Opthea Ltd Files 20-F/A Amendment

Ticker: OPTEY · Form: 20-F/A · Filed: Sep 20, 2024 · CIK: 1815620

Sentiment: neutral

Topics: amendment, financials, equity

TL;DR

Opthea Ltd filed an amended 20-F for FY24, check for updated financials and equity details.

AI Summary

Opthea Ltd filed an amendment to its 20-F form on September 20, 2024, for the period ending June 30, 2024. The filing details its financial position and business operations, including information on share capital and equity instruments. Key dates mentioned include the fiscal year end of June 30 and potential expiry dates for certain options and rights.

Why It Matters

This amendment provides updated financial and operational information for Opthea Ltd, crucial for investors to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — As a biotechnology company, Opthea Ltd is subject to inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

Key Players & Entities

FAQ

What is the primary purpose of this 20-F/A filing for Opthea Ltd?

The filing is an amendment to Opthea Ltd's annual report (20-F) for the period ending June 30, 2024, providing updated information.

What is the fiscal year end for Opthea Ltd?

Opthea Ltd's fiscal year ends on June 30.

When was this amendment filed with the SEC?

This amendment was filed on September 20, 2024.

What does the 'ExpiryOfJanuary2025Member' likely refer to?

The 'ExpiryOfJanuary2025Member' with a value of 0.3220 likely refers to options or equity instruments that are set to expire in January 2025.

What industry is Opthea Ltd classified under?

Opthea Ltd is classified under 'BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES)' with SIC code 2836.

Filing Stats: 4,483 words · 18 min read · ~15 pages · Grade level 12.3 · Accepted 2024-09-20 06:06:03

Key Financial Figures

Filing Documents

Item 18

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 EXPLANATORY NOTE This Amendment No. 1 on Form 20-F/A (this "Amendment") is being filed by Opthea Limited (the "Company") to amend its Annual Report on Form 20-F for the fiscal year ended June 30, 2024, originally filed with the U.S. Securities Exchange Commission (the "SEC") on August 30, 2024 (the "Original Filing"). All references in this Amendment to the "annual report on Form 20-F" or "annual report" shall be deemed to refer to this Amendment. The Company is filing this Amendment solely to (a) amend the Report of Independent Registered Public Accounting Firm contained in the Original Filing which inadvertently omitted the signature of Deloitte Touche Tohmatsu, the Company's independent registered public accounting firm ("Deloitte"); (b) amend Exhibit 15.1 Consent of Deloitte Touche Tohmatsu, independent registered public accounting firm, filed with the Original Filing which inadvertently omitted the signature of Deloitte; (c) include new Section 302 Certifications filed as Exhibits 12.1 and 12.2, as required by Rule 12b-15 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"); (d) include a new Section 906 Certification furnished as Exhibit 13.1, as required by Rule 12b-15 of the Exchange Act and (e) amend the text of the Exhibit Index contained in the Original Filing to include some footnote notations. Although this Amendment includes all of the Parts, Items, information, disclosures and Exhibits contained in the Original Filing as required by the SEC's rules, it speaks as of the filing date of the Original Filing and does not, and does not purport to, amend, modify, update, restate or change in any way any of such Parts, Items, information, disclosure or Exhibits contained in the Original Fling, including the previously reported consolidated financial statements, except as

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS 8 PART I 10 Item 1. Identity of Directors, Senior Management and Advisers 10 Item 2. Offer Statistics and Expected Timetable 10 Item 3. Key Information 10 3A. Reserved 10 3B. Capitalization and Indebtedness 10 3C. Reasons for the offer and use of proceeds 10 3D.

Risk Factors

Risk Factors 10 Item 4. Information on the Company 70 4A. History and Development of Opthea 70 4B. Business Overview 70 4C. Organizational Structure 118 4D. Property, Plants and Equipment 118 Item 4A. Unresolved Staff Comments 118 Item 5. Operating and Financial Review and Prospects 118 5A. Operating Results 121 5B. Liquidity and Capital Resources 127 5C. Research and Development, Patents and Licenses 133 5D. Trend Information 133 5E. Critical Accounting Estimates 133 Item 6. Directors, Senior Management and Employees 137 6A. Directors and Senior Management 137 6B. Compensation 142 6C. Board Practices 146 6D. Employees 150 6E. Share Ownership 150 6F. Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation 151 Item 7. Major Shareholders and Related Party Transactions 151 7A. Major Shareholders 151 7B. Related Party Transactions 153 7C. Interests of Experts and Counsel 155 Item 8. Financial Information 156 8A. Consolidated Statements and Other Financial Information 156 8B. Significant Changes 156 Item 9. The Offer and Listing 156 9A. Offer and Listing Details 156 9B. Plan of Distribution 156 9C. Markets 156 9D. Selling Shareholders 156 9E.

