{"id":35820,"date":"2025-10-14T15:24:54","date_gmt":"2025-10-14T08:24:54","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=35820"},"modified":"2025-10-14T15:24:54","modified_gmt":"2025-10-14T08:24:54","slug":"telix-reports-us206m-revenue-fy-2025-guidance-upgraded","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=35820","title":{"rendered":"Telix Reports US$206M Revenue, FY 2025 Guidance Upgraded"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1920208\/Telix_Main_Logo_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MELBOURNE<\/span>, Australia\u00a0and\u00a0INDIANAPOLIS<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Oct. 14, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, &#8220;Telix&#8221;) today provides an update on its commercial and operational performance for the quarter ended <span class=\"xn-chron\">30 September 2025<\/span> (Q3 2025). All figures are in USD unless stated otherwise.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<p><b>Q3\u00a02025\u00a0Highlights<\/b><\/p>\n<ul type=\"disc\">\n<li>Q3 2025 unaudited group revenue of approximately <span class=\"xn-money\">$206 million<\/span>, up 53% year-over-year.<\/li>\n<li>FY 2025 revenue guidance increased to <span class=\"xn-money\">$800 million<\/span> to <span class=\"xn-money\">$820 million<\/span><sup>[1]<\/sup>.<\/li>\n<li>Gozellix\u00ae now fully reimbursed by Centers for Medicare and Medicaid Services (CMS): Level II HCPCS<sup>[<\/sup><sup>2]<\/sup> code and Transitional Pass-Through (TPT) payment status effective <span class=\"xn-chron\">1 October 2025<\/span><sup>[3]<\/sup>.<\/li>\n<li>Illuccix\u00ae now approved in 19 European markets<sup>[<\/sup><sup>4]<\/sup> and the <span class=\"xn-location\">United Kingdom<\/span> (UK); commercial launch has commenced in the UK, <span class=\"xn-location\">Germany<\/span>, <span class=\"xn-location\">France<\/span>, <span class=\"xn-location\">Finland<\/span>, <span class=\"xn-location\">Sweden<\/span>, <span class=\"xn-location\">Norway<\/span> and <span class=\"xn-location\">Denmark<\/span>.<\/li>\n<li>First patients dosed in the BiPASS\u2122 trial of MRI + PSMA-PET<sup>[<\/sup><sup>5]<\/sup> for the diagnosis and detection of prostate cancer.<\/li>\n<li>ProstACT\u00ae Global Phase 3 trial \u2013 Part 2 open for enrollment in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">New Zealand<\/span> and <span class=\"xn-location\">Canada<\/span> and study approved to commence in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Singapore<\/span>, T\u00fcrkiye and <span class=\"xn-location\">Japan<\/span>. Part 1 preliminary readout of safety profile and dosimetry to follow completion of patient monitoring and data analysis.<\/li>\n<\/ul>\n<p><b>Q3 2025 Revenue (Unaudited)<\/b><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Revenue US$M<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prngen10\"><span class=\"prnews_span\"><b>Q3 2025<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Q3 2024<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Variation<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Q2 2025<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prngen10\"><span class=\"prnews_span\"><b>Variation<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">Group revenue<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">206<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">135<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">53\u00a0%<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">204<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">1\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">PSMA imaging revenue<sup>[6]<\/sup><\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">155<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">132<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">17\u00a0%<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">154<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">1\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">RLS third-party revenue<sup>[7]<\/sup><\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">47<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u2014<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u2014<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">46<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">2\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p><b>Commentary and business highlights<\/b><\/p>\n<p>Dr. <span class=\"xn-person\">Christian Behrenbruch<\/span>, Managing Director and Group CEO, stated, &#8220;We believe this is a solid result, particularly in light of the reimbursement dynamics during the quarter. Moreover, a 3% increase in dose volumes suggests competitive pricing pressures are beginning to stabilize. Telix has entered Q4 in a position of strength, supported by a growing customer base, two FDA- approved PSMA\u00a0imaging agents and CMS reimbursement for Gozellix effective from 1 October in the U.S. This differentiated two-product strategy enables us to expand market share across all customer segments, with Gozellix enhancing our production flexibility and providing customer choice based on patient reimbursement pathways.