf in connection with the deposit agreement, any registered holder or holders of ADRs, any ADRs or otherwise related to the deposit agreement or ADRs to the extent such information is requested or required by or pursuant to any lawful authority, including without limitation laws, rules, regulations, administrative or judicial process, banking, securities or other regulators. The depositary shall not be liable for the acts or omissions made by, or the insolvency of, any securities depository, clearing agency or settlement system. Furthermore, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, the insolvency of any custodian that is not a branch or affiliate of JPMorgan Chase Bank, N.A. Notwithstanding anything to the contrary contained in the deposit agreement or any ADRs, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, any act or omission to act on the part of the custodian except to the extent that the custodian committed fraud or willful misconduct in the provision of custodial services to the depositary or (ii) failed to use reasonable care in the provision of custodial services to the depositary as determined in accordance with the standards prevailing in the jurisdiction in which the custodian is located. The depositary and the custodian(s) may use third party delivery services and providers of information regarding matters such as pricing, proxy voting, corporate actions, class action litigation and other services in connection with the ADRs and the deposit agreement, and use local agents to provide extraordinary services such as attendance at annual meetings of issuers of securities. Although the depositary and the custodian will use reasonable care (and cause their agents to use reasonable care) in the selection and retention of such third party providers and local agents, they will not be responsible for any errors or omissions made by them in providing the relevant information or services. The depositary shall not have any liability for the price received in connection with any sale of securities, the timing thereof or any delay in action or omission to act nor shall it be responsible for any error or delay in action, omission to act, default or negligence on the part of the party so retained in connection with any such sale or proposed sale.

The depositary has no obligation to inform ADR holders or other holders of an interest in any ADSs about the requirements of Australian law, rules or regulations or any changes therein or thereto.

Additionally, none of us, the depositary or the custodian shall be liable for the failure by any registered holder of ADRs or beneficial owner therein to obtain the benefits of credits on the basis of non-U.S. tax paid

 

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against such holder’s or beneficial owner’s income tax liability. Neither we nor the depositary shall incur any liability for any tax consequences that may be incurred by holders or beneficial owners on account of their ownership of ADRs or ADSs.

Neither the depositary nor its agents will be responsible for any failure to carry out any instructions to vote any of the deposited securities, for the manner in which any such vote is cast or for the effect of any such vote. The depositary may rely upon instructions from us or our counsel in respect of any approval or license required for any currency conversion, transfer or distribution. The depositary shall not incur any liability for the content of any information submitted to it by us or on our behalf for distribution to ADR holders or for any inaccuracy of any translation thereof, for any investment risk associated with acquiring an interest in the deposited securities, for the validity or worth of the deposited securities, for the credit-worthiness of any third party, for allowing any rights to lapse upon the terms of the deposit agreement or for the failure or timeliness of any notice from us. The depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the depositary or in connection with any matter arising wholly after the removal or resignation of the depositary, provided that in connection with the issue out of which such potential liability arises the depositary performed its obligations without negligence while it acted as depositary. Neither the depositary nor any of its agents shall be liable to registered holders of ADRs or beneficial owners of interests in ADSs for any indirect, special, punitive or consequential damages (including, without limitation, lost profits) of any form incurred by any person or entity, whether or not foreseeable and regardless of the type of action in which such a claim may be brought.

In the deposit agreement each party thereto (including, for avoidance of doubt, each holder and beneficial owner and/or holder of interests in ADRs) irrevocably waives, to the fullest extent permitted by applicable law, any right it may have to a trial by jury in any suit, action or proceeding against the depositary and/or us directly or indirectly arising out of or relating to the shares or other deposited securities, the ADSs or the ADRs, the deposit agreement or any transaction contemplated therein, or the breach thereof (whether based on contract, tort, common law or any other theory).

The depositary and its agents may own and deal in any class of our securities and in ADSs.

Disclosure of Interest in ADSs

To the extent that the provisions of or governing any deposited securities may require disclosure of or impose limits on beneficial or other ownership of deposited securities, other shares and other securities and may provide for blocking transfer, voting or other rights to enforce such disclosure or limits, you agree to comply with all such disclosure requirements and ownership limitations and to comply with any reasonable instructions we may provide in respect thereof. We reserve the right to instruct you to deliver your ADSs for cancellation and withdrawal of the deposited securities so as to permit us to deal with you directly as a holder of shares and, by holding an ADS or an interest therein, you will be agreeing to comply with such instructions.

Books of Depositary

The depositary or its agent will maintain a register for the registration, registration of transfer, combination and split-up of ADRs, which register shall include the depositary’s direct registration system. Registered holders of ADRs may inspect such records at the depositary’s office at all reasonable times, but solely for the purpose of communicating with other holders in the interest of the business of our company or a matter relating to the deposit agreement. Such register may be closed from time to time, when deemed expedient by the depositary.

The depositary will maintain facilities for the delivery and receipt of ADRs.

Pre-release of ADSs

In its capacity as depositary, the depositary shall not lend shares or ADSs; provided, however, that the depositary may (i) issue ADSs prior to the receipt of shares and (ii) deliver shares prior to the receipt of ADSs for withdrawal of deposited securities, including ADSs which were issued under (i) above but for which shares may

 

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not have been received (each such transaction a “pre-release”). The depositary may receive ADSs in lieu of shares under (i) above (which ADSs will promptly be canceled by the depositary upon receipt by the depositary) and receive shares in lieu of ADSs under (ii) above. Each such pre-release will be subject to a written agreement whereby the person or entity (the “applicant”) to whom ADSs or shares are to be delivered (a) represents that at the time of the pre-release the applicant or its customer owns the shares or ADSs that are to be delivered by the applicant under such pre-release, (b) agrees to indicate the depositary as owner of such shares or ADSs in its records and to hold such shares or ADSs in trust for the depositary until such shares or ADSs are delivered to the depositary or the custodian, (c) unconditionally guarantees to deliver to the depositary or the custodian, as applicable, such shares or ADSs, and (d) agrees to any additional restrictions or requirements that the depositary deems appropriate. Each such pre-release will be at all times fully collateralized with cash, U.S. government securities or such other collateral as the depositary deems appropriate, terminable by the depositary on not more than five (5) business days’ notice and subject to such further indemnities and credit regulations as the depositary deems appropriate. The depositary will normally limit the number of ADSs and shares involved in such pre-release at any one time to thirty percent (30%) of the ADSs outstanding (without giving effect to ADSs outstanding under (i) above), provided, however, that the depositary reserves the right to change or disregard such limit from time to time as it deems appropriate. The depositary may also set limits with respect to the number of ADSs and shares involved in pre-release with any one person on a case-by-case basis as it deems appropriate. The depositary may retain for its own account any compensation received by it in conjunction with the foregoing. Collateral provided in connection with pre-release transactions, but not the earnings thereon, shall be held for the benefit of the ADR holders (other than the applicant).

Appointment

In the deposit agreement, each registered holder of ADRs and each person holding an interest in ADSs, upon acceptance of any ADSs (or any interest therein) issued in accordance with the terms and conditions of the deposit agreement will be deemed for all purposes to:

 

•

be a party to and bound by the terms of the deposit agreement and the applicable ADR or ADRs, and

 

•

appoint the depositary its attorney-in-fact, with full power to delegate, to act on its behalf and to take any and all actions contemplated in the deposit agreement and the applicable ADR or ADRs, to adopt any and all procedures necessary to comply with applicable laws and to take such action as the depositary in its sole discretion may deem necessary or appropriate to carry out the purposes of the deposit agreement and the applicable ADR and ADRs, the taking of such actions to be the conclusive determinant of the necessity and appropriateness thereof.

Governing Law

The deposit agreement and the ADRs shall be governed by and construed in accordance with the laws of the State of New York. In the deposit agreement, we have submitted to the jurisdiction of the courts of the State of New York and appointed an agent for service of process on our behalf. Notwithstanding the foregoing, any action based on the deposit agreement or the transactions contemplated thereby may be instituted by the depositary and holders in any competent court in Australia.

By holding an ADS or an interest therein, registered holders of ADRs and owners of ADSs each irrevocably agree that any legal suit, action or proceeding against or involving us or the depositary, arising out of or based upon the deposit agreement or the transactions contemplated thereby, may only be instituted in a state or federal court in New York, New York, and each irrevocably waives any objection which it may have to the laying of venue of any such proceeding, and irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action or proceeding.

 

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SHARES ELIGIBLE FOR FUTURE SALE

Upon completion of this offering, we will have outstanding                  ADSs representing              approximately     % of our ordinary shares in issue. In addition, we will have outstanding              ordinary shares not represented by ADSs. All of the ADSs sold in this offering will be freely transferable by persons other than our “affiliates” without restriction or further registration under the Securities Act. Sales of substantial amounts of our ADSs in the public market could have a material adverse effect on the prevailing market prices of our ADSs.

Our ordinary shares have been trading on the ASX since December 16, 2004. While application has been made for the ADSs to be listed on the                     , we cannot assure you that an active trading market for our ADSs will develop.

Lock-up agreements

Our directors, our chief executive officer, and our chief financial officer have each entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each of these persons or entities, with limited exceptions, for a period of 180 days after the date of this prospectus, may not, without the prior written consent of J.P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC, (1) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any ordinary shares or ADSs or any securities convertible into or exercisable or exchangeable for our ordinary shares or ADSs (including, without limitation, ordinary shares or such other securities which may be deemed to be beneficially owned by such directors, senior management, managers and members in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a share option or warrant) or (2) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the ordinary shares or ADSs or such other securities, whether any such transaction described in clause (1) or (2) above is to be settled by delivery of ordinary shares or ADSs or such other securities, in cash or otherwise, or (3) make any demand for or exercise any right with respect to the registration of any ordinary shares or ADSs or any security convertible into or exercisable or exchangeable for ordinary shares or ADSs.

Escrowed Ordinary Shares

As part of the consideration for our acquisitions of Osiris’ assets pertaining to culture-expanded MSCs and certain assets from Provasculon, we issued certain amounts of our ordinary shares to these entities. Pursuant to contractual arrangements, these ordinary shares were issued into an escrow account with the only condition to release to Osiris and Provasculon each being expiration of specified restricted periods. We set forth below the amount of shares and date of release from escrow:

 

•

70,164 shares held by Provasculon were released from escrow on October 29, 2014, and

 

•

2,948,729 shares held by Osiris will be released from escrow on December 18, 2014.

Rule 144

In general, under Rule 144 as currently in effect, beginning 90 days after the date of this prospectus a person who has beneficially owned our “restricted securities” within the meaning of Rule 144 for at least six months is entitled to sell the restricted securities without registration under the Securities Act, subject to certain restrictions. Persons who are our affiliates may sell within any three-month period a number of restricted securities that does not exceed the greater of the following:

 

•

1% of the number of our ordinary shares then outstanding, in the form of ADSs or otherwise, which will equal approximately              shares immediately after this offering, or approximately              shares if the underwriters exercise their option to purchase additional ADSs in full; and

 

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•

The average weekly trading volume of our ADSs on the              during the four calendar weeks preceding the date on which notice of the sale is filed with the SEC.

Sales under Rule 144 by persons who are deemed our affiliates are subject to manner-of-sale provisions, notice requirements and the availability of current public information about us. Persons who are not our affiliates and have beneficially owned our restricted securities for more than six months but not more than one year may sell the restricted securities without registration under the Securities Act, subject to the availability of current public information about us. Persons who are not our affiliates and have beneficially owned our restricted securities for more than one year may freely sell the restricted securities without registration under the Securities Act.

In addition, in each case, these shares would remain subject to lock-up arrangements and would only become eligible for sale when the lock-up period expires.

Rule 701

Beginning 90 days after the date of the prospectus, persons other than our affiliates who purchased ordinary shares under a written compensatory plan or contract may be entitled to sell such shares in the United States in reliance on Rule 701. Rule 701 permits affiliates to sell their Rule 701 shares under Rule 144 without complying with the holding period requirements of Rule 144. Rule 701 further provides that non-affiliates may sell these shares in reliance on Rule 144 subject only to its manner-of-sale requirements.

Share options

Shortly after the completion of this offering, we intend to file a registration statement on Form S-8 under the Securities Act to register all ordinary shares issuable under our equity-based compensation plan. See “Management—Remuneration—Non-CEO Executive Remuneration” for a description of such plan.

This Form S-8 registration statement is expected to become effective immediately upon filing, and ordinary shares covered by that registration statement will then be eligible for sale in the public markets, subject to:

 

•

The Rule 144 limitations applicable to affiliates;

 

•

The expiration of the lock-up period; and

 

•

Vesting restrictions imposed by us.

As of June 30, 2014, there were employee options and loan funded share plan shares outstanding to purchase 17,549,542 fully paid ordinary shares.

 

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TAXATION

The following summary of the material Australian and U.S. federal income tax consequences of an investment in our ADSs or ordinary shares is based upon laws and relevant interpretations thereof in effect as of the date of this prospectus, all of which are subject to change, possibly with retroactive effect. This summary does not deal with all possible tax consequences relating to an investment in our ADSs or ordinary shares, such as the tax consequences under U.S. state, local and other tax laws other than Australian and U.S. federal income tax laws. To the extent that the discussion relates to matters of Australian tax law, it represents the opinion of Minter Ellison, our Australian counsel. To the extent that the discussion states definitive legal conclusions under U.S. federal income tax law as to the material U.S. federal income tax consequences of an investment in our ADSs or ordinary shares, and subject to the qualifications, assumptions and limitations set forth herein, it represents the opinion of Wilson, Sonsini, Goodrich & Rosati, Professional Corporation, our special U.S. tax counsel.

Material U.S. Federal Income Tax Considerations to U.S. Holders

The following summary describes the material U.S. federal income tax consequences to U.S. holders (as defined below) of the ownership and disposition of our ordinary shares and ADSs as of the date hereof. Except where noted, this summary deals only with ordinary shares or ADSs acquired in the initial offering and held as capital assets within the meaning of Section 1221 of the Internal Revenue Code of 1986, as amended, or the Code. This section does not discuss the tax consequences to any particular holder, nor any tax considerations that may apply to holders subject to special tax rules, such as:

 

•

banks, insurance companies, regulated investment companies and real estate investment trusts;

 

•

financial institutions;

 

•

individual retirement and other tax-deferred accounts;

 

•

certain former U.S. citizens or long-term residents;

 

•

brokers or dealers in securities or currencies;

 

•

traders that elect to use a mark-to-market method of accounting;

 

•

partnerships and other entities treated as partnership or pass through entities for U.S. federal income tax purposes, and partners or investors in such entities;

 

•

tax-exempt organizations (including private foundations);

 

•

persons subject to the alternative minimum tax;

 

•

persons that hold or dispose of ordinary shares or ADSs as a position in a straddle or as part of a hedging, constructive sale, conversion or other integrated transaction;

 

•

persons that have a functional currency other than the U.S. dollar;

 

•

persons that own (directly, indirectly or constructively) 10% or more of our equity; or

 

•

persons that are not U.S. holders (as defined below).

In this section, a “U.S. holder” means a beneficial owner of ordinary shares or ADSs, other than a partnership or other entity treated as a partnership for U.S. federal income tax purposes, that is, for U.S. federal income tax purposes:

 

•

an individual who is a citizen or resident of the United States (for U.S. federal income tax purposes);

 

•

a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States or any state thereof or the District of Columbia;

 

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•

an estate the income of which is includable in gross income for U.S. federal income tax purposes regardless of its source; or

 

•

a trust (i) the administration of which is subject to the primary supervision of a court in the United States and for which one or more U.S. persons have the authority to control all substantial decisions or (ii) that has an election in effect under applicable income tax regulations to be treated as a U.S. person.

The discussion below is based upon the provisions of the Code, and the U.S. Treasury regulations, rulings and judicial decisions thereunder as of the date hereof, and such authorities may be replaced, revoked or modified, possibly with retroactive effect, so as to result in U.S. federal income tax consequences different from those discussed below. In addition, this summary is based, in part, upon representations made by the depositary to us and assumes that the deposit agreement, and all other related agreements, will be performed in accordance with their terms.

If a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes acquires, owns or disposes of ordinary shares or ADSs, the U.S. federal income tax treatment of a partner generally will depend on the status of the partner and the activities of the partnership. Partners of partnerships that acquire, own or dispose of ordinary shares or ADSs should consult their tax advisors.

You are urged to consult your own tax advisor with respect to the U.S. federal, as well as state, local and non-U.S., tax consequences to you of acquiring, owning and disposing of ordinary shares or ADSs in light of your particular circumstances, including the possible effects of changes in U.S. federal income and other tax laws.

ADSs

Based in part on certain representations from the depositary bank, a U.S. holder of ADSs will be treated as the beneficial owner for United States federal income tax purposes of the underlying shares represented by the ADSs. The U.S. Treasury has expressed concerns that parties to whom American depositary shares are released before shares are delivered to the depositary, or intermediaries in the chain of ownership between holders of American depositary shares and the issuer of the security underlying the American depositary shares, may be taking actions that are inconsistent with claiming foreign tax credits by holders of American depositary shares. These actions would also be inconsistent with claiming the reduced rate of tax, described below, applicable to dividends received by certain noncorporate holders. Accordingly, the creditability of any foreign taxes and the availability of the reduced tax rate for dividends received by certain non-corporate U.S. Holders, each described below, could be affected by actions taken by such parties or intermediaries.

Distributions

Subject to the passive foreign investment company, or PFIC, rules discussed below, U.S. holders generally will include as dividend income the U.S. dollar value of the gross amount of any distributions of cash or property (without deduction for any withholding tax), other than certain pro rata distributions of ordinary shares, with respect to ordinary shares or ADSs to the extent the distributions are made from our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. A U.S. holder will include the dividend income on the day actually or constructively received: (i) by the holder, in the case of ordinary shares, or (ii) by the depositary, in the case of ADSs. To the extent, if any, that the amount of any distribution by us exceeds our current and accumulated earnings and profits, as so determined, the excess will be treated first as a tax-free return of the U.S. holder’s tax basis in the ordinary shares or ADSs and thereafter as capital gain. Notwithstanding the foregoing, we do not intend to determine our earnings and profits on the basis of U.S. federal income tax principles. Consequently, any distributions generally will be reported as dividend income for U.S. information reporting purposes. See “—Backup Withholding Tax and Information Reporting Requirements” below. Dividends paid by us will not be eligible for the dividends-received deduction generally allowed to U.S. corporate shareholders.

The U.S. dollar amount of dividends received by an individual, trust or estate with respect to the ordinary shares or ADSs will be subject to taxation at a maximum rate of 20% if the dividends are “qualified dividends.”

 

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Dividends paid on ordinary shares or ADSs will be treated as qualified dividends if (i)(a) we are eligible for the benefits of a comprehensive income tax treaty with the United States that the Secretary of the Treasury of the United States determines is satisfactory for this purpose and includes an exchange of information program or (b) the dividends are with respect to ordinary shares (or ADSs in respect of such shares) which are readily tradable on a U.S. securities market; (ii) certain holding period requirements are met; and (iii) we are not classified as a PFIC for the taxable year in which the dividend is paid or for the preceding taxable year. The Agreement between the Government of the United States of America and the Government of Australia for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, or the Treaty, has been approved for the purposes of the qualified dividend rules, and we expect to qualify for benefits under the Treaty. We intend to apply to list the ADSs on the                     . Provided that the listing is approved, U.S. Treasury Department guidance indicates that the ADSs will be readily tradable on an established U.S. securities market. Thus, we believe that as long as we are not a PFIC, dividends we pay generally should be eligible for the reduced income tax rate on qualified dividends. However, the determination of whether a dividend qualifies for the preferential tax rates must be made at the time the dividend is paid. U.S. holders should consult their own tax advisors.

Includible distributions paid in Australian dollars, including any Australian withholding taxes, will be included in the gross income of a U.S. holder in a U.S. dollar amount calculated by reference to the spot exchange rate in effect on the date of actual or constructive receipt, regardless of whether the Australian dollars are converted into U.S. dollars at that time. If Australian dollars are converted into U.S. dollars on the date of actual or constructive receipt, the tax basis of the U.S. holder in those Australian dollars will be equal to their U.S. dollar value on that date and, as a result, a U.S. holder generally should not be required to recognize any foreign currency exchange gain or loss. If Australian dollars so received are not converted into U.S. dollars on the date of receipt, the U.S. holder will have a basis in the Australian dollars equal to their U.S. dollar value on the date of receipt. Any foreign currency exchange gain or loss on a subsequent conversion or other disposition of the Australian dollars generally will be treated as ordinary income or loss to such U.S. holder and generally will be income or loss from sources within the United States for foreign tax credit limitation purposes.

Dividends received by a U.S. holder with respect to ordinary shares (or ADSs in respect of such shares) will be treated as foreign source income, which may be relevant in calculating the holder’s foreign tax credit limitation. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to ADSs or ordinary shares will generally constitute “passive category income” but could, in the case of certain U.S. holders, constitute “general category income.”

