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    LNTH
    Earnings call· Dec 2025(Q4 FY25)

    Lantheus Holdings Q4 FY25 earnings call LNTH

    Feb 26, 2026 Source

    Executive summary

    Lantheus Q4 FY25 — Strategic Focus on Radiodiagnostics and Strong Pipeline Progress

    Lantheus is sharpening its strategic focus on radiodiagnostics, divesting its legacy SPECT business and pursuing value-maximizing alternatives for radiotherapeutic assets. The company anticipates multiple FDA approvals in 2026, setting the stage for accelerated revenue and earnings growth in 2027, despite an expected PYLARIFY net revenue decline in FY26. Management is prioritizing commercial execution and pipeline advancement while optimizing its cost structure to deliver on EPS targets.

    Highlights

    5

    • Impacted approximately 7 million patients in 2025, underscoring real-world importance.

    • Neuraceq contributed $31 million in Q4 and is expected to grow triple digits (140-150%) in FY26.

    • DEFINITY remained a strong contributor with $85.3 million in Q4 and over 80% market share.

    • PYLARIFY volume was up approximately 4% year-over-year in Q4, demonstrating resilience in a competitive market.

    • Multiple potential FDA approvals in 2026 for new PSMA PET formulation, OCTEVY, PNT2003, and MK-6240.

    Concerns

    5

    • PYLARIFY net revenue is forecast to decline 8% to 10% year-over-year in FY26 due to pricing decisions and competitive dynamics.

    • Gross profit margin decreased by 289 basis points year-over-year in Q4 to 65.1%.

    • Operating profit decreased by 8.5% in Q4 to $138.9 million.

    • Free cash flow was $81.4 million in Q4, a decrease of $60 million from the prior year period.

    • A $9 million headwind is expected in FY26 net interest expense due to lost interest income from 2025 M&A and share repurchases.

    Guidance & targets

    21
    CategoryTargetConfidence
    Worldwide Net Revenue
    $1.4 billion to $1.45 billion
    high materiality
    High
    PYLARIFY Net Revenue Growth
    declining 8% to 10%
    high materiality
    High
    Neuraceq Growth
    triple digits (140% to 150%)
    medium materiality
    High
    DEFINITY Growth
    low to mid-single digits
    medium materiality
    High
    Gross Margin
    approximately 65.5%
    high materiality
    High
    R&D as % of Revenue
    10% to 11%
    medium materiality
    High
    G&A as % of Net Revenue
    10%
    low materiality
    High
    Net Interest Expense and Other
    $5 million of expense
    medium materiality
    High
    Effective Tax Rate
    26%
    low materiality
    High
    Fully Diluted Shares Outstanding
    66 million shares
    low materiality
    High
    Adjusted EPS
    $5.00 to $5.25
    high materiality
    High
    New PSMA PET Formulation PDUFA Date
    March 6
    high materiality
    High
    New PSMA PET Formulation Commercial Launch
    Q4 2026
    high materiality
    High
    New PSMA PET Formulation HCPCS Code and TPT Status
    in place by October 1
    high materiality
    High
    OCTEVY PDUFA Date
    March 29
    high materiality
    High
    OCTEVY Commercial Launch
    second half of this year
    high materiality
    High
    PNT2003 Court Ruling
    midyear
    high materiality
    High
    MK-6240 PDUFA Date
    August 13
    high materiality
    High
    CEO Search Completion
    progressing
    high materiality
    Medium
    M&A Activity
    no significant M&A activity
    medium materiality
    High
    Radiotherapeutic Assets Strategy
    pursue value-maximizing alternatives
    high materiality
    High

    Segment performance

    4
    SegmentRevenueYoYQoQMargin
    Radiopharmaceutical Oncology
    Comprised solely of PYLARIFY. Full year revenue was $989.1 million, down 6.5% from prior year. Results were above expectation due to price and volume favorability.
    PYLARIFY volume: up 4% year-over-year
    		$240.2 million-9.7%flat sequentially—
    Precision Diagnostics
    Driven by Neuraceq acquisition. Full year revenue was $330.2 million, up 3.9%.
    DEFINITY revenue: $85.3 millionDEFINITY growth: -1% (due to prior year competitor supply challenges)Neuraceq revenue: $31 millionNeuraceq revenue since acquisition (late July): $51.4 million
    		$143.2 million22%——
    TechneLite and other SPECT
    Full year revenue was $111.4 million. This business was divested effective January 1, 2026.
    		$26.9 million———
    Strategic Partnerships and Other
    Strong quarter due to MK-6240 and a $6 million milestone receipt relating to an out-licensed asset. Full year revenue was $59.4 million.
    MK-6240 contribution: slightly less than half of full year amount
    		$23.3 million203.3%——

    Operational metrics

    17
    Full Year Revenue Growth
    0.5%
    FY25

    Total revenue for the full year was $1.5416 billion, an increase of 0.5%.

