Financial Data and Key Metrics Changes - Consolidated net revenue for Q3 2025 was $384 million, an increase of 1.4% year-over-year [15] - Gross profit margin decreased to 63.5%, down 471 basis points due to unfavorable pricing impacts and integration costs from acquisitions [16] - Net income for Q3 was $27.8 million, with adjusted net income at $85.7 million, a decrease of 30.9% [17] - Operating cash flow totaled $105.3 million, down $69.8 million from the prior year [18] Business Line Data and Key Metrics Changes - PYLARIFY sales were $240.6 million, down 7.4% year-over-year, with U.S. volumes up 3.3% [15][7] - Precision diagnostic revenue increased by 25% to $129.7 million, with DEFINITY sales at $81.8 million, up 6.3% [15] - Neuraceq contributed $20.4 million in sales, consistent with expectations [10] Market Data and Key Metrics Changes - The U.S. Alzheimer's disease radiodiagnostic market is expected to grow significantly, driven by rising prevalence and expanded PET imaging guidelines [10] - The market for PSMA agents is stabilizing, with PYLARIFY maintaining its market leadership despite competition [9][48] Company Strategy and Development Direction - The company is preparing for the launch of a new F18 PSMA PET formulation expected in 2026, which aims to enhance production efficiency and patient access [8][9] - A leadership transition plan has been announced, with Mary Anne Heino stepping in as interim CEO [3][4] - The company is focused on executing its commercial strategy for prostate cancer and expanding its product pipeline in oncology, neurology, and cardiology [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the company, particularly in the radiopharmaceutical sector [22][23] - The company anticipates low single-digit volume growth for PYLARIFY in the remainder of 2025, offset by price compression [9] - Management noted that the competitive landscape remains challenging but is optimistic about maintaining market share through service excellence and clinical differentiation [48] Other Important Information - The company completed the acquisition of Life Molecular Imaging for approximately $309 million, enhancing its capabilities in the neuroscience space [18][61] - The effective tax rate for the quarter was 26.9% [17] Q&A Session Summary Question: Strategies for PYLARIFY and Neuraceq - Management noted stabilization in the PSMA market and increasing customer return to PYLARIFY, with a focus on availability and expansion for Neuraceq [25][26] Question: 2026 Guidance and Market Resets - Management refrained from providing specific 2026 guidance but indicated positive trends for PYLARIFY and Neuraceq [29][31] Question: Management Changes - The CEO's retirement was described as a personal decision, with a seamless transition to the interim CEO, who has extensive experience with the company [33][35] Question: Competitive Landscape in Alzheimer's Imaging - MK-6240 is positioned as a second-generation tau agent with significant competitive advantages, although the market remains immature [40][42] Question: Pricing Stabilization Factors - Management highlighted disciplined pricing strategies and superior service as key factors in achieving market stabilization [45][48] Question: Medicare Hospital Outpatient Rule - Management expressed uncertainty about immediate changes but anticipated potential meaningful changes to ASP by 2027 [54][56]

Financial Performance - Lantheus reported revenues of $384 million for Q3 2025, a 1.4% increase year-over-year[13, 35] - Adjusted EPS for Q3 2025 was $1.27, a 25.3% decrease year-over-year[13, 35] - Radiopharmaceutical Oncology sales were $240.6 million, a 7.4% decrease year-over-year, while U S volumes grew by 3 3%[35, 19] - Precision Diagnostics sales were $129.7 million, a 25 0% increase year-over-year, driven by DEFINITY sales growth of 6 3% and the addition of Neuraceq[35, 21] - Strategic Partnerships sales were $13.7 million, a 10.1% decrease year-over-year[35] Strategic Initiatives and Pipeline - Lantheus completed the acquisition of Life Molecular Imaging and repurchased $100 million of stock during the quarter[39] - The company anticipates four key product approvals by year-end 2026, including a new PSMA PET imaging agent, MK-6240, LNTH-2501, and PNT2003[15, 46] - Lantheus is expanding geographic coverage for Alzheimer's disease imaging, aiming for broad access across leading centers and community practices[25] - The company is advancing MK-6240, a F18 PET imaging agent for detecting tau in adults being evaluated for Alzheimer's disease, with a PDUFA date of August 13, 2026[29, 31] Financial Guidance - Lantheus updated its FY 2025 revenue guidance to $1.49 billion-$1.51 billion[42] - The company updated its FY 2025 adjusted fully diluted EPS guidance to $5.50-$5.65[42]

