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    BIIB
    Earnings call· Dec 2025(Q4 FY25)

    BIOGEN Q4 FY25 earnings call BIIB

    Feb 6, 2026 Source

    Executive summary

    Biogen Q4 FY25 — Pipeline Transformation and Growth Product Momentum

    Biogen concluded FY25 above guidance, driven by strong performance from growth products and new launches, which collectively generated approximately $4.3 billion. The company is actively transforming its pipeline, accelerating key Phase III readouts for litifilimab and felzartamab, and expanding its early-stage portfolio. Despite anticipated mid-single-digit revenue decline in 2026 due to MS erosion, Biogen is strategically investing in future launches and maintaining financial discipline to bridge to long-term growth.

    Highlights

    5

    • Growth products generated $3.3 billion in fiscal 2025, up 19% year-over-year.

    • New launches (LEQEMBI, SKYCLARYS, ZURZUVAE, QALSODY) generated around $1 billion in revenue in fiscal 2025.

    • LEQEMBI maintains market leadership with over 60% of the anti-amyloid therapy market share.

    • ZURZUVAE sales more than doubled in 2025, highlighting significant unmet need in postpartum depression.

    • Full year 2025 non-GAAP diluted EPS was $15.28, slightly above the upper end of guidance.

    Concerns

    5

    • Total revenue is expected to decline by a mid-single-digit percentage for 2026 compared to 2025.

    • MS products, excluding VUMERITY, are expected to decline by a mid-teen percentage in 2026 due to competitive pressures.

    • SKYCLARYS Q4 U.S. revenue benefited from a $9 million favorable inventory build, expected to be drawn down in Q1 2026.

    • SKYCLARYS Q4 ex-U.S. revenue was negatively impacted by $12 million in net pricing adjustments.

    • LEQEMBI IQLIK (subcutaneous) is not fully reimbursed until January 1, 2027, requiring formulary exemptions for patients.

    Guidance & targets

    7
    CategoryTargetConfidence
    Non-GAAP diluted EPS
    $15.25 to $16.25
    high materiality
    High
    Total revenue growth
    decline by a mid-single-digit percentage
    high materiality
    High
    MS products revenue growth (excluding VUMERITY)
    decline by a mid-teen percentage
    medium materiality
    High
    Contract manufacturing revenue
    roughly $300 million in each half
    low materiality
    High
    Gross margin
    roughly consistent with 2025
    medium materiality
    High
    Core Operating Expenses (OpEx)
    roughly consistent with 2025
    medium materiality
    High
    Q1 expense growth
    roughly 10% higher than Q1 of last year
    low materiality
    High

    Operational metrics

    34
    Growth Products Revenue
    $3.3 billionup 19%
    FY25

    Includes VUMERITY, LEQEMBI, SKYCLARYS, ZURZUVAE, QALSODY.

    New Launches Revenue
    $1 billiongrown very strongly
    FY25

    Products launched since 2023, including LEQEMBI, SKYCLARYS, ZURZUVAE, QALSODY.

    MS Business Revenue
    $3 billion
    FY25

    Excludes VUMERITY, which is now included in growth products.

    Non-GAAP diluted EPS
    $1.99
    Q4 2025

    Reflected $222 million of IPR&D charges, a $1.26 impact on EPS.

    Non-GAAP diluted EPS
    $15.28
    FY25

    Slightly above the upper end of guidance.

    IPR&D charges
    $222 million
    Q4 2025

    For Q4 business development transactions, including license agreements with Vanqua Bio, Dayra Therapeutics and acquisition of Alcyone Therapeutics.

    GAAP operating income impact
    $180 million
    Q4 2025

    One-time charges relating to litigation and other matters.

    Total Revenue
    $9.9 billionup 2% versus 2024
    FY25

    Full year 2025 total revenue.

    Cash and marketable securities
    $4.2 billion
    end of FY25

    Strengthened balance sheet.

    Net Debt
    $2 billion
    end of FY25

    At the close of fiscal year 2025.

    Growth Products Revenue
    $800 millionup 6%
    Q4 2025

    Q4 2025 revenue, up 6% versus Q4 2024.

    LEQEMBI in-market sales (Eisai)
    $134 millionup 10% vs Q3 2025 and 54% vs Q4 2024
    Q4 2025

    Steady sequential demand growth globally.

    SKYCLARYS global revenue
    $133 million30% growth year-over-year
    Q4 2025

    Sequential global patient demand growth.

