BEDFORD, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026.  The extension and revised target Prescription D ...

Summary of Lantheus Conference Call Company Overview - **Company**: Lantheus - **Industry**: Healthcare, specifically in radiopharmaceuticals and diagnostics Key Points and Arguments 1. **Competitive Landscape**: Lantheus faced significant challenges in 2025, particularly with its flagship product PYLARIFY, due to increased competition and the loss of pass-through status affecting reimbursement rates for Medicare patients [7][8][9] 2. **FDA Approvals**: The company received two FDA approvals in recent weeks: a conditional approval for PNT2003 and full approval for PYLARIFY TruVu, which is expected to enhance market competitiveness and customer engagement [8][9] 3. **Future Growth Strategy**: Lantheus is positioning itself for growth in 2026 and beyond, focusing on consolidating its portfolio in nuclear medicine and re-engaging price-sensitive customers who switched to competitors [9][11] 4. **Market Dynamics**: The PSMA PET franchise is expected to stabilize, with projected market volume growth of 10%-11% in 2026, down from 20% in 2025 [31][32] 5. **Manufacturing Advantages**: PYLARIFY TruVu offers significant manufacturing improvements, allowing for up to 50% more doses per batch, addressing customer demand for increased availability [36][37] 6. **Alzheimer's Diagnostics**: The total addressable market (TAM) for Alzheimer's diagnostics is projected to reach $1.5 billion by the end of the decade, driven by the approval of new therapeutic drugs and changes in reimbursement guidelines [49][50] 7. **Capital Allocation**: Lantheus plans to pause on large business development (BD) initiatives to focus on integrating recent acquisitions and optimizing existing product lines [54][55] 8. **Reimbursement Strategy**: The company anticipates a smooth transition to PYLARIFY TruVu, with expectations for transitional pass-through coverage to be effective by October, which will aid in market adoption [65][66] Additional Important Insights 1. **Sales and Marketing Focus**: The company plans to invest 12%-12.5% of revenue in sales and marketing to support the launch of PYLARIFY TruVu and other products [60] 2. **Contracting Dynamics**: Transitioning to PYLARIFY TruVu will involve amending existing contracts rather than creating new ones, which is expected to streamline the process [19][20] 3. **Market Education**: Lantheus aims to raise awareness about the role of radiopharmaceuticals in life sciences, emphasizing their unique market dynamics compared to traditional pharmaceuticals [68][69] This summary encapsulates the critical aspects of Lantheus' current position, strategic direction, and market outlook as discussed in the conference call.

Core Viewpoint - The FDA has approved PYLARIFY TruVu, a new formulation of Lantheus' PSMA PET imaging agent, which aims to enhance diagnostic performance and patient access, with a launch expected in Q4 2026 [1][2]. Group 1: Product Details - PYLARIFY TruVu is indicated for PET imaging of PSMA positive lesions in men with prostate cancer suspected of metastasis or recurrence based on elevated PSA levels [1][11]. - The new formulation is designed to improve product stability at higher radioactive concentrations, which will support more efficient manufacturing and distribution [3]. - PYLARIFY TruVu will be introduced on a rolling geographic basis to ensure a smooth transition for customers from the existing PYLARIFY product [4]. Group 2: Clinical Studies and Efficacy - The safety and efficacy of PYLARIFY TruVu were established through pivotal trials OSPREY and CONDOR, which demonstrated significant improvements in diagnostic performance compared to standard imaging [6][7]. - In the OSPREY trial, PYLARIFY showed a median specificity of 96% and nearly three times the positive predictive value (PPV) compared to standard imaging [7]. - The CONDOR trial reported a correct localization rate (CLR) of 85%-87% for PYLARIFY in patients with biochemical recurrent prostate cancer [7]. Group 3: Market Context and Impact - Prostate cancer is the second most common cancer among men in the U.S., with an estimated 334,000 new cases and over 36,000 deaths expected in 2026 [8]. - More than 760,000 patients have undergone PSMA PET scans with PYLARIFY since its approval in May 2021, highlighting the growing demand for advanced diagnostic tools in prostate cancer [5][9]. - The introduction of PYLARIFY TruVu is seen as a response to the increasing incidence of prostate cancer and the need for timely and accurate imaging solutions [5].

