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Lantheus Holdings(LNTH) - 2025 Q4 - Earnings Call Presentation
2026-02-26 13:00
© 2026 Lantheus. All rights reserved. Agenda Lantheus Fourth Quarter & Full Year 2025 Results FEBRUARY 26, 2026 Highlights and Business Update Commercial Update Financial Update Closing Remarks Q&A SPEAKERS Mary Anne Heino Executive Board Chair & CEO © 2026 Lantheus. All rights reserved. 2 Bob Marshall CFO and Treasurer Amanda Morgan Chief Commercial Officer Mark Kinarney Vice President, Investor Relations Safe Harbor Statements Cautionary Statement Regarding Forward-Looking Statements This document contain ...
Radiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01)
Globenewswire· 2026-02-24 12:30
First radiotherapeutic agent developed by Radiopharm Ventures, the joint venture between Radiopharm Theranostics and MD Anderson Cancer Center Preclinical animal studies of BetaBart (RV-01) have demonstrated tumor shrinkage and prolonged survival SYDNEY, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today annou ...
Telix Pharmaceuticals H2 Earnings Call Highlights
Yahoo Finance· 2026-02-20 04:08
Launching two additional products pending regulatory outcomes: Pixclara (Pixlumia in Europe) for glioblastoma and Zircaix for renal cancer.Continuing to grow approved products, including building on the launch of Gozetotide and the FDA approval of Gleolan in 2025.He also said the precision medicine business is more than a cash generator, calling it strategic validation of therapeutic targets, a way to streamline clinical trials, and an avenue to deepen relationships with physician stakeholders. Looking ahea ...
Telix Pharmaceuticals Ltd(TLX) - 2025 Q4 - Earnings Call Transcript
2026-02-19 23:32
Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to $804 million, marking its third consecutive year of double-digit revenue growth [17][19] - EBITDA improved by 25% to $216 million, driven by strong demand for Illuccix and the launch of Gleolan [19][23] - The gross margin remained stable at 53%, with a significant portion of gross margin generated from the precision medicine business [22][23] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional $113 million [19][23] - The precision medicine business generated approximately $400 million in gross margin, with 94% of the gross margin coming from this segment [20][23] - Investments in product development totaled $157 million, focusing on late-stage pipeline projects [22] Market Data and Key Metrics Changes - The precision medicine portfolio delivered $622 million in revenue, with sequential growth every quarter, even during challenging market conditions [30] - The company is expanding its market presence, with Illuccix now available in 17 countries and marketing authorizations in over 24 markets [35] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investments ranging from $200 million to $240 million in 2026 [26] - A dual product strategy for Illuccix and Gleolan is in place to manage economic needs and reimbursement preferences effectively [58][60] - The company is focused on expanding its product offerings, indications, and geographical reach, particularly in key markets like the U.K., Germany, and China [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving approximately 20% revenue growth in 2026, with guidance set at $950 million to $970 million [28][29] - The company is committed to reinvesting earnings into R&D and commercial growth rather than optimizing near-term earnings per share [68] - Management highlighted the importance of clinical credibility and operational reliability in sustaining market leadership [32][33] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials expected to generate significant data this year [47] - The ProstACT Global study is progressing well, with recruitment for part two ramping up [48][49] Q&A Session Questions and Answers Question: When might we see data for 591, the safety data? - The company is completing clinical case report forms and will disclose the data simultaneously with the FDA submission, with no delays expected from the FDA side [54][56] Question: Can you elaborate on the early performance of the two-product strategy for Illuccix and Gleolan? - The two-product strategy allows the company to manage economic needs and reimbursement preferences effectively, adapting to changes in the reimbursement environment [58][60] Question: Will the company reinvest earnings to achieve close to zero NPAT for F-26, F-27, and F-28? - The company will reinvest the majority of earnings back into R&D and commercial growth, with no profit objective for the next two years [68] Question: How much growth in precision medicine revenue is coming from markets outside of the U.S.? - Currently, 95% of revenue is U.S.-based, but the company expects this mix to change as it expands into other markets like Japan [74]
Telix Pharmaceuticals Ltd(TLX) - 2025 Q4 - Earnings Call Transcript
2026-02-19 23:30
Telix Pharmaceuticals (NasdaqGS:TLX) H2 2025 Earnings call February 19, 2026 05:30 PM ET Speaker13Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.Speaker9Thank you, and thank you to everybody for joining us on this call this morning, this evening, wherever you are in the world. We launched our annual report and full year results on the ASX ...
