Washington, D.C. 20549

 Form 6-K

Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934

For the month of May 2018

Commission File Number 001-37626

Mesoblast Limited

(Exact name of Registrant as specified in its charter)

Not Applicable

(Translation of Registrant’s name into English)

Australia
(Jurisdiction of incorporation or organization)

 

Silviu Itescu

Chief Executive Officer and Executive Director

Level 38

55 Collins Street

Melbourne 3000

Australia

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:

Form 20-F ☑ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes ☐ No ☑

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes ☐ No ☑

 

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INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K

On May 31, 2018, Mesoblast Limited filed with the Australian Securities Exchange new release announcements and an investor presentation, which are attached hereto as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, and are incorporated herein by reference.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.

Dated: May 31, 2018

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

 

FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS FOR THE

THIRD QUARTER ENDED MARCH 31, 2018

 

Melbourne, Australia; May 31, 2018; and New York, USA, May 30, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced strong financial results for the nine months ended March 31, 2018 and provided operational highlights for the third quarter ended March 31, 2018.  

Key financial results for the nine months ended March 31, 2018

Recent operational highlights and anticipated upcoming milestones

MSC-100-IV for acute Graft Versus Host Disease (aGVHD):

MPC-150-IM for Advanced and End-Stage Heart Failure:

 

 

 

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MPC-06-ID for Chronic Low Back Pain:

 

Continue to access non-dilutive capital for commercialization of MSC-100-IV (remestemcel-L).

 

Establish U.S., global and regional commercial partnerships for high volume products.

 

Financial Results for the Three Months Ended March 31, 2018 (third quarter) (in U.S. Dollars)

Revenues were US$1.1 million in the third quarter of FY2018 compared with US$0.9 million in the third quarter of FY2017, an increase of US$0.2 million (19%).

There was an increase of US$11.4 million (116%) in the loss after income tax for the third quarter of FY2018, compared with the third quarter of FY2017.

 

The main items which impacted the loss after income tax movement were:

 

 

 

 

The overall increase in loss after income tax also includes movements in other items which did not impact current cash reserves, such as: fair value remeasurement of contingent consideration, and foreign exchange movements within other operating income and expenses.

 

A non-cash income tax benefit of US$3.4 million was recognized in the third quarter of FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, compared to

US$3.1 million in the third quarter of FY2017.

 

The net loss attributable to ordinary shareholders was US$21.1 million, or 4.47 cents loss per share, for the third quarter of FY2018, compared with US$9.8 million, or 2.43 cents loss per share, for the third quarter of FY2017.

 

At March 31, 2018, the Company had cash reserves of US$59.5 million.

 

 

 

 

 

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In March 2018, Mesoblast established a non-dilutive, four-year credit facility with Hercules Capital for up to US$75 million with US$35.0 million drawn at closing. An additional US$15.0 million may be drawn on or before Q4 CY2018, and a further US$25.0 million may be drawn on or before Q3 CY2019, in each case as certain milestones are met.

 

Mesoblast retains an equity facility for up to A$120 million/US$90 million, to be used at its discretion over the next 15 months to provide additional funds as required.

 

Financial Results for the Nine Months Ended March 31, 2018 (the nine months) (in U.S. Dollars)

Revenues were US$15.6 million in the nine months of FY2018 compared with US$1.8 million in the nine months of FY2017, an increase of US$13.8 million.

There was a decrease of US$35.2 million (71%) in the loss after income tax for the nine months of FY2018, compared with the nine months of FY2017.

 

The main items which impacted the loss after income tax movement were:

 

 

 

 

The overall decrease in loss after income tax also includes movements in other items which did not impact current cash reserves, such as: fair value remeasurement of contingent consideration, and foreign exchange movements within other operating income and expenses.

 

A non-cash income tax benefit of US$29.7 million was recognized in the nine months of FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, primarily due to a revaluation of our deferred tax assets and liabilities recognized as a result of changes in tax rates. On December 22, 2017, the United States signed into law the Tax Cuts and Jobs Act (the Tax Act), which changed many aspects of United States corporate income taxation, including a reduction in the corporate income tax rate from 35% to 21%.

 

 

 

 

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A non-cash income tax benefit of US$9.3 million was recognized in the nine months of FY2017 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period.

 

The net loss attributable to ordinary shareholders was US$14.5 million, or 3.12 cents loss per share, for the nine months of FY2018, compared with US$49.6 million, or 12.75 cents loss per share, for the nine months of FY2017.

 

Conference Call Details

 

There will be a webcast today on the financial results beginning at 6:30 pm ET on Wednesday, May 30, 2018; 8:30 am Thursday, May 31, 2018 AEST.  