Summary of Lantheus Conference Call Company Overview - **Company**: Lantheus - **Key Executives**: Mary Anne Heino (CEO), Bob Marshall (CFO) - **Event**: TD Cowen's 46th Annual Healthcare Conference Core Industry Insights - **Focus on Diagnostics**: Lantheus has strategically chosen to focus on its diagnostic assets over therapeutic assets, citing a broad portfolio that was too extensive for the company's current scale and capitalization [3][4] - **Recent Acquisitions**: The company completed significant M&A activities in 2025, acquiring LMI and Evergreen, which contributed to the expanded portfolio [4] Key Product Developments - **PYLARIFY Launch**: The new formulation of PYLARIFY is set to launch, with key milestones including obtaining coding, coverage, and reimbursement. The company aims for pass-through status by October 1, 2026, and HCPCS code submission by April 1, 2026 [6][9][12] - **Increased Production Capacity**: The new formulation is expected to yield up to 50% more doses per batch compared to the current formulation, enhancing market availability [14][15] - **PNT2003 Asset**: Lantheus received conditional FDA approval for PNT2003, which is positioned as a radio equivalent to Lutathera. The company is preparing for commercialization, pending the expiration of the Hatch-Waxman litigation period [5][38][39] Financial Guidance - **Revenue Projections**: For 2026, Lantheus provided revenue guidance of $1.4 billion to $1.45 billion, adjusted for a $111 million divestiture of the SPECT business. The guidance reflects a year-over-year comparison [18][19] - **EPS Guidance**: The company anticipates an EPS of approximately $575 million, with investments in sales and marketing expected to be around 12%-12.5% of revenue [55] Market Dynamics - **Competitive Landscape**: Lantheus is aware of competitors like Telix and their new formulations. The company is monitoring pricing strategies and market dynamics closely [21] - **Alzheimer's Imaging Market**: Lantheus is developing multiple products for Alzheimer's, including NeuroSeq and MK-6240, with a focus on both beta-amyloid and tau imaging. The market is seen as large and underserved, with potential for significant growth [25][27][28] Strategic Decisions - **Shift from Therapeutics**: The decision to focus on diagnostics over therapeutics is based on lower development costs and higher success probabilities in radiopharmaceuticals. The company aims to leverage its expertise in this area [40][42][43] - **OCTEVY Rollout**: The acquisition of OCTEVY is seen as complementary to Lantheus's existing portfolio, targeting near-term revenue opportunities [49] Underappreciated Aspects - **Market Education**: The CEO emphasized the importance of educating investors about radiopharmaceuticals and believes the stock is undervalued due to a lack of understanding in the market [60][61] This summary encapsulates the key points discussed during the conference call, highlighting Lantheus's strategic focus, product developments, financial guidance, and market dynamics.

Core Viewpoint - Lantheus Holdings, Inc. has received FDA tentative approval for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of LUTATHERA, aimed at treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][2][3]. Group 1: FDA Approval and Product Details - The FDA tentative approval signifies that the ANDA for PNT2003 meets the necessary requirements under the Federal Food, Drug, and Cosmetics Act, with full approval pending the expiration of a 30-month stay in June 2026 due to patent litigation [3]. - PNT2003 is the first radioequivalent to LUTATHERA to receive FDA tentative approval, representing a significant advancement in treatment options for GEP-NET patients [2]. Group 2: Market Context and Company Commitment - The approval comes at a time when advancements in imaging and clinical guidelines are increasing the identification of patients who could benefit from targeted radiopharmaceutical therapies [2]. - Lantheus is committed to meeting the growing demand for such therapies and aims to make PNT2003 available to patients pending final FDA approval [2]. Group 3: Background on GEP-NETs - GEP-NETs are rare, often slow-growing cancers affecting the digestive system and pancreas, with an estimated prevalence of approximately 200,000 patients in the U.S. [5]. - Due to their slow growth and non-specific symptoms, up to 50% of GEP-NETs are initially misdiagnosed, with an average delay of 4.3 years from symptom onset to diagnosis [5]. Group 4: Company Overview - Lantheus is a leading radiopharmaceutical-focused company with over 70 years of experience in providing radiopharmaceutical solutions, headquartered in Massachusetts with a global presence [6].

