Biogen
29 named things its latest annual report says its results depend on, each in the company's own words. 12 of them are also named by other companies we've read.
Customers
Two U.S. wholesale distributors
earns from · approximately 43.9%Our product sales to two wholesale distributors each accounted for more than 10.0% of our total revenue for the years ended December 31, 2025, 2024 and 2023, and on a combined basis, accounted for approximately 43.9%, 39.3% and 36.9%, respectively, of our gross product revenue.Business (Item 1)
Suppliers
Third-party contract manufacturing organizations
depends onnamed as a riskWe source the majority of our fill-finish and all of our final product assembly and storage operations for our products, along with a substantial part of our label and packaging operations, to a concentrated group of third-party contract manufacturing organizations.Business (Item 1)
Also named by EXEL
Single source raw material suppliers
depends onnamed as a riskIn some cases, due to the unique manner in which our products are manufactured, we rely on single source providers of raw materials and manufacturing supplies.Risk factors (Item 1A)
Also named by AXGN
Samsung Bioepis
depends onnamed as a riskWe are dependent on a third party for the manufacture of our biosimilar products and such third party may not perform its obligations in a timely and cost-effective manner or in compliance with applicable regulations and may be unable or unwilling to increase production capacity commensurate with demand for our existing or future biosimilar products;Risk factors (Item 1A)
Contract research organization (CRO)
depends onnamed as a riskOne CRO has responsibility for a substantial portion of our activities and reporting related to our clinical trials and if such CRO does not adequately perform, many of our trials may be significantly affected, including adversely affecting our expenses associated with such trials.Risk factors (Item 1A)
Partners and platforms
Eisai
depends on · 50.0% share of LEQEMBI product revenuenamed as a riskSubject to the limitations in the LEQEMBI Collaboration Agreement, Eisai has final decision-making authority on all matters relating to the collaboration and serves as the lead of LEQEMBI development and regulatory submissions globally.Business (Item 1)
Also named by EXEL
Royalty Pharma
$200.0 millionIn February 2025 we entered into a funding agreement with Royalty Pharma under which we received $200.0 million in 2025 and will receive up to $50.0 million in 2026 to co-fund our development costs for the litifilimab program.Business (Item 1)
Stoke Therapeutics
depends on · $165.0 millionIn connection with the closing of this transaction we made an upfront payment of $165.0 million to Stoke, which was recognized in acquired in-process research and development, upfront and milestone expense within our consolidated statements of income for the year ended December 31, 2025.Business (Item 1)
Ionis Pharmaceuticals
depends onWe have several exclusive, worldwide option and collaboration agreements with Ionis to develop and commercialize antisense therapeutics, including SPINRAZA for the treatment of SMA and QALSODY for the treatment of ALS with SOD1 mutations, as well as other research programs for a broad range of neurological diseases.Business (Item 1)
Supernus Pharmaceuticals
depends onUnder this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S.Business (Item 1)
Other companies
TYSABRI
earns from · more than 10.0% of our total revenueProduct sales for TYSABRI and SPINRAZA each accounted for more than 10.0% of our total revenue for the years ended December 31, 2025, 2024 and 2023.Business (Item 1)
International Chamber of Commerce arbitration with Eisai
named as a riskIn June 2025 we filed a request for arbitration in the International Court of Arbitration of the International Chamber of Commerce seeking adoption of a budget and commercialization plan for the European Territory that allocates commercialization activities to Biogen and Eisai in an equitable fashion taking into account our respective capabilities and provides a meaningful role for each party.Business (Item 1)
Competitors
Eli Lilly and Company (KISUNLA)
competes withnamed as a riskA competing product, KISUNLA, a treatment for early symptomatic Alzheimer's disease that was developed by Eli Lilly and Company, was approved in the U.S. in 2024 and in the E.U. in 2025.Business (Item 1)
TECFIDERA generic competitors
competes withnamed as a riskThe generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline.Business (Item 1)