Core Insights - Lantheus Holdings, Inc. reported third quarter 2025 financial results, highlighting a slight increase in worldwide revenue but significant declines in net income and earnings per share [3][7][8] - The company is focusing on the commercial execution of its prostate cancer franchise, particularly PYLARIFY, while also advancing its strategic diversification plan [2][5] Financial Performance - Worldwide revenue for Q3 2025 was $384.0 million, a 1.4% increase from $378.7 million in Q3 2024 [3][21] - GAAP net income decreased by 78.8% to $27.8 million compared to $131.1 million in the prior year [3][8] - GAAP fully diluted earnings per share fell by 77.1% to $0.41 from $1.79 in Q3 2024 [3][8] - Adjusted net income (non-GAAP) was $85.7 million, down 30.9% from $124.1 million in the previous year [3][8] - Adjusted fully diluted earnings per share (non-GAAP) decreased by 25.3% to $1.27 from $1.70 [3][8] Business Developments - The company announced the retirement of CEO Brian Markison effective December 31, 2025, and is conducting a search for a new CEO [5][7] - Lantheus closed the acquisition of Life Molecular Imaging in July 2025, enhancing its commercial portfolio [7][16] - The company repurchased $100 million of its common stock in Q3 2025 as part of its stock repurchase plan [7][8] Product Sales - Sales of PYLARIFY were $240.6 million, a decrease of 7.4% year-over-year [8][21] - Sales of DEFINITY increased by 6.3% to $81.8 million [8][21] - Operating income decreased by 67.4% to $43.6 million, while adjusted operating income (non-GAAP) fell by 27.6% to $119.6 million [8][21] Cash Flow and Balance Sheet - Free cash flow for Q3 2025 was $94.7 million, down from $159.3 million in Q3 2024 [8][26] - As of September 30, 2025, cash and cash equivalents were $382.0 million, significantly reduced from $912.8 million at the end of 2024 [8][27] Guidance - The updated corporate guidance for full year 2025 revenue is projected to be between $1.49 billion and $1.51 billion [10] - Adjusted fully diluted earnings per share guidance for FY 2025 is set at $5.50 to $5.65 [10]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q2 2025 was $378 million, a decrease of 4.1% year over year [23] - Adjusted net income for Q2 was $110.6 million, a decrease of 12.8% [27] - GAAP fully diluted earnings per share for Q2 were $1.12, with adjusted EPS at $1.57, both down 12.8% [27] Business Line Data and Key Metrics Changes - Sales of Polarify were $251 million during the quarter, down 8.3% year over year [14] - U.S. volumes for Polarify were up 2% year over year and more than 4% sequentially, both lower than expectations [14] - Precision Diagnostics revenue was $115.8 million, up 3.3%, with DEFINITY sales at $83.9 million, up 7.5% [24] Market Data and Key Metrics Changes - The PSMA PET market faced competitive pricing pressures, particularly from an F-eighteen competitor, leading to account losses [15] - The broader market for PSMA PET is expected to grow in the mid to high teens, while Polarify is anticipated to grow in the low single digits [44] Company Strategy and Development Direction - The company is focused on diversifying its portfolio and enhancing capabilities across the radiopharmaceutical value chain [10] - A new $400 million stock repurchase program was authorized, reflecting confidence in the business's intrinsic value and future growth potential [12] - The FDA has accepted the NDA for a new formulation of Polarify, expected to increase batch size by approximately 50% [8] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q2 results were below expectations and lowered the financial outlook for the remainder of 2025 [5] - There are signs of stabilization in the PSMA PET marketplace, which is encouraging for future growth [41] - The company is committed to maintaining Polarify's market leadership despite competitive pressures [17] Other Important Information - The company completed the acquisition of Evergreen and Life Molecular, which are expected to contribute to growth and diversify revenue [10] - The strategic partnerships have been effective in maintaining and growing volumes, particularly in contracted accounts [16] Q&A Session Summary Question: Thoughts on achieving double-digit growth in 2026 - Management believes it is achievable through a combination of organic and inorganic growth, with key factors including the performance of DEFINITY and the impact of recent acquisitions [34][35] Question: Guidance for LMI's contribution to revenue - Forecasting a contribution of $40 million to $45 million in revenue from LMI for the latter half of 2025, with a low single-digit dilution expected [42] Question: Timing for the new formulation of Polarify - The new formulation is expected to be commercialized potentially by mid-2026, with a focus on securing coding coverage and payment [52] Question: Impact of new formulation on long-term contracts - The new formulation will be an add-on to existing contracts, potentially allowing for a 340B price reset [55] Question: Commercial opportunity for tau imaging - The tau imaging market is expected to grow, with the potential for significant demand as it becomes integrated into Alzheimer's treatment