Core Insights - Telix Pharmaceuticals Limited has announced a research collaboration with University Hospital Essen to explore the prognostic value of PSMA-PET imaging through artificial intelligence [1][4]. Group 1: Research Collaboration - The PROMISE-PET registry is a multi-center, prospective, observational study aimed at assessing the prognostic value of PSMA-PET imaging and comparing it with established clinical risk scores [2]. - The registry has been collecting data since 2018, standardizing PET readings from over 15,000 patients across more than 50 institutions globally [2]. Group 2: AI and Imaging Technology - The collaboration aims to develop AI-based prediction models for survival using gallium-68 (Ga)-PSMA-11-PET imaging data, leveraging Telix's automated machine learning platform [3]. - PSMA-PET imaging is now considered a standard of care in prostate cancer management, offering greater accuracy than conventional imaging methods [3]. Group 3: Expert Commentary - Wolfgang Fendler, MD, emphasized the importance of Telix's involvement in enhancing risk stratification and informing future clinical guidelines [4]. - Simon Wail from Telix highlighted the significance of accessing a large, standardized PSMA-PET dataset for developing clinically relevant prognostic models [4]. Group 4: Company Overview - Telix Pharmaceuticals is focused on developing therapeutic and diagnostic radiopharmaceuticals, with operations in multiple countries including the U.S., U.K., and Japan [5]. - The company has received approvals for its first-generation PSMA-PET imaging agent, Illuccix®, in various global markets [6].

MELBOURNE, Australia and INDIANAPOLIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the year ended December 31, 2025. FY 2025 key results1 Group performance2: Double-digit revenue growth and positive adjusted operating cash flow Revenue of US$803.8 million, up by 56%3 and achieving upsized full year guidance4.US$157.1 million invested in research and development (R&D) product development for late-stage therapeutics ...

This presentation should be read 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 on Form 20-F filed with the SEC, or on our website. The information contained in this presentation 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 U ...

Core Insights - Telix Pharmaceuticals has announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, to develop novel clinical applications that integrate Telix's theranostic products with external beam radiation therapy (EBRT) [1][2]. Group 1: Collaboration Details - The collaboration aims to enhance the role of EBRT in cancer treatment by integrating therapeutic radiopharmaceuticals and precision diagnostics, potentially improving patient selection and targeted treatment delivery [2][4]. - The initial focus will be on PSMA-PET imaging for prostate cancer radiotherapy patients, utilizing Telix's Gozellix® and Illuccix® products to develop personalized treatment plans and monitor treatment responses [3][4]. Group 2: Future Opportunities - The partnership is structured as a general framework for future co-development opportunities, which may include other PET imaging candidates in Telix's pipeline, such as TLX250-CDx and TLX101-CDx, as well as future therapeutic radiopharmaceuticals [4]. - By combining Telix's expertise in molecular imaging with Varian's leadership in radiation therapy, the collaboration aims to advance personalized cancer care and improve patient outcomes [5]. Group 3: Company Background - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in multiple countries [20]. - Varian, as a Siemens Healthineers company, has over 75 years of experience in developing technologies for cancer treatment, supporting various stages of the cancer care journey [22].

Core Insights - Telix Pharmaceuticals has received recognition for its investigational PET agent TLX250-CDx in updated clinical guidelines for molecular imaging of renal masses, marking a significant advancement in precision medicine for renal cancer [1][5][6] Group 1: Clinical Guidelines and Implications - The updated guidelines from SNMMI, EANM, and ACNM highlight the potential of molecular imaging for risk stratification of indeterminate renal masses, which can enhance patient management decisions [2] - The guidelines endorse TLX250-CDx PET as a well-tolerated and accurate method for non-invasive identification of clear cell renal cell carcinoma (ccRCC), contrasting with traditional F-FDG PET methods that have high renal excretion rates [3][4] Group 2: Clinical Trial Data - Data from Telix's pivotal Phase 3 ZIRCON trial demonstrated that TLX250-CDx met all primary and secondary endpoints, achieving a sensitivity of 86%, specificity of 87%, and a positive predictive value (PPV) of 93% for ccRCC, including small lesions [4][6] - TLX250-CDx specifically binds to carbonic anhydrase IX (CAIX), a target protein present in over 95% of ccRCC cells, resulting in high tumor-to-background ratios and consistent imaging results [4][6] Group 3: Company Statements and Future Outlook - Experts, including Professor Brian Shuch, emphasize that the inclusion of TLX250-CDx PET in clinical guidelines represents a shift towards precision medicine, providing clinicians with improved diagnostic tools for individualized treatment planning [5] - Telix's CEO, Kevin Richardson, noted that this endorsement by a global expert panel is expected to drive adoption and implementation of TLX250-CDx in clinical workflows, ultimately enhancing patient outcomes [5]

Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer, marking a significant milestone in Telix's U.S. commercial strategy [1][2] Group 1: Product and Market Impact - Gozellix® will have separate reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) starting October 1, 2025, and has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 [2] - The TPT status will reduce the out-of-pocket burden for patients and enhance access to advanced prostate cancer imaging [5] - Gozellix® offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, addressing logistical barriers to PSMA-PET imaging [4] Group 2: Production and Technology - The innovative formulation of Gozellix® allows for scalable production via gallium generators or cyclotron-based methods, improving efficiency and scheduling flexibility for scanning clinics [4] - Cyclotron production is supported by GE FASTlab™ and Telix's ARTMS QUANTM Irradiation System® (QIS®), enabling large-scale production across commercial networks and academic centers [4] Group 3: Clinical Application - Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and those with suspected biochemical recurrence based on elevated serum prostate-specific antigen (PSA) levels [3]