 

The live webcast can be accessed via http://webcasting.brrmedia.com/broadcast/5b0b3e055f522f0d08dbbb1c

 

To access the call only, dial 1 855 881 1339 (U.S.), 1 800 558 698 (toll-free Australia) or +61 2 9007 3187 (outside of the U.S. and Australia). The conference identification code is 461736.

The archived webcast will be available on the Investor page of the Company’s website – www.mesoblast.com

 

Forward-Looking Statements

This press release 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. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s 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 Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact:

 

 

 

             

 

 

 

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Consolidated Income Statement

 

 

 

 

Consolidated Statement of Comprehensive Income

 

 

 

 

 

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Consolidated Statement of Balance Sheet

 

 

 

 

 

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Consolidated Statement of Cash Flows

 

 

 

 

 

 

Exhibit 99.2

 

 

 

MESOBLAST APPOINTS NEW CHIEF FINANCIAL OFFICER

 

Melbourne, Australia; May 31, 2018 and New York; USA; May 30, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced the appointment of Josh Muntner as its new Chief Financial Officer, based in New York.

 

Chief Executive Dr Silviu Itescu welcomed the appointment of Mr Muntner stating he would bring substantial U.S. corporate finance, transactional and capital markets experience to Mesoblast.

 

Mr Muntner has accrued 20 years’ experience in healthcare investment banking and corporate finance, and has been involved in a wide range of healthcare-related transactions with approximately $11 billion in value. Most recently, he led corporate development and financial transactions at Nasdaq-listed biotechnology company, ContraFect Corporation. Previously, Mr Muntner served as Managing Director and Co-Head of Healthcare Investment Banking at Janney Montgomery Scott, and spent nine years at Oppenheimer & Co. and its U.S. predecessor, CIBC World Markets. He also served as an investment banker at Prudential Securities.

 

Mr Muntner said he was delighted to be joining Mesoblast as it transitions to a commercial organization. “Mesoblast is a dynamic company that is well positioned to capitalize on its portfolio of cell therapy product candidates with the potential to bring about paradigm-changing clinical outcomes.”

 

The Mesoblast Board and management thanked outgoing Chief Financial Officer Paul Hodgkinson for his significant contribution over the past four years and wished him well in his future endeavors.

 

Ignite Partners advised Mesoblast on the appointment of Mr Muntner.

 

About Mesoblast

Mesoblast Limited (ASX: MSB; Nasdaq:MESO) is a global leader in developing innovative cell-based medicines. Through a proprietary process, Mesoblast selects highly purified mesenchymal lineage precursor and stem cells from the bone marrow of healthy adults, and creates master cell banks which can be industrially expanded to produce thousands of doses from each donor that meet stringent release criteria, have lot to lot consistency, and can be used off the shelf without the need for tissue matching.

The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates are being evaluated in their ability to target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

 

Forward-Looking Statements

This announcement 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. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product

 

 

 

 

 

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candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s 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 Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact:

 

Julie Meldrum                                                   Schond Greenway

Corporate Communications                                Investor Relations

T: +61 3 9639 6036                                          T: +1 212 880 2060

E: julie.meldrum@mesoblast.com                       E: schond.greenway@mesoblast.com 

 

 

 

 

Financial Results for the Quarter Ended March 31, 2018 May 2018 Nasdaq: MESO ASX:MSB Exhibit 99.3

Mesoblast is committed to bringing to market disruptive cellular medicines to treat serious and life-threatening illnesses.

Premier global cellular medicines company Multiple Revenue Generating Products & Phase 3 Assets Industrial Scale Manufacturing Disruptive Technology Platform1 Immuno-selected, culture expanded cellular medicines Well characterized mechanisms of action targeting multiple pathways Extensive, robust IP estate Targeting the most severe disease states refractory to conventional therapies Unique cell properties enable large scale expansion and use in unrelated recipients Proprietary media formulations meet industrial scale needs ‘Off the shelf’ delineated products with batch to batch consistency and reproducibility 2 approved products commercialized by licensees in Japan2 and Europe3 3 product candidates in U.S. Phase 3 Major near-term data readouts Revenue from approved and late-stage assets will help fund deep product pipeline Mesenchymal precursor cells (MPCs) and their culture-expanded progeny mesenchymal stem cells (MSCs) TEMCELL® Hs Inj licensee JCR Pharmaceuticals Co., Ltd. received the first full PMDA approval for an allogeneic cellular medicine in Japan Alofisel ® licensee TiGenix NV/Takeda received first central marketing authorization (MA) approval from the European Commission (EC) for an allogeneic stem cell therapy

