Summary of Telix Pharmaceuticals (TLX) Update / Briefing August 27, 2025 Company Overview - **Company**: Telix Pharmaceuticals - **Product**: TLX250 CDx, provisionally designated as ZERKAICS - **Context**: Discussion regarding the FDA Biologics License application and the recent complete response letter (CRL) received from the FDA Key Points FDA Response and Issues - **CRL Received**: Telix received a complete response letter from the FDA regarding TLX250 CDx, which was unexpected and not positive news [2][4] - **Key Issues Identified**: 1. **Chemistry Manufacturing Controls (CMC)**: Issues related to the complexity of the manufacturing package [3][4] 2. **Comparability Demonstration**: Inadequacies in demonstrating comparability between the drug product used in the successful Zircon Phase III trial and the commercial manufacturing process [3][4] 3. **Supply Chain Complexity**: Reliance on multiple third-party suppliers, with two suppliers receiving Form 483 observations during inspections [3][4] Remediation Plans - **Next Steps**: Telix plans to request a Type A meeting with the FDA to address the issues raised in the CRL [4][5] - **Timeline for Remediation**: Preparation of the briefing document for the meeting is expected to take a few weeks, with a potential timeline for resubmission not exceeding a year [5][17] - **Breakthrough Therapy Designation**: The product has a breakthrough therapy designation, which may expedite the review process [18][35] Product Novelty and Market Impact - **First-in-Class Product**: TLX250 CDx is a novel biologic-based PET agent, marking a first in this category [5][6] - **Commercialization Delay**: The delay in commercialization does not impact the financial guidance for FY 2025, as revenue from unapproved products is not included [6][66] Comparability Data and Clinical Trials - **Existing Data**: Telix has additional comparability data that was not included in the original BLA submission, which may address FDA concerns [29][58] - **Clinical Comparability**: The company has conducted additional studies to prepare for potential questions from regulators, indicating readiness to provide further data if required [29][58] Supply Chain and Manufacturing - **Third-Party Suppliers**: The two suppliers with deficiencies are independent, and the issues do not relate to critical components of the product [27][49] - **Alternative Suppliers**: Telix has already qualified alternative suppliers for one of the components, indicating a proactive approach to supply chain management [46][47] Financial and R&D Implications - **R&D Spending**: The company does not foresee a material impact on R&D spending due to the CRL, as they are financially positioned to continue their current projects [66][73] - **Market Launches**: Telix is actively preparing for market launches in Europe and other regions, indicating ongoing business activities despite the setback [66][67] Regulatory Environment - **Increased Scrutiny**: The regulatory environment has become more stringent, with the FDA applying higher standards to novel products, which may contribute to the challenges faced by Telix [39][41] Conclusion - **Commitment to Product Development**: Telix remains committed to addressing the FDA's concerns and bringing TLX250 CDx to market, viewing the current challenges as learning opportunities for future product developments [76]

Company Overview - Telix Pharmaceuticals Limited is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals and associated medical technologies [2] - The company is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan [2] - Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX) [2] Upcoming Events - Dr. Christian Behrenbruch, Managing Director and Group CEO, will participate in fireside chats at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, and at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025 [1][2] - Each session will be webcast live and available on demand following the events [2] Investor Relations - For more information regarding Telix, including share price, SEC filings, and investor presentations, the Telix Investor Relations website can be visited [3] - Contact information for investor relations includes Ms. Kyahn Williamson for global inquiries and Annie Kasparian for U.S. inquiries [4]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Telix Pharmaceuticals Limited for possible violations of federal securities laws and unlawful business practices [1][2]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Telix to contact them to discuss their legal rights [1]. - On July 22, 2025, Telix received a subpoena from the U.S. Securities and Exchange Commission regarding disclosures related to its prostate cancer therapeutic candidates [2]. - Following the subpoena news, Telix's American Depositary Receipt (ADR) price dropped by $1.70, or 10.44%, closing at $14.58 per ADR on July 23, 2025 [2]. Group 2: Contact Information - Investors can reach out to Bragar Eagel & Squire for more information about the claims or their rights without any cost or obligation [3]. - Contact details for the law firm include phone number (212) 355-4648 and email investigations@bespc.com [6].

