Telix Reports US$186M Q1 Revenue, Up 62% YOY

Melbourne (Australia) | 22 April 2025

Telix today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise.

Strong Q1 2025 revenue growth

  • Q1 2025 unaudited revenue of approximately $186 million represents an increase of 62% over the prior year corresponding quarter (Q1 2024: $115M) and a quarter-over-quarter increase of 31% (Q4 2024: $142 million) and includes:
    • $151 million from global sales of Illuccix®, up 35% over the prior year corresponding quarter (Q1 2024: $112 million) and a quarter-over-quarter increase of 9% (Q4 2024: $139 million).
    • $33 million from RLS Radiopharmacies (RLS) since the acquisition completed on 27 January 2025[1].

FY 2025 guidance reaffirmed

  • Telix confirms FY 2025 revenue guidance of $770 million to $800 million[2].
  • Guidance reflects revenue from Illuccix® sales in jurisdictions with a marketing authorization, and 11 months of revenue from RLS 1,[3].
  • Revenue guidance is expected to be updated at the appropriate time, following and subject to reimbursement for Gozellix® in the United States (U.S.) and Illuccix® in ex-U.S. markets.
  • 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.

Q1 2025 commentary and recent highlights

Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, stated, “Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape. Telix is the only company with two FDA[4]-approved PSMA-PET[5] imaging agents – Illuccix and Gozellix – enabling us to broaden patient reach and maximize choice for our customers. The expansion of our commercial portfolio and launches of Illuccix into new international markets provides a foundation to diversify and grow revenue globally, while we continue to deliver on multiple catalysts in our pipeline. This quarter also includes the first two months of revenue from RLS since completion of our acquisition, highlighting its potential as a platform to drive further growth. This strategic acquisition has significantly expanded our manufacturing footprint in the U.S., which we believe is an increasingly important consideration amid changing global trade dynamics.”

Therapeutics business

  • ProstACT™ Global, the Phase 3 trial of TLX591 (177Lu-rosopatamab tetraxetan), Telix’s prostate cancer therapy candidate, continues to recruit and remains on track to deliver a Part 1 readout (safety and dosimetry) in H1 2025.
  • IPAX-Linz, a Phase 2 investigator-initiated trial of TLX101 (131I-iodofalan, or 131I-IPA), Telix’s brain cancer therapy candidate, reported positive preliminary results. Early efficacy from IPAX-1 was substantiated and TLX101 was found to be well tolerated in combination with external beam radiation therapy. No serious adverse events were reported in patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma, often after multiple resections[6].
  • Following consultations with the FDA, the Company remains on track to submit Investigational New Drug (IND) applications to enable pivotal trials for TLX101 and Telix’s kidney cancer therapy candidate (TLX250, 177Lu-DOTA-girentuximab) to commence this year, subject to regulatory approval.
  • The first patient was dosed in the Phase 1 ZOLAR[7] trial of TLX300-CDx (89Zr-olaratumab), which aims to validate the use of olaratumab, an antibody exclusively licensed from Eli Lilly and Company (Lilly), as a potential treatment for advanced, metastatic soft tissue sarcoma.
  • Telix completed the acquisition of a suite of clinically validated FAP[8]-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates. Telix has added the lead FAP-targeting therapeutic compound to its pipeline under the designation TLX400.
  • Telix acquired the therapeutics assets of antibody engineering company ImaginAb, Inc. The transaction included a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility in Los Angeles, California[9], staffed by a talented team of discovery, protein engineering and radiopharmaceutical development experts who joined the Company on the ImaginAb acquisition closing.
  • Telix announced that it has developed and validated a breakthrough generator technology for the production of lead-212 (212Pb) and successfully completed first production of this promising alpha-emitting therapeutic radioisotope[10]. The new generator technology, developed internally by Telix’s IsoTherapeutics team, significantly increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators and provides an additional isotope supply for Telix’s next-generation targeted alpha therapy program.

