Biogen reports strong third quarter 2025 results and updates full year 2025 guidance

On October 30, 2025 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2025 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"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."
Financial Highlights
Q3 ’25 Q3 ’24 △
r (CC*)
Total Revenue (in millions) $2,535 $2,466 3% 2%
GAAP diluted EPS $3.17 $2.66 19% N/A
Non-GAAP diluted EPS $4.81 $4.08 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q3 ’25 Q3 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,062 $1,054 1% —%
Rare disease revenue(2)
$533 $495 8% 6%
Biosimilars revenue $197 $197 —% —%
Other product revenue(3)
$55 $24 129% 130%
Total product revenue $1,847 $1,769 4% 3%
Revenue from anti-CD20 therapeutic programs $494 $446 11% 11%
Alzheimer’s collaboration revenue(4)
$43 $19 130% 129%
Contract manufacturing, royalty and other revenue $151 $232 (35)% (35)%
Total revenue $2,535 $2,466 3% 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
2

Expense Summary
(in millions, except effective tax rate) Q3 ’25 Q3 ’24 △
GAAP cost of sales*
$674 $639 (6)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$510 $593 14%
% of Total Revenue 20% 24%
GAAP R&D expense $436 $516 16%
Non-GAAP R&D expense $432 $465 7%
GAAP SG&A expense $595 $588 (1)%
Non-GAAP SG&A expense $592 $556 (6)%
GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in third quarter 2025 GAAP cost of sales as a percentage of total revenue was driven primarily by a pre-tax charge related to a judgment on Genentech’s claim for past royalties and interest on sales of TYSABRI, partially offset by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue. The decrease in third quarter 2025 Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue.

•The decrease in third quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by the favorable impact from the Company’s Fit for Growth initiative and R&D funding received, partially offset by increased investment in late-stage programs including felzartamab and litifilimab.

•The increase in third quarter 2025 GAAP and Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Third quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $2 million.
Other Financial Highlights

•Third quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $87 million, which includes approximately $67 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $21 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•Third quarter 2025 GAAP and Non-GAAP other expense was approximately $34 million and approximately $44 million, respectively, primarily driven by net interest expense.

•Third quarter 2025 GAAP and Non-GAAP effective tax rates were 16.3% and 17.2%, respectively. Third quarter 2024 GAAP and Non-GAAP effective tax rates were 13.9% and 13.8%, respectively.
Financial Position

•Third quarter 2025 net cash flow from operations was approximately $1.3 billion. Capital expenditures were approximately $46 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $1.2 billion.

•As of September 30, 2025, Biogen had cash and cash equivalents totaling approximately $4.0 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $2.3 billion.

•For the third quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.
Full Year 2025 Financial Guidance

Biogen is updating its guidance for full year 2025 to reflect a stronger business outlook since July 2025 and the impact of business development transactions that are expected to close in the fourth quarter of 2025. Full year 2025 Non-GAAP diluted EPS range is expected as follows:
Full Year 2025 Non-GAAP Diluted EPS
Prior Guidance (July 2025) $15.50 to $16.00
Benefit from stronger business outlook +$0.25
Revised business outlook (October 2025) $15.75 to $16.25
Approx. impact from BD transactions expected to close in Q4’25 ~($1.25)
Updated Guidance $14.50 to $15.00

This updated Non-GAAP diluted EPS guidance range reflects a $0.25 EPS benefit from an expected stronger business outlook for the full year, partially offset by the expected ~($1.25) EPS impact from business development transactions expected to close in the fourth quarter of 2025.
For 2025 as compared to 2024, Biogen now expects total revenue to be approximately flat to increasing 1%, at constant currency. This reflects the strong revenue performance year-to-date, including the resilient performance of the U.S. MS business. Biogen expects increased competitive pressures on the ex-U.S. MS business in the fourth quarter of 2025, particularly for TECFIDERA in Europe. Due to planned campaign timing of contract manufacturing versus Biogen innovator product manufacturing, Biogen expects manufacturing revenue in the fourth quarter of 2025 of between $10 million and $20 million.

The Fit for Growth program is expected to generate approximately $1 billion of gross savings and $800 million net of reinvestment by the end of 2025. In 2025, Biogen plans to make additional investments in R&D to enable acceleration and expansion of the clinical development activities, primarily in support of rare disease, as well as additional investments in spend to support launch products. Biogen expects combined Non-GAAP R&D expense and Non-GAAP SG&A expense to total approximately $1.1 billion in the fourth quarter of 2025.
This financial guidance incorporates the Company’s view that Biogen’s 2025 financial outlook is not currently expected to be materially impacted by potential tariffs announced by the U.S. Administration during 2025, even if the exemption for pharmaceuticals were to be removed. This expectation is based on both a significant proportion of U.S. revenue being derived from products which have manufacturing operations in the U.S., and the Company’s current global inventory positions. The U.S. and international tariff landscape remains uncertain, and this guidance does not include contemplation of any new tariffs.
This financial guidance also assumes that foreign exchange rates as of October 24, 2025, will remain in effect for the remainder of the year, net of hedging activities.
Unless expressly stated above, this financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are hard to predict. Some other financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2025 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Other Key Recent Events

•In October 2025, Biogen announced a license agreement granting Biogen exclusive worldwide rights to Vanqua Bio’s preclinical, oral C5aR1 antagonist designed to modulate neutrophil-driven inflammation, a central mechanism underlying many inflammatory diseases. Under the terms of the agreement, Vanqua Bio will receive a $70 million upfront payment.

•In September 2025, Biogen announced it entered into a definitive agreement to acquire Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides. Under the terms of the agreement, Biogen has agreed to acquire Alcyone Therapeutics for an upfront cash payment of $85 million plus certain milestones payable related to the development and regulatory approval of ThecaFlex DRx with nusinersen and additional pipeline products, securing all rights to ThecaFlex DRx. The transaction is subject to customary closing conditions.

Conference Call and Webcast

The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 30, 2025 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, OCT 30, 2025, View Source [SID1234657141])