Lantheus Holdings, Inc.
Price History
Company Overview
Business Model: Lantheus Holdings, Inc. is a radiopharmaceutical-focused company dedicated to enabling clinicians to Find, Fight and Follow disease, aiming to deliver improved patient outcomes. The Company classifies its products into three categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Its diagnostic products provide information to healthcare professionals to better detect and characterize, or rule out, disease, with the potential to achieve better patient outcomes, reduce patient risk, and limit overall costs. Revenue is generated through product sales, licensing and royalty arrangements, and contract development and manufacturing organization (CDMO) services.
Market Position: Lantheus Holdings, Inc. is positioned as a leading radiopharmaceutical-focused company. As of December 31, 2025, its product DEFINITY held over 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures. The Company aims to maintain and expand its market leadership through innovation, strategic acquisitions, and clinical differentiation of its product portfolio.
Recent Strategic Developments:
- SPECT Business Divestiture: On January 1, 2026, the Company completed the sale of its single-photon emission computerized tomography (SPECT) business to SHINE Technologies, LLC for total consideration of up to $155.0 million, consisting of cash, a convertible installment note, a term note, and contingent earnout payments. This divestiture allows the Company to focus on its commercial portfolio of innovative positron emission tomography (PET) radiodiagnostics and microbubbles.
- Acquisition of Life Molecular Imaging Limited: On July 21, 2025, the Company acquired Life Molecular Imaging Limited for an upfront cash payment of $352.9 million (after working capital settlements) and potential earn-out and milestone payments of up to $400.0 million. This acquisition included Neuraceq, an Alzheimer’s disease radiodiagnostic, and expanded the Company's Alzheimer's disease radiodiagnostic commercial infrastructure, research and development (R&D) capabilities, and international footprint. Life Molecular Imaging Limited was renamed Lantheus Biosciences Ltd. in February 2026.
- Acquisition of Evergreen Theragnostics, Inc.: On April 1, 2025, the Company acquired Evergreen Theragnostics, Inc. for an upfront cash payment of $276.4 million, with potential additional milestone payments of up to $727.5 million. This acquisition brought in CDMO services and drug discovery/commercialization capabilities for proprietary products.
- Acquisition of NAV-4694: On June 18, 2024, the Company acquired Meilleur, including its asset NAV-4694, an investigational late-stage F-18-labeled PET imaging agent for beta amyloids in Alzheimer’s disease, for an upfront payment of $32.9 million and an additional $10.0 million for technology transfer. In May 2025, the Company paid AstraZeneca AB $10.0 million to reduce future royalty obligations related to NAV-4694.
- Strategic Agreements with Perspective Therapeutics, Inc.: On January 8, 2024, the Company obtained an option to exclusively license Perspective Therapeutics, Inc.'s Pb212-VMT-α-NET and co-develop certain early-stage therapeutic candidates for prostate cancer for an aggregate upfront payment of $28.0 million. The Company also purchased Perspective Therapeutics, Inc. common stock for $57.4 million in 2024.
- Exclusive License for PNT2003: The Company holds an exclusive worldwide license (excluding certain Asian countries) to co-develop and commercialize POINT Biopharma Global Inc.'s PNT2003, a somatostatin receptor (SSTR) therapy. The Abbreviated New Drug Application (ANDA) for PNT2003 was accepted by the U.S. Food and Drug Administration (FDA) on January 11, 2024, but is subject to ongoing patent infringement litigation.
- Leadership Transition: Effective November 7, 2025, Mary Anne Heino was appointed Executive Chair and principal executive officer, becoming Chief Executive Officer on January 1, 2026, following the retirement of former CEO Brian Markison.
- Pipeline Progress: The FDA accepted New Drug Applications (NDAs) for a new formulation of the Company's F-18 prostate-specific membrane antigen (PSMA) PET imaging agent (PDUFA target action date March 6, 2026), LNTH-2501 (PDUFA target action date March 29, 2026), and MK-6240 (PDUFA target action date August 13, 2026).
Geographic Footprint: The Company produces and markets its products throughout the United States, selling primarily to hospitals, independent imaging centers, and government facilities. Outside the United States, it operates through a combination of direct distribution in Canada and third-party distribution relationships in Europe, Canada, Australia, Asia-Pacific, Central America, and South America, as well as licensing exclusive rights to develop and commercialize certain products. The Company is headquartered in Massachusetts, with offices in New Jersey, Canada, Germany, Switzerland, Sweden, and the United Kingdom.
