UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended June 30, 2022

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

For the transition period from                 to                

Commission file number 001-37626

MESOBLAST LIMITED

(Exact name of Registrant as specified in its charter)

N/A

(Translation of Registrant’s name into English)

AUSTRALIA

(Jurisdiction of incorporation or organization)

Level 38, 55 Collins Street

Melbourne, VIC, 3000, Australia

Telephone: +61 (3) 9639 6036

(Address of principal executive offices)

Silviu Itescu

Chief Executive Officer

Telephone: +61 (3) 9639 6036; Fax: +61 (3) 9639 6030

Level 38, 55 Collins Street

Melbourne, VIC, 3000, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing five Ordinary Shares*	MESO	The NASDAQ Global Select Market

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

None

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

650,454,551 Ordinary Shares

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

☐  Yes    ☒  No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

☐  Yes    ☒  No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

☒  Yes    ☐  No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

☒  Yes    ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer	☒	Accelerated filer	☐	Non-accelerated filer	☐
				Emerging growth company	☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.    ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☐ International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17  ☐    Item 18  ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

☐  Yes    ☒  No

Table of Contents

INTRODUCTION AND USE OF CERTAIN TERMS			3
FORWARD-LOOKING STATEMENTS			4
PART I			6
	Item 1.	Identity of Directors, Senior Management and Advisers	6
	Item 2.	Offer Statistics and Expected Timetable	6
	Item 3.	Key Information	6
	3.A	[Reserved]	6
	3.B	Capitalization and Indebtedness	6
	3.C	Reasons for the offer and use of proceeds	6
	3.D	Risk Factors	6
	Item 4.	Information on the Company	41
	4.A	History and Development of Mesoblast	41
	4.B	Business Overview	51
	4.C	Organizational Structure	73
	4.D	Property, Plants and Equipment	73
	Item 4A.	Unresolved Staff Comments	73
	Item 5.	Operating and Financial Review and Prospects	73
	5.A	Operating Results	73
	5.B	Liquidity and Capital Resources	83
	5.C	Research and Development, Patents and Licenses	87
	5.D	Trend Information	87
	5.E	Critical Accounting Estimates	87
	Item 6.	Directors, Senior Management and Employees	88
	6.A	Directors and Senior Management	90
	6.B	Compensation	98
	6.C	Board Practices	120
	6.D	Employees	122
	6.E	Share Ownership	123
	Item 7.	Major Shareholders and Related Party Transactions	124
	7.A	Major Shareholders	124
	7.B	Related Party Transactions	124
	7.C	Interests of Experts and Counsel	124
	Item 8.	Financial Information	124
	8.A	Consolidated Statements and Other Financial Information	124
	8.B	Significant Changes	125
	Item 9.	The Offer and Listing	125
	9.A	Offer and Listing Details	125
	9.B	Plan of Distribution	125
	9.C	Markets	125
	9.D	Selling Shareholders	126
	9.E	Dilution	126
	9.F	Expenses of the Issue	126

	Item 10.	Additional Information	126
	10.A	Share Capital	126
	10.B	Memorandum and Articles of Association	126
	10.C	Material Contracts	131
	10.D	Exchange Controls	135
	10.E	Taxation	136
	10.F	Dividends and Paying Agents	143
	10.G	Statement by Experts	143
	10.H	Documents on Display	143
	10.I	Subsidiary Information	143
	Item 11.	Quantitative and Qualitative Disclosures about Market Risk	143
	Item 12.	Description of Securities Other than Equity Securities	143
	12.A	Debt Securities	143
	12.B	Warrants and Rights	143
	12.C	Other Securities	143
	12.D	American Depositary Shares	144
PART II			145
	Item 13.	Defaults, Dividend Arrearages and Delinquencies	145
	Item 14.	Material Modifications to the Rights of Security Holders and Use of Proceeds	145
	Item 15.	Controls and Procedures	145
	Item 16.	[Reserved]	145
	Item 16A.	Audit Committee Financial Expert	145
	Item 16B.	Code of Ethics	146
	Item 16C.	Principal Accountant Fees and Services	146
	Item 16D.	Exemptions from the Listing Standards for Audit Committees	146
	Item 16E.	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	146
	Item 16F.	Change in Registrant’s Certifying Accountant	146
	Item 16G.	Corporate Governance	146
	Item 16H.	Mine Safety Disclosure	147
	Item 16I.	Disclosure Regarding Foreign Jurisdiction that Prevent Inspections	147
PART III			147
	Item 17.	Financial Statements	147
	Item 18.	Financial Statements	147
	Item 19.	Exhibits	226
SIGNATURES			229

