Gallium GA-68 Gozetotide

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 quarterTLX101-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 2024The 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, andProgression 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 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. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the U.S., Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA11, by the Australian Therapeutic Goods Administration (TGA)12, and by Health Canada13. No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Board of Directors. Legal Notices The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. The information contained in this announcement is subject to change without notification. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “guidance”, or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, Zircaix™4, Pixclara™4, ARTMS® and IsoTherapeutics™ names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. ___________________ 1 Conversion to AUD$ is at an average exchange rate realised during Q1 2024 of AUD$1 = US$0.657 2 Conversion to AUD$ is at an average exchange rate realised during Q4 2023 of AUD$1 = US$0.656 3 177Lu rosopatamab tetraxetan, Telix’s lead investigational radio antibody-drug conjugate (rADC) in prostate cancer.4 Brand name subject to final regulatory approval.5 Positron emission tomography.6 Telix ASX disclosure 16 April 2024. 7 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).8 Telix ASX disclosure 11 April 2024.9 Telix ASX disclosure 9 April 2024.10 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.11 Telix ASX disclosure 20 December 2021.12 Telix ASX disclosure 2 November 2021.13 Telix ASX disclosure 14 October 2022.