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]

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, Brazil, Canada, Europe (Belgium and Switzerland), and Japan [2] - Telix aims to address significant unmet medical needs in oncology and rare diseases through its portfolio of clinical and commercial stage products [2] Financial Results Announcement - Telix will release its financial results for the half-year ended 30 June 2025 on Thursday, 21 August 2025 [1] - An investor webcast and conference call is scheduled for 9.30 am AEST on the same day [1] - Participants can register for the webcast and teleconference through provided links [1]

Core Viewpoint - Telix Pharmaceuticals Limited has faced a significant drop in the price of its American Depositary Shares following the announcement of an SEC subpoena related to its disclosures about prostate cancer therapeutic candidates [1][3]. Group 1: SEC Investigation - The SEC is investigating Telix regarding its statements about the development of its prostate cancer therapeutic candidates, which has raised concerns among investors [3]. - The investigation was triggered by Telix's announcement on July 22, 2025, which led to a sharp decline in share price during intraday trading on July 23, 2025 [3]. 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 and is urging affected investors to report their losses [2][4]. - The firm is also seeking individuals with knowledge that could assist in the investigation, emphasizing the importance of whistleblower information [4]. Group 3: Legal and Financial Context - Hagens Berman has a history of securing substantial recoveries for investors, having achieved over $2.9 billion in similar cases [5]. - The firm is encouraging whistleblowers to consider their options under the SEC Whistleblower program, which offers rewards of up to 30% of any successful recovery [4].

Core Insights - Telix Pharmaceuticals shows strong sales growth in imaging diagnostics, indicating a positive investment outlook [1] Company Analysis - The company has a solid foundation in biochemistry and clinical trials, enhancing its credibility in the biotech sector [1] - The focus on educating investors about the science behind the business reflects a commitment to transparency and informed decision-making [1] Industry Context - The biotech industry is characterized by its complexities, necessitating thorough due diligence to avoid investment pitfalls [1]