Telix’s Growth Hinges on Gozellix Uptake and Varian Partnership Risks

Strong Financial Performance

Telix Pharmaceuticals has delivered on its FY 2025 revenue guidance, reporting approximately US$804 million (A$1.2 billion) in unaudited group revenue. This figure aligns with the company’s upgraded guidance range of US$800-$820 million, reflecting robust commercial momentum. The fourth quarter alone saw revenues surge 46% year-over-year to US$208 million, underscoring accelerating growth.

The Precision Medicine business was a key driver, generating US$161 million in Q4 revenue, a 4% increase quarter-over-quarter, largely propelled by the successful US launch of Gozellix. This launch followed reimbursement approval by the Centers for Medicare and Medicaid Services, effective from October 2025, marking a significant milestone for Telix’s US market penetration.

Clinical Pipeline Advances

Beyond commercial success, Telix made notable progress across its therapeutic pipeline. The ProstACT Global Phase 3 study for TLX591-Tx in advanced prostate cancer entered its randomized expansion phase with first international patients treated. Similarly, the SOLACE Phase 1 study commenced dosing US patients for TLX090-Tx, targeting pain from bone metastases.

Other clinical programs are advancing, including site activations for LUTEON and ALPHIX trials in kidney cancer, and enrollment in the IPAX-BrIGHT trial for recurrent glioblastoma. These developments reflect Telix’s commitment to expanding its therapeutic radiopharmaceutical portfolio across multiple cancer indications.

Regulatory and Market Expansion

Telix’s regulatory footprint continues to broaden. Illuccix, its PSMA PET imaging agent, gained approval in Spain, completing marketing authorizations across 19 European countries. Commercial launches are underway in major markets including France, Germany, Spain, and the UK. In Australia, Illuccix has become the leading PSMA PET tracer nationally, capturing approximately 55% market share.

In Asia, the Chinese regulatory authority accepted the New Drug Application for Illuccix, following strong Phase 3 data demonstrating high tumor detection accuracy. Japan also saw the first patient dosed in a Phase 3 registration study, supporting future marketing authorization efforts.

Strategic Collaboration and Manufacturing Investments

Telix announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, to explore combining Telix’s radiopharmaceuticals with external beam radiation therapy. This partnership aims to develop novel treatment approaches, starting with prostate cancer imaging and potentially extending to therapeutic applications.

On the manufacturing front, Telix is investing heavily in supply chain capabilities. Key initiatives include cyclotron installations at radiopharmacy sites, upgrades to Good Manufacturing Practice facilities in Texas, and the opening of a new cyclotron facility in Yokohama, Japan. A translational research hub in Melbourne is nearing completion, enhancing Telix’s capacity for clinical dose production and imaging.

Looking Ahead

With a strong finish to 2025, Telix is well positioned for sustained growth in 2026. The company’s dual focus on commercial execution and clinical innovation, supported by strategic partnerships and manufacturing expansion, sets the stage for further market penetration and pipeline maturation.