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Telix Pharmaceuticals Ltd
Awaiting Response
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Telix Pharmaceuticals Ltd
Response Received
2 company response(s)
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Company responded
2024-11-12
Telix Pharmaceuticals Ltd
Filing - Correspondence from Telix Pharmaceuticals Ltd
CORRESP · 2024-11-12
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Telix Pharmaceuticals Ltd
Response Received
1 company response(s)
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Company responded
2024-10-17
Telix Pharmaceuticals Ltd
Filing - Correspondence from Telix Pharmaceuticals Ltd
CORRESP · 2024-10-17
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-23 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 001-42128 | Read Filing View |
| 2026-04-17 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
| 2026-04-03 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 001-42128 | Read Filing View |
| 2024-11-12 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
| 2024-10-17 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
| 2024-10-10 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 377-07439 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-23 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 001-42128 | Read Filing View |
| 2026-04-03 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 001-42128 | Read Filing View |
| 2024-10-10 | SEC Comment Letter | Telix Pharmaceuticals Ltd | Australia | 377-07439 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-17 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
| 2024-11-12 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
| 2024-10-17 | Company Response | Telix Pharmaceuticals Ltd | Australia | N/A | Read Filing View |
2026-04-23 - UPLOAD - Telix Pharmaceuticals Ltd File: 001-42128
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 23, 2026 Darren Smith Group Chief Financial Officer Telix Pharmaceuticals Limited 55 Flemington Road North Melbourne, Victoria 3051 Australia Re: Telix Pharmaceuticals Limited Form 20-F for Fiscal Year Ended December 31, 2025 File No. 001-42128 Dear Darren Smith: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2026-04-17 - CORRESP - Telix Pharmaceuticals Ltd
CORRESP 1 filename1.htm Telix Pharmaceuticals Limited ACN 616 620 369 55 Flemington Road North Melbourne, Victoria, 3051, Australia telixpharma.com April 17, 2026 Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Gary Newberry and Tara Harkins Re: Telix Pharmaceuticals Limited Form 20-F for Fiscal Year Ended December 31, 2025 File No. 001-42128 Ladies and Gentlemen: Set forth below are the responses of Telix Pharmaceuticals Limited (the “Company,” “Telix,” “we,” “us” or “our”) to a comment received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter, dated April 3, 2026. For your convenience, the response is prefaced by the exact text of the Staff’s comment in bold, italicized text. Form 20-F for the Fiscal Year Ended December 31, 2025 Item 5. Operating and Financial Review and Prospects A. Operating Results Alternative Performance Measures, page 161 We note that you present Adjusted EBITDAR, a non-IFRS measure, that adjusts for costs associated with research and development costs and revenue from contracts with customers. Please tell us how you considered the guidance in Item 10(e) of Regulation S-K and Question 100.01 of the Non-GAAP Corporation Finance Interpretations in presenting this non-IFRS measure and explain why these adjustments are appropriate. Response: The Company advises the Staff that it considered the guidance in Item 10(e) of Regulation S-K and Question 100.01 of the Non-GAAP Corporation Finance Interpretations in presenting Adjusted EBITDAR as a non-IFRS financial measure. Adjusted EBITDAR was designed and used primarily as an internal performance and incentive metric. It was intended to isolate the performance of the Company’s commercial activities by starting from Operating profit and adjusting for items including product development related revenue from contracts with customers, research and development costs, U.S. listing costs, acquisition transaction costs, depreciation and amortization and other gains or losses. Management’s objective was to separate the results of the commercial business from product development activities, which are evaluated using separate financial and non-financial key-performance indicators such as development milestones, regulatory approvals and pipeline progression. However, the Company has determined that it will no longer present Adjusted EBITDAR as a non-IFRS financial measure in its SEC filings. Beginning with its next Annual Report