&#8221;<\/p>\n<p><b>Therapeutics business<\/b><\/p>\n<ul type=\"disc\">\n<li><b>TLX591 (<\/b><b><sup>177<\/sup>Lu-rosopatamab tetraxetan): <\/b>Telix has closed enrollment into Part 1 of ProstACT Global<sup>[8]<\/sup>, the Phase 3 trial of its lead prostate cancer therapy candidate. A preliminary readout of safety and dosimetry will follow the completion of patient treatment (with standard of care), monitoring and data analysis. Part 2 (randomized treatment expansion) has opened for enrollment in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">New Zealand<\/span> and <span class=\"xn-location\">Canada<\/span>, and with further sites to be opened in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Singapore<\/span>, T\u00fcrkiye and <span class=\"xn-location\">Japan<\/span>, where the study has regulatory approval.<\/li>\n<li><b>TLX250 (<\/b><b><sup>177<\/sup>Lu-DOTA-girentuximab): <\/b>Telix received ethics approval in <span class=\"xn-location\">Australia<\/span> to commence LUTEON<sup>[9]<\/sup>, a pivotal trial of TLX250 as a monotherapy in advanced metastatic clear cell renal cell carcinoma (ccRCC). STARLITE-1<sup>[10]<\/sup>\u00a0&#8211; a Phase <span class=\"xn-money\">1b<\/span>\/2 clinical trial investigating the use of TLX250 in combination with cabozantinib and nivolumab, in ccRCC, has commenced dosing patients.<\/li>\n<li><b>TLX101 (<\/b><b><sup>131<\/sup>I-iodofalan, or <\/b><b><sup>131<\/sup>I-IPA): <\/b>Telix received approval<sup>[<\/sup><sup>11]<\/sup> to commence IPAX-BrIGHT in <span class=\"xn-location\">Europe<\/span>. This international pivotal trial of TLX101 in patients with recurrent glioblastoma is currently activating its first site in <span class=\"xn-location\">Australia<\/span>, following receipt of ethics approval in Q2 2025<sup>[12]<\/sup>.<\/li>\n<li><b>TLX090 (<\/b><b><sup>153<\/sup>Sm-DOTMP): <\/b>Telix is preparing to dose the first patient in SOLACE, a Phase 1 study of Telix&#8217;s therapeutic candidate for treating bone pain in patients with osteoblastic metastatic cancer.<\/li>\n<li><b>TLX400 (<\/b><b><sup>177<\/sup>Lu-DOTAGA.Glu.(FAPi)<sub>2<\/sub>): <\/b>A study of Telix&#8217;s Fibroblast Activation Protein (FAP)- targeting therapy candidate, TLX400, was published in the <i>Journal of Nuclear Medicine<\/i>, demonstrating clinical antitumor activity with an encouraging safety profile in subjects with advanced sarcoma<sup>[13]<\/sup>.<\/li>\n<\/ul>\n<p><b>Precision\u00a0Medicine\u00a0business<\/b><\/p>\n<p><i><b>PSMA\u00a0portfolio\u00a0(Illuccix\u00a0and\u00a0Gozellix):<\/b><\/i><\/p>\n<ul type=\"disc\">\n<li>Gozellix is now a fully reimbursed product in the U.S., having been granted a Level II HCPCS code<sup>[14]<\/sup> and TPT payment status (effective <span class=\"xn-chron\">1 October 2025<\/span>)<sup>[15]<\/sup>. Telix is the only company with two U.S. Food and Drug\u00a0Administration (FDA)-approved PSMA\u00a0imaging products.<\/li>\n<li>Following country-level approval for Illuccix in <span class=\"xn-location\">Spain<\/span><sup>[16]<\/sup>, Telix now has approvals for all 19 markets in the Company&#8217;s decentralized procedure (DCP) submission in <span class=\"xn-location\">Europe<\/span>. Commercial launch\u00a0has\u00a0commenced\u00a0in\u00a0the\u00a0UK,\u00a0Germany,\u00a0France, Finland,\u00a0Sweden,\u00a0Norway and\u00a0Denmark, as Illuccix is rolled out on a market-by-market basis when reimbursement is secured.<\/li>\n<li>Telix dosed the first patients in the BiPASS\u2122 study<sup>[17]<\/sup> to evaluate the performance of MRI combined with PSMA-PET imaging in diagnosing prostate cancer, with the aim of reducing the need for invasive biopsies. This Phase 3 registration-enabling trial aims to expand the\u00a0indications\u00a0for\u00a0Illuccix and\u00a0Gozellix.\u00a0Telix has\u00a0commenced\u00a0the\u00a0study\u00a0in\u00a0Melbourne,\u00a0Australia and has filed an investigational new drug application (IND) with the FDA\u00a0to commence the study in the U.S.<\/li>\n<li>Telix successfully received a Prior\u00a0Approval Supplement (PAS) to update the U.S. Prescribing Information for Illuccix. The Illuccix label now includes patient selection for radioligand therapy (RLT) in the pre-taxane setting.<\/li>\n<\/ul>\n<p><b><i>Pixclara\u00ae<\/i><\/b><sup>[<\/sup><sup>18]<\/sup> <b>(TLX101-CDx, <\/b><b><sup>18<\/sup>F-floretyrosine or <\/b><b><sup>18<\/sup>F-FET): <\/b>Telix reached agreement with the FDA on a pathway for resubmission of the New Drug\u00a0Application (NDA) for Telix&#8217;s brain cancer imaging candidate, confirming it plans to resubmit the NDA during Q4 2025<sup>[<\/sup><sup>19]<\/sup>.<\/p>\n<p><b><i>Zircaix\u00ae<\/i><\/b><sup>[<\/sup><sup>18]<\/sup>\u00a0<b>(TLX250-CDx, <\/b><b><sup>89<\/sup>Zr-DFO-girentuximab): <\/b>Following the receipt of a Complete Response Letter from the FDA in <span class=\"xn-chron\">August 2025<\/span><sup>[20<\/sup><sup>]<\/sup>,\u00a0Telix\u00a0is\u00a0requesting\u00a0a\u00a0Type\u00a0A\u00a0meeting,\u00a0ahead of\u00a0the resubmission of the Biologics License\u00a0Application (BLA) for its kidney cancer imaging agent.<\/p>\n<p><b>Telix\u00a0Manufacturing\u00a0Solutions (TMS)<\/b><\/p>\n<p>Telix has been granted radiation licenses for its TMS North Melbourne (<span class=\"xn-location\">Australia<\/span>) and <span class=\"xn-location\">Yokohama<\/span> (<span class=\"xn-location\">Japan<\/span>)\u00a0facilities\u00a0&#8211;\u00a0for\u00a0a\u00a0broad\u00a0range of\u00a0clinically\u00a0and\u00a0commercially\u00a0important\u00a0medical\u00a0isotopes.\u00a0Both facilities are in the final stages of fit-out and preparing for operational readiness.