IN DEVELOPMENT PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MSC (Bone Marrow) TEMCELL® HS Inj1 Acute GVHD Japan Only MSC (Adipose) Alofisel2 Perianal Fistula World Wide MARKETED Clinical pipeline and products commercialized by licensees Mesoblast receives royalty income on sales of TEMCELL® in Japan by its licensee JCR Pharmaceuticals Co Ltd Mesoblast will receive royalty income on world wide sales of Alofisel® in the local treatment of perianal fistulae by its licensee TiGenix NV/Takeda Pharmaceuticals Study funded by the United States National Institutes of Health (NIH) and the Canadian Health Research Institute; conducted by the NIH-funded Cardiothoracic Surgical Trials Network This chart is figurative and does not purport to show individual trial progress within a clinical program PLATFORM PRODUCT CANDIDATE THERAPEUTIC AREA PRE-CLINICAL / PRE- IND PHASE 2 PHASE 3 COMMERCIAL RIGHTS MSC MSC-100-IV Acute GVHD MPC MPC-150-IM Advanced HF (Class II & III) End-Stage HF (Class III & IV)3 MPC MPC-06-ID Chronic Low Back Pain MPC MPC-300-IV Rheumatoid Arthritis Diabetic Nephropathy Includes MSC-100-IV (Crohn’s disease – biologic refractory), MPC-25-IC (Acute Cardiac Ischemia), MPC-25-Osteo (Spinal Fusion) and MPC-75-IA (Knee Osteoarthritis) TIER 1 TIER 2

Financials

March 31, 2018 June 30, 2017 $Change Cash on Hand 59.5 45.7 13.8 March 31, 2018 March 31, 2017 $Change %Change Operating net cash (outflows)/inflows (54.8) (72.0) 17.2 24% Investing net cash (outflows)/inflows (0.7) 0.1 (0.8) NM Financing net cash inflows 69.6 59.9 9.7 16% Forex (0.3) 0.2 (0.5) NM Net increase/(decrease) in cash 13.8 (11.8) 25.6 NM Q3 FY18 Cash position and cash flows for the nine months ending March 31, 2018 (US$m) Operating net cash flows reduced by 24% for the 9 months ended March 31, 2018 versus the prior period. US$59.5 million cash on hand includes a US$35 million draw down of a non-dilutive, four-year, US$75 million credit facility with Hercules Capital, Inc. The facility has an interest only period up to 30 months upon the satisfaction of certain conditions, and no warrants

Q3 FY18 Profit and Loss for the nine months ending March 31, 2018 (US$m) For the nine months ending March 31, 2018 March 31, 2017 $Change % Revenue 15.6 1.8 13.8 NM Research and Development (48.4) (43.0) (5.4) (13%) Manufacturing Commercialization (3.4) (10.9) 7.5 69% Management & Administration (16.7) (15.9) (0.8) (5%) Contingent Consideration 7.9 7.8 0.1 1% Other Operating Income & Expenses 1.2 1.2 - 0% Finance Costs (0.4) - (0.4) NM Loss Before Tax (44.2) (59.0) 14.8 25% Income Tax Benefit 29.7 9.3 20.4 NM Loss After Tax (14.5) (49.7) 35.2 71% Revenue increased by US$13.8 million vs the comparative period in FY17 due to: 162% increase in commercialization revenue (US$1.6 million) from royalty income on sales of TEMCELL® Hs. Inj. An upfront payment of US$5.9 million (€5.0 million) received upon execution of our patent license agreement with TiGenix in December 2017 A future payment from TiGenix of US$5.9 million (€5.0 million), due by December 2018, was recognized US$0.5 million sales milestone recognized on sales of TEMCELL® Hs. Inj.

Q3 FY18 Profit and Loss for the nine months ending March 31, 2018 (US$m) For the nine months ending March 31, 2018 March 31, 2017 $Change % Revenue 15.6 1.8 13.8 NM Research and Development (48.4) (43.0) (5.4) (13%) Manufacturing Commercialization (3.4) (10.9) 7.5 69% Management & Administration (16.7) (15.9) (0.8) (5%) Contingent Consideration 7.9 7.8 0.1 1% Other Operating Income & Expenses 1.2 1.2 - 0% Finance Costs (0.4) - (0.4) NM Loss Before Tax (44.2) (59.0) 14.8 25% Income Tax Benefit 29.7 9.3 20.4 NM Loss After Tax (14.5) (49.7) 35.2 71% Loss after tax reduced by US$35.2 million (71%) for the 9 months ended March 31, 2018 versus the comparative period of FY17 due to: Reduced spend on manufacturing by 69% due to sufficient clinical product having been manufactured in the comparative period of FY17 for ongoing Phase 3 trials A non-cash income tax benefit recognized due to revaluation of deferred tax assets and liabilities after changes in US corporate income tax rates