Financial Performance
Revenue Analysis
| Metric | Current Year (2025) | Prior Year (2024) | Change |
|---|---|---|---|
| Total Revenue | $1,541.6 million | $1,533.9 million | +0.5% |
| Gross Profit | $942.0 million | $988.3 million | -4.7% |
| Operating Income | $310.8 million | $457.0 million | -32.0% |
| Net Income | $233.6 million | $312.4 million | -25.2% |
Profitability Metrics (2025):
- Gross Margin: 61.1%
- Operating Margin: 20.2%
- Net Margin: 15.1%
Investment in Growth:
- R&D Expenditure: $177.3 million (11.5% of revenue)
- Capital Expenditures: $36.1 million
- Strategic Investments:
- Evergreen Theragnostics, Inc. acquisition: $276.4 million cash upfront.
- Life Molecular Imaging Limited acquisition: $352.9 million cash upfront.
- NAV-4694 acquisition: $42.9 million in 2024 (upfront and technology transfer payment), plus $10.0 million in 2025 to AstraZeneca AB to reduce future royalty obligations.
- Radiopharm Theranostics Limited: $2.0 million upfront in 2024 for preclinical assets, plus $10.0 million in 2025 for additional common stock.
- Perspective Therapeutics, Inc.: $28.0 million upfront in 2024 for license options, plus $57.4 million in 2024 for common stock.
- PNT2003/PNT2002: $260.0 million upfront in 2022 for license rights.
Business Segment Analysis
Radiopharmaceutical Oncology
Financial Performance:
- Revenue: $989.1 million (-6.5% YoY)
- Key Growth Drivers: The continued substantial revenue contribution from PYLARIFY is dependent on the Company's ability to clinically and commercially differentiate it from competitive products, maintain its position as a widely utilized PSMA PET imaging agent, and secure strategic contracts. Growth is also anticipated from expanding PYLARIFY's use into new patient populations, such as those with favorable intermediate-risk prostate cancer, and potential label updates for patient selection in PSMA-targeted therapeutics. The new formulation of the F-18 PSMA PET imaging agent, with a PDUFA target action date of March 6, 2026, is designed to enhance product stability and increase batch production, potentially improving supply flexibility and operating leverage. Product Portfolio:
- PYLARIFY (piflufolastat F-18): An F-18-labeled PET imaging agent targeting PSMA, indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis or recurrence based on elevated prostate-specific antigen (PSA) levels.
- New formulation of F-18 PSMA PET imaging agent: An investigational formulation designed to enhance product stability and increase batch production. Market Dynamics: The market for PYLARIFY is highly competitive, facing competition from three Gallium-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based conventional imaging agents. The expiration of PYLARIFY's five-year new chemical entity (NCE) exclusivity period in May 2026, along with the ongoing development of additional F-18, Gallium-68, and Copper-64 tracers, is expected to intensify competition. The expiration of transitional pass-through payment (TPT) status for PYLARIFY on December 31, 2024, resulted in a shift to lower mean unit cost (MUC)-based payment, while some competitors retain higher average sales price (ASP)-based TPT status, creating a financial incentive for customers to use competing products.
Precision Diagnostics
Financial Performance:
- Revenue: $493.1 million (+12.7% YoY)
- Key Growth Drivers:
- DEFINITY: Growth is driven by continued education of physicians and healthcare professionals on the benefits of ultrasound enhancing agents in suboptimal echocardiograms. The FDA approval for use in pediatric patients in March 2024 also contributes to market expansion.
- Neuraceq: Future growth depends on engaging existing PYLARIFY customers, expanding geographical access by increasing manufacturing capacity, increasing adoption and utilization of beta-amyloid PET and anti-amyloid therapeutics, leveraging updated prescribing information for patient selection, and educating customers on its approved uses, including quantifying amyloid burden. Product Portfolio:
- DEFINITY: An injectable ultrasound enhancing agent with perflutren-containing lipid microspheres, used in adult and pediatric patients with suboptimal echocardiograms to improve left ventricular chamber and endocardial border delineation.
- Neuraceq: An F-18 labeled PET imaging agent that selectively binds to beta-amyloid plaques in the brain, indicated for PET imaging to estimate amyloid beta neuritic plaque density in adults with cognitive impairment and for patient selection for amyloid beta-directed therapy. Acquired in July 2025. Market Dynamics:
- DEFINITY: Competes with other FDA-approved ultrasound enhancing agents from GE HealthCare Limited and Bracco Diagnostics Inc., as well as non-contrast echocardiography and other non-echocardiography imaging modalities. The Company faces potential future competition from generic manufacturers.