on Form 20-F for the fiscal year ending December 31, 2026 (and in any applicable interim filings), Adjusted EBITDAR will be removed from the Company’s non-IFRS disclosures. The Company will instead focus on IFRS measures and, where appropriate, other non-IFRS financial measures that do not exclude normal, recurring operating expenses or revenues that are necessary to its business, and will ensure that any such measures comply with Item 10(e) of Regulation S-K and the Non-GAAP Corporation Finance Interpretations. Page 1 Should you have any questions with respect to the foregoing or if any additional supplemental information is required by the Staff, please contact Alexander T. Yarbrough of Troutman Pepper Locke LLP, the Company’s outside counsel at (704) 998-4077. Sincerely, Telix Pharmaceuticals Limited /s/ Darren Smith Darren Smith Group Chief Financial Officer cc: Christian Krautkramer, General Counsel, Telix Pharmaceuticals Limited Oliver J. Newman, U.S. Securities & Governance Counsel, Telix Pharmaceuticals Limited Alexander T. Yarbrough, Troutman Pepper Locke LLP Tim McEwen, Herbert Smith Freehills Kramer Page 2 Telix Pharmaceuticals Limited ACN 616 620 369 55 Flemington Road North Melbourne, Victoria, 3051, Australia telixpharma.com
2026-04-03 - UPLOAD - Telix Pharmaceuticals Ltd File: 001-42128
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 3, 2026 Darren Smith Group Chief Financial Officer Telix Pharmaceuticals Limited 55 Flemington Road North Melbourne, Victoria 3051 Australia Re: Telix Pharmaceuticals Limited Form 20-F for Fiscal Year Ended December 31, 2025 File No. 001-42128 Dear Darren Smith: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 20-F for the Fiscal Year Ended December 31, 2025 Item 5. Operating and Financial Review and Prospects A. Operating Results Alternative Performance Measures, page 161 1. We note that you present Adjusted EBITDAR, a non-IFRS measure, that adjusts for costs associated with research and development costs and revenue from contracts with customers. Please tell us how you considered the guidance in Item 10(e) of Regulation S-K and Question 100.01 of the Non-GAAP Corporation Finance Interpretations in presenting this non-IFRS measure and explain why these adjustments are appropriate. April 3, 2026 Page 2 In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Gary Newberry at 202-551-3761 or Tara Harkins at 202-551-3639 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2024-11-12 - CORRESP - Telix Pharmaceuticals Ltd
CORRESP
1
filename1.htm
Telix Pharmaceuticals Limited
55 Flemington Road
North Melbourne, Victoria, 3051, Australia
November 12, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Telix Pharmaceuticals Limited
Registration Statement on Form 20-F
File No. 001-42128
Ladies and Gentlemen:
Pursuant to Rule 12d1-2 promulgated under the Securities Exchange Act of 1934, as amended, Telix Pharmaceuticals Limited (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the Registration Statement on Form 20-F (File No. 001-42128), as amended, to become effective at 4:00 p.m. Eastern time on November 12, 2024, or as soon thereafter as practicable, or at such later time as the Registrant or its counsel may
orally request by telephone call to the staff of the Commission.
Please contact Craig Hilts of Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Registrant, at (617) 526-6083, to provide notice of effectiveness, or if you have any comments or questions regarding this matter.
[Remainder of Page Intentionally Left Blank]
Very truly yours,
TELIX PHARMACEUTICALS LIMITED
By:
/s/ Dr. Christian Behrenbruch
Name:
Dr. Christian Behrenbruch
Title:
Group Chief Executive Officer and Managing Director
2024-10-17 - CORRESP - Telix Pharmaceuticals Ltd
CORRESP
1
filename1.htm
October 17, 2024
+1 617 526 6000 (t)
+1 617 526 5000 (f)
wilmerhale.com
By Electronic Submission
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Alan Campbell and Daniel Crawford
Re:
Telix Pharmaceuticals Limited
Draft Registration Statement on Form 20-F
Submitted September 13, 2024
CIK No. 0002007191
Ladies and Gentlemen:
On behalf of Telix Pharmaceuticals Limited (the “Company”), we are responding to the comments contained in a letter, dated October 10, 2024 (the “Letter”) from the Staff (the “Staff”) of the Office of Life Sciences of the
Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) to Christian Behrenbruch, Ph.D., the Company’s Chief Executive Officer, relating to the above referenced Draft Registration Statement on Form 20-F.
The Company is also filing a Registration Statement on Form 20-F (the “Registration Statement”) relating to the registration of securities pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended.