protocols [58] Question: Share of contracted versus non-contracted business - The vast majority of the business is under contract, with strategic partnerships designed to level the playing field against competitive pricing pressures [66]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q2 2025 was $378 million, a decrease of 4.1% year over year [20] - Adjusted net income for Q2 was $110.6 million, a decrease of 12.8% [24] - GAAP fully diluted earnings per share for Q2 were $1.12, with adjusted earnings per share at $1.57, both down 12.8% [24] Business Line Data and Key Metrics Changes - Sales of Polarify were $251 million, down 8.3% year over year, with U.S. volumes up 2% year over year and over 4% sequentially [12][21] - Precision Diagnostics revenue was $115.8 million, up 3.3%, with DEFINITY sales at $83.9 million, up 7.5% [21] - Strategic partnerships and other revenue increased by 32.8% to $11.6 million, driven by contributions from MK6240 and the newly acquired Evergreen CDMO business [22] Market Data and Key Metrics Changes - The PSMA PET market faced competitive pricing pressures, particularly from an F-eighteen competitor, leading to account losses and renegotiations [13][14] - The broader market for PSMA PET is expected to grow in the mid to high teens, while Polarify is anticipated to grow in the low single digits [39] Company Strategy and Development Direction - The company is focused on diversifying its portfolio and enhancing its capabilities in the radiopharmaceutical value chain through acquisitions [9] - A new $400 million stock repurchase program was authorized, reflecting confidence in the business's intrinsic value and future growth potential [11] - The FDA has accepted the NDA for a new formulation of Polarify, expected to increase batch size by approximately 50%, enhancing production efficiency and patient access [6][17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q2 results were below expectations and lowered the financial outlook for the remainder of 2025 [4] - The company is taking a disciplined approach to pricing to preserve the long-term value of its PSMA PET franchise [7][16] - Management expressed confidence in the long-term strategy and the ability to execute, despite current market dynamics [11][28] Other Important Information - The company expects full-year revenue to be in the range of $1.475 to $1.51 billion, down from the previous range of $1.55 to $1.585 billion [27] - The anticipated launch of four additional radiopharmaceutical products is expected to diversify revenue streams [10] Q&A Session Summary Question: Thoughts on achieving double-digit growth in 2026 - Management believes it is achievable through a combination of organic and inorganic growth, with key factors including the performance of DEFINITY and the impact of recent acquisitions [30][31] Question: Guidance for LMI's contribution to revenue - The forecast for LMI's contribution is $40 million to $45 million in net revenue with an EPS accretion of $0.04 [37] Question: Impact of new formulation on long-term contracts - The new formulation will be an add-on to existing contracts, potentially allowing for a 340B price reset [49] Question: Commercial opportunity for tau imaging - The company sees significant potential in the tau imaging market, which could be similar in size to Polarify [52] Question: Market share and contracted business for Polarify - The majority of the business is under contract, and management has made strategic decisions to walk away from certain accounts to protect long-term value [56][61]

Financial Performance - Lantheus' Q2 2025 revenues were $378 million, a decrease of 4.1% compared to Q2 2024[15, 52] - Adjusted EPS for Q2 2025 was $1.57, a decrease of 12.8% year-over-year[15, 52] - Radiopharmaceutical Oncology sales were $250.6 million, down 8.3% year-over-year, but with a 4% sequential volume increase[52] - Precision Diagnostics sales were $115.8 million, up 3.3% year-over-year, driven by DEFINITY sales growth of 7.5%[52] - Strategic Partnerships sales were $11.6 million, up 32.8% year-over-year[52] Financial Position - Cash provided by operations increased to $87.1 million in Q2 2025 from $84.7 million in Q2 2024[55] - Free cash flow for Q2 2025 was $79.1 million[58] - Lantheus has $695.6 million in cash on hand and $750 million available in revolving credit[58] Guidance - Updated FY 2025 revenue guidance is $1.475 billion - $1.51 billion[61] - Updated FY 2025 adjusted fully diluted EPS guidance is $5.50 - $5.70[61] Strategic Initiatives - Lantheus anticipates four key product launches in the next 18 months: MK-6240, OCTEVY, PNT2003, and a new PSMA PET formulation[20] - The company has a board authorization for a new $400 million stock repurchase program[59]