- Neuraceq: Competes with two commercially available F-18 beta-amyloid-targeting PET imaging agents from Eli Lilly and Co and GE HealthCare Limited. The MUC payment rates for Neuraceq are currently lower than those for competitive products, posing a challenge to its market adoption.
Strategic Partnerships and Other Revenue
Financial Performance:
- Revenue: $59.4 million (+55.5% YoY)
- Key Growth Drivers: This category is driven by advancing innovative imaging biomarker solutions, leveraging the microbubble platform for therapeutic applications, developing and commercializing digital applications, and providing CDMO services. The Company seeks to monetize assets through out-licensing agreements and geographic optimization. Product Portfolio:
- Automated Bone Scan Index (aBSI): FDA cleared and CE Marked artificial intelligence (AI) software that automatically calculates prostate cancer disease burden from bone scans.
- aPROMISE (PYLARIFY AI): FDA-cleared and CE Marked AI medical device software for standardized quantitative assessment of PSMA PET/CT images in prostate cancer.
- CDMO Services: Acquired through the Evergreen Theragnostics, Inc. merger, offering end-to-end manufacturing services for alpha- and beta-emitting radiopharmaceuticals.
- Research Tools: Includes investigational products like MK-6240, NAV-4694, and LNTH-2620 (Alzheimer’s disease radiodiagnostic candidates), LNTH-1363S (copper-64 labeled PET imaging agent for oncology/fibrosis), LNTH-2401/LNTH-2402 (GRPR-targeting theranostic pair), LNTH-2403 (LRRC15-targeted radiotherapeutic), LNTH-2404 (TROP2-targeted radiodiagnostic), LNTH-2501 (diagnostic kit for neuroendocrine tumors), and LNTH-2515 (florbetaben F-18 injection for cardiac amyloidosis).
- Licensed Products: Flurpiridaz (Flyrcado) licensed to GE HealthCare Limited (FDA approved 2024, launched April 2025). Piflufolastat F-18 licensed to GE HealthCare Limited in Japan. Retained sales-based milestone rights for RELISTOR, earning $5.0 million in 2025. Market Dynamics: The success of neurology diagnostic candidates (MK-6240, NAV-4694, LNTH-2620) is linked to the successful development of disease-modifying treatments for Alzheimer’s disease. Pipeline products face competition from established players and emerging therapies.
Capital Allocation Strategy
Shareholder Returns:
- Share Repurchases: In 2025, the Company repurchased approximately 3.5 million shares for $200.0 million under the 2025 Program, and 1.3 million shares for $100.0 million under the 2024 Program. As of December 31, 2025, approximately $200.0 million remained available for repurchase under the 2025 Program, which expires on December 31, 2027.
- Dividend Payments: The Company did not declare or pay any cash dividends in 2025, 2024, or 2023, and does not anticipate paying any in the foreseeable future, intending to retain future earnings for business growth and debt repayment.
- Future Capital Return Commitments: The 2025 Program authorizes repurchases of up to $400.0 million of common stock through December 31, 2027.
Balance Sheet Position (as of December 31, 2025):
- Cash and Equivalents: $359.1 million
- Total Debt: $569.4 million (includes $575.0 million aggregate principal of 2.625% Convertible Senior Notes due December 2027, less unamortized debt issuance costs, plus finance lease liabilities)
- Net Cash Position: -$210.3 million
- Debt Maturity Profile: The 2.625% Convertible Senior Notes due December 2027 have a principal amount of $575.0 million, with no principal due within the next twelve months. Future interest payments total $29.3 million, with $15.3 million payable within twelve months. The Company's $750.0 million 2022 Revolving Facility, amended in December 2024 to extend maturity to December 19, 2029, had no outstanding borrowings as of December 31, 2025.
Cash Flow Generation (2025):
- Operating Cash Flow: $390.1 million
Operational Excellence
Production & Service Model: The Company's production model is tailored to the specific characteristics of its products. PYLARIFY and Neuraceq, which utilize F-18 radioisotopes with a 110-minute half-life, are manufactured and distributed rapidly on a just-in-time basis through a field-based network of specialized PET manufacturing facilities (PMFs) with radioisotope-producing cyclotrons. Each PMF site requires separate FDA approval. DEFINITY is produced in the Company's specialized in-house FDA-approved manufacturing facility at its North Billerica campus, providing supply chain redundancy, flexibility, and reduced costs. Through the Evergreen Theragnostics, Inc. acquisition, the Company now offers contract development and manufacturing organization (CDMO) services from a cGMP certified radiopharmaceutical manufacturing facility, providing end-to-end services for alpha- and beta-emitting radiopharmaceuticals.