TYSABRI biosimilar
competes withnamed as a riskWe expect that future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar worldwide.Business (Item 1)
EVRYSDI and ZOLGENSMA
competes withnamed as a riskWe expect that we will experience competition from both products in additional jurisdictions and new formulations of those products, which may adversely affect our sales of SPINRAZA.Business (Item 1)
Places
China
depends onnamed as a riskadditional complexity in manufacturing or conducting clinical research internationally, including materials manufactured in China or working with CROs in China;Risk factors (Item 1A)
Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more
Solothurn, Switzerland
operates innamed as a riskAlthough the Solothurn facility was approved by the FDA for LEQEMBI and TYSABRI, there can be no assurance that the regulatory authorities will approve the Solothurn facility for the manufacturing of other products.Risk factors (Item 1A)
Research Triangle Park, North Carolina
operates inWe have an oligonucleotide synthesis manufacturing facility in RTP.Business (Item 1)
Athlone, Ireland
operates inAdditionally, in 2025 we acquired a sterile fill finish manufacturing facility in Athlone, Ireland.Business (Item 1)
Commodities and inputs
Euro
exposed to its price · $278.0 millionnamed as a riskAs a result, our consolidated financial position, results of operations and cash flow can be affected by market fluctuations in foreign currency exchange rates, primarily with respect to the Euro, British pound sterling, Canadian dollar, Swiss franc and the Polish złoty.Market risk (Item 7A)
Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more
Laws and programs
One Big Beautiful Bill Act (OBBBA)
subject tonamed as a riskIn July 2025 the U.S. signed into law the OBBBA, which enacts significant potential changes to Medicaid funding and rescinds or does not continue elements of the PPACA.Risk factors (Item 1A)
Also named by AA, ABR, ADI, ADM, ALB, AMAT, AMGN, AMKR and 121 more
Inflation Reduction Act (IRA)
subject tonamed as a riskFor example, we expect the IRA's drug pricing controls and Medicare Part D redesign to have an adverse impact on sales, particularly for our products that are more substantially reliant on Medicare reimbursement.Risk factors (Item 1A)
Also named by AEE, AMGN, ARWR, BKNG, BMY, CAH, CI, CNC and 26 more
Most Favored Nation (MFN) drug pricing policy
subject tonamed as a riskIf HHS sets MFN pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the U.S., or if legislation is passed enabling generic drug or biosimilar entry sooner than expected, our business could be materially harmed, including with respect to our ability to set adequate pricing for new drugs to recover our research and development costs.Risk factors (Item 1A)
U.S. Section 232 pharmaceutical import investigations
subject tonamed as a riskThe result of these Section 232 investigations and any subsequent rulemaking could result in the government taking actions such as trade protection measures, embargoes, import or export licensing requirements, the imposition of trade sanctions or similar restrictions, which could have adverse consequences to our business and operations.Risk factors (Item 1A)
Switzerland tax law
subject tonamed as a riskOur effective tax rate may be different than experienced in the past or our current expectations due to many factors, including changes in the mix of our profitability from country to country, the results of examinations and audits of our tax filings, adjustments to the value of our uncertain tax positions, interpretations by tax authorities or other bodies with jurisdiction, the result of tax cases, changes in accounting for income taxes and changes in tax laws, especially in the U.S. (including the OBBBA) and Switzerland, and regulations either prospectively or retrospectively and the effects of the integrations of Reata and HI-Bio.Risk factors (Item 1A)
OECD Pillar Two GloBE Model Rules
subject tonamed as a riskMany countries have or are in the process of enacting legislation intended to implement the OECD GloBE Model Rules.Risk factors (Item 1A)
340B Drug Pricing Program
subject toTo maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part B, we are required to extend significant discounts to certain covered entities that purchase products under Section 340B of the PHS pharmaceutical pricing program.Business (Item 1)
Also named by ABBV, BAX, BMY, CAH, COR, CVS, EXEL, GILD and 13 more