Curium Group, PeptiDream and PDRadiopharma Enroll First Patient to Registrational Clinical Trial of Lu-PSMA-I&T for Prostate Cancer in Japan
Globenewswire· 2026-02-04 06:30
Core Insights - Curium Group, in collaboration with PeptiDream Inc. and PDRadiopharma Inc., has initiated a registrational Phase 2 clinical trial for 177Lu-PSMA-I&T in Japan targeting patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1][2] Company and Industry Overview - 177Lu-PSMA-I&T is a radiotherapeutic agent designed to target PSMA, conjugated with Lutetium-177, and is being evaluated for its efficacy and safety in a multicenter, open-label, single-arm trial [2] - The trial will utilize bridging data from ongoing global clinical trials under the strategic collaboration between Curium and PDRadiopharma [2] - Prostate cancer remains prevalent in Japan, with approximately 90,000 to 100,000 new cases annually, highlighting a significant unmet medical need for effective therapies [5] - The overall survival rate for patients with mCRPC is approximately three years in clinical trial settings, indicating a critical demand for innovative treatment options [5] Clinical Trial Progress - The Phase 3 ECLIPSE trial for 177Lu-PSMA-I&T has met its primary endpoint, demonstrating a statistically significant benefit for patients with mCRPC [6] - Additional trials for 64Cu-PSMA-I&T are being conducted to diagnose biochemical recurrence and for newly diagnosed patients with high-risk prostate cancer [7] Partnership Details - Under the partnership, Curium and PDRadiopharma will collaborate on the clinical development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory, manufacturing, and commercialization efforts [9] - Curium will support PDRadiopharma through technology transfer to establish manufacturing capabilities in Japan, including a high throughput Copper 64 manufacturing line [9] Company Profiles - Curium Pharma is a leading global radiopharmaceutical company focused on developing and supplying innovative cancer diagnostics and treatments, with a mission to improve patient care [10][11] - PeptiDream Inc. specializes in translating macrocyclic peptides into innovative medicines, with a focus on radiopharmaceuticals through its subsidiary PDRadiopharma [13][14] - PDRadiopharma has been a key player in the radiopharmaceutical field since 1968, currently marketing 22 radiodiagnostic products and 8 radiotherapeutic products in Japan [14]
Radiopharm Theranostics Reports Half-Year Financial Results and Business Updates
Globenewswire· 2026-01-28 12:00
Core Insights - The interim results from the Phase 2b clinical trial of RAD 101 indicate that 92% of evaluable participants met the primary endpoint of MRI concordance in patients with brain metastases [1][5] - The company has approximately $34.52 million in cash and cash equivalents, providing a financial runway into 2027 to advance its pipeline of radiotherapeutic programs [1][19] - The CEO emphasized a focus on advancing radiopharmaceutical assets and delivering meaningful data across multiple programs in 2026 [2] Clinical Pipeline Updates - RAD 101 is currently in a Phase 2b clinical trial for patients with recurrent brain metastases, with enrollment expected to complete in Q1 2026 [3] - RAD 202 is being evaluated in a Phase 1 'HEAT' clinical trial for HER2-positive advanced solid tumors, with a recent recommendation to escalate dosing to 75mCi [4][6] - RAD 204 is in a Phase 1 study for PD-L1-driven cancers, with initial data showing stable disease in 2 out of 3 patients for 5.5 months, compared to 3.5 months with standard care [12] Financial Performance - The company reported a net cash outflow of $22.67 million for the six months ending December 31, 2025, with a cash balance increase from $29.12 million to $34.52 million [19] - In October 2025, the company secured commitments to raise approximately $35 million through a private placement [19] Strategic Developments - The company increased its ownership in Radiopharm Ventures from 75% to 87.5%, indicating progress in its cancer therapeutic pipeline [13] - RAD 402 received ethics committee approval to initiate a Phase 1 clinical trial for metastatic or locally advanced prostate cancer, expected to start in Q1 2026 [14]
Perspective Therapeutics (NYSEAM:CATX) FY Conference Transcript
2026-01-14 23:17
