Telix Reports US$206M Revenue, FY 2025 Guidance Upgraded
Melbourne (Australia) and Indianapolis, IN (U.S.) | 14 October 2025
Telix today provides an update on its commercial and operational performance for the quarter ended 30 September 2025 (Q3 2025). All figures are in USD unless stated otherwise.
Q3 2025 Highlights
- Q3 2025 unaudited group revenue of approximately $206 million, up 53% year-over-year.
- FY 2025 revenue guidance increased to $800 million to $820 million[1].
- Illuccix® now approved in 19 European markets[4] and the United Kingdom (UK); commercial launch has commenced in the UK, Germany, France, Finland, Sweden, Norway and Denmark.
- First patients dosed in the BiPASS™ trial of MRI + PSMA-PET[5] for the diagnosis and detection of prostate cancer.
- ProstACT® Global Phase 3 trial – Part 2 open for enrollment in Australia, New Zealand and Canada and study approved to commence in China, Singapore, Türkiye and Japan. Part 1 preliminary readout of safety profile and dosimetry to follow completion of patient monitoring and data analysis.
Q3 2025 Revenue (Unaudited)
Commentary and business highlights
Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “We believe this is a solid result, particularly in light of the reimbursement dynamics during the quarter. Moreover, a 3% increase in dose volumes suggests competitive pricing pressures are beginning to stabilize. Telix has entered Q4 in a position of strength, supported by a growing customer base, two FDA-approved PSMA imaging agents and CMS reimbursement for Gozellix effective from 1 October in the U.S. This differentiated two-product strategy enables us to expand market share across all customer segments, with Gozellix enhancing our production flexibility and providing customer choice based on patient reimbursement pathways.”
Therapeutics business
- TLX591 (177Lu-rosopatamab tetraxetan): Telix has closed enrollment into Part 1 of ProstACT Global[8], the Phase 3 trial of its lead prostate cancer therapy candidate. A preliminary readout of safety and dosimetry will follow the completion of patient treatment (with standard of care), monitoring and data analysis. Part 2 (randomized treatment expansion) has opened for enrollment in Australia, New Zealand and Canada, and with further sites to be opened in China, Singapore, Türkiye and Japan, where the study has regulatory approval.
- TLX250 (177Lu-DOTA-girentuximab): Telix received ethics approval in Australia to commence LUTEON[9], a pivotal trial of TLX250 as a monotherapy in advanced metastatic clear cell renal cell carcinoma (ccRCC). STARLITE-1[10] – a Phase 1b/2 clinical trial investigating the use of TLX250 in combination with cabozantinib and nivolumab, in ccRCC, has commenced dosing patients.
- TLX090 (153Sm-DOTMP): Telix is preparing to dose the first patient in SOLACE, a Phase 1 study of Telix’s therapeutic candidate for treating bone pain in patients with osteoblastic metastatic cancer.
- TLX400 (177Lu-DOTAGA.Glu.(FAPi)2): A study of Telix’s Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, was published in the Journal of Nuclear Medicine, demonstrating clinical antitumor activity with an encouraging safety profile in subjects with advanced sarcoma[13].
Precision Medicine business
PSMA portfolio (Illuccix and Gozellix):
- Following country-level approval for Illuccix in Spain[16], Telix now has approvals for all 19 markets in the Company’s decentralized procedure (DCP) submission in Europe. Commercial launch has commenced in the UK, Germany, France, Finland, Sweden, Norway and Denmark, as Illuccix is rolled out on a market-by-market basis when reimbursement is secured.
- Telix dosed the first patients in the BiPASS™study[17] to evaluate the performance of MRI combined with PSMA-PET imaging in diagnosing prostate cancer, with the aim of reducing the need for invasive biopsies. This Phase 3 registration-enabling trial aims to expand the indications for Illuccix and Gozellix. Telix has commenced the study in Melbourne, Australia and has filed an investigational new drug application (IND) with the FDA to commence the study in the U.S.
- Telix successfully received a Prior Approval Supplement (PAS) to update the U.S. Prescribing Information for Illuccix. The Illuccix label now includes patient selection for radioligand therapy (RLT) in the pre-taxane setting.
Zircaix®18 (TLX250-CDx, 89Zr-DFO-girentuximab): Following the receipt of a Complete Response Letter from the FDA in August 2025[20], Telix is requesting a Type A meeting, ahead of the resubmission of the Biologics License Application (BLA) for its kidney cancer imaging agent.
Telix Manufacturing Solutions (TMS)
Telix has been granted radiation licenses for its TMS North Melbourne (Australia) and Yokohama (Japan) facilities – for a broad range of clinically and commercially important medical isotopes. Both facilities are in the final stages of fit-out and preparing for operational readiness.
Corporate updates
Final royalty payment to ANMI
In 2018, Telix acquired Advanced Nuclear Medicine Ingredients (ANMI), the developer of the underlying Illuccix technology. The acquisition agreement included contingent consideration (variable payments) based on Illuccix global sales for five years following marketing authorization of Illuccix, with an option to buy out remaining payments in the third year following marketing authorization if agreed sales thresholds were met. As a result of strong sales performance, Telix has successfully exercised its option to buy-out the remaining variable payments. The final payment of $51.7 million comprising the option payment and third and final annual variable payment was made in July 2025, and will be reflected in the cash flows for H2 2025, included in the Company’s full year financial results.
FY 2025 guidance
- Telix increases FY 2025 revenue guidance to $800 million to $820 million[21].
- Guidance reflects revenue from PSMA imaging (Illuccix and Gozellix) product sales in jurisdictions with a marketing authorization, and 11 months of revenue contribution from RLS[22].
- Telix confirms research and development (R&D) expenditure guidance, expecting a year-over-year increased investment range for FY 2025 of 20% to 25% compared to FY 2024.
Read the full ASX release here
With the exception of Illuccix® and Gozellix®, Telix’s investigational assets have not received marketing authorization in any jurisdiction.
[1] Previous FY 2025 revenue guidance: $770 million to $800 million.
[2] Healthcare Common Procedure Coding System.
[3] Telix ASX disclosure 23 September 2025.
[4] All European countries included in Telix’s European Economic Area submission.
[5] Magnetic resonance imaging; imaging of prostate-specific membrane antigen with positron emission tomography.
[6] PSMA imaging revenue represents sales of Illuccix® and Gozellix® in our Precision Medicine business.
[7] RLS Radiopharmacies revenue excludes revenue contribution from Illuccix and Gozellix sales.
[8] ClinicalTrials.gov ID: NCT06520345.
[9] ClinicalTrials.gov ID: NCT07197580.
[10] ClinicalTrials.gov ID: NCT05663710.
[11] Approved with conditions.
[12] Telix ASX disclosure 22 July 2025. ClinicalTrials.gov ID: NCT07100730.
[13] Telix media release 6 October 2025. Ballal et al. J Nucl Med. 2025.
[14] Telix ASX disclosure 9 July 2025.
[15] Telix ASX disclosure 23 September 2025.
[16] Telix media release 29 August 2025.
[17] Biopsy of the Prostate Avoidance Stratification Study; ClinicalTrials.gov ID: NCT07052214. Telix media release 9 September 2025.
[18] Brand name subject to final regulatory approval.
[19] Telix ASX disclosure 9 September 2025
[20] Telix ASX disclosure 28 August 2025.
[21] Telix ASX disclosure 20 February 2025.
[22] See Guidance disclaimer for further information.