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BIOGEN INC. (BIIB) Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 total revenue was $2.431B, up 6% YoY (8% at constant currency); non-GAAP diluted EPS was $3.02, reflecting a ~$0.95 impact from a $165M upfront payment to Stoke Therapeutics; GAAP diluted EPS was $1.64 .
  • Strength from launch products: LEQEMBI in-market sales ~$96M (U.S. ~$52M), SKYCLARYS global revenue ~$124M, and ZURZUVAE revenue ~$28M; MS franchise declined 11% YoY amid competition .
  • Guidance updated: 2025 non-GAAP diluted EPS $14.50–$15.50 (prior $15.25–$16.25) to reflect the $165M upfront offset by ~$0.20 FX tailwind; total revenue expected to decline mid-single digits YoY; combined non-GAAP R&D+SG&A of ~$3.9B maintained .
  • Management highlighted reduced tariff risk due to U.S.-based manufacturing and diversified ex-U.S. revenue; reiterated steady sequential growth in launch products and pipeline execution as catalysts (subcutaneous LEQEMBI maintenance PDUFA Aug 31, 2025) .

What Went Well and What Went Wrong

What Went Well

  • Launch portfolio momentum: “our commercial portfolio…now gotten to be about 45% of our product revenue” with LEQEMBI ~$96M, SKYCLARYS ~$124M, ZURZUVAE ~$28M; approvals in EU (LEQEMBI), U.K. and Brazil (SKYCLARYS) .
  • Pipeline advances: BIIB080 received FDA Fast Track; felzartamab Phase 3 initiated in AMR with more Phase 3 starts in IgAN and PMN planned; zorevunersen deal expands rare disease pipeline .
  • Operating discipline: Combined non-GAAP R&D+SG&A guided to ~$3.9B in 2025; Fit for Growth remains on track to deliver ~$1B gross / $800M net savings by end of 2025 .

What Went Wrong

  • MS franchise pressure: Global MS product revenue fell 11% YoY, impacted by TYSABRI biosimilar in Europe and TECFIDERA generics globally; further TECFIDERA generics expected in Europe (France, Netherlands) .
  • Margin mix headwind: Cost of sales increased to 26% of revenue (non-GAAP 24%) due to higher lower-margin contract manufacturing, partially offset by launch product mix .
  • Non-GAAP EPS down 18% YoY to $3.02, primarily reflecting ~$0.95 from the $165M Stoke upfront in acquired IPR&D; GAAP EPS down 39% YoY to $1.64 .

Financial Results

Core Financials vs Prior Periods and Estimates

MetricQ3 2024Q4 2024Q1 2025YoY (Q1 2025 vs Q1 2024)Vs. Est. (Q1 2025)
Total Revenue ($USD Billions)$2.466 $2.455 $2.431 +6% (from $2.291B) Beat: $2.233B* vs $2.431B
GAAP Diluted EPS ($)N/AN/A$1.64 (39)% (from $2.70) N/A
Non-GAAP Diluted EPS ($)$4.08 $3.44 $3.02 (18)% (from $3.67) Beat: $2.95* vs $3.02
Non-GAAP Cost of Sales (% Revenue)N/AN/A24% +200 bps (22% prior year) N/A
EBITDA ($USD Billions)$0.794*$0.692*$0.865*N/ABeat: $0.852* vs $0.865*

Values marked with * retrieved from S&P Global.

Estimates disclaimer: Values retrieved from S&P Global.

