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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

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

Filed in the month of February 2022 for the period ended December 31, 2021

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 

 

 

 

 


 

 

TABLE OF CONTENTS

 

 

 

Page

Currency of Presentation and Certain Defined Terms

 

3

Forward-Looking Statements

 

3

Unaudited Financial Statements

 

5

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

42

Risk Factors

 

64

Signatures

 

100

Exhibits

 

101

 

 

 

 

 

 

 

 

Page 2


 

 

REPORT ON FORM 6-K

FOR THE THREE AND SIX MONTHS ENDED DECEMBER 2021

 

Foreword

 

The Board of Directors of Mesoblast Limited (ABN 68 109 431 870) has resolved to submit the following report of Mesoblast Limited and its subsidiaries for the three and six months ended December 31, 2021 in compliance with the provisions of the Corporations Act 2001.

 

Directors of Mesoblast Limited in office at any time during or since the end of the six months ended December 31, 2021 were:

 

Name

 

Position

Silviu Itescu

 

Executive Director

Joseph Swedish

 

Chairman

William M Burns

 

Non-executive Director, Vice Chairman

Donal O’Dwyer(2)

 

Non-executive Director, Chair of Nomination and Remuneration Committee

Eric Rose(1)

 

Non-executive Director

Michael Spooner

 

Non-executive Director, Chair of Audit and Risk Committee

Philip Facchina

 

Non-executive Director

Shawn C Tomasello  

 

Non-executive Director

 

(1)

In February 2022, Dr Eric Rose was appointed as the new Chief Medical Officer (CMO). Dr. Rose brings an extensive record of excellence in clinical development and successful interactions at the highest levels with key regulatory, industry and government stakeholders including the United States Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).

 

(2)

Mr. Donal O’Dwyer retired on February 25, 2022.

Currency Presentation and Certain Defined Terms

In this Report on Form 6-K, references to “U.S.” or “United States” are to the United States of America, its territories and its possessions. References to “US$” or “$” or “U.S. dollars” are to the legal currency of the United States, references to “€” or “Euro” are to the legal currency of the European Union, references to “S$” or “SGD” or “Singapore dollars” are to the legal currency of Singapore and references to “A$” or “Australian Dollars” are to the legal currency of Australia. Our financial statements are presented in U.S. dollars and are prepared in accordance with the International Financial Reporting Standards as issued by the International Accounting Standards Board, or “IFRS”. References to a particular “fiscal” year are to our fiscal year ended June 30 of such year.

All references to “we”, “us”, “our”, “Mesoblast” or “the Group” shall mean Mesoblast Limited (ABN 68 109 431 870) and its subsidiaries. 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 Report are the property of their respective owners.

Forward-Looking Statements

This Report on Form 6-K 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”, “target”, “likely”, “will”, “would”, “could”, “should”, “may”, “goal”, “objective” 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;

Page 3


 

 

 

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

 

the impact that the COVID-19 pandemic could have on business operations;

 

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 they 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;

 

our ability to obtain additional financing;

 

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

 

our financial performance;

 

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” included elsewhere in this Report on Form 6-K.

You should read thoroughly this Report on Form 6-K 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 Report on Form 6-K 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.

You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this Report on Form 6-K relate only to events or information as of the date on which the statements are made in this Report on Form 6-K. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Page 4


 

Consolidated Income Statement

(unaudited)

 

 

 

 

 

Three Months Ended

December 31,

 

 

Six Months Ended

December 31,

 

(in U.S. dollars, in thousands, except per share amount)

 

Note

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

 

3

 

 

2,383

 

 

 

2,241

 

 

 

5,977

 

 

 

3,546

 

Research & development

 

 

 

 

(10,198

)

 

 

(14,238

)

 

 

(19,526

)

 

 

(33,516

)

Manufacturing commercialization

 

 

 

 

(6,590

)

 

 

(6,450

)

 

 

(14,127

)

 

 

(18,374

)

Management and administration

 

 

 

 

(7,814

)

 

 

(7,867

)

 

 

(13,692

)

 

 

(15,546

)

Fair value remeasurement of contingent consideration

 

3

 

 

(351

)

 

 

1,462

 

 

 

(71

)

 

 

16,569

 

Fair value remeasurement of warrant liability

 

3

 

 

2,152

 

 

 

 

 

 

2,152

 

 

 

 

Other operating income and expenses

 

3

 

 

(227

)

 

 

296

 

 

 

(405

)

 

 

395

 

Finance costs

 

3

 

 

(5,380

)

 

 

(1,062

)

 

 

(9,040

)

 

 

(3,966

)

Loss before income tax

 

3

 

 

(26,025

)

 

 

(25,618

)

 

 

(48,732

)

 

 

(50,892

)

Income tax benefit/(expense)

 

4

 

 

80

 

 

 

(74

)

 

 

142

 

 

 

656

 

Loss attributable to the owners of Mesoblast Limited

 

 

 

 

(25,945

)

 

 

(25,692

)

 

 

(48,590

)

 

 

(50,236

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Losses per share from continuing operations attributable

   to the ordinary equity holders of the Group:

 

 

 

Cents

 

 

Cents

 

 

Cents

 

 

Cents

 

Basic - losses per share

 

10

 

 

(4.00

)

 

 

(4.38

)

 

 

(7.50

)

 

 

(8.60

)

Diluted - losses per share

 

10

 

 

(4.00

)

 

 

(4.38

)

 

 

(7.50

)

 

 

(8.60

)

 

The above consolidated income statement should be read in conjunction with the accompanying Notes.