Core Viewpoint - The Schall Law Firm is investigating Telix Pharmaceuticals Limited for potential violations of securities laws related to misleading statements and undisclosed information regarding its prostate cancer therapeutic candidates [1][2]. Group 1: Investigation Details - The investigation centers on whether Telix issued false or misleading statements and failed to disclose relevant information to investors [2]. - On July 22, 2025, Telix announced it received a subpoena from the SEC concerning its disclosures about the development of its prostate cancer therapeutic candidates [2]. - Following the SEC subpoena announcement, Telix's American Depositary Receipts (ADRs) experienced a decline of over 10.4% the next day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who have suffered losses are encouraged to contact the Schall Law Firm for a free discussion of their rights [3].

Financial Data and Key Metrics Changes - Group revenues increased by 63% year on year, reaching $390 million, driven by growth in Elucix and the addition of third-party revenue from RLS [9][10] - Precision medicine revenues rose by 30% year on year, with EBITDA improving by 24% [9] - Gross margins in the precision medicine business remained stable at 64%, while the group's overall gross margin was 53% [9][10] Business Line Data and Key Metrics Changes - The precision medicine business saw a revenue increase of 29%, with EBITDA improving by $20 million year on year [14] - RLS contributed $79 million in third-party sales, with a gross margin of 7% [10][16] - Selling and marketing expenses increased to 13% of revenue from 10% last year, reflecting preparations for product and geographic expansion [12] Market Data and Key Metrics Changes - Elucix continues to deliver strong growth, with revenues up 25% year on year and dose volumes up 7% [43] - The global rollout of Elucix is progressing well, with marketing authorizations secured in over 23 countries [45] - The company is focusing on expanding into key markets such as France, Germany, Italy, Spain, China, and Japan [45] Company Strategy and Development Direction - The company is transitioning from a single product to a multi-product, multi-region organization, with a focus on long-term growth rather than short-term EPS optimization [21][25] - Strategic investments have been made in R&D, commercial performance, M&A opportunities, and supply chain resilience [19] - The acquisition of RLS is seen as a critical move to enhance U.S. presence and improve distribution capabilities [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the current operating environment and emphasized the importance of strategic investments for long-term growth [21][39] - The company is focused on building long-term asset value and is committed to delivering value for shareholders and patients [75] - Management acknowledged the SEC inquiry but clarified that it has no impact on the commercial portfolio or pipeline development [39] Other Important Information - The company has made significant investments in its global manufacturing infrastructure, with cash on hand at $27 million [10][18] - R&D investments increased by 47% year on year, reflecting a commitment to advancing the therapeutic pipeline [10][12] Q&A Session Summary Question: Outlook for gross margins and impact of PSMA pricing changes - Management noted that Elucix's gross margin remained consistent at 64% and that RLS's gross margin is expected to improve as more Elucix products are integrated [80][81] Question: Guidance and growth of Elucix moving forward - Management confirmed that July 1 marked the end of pass-through status for one product, but they reported 7% growth quarter on quarter, indicating strong performance despite market challenges [86][87] Question: Launch readiness for Zurkayx - Management indicated that specific details about the launch readiness for Zurkayx could not be disclosed at this time [95]