    SKYCLARYS U.S. revenue
    $89 millionsequential growth of $14 million
    Q4 2025

    Benefited from favorable inventory dynamics, expected to be drawn down in Q1 2026.

    SKYCLARYS ex U.S. net pricing adjustments
    $12 million
    Q4 2025

    Negative impact from net pricing adjustments in Q4, related to 2 countries in Europe and a one-time item.

    SPINRAZA global revenue
    $356 million
    Q4 2025

    Q4 2025 global revenue.

    SPINRAZA U.S. revenue
    $169 milliongrowth year-over-year
    Q4 2025

    Q4 2025 U.S. revenue.

    SPINRAZA ex U.S. revenue
    $188 million
    Q4 2025

    Q4 2025 ex U.S. revenue, impacted by timing of shipments.

    SPINRAZA full year revenue growth
    down 2%year-over-year
    FY25

    Demonstrated resilience in a competitive market.

    VUMERITY revenue
    $181 million
    Q4 2025

    Driven by steady year-over-year demand growth, boosted by improved affordability in the U.S. with the IRA Part D redesign. Q4 U.S. revenue negatively impacted by timing of shipments associated with favorable inventory build from Q3.

    VUMERITY full year revenue
    $747 million19% year-over-year growth
    FY25

    Full year 2025 revenue.

    TYSABRI global revenue
    $398 million
    Q4 2025

    Demonstrating continued resilience.

    TYSABRI U.S. revenue
    $244 million
    Q4 2025

    Q4 2025 U.S. revenue.

    TYSABRI ex U.S. revenue
    $153 million
    Q4 2025

    Q4 2025 ex U.S. revenue, where biosimilar competition for IV formulation in EU was partially offset by continued demand growth for subcutaneous formulation.

    Anti-CD20 therapeutic programs revenue
    $521 millionup 12% year-over-year
    Q4 2025

    Driven largely by royalties from OCREVUS, which benefited from the subcutaneous launch.

    Non-GAAP R&D expense change
    decreased 6%vs Q4 2024
    Q4 2025

    Primarily driven by continued cost reduction measures from portfolio prioritization and Fit for Growth program, offset by investment in Phase III clinical programs (felzartamab and litifilimab).

    Non-GAAP R&D expense change
    decreased 10%vs FY24
    FY25

    Primarily driven by continued cost reduction measures from portfolio prioritization and Fit for Growth program, offset by investment in Phase III clinical programs (felzartamab and litifilimab).

    SG&A change
    up roughly 1%vs 2024
    Q4 and FY25

    Driven primarily by planned prelaunch activities supporting lupus and nephrology and direct-to-consumer advertising for LEQEMBI and VUMERITY.

    Alzheimer's new patients diagnosed
    500,000
    annual

    Approximately 500,000 new patients diagnosed with Alzheimer's every year.

    Neurologists
    13,000
    current

    Approximately 13,000 neurologists available to treat Alzheimer's patients.

    LEQEMBI persistency
    70%
    current

    Persistency data suggests about 70% of patients continue with therapy after the plaque removal phase.

    Blood-based diagnostics utilization (Alzheimer's)
    10% to 15%expected to grow
    current

    Percentage of neurologists using blood-based diagnostics to validate diagnosis, expected to increase.

    Postpartum depression mothers suffering
    0.5 million
    annual

    Approximately 0.5 million mothers suffer from postpartum depression every year.

    Postpartum depression mothers diagnosed
    80,000
    annual

    Approximately 80,000 mothers are diagnosed with postpartum depression annually, with fewer treated with ZURZUVAE.

    Industry KPIs

    10
    MetricValueDetails
    Capital deployment$4.2 billionUSD
    Launch access metrics—
    Patent cliff loe bridge—
    Pipeline read out calendar10units
    Product franchise net sales—
    Regulatory approvals filings—
    Therapeutic drug market share60%%
    Prescription volume new starts60%%
    Clinical trial efficacy safety data—
    Collaboration milestone royalty revenue—

    Product announcements

    1
    ProductTypeDetails
    LEQEMBI IQLIKlaunch

    Deals & partnerships

    3
    Alcyone Therapeuticsacquisition

    Acquisition to improve the experience of patients who get intrathecal injections, potentially replacing intrathecal with a more convenient delivery mechanism (e.g., for SPINRAZA).

    Vanqua Biocollaboration

    New collaboration in Q4 2025.

    Dayra Therapeuticscollaboration

    New collaboration in Q4 2025.

