Telix Pharmaceuticals Ltd
For the period ended Dec 31, 2024. Filed Feb 24, 2025.
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The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2024 · Filed Feb 24, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
| ☐ | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR
For the fiscal year ended December 31, 2024
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| For the transition period from | to |
OR
| ☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Date of event requiring this shell company report:
Commission file number 001-42128
Telix Pharmaceuticals Limited
(Exact name of registrant as specified in its charter and translation of Registrant’s name into English)
Australia
(Jurisdiction of incorporation or organization)
55 Flemington Road
North Melbourne, Victoria 3051, Australia
(Address of principal executive offices)
Christian Behrenbruch
55 Flemington Road
North Melbourne, Victoria 3051, Australia
Tel: +61 3 9093 3855
(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 | Name of each exchange on which registered |
|---|---|---|
| American depositary shares, each representing one ordinary share, no par value Ordinary shares, no par value* | TLX | The Nasdaq Global Select Market |
- Listed not for trading, but only in connection with the listing of the American Depositary Shares, pursuant to the requirements of the Securities & Exchange Commission
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: The number of ordinary shares outstanding as of December 31, 2024 was 334,724,485
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, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | Non-accelerated filer | ☒ | Emerging growth company | ☒ |
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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.☐
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
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.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
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
| ITEM 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS | 4 |
|---|---|---|
| ITEM 2. | OFFER STATISTICS AND EXPECTED TIMETABLE | 4 |
| ITEM 3. | KEY INFORMATION | 4 |
| ITEM 4. | INFORMATION ON THE COMPANY | 90 |
| ITEM 4A. | UNRESOLVED STAFF COMMENTS | 172 |
| ITEM 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS | 173 |
| ITEM 6. | DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES | 195 |
| ITEM 7. | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS | 211 |
| ITEM 8. | FINANCIAL INFORMATION | 213 |
| ITEM 9. | THE OFFER AND LISTING | 215 |
| ITEM 10. | ADDITIONAL INFORMATION | 215 |
| ITEM 11. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 222 |
| ITEM 12. | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES | 224 |
| ITEM 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES | 227 |
| ITEM 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS | 227 |
| ITEM 15. | CONTROLS AND PROCEDURES | 227 |
| ITEM 16. | RESERVED | 228 |
| ITEM 16A. | AUDIT COMMITTEE FINANCIAL EXPERT | 228 |
| ITEM 16B. | CODE OF ETHICS | 228 |
| ITEM 16C. | PRINCIPAL ACCOUNTANT FEES AND SERVICES | 228 |
| ITEM 16D. | EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES | 229 |
| ITEM 16E. | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS | 229 |
| ITEM 16F. | CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT | 229 |
| ITEM 16G. | CORPORATE GOVERNANCE | 229 |
| ITEM 16H. | MINE SAFETY DISCLOSURE | 230 |
| ITEM 16I. | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | 230 |
| ITEM 16J. | INSIDER TRADING POLICIES | 230 |
| ITEM 16K. | CYBERSECURITY | 231 |
| ITEM 17. | FINANCIAL STATEMENTS | 233 |
| ITEM 18. | FINANCIAL STATEMENTS | 233 |
| ITEM 19. | EXHIBITS | 233 |
INTRODUCTION
Telix Pharmaceuticals Limited was incorporated under the laws of Australia in January 2017. Our ordinary shares have been listed on the Australian Securities Exchange, or ASX, since November 2017, and since November 2024, have been listed on the Nasdaq Global Select Market in the form of American depositary shares, or ADSs, with each ADS representing one of our ordinary shares. JP Morgan Chase Bank, N.A., acts as depositary for the ADSs. Throughout this annual report, all references to “ADRs” mean the American depositary receipts that evidence the ADSs.
Our reporting currency is the Australian dollar, or A$. All amounts presented in this annual report are presented in Australian. dollars, or A$, unless otherwise indicated. Solely for the convenience of the reader, this annual report contains translations of certain Australian dollar amounts into U.S. dollars at specified rates. No representation is made that Australian dollar amounts referred to in this annual report could have been or could be converted into U.S. dollars at such rates or any other rates. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding.
The consolidated financial statements and related notes included elsewhere in this annual report have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board, (“IFRS Accounting Standards”), which differ in certain significant respects from generally accepted accounting principles in the United States, or U.S. GAAP.
We also maintain a website at www.telixpharma.com. The information contained on our website or available through our website is not incorporated by reference into and should not be considered a part of this annual report, and any references to our website throughout this annual report are inactive textual references only.
