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Biogen Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 6 February 2026: press release. Guidance figures: 2 new. The quarter’s numbers.

Key takeaways

  • Fourth quarter revenue and EPS declined: Fourth quarter total revenue was $2.3 billion, down 7% year-over-year. GAAP diluted EPS was $(0.33) against $1.83 a year earlier. Non-GAAP diluted EPS was $1.99 against $3.44. Source
  • Growth products offset MS decline: Full year revenue from growth products rose 19%, offsetting the decline in multiple sclerosis product revenue. Growth products are SKYCLARYS, QALSODY, ZURZUVAE, VUMERITY, SPINRAZA and Biogen's 50% share of LEQEMBI. Source
  • MS product revenue declined: Multiple sclerosis product revenue fell 14% in the fourth quarter to $917 million and 7% for the full year to $4,039 million. Source
  • Cost of sales ratio improved on mix: Non-GAAP cost of sales fell to 20% of total revenue in the fourth quarter from 22%, and to 21% for the full year from 22%, driven primarily by favorable product mix. Source
  • Litifilimab gains Breakthrough designation: FDA granted Breakthrough Therapy Designation for litifilimab in cutaneous lupus, which the company describes as a disease with no targeted treatment options. Source
  • LEQEMBI IQLIK under Priority Review: FDA granted Priority Review for LEQEMBI IQLIK subcutaneous treatment initiation. Regulatory filings are under review in Japan and China. Source
  • Fourth quarter free cash flow reported: Fourth quarter operating cash flow was about $512 million and capital expenditure about $44 million, giving free cash flow of about $468 million. Source
  • Full year free cash flow reported: Full year operating cash flow was about $2.2 billion and capital expenditure about $154 million, giving free cash flow of about $2.1 billion. Source

“These milestones highlight both the innovative and differentiated value of our medicines and the strength of our late-stage pipeline.”

President and Chief Executive Officer Christopher A. Viehbacher

Guidance

AreaPeriodFigureAgainst last quarter
Non-GAAP diluted EPS Sourcefull year 2026$15.25 to $16.25New
Non-GAAP effective tax rate Sourcefull year 2026between approximately 17% and 18%New

What changed from last quarter

  • New guidance: Full year 2026 financial guidance was given in this release, covering Non-GAAP diluted EPS, total revenue direction, gross margin, combined R&D and SG&A, and tax rate. Source
  • New: FDA granted Breakthrough Therapy Designation for litifilimab in cutaneous lupus. Source
  • New: The BTK degrader BIIB145, aimed at autoimmune diseases, started a Phase 1 study in healthy volunteers. Source
  • New: FDA granted Priority Review for LEQEMBI IQLIK subcutaneous treatment initiation. Source

Results and growth drivers

  • Fourth quarter revenue and EPS declined: Fourth quarter total revenue was $2.3 billion, down 7% year-over-year. GAAP diluted EPS was $(0.33) against $1.83 a year earlier. Non-GAAP diluted EPS was $1.99 against $3.44. Source
  • Full year revenue rose, GAAP EPS fell: Full year total revenue was $9.9 billion, up 2% year-over-year. Full year GAAP diluted EPS was $8.79, down 21% from $11.18. Source
  • Growth products offset MS decline: Full year revenue from growth products rose 19%, offsetting the decline in multiple sclerosis product revenue. Growth products are SKYCLARYS, QALSODY, ZURZUVAE, VUMERITY, SPINRAZA and Biogen's 50% share of LEQEMBI. Source
  • Anti-CD20 program revenue grew: Revenue from anti-CD20 therapeutic programs rose 12% in the fourth quarter to $521 million and 6% for the full year to $1,861 million. Source