Supply Chain Architecture: Key Suppliers & Partners:
- PMF Networks: Multiple commercial and academic partners for the manufacturing of PYLARIFY and Neuraceq.
- Contract Manufacturers: Jubilant HollisterStier is a significant supplier for DEFINITY.
- Raw Materials & Components: The Company relies on sole suppliers for certain critical components, such as specially designed chemistry synthesis boxes for PYLARIFY and Neuraceq, and lipid blend material and perflutren gas for DEFINITY.
Facility Network:
- Manufacturing: The Company owns a manufacturing, laboratory, and mixed-use facility in North Billerica, Massachusetts (354,000 sq ft), a portion of which was sold with the SPECT business. It also owns a manufacturing facility in Springfield, New Jersey (13,079 sq ft). The acquired Evergreen Theragnostics, Inc. facility is a cGMP certified radiopharmaceutical manufacturing facility.
- Research & Development: R&D activities are supported across various office and laboratory spaces, including Bedford, Massachusetts (88,181 sq ft leased), Berlin, Germany (11,657 sq ft leased), and other international locations.
- Distribution: Radiopharmaceutical products are distributed rapidly to end-users via next-day delivery services or ground/air custom logistics due to their limited half-lives.
Market Access & Customer Relationships
Go-to-Market Strategy: Distribution Channels:
- Direct Sales: The Company utilizes internal sales teams for PYLARIFY, DEFINITY, and Neuraceq in the United States.
- Channel Partners: Sales of PYLARIFY are also generated through sales teams at some of its PMF partners. Outside the United States, the Company generally relies on third-party distributors in Europe, Canada, Australia, Asia-Pacific, Central America, and South America for its nuclear imaging and ultrasound enhancing agent products.
- Digital Platforms: The Company offers digital solutions such as Automated Bone Scan Index (aBSI) and aPROMISE (PYLARIFY AI) for clinical use and pharmaceutical development.
Customer Portfolio:
- Enterprise Customers: Primary customers include hospitals, independent imaging centers, and government facilities.
- Strategic Partnerships: The Company engages in partnerships with pharmaceutical companies and academic institutions that use its commercial or investigational products as research tools. Key partners include GE HealthCare Limited (for Flurpiridaz and piflufolastat F-18 in Japan), POINT Biopharma Global Inc. (for PNT2003), and Perspective Therapeutics, Inc. (for therapeutic candidates).
- Customer Concentration: No single customer accounted for greater than 10% of total revenues for the years ended December 31, 2025, 2024, or 2023.
Geographic Revenue Distribution (2025):
- United States: 94.6% of total revenue
- Rest of world: 5.4% of total revenue
Competitive Intelligence
Market Structure & Dynamics
Industry Characteristics: The markets for the Company's products are highly competitive and continuously evolving, characterized by rapid and continuous technological change, evolving clinical practices, and shifting customer expectations. The radiopharmaceutical and biopharmaceutical industry is strategically dynamic, with several market participants recently acquired by larger companies possessing more significant resources. Supply-demand dynamics are complex due to large market positions of some participants, legacy businesses, government subsidies, and group purchasing arrangements, often with limited sources for isotopes and raw materials.
Competitive Positioning Matrix:
| Competitive Factor | Company Position | Key Differentiators |
|---|---|---|
| Technology Leadership | Strong | Focus on innovative PET radiodiagnostics and microbubbles; pipeline of novel diagnostic and therapeutic candidates. |
| Market Share | Leading | DEFINITY holds over 80% share of the U.S. ultrasound enhancing agent market. |
| Cost Position | Advantaged | In-house manufacturing for DEFINITY provides supply chain redundancy, improved flexibility, and reduced costs. |
| Customer Relationships | Strong | Diverse, multi-partner PMF network for PYLARIFY and Neuraceq ensuring convenient and reliable supply; internal sales teams; best-in-class customer experience. |
Direct Competitors
Primary Competitors:
- PYLARIFY: Telix Pharmaceuticals Limited, Blue Earth Diagnostics Ltd. (a subsidiary of Bracco Diagnostics Inc.), and Novartis AG (for Gallium-68-based PSMA imaging agents), other F-18 PSMA imaging agents, and non-PSMA-based conventional imaging.