Segment/Source Breakdown (Q1 2025 vs Q1 2024)

Segment/Revenue Source ($USD Millions)Q1 2024Q1 2025Δ YoYCC YoY
MS Product Revenue$1,076 $953 (11)% (10)%
Rare Disease Revenue$424 $563 +33% +36%
Biosimilars Revenue$197 $181 (8)% (5)%
Other Product Revenue$15 $29 +93% +92%
Total Product Revenue$1,712 $1,727 +1% +3%
Anti-CD20 Therapeutic Programs$394 $378 (4)% (4)%
Alzheimer’s Collaboration Revenue$3 $33 NMF NMF
Contract Manufacturing, Royalty & Other$182 $293 +61% +63%
Total Revenue$2,290 $2,431 +6% +8%

Product/Geography Highlights (Q1 2025)

KPIValueNotes
LEQEMBI Global In-Market Sales~$96M U.S. ~$52M
SKYCLARYS Global Revenue~$124M U.S. $69M (Medicare discount impact)
ZURZUVAE Revenue~$28M Q1 2025
Free Cash Flow~$222M CFO reconcilable
Cash & Cash Equivalents~$2.6B As of 3/31/2025
Total Debt / Net Debt~$6.3B / ~$3.7B As of 3/31/2025
Diluted Weighted Avg. Shares~147M Q1 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Non-GAAP Diluted EPSFY 2025$15.25–$16.25 (Feb 2025) $14.50–$15.50 Lowered (−$0.95 Stoke upfront, +$0.20 FX)
Total RevenueFY 2025Mid-single digit decline vs FY 2024 Mid-single digit decline vs FY 2024 (unchanged) Maintained
Combined Non-GAAP R&D + SG&AFY 2025~$3.9B ~$3.9B Maintained
Corporate Partner RevenueFY 2025Roughly consistent YoY; minimal in Q4 Roughly consistent YoY; minimal in Q4 (unchanged) Maintained
Tariff AssumptionsFY 2025Not expected to materially impact outlook Not expected to materially impact outlook Maintained
Tax RateFY 2025Not guidedNot guidedN/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
LEQEMBI commercialization & diagnosticsEmphasis on infrastructure hurdles; pursuit of IV maintenance and subcutaneous; blood-based diagnostics expected; prescriber growth Sequential growth to ~$96M; EU approval; subcutaneous maintenance PDUFA 8/31/2025; direct patient engagement; diagnostics as enabler Improving with catalysts; broader access expected
SKYCLARYS adoptionEx-U.S. early access and reimbursement sequencing; strong growth; U.S. Medicare discount dynamics $124M global; ~2,400 patients on therapy; approvals in U.K./Brazil; Medicare discounts impacted net U.S. revenue Growing; geographic expansion
ZURZUVAE trajectoryOutperformed expectations; $22M Q3; prescriber base widening $28M Q1; ~10,000 women treated; 80% of scripts from OB/GYNs; first-line usage increasing Steady growth; prescriber expansion
Tariffs/MacroNot expected to materially impact 2025; U.S.-based manufacturing; diversified ex-U.S. revenue No material 2025 impact expected even if pharma exemption removed; inventory and U.S. manufacturing mitigate risk Stable risk posture
Pipeline & R&D executionMultiple Phase III starts; BIIB080 Phase 2 readout 2026; lupus and renal programs progressing BIIB080 Fast Track; felzartamab Phase 3 initiated; zorevunersen Phase 3 planned soon Advancing; increased shots on goal
Manufacturing & CDMOCapacity utilization and contract manufacturing dynamics CDMO activity (Solothurn); third-party manufacturing at RTP; minimal corporate partner revenue anticipated in Q4 Balanced; predictable maintenance timing

Management Commentary

  • “We actually have a commercial portfolio…that’s now gotten to be about 45% of our product revenue.” — CEO Christopher Viehbacher .
  • “LEQEMBI…$96 million…now we’re into serious product territory…approval in the EU…recognized…by all major regulators.” — CEO Christopher Viehbacher .
  • “This quarter…BIIB080…received Fast Track designation…encouraging Phase Ib data…dose-dependent CSF tau reductions.” — Head of Development Priya Singhal .
  • “We are updating our full year EPS guidance…$14.50 to $15.50…reflect the approximately $0.95 impact from the Stoke transaction…$0.20…tailwind from foreign exchange.” — CFO Robin Kramer .

