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Lantheus Holdings (LNTH -0.76%) held its fourth-quarter and full-year 2024 earnings call on Feb. 26, 2025, highlighting achievements in its radiopharmaceutical portfolio and announcing strategic transactions.Pylarify Achieves $1 Billion Sales MilestoneProstate imaging drug Pylarify has become the first radiodiagnostic blockbuster, achieving over $1 billion in sales for 2024. The addressable market continues to expand.We estimate [the addressable market] to be $2.5-plus billion in 2025 up from $2-plus billio ...

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $391.1 million, an increase of 10.5%, while full-year revenue was $1.534 billion, up 18.3% [26] - Operating profit for Q4 was $151.8 million, a decrease of 8.4%, and for the full year, it was $643.3 million, an increase of 7.7% [31] - The reported net loss for Q4 was $11.8 million, while adjusted profit was $115.4 million, a decrease of 5.9% from the prior year [33] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology contributed $266 million in sales for Q4, up 15.3%, primarily driven by Pylarify, which had sales of $266 million, an increase of 15.7% [27] - Precision Diagnostics Q4 revenue was $117.5 million, up 16.8%, with DEFINITY at $86.2 million, an increase of 17.9% [28] - DEFINITY's full-year revenue was $317.8 million, up 13.6%, while TechneLite revenue was $95.5 million, up 9.3% [28] Market Data and Key Metrics Changes - The addressable market for PSMA PET imaging is estimated to grow from over $2 billion in 2024 to over $2.5 billion in 2025, with potential to exceed $3.5 billion by the end of the decade [15] - The total addressable market for Alzheimer's disease radio diagnostics is projected to grow to $1.5 billion by the end of the decade [20] Company Strategy and Development Direction - The company aims to enhance capabilities across the radiopharmaceutical value chain, particularly in Alzheimer's diagnostics and oncology therapeutics [8][44] - Strategic transactions are expected to drive sustained double-digit revenue growth beginning in 2026 [8] - The company plans to advance its pipeline with potentially best or first-in-class radiopharmaceutical theragnostic pairs [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining market leadership for Pylarify and DEFINITY, despite competitive pressures [14][62] - The new CMS payment policy is seen as a significant step that will support long-term radiopharmaceutical diagnostic innovation [11] - The company anticipates free cash flow to expand through 2025, with an expected range of $550 million to $600 million [41] Other Important Information - The company executed a series of asset in-licensing deals to expand its pipeline, particularly for Alzheimer's disease and oncology [10] - The company refinanced its revolving senior credit facility, increasing borrowing capacity to $750 million [36] Q&A Session Summary Question: Status update on the mirror study and its implications on Pylarify - The mirror study is assessing PSMA PET with Pylarify in intermediate favorable patients, with the last patient expected to enroll by Q4 2025 [48][50] Question: Competitive dynamics with new reimbursement changes - The new reimbursement code is expected to benefit Pylarify, and the company is confident in maintaining its market leadership despite competition [54][58] Question: Growth expectations for Pylarify in 2025 - Guidance suggests low to mid-single-digit growth for Pylarify, with potential for modest growth in the first half of the year [68][70] Question: Potential for ASP-based methodology and its impact - If CMS migrates to ASP, it would be seen as upside for the business, with draft rules expected in July [78] Question: Dynamics of Pylarify's market share and competition - The company has secured contracts with the majority of customers, which is expected to mitigate competitive pressures [82][86] Question: Future growth drivers and pipeline assets - Anticipated growth in 2026 will be led by Pylarify and DEFINITY, along with new launches from pending acquisitions [128]

Agenda February 26, 2025 © 2025 Lantheus. All rights reserved. Highlights & Business Update Lantheus Fourth Quarter & FY2024 Results Operational Update Financial Update Closing Remarks Q&A Session © 2025 Lantheus. All rights reserved. 2 Brian Markison CEO Paul Blanchfield President Bob Marshall CFO and Treasurer Amanda Morgan Chief Commercial Officer Mark Kinarney Vice President, Investor Relations Safe Harbor Statements This document contains forward-looking statements within the meaning of the Private Sec ...

