Telix Reports 63% Revenue Growth to $204M, Confirms $770M FY Guidance
Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase to $204 million in Q2 2025, launched its new prostate cancer imaging agent Gozellix in the U.S., and advanced key clinical trials despite an ongoing SEC inquiry.
- Q2 2025 revenue up 63% to $204 million
- U.S. launch of Gozellix with HCPCS reimbursement code secured
- ProstACT Global Phase 3 trial reaches key patient recruitment milestone
- New manufacturing facilities operational in Japan and Belgium
- SEC subpoena related to prostate cancer therapy disclosures disclosed
Strong Revenue Growth and Market Expansion
Telix Pharmaceuticals Limited has delivered a striking financial performance in the second quarter of 2025, reporting unaudited group revenue of approximately $204 million, marking a 63% increase compared to the same period last year. This growth underscores the company's expanding footprint in the radiopharmaceutical sector, particularly in oncology diagnostics and therapeutics.
The company reaffirmed its full-year 2025 revenue guidance of $770 million to $800 million, reflecting confidence in its commercial momentum and pipeline progress. Notably, revenue from its flagship prostate cancer imaging product, Illuccix, continues to grow, with dose volumes rising 7% quarter-on-quarter in the U.S. market despite emerging pricing pressures.
Gozellix Launch and Reimbursement Milestone
Telix marked a significant commercial milestone with the U.S. launch of Gozellix, a new gallium-68 based prostate cancer imaging agent. The assignment of a Level II Healthcare Common Procedure Coding System (HCPCS) code effective October 1, 2025, is a critical step toward securing Transitional Pass-Through payment status, facilitating reimbursement and broader adoption in clinical practice.
This launch complements Telix’s existing PSMA portfolio and positions the company to better compete in a dynamic market. The company’s strategic approach to managing pricing pressures includes leveraging such reimbursement advancements to sustain average selling prices.
Clinical Pipeline Progress and Global Trial Expansion
On the clinical front, Telix achieved a key milestone in its ProstACT Global Phase 3 trial for its lead prostate cancer therapeutic candidate, TLX591. All 30 patients required for Part 1 of the trial have been consented, with dosing completed in two arms. The trial is set to expand into China, Japan, and Canada following regulatory approvals, underscoring Telix’s commitment to global development.
Additional pipeline developments include Phase 1 and pivotal trials for other candidates such as TLX592, TLX101, and TLX250, targeting various cancers and metastatic diseases. These efforts reflect Telix’s broad therapeutic ambitions beyond diagnostics.
Manufacturing Expansion and Strategic Partnerships
Telix has also bolstered its manufacturing capabilities with the opening of a Good Manufacturing Practice (GMP) facility in Yokohama, Japan, its first cyclotron site in the Asia Pacific region. This facility will support commercial and clinical supply needs and future R&D activities. Additionally, the Brussels South facility in Belgium has commenced commercial radiopharmaceutical production, marking a significant step in Telix’s European manufacturing footprint.
Regulatory and Legal Update
In a notable disclosure, Telix revealed it has received a subpoena from the U.S. Securities and Exchange Commission (SEC) concerning its disclosures related to prostate cancer therapeutic candidates. The company is cooperating fully and characterizes the inquiry as a fact-finding request without any indication of wrongdoing. Importantly, the inquiry does not affect Telix’s commercial or late-stage precision medicine products.
While the SEC investigation introduces an element of regulatory uncertainty, Telix continues its clinical and commercial activities unabated, maintaining focus on its growth trajectory and pipeline advancement.
Bottom Line?
Telix’s strong commercial momentum and pipeline progress set the stage for continued growth, but the unfolding SEC inquiry adds a watchpoint for investors.
Questions in the middle?
- How will the SEC inquiry impact Telix’s clinical trial timelines and investor confidence?
- What are the competitive dynamics and pricing pressures facing Gozellix and Illuccix in the U.S. market?
- When can investors expect interim clinical data from the ProstACT Phase 3 trial and its potential regulatory implications?