Subject to certain complex limitations, including the PFIC rules discussed above, a U.S. holder generally will be entitled, at its option, to claim either a credit against its U.S. federal income tax liability or a deduction in computing its U.S. federal taxable income in respect of any Australian taxes withheld. If a U.S. holder elects to claim a deduction, rather than a foreign tax credit, for Australian taxes withheld for a particular taxable year, the election will apply to all foreign taxes paid or accrued by or on behalf of the U.S. holder in the particular taxable year.

The availability of the foreign tax credit and the application of the limitations on its availability are fact specific and are subject to complex rules. You are urged to consult your own tax advisor as to the consequences of Australian withholding taxes and the availability of a foreign tax credit or deduction. See “—Australian Tax Considerations Australian Income Tax—Taxation of Dividends” below.

Sale, Exchange or Other Disposition of Ordinary Shares or ADSs

Subject to the PFIC rules discussed below, a U.S. holder generally will, for U.S. federal income tax purposes, recognize capital gain or loss, if any, on a sale, exchange or other disposition of ordinary shares or ADSs equal to the difference between the amount realized on the disposition and the U.S. holder’s tax basis (in U.S. dollars) in the ordinary shares or ADSs. This recognized gain or loss will generally be long-term capital gain or loss if the U.S. holder has held the ordinary shares or ADSs for more than one year. Generally, for U.S.

 

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holders who are individuals (as well as certain trusts and estates), long-term capital gains are subject to U.S. federal income tax at preferential rates. For foreign tax credit limitation purposes, gain or loss recognized upon a disposition generally will be treated as from sources within the United States. The deductibility of capital losses is subject to limitations for U.S. federal income tax purposes.

You should consult your own tax advisor regarding the tax consequences if a foreign tax is imposed on a disposition of ADSs or ordinary shares, including availability of a foreign tax credit or deduction in respect of any Australian tax imposed on a sale or other disposition of ordinary shares or ADSs. See “—Australian Tax Considerations—Tax on Sales or Other Dispositions of Shares—Capital Gains Tax.”

Passive Foreign Investment Company

As a non-U.S. corporation, we will be a PFIC for any taxable year if either: (i) 75% or more of our gross income for the taxable year is passive income (such as certain dividends, interest, rents or royalties and certain gains from the sale of shares and securities or commodities transactions, including amounts derived by reason of the temporary investment of funds raised in offerings of our ordinary shares or ADSs); or (ii) the average percentage value of our gross assets during the taxable year that produce passive income or are held for the production of passive income is at least 50% of the value of our total assets. For purposes of the PFIC asset test, passive assets generally include any cash, cash equivalents and cash invested in short-term, interest bearing debt instruments or bank deposits that is readily convertible into cash. If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC income and asset tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income.

We believe we were not a PFIC for the taxable year ending June 30, 2014 and we do not expect to be a PFIC for the taxable year ending June 30, 2015. However, if there is a change in the type or composition of our gross income, or our actual business results do not match our projections, it is possible that we may become a PFIC in future taxable years. Investors should be aware that our gross income for purposes of the PFIC income test depends on the receipt of Australian research and development tax incentive credits and other revenue, and there can be no assurances that such tax incentive credit programs will not be revoked or modified, that we will continue to conduct our operations in the manner necessary to be eligible for such incentives or that we will receive other gross income that is not considered passive for purposes of the PFIC income test. The value of our assets for purposes of the PFIC asset test will generally be determined by reference to our market capitalization, which may fluctuate. The composition of our income and assets will also be affected by how, and how quickly, we spend the cash raised in this offering. Under circumstances where our gross income from activities that produce passive income significantly increases relative to our gross income from activities that produce non-passive income or where we decide not to deploy significant amounts of cash for active purposes, our risk of becoming classified as a PFIC may substantially increases. Since a separate factual determination as to whether we are or have become a PFIC must be made each year (after the close of such year), we cannot assure you that we will not be or become a PFIC in the current year or any future taxable year. There can be no assurance that we will not be a PFIC for any taxable year, as PFIC status is determined each year and depends on the composition of our income and assets and the value of our assets in such year. If we are a PFIC for any taxable year, we intend to provide U.S. holders with the information necessary to make and maintain a “Qualified Electing Fund” election, as described below.

Default PFIC Rules

If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, unless you make the mark-to-market election or the Qualified Electing Fund election described below, you will generally be (and remain) subject to additional taxes and interest charges, regardless of whether we remain a PFIC in any subsequent taxable year (i) on certain “excess” distributions we may make and (ii) on any gain realized on the disposition or deemed disposition of your ordinary shares or ADSs. Distributions in respect of your ordinary shares (or ADSs in respect of such shares) during the taxable year will generally constitute “excess” distributions if, in the aggregate, they exceed 125% of the average amount of distributions in respect of your ordinary shares (or ADSs) over the three preceding taxable years or, if shorter, the portion of your holding period before such taxable year.

 

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To compute the tax on “excess” distributions or any gain: (i) the “excess” distribution or the gain will be allocated ratably to each day in your holding period for the ADSs or the ordinary shares; (ii) the amount allocated to the current taxable year and any taxable year before we became a PFIC will be taxed as ordinary income in the current year; (iii) the amount allocated to other taxable years will be taxable at the highest applicable marginal rate in effect for that year; and (iv) an interest charge at the rate for underpayment of taxes will be imposed with respect to any portion of the “excess” distribution or gain described under (iii) above that is allocated to such other taxable years. In addition, if we are a PFIC or, with respect to a particular U.S. holder, we are treated as a PFIC for the taxable year in which the distribution was paid or the prior taxable year, no distribution that you receive from us will qualify for taxation at the preferential rate for non-corporate holders discussed in “—Distributions” above. You should consult with your own tax advisor regarding the application of the default PFIC rules based on your particular circumstances.

If we are a PFIC for any taxable year during which a U.S. holder holds our ADSs or ordinary shares and any of our non-U.S. subsidiaries is also a PFIC (i.e., a lower-tier PFIC), such a U.S. holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC and would be subject to the rules described above on certain distributions by the lower-tier PFIC and our disposition of shares of the lower-tier PFIC, even though such U.S. holder would not receive the proceeds of those distributions or dispositions. You should consult with your own tax advisor regarding the application to you of the PFIC rules to any of our subsidiaries if we are a PFIC.

Mark-to-Market Election

If we are a PFIC for any taxable year during which you own our ADSs or ordinary shares, you will be able to avoid the rules applicable to “excess” distributions or gains described above if the ordinary shares or ADSs are “marketable” and you make a timely “mark-to-market” election with respect to your ordinary shares or ADSs. The ordinary shares or ADSs will be “marketable” stock as long as they remain regularly traded on a national securities exchange, such as the                     , or a foreign securities exchange regulated by a governmental authority of the country in which the market is located and which meets certain requirements, including that the rules of the exchange effectively promote active trading of listed stocks. If such stock is traded on such a qualified exchange or other market, such stock generally will be “regularly traded” for any calendar year during which such stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter, but no assurances can be given in this regard. Our ordinary shares are traded on the ASX, which may qualify as an eligible foreign securities exchange for this purpose.

If you are eligible to make a “mark-to-market” election with respect to our ordinary shares or ADSs and you make this election in a timely fashion, you will generally recognize as ordinary income or ordinary loss the difference between the fair market value of your ordinary shares or ADSs on the last day of any taxable year and your adjusted tax basis in the ordinary shares or ADSs. Any ordinary income resulting from this election will generally be taxed at ordinary income rates. Any ordinary losses will be deductible only to the extent of the net amount of previously included income as a result of the mark-to-market election, if any. Your adjusted tax basis in the ordinary shares or ADSs will be adjusted to reflect any such income or loss. Any gain recognized on the sale or other disposition of your ordinary shares or ADSs in a year when we are a PFIC will be treated as ordinary income, and any loss will be treated as an ordinary loss (but only to the extent of the net amount previously included as ordinary income as a result of the mark-to-market election).

Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. holder may continue to be subject to the PFIC rules with respect to its indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes, including shares in any of our subsidiaries that are treated as PFICs.

You should consult with your own tax advisor regarding the applicability and potential advantages and disadvantages to you of making a “mark-to-market” election with respect to your ordinary shares or ADSs if we are or become a PFIC, including the tax issues raised by lower-tier PFICs that we may own and the procedures for making such an election.

 

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QEF Election

Alternative rules to those set forth in the third preceding paragraph above apply if an election is made to treat us as a “Qualified Electing Fund,” or QEF, under Section 1295 of the Code. A QEF election is available only if the U.S. holder receives an annual information statement from the PFIC setting forth its ordinary earnings and net capital gains, as calculated for U.S. federal income tax purposes.

Upon request from a U.S. holder, we will endeavor to provide to the U.S. holder no later than 90 days after the request an annual information statement, in order to enable the U.S. holder to make and maintain a QEF election for us or for any of our subsidiaries that is or becomes a PFIC. However, there is no assurance that we will have timely knowledge of our or our subsidiaries’ status as a PFIC in the future or of the required information to be provided. You should consult your own tax advisor regarding the availability and tax consequences of a QEF election with respect to the ordinary shares or ADSs or with respect to any lower-tier PFIC that we may own under your particular circumstances.

If we are a PFIC for any taxable year during which you own our ordinary shares or ADSs, as a U.S. holder, you will generally be required to file IRS Form 8621 on an annual basis, and other reporting requirements may apply. The PFIC rules are complex and you should consult with your own tax advisor regarding whether we or any of our subsidiaries are a PFIC, the tax consequences of any elections that may be available to you, and how the PFIC rules may affect the U.S. federal income tax consequences of the receipt, ownership, and disposition of our ordinary shares or ADSs.

Tax on Net Investment Income

Certain non-corporate U.S. holders will be subject to a 3.8% tax on the lesser of (i) the U.S. holder’s “net investment income” for the relevant taxable year and (ii) the excess of the U.S. holder’s modified adjusted gross income for the taxable year over a certain threshold. A U.S. holder’s net investment income will generally include dividends received on the ordinary shares or ADSs and net gains from the disposition of ordinary shares or ADSs, unless such dividend income or net gains are derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). A U.S. holder that is an individual, estate or trust should consult the holder’s tax advisor regarding the applicability of the tax on net investment income to the holder’s dividend income and gains in respect of the holder’s investment in the ordinary shares or ADSs.

Backup Withholding Tax and Information Reporting Requirements

U.S. backup withholding tax and information reporting requirements generally apply to payments to non-corporate holders of ordinary shares or ADSs. Information reporting will apply to payments of dividends on, and to proceeds from the disposition of, ordinary shares or ADSs by a paying agent within the United States to a U.S. holder, other than U.S. holders that are exempt from information reporting and properly certify their exemption. A paying agent within the United States will be required to withhold at the applicable statutory rate, currently 28%, in respect of any payments of dividends on, and the proceeds from the disposition of, ordinary shares or ADSs within the United States to a U.S. holder (other than U.S. holders that are exempt from backup withholding and properly certify their exemption) if the holder fails to furnish its correct taxpayer identification number or otherwise fails to comply with applicable backup withholding requirements. U.S. holders who are required to establish their exempt status generally must provide a properly completed IRS Form W-9.

Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a U.S. holder’s U.S. federal income tax liability. A U.S. holder generally may obtain a refund of any amounts withheld under the backup withholding rules in excess of such holder’s U.S. federal income tax liability by filing the appropriate claim for refund with the IRS in a timely manner and furnishing any required information.

Certain U.S. holders may be required to report information with respect to such holder’s interest in “specified foreign financial assets” (as defined in Section 6038D of the Code), including stock of a non-U.S.

 

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corporation that is not held in an account maintained by a U.S. “financial institution”. Persons who are required to report specified foreign financial assets and fail to do so may be subject to substantial penalties. U.S. holders are urged to consult their own tax advisors regarding foreign financial asset reporting obligations and their possible application to the holding of ordinary shares or ADSs.

The discussion above is not intended to constitute a complete analysis of all tax considerations applicable to an investment in our ordinary shares or ADSs. You should consult with your own tax advisor concerning the tax consequences to you in your particular situation.

Australian Tax Considerations

In this section, we discuss the material Australian income tax, stamp duty and goods and services tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs. This discussion represents the opinion of Minter Ellison, of our Australian counsel. It is based upon existing Australian tax law as of the date of this registration statement, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian tax law which may be important to particular investors in light of their individual investment circumstances, such as shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty and goods and services tax. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the acquisition, ownership and disposition of the shares. This summary is based upon the premise that the holder is not an Australian tax resident and is not carrying on business in Australia through a permanent establishment.

Australian Income Tax

Nature of ADSs for Australian Taxation Purposes

Ordinary shares represented by ADSs held by a U.S. holder will be treated for Australian taxation purposes as held under a “bare trust” for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for Australian income tax and capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to the ADS holder, as the person beneficially entitled to those dividends. Therefore, in the following analysis we discuss the tax consequences to non-Australian resident holders of ordinary shares which, for Australian taxation purposes, will be the same as to U.S. holders of ADSs.

Taxation of Dividends

Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent of tax paid on company profits. Fully franked dividends are not subject to dividend withholding tax. Dividends payable to non-Australian resident shareholders that are not operating from an Australian permanent establishment, or Foreign Shareholders, will be subject to dividend withholding tax, to the extent the dividends are not foreign (i.e., non-Australian) sourced and declared to be conduit foreign income, or CFI, and are unfranked. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country with which Australia has a double taxation agreement and qualifies for the benefits of the treaty. Under the provisions of the current Double Taxation Convention between Australia and the United States, the Australian tax withheld on unfranked dividends that are not CFI paid by us to which a resident of the United States is beneficially entitled is limited to 15%.

If a company that is a non-Australian resident shareholder directly owns a 10% or more interest, the Australian tax withheld on unfranked dividends (that are not CFI) paid by us to which a resident of the United States is beneficially entitled is limited to 5%. In limited circumstances the rate of withholding can be reduced to zero.

 

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Tax on Sales or Other Dispositions of Shares—Capital Gains Tax

Foreign Shareholders will not be subject to Australian capital gains tax on the gain made on a sale or other disposal of our ordinary shares, unless they, together with associates, hold 10% or more of our issued capital, at the time of disposal or for 12 months of the last 2 years prior to disposal.

Foreign Shareholders who own a 10% or more interest would be subject to Australian capital gains tax if more than 50% of our assets held directly or indirectly, determined by reference to market value, consists of Australian real property (which includes land and leasehold interests) or Australian mining, quarrying or prospecting rights. The Double Taxation Convention between the United States and Australia is unlikely to limit the amount of this taxable gain. Australian capital gains tax applies to net capital gains of Foreign Shareholders at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5%. Net capital gains are calculated after reduction for capital losses, which may only be offset against capital gains.

The 50% capital gains tax discount is not available to non-Australian residents individuals on gains accrued after May 8, 2012. Companies are not entitled to a capital gains tax discount.

The previous Australian Government has announced that it would introduce a withholding regime which applies to the disposal by non-Australian residents of certain taxable Australian property which is subject to capital gains tax. Broadly, where a foreign resident disposes of certain taxable Australian property, the purchaser will be required to withhold and remit to the Australian Taxation Office, or ATO, 10% of the proceeds from the sale. No legislation has been introduced although the current Government has announced that it will proceed with this measure, which is proposed to apply from July 1, 2016.

Tax on Sales or Other Dispositions of Shares—Shareholders Holding Shares on Revenue Account

Some Foreign Shareholders may hold ordinary shares on revenue rather than on capital account for example, share traders. These shareholders may have the gains made on the sale or other disposal of the ordinary shares included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.

Non-Australian resident shareholders assessable under these ordinary income provisions in respect of gains made on ordinary shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5%. Some relief from Australian income tax may be available to such non-Australian resident shareholders under the Double Taxation Convention between the United States and Australia.

To the extent an amount would be included in a non-Australian resident shareholder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the shareholder would not be subject to double tax on any part of the income gain or capital gain.

The proposed withholding regime which has been announced by the Australian Government to apply from July 1, 2016 is proposed to also apply where the disposal of the Australian real property asset by a foreign resident is likely to generate gains on revenue account, and therefore be taxable as ordinary income rather than a capital gain.

Dual Residency

If a shareholder were a resident of both Australia and the United States under those countries’ domestic taxation laws, that shareholder may be subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, the Australian tax may be subject to limitation by the Double Taxation Convention. Shareholders should obtain specialist taxation advice in these circumstances.

 

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Australian Death Duty

Australia does not have estate or death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a deceased person’s ordinary shares. The disposal of inherited ordinary shares by beneficiaries may, however, give rise to a capital gains tax liability if the gain falls within the scope of Australia’s jurisdiction to tax (as discussed above).

Stamp Duty

No Australian stamp duty is payable on the issue, trading or surrender of the ADSs. Further, no Australian stamp duty is payable on the issue or trading of the underlying Mesoblast ordinary shares provided that all of our issued ordinary shares remain quoted on the ASX and no person commences to hold an associate inclusive interest of 90% or more in Mesoblast

Goods and Services Tax

The issue or transfer of ordinary shares to a non-Australian resident investor will not incur Australian goods and services tax.

 

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UNDERWRITING

We are offering the ADSs described in this prospectus through a number of underwriters. J.P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC are acting as joint book running managers of the offering and as representatives of the underwriters. We have entered into an underwriting agreement with the underwriters. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters, and each underwriter has severally agreed to purchase, at the public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus, the number of ADSs listed next to its name in the following table:

 

Name		Number of ADSs
J.P. Morgan Securities LLC
Credit Suisse Securities (USA) LLC
Piper Jaffray & Co.
Total

The underwriters are committed to purchase all the ADSs offered by us if they purchase any ADSs. The underwriting agreement also provides that if an underwriter defaults, the purchase commitments of non-defaulting underwriters may also be increased or the offering may be terminated.

The underwriters propose to offer the ADSs directly to the public at the initial public offering price set forth on the cover page of this prospectus and to certain dealers at that price less a concession not in excess of US$         per ADS. After the initial public offering of the ADSs, the offering price and other selling terms may be changed by the underwriters. Sales of ADSs made outside of the United States may be made by affiliates of the underwriters.

The underwriters have an option to buy up to              additional ADSs from us to cover sales of ADSs by the underwriters which exceed the number of ADSs specified in the table above. The underwriters have 30 days from the date of this prospectus to exercise this over allotment option. If any ADSs are purchased with this over-allotment option, the underwriters will purchase ADSs in approximately the same proportion as shown in the table above. If any additional ADSs are purchased, the underwriters will offer the additional ADSs on the same terms as those on which the ADSs are being offered.

The underwriting fee is equal to the public offering price per ADS less the amount paid by the underwriters to us per ADS. The underwriting fee is US$         per ADS. The following table shows the per ADS and total underwriting discounts and commissions to be paid to the underwriters assuming both no exercise and full exercise of the underwriters’ option to purchase additional ADSs. Underwriting discounts and commissions

 

		Without over allotment exercise				With full over allotment exercise
Per ADS		US$				US$
Total		US$				US$

We estimate that the total expenses of this offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding the underwriting discounts and commissions, will be approximately US$        .

A prospectus in electronic format may be made available on the web sites maintained by one or more underwriters, or selling group members, if any, participating in the offering. The underwriters may agree to allocate a number of ADSs to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the representatives to underwriters and selling group members that may make internet distributions on the same basis as other allocations.

 

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We have agreed that we will not (i) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise dispose of, directly or indirectly, or file with the SEC a registration statement under the Securities Act relating to, any ordinary shares or ADSs or securities convertible into or exchangeable or exercisable for any shares of our ordinary shares or ADSs, or publicly disclose the intention to make any offer, sale, pledge, disposition or filing, or (ii) enter into any swap or other arrangement that transfers all or a portion of the economic consequences associated with the ownership of any ordinary shares or ADSs or any such other securities (regardless of whether any of these transactions are to be settled by the delivery of ordinary shares or ADSs or such other securities, in cash or otherwise), in each case without the prior written consent of J.P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC for a period of 180 days after the date of this prospectus, other than the ADSs to be sold hereunder and any ordinary shares or ADSs issued upon the exercise of options granted under our existing management incentive plans.

Our directors, our chief executive officer, and our chief financial officer have each entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each of these persons or entities, with limited exceptions, for a period of 180 days after the date of this prospectus, may not, without the prior written consent of J.P. Morgan Securities LLC and Credit Suisse Securities (USA) LLC, (1) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any ordinary shares or ADSs or any securities convertible into or exercisable or exchangeable for our ordinary shares or ADSs (including, without limitation, ordinary shares or such other securities which may be deemed to be beneficially owned by such directors, senior management, managers and members in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a share option or warrant) or (2) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the ordinary shares or ADSs or such other securities, whether any such transaction described in clause (1) or (2) above is to be settled by delivery of ordinary shares or ADSs or such other securities, in cash or otherwise, or (3) make any demand for or exercise any right with respect to the registration of any ordinary shares or ADSs or any security convertible into or exercisable or exchangeable for ordinary shares or ADSs.

We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act of 1933.

We intend to apply to have our ADSs approved for listing/quotation on the              under the symbol “            .”