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $406.8 million, an increase of 4% year-over-year, while full-year revenue was $1.546 billion, up 0.5% [20] - Adjusted EPS for Q4 was $1.67, an increase of 4.7%, while full-year adjusted EPS was $6.08, a decrease of 10% from the prior year [26][30] - Operating cash flow for Q4 totaled $90.2 million, down from $157.7 million in Q4 2024 [27] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology, primarily from PYLARIFY, generated Q4 revenue of $240.2 million, down 9.7% year-over-year, and full-year revenue of $989.1 million, down 6.5% [20] - Precision Diagnostics delivered Q4 revenue of $143.2 million, a 22% increase, driven by DEFINITY and Neuraceq, which contributed $31 million in Q4 [21][14] - Strategic partnerships and other revenue increased by 203.3% to $23.3 million, largely due to MK-6240 [22] Market Data and Key Metrics Changes - PYLARIFY's volume grew approximately 4% year-over-year, with pricing discipline contributing to performance despite competitive pressures [12] - Neuraceq is expected to grow triple digits in 2026, driven by increased demand for Alzheimer's imaging [14] - DEFINITY maintained over 80% market share, delivering over $85 million in Q4 [14] Company Strategy and Development Direction - The company is focusing on radiodiagnostics, with plans to maintain leadership in PSMA PET imaging and prepare for the launch of a new PSMA PET formulation in Q4 2026 [8][36] - The strategic intent includes optimizing the cost structure and prioritizing investments in innovative PET radiodiagnostics [10] - The company plans to pursue value-maximizing alternatives for its radiotherapeutic assets while focusing on diagnostic opportunities [11][62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to drive meaningful performance gains and deliver sustainable revenue growth in the mid and long term [11][36] - The company anticipates several product approvals in 2026, with a focus on commercial execution and regulatory milestones [30] - Management highlighted the importance of maintaining operational excellence and customer relationships to support growth [13] Other Important Information - The company completed the divestiture of its legacy SPECT business on January 1, 2026, to focus on PET radiodiagnostics [8] - The effective tax rate for Q4 was 19%, with a full-year rate of 25.3% [25] - Cash and cash equivalents stood at $359.1 million, with $200 million remaining for share buybacks [28] Q&A Session Summary Question: What is the timing for the new PSMA PET imaging agent's coding and reimbursement? - Management anticipates securing HCPCS code and transitional pass-through status by October 1, 2026, with a regional rollout planned for Q4 2026 [41][42] Question: How does the POSLUMA versus PYLARIFY study impact market dynamics? - Management expressed concerns about the study design and stated that its results do not factor into the current forecast for PYLARIFY [46][48] Question: Can you elaborate on pricing and unit growth for PYLARIFY in Q4? - Management indicated that Q4 performance exceeded expectations, with both volume growth and favorable pricing contributing to results [52] Question: What are the plans for radiotherapeutic assets? - Management is reviewing therapeutic assets for value optimization and may consider tuck-in acquisitions for diagnostic opportunities [61][62] Question: What is the growth outlook for Neuraceq? - Management expects Neuraceq to achieve triple-digit growth in 2026, supported by expanded manufacturing and deeper penetration in existing accounts [14][66]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $406.8 million, an increase of 4% year-over-year, while full-year revenue was $1,541.6 million, up 0.5% from the previous year [20][21] - Adjusted GAAP fully diluted earnings per share for Q4 were $1.67, an increase of 4.7%, while for the full year, it was $6.08, a decrease of 10% [26][30] - Gross profit margin for Q4 was 65.1%, down 289 basis points from Q4 2024, primarily due to decreases in PYLARIFY net price [22] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology, solely comprised of PYLARIFY, generated Q4 revenue of $240.2 million, down 9.7% year-over-year, and full-year revenue of $989.1 million, down 6.5% [20][21] - Precision Diagnostics delivered Q4 revenue of $143.2 million, a 22% increase, driven by DEFINITY's sales of $85.3 million [21] - Neuraceq contributed $31 million in Q4 and $51.4 million since its acquisition in late July [21][14] Market Data and Key Metrics Changes - The market for PYLARIFY is expected to see a decline of 8%-10% year-over-year due to increased competition and pricing dynamics [30][45] - Neuraceq is projected to grow triple digits in 2026, driven by increased demand for Alzheimer's imaging [14][31] - DEFINITY is expected to grow in the low to mid-single digits in 2026 [31] Company Strategy and Development Direction - The company is focusing on radiodiagnostics, with plans to maintain leadership in PSMA PET imaging and prepare for the launch of a new PSMA PET formulation in Q4 2026 [8][10] - The strategic intent includes divesting the legacy SPECT business to prioritize innovative PET radiodiagnostics [8][11] - The company aims to optimize its cost structure and selectively pursue value-maximizing alternatives for radiotherapeutic assets [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to drive performance gains and deliver sustainable revenue growth in the mid and long term [11][36] - The focus for 2026 will be on commercial execution and regulatory milestones, with expectations for several