Page 5


 

Consolidated Statement of Comprehensive Income

(unaudited)

 

 

 

 

 

Three Months Ended

December 31,

 

 

Six Months Ended

December 31,

 

(in U.S. dollars, in thousands)

 

Note

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Loss for the period

 

 

 

 

(25,945

)

 

 

(25,692

)

 

 

(48,590

)

 

 

(50,236

)

Other comprehensive (loss)/income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that may be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange differences on translation of foreign operations

 

 

 

 

166

 

 

 

904

 

 

 

(183

)

 

 

1,312

 

Items that will not be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial assets at fair value through other comprehensive income

 

 

 

 

112

 

 

 

(53

)

 

 

266

 

 

 

28

 

Other comprehensive (loss)/income for the period,

   net of tax

 

 

 

 

278

 

 

 

851

 

 

 

83

 

 

 

1,340

 

Total comprehensive losses attributable to the

   owners of Mesoblast Limited

 

 

 

 

(25,667

)

 

 

(24,841

)

 

 

(48,507

)

 

 

(48,896

)

 

The above consolidated statement of comprehensive income should be read in conjunction with the accompanying Notes.

 

 


Page 6


 

 

Consolidated Statement of Changes in Equity

For the six months ended December 31, 2021 and 2020

(unaudited)

 

(in U.S. dollars, in thousands)

 

Note

 

Issued Capital

 

 

Share Option

Reserve

 

 

Investment

Revaluation

Reserve

 

 

Foreign

Currency

Translation Reserve

 

 

Warrant

Reserve

 

 

Retained

Earnings/

(accumulated losses)

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of July 1, 2020

 

 

 

 

1,051,450

 

 

 

85,330

 

 

 

(429

)

 

 

(38,267

)

 

 

 

 

 

(548,758

)

 

 

549,326

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,236

)

 

 

(50,236

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

 

 

28

 

 

 

1,312

 

 

 

 

 

 

 

 

 

1,340

 

Total comprehensive profit/(loss) for the period

 

 

 

 

 

 

 

 

 

 

28

 

 

 

1,312

 

 

 

 

 

 

(50,236

)

 

 

(48,896

)

Transactions with owners in their

   capacity as owners:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contributions of equity net of transaction costs

 

 

 

 

9,807

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9,807

 

 

 

 

 

 

9,807

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9,807

 

Tax credited / (debited) to equity

 

 

 

 

 

 

 

74

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74

 

Transfer of exercised options

 

 

 

 

4,282

 

 

 

(4,282

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair value of share-based payments

 

 

 

 

 

 

 

8,420

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,420

 

 

 

 

 

 

4,282

 

 

 

4,212

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,494

 

Balance as of December 31, 2020

 

8(a)

 

 

1,065,539

 

 

 

89,542

 

 

 

(401

)

 

 

(36,955

)

 

 

 

 

 

(598,994

)

 

 

518,731

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of July 1, 2021

 

 

 

 

1,163,153

 

 

 

92,855

 

 

 

(220

)

 

 

(39,791

)

 

 

12,969

 

 

 

(647,569

)

 

 

581,397

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(48,590

)

 

 

(48,590

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

 

 

266

 

 

 

(183

)

 

 

 

 

 

 

 

 

83

 

Total comprehensive profit/(loss) for the period

 

 

 

 

 

 

 

 

 

 

266

 

 

 

(183

)

 

 

 

 

 

(48,590

)

 

 

(48,507

)

Transactions with owners in their

   capacity as owners:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contributions of equity net of transaction costs

 

 

 

 

205

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

205

 

 

 

 

 

 

205

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

205

 

Tax credited / (debited) to equity

 

 

 

 

 

 

 

(142

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(142

)

Transfer of exercised options

 

 

 

 

228

 

 

 

(228

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair value of share-based payments

 

 

 

 

 

 

 

2,556

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,556

 

 

 

 

 

 

228

 

 

 

2,186

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,414

 

Balance as of December 31, 2021

 

8(a)

 

 

1,163,586

 

 

 

95,041

 

 

 

46

 

 

 

(39,974

)

 

 

12,969

 

 

 

(696,159

)

 

 

535,509

 

 

Page 7


 

 

Consolidated Statement of Changes in Equity

For the three months ended December 31, 2021 and 2020

(unaudited)

 

(in U.S. dollars, in thousands)

 

Note

 

Issued Capital

 

 

Share Option

Reserve

 

 

Investment

Revaluation

Reserve

 

 

Foreign

Currency

Translation Reserve

 

 

Warrant

Reserve

 

 

Retained

Earnings/

(accumulated losses)

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of October 1, 2020

 

 

 

 

1,063,005

 

 

 

87,010

 

 

 

(348

)

 

 

(37,859

)

 

 

 

 

 

(573,302

)

 

 

538,506

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,692

)

 

 

(25,692

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

 

 

(53

)

 

 

904

 

 

 

 

 

 

 

 

 

851

 

Total comprehensive profit/(loss) for the period

 

 

 

 

 

 

 

 

 

 

(53

)

 

 

904

 

 

 

 

 

 

(25,692

)

 

 

(24,841

)

Transactions with owners in their

   capacity as owners:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contributions of equity net of transaction costs

 

 

 

 

1,452

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,452

 

 

 

 

 

 

1,452

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,452

 

Tax credited / (debited) to equity

 

 

 

 

 

 

 

74

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74

 

Transfer of exercised options

 

 

 

 

1,082

 

 

 

(1,082

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair value of share-based payments

 

 

 

 

 

 

 

3,540