Telix Pharmaceuticals (ASX: TLX), founded in 2015 and headquartered in Melbourne, is a global biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. The company operates in Australia, the United States, Europe, Brazil, Canada, and Japan. Telix’s product portfolio targets high-value clinical indications in oncology and rare diseases, with multiple FDA– and TGA-approved products already commercialised. Its flagship imaging agent, Illuccix®, is approved in major global markets, and its broader pipeline continues to address unmet needs in prostate, kidney, brain, and soft tissue cancers. Currently, the company’s shares are trading at $25.18.

Commercial Growth Driven by Illuccix® and RLS Acquisition

The lion’s share of Telix’s revenue was generated by its FDA-approved prostate cancer imaging agent, Illuccix®, which brought in US$151 million in Q1, a 35% increase from the same period last year. The recent acquisition of RLS Radiopharmacies, completed in late January, contributed an additional US$33 million, underscoring Telix’s successful vertical integration strategy in the US.

The integration of RLS expands Telix’s radiopharmaceutical manufacturing and distribution capabilities, significantly strengthening its domestic supply chain and market access within the US. The company expects RLS to serve as a scalable platform for future product launches and continued revenue growth.

Reaffirmed Revenue and R&D Guidance for FY2025

Telix reaffirmed its FY2025 revenue guidance of US$770 to US$800 million, incorporating 11 months of contribution from RLS and continued sales momentum from Illuccix® in authorised markets. The company also confirmed an R&D expenditure increase of 20–25% year-on-year, reflecting its ongoing investment in pipeline development and commercial readiness for upcoming product launches.

The outlook may be updated once reimbursement is secured for Gozellix® in the US and for Illuccix® in additional ex-US jurisdictions, including Europe and Brazil.

Clinical Pipeline Advances Across Key Therapeutic Areas

Telix made significant progress across its therapeutic portfolio during the quarter. Recruitment continues for the ProstACT™ Global Phase 3 trial of TLX591 for prostate cancer, with a safety and dosimetry readout from Part 1 expected in H1 2025. Positive interim results were reported for TLX101, the company’s brain cancer therapy candidate, in the IPAX-Linz Phase 2 trial, with favourable safety and efficacy data in glioblastoma patients.

Regulatory filings are underway for investigational new drug (IND) applications to initiate pivotal trials for both TLX101 and TLX250, Telix’s kidney cancer therapy, expected later this year. Additionally, the company dosed its first patient in the ZOLAR trial evaluating TLX300-CDx for metastatic soft tissue sarcoma.

Further strengthening its pipeline, Telix completed the acquisition of ImaginAb’s therapeutic assets, adding next-generation radiopharmaceutical candidates and biologics development capabilities to its operations in Los Angeles.

Precision Medicine and Regulatory Milestones

In the diagnostics segment, Telix secured FDA approval for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer, offering extended shelf life and wider geographic distribution. A US commercial launch is scheduled for Q2 2025 through partners Cardinal Health and RLS.

Illuccix® received regulatory approvals in the UK, Brazil, and multiple European Economic Area (EEA) countries, including Denmark, Sweden, Ireland, and the Netherlands. Commercial launches are scheduled across these markets throughout Q2 2025.

Meanwhile, TLX250-CDx (Zircaix®) for kidney cancer and TLX101-CDx (Pixclara®) for brain cancer continue to progress through the US regulatory review process, with FDA PDUFA dates set for 27 August and 26 April 2025, respectively.

Manufacturing Expansion and Strategic Resilience

In April, Telix’s Brussels South (Seneffe) facility received GMP accreditation, enabling commercial production of radiopharmaceuticals. The company also announced the successful development of a new generator technology for lead-212 (212Pb), significantly improving radioisotope yield and shelf life. This innovation will support Telix’s targeted alpha therapy development.

Despite recent global trade developments, Telix confirmed that its diversified US manufacturing base and minimal reliance on rare earth elements shield it from exposure to semiconductor-related export controls and tariffs announced by the US and Chinese governments.

Governance and Board Renewal

As part of an ongoing board renewal process, Telix announced that Chairman H Kevin McCann AO will retire in May following the Annual General Meeting. Tiffany Olson has been appointed as the incoming Chair. New non-executive directors Marie McDonald and Anne Whitaker joined the board during Q1, strengthening the company’s governance and international expertise.

Outlook for 2025 and Beyond

With strong revenue momentum, global regulatory progress, and a robust pipeline of both diagnostic and therapeutic assets, Telix is poised for a transformative year. Continued investment in R&D, commercial expansion of Illuccix® and Gozellix®, and the integration of RLS and ImaginAb assets position the company to further scale its operations and deliver value to shareholders across international markets. Investors will be watching closely for upcoming clinical data readouts, FDA approvals, and market launches that could significantly elevate Telix’s global footprint.