Shares in Telix Pharmaceuticals Ltd (ASX: TLX) are expected to be closely monitored today following the company’s announcement that it has met its full-year revenue guidance and achieved significant growth in its fourth-quarter revenue. Late yesterday, the drug developer reported full-year revenue of US$804 million (approximately $1.2 billion AUD), aligning with the company’s revised guidance of US$800 to US$820 million.
Telix’s fourth-quarter revenue reached US$208 million, marking a 46% increase compared to the same period last year. The company’s precision medicine division generated revenue of about US$161 million, a 4% rise from the previous quarter, largely attributed to the successful U.S. launch of Gozellix. This launch followed the reimbursement approval by the Centers for Medicare and Medicaid Services (CMS), effective from October 1, 2025.
Strong Performance Across Divisions
Dr. Christian Behrenbruch, Telix’s managing director, expressed satisfaction with the results, noting the impressive growth in the Precision Medicine sector. “Telix’s Precision Medicine business delivered excellent sequential growth in Q4 2025, driven in part by the successful U.S. launch of Gozellix,” he stated.
“This revenue growth outpaced a 3% increase in dose volumes, demonstrating the positive impact of our two-product strategy on market share and pricing. With strong early uptake of Gozellix and a robust pipeline of key accounts integrating Gozellix and ARTMS technology, Telix is well positioned for sustained growth in 2026.”
The company’s strategic focus on precision medicine and its two-product strategy appear to be paying dividends, as evidenced by the robust financial performance. The successful introduction of Gozellix in the U.S. market highlights Telix’s ability to capitalize on new opportunities and drive revenue growth.
Advancements in Clinical Trials
Meanwhile, Telix is making significant strides in its clinical trial programs. The company reported that the first international patients have been dosed in Part 2 of the ProstACT Global Phase 3 study of TLX591-Tx, aimed at treating advanced prostate cancer. This compound is Telix’s leading prostate cancer therapy candidate, and the company is gearing up for a readout of safety and dosimetry data from Part 1 of the trial.
The study is currently open for enrollment in Australia, New Zealand, and Canada, with plans to expand to China, Singapore, South Korea, Türkiye, the United Kingdom, and Japan, where regulatory approvals have been secured. Data from Part 1 will be presented to the U.S. Food and Drug Administration (FDA) to determine eligibility for U.S. patient participation in Part 2.
Additionally, Telix has initiated dosing for the first U.S. patients in the Solace study, which explores a therapeutic candidate for managing pain in patients with osteoblastic bone metastases from prostate and breast cancers.
Regulatory Milestones and Market Expansion
In a significant regulatory development, China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted a new drug application (NDA) for Illuccix, Telix’s leading prostate cancer imaging agent. This NDA was submitted in collaboration with Telix’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited.
“The NDA submission seeks a broad label that reflects clinical utility at multiple stages of prostate cancer care, including data from the Illuccix China Pivotal Phase 3 Registration study, which reported positive top-line results in December 2025.”
Illuccix has already received approval from the FDA, Australia’s Therapeutic Goods Administration, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, and in 19 countries within the European Economic Area. The drug’s potential market impact is underscored by the rising incidence of prostate cancer, with over 134,000 men diagnosed in 2022 and an annual increase of approximately 6%.
Future Outlook
Telix’s recent achievements underscore its strategic positioning for continued growth and innovation in the precision medicine sector. The company’s focus on expanding its market presence and advancing its clinical programs positions it well for future success. As Telix continues to navigate regulatory landscapes and clinical trials, its ability to adapt and innovate will be crucial in maintaining its competitive edge.
Investors and industry observers will be keenly watching Telix’s next moves as it seeks to build on its recent successes and explore new opportunities in the rapidly evolving pharmaceutical landscape.
