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    LNTH
    Earnings call· Mar 2026(Q1 FY26)

    Lantheus Holdings Q1 FY26 earnings call LNTH

    May 7, 2026 Source

    Executive summary

    Lantheus Q1 FY26 — Strong Start with Key Regulatory Approvals and Reaffirmed FY26 Guidance

    Lantheus delivered a strong Q1 FY26, driven by solid performance across its core products and significant regulatory milestones for PYLARIFY TRUVU and PNT2003. The company reaffirmed its full-year guidance, balancing early-year strength with upcoming competitive dynamics and a CEO transition. Strategic focus remains on radio diagnostics, advancing its late-stage pipeline, and disciplined capital allocation to accelerate growth in 2027.

    Highlights

    5

    • PYLARIFY U.S. volume increased approximately 5.8% year-over-year.

    • NEURACEQ revenue grew 14.3% quarter-over-quarter to $35.4 million.

    • DEFINITY revenue grew 6.8% year-over-year to $84.6 million.

    • FDA approved PYLARIFY TRUVU, a new PSMA PET imaging agent.

    • PNT2003 received tentative FDA approval.

    Concerns

    4

    • PYLARIFY revenue decreased 6.5% year-over-year, impacted by pricing headwinds.

    • Operating profit decreased 10.5% to $129.1 million.

    • Adjusted EPS decreased 4.6% to $1.46.

    • Full-year guidance for revenue and adjusted EPS was reaffirmed despite a strong Q1, implying a step-down in growth for the remainder of the year due to competitive dynamics and CEO transition.

    Guidance & targets

    6
    CategoryTargetConfidence
    Full-year 2026 Revenue
    $1.4 billion to $1.45 billion
    high materiality
    High
    Full-year 2026 Adjusted EPS
    $5 to $5.25
    high materiality
    High
    Full-year 2026 Gross Profit Margin
    65% and 66%
    medium materiality
    Medium
    PSMA PET Market Growth
    low teens
    medium materiality
    High
    PYLARIFY TRUVU Revenue Contribution
    meaningful
    high materiality
    High
    Growth Acceleration
    expected
    high materiality
    High

    Segment performance

    4
    SegmentRevenueYoYQoQMargin
    Oncology
    Consisting of PYLARIFY, revenue decreased year-over-year.
    		$240.9M-6.5%——
    Neurology
    Consisting of NEURACEQ, revenue increased quarter-over-quarter.
    		$35.4M—14.3%—
    Cardiology
    Consisting of DEFINITY, revenue increased year-over-year.
    		$84.6M6.8%——
    Strategic Partnerships and Other
    Revenue increased significantly due to strength of Pharma Solutions portfolio and inclusion of Evergreen CDMO business. MK-6240 represented over half of this revenue.
    		$16.3M52.1%——

    Operational metrics

    21
    Total Revenue (adjusted for divestiture)
    $377.3M8.6% increase YoY
    Q1 FY26

    Total revenue for the quarter, adjusted to exclude the divested spec business.

    Gross Profit Margin
    67.0%flat YoY
    Q1 FY26

    Gross profit margin for the quarter, flat compared to the prior year.

    Operating Expenses as % of Net Revenue
    32.8%455 bps unfavorable YoY
    Q1 FY26

    Operating expenses as a percentage of net revenue, unfavorable compared to the prior period.

    Operating Profit
    $129.1M10.5% decrease
    Q1 FY26

    Operating profit for the quarter.

    Adjusted Net Income
    $95.8M12.5% decrease YoY
    Q1 FY26

    Adjusted net income for the quarter.

    GAAP Fully Diluted EPS
    $1.80
    Q1 FY26

    GAAP fully diluted earnings per share for the quarter.

    Adjusted Fully Diluted EPS
    $1.464.6% decrease
    Q1 FY26

    Adjusted fully diluted earnings per share for the quarter.

    Capital Expenditures
    $3.2M$5.5M less than prior year
    Q1 FY26

    Capital expenditures for the first quarter.

    Cash and Cash Equivalents (net of restricted cash)
    $498.6M
    Q1 FY26

    Cash and cash equivalents balance at the end of Q1 FY26.

    Remaining Share Buyback Authorization
    $200M
    Q1 FY26

    Amount remaining on the Board authorized buyback program.