Product and segment revenue

  • MS product revenue declined: Multiple sclerosis product revenue fell 14% in the fourth quarter to $917 million and 7% for the full year to $4,039 million. Source
  • Rare disease grew for the year: Rare disease revenue was $2,154 million for the full year, up 8%. Fourth quarter rare disease revenue was $515 million, down 4%. Source
  • Biosimilars revenue declined: Biosimilars revenue fell 16% in the fourth quarter to $170 million and 8% for the full year to $729 million. Source
  • Other product revenue rose sharply: Other product revenue, which includes ZURZUVAE and ADUHELM, rose 157% in the fourth quarter to $66 million and 139% for the full year to $197 million. Source
  • Alzheimer's collaboration revenue grew: Alzheimer's collaboration revenue, Biogen's 50% share of LEQEMBI net revenue and cost of sales including royalties, was $47 million in the fourth quarter, up 77%. Source

“This multi-year registrational data flow has the potential to drive meaningful innovation for patients and long-term value for shareholders.”

President and Chief Executive Officer Christopher A. Viehbacher

Growth products and launches

  • LEQEMBI in-market sales grew: LEQEMBI fourth quarter global in-market sales were approximately $134 million, up 54% year-over-year, and U.S. in-market sales were approximately $78 million. Source
  • SKYCLARYS ex-U.S. revenue included true-up: Ex-U.S. SKYCLARYS revenue was about $44 million in the fourth quarter. Demand growth was reported, and revenue was also affected by a one-time reimbursement true-up. Global patients on therapy rose about 30% in 2025. Source
  • VUMERITY revenue grew modestly: VUMERITY revenue grew 3% year-over-year in the fourth quarter. Source
  • ZURZUVAE revenue rose from prior year: ZURZUVAE revenue was approximately $66 million in the fourth quarter, compared with about $23 million a year earlier. Source
  • SPINRAZA revenue fell on shipment timing: SPINRAZA revenue fell 15% in the fourth quarter, with shipment timing outside the U.S. cited, and fell 2% for the full year. Source

Costs, margins and tax

  • Cost of sales ratio improved on mix: Non-GAAP cost of sales fell to 20% of total revenue in the fourth quarter from 22%, and to 21% for the full year from 22%, driven primarily by favorable product mix. Source
  • GAAP cost of sales rose on TYSABRI charge: Full year GAAP cost of sales was 24% of total revenue, reflecting a pre-tax charge on a judgment on Genentech's royalty and interest claim on TYSABRI sales. The Non-GAAP reconciliation excludes a $104.8 million litigation matter. Source
  • R&D spend fell on Fit for Growth: Non-GAAP R&D expense was $478 million in the fourth quarter and $1,731 million for the full year, down 7%, as savings and R&D funding received offset late-stage investment. Source
  • SG&A rose on launch spending: Non-GAAP SG&A was $678 million in the fourth quarter and $2,421 million for the full year, up 3%, reflecting launch sales and marketing spend partly offset by savings. Source
  • Tax rate and other expense: Non-GAAP effective tax rate was 10.1% in the fourth quarter and 15.5% for the full year. Full year Non-GAAP other expense was about $179 million, mainly net interest expense. Source

Pipeline and regulatory progress

  • Litifilimab gains Breakthrough designation: FDA granted Breakthrough Therapy Designation for litifilimab in cutaneous lupus, which the company describes as a disease with no targeted treatment options. Source
  • LEQEMBI IQLIK under Priority Review: FDA granted Priority Review for LEQEMBI IQLIK subcutaneous treatment initiation. Regulatory filings are under review in Japan and China. Source
  • High-dose SPINRAZA approved abroad: The high-dose SPINRAZA regimen is approved in Japan and the E.U. The U.S. FDA PDUFA date is April 3, 2026. Source
  • BIIB145 BTK degrader enters Phase 1: The BTK degrader BIIB145, aimed at autoimmune diseases, started a Phase 1 study in healthy volunteers. Source