Market Position and Product Development - DEFINITY has been used in over 28 million echocardiograms globally since its launch in 2001, with an estimated 5 to 10 million echocardiograms producing suboptimal images in the U.S. in 2023[69][70]. - As of December 31, 2024, DEFINITY holds over 80% market share in the U.S. for ultrasound enhancing agents in echocardiography procedures[70]. - The company received FDA approval for DEFINITY's use in pediatric patients in March 2024, based on data from three clinical trials[70]. - The FDA approved flurpiridaz, an F-18-based PET MPI agent, under the name Flyrcado for coronary artery disease diagnosis, with commercialization expected in the first half of 2025[87]. - MK-6240 and NAV-4694 are investigational late-stage PET imaging agents for Alzheimer's disease, currently in Phase 3 development and used in over 100 clinical trials[81][82]. - PNT2002 has shown positive topline results in the Phase 3 SPLASH trial for mCRPC, with interim overall survival (OS) results at 46% of the pre-specified target OS events reached, and a hazard ratio (HR) of 1.11[90]. - PNT2003 is in registration to treat SSTR-positive neuroendocrine tumors, with an ANDA accepted for filing by the FDA[90]. - LNTH-2402, a novel radiotherapeutic targeting gastrin-releasing peptide receptor, is expected to begin a Phase 1/2a study in prostate cancer patients in 2025[90]. - The company is actively pursuing additional patents for DEFINITY, with the last Orange Book-listed method-of-use patent expiring in 2037[71]. Financial Performance - Total revenues for the year ended December 31, 2024, were $1.534 billion, an increase of 18.3% compared to $1.296 billion in 2023[538]. - The company's net income for 2024 was $312.4 million, a decrease of 4.4% from $326.7 million in 2023[540]. - Gross profit for 2024 was $988.3 million, representing a gross margin of 64.4% compared to 54.7% in 2023[538]. - Operating income for 2024 was $457.0 million, an increase of 25.4% from $364.6 million in 2023[538]. - Cash and cash equivalents increased to $912.8 million in 2024 from $713.7 million in 2023, indicating improved liquidity[536]. - The company’s total stockholders' equity rose to $1.088 billion in 2024, compared to $815.9 million in 2023, reflecting strong retained earnings growth[536]. - Operating cash flow for 2024 was $544,750 thousand, up 78.3% from $305,260 thousand in 2023, and an increase from $281,781 thousand in 2022[545]. - Stock-based compensation expenses rose to $76,393 thousand in 2024, compared to $50,507 thousand in 2023 and $29,262 thousand in 2022[545]. - The company reported a loss on other comprehensive income of $(578) thousand in 2024, compared to a gain of $222 thousand in 2023[543]. Research and Development - The company invested $168.1 million in research and development for the year ended December 31, 2024, compared to $77.7 million in 2023[89]. - Research and development expenses increased to $168.1 million in 2024, up from $77.7 million in 2023, indicating a focus on innovation and new product development[538]. Regulatory Environment - The company is subject to comprehensive governmental regulation, which increases the time and costs for obtaining product approvals[148]. - The FDA approval process requires substantial time and financial resources, with no certainty of timely approvals for products in development[151]. - The FDA may require additional clinical trials or information before granting NDA approval, which can lead to delays and increased costs[156]. - The Hatch-Waxman Act allows for the approval of ANDAs for generic drugs if they demonstrate bioequivalence to the innovator product[168]. - Patent term extensions can compensate for time lost during clinical development, allowing up to five years of additional patent life[171]. - The FDA strictly regulates the promotion and advertising of drug products, requiring compliance with approved indications and safety information[161]. Supply Chain and Manufacturing - The company has a diverse supply chain for Mo-99, with purchases from IRE, NTP, and ANSTO, accounting for approximately 7.8% of total purchases in 2024[102]. - The company has established relationships with key suppliers to mitigate supply chain challenges, particularly for Mo-99[105]. - The company has received FDA approval for DEFINITY manufacturing at a new facility, which became commercially available on February 23, 2022[110]. Employee and Corporate Governance - As of December 31, 2024, the company had 808 employees, with 783 located in the U.S. and 25 internationally[206]. - Approximately 49% of the company's employees are women, and over half of the senior management team are women[208]. - The company has a formal Ethics and Compliance Committee overseeing its ethics and compliance programs, including anti-bribery and anti-corruption training[209]. Market Competition and Sales - The market for the company's products is highly competitive, with principal competitors including Novartis AG, GE Healthcare, and Curium[99][100]. - PYLARIFY sales are generated through an internal sales team and PMF partners, with no customer accounting for more than 10% of revenues in the last three years[92][95]. - The company's products are primarily sold to hospitals and independent diagnostic testing facilities in the U.S., with international sales through third-party distributors[553]. - Lantheus's diagnostic products are utilized by various healthcare professionals, including oncologists and cardiologists, across diverse clinical settings[552].

Topic 1: Financial Performance - [Key Point 1] Revenue increased by 15% year-over-year, driven by strong sales in the Asia-Pacific region. [1] - [Key Point 2] Net profit margin improved to 12%, up from 10% in the previous quarter. [2] - [Key Point 3] Operating expenses rose by 8%, primarily due to increased marketing and R&D investments. [3] Topic 2: Market Expansion - [Key Point 1] The company successfully entered two new markets in Europe, contributing to a 20% increase in international sales. [1] - [Key Point 2] A new distribution center was opened in South America to support regional growth. [4] - [Key Point 3] Strategic partnerships were formed with local retailers in Southeast Asia to enhance market penetration. [2] Topic 3: Product Development - [Key Point 1] Launched three new products in the tech segment, which accounted for 25% of total revenue. [3] - [Key Point 2] R&D investment increased by 10% to accelerate innovation in the healthcare sector. [4] - [Key Point 3] A new line of eco-friendly products was introduced, receiving positive customer feedback. [1] Topic 4: Operational Efficiency - [Key Point 1] Implemented a new ERP system, reducing operational costs by 5%. [2] - [Key Point 2] Streamlined supply chain processes, resulting in a 10% reduction in delivery times. [3] - [Key Point 3] Enhanced inventory management, leading to a 15% decrease in stockouts. [4] Topic 5: Corporate Social Responsibility - [Key Point 1] The company achieved a 30% reduction in carbon emissions through sustainable practices. [1] - [Key Point 2] Launched a community outreach program, benefiting over 10,000 individuals in underserved areas. [2] - [Key Point 3] Increased diversity in the workforce, with women now representing 40% of leadership roles. [3] Topic 6: Future Outlook - [Key Point 1] The company plans to expand its digital transformation initiatives, aiming for a 20% increase in online sales. [4] - [Key Point 2] A new product line is expected to be launched in Q4, targeting the premium segment. [1] - [Key Point 3] The company is exploring opportunities in the renewable energy sector to diversify its portfolio. [2]