Group Performance - Telix Pharmaceuticals reported a revenue of $390.4 million for H1 2025, representing a 63% increase compared to H1 2024's $239.6 million [5][8] - The group gross profit margin was 53%, reflecting a change in product mix to include third-party RLS sales, while the Illuccix® margin remained stable [5] - Adjusted EBITDA was $21.1 million, down from $37.1 million in H1 2024, attributed to increased operating expenditures from strategic acquisitions and investments [5][8] Precision Medicine Segment - Revenue from the Precision Medicine segment increased by 30% compared to H1 2024, driven by higher Illuccix dose volumes [5] - Illuccix gross margin remained stable at 64% [5] - Selling and marketing expenses rose to $40.9 million due to investments in commercial infrastructure for new product launches [5] Manufacturing Solutions - Telix Manufacturing Solutions (TMS) reported $109.5 million in revenue, with $79.0 million from third-party PET and SPECT product sales [5] - Operating expenses for TMS were $30.5 million, which included $14.9 million for the RLS business and $15.6 million for start-up and integration activities [5] - TMS facilities are located in the U.S., Belgium, Australia, and Japan, enhancing global production capabilities [5] Research and Development - Total R&D investment was $81.6 million, a 47% increase year-over-year, with 54% allocated to the therapeutics pipeline [5] - Key milestones included the completion of target enrollment for Phase 3 studies and approvals for new therapeutic studies [5][6] - Full year R&D investment guidance is maintained, expecting a year-over-year increase of 20% to 25% compared to FY 2024 [10] Financial Guidance - The company confirmed FY 2025 revenue guidance of $770 million to $800 million, reflecting expected contributions from Illuccix sales and RLS [10] - Positive operating net cash flow of $17.7 million was reported, with a cash balance of $207.2 million following significant M&A investments [5]

Financial Performance - Group revenue increased by 63% year-over-year to $390.4 million [26] - Precision Medicine revenue increased by approximately 30% year-over-year [26] - R&D investment increased by 47% year-over-year [26] - The company maintained positive operating cash flow of $17.7 million [26] - The company invested $241.8 million in strategic M&A [26] Business Segments - RLS revenue was $79.0 million, including third-party sales of PET and SPECT products [28, 29] - Precision Medicine gross margins remained stable at 64% [26, 36] - TMS (excluding RLS) experienced operating expenses that support expansion of global facilities and start-up and integration activities [38] Guidance and Future Outlook - The company reaffirmed FY 2025 revenue guidance of $770 million - $800 million [26, 48] - Research & Development (R&D) expenditure is expected to increase 20% - 25% compared to FY 2024 [49] Strategic Initiatives - The company completed target enrollment of 30 patients for ProstACT Global Phase 3 Part 1 [21, 109, 126] - The company received approval to commence IPAX-BrIGHT pivotal trial in glioblastoma (ex-U S) [21, 126] - The company is planning NDA resubmission for Pixclara® in approximately three months [21, 99]

Core Insights - Telix Pharmaceuticals has received a permanent HCPCS code for its next-generation PSMA PET imaging agent, Gozellix, which will enhance billing and reimbursement processes in the U.S. healthcare system [1][2][4] Group 1: Product Development and Approval - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, particularly those with suspected metastasis or biochemical recurrence [3] - The product features an extended shelf-life and flexible production options, addressing logistical barriers to PSMA-PET imaging access [3][4] - Gozellix has been approved by the U.S. FDA, following the success of Telix's first-generation PSMA-PET imaging agent, Illuccix [5] Group 2: Market Impact and Future Prospects - The HCPCS code assignment is a significant milestone that supports clinical adoption and reimbursement for Gozellix, facilitating its commercial scale-up in the U.S. [2][4] - The CEO of Telix emphasized that this development is crucial for improving access to precision medicine imaging for prostate cancer patients across the U.S. [4] Group 3: Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [4] - The company operates internationally, with a presence in the U.S., Brazil, Canada, Europe, and Japan, aiming to address unmet medical needs in oncology and rare diseases [4]

Core Viewpoint - The U.S. FDA has approved a label expansion for Telix Pharmaceuticals' Illuccix® to include patient selection for radioligand therapy (RLT) in the pre-taxane setting, which is expected to significantly increase its clinical utilization [1][2]. Group 1: FDA Approval and Market Impact - The label expansion for Illuccix® is its third indication, allowing for the selection of patients indicated for PSMA-directed therapy [2]. - Following the FDA's approval of Pluvicto® for use in metastatic castration-resistant prostate cancer (mCRPC) patients, the clinical utilization of Illuccix® is projected to increase by at least 20,000 scans annually [2]. Group 2: Clinical Significance - The expansion of the indication allows clinicians to make more informed and personalized decisions earlier in the disease course, potentially providing access to life-prolonging targeted radionuclide therapy for more prostate cancer patients [3]. - PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer, enhancing the diagnostic accuracy of Illuccix® [3]. Group 3: Product Information - Illuccix® is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer [4]. - The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, with the most commonly reported adverse reactions being nausea, diarrhea, and dizziness, occurring at a rate of less than 1% [7][8].