Telix Pharmaceuticals (ASX:TLX) has raised its full-year revenue guidance to between US$800 million and US$820 million following a solid third quarter marked by 53 per cent year-on-year revenue growth, reimbursement wins for Gozellix in the United States, and further expansion of its commercial footprint in Europe .
The company reported unaudited third-quarter revenue of US$206 million, up from US$135 million in the same period last year, supported by growing adoption of its PSMA imaging portfolio and additional contributions from radiopharmacy operations.
A significant milestone for the quarter was the granting of full reimbursement status for Gozellix in the US from 1 October, with both Level II HCPCS coding and Transitional Pass-Through payment confirmed. Telix is now the only company with two FDA-approved PSMA imaging products, Gozellix and Illuccix, giving it a differentiated commercial position in the world’s largest nuclear medicine market.
In Europe, Illuccix is now approved in 19 markets plus the UK, with commercial launches underway in Germany, France, the UK and Scandinavia. These launches are expected to support continued revenue momentum as reimbursement pathways are secured country by country.
“We believe this is a solid result, particularly in light of the reimbursement dynamics during the quarter,” said Telix CEO Christian Behrenbruch. “Telix has entered Q4 in a position of strength, supported by a growing customer base, two FDA-approved PSMA imaging agents, and CMS reimbursement for Gozellix.”
The company continues to advance its clinical pipeline across oncology indications. Part 2 of the ProstACT Global Phase 3 trial of TLX591 is now enrolling patients in Australia, New Zealand and Canada, with regulatory approval to expand to China, Singapore, Türkiye and Japan.
The pivotal trial LUTEON of TLX250 in advanced ccRCC has received ethics approval in Australia, while STARLITE-1 (Phase 1b/2) has commenced dosing in combination with cabozantinib and nivolumab. The international IPAX-BrIGHT pivotal study of TLX101 has begun site activation in Australia. The first patient is expected to be dosed shortly in the SOLACE study of TLX090. Early clinical data on TLX400 were recently published, demonstrating antitumor activity with an encouraging safety profile.
Additionally, Telix has dosed its first patients in the BiPASS Phase 3 trial, which is evaluating MRI combined with PSMA-PET for diagnosing prostate cancer. This study aims to expand indications for both Illuccix and Gozellix while potentially reducing the need for invasive biopsies.
Telix has also secured radiation licenses for its new manufacturing facilities in North Melbourne and Yokohama, which are moving toward operational readiness. These sites are expected to enhance production flexibility and secure a long-term supply of critical medical isotopes.
The company completed its final royalty buy-out to Advanced Nuclear Medicine Ingredients (ANMI) during the quarter, paying US$51.7 million. This payment removes future variable royalty obligations associated with the Illuccix technology, improving cash flow predictability in the coming years.
Telix confirmed it expects R&D investment to grow by 20–25 per cent year-on-year in the financial year 2025, reflecting a broad late-stage clinical development program. “This differentiated two-product strategy enables us to expand market share across all customer segments, with Gozellix enhancing our production flexibility and providing customer choice based on patient reimbursement pathways,” Dr Behrenbruch said.