Financial Data and Key Metrics Changes - Group revenues improved by 63% year on year, reaching $390 million, driven by growth in Elucix and the addition of third-party revenue from RLS [7][8][9] - Precision medicine revenues increased by 30% year on year, with EBITDA improving by 24% [7][8] - Gross margins in the precision medicine business remained stable at 64%, while the group's gross margin was 53% [8][11] Business Line Data and Key Metrics Changes - The precision medicine business saw a revenue increase of 29%, with adjusted EBITDA improving by $20 million year on year [12][13] - RLS contributed $79 million in revenues, with gross margins at 7% [14][15] - Selling and marketing expenses increased to 13% of revenue from 10% last year, reflecting preparations for product and geographic expansion [11] Market Data and Key Metrics Changes - The company secured marketing authorizations for Elucix in over 23 countries, with ongoing launches in key markets like France, Germany, Italy, and Spain [42][43] - The global rollout of Elucix is progressing well, with strong uptake in the UK following its launch [41][42] Company Strategy and Development Direction - The company is focused on four strategic pillars: expanding precision medicine, delivering on late-stage therapeutics, building a next-generation pipeline, and expanding global delivery infrastructure [4][17] - The acquisition of RLS is seen as a strategic investment to enhance US presence and improve manufacturing capabilities [27][31] - The company aims to transition from a single product to a multi-product, multi-region organization, leveraging its global infrastructure for future therapeutic rollouts [23][26] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining operational efficiency and investing in R&D to support long-term growth [8][19] - The company is committed to building long-term asset value rather than optimizing near-term EPS growth, focusing on strategic investments to unlock the full potential of its pipeline [19][20] - Management expressed confidence in the company's ability to navigate the current operating environment and continue delivering value to shareholders [74] Other Important Information - The company is responding to an SEC subpoena regarding disclosure activities related to prostate cancer therapeutic candidates, clarifying that there are no allegations or charges against the company [36] - The company is focused on maintaining a healthy cash position, ending the half-year with $27 million in cash on hand [8][16] Q&A Session Summary Question: Outlook for gross margins and impact of PSMA pricing changes - Management noted that Elucix's gross margin remained consistent at 64%, while RLS achieved a 7% gross margin [79][80] - The integration of RLS is expected to improve gross margins as more Elucix products are distributed through the RLS network [81] Question: Guidance and growth of Elucix moving forward - Management confirmed that July 1 marked the end of pass-through status for one product, but reported 7% growth quarter on quarter in volume [86][87] - The company is implementing a stabilization strategy to bridge the gap between products coming off and gaining reimbursement [88][89] Question: Launch readiness for Zurkayx - The commercial team is prepared for the launch, leveraging existing customer relationships from Elucix [94][96] - An expanded access program has been successful, indicating strong market readiness for Zurkayx [95][96]

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 Viewpoint - Telix Pharmaceuticals Limited is under investigation by the SEC, leading to a significant drop in the price of its American Depositary Shares after the announcement on July 23, 2025 [1][4]. Group 1: SEC Investigation - The SEC is investigating Telix regarding its disclosures related to the development of its prostate cancer therapeutic candidates [4]. - The investigation was triggered by Telix's announcement on July 22, 2025, which revealed the SEC's scrutiny [4]. Group 2: Shareholder Response - Hagens Berman, a national shareholders rights firm, has initiated an investigation to determine if Telix misled investors about its drug candidates [2][5]. - The firm is encouraging investors who have suffered substantial losses to come forward and submit their losses [2][5]. Group 3: Whistleblower Information - Individuals with non-public information about Telix are encouraged to assist in the investigation or consider the SEC Whistleblower program, which offers rewards of up to 30% of any successful recovery [7].

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Telix Pharmaceuticals Limited regarding potential securities fraud or unlawful business practices [1] - On July 22, 2025, Telix received a subpoena from the U.S. Securities and Exchange Commission related to disclosures about its prostate cancer therapeutic candidates, leading to a significant drop in its ADR price [3] Group 1 - The investigation by Pomerantz LLP focuses on whether Telix and its officers or directors have engaged in unlawful business practices [1] - Following the SEC subpoena, Telix's ADR price fell by $1.70, or 10.44%, closing at $14.58 on July 23, 2025 [3]