- DEFINITY: GE HealthCare Limited and Bracco Diagnostics Inc. (for ultrasound enhancing agents), as well as echocardiography without ultrasound enhancing agents and other non-echocardiography imaging modalities.
- Neuraceq: Eli Lilly and Co and GE HealthCare Limited (for F-18 beta-amyloid-targeting PET imaging agents).
- PNT2003 (pipeline): Novartis AG, ITM Radiopharma, Curium, and RayzeBio (acquired by Bristol Myers Squibb).
- MK-6240 and NAV-4694 (pipeline): Eli Lilly and Co and GE HealthCare Limited.
- LNTH-2501 (pipeline): Curium and Novartis AG.
Emerging Competitive Threats: The potential for future generic entrants to the market for PYLARIFY (following NCE exclusivity expiry in May 2026) and DEFINITY (composition of matter patent expired June 2019). The ongoing development of additional F-18, Gallium-68, and Copper-64 tracers, as well as new entrants and disruptive technologies, could increase competition.
Competitive Response Strategy: The Company aims to maintain its competitive advantage by clinically and commercially differentiating its products, ensuring flexible and dependable national access to products like PYLARIFY, providing a best-in-class customer experience, and entering into strategic contracts. It also focuses on expanding product use into new patient populations and through strategic partnerships and collaborations.
Risk Assessment Framework
Strategic & Market Risks
- Market Dynamics: Continued substantial revenue from PYLARIFY is dependent on its differentiation in an increasingly competitive environment, which includes other PSMA PET imaging agents, potential generic versions after NCE exclusivity expiry in May 2026, and the impact of the expiration of TPT Status on December 31, 2024, leading to lower MUC-based reimbursement compared to competitors with ASP-based TPT status. Growth of Neuraceq is contingent on expanded geographical access, increased adoption of beta-amyloid PET and anti-amyloid therapeutics, and clinical differentiation despite MUC payment disparities.
- Technology Disruption: The healthcare and diagnostic imaging industries are characterized by rapid technological change, evolving clinical practices, and new imaging agents, equipment, software, and diagnostic modalities. Advances in technology or shifts in clinical preferences could render current products obsolete or uneconomical.
- Customer Concentration: While no single customer accounts for more than 10% of revenue, dependence on third-party healthcare payors for reimbursement is a significant risk.
Operational & Execution Risks
- Supply Chain Vulnerabilities: The Company relies on third-party manufacturers and suppliers for a substantial portion of its products (e.g., PMF networks for PYLARIFY and Neuraceq, Jubilant HollisterStier for DEFINITY) and certain sole-sourced key components. Disruptions in supply, logistics, or manufacturing processes (e.g., equipment failure, regulatory non-compliance) could impact product delivery and revenue. Just-in-time manufacturing for radiopharmaceuticals with limited half-lives adds complexity.
- Capacity Constraints: The availability of staff at imaging centers and hospitals, as well as PET scanner capacity, is critical for the utilization of radiopharmaceutical diagnostic products. Shortages or constraints could adversely affect revenue generation and product launches.
- Product Quality & Performance: The complex manufacturing processes must meet stringent quality requirements (cGMPs). Manufacturing flaws, component failures, or design defects could lead to recalls, reputational harm, and significant costs.
- Acquisitions & Dispositions: Recent acquisitions (Life Molecular Imaging Limited, Evergreen Theragnostics, Inc.) and the divestiture of the SPECT business involve risks related to integration challenges, unforeseen expenses, diversion of management attention, and the ability to realize anticipated benefits.
- Talent Management: Intense competition for highly skilled scientific, medical, and sales personnel poses a risk to R&D expansion, product sales, and approval/commercialization timelines.
- Leadership Changes: Recent significant turnover in the executive leadership team, including the CEO and President, could disrupt business operations, strategic planning, and employee/third-party relationships.
- IT Infrastructure: Dependence on computer networks and systems, including those managed by third parties, makes the Company vulnerable to unauthorized access, security breaches, and system disruptions, which could lead to data loss, reputational harm, and operational inefficiencies.
- AI/Emerging Technologies: The use of artificial intelligence and other emerging technologies carries risks of deficient content, competitive disadvantages, and exacerbation of regulatory or cybersecurity risks.
Financial & Regulatory Risks
- Market & Financial Risks: The Company's financial performance is exposed to prevailing economic conditions, including unemployment rates, inflationary pressures, and escalating prices (e.g., from tariffs), which could impact customer demand, operating expenses, and cash flow.
- Foreign Exchange: International operations expose the Company to fluctuations in foreign currency exchange rates, particularly the Euro and Canadian dollar.