<\/p>\n<p><b>Corporate updates<\/b><\/p>\n<p><i><b>Final royalty payment to\u00a0ANMI<\/b><\/i><\/p>\n<p>In 2018, Telix acquired Advanced Nuclear Medicine Ingredients (ANMI), the developer of the underlying Illuccix technology. The acquisition agreement included contingent consideration (variable payments) based on Illuccix global sales for five years following marketing authorization\u00a0of Illuccix, with an option to buy out remaining payments in the third year following marketing authorization if agreed sales thresholds were met. As a result of strong sales performance, Telix has successfully exercised its option to buy-out the remaining variable payments. The final payment of <span class=\"xn-money\">$51.7 million<\/span> comprising the option payment and third and final annual variable payment was made in <span class=\"xn-chron\">July 2025<\/span>, and will be reflected in the cash flows for H2 2025, included in\u00a0the Company&#8217;s full year financial results.<\/p>\n<p><b>FY\u00a02025\u00a0guidance<\/b><\/p>\n<ul type=\"disc\">\n<li>Telix\u00a0increases\u00a0FY 2025 revenue guidance to <span class=\"xn-money\">$800 million<\/span> to <span class=\"xn-money\">$820 million<\/span><sup>[21<\/sup><sup>]<\/sup>.<\/li>\n<li>Guidance reflects revenue from PSMA\u00a0imaging (Illuccix\u00a0and\u00a0Gozellix) product sales in jurisdictions with a marketing authorization, and 11 months of revenue contribution from RLS<sup>[22<\/sup><sup>]<\/sup>.<\/li>\n<li>Telix confirms research and development (R&amp;D) expenditure guidance, expecting a year-over- year increased investment range for FY 2025 of 20% to 25% compared to FY 2024.<\/li>\n<\/ul>\n<p><b>Guidance\u00a0disclaimer<\/b><\/p>\n<p>The stated revenue 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\u00a0Telix 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 listed below.<\/p>\n<p>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, regulation, or policy that affects product production, distribution, pricing,\u00a0reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix&#8217;s ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions.<\/p>\n<p><b>About\u00a0Telix\u00a0Pharmaceuticals\u00a0Limited<\/b><\/p>\n<p>Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in <span class=\"xn-location\">Melbourne, Australia<\/span>, with international operations in <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">United Kingdom<\/span>, <span class=\"xn-location\">Brazil<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">Europe<\/span> (<span class=\"xn-location\">Belgium<\/span> and <span class=\"xn-location\">Switzerland<\/span>), and <span class=\"xn-location\">Japan<\/span>. 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) and the Nasdaq Global Select Market (NASDAQ: TLX).<\/p>\n<p>Telix&#8217;s prostate imaging product, gallium-68 (<sup>68<\/sup>Ga) gozetotide injection (also known as <sup>68<\/sup>Ga PSMA-11 and marketed under the brand name Illuccix\u00ae), has been approved by the FDA<sup>[23]<\/sup>, and in multiple markets globally. Gozellix\u00ae (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the FDA<sup>[24]<\/sup>.<\/p>\n<p>Telix&#8217;s osteomyelitis (bone infection) imaging agent, technetium-99m (<sup><span class=\"xn-money\">99m<\/span><\/sup>Tc) besilesomab, marketed under the brand name Scintimun\u00ae, is approved in 32 European countries and <span class=\"xn-location\">Mexico<\/span>. Telix&#8217;s miniaturized surgical gamma probe, SENSEI\u00ae, for minimally invasive and robotic-assisted surgery, is registered with the FDA\u00a0for use in the U.S. and has attained a Conformit\u00e9 Europ\u00e9enne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.<\/p>\n<p>Visit <u><a href=\"http:\/\/www.telixpharma.com\/\" target=\"_blank\" rel=\"nofollow\">www.telixpharma.com<\/a><\/u>\u00a0for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest.\u00a0You can also follow Telix on <u><a href=\"https:\/\/www.linkedin.com\/company\/telixpharma\/\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>,<\/u>\u00a0<u><a href=\"https:\/\/x.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow\">X<\/a><\/u> and <u><a href=\"https:\/\/www.facebook.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow\">Facebook<\/a><\/u>.<\/p>\n<p><b>Telix\u00a0Investor\u00a0Relations (Global)<\/b><\/p>\n<p>Ms. Kyahn Williamson<br \/>Telix Pharmaceuticals\u00a0Limited<br \/>SVP Investor Relations\u00a0and\u00a0Corporate\u00a0Communications<br \/>Email: <u><a href=\"mailto:kyahn.williamson@telixpharma.com\" target=\"_blank\" rel=\"nofollow\">kyahn.williamson@telixpharma.com<\/a><\/u><\/p>\n<p><b>Telix Investor Relations\u00a0(U.S.)<\/b><\/p>\n<p><span class=\"xn-person\">Annie Kasparian<\/span><br \/>Telix Pharmaceuticals\u00a0Limited<br \/>Director Investor Relations and Corporate Communications<br \/>Email: <u><a href=\"mailto:annie.kasparian@telixpharma.com\" target=\"_blank\" rel=\"nofollow\">annie.kasparian@telixpharma.com<\/a><\/u><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb0 prnrbrb0 prnsbbb0 prnsblb0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Previous FY\u00a02025\u00a0revenue guidance:\u00a0$770\u00a0million to\u00a0$800\u00a0million.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[2] Healthcare Common Procedure Coding System.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[3] Telix\u00a0ASX\u00a0disclosure\u00a023\u00a0September\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[4] All European countries included in Telix&#8217;s\u00a0European Economic\u00a0Area\u00a0submission.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[5] Magnetic resonance imaging; imaging of prostate-specific membrane antigen with positron emission tomography.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[6] PSMA\u00a0imaging\u00a0revenue\u00a0represents\u00a0sales\u00a0of\u00a0Illuccix\u00ae\u00a0and\u00a0Gozellix\u00ae\u00a0in\u00a0our\u00a0Precision Medicine\u00a0business.