Disruptive cellular medicine technology STRO-1+ Mesenchymal Precursor Cells (MPCs) are at the apex of the hierarchy of Mesenchymal Lineage STRO-1/STRO-3 immuno-selection provides a homogeneous population of MPCs with receptors that respond to activating inflammation and damaged-tissue signals In response to activating signals present in the endogenous environment, MPCs secrete a diverse variety of biomolecules responsible for immunomodulation and tissue repair Targeting multiple pathways may result in greater therapeutic benefits in complex diseases Simmons PJ, et al, Blood. 1991;78:55-62 Gronthos S, et al, J Cell Sci. 2003;116(Pt 9):1827-35 See F, et al, J Cell Mol Med. 2011;15:2117-29 Psaltis PJ, et al, J Cell Physiol. 2010;223(2):530-40

Global IP estate provides substantial competitive advantage ~800 Patents and patent applications (69 Patent families) across all major jurisdictions Covers composition of matter, manufacturing, and therapeutic applications of MLCs Provides strong commercial protection for product candidates under development Enables licensing to third parties for indications, when in alignment with our corporate strategy Mesenchymal Lineage Precursors and Progeny Markets U.S. , Europe, China, and Japan Sources Allogeneic, Autologous, (Bone Marrow, Adipose, Dental Pulp, Placenta), Pluripotent ( iPS ) Diseases All Tier 1 & Tier 2 Indications, and multiple additional conditions

Industrial scale manufacturing Immune privileged cellular technology platform enables allogeneic ‘off the shelf’ product candidates Scalable culture expansion sufficient to produce anticipated commercial quantities Proprietary media formulations, advances in development of 3D bioreactor technology and automation to deliver step-changes in yield and significant COGS reductions

The 21st Century Cures Act (Cures Act) Regenerative Medicine Advanced Therapies (RMAT) Cellular medicines may be designated as regenerative advanced therapies, if they are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and there is preliminary evidence indicating the potential to address the unmet medical need Key benefits of the legislation for cell-based medicines, designated as regenerative advanced therapies, include: Potential eligibility for priority review Potential to utilize surrogate endpoints for accelerated review Potential to utilize a patient registry data and other sources of ‘real world evidence’ for post-approval studies, subject to approval by the FDA Our portfolio of advanced product candidates is well positioned to access accelerated review pathways under the Cures Act

Clinical pipeline Study funded by the United States National Institutes of Health (NIH) and the Canadian Health Research Institute; conducted by the NIH-funded Cardiothoracic Surgical Trials Network. This chart is figurative and does not purport to show individual trial progress within a clinical program. IN DEVELOPMENT PLATFORM PRODUCT CANDIDATE THERAPEUTIC AREA PRE-CLINICAL / PRE- IND PHASE 2 PHASE 3 COMMERCIAL RIGHTS MSC MSC-100-IV Acute GVHD FDA Fast Track MPC MPC-150-IM Advanced HF (Class II & III) End-Stage HF (Class III & IV)1 FDA RMAT MPC MPC-06-ID Chronic Low Back Pain MPC MPC-300-IV Rheumatoid Arthritis Diabetic Nephropathy Includes MSC-100-IV (Crohn’s disease – biologic refractory), MPC-25-IC (Acute Cardiac Ischemia), MPC-25-Osteo (Spinal Fusion) and MPC-75-IA (Knee Osteoarthritis) TIER 1 TIER 2

CY 2018 corporate milestones MSC-100-IV for Acute Graft versus Host Disease Successfully met Day 28 primary end point pediatric Phase 3 trial (Q1 CY18) Day 100 survival/safety data pediatric Phase 3 trial (Q2 CY18) Day 180 survival/safety data pediatric Phase 3 trial (Q3 CY18) MPC-150-IM for Advanced and End-Stage Heart Failure 12 month data read-out for trial in end-stage heart failure patients with LVADs (Q3 CY18) Phase 3 events-driven trial for advanced heart failure (Class II/III) enrollment completion (H2 CY18) MPC-06-ID for Chronic Low Back Pain Phase 3 trial completed enrollment (Q1 CY18) Access non-dilutive, capital for commercialization of MSC-100-IV (remestemcel-L) Establish U.S., global and regional commercial partnerships for high volume products

Questions