MELBOURNE, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced that for the quarter ended March 31, 2024 (Q1 2024) Announcing the latest information on earnings and business results.
Overview: Financial performance for the first quarter of 2024
The company reports unaudited total revenue of US$114.9 million.1 (A$175 million), an 18% increase compared to the previous quarter (US$97.1 million)2 or AU$148.1 million). Revenues were primarily generated from sales of his Telix prostate cancer imaging product, Illuccix®.
U.S. revenue increased 18% to US$111.8 million (US$95.1 million in Q4 2023, compared to 11% growth from Q3 2023 to Q4 2023). ) have become.
Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, commented: With the dual benefits of early revenue streams and funding for late-stage treatment programs, the Company is on track for key milestones in 2024, including progress on his three drug applications in the U.S. and Phase III international expansion. We are well on our way to achieving this goal. His ProstACT GLOBAL treatment trial in prostate cancer. Subject to necessary regulatory approvals.
“The recently completed acquisitions of ARTMS, Inc. (ARTMS) and IsoTherapeutics Group (IsoTherapeutics) strengthen the vertical integration of our business by adding manufacturing capacity and equipment and isotope manufacturing technology to Telix, expanding our global What sets Telix apart as a leading independent radiopharmaceutical company?
Operational Highlights for Q1 2024
Telix continued to advance its extensive oncology pipeline.
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Investigational New Drug (IND) Application Submitted to the U.S. Food and Drug Administration (FDA) to Initiate the ProstACT GLOBAL Phase III Study of TLX5913 in the united states
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ProstACT GLOBAL enrollment continues at Australian locations, with 13 new locations introduced during the quarter
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TLX101-CDx (Pixclara™)Four, 18F-fluoretyrosine or 18F-FET) received Fast Track designation for PETFive Characterization of glioma6. At the same time, Telix is finalizing a U.S. new drug application (NDA), expected to be filed in the first half of 2024.
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Biologics License Application (BLA) for TLX250-CDx (for Zircaix™)Four, 89Zr-DFO-girentuximab) is progressing under Breakthrough Therapy’s rolling review submission and is expected to be completed by the end of May. Telix has requested a priority review7 For Zircaix™Fourand
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NDA progress for a novel prostate cancer contrast agent. Towards this quarter’s submission goal.
Recent acquisitions strengthen supply chain and manufacturing
Telix continued to strengthen its product development and manufacturing capabilities with two strategic acquisitions:
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arts, A company specializing in the physics, chemistry, and materials science of cyclotron-generated radionuclides.Acquisition brings advanced cyclotron-based diagnostic and therapeutic isotope production platform, manufacturing plant, and stockpile of ultra-high purity rare metals8.
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isotherapeutics, A leading radiochemistry and bioconjugation company. The acquisition further strengthens Telix’s internal development capabilities and expands Telix’s U.S. manufacturing footprint with a particular focus on bioconjugation and isotope processing.9.
Full-year 2024 outlook and guidance
Telix expects full-year earnings to be in the range of $445 million to $465 million (A$675 million to $705 million at current exchange rates) as of February 22, 2024. expected and reaffirmed guidance of approximately 35-40% increase compared to 2023.
The Company also expects research and development (R&D) investments to increase by 40-50% in full year 2024 (compared to 2023), including external and internal costs, covered by operating cash flow and roughly in line with revenue growth. We are reaffirming the guidance that this is expected.
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. affected. Investors are therefore cautioned not to rely unduly on this guidance and in particular that Telix cannot guarantee any specific results. When developing financial projections, a number of key variables that can have a material impact on guidance have been identified and are described as footnotes below.Ten.
about TELIX PHARMACEUTICALS LIMITED.
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and related medical devices. Telix is headquartered in Melbourne, Australia and operates internationally in the United States, Europe (Belgium and Switzerland), and Japan. Telix develops a portfolio of clinical-stage and commercial-stage products aimed at addressing important unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s flagship imaging product, Gallium-68 (68Ga) Gozetotide injection (also known as) 68Ga PSMA-11 is sold under the brand name Illuccix® and is approved by the FDA.11by the Australian Therapeutic Agency (TGA)12by Health Canada13. No other Telix products are authorized for sale in any jurisdiction.