    Gross Profit Margin
    65.1%down 289 bps
    Q4 FY25

    Gross profit margin for the fourth quarter was 65.1%, down 289 basis points from Q4 2024.

    Operating Expenses as % of Net Revenue
    30.9%179 bps unfavorable
    Q4 FY25

    Operating expenses at 30.9% of net revenue were 179 basis points unfavorable from the prior year, but within previously guided spending levels.

    Operating Profit Decrease
    8.5%YoY
    Q4 FY25

    Operating profit for the quarter was $138.9 million, a decrease of 8.5%.

    Adjusted Profit
    $110.7 milliondecrease of 4.1%
    Q4 FY25

    Adjusted profit for the fourth quarter was $110.7 million, a decrease of 4.1% from the prior year period.

    Adjusted EPS
    $1.67increase of 4.7%
    Q4 FY25

    Adjusted EPS for the fourth quarter was $1.67, an increase of 4.7%.

    Adjusted EPS
    $6.08decrease of 10%
    FY25

    Adjusted EPS for the full year was $6.08, a decrease of 10% from the prior year.

    Capital Expenditures
    $8.8 million$7.6 million less than prior year
    Q4 FY25

    Capital expenditures totaled $8.8 million in Q4 2025.

    Working Capital Decrease
    $49.3 million
    Q4 FY25

    The majority of the FCF variance lies within working capital with a $49.3 million decrease.

    Share Repurchases
    $100 million
    Q4 FY25

    The company repurchased $100 million or $1.77 million of its own shares during the quarter.

    Remaining Buyback Authorization
    $200 million
    Q4 FY25

    Leaving $200 million of authorization for buybacks outstanding.

    Cash and Cash Equivalents
    $359.1 million
    Q4 FY25

    Cash and cash equivalents net of restricted cash now stand at $359.1 million.

    Adjusted EPS Comparison Baseline
    $5.75
    FY25

    The appropriate adjusted EPS comparison for FY25, after normalization adjustments, should be $5.75.

    Sales and Marketing as % of Revenue
    12-12.5%
    FY26

    Management expects sales and marketing to be in the 12-ish, 12.5% range of revenue for FY26.

    Neuraceq PMF Sites
    16
    acquisition date

    The starting number of PMF sites for Neuraceq when acquired was 16. The company plans to add 6 more in 2026.

    MK-6240 Therapeutic Programs
    17
    current

    MK-6240 currently serves as the imaging agent for treatment eligibility in 17 pharma-sponsored therapeutic programs.

    OCTEVY Market Hospital-Based
    80%
    current

    The OCTEVY market is approximately 80% hospital-based, making transitional pass-through status an important consideration.

    Industry KPIs

    7
    MetricValueDetails
    Pricing realized price8% to 10%%
    New product launch rampQ4 2026
    Procedure volume growth4%%
    FCF conversion leverage guidance$81.4 millionUSD
    Installed base system placements16sites
    Segment franchise organic growth4%%
    Consumables recurring revenue mix80%%

    Deals & partnerships

    3
    NeuraceqAcquisition of beta-amyloid-targeted PET radiodiagnostic.

    Neuraceq now serves as the commercial cornerstone of the Alzheimer's disease portfolio. Acquired in late July 2025.

    OCTEVYAcquisition of neuroendocrine PET radiodiagnostic product candidate.

    Currently under FDA review. Upon approval, it will broaden offerings to existing customers.

    Legacy SPECT businessDivestiture of legacy SPECT business.

    Completed on January 1, 2026. Strategic intent is to prioritize investment in innovative PET radiodiagnostics.

    Risks & headwinds

    6
    PYLARIFY Net Revenue DeclineFY26

    8% to 10% decline

    Mitigation: Maintaining pricing discipline, focusing on volume growth, and preparing for seamless transition to new PSMA PET formulation.

    Competitive Pricing DynamicsFY26

    Modest price erosion

    Mitigation: Company will remain disciplined and not chase business that is not good for long-term value; leveraging operational excellence and supply continuity.

    Lost Interest IncomeFY26

    $9 million headwind

    Mitigation: Optimizing cost structure and focusing on high-return investments to offset financial impact.