    Risks & headwinds

    7
    Competitive pressures and generic erosion in MS marketFull year 2026

    Full year revenue for MS products (excluding VUMERITY) to decline by a mid-teen percentage versus 2025.

    Mitigation: Strong market share for TYSABRI brand, strong patient services organization, growth products offsetting some decline.

    Accelerated generic erosion of TECFIDERA in the EU2026

    Expected to continue in 2026.

    Introduction of biosimilar for TYSABRIStarting end of 2025

    Early days, unable to determine erosion.

    Mitigation: Optimistic about maintaining strong market share for TYSABRI brand due to physician belief and patient services.

    Favorable inventory build for SKYCLARYS U.S. revenueQ1 2026

    $9 million

    Mitigation: Expected to be drawn down in Q1 2026.

    Net pricing adjustments impacting SKYCLARYS ex-U.S. revenueQ4 2025

    $12 million

    Mitigation: One-time item related to 2 countries in Europe.

    Lack of full Part D reimbursement for LEQEMBI IQLIKUntil 2027

    Not fully reimbursed until 1/1/27.

    Mitigation: Patients can request formulary exemptions, and virtually everyone asking seems to be getting it.

    Pricing challenges for ZURZUVAE in EuropeOngoing

    Initial pricing assessments didn't make sense.

    Mitigation: Highly selective rollout in 3-4 countries, not pan-European, due to pricing questions and MFN environment.

    Q&A highlights

    8

    How to think about the cadence of LEQEMBI sales growth, considering maintenance and the IQLIK, and its impact on revenue?

    Chris Viehbacher indicated a 70% persistency for LEQEMBI maintenance, with most patients on monthly infusion. The subcutaneous pen is seeing progressive uptake despite lack of full reimbursement. He expects continued sequential linear growth, with potential acceleration in H2 2026 or 2027, especially if the IQLIK for induction is approved and fully reimbursed by payers in 2027. Increased use of blood-based diagnostics is also aiding patient identification.

    “I think you're going to continue to see, as I said, that linear growth pattern. But I think we're also seeing some very strong response to direct-to-consumer advertising.”

    asked by Alexandria Hammond · answered by Christopher Viehbacher

    2 min read5 chapters

    Detailed Narrative

    01

    Pipeline Transformation and Future Growth

    Biogen has significantly expanded and transformed its development pipeline, moving from a limited late-stage portfolio to 10 Phase III programs. This includes new high scientific conviction opportunities with significant commercial potential, balanced with early-stage high-risk, high-reward assets. The company anticipates a multiyear registrational data flow starting in 2026, with key readouts expected for litifilimab in SLE and CLE, and felzartamab in AMR.

    02

    LEQEMBI Market Leadership and IQLIK Potential

    LEQEMBI continues to lead the anti-amyloid therapy market with over 60% share, driven by its maintenance indication and strong persistency data (70%). The upcoming FDA decision for the LEQEMBI IQLIK (subcutaneous) for induction in May 2026 is seen as a potential game-changer, aiming to reduce the burden on neurologists and patients, especially those in rural areas, and potentially accelerating market growth in 2027 with full reimbursement. Increased use of blood-based diagnostics is also aiding patient identification.

    03

    Growth Products Momentum

    Products launched since 2023 (LEQEMBI, SKYCLARYS, ZURZUVAE, QALSODY) generated approximately $1 billion in revenue, demonstrating strong growth. VUMERITY, now included in growth products, also saw 19% year-over-year growth in FY25. SPINRAZA's high-dose launch in Japan is exceeding expectations, with a U.S. PDUFA date in April, and ZURZUVAE sales more than doubled in 2025, highlighting a significant unmet need in postpartum depression.

    04

    Strategic Investments and Financial Discipline

    Despite expected mid-single-digit revenue decline in 2026 due to MS erosion, Biogen is strategically investing in prelaunch activities for its lupus and nephrology portfolio. The company aims to keep core OpEx consistent with 2025, focusing on building capabilities in new therapeutic areas while maintaining financial discipline and robust cash flow generation, ending FY25 with $4.2 billion in cash and marketable securities.

    05

    Early-Stage Pipeline Expansion

    Biogen is actively broadening its early-stage pipeline through internal research and business development. Recent additions include a BTK degrader (BIIB145) entering Phase I and collaborations with Vanqua and Dayra Therapeutics. The company is also exploring new modalities like an anti-tau ASO and aims to add more INDs over the next 18 months, particularly in immunology, while maintaining focus on ALS and Alzheimer's.

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