Telix Pharmaceuticals — company and radiopharmaceutical pipeline record

AI-powered research: MII Research actively used AI for evidence extraction, comparison, analysis, drafting and explanatory presentation. Material claims were checked against the cited public sources before publication.

Recording rule: Regulatory submission, acceptance, approval, commercial launch, patient dosing, trial completion and positive clinical outcome are different states. Company-reported trial and commercial results are identified as such. The report records disclosed events and figures without assigning speculative outcomes.

Telix's diagnostic products combine a targeting molecule with a radioisotope for imaging. Selected therapeutic programmes use the same or related biological targets with therapeutic radioisotopes. The company also operates or owns radiopharmacy, isotope-production, manufacturing, dosimetry and surgical-navigation assets. These activities are recorded separately below because product approval does not establish therapeutic efficacy, and facility ownership does not by itself establish utilisation or profitability.

FY2021 — first Illuccix approvals and commercial-launch preparation

• Telix progressed Illuccix regulatory filings in 17 countries, established and trained a U.S. sales and field organisation, built distribution arrangements and prepared commercial-scale manufacturing.
• The Australian TGA approved Illuccix for prostate-cancer imaging in November 2021. The U.S. FDA approved Illuccix in December 2021 for PET imaging of PSMA-positive lesions in specified patients with suspected metastasis or suspected recurrence.
• European regulatory assessment continued, and distribution arrangements were announced for Germany, Italy and Spain. These arrangements did not represent European-wide marketing approval.
• The company continued clinical work across prostate, kidney, brain and haematological programmes while commercial revenue remained limited before the U.S. launch.
• Reported revenue was A$7.6m, loss after tax A$80.5m and year-end cash A$22.0m.

FY2022 — U.S. Illuccix launch and first commercial-scale revenue

• The first U.S. patient was scanned with Illuccix on 14 April 2022. The company recorded A$149.7m of U.S. Illuccix revenue during the first nine months of commercial sales.
• Total group revenue increased to A$160.1m. Commercial doses were delivered in the United States, Australia and New Zealand.
• The ZIRCON Phase 3 study of TLX250-CDx in kidney-cancer imaging completed and the company reported positive top-line data. A top-line announcement preceded regulatory filing and approval.
• Patients were dosed in the ProstACT SELECT and TARGET prostate-cancer therapy studies. Manufacturing work was conducted for the proposed ProstACT GLOBAL study.
• Patients were dosed in STARLITE-2, studying TLX250 therapy with immunotherapy in advanced clear-cell renal-cell carcinoma.
• The group remained loss-making: loss after tax was A$104.1m, operating cash outflow A$64.0m and closing cash A$116.3m.

FY2023 — first annual profit and broader late-stage activity

• Revenue reached A$502.5m, primarily from the second year of U.S. Illuccix sales. Illuccix revenue was A$496.2m.
• Gross margin was reported at 63%, profit after tax at A$5.2m, adjusted EBITDA at A$58.4m and operating cash inflow at A$23.9m.
• The first patient was dosed in the Australian portion of the ProstACT GLOBAL Phase 3 programme. ProstACT SELECT interim results were reported by the company.
• A rolling U.S. BLA submission for TLX250-CDx/Zircaix was commenced. Named-patient and expanded-access activity began in Europe and the United States; this was not general marketing approval.
• Multiple TLX250 therapy studies were dosing patients. IPAX-2 enrolled a second cohort in newly diagnosed glioblastoma.
• Telix prepared a U.S. NDA for TLX101-CDx/Pixclara and an expanded-access programme. Submission preparation was not FDA acceptance or approval.
• Stage one of Telix Manufacturing Solutions was completed. Optimal Tracers integration was reported complete. Telix also acquired Dedicaid and Lightpoint Medical's SENSEI business and announced an agreement concerning QSAM Biosciences.

FY2024 — continued Illuccix growth, acquisitions and preparation for additional launches

• Revenue increased to A$783.2m, profit after tax to A$49.9m, operating cash inflow to A$43.0m and adjusted EBITDA to A$99.3m.
• R&D investment was A$194.6m and manufacturing/distribution investment increased as the company expanded production and supply infrastructure.
• Telix acquired ARTMS and IsoTherapeutics. It expanded the Brussels South manufacturing site and continued work at North Melbourne and Yokohama.
• The company prepared three additional precision-medicine products: Gozellix, Zircaix and Pixclara. Preparation, submission and review status differed for each product and did not establish approval.
• The company announced the proposed RLS radiopharmacy acquisition in 2024; the acquisition closed in January 2025, so RLS financial results were not consolidated in FY2024.
• Therapeutic work continued across TLX591, TLX250 and TLX101, while additional alpha and acquired programmes expanded the disclosed pipeline.