In connection with this offering, the underwriters may engage in stabilizing transactions, which involves making bids for, purchasing and selling ADSs in the open market for the purpose of preventing or retarding a decline in the market price of the ADSs while this offering is in progress. These stabilizing transactions may include making short sales of the ADSs, which involves the sale by the underwriters of a greater number of ADSs than they are required to purchase in this offering, and purchasing ADSs on the open market to cover positions created by short sales. Short sales may be “covered” shorts, which are short positions in an amount not greater than the underwriters’ over-allotment option referred to above, or may be “naked” shorts, which are short positions in excess of that amount. The underwriters may close out any covered short position either by exercising their over-allotment option, in whole or in part, or by purchasing ADSs in the open market. In making this determination, the underwriters will consider, among other things, the price of ADSs available for purchase in the open market compared to the price at which the underwriters may purchase ADSs through the over allotment option. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the ADSs in the open market that could adversely affect investors who purchase in this offering. To the extent that the underwriters create a naked short position, they will purchase ADSs in the open market to cover the position.

 

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The underwriters have advised us that, pursuant to Regulation M of the Securities Act of 1933, as amended they may also engage in other activities that stabilize, maintain or otherwise affect the price of the ADSs, including the imposition of penalty bids. This means that if the representatives of the underwriters purchase ADSs in the open market in stabilizing transactions or to cover short sales, the representatives can require the underwriters that sold those ADSs as part of this offering to repay the underwriting discount received by them.

These activities may have the effect of raising or maintaining the market price of our ordinary shares and the ADSs or preventing or retarding a decline in the market price of the ADSs, and, as a result, the price of the ADSs may be higher than the price that otherwise might exist in the open market. If the underwriters commence these activities, they may discontinue them at any time. The underwriters may carry out these transactions on the                     , in the over-the-counter market or otherwise.

Prior to this offering, our ADSs have been quoted on the over-the-counter markets under the symbol “MBLTY.” Our ordinary shares have been trading on the ASX since December 2004 under the symbol “MSB.” The initial public offering price will be determined by negotiations between us and the representatives of the underwriters. In determining the initial public offering price, we and the representatives of the underwriters expect to consider a number of factors including:

 

•

the information set forth in this prospectus and otherwise available to the representatives;

 

•

our prospects and the history and prospects for the industry in which we compete;

 

•

an assessment of our management;

 

•

our prospects for future earnings;

 

•

the general condition of the securities markets at the time of this offering;

 

•

the recent market prices of, and demand for, publicly traded ADSs of generally comparable companies;

 

•

the trading price of our ordinary shares on the ASX; and

 

•

other factors deemed relevant by the underwriters and us.

Neither we nor the underwriters can assure investors that an active trading market will develop for our ADSs, or that the ADSs will trade in the public market at or above the initial public offering price.

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

This document is only being distributed to and is only directed at (i) persons who are outside the United Kingdom or (ii) to investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, or (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling with Article 49(2)(a) to (d) of the Order, all such persons together being referred to as “relevant persons”. The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

 

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In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, or each, a Relevant Member State, from and including the date on which the European Union Prospectus Directive, or the EU Prospectus Directive, was implemented in that Relevant Member State, or the Relevant Implementation Date, an offer of securities described in this prospectus may not be made to the public in that Relevant Member State prior to the publication of a prospectus in relation to the securities which has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the competent authority in that Relevant Member State, all in accordance with the EU Prospectus Directive, except that, with effect from and including the Relevant Implementation Date, an offer of securities described in this prospectus may be made to the public in that Relevant Member State at any time:

 

•

to any legal entity which is a qualified investor as defined under the EU Prospectus Directive;

 

•

to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150 natural or legal persons (other than qualified investors as defined in the EU Prospectus Directive); or

 

•

in any other circumstances falling within Article 3(2) of the EU Prospectus Directive, provided that no such offer of securities described in this prospectus shall result in a requirement for the publication by us of a prospectus pursuant to Article 3 of the EU Prospectus Directive.

For the purposes of this provision, the expression an “offer of securities to the public” in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the same may be varied in that Member State by any measure implementing the EU Prospectus Directive in that Member State. The expression “EU Prospectus Directive” means Directive 2003/71/EC (and any amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State) and includes any relevant implementing measure in each Relevant Member State, and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.

Certain of the underwriters and their affiliates have provided in the past to us and our affiliates and may provide from time to time in the future certain commercial banking, financial advisory, investment banking and other services for us and such affiliates in the ordinary course of their business, for which they have received and may continue to receive customary fees and commissions. In addition, from time to time, certain of the underwriters and their affiliates may effect transactions for their own account or the account of customers, and hold on behalf of themselves or their customers, long or short positions in our debt or equity securities or loans, and may do so in the future.

 

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EXPENSES RELATING TO THIS OFFERING

The following table sets forth the estimated costs and expenses, other than the underwriting discounts and commissions, payable by us in connection with the offering (all amounts are estimated except the SEC registration fee and the FINRA filing fee):

 

SEC registration fee		US$		*
FINRA filing fee				*
Listing fee				*
Printing expenses				*
Legal fees and expenses				*
Accounting fees and expenses				*
Miscellaneous				*
Total

 

*	To be provided by amendment.

 

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LEGAL MATTERS

Certain legal matters as to United States federal and New York law in connection with this offering will be passed upon for us by Wilson Sonsini Goodrich & Rosati, P.C., Palo Alto, California. Certain legal matters as to Australian law in connection with this offering will be passed upon for us by Minter Ellison. Wilson Sonsini Goodrich & Rosati, P.C., may rely upon Minter Ellison with respect to matters governed by Australian law. Certain legal matters as to United States federal and New York law in connection with the offering will be passed upon for the underwriters by Skadden, Arps, Slate, Meagher & Flom LLP.

EXPERTS

Our consolidated financial statements as of June 30, 2014 and 2013 and for each of the two years in the period ended June 30, 2014 included in this prospectus have been so included in reliance on the report of PricewaterhouseCoopers, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. The offices of PricewaterhouseCoopers are located at Freshwater Place, 2 Southbank Boulevard, Southbank, VIC 3006, Australia.

ENFORCEMENT OF CIVIL LIABILITIES

We are a public limited company incorporated under the laws of Australia. Certain of our directors are non-residents of the United States and all or substantially all of their assets are located outside the United States. As a result, it may not be possible for you to:

 

•

effect service of process within the United States upon our non-U.S. resident directors or on us;

 

•

enforce in U.S. courts judgments obtained against our non-U.S. resident directors or us in the U.S. courts in any action, including actions under the civil liability provisions of U.S. securities laws;

 

•

enforce in U.S. courts judgments obtained against our non-U.S. resident directors or us in courts of jurisdictions outside the United States in any action, including actions under the civil liability provisions of U.S. securities laws; or

 

•

bring an original action in an Australian court to enforce liabilities against our non-U.S. resident directors or us based solely upon U.S. securities laws.

You may also have difficulties enforcing in courts outside the United States judgments that are obtained in U.S. courts against any of our non-U.S. resident directors or us, including actions under the civil liability provisions of the U.S. securities laws.

With that noted, there are no treaties between Australia and the United States that would affect the recognition or enforcement of foreign judgments in Australia. We also note that investors may be able to bring an original action in an Australian court against us to enforce liabilities based in part upon U.S. federal securities laws.

We have appointed Mesoblast, Inc., as our agent to receive service of process with respect to any action brought against us in the U.S. District Court for the Southern District of New York under the federal securities laws of the United States or any action brought against us in the Supreme Court of the State of New York in the County of New York under the securities laws of the State of New York.

 

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WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form F-1 under the Securities Act with respect to the underlying ordinary shares represented by the ADSs to be sold in this offering. This prospectus, which forms a part of the registration statement, does not contain all of the information set forth in the registration statement and the exhibits and schedules thereto. You should refer to the registration statement for further information. Statements contained in this prospectus as to the content of any contract or other document that is filed as an exhibit to the registration statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or document. We intend to file a registration statement on Form F-6 to register the issuance of the ADSs offered hereby.

Upon declaration by the SEC of the effectiveness of the registration statement, we will become subject to the periodic reporting and other informational requirements of the Exchange Act applicable to a foreign private issuer. Under the Exchange Act, we will be required to file reports, including annual reports on Form 20-F, and other information with the SEC. All information filed with the SEC can be inspected and copied at the public reference facilities maintained by the SEC at Room 1580, 100 F Street, N.E., Washington, D.C. 20549. You can request copies of these documents, upon payment of a duplicating fee, by writing to the SEC. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference rooms. You may also obtain additional information over the Internet at the SEC’s website at www.sec.gov.

 

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Mesoblast Limited

Index to Financial Statements

 

Report of Independent Registered Public Accounting Firm			F-2
Consolidated Income Statements for the years ended June 30, 2014 and 2013			F-3
Consolidated Statements of Comprehensive Income for the years ended June 30, 2014 and 2013			F-4
Consolidated Statements of Changes in Equity for the years ended June 30, 2014 and 2013			F-5
Consolidated Balance Sheets as of June 30, 2014 and 2013			F-6
Consolidated Statements of Cash Flows for the years ended June 30, 2014 and 2013			F-7
Notes to Consolidated Financial Statements			F-8

 

F-1

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Index to Financial Statements

Report of Independent Registered Public Accounting Firm

To the Board of Directors and shareholders of Mesoblast Limited:

In our opinion, the accompanying consolidated income statements, consolidated statements of comprehensive income, consolidated statements of changes in equity, consolidated statements of cash flows and consolidated balance sheets present fairly, in all material respects, the financial position of Mesoblast Limited and its subsidiaries as of June 30, 2014 and 2013, and the results of their operations and their cash flows for each of the two years in the period ended June 30, 2014 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

/s/ PricewaterhouseCoopers

Melbourne, Australia

November 10, 2014

 

F-2

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Index to Financial Statements

Mesoblast Limited

Consolidated Income Statements

(in Australian dollars)

 

(in thousands, except per share amounts)				Year Ended June 30,
		Note		2014				2013
Revenue from continuing operations		3(a)			25,980				28,786
Other income		3(b)			11,119				5,924
					37,099				34,710
Expenses from continuing operations		3(c)
Research and development					(55,305	)			(47,835	)
Manufacturing commercialization					(27,608	)			(23,230	)
Management and administration					(26,562	)			(22,840	)
Finance costs					(4,329	)			—
Other expenses					(4,248	)			(883	)
					(118,052	)			(94,788	)
Loss before income tax					(80,953	)			(60,078	)
Income tax expense		4			(5	)			(1,585	)
Loss attributable to the owners of Mesoblast Limited					(80,958	)			(61,663	)
				Cents				Cents
Losses per share from continuing operations attributable to the ordinary equity holders of the Group:
Basic — losses per share		20			(25.34	)			(21.06	)
Diluted — losses per share		20			(25.34	)			(21.06	)

 

The above consolidated income statements should be read in conjunction with the accompanying notes.

 

F-3

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Index to Financial Statements

Mesoblast Limited

Consolidated Statements of Comprehensive Income

(in Australian dollars)

 

(in thousands)				Year Ended June 30,
		Note		2014				2013
Loss for the year					(80,958	)			(61,663	)
Other comprehensive income
Items that may be reclassified to profit and loss
Exchange differences on translation of foreign operations		7(b)			(6,620	)			32,003
Other comprehensive income for the period, net of tax					(6,620	)			32,003
Total comprehensive loss attributable to the owners of Mesoblast Limited					(87,578	)			(29,660	)

 

The above consolidated statements of comprehensive income should be read in conjunction with the accompanying notes.

 

F-4

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Index to Financial Statements

Mesoblast Limited

Consolidated Statements of Changes in Equity

(in Australian dollars)

 

(in thousands)
		Note		Issued Capital				Share Option Reserve				Foreign Currency Translation Reserve				Retained Earnings				Total
Balance as of July 1, 2012					485,004				37,505				(7,497	)			(36,164	)			478,848
Loss for the year					—				—				—				(61,663	)			(61,663	)
Other comprehensive income					—				—				32,003				—				32,003
Total comprehensive profit/(loss) for the period					—				—				32,003				(61,663	)			(29,660	)
Transactions with owners in their capacity as owners:
Contributions of equity net of transaction costs					168,785				—				—				—				168,785
		7(a)			168,785				—				—				—				168,785
Tax effect of options deductible for tax					—				—				—				—				—
Transfer exercised options					669				(669	)			—				—				—
Fair value of share-based payments		18			—				12,293				—								12,293
					669				11,624				—				—				12,293
Balance as of June 30, 2013					654,458				49,129				24,506				(97,827	)			630,266
Loss for the year					—				—				—				(80,958	)			(80,958	)
Other comprehensive income					—				—				(6,620	)			—				(6,620	)
Total comprehensive loss for the period					—				—				(6,620	)			(80,958	)			(87,578	)
Transactions with owners in their capacity as owners:
Contributions of equity net of transaction costs					19,611				—				—				—				19,611
		7(a)			19,611				—				—				—				19,611
Tax effect of options deductible for tax					—				—				—				—				—
Transfer exercised options					3,018				(3,018	)			—				—				—
Fair value of share-based payments		18			—				9,419				—				—				9,419
					3,018				6,401				—				—				9,419
Balance as of June 30, 2014					677,087				55,530				17,886				(178,785	)			571,718

 

The above consolidated statements of changes in equity should be read in conjunction with the accompanying notes.

 

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Index to Financial Statements

Mesoblast Limited

Consolidated Balance Sheets

(in Australian dollars)

 

(in thousands)				As of June 30,
		Note		2014				2013
Assets
Current assets
Cash and cash equivalents		5(a)			196,394				315,309
Trade and other receivables		5(b)			6,098				12,063
Prepayments					1,257				986
Derivative financial instruments		10(a)			—				3,486
Total current assets					203,749				331,844
Non-current assets
Property, plant and equipment		6(a)			4,683				2,757
Other non-current assets		5(c)			2,978				1,277
Intangible assets		6(b)			687,904				547,834
Total non-current assets					695,565				551,868
Total assets					899,314				883,712
Liabilities
Current liabilities
Trade and other payables		5(d)			20,723				20,780
Deferred revenue		6(c)			15,928				16,176
Derivative financial instruments		10(a)			337				—
Provisions		6(d)			5,687				13,632
Total current liabilities					42,675				50,588
Non-current liabilities
Deferred revenue		6(c)			39,818				56,617
Deferred tax liability		6(f)			158,585				146,038
Provisions		6(d)			86,518				203
Total non-current liabilities					284,921				202,858
Total liabilities					327,596				253,446
Net assets					571,718				630,266
Equity
Issued capital		7(a)			677,087				654,458
Reserves		7(b)			73,416				73,635
Accumulated losses					(178,785	)			(97,827	)
Total equity					571,718				630,266

 

The above consolidated balance sheets should be read in conjunction with the accompanying notes.

 

F-6

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Index to Financial Statements

Mesoblast Limited

Consolidated Statements of Cash Flows

(in Australian dollars)

 

(in thousands)				Year Ended June 30,
		Note		2014				2013
Cash flows from operating activities
Research and development tax incentive received					9,340				—
Payments to suppliers and employees (inclusive of goods and services tax)					(106,310	)			(67,716	)
					(96,970	)			(67,716	)
Interest received					12,578				10,338
Income taxes refunded					2,531				3,297
Net cash (outflows) in operating activities		8(b)			(81,861	)			(54,081	)
Cash flows from investing activities
Payments for financial derivatives					(1,483	)			(2,204	)
Payments for business combination					(35,585	)			(1,537	)
Payments for licenses					(468	)			(77	)
Payments for rental deposits					(1,728	)			—
Investment in fixed assets					(1,865	)			(1,224	)
Receipts from repayments of loans from employees					320				—
Net cash (outflows) in investing activities					(40,809	)			(5,042	)
Cash flows from financing activities
Proceeds from issue of shares					2,476				174,878
Payments for share issue costs					(46	)			(5,529	)
Net cash inflows by financing activities					2,430				169,349
Net (decrease)/increase in cash and cash equivalents					(120,240	)			110,226
Cash and cash equivalents at beginning of year					315,309				205,591
FX gains/(losses) on the translation of foreign bank accounts					1,325				(508	)
Cash and cash equivalents at end of year		8(a)			196,394				315,309

 

The above consolidated statements of cash flows should be read in conjunction with the accompanying notes.

 

F-7

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements

Mesoblast Limited (the “Company”) and its subsidiaries (the “Group”) are primarily engaged in the development of regenerative medicine products. The Company’s proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage adult stem cells (“MLCs”).

The Company was formed in 2004 as an Australian company and has been listed on the Australian Stock Exchange (the “ASX”) since 2004.

These financial statements are presented in thousands of Australian dollars, unless otherwise noted, including certain amounts that are presented in U.S. dollars (“USD”).

 

1.	Significant changes in the current reporting period

The financial position and performance of the Group was particularly affected by the following events and transactions during the reporting period:

 

•

The acquisition of the entire culture-expanded mesenchymal stem cells (“MSC”) business of Osiris Therapeutics, Inc. (“Osiris”) (see Note 12) which resulted in a recognition of in-process research & development acquired and goodwill (see Note 6(b)).

 

2.	Segment information

Operating segments are identified on the basis of whether the allocation of resources and/or the assessment of performance of a particular component of the Company’s activities are regularly reviewed by the Company’s chief operating decision maker as a separate operating segment. By these criteria, the activities of the Company are considered to be one segment which comprises the discovery, development, and commercialization of innovative biologic products, and the segmental analysis is the same as the analysis for the Company as a whole. The chief operating decision maker (Chief Executive Officer) reviews the consolidated income statement, balance sheet, and statement of cash flows regularly to make decisions about the Company’s resources and to assess overall performance.

 

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

3.	Revenue and expenses from continuing operations

 

						Year Ended June 30,
(in thousands)				Note		2014				2013
(a)		Revenue from continuing operations
		Commercialization revenue(1)		6(c)			16,410				18,260
		Interest revenue					9,570				10,526
							25,980				28,786
(b)		Other income
		Research and development tax incentive(2)					8,595				5,924
		Release of excess provision for services		6(d)			2,524				—
							11,119				5,924
(c)		Expenses from continuing operations
		Clinical trial research and development					20,812				19,769
		Manufacturing production and development					22,932				20,199
		Employee benefits
		Salaries and employee benefits					28,897				20,018
		Defined contribution superannuation expenses					408				307
		Equity settled share-based payment transactions(3)					9,419				12,293
		Total employee benefits					38,724				32,618
		Depreciation and amortization of non-current assets
		Plant and equipment depreciation		6(a)			974				670
		Intellectual property amortization		6(b)			146				102
		Total depreciation and amortization of non-current assets					1,120				772
		Other management and administration expenses
		Overheads & administration					10,698				8,812
		Consultancy					6,831				5,163
		Legals, patent and other professional fees					5,522				5,647
		Intellectual property expenses (excluding the amount amortized above)					2,836				925
		Total other management and administration expenses					25,887				20,547

 

F-9

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

3.	Revenue and expenses from continuing operations (continued)

 

				Year Ended June 30,
(in thousands)		Note		2014				2013
Other expenses
Foreign exchange losses					3,980				883
Remeasurement of contingent consideration					268				—
Total other expenses					4,248				883
				Year Ended June 30,
(in thousands)		Note		2014				2013
Finance costs
Provisions: unwinding of discount		6(d)(ii)			4,329				—
Total finance costs					4,329				—
Total expenses from continuing operations					118,052				94,788

 

(1)	In November 2010, the Group signed a development and commercialization agreement with Cephalon, Inc., a major global biopharmaceutical company.

The total upfront cash received under the development and commercialization agreement was USD130,000. For the years ended June 30, 2014 and 2013, the Group has recognized revenue of $16,410 and $18,260, respectively, for this payment on the basis that the revenue will be earned through-out the life of the development of those products pertaining to that payment. See Note 21(e).

 

(2)	Research & development tax incentive

The Group’s research and development activities are eligible under an Australian Government tax incentive for eligible expenditures from July 1, 2011. Management has assessed these activities and expenditures to determine which are likely to be eligible under the incentive scheme. At each period end management estimates the refundable tax offset available to the Group based on available information at the time. This estimate is also reviewed by external tax advisors. For the years ended June 30, 2014 and 2013, the Group has recognized income of $8,595 and $5,924, respectively. See Note 21(e).

Of the $8,595 research and development tax incentive recorded in other income for the year ended June 30, 2014, $3,400 relates to research and development tax incentive income the Group received from the Australian Government for the year ended June 30, 2013 following a change in the original estimate. The change in estimate was due to the fact the research and development tax incentives were introduced in 2011 and were dependent on the level of qualifying research and development expenditure and as such conservative risk adjustments were made in the estimate in the year ended June 30, 2013.

 

(3)	Equity settled share-based payment transactions

For the years ended June 30, 2014 and 2013, equity settled share-based payment transactions have been reflected in the Income Statement functional expense categories as follows: research & development $5,063 and $7,831, respectively, manufacturing commercialization $865 and $495, respectively, and management & administration $3,491 and $3,968, respectively.