    Undrawn Bank Revolver Capacity
    $750M
    Q1 FY26

    Available capacity on the undrawn bank revolver.

    Effective Tax Rate
    25.3%
    Q1 FY26

    Effective tax rate for the quarter.

    Gain on Sale of SPC
    $59.3M
    Q1 FY26

    Gain recorded on the sale of the spec business.

    Unrecognized Gain on Equity Investment
    $16.6M
    Q1 FY26

    Unrecognized gain attributed to equity investment in Perspective Therapeutics.

    Noncash Stock and Incentive Plans Expense
    $16.0M
    Q1 FY26

    Expense associated with noncash stock and incentive plans.

    Acquired Intangible Amortization Expense
    $16.7M
    Q1 FY26

    Expense related to acquired intangible amortization.

    Other Acquisition, Integration and Divestiture Costs
    $6.4M
    Q1 FY26

    Costs incurred for acquisition, integration, and divestiture activities.

    Other Nonrecurring Expenses
    $7M
    Q1 FY26

    Remaining nonrecurring expenses.

    NEURACEQ PMF Sites
    22
    Q1 FY26

    Number of PMF sites for NEURACEQ, supporting expanded availability.

    DEFINITY Market Share
    80%
    Q1 FY26

    Market share for DEFINITY, demonstrating its market-leading position.

    PYLARIFY TRUVU Supply from High-Energy Cyclotron PMFs
    70%
    Q1 FY26

    Estimated percentage of current PYLARIFY supply produced at PMF sites equipped with high-energy cyclotrons, indicating readiness for TRUVU.

    Industry KPIs

    8
    MetricValueDetails
    Pricing realized price—
    New product launch ramp—
    Procedure volume growth5.8%%
    FCF conversion leverage guidance$121.9MUSD
    Segment franchise organic growth5.8%%
    Sales force commercial capacity build—
    Indicated addressable patient population—
    Pivotal trial clinical evidence milestones—

    Product announcements

    2
    ProductTypeDetails
    PYLARIFY TRUVUlaunch
    PNT2003launch

    Deals & partnerships

    3
    Spec businessDivestiture of the spec business$25.2M (prior year revenue contribution)

    The spec business was divested on January 1, 2026. Its prior year revenue contribution was $25.2 million.

    Evergreen CDMO businessAcquisition of Evergreen CDMO business

    The Evergreen CDMO business was added, contributing to the Strategic Partnerships and Other segment.

    LMI operationsAcquisition of LMI operations

    The acquisition of LMI operations contributed to increased operating expenses and provided strategic opportunities, particularly for NEURACEQ.

    Risks & headwinds

    5
    Competitive dynamics in PSMA PET marketOngoing, with one competitor losing pass-through later this year (October 1).

    PYLARIFY revenue down 6.5% YoY; net ASP and volume stable sequentially despite ongoing competitive activity.

    Mitigation: Protecting PSMA franchise, disciplined execution, deep customer relationships, and seamless transition to PYLARIFY TRUVU.

    PYLARIFY pricing headwindsOngoing.

    Decrease in PYLARIFY net price.

    Mitigation: Offset by the benefit from the spec divestiture, which was an intentional strategy.

    CEO transitionNear future.

    Not quantified.

    Mitigation: Board's process is progressing well, search narrowed to highly qualified candidates; current leadership remains fully focused on execution.

    PNT2003 launch delays due to Hatch-Waxman stay and legal proceedingsUntil resolution of legal and regulatory issues.

    Tentative FDA approval received, but final launch depends on resolution of 30-month Hatch-Waxman stay and related legal findings.

    Mitigation: Ensuring launch readiness, customer preparedness, and all coding/reimbursement benefits are in place before market entry.

    Actinium regulatory delayUntil June 29, 2026.

    PDUFA date extended by 3 months to June 29, 2026.

    Mitigation: Using the additional time to review manufacturing-related information and advancing launch readiness for a full commercial launch in early 2027.

    What to watch in Q2 FY26

    5

    PYLARIFY TRUVU transition progress

    Q4 2026
    CurrentFDA approved, application for HIC6 code submitted, preparing for TPT.
    TargetInitiation of conversions in Q4 2026, with reimbursement coding and customer systems ready.