    Increased R&D SpendFY26

    200 basis points increase (10-11% of revenue)

    Mitigation: Investments are planned for phase-gated projects, anchored by GRPR diagnostic agent, with expectation of future returns.

    Hatch-Waxman Litigation for PNT2003mid-2026

    Court ruling midyear

    Mitigation: Awaiting court ruling; product remains a natural fit for the portfolio and customer base.

    POSLUMA vs PYLARIFY Study Design ConcernsASCO readout

    Study not powered for statistical significance, no randomization, no truth standard, patients not allowed to void prior to scan

    Mitigation: Management believes the study design is flawed and its results are not factored into PYLARIFY's FY26 forecast.

    What to watch in Q1 FY26

    5

    New PSMA PET Formulation FDA Approval

    March 6, 2026
    CurrentUnder FDA review
    TargetApproval decision

    Why it matters

    This approval is crucial for the company's prostate cancer franchise and its planned transition from PYLARIFY, impacting future revenue growth and market leadership.

    First, our new PSMA PET formulation with a PDUFA date of March 6, offers the same diagnostic properties of PYLARIFY with a similar safety and efficacy profile while delivering manufacturing efficiencies that will immediately improve supply availability.

    Q&A highlights

    5

    Assuming FDA approval for the new PSMA PET agent on March 6, what is the timing for securing coding and transitional pass-through (TPT) reimbursement, and how will the transition from PYLARIFY be managed, especially with long-term contracts?

    Management expects to have the HCPCS code and TPT status in place by October 1, 2026, following a June 1 application for TPT. The operational rollout will be a regional, rolling basis in Q4 2026 to ensure supply continuity and minimize disruption, with significant revenue impact expected in 2027. This approach is informed by prior F-18 product launches.

    “We would anticipate that we would have in place by October 1, our HCPCS code and after having submitted our transitional pass-through application by June 1, that, that will also be in place by October 1. And it's very important that those events precede your commercial entry into the market.”

    asked by Anthony Petrone · answered by Mary Heino

    2 min read5 chapters

    Detailed Narrative

    01

    Strategic Refocus on Radiodiagnostics

    Lantheus is strategically narrowing its focus to innovative PET radiodiagnostics, having completed the divestiture of its legacy SPECT business on January 1, 2026. This shift aims to prioritize investment and commercialization efforts in high-growth areas, leveraging the company's existing nuclear medicine customer base. The company believes this focused approach will deliver sustainable and attractive revenue growth in the mid and long term, optimizing its cost structure to support EPS targets.

    02

    Pipeline Strategy and Value Maximization

    The company has built a broad radiodiagnostic pipeline, including the acquired Neuraceq and OCTEVY, and advanced Lantheus 2401 to Phase III-ready status. While committed to its diagnostic portfolio, Lantheus is pursuing value-maximizing alternatives for its radiotherapeutic assets (excluding PNT2003), recognizing that it cannot advance the entire portfolio internally. This process is expected to take most of 2026, aiming to unlock shareholder value not currently reflected in the stock price or guidance.

    03

    Commercial Execution and Launch Preparedness

    Lantheus is intensely focused on commercial execution and revenue generation from current assets, alongside preparing for multiple upcoming launches. Key to this is ensuring market access, coding, and broad payer coverage are in place before commercial launch, particularly for the new PSMA PET formulation and OCTEVY. The company plans a rolling regional rollout for the new PSMA PET formulation in Q4 2026 to minimize risk and ensure supply continuity, with material impact expected in 2027.

    04

    Neuraceq Growth and Market Opportunity

    Neuraceq, acquired in late July 2025, contributed $31 million in Q4 and is projected for triple-digit inorganic growth in FY26. The growth is driven by expanding the PMF manufacturing network (adding 6 sites in 2026 to the initial 16), increasing penetration in existing accounts, and leveraging relationships with PYLARIFY customers. The expanding Alzheimer's disease PET imaging market, fueled by disease-modifying therapies and guideline changes, presents a significant opportunity for Neuraceq.

    05

    PYLARIFY Performance and Competitive Landscape

    PYLARIFY, the market-leading PSMA PET agent, posted solid Q4 performance with volume up 4% year-over-year, despite a competitive market and pricing concessions in Q2 2025. Management expects PYLARIFY net revenue to decline 8-10% in FY26 due to pricing decisions and potential competitive dynamics as another F-18 agent's pass-through period ends. The company remains disciplined on pricing, refusing to chase business that would erode long-term value.

    AI-generated summary of the company’s earnings call. Not investment advice.