Dilution

Dilution 156 9F. Expenses of the Issue 156 Item 10. Additional Information 157 10A. Share Capital 157 10B. Constitution 157 10C. Material Contracts 157 10D. Exchange Controls 157 10E. Taxation 157 10F. Dividends and Paying Agents 165 10G. 165 10H. Documents on Display 165 10I. Subsidiary Information 165 10J. Annual Report to Security Holders 166 Item 11.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 166 Item 12.

Description of Securities Other than Equity Securities

Description of Securities Other than Equity Securities 166 12A. Debt Securities 166 12B. Warrants and Rights 166 3 TABLE OF CONTENTS 12C. Other Securities 166 12D. American Depositary Shares 166 PART II 169 Item 13. Defaults, Dividend Arrearages and Delinquencies 169 Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds 169 Item 15.

Controls and Procedures

Controls and Procedures 169 Item 16 Reserved 170 16A. Audit Committee Financial Expert 170 16B. Code of Ethics 170 16C. Principal Accountant Fees and Services 170 16D. Exemptions from the Listing Standards for Audit Committees 171 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers 171 16F. Change in Registrant's Certifying Accountant 171 16G. Corporate Governance 171 16H. Mine Safety Disclosure 172 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 172 16J. Insider Trading Policies 172 16K Cybersecurity 172 PART III 174 Item 17.

Financial Statements

Financial Statements 174 Item 18.

Financial Statements

Financial Statements 174 Item 19. Exhibits 174 4 presentation of financia l and other information Our reporting and functional currency is the U.S. dollar, and our financial statements included elsewhere in this Annual Report on Form 20-F, or annual report, are presented in U.S. dollars. The consolidated financial statements and related notes included elsewhere in this annual report have been prepared under the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, which differs in certain significant respects from U.S. Generally Accepted Accounting Principles, or GAAP. Except where the context requires otherwise and for purposes of this annual report only: "ADSs" refers to our American depositary shares, each of which represents eight of our ordinary shares, no par value, and "ADRs" refers to the American depositary receipts that evidence our ADSs. "Opthea," "we," "us" "Group" or "our" refer to Opthea Limited and its subsidiaries. "A$" or "Australian dollar" refers to the legal currency of Australia. "IFRS" refers to the International Financial Reporting Standards as issued by the International Accounting Standards Board, or IASB. "AIFRS" refers to the Australian equivalents to International Financial Reporting Standards as issued by the Australian Accounting Standards Board, or AASB. "U.S. GAAP" refers to the Generally Accepted Accounting Principles in the United States. "EMA" refers to the European Medicines Agaency "FDA" refers to the United States Food and Drug Administration. "US$" 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. Except with respect to U.S. dollar amounts presented as contractual terms, amounts denominated in U.S. dollars when received or paid and unless otherwise indicated, certain Australian dollar amounts contained in this annual report have been transl

Identity of Dire ctors, Senior Management and Advisers

Item 1. Identity of Dire ctors, 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 3A. Re serve d 3B. Capitalization and Indebtedness Not applicable. 3C. Reasons for the off er and use of proceeds Not applicable. 3D. Risk Factors Investing in our securities involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as other information included in this annual report, including our consolidated financial statements and related notes included elsewhere in this annual report, before making an investment decision. If any of the following risks actually occur, it could harm our business, prospects, results of operations and financial condition. In such event, the trading price of the ADSs could decline and you might lose all or part of your investment. You should not interpret our disclosure of any of the following risks to imply that such risks have not already materialized. Risk Factors Summary Our business is subject to a number of risks and uncertainties, including those risks discussed at-length below in this summary. These risks include, among others, the following: Risks Related to our Financial Position, Need for Capital and the Funding Agreement We have not received approval for any product candidate for commercial sale and, as a result, we have never generated any revenue from products, have incurred significant financial losses and expect to continue to incur significant financial losses in the future, which makes it difficult to assess our future viability. We will require additional capital in the future, including funding to complete the efficacy and safety stages of the trials, which may not be available to us on commercially favorable terms, or at all. Our ability to continue our development activities as a going concern may be dependent on raising such additional capital. Raising additional capital may cause dilution to holders of our ordinary shares and ADSs. The Funding Agreement contains terms that require us to

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