    Why it matters

    Successful transition is key to maintaining PSMA PET market leadership and realizing operational advantages of TRUVU.

    With approval secured, we are now executing against our transition plan with meaningful revenue contribution expected in 2027. We have submitted our application for a HIC6 code and are preparing to apply for transitional pass-through status. In parallel, we are working closely with our PMF partners to secure necessary FDA approvals for each manufacturing site ahead of the planned conversion, targeted to begin in the fourth quarter of this year.

    Q&A highlights

    6

    Why was full-year guidance reaffirmed despite a strong Q1 beat? Is it conservatism, competitive caution, or CEO transition? What is the assumed PSMA PET market growth for 2026?

    Management stated that the reaffirmation is due to the early stage of the year, the competitive environment (new products and a competitor losing pass-through in Q4), and prudence given the upcoming CEO transition. They expect PSMA PET market growth for 2026 to be in the low teens, consistent with prior expectations.

    “But it's early in the year. And so we're going to remain vigilant to the market, the competitive environment out there. We still have one competitor who is maybe find some footing with their new products, launch themselves as well as one that will be losing pass-through later this year, call it, October 1. So for us, we're going to -- to your point, we're going to be prudent with this.”

    asked by Richard Newitter · answered by Robert Marshall

    2 min read6 chapters

    Detailed Narrative

    01

    Strategic Focus and Priorities

    Lantheus is strategically centered on radio diagnostics, with clear priorities for 2026. These include maintaining market leadership in PSMA PET through a seamless transition to PYLARIFY TRUVU, building momentum for NEURACEQ by expanding its manufacturing footprint and leveraging existing accounts, and advancing the late-stage clinical portfolio through key regulatory milestones. The company is also focused on disciplined capital allocation, prioritizing radio diagnostics while evaluating alternatives for radiotherapeutic assets.

    02

    PYLARIFY TRUVU Approval and Transition

    The FDA approved PYLARIFY TRUVU, a new PSMA PET imaging agent, on March 6, 2026. This new formulation offers larger batch sizes and enhanced stability, enabling broader geographic reach. Over 70% of current PYLARIFY supply is produced at PMF sites compatible with high-energy cyclotrons. The transition is planned to begin in Q4 2026, contingent on securing reimbursement coding (HCPCS and transitional pass-through status) and ensuring customer and payer system readiness, with meaningful revenue contribution expected in 2027.

    03

    Pipeline Advancement

    Lantheus is advancing several key pipeline programs. MK-6240, a registrational stage tau-targeted PET radio diagnostic for Alzheimer's disease, has a PDUFA date of August 13, 2026, and is widely used in 17 pharma-sponsored AD therapeutic programs. Lantheus 2401, a GRPR-targeted PET radio diagnostic for prostate cancer, is progressing towards its registrational program this year, offering a differentiated target to complement PSMA PET imaging.

    04

    PNT2003 Tentative Approval and Launch Outlook

    PNT2003, the first radio equivalent to Lutathera for Gep/NET, received tentative FDA approval on March 2, 2026. This confirms the FDA's substantive review is complete and the application meets approval requirements. Final approval and launch timing are dependent on the expiration or resolution of the 30-month Hatch-Waxman stay, related legal proceedings, and ensuring comprehensive launch readiness, including coding and reimbursement. A full commercial launch is targeted for early 2027.

    05

    NEURACEQ Growth and Expansion

    NEURACEQ, the company's beta amyloid PET imaging agent, generated $35.4 million in Q1 revenue, representing 14.3% growth QoQ. This growth is driven by increased utilization within existing accounts, supported by broader adoption of Alzheimer's disease-modifying therapies and clinical guidelines favoring earlier diagnostic use. Lantheus is expanding its NEURACEQ PMF footprint to 22 sites to drive execution and incremental growth, leveraging its nuclear medicine relationships.

    06

    Financial Performance and Capital Allocation

    Lantheus reported Q1 revenue of $377.3 million, an increase of 1.2% YoY, or 8.6% when adjusted for the spec business divestiture. Operating cash flow totaled $125.1 million, and free cash flow was $121.9 million. The company ended the quarter with $498.6 million in cash and equivalents, $200 million remaining on its share buyback program, and access to a $750 million undrawn bank revolver. Capital allocation prioritizes radio diagnostics and strategic investments.

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