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Q1 2024 Revenue and Business Update

MELBOURNE, Australia, April 17, 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 31 March 2024 (Q1 2024). Summary: Q1 2024 financial performance The Company reports unaudited total revenue of US$114.9M1 (AU$175.0M), an increase of 18% on the prior quarter (US$97.1M2 or AU$148.1M). Revenue was primarily generated from sales of Telix's prostate cancer imaging product Illuccix®. 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 TLX101-CDx (Pixclara™4, 18F-floretyrosine or 18F-FET) has been granted Fast Track designation for PET5 characterisation of glioma6. Concurrently, Telix is finalising its U.S. New Drug Application (NDA) with submission on track for H1 2024 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 a 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 ...