Analyst Conference Call Summary

biotechnology

conference date: October 30, 2025 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2025 (third quarter, Q3 2025)

Forward-looking statements

Overview: Rapid growth of Leqembi, Skyclary's and Zurzuvae revenue more than offset declines in loss-of-exclusivity drugs.

Basic data (GAAP):

Revenues were $2.54 billion, down 4% sequentially from $2.65 billion and up 3% from $2.47 billion in the year-earlier quarter.

Net income $466 million, down 27% sequentially from $635 million and up 20% from $389 million in the year-earlier quarter.

EPS (earnings per share, diluted) were $3.17, down 27% sequentially from $4.33 and up 19% from $2.66 year-earlier.

Guidance:

Increased non-GAAP diluted EPS 2025 guidance $0.25 to $15.75 - $16.25, or adjusted for Q4 business development transactions, $14.50 to $15.00.

Conference Highlights:

CEO Christopher A. Viehbacher said: "We delivered another quarter of strong financial performance driven by continued commercial momentum in our launch products, resilience in our MS franchise and our ongoing focus on disciplined cost management. Looking ahead we are further advancing our new Biogen roadmap with a cadence of potentially registrational Phase 3 readouts beginning next year, including data now expected in 2026 from both SLE studies for litifilimab which are fully enrolled. We believe this execution on our strategic objectives, combined with our resilient business model and footprint, positions Biogen to deliver long-term sustainable growth." Announced will acquire Alcyone Therapeutics for RNAi (antisense oligonucleotide) therapies. Expects one or two more research stage deals by end of the year.

In Q4 2025 Zurzuvae was approved for post-partum depression in the EU. It is a major revenue growth driver.

In Q4 2025 litifilimab Phase 3 studies for systemic lupus erythmatosus were fully enrolled. Data expected in H2 2026. Lupus is a very competitive area, but physicians are seeing something special.

In Q3 2025 high dose Spinraza was resubmitted to the FDA, PDUFA is April 3, 2026.

In Q3 2025 the IRAK4 degrader (BIIB142) for autoimmune disease, including lupus, initiated Phase 1 study in healthy volunteers.

In Q2 2025 a Phase 3 Felzartamab study in late antibody-mediated kidney transplant rejection (AMR) initiated. Also initiated Phase 3 trials in IgA nephropathy and primary membranous nephropathy in Q2 2025.

In Q4 2025 Leqembi Iqlik subcutaneous injection launched. Leqembi (lecanemab) for Alzheimer's patients global growth continued, with U.S. sales at $69 million, up sequentially from $63 million, and global at $121 million, up sequentially from $160 million. Partnered with Eisai, which is doing strong sales in Asia, including China. Introduction of blood-based diagnostics in H2 2025 would also help. Has approval for IV maintenance. AHEAD 3-45 study in presymptomatic AD should readout in 2028. Positive data announced in Q2 2025 shows continuous treatment has sustained benefit.

BIIB080 for tau in Alzheimer's received FDA Fast Track and is currently in a Phase 2 trial with data readout due in 2026.

Zurzuvae launch is going well, exceding expectations, received positive EU CHMP opinion. Well over 10,000 women now treated for PPD. Physicians are writing repeat prescriptions and are becoming more proactive about diagnosing PPD.

Salanersen for SMA high dose filings accepted by FDA and EMA. PDUFA September 22, 2025, but got CRL instead for more manufacturing data.

In Q2 2025 Dapirolizumab pegol Phase 3 data presented at EULAR show improvement in fatigue and reduction of disease activity in SLE.

Non-GAAP net income was $708 million, down 12% sequentially from $803 million and up 19% from $596 million year-earlier. Non-GAAP EPS diluted was $4.81, down 12% sequentially from $5.47 and up 18% from $4.08 year-earlier.

Total product revenue was $1.85 billion, down 2% sequentially from $1.88 billion and up 5% from $1.77 billion year-earlier. That excludes the Rituxan revenue, Alzheimer's collaboration, royalties and other revenue.

* unconsolidated joint business revenue, Anti-CD20 products
** mainly contract manufacturing

Cash and equivalents (including marketable securities) balance ended at $4.0 billion, up sequentially from $2.80 billion. $6.3 billion debt. $0 million was spent to repurchase shares. $1.3 billion cash flow from operations. $46 million cap ex. $1.2 billion free cash flow.

GAAP Cost of sales was $674 million. R&D expense was $436 million. Acquired in-process R&D expense $2 million. SG&A expense $594 million. Amortization of acquired intangible assets $136 million. Collaboration profit sharing income $87 million. Restructuring charges $7 million. Loss on contingent consideration $6 million. Other expense $34 million. Total cost and expenses $1.98 billion. Leaving income from operations of $557 million. Income tax $91 million.

See also the Biogen product pipeline. The entire pipeline includes 27 clinical programs.

Q&A selective summary:

Evoke trials v. leqembi? We need to see results first. If positive believe it would be used in a primary care setting. We don't believe it would effect the amount of plaque. There is no lack of GLP1s out there.

Immunology future? MS franchise was immunology. Dupixent demonstrated the possibilities. Short run, we are focussed on rare immunologies like lupus. We will be able to develop that market better than competitors have done. There is still a lot to be learned. Over time we will move into broader indications.

Late stage trials, confidence in? Zel had compeling Phase 2 data. BIIB80 is pioneering, will need to see results. In lupus saw strong Phase 2 results. No guarantees on Phase 3 trials, but good indications and derisking.

Triaging in Alzheimer's has improved with blood-based biomarkets, so the % of positive PET scans has trended up. With subq and blood testing the workload is greatly decreased so capacity is increased.

We have seen that if patients drop off Skyclaris they rapidly decline and then go back on. We continue to expand internationally.

Zurzuvae with new partner Supernus? We are happy with the Supernus partnership. There is a huge unmet need for the product. We see it as a significant opportunity.

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