FY2025 — Gozellix approval and launch, RLS consolidation, two diagnostic CRLs

• The U.S. FDA approved Gozellix in March 2025. It entered U.S. commercial use during 2025 and received three-year CMS Transitional Pass-Through payment status effective October 2025.
• RLS Radiopharmacies was acquired in January 2025 for US$230m upfront cash plus up to US$20m contingent consideration. RLS operated more than 30 radiopharmacies in 18 U.S. states and served about 1,500 customers.
• FY2025 group revenue was US$803.8m. Precision Medicine revenue was US$621.9m. RLS reported US$238.4m total segment revenue, including US$170.1m from third parties and US$68.3m inter-segment revenue. Inter-segment activity was eliminated on consolidation.
• Group gross margin was 53% and Precision Medicine gross margin 64%. Adjusted EBITDA was US$39.5m. Loss after tax was US$7.1m and operating cash outflow US$17.3m.
• Reported expenses included US$171.2m R&D, US$96.8m selling and marketing, US$44.6m manufacturing and distribution, and US$95.7m general and administration.
• The FDA issued a Complete Response Letter for Pixclara in April 2025 requesting additional confirmatory clinical evidence. The FDA issued a CRL for Zircaix in August 2025; the company described the remaining work as CMC, including comparability between clinical-trial and commercial-scale material. A CRL is not approval and is not the same as withdrawal of an application.
• ProstACT GLOBAL Part 1 completed its target enrolment of 30 patients and first patients entered the randomised Part 2 in December 2025. LUTEON, IPAX-BrIGHT, AlphaPRO and ALPHIX received regulatory permissions to commence in identified jurisdictions, and early patients were dosed in STARLITE-1, ZOLAR and SOLACE as separately disclosed.
• Brussels South produced its first commercial GMP radiopharmaceutical in June 2025. The group continued facility and supply-chain build-out in Europe, North America, Australia and Japan.

*The FY2025 report changed its primary presentation to USD and included a US$516.6m FY2024 revenue comparative. This report does not directly calculate a five-year growth rate across the AUD and USD series. The FY2024 annual report should be used for its full year-end balance sheet and financing detail.

• FY2023 and FY2024 were profitable and generated positive operating cash flow. FY2025 returned to a reported loss and operating cash outflow while revenue increased.
• FY2025 loss included US$26.7m of non-cash finance costs associated with convertible bonds and higher amortisation after the RLS acquisition, but those classifications do not change the reported cash-flow line.
• FY2025 investing cash outflow was US$285.9m, reflecting acquisitions, facilities and other investment. Acquisition payments, recurring operating costs and non-cash accounting charges are therefore kept separate.

Illuccix — gallium-68 gozetotide PSMA PET imaging

• Australian TGA approval: November 2021. U.S. FDA approval: December 2021. U.S. commercial launch: April 2022.
• The approved U.S. indications concern PET imaging of PSMA-positive lesions in specified prostate-cancer staging and suspected-recurrence settings. Imaging approval is not approval of a therapeutic product.
• U.S. indication was later expanded to include selection of patients for PSMA-directed radioligand therapy.
• Illuccix was the principal source of revenue growth from FY2022 through FY2024. Product revenue is reported at group or franchise level in later periods, and dose volume, price and geographic mix are not all disclosed as one complete public series.

Gozellix — next-generation gallium-68 PSMA kit

• The FDA approved Gozellix in March 2025. The product has a usable period of up to six hours after preparation, as disclosed in product material.
• Commercial use began in 2025. CMS Transitional Pass-Through status took effect in October 2025 for three years.
• Illuccix and Gozellix use the same PSMA imaging franchise. Public revenue does not fully separate incremental market growth from substitution between the two products.

Zircaix/TLX250-Px — CAIX kidney-cancer imaging

• The Phase 3 ZIRCON trial completed and top-line results were reported in 2022. A rolling BLA submission began in 2023.
• The FDA issued a CRL in August 2025. The company identified CMC work, including comparability between clinical-trial and commercial-scale material, as the outstanding matter.
• Two FDA Type A meetings were held. At the FY2025 results the company said it believed key requirements were aligned and was preparing a resubmission.
• At the evidence cut-off, a resubmission plan or regulatory dialogue did not constitute FDA approval.

Pixclara/TLX101-Px — LAT1 glioma imaging

• A U.S. NDA was prepared and submitted after the FY2023 period. The FDA issued a CRL in April 2025 seeking additional confirmatory clinical evidence.
• Telix submitted a European marketing-authorisation application in February 2026.
• U.S. remediation/resubmission and European review are separate regulatory processes. Neither is recorded here as commercial approval at the cut-off.

Other commercial technologies

• Scintimun is approved for osteomyelitis imaging in specified European jurisdictions and Mexico.
• SENSEI is a gamma-probe platform for minimally invasive and robotic surgery with U.S. registration and CE marking.
• QDOSE is patient-specific radiopharmaceutical-dosimetry software with U.S. 510(k), CE marking and Korean clearance.
• These products demonstrate additional commercial registrations, but public product-level revenue was not large enough to be presented as a complete standalone series in the reviewed reports.

