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    BIIB
    Earnings call· Mar 2025(Q1 FY25)

    BIOGEN Q1 FY25 earnings call BIIB

    May 1, 2025 Source

    Executive summary

    Biogen Q1 FY25 — Strong Launch Product Growth and Pipeline Advancement

    Biogen delivered a strong Q1 FY25, showcasing significant growth in its new launch products like LEQEMBI, ZURZUVAE, and SKYCLARYS, which now constitute 45% of product revenue. The company is actively diversifying its pipeline beyond neuroscience into immunology and rare diseases, with multiple Phase III initiations and key regulatory milestones. While the legacy MS portfolio continues to decline due to competition, Biogen maintains a strong balance sheet and is strategically pursuing external innovation to drive future growth.

    Highlights

    5

    • Launch products generated $200M in revenue in Q1 FY25, increasing 22% QoQ and more than doubling YoY.

    • LEQEMBI sales reached $96M in Q1 FY25, with marketing authorization obtained in the EU.

    • SKYCLARYS global sales were $124M, up 59% YoY and 21% QoQ, with 2,400 patients on therapy globally.

    • ZURZUVAE Q1 sales of $28M, having treated 10,000 women with PPD since launch, with 80% of Q1 scripts from OB/GYNs.

    • Pipeline advanced with 5 Phase III studies initiating this year, including felzartamab in AMR, IgAN, and PMN, and FDA Fast Track designation for BIIB080.

    Concerns

    4

    • MS franchise global product revenue declined 11% YoY due to competition from TYSABRI biosimilars in Europe and TECFIDERA generics globally.

    • Full-year 2025 total revenue is expected to decline by a mid-single-digit percentage, driven by an increased decline in the MS business.

    • Non-GAAP diluted EPS was $3.02, down 18% YoY, impacted by a $165M upfront payment for the Stoke transaction.

    • A potential biosimilar entry for TYSABRI in the U.S. is expected in Q4 FY25.

    Guidance & targets

    10
    CategoryTargetConfidence
    Full-year 2025 Non-GAAP diluted EPS
    $14.50 to $15.50
    high materiality
    High
    Full-year 2025 Total Revenue
    decline by a mid-single-digit percentage
    high materiality
    High
    Full-year 2025 Corporate Partner Revenue
    roughly consistent
    medium materiality
    High
    Q4 FY25 Corporate Partner Revenue
    minimal
    low materiality
    High
    Launch Products Revenue Growth
    sequential revenue growth
    medium materiality
    High
    MS Business Revenue Decline
    steeper than launch product growth
    medium materiality
    High
    TYSABRI U.S. Biosimilar Entry
    potential entry
    medium materiality
    High
    TECFIDERA Generics in Europe
    further impacts
    medium materiality
    High
    Fit for Growth Initiative Savings
    $1B gross savings and $800M net savings
    medium materiality
    High
    Tariff Impact
    no material impact
    high materiality
    High

    Segment performance

    7
    SegmentRevenueYoYQoQMargin
    MS Franchise
    Driven primarily by competition, including biosimilar for TYSABRI in Europe and generic competition for TECFIDERA globally. Generics for TECFIDERA have launched in certain European countries.
    TYSABRI biosimilar impact in EuropeTECFIDERA generic competition globally
    		—declined 11%——
    VUMERITY
    Saw an increase in demand and remains the #1 branded oral therapy.
    Increase in demand#1 branded oral therapy
    		————
    SPINRAZA
    Continued consistency in demand globally, with 4% growth in the U.S. Ex-U.S. revenue benefited by $26M from a onetime VAT refund and timing of shipments.
    Consistency in demand globally
    		—4% in U.S.——
    Launch Products (LEQEMBI, ZURZUVAE, SKYCLARYS, QALSODY)
    Combined revenue for the four launch products.
    		$200Mmore than doubling22%—
    LEQEMBI
    Global in-market sales booked by Eisai. Marketing authorization obtained in the EU, recognized by all major regulators.
    EU marketing authorization obtained
    		$96M—11% sequentially—
    ZURZUVAE
    Continues to do nicely, with 10,000 women treated for PPD since launch. Majority of prescriptions are first-line therapy, with OB/GYNs being key prescribers. Physician base expanded by 20% in Q1.
    10,000 women treated since launch80% of Q1 scripts from OB/GYNs20% expansion in prescribing physicians in Q1
    		$28M—sequentially growing—
    SKYCLARYS
    Global sales up significantly. U.S. revenue was $69M, impacted by Medicare discount dynamics, partially offset by demand growth. Strong patient growth and geographic expansion.
    2,400 patients on therapy globallyAvailable in 26 marketsBrazil approval
    		$124M59%21%—

    Operational metrics

    19
    Product revenue from new products
    45%
    Q1 FY25

    Commercial portfolio of rare disease, AD, ZURZUVAE, and VUMERITY.

