Analyst Conference Call Summary

biotechnology

conference date: February 6, 2025 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2025 (fourth quarter, Q4 2025)

Forward-looking statements

Overview: Overall revenue annual decline despite newer drug ramps.

Basic data (GAAP):

Revenues were $2.28 billion, down 10% sequentially from $2.54 billion and down 7% from $2.46 billion in the year-earlier quarter.

Net income negative $49 million, down sequentially from $466 million and down from $267 million in the year-earlier quarter.

EPS (earnings per share, diluted) were negative $0.33, down sequentially from $3.17 and down from $1.83 year-earlier.

Guidance:

Biogen expects 2026 revenue to decline in the mid-single digit percentage range, y/y. Non-GAAP diluted EPS range $15.25 to $16.25.

Conference Highlights:

CEO Christopher A. Viehbacher said: "“Our 2025 performance reflected continued focus on strong execution and financial discipline, driven by our revenue of nearly $1 billion from Leqembi, Skyclarys, Zurzuvae, and Qalsody, progression of our pipeline, and resilience of our MS franchise. Our pipeline momentum continues with a strong start in 2026, with the FDA recently granting Priority Review for Leqembi IQLIK initiation and Breakthrough Therapy Designation for litifilimab in CLE. These milestones highlight both the innovative and differentiated value of our medicines and the strength of our late-stage pipeline. Going into 2026, we are looking forward to data from two Phase 3 studies in lupus for litifilimab, with 10 additional potentially registrational studies across our pipeline expected to read out sequentially over the next four years. This multi-year registrational data flow has the potential to drive meaningful innovation for patients and long-term value for shareholders."

In Q1 2026 the FDA granted Breakthrough Therapy Designation to litifilimab in cutaneous lupus (CLE). Both litifilimab Phase 3 systemic lupus (SLE) studies are fully enrolled and expected to read out in Q4 2026. Lupus is a very competitive area, but physicians are seeing something special.

2026 begins a multi-year registrational data flow peaking in 2028 to 2030.

$180 million in one-time ligitagation and other charges were the reason GAAP net income and EPS were negative in Q4. But had good free cash flow.

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

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 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. The Leqembi IQLIK SC-AI initiation (for treatment initiation, already approved for mainenance) is under review in the U.S., Japan, and China with FDA PDUFA May 24, 2026.

In Q1 2026 Biogen began a Phase 1 trial of BIIB145, a BTK degrader.

Salanersen for SMA high dose PDUFA was September 22, 2025, but got CRL instead for more manufacturing data.

Non-GAAP net income was $294 million, down 58% sequentially from $708 million and down 41% from $502 million year-earlier. Non-GAAP EPS diluted was $1.99, down 59% sequentially from $4.81 and down 42% from $3.44 year-earlier.

Total product revenue was $1.67 billion, down 10% sequentially from $1.85 billion and down 9% from $1.83 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 $4.2 billion, up sequentially from $ billion. $6.3 billion debt. $0 million was spent to repurchase shares. $512 million cash flow from operations. $44 million cap ex. $468 million free cash flow.

GAAP Cost of sales was $496 million. R&D expense was $509 million. Acquired in-process R&D expense $222 million. SG&A expense $683 million. Amortization of acquired intangible assets $137 million. Collaboration profit sharing income $70 million. Restructuring charges $7 million. Loss on contingent consideration $5 million. Other expense $154 million. Total cost and expenses $2.34 billion. Leaving income from operations of $56 million. Income tax benefit $7 million.

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

Q&A selective summary:

Leqembi cadence of sales growth in 2026? We don't have clear data on number of patients on maintenance. We are seeing increased in the pen, but we don't have full reimbursement for that yet. We are seeing increasing use of drug based diagnostics. So be expect continuing sequential growth. If pen for induction is approved that could be a benefit.

Timeline for return to revenue growth? In 2026 will see Tecfidera generic erosion in Europe. Tysabri generic introduction recently will also impact. For growth we need to see more positive Phase 3 results and commercial launches. In business development we are looking for post Phase 3 result companies, but they need to be priced to generate value for us.

BIIB080 commercial opportunity? We need to see the data, as does the neurology community. Tau can be reduced, the question is can it improve cognition? We believe it is the intracellular tau as opposed to the intercellular tau that, if treatable, would produce positive results. But even if Phase 2 results are good, we will need to do a Phase 3 trial.

Felzartamab AMR and transplants? Proof of concept is from a small trial. We are looking at addressing the PD38 autoantibodies in other transplants. Microvascular inflamation trial we are looking to initiate would also affect this.

SMA physicians report they prefer Spinraza, but some patients are attracted to the oral treatment.

We are recruiting people for the product launches, including market research, but we do not see that as a major increase in investment. We are reallocating resources from legacy products. We hope to see increasing margins over time as revenue increases.

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