Melbourne (Australia) | 17 April 2024
Telix today provides an update on its revenue and operational performance for the quarter ended 31 March 2024 (Q1 2024).
Summary: Q1 2024 financial performance
U.S. revenue grew by 18% to US$111.8M (US$95.1M in Q4 2023), compared to 11% growth between Q3 2023 and Q4 2023.
Dr Christian Behrenbruch, Managing Director and Group CEO of Telix, commented, “The continued, consistent growth of our precision diagnostics business is further evidence of an effective market growth strategy for our prostate cancer franchise. The dual benefit of an early revenue stream, and the ability to fund our late-stage therapeutic programs ensures we are on track to achieve major milestones in 2024 including the progression of three drug approval submissions in the U.S. and the international expansion of our Phase III ProstACT GLOBAL therapy trial in prostate cancer, subject to requisite regulatory approvals.
“The recently closed acquisitions of ARTMS, Inc. (ARTMS) and IsoTherapeutics Group (IsoTherapeutics) enhance the vertical integration of our business and differentiate Telix as a leading independent radiopharmaceutical company worldwide by adding manufacturing capabilities and facilities, and isotope production technologies to the Telix Group of companies.”
Q1 2024 operational highlights
Telix continued to progress an extensive oncology pipeline:
- Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) to start the ProstACT GLOBAL Phase III trial of TLX5913 in the U.S.
- Continued enrolment of ProstACT GLOBAL at Australian sites with 13 new sites onboarded during the quarter
- The Biologics License Application (BLA) for TLX250-CDx (Zircaix®4, 89Zr-DFO-girentuximab) is progressing under a Breakthrough Therapy rolling review submission and is due for completion by end-May. Telix has requested a Priority Review7 for Zircaix®4, and
- Progression of an NDA for a novel prostate cancer imaging agent, with a submission goal of this quarter.
Supply chain and manufacturing bolstered by recent acquisitions
Telix continued to augment its product development and manufacturing capabilities with two strategic acquisitions:
- ARTMS, a company which specialises in the physics, chemistry and materials science of cyclotron-produced radionuclides. The acquisition brings an advanced cyclotron-based diagnostic and therapeutic isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals8.
- IsoTherapeutics, a leading radiochemistry and bioconjugation firm. The acquisition further enhances Telix’s in-house development capabilities and expands Telix’s U.S. manufacturing footprint with particular focus on bioconjugation and isotope processing9.
Full year 2024 outlook and guidance
Telix reaffirms guidance provided on 22 February 2024 for full year revenue expected to be in the range of US$445M to $465M (AU$675M to $705M at current exchange rates), representing an approximate 35-40% increase versus 2023.
The Company also reaffirms guidance that research and development (R&D) investment is expected to increase by 40-50% for full year 2024 (compared with 2023) including external and internal costs funded by operating cash flow and broadly in line with revenue growth.
The above guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are included below as a footnote10.
Read the full ASX release here
- Conversion to AUD$ is at an average exchange rate realised during Q1 2024 of AUD$1 = US$0.657 ↩︎
- Conversion to AUD$ is at an average exchange rate realised during Q4 2023 of AUD$1 = US$0.656 ↩︎
- 177Lu rosopatamab tetraxetan, Telix’s lead investigational radio antibody-drug conjugate (rADC) in prostate cancer. ↩︎
- Brand name subject to final regulatory approval. ↩︎
- Positron emission tomography. ↩︎
- Telix ASX disclosure 16 April 2024. ↩︎
- A Priority Review designation means FDA’s goal is to take action on an application within six months (compared to 10 months under standard review). ↩︎
- Telix ASX disclosure 11 April 2024. ↩︎
- Telix ASX disclosure 9 April 2024. ↩︎
- 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 or regulations that affect 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. ↩︎