Telix’s 2025: US$803.8M Revenue, US Expansion, and Pipeline Progress

Strong Commercial Momentum

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) reported robust financial results for the year ended 31 December 2025, with total revenue soaring 56% to US$803.8 million. This growth was primarily fuelled by continued strong U.S. sales of its prostate cancer imaging agent Illuccix and the successful launch of Gozellix, its next-generation PSMA-PET imaging product. The company’s Precision Medicine segment, which includes these products, generated US$621.9 million in revenue, underscoring Telix’s growing footprint in the competitive prostate cancer imaging market.

Despite the revenue surge, Telix recorded a net loss after tax of US$7.1 million, a reversal from a profit of US$33.7 million in 2024. This loss reflects significant investments in research and development (R&D), which rose 34% to US$171.2 million, as well as increased manufacturing scale-up costs and finance expenses related to convertible bonds issued in mid-2024. The company’s adjusted EBITDA declined 41% to US$39.5 million, highlighting the transitional nature of 2025 as Telix balances commercial expansion with pipeline advancement.

Advancing a Deep Therapeutic Pipeline

Telix continues to progress its therapeutic radiopharmaceutical pipeline, with multiple pivotal clinical trials underway. The Phase 3 ProstACT Global trial of TLX591-Tx, a lutetium-labelled radio antibody-drug conjugate targeting prostate cancer, is actively recruiting patients across multiple countries including Australia, Canada, China, Japan, and the U.K. This trial aims to evaluate TLX591-Tx in combination with standard of care therapies in metastatic castration-resistant prostate cancer (mCRPC).

Other late-stage programs include TLX250-Tx for kidney cancer and TLX101-Tx for glioblastoma, both of which have received regulatory approvals to commence pivotal trials in Australia and Europe. The company is also developing next-generation alpha therapies such as TLX592-Tx and TLX252-Tx, with Phase 1 studies initiated in 2025. These efforts position Telix at the forefront of targeted radionuclide therapy innovation.

Expanding Manufacturing and Distribution Infrastructure

To support its growing commercial and clinical activities, Telix has made strategic investments in manufacturing and supply chain capabilities. The acquisition of RLS Radiopharmacies in January 2025 significantly expanded Telix’s U.S. footprint, adding over 30 radiopharmacies and enabling the company to build a radiometal production network for domestic manufacturing of radiopharmaceuticals.

In Europe, Telix’s TMS Brussels South facility in Belgium received Good Manufacturing Practice (GMP) accreditation and commenced commercial production of Illuccix. The company also advanced new facilities in Yokohama, Japan, and North Melbourne, Australia, further reinforcing its global manufacturing platform. Additionally, Telix acquired ARTMS Inc., a Canadian cyclotron technology company, enhancing its ability to produce key isotopes such as gallium-68 and zirconium-89.

Sustainability and Governance

In 2025, Telix published its first comprehensive Sustainability report aligned with the Australian Sustainability Reporting Standard AASB S2, focusing on climate-related financial disclosures. The company conducted a Double Materiality Assessment to identify key environmental, social and governance (ESG) risks and opportunities, including physical climate risks such as extreme weather events and transition risks related to energy dependency. Telix’s Board and Audit and Risk Committee oversee sustainability strategy and risk management, with ongoing efforts to set emissions reduction targets and integrate ESG considerations into corporate governance.

Governance changes included the retirement of founding chairman Kevin McCann AO in May 2025, succeeded by Tiffany Olson, who resigned in February 2026 and was replaced by Mark Nelson as interim chair. The Board continues to focus on renewal and strengthening oversight as Telix evolves as a dual-listed company on the ASX and Nasdaq.

Regulatory and Legal Challenges

Telix faces ongoing regulatory challenges, including Complete Response Letters from the FDA for its kidney cancer imaging agent TLX250-Px and glioma imaging agent TLX101-Px. The company is actively engaging regulators and preparing resubmissions, with the expectation of eventual marketing authorizations. Meanwhile, Telix is cooperating with a U.S. Securities and Exchange Commission subpoena related to disclosures about its prostate cancer therapeutic candidates and is defending a recently filed securities class action lawsuit in Indiana.

These regulatory and legal matters underscore the complexities of pioneering novel radiopharmaceutical therapies and diagnostics, and investors should monitor developments closely.

Outlook

Telix’s 2025 results reflect a company in transition, balancing strong commercial growth with significant investment in its therapeutic pipeline and manufacturing infrastructure. The company’s commitment to sustainability and governance, alongside its expanding global footprint, positions it well for long-term growth in precision oncology. However, regulatory uncertainties and legal proceedings present risks that require careful attention.