Summary of Perspective Therapeutics FY Conference Call Company Overview - **Company**: Perspective Therapeutics (NYSEAM:CATX) - **Industry**: Oncology, specifically focusing on radiopharmaceuticals Core Points and Arguments 1. **Patient-Centric Approach**: The CEO emphasized the importance of patient outcomes, sharing a case of an elderly woman with neuroendocrine cancer who showed significant tumor reduction after treatment with VMT Alphanet, highlighting the company's mission to transform patients' lives [2][3][4] 2. **Radiotherapy's Role in Oncology**: The company positions radiotherapy as a critical pillar in cancer treatment alongside chemotherapy and immunotherapy, advocating for the use of radiopharmaceuticals to target previously undruggable cancer cell surfaces [4][5] 3. **Innovative Drug Delivery**: Perspective Therapeutics utilizes a proprietary chemical chelator designed for superior biodistribution, allowing for targeted delivery of potent alpha particle payloads to cancer cells, which is more effective than traditional beta particles [5][6][9] 4. **Clinical Programs**: The company has three active clinical programs: - **VMT-NET**: Targeting neuroendocrine tumors, with a reported 39% overall response rate and 78% of patients remaining progression-free after one year [29][31] - **Melanoma Program**: Actively enrolling patients, focusing on combining treatments with checkpoint inhibitors [7][36] - **FAP-alpha Program**: Targeting a broad range of solid tumors, leveraging the stroma's role in tumor growth [39][40] 5. **Manufacturing Capabilities**: Perspective Therapeutics has established end-to-end manufacturing capabilities, ensuring a reliable supply chain for their isotopes and clinical products, which is crucial for timely patient treatment [25][26][57] 6. **Regulatory Progress**: The company has received fast-track designation from the FDA for its VMT-NET program and is moving towards registrational studies based on positive initial data [30][35] 7. **Financial Position**: As of the last quarterly filing, the company reported $174 million in cash, indicating a strong financial position to support ongoing and future clinical trials [44] 8. **Market Potential**: The company identifies a significant total addressable market in oncology for radiopharmaceuticals, citing existing successful products like Pluvicto and Lutathera, which generate billions in revenue [24][28] Additional Important Content 1. **Patient Selection and Imaging**: The use of Lead-203 for imaging tumors allows for better patient selection for therapies, enhancing treatment efficacy and safety [18][19] 2. **Safety Profile**: The company claims a best-in-class safety profile for its therapies, with no serious adverse events reported in recent trials, which is a significant differentiator from competitors [34][35] 3. **Community Engagement**: Positive feedback from clinicians and increased interest in the company's studies indicate a strong demand for their therapies within the medical community [47][49] 4. **Supply Chain Resilience**: The company has secured a robust supply chain for its isotopes, with the ability to stockpile parent isotopes, ensuring long-term operational stability [52][53] 5. **Future Data Updates**: The company plans to provide updates on its clinical programs throughout 2026, which will be critical for investor confidence and market positioning [45] This summary encapsulates the key points discussed during the conference call, highlighting the company's innovative approach, clinical progress, and market potential in the oncology sector.
Telix Pharmaceuticals Limited (TLX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-12 20:25
Company Overview - Telix is an increasingly recognized company in the radiopharmaceutical space, focusing solely on oncology and radiopharmaceuticals with a precision medicine-oriented approach [2][3] - The company is vertically integrated, which allows it to control various aspects of its operations in the radiopharma sector [2] Product Development Strategy - Telix develops both imaging agents and therapeutic agents for each target, leveraging the valuable signals obtained from radiopharmaceuticals to understand efficacy and improve delivery [3][4] - This dual approach of combining imaging and therapeutic capabilities has proven beneficial for the company's commercial trajectory [4]
Telix Pharmaceuticals (NasdaqGS:TLX) FY Earnings Call Presentation
2026-01-12 17:00
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 ...