- Credit & Liquidity: The Company has $575.0 million in 2.625% Convertible Senior Notes due December 2027 and a $750.0 million revolving credit facility. Indebtedness may limit financial flexibility, increase interest expense, and affect the ability to incur additional debt or withstand economic downturns.
- Regulatory & Compliance Risks: The Company operates in a highly regulated industry, subject to extensive and evolving federal, state, local, and foreign regulations (e.g., FDA, NRC, anti-kickback, false claims, data privacy laws like GDPR and CCPA/CPRA). Non-compliance can result in enforcement actions, fines, penalties, and operational limitations. Healthcare reform measures (e.g., Inflation Reduction Act of 2022, One Big Beautiful Bill Act) could impact reimbursement, drug pricing, and patient coverage.
- Legal Proceedings: The Company is involved in patent infringement litigation related to PNT2003 (with Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA) and another healthcare-related imaging software developer. It is also subject to putative securities class actions and a shareholder derivative action alleging false or misleading statements and breaches of fiduciary duties.
Geopolitical & External Risks
- Geographic Dependencies: Approximately 5.4% of revenues and 12.0% of costs of goods sold are derived from outside the United States, exposing the Company to international economic, political, and trade risks, including changes in trade policies, tariffs, global air transport disruptions, and compliance with anti-bribery laws (FCPA, U.K. Bribery Act).
- Trade Relations: U.S. trade sanctions and tariffs could increase raw material costs, disrupt supply chains, and impact customers.
Innovation & Technology Leadership
Research & Development Focus: The Company makes substantial and ongoing investments in new product development and lifecycle management for existing products, focusing on radiopharmaceutical oncology, precision diagnostics (particularly Alzheimer's disease and cardiac amyloidosis), and theranostics. Core Technology Areas:
- Radiopharmaceutical Oncology: Development of new formulations for F-18 PSMA PET imaging agents.
- Neurology: Investigational F-18 tau-targeted PET imaging agents (MK-6240, LNTH-2620) and F-18 beta-amyloid PET imaging agents (NAV-4694) for Alzheimer's disease.
- Theranostics: Development of GRPR-targeting radiodiagnostic (LNTH-2401) and radiotherapeutic (LNTH-2402) pair for solid tumors.
- Other Oncology: LRRC15-targeted radiotherapeutic (LNTH-2403) for osteosarcoma, TROP2-targeted radiodiagnostic (LNTH-2404).
- Cardiac Amyloidosis: Development of LNTH-2515 (florbetaben F-18 injection) for diagnosis.
- Neuroendocrine Tumors: LNTH-2501 (diagnostic kit for Ga-68 edotreotide injection) and PNT2003 (SSTR therapy). Innovation Pipeline:
- New F-18 PSMA PET imaging agent formulation: NDA accepted, PDUFA target action date March 6, 2026.
- LNTH-2501: NDA accepted, PDUFA target action date March 29, 2026.
- MK-6240: NDA accepted, PDUFA target action date August 13, 2026. Successfully met co-primary endpoints in two pivotal studies.
- NAV-4694: Currently in Phase 3 development.
- LNTH-2620: Currently in a Phase 3 study.
- LNTH-1363S: Completed Phase 1 study, now enrolling sarcoma patients in Phase 1/2a study, exploring utility in lung and cardiac fibrosis.
- LNTH-2401/LNTH-2402: IND applications submitted for Phase 1b/2 clinical trial in prostate cancer patients.
- LNTH-2403: Initiated Phase 1/2 clinical trial in relapsed/refractory osteosarcoma patients.
- LNTH-2515: Granted Fast Track designation by the FDA for cardiac amyloidosis indications.
- PNT2003: ANDA accepted by FDA, currently in patent infringement litigation.
- PNT2002: Phase 3 SPLASH study results comparable, but no current plan to pursue NDA or further investment.
Intellectual Property Portfolio: The Company actively pursues patents in the United States and internationally, and relies on trade secrets, manufacturing know-how, licensing agreements, confidentiality agreements, and regulatory exclusivities.
- Patent Strategy: Seek patent protection in major markets globally, including composition of matter, method-of-use, formulation, and manufacturing patents.
- Patent Holdings:
- PYLARIFY: Six Orange Book-listed patents, with the last expiring in 2037. NCE exclusivity expires May 2026.
- DEFINITY: Nine Orange Book-listed method-of-use patents, with the last expiring in 2037. Manufacturing patents (non-Orange Book) expire in 2037.