product approvals [11][30] - Management acknowledged the importance of maintaining operational excellence and customer relationships to support growth [13][14] Other Important Information - The company repurchased $100 million of its own shares during Q4 2025, leaving $200 million of authorization for buybacks outstanding [28] - The effective tax rate for Q4 was 19%, with an expected increase to 26% in 2026 [25][32] Q&A Session Summary Question: What is the timing for the new PSMA PET imaging agent's coding and reimbursement? - Management anticipates securing HCPCS coding and transitional pass-through status by October 1st, with a commercial rollout planned for Q4 2026 [41][42] Question: How does the study comparing PYLARIFY and POSLUMA impact market dynamics? - Management expressed concerns about the study design and stated that the results do not factor into their forecast for PYLARIFY [46][48] Question: Can you elaborate on pricing and unit growth in Q4 2025? - Management reported a 4% volume growth for PYLARIFY in Q4, with expectations for low single-digit growth in 2026 [52][54] Question: What are the plans for radiotherapeutic assets? - Management is reviewing the therapeutic assets for value optimization and may consider tuck-in acquisitions for diagnostic opportunities [60][62] Question: What is the growth outlook for Neuraceq? - Management expects triple-digit growth for Neuraceq in 2026, driven by expanding manufacturing and market penetration [14][66]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $406.8 million, an increase of 4% year-over-year, while full-year revenue was $1,541.6 million, up 0.5% [21] - Gross profit margin for Q4 was 65.1%, down 289 basis points from Q4 2024, primarily due to decreases in PYLARIFY net price [23] - Operating profit for Q4 was $138.9 million, a decrease of 8.5%, with reported profit for Q4 at $54.1 million [26] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology, solely comprised of PYLARIFY, generated Q4 revenue of $240.2 million, down 9.7% year-over-year, and full-year revenue of $989.1 million, down 6.5% [21] - Precision Diagnostics delivered Q4 revenue of $143.2 million, a 22% increase, driven by DEFINITY and Neuraceq, which contributed $31 million in Q4 [22][14] - Strategic partnerships and other revenue was $23.3 million, up 203.3%, due to strong performance from MK-6240 [22] Market Data and Key Metrics Changes - PYLARIFY volume increased approximately 4% year-over-year, with pricing concessions resetting 340B pricing in Q4 2025 [12] - Neuraceq is positioned as the second-most utilized and fastest-growing beta-amyloid PET imaging agent, addressing a large and expanding market [15] - DEFINITY maintained over 80% market share, delivering over $85 million in Q4 [15] Company Strategy and Development Direction - The company is focusing on radiodiagnostics, having divested its legacy SPECT business to prioritize innovative PET radiodiagnostics [8] - The strategy includes maintaining leadership in PSMA PET imaging with PYLARIFY and preparing for the launch of a new PSMA PET formulation in Q4 2026 [8][36] - The company plans to maximize the value of its current product portfolio while selectively developing pipeline assets and optimizing the therapeutic pipeline [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to drive meaningful performance gains and deliver sustainable revenue growth in the mid and long term [11] - The focus for 2026 will be on commercial execution and regulatory milestones, with expectations for multiple FDA approvals [9][11] - Management highlighted the importance of maintaining operational excellence and customer relationships to support growth [12] Other Important Information - The company repurchased $100 million of its own shares during Q4, leaving $200 million of authorization for buybacks outstanding [28] - The effective tax rate was 19% for Q4 and 25.3% for the full year [26] - The company anticipates a revenue forecast of $1.4 billion to $1.45 billion for 2026, with PYLARIFY expected to decline 8%-10% year-over-year [31] Q&A Session Summary Question: What will be the timing for securing coding and reimbursement for the new PSMA PET imaging agent? - Management anticipates securing HCPCS code and transitional pass-through status by October 1st, with a commercial rollout planned for Q4 2026 [42][43] Question: How does the study comparing PYLARIFY and POSLUMA impact the forecast? - Management expressed concerns about the study design and stated that the results do not impact their forecast [46][49] Question: Can you elaborate on pricing and unit growth in Q4 2025? - Management noted a strong quarter for PYLARIFY, with volume growth of 4% and a favorable pricing environment [51][52] Question: What are the plans for radiotherapeutic assets? - The company is reviewing its therapeutic assets and considering value-maximizing alternatives while focusing on diagnostic assets [60][62] Question: What is the growth potential for Neuraceq? - Management expects triple-digit growth for Neuraceq, driven by expanding manufacturing and deeper penetration in existing accounts [66][68]