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[7] RLS\u00a0Radiopharmacies\u00a0revenue\u00a0excludes revenue\u00a0contribution\u00a0from\u00a0Illuccix\u00a0and\u00a0Gozellix\u00a0sales.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[8] ClinicalTrials.gov\u00a0ID:\u00a0NCT06520345.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[9] ClinicalTrials.gov\u00a0ID:\u00a0NCT07197580.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[10] ClinicalTrials.gov\u00a0ID:\u00a0NCT05663710.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[11] Approved with conditions.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[12] Telix\u00a0ASX\u00a0disclosure\u00a022\u00a0July\u00a02025.\u00a0ClinicalTrials.gov\u00a0ID:\u00a0NCT07100730.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[13] Telix\u00a0media\u00a0release\u00a06\u00a0October\u00a02025.\u00a0Ballal\u00a0et\u00a0al.\u00a0J\u00a0Nucl\u00a0Med.\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[14] Telix\u00a0ASX\u00a0disclosure\u00a09\u00a0July\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[15] Telix\u00a0ASX\u00a0disclosure\u00a023\u00a0September\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[16] Telix\u00a0media release\u00a029\u00a0August 2025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[17] Biopsy of the Prostate Avoidance Stratification Study; ClinicalTrials.gov\u00a0ID:\u00a0NCT07052214.\u00a0Telix\u00a0media\u00a0release 9 September 2025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[18] Brand name subject to final regulatory approval.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[19] Telix\u00a0ASX\u00a0disclosure\u00a09\u00a0September\u00a02025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[20] Telix\u00a0ASX\u00a0disclosure\u00a028\u00a0August\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[21] Telix\u00a0ASX\u00a0disclosure\u00a020\u00a0February\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[22] See Guidance disclaimer for further information.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[23] Telix\u00a0ASX\u00a0disclosure\u00a020\u00a0December\u00a02021.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[24] Telix\u00a0ASX\u00a0disclosure\u00a021\u00a0March\u00a02025.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p class=\"prntac\"><i>This\u00a0announcement\u00a0has\u00a0been\u00a0authorized\u00a0for\u00a0release\u00a0by\u00a0the\u00a0Telix Pharmaceuticals\u00a0Limited Board\u00a0of\u00a0Directors.<\/i><\/p>\n<p class=\"prntac\">Legal Notices<\/p>\n<p class=\"prntac\"><i>Cautionary Statement Regarding Forward-Looking Statements.<\/i><\/p>\n<p><i>You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report\u00a0on Form 20-F filed with the SEC, or on our website.<\/i><\/p>\n<p><i>The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the\u00a0United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. 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.<\/i><\/p>\n<p><i>This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or\u00a0business developments. Forward-looking statements can generally be identified by the use of words such as &#8220;may&#8221;, &#8220;expect&#8221;, &#8220;intend&#8221;, &#8220;plan&#8221;, &#8220;estimate&#8221;, &#8220;anticipate&#8221;, &#8220;believe&#8221;, &#8220;outlook&#8221;, &#8220;forecast&#8221; and &#8220;guidance&#8221;, or the negative of these words\u00a0or\u00a0other\u00a0similar terms\u00a0or\u00a0expressions.\u00a0Forward-looking\u00a0statements\u00a0involve known\u00a0and\u00a0unknown risks,\u00a0uncertainties 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 Telix&#8217;s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix&#8217;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&#8217;s business, forward- looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix&#8217;s preclinical and clinical trials, and Telix&#8217;s research and development programs; Telix&#8217;s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing\u00a0or\u00a0likelihood\u00a0of\u00a0regulatory\u00a0filings and\u00a0approvals\u00a0for\u00a0Telix&#8217;s\u00a0product candidates,\u00a0manufacturing\u00a0activities\u00a0and\u00a0product marketing activities; Telix&#8217;s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix&#8217;s product candidates, if or when they have been approved; Telix&#8217;s ability to obtain an\u00a0adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix&#8217;s expenses, future revenues and capital requirements; Telix&#8217;s financial performance; developments relating to Telix&#8217;s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on\u00a0Telix&#8217;s business; and the pricing and reimbursement of Telix&#8217;s product candidates, if and after they have been approved. Telix&#8217;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.<\/i><\/p>\n<p><i>Trademarks\u00a0and\u00a0Trade\u00a0Names.\u00a0All\u00a0trademarks\u00a0and\u00a0trade\u00a0names\u00a0referenced\u00a0in\u00a0this\u00a0press\u00a0release\u00a0are\u00a0the\u00a0property of\u00a0Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the \u00ae or \u2122 symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not\u00a0intend the\u00a0use or\u00a0display of\u00a0any third-party\u00a0trademarks or\u00a0trade names\u00a0to imply\u00a0any affiliation\u00a0with, endorsement by, or sponsorship from those third parties.<\/i><\/p>\n<p><i>\u00a92025\u00a0Telix\u00a0Pharmaceuticals\u00a0Limited.\u00a0All\u00a0rights reserved.