Core Insights - Lantheus Holdings, Inc. reported significant growth in its financial results for 2024, with a notable increase in worldwide revenue and the achievement of blockbuster status for its radiodiagnostic product PYLARIFY [2][4][5] - The company plans to expand its commercial portfolio and pipeline in 2025, focusing on innovative radiopharmaceutical solutions to enhance patient outcomes and shareholder value [2][6] Financial Performance - Worldwide revenue for Q4 2024 was $391.1 million, a 10.5% increase from $354.0 million in Q4 2023 [4][5] - Full-year revenue for 2024 reached $1.53 billion, up 18.3% from $1.30 billion in 2023 [4][20] - PYLARIFY sales were $266.0 million in Q4 2024, reflecting a 15.7% increase, while DEFINITY sales rose 17.9% to $86.2 million [5][20] - The company reported a GAAP net loss of $11.8 million for Q4 2024, compared to a net income of $103.4 million in Q4 2023 [4][5] - Adjusted net income for Q4 2024 was $115.4 million, down 5.9% from $122.7 million in Q4 2023 [4][21] Strategic Initiatives - Lantheus has closed multiple strategic transactions in 2024, adding five new assets to its pipeline, including acquisitions that enhance its presence in prostate cancer and Alzheimer's disease diagnostics [6][7] - The company is focusing on diversifying its portfolio with early- to late-stage assets and expanding its capabilities in high-potential markets [2][6] - In 2025, Lantheus plans to acquire Life Molecular Imaging and Evergreen Theragnostics, which will strengthen its position in the radiopharmaceutical market [7][9] Guidance and Future Outlook - For FY 2025, Lantheus projects revenue between $1.545 billion and $1.610 billion, with adjusted fully diluted EPS guidance of $7.00 to $7.20 [9][10] - The company aims to continue executing a strategy that emphasizes sustainable growth and value creation for shareholders [2][6]

Core Insights - The Motley Fool aims to enhance the financial well-being of individuals by providing investment solutions and market analysis [1] Company Overview - Founded in 1993, The Motley Fool is a financial services company focused on making the world smarter, happier, and richer [1] - The company reaches millions of people monthly through various platforms, including premium investing solutions, free guidance, and market analysis on Fool.com [1] - The Motley Fool also produces top-rated podcasts and operates a non-profit organization, The Motley Fool Foundation [1]

Core Insights - Lantheus Holdings, Inc. is a leading company in the radiopharmaceutical sector, focused on improving patient outcomes through innovative solutions [3]. Company Information - Lantheus has been providing radiopharmaceutical solutions for over 65 years and is headquartered in Massachusetts, with additional offices in Canada and Sweden [3]. - The company is committed to enabling clinicians to Find, Fight, and Follow disease [3]. Upcoming Events - Lantheus management will present at several investor conferences, including: - B. Riley Securities Precision Oncology & Radiopharma Day in New York on February 28 [4]. - TD Cowen 45th Annual Health Care Conference in Boston on March 4 at 2:30 pm ET [4]. - Leerink Global Healthcare Conference 2025 in Miami on March 11 at 1:40 pm ET [4]. - Live webcasts of the presentations will be available on the company's website, with replays accessible for at least 30 days [2].

Core Viewpoint - Lantheus Holdings, Inc. will host a conference call and webcast to discuss its financial and operating results for Q4 and the full year of 2024 on February 26, 2025 [1]. Group 1: Conference Call Details - The conference call and webcast will take place at 8:00 a.m. ET on February 26, 2025 [1]. - Participants can register online to access the conference call or webcast, with a recommendation to register fifteen minutes in advance to avoid delays [2]. - A replay of the webcast will be available approximately two hours after its completion and will be archived for at least 30 days [2]. Group 2: Company Overview - Lantheus is a leading company in the radiopharmaceutical sector, focusing on delivering solutions that help clinicians in disease detection and management [3]. - The company has been providing radiopharmaceutical solutions for over 65 years and is headquartered in Massachusetts, with additional offices in Canada and Sweden [3].