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Introduction & Market Context
Biogen Inc (NASDAQ:BIIB) reported its first quarter 2025 financial results on May 1, 2025, showing a 6% year-over-year revenue increase to $2.4 billion, driven by strong performance from its newer launch products. Despite this quarterly growth, the company maintained its outlook for a mid-single-digit revenue decline for the full year 2025, while adjusting its earnings guidance to reflect recent business development activities.
The biotech company continues its strategic transformation, balancing its traditional focus on neurological disorders with an expanding immunology portfolio, while demonstrating momentum in key launch products across Alzheimer’s disease and rare disorders.
Quarterly Performance Highlights
Biogen reported Q1 2025 total revenue of $2.4 billion, representing a 6% increase year-over-year (8% at constant currency). The company posted GAAP diluted EPS of $1.64 and Non-GAAP diluted EPS of $3.02, with both figures impacted by a $0.95 per share charge related to the $165 million upfront payment to Stoke Therapeutics (NASDAQ:STOK) for the zorevunersen collaboration.
As shown in the following revenue breakdown, the company’s growth was primarily driven by rare disease products and contract manufacturing revenue, which offset declines in multiple sclerosis products:
Free cash flow for the quarter reached $222 million, which includes the impact of the Stoke Therapeutics transaction. The company maintained a solid balance sheet with $2.6 billion in cash and $3.7 billion in net debt as of March 31, 2025.
The following slide summarizes Biogen’s key financial metrics for the quarter:
Launch Products Building Momentum
A key highlight of Biogen’s Q1 results was the strong performance of its newer launch products, which collectively generated $200 million in revenue, representing 105% growth year-over-year and 22% growth quarter-over-quarter.
LEQEMBI, Biogen’s treatment for early Alzheimer’s disease developed in collaboration with Eisai, showed particularly impressive growth with Q1 worldwide in-market sales of $96 million, up 395% year-over-year and 11% quarter-over-quarter. The product received marketing authorization in the European Union in April, expanding its global reach.
SKYCLARYS, Biogen’s treatment for Friedreich ataxia, delivered Q1 worldwide sales of $124 million, increasing 59% year-over-year and 21% quarter-over-quarter. The product received new approvals in the UK and Brazil in April, further expanding its geographic footprint.
ZURZUVAE for postpartum depression generated Q1 sales of $28 million, growing 123% year-over-year and 21% quarter-over-quarter, with over 10,000 women treated since launch.
The following slide details the performance of these key launch products:
The SKYCLARYS launch continues to gain traction globally, with approximately 2,400 patients on therapy as of March 2025, as illustrated in this patient growth chart:
Pipeline Transformation Strategy
Biogen highlighted its strategic pipeline transformation, which has evolved from being predominantly focused on neurology (94% of pipeline in 2022) to a more balanced portfolio with increased presence in immunology (37% of pipeline in 2025 versus 6% in 2022). Additionally, the company has increased the proportion of Phase 3 programs with established proof-of-concept from 54% in 2022 to 86% in 2025.
This strategic shift is illustrated in the following slide:
The company’s pipeline now includes several high-conviction late-stage programs across neurology and immunology, including BIIB080 for early Alzheimer’s disease (which received FDA Fast Track designation), litifilimab for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), dapirolizumab pegol for SLE, felzartamab for antibody-mediated rejection (AMR) and other indications, and zorevunersen for Dravet syndrome.
The following slide details Biogen’s high-conviction late-stage pipeline:
A notable addition to Biogen’s pipeline is zorevunersen for Dravet syndrome, acquired through the collaboration with Stoke Therapeutics. This antisense oligonucleotide (ASO) is designed to increase NaV1.1 protein expression and has shown promising results in early clinical studies, with potential to be the first disease-modifying therapy for this rare neurological disorder.
Financial Outlook and Guidance
Biogen updated its full-year 2025 Non-GAAP diluted EPS guidance to $14.50-$15.50, compared to the previous guidance of $15.25-$16.25. This adjustment reflects the approximately $0.95 per share impact from the Stoke Therapeutics upfront payment, partially offset by a $0.20 benefit primarily from favorable foreign exchange trends.
The company maintained its expectation for a mid-single-digit percentage revenue decline at constant currency for full-year 2025 versus 2024, primarily due to anticipated declines in multiple sclerosis product revenue, partially offset by growth from launch products.
The following slide summarizes the updated guidance:
Biogen remains on track with its "Fit for Growth" initiative, expecting to deliver $1 billion in gross savings and $800 million in net savings by the end of 2025, with full-year 2025 operating expenses projected at approximately $3.9 billion.
Future Milestones and Catalysts
Looking ahead, Biogen outlined several key milestones expected over the next 18 months, including four Phase 3 study initiations, three clinical trial readouts, and three regulatory decisions.
Notable upcoming events include the initiation of the Phase 3 study for zorevunersen in Dravet syndrome, the Phase 2 readout for BIIB080 in early Alzheimer’s disease, and regulatory decisions for LEQEMBI’s subcutaneous formulation with autoinjector.
The following slide details these expected milestones:
In the Alzheimer’s disease space, Biogen is pursuing a multi-faceted strategy that includes expanding approvals and enhancing the convenience of LEQEMBI, evaluating LEQEMBI in presymptomatic Alzheimer’s disease through the AHEAD 3-45 study, and advancing next-generation therapies such as BIIB080, an ASO targeting tau.
With its evolving pipeline, strong launch product momentum, and strategic focus on high-growth therapeutic areas, Biogen is positioning itself for future growth despite near-term revenue challenges in its established multiple sclerosis franchise.
Full presentation:
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