    U.S. product revenue from U.S. manufacturing
    75%
    FY24

    Attributable to products that already have manufacturing operations in the U.S., relevant for tariff exposure.

    Product revenue from ex-U.S. countries
    55%
    FY24

    Approximately 55% of 2024 product revenue came from countries outside the U.S., indicating diversification.

    Industry US product revenue range
    60% to 80%
    general

    In most of this industry, what you see is 60% to 80% of product revenues come from the U.S. Biogen is a whole lot more diversified.

    Non-GAAP diluted EPS
    $3.02down 18% YoY
    Q1 FY25

    Includes $165M upfront paid for Stoke transaction, impacting EPS by $0.95.

    Non-GAAP diluted EPS (ex-Stoke impact)
    $3.97up 8% YoY
    Q1 FY25

    Excluding the $165M upfront payment for Stoke transaction.

    Cash balance
    $2.6B
    Q1 FY25 end

    As of the end of the quarter.

    Net debt
    $3.7B
    Q1 FY25 end

    As of the end of the quarter.

    SPINRAZA ex-U.S. revenue benefit
    $26Mvs Q1 FY24
    Q1 FY25

    Benefit from a onetime VAT refund and timing of shipments in certain markets.

    Acquired in-process R&D charges
    $201M
    Q1 FY25

    Will be broken out in a separate P&L line item going forward for better transparency.

    Non-GAAP operating income (ex-acquired IPR&D)
    $748Mup 7% YoY
    Q1 FY25

    Excluding the $165M upfront payment for Stoke transaction.

    EPS impact from Stoke transaction
    $0.95
    Q1 FY25

    Impact from the $165M upfront payment.

    EPS tailwind from FX
    $0.20
    FY25

    Reflected in updated full-year EPS guidance.

    ZURZUVAE prescribing physicians expansion
    20%
    Q1 FY25

    Expansion in the number of physicians writing repeat prescriptions.

    Dravet syndrome patients with seizures despite treatment
    more than 90%
    current

    More than 90% of patients continue to experience seizures despite treatment with best available antiseizure medicines.

    Zorevunersen seizure reduction
    87%on top of standard of care
    Phase I/IIa

    Observed in Phase I/IIa study, durable out to 6 months.

    LEQEMBI low tau patients stable
    70%
    6 months

    Demonstrated stability after 6 months of treatment for early-stage patients.

    LEQEMBI low tau patients improved
    60%
    6 months

    Demonstrated some level of improvement after 6 months of treatment for early-stage patients.

    New research collaborations target
    4 to 5
    FY25

    Goal for the year, focusing on preclinical stage.

    Industry KPIs

    4
    MetricValueDetails
    Pipeline read out calendar5 Phase III studies initiatingstudies
    Regulatory approvals filingsLEQEMBI EU marketing authorization; SKYCLARYS U.K. and Brazil approvals; BIIB080 FDA Fast Track designation
    Clinical trial efficacy safety data87% seizure reduction%
    Cumulative patients uptake since launch10,000 womenpatients

    Deals & partnerships

    1
    Stoke TherapeuticsAcquired rights to Zorevunersen in Dravet syndrome for all territories outside the United States, Canada, and Mexico.$165M upfront payment

    Partnership to advance the Phase III EMPEROR study for Zorevunersen in Dravet syndrome.

    Risks & headwinds

    5
    Increased competition in MS franchiseQ1 FY25, ongoing

    Global product revenue declined 11% YoY

    Mitigation: Defending IP for TECFIDERA, focusing on VUMERITY growth and new launch products.

