Telix Pharmaceuticals (ASX: TLX) has reported full-year 2025 revenue of approximately US$804 million (A$1.2 billion), meeting its upgraded guidance range of US$800-820 million. The precision medicine specialist’s fourth quarter performance demonstrated accelerating momentum, with revenue of US$208 million representing 46% year-over-year growth. The successful United States launch of Gozellix, following Centers for Medicare and Medicaid Services reimbursement approval effective from 1 October 2025, emerged as a primary catalyst for the company’s commercial expansion.
Why Did Telix Achieve US$804M Revenue?
The company’s revenue growth was underpinned by its Precision Medicine business, which generated approximately US$161 million in Q4 2025, representing 4% quarter-over-quarter growth. This sequential increase is particularly significant as it outpaced a 3% increase in dose volumes, demonstrating improved pricing power and market share gains from the dual-product strategy combining Illuccix and Gozellix.
| Revenue Metric (US$M) | Q4 2025 | Q4 2024 | YoY Change | Q3 2025 | QoQ Change |
|---|---|---|---|---|---|
| Group Revenue | 208 | 142 | +46% | 206 | +1% |
| Precision Medicine | 161 | 139 | +16% | 155 | +4% |
| RLS Third-Party | 45 | — | — | 47 | -4% |
Managing Director and Group CEO Dr. Christian Behrenbruch 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 revenue growth mechanics reveal strategic advantages beyond simple volume expansion. Revenue growth outpacing volume growth signals pricing discipline and the company’s ability to capture value from its innovation rather than competing solely on scale. The two-product portfolio enables radiopharmacies to optimise logistics and provides hospitals with operational flexibility, creating switching costs that strengthen Telix’s competitive position.
Commercial Portfolio Expansion
Telix has systematically expanded its international footprint for Illuccix, now holding marketing authorisations across 19 European countries following decentralised procedure approval. Commercial launches have commenced in 12 European markets, including France, Germany, Spain and the United Kingdom, as reimbursement is secured on a market-by-market basis.
In Australia, hospitals and imaging centres continue transitioning from in-house production of 68Ga-PSMA-11 to Illuccix, with the approved agent capturing approximately 55% market share nationally as of 31 December 2025. This domestic performance validates the product’s clinical and economic value proposition in a competitive market.
Key international regulatory milestones include:
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China: The National Medical Products Administration accepted the New Drug Application filing for TLX591-Px (Illuccix) following positive Phase 3 results demonstrating 94.8% positive predictive value for detecting tumours in patients with biochemical recurrence of prostate cancer.
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Japan: The company dosed its first patient in a Phase 3 registration study across 11 sites, enrolling up to 105 Japanese men to support a future marketing authorisation application.
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BiPASS Phase 3 Study: First U.S. patients were dosed in the trial evaluating magnetic resonance imaging combined with PSMA-PET imaging agents in the initial prostate cancer diagnosis setting, potentially expanding the addressable market beyond staging and recurrence detection.
What Is Gozellix and Why Does It Matter?
PSMA-PET imaging technology enables physicians to visualise prostate-specific membrane antigen, a protein highly expressed on prostate cancer cells. This allows for more precise detection and staging of prostate cancer compared to traditional imaging methods. Gozellix represents a fluorine-18 based PSMA-PET tracer, whilst Illuccix utilises gallium-68 as its radioactive isotope.
The technical distinction translates into practical advantages. Fluorine-18 has a longer half-life than gallium-68, enabling broader geographic distribution from centralised production facilities and potentially improved operational economics for radiopharmacies. This logistical flexibility addresses a key constraint in radiopharmaceutical distribution, where decay rates limit the distance products can travel from manufacturing sites.
The dual-product strategy creates operational stickiness within hospital and imaging centre networks. Radiopharmacies integrating both products gain logistical flexibility to optimise scheduling and production capacity, whilst clinical teams access choice in selecting the most appropriate tracer for specific patient scenarios.
Key advantages of the two-product portfolio include:
- Logistical flexibility for radiopharmacies managing production and distribution schedules
- Competitive differentiation versus single-product competitors in procurement negotiations
- Pricing leverage through product choice and complementary positioning rather than direct substitution
The dual-product strategy creates hospital switching costs and operational stickiness. Competitors must now match two products, not one, to displace Telix’s commercial position. This represents a structural competitive advantage in an expanding precision medicine market.
Therapeutic Pipeline Progress
Telix’s therapeutic pipeline represents a portfolio of candidates targeting multi-billion-dollar market opportunities across multiple cancer types. The advancement of late-stage programmes beyond diagnostic imaging into therapeutic applications positions the company to capture both diagnostic and treatment revenues within the same patient populations, creating integrated care pathways.
Advanced Prostate Cancer Therapy
The ProstACT Global Phase 3 study of TLX591-Tx (lutetium-177 rosopatamab tetraxetan) has commenced Part 2 randomised treatment expansion following data safety review. International patients have been dosed across sites in Australia, New Zealand and Canada, with regulatory approvals secured for expansion into China, Singapore, South Korea, Türkiye, the United Kingdom and Japan.