<\/i><\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1920208\/Telix_Main_Logo_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MELBOURNE<\/span>, Australia\u00a0and\u00a0INDIANAPOLIS<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Oct. 14, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, &#8220;Telix&#8221;) today provides an update on its commercial and operational performance for the quarter ended <span class=\"xn-chron\">30 September 2025<\/span> (Q3 2025). All figures are in USD unless stated otherwise.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<p><b>Q3\u00a02025\u00a0Highlights<\/b><\/p>\n<ul type=\"disc\">\n<li>Q3 2025 unaudited group revenue of approximately <span class=\"xn-money\">$206 million<\/span>, up 53% year-over-year.<\/li>\n<li>FY 2025 revenue guidance increased to <span class=\"xn-money\">$800 million<\/span> to <span class=\"xn-money\">$820 million<\/span><sup>[1]<\/sup>.<\/li>\n<li>Gozellix\u00ae now fully reimbursed by Centers for Medicare and Medicaid Services (CMS): Level II HCPCS<sup>[<\/sup><sup>2]<\/sup> code and Transitional Pass-Through (TPT) payment status effective <span class=\"xn-chron\">1 October 2025<\/span><sup>[3]<\/sup>.<\/li>\n<li>Illuccix\u00ae now approved in 19 European markets<sup>[<\/sup><sup>4]<\/sup> and the <span class=\"xn-location\">United Kingdom<\/span> (UK); commercial launch has commenced in the UK, <span class=\"xn-location\">Germany<\/span>, <span class=\"xn-location\">France<\/span>, <span class=\"xn-location\">Finland<\/span>, <span class=\"xn-location\">Sweden<\/span>, <span class=\"xn-location\">Norway<\/span> and <span class=\"xn-location\">Denmark<\/span>.<\/li>\n<li>First patients dosed in the BiPASS\u2122 trial of MRI + PSMA-PET<sup>[<\/sup><sup>5]<\/sup> for the diagnosis and detection of prostate cancer.<\/li>\n<li>ProstACT\u00ae Global Phase 3 trial \u2013 Part 2 open for enrollment in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">New Zealand<\/span> and <span class=\"xn-location\">Canada<\/span> and study approved to commence in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Singapore<\/span>, T\u00fcrkiye and <span class=\"xn-location\">Japan<\/span>. Part 1 preliminary readout of safety profile and dosimetry to follow completion of patient monitoring and data analysis.<\/li>\n<\/ul>\n<p><b>Q3 2025 Revenue (Unaudited)<\/b><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Revenue US$M<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prngen10\"><span class=\"prnews_span\"><b>Q3 2025<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Q3 2024<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Variation<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Q2 2025<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prngen10\"><span class=\"prnews_span\"><b>Variation<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">Group revenue<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">206<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">135<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">53\u00a0%<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">204<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">1\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">PSMA imaging revenue<sup>[6]<\/sup><\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">155<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">132<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">17\u00a0%<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">154<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">1\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">RLS third-party revenue<sup>[7]<\/sup><\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">47<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u2014<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u2014<\/span><\/p>\n<\/td>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">46<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">2\u00a0%<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><b>Commentary and business highlights<\/b><\/p>\n<p>Dr. <span class=\"xn-person\">Christian Behrenbruch<\/span>, Managing Director and Group CEO, stated, &#8220;We believe this is a solid result, particularly in light of the reimbursement dynamics during the quarter. Moreover, a 3% increase in dose volumes suggests competitive pricing pressures are beginning to stabilize. Telix has entered Q4 in a position of strength, supported by a growing customer base, two FDA- approved PSMA\u00a0imaging agents and CMS reimbursement for Gozellix effective from 1 October in the U.S. This differentiated two-product strategy enables us to expand market share across all customer segments, with Gozellix enhancing our production flexibility and providing customer choice based on patient reimbursement pathways.&#8221;<\/p>\n<p><b>Therapeutics business<\/b><\/p>\n<ul type=\"disc\">\n<li><b>TLX591 (<\/b><b><sup>177<\/sup>Lu-rosopatamab tetraxetan): <\/b>Telix has closed enrollment into Part 1 of ProstACT Global<sup>[8]<\/sup>, the Phase 3 trial of its lead prostate cancer therapy candidate. A preliminary readout of safety and dosimetry will follow the completion of patient treatment (with standard of care), monitoring and data analysis. Part 2 (randomized treatment expansion) has opened for enrollment in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">New Zealand<\/span> and <span class=\"xn-location\">Canada<\/span>, and with further sites to be opened in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Singapore<\/span>, T\u00fcrkiye and <span class=\"xn-location\">Japan<\/span>, where the study has regulatory approval.