Set forth below are the Company’s responses to the Staff’s comments. The responses are based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The responses are keyed to the numbering of the comments and the
headings used in the Letter. Where appropriate, the Company has responded to the Staff’s comment by making changes to the disclosure in the Registration Statement. Page numbers referred to in the responses reference the applicable page numbers in the
Registration Statement.
October 17, 2024
Page 2
Draft Registration Statement on Form 20-F
Item 4. Information on the Company
B. Business Overview
Our Product Pipeline, page 96
1.
We note your inclusion of TLX007 in your product pipeline table. Please revise your disclosure accompanying your pipeline table to clarify, if true, that TLX007 is an extended stability version of Illuccix.
Alternatively, please advise.
Response:
The Company advises the Staff that while TLX007-CDx is designed to provide extended stability post-production due to its higher radioactivity, TLX007-CDx has its own new drug application as it
has a different formulation than Illuccix. In response to the Staff’s comment, the Company has revised its disclosure on page 98 of the Registration Statement to provide this clarification.
Glioma and LAT1/LAT2, page 100
2.
Please provide the basis for the statement on pages 100 and 117 that TLX102 demonstrated a “favorable efficacy and safety profile.” To the extent that this claim is based on management’s belief, please so state.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 101 and 118 of the Registration Statement to state that this statement is based on management belief’s that
TLX102 has the potential to have a favorable efficacy and safety profile based on pre-clinical studies with TLX102.
Bone Metastases and Pain Palliation, page 102
3.
We note your claim that TLX090 has improvements in formulation and manufacturing that enabled it to demonstrate fewer impurities, lower toxicity, lower costs and expanded availability in early clinical trials as
compared to Quadramet®. To the extent that this statement is not based on head-to-head clinical trial data, please remove it.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 103 and 124 of the Registration Statement to remove the statement.
Intellectual Property, page 128
4.
Please revise your Intellectual Property section starting on page 128 to disclose all jurisdictions where you have patent applications for each of your patent families.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 132, 133, 134 and 135 of the Registration Statement to disclose all jurisdictions where the Company has
patient applications for each its patent families.
October 17, 2024
Page 3
If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 526-6083 or e-mail at craig.hilts@wilmerhale.com. Thank you for your assistance.
Very truly yours,
/s/ Craig Hilts
Craig Hilts
cc:
Christian Behrenbruch, Ph.D., Telix Pharmaceuticals Limited
Lena Moran-Adams, Telix Pharmaceuticals Limited
Jason Kropp, Wilmer Cutler Pickering Hale and Dorr LLP
2024-10-10 - UPLOAD - Telix Pharmaceuticals Ltd File: 377-07439
October 10, 2024
Christian Behrenbruch
Managing Director and Group Chief Executive Officer
Telix Pharmaceuticals Limited
55 Flemington Road
North Melbourne, Victoria 3051, Australia
Re:Telix Pharmaceuticals Limited
Draft Registration Statement on Form 20-F
Submitted September 13, 2024
CIK No. 0002007191
Dear Christian Behrenbruch:
We have reviewed your draft registration statement and have the following comments.
Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form 20-F
Item 4. Information on the Company
B. Business Overview
Our Product Pipeline, page 96
1.We note your inclusion of TLX007 in your product pipeline table. Please revise your
disclosure accompanying your pipeline table to clarify, if true, that TLX007 is an
extended stability version of Illuccix. Alternatively, please advise.
October 10, 2024
Page 2
Glioma and LAT1/LAT2, page 100
2.Please provide the basis for the statement on pages 100 and 117 that TLX102
demonstrated a “favorable efficacy and safety profile.” To the extent that this claim is
based on management's belief, please so state.
Bone Metastases and Pain Palliation, page 102
3.We note your claim that TLX090 has improvements in formulation and
manufacturing that enabled it to demonstrate fewer impurities, lower toxicity, lower
costs and expanded availability in early clinical trials as compared to Quadramet®. To
the extent that this statement is not based on head-to-head clinical trial data, please
remove it.
Intellectual Property, page 128
4.Please revise your Intellectual Property section starting on page 128 to disclose all
jurisdictions where you have patent applications for each of your patent families.
Please contact Gary Newberry at 202-551-3761 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at 202-551-4224
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Craig Hilts
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