Core Insights - Telix Pharmaceuticals Limited announced positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®) for prostate cancer imaging in Chinese patients, achieving a patient-level positive predictive value (PPV) of 94.8% for tumor detection [2][3][6] Group 1: Study Results - The Illuccix China trial met its primary endpoint, confirming that TLX591-CDx PSMA-PET imaging is effective in detecting tumors in patients with biochemical recurrence of prostate cancer [2][3] - The study involved 140 patients and demonstrated a region-level PPV of 100.0% in the prostate bed and extra-pelvic soft tissue, with varying PPV rates in other regions [3][4] - More than two-thirds (67.2%) of patients had a change in their treatment plan due to TLX591-CDx PSMA-PET imaging, indicating its significant impact on clinical decision-making [5] Group 2: Future Plans - The positive results from the Phase 3 study provide a basis for Telix and Grand Pharma to submit a New Drug Application (NDA) for Illuccix in China, a strategically important market [6][7] - Telix is also finalizing its NDA resubmission for TLX101-CDx (Pixclara®) and has had productive interactions with the FDA regarding additional clinical data [9][10] - For TLX250-CDx (Zircaix®), Telix has reached alignment with the FDA on addressing deficiencies identified in a previous Complete Response Letter [11][12] Group 3: Market Context - In China, over 134,000 men were diagnosed with prostate cancer in 2022, with an annual increase of approximately 6% [6] - The number of PET/CT cameras installed in China is projected to exceed 1,600 by the end of 2025, a significant increase from 133 in 2010 [8]

Core Insights - Telix Pharmaceuticals reported a strong third-quarter performance for fiscal 2025, with revenues of $206 million, reflecting a 53% year-over-year increase and a 1% sequential increase [1] - The company has raised its fiscal year 2025 sales guidance from a range of $770 million-$800 million to $800 million-$820 million [6] Revenue Breakdown - PSMA imaging revenue increased by 17% to $155 million, while RLS third-party revenue reached $47 million [1] - The increase in dose volumes by 3% indicates that competitive pricing pressures are stabilizing [5] Product Developments - Gozellix, a radioactive diagnostic agent for prostate cancer, is now fully reimbursed by CMS, effective October 1 [2] - Illuccix has been approved in 19 European markets and the U.K., with commercial launches already initiated in several countries including the U.K., Germany, and France [3] Clinical Trials - The BiPASS trial for MRI + PSMA-PET for prostate cancer diagnosis has begun dosing its first patients [4] - The ProstACT Global Phase 3 trial–Part 2 is now open for enrollment, with preliminary safety profile and dosimetry results expected after patient monitoring [4] Market Performance - Telix Pharmaceuticals' stock increased by 3.60%, reaching $9.88 at the time of publication [6]

Core Insights - Telix Pharmaceuticals reported a significant increase in Q3 2025 revenue, reaching approximately $206 million, which is a 53% increase year-over-year [3][6] - The company has raised its full-year 2025 revenue guidance to between $800 million and $820 million, reflecting strong performance in its PSMA imaging products [6][16] - Gozellix has received full reimbursement from the Centers for Medicare and Medicaid Services (CMS) in the U.S., effective October 1, 2025, enhancing its market position [6][15] Financial Performance - Q3 2025 group revenue was $206 million, compared to $135 million in Q3 2024, marking a 53% increase [3] - PSMA imaging revenue for Q3 2025 was $155 million, up 17% from $132 million in Q3 2024 [3] - RLS third-party revenue reached $47 million, with a notable increase from zero in Q3 2024 [3] Business Highlights - The company has two FDA-approved PSMA imaging agents, which are expected to enhance market share across various customer segments [4] - Gozellix's reimbursement status is expected to improve production flexibility and customer choice [4] - Telix has commenced commercial launches of Illuccix in multiple European markets, including the UK, Germany, and France [6][15] Clinical Development - The first patients have been dosed in the BiPASS™ trial, which aims to evaluate MRI combined with PSMA-PET imaging for prostate cancer diagnosis [6][15] - The ProstACT Global Phase 3 trial has opened for enrollment in several countries, including Australia, New Zealand, and Canada [7] - TLX250 has received ethics approval to commence a pivotal trial in advanced metastatic clear cell renal cell carcinoma [7] Regulatory and Corporate Updates - Telix has received radiation licenses for its manufacturing facilities in North Melbourne and Yokohama, preparing for operational readiness [12] - The company successfully executed a buy-out of remaining variable payments related to the acquisition of Advanced Nuclear Medicine Ingredients (ANMI) due to strong sales performance [13] - Telix plans to resubmit the New Drug Application for its brain cancer imaging candidate, Pixclara, during Q4 2025 [10]