Financial Performance & Guidance - Lantheus' Q1 2025 revenues reached $372.8 million, reflecting a 0.8% increase[9] - The company's updated full-year 2025 revenue guidance is $1.55 billion to $1.585 billion[17] - The updated adjusted fully diluted EPS guidance for 2025 is $6.60 to $6.70[17] - As of March 31, 2025, Lantheus had $938.5 million in cash on hand and $750 million available in revolving credit[17, 18] Acquisitions & Divestments - Lantheus closed the acquisition of Evergreen Theragnostics in April 2025[9] - The company anticipates closing the acquisition of Life Molecular Imaging in Q2 2025[9] - Lantheus plans to finalize the divestment of its SPECT business by the end of 2025[9] Key Products & Market - PYLARIFY net sales were $257.7 million in Q1 2025, and it is the 1 utilized PSMA PET imaging agent[26, 24] - 99% of enrolled patients in the CONDOR study experienced a change in intended patient management based on PYLARIFY results[29] - The PSMA PET market may exceed $3.5 billion by the end of the decade[38] - DEFINITY net sales were $79.2 million in Q1 2025, with a 3.5% year-over-year growth, remaining the 1 utilized ultrasound enhancing agent[61] - The U S Ultrasound Enhancing Agent TAM is $600M+[68] Pipeline & Development - Lantheus is advancing a diversified radiotherapeutic and radiodiagnostic pipeline, including MK-6240 for Tau imaging and NAV-4694 for β amyloid imaging in Alzheimer's disease[71, 74] - PNT2003, a somatostatin receptor (SSTR)-targeted radiotherapeutic, has a potential launch in 2026[75] - LNTH-2401/2402 (GRPR-targeted) are in development for metastatic prostate cancer, with an IND filing for LNTH-2401 expected in Q4 2025 and Phase 1 initiation for LNTH-2402 planned for 2026[141]

Commercial Portfolio Performance - PYLARIFY achieved blockbuster status in 2024 with over $1 billion in sales[154], and Q1 2025 net sales reached $257.7 million[13] - DEFINITY remains the 1 utilized ultrasound enhancing agent, with Q1 2025 net sales of $79.2 million, a 3.5% year-over-year growth[24] Market Opportunities - The U S PSMA PET imaging market has a potential of over $3.5 billion by 2030, driven by expansion of radiotherapeutics and increasing clinical utility in BCR population[19, 20] - The U S ultrasound enhancing agent total addressable market is over $600 million[35] Pipeline Development - Lantheus is advancing an innovative pipeline of radiopharmaceuticals, including diagnostic and therapeutic candidates for prostate cancer, neuroendocrine tumors, and Alzheimer's disease[38, 40] - LNTH-2402, a GRPR-targeted radiotherapeutic, is expected to have an IND filing in Q4 2025, with Phase 1 initiation planned for 2026[109] Financial Highlights - As of March 31, 2025, Lantheus had $938.5 million in cash on hand and $98.8 million in free cash flow in Q1 2025[10] - The updated interim corporate financial guidance for the full year 2025 projects revenue between $1.550 billion and $1.585 billion, and adjusted fully diluted EPS between $6.60 and $6.70[142] Strategic Transactions - The acquisition of Evergreen Theragnostics closed in April 2025, strengthening radiodiagnostic and therapeutic capabilities[10, 165] - The acquisition of Life Molecular Imaging is expected to close by 2Q 2025, expanding the commercial portfolio and pipeline in Alzheimer's disease[10, 144]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q1 2025 was $372.8 million, an increase of 0.8% year-over-year [23] - GAAP net income for Q1 was $72.9 million, with adjusted net income at $109.5 million, a decrease of 7.5% [27] - Gross profit margin for Q1 was 67%, a decrease of 180 basis points due to various factors including strategic partnership contracting initiatives [24] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology, primarily from Polarify, contributed $257.7 million in sales, flat compared to the prior year [23] - Precision Diagnostic revenue was $104.4 million, also flat year-over-year, with DEFINITY sales at $79.2 million, up 3.5% [24] - Strategic partnerships and other revenue increased by 65.1% to $10.7 million, driven by contributions from investigational asset MK6240 [24] Market Data and Key Metrics Changes - The U.S. Alzheimer's disease radio diagnostics total addressable market is projected to grow to over $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s [10] - The PSMA PET addressable market is anticipated to exceed $3.5 billion by 2025, driven by rising disease incidence and broader adoption of targeted therapies [15] Company Strategy and Development Direction - The company plans to divest its SPECT business to Shine Technologies, focusing on PET radio diagnostics and radiotherapeutics [5][11] - Recent acquisitions of Evergreen Theranostics and Life Molecular Imaging are aimed at enhancing radiopharmaceutical leadership and diversifying revenue streams [5][6] - The company is committed to advancing its position in the radiopharmaceutical sector through both organic growth and strategic acquisitions [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining market leadership despite competitive pressures, particularly in the Polarify segment [40] - The divestiture of the SPECT business is expected to unlock future revenue growth and gross margin