<\/li>\n<li><b>TLX250 (<\/b><b><sup>177<\/sup>Lu-DOTA-girentuximab): <\/b>Telix received ethics approval in <span class=\"xn-location\">Australia<\/span> to commence LUTEON<sup>[9]<\/sup>, a pivotal trial of TLX250 as a monotherapy in advanced metastatic clear cell renal cell carcinoma (ccRCC). STARLITE-1<sup>[10]<\/sup>\u00a0&#8211; a Phase <span class=\"xn-money\">1b<\/span>\/2 clinical trial investigating the use of TLX250 in combination with cabozantinib and nivolumab, in ccRCC, has commenced dosing patients.<\/li>\n<li><b>TLX101 (<\/b><b><sup>131<\/sup>I-iodofalan, or <\/b><b><sup>131<\/sup>I-IPA): <\/b>Telix received approval<sup>[<\/sup><sup>11]<\/sup> to commence IPAX-BrIGHT in <span class=\"xn-location\">Europe<\/span>. This international pivotal trial of TLX101 in patients with recurrent glioblastoma is currently activating its first site in <span class=\"xn-location\">Australia<\/span>, following receipt of ethics approval in Q2 2025<sup>[12]<\/sup>.<\/li>\n<li><b>TLX090 (<\/b><b><sup>153<\/sup>Sm-DOTMP): <\/b>Telix is preparing to dose the first patient in SOLACE, a Phase 1 study of Telix&#8217;s therapeutic candidate for treating bone pain in patients with osteoblastic metastatic cancer.<\/li>\n<li><b>TLX400 (<\/b><b><sup>177<\/sup>Lu-DOTAGA.Glu.(FAPi)<sub>2<\/sub>): <\/b>A study of Telix&#8217;s Fibroblast Activation Protein (FAP)- targeting therapy candidate, TLX400, was published in the <i>Journal of Nuclear Medicine<\/i>, demonstrating clinical antitumor activity with an encouraging safety profile in subjects with advanced sarcoma<sup>[13]<\/sup>.<\/li>\n<\/ul>\n<p><b>Precision\u00a0Medicine\u00a0business<\/b><\/p>\n<p><i><b>PSMA\u00a0portfolio\u00a0(Illuccix\u00a0and\u00a0Gozellix):<\/b><\/i><\/p>\n<ul type=\"disc\">\n<li>Gozellix is now a fully reimbursed product in the U.S., having been granted a Level II HCPCS code<sup>[14]<\/sup> and TPT payment status (effective <span class=\"xn-chron\">1 October 2025<\/span>)<sup>[15]<\/sup>. Telix is the only company with two U.S. Food and Drug\u00a0Administration (FDA)-approved PSMA\u00a0imaging products.<\/li>\n<li>Following country-level approval for Illuccix in <span class=\"xn-location\">Spain<\/span><sup>[16]<\/sup>, Telix now has approvals for all 19 markets in the Company&#8217;s decentralized procedure (DCP) submission in <span class=\"xn-location\">Europe<\/span>. Commercial launch\u00a0has\u00a0commenced\u00a0in\u00a0the\u00a0UK,\u00a0Germany,\u00a0France, Finland,\u00a0Sweden,\u00a0Norway and\u00a0Denmark, as Illuccix is rolled out on a market-by-market basis when reimbursement is secured.<\/li>\n<li>Telix dosed the first patients in the BiPASS\u2122 study<sup>[17]<\/sup> to evaluate the performance of MRI combined with PSMA-PET imaging in diagnosing prostate cancer, with the aim of reducing the need for invasive biopsies. This Phase 3 registration-enabling trial aims to expand the\u00a0indications\u00a0for\u00a0Illuccix and\u00a0Gozellix.\u00a0Telix has\u00a0commenced\u00a0the\u00a0study\u00a0in\u00a0Melbourne,\u00a0Australia and has filed an investigational new drug application (IND) with the FDA\u00a0to commence the study in the U.S.<\/li>\n<li>Telix successfully received a Prior\u00a0Approval Supplement (PAS) to update the U.S. Prescribing Information for Illuccix. The Illuccix label now includes patient selection for radioligand therapy (RLT) in the pre-taxane setting.<\/li>\n<\/ul>\n<p><b><i>Pixclara\u00ae<\/i><\/b><sup>[<\/sup><sup>18]<\/sup> <b>(TLX101-CDx, <\/b><b><sup>18<\/sup>F-floretyrosine or <\/b><b><sup>18<\/sup>F-FET): <\/b>Telix reached agreement with the FDA on a pathway for resubmission of the New Drug\u00a0Application (NDA) for Telix&#8217;s brain cancer imaging candidate, confirming it plans to resubmit the NDA during Q4 2025<sup>[<\/sup><sup>19]<\/sup>.<\/p>\n<p><b><i>Zircaix\u00ae<\/i><\/b><sup>[<\/sup><sup>18]<\/sup>\u00a0<b>(TLX250-CDx, <\/b><b><sup>89<\/sup>Zr-DFO-girentuximab): <\/b>Following the receipt of a Complete Response Letter from the FDA in <span class=\"xn-chron\">August 2025<\/span><sup>[20<\/sup><sup>]<\/sup>,\u00a0Telix\u00a0is\u00a0requesting\u00a0a\u00a0Type\u00a0A\u00a0meeting,\u00a0ahead of\u00a0the resubmission of the Biologics License\u00a0Application (BLA) for its kidney cancer imaging agent.<\/p>\n<p><b>Telix\u00a0Manufacturing\u00a0Solutions (TMS)<\/b><\/p>\n<p>Telix has been granted radiation licenses for its TMS North Melbourne (<span class=\"xn-location\">Australia<\/span>) and <span class=\"xn-location\">Yokohama<\/span> (<span class=\"xn-location\">Japan<\/span>)\u00a0facilities\u00a0&#8211;\u00a0for\u00a0a\u00a0broad\u00a0range of\u00a0clinically\u00a0and\u00a0commercially\u00a0important\u00a0medical\u00a0isotopes.\u00a0Both facilities are in the final stages of fit-out and preparing for operational readiness.<\/p>\n<p><b>Corporate updates<\/b><\/p>\n<p><i><b>Final royalty payment to\u00a0ANMI<\/b><\/i><\/p>\n<p>In 2018, Telix acquired Advanced Nuclear Medicine Ingredients (ANMI), the developer of the underlying Illuccix technology. The acquisition agreement included contingent consideration (variable payments) based on Illuccix global sales for five years following marketing authorization\u00a0of Illuccix, with an option to buy out remaining payments in the third year following marketing authorization if agreed sales thresholds were met. As a result of strong sales performance, Telix has successfully exercised its option to buy-out the remaining variable payments. The final payment of <span class=\"xn-money\">$51.7 million<\/span> comprising the option payment and third and final annual variable payment was made in <span class=\"xn-chron\">July 2025<\/span>, and will be reflected in the cash flows for H2 2025, included in\u00a0the Company&#8217;s full year financial results.