INTRODUCTION AND USE OF CERTAIN TERMS

Mesoblast Limited and its consolidated subsidiaries publish consolidated financial statements expressed in U.S. dollars, unless otherwise indicated. This Annual Report on Form 20-F is presented in U.S. dollars, unless otherwise indicated. Our consolidated financial statements found in Item 18 of this Annual Report on Form 20-F are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board and Australian equivalents to International Financial Reporting Standards as issued by the Australian Accounting Standards Board.

Except where the context requires otherwise and for purposes of this Form 20-F 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.

• “AIFRS” refers to the Australian equivalents to International Financial Reporting Standards as issued by the Australian Accounting Standards Board, or AASB.

• “CHF” refers to the legal currency of Switzerland.

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

• “GBP” refers to the legal currency of the United Kingdom.

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

• “S$” or “SGD” or “Singapore dollar” refers to the legal currency of Singapore.

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

• “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.

• “€” or “Euro” refers to the legal currency of the European Union.

Australian Disclosure Requirements

Our ordinary shares are primarily quoted on the Australian Securities Exchange (“ASX”) in addition to our listing of our ADSs on The Nasdaq Global Select Market. As part of our ASX listing, we are required to comply with various disclosure requirements as set out under the Australian Corporations Act 2001 and the ASX Listing Rules. Information furnished under the sub-heading “Australian Disclosure Requirements” is intended to comply with ASX listing and Corporations Act 2001 disclosure requirements and is not intended to fulfill information required by this Annual Report on Form 20-F.

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FORWARD-LOOKING STATEMENTS

This Form 20-F includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our current expectations, assumptions, estimates and projections about the Company, our industry, economic conditions in the markets in which we operate, and certain other matters. These statements include, among other things, the discussions of our business strategy and expectations concerning our market position, future operations, margins, profitability, liquidity and capital resources. These statements are subject to 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;

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

• our ability to take advantage of the potential benefits of the 21st Century Cures Act;

• 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 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;

• 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”.

You should read this Form 20-F and the documents that we refer to herein thoroughly 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 Form 20-F 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 Form 20-F also contains third-party data relating to the biopharmaceutical market 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 ordinary shares and 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 Form 20-F relate only to events or information as of the date on which the statements are made in this Form 20-F. 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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PART I

Item 1. Identity of Directors, Senior Management and Advisers

Not applicable.

Item 2. Offer Statistics and Expected Timetable

Not applicable.

Item 3. Key Information

3.A [Reserved]

3.B Capitalization and Indebtedness

Not applicable.

3.C Reasons for the offer and use of proceeds

Not applicable.

3.D Risk Factors

You should carefully consider the risks described below and all other information contained in this Annual Report on Form 20-F 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 ordinary shares and ADSs could decline, and you may lose part or all of your investment. This Annual Report on Form 20-F 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 Annual Report on Form 20-F.

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. Our net loss for the year ended June 30, 2022 was $91.3 million. As of June 30, 2022, we have an accumulated deficit of $738.9 million since our inception. We do not know whether or when we will become profitable. Our losses have resulted principally from costs incurred in clinical development and manufacturing activities.

We anticipate that our expenses will increase as we move toward commercialization, including the scaling up of our manufacturing activities and our establishment of infrastructure and logistics necessary to support potential product launches. 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 and maintain 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 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 currently generate revenues from product sales (other than licensing revenue from sales of TEMCELL® HS. Inj. (“TEMCELL”), a registered trademark of JCR Pharmaceuticals Co., Ltd. (“JCR”), by JCR in Japan, and royalty revenue from net

6

sales of Alofisel® a registered trademark of TiGenix NV (“TiGenix”), previously known as Cx601, an adipose-derived mesenchymal stromal cell product developed by TiGenix, now a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”) and approved for marketing in the EU), 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, 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 commercial and distribution capabilities necessary to effectively seek and maintain market access and ensure compliance with legal and regulatory requirements relating to interactions with healthcare providers, healthcare organizations and government agencies;

• obtaining market acceptance of our product candidates as viable treatment options;

•