    Generic competition for TECFIDERA in EuropeOngoing in 2025

    Generics launched in certain countries (e.g., France, Netherlands)

    Mitigation: Vigorously defending IP, but further impacts expected.

    Potential biosimilar entry for TYSABRI in the U.S.Q4 FY25

    Expected Q4 FY25

    Uncertainty in U.S. and international tariff landscapeOngoing

    Potential retaliatory tariffs from China

    Mitigation: No material impact expected in 2025 due to U.S. manufacturing footprint and global inventory position; guidance does not contemplate new tariffs.

    Challenging launch for LEQEMBI due to physician workloadOngoing

    Workload for treating physicians

    Mitigation: Innovations like IV maintenance, subcutaneous formulations (maintenance and initiation), and blood-based biomarkers are expected to reduce workload.

    What to watch in Q2 FY25

    5

    LEQEMBI subcutaneous maintenance approval

    August
    CurrentUnder regulatory review
    TargetApproval decision

    Why it matters

    This approval will enable at-home administration, significantly improving patient convenience and potentially accelerating LEQEMBI uptake by reducing the burden on infusion centers and caregivers.

    Then we're going to make that even easier for physicians with hopefully💬 an approval in August for the subcutaneous formulation, and that offers the potential of at-home administration with an auto-injector.

    Q&A highlights

    6

    What is the rollout strategy for LEQEMBI in Europe, and what is the outlook for reimbursement given the thorough approval process?

    The EU approval process was extensive, which should aid reimbursement discussions. Launch will be market-by-market, with some countries moving faster. As a first-in-class product, it's an incremental budget add, which can be challenging, but the deep evaluation by EU countries should ultimately be beneficial.

    “The fact that the approval took a while tells you that there's an awful lot of thought going into that.”

    asked by Brian Abrahams · answered by Christopher Viehbacher

    2 min read5 chapters

    Detailed Narrative

    01

    Shifting Portfolio Dynamics

    Biogen is transitioning from a primarily MS-focused company to a diversified entity with growing contributions from rare disease and Alzheimer's treatments. New products like LEQEMBI, ZURZUVAE, and SKYCLARYS now account for 45% of product revenue and are expected to drive long-term growth. This shift is aimed at offsetting the gradual decline in the legacy MS portfolio due to increasing competition.

    02

    LEQEMBI Launch Acceleration and Future Catalysts

    The company anticipates significant catalysts for LEQEMBI, including the recent EU marketing authorization, which validates its efficacy and safety globally. Upcoming innovations like the approval of IV maintenance (reducing dosing to once monthly after 18 months) and subcutaneous formulations for maintenance (expected August) and initiation (expected H1 next year) are designed to reduce physician workload and improve patient convenience. These advancements are crucial for expanding market access and uptake, particularly in rural settings, and are expected to establish LEQEMBI as a long-term chronic therapy.

    03

    Pipeline Diversification and Maturation

    Biogen is strategically balancing its pipeline between neuroscience and immunology, with 5 Phase III studies initiating this year. This includes felzartamab in AMR, IgAN, and PMN, and the acquisition of rights to Zorevunersen for Dravet syndrome outside North America. Zorevunersen showed compelling Phase I/IIa data with 87% seizure reduction, durable to 76% at 6 months, and improvements in cognition and behavior, positioning it as a potential first disease-modifying therapy. The company aims for a sustainable pipeline with increased data flow and expected registrational data starting next year.

    04

    Tariff Exposure Mitigation and Financial Strength

    Biogen believes it is structurally less exposed to potential U.S. tariffs than some peers, with 75% of 2024 U.S. product revenue from products manufactured in the U.S. and 55% of total product revenue from outside the U.S. The company does not expect a material impact on its 2025 financial outlook from currently announced tariffs, even if pharmaceutical exemptions are removed. Biogen ended Q1 FY25 with $2.6B in cash and $3.7B in net debt, maintaining a strong balance sheet for internal and external growth opportunities.

    05

    Research Strategy and Collaborations

    Biogen is restructuring its research efforts to focus on early-stage collaborations, aiming for 4-5 new research partnerships this year. This strategy emphasizes cost-effective preclinical collaborations to augment the pipeline. The company plans to host thematic seminars, starting June 11, to provide deeper educational dives into pipeline assets and disease areas like AMR, leveraging internal expertise to engage investors.

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