Telix Exceeds FY24 Guidance with US$142M Q4 Revenue

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024).

Sustained revenue growth

   -- Q4 2024 unaudited revenue of approximately US$142 million (AU$218 
      million)1, represents an increase of 46% over the prior year 
      corresponding quarter (Q4 2023: US$97 million or AU$148 million) and a 
      quarter-over-quarter increase of 5% (Q3 2024: US$135 million or AU$201 
      million). 
 
   -- Telix's revenue is currently generated predominantly from sales of 
      Illuccix$(R)$, its diagnostic radiopharmaceutical for prostate cancer PET2 
      imaging. 

Full year guidance exceeded

   -- Total FY2024 unaudited revenue is approximately US$517 million (AU$783 
      million) exceeding previously stated guidance of US$490 million to US$510 
      million (AU$745 million to AU$776 million), representing a 55% increase 
      over FY2023. 
 
   -- FY2024 investment into research and development (R&D) remains in line 
      with guidance, funded by earnings generated from product sales. 
 
   -- The Company intends to provide FY2025 guidance when it reports audited 
      FY2024 annual results on 20 February 2025. 

Q4 2024 business update

Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, "This has been another great quarter of commercial performance. Strong sales of Illuccix have led Telix to close out the year with revenue above guidance, while significantly progressing our strategic priorities. Boosting our balance sheet and the Nasdaq listing were major corporate milestones. The acquisition of FAP-targeting assets is a major addition to our superb product pipeline. We are well-positioned for significant expansion, including planned launches of multiple imaging products in key markets and advancing late-stage therapeutic assets into pivotal trials. 2025 is shaping up to be transformative year for Telix."

Therapeutics Business

   -- Prostate cancer therapy candidate, TLX591 (177Lu-rosapatamab): During Q4 
      2024 Telix progressed ProstACT GLOBAL, the registrational clinical trial 
      for Telix's lead clinical therapeutic asset with first interim read out 
      expected in H1 2025. 
   -- Kidney cancer therapy candidate, TLX250 (177Lu-girentuximab): The Company 
      was granted a pre-investigational new drug (pre-IND) meeting with the 
      U.S. Food and Drug Administration (FDA) in Q4 2024, to discuss a proposed 
      Telix-sponsored pivotal trial of TLX250. 
   -- Glioblastoma therapy candidate, TLX101 (131I-iodofalan, or 131I-IPA): 
      During Q4 2024, the Company held a pre-IND meeting with the FDA to 
      discuss the design of a pivotal trial for TLX101. Based on positive 
      feedback from the meeting, Telix will move forward with an IND submission 
      in H1 2025. 
   -- Fibroblast Activation Protein (FAP) targeting therapy candidate, TLX400: 
      Telix entered into asset purchase and exclusive worldwide in-license 
      agreements for a suite of clinically validated assets targeting FAP. FAP 
      is one of the most promising pan-cancer targets, with an initial focus on 
      bladder cancer rounding out Telix's leading urology theranostics 
      franchise. 
   -- Proprietary engineered antibody platform and pipeline: Today, Telix 
      announced it has entered into a transaction with ImaginAb Inc. to acquire 
      a groundbreaking platform technology and drug discovery capability, along 
      with a pipeline of next-generation biologic-based therapeutic candidates 
      with significant potential to deliver future innovation in 
      radiopharmaceuticals3. 

Precision Medicine Business

   -- Kidney cancer imaging, TLX250-CDx (Zircaix(R)4, 89Zr-girentuximab): Telix 
      submitted a Biologics License Application $(BLA.AU)$ for its renal cancer 
      imaging candidate on 27 December 2024 and continues to target a U.S. 
      commercial launch in H2 20255. 
   -- Brain cancer imaging, TLX101-CDx, (Pixclara(R)4, 18F-floretyrosine or 
      18F-FET): The FDA formally accepted Telix's New Drug Application (NDA), 
      granted a Priority Review and provided a PDUFA6 goal date of 26 April 
      2025. 
   -- Illuccix(R) global regulatory submissions: The German Federal Institute 
      for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und 
      Medizinprodukte, or BfArM) is expected to provide its decision on the 
      Company's EU marketing authorization application on 15 January 2025. In 
      the United Kingdom (UK), the Company has responded to all queries with no 
      substantive issues raised. The UK regulator (the Medicines and Healthcare 
      products Regulatory Agency - MHRA) is experiencing significant 
      administrative delays but an approval decision is expected this month. 
      The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a 
      decision imminently after protracted administrative delays also unrelated 
      to Telix's marketing authorization application. 
   -- MedTech partnership with Subtle Medical: Telix has concluded a 
      partnership with California-based Subtle Medical, Inc. for artificial 
      intelligence (AI)-powered PET imaging with Illuccix7. This technology 
      enhances scanning workflow, increasing scanner throughput and capacity. 
   -- Scintimun(R): Today, Telix announced that it has entered into an 
      agreement with Curium Pharma for the transfer of marketing and 
      distribution rights for Scintimun(R) (99mTc-besilesomab, also known as 
      TLX66-CDx)8. Scintimun is approved in 33 countries to image infection 
      (osteomyelitis), with significant clinical indication expansion and 
      theranostic potential. 

Telix Manufacturing Solutions $(TMS.AU)$

   -- RLS $(USA)$ Inc acquisition: During Q4 2024, Telix progressed integration 
      planning and expects to close the transaction in the first quarter of 
      20259. 
   -- Brussels South production facility buildout: Telix completed the 
      installation of two new cyclotrons at its facility in Brussels South, 
      Belgium, facilitating the production of radioisotopes and patient doses 
      on-site from 202510. Formal Good Manufacturing Practice $(GMP.UK)$ 
      accreditation for the facility is expected imminently. 

Corporate milestones

   -- On 14 November 2024, Telix American Depository Shares (ADSs) commenced 
      trading on the Nasdaq Global Select Market (Nasdaq) under the symbol 
      'TLX'11. Telix continues to maintain its primary listing on the 
      Australian Securities Exchange (ASX). 

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), Canada, and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix's lead imaging product, gallium-68 ((68) Ga) gozetotide injection (also known as (68) Ga PSMA-11 and marketed under the brand name Illuccix(R)), has been approved by the FDA(12) , the Australian Therapeutic Goods Administration $(TGA)$(13) , and Health Canada(14) . No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

Telix Investor Relations

Ms. Kyahn Williamson

Telix Pharmaceuticals Limited

SVP Investor Relations and Corporate Communications

Email: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission $(SEC.UK)$, including our registration statement on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

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