Telix Exceeds FY24 Guidance with US$142M Q4 Revenue

 

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®, its diagnostic radiopharmaceutical for prostate cancer PET[2] 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 radiopharmaceuticals[3].

Precision Medicine Business

  • Kidney cancer imaging, TLX250-CDx (Zircaix®[4]89Zr-girentuximab): Telix submitted a Biologics License Application (BLA) for its renal cancer imaging candidate on 27 December 2024 and continues to target a U.S. commercial launch in H2 2025[5].
  • Brain cancer imaging, TLX101-CDx, (Pixclara®[4]18F-floretyrosine or 18F-FET): The FDA formally accepted Telix’s New Drug Application (NDA), granted a Priority Review and provided a PDUFA[6] goal date of 26 April 2025.
  • Illuccix® 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 Illuccix[7]. This technology enhances scanning workflow, increasing scanner throughput and capacity.
  • Scintimun®: Today, Telix announced that it has entered into an agreement with Curium Pharma for the transfer of marketing and distribution rights for Scintimun® (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)

  • RLS (USA) Inc acquisition: During Q4 2024, Telix progressed integration planning and expects to close the transaction in the first quarter of 2025[9].
  • Brussels South production facility buildoutTelix 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 2025[10]. Formal Good Manufacturing Practice (GMP) 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).
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