Telix is preparing for a readout of safety and dosimetry data from Part 1, which will be presented to the U.S. Food and Drug Administration to determine eligibility for U.S. patient participation in Part 2. The alpha therapy candidate TLX592-Tx is preparing for site activation in the AlphaPRO first-in-human study, initially recruiting ex-U.S.
Therapeutic candidates in advanced prostate cancer represent a multi-billion-dollar market opportunity where current standards of care provide limited options for patients with metastatic castration-resistant disease. Successful development would position Telix to address both imaging and treatment needs within integrated care pathways.
Beyond Prostate: Kidney and Brain Cancers
The company is diversifying its therapeutic portfolio across multiple solid tumour types, reducing dependence on prostate cancer whilst leveraging radiopharmaceutical platform expertise. The LUTEON pivotal trial of TLX250-Tx as monotherapy in metastatic clear cell renal cell carcinoma is commencing site activations, initially recruiting ex-U.S.
TLX252-Tx received approval in Australia to commence ALPHIX, a Phase 1 first-in-human study of targeted alpha therapy for advanced metastatic kidney cancer and cancers expressing carbonic anhydrase IX. The IPAX-BrIGHT trial is enrolling patients at Australian sites for TLX101-Tx in recurrent glioblastoma, with European sites expected to join in Q1 2026.
FDA-acknowledged regulatory milestones include:
- TLX102-Tx for leptomeningeal disease: FDA acknowledged as “significant unmet medical need” with positive written feedback on two-part study design
- TLX101-Px (Pixclara): Productive Type A meeting conducted, finalising resubmission package following Complete Response Letter
- TLX250-Px (Zircaix): Type A meetings in December 2025 and January 2026 establishing alignment on chemistry, manufacturing, and controls deficiencies and clinical comparability
Pain Management and Bone Metastases
The SOLACE Phase 1 study of TLX090-Tx dosed its first U.S. patients, evaluating the therapeutic candidate for treating pain in patients with osteoblastic bone metastases from prostate and breast cancers. This supportive care application addresses quality-of-life considerations whilst representing a commercial opportunity in a large patient population requiring palliative interventions.
Strategic Collaboration with Varian
Telix announced a strategic clinical collaboration with Varian, a Siemens Healthineers company and global leader in radiation oncology. The partnership focuses on developing clinical applications combining Telix’s theranostic products with external beam radiation therapy, starting with PSMA-PET imaging for prostate cancer.
The collaboration framework supports future co-development opportunities across Telix’s pipeline, including TLX250-Px and TLX101-Px imaging candidates, and potential therapeutic radiopharmaceuticals. Varian’s market leadership in radiation oncology provides access to established clinical networks and treatment planning infrastructure.
The partnership opens new clinical pathways and enhances product differentiation. Competitors without integrated imaging-therapy combinations may face adoption headwinds as treatment paradigms evolve toward precision medicine approaches combining molecular imaging with targeted radiation delivery.
Manufacturing Infrastructure Buildout
Telix Manufacturing Solutions is executing a vertical integration strategy through targeted infrastructure investments securing future supply and protecting gross margins as therapeutic candidates scale to commercial volumes. Manufacturing control mitigates supply chain risk critical for radiopharmaceuticals where short half-lives require proximity to clinical sites.
Key infrastructure projects include:
- Cyclotron installations at select RLS Radiopharmacies network sites enabling in-house production of critical therapeutic and diagnostic isotopes
- Angleton, Texas upgrades to Good Manufacturing Practice production facilities and clean rooms at IsoTherapeutics
- Yokohama, Japan facility representing Telix’s first cyclotron site in Asia Pacific supporting future product launches and regional clinical trials
- North Melbourne translational research hub incorporating radiochemistry hot labs for clinical dose production and patient dosing suite with in-house SPECT/CT capabilities
These investments position Telix to control production economics whilst establishing global centres of excellence for advancing next-generation therapeutic radiopharmaceuticals.
Near-Term Catalysts and 2026 Outlook
Multiple regulatory catalysts in the first half of 2026 create potential for significant valuation re-rating as both therapeutic and diagnostic pipelines advance toward commercialisation. Key inflection points include the Biologics License Application resubmission for TLX250-Px (Zircaix) following FDA alignment on chemistry, manufacturing, and controls requirements and clinical comparability.
The TLX101-Px (Pixclara) resubmission package is being finalised following productive Type A meeting discussions on additional clinical data and revised statistical analysis. The BiPASS Phase 3 study enrollment continues evaluating magnetic resonance imaging combined with PSMA-PET imaging in initial prostate cancer diagnosis, potentially expanding the addressable market for Telix’s commercial products.
Management reiterated its positioning for sustained growth in 2026, supported by the two-product commercial portfolio, advancing therapeutic pipeline, and manufacturing infrastructure investments. The combination of near-term regulatory catalysts and operational execution provides multiple pathways for value creation as the precision medicine platform matures.
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Telix’s US$804 million revenue milestone and expanding therapeutic pipeline demonstrate the transformative potential of precision medicine. For investors seeking to stay ahead of developments in Biotech, Healthcare, and other high-growth ASX sectors, timing is everything.
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