Telix Hits US$804M Revenue Target With 46% Growth Driven by Gozellix Launch

Telix Pharmaceuticals has closed FY25 with unaudited Group revenue of approximately US$804M (A$1.2B), meeting its upgraded guidance range of US$800-820M and demonstrating revenue growth momentum driven by the successful US launch of Gozellix. The biotechnology company’s Q4 2025 performance reflected 46% year-on-year growth, with quarterly revenue reaching US$208M, while Precision Medicine business revenue climbed to US$161M (up 4% quarter-on-quarter).

The company’s two-product PSMA strategy has delivered measurable commercial impact since Centers for Medicare and Medicaid Services (CMS) reimbursement for Gozellix became effective on 1 October 2025. Notably, revenue growth outpaced dose volume growth (3%), suggesting pricing power and market share gains are contributing to value accretion beyond simple volume expansion.

Gozellix US Launch Demonstrates Commercial Execution Strength

The strategic significance of Gozellix extends beyond immediate revenue contribution. By diversifying Telix’s PSMA-PET imaging portfolio beyond Illuccix, the company has created competitive differentiation in the prostate cancer diagnostic market. The two-product approach allows hospitals and imaging centres to select between gallium-68-based (Illuccix) and fluorine-18-based (Gozellix) tracers based on facility infrastructure and clinical preferences, reducing dependence on single-product performance.

Management has highlighted sustained growth visibility into 2026, supported by a robust pipeline of key accounts integrating both Gozellix and the company’s ARTMS technology platform. The 4% sequential Precision Medicine growth in Q4, despite flat overall Group revenue compared to Q3, demonstrates the concentrated impact of Gozellix adoption following CMS reimbursement approval.

“Telix’s Precision Medicine business delivered excellent sequential growth in Q4 2025, driven in part by the successful U.S. launch of Gozellix. 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,” stated Dr. Christian Behrenbruch, Managing Director and Group CEO.

For investors, the divergence between revenue growth (46%) and dose volume growth (3%) represents a critical indicator of market dynamics. This gap suggests Telix is capturing premium pricing through its dual-product positioning whilst simultaneously expanding market penetration.

Understanding PSMA-PET Imaging: The Technology Driving Telix’s Growth

PSMA-PET (prostate-specific membrane antigen positron emission tomography) imaging represents a precision medicine approach to detecting prostate cancer recurrence and metastases. The technology works by targeting PSMA, a protein overexpressed on prostate cancer cells, enabling highly specific visualisation of disease spread compared to conventional imaging methods.

Telix’s strategic decision to commercialise two PSMA-PET tracers addresses distinct clinical and operational requirements:

1. Illuccix (68Ga-PSMA-11): Gallium-68-based tracer produced via on-site generator systems
2. Gozellix (18F-PSMA-1007): Fluorine-18-based tracer enabling centralised production and wider distribution due to longer radioactive half-life

This dual-product portfolio reduces single-product risk whilst capturing diverse facility preferences. Hospitals with cyclotron access may prefer fluorine-18 tracers, whilst those with generator systems favour gallium-68 options. The commercial implications extend beyond mere product choice, as broader portfolio offerings strengthen negotiating positions with group purchasing organisations and hospital networks.

The company’s BiPASS Phase 3 trial, which has begun dosing US patients, aims to combine MRI with PSMA-PET imaging for initial prostate cancer diagnosis (beyond current indications focused on biochemical recurrence). If successful, this represents addressable market expansion into earlier diagnostic stages, where patient volumes substantially exceed the recurrence population.

Global Market Expansion: Europe, Australia, and China Milestones

Telix now holds marketing authorisations across all 19 European countries included in its decentralised procedure submission, with commercial launches active in 12 markets including France, Germany, Spain, and the United Kingdom. This geographic diversification provides revenue stability beyond US market dynamics, particularly as reimbursement negotiations progress on a country-by-country basis.

In Australia, Illuccix has captured approximately 55% market share as of 31 December 2025, displacing in-house production of 68Ga-PSMA-11 by hospitals and imaging centres. This transition demonstrates the commercial viability of approved, standardised radiopharmaceuticals versus facility-specific production methods.

The Chinese National Medical Products Administration has accepted the New Drug Application filing for Illuccix, supported by Phase 3 data demonstrating 94.8% positive predictive value in detecting biochemical recurrence of prostate cancer. China represents a substantial long-term market opportunity given demographic trends and increasing prostate cancer incidence in Asia-Pacific regions.

Therapeutic Pipeline: From Lab to Late-Stage Trials

Telix’s therapeutic pipeline encompasses eight-plus clinical programmes spanning prostate, kidney, brain, and bone cancers. This multi-asset portfolio creates optionality for investors beyond the company’s established imaging franchise, with several candidates approaching pivotal data readouts.

TLX591-Tx, the lead prostate cancer therapy candidate, has commenced Part 2 (randomised expansion) of the ProstACT Global Phase 3 trial following safety review of Part 1 data. The study is enrolling patients across Australia, New Zealand, Canada, with regulatory approvals secured for expansion into China, Singapore, South Korea, Türkiye, the United Kingdom, and Japan. Management plans to present Part 1 safety and dosimetry data to the FDA to determine US patient eligibility for Part 2 participation.