For more information about Telix, including the latest share price details, ASX announcements, investor and analyst presentations, news releases, event details and other publications of interest, please visit www.telixpharma.com . You can also follow Telix on X and LinkedIn.
Telix Investor Information
Kyan Williamson
TELIX PHARMACEUTICALS LIMITED.
Senior Vice President, Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorized for publication by the Telix Pharmaceuticals Limited Board of Directors.
legal notice
The information contained in this announcement is not intended as an offer, solicitation, or recommendation with respect to the shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representations or warranties, express or implied, are made as to the accuracy or completeness of the information contained or to the opinions expressed in the course of this publication. Information contained in this announcement is subject to change without notice.
This announcement may contain forward-looking statements relating to expected future events, financial performance, plans, strategies or business developments. Forward-looking statements generally include words such as “may”, “anticipates”, “intends”, “plans”, “estimates”, “anticipates”, “outlook”, “predicts”, “guidance”, etc. can be identified by the use of words such as “. , or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and risks that may affect our actual results, level of activity, performance or achievements, including any future results, activities expressed or implied by these forward-looking statements. and other factors that may cause the level, performance or results of the Company to differ materially. The statement you are looking for. Forward-looking statements are based on our good faith assumptions about financial, market, regulatory and other risks and considerations that will affect our business and operations in the future, and whether any of these assumptions will There is no guarantee that it will have an impact. I’ll prove you right. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements regarding: Telix’s preclinical and clinical studies and the initiation, timing, progress and results of Telix’s research and development programs; Telix’s ability to advance, enroll and successfully complete clinical studies, including multinational clinical trials, of its product candidates; the timing or potential of regulatory filings and approvals, manufacturing activities and product marketing activities; Telix’s product candidates will be commercialized if or at the time they are approved; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; Telix’s competitors and industry trends; Pricing and Refunds If and After Telix’s Product Candidates Are Approved. Telix’s actual results, performance or achievements may differ materially from those expressed or implied by such statements, and such differences may be adverse to you. Therefore, you should not place undue reliance on these forward-looking statements. Please read this announcement together with our risk factors as disclosed in recent filings with the ASX or on our website.
To the fullest extent permitted by law, Telix does not intend to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments, or changes in expectations or assumptions. disclaims any obligation or undertaking to do so.
©2024 TELIX PHARMACEUTICALS LIMITED.Teryx Pharmaceuticals®Illtix®Jill Cakes™FourPikclara™FourArts® and isotherapeutics™ Names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates, all rights reserved.
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1 Conversion to Australian dollars is based on the average exchange rate realized in the first quarter of 2024: 1 Australian dollar = 0.657 USD.
2 Conversion to Australian dollars is based on the average exchange rate realized in the fourth quarter of 2023: 1 Australian dollar = 0.656 US dollar.
3 177Lu rosopatamab tetraxetane, Telix’s lead investigational wireless antibody-drug conjugate (rADC) in prostate cancer.
Four Brand names are subject to final regulatory approval.
Five Positron emission tomography.
6 Telix ASX disclosure April 16, 2024.
7 A priority review designation means that FDA’s goal is to take action on your application within six months (versus standard review, which takes 10 months).
8 Telix ASX disclosure April 11, 2024.
9 Telix ASX disclosure date is April 9, 2024.
Ten Key variables that could cause actual results to differ include: the success and timing of our research and development activities; regulatory decisions regarding the approval and labeling of our products; competitive developments affecting our products; our ability to successfully market new and existing products; manufacturing difficulties or delays; transaction purchasing patterns and changes in interest rates and exchange rates; laws or regulations affecting the production, distribution, pricing, reimbursement, access or taxes of products; Acquisitions and divestitures. Research cooperation. Litigation or Government Investigation. and Telix’s ability to protect its patents and other intellectual property.
11 Telix ASX disclosure will take place on 20 December 2021.
12 Telix ASX disclosure date 2 November 2021.
13 Telix ASX disclosure October 14, 2022.