 

F-10

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

4.	Income tax expense

 

		Year Ended June 30,
(in thousands)		2014				2013
(a) Reconciliation of income tax to prima facie tax payable
Loss from continuing operations before income tax			(80,953	)			(60,078	)
Tax benefit at the Australian tax rate of 30% (2013: 30%)			(24,286	)			(18,023	)
Tax effect of amounts which are (not deductible)/taxable in calculating taxable income:
Share-based payments expense			2,776				3,688
Research and development tax concessions			3,771				3,594
Other sundry items			3,509				(34	)
Current year tax benefit			(14,230	)			(10,775	)
Adjustments for current tax of prior periods			2,485				(219	)
Differences in overseas tax rates			(2,584	)			(2,246	)
Tax benefit not recognized			14,329				13,239
Alternative minimum tax charge (USA)			—				1,585
USA City and State tax benefit			(2,836	)			(1,586	)
USA City and State tax benefit — not recognized			2,841				1,587
Income tax expense attributable to profit before income tax			5				1,585
(b) Income tax expense
Current tax			5				1,585
Deferred tax			—				—
			5				1,585
(c) Amounts that would be recognized directly in equity if brought to account
Aggregate current and deferred tax arising in the reporting period and not recognized in net loss or other comprehensive income but which would have been directly applied to equity had it been brought to account:
Current tax recorded in equity (if brought to account)			(157	)			1,545
Deferred tax recorded in equity (if brought to account)			454				487
			297				2,032

 

(d) Amounts recognized directly in equity
Aggregate current and deferred tax arising in the reporting period and not recognized in net loss or other comprehensive income but debited/credited to equity:
Current tax recorded in equity			—				—
Deferred tax recorded in equity			—				—
(e) Tax Losses
Unused tax losses for which no deferred tax asset has been brought to account			146,798				130,202
Potential tax benefit at local tax rates			44,992				41,660
(f) Unrecognized temporary differences
Temporary differences not brought to account			8,928				8,895

 

F-11

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

4.	Income tax expense (continued)

 

Temporary differences have been brought to account only to the extent that it is foreseeable that they are recoverable against future tax liabilities.

 

a.	Significant estimates

The Group is subject to income taxes in Australia, Singapore, Switzerland, the United Kingdom and the United States of America. Significant judgment is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The Group consulted professional tax advisers to assist in the estimate of its tax liabilities based on the Group’s understanding of the tax law. Where the final outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.

The Group has recognized deferred tax assets to the extent that it is probable that the asset will be utilized either through the application of carry back rules or the utilization of taxable temporary differences (deferred tax liabilities) relating to the same taxation authority and the same subsidiary against which the unused tax losses can be utilized. As of June 30, 2014 and June 30, 2013, the group has recorded deferred tax assets of $Nil due to the Company’s plans to centralize intellectual property and therefore taxable temporary differences will not be available to offset deferred tax assets in the same jurisdictions.

 

5.	Financial assets and liabilities

This note provides information about the Group’s financial instruments, including:

 

•

an overview of all financial instruments held by the Group;

 

•

specific information about each type of financial instrument;

 

•

accounting policies; and

 

•

information about determining the fair value of the instruments, including judgments and estimation uncertainty involved.

The Group holds the following financial instruments:

 

Financial assets: (in thousands)		Notes				Assets at FVTPL				Financial assets at amortized cost				Total
As of June 30, 2014:
Cash and cash equivalents			5(a)				—				196,394				196,394
Trade and other receivables			5(b)				—				6,098				6,098
Other non-current assets			5(c)				—				2,978				2,978
							—				205,470				205,470
As of June 30, 2013:
Cash and cash equivalents			5(a)				—				315,309				315,309
Trade and other receivables			5(b)				—				12,063				12,063
Derivative financial instruments			10(a)				3,486				—				3,486
Other non-current assets			5(c)				—				1,277				1,277
							3,486				328,649				332,135

 

F-12

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

5.	Financial assets and liabilities (continued)

 

Financial liabilities (in thousands)		Notes		Liabilities at FVTPL				Liabilities at amortized cost				Total
As of June 30, 2014:
Trade and other payables		5(d)			—				20,723				20,723
Provisions		6(d)(iii)			86,249				—				86,249
Derivative financial instruments		10(a)			337				—				337
					86,586				20,723				107,309
As of June 30, 2013:
Trade and other payables		5(d)			—				20,780				20,780
					—				20,780				20,780

The Group’s exposure to various risks associated with the financial instruments is discussed in Note 10. The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of financial assets mentioned above.

a. Cash and cash equivalents

 

		As of June 30,
(in thousands)		2014				2013
Cash at bank			3,827				12,744
Deposits at call(1)			192,567				302,565
			196,394				315,309

 

(1)	As of June 30, 2014 and 2013, deposits at call include $6,100 and $6,100, respectively, held as security against future foreign exchange deals and is restricted for use.

(i) Classification as cash equivalents

Term deposits are presented as cash equivalents if they have a maturity of three months or less from the date of acquisition and are repayable with 24 hours notice with no loss in interest. See Note 21(m) for the Group’s other accounting policies on cash and cash equivalents.

b. Trade and other receivables

 

(in thousands)		June 30,
		2014				2013
Other receivables			405				—
Interest receivables			296				3,306
Sundry debtors			11				7
Income tax and tax incentives recoverable			5,254				8,317
Other recoverable taxes (good and services tax and value-added tax)			132				113
Loan to an employee covered by a contract			—				320
			6,098				12,063

 

F-13

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

5.	Financial assets and liabilities (continued)

 

(i) Classification as trade and other receivables

Interest receivables are amounts due at maturity of Term Deposits. All trade and other receivable balances are within their due dates and none are considered to be impaired as of June 30, 2014 and June 30, 2013. The Group’s impairment and other accounting policies for trade and other receivables are outlined in Notes 10(c) and 21(n) respectively. The Group issued interest free loans to employees to cover the exercise of options that could not be funded as planned due to an ASX share trading black out period.

(ii) Other receivables

These amounts generally arise from transactions outside the usual operating activities of the Group.

(iii) Fair values of trade and other receivables

Due to the short-term nature of the current receivables, their carrying amount is assumed to be the same as their fair value.

(iv) Impairment and risk exposure

Information about the impairment of trade and other receivables, their credit quality and the Group’s exposure to credit risk, foreign currency risk and interest rate risk can be found in Note 10(c) and (b).

c. Other non-current assets

 

(in thousands)		As of June 30,
		2014				2013
Bank guarantee			960				—
Letter of credit			2,018				1,277
			2,978				1,277

(i) Classification of financial assets as other non-current assets

Bank guarantee

These funds are held in an account named Mesoblast Limited at National Australia Bank according to the terms of a Bank Guarantee which is security for the sublease agreement for our occupancy of Level 38, 55 Collins Street, Melbourne, Victoria, Australia. The Bank Guarantee is security for the full and faithful performance and observance by the subtenant of the terms, covenants and conditions of the sublease. The Bank Guarantee continues in force until it is released by the lessor.

Letter of credit

These funds are held in an account named Mesoblast, Inc. at the Bank of America according to the terms of two Irrevocable Standby Letters of Credit which are security for the sublease agreement for our occupancy of 505 Fifth Avenue, New York, New York, United States of America. The Letters of Credit are security for the full and faithful performance and observance by the subtenant of the terms, covenants and conditions of the sublease. The Letters of Credit are deemed to automatically extend without amendment for a period of one year at each anniversary but it will not automatically extend beyond the final expiration of July 31, 2021 (USD1,186) and August 3, 2021 (USD715).

 

F-14

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

5.	Financial assets and liabilities (continued)

 

(ii) Impairment and risk exposure

None of the other non-current assets are past due or impaired.

d. Trade and other payables

 

		As of June 30,
(in thousands)		2014				2013
Trade payables and other payables			20,723				20,780
			20,723				20,780

The carrying amounts of trade and other payables are assumed to be the same as their fair values, due to their short-term nature.

e. Recognized fair value measurements

(i) Fair value hierarchy

The following table presents the Group’s financial assets and financial liabilities measured and recognized at fair value as of June 30, 2014 and June 30, 2013 on a recurring basis, categorized by level according to the significance of the inputs used in making the measurements:

 

As of June 30, 2014:
(in thousands)
Financial liabilities		Notes		Level 1				Level 2				Level 3				Total
Financial liabilities at fair value through profit or loss
Derivative financial instruments		10(a)			—				337				—				337
Provisions		6(d)			—				—				86,249				86,249
Total financial liabilities					—				337				86,249				86,586
As of June 30, 2013:
(in thousands)
Financial assets
Financial assets at fair value through profit or loss
Derivative financial instruments		10(a)			—				3,486				—				3,486
Total financial assets					—				3,486				—				3,486

There were no transfers between any of the levels for recurring fair value measurements during the year.

The Group’s policy is to recognize transfers into and transfers out of fair value hierarchy levels as at the end of the reporting period.

Level 1: The fair value of financial instruments traded in active markets (such as publicly traded derivatives, and trading and available-for-sale securities) is based on quoted market prices at the end of the reporting period. The quoted market price used for financial assets held by the Group is the current bid price. These instruments are included in level 1.

Level 2: The fair value of financial instruments that are not traded in an active market (for example, foreign exchange contracts) is determined using valuation techniques which maximize the use of observable market data and rely as little as possible on entity-specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2.

 

F-15

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

5.	Financial assets and liabilities (continued)

 

Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for provisions (contingent consideration).

(ii) Valuation techniques used to derive level 2 fair values

The Group used the following techniques to determine the fair value measurements categorized in Level 2: The fair value of forward foreign exchange contracts is determined using forward exchange rates at the balance sheet date.

(iii) Fair value measurements using significant unobservable inputs (level 3)

The following table presents the changes in level 3 instruments for the year ended June 30, 2014 and 2013:

 

(in thousands)		Note				Contingent consideration provision				Total
Opening balance — June 30, 2013							—				—
Initial recognition			12	(b)			81,660				81,660
Unwinding of discount							4,329	(1)			4,329
Exchange difference							260				260
Closing balance — June 30, 2014							86,249				86,249

 

(1)	The unwinding of the risk adjusted discount as the time period shortens between the valuation date and the potential settlement date of the contingent consideration.

(iv) Valuation inputs and relationship to fair value

The following table summarizes the quantitative information about the significant unobservable inputs used in level 3 fair value measurements:

 

Description

Fair value as of June 30, 2014

Valuation technique

Unobservable Inputs*

Range of inputs (weighted average)

Relationship of unobservable inputs to fair value

Contingent consideration provision

86,249

Discounted cash flows

Risk adjusted discount rate

11%-13% (12.5%)

A change in the discount rate by 0.5% would increase/decrease the fair value by 3%

Expected unit revenues

n/a

a 10% increase in the price assumptions adopted would increase the fair value by 5%

 

*	There were no significant inter-relationships between unobservable inputs that materially affect fair values.

(v) Valuation processes

In connection with the Osiris acquisition, on October 11, 2013 (the acquisition date), an independent valuation of the contingent consideration was carried out by an independent valuer.

The CFO and the valuation team have reviewed the valuation as at June 30, 2014, and determined there has been no change to the inputs supporting the fair value that was recorded at the date of acquisition (October 11, 2013). A key reason for this determination is that the independent valuation was completed recently and no significant events have occurred since it was completed that would lead to the valuation changing.

 

F-16

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

5.	Financial assets and liabilities (continued)

 

The main level 3 inputs used by the Group are evaluated as follows:

 

Risk adjusted discount rate:		The discount rate used in the valuation has been determined based on required rates of returns of listed companies in the biotechnology industry (having regards to their stage of development, their size and number of projects) and the indicative rates of return required by suppliers of venture capital for investments with similar technical and commercial risks.
Expected unit revenues:		Expected market sale price based an independent expert’s review of the most comparable products currently available in the market place.

 

6.	Non-financial assets and liabilities

This note provides information about the Group’s non-financial assets and liabilities, including:

 

•

specific information about each type of non-financial asset and non-financial liability;

 

•

property, plant and equipment (Note 6(a));

 

•

intangible assets (Note 6(b));

 

•

deferred revenue (Note 6(c));

 

•

provisions (Note 6(d));

 

•

deferred tax liability (Note 6(e));

 

•

accounting policies; and

 

•

information about determining the fair value of the instruments, including judgments and estimation uncertainty involved.

a. Property, plant and equipment

 

(in thousands)		Plant and equipment				Office furniture and equipment				Computer hardware and  software				Total
Year Ended June 30, 2013
Opening net book amount			374				873				751				1,998
Exchange differences			91				75				39				205
Additions			667				45				512				1,224
Depreciation charge			(173	)			(114	)			(383	)			(670	)
Closing net book value			959				879				919				2,757
As of June 30, 2013
Cost or fair value			1,208				1,085				1,857				4,150
Accumulated depreciation			(249	)			(206	)			(938	)			(1,393	)
Net book value			959				879				919				2,757

 

F-17

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

6.	Non-financial assets and liabilities (continued)

 

(in thousands)		Plant and equipment				Office furniture and equipment				Computer hardware and  software				Total
Year Ended June 30, 2014:
Opening net book amount			959				879				919				2,757
Exchange differences			(14	)			(15	)			(6	)			(35	)
Additions			2,066				245				624				2,935
Depreciation charge			(306	)			(128	)			(540	)			(974	)
Closing net book value			2,705				981				997				4,683
As of June 30, 2014:
Cost or fair value			3,248				1,309				2,463				7,020
Accumulated depreciation			(543	)			(328	)			(1,466	)			(2,337	)
Net book value			2,705				981				997				4,683

(i) Depreciation methods and useful lives

Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts, net of their residual values, over the estimated useful lives. The estimated useful lives are:

 

•

Plant and equipment: 10-15 years

 

•

Office furniture and equipment: 5-10 years

 

•

Computer hardware and software: 3-4 years

See Note 21(p) for the other accounting policies relevant to property, plant and equipment.

b. Intangible assets

 

(in thousands)		Goodwill				Acquired licenses to patents				In-process research and development acquired				Total
Year Ended June 30, 2013
Opening net book value			116,211				1,261				379,747				497,219
Additions			—				—				1,614	^			1,614
Exchange differences			11,476				123				37,504				49,103
Amortization charge			—				(102	)			—				(102	)
Impairment charge			—				—				—				—
Closing net book value			127,687				1,282				418,865				547,834
As of June 30, 2013
Cost			127,687				1,748				418,865				548,300
Accumulated amortization			—				(466	)			—				(466	)
Accumulated impairment			—				—				—				—
Net book amount			127,687				1,282				418,865				547,834

 

F-18

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

6.	Non-financial assets and liabilities (continued)

 

(in thousands)		Goodwill				Acquired licenses to patents				In-process research and development acquired				Total
Year Ended June 30, 2014:
Opening net book value			127,687				1,282				418,865				547,834
Additions			14,748				963				132,485				148,196
Exchange differences			(1,918	)			(38	)			(6,024	)			(7,980	)
Amortization charge			—				(146	)			—				(146	)
Impairment charge			—				—				—				—
Closing net book value			140,517				2,061				545,326				687,904
As of June 30, 2014:
Cost			140,517				2,667				545,326				688,510
Accumulated amortization			—				(606	)			—				(606	)
Accumulated impairment			—				—				—				—
Net book amount			140,517				2,061				545,326				687,904

(i) Carrying value of in-process research and development acquired by product

 

		As of June 30,
(in thousands)		2014				2013
Cardiovascular products			270,012				274,233
Intravenous products for metabolic diseases and inflammatory/immunologic conditions			75,085				76,259
Ophthalmic product			33,004				33,520
Bone marrow transplantation			32,727				33,239
MLCs			134,498				1,614
			545,326				418,865

For all products the above balances are reported in Australian dollars; however the underlying currency of the item recorded is U.S. dollars. Apart from the MSCs product which was acquired during the current financial year, the year on year movement in each balance is due to the movement in the Australian dollars:U.S. dollar exchange rate.

The total additions of In-process research & development recorded in Note 12 is $134,099 which represents the total for the years ended June 30, 2014 and 2013.

(ii) Amortization methods and useful lives

The Group amortizes intangible assets with a limited useful life using the straight-line method over the following periods:

 

•

Acquired licenses to patents: 13-16 years

See Note 21(q) for the other accounting policies relevant to intangible assets and Note 21(l) for the Group’s policy regarding impairments.

(iii) Significant estimate: Impairment of goodwill and assets with an indefinite useful life

The Group tests annually whether goodwill and its assets with indefinite useful lives have suffered any impairment in accordance with its accounting policy stated in Note 21(l). The recoverable amounts of these assets and cash-generating units have been determined based on fair value less costs to sell calculations, which require the use of certain assumptions.

 

F-19

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

6.	Non-financial assets and liabilities (continued)

 

(iv) Impairment tests for goodwill and intangible assets with an indefinite useful life

In-process research and development acquired is considered to be an indefinite life intangible asset on the basis that it is incomplete and cannot be used in its current form (see Note 21(q)(iii)). The carrying value of in-process research and development (AUD 545,326 : USD 513,697) is a separate asset which has been subject to impairment testing at the cash generating unit level, which has been determined to be at the product level.

For the purpose of impairment testing, goodwill is monitored by management at the operating segment level. The Group is managed as one operating segment, being the development of adult stem cell technology platform for commercialization. The carrying value of goodwill has been allocated to the appropriate operating segment for the purpose of impairment testing.

The recoverable amount of both goodwill and in-process research and development was assessed as of May 31, 2014 based on the fair value less costs to sell. An independent valuation was carried out by an independent valuer.

(v) Key assumptions used for fair value less costs to sell calculations

In determining the fair value less costs to sell we have given consideration to the following indicators:

 

•

the valuation of the company that was applicable to the recent (March 14, 2013) capital raising undertaken through issuing of the companies securities to investors;

 

•

the market capitalization of Mesoblast Limited on the ASX (ASX:MSB) on the impairment testing date as of May 31, 2014;

 

•

the amount of time that has elapsed since the goodwill acquisition of MSC assets from Osiris in October 2013 and of certain other products from Angioblast in December 2010;

 

•

discounted expected future cash flows of programs; and

 

•

the scientific results and progress of the trials since acquisition.

Costs of disposal were assumed to be immaterial.

Discounted cash-flows used a pre-tax discount rate range of 17.5% to 19.5%, and include estimated cash inflows and outflows for each program through to patent expiry, at which point a terminal value is assigned to the program. The assessment showed the recoverable amount of goodwill and in-process research and development exceeds the carrying amounts, and therefore there is no impairment.

In relation to cash outflows consideration has been given to cost of goods sold, selling costs and clinical trial schedules including estimates of numbers of patients and per patient costs. Associated expenses such as regulatory fees and patent maintenance have been included as well as any further preclinical development if applicable.

The assessment of goodwill showed the recoverable amount of the Group’s operating segment, including goodwill and in-process research and development, exceeds the carrying amounts, and therefore there is no impairment.

There are no standard growth rates applied, other than our estimates of market penetration which increase initially, plateau and then decline.

The assessment of the recoverable amount of each product has been made in accordance with the discounted cash-flow assumptions outlined above. The assessment showed that the recoverable amount of each product exceeds the carrying amount and therefore there is no impairment.

 

F-20

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

6.	Non-financial assets and liabilities (continued)

 

(vi) Impact of possible changes in key assumptions

Due to the significant excess value of the recoverable amount over the carrying value, a reasonably possible change in the key assumptions would not cause the carrying amount of the segment to exceed its recoverable amount.

Whilst we note there is no impairment the key sensitivities in the valuation remain the continued successful development of our technology platform.

c. Deferred revenue

 

(in thousands)		Year Ended June 30,
		2014				2013
Opening Balance			72,793				84,571
Amount recognized as revenue in the year			(16,410	)			(18,261	)
Foreign exchange difference			(637	)			6,483
Balance as of the end of the year			55,746				72,793
– To be recognized in the next twelve months (current deferred revenue)			15,928				16,176
– To be recognized beyond twelve months (non-current deferred revenue)			39,818				56,617
Balance as of the end of the year			55,746				72,793

d. Provisions

 

		Year Ended June 30,
(in thousands)		2014												2013
		Current				Non-current				Total				Current				Non-current				Total
Other			796				—				796				9,266				—				9,266
Employee benefits			4,891				269				5,160				4,366				203				4,569
Contingent consideration			—				86,249				86,249				—				—				—
			5,687				86,518				92,205				13,632				203				13,835

(i) Information about individual provisions and significant estimates

Other

During the ordinary course of business the Group occasionally has disputes with service providers. This provision allows for those disputes in the event the disputed amounts may become due and payable. Further disclosure is considered to be prejudicial to the Group.

Employee benefits

The provision for employee benefits relates to the Group’s liability for annual leave, short term incentives and long service leave.

Employee benefits include accrued annual leave. As of June 30, 2014 and 2013, the entire amount of the accrual was $590 and $528, respectively, and is presented as current, since the Group does not have an unconditional right to defer settlement for any of these obligations. However, based on past experience, the Group expects all employees to take the full amount of the accrued leave or require payment within the next 12 months.