- Neuraceq: Two Orange Book-listed patents, with the last expiring in July 2032.
- aPROMISE: U.S. patents and pending applications with expiration dates ranging from 2037 to 2041.
- aBSI: U.S. patents expire in 2032, ex-U.S. in 2028. Improvements patents/applications expire 2040-2041.
- Flyrcado (flurpiridaz): Composition of matter patent expires 2026, formulation 2032, method-of-use 2028, manufacturing 2031 and 2033.
- MK-6240: Exclusively licensed patents expire in 2035.
- NAV-4694: Exclusively licensed patents expire in 2028 and 2029.
- LNTH-2620: Co-owned patents expire in 2037.
- LNTH-2403: Owned patent applications, last expires in 2045.
- PNT2002: Exclusively licensed U.S. patents expire in 2041.
- PNT2003: Exclusively licensed pending U.S. patent applications, if granted, would expire in 2043.
- Licensing Programs: The Company licenses its products and technologies to strategic partners, including GE HealthCare Limited (Flurpiridaz, piflufolastat F-18 in Japan), POINT Biopharma Global Inc. (PNT2003), and partners for Neuraceq in selected markets.
- IP Litigation: Currently involved in a patent infringement lawsuit by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA (Novartis entities) regarding PNT2003, and a separate patent infringement lawsuit against a healthcare-related imaging software developer.
Technology Partnerships: The Company collaborates with various partners for technology development and commercialization, including Ratio Therapeutics LLC (LNTH-1363S), CarThera SAS (SonoCloud with microbubbles), Insightec Ltd. (focused ultrasound device with microbubbles), GE HealthCare Limited, POINT Biopharma Global Inc., Perspective Therapeutics, Inc., Radiopharm Theranostics Limited, and AC Immune SA (LNTH-2620).
Leadership & Governance
Executive Leadership Team
| Position | Executive | Tenure | Prior Experience |
|---|---|---|---|
| Chief Executive Officer | Mary Anne Heino | Appointed Jan 1, 2026 | Executive Chair and principal executive officer (from Nov 7, 2025) |
| Chief Financial Officer | Robert J. Marshall, Jr. | Not disclosed | Not disclosed |
| Chief Accounting Officer | Kimberly Brown | Not disclosed | Not disclosed |
Leadership Continuity: Mary Anne Heino was appointed CEO on January 1, 2026, following the retirement of former CEO Brian Markison on December 31, 2025. The Board of Directors is conducting a comprehensive search for the next CEO. The Company emphasizes the importance of leadership continuity, succession planning, and leadership development initiatives.
Board Composition: Five of the ten directors on the Board, including the Chairperson, are women. The Board actively oversees corporate strategy and enterprise risk management programs.
Human Capital Strategy
Workforce Composition (as of December 31, 2025):
- Total Employees: 1,193
- Geographic Distribution: 1,056 in the United States, 137 internationally.
- Skill Mix: The Company emphasizes the need for qualified scientific, medical, and sales personnel to support R&D and commercialization efforts.
Talent Management: Acquisition & Retention: The Company offers competitive compensation packages, including market-competitive pay, cash bonuses, healthcare and defined contribution plan benefits, paid time off, family leave, and equity grants (restricted stock and other equity). It focuses on pay equity and regularly assesses compensation against similar roles and peer groups. Employee Value Proposition: The Company fosters an inclusive, ethical, and compliant culture, believing it makes them an employer of choice. It utilizes various channels for open communication, including quarterly town hall meetings, newsletters, and an intranet site, and has employee recognition award programs.
Diversity & Development:
- Diversity Metrics: 50% of the Board of Directors (5 out of 10) are women, and 45% of senior leaders (Vice President or above) self-identify as women. Approximately 43% of employees self-identify as women. The Company requires recruiters to present inclusive candidate slates.
- Development Programs: Employees complete mandatory training covering anti-bribery/anti-corruption, insider trading, confidentiality, and healthcare industry marketing practices.
- Culture & Engagement: The Company promotes a culture of ethics and compliance, supported by a formal Ethics and Compliance Committee and a Supplier Code of Conduct that encourages business with diverse organizations.
Environmental & Social Impact
Environmental Commitments: Climate Strategy: The Company actively monitors and seeks to reduce its solid waste, energy and water usage, wastewater discharge, and greenhouse gas emissions. It developed a stormwater management operations and maintenance plan in 2020 to minimize pollution. Carbon Neutrality: Since 2022, the Company has powered its North Billerica campus with renewable wind energy through a contract with National Grid. Supply Chain Sustainability: The Company has a Supplier Code of Conduct and seeks to do business with minority-owned, female-owned, and other inclusive businesses and organizations.
