HomeBiotechnologyTelix Pharmaceuticals (ASX:TLX)

Telix’s Pipeline Expansion and Nasdaq Listing Heighten 2025 Risks and Rewards

Biotechnology By Ada Torres 3 min read

Telix Pharmaceuticals has exceeded its full-year 2024 revenue guidance, driven by strong sales of its prostate cancer diagnostic Illuccix® and strategic pipeline advancements.

  • Q4 2024 revenue hits US$142 million, up 46% year-on-year
  • Full-year 2024 revenue reaches US$517 million, surpassing guidance
  • Progress on multiple therapeutic candidates including TLX591 and TLX250
  • Acquisition of FAP-targeting assets and antibody platform expands pipeline
  • Regulatory milestones and Nasdaq listing bolster corporate profile

Robust Revenue Growth

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) has reported a strong finish to 2024, with unaudited Q4 revenue reaching approximately US$142 million (AU$218 million), marking a 46% increase compared to the same quarter last year. This growth also represents a 5% uplift from the previous quarter, underscoring sustained momentum in the company’s commercial operations.

The full-year revenue for 2024 stands at an impressive US$517 million (AU$783 million), exceeding the company’s prior guidance range of US$490 million to US$510 million. This 55% year-on-year increase highlights Telix’s expanding footprint in the diagnostic radiopharmaceutical market, predominantly driven by sales of Illuccix®, its FDA-approved prostate cancer PET imaging agent.

Pipeline Progress and Strategic Acquisitions

Beyond commercial success, Telix has made significant strides in advancing its therapeutic pipeline. The lead prostate cancer therapy candidate, TLX591 (177Lu-rosapatamab), is progressing through the ProstACT GLOBAL registrational trial, with a first interim readout expected in the first half of 2025. Meanwhile, the kidney cancer therapy candidate TLX250 (177Lu-girentuximab) has secured a pre-IND meeting with the FDA, setting the stage for a pivotal trial.

In addition, Telix has expanded its portfolio through the acquisition of Fibroblast Activation Protein (FAP)-targeting assets, a promising pan-cancer target, particularly for bladder cancer. The company also announced a transaction to acquire a proprietary engineered antibody platform and a pipeline of next-generation biologic therapeutics from ImaginAb Inc., signaling a commitment to innovation in radiopharmaceutical development.

Regulatory and Corporate Milestones

On the regulatory front, Telix is advancing multiple submissions. The FDA formally accepted the New Drug Application for TLX101-CDx (Pixclara®) with a Priority Review and a PDUFA goal date set for April 26, 2025. The company also submitted a Biologics License Application for TLX250-CDx (Zircaix®) targeting a U.S. commercial launch in the second half of 2025. European and UK regulatory decisions on Illuccix® marketing authorizations are anticipated imminently despite administrative delays.

Corporate developments include the completion of two new cyclotrons at Telix’s Brussels South production facility, expected to enhance onsite radioisotope production by 2025. Additionally, Telix’s American Depository Shares commenced trading on the Nasdaq Global Select Market in November 2024, broadening its investor base and market visibility.

Looking Ahead

Telix’s Managing Director and CEO, Dr. Christian Behrenbruch, described 2024 as a year of significant commercial and strategic achievements, positioning the company for transformative growth in 2025. With multiple late-stage clinical trials underway, regulatory milestones approaching, and a strengthened product pipeline, Telix is poised to capitalize on emerging opportunities in oncology diagnostics and therapeutics.

Bottom Line?

Telix’s strong FY24 finish sets the stage for a pivotal 2025 as clinical and regulatory catalysts converge.

Questions in the middle?

  • How will Telix’s upcoming FY25 guidance reflect its accelerated growth trajectory?
  • What impact will the FAP-targeting assets and antibody platform acquisition have on long-term pipeline value?
  • Can Telix sustain momentum amid regulatory uncertainties and competitive pressures in radiopharmaceuticals?