 

F-21

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

6.	Non-financial assets and liabilities (continued)

 

(ii) Movements

Movements in each class of provision during the financial year, other than employee benefits, are set out below:

 

(in thousands)		Notes				Contingent Consideration				Other				Total
Carrying amount at start of year — July 1, 2013							—				9,266				9,266
Initial recognition on business combination			12(b)				81,660				—				81,660
Amounts used during the year							—				(5,922	)			(5,922	)
Charged/(credited) to consolidated income statement
— Unwinding of discount			5(e)(iii)				4,329				—				4,329
— Unused amounts reversed							—				(2,524	)			(2,524	)
Foreign exchange difference							260				(24	)			236
Carrying amount as of June 30, 2014							86,249				796				87,045

e. Deferred tax balances

 

(in thousands)		As of June 30,
		2014				2013
(i) Deferred tax liabilities
The balance comprises temporary differences attributable to:
Intangible assets			158,585				146,038
Total deferred tax liabilities			158,585				146,038
Deferred tax liabilities expected to be settled within 12 months			—				—
Deferred tax liabilities expected to be settled after 12 months			158,585				146,038

 

(in thousands)
Movements		Intellectual Property				Total
As of June 30, 2012			132,911				132,911
Foreign exchange difference			13,127				13,127
As of June 30, 2013			146,038				146,038
Foreign exchange difference			(2,201	)			(2,201	)
Acquisition of in-process research & development			14,748				14,748
As of June 30, 2014			158,585				158,585

 

7.

Equity

a. Contributed equity

 

Contributed equity		As of June 30,								As of June 30,
(in thousands)		2014				2013				2014				2013
(i) Share capital
Ordinary shares			321,640,094				316,468,901				677,087				654,458
Less: Treasury Shares			(4,485,000	)			(3,320,000	)			—				—
Total Contributed Equity			317,155,094				313,148,901				677,087				654,458

 

F-22

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

7.	Equity (continued)

 

(ii) Movements in ordinary share capital

 

Details		Shares No.				Issue price				Dollars in thousands
Opening Balance July 1, 2012			285,835,106								485,004
Exercise of share options			150,000				USD 0.31				47
Exercise of share options			255,913				USD 0.34				84
Exercise of share options			255,913				USD 0.47				116
Exercise of share options			80,000			$	0.96				77
Exercise of share options			646,000			$	1.00				646
Exercise of share options			300,000			$	1.58				474
Exercise of share options			72,000			$	2.00				144
Exercise of share options			40,000			$	2.64				106
Exercise of share options			475,600			$	3.48				1,655
Exercise of share options			277,390			$	3.78				1,048
Share issue to institutions and sophisticated investors			26,970,979			$	6.30				169,917
Placement of shares under LSFP(1)			50,000			$	6.29				—
Placement of shares under LSFP(1)			235,000			$	6.36				—
Placement of shares under LSFP(1)			50,000			$	6.69				—
Placement of shares under LSFP(1)			775,000			$	6.70				—
			30,633,795								174,314
Transaction costs arising on share issue											(5,529	)
Contribution of equity (net of transaction costs)											168,785
Share options reserve transferred to equity on exercise of options											669
Movement for the year											169,454
Balance as of June 30, 2013			316,468,901								654,458
Balance as of June 30, 2013			316,468,901								654,458
Exercise of share options			230,000			$	1.58				363
Exercise of share options			150,000			$	1.73				260
Exercise of share options			310,000			$	2.64				818
Exercise of share options			297,300			$	3.48				1,035
Consideration for In-process research & development acquired (Note 12)			2,948,729			$	5.69				16,764
Consideration for Acquired licenses to patents			70,164			$	5.96				417
Placement of shares under LSFP(1)			900,000			$	5.92				—
Placement of shares under LSFP(1)			100,000			$	6.28				—
Placement of shares under LSFP(1)			165,000			$	6.70				—
			5,171,193								19,657
Transaction costs arising on share issues											(46	)
Contribution of equity (net of transaction costs)											19,611
Share options reserve transferred to equity on exercise of options											3,018
Movement for the year											22,629
Balance as of June 30, 2014			321,640,094								677,087

 

F-23

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

7.	Equity (continued)

 

 

(1)	Initially these shares are issued and held in trust. Therefore there is no dollar movement recorded in ordinary share capital at this time. If the shares are purchased in accordance with the conditions of the Loan Funded Share Plan (“LFSP”) a dollar movement will be recorded at that date.

(iii) Ordinary shares

Ordinary shares participate in dividends and the proceeds on winding up of the Group in equal proportion to the number of shares held. At shareholders meetings each ordinary share is entitled to one vote when a poll is called, otherwise each shareholder has one vote on a show of hands. Ordinary shares have no par value and the Company does not have a limited amount of authorized capital.

(iv) Employee share options

Information relating the Group’s employee share option plan, including details of shares issued under the scheme, is set out in Note 18.

b. Reserves

 

(in thousands)		As of June 30,
		2014				2013
(i) Reserves
Share-based payments reserve			55,530				49,129
Foreign currency translation reserve			17,886				24,506
			73,416				73,635
(ii) Reconciliation of reserves
Share-based payments reserve
Opening balance			49,129				37,505
Transfer to ordinary shares on exercise of options			(3,018	)			(669	)
Share option expense for the year			9,419				12,293
Closing balance			55,530				49,129
Foreign currency translation reserve
Opening balance			24,506				(7,497	)
Currency (loss)/gain on translation of foreign operations net assets(1)			(6,620	)			32,003
Closing balance			17,886				24,506
(1) Total currency exchange differences on translation of foreign operations			(6,620	)			32,003

(iii) Nature and purpose of reserves

Share-based payment reserve

The share-based payments reserve is used to recognize:

 

•

the grant date fair value of options issued but not exercised; and

 

•

the grant date fair value of deferred shares granted but not yet vested.

 

F-24

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

7.	Equity (continued)

 

Foreign currency translation reserve

Exchange differences arising on translation of a foreign controlled entity are recognized in other comprehensive income and accumulated in a separate reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is disposed of.

 

8.	Cash flow information

 

(in thousands)		Year Ended June 30,
		2014				2013
(a) Reconciliation of cash and cash equivalents
Cash at bank			3,827				7,875
Deposit at call			192,567				307,434
			196,394				315,309
(b) Reconciliation of net cash flows used in operations with loss after income tax
Loss for the year			(80,958	)			(61,663	)
Add/(deduct) net loss items as follows:
Commercialization revenue			(16,410	)			(18,261	)
Depreciation and amortization			1,120				772
Foreign exchange losses			4,016				1,696
Finance costs			4,329				—
Release of excess provision for services			(2,524	)			—
Equity settled share-based payment			9,419				12,293
Change in operating assets and liabilities:
Decrease in trade and other receivables			2,911				2,786
(Increase) in prepayments			(271	)			(667	)
Decrease/(increase) in tax assets			3,281				(1,055	)
(Decrease)/increase in trade creditors and accruals			(1,362	)			8,221
(Decrease)/increase in provisions			(5,412	)			1,797
Net cash outflows used in operations			(81,861	)			(54,081	)

 

9.	Significant estimates, judgments and errors

The preparation of financial statements requires the use of accounting estimates which, by definition, will seldom equal the actual results. Management also needs to exercise judgment in applying the Group’s accounting policies

This note provides an overview of the areas that involved a higher degree of judgment or complexity, and of items which are more likely to be materially adjusted due to estimates and assumptions turning out to be wrong. Detailed information about each of these estimates and judgments is included in Notes 1 to 8 together with information about the basis of calculation for each affected line item in the financial statements. In addition, this note also explains where there have been actual adjustments this year as a result of an error and of changes to previous estimates.

a. Significant estimates and judgments

The areas involving significant estimates or judgments are:

 

•

recognition of revenue (Note 3);

 

•

fair value of contingent liabilities and contingent purchase consideration in a business combination (Note 12);

 

F-25

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

9.	Significant estimates, judgments and errors (continued)

•

fair value of goodwill and other intangible assets including in-process research and development (Note 6(b));

 

•

useful life of intangible asset (Note 6(b));

 

•

fair value of tax payable and current tax expense (Note 4(b));

 

•

accrued research and development and manufacturing commercialization expenses (Note 5(d)); and

 

•

fair value of share-based payments (Note 18).

Estimates and judgments are continually evaluated. They are based on historical experience and other factors, including expectations of future events that may have a financial impact on the entity and that are believed to be reasonable under the circumstances.

 

10.	Financial risk management

This note explains the Group’s exposure to financial risks and how these risks could affect the Group’s future financial performance. Current year net loss information has been included where relevant to add further context.

 

Risk		Exposure arising from		Measurement		Management
Market risk — currency risk		Future commercial transactions Recognized financial assets and liabilities not denominated in Australian dollars		Cash flow forecasting Sensitivity analysis		Forward foreign exchange contracts
Market risk — interest rate risk		Term deposits at fixed rates		Sensitivity analysis		Vary length of term deposits
Credit risk		Cash and cash equivalents, trade receivables and derivative financial instruments		Aging analysis Credit ratings		Only transact with “A” rated banks
Liquidity risk		Cash and cash equivalents		Rolling cash flow forecasts		Sufficient cash balance to meet the commitment of the Group

a. Derivatives

Derivatives are only used for economic hedging purposes and not as trading or speculative instruments. The Group has the following derivative financial instruments:

 

		As of June 30,
(in thousands)		2014				2013
Current assets
Forward foreign exchange contracts — held for trading			—				3,486
			—				3,486
Current liabilities
Forward foreign exchange contracts — held for trading			337				—
			337				—

 

F-26

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

10.	Financial risk management (continued)

 

(i) Classification of derivatives

Derivatives are classified as held for trading and accounted for at fair value through profit or loss. They are presented as current assets or liabilities if they are expected to be settled within 12 months after the end of the reporting period.

(ii) Change in accounting policy

The Group has applied the new standard on fair value measurement from July 1, 2013. As explained in Note 22, the adoption of the standard has not affected the measurement of the fair value of certain derivative liabilities.

(iii) Fair value measurement

For information about the methods and assumptions used in determining the fair value of derivatives please refer to Note 5(e).

b. Market risk

(i) Currency risk

The Group has certain clinical, regulatory and manufacturing activities which are being conducted internationally. The primary currency exposure to the Group is the clinical trial activities which are occurring offshore on behalf of Mesoblast Limited (an Australian company) in the United States of America and manufacturing activities occurring in Singapore. As a result of these activities, the Group has foreign currency amounts owing primarily in U.S. dollars and Singapore dollars (“SGD”), as well as some smaller amounts in various other currencies as tabled below. These foreign currency balances give rise to a currency risk, which is the risk of the exchange rate moving, in either direction, and the impact it may have on the Group’s financial performance.

The Group manages the currency risk by evaluating the trend of the relevant foreign currency rates (“FX rates”) to the Australian dollar and making decisions as to the levels to hold in each currency by assessing its future activities which will likely be incurred in those currencies. The Group is currently evaluating the requirement for and use of forward foreign exchange contracts in light of the recent 2014/2015 budget. The Group engages professional advice when considering forward foreign exchange contracts.

As of June 30, 2014, the Group held 45% of its cash in U.S. dollars, and 55% in Australian dollars. 12% of the Australian dollars balance is subject to forward contracts to purchase U.S. dollars at a predetermined rate in the future. After allowing for financial derivative contracts, at year end the Group held 51% U.S. dollars and 49% Australian dollars. The Group has entered financial derivative contracts to take advantage of enhanced interest rates yields available on Australian dollar deposit when compared to U.S. dollar deposits. The Group sells U.S. dollars and buys Australian dollars from the bank at a pre-agreed FX rate and agrees to then sell those Australian dollars and buy U.S. dollars from the bank on maturity also at a pre-agreed rate. As these FX rates are known at the outset there is no currency risk. It should be noted that trading in speculative derivatives is strictly prohibited in accordance with the Group’s treasury and financial risk management policy.

The balances held at the end of the year that give rise to currency risk exposure are presented in the following table, together with a sensitivity analysis which assesses the impact that a change of +/-20% (2013: +/-20%) in the exchange rate as of June 30, 2014 and 2013 would have had on the Group’s reported net profits/(losses) and/or equity balance. The AUD : USD rate prevailing as of June 30, 2014 was 0.9420 (2013: 0.9275).

 

F-27

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

10.	Financial risk management (continued)

 

The Group’s exposure to foreign currency risk at the end of the reporting period was as follows:

 

As of June 30, 2014		Foreign currency balance held				+20% Profit/(loss)  AUD				-20% Profit/(loss)  AUD
(in thousands)
Bank accounts			USD 82,853				(14,659	)			21,989
Bank accounts			CHF 632				(125	)			188
Forward exchange contracts
Buy foreign currency (Note 10(a))			USD76,000				(13,447	)			20,170
Trade and other receivables — USD			USD 990				(175	)			263
Trade and other receivables — Swiss franc (“CHF”)			CHF 3				(1	)			1
Trade payables & accruals — USD			(USD 16,788	)			2,970				(4,455	)
Trade payables & accruals — AUD(2)			(AUD 222	)			35				(52	)
Trade payables & accruals — SGD			(SGD 722	)			102				(153	)
Trade payables & accruals — Pound sterling (“GBP”)			(GBP 27	)			8				(12	)
Trade payables & accruals — EUR			(EUR 86	)			21				(31	)
Trade payables & accruals — CHF			(CHF 12	)			2				(4	)
Trade payables & accruals — Danish kroner (“DKK”)			(DKK 2	)			0				(0	)
Provisions — USD			(USD 3,144	)			556				(834	)
Provisions — SGD			(SGD 34	)			5				(7	)
							(24,708	)			37,063

 

As of June 30, 2013		Foreign currency balance held				+20% Profit/(loss) AUD Dollars				-20% Profit/(loss) AUD Dollars
(in thousands)
Bank accounts			USD 6,955				(1,250	)			1,875
Bank accounts			CHF 100				(19	)			29
Forward exchange contracts:
— buy foreign currency (see Note 10(a))(1)			USD 28,138				(5,056	)			7,584
Intercompany loan(1)			(USD 28,000	)			5,031				(7,547	)
Trade and other receivables — USD			USD 3,556				(639	)			959
Trade payables & accruals — USD			(USD 9,581	)			1,722				(2,582	)
Trade payables & accruals — AUD(2)			(AUD 96	)			15				(22	)
Trade payables & accruals — SGD			(SGD 4,610	)			655				(983	)
Trade payables & accruals — GBP			(GBP 13	)			4				(5	)
Trade payables & accruals — Swedish krona (“SEK”)			(SEK 90	)			2				(4	)
Trade payables & accruals — EUR			(EUR 8	)			2				(3	)
							467				(699	)

 

(1)	Relates to monies owned by the U.S. subsidiary, which have been lent to the parent entity to manage the cash on hand. The FX exposure is mitigated through the forward exchange contract.

 

(2)	These AUD balances are held by the U.S. based subsidiary and are therefore subject to currency risk.

 

F-28

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

10.	Financial risk management (continued)

 

(ii) Interest rate risk

The Group is not exposed to typical interest rate risk, being the impact of fixed versus floating interest rates on debt. The Group’s exposure is to interest rate movements in regards to interest income it earns on its deposits. The interest income derived from these balances can fluctuate due to interest rate changes. This interest rate risk is managed by spreading the maturity date of our deposits across various periods. The Group ensures that sufficient funds are available, in at call accounts, to meet the cash flow requirements of the Group.

The deposits held which derive interest revenue are described in the table below, together with the maximum and minimum interest rates being earned as of June 30, 2014 and 2013. The effect on profit is shown if interest rates change by 10%, in either direction, is as follows:

 

(in thousands, except percent data)		2014												2013
AUD		Low				High				AUD				Low				High				AUD
Funds invested as of June 30,			3.41	%			3.60	%			107,540				3.85	%			4.66	%			302,565
Rate increase by 10%			3.75	%			3.96	%			374				4.24	%			5.13	%			1,286
Rate decrease by 10%			3.07	%			3.24	%			(374	)			3.47	%			4.19	%			(1,286	)
USD		Low				High				USD				Low				High				USD
Funds invested as of June 30,			0.04	%			0.27	%			81,000				—				—				—
Rate increase by 10%			0.04	%			0.30	%			3				—				—				—
Rate decrease by 10%			0.04	%			0.24	%			(3	)			—				—				—

(iii) Price risk

Price risk is the risk that future cash flows derived from financial instruments will be altered as a result of a market price movement, other than foreign currency rates and interest rates. The Group does not consider it has any exposure to price risk other than those already described above.

c. Credit risk

Credit risk is the risk that one party to a financial instrument will fail to discharge its obligation and cause financial loss to the other party. As the Group is non–revenue generating it generally does not have trade receivables. The Group’s receivables are tabled below.

 

		As of June 30,
(in thousands)		2014				2013
Cash and cash equivalents
Cash and cash equivalents (Note 5(a)) — minimum A rated			196,394				315,309
Trade and other receivables
Receivable from the Australian Government (goods and services tax)			128				111
Receivable from the Australian Government (Income Tax)			5,180				5,924
Receivable from the United States Government (Income Tax)			74				2,393
Receivable from the Swiss Government (value-added tax)			4				1
Receivable from minimum A rated bank deposits (interest)			296				3,306
Employee loan contracts(1)			—				320
Receivable from other parties (non-rated)			416				8

 

(1)	The employee loan balance is covered by a contract.

 

F-29

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

10.	Financial risk management (continued)

 

d. Liquidity risk

Liquidity risk is the risk that the Group will not be able to pay its debts as and when they fall due. The Group has no borrowings to date and the Directors ensure that cash on hand is sufficient to meet the commitments of the Group at all times while it is in a loss making phase of research and development.

All financial liabilities held by the Group as of June 30, 2014 and 2013 are non-interest bearing and mature within 6 months. The total contractual cash flows associated with these liabilities equate to the carrying amount disclosed within the financial statements.

 

11.	Capital management

The Group’s objective when managing capital is to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders. See Note 5(a) for the cash reserves of the Group as at the end of the financial reporting period.

 

12.	Business combination

a. Summary of acquisition

On October 11, 2013, the Group acquired the culture-expanded mesenchymal stem cells business of Osiris.

The acquisition is complementary in its nature with many commercial and strategic benefits. The potential benefits derived from acquiring the approved and late-stage mesenchymal stem cells products include:

 

•

near term market launch of a mesenchymal lineage product in major jurisdictions;

 

•

broadened late-phase clinical programs in strategic areas of focus;

 

•

leveraged roll out of infrastructure, skills and expertise needed to commercialize mesenchymal precursor cell products;

 

•

ownership of extensive long-term clinical data from over 1,500 patients treated with culture-expanded mesenchymal stem cells, including safety, efficacy and repeat dosing data; and

 

•

acquisition of new intellectual property which is highly complementary to the Group’s existing patent estate.

Details of the purchase consideration, the net assets acquired and goodwill are as follows:

Purchase consideration at fair value

 

(in thousands)		Fair value  at Osiris acquisition date
Cash on closing			21,196
Cash payment made on the six month anniversary of the agreement (Fair Value)(1)			15,610
Securities allotment (2,948,729 shares were allotted)(2)			15,873
Contingent consideration(3)(Note 6(d)(ii))			81,660
Total purchase consideration			134,339

 

F-30

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

12.	Business combination (continued)

 

Net assets acquired at fair value

 

(in thousands)		Fair value at  Osiris acquisition date
Property, plant and equipment			240
Intangible assets: (in-process research & development)			134,099
Deferred tax liability on future revenue streams, recorded in accordance with IFRS 3			(14,748	)
Net identifiable assets acquired			119,591
add: Goodwill			14,748
Net assets acquired			134,339

 

(1)	The cash payment due on the six-month anniversary of the agreement of $15,610 has a USD denominated value of USD 15,000.

(2)	The Company’s securities were issued as consideration upon the transfer of assets on December 18, 2013, which had a value of $16,717 on that date.

(3)	At acquisition date contingent consideration of $81,660 was recorded as tabled above. Please refer to Note 6(d)(ii) for the reconciliation of the subsequent movements of this contingent consideration provision.

The fair value amounts reported above are final.

All assets acquired and purchase consideration amounts are denominated in U.S. dollars. The amounts presented above are in Australian dollars and have been translated at the rate applicable at the acquisition date (October 11, 2013) being AUD 1 : USD 0.9450. The goodwill is attributable to the deferred tax liability that is required to be recognized on the difference between the intangible asset’s book value compared to its tax value.

No amount of goodwill is expected to be deducted for tax purposes.

The tax base of the asset assumes that the asset is held for use and is therefore $Nil resulting in a deferred tax liability calculated at the tax rate of the jurisdiction where the underlying intangible assets are held.

b. Contingent consideration

In the event that certain pre-determined milestones and royalties are achieved additional consideration is payable. The fair value of the contingent consideration is set out in the table below. The fair value estimates have been calculated on the basis of fair value less cost to sell by using the income approach, with reference to both the excess earnings and relief from royalty methods as set out below:

 

		Fair value at  Osiris acquisition date
The fair value of contingent consideration
(in thousands)
Fair value of cash or stock payable, dependent on achievement of future late-stage clinical or regulatory targets(1)			24,507
Fair value of royalty payments from commercialization of the intellectual property acquired(2)			57,153
			81,660

 

(1)

The contingent consideration payable for each milestone is a fixed dollar amount and can be paid either in cash or through the allotment of Mesoblast Limited securities at the date of payment, at the discretion of the Mesoblast Group. The potential undiscounted amount of the contingent consideration for milestones is a minimum of USD Nil and a maximum of USD 50,000.