TLX250-Tx, targeting metastatic clear cell renal cell carcinoma, is activating sites for the LUTEON pivotal trial. This lutetium-177-based therapeutic complements the company’s Zircaix imaging candidate (TLX250-Px), creating a potential theranostic pairing for kidney cancer.

Alpha therapy candidates represent next-generation differentiation within the portfolio. TLX592-Tx (actinium-225-based prostate therapy) and TLX252-Tx (actinium-225-based kidney therapy) utilise higher-energy alpha particles compared to beta-emitting therapies, potentially enabling greater tumour cell killing whilst minimising damage to surrounding healthy tissue.

Strategic Manufacturing Investments Position for Scale

Telix Manufacturing Solutions (TMS) represents the company’s vertical integration strategy, addressing supply chain control and margin protection as demand scales. Key investments include cyclotron installations at select RLS Radiopharmacies network sites, enabling in-house production of therapeutic and diagnostic isotopes rather than reliance on third-party suppliers.

The Yokohama, Japan facility marks Telix’s first Asia-Pacific cyclotron installation, supporting regional clinical trial activity and future commercial launches. Concurrent upgrades at the Angleton, Texas site (IsoTherapeutics) focus on expanding Good Manufacturing Practice facilities and cleanroom capacity for therapeutic isotope production.

The North Melbourne, Australia translational research hub, nearing completion, incorporates radiochemistry laboratories for clinical dose production alongside a patient imaging suite with in-house SPECT/CT capabilities. This infrastructure enables faster research-to-clinic translation for pipeline candidates.

For investors, vertical integration strategies typically involve significant upfront capital expenditure in exchange for long-term margin protection and supply security. These investments become particularly relevant as therapeutic candidates progress toward commercialisation, where manufacturing capacity constraints can limit revenue capture even with regulatory approval.

Regulatory Updates: Pixclara and Zircaix Path to Approval

Both Pixclara (TLX101-Px) and Zircaix (TLX250-Px) received Complete Response Letters from the FDA, representing regulatory setbacks that delayed commercial launches. However, Telix has engaged in Type A meetings to address deficiencies and is progressing resubmission packages for both candidates.

For Pixclara, collaborative FDA discussions have focused on additional clinical data and revised statistical analysis plans. The company is finalising its resubmission package following productive regulatory alignment. The continued operation of an Expanded Access Program for TLX101-Px demonstrates ongoing patient demand despite the approval delay.

Zircaix regulatory engagement has addressed chemistry, manufacturing, and controls deficiencies alongside clinical comparability between Phase 3 trial material and scaled-up commercial manufacturing. Following January 2026 Type A meetings, Telix management believes alignment has been achieved on key resubmission aspects, pending receipt of official FDA minutes.

The clinical utility of Zircaix received external validation through inclusion in updated SNMMI/EANM/ACNM guidelines for molecular imaging of renal masses, reflecting expert consensus on the technology’s diagnostic value pre-approval. ZIRCON-X study data, presented at the Society of Urologic Oncology annual meeting, demonstrated that 48.6% of patients would have experienced changed management decisions with Zircaix imaging, with over 20% potentially avoiding invasive biopsy procedures.

These regulatory pathways represent near-term binary catalysts for investors. Successful resubmissions would unlock substantial market opportunities in clear cell renal cell carcinoma imaging (Zircaix) and glioma diagnosis (Pixclara), whilst continued delays would push revenue contributions further into future periods.

What This Means for Investors: 2026 Growth Catalysts

The convergence of commercial momentum and pipeline progression establishes multiple value drivers for 2026. Key catalysts warrant investor attention:

1. Gozellix Continued Ramp: Sequential uptake tracking across additional key accounts and institutional contracts will validate the two-product strategy’s sustainability
2. ProstACT Global Part 1 Data: Safety and dosimetry readouts from the TLX591-Tx trial represent the most material near-term pipeline catalyst, potentially enabling US trial participation
3. Regulatory Resubmissions: FDA acceptance of Pixclara and Zircaix refiling packages could establish approval timelines for both imaging candidates
4. TMS Capacity Online: Manufacturing infrastructure becoming operational will provide visibility into supply chain control and margin trajectory

The company’s strategic collaboration with Varian, announced in December 2025, creates optionality for combination therapy development. By exploring integration between Telix’s radiopharmaceuticals and Varian’s external beam radiation therapy platforms, this partnership could expand addressable indications beyond current PSMA-PET imaging applications.

Financial visibility stems from the two-product PSMA strategy combined with manufacturing vertical integration. As Gozellix achieves broader institutional adoption, the 46% revenue growth versus 3% dose volume growth dynamic suggests pricing power that could support margin expansion if sustained through 2026.

Geographic diversification across the US, Europe, Australia, and emerging China market reduces single-territory dependence. Pipeline depth across eight-plus clinical programmes provides a multi-year growth runway independent of near-term regulatory outcomes for specific candidates.

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Telix’s US$804M revenue milestone and 46% growth trajectory demonstrates the commercial power of precision medicine platforms entering mainstream adoption. For investors seeking early intelligence on similar biotechnology developments across ASX-listed healthcare and technology sectors, the Big News Blast delivers breaking announcements with comprehensive analysis—completely free.

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