TLX591-Tx — lutetium-177 PSMA antibody therapy

• TLX591-Tx is a lutetium-177-labelled PSMA-targeting antibody being studied in metastatic castration-resistant prostate cancer.
• ProstACT SELECT and TARGET dosed patients during FY2022. The company reported ProstACT SELECT interim data in FY2023.
• ProstACT GLOBAL is a multinational, randomised, open-label Phase 3 study. Part 1 enrolled 30 patients. First patients were treated in Part 2 in December 2025.
• The overall plan is approximately 520 participants, including about 490 in Part 2. The principal comparison is TLX591-Tx plus standard of care versus standard of care, with radiographic progression-free survival as the primary endpoint and overall survival, response, skeletal events, PSA measures, quality of life and safety among secondary measures.
• In H1 2026 the company reported that Part 1 met its safety and dosimetry objectives with no new safety signals, and that FDA feedback allowed Part 2 to progress in the United States with alignment on the protocol. This is a study-progression statement, not a Phase 3 efficacy result.

TLX250-Tx — lutetium-177 CAIX therapy

• TLX250-Tx targets CAIX in metastatic clear-cell renal-cell carcinoma and other CAIX-expressing tumours.
• STARLITE studies have evaluated TLX250-Tx with systemic therapies. First patients were dosed in STARLITE-1 with cabozantinib and nivolumab as disclosed in FY2025.
• LUTEON is designed as a global Phase 2/3 monotherapy programme moving from safety and dosimetry into randomised efficacy. Permission to commence and site activation do not establish treatment benefit.

TLX101-Tx — iodine-131 LAT1 therapy

• TLX101-Tx is being studied in glioma, including recurrent glioblastoma. Earlier IPAX studies and IPAX-2 generated dosing and cohort information.
• IPAX-BrIGHT compares TLX101-Tx plus lomustine with lomustine. Its initial stage evaluates safety, tolerability and dosimetry in at least 18 patients before the randomised-stage size is determined.
• Regulatory permission was reported in Australia and the European Union to commence the trial. No pivotal efficacy outcome had been reported at the cut-off.

• RLS Radiopharmacies: acquired January 2025; more than 30 radiopharmacies across 18 U.S. states and approximately 1,500 customers at acquisition. FY2025 total segment revenue included both third-party and eliminated inter-segment revenue.
• Brussels South/Seneffe: approximately 30,000 square feet, nine GMP lines and two cyclotrons. The first commercial GMP radiopharmaceutical was produced in June 2025; the first GMP production run of a lutetium-based therapeutic candidate was reported in H1 2026.
• North Melbourne: licensed for multiple medical isotopes and opened with the Melbourne Theranostic Innovation Centre partnership in H1 2026.
• Yokohama: Telix's first Asia-Pacific cyclotron facility, intended for clinical, commercial and R&D supply.
• IsoTherapeutics and ARTMS: acquired in 2024 to add isotope, process-development and production capability.
• Supply relationships: disclosed relationships include ANSTO, Cardinal Health, Eckert & Ziegler, Isotopia, ITM, PanTera and SHINE.
• Lead-212 generator: the company reported internal development and validation capability for a next-generation alpha-therapy supply component.

Facility completion, GMP production, segment revenue and segment profitability are different facts. In H1 2026 TMS reported US$146m total segment revenue, including US$89m third-party and US$58m internal revenue, an operating loss of US$33m and adjusted EBITDA loss of US$23m. Internal revenue is eliminated in group consolidation.

• H1 2026 Precision Medicine gross margin was reported at 65%. TMS remained loss-making while the wider group reported a profit.
• Telix issued US$600m of new convertible bonds due 2031 to refinance the existing convertible-bond structure. Gross issuance is not equivalent to unrestricted net cash after refinancing and transaction effects.
• FY2026 revenue guidance remained US$950m–US$970m, and expected revenue plus the US$40m other-income payment was described as exceeding US$1bn. Guidance is a company forecast, not completed FY2026 revenue.
• R&D expenditure guidance was US$230m–US$270m at the H1 update.
• On 20 August 2026 the company established an at-the-market facility for possible ADS issuance. The company retained discretion over use; facility establishment is not evidence that shares had already been sold.

• Complete product-level Illuccix and Gozellix dose volumes, net pricing, rebates, geographic gross margin and substitution between the products.
• The eventual outcome, timing and total remediation cost for the Zircaix and Pixclara CRLs.
• Phase 3 efficacy results for ProstACT GLOBAL and pivotal efficacy results for LUTEON or IPAX-BrIGHT.
• Commercial-scale utilisation and fully allocated profitability for each manufacturing site and radiopharmacy.
• Full retained economics after all product-specific royalties, milestones and contingent acquisition consideration.
• Whether FY2026 guidance will be achieved; the guidance period was incomplete at the evidence cut-off.
• Programme-level development budgets, probability of success or commercial value. This report does not estimate them.

• Telix FY2021 Annual Report
• Telix FY2022 Annual Report
• Telix FY2023 Annual Report
• Telix FY2024 Annual Report
• Telix FY2025 results and Annual Report access
• Telix H1 2026 results
• Australian Illuccix approval
• U.S. Illuccix approval
• RLS acquisition completion
• Telix ASX announcements archive

Evidence treatment and copyright

The report separates annual periods, later announcements, approvals, CRLs, permissions to commence, patient dosing and study outcomes. Tables were newly prepared from reported figures. It does not reproduce company photographs, proprietary charts or long source passages. Company forecasts and company-reported clinical observations are not rewritten as completed outcomes.