expansion [31] - The company anticipates low single-digit dilution from the combined addition of Evergreen and LMI, with adjusted EPS projected in the range of $6.60 to $6.70 [31] Other Important Information - The company is actively monitoring tariff activities and their potential impact on operations, though current effects are minimal [28] - The effective tax rate for the quarter was 26.5% [27] Q&A Session Summary Question: Insights on Polarify trends and competitive dynamics - Management noted successful revenue stabilization through strategic partnerships, despite experiencing short-term competitive disruption among smaller non-contracted sites [39][40] Question: Rationale for exiting the SPECT business - The SPECT business was deemed non-core to future growth, allowing the company to streamline operations and focus on higher growth areas [43][44] Question: Fiscal 2025 guidance drivers - Guidance was tightened primarily due to Polarify's performance, with expectations for healthy dose volumes throughout the year [49] Question: Long-term opportunity for GRPR targeting in prostate cancer - Management highlighted the potential for GRPR imaging and therapy, noting its relevance in various stages of prostate cancer treatment [82][84] Question: Impact of MUC-based pricing on revenue - MUC-based pricing currently affects about 20% of patients, with management expecting stabilization as customers adapt to new reimbursement structures [90]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q1 2025 was $372.8 million, an increase of 0.8% year-over-year [24] - GAAP net income for Q1 was $72.9 million, with adjusted net income at $109.5 million, a decrease of 7.5% [29] - Gross profit margin for Q1 was 67%, a decrease of 180 basis points compared to the previous year [25] - Operating profit for the quarter was $144.3 million, a decrease of 7.1% [27] Business Line Data and Key Metrics Changes - Radiopharmaceutical oncology, primarily from Polarify, contributed $257.7 million in sales, flat year-over-year [24] - Precision Diagnostic revenue was $104.4 million, also flat year-over-year, with DEFINITY sales at $79.2 million, up 3.5% [25] - Strategic partnerships and other revenue increased by 65.1% to $10.7 million, driven by investigational asset MK6240 [25] Market Data and Key Metrics Changes - The U.S. Alzheimer's disease radio diagnostics total addressable market is projected to grow to over $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s [11] - The PSMA PET addressable market is anticipated to exceed $3.5 billion by 2026, driven by rising disease incidence and broader adoption [15] Company Strategy and Development Direction - The company plans to divest its SPECT business to Shine Technologies to focus on PET radio diagnostics and radiotherapeutics [5][12] - Recent acquisitions of Evergreen Theranostics and Life Molecular Imaging are aimed at enhancing radiopharmaceutical leadership and long-term growth [5][6] - The company is committed to advancing its position in nuclear medicine through both organic growth and strategic acquisitions [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining market leadership despite competitive pressures and pricing dynamics [41] - The divestiture of the SPECT business is expected to unlock future revenue growth and gross margin expansion [46] - The company anticipates low single-digit dilution from the combined addition of Evergreen and LMI, with an updated revenue guidance of $1.55 to $1.585 billion for 2025 [32][34] Other Important Information - The company is actively monitoring tariff activities and their potential impact on operations, though current effects are minimal [30] - R&D expenses are expected to be approximately 7.5% of revenue, reflecting increased investments in growth initiatives [33] Q&A Session Summary Question: Can you elaborate on Polarify trends and competitive dynamics? - Management noted successful revenue stabilization through strategic partnerships, despite experiencing short-term competitive disruption among smaller non-contracted sites [40][41] Question: What is the rationale for exiting the SPECT business now? - The SPECT business is viewed as non-core to future growth, allowing the company to streamline operations and focus on higher growth areas [45][46] Question: How does the divestiture of the SPECT business free up resources? - The divestiture allows for a sharper organizational focus on PET radio diagnostics and radiotherapeutics, enhancing growth potential [55] Question: What is the expected impact of MUC-based pricing on revenue? - MUC-based pricing currently affects about 20% of patients, with management expecting stabilization as sites adapt to new reimbursement structures [93][95] Question: How does the company view the long-term opportunity for GRPR targeting in prostate cancer? - There is potential for GRPR imaging and therapy to play a significant role in various stages of prostate cancer treatment, with ongoing development efforts [86][88]