 

F-31

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

12.	Business combination (continued)

 

(2)

The amount of the contingent consideration payable as royalties is variable. The contingent consideration paid could range from zero dollars if no sale of product occurs, up to a maximum that is unlimited. This maximum is calculated at a commercial arm’s length percentage of net sales. Royalty payments will cease after a 10 year commercial sales period. Royalties are payable in cash after the conclusion of the period in which the sales were made.

c. Purchase consideration — cash outflow

 

(in thousands)
Cash consideration (fair value) owed pursuant to the asset purchase agreement			36,806
less: amount paid during the full year ended June 30, 2013			(1,537	)
Cash outflow reported for the year ended June 30, 2014(1)			35,269

 

(1)	Included within cashflows from investing activities within the statement of cashflows.

d. Revenue and profit contribution

The acquired business contributed revenues of $Nil and net loss of $5,951 to the Group for the period October 11, 2013 to June 30, 2014.

If the acquisition had occurred on July 1, 2013, consolidated revenue and loss for the year ended June 30, 2014 would have been $25,980 and $83,298, respectively. These amounts have been calculated using the Osiris audited financial statements segment information. This has been calculated based on expenditure incurred with external providers to develop programs acquired from Osiris. There were no allocations of internal labor or other internal cost bases.

e. Acquisition-related costs

Directly attributable acquisition-related costs of approximately $954 are included in management and administration expenses in the income statement, and in the operating cash flows section in the statement of cash flows, for the year ended June 30, 2014.

 

13.	Interests in other entities

a. Material subsidiaries

The Group’s principal subsidiaries as of June 30, 2014 are set out below. Unless otherwise stated, they have share capital consisting solely of ordinary shares that are held directly by the Group, and the proportion of ownership interests held equals the voting rights held by the Group. The country of incorporation or registration is also their principal place of business.

 

Name of entity

Country of incorporation

Class of shares

Equity holding

June 30, 2014

June 30, 2013

%

%

Mesoblast, Inc.

USA

Ordinary

100

100

Mesoblast International Sárl

Switzerland

Ordinary

100

100

Mesoblast Australia Pty Ltd

Australia

Ordinary

100

100

Mesoblast UK Limited

United Kingdom

Ordinary

100

100

 

F-32

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

14.	Contingent assets and contingent liabilities

a. Contingent assets

The Group did not have any contingent assets outstanding as of June 30, 2014 or 2013.

b. Contingent liabilities

(i) Central Adelaide Local Health Network Incorporated (“CALHNI”) (formerly Medvet)

The Group will be required to make a milestone payment to CALHNI of USD 250 on completion of Phase 3 clinical trials and USD 350 on FDA marketing approval for products in the orthopedic field. The Group will pay CALHNI a commercial arm’s length royalty based on net sales by the Group of licensed products in the orthopedic field each quarter.

Additionally, in regards to certain intellectual property assets originally assigned to Mesoblast, Inc., the Group may be required to pay consideration to CALHNI depending on the achievement of future milestones. They represent payments on successful completion of subsequent clinical milestones in fields other than orthopedic. If all milestones were to be reached these payments total USD 1,850. In addition it stipulates the requirement for royalty payments as a percentage of sales of product in fields other than orthopedic at a commercial arm’s length rate as well as minimum annual royalties after commercial sale of product scaling up from USD 100 to USD 500 over 5 years.

Across all fields, if all milestones were reached, milestone payments would total USD 2,450.

 

15.	Commitments

a. Capital commitments

The Group did not have any commitments for future capital expenditure outstanding as of June 30, 2014 or 2013.

b. Lease commitments: Group as lessee

(i) Non-cancellable operating leases

The Group leases various offices under non-cancellable operating leases expiring within 1 to 7 years. The leases have varying terms, escalation clauses and renewal rights. On renewal, the terms of the leases are renegotiated.

 

(in thousands)		Total				Within one year				Later than one year but no later than three years				Later than three years but no later than five years				Later than five years
Operating leases			19,502				2,814				5,635				5,932				5,121
Total Commitments			19,502				2,814				5,635				5,932				5,121

Lease commitments include amounts in U.S. dollars and Singapore dollars which have been translated to AUD as of June 30, 2014 foreign exchange rates published by the Reserve Bank of Australia.

 

16.	Events occurring after the reporting period

There are no events that have occurred after June 30, 2014 and prior to the signing of this financial report that would likely have a material impact on the financial results presented.

 

F-33

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

17.	Related party transactions

a. Parent entity

The parent entity within the Group is Mesoblast Limited.

b. Subsidiaries

Details of interests in subsidiaries are disclosed in Note 13 to the financial statements.

c. Key management personnel compensation

The aggregate compensation made to Directors and other members of key management personnel of the Group is set out below:

 

		Year Ended June 30,
(in dollars)		2014				2013
Short-term employee benefits			2,768,360				2,457,392
Post-employment benefits			65,319				59,565
Share-based payments			—				5,032
			2,833,679				2,521,989

Further disclosures regarding key management personnel compensation are contained within the remuneration report.

d. Transactions with other related parties

Accounts receivable from, accounts payable to and loans from subsidiaries as of the end of the financial year have been eliminated on consolidation of the Group.

e. Terms and conditions

All other transactions were made on normal commercial terms and conditions and at market rates, except that there are no fixed terms for the repayment of loans between the parties.

Outstanding balances are unsecured and are repayable in cash.

 

18.	Share-based payments

The Company has adopted an Employee Share Option Plan (“ESOP”) and a LFSP to foster an ownership culture within the Company and to motivate senior management and consultants to achieve performance targets. Selected directors, employees and consultants may be eligible to participate in the plans at the absolute discretion of the board of directors, and in the case of directors, upon approval by shareholders.

Grant policy

In accordance with the Company’s current policy, options and loan funded shares are issued in three equal tranches, each tranche having an expiry date of five years following grant date. The first tranche typically vests 12 months after grant date, the second tranche 24 months after grant date, and the third tranche 36 months after grant date.

The exercise price for options is determined by reference to Company policy which is generally the volume weighted market price of a share sold on the ASX on the 5 trading days immediately before the grant date plus a premium determined by the Company’s board of directors (typically 10%). The same approach is used to determine the purchase price to acquire a loan-funded share for the purposes of the LFSP.

 

F-34

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

18.	Share-based payments (continued)

 

The aggregate number of options which may be issued pursuant to the ESOP must not exceed 10,000,000 with respect to US incentive stock options, and with respect to Australian residents, that limit imposed under ASIC Class Order [CO 03/184].

In addition the LFSP has the following characteristics:

On grant date, the Company issues new equity (rather than purchasing shares on market), and the loan funded shares are placed in a trust which holds the shares on behalf of the employee. The trustee issues a limited recourse, interest free, loan to the employee which is equal to the number of shares multiplied by the price. A limited-recourse loan means that the repayment amount will be the lesser of the outstanding loan value (the loan value less any amounts that may have already been repaid) and the market value of the shares that are subject to the loan. The price is the amount the employee must pay for each loan funded share if exercised.

The trustee continues to hold the shares on behalf of the employee until the employee chooses to settle the loan pertaining to the shares and all vesting conditions have been satisfied, at which point ownership of the shares is fully transferred to the employee.

Any dividends paid by the Company, while the shares are held by the trustee, are applied as a repayment of the loan at the after-tax value of the dividend.

 

F-35

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

18.	Share-based payments (continued)

 

a. Reconciliation of outstanding share based payments

 

ESOP Series		Grant Date				Expiry Date				Exercise Price				Opening Balance				Granted No. (during the year)				Exercised No. (during the year)				Lapsed/ Cancelled No. (during the year)				Closing Balance				Vested and exercisable No (end of year)
8			7/07/2008				30/06/2013			$	1.00				180,000				—				—				(180,000	)			—				—
10			30/11/2009				30/11/2014			$	1.73				300,000				—				(150,000	)			—				150,000				150,000
11			30/11/2009				30/11/2014			$	1.58				710,000				—				(230,000	)			—				480,000				480,000
13			22/09/2010				21/09/2015			$	2.64				445,000				—				(310,000	)			—				135,000				135,000
14			29/11/2010				29/11/2015			$	3.48				1,866,600				—				(297,300	)			—				1,569,300				1,569,300
15/LF1			22/12/2011				30/06/2016			$	7.99				4,560,000	(1)			—				—				(316,666	)			4,243,334				3,543,339
16/LF2			24/02/2012				23/02/2017			$	8.48				340,000				—				—				—				340,000				226,668
17/LF3			9/07/2012				8/07/2018			$	6.69				250,000				—				—				—				250,000				83,331
18/LF4			21/09/2012 - 29/10/2012				30/06/2017			$	6.70				2,915,000	(1)			—				—				(261,667	)			2,653,333				1,275,002
19/LF5			25/01/2013 - 29/01/2013				24/01/2018 - 28/01/2008			$	6.29				100,000				—				—				—				100,000				33,334
20/LF6			24/05/2013				23/05/2018			$	6.36				1,000,000				—				—				—				1,000,000				378,338
21/LF7			3/09/2013				30/06/2018			$	5.92				—				3,490,000				—				(200,000	)			3,290,000				325,001
22/LF8			4/09/2013				27/08/2018			$	6.28				—				325,000				—				—				325,000				—
23a			26/11/2013				10/10/2018			$	6.20				—				50,000				—				—				50,000				—
23b			30/11/2013				29/11/2018			$	6.79				—				200,000				—				—				200,000				—
24			17/12/2013				16/12/2018			$	6.25				—				190,000				—				(10,000	)			180,000				—
24a (i)			10/02/2014				9/02/2019			$	6.41				—				100,000				—				—				100,000				—
24a (ii)			17/02/2014				16/02/2019			$	6.33				—				25,000				—				—				25,000				—
25a (i&ii)			1/01/2014				31/12/2018			$	6.38				—				650,000				—				—				650,000				—
LF9.4			11/12/2013				30/06/2017			$	6.70				—				165,000				—				—				165,000				110,000
LF9.7			3/09/2013				30/06/2018			$	5.92				—				200,000				—				—				200,000				66,667
INC			7/12/2010				7/07/2015				USD 0.046				287,903				—				—				—				287,903				287,903
INC			7/12/2010				26/10/2018				USD 0.305				195,999				—				—				—				195,999				195,999
INC			7/12/2010				26/10/2019				USD 0.340				703,761				—				—				—				703,761				703,761
INC			7/12/2010				25/04/2017				USD 0.444				127,956				—				—				—				127,956				127,956
INC			7/12/2010				2/05/2017				USD 0.444				127,956				—				—				—				127,956				127,956
June 30, 2014															14,110,175				5,395,000				(987,300	)			(968,333	)			17,549,542				9,819,555
Weighted average share purchase price														$	5.46			$	6.08			$	2.51			$	5.90			$	5.82			$	5.32
June 30, 2013															12,731,391				4,345,000				(2,552,816	)			(558,400	)			13,965,175				7,023,249
Weighted average share purchase price														$	4.42			$	6.61			$	1.72			$	6.33			$	5.46			$	4.40

 

(1)	The opening balance for 15/LF1 and 18/LF4 has been restated to increase the balance by 100,000 and 45,000 loan funded shares respectively. These shares were forfeited by participants in accordance with the terms of the loan funded share plan and are now the property of the Employee Share Trust.

The weighted average share price at the date of exercise of options exercised during the year ended June 30, 2014 and 2013 was $5.83 and $5.94, respectively.

The weighted average remaining contractual life of share options and loan funded shares outstanding as of June 30, 2014 and 2013 was 2.96 years and 3.38 years, respectively.

 

F-36

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

18.	Share-based payments (continued)

 

b. Existing share-based payment arrangements

General terms and conditions attached to share based payments

Share options pursuant to the employee share option plan and shares pursuant to loan funded share plan are granted in three equal tranches with expiry dates five years post grant date. Vesting occurs progressively over the life of the option/share with the first tranche vesting one year from grant date, the second tranche two years from grant date, and the third tranche three years from grant date. On cessation of employment the Company’s board of directors determines if a leaver is a bad leaver or not. If a participant is deemed a bad leaver, all rights, entitlements and interests in any unexercised options or shares (pursuant to the loan funded share plan) held by the participant will be forfeited and will lapse immediately. If a leaver is not a bad leaver they may retain vested options and shares (pursuant to the loan funded share plan), however, they must be exercised within 60 days of cessation of employment (or within a longer period if so determined by the Company’s board of directors), after which time they will lapse. Unvested options will normally be forfeited and lapse. This policy applies to all issues shown in the above table with the exception of the following:

 

Series 10

Options granted to the Chairman were approved by shareholders at the Annual General Meeting held on November 30, 2010. The options were granted in four equal tranches vesting on the achievement of certain milestones, being the date on which:

 

•

Mesoblast signs a commercial partnering contract, e.g. a commercial license to one of its products (vested December 7, 2010);

 

•

Mesoblast receives IND clearance from the FDA for its first clinical trial for Intervertebral Disc Repair (vested March 17, 2011);

 

•

Mesoblast completes patient enrollment for its first clinical trial under IND for Intervertebral Disc Repair (vested October 12, 2012);

 

•

Mesoblast obtains a license from the Therapeutics Goods Administration for the manufacture (vested July 20, 2010.

 

All four tranches expire on November 30, 2014.

 

25a (i&ii)

Options were granted in two equal tranches and will vest on the date that the option holder has direct involvement (to the reasonable satisfaction of the Company’s board of directors) in the Company achieving certain confidential commercial objectives.

 

INC.

As part of the acquisition of Mesoblast, Inc., Mesoblast, Inc. options were converted to options of the Company at a conversion ratio of 63.978. The Mesoblast, Inc. option exercise price per option was adjusted using the same conversion ratio. All options vested on acquisition date (December 7, 2010), and will expire according to their original expiry dates (with the exception of options held by directors which were limited to an expiry date not exceeding four years from acquisition).

Modifications to terms and conditions

There has been no modification to terms and conditions in either the current or previous financial years.

c. Fair values of share based payments

The weighted average fair value of share options and loan funded shares granted during the years ended June 30, 2014 and 2013 was $1.71 and $2.69, respectively.

 

F-37

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

18.	Share-based payments (continued)

 

The fair value of all shared-based payments made has been calculated using the Black-Scholes model. This model requires the following inputs:

Share price at grant date

The share price underpinning the exercise price has been used as the share price at grant date for valuation purposes. This price is generally the volume weighted average share price for the 5 trading days leading up to grant date.

Exercise price

The exercise price is a known value that is contained in the agreements.

Share price volatility

The model requires the Company’s share price volatility to be measured. In estimating the expected volatility of the underlying shares our objective is to approximate the expectations that would be reflected in a current market or negotiated exchange price for the option or loan funded share.

Share price date from January 1, 2012 through to the end of each applicable financial year has been used to calculate share price volatility.

Life of the option/share

The life is generally the time period from grant date through to expiry. Certain assumptions have been made regarding “early exercise” i.e. options exercised ahead of the expiry date, with respect to option series 14 and later. These assumptions have been based on historical trends for option exercises within the Company and take into consideration exercise trends that are also evident as a result of local taxation laws.

Dividend yield

The Company has yet to pay a dividend so it has been assumed the dividend yield on the shares underlying the options will be 0%.

Risk free interest rate

This has been sourced from the Reserve Bank of Australia historical interest rate tables for government bonds.

 

F-38

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

18.	Share-based payments (continued)

 

Model inputs

The model inputs for the valuations of options approved and issued during the current and previous financial years are as follows:

 

ESOP Option Series		Financial year of grant				Exercise/Loan Price per share				Share price at grant date				Expected share price				Life				Dividend yield				Risk-free interest rate
						$				$				volatility
15 & LF1			2014				7.99				7.00-7.48				51.48	%			0.6-4.5 yrs				0	%			3.18	%
17 & LF3			2013				6.69				6.00				49.61	%			5 yrs				0	%			2.73	%
18 & LF4			2013/2014				6.70				5.83-7.14				48.49	%			4.75 yrs				0	%			2.78	%
19 & LF5			2013				6.29				5.56-5.61				40.10	%			5 yrs				0	%			3.09	%
20 & LF6			2013				6.36				6.01				40.96	%			5 yrs				0	%			2.84	%
21 & LF7			2014				5.92				5.56				38.80	%			3.6 yrs				0	%			3.31	%
22			2014				6.28				5.49				38.79	%			3.7 yrs				0	%			3.37	%
LF8			2014				5.92				6.28				38.79	%			3.7 yrs				0	%			3.37	%
LF9.4			2014				6.70				5.88				38.79	%			2.6 yrs				0	%			3.47	%
LF9.7			2014				5.92				5.88				38.79	%			3.4 yrs				0	%			3.47	%
23a			2014				6.20				6.04				38.74	%			3.6 yrs				0	%			3.45	%
23b			2014				6.20				6.79				38.73	%			3.7 yrs				0	%			3.44	%
24			2014				6.25				5.58				38.80	%			3.7 yrs				0	%			3.38	%
24a.(i)			2014				6.41				5.75				38.37	%			3.7 yrs				0	%			3.44	%
24a.(ii)			2014				6.33				5.76				38.20	%			3.7 yrs				0	%			3.45	%
25a.(i)			2014				6.38				5.84				38.04	%			3.6 yrs				0	%			3.43	%
25a.(ii)			2014				6.38				5.84				38.04	%			4.9 yrs				0	%			3.43	%

The closing share market price of an ordinary share of Mesoblast Limited on the ASX as of June 30, 2014 and 2013 was $4.47 and $5.30, respectively.

 

19.	Remuneration of auditors

During the year the following fees were paid or payable for services provided by the auditor of the parent entity, its related practices and non-related audit firms:

 

		Year Ended June 30,
(in thousands)		2014				2013
a. PricewaterhouseCoopers Australia
(i) Audit and other assurance services
Audit and review of financial reports			326,009				213,129
Total remuneration of PricewaterhouseCoopers Australia			326,009				213,129
b. Network firms of PricewaterhouseCoopers Australia
(i) Audit and other assurance services
Audit and review of financial reports			110,393				68,126
Total remuneration of Network firms of PricewaterhouseCoopers Australia			110,393				68,126
Total auditors’ remuneration			436,402				281,255

 

F-39

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

20.	Losses per share

 

				Year Ended June 30,
				2014 Cents				2013 Cents
a.		Basic losses per share
		From continuing operations attributable to the ordinary equity holders of the company			(25.34	)			(21.06	)
		Total basic losses per share attributable to the ordinary equity holders of the company			(25.34	)			(21.06	)
b.		Diluted losses per share
		From continuing operations attributable to the ordinary equity holders of the company			(25.34	)			(21.06	)
		Total basic losses per share attributable to the ordinary equity holders of the company			(25.34	)			(21.06	)
c.		Reconciliation of losses used in calculating loss per share
		(in thousands)
		Basic losses per share
		Profit attributable to the ordinary equity holders of the company used in calculating basic losses per share:
		From continuing operations			(80,958	)			(61,663	)
		Diluted losses per share
		Profit from continuing operations attributable to the ordinary equity holders of the company:
		Used in calculating basic losses per share			(80,958	)			(61,663	)
		Losses attributable to the ordinary equity holders of the company used in calculating diluted losses per share			(80,958	)			(61,663	)

 

		Year Ended June 30,
		2014 Number				2013 Number
Weighted average number of ordinary shares used as the denominator in calculating basic losses per share			319,450,496				292,768,143
Weighted average number of ordinary shares and potential ordinary shares used in calculating diluted losses per share			319,450,496				292,768,143

Options granted to employees (see Note 18) are considered to be potential ordinary shares. These securities have been excluded from the determination of basic earnings per shares. They have also been excluded from the calculation of diluted earnings per share because they are anti-dilutive for the years ended June 30, 2014 and 2013. Shares that may be paid as contingent consideration (see Note 12(b)) have also been excluded from basic earnings per share. They have also been excluded from the calculation of diluted earnings per share because they are anti-dilutive for the year ended June 30, 2014.

 

21.	Summary of significant accounting policies

This note provides the principal accounting policies adopted in the preparation of these consolidated financial statements as set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. The financial statements are for the consolidated entity consisting of Mesoblast Limited and its subsidiaries.

a. Basis of preparation

The consolidated financial statements of Mesoblast Limited and its subsidiaries have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”). Mesoblast Limited is a for-profit entity for the purpose of preparing the financial statements.

 

F-40

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

(i) Historical cost convention

These financial statements have been prepared under the historical cost convention, as modified by the revaluation of available-for-sale financial assets, financial assets and liabilities (including derivative instruments) at fair value through profit or loss, certain classes of property, plant and equipment and investment property.