<\/p>\n<p><b>FY\u00a02025\u00a0guidance<\/b><\/p>\n<ul type=\"disc\">\n<li>Telix\u00a0increases\u00a0FY 2025 revenue guidance to <span class=\"xn-money\">$800 million<\/span> to <span class=\"xn-money\">$820 million<\/span><sup>[21<\/sup><sup>]<\/sup>.<\/li>\n<li>Guidance reflects revenue from PSMA\u00a0imaging (Illuccix\u00a0and\u00a0Gozellix) product sales in jurisdictions with a marketing authorization, and 11 months of revenue contribution from RLS<sup>[22<\/sup><sup>]<\/sup>.<\/li>\n<li>Telix confirms research and development (R&amp;D) expenditure guidance, expecting a year-over- year increased investment range for FY 2025 of 20% to 25% compared to FY 2024.<\/li>\n<\/ul>\n<p><b>Guidance\u00a0disclaimer<\/b><\/p>\n<p>The stated revenue 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\u00a0Telix 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 listed below.<\/p>\n<p>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, regulation, or policy that affects product production, distribution, pricing,\u00a0reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix&#8217;s ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions.<\/p>\n<p><b>About\u00a0Telix\u00a0Pharmaceuticals\u00a0Limited<\/b><\/p>\n<p>Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in <span class=\"xn-location\">Melbourne, Australia<\/span>, with international operations in <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">United Kingdom<\/span>, <span class=\"xn-location\">Brazil<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">Europe<\/span> (<span class=\"xn-location\">Belgium<\/span> and <span class=\"xn-location\">Switzerland<\/span>), and <span class=\"xn-location\">Japan<\/span>. 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) and the Nasdaq Global Select Market (NASDAQ: TLX).<\/p>\n<p>Telix&#8217;s prostate imaging product, gallium-68 (<sup>68<\/sup>Ga) gozetotide injection (also known as <sup>68<\/sup>Ga PSMA-11 and marketed under the brand name Illuccix\u00ae), has been approved by the FDA<sup>[23]<\/sup>, and in multiple markets globally. Gozellix\u00ae (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the FDA<sup>[24]<\/sup>.<\/p>\n<p>Telix&#8217;s osteomyelitis (bone infection) imaging agent, technetium-99m (<sup><span class=\"xn-money\">99m<\/span><\/sup>Tc) besilesomab, marketed under the brand name Scintimun\u00ae, is approved in 32 European countries and <span class=\"xn-location\">Mexico<\/span>. Telix&#8217;s miniaturized surgical gamma probe, SENSEI\u00ae, for minimally invasive and robotic-assisted surgery, is registered with the FDA\u00a0for use in the U.S. and has attained a Conformit\u00e9 Europ\u00e9enne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.<\/p>\n<p>Visit <u><a href=\"http:\/\/www.telixpharma.com\/\" target=\"_blank\" rel=\"nofollow\">www.telixpharma.com<\/a><\/u>\u00a0for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest.\u00a0You can also follow Telix on <u><a href=\"https:\/\/www.linkedin.com\/company\/telixpharma\/\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>,<\/u>\u00a0<u><a href=\"https:\/\/x.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow\">X<\/a><\/u> and <u><a href=\"https:\/\/www.facebook.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow\">Facebook<\/a><\/u>.<\/p>\n<p><b>Telix\u00a0Investor\u00a0Relations (Global)<\/b><\/p>\n<p>Ms. Kyahn Williamson<br \/>Telix Pharmaceuticals\u00a0Limited<br \/>SVP Investor Relations\u00a0and\u00a0Corporate\u00a0Communications<br \/>Email: <u><a href=\"mailto:kyahn.williamson@telixpharma.com\" target=\"_blank\" rel=\"nofollow\">kyahn.williamson@telixpharma.com<\/a><\/u><\/p>\n<p><b>Telix Investor Relations\u00a0(U.S.)<\/b><\/p>\n<p><span class=\"xn-person\">Annie Kasparian<\/span><br \/>Telix Pharmaceuticals\u00a0Limited<br \/>Director Investor Relations and Corporate Communications<br \/>Email: <u><a href=\"mailto:annie.kasparian@telixpharma.com\" target=\"_blank\" rel=\"nofollow\">annie.kasparian@telixpharma.com<\/a><\/u><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb0 prnrbrb0 prnsbbb0 prnsblb0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Previous FY\u00a02025\u00a0revenue guidance:\u00a0$770\u00a0million to\u00a0$800\u00a0million.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[2] Healthcare Common Procedure Coding System.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[3] Telix\u00a0ASX\u00a0disclosure\u00a023\u00a0September\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[4] All European countries included in Telix&#8217;s\u00a0European Economic\u00a0Area\u00a0submission.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[5] Magnetic resonance imaging; imaging of prostate-specific membrane antigen with positron emission tomography.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[6] PSMA\u00a0imaging\u00a0revenue\u00a0represents\u00a0sales\u00a0of\u00a0Illuccix\u00ae\u00a0and\u00a0Gozellix\u00ae\u00a0in\u00a0our\u00a0Precision Medicine\u00a0business.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[7] RLS\u00a0Radiopharmacies\u00a0revenue\u00a0excludes revenue\u00a0contribution\u00a0from\u00a0Illuccix\u00a0and\u00a0Gozellix\u00a0sales.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[8] ClinicalTrials.gov\u00a0ID:\u00a0NCT06520345.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[9] ClinicalTrials.gov\u00a0ID:\u00a0NCT07197580.