Unless otherwise stated or the context indicates otherwise, all references herein to “Telix,” “Telix Pharmaceuticals,” the “Company,” “our company,” “we,” “us,” “our” and similar references refer to Telix Pharmaceuticals Limited and its consolidated subsidiaries, taken as a whole.
INDUSTRY AND MARKET DATA
This annual report contains estimates and information concerning our industry and our business, including estimated market size and projected growth rates of the markets for our product candidates. Unless otherwise expressly stated, we obtained this industry, business, market, medical and other information from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources.
This information involves a number of assumptions and is based on limited available information. Although we are responsible for all of the disclosure contained in this annual report and we believe the third-party market position, market opportunity and market size data included in this annual report are reliable, we have not independently verified the accuracy or completeness of this third-party data. In addition, projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Item 3. Key Information — D. Risk Factors.” These and other factors could cause results to differ materially from those expressed in these publications and reports.
TRADEMARKS AND SERVICE MARKS
“Telix Pharmaceuticals,” the Telix logo and other trademarks or service marks of Telix appearing in this annual report are the property of Telix or its subsidiaries. Solely for convenience, the trademarks, service marks and trade names referred to in this annual report are listed without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their right thereto. All other trademarks, trade names and service marks appearing in this annual report are the property of their respective owners.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this annual report, including statements regarding our future results of operations, financial condition, business strategy, prospective products, product approvals, research and development costs, future revenue and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties, other factors and assumptions, including the risks described in “Item 3. Key Information — D. Risk Factors” and elsewhere in this annual report, regarding, among other things:
| • | the ongoing commercialization of Illuccix® and our preparation for the commercialization of our products and product candidates, if or when they are approved; |
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| • | the timing and review of submissions for regulatory approval of our product candidates, including review of our accepted submissions for Gozellix® (TLX007-CDx) and Pixclara® (TLX101-CDx), our resubmission for Zircaix® (TLX250-CDx), and our ability to obtain and maintain such regulatory approvals; |
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| • | the initiation, timing, progress and results of our ongoing and planned clinical trials, including the timing of dosing of patients, enrollment and completion of these trials, including multi-national trials, and the anticipated results from these trials; |
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| • | our sales, marketing and distribution capabilities and strategies, including for the commercialization and manufacturing of Illuccix and any future products; |
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| • | our ability to obtain an adequate supply at reasonable costs of raw materials we may incorporate into our products and product candidates; |
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| • | our ability to address the fulfillment and logistical challenges posed by the time-limited stabilization of our products and product candidates; |
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| • | our commercialization, marketing and manufacturing capabilities and strategy, including the timing and costs of expanding our manufacturing capabilities; |
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| • | the rate and degree of market acceptance and clinical utility of our products and product candidates; |
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| • | the pricing and reimbursement of our products and product candidates, if and after they have been approved; |
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| • | estimates of our expenses, future revenues and capital requirements; |
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| • | our financial performance; |
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| • | developments relating to our competitors and industry; |
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| • | the success of our collaborations and partnerships with third parties; |
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| • | our ability to maintain, expand, protect and enforce our regulatory exclusivity and intellectual property, or IP, portfolio; |
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| • | our expectations regarding our ability to obtain and maintain regulatory exclusivity and intellectual property protection for our products and product candidates; |
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| • | our ability to successfully integrate the businesses that we have acquired or may acquire in the future; |
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| • | our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
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| • | legal and regulatory developments in the United States, Australia and other jurisdictions; |
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| • | our ability to remain compliant with the respective listing rules and standards of the Australian Securities Exchange, or ASX, Singapore Exchange Securities Trading Limited, or SGX, and the Nasdaq Global Select Market, or Nasdaq; |
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| • | our ability to attract and retain key scientific or management personnel; |
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| • | the success of competing therapies that are or may become available; |
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| • | our expectations regarding the period during which we qualify as an emerging growth company, or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act; |
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| • | the volatility of currency exchange rates; |
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| • | the impact of and changes in governmental regulations or the enforcement thereof, tax laws and rates, accounting guidance and similar matters in regions in which we operate or will operate in the future; and |
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| • | other risks and uncertainties, including those listed under “Item 3. Key Information — D. Risk Factors.” |
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These risks are not exhaustive. Other sections of this annual report may include additional factors that could harm our business and financial performance. New risk factors may 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, or implied by, any forward-looking statements.
You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this annual report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We undertake no obligation to update any forward-looking statements made in this annual report to reflect events or circumstances after the date of this annual report or to reflect new information or the occurrence of unanticipated events, except as required by law.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.
These statements are based on information available to us as of the date of this annual report. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
You should read this annual report and the documents that we reference and have filed as exhibits to the annual report with the understanding that our actual future results, performance and achievements may be different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
PART I
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.