(ii) Changes to comparative figures

Comparative figures, are, where appropriate, revised to be comparable with figures presented in the current financial year. During the year, intellectual property costs, travel expenses and employee recruitment fees that have been identified as being directly attributable to research and development and manufacturing commercialization have been revised into the appropriate classification for our consolidated statement of income for the year ending as of June 30, 2013. The change in presentation is considered to provide more relevant information and has also been adopted in the current year.

For the year ended June 30, 2014 and 2013, research and development was $43,108 and $47,835, respectively. For the year ended June 30, 2014 and 2013, manufacturing and commercialization was $20,946 and is $23,230, respectively. Management and administration was $30,734 and $22,840, respectively. For the year ended June 30, 2014 and 2013, other expenses was $Nil and $883, respectively.

(iii) New and amended standards adopted by the Group

The Group has applied the following standards and amendments for first time for their annual reporting period commencing July 1, 2013:

 

•

IFRS 10 Consolidated Financial Statements;

 

•

IFRS, Consolidated Financial Statements, Joint Arrangements and Disclosure of Interests in Other Entities: Transition Guidance (Amendments to IFRS 10, IFRS 11 and IFRS 12);

 

•

IFRS 13 Fair Value Measurement and IFRS, Amended by Annual Improvement to IFRSs 2010-2012 Cycle (short-term receivables and payables);

 

•

IAS 19 Employee Benefits (September 2011) and IAS 19 Defined Benefit Plans: Employee Contributions (amendments to IAS 19);

 

•

IFRS, Annual Improvements to IFRSs 2011–2013 Cycle; and

 

•

Amendments to IAS 32 Offsetting Financial Assets and Liabilities.

The adoption of IFRS 13 and IAS 19 resulted in changes in accounting policies however did not result in an adjustment to the amounts recognized in the financial statements. The amendment to the standards are explained in Note 22 below. The other standards only affected the disclosures in the notes to the financial statements.

(iv) New accounting standards and interpretations

There are no IFRS or International Financial Report Interpretation Committee interpretations that are effective for the first time for the financial year beginning on or after June 30, 2014 that would be expected to have a material impact on the Group.

 

F-41

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

Accounting Standards issued but not yet effective

Certain new accounting standards and interpretations have been published that are not mandatory for June 30, 2014 reporting periods. Initial application of the following Standards and Interpretations are not expected to affect any of the amounts recognized in the financial report, but may change the disclosures presently made in relation to the Group.

 

Pronouncement		Title (Issue date)		Impact		Effective date
IFRS 9		Financial Instruments (July 2014)		A finalized version of IFRS 9 which contains accounting requirements for financial instruments, replacing IAS 39 Financial Instruments: Recognition and Measurement. The standard contains requirements in the following areas:   •   Classification and measurement. Financial assets are classified by reference to the business model within which they are held and their contractual cash flow characteristics. The 2014 version of IFRS 9 introduces a ‘fair value through other comprehensive income’ category for certain debt instruments. Financial liabilities are classified in a similar manner to under IAS 39, however there are differences in the requirements applying to the measurement of an entity’s own credit risk.   •   Impairment. The 2014 version of IFRS 9 introduces an ‘expected credit loss’ model for the measurement of the impairment of financial assets, so it is no longer necessary for a credit event to have occurred before a credit loss is recognized   •   Hedge accounting. Introduces a new hedge accounting model that is designed to be more closely aligned with how entities undertake risk management activities when hedging financial and non-financial risk exposures   •   Derecognition. The requirements for the derecognition of financial assets and liabilities are carried forward from IAS 39   The Company does not expect the new standard to have a material impact on the financial statements. The Company intends to apply the changes from July 1, 2018.		Annual periods beginning on or after January 1, 2018.   Earlier application is permitted.
IFRS 15		Revenue from Contracts with Customers (May 2014)		IFRS 15 provides a single, principles based five-step model to be applied to all contracts with customers.   The five steps in the model are as follows:   •   Identify the contract with the customer   •   Identify the performance obligations in the contract   •   Determine the transaction price		Annual periods beginning on or after January 1, 2017.   Earlier application is permitted.

 

F-42

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Table of Contents

Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

Pronouncement		Title (Issue date)		Impact		Effective date
				•   Allocate the transaction price to the performance obligations in the contracts   •   Recognise revenue when (or as) the entity satisfies a performance obligation.   •   Guidance is provided on topics such as the point in which revenue is recognised, accounting for variable consideration, costs of fulfilling and obtaining a contract and various related matters. New disclosures about revenue are also introduced.   The Company is assessing the impact of the new standard on its revenue recognition policy. The Company intends to apply the new standard from July 1, 2017.
Amendments to IAS 16 and IAS 38		Clarification of Acceptable Methods of Depreciation and Amortization (May 2014)		Amends IAS 16 Property, Plant and Equipment and IAS 38 Intangible Assets to:   •   clarify that a depreciation method that is based on revenue that is generated by an activity that includes the use of an asset is not appropriate for property, plant and equipment   •   introduce a rebuttable presumption that an amortization method that is based on the revenue generated by an activity that includes the use of an intangible asset is inappropriate, which can only be overcome in limited circumstances where the intangible asset is expressed as a measure of revenue, or when it can be demonstrated that revenue and the consumption of the economic benefits of the intangible asset are highly correlated   •   add guidance that expected future reductions in the selling price of an item that was produced using an asset could indicate the expectation of technological or commercial obsolescence of the asset, which, in turn, might reflect a reduction of the future economic benefits embodied in the asset.   The Company does not expect the amendments to have a material impact on the financial statements. The Company intends to apply the changes from July 1, 2016.		Annual periods beginning on or after January 1, 2016.   Earlier application is permitted.

 

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

Pronouncement		Title (Issue date)		Impact		Effective date
Annual Improvements to IFRSs 2010–2012 Cycle		International Financial Reporting Standards (December 2013)		Makes amendments to the following standards:   •   IFRS 2 — Amends the definitions of ‘vesting condition’ and ‘market condition’ and adds definitions for ‘performance condition’ and ‘service condition’   •   IFRS 3 — Require contingent consideration that is classified as an asset or a liability to be measured at fair value at each reporting date   •   IFRS 8 — Requires disclosure of the judgements made by management in applying the aggregation criteria to operating segments, clarify reconciliations of segment assets only required if segment assets are reported regularly   •   IFRS 13 — Clarify that issuing IFRS 13 and amending IFRS 9 and IAS 39 did not remove the ability to measure certain short-term receivables and payables on an undiscounted basis (amends basis for conclusions only)   •   IAS 16 and IAS 38 — Clarify that the gross amount of property, plant and equipment is adjusted in a manner consistent with a revaluation of the carrying amount   The Company does not expect the amendments to have a material impact on amounts recognised in the financial statements or significantly impact disclosures made in the financial statements. The Company intends to apply the changes from July 1, 2014.		Annual periods beginning on or after July 1, 2014.   Earlier application is permitted.
Amendments to IFRS 9, IFRS 7, and IAS 39		IFRS 9 Financial Instruments — Hedge Accounting and amendments to IFRS 9, IFRS 7, and IAS 39 (November 2013)		A revised version of IFRS 9 which:   •   Introduces a new chapter to IFRS 9 on hedge accounting, putting in place a new hedge accounting model that is designed to be more closely aligned with how entities undertake risk management activities when hedging financial and non-financial risk exposures   •   Permits an entity to apply only the requirements introduced in IFRS 9 (2010) for the presentation of gains and losses on financial liabilities designated as at fair value through profit or loss without applying the other requirements of IFRS 9, meaning the		The amendments to IFRS 9 have removed the previous mandatory effective date of January 1, 2015, but the standard is available for immediate application. The standard provides an accounting

 

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

Pronouncement		Title (Issue date)		Impact		Effective date
				portion of the change in fair value related to changes in the entity’s own credit risk can be presented in other comprehensive income rather than within profit or loss   •   Removes the mandatory effective date of IFRS 9 (2013), IFRS 9 (2010) and IFRS 9 (2009), leaving the effective date open pending the finalization of the impairment and classification and measurement requirements. Notwithstanding the removal of an effective date, each standard remains available for application.   The Company does not expect the amendments to have a material impact on amounts recognised in the financial statements.		policy choice for an entity to continue to apply hedge accounting (and hedge accounting only) under IAS 39 instead of IFRS 9 until the IASB completes its separate macro hedging project.
Amendments to IAS 36		Recoverable Amount Disclosures for Non-Financial Assets (May 2013)		Amends IAS 36 Impairment of Assets to reduce the circumstances in which the recoverable amount of assets or cash-generating units is required to be disclosed, clarify the disclosures required, and to introduce an explicit requirement to disclose the discount rate used in determining impairment (or reversals) where recoverable amount (based on fair value less costs of disposal) is determined using a present value technique.   The Company does not expect the amendments to significantly impact disclosures made in the financial statements. The Company intends to apply the changes from July 1, 2014.		Annual periods beginning on or after January 1, 2014.   Earlier application is permitted.
Amendments to IAS 32		Offsetting Financial Assets and Financial Liabilities (December 2011)		Amends IAS 32 Financial Instruments: Presentation to clarify certain aspects because of diversity in application of the requirements on offsetting, focused on four main areas:   •   the meaning of ‘currently has a legally enforceable right of set-off’   •   the application of simultaneous realization and settlement   •   the offsetting of collateral amounts   •   the unit of account for applying the offsetting requirements.   The Company does not expect the amendments to significantly impact disclosures made in the financial statements. The Company intends to apply the changes from July 1, 2014.		Annual periods beginning on or after January 1, 2014.

 

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Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

Pronouncement		Title (Issue date)		Impact		Effective date
Amendments to IFRS 9 and 7		Mandatory Effective Date and Transition Disclosures (December 2011)		The IASB published amendments to IFRS 9 Financial Instruments that defer the mandatory effective date from January 1, 2013, to January 1, 2015. The deferral will make it possible for all phases of the project to have the same mandatory effective date. The amendments also provide relief from the requirement to restate comparative financial statements for the effect of applying IFRS 9.   The Company does not expect the new amendments to have a material impact on amounts recognised in the financial statements or significantly change disclosures made in the financial statements. The Company does not intend to early adopt the amendments.		January 1, 2013 to January 1, 2015 (TBD).
IFRIC Interpretation 21		Levies		IFRIC 21 is an interpretation of IAS 37 Provisions, Contingent Liabilities and Contingent Assets. IAS 37 sets out criteria for the recognition of a liability, one of which is the requirement for the entity to have a present obligation as a result of a past event (known as an obligating event). The Interpretation clarifies that the obligating event that gives rise to a liability to pay a levy is the activity described in the relevant legislation that triggers the payment of the levy. The Interpretation includes guidance illustrating how the Interpretation should be applied.   The Company does not expect the interpretation to have a material impact on the financial statements. The Company intends to apply the changes from July 1, 2014.		Annual periods beginning on or after January 1, 2014.

(v) Early adoption of standards

The Group has not elected to apply any pronouncements before their operative date in the annual reporting period beginning July 1, 2014.

 

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Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

b. Principles of consolidation

(i) Subsidiaries

The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Mesoblast Limited as of June 30, 2014 and the results of all subsidiaries for the year then ended. Mesoblast Limited and its subsidiaries together are referred to in this financial report as the Group or the consolidated entity.

Subsidiaries are all entities over which the Group has the power to govern the financial and operating policies, generally accompanying a shareholding of more than one half of the voting rights. The existence and effect of potential voting rights that are currently exercisable or convertible are considered when assessing whether the Group controls another entity.

Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are de-consolidated from the date that control ceases.

The acquisition method of accounting is used to account for business combinations by the Group.

Intercompany transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group.

(ii) Employee share trust

The Group has formed a trust to administer the Group’s employee share scheme. This trust is consolidated, as the substance of the relationship is that the trust is controlled by the Group.

c. Segment reporting

The Group predominately operates in one segment as set out in Note 2.

d. Foreign currency translation

(i) Functional and presentation currency

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (the “functional currency”). The consolidated financial statements are presented in Australian dollars, which is Mesoblast Limited’s functional and presentation currency.

(ii) Translations and balances

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the transaction at period end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in net loss, except when they are deferred in equity as qualifying cash flow hedges and qualifying net investment hedges or attributable to part of the net investment in a foreign operation.

Non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair value through profit or loss are recognized in net loss as part of

 

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Index to Financial Statements

Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

the fair value gain or loss and translation differences on non-monetary assets such as equities classified as available for sale financial assets are recognized in other comprehensive income.

(iii) Group companies

The results and financial position of all the Group entities (none of which has the currency of a hyperinflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

 

•

assets and liabilities for the balance sheets presented are translated at the closing rate at the date of that balance sheets;

 

•

income and expenses for the statements of comprehensive income are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and

 

•

all resulting exchange differences are recognized in other comprehensive income.

(iv) Other

On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings and other financial instruments designated as hedges of such investments, are recognized in other comprehensive income. When a foreign operation is sold or any borrowings forming part of the net investment are repaid, the associated exchange differences are reclassified to net loss, as part of the gain or loss on sale.

Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities of the foreign entities and translated at the closing rate.

e. Revenue recognition

Revenue is measured at the fair value of the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected on behalf of third parties.

The Group recognizes revenue when the amount of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria have been met for each of the Group’s activities as described below. The Group bases its estimates on historical results, taking into consideration the type of customer, the type of transaction and the specifics of each arrangement.

Revenue is recognized for the major business activities as follows:

(i) Commercialization revenue

Development and commercialization revenue generally includes non-refundable up-front license and collaboration fees, milestone payments, the receipt of which is dependent upon the achievement of certain clinical, regulatory or commercial milestones, as well as royalties on product sales of licensed products, if and when such product sales occur, and revenue from the supply of products. Development and commercialization revenue was AUD$16,410 and AUD$18,260 for the years ended June 30, 2014 and 2013, respectively.

Where such arrangements can be divided into separately identifiable components (each component constituting a separate earnings process), the arrangement consideration is allocated to the different components

 

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21.	Summary of significant accounting policies (continued)

 

based on their relative fair values and recognized over the respective performance period in accordance with IAS 18 Revenue. Where the components of the arrangement cannot be divided into separate units, the individual deliverables are combined as a single unit of accounting and the total arrangement consideration is recognized over the estimated collaboration period. Such analysis requires considerable estimates and judgments to be made by the Group, including the relative fair values of the various elements included in such agreements and the estimated length of the respective performance periods.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, non-current portion.

Cephalon arrangement

In December 2010, the Group entered into a development and commercialization agreement (the “DCA”) with Cephalon, Inc., now a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd (collectively “Teva”), which allows for Teva to obtain world-wide rights to commercialize specific products based on the Group’s proprietary adult stem cell technology platform. As part of the DCA, the Group received USD 130,000 as a non-refundable up-front payment.

Further payments up to USD 1,700,000 may be received on achievement of certain regulatory milestones with respect to each product Teva may choose to capitalize. The milestones are based on approvals in specific indications of product candidates in certain major jurisdictions. The Group would also be entitled to receive future royalty payments for supply of commercialized product as escalating double digit percentage of net sales of certain product candidates. No such payments have been received.

The Group analyzed the arrangement to determine whether the components which include a license, participation in a joint steering committee, a development program, and manufacturing and supply services, can be separated or must be treated as a single transaction in assessing revenue recognition criteria.

As the Group’s obligations in relation to the steering committee and the development program are substantive and cannot be readily separated from the initial license transfer, the Group has not accounted for the license as a separate component. As the Group cannot readily estimate the costs required to complete the development program, due to significant uncertainties as development is the joint responsibility of the Group and Teva, revenue has been recognized on a straight line basis over the estimated development term of the main product, being MPC-150-IM. If the Group shortens or lengthens the development period then the amount of revenues recognized would change.

For the years ended June 30, 2014 and 2013, the Group recognized AUD16,410 and AUD18,260 of revenue respectively being the amortization of the initial payment over the estimated development program term. No revenue has been recognized for any future development milestones or royalties specified in the DCA as we cannot reliably estimate whether we would become entitled to such payments.

JCR arrangement

In October 2013, the Group acquired all of Osiris’ business and assets. These assets included assumption of a collaboration agreement with JCR, a research and development oriented pharmaceutical company in Japan.

Under the JCR Agreement, JCR is responsible for all development and manufacturing costs including sales and marketing expenses. With respect to the First JCR Field, the Group is entitled to payments when JCR reaches

 

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Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

certain development and commercial milestones and to escalating double-digit royalties. These royalties are subject to possible renegotiation downward in the event of competition from non-infringing products in Japan. With respect to the Second JCR Field, the Group is entitled to a double digit profit share. Revenue recognized under this model is limited to the amount of cash received or for which the Group is entitled, as JCR has the right to terminate the agreement at any time. Royalty revenue is recognized upon the sale of the related products provided the Group has no remaining performance obligations under the arrangement.

(ii) Interest revenue

Interest revenue is accrued on a time basis by reference to the principal outstanding and at the effective interest rate applicable, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to that asset’s net carrying amount.

(iii) Research and development tax incentive

The Australian Government replaced the research and development tax concession with the research and development tax incentive from July 1, 2011. The provisions provide refundable or non-refundable tax offsets.

The research and development tax incentive applies to expenditure incurred and the use of depreciating assets in an income year commencing on or after July 1, 2011. A refundable tax offset is available to eligible companies with an annual aggregate turnover of less than $20 million. Eligible companies can receive a refundable tax offset of 45% of their research and development spending. Up to June 30, 2013 the rate of the refundable tax offset is 45%, after that date the rate is 43.5%.

The Group’s research and development activities are eligible under an Australian government tax incentive for eligible expenditure from July 1, 2011. Management has assessed these activities and expenditure to determine which are likely to be eligible under the incentive scheme. At each period end management estimates and recognizes the refundable tax offset available to the Group based on available information at the time.

g. Research and development undertaken internally

Research expenditure is recognized as an expense as incurred. Costs incurred on development projects, which consist of preclinical and clinical trials, manufacturing development, and general research, are recognized as intangible assets when it is probable that the project will, after considering its commercial and technical feasibility, be completed and generate future economic benefits and its costs can be measured reliably.

The expenditure capitalized comprises all directly attributable costs, including costs of materials, services, direct labor and an appropriate proportion of overheads. Other development costs that do not meet these criteria are expensed as incurred. Development costs previously recognized as expenses, are not recognized as an asset in a subsequent period, and will remain expensed. Capitalized development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight-line basis over its useful life. The Group currently does not have any capitalized development costs.

h. Income tax

The income tax expense or benefit for the period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.

The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Group’s subsidiaries and associates operate and

 

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Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.

Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, the deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting, nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized or the deferred income tax liability is settled.

Deferred tax assets are recognized for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilize those temporary differences and losses.

Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount and tax bases of investments in controlled entities where the parent entity is able to control the timing of the reversal of the temporary differences and it is probable that the differences will not reverse in the foreseeable future.

Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities and when the deferred tax balances relate to the same taxation authority. Current tax assets and tax liabilities are offset where the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously.

Current and deferred tax is recognized in net loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.

i. Investments and other financial assets

Classification

The Group classifies its financial assets in the following categories: financial assets at fair value through profit or loss, loans and receivables, held-to-maturity investments and available-for-sale financial assets. The classification depends on the purpose for which the investments were acquired. Management determines the classification of its investments at initial recognition and, in the case of assets classified as held-to-maturity, re-evaluates this designation at the end of each reporting date.

(i) Financial assets and liabilities at fair value through profit or loss if it is either:

(a) classified as held for trading (acquired or incurred principally for the purpose of selling or repurchasing in the near future), or

(b) upon initial recognition designated as at fair value through profit or loss.

(ii) Loans and receivables

Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for those with maturities greater than 12 months after the reporting period which are classified as non-current assets. Loans and receivables are included in trade and other receivables (Note 5(b)) in the balance sheet.

(iii) Held-to-maturity investments

 

 

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21.	Summary of significant accounting policies (continued)

 

Held-to-maturity investments are non-derivative financial assets quoted in an active market with fixed or determinable payments and fixed maturities that the Group’s management has the positive intention and ability to hold to maturity. If the Group were to sell other than an insignificant amount of held-to maturity financial assets, the whole category would be tainted and reclassified as available-for-sale. Held-to-maturity financial assets are included in non-current assets, except for those with maturities less than 12 months from the end of the reporting period, which would be classified as current assets.

j. Leases

Leases in which a significant portion of the risks and rewards of ownership are not transferred to the Group as lessee are classified as operating leases (Note 15). Payments made under operating leases (net of any incentives received from the lessor) are charged to net loss on a straight-line basis over the period of the lease.

k. Business combinations

The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments or other assets are acquired. The consideration transferred for the acquisition of a subsidiary comprises the fair values of the assets transferred, the liabilities incurred and the equity interests issued by the Group. The consideration transferred also includes the fair value of any asset or liability resulting from a contingent consideration arrangement and the fair value of any pre-existing equity interest in the subsidiary. Acquisition-related costs are expensed as incurred. Identifiable assets acquired and liabilities and contingent liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date. On an acquisition-by-acquisition basis, the Group recognizes any non-controlling interest in the acquiree either at fair value or at the non-controlling interest’s proportionate share of the acquiree’s net identifiable assets.