Core Insights - Telix Pharmaceuticals Limited is recognized as one of the most oversold healthcare stocks in 2025, focusing on precision oncology and targeted radiotherapies with active clinical programs in prostate cancer and rare oncologic conditions [1] Financial Performance - In the 2025 half-year update, Telix reported a 30% revenue increase in its Precision Medicine segment, driven by strong demand for its PET imaging agent, Illuccix, and the launch of new products like Gozellix, Zircaix, and Pixclara in international markets [2] - The company has expanded its manufacturing capabilities through Telix Manufacturing Solutions to support clinical and commercial operations globally [2] Research and Development - Telix increased its R&D spending by 47% year-over-year to $81.6 million, continuing to invest in its therapeutics pipeline despite being oversold [3] - Key milestones include the completion of target enrollment for the Phase 3 TLX591 trial in advanced metastatic castration-resistant prostate cancer (mCRPC), initiation of a Phase 1 trial for TLX592, and the start of the pivotal IPAX BrIGHT trial for TLX101 in metastatic brain cancer [3][4] - The company also gained IND approval for a Phase 1 study of TLX090 to manage bone pain in osteoblastic metastatic disease [3] Strategic Positioning - Diagnostic growth is further supported by the dosing of the first patient in the pivotal Phase 3 BiPASS trial, aimed at expanding indications for Illuccix and Gozellix in prostate cancer imaging [4] - Telix's dual strategy of commercial expansion and clinical innovation positions it as a leader in radiopharmaceuticals and precision oncology globally [4]

Core Insights - Telix Pharmaceuticals reported a significant increase in Q2 2025 revenue, reaching approximately $204 million, a 63% increase year-over-year, and reaffirmed its FY 2025 revenue guidance of $770 million to $800 million [3][6][22]. Financial Performance - Group revenue for Q2 2025 was $204 million, compared to $125 million in Q2 2024, marking a 63% increase. Revenue for Q1 2025 was $186 million, showing a 10% increase quarter-over-quarter [3][6]. - Global Illuccix® revenue was $154 million in Q2 2025, up 25% from $123 million in Q2 2024, and slightly increased by 2% from $151 million in Q1 2025 [3]. - RLS revenue reached $46 million in Q2 2025, with no revenue reported in Q2 2024, and a 39% increase from $33 million in Q1 2025 [3]. Business Highlights - Dose volumes for Illuccix rose 7% quarter-on-quarter in the U.S., indicating strong market demand despite competitive pricing pressures [4]. - The launch of Gozellix in the U.S. has commenced, with the product assigned a Level II HCPCS code, a key step towards reimbursement [6]. - The ProstACT Global Phase 3 trial achieved a milestone with all 30 patients consented for Part 1, and the trial is expanding into China, Japan, and Canada [7]. Therapeutics Development - TLX591 (Lu-rosopatamab tetraxetan) is progressing in its Phase 3 trial, with dosing completed for patients in two of the three arms [7]. - TLX592 (Ac-PSMA-RADmAb) has submitted an application for a Phase 1 study in Australia [7]. - TLX101 (I-iodofalan) received HREC approval in Australia for an international pivotal trial [7]. - TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is enrolling patients in a Phase 1b/2 clinical trial for clear cell renal cell carcinoma [7]. Regulatory and Corporate Updates - Telix is cooperating with the U.S. SEC regarding a subpoena for documents related to its prostate cancer therapeutic candidates [11][12]. - The company has received country-level approvals for Illuccix in multiple European countries and is launching on a market-by-market basis [13]. - Telix has completed enrollment for the Illuccix China Phase 3 study, aiming for marketing authorization in Q4 2025 [13]. Manufacturing and R&D - Telix announced a GMP manufacturing facility in Yokohama, Japan, enhancing its global manufacturing strategy [14]. - The TMS facility in Brussels South, Belgium, has produced its first GMP commercial radiopharmaceutical doses [14]. - The company expects a 20% to 25% increase in R&D expenditure for FY 2025 compared to FY 2024 [22].

TABLE OF CONTENTS Registration No. 333-279471 As filed with the United States Securities and Exchange Commission on June 5, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Telix Pharmaceuticals Limited (Exact name of registrant as specified in its charter) Australia 2834 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code ...

TABLE OF CONTENTS Registration No. 333- As filed with the United States Securities and Exchange Commission on May 17, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Australia 2834 Not Applicable (I.R.S. Employer Identification Number) Telix Pharmaceuticals Limited 55 Flemin ...