Biogen's Q3 2025: Contradictions Emerge on LEQEMBI Administration, Alzheimer's Trial and Market Dynamics, and External Business Development Strategy

Date of Call: October 30, 2025

Financials Results

• Revenue: Total revenue grew 3% vs Q3 2024; launch products generated $257M in the quarter, up 67% YOY
• EPS: Non-GAAP diluted EPS up 18% vs Q3 2024; updated outlook improved by $0.25 per share while full-year guidance includes ~$(1.25) per share impact for Q4 BD transactions

Guidance:

• Sales expected roughly flat to up 1% vs prior year at constant currency
• Non-GAAP EPS outlook improved by $0.25 per share (offset by ~$(1.25) per share BD-related impact expected in Q4)
• Expect ex-U.S. MS competitive pressure to accelerate (TECFIDERA erosion in Europe; Q4 sequential impact ~2x Q3)
• Q4 operating expenses expected ~ $1.1B
• Q4 contract manufacturing revenue expected $10M–$20M
• On track to deliver $1B gross savings and $800M net savings by end of 2025
• SPINRAZA full-year revenue expected to be relatively similar to 2024

Business Commentary:

* Revenue and Launch Product Growth: - Biogen reported 3% revenue growth for Q3, driven by a 67% increase in revenue from its launch products, which generated $257 million. - This growth is attributed to the strong commercial execution of new product launches, offsetting the decline in MS product revenue, which has seen increased generic erosion.

• Pipeline and Clinical Trial Progress:
• Biogen's pipeline shows progress, with litifilimab Phase III studies now fully enrolled and expected to read out in 2026.

• This is due to Biogen's successful patient recruitment and strategic focus on advancing clinical trials in competitive therapeutic areas.

• Alzheimer's Disease and LEQEMBI Expansion:

• LEQEMBI's global revenue grew 82% compared to Q3 2024, with U.S. prescriber base increasing by 14% quarter-over-quarter.

• Expansion is driven by customer engagement, new patient growth, and the launch of the iClick subcutaneous auto-injector for maintenance, enhancing patient access and satisfaction.

• Immunology Pipeline and New Indications:

• Biogen's immunology pipeline is growing, with expected research collaborations and licensing agreements in the works.
• Recent focus on rare immunology and immunology-related indications is aimed at leveraging Biogen's commercial strengths and existing patient bases in related disease areas, such as MS and lupus.

Sentiment Analysis:

Overall Tone: Positive

• Management called Q3 "very strong," noting launch products grew 67% YOY and total revenue grew 3% vs Q3 2024, non-GAAP EPS rose 18% and free cash flow was $1.2B. Executives highlighted fully enrolled litifilimab Phase IIIs and multiple upcoming readouts, while reaffirming cost savings and disciplined BD—all signaling constructive momentum.

Q&A:

• Question from Umer Raffat (Evercore): If the VOC/EVOKE-type trial shows a trend, how would that impact the LEQEMBI franchise and your portfolio strategy (need for GLP-1 collaboration or in-house asset)?
  Response: Wait for the data; if positive it may push treatment earlier (more primary care use); Biogen aims to have a full Alzheimer's portfolio and will evaluate adding or collaborating on complementary assets as data emerge.

• Question from Evan Seigerman (BMO Capital Markets): How can renewed focus on immunology drive growth and pipeline expansion into the end of the decade?
  Response: Biogen leverages MS/immunology expertise to expand into rare immunology (e.g., lupus, nephrology, transplant), expects portfolio expansion via targeted BD and internal programs, and views immunology as a multi‑indication growth area over 5–10 years.

• Question from Salveen Richter (Goldman Sachs): Given ~10 Phase IIIs, how confident are you in the late-stage pipeline and does that justify BD to expand early-stage assets?
  Response: High conviction based on strong Phase II data (felzartamab, BIIB080, lupus signals) and deliberate derisking; still acknowledge R&D risk but are building commercial capability and selectively adding early‑stage BD to feed future launches.

• Question from Brian Abrahams (RBC Capital Markets): Early experience with LEQEMBI subcutaneous maintenance uptake, non‑formulary exceptions, timelines to formularies, and net price parity versus IV?
  Response: Early feedback from payers/HCPs is positive; expect gradual uptake with subcu enabling longer therapy; non‑formulary transitions manageable and some patients already switched; aim for full Medicare Part D access by 2027.

• Question from Paul Matteis (Stifel): If prevention studies are positive, how do you think about commercial implications given capacity constraints (MRIs, PET, treatment infrastructure)?
  Response: Scaling diagnostics (blood‑based biomarkers) and PCP education will improve triage and referral quality; subcutaneous delivery plus BBMs should materially reduce specialist workload and ease capacity constraints over time.

• Question from Marc Goodman (Clearlink Partners): Can you give more color on Sky Claris volume growth, persistence, discontinuations and ex-U.S. reimbursement issues?
  Response: Global availability now in 34 countries with steady patient adds; U.S. opportunity remains in community prescribers; early discontinuations have improved with physician/patient education and persistence trends have strengthened.

• Question from Lin Tsai (Jefferies): For the Phase II BIIB080 tau readout mid-2026, what would you want to see on CDR‑SB and biomarkers and what regulatory path if positive?
  Response: Need clear target engagement on fluid and imaging biomarkers plus at least a clinical trend; a positive result would prompt stepwise evaluation of combination/sequence strategies and inform regulatory positioning.