Precision Medicine business

  • On 21 March 2025, the FDA approved the New Drug Application (NDA) for Gozellix®[11], Telix’s next-generation PSMA-PET imaging agent for prostate cancer that provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.
  • Commercial launch of Gozellix® in the U.S. is expected to commence during Q2 2025 where Telix has appointed Cardinal Health, Inc. (Cardinal Health)[12] and RLS Radiopharmacies as distribution partners.
  • Telix received a positive decision on the decentralized Marketing Authorization Application (MAA) for Illuccix® in the European Economic Area (EEA)[13]. Illuccix® also received MAA approval in the United Kingdom (UK) and Brazil. Country level approvals are now being implemented in the EEA, with approvals to date granted in Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway, and Sweden[14].
  • Illuccix® is now commercially available in Brazil, under the joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.), and commercial launches will commence in the UK and in European markets where Illuccix® has received approval during Q2 2025.
  • The FDA accepted the Biologics License Application (BLA) for Telix’s kidney cancer imaging candidate TLX250-CDx (Zircaix®[15], 89Zr-DFO-girentuximab), granted a Priority Review, and provided a PDUFA[16] goal date of 27 August 2025.
  • The NDA for TLX101-CDx (Pixclara®15, 18F-floretyrosine or 18F-FET), Telix’s brain cancer imaging candidate, continues to progress with a PDUFA goal date of 26 April 2025.

Telix Manufacturing Solutions (TMS)

  • In April, the TMS Brussels South facility (Seneffe) received notice of its GMP accreditation, enabling first commercial radiopharmaceutical dose production.
  • Telix reaffirms that it does not expect any material impact on its business or supply chain as a result of the international trade tariffs announced by the U.S. government on 2 April 2025 (subject to a three-month delay) or the subsequent inclusion of pharmaceuticals. Telix has an extensive U.S.-based manufacturing and distribution infrastructure, including third-party manufacturing sites and radiopharmacy partner networks, for the production and delivery of its FDA-approved products Illuccix® and Gozellix®[17].
  • Telix also notes that it does not rely on rare earth elements of the kind utilized in semi-conductor supply chains and is therefore not impacted by the recent export controls imposed by the Chinese government this month.

Board renewal

Telix announced new Director appointments as part of a Board succession planning and renewal process[18]: 

  • H Kevin McCann AO will retire as a Non-Executive Director (NED) and Board Chairman on 21 May 2025, immediately following Telix’s Annual General Meeting.
  • Tiffany Olson will be appointed Board Chair following Mr. McCann’s retirement.
  • Marie McDonald joined the Board as a NED, effective 3 March 2025 and, on appointment, immediately succeeded Mr. McCann as Chair of the People Committee.
  • Anne Whitaker joined the Board as a NED, effective 7 April 2025, and was appointed as a member of the Audit and Risk Committee and the People Committee.

Guidance disclaimer

The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below.

Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. See the Legal Notices section in today’s disclosure lodged with the ASX for additional information, risks and assumptions.

[1] Excludes revenue contribution from Illuccix® sales.

[2] Refer to ASX disclosures 20 February 2025.

[3] See Guidance Disclaimer for further information.

[4] U.S. Food and Drug Administration.

[5] Imaging of prostate-specific membrane antigen with positron emission tomography.

[6] Telix ASX disclosure 16 April 2025.

[7] Telix media release 1 April 2025. ClinicalTrials.gov ID: NCT06537596.

[8] Fibroblast activation protein.

[9] Telix ASX disclosure 13 January 2025.

[10] Telix media release 13 March 2025.

[11] Telix ASX disclosure 21 March 2025.

[12] Telix media release 8 April 2025.

[13] Telix ASX disclosure 17 March 2025.

[14] Illuccix® received marketing authorization in the UK, Brazil, Denmark, Luxembourg, Malta, the Netherlands and Norway during Q1 2025. Illuccix® received marketing authorization in Ireland and Sweden on 4 and 11 April 2025, respectively.

[15] Brand name subject to final regulatory approval. 

[16] Prescription Drug User Fee Act.   

[17] Telix ASX disclosure 7 April 2025.

[18] Telix ASX disclosure 26 February 2025.