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[10] ClinicalTrials.gov\u00a0ID:\u00a0NCT05663710.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[11] Approved with conditions.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[12] Telix\u00a0ASX\u00a0disclosure\u00a022\u00a0July\u00a02025.\u00a0ClinicalTrials.gov\u00a0ID:\u00a0NCT07100730.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[13] Telix\u00a0media\u00a0release\u00a06\u00a0October\u00a02025.\u00a0Ballal\u00a0et\u00a0al.\u00a0J\u00a0Nucl\u00a0Med.\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[14] Telix\u00a0ASX\u00a0disclosure\u00a09\u00a0July\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[15] Telix\u00a0ASX\u00a0disclosure\u00a023\u00a0September\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[16] Telix\u00a0media release\u00a029\u00a0August 2025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[17] Biopsy of the Prostate Avoidance Stratification Study; ClinicalTrials.gov\u00a0ID:\u00a0NCT07052214.\u00a0Telix\u00a0media\u00a0release 9 September 2025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[18] Brand name subject to final regulatory approval.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[19] Telix\u00a0ASX\u00a0disclosure\u00a09\u00a0September\u00a02025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[20] Telix\u00a0ASX\u00a0disclosure\u00a028\u00a0August\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[21] Telix\u00a0ASX\u00a0disclosure\u00a020\u00a0February\u00a02025.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[22] See Guidance disclaimer for further information.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[23] Telix\u00a0ASX\u00a0disclosure\u00a020\u00a0December\u00a02021.<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[24] Telix\u00a0ASX\u00a0disclosure\u00a021\u00a0March\u00a02025.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p class=\"prntac\"><i>This\u00a0announcement\u00a0has\u00a0been\u00a0authorized\u00a0for\u00a0release\u00a0by\u00a0the\u00a0Telix Pharmaceuticals\u00a0Limited Board\u00a0of\u00a0Directors.<\/i><\/p>\n<p class=\"prntac\">Legal Notices<\/p>\n<p class=\"prntac\"><i>Cautionary Statement Regarding Forward-Looking Statements.<\/i><\/p>\n<p><i>You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report\u00a0on Form 20-F filed with the SEC, or on our website.<\/i><\/p>\n<p><i>The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the\u00a0United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. 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.<\/i><\/p>\n<p><i>This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or\u00a0business developments. Forward-looking statements can generally be identified by the use of words such as &#8220;may&#8221;, &#8220;expect&#8221;, &#8220;intend&#8221;, &#8220;plan&#8221;, &#8220;estimate&#8221;, &#8220;anticipate&#8221;, &#8220;believe&#8221;, &#8220;outlook&#8221;, &#8220;forecast&#8221; and &#8220;guidance&#8221;, or the negative of these words\u00a0or\u00a0other\u00a0similar terms\u00a0or\u00a0expressions.\u00a0Forward-looking\u00a0statements\u00a0involve known\u00a0and\u00a0unknown risks,\u00a0uncertainties 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 Telix&#8217;s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix&#8217;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&#8217;s business, forward- looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix&#8217;s preclinical and clinical trials, and Telix&#8217;s research and development programs; Telix&#8217;s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing\u00a0or\u00a0likelihood\u00a0of\u00a0regulatory\u00a0filings and\u00a0approvals\u00a0for\u00a0Telix&#8217;s\u00a0product candidates,\u00a0manufacturing\u00a0activities\u00a0and\u00a0product marketing activities; Telix&#8217;s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix&#8217;s product candidates, if or when they have been approved; Telix&#8217;s ability to obtain an\u00a0adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix&#8217;s expenses, future revenues and capital requirements; Telix&#8217;s financial performance; developments relating to Telix&#8217;s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on\u00a0Telix&#8217;s business; and the pricing and reimbursement of Telix&#8217;s product candidates, if and after they have been approved. Telix&#8217;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.<\/i><\/p>\n<p><i>Trademarks\u00a0and\u00a0Trade\u00a0Names.\u00a0All\u00a0trademarks\u00a0and\u00a0trade\u00a0names\u00a0referenced\u00a0in\u00a0this\u00a0press\u00a0release\u00a0are\u00a0the\u00a0property of\u00a0Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the \u00ae or \u2122 symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not\u00a0intend the\u00a0use or\u00a0display of\u00a0any third-party\u00a0trademarks or\u00a0trade names\u00a0to imply\u00a0any affiliation\u00a0with, endorsement by, or sponsorship from those third parties.<\/i><\/p>\n<p><i>\u00a92025\u00a0Telix\u00a0Pharmaceuticals\u00a0Limited.\u00a0All\u00a0rights reserved.<\/i><\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-35820","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/35820","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=35820"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/35820\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35820"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=35820"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=35820"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}