• Question from Terence Flynn (Morgan Stanley): How should we read through J&J's anti‑tau antibody data to your ASO program if J&J reports earlier?
  Response: Mechanisms differ (antibody vs intracellular ASO); historical antibody results are mixed; Biogen will analyze any J&J data but believes ASO intracellular targeting and tau PET readouts are critical for direct read‑through.

• Question from David Amsellem (Piper Sandler): How does ZURZUVAE fit commercially given it's a women's health product and partner dynamics (other party controls 50%)?
  Response: Biogen sees large unmet need and market‑shaping opportunity; partnership has been constructive and Biogen provides commercial/back‑office scale (data, omnichannel, DTC plans) to support continued rollout.

• Question from Ross (for Jeff Meacham) (Citi): How are you thinking about capital allocation between BD, new launches and building an earlier‑stage pipeline?
  Response: Discipline-first approach: prioritize investments that drive long‑term growth, maintain capital efficiency (R&D spend below levels 3 years ago), favor cost-effective pre‑IND BD to build early‑stage portfolio while remaining selective on expensive late‑stage buys.

Contradiction Point 1

Subcutaneous LEQEMBI Administration and Logistics

It involves differing perspectives on the administration and logistics of the subcutaneous form of LEQEMBI, which could impact patient experiences and healthcare resource utilization.

What are the commercial implications if Alzheimer's prevention studies are positive? - Paul Mattis (Stifel)

2025Q3: Subcutaneous LEQEMBI could be administered by patient, caregiver, or physician. - Priya Singhal(Executive VP & Head of Development)

What is the impact and logistics of introducing subcutaneous LEQEMBI? - Jay Olson (Oppenheimer & Co. Inc.)

2025Q2: Subcutaneous LEQEMBI could be administered by patient, caregiver, or physician. - Priya Singhal(Executive VP & Head of Development)

Contradiction Point 2

Alzheimer's Trial and Market Dynamics

It involves differing perspectives on the market dynamics and competitive environment related to Alzheimer's trials and treatments, which could impact strategic decision-making and investor expectations.

How would VOC trial trends affect the LEQEMBI franchise, and would that impact the portfolio? - Umer Raffat (Evercore)

2025Q3: If the VOC trial is positive, it might be more used in primary care settings, but it may not affect plaque removal. - Christopher Viehbacher(President, CEO & Director)

Can you comment on the competitive dynamics and the impact of donanemab’s label update on LEQEMBI’s market share? - Eric Schmidt (Cantor Fitzgerald & Co.)

2025Q2: LEQEMBI holds 70% market share, with awareness driving market expansion. - Alisha Alaimo(President & Head of North America)

Contradiction Point 3

LEQEMBI's Uptake and Access

It involves expectations for the uptake and access of LEQEMBI's subcutaneous maintenance form, which could impact revenue and market penetration.

What are your expectations for the adoption and availability of LEQEMBI subcutaneous maintenance, and its pricing parity with IV formulations? - Brian Abrahams(RBC Capital Markets)

2025Q3: Positive feedback from payers and HCPs for subcu maintenance; gradual uptake expected with education on non-formulary redemption processes. Full Medicare Part D access expected by 2027, with existing patients already utilizing subcu injections. - Alisha Alaimo(CMO)

How will Lilly's success in the Trailblazer Alzheimer's III trial impact the AHEAD 3-45 timelines? What lessons have been learned from past M&A decisions? - Umer Raffat(Evercore ISI)

2024Q4: We expect LEQEMBI's commercial growth story will continue into the second half of this year and beyond, driven by strong uptake and patient access in both the U.S. and ex-U.S. - Chris Viehbacher(CEO)

Contradiction Point 4

External Business Development (BD) and Pipeline Strategy

It pertains to the company's strategy and prioritization in external business development and pipeline expansion, which could influence future growth and product offerings.

What is the confidence level in the late-stage pipeline's ability to expand into earlier stages? - Salveen Richter(Goldman Sachs)

2025Q3: We remain excited about our pipeline but aim to reinforce it. We've restructured research to create capacity for more collaborations and acquisitions. We'll look at every phase but prefer early-stage development or pre-GLP tox. We're interested in immunology and rare diseases acquisitions. - Chris Viehbacher(CEO)

Can you sustain revenue growth internally, or is external BD needed? - Paul Matteis(Stifel)

2024Q4: LEQEMBI has the most potential to offset MS revenue decline. We believe in our current pipeline's ability to drive growth. External BD could enhance growth, but our internal products can still drive sustainable growth. - Chris Viehbacher(CEO)

Contradiction Point 5

Subcutaneous LEQEMBI Rollout and Market Impact

It involves differing perspectives on the rollout strategy and market impact of the subcutaneous LEQEMBI formulation, which directly impacts product adoption and market growth.

How can a renewed focus on immunology drive growth and pipeline expansion by the end of the decade? - Evan Seigerman (BMO Capital Markets)

2025Q3: Subcutaneous formulations simplify patient administration, enhancing physician workload reduction. Initiation may vary by setting, but the goal is to increase patient retention post-initiation. The market is still early in LEQEMBI's launch, with potential for expansion. - Christopher Viehbacher(CEO)

How will LEQEMBI's subcutaneous formulation accelerate sales in the U.S.? - Evan Seigerman (BMO Capital Markets)

2025Q1: Subcutaneous formulations simplify patient administration, enhancing physician workload reduction. Initiation may vary by setting, but the goal is to increase patient retention post-initiation. The market is still early in LEQEMBI's launch, with potential for expansion. - Chris Viehbacher(President & CEO)