Cash, balance sheet and share count

  • Fourth quarter free cash flow reported: Fourth quarter operating cash flow was about $512 million and capital expenditure about $44 million, giving free cash flow of about $468 million. Source
  • Full year free cash flow reported: Full year operating cash flow was about $2.2 billion and capital expenditure about $154 million, giving free cash flow of about $2.1 billion. Source
  • Net debt position at year end: At December 31, 2025, cash and cash equivalents were about $4.2 billion, total debt about $6.3 billion and net debt about $2.0 billion. Source
  • Antidilutive awards in quarter: Weighted average shares were 147 million for GAAP and 148 million for Non-GAAP diluted EPS in the fourth quarter. Unvested awards were antidilutive for GAAP because of the net loss. Source

Litigation, impairment and collaborations

  • Litigation charge in other expense: Fourth quarter GAAP other expense included about $131 million for litigation matters. Full year other expense included the same amount. Source
  • Reata lease right-of-use impairment: Following a fourth quarter impairment assessment of the Reata building in Plano, Texas, of about 327,400 square feet, the company recorded an impairment charge of about $52.9 million. Source
  • Collaboration profit sharing expense: Fourth quarter collaboration profit sharing was about $70 million net expense, including about $47 million for Samsung Bioepis and $22 million for Supernus on ZURZUVAE. Full year was about $290 million. Source
  • Acquired IPR&D expense rose: Acquired IPR&D, upfront and milestone expense was about $222 million in the fourth quarter, against $19 million a year earlier. Full year expense was $472 million. Source

Coming up, as management said on 6 February 2026

  • LEQEMBI IQLIK decision date: The FDA decision date for LEQEMBI IQLIK subcutaneous treatment initiation, under Priority Review, is May 24, 2026. Source
  • SPINRAZA U.S. decision date: The U.S. FDA PDUFA date for the high-dose SPINRAZA regimen is April 3, 2026. Source
  • Litifilimab lupus readouts due: Both litifilimab Phase 3 systemic lupus studies are expected to read out in Q4 2026. Source
  • Ten more registrational readouts: Management expects 10 additional potentially registrational studies across the pipeline to read out sequentially over the next four years. Source

Figures management reported

FigureReported
LEQEMBI in-market sales (Q4 2025) Sourceapproximately $134 million, up 54% year-over-year; U.S. approximately $78 million
SKYCLARYS patients on therapy (2025) Sourcegrew approximately 30%
SKYCLARYS ex-U.S. revenue (Q4 2025) Sourceapproximately $44 million
ZURZUVAE revenue (Q4 2025) Sourceapproximately $66 million
VUMERITY revenue growth (Q4 2025) Source3% year-over-year
SPINRAZA revenue (Q4 and full year 2025) SourceQ4 down 15%; full year down 2%
Non-GAAP R&D expense (Q4 and full year 2025) Source$478 million in Q4; $1,731 million for the full year
BIIB145 BTK degrader SourcePhase 1 initiated in healthy volunteers
Litifilimab in cutaneous lupus SourceBreakthrough Therapy Designation granted
LEQEMBI IQLIK subcutaneous initiation SourceFDA Priority Review; PDUFA date May 24, 2026
High-dose SPINRAZA regimen Sourceapproved in Japan and E.U.; U.S. PDUFA April 3, 2026

Risks management discussed

  • Demand: Management expects further declines in MS product revenue, excluding VUMERITY, in 2026, partly offset by growth products. Source
  • Regulatory: The 2026 guidance excludes the impact of pending and future litigation and of potential healthcare reform, which management says are hard to predict. Source
  • Regulatory: A judgment on Genentech's claim for past royalties and interest on TYSABRI sales produced a pre-tax charge in full year 2025 cost of sales. Source
  • Operational: SPINRAZA revenue was affected by the timing of shipments outside the U.S. in the fourth quarter. Source

Earlier plans management reported on

  • Not stated: Management attributes part of the R&D expense decline to savings from the Fit for Growth initiative and to R&D funding received. Source
  • Ahead: Full year 2025 Non-GAAP diluted EPS was reported above the top of the 2025 guidance range of $14.50 to $15.00. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.