Product Development and Market Position - DEFINITY has been used in approximately 33 million echocardiograms globally since its launch in 2001, with an estimated 5 to 9 million echocardiograms producing suboptimal images in the U.S. in 2024[78][77]. - As of December 31, 2025, DEFINITY holds over 80% market share in the U.S. for ultrasound enhancing agents in echocardiography procedures[78]. - The FDA approved DEFINITY for pediatric patients in March 2024, based on data from three clinical trials[78]. - MK-6240, an F-18 tau-targeted PET imaging agent, met its co-primary endpoints in two pivotal studies, supporting its NDA submission to the FDA, with a target action date set for August 13, 2026[91]. - NAV-4694, an investigational F-18-labeled PET imaging agent, is currently in Phase 3 development and is being utilized in various clinical trials[92]. - The company has a specialized in-house FDA-approved manufacturing facility for DEFINITY, which first became commercially available on February 23, 2022[123]. - The markets for the company's products are highly competitive, with principal competitors including Novartis AG, GE Healthcare, and others[113]. Financial Performance and Revenue - The company received approximately $98.0 million from the sale of its RELISTOR net sales royalty asset in 2023, with additional milestone payments expected based on U.S. net sales targets[95]. - The company invested $177.3 million, $168.1 million, and $77.7 million in research and development (R&D) for the years ended December 31, 2025, 2024, and 2023, respectively, primarily related to clinical development candidates[102]. - PYLARIFY sales are generated in the United States through an internal sales team and some PMF partners, while DEFINITY sales are generated through an internal sales team[105]. - The company has entered into separate commercial supply agreements with different PMF networks for PYLARIFY and Neuraceq, with agreements generally terminating between 2027 and 2030[127]. Regulatory and Compliance - The company is subject to comprehensive governmental regulation, which increases the time and costs incurred in obtaining and maintaining product approvals[158]. - The FDA approval process requires substantial time and financial resources, and there is no certainty that approvals for products in development will be granted on a timely basis[161]. - The FDA requires annual progress reports on clinical trials and safety reports for serious adverse events[163]. - Compliance with FDA regulations requires ongoing investment in quality systems and may lead to administrative actions if standards are not met[171]. - The Hatch-Waxman Act allows for patent term extensions and provides exclusivity periods for new drugs approved by the FDA[181]. - The FDA can withdraw marketing authorization if compliance with regulatory standards is not maintained, impacting product availability[174]. - The company is subject to stringent healthcare fraud and abuse laws, with potential penalties for violations impacting business operations[198]. - Data protection and privacy laws are evolving, with compliance necessary to avoid penalties and reputational harm[202]. Intellectual Property - The company relies on patents, trademarks, and other intellectual property rights to maintain its competitive position in the market[126]. - The company has a portfolio of patents for PYLARIFY, with the longest duration patent extending until June 2037, and the NCE-1 date for PYLARIFY is May 26, 2025, after which FDA may accept ANDA or 505(b)(2) applications from generic challengers[155]. - The company has nine Orange Book-listed patents for DEFINITY, with the longest duration patent extending until May 2037[150]. - The company has exclusive licenses for patents related to LNTH-1363S, with the last patent expiring in 2043[152]. - The company has two Orange Book-listed patents for Neuraceq, with the longest duration patent extending until July 2032[154]. - The company has pending U.S. patent applications for PNT2003, which, if granted, would expire in 2043[157]. Employee and Operational Insights - As of December 31, 2025, the company had 1,193 employees, with 1,056 located in the United States and 137 internationally[220]. - The company has a commitment to pay equity and regularly assesses compensation among similar roles to attract and retain employees[224]. - The company has established various employee recognition award programs to foster a positive employee relations climate[225]. Environmental and Sustainability Efforts - The company is committed to reducing solid waste, energy and water usage, and greenhouse gas emissions, with a focus on sustainability since 2022 by using renewable wind energy[215][216]. - The company has implemented third-party environmental software to improve efficiency in data collection and reporting, expanding its scope to include data for all locations in 2024[217]. Market and Economic Factors - Changes in U.S. drug pricing policies may increase pricing pressure on products, affecting revenue and operational results[197]. - The Inflation Reduction Act of 2022 allows Medicare to negotiate prices for high-spend drugs starting in 2028, impacting the pharmaceutical industry significantly[192]. - The Budget Control Act mandates a 2% reduction in Medicare payments, effective from April 1, 2022, continuing through fiscal year 2030[195]. - The One Big Beautiful Bill Act signed on July 4, 2025, will reduce Medicaid coverage and financing, potentially impacting reimbursement rates[196]. Financial Risk Management - The company is exposed to market risk from changes in interest rates and foreign currency exchange rates, and may use derivative financial instruments to hedge these exposures[548]. - The net impact of foreign currency changes on transactions for the year ended December 31, 2025, was a loss of $1.0 million, compared to $0.7 million in 2024 and $0.1 million in 2023[551]. - The primary currency risk on earnings is associated with the Euro and Canadian dollar[552].

© 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 ...