Social Impact Initiatives:
- Community Investment: The Company's Supplier Code of Conduct and efforts to engage with inclusive businesses reflect a commitment to supporting local communities.
- Product Impact: The Company's diagnostic products are designed to provide information that enables healthcare professionals to achieve better patient outcomes, reduce patient risk, and limit overall costs.
Business Cyclicality & Seasonality
Demand Patterns: The Company experiences some modest seasonality for its products, with patients tending to schedule diagnostic imaging and other procedures less frequently during the summer vacation months and over the year-end holidays.
Regulatory Environment & Compliance
Regulatory Framework: The Company's development, manufacture, and commercialization activities are subject to extensive and complex governmental regulation in the United States and internationally.
- Industry-Specific Regulations: This includes regulations from the FDA (pre-clinical testing, clinical trials, manufacturing, safety, labeling, marketing, cGMPs), U.S. Nuclear Regulatory Commission (NRC), U.S. Department of Health and Human Services (HHS), Health Canada, European Medicines Agency (EMA), U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), National Medical Products Administration (NMPA), and various state and provincial boards of pharmacy and health departments.
- International Compliance: The Company must comply with varying regulations across jurisdictions, including data privacy laws such as the General Data Protection Regulation (GDPR) in the European Economic Area (EEA) and the California Consumer Privacy Act (CCPA) and California Privacy Rights Act (CPRA) in the U.S.
Trade & Export Controls: The Company is subject to U.S. federal and foreign laws governing international business practices, including the Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act, which prohibit improper payments to government officials. It is also subject to trade control regulations and trade sanctions laws that restrict the movement of goods and services to certain countries or persons.
Legal Proceedings:
- PNT2003 Patent Infringement: On January 26, 2024, the Company was sued by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA (Novartis entities) for patent infringement in response to its ANDA filing for PNT2003. A trial was conducted in December 2025, and the Company is awaiting the court's decision. This litigation could result in a stay of up to 30 months on FDA approval for PNT2003.
- Other Patent Litigation: On February 23, 2024, the Company filed a patent infringement lawsuit against a healthcare-related imaging software developer, which is ongoing.
- Securities Class Action: On September 9, 2025, a putative securities class action (Margolis v. Lantheus Holdings, Inc., et al.) was initiated, consolidated with a related action (Indiana Pub. Ret. Sys. v. Lantheus Holdings, Inc., et al.), alleging materially false or misleading statements. An amended complaint is due by March 13, 2026.
- Shareholder Derivative Action: On December 17, 2025, a shareholder derivative action (Lelchuk v. Heino et al.) was filed, repeating allegations from the securities class action.
Tax Strategy & Considerations
Tax Profile:
- Effective Tax Rate: The Company's effective tax rate was 25.6% in 2025, 27.5% in 2024, and 20.5% in 2023. The 2025 rate differs from the U.S. statutory rate of 21% primarily due to state income taxes, partially offset by tax credits.
- Tax Reform Impact: The One Big Beautiful Bill Act (OBBBA), signed into law on July 4, 2025, introduced significant U.S. tax law changes, including the permanent extension of certain Tax Cuts and Jobs Act provisions and modifications to the international tax framework. These provisions did not have a material impact on the Company's effective income tax rate for 2025.
- Net Operating Loss Carryforwards: As of December 31, 2025, the Company had U.S. federal income tax loss carryforwards of $281.4 million ($108.2 million expiring between 2029 and 2037, $173.2 million indefinite), foreign net operating losses of $76.3 million ($3.9 million expiring between 2032 and 2035, $72.4 million indefinite), and state income tax loss carryforwards of $9.2 million (tax-effected, majority expiring between 2032 and 2045).
- Unrecognized Tax Benefits: As of December 31, 2025, the Company had $29.6 million in unrecognized tax benefits, including interest and penalties, primarily related to tax uncertainties from the Life Molecular Imaging Limited acquisition.
Insurance & Risk Transfer
Risk Management Framework:
- Insurance Coverage: The Company maintains product liability insurance coverage with policy limits considered customary and adequate for pharmaceutical companies in the diagnostic medical imaging industry.
- Risk Transfer Mechanisms: The Company provides a $30.3 million surety bond to the Massachusetts Department of Public Health as financial assurance for the decommissioning and decontamination costs of its North Billerica, Massachusetts facility.