Mesoblast Ltd. Files 20-F Annual Report

Ticker: MEOBF · Form: 20-F · Filed: Aug 29, 2024 · CIK: 1345099

Mesoblast LTD 20-F Filing Summary
FieldDetail
CompanyMesoblast LTD (MEOBF)
Form Type20-F
Filed DateAug 29, 2024
Risk Levelmedium
Pages15
Reading Time18 min
Key Dollar Amounts$88.0 million, $908.8 million, $63.0 million, $48.5 million, $50.0 million
Sentimentneutral

Sentiment: neutral

Topics: annual-report, 20-F, biotechnology

TL;DR

MESOBLAST LTD FILED ITS 20-F ANNUAL REPORT FOR FY24 - CHECK FINANCIALS AND RISKS.

AI Summary

Mesoblast Ltd. filed its annual report on Form 20-F for the fiscal year ending June 30, 2024. The filing provides a comprehensive overview of the company's business, financial condition, and risk factors. Key financial data and operational details are presented for the reporting period and comparative prior years.

Why It Matters

This filing is crucial for investors and stakeholders as it contains the official audited financial statements and detailed business disclosures for Mesoblast Ltd., impacting investment decisions and regulatory compliance.

Risk Assessment

Risk Level: medium — The company operates in the highly regulated and competitive biotechnology sector, which inherently carries significant risks related to research, development, clinical trials, and market approval.

Key Numbers

Key Players & Entities

FAQ

What is the primary business of Mesoblast Ltd. as indicated by its SIC code?

Mesoblast Ltd.'s Standard Industrial Classification (SIC) code is 2836, which corresponds to Biological Products (No Diagnostic Substances).

What is the fiscal year end for Mesoblast Ltd.?

Mesoblast Ltd.'s fiscal year ends on June 30 (0630).

When was the 20-F filing submitted to the SEC?

The 20-F filing was submitted on August 29, 2024 (20240829).

What is the company's business address?

The business address is Level 38, 55 Collins Street, Melbourne, Victoria, 3000.

What is the SEC file number for Mesoblast Ltd.?

The SEC file number for Mesoblast Ltd. is 001-37626.

Filing Stats: 4,414 words · 18 min read · ~15 pages · Grade level 13.9 · Accepted 2024-08-29 06:09:53

Key Financial Figures

Filing Documents

o Item 18 o

Item 17 o Item 18 o 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). o Yes x No Table of Contents Table of Contents INTRODUCTION AND USE OF CERTAIN TERMS 3

FORWARD-LOOKING STATEMENTS

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

Risk Factors 6 Item 4. Information on the Company 44 4.A History and Development of Mesoblast 44 4.B Business Overview 54 4.C Organizational Structure 79 4.D Property, Plants and Equipment 79 Item 4A. Unresolved Staff Comments 79 Item 5. Operating and Financial Review and Prospects 79 5.A Operating Results 79 5.B Liquidity and Capital Resources 89 5.C Research and Development, Patents and Licenses 91 5.D Trend Information 91 5.E Critical Accounting Estimates 91 Item 6. Directors, Senior Management and Employees 91 6.A Directors and Senior Management 91 6.B Compensation 100 6.C Board Practices 127 6.D Employees 130 6.E Share Ownership 131 6.F Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation 132 Item 7. Major Shareholders and Related Party Transactions 132 7.A Major Shareholders 132 7.B Related Party Transactions 133 7.C Interests of Experts and Counsel 133 Item 8. Financial Information 133 8.A Consolidated Statements and Other Financial Information 133 8.B Significant Changes 134 Item 9. The Offer and Listing 134 9.A Offer and Listing Details 134 9.B Plan of Distribution 134 9.C Markets 134 9.D Selling Shareholders 135 9.E

Dilution

Dilution 135 9.F Expenses of the Issue 135 Item 10. Additional Information 135 10.A Share Capital 135 Table of Contents 10.B Memorandum and Articles of Association 135 10.C Material Contracts 140 10.D Exchange Controls 144 10.E Taxation 146 10.F Dividends and Paying Agents 153 10.G 153 10.H Documents on Display 153 10.I Subsidiary Information 154 10.J Annual Report to Security Holders 154 Item 11.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 154 Item 12.

Description of Securities Other than Equity Securities

Description of Securities Other than Equity Securities 154 12.A Debt Securities 154 12.B Warrants and Rights 154 12.C Other Securities 154 12.D American Depositary Shares 154 PART II 155 Item 13. Defaults, Dividend Arrearages and Delinquencies 155 Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds 155 Item 15.

Controls and Procedures

Controls and Procedures 155 Item 16. [Reserved] 155 Item 16A. Audit Committee Financial Expert 155 Item 16B. Code of Ethics 156 Item 16C. Principal Accountant Fees and Services 156 Item 16D. Exemptions from the Listing Standards for Audit Committees 156 Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers 156 Item 16F. Change in Registrant's Certifying Accountant 156 Item 16G. Corporate Governance 156 Item 16H. Mine Safety Disclosure 157 Item 16I. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections 157 Item 16J. Insider Trading Policies 157

Cybersecurity

Item 16K. Cybersecurity 157 PART III 158 Item 17.

Financial Statements

Financial Statements 158 Item 18.

Financial Statements

Financial Statements 158 Item 19. Exhibits 243

SIGNATURES

SIGNATURES 246 Table of Contents 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

FORWARD-LOOKING STATEMENTS

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

Identity of Directors, Senior Management and Advisers

Item 1. Identity of Directors, Senior Management and Advisers Not applicable.

Offer Statistics and Expected Timetable

Item 2. Offer Statistics and Expected Timetable Not applicable.

Key Information

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, 2024 was $88.0 million. As of June 30, 2024, we have an accumulated deficit of $908.8 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 produ

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