The excess of the consideration transferred and the amount of any non-controlling interest in the acquiree over the fair value of the net identifiable assets acquired is recorded as goodwill. If those amounts are less than the fair value of the net identifiable assets of the subsidiary acquired and the measurement of all amounts has been reviewed, the difference is recognized directly in net loss as a bargain purchase.

Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate used is the entity’s incremental borrowing rate, being the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and conditions.

Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are subsequently remeasured to fair value with changes in fair value recognized in profit or loss.

l. Impairment of assets

Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested annually for impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are

 

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21.	Summary of significant accounting policies (continued)

 

separately identifiable cash inflows which are largely independent of the cash inflows from other assets or groups of assets (cash-generating units). Non-financial assets (other than goodwill) that have suffered impairment are reviewed for possible reversal of the impairment at the end of each reporting period.

m. Cash and cash equivalents

For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term and highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

n. Trade and other receivables

Trade receivables and other receivables represent the principal amounts due at balance date less, where applicable, any provision for doubtful debts. An estimate for doubtful debts is made when collection of the full amount is no longer probable and there is objective evidence of impairment. Debts which are known to be uncollectible are written off in the statement of comprehensive income. All trade receivables and other receivables are recognized at the value of the amounts receivable, as they are due for settlement within 60 days and therefore do not require remeasurement.

o. Derivatives

Derivatives are initially recognized at fair value on the date a derivative contract is entered into and are subsequently remeasured to their fair value at the end of each reporting period.

(i) Derivatives that do not qualify for hedge accounting

Certain derivative instruments do not qualify for hedge accounting. Changes in the fair value of any derivative instrument that does not qualify for hedge accounting are recognized immediately in profit or loss and are included in other income or other expenses.

p. Property, plant and equipment

Plant and equipment are stated at cost less accumulated depreciation and impairment. Cost includes expenditure that is directly attributable to the acquisition of the item.

Property, plant and equipment, other than freehold land, are depreciated over their estimated useful lives using the straight line method (see Note 6(a)).

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period.

An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount.

Gains and losses on disposal of plant and equipment are taken into account in determining the profit for the year.

q. Intangible assets

(i) Goodwill

Goodwill is measured as described in Note 21(k) — Business combinations. Goodwill on acquisition of subsidiaries is included in intangible assets (Note 6(b)). Goodwill is not amortized but it is tested for impairment

 

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21.	Summary of significant accounting policies (continued)

 

annually or more frequently if events or changes in circumstances indicate that it might be impaired, and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold.

Goodwill is allocated to cash generating units for the purpose of impairment testing. The allocation is made to those cash generating units or groups of cash generating units that are expected to benefit from the business combination in which the goodwill arose.

(ii) Trademarks and licenses

Trademarks and licenses have a finite useful life and are carried at cost less accumulated amortization and impairment losses.

(iii) In-process research and development acquired

In-process research and development that has been acquired as part of a business acquisition is considered to be an indefinite life intangible asset on the basis that it is incomplete and cannot be used in its current form. Indefinite life intangible assets are not amortized but rather are tested for impairment annually at May 31 of each year, or whenever events or circumstances present an indication of impairment.

In-process research and development will continue to be tested for impairment until the related research and development efforts are either completed or abandoned. Upon completion of the related research and development efforts, management determines the remaining useful life of the intangible assets and amortizes them accordingly. In order for management to determine the remaining useful life of the asset, management would consider the expected flow of future economic benefits to the entity with reference to the product life cycle, competitive landscape, obsolescence, market demand, any remaining patent useful life and various other relevant factors.

In the case of abandonment, the related research and development efforts are considered impaired and the asset is fully expensed.

r. Trade and other payables

Payables represent the principal amounts outstanding at balance date plus, where applicable, any accrued interest. Liabilities for payables and other amounts are carried at cost which approximates fair value of the consideration to be paid in the future for goods and services received, whether or not billed. The amounts are unsecured and are usually paid within 30 to 60 days of recognition.

s. Provisions

Provisions are recognized when the Group has a present legal obligation as a result of a past event, it is probable that the Group will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation.

Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present obligation at the end of the reporting period. The discount rate used to determine the present value is a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the liability. The increase in the provision due to the passage of time is recognized as interest expense.

 

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21.	Summary of significant accounting policies (continued)

 

Provisions are recorded on acquisition of a subsidiary, to the extent they relate to a subsidiary’s contingent liabilities, if it relates to a past event, regardless of whether it is probable the amount will be paid.

t. Employee benefits

A liability is recognized for benefits accruing to employees in respect of wages and salaries, bonuses, annual leave and long service leave.

Liabilities recognized in respect of employee benefits which are expected to be settled within 12 months after the end of the period in which the employees render the related services are measured at their nominal values using the remuneration rates expected to apply at the time of settlement.

Liabilities recognized in respect of employee benefits which are not expected to be settled within 12 months after the end of the period in which the employees render the related services are measured as the present value of the estimated future cash outflows to be made by the Group in respect of services provided by employees up to reporting date.

u. Share-based payments

Share-based payments are provided to employees, directors and consultants via the ESOP and the LFSP. The terms and conditions of the LFSP are in substance the same as the employee share options and therefore they are accounted for on the same basis.

Equity-settled share-based payments with employees and others providing similar services are measured at the fair value of the equity instrument at grant date. Fair value is measured using the Black-Scholes model. The expected life used in the model has been adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions, and behavioral considerations. It does not make any allowance for the impact of any service and non-market performance vesting conditions. Further details on how the fair value of equity-settled share-based transactions has been determined can be found in Note 18.

The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straight-line basis over the vesting period, based on management’s estimate of shares that will eventually vest, with a corresponding increase in equity. At the end of each period, the entity revises its estimates of the number of shared-based payments that are expected to vest based on the non-market vesting conditions. It recognizes the impact of the revision to original estimates, if any, in net loss, with a corresponding adjustment to equity.

v. Contributed equity

The Company’s ordinary shares are classified as equity.

Transaction costs arising on the issue of equity instruments are recognized directly in equity as a reduction of the proceeds of the equity instruments to which the costs relate. Transaction costs are the costs that are incurred directly in connection with the issue of those equity instruments and which would not have been incurred had those instruments not been issued.

w. Loss per share

(i) Basic losses per share

Basic losses per share is calculated by dividing:

 

•

the loss attributable to equity holders of the Group, excluding any costs of servicing equity other than ordinary shares;

 

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Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

21.	Summary of significant accounting policies (continued)

 

•

by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the year.

(ii) Diluted losses per share

Diluted losses per share adjusts the figures used in the determination of basic losses per share to take into account:

 

•

the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares; and

 

•

the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

For all periods presented, diluted losses per share is equivalent to basic loss per share as the potentially dilutive securities are excluded from the computation of diluted losses per share because the effect is anti-dilutive.

x. Goods and services tax (“GST”)

Revenues, expenses and assets are recognized net of the amount of GST except where the GST incurred on a purchase of goods and services is not recoverable from the taxation authority, in which case the GST is recognized as part of the cost of acquisition of the asset or as part of the expense.

Receivables and payables are stated with the amount of GST included. The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables in the Balance Sheet.

Cash flows are included in the statement of cash flow on a gross basis. The GST component of cash flows arising from investing and financing activities, which is recoverable from, or payable to, the taxation authority, are classified as operating cash flows.

y. Comparative figures

Comparatives have been reclassified where necessary so as to be consistent with the figures presented in the current year.

z. Rounding of amounts

Amounts in the financial statements have been rounded off to the nearest thousand dollars, or in certain cases, the nearest dollar.

 

22.	Changes in accounting policies

As explained in Note 21(a) above, the Group has adopted a number of new or revised accounting standards this year that have resulted in changes in accounting policies. The changes have not resulted in amendments to the amount recognized in the financial statements in the current year.

a. Consolidated financial statements

IFRS 10 Consolidated Financial Statements was issued in August 2011 and replaces the guidance on control and consolidation in IAS 27 Consolidated and Separate Financial Statements and in Interpretation 112 Consolidation — Special Purpose Entities.

 

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Mesoblast Limited

Notes to Consolidated Financial Statements (continued)

 

22.	Changes in accounting policies (continued)

 

The Group has reviewed its investments in other entities to assess whether the conclusion to consolidate is different under IFRS 10 than under IAS 27. No differences were found and therefore no adjustments to any of the carrying amounts in the financial statements are required as a result of the adoption of IFRS 10.

b. Fair value measurement

IFRS 13 Fair Value Measurement aims to improve consistency and reduce complexity by providing a precise definition of fair value and a single source of fair value measurement and disclosure requirements for use across Australian Accounting Standards. The standard does not extend the use of fair value accounting but provides guidance on how it should be applied where its use is already required or permitted by other Australian Accounting Standards.

Previously the fair value of financial liabilities (including derivatives) was measured on the basis that the financial liability would be settled or extinguished with the counterparty. The adoption of IFRS 13 has clarified that fair value is an exit price notion, and as such, the fair value of financial liabilities should be determined based on a transfer value to a third party market participant. As a result of this change, the fair value of derivative liabilities changed on transition to IFRS 13, due to incorporating own credit risk into the valuation.

As required under IFRS 13, the change to fair value measurements on adoption of the standard is applied prospectively, in the same way as a change in an accounting estimate. As a consequence, no balances from the current year and previous year have been adjusted due to the change in the standard.

c. Employee benefits

The adoption of the revised IAS 19 Employee Benefits has not changed the accounting for the Group’s annual leave obligations.

 

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             American Depositary Shares

representing ordinary shares

 

Mesoblast Limited

 

 

Prospectus

 

 

 

J.P. Morgan		Credit Suisse
Piper Jaffray

 

 

                    , 2014

You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with information that is different from that contained in this prospectus. We are offering to sell, and seeking offers to buy, ADSs only in jurisdictions where offers and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our ADSs.

No action is being taken in any jurisdiction outside the United States to permit a public offering of the ADSs or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable that jurisdiction.

Until                     , 2015, (the 25^th day after the date of this prospectus) all dealers that buy, sell or trade in our ADSs, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to their unsold allotments or subscriptions.

 

 

 

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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 6.

Indemnification of directors and officers

Australian law. Australian law provides that a company or a related body corporate of the company may provide for indemnification of officers and directors, except to the extent of any of the following liabilities incurred as an officer or director of the company:

 

•

a liability owed to the company or a related body corporate of the company;

 

•

a liability for a pecuniary penalty order made under section 1317G or a compensation order under section 1317H, 1317HA or 1317HB of the Australian Corporations Act 2001;

 

•

a liability that is owed to someone other than the company or a related body corporate of the company and did not arise out of conduct in good faith;

 

•

a liability to pay a pecuniary penalty for a contravention of a provision of Part IV or Part V of the Australian Competition and Consumer Act 2010 which deal respectively with certain restrictive traded practices and carbon price reduction obligations;

 

•

a liability to pay a pecuniary penalty for a contravention of provisions of the Australian Consumer Law dealing with:

 

•

unconscionable conduct;

 

•

unfair practices;

 

•

display notices;

 

•

unsolicited consumer agreements;

 

•

lay-by agreements;

 

•

proof of transaction and itemized bills;

 

•

prescribed requirements for warranties and repairers;

 

•

safety of consumer goods and product related services;

 

•

information standards;

 

•

substantiation notices; and

 

•

attempting, abetting, inducing, conspiring with others or being involved in a contravention of those provisions

 

•

liability to pay a pecuniary penalty for a contravention of provisions of the Australian Securities and Investments Commission Act 2001 dealing with:

 

•

unconscionable conduct in relation to financial services; and

 

•

certain consumer protection provisions in connection with financial services; or

 

•

legal costs incurred in defending an action for a liability incurred as an officer or director of the company if the costs are incurred:

 

•

in defending or resisting proceedings in which the officer or director is found to have a liability for which they cannot be indemnified as set out above;

 

•

in defending or resisting criminal proceedings in which the officer or director is found guilty;

 

•

in defending or resisting proceedings brought by the Australian Securities & Investments Commission or a liquidator for a court order if the grounds for making the order are found by the

 

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court to have been established (except costs incurred in responding to actions taken by the Australian Securities & Investments Commission or a liquidator as part of an investigation before commencing proceedings for a court order); and

 

•

in connection with proceedings for relief to the officer or a director under the Corporations Act, in which the court denies the relief.

Constitution. Our Constitution provides, to the extent permitted by the law and the Corporations Act, for the indemnification of every person who is or has been an officer or a director of the company against liability incurred by that person as an officer or director. This includes any liability incurred by that person in their capacity as an officer or director of any of our subsidiaries (other than to us or a related body corporate that does not arise out of conduct involving a lack of good faith or conduct known to the other person to be unlawful. The indemnity also applies to the extent permitted by the Corporations Act to costs and expenses incurred by the person in defending proceedings, whether civil or criminal, in which the courts grant relief to the person under the Corporations Act.

Indemnification Agreements. Pursuant to Deeds of Access, Insurance and Indemnity, the form of which is filed as Exhibit 10.5 to this registration statement, we have agreed to indemnify our directors and certain officers against certain liabilities and expenses incurred by such persons in connection with claims made by reason of their being such a director or officer.

SEC Position. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, or the Securities Act, may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

Pursuant to the underwriting agreement for this offering, the form of which is filed as Exhibit 1.1 to this registration statement, the underwriters will agree to indemnify our directors and officers and persons controlling us, within the meaning of the Securities Act, against certain liabilities that might arise out of or are based upon certain information furnished to us by any such underwriter.

 

Item 7.

Recent sales of unregistered securities

In the past three years, we have issued and sold to third parties the securities listed below without registering the securities under the Securities Act of 1933, as amended. None of these transactions involved any public offering. All our securities were sold through private placement either (i) outside the United States or (ii) in the United States to a limited number of investors in transactions not involving any public offering. As discussed below, we believe that each issuance of these securities was exempt from, or not subject to, registration under the Securities Act.

 

•

On March 14, 2013, we issued 26,970,979 ordinary shares to institutional investors in a private placement in Australia and certain other countries. Consideration per share was A$6.30, for aggregate amount of approximately A$170 million. This issuance was exempt from registration under the Securities Act in reliance on Regulation S.

 

•

On October 29, 2013, we issued 70,164 ordinary shares as consideration for the acquisition of certain assets from Provasculon, Inc. Consideration per share was A$5.96, for aggregate amount of approximately A$0.4 million. This issuance was exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act and Regulation S.

 

•

On December 18, 2013, we issued 2,948,729 ordinary shares to Osiris Therapeutics, Inc. as consideration for taking delivery of the assigned and other assets pursuant to the purchase agreement for the acquisition of the entire culture expanded mesenchymal stem cell business of Osiris

 

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Therapeutics, Inc. Consideration per share was A$5.69, for aggregate amount of approximately A$17 million. This issuance was exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act and Regulation S.

In addition, we issued the following fully-paid ordinary shares upon exercise of employee options over the past three years, ranging from A$4.43 to A$8.48 per share:

 

•

987,300 ordinary shares in the year ended June 30, 2014;

 

•

2,552,816 ordinary shares in the year ended June 30, 2013; and

 

•

3,279,848 ordinary shares in the year ended June 30, 2012.

We believe that the issuance of these securities were exempt from registration under the Securities Act in reliance upon Regulation S or Rule 701 of the Securities Act as transactions pursuant to written compensatory plans or pursuant to a written contract relating to compensation. No underwriters were employed in connection with the foregoing option grants and restricted share unit awards.

 

Item 8.

Exhibits and financial statement schedules

(a) Exhibits

See exhibit index of this registration statement.

(b) Financial statement schedules

All schedules have been omitted because the information required to be presented in them is not applicable or is shown in the consolidated financial statements or related notes.

 

Item 9.

Undertakings

The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described in Item 6, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

1. For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

2. For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in         on this     day of              2014.

 

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below constitutes and appoints Brian Jamieson, Dr. Silviu Itescu, and Peter Howard, and each of them, his or her true and lawful attorneys in fact and agents with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post effective amendments) to this registration statement, and to sign any registration statement for the same offering covered by this registration statement that is to be effective on filing pursuant to Rule 462(b) promulgated under the Securities Act of 1933, as amended, and all post effective amendments thereto, and to file the same, with all exhibits thereto and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys in fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys in fact and agents or any of them, or his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

 

Signature		Title		Date
Brian Jamieson		Chairman of the Board of Directors		, 2014
Dr. Silviu Itescu		Executive Director and Chief Executive Officer (Principal Executive Officer)		, 2014
Paul Hodgkinson		Chief Financial Officer (Principal Financial and Accounting Officer)		, 2014
William Burns		Director		, 2014
Donal O’Dwyer		Director		, 2014
Eric Rose		Director		, 2014
Ben-Zion Weiner		Director		, 2014
Michael Spooner		Director		, 2014

 

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SIGNATURE OF AUTHORIZED REPRESENTATIVE OF THE REGISTRANT

Pursuant to the Securities Act, the undersigned, the duly authorized representative in the United States of Mesoblast, Inc, has signed this registration statement in                  on             , 2014.

 

 

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EXHIBIT INDEX

 

Exhibit Number		Description
1.1*		Form of Underwriting Agreement.
3.1**		Certificate of Registration of Mesoblast Limited.
3.2**		Constitution of Mesoblast Limited.
4.1*		Form of Deposit Agreement between Mesoblast Limited and JPMorgan Chase Bank, N.A., as depositary, and Owners and Holders of the American Depositary Shares.
4.2*		Form of American Depositary Receipt evidencing American Depositary Shares (included in Exhibit 4.1).
5.1*		Opinion of Minter Ellison.
10.1†**		Development and Commercialization Agreement by and between Angioblast Systems, Inc. and Cephalon, Inc., dated December 7, 2010.
10.2†**		Letter Agreement pertaining to the Development and Commercialization Agreement by and between Angioblast Systems, Inc. and Cephalon, Inc., dated August 10, 2011.
10.3†**		Amendment to Development and Commercialization Agreement by and between Mesoblast, Inc. as successor to Angioblast Systems, Inc. and Cephalon, Inc., dated September 24, 2013.
10.4**		Clinical Trial Agreement by and between The National Heart, Lung, and Blood Institute and Mesoblast, Inc. dated July 28, 2014.
10.5**		Subscription Deed by and between Mesoblast Limited and Cephalon International Holdings, Inc., dated December 2010.
10.6†**		Manufacturing Services Agreement by and between Mesoblast Limited and Lonza Walkersville, Inc. and Lonza Bioscience Singapore Pte. Ltd., dated September 20, 2011.
10.7**		Purchase Agreement by and between Mesoblast International Sàrl and Osiris Therapeutics, Inc., dated October 10, 2013.
10.8†**		License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co., dated August 26, 2003.
10.9†**		Amendment 1 to License Agreement by and between Osiris Acquisition II, Inc. and JCR Pharmaceuticals Co. Ltd., dated June 27, 2005.
10.10**		Technology Transfer and License Agreement by and between Case Western Reserve University and Osiris Therapeutics, Inc., dated January 1, 1993.
10.11**		Amendment No. 1 to the Technology Transfer and License Agreement by and between Case Western Reserve University and Osiris Therapeutics, Inc., dated November 3, 1993.
10.12**		Amendment No. 2 to the Technology Transfer and License Agreement by and between Case Western Reserve University and Osiris Therapeutics, Inc., dated October 18, 1999.
10.13**		Amendment No. 3 to the Technology Transfer and License Agreement by and between Case Western Reserve University and Osiris Therapeutics, Inc., dated October 27, 2003.
10.14**		Intellectual Property Assignment Deed by and between Mesoblast Limited and Medvet Science Pty Ltd, dated October 4, 2004.
10.15**		Deed of Option and Assignment and Termination, by and between Mesoblast Limited and Peter MacCallum Cancer Institute, dated August 10, 2010.
10.16*#		Loan Funded Share Plan Rules, as amended, and form of loan agreement thereunder.

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Exhibit Number		Description
10.17*#		Employee Share Option Plan Rules, and form of option agreement thereunder.
10.18*#		Employment Agreement, dated August 8, 2014, by and between Mesoblast Limited and Silviu Itescu.
10.19**		Sub-Sublease, by and between Mesoblast Limited and Carlo Pazolini (USA), LLC, dated September 23, 2013.
10.20**		Sublease, by and between Mesoblast Limited and CIT Group Inc., dated September 27, 2011.
10.21**		Sublease, by and between Mesoblast Limited and Collins Place Pty Ltd, AMP Capital Investors Limited, and Australia and New Zealand Banking Group Limited, dated April 21, 2014.
21.1**		List of Subsidiaries of Mesoblast Limited.
23.1*		Consent of Pricewaterhousecoopers, Independent Registered Public Accounting Firm.
23.2*		Consent of Minter Ellison (included in Exhibit 5.1).
24.1*		Powers of Attorney (included in page II-4 to the original filing of this registration statement).

 

*	To be filed in a subsequent amendment

**	Previously filed

†	Confidential treatment will be requested with respect to certain portions of this exhibit. Omitted portions will be filed separately with the Securities and Exchange Commission.

#	Indicates management contract or compensatory plan.