Q&A Highlights

  • LEQEMBI EU rollout and reimbursement: Launch will proceed market-by-market; EU decision underscores thorough efficacy/safety/economic review; timeline will take time .
  • Subcutaneous LEQEMBI and diagnostics: Subcutaneous maintenance expected to ease burden, extend treatment; blood-based diagnostics can accelerate early diagnosis and reduce need for PET/LP over time .
  • Competitive dynamics vs donanemab: Market likely split; education on maintenance benefit key; focus remains on expanding treated population, not share battles .
  • Business development: Discipline amid financing pressures in biotech; opportunity for early-stage collaborations; capacity strong; priority to augment pipeline without overpaying .
  • Manufacturing partnerships: Willingness to leverage excess capacity (CDMO) in Solothurn and RTP; mixed own and partner production .

Estimates Context

  • Q1 2025 vs S&P Global consensus: Revenue $2.431B vs $2.233B* (beat); Non-GAAP EPS $3.02 vs $2.95* (beat); EBITDA $0.865B* vs $0.852B* (beat). Sequential revenue declined vs Q4 ($2.455B) but grew YoY (+6%); EPS impacted by $165M upfront .
MetricQ3 2024Q4 2024Q1 2025
Revenue Consensus ($USD Billions)$2.435*$2.416*$2.233*
Revenue Actual ($USD Billions)$2.466 $2.455 $2.431
EPS Consensus ($)$3.785*$3.364*$2.948*
EPS Actual ($)$4.08 $3.44 $3.02
EBITDA Consensus ($USD Billions)$1.112*$0.702*$0.852*
EBITDA Actual ($USD Billions)$0.794*$0.692*$0.865*

Estimates disclaimer: Values retrieved from S&P Global.

Where estimates may adjust:

  • LEQEMBI trajectory and EU approval could support upward revisions to Alzheimer’s collaboration revenue and corporate partner revenue timing in mid-2025 .
  • SKYCLARYS ex-U.S. ramp and broader approvals (U.K., Brazil) may lift rare disease revenue estimates; U.S. Medicare dynamics temper net pricing .
  • MS erosion likely to steepen in 2H 2025 (TYSABRI U.S. biosimilar risk; TECFIDERA generics in Europe), supporting conservative top-line estimates .

Key Takeaways for Investors

  • Q1 print was clean on operations with a notable beat vs revenue/EPS consensus despite the $165M Stoke upfront; underlying non-GAAP EPS would have been $3.97 absent the charge .
  • Alzheimer’s franchise is building momentum; EU approval, subcutaneous maintenance (Aug 2025), and blood-based diagnostics are key catalysts to broaden access and reduce care-path friction .
  • Rare disease is a durable second growth pillar; SKYCLARYS’ global expansion and patient-finding capabilities underpin steady increases; expect ex-U.S. reimbursement conversions to create lumpiness .
  • MS decline remains a headwind and is likely to intensify with competitive events; management is offsetting via launch products, disciplined OpEx, and pipeline milestones .
  • Tariff risk appears contained for 2025 due to U.S.-based manufacturing and inventories; not a near-term driver of estimate variance .
  • Near-term trading catalysts: LEQEMBI subcutaneous maintenance PDUFA (Aug 31, 2025), ongoing prescriber expansion data points, SKYCLARYS reimbursement wins; watch for corporate partner revenue cadence and Q4 minimal contribution .
  • Medium-term thesis: Pipeline maturation (felzartamab Phase 3 programs; BIIB080 Phase 2 in 2026) increases shots on goal; disciplined BD to augment growth without over-levering .

Notes and Non-GAAP Adjustments

  • Q1 2025 acquired IPR&D ~$201M includes $165M Stoke upfront and $35M MorphoSys milestone; EPS impact ~$0.95; non-GAAP reconciliations detailed in tables .
  • Non-GAAP cost of sales increased due to product mix (contract manufacturing) despite launch product contribution .

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