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Q2 2024 Revenue and Business Highlights, Guidance Upgrade

MELBOURNE, Australia, July 18, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 June 2024 (Q2 2024). Q2 2024 Financial Performance and Guidance Upgrade The Company reports unaudited total revenue of approximately US$124M1 (AU$189M) primarily generated from sales of Telix's prostate cancer imaging product Illuccix®. This represents an increase of 55% on the prior corresponding quarter (Q2 2023: US$80M or AU$120M) and an increase of 8% on the previous quarter (Q1 2024: US$115M or AU$175M). Revenue generated from sales of Illuccix® in the United States (U.S.) was approximately US$121M (AU$184M, Q2 2023: US$78M or AU$116M). On the basis of these results, the Company has upgraded revenue guidance for FY2024 which is now expected to be in the range of US$490M to US$510M (AU$745M to AU$776M at current exchange rates). This represents an approximate increase of 48% to 54% on 2023 revenue. Prior guidance was ranged at US$445M to US$465M2 (AU$675M to AU$705M). Dr Christian Behrenbruch, Managing Director and Group Chief Executive Officer said, "We have continued to deliver excellent quarterly growth in both revenue and dose volume sales of Illuccix. We have leveraged our unrivalled scheduling flexibility and clinical differentiation, to increase our market share and minimise the impact of new entrants." Revenue guidance is based on approved products in jurisdictions with a marketing authorisation3. Telix reaffirms guidance for R&D expenditure, which remains at an expected 40-50% increase compared with 2023, funded by earnings. 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 footnote4. The Company will release its interim report and Appendix 4D for the six months ended 30 June 2024 on 22 August 2024. Q2 2024 Operational Highlights Telix continued to progress its extensive theranostic pipeline during the quarter. Highlights include positive data from prostate cancer therapy programs: TLX591 (177Lu rosopatamab tetraxetan): Telix reported a positive efficacy signal from the ProstACT SELECT trial of TLX591, its lead investigational radio antibody-drug conjugate (rADC) in prostate cancer. The median radiographic progression-free survival (rPFS) of 8.8 months compares favourably to small molecule radioligand therapy (RLT) agents at a similar stage of development and builds on earlier results from ProstACT SELECT confirming the favourable safety profile and clinical utility of the short, two-dose treatment regimen. TLX591 is being further evaluated in the Phase III ProstACT GLOBAL trial. The study received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) during the quarter. Multiple sites across the U.S. are now being activated and preparing to dose first patients. Patient recruitment continues at sites in Asia Pacific. TLX592 (225Ac-RADmAb®): Successful proof-of-concept study completed for targeted alpha therapy in prostate cancer. The initial results demonstrated Telix's proprietary RADmAb engineered antibody is rapidly eliminated from the blood circulation and cleared via the liver, desirable characteristics for use with alpha emitting radioisotopes. Based on the outcomes of this trial, the program will progress to a Phase I/II therapeutic trial with Actinium 225. Telix is progressing multiple marketing authorisation applications across its precision medicine (diagnostic) portfolio, including: New Drug Application (NDA) submission for new prostate cancer imaging agent TLX007-CDx (PSMA-PET ...