AddedRisk Factors
•the approval and/or greater acceptance of other new products for the same or similar indications;
BIIBBiogen
Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases. 10-K, Item 1
- Employees
- 7,500
- Headquarters
- Cambridge, MA
- Next results
- around Jan 13, 2027
10-K 0000875045-26-000013 (2026-02-06) vs 10-K 0000875045-25-000009 (2025-02-12)
| Section | Compared text | Words now | Changed |
|---|---|---|---|
| Risk Factors | Item 1A | 12,136 | 13.8% |
| MD&A | Item 7 | 16,678 | 39.8% |
| Legal Proceedings | Item 3, via Note 21 – Litigation | 1,812 | 39.1% |
| Accounting Policies | 10-K text, Note 1 – Summary of Significant Accounting Policies | 9,237 | 12.2% |
The redline: what was cut and what was added
In each section, the paragraph that changed most, marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
MD&A 208 words changed in this paragraph; it is 32% similar to last year's version.
As of December 31, 2024, 2025, we had cash and cash, cash equivalents and marketable securities totaling approximately $2.4 $4.2 billion compared to approximately $1.0 $2.4 billion as of December 31, 2023. 2024. The increase in the balance was primarily due to cash generated by our operations, the receipt which includes $200.0 million of $437.5 research and development funding received from Royalty Pharma, partially offset by worldwide tax payments of approximately $864.0 million, an upfront payment made to Stoke of $165.0 million in April 2024 from Samsung BioLogics related connection with the closing of our collaboration and license agreement, milestone payments made to the sale former shareholders of HI-Bio totaling $300.0 million, a payment of $50.0 million in connection with our 49.9% equity interest acquisition of Alcyone and total payments of $166.0 million in Samsung Bioepis, connection with our agreements with City Therapeutics, Dayra and Vanqua. During the second quarter of 2025 we received $1.75 billion in net cash receipt of $88.6 million from the sale of one of our two PRV's and proceeds from the sale of a portion issuance of our Denali common stock and our remaining Sangamo common stock during 2024. The increase 2025 Senior Notes, which was offset in part by $1.15 a $1.75 billion of cash and cash equivalents used to fund our acquisition of HI-Bio in July 2024 and $650.0 million of cash used payment made for the repayment redemption of our 2023 Term Loan. 4.050% Senior Notes due September 15, 2025.
Source: Item 7, 10-K 0000875045-26-000013 vs Item 7, 10-K 0000875045-25-000009
Risk Factors 181 words changed in this paragraph; it is 63% similar to last year's version.
Our activities, and the activities of our collaborators, distributors and other third-party providers, are subject to extensive government regulation and oversight in the U.S. and in foreign jurisdictions, and are subject to change and evolving interpretations, which could require us to incur substantial costs associated with compliance or to alter one or more of our business practices. The FDA and comparable foreign agencies directly regulate many of our most critical business activities, including the conduct of preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse event reporting, product risk management and our compliance with good practice quality guidelines and regulations. Our interactions with physicians and other health care healthcare providers that prescribe or purchase our products are also subject to laws and government regulation designed to prevent fraud and abuse in the sale and use of products and place significant restrictions on the marketing practices of health care healthcare companies. Health care Healthcare companies are facing heightened scrutiny of their relationships with health care providers and have been the target of lawsuits and investigations alleging violations of laws and government regulation, including claims asserting submission of incorrect pricing information, impermissible off-label promotion of pharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, antitrust violations or violations related to environmental matters. There is also enhanced scrutiny of company-sponsored patient assistance programs, including testing, insurance premium and co-pay assistance programs and donations to third-party charities that provide such assistance. The U.S. government has challenged some of our donations to third-party charities that provide patient assistance. If we, or our vendors or donation recipients, are found to fail to comply with relevant laws, regulations or government guidance in the operation of these or other patient assistance programs, we could be subject to significant fines or penalties. Risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic areas with different patient populations, which
Source: Item 1A, 10-K 0000875045-26-000013 vs Item 1A, 10-K 0000875045-25-000009
Legal Proceedings 121 words changed in this paragraph; it is 39% similar to last year's version.
In June 2024, the Technical Boards of Appeal of the European Patent Office upheld the validity of Fresenius Kabi Deutschland GmbH's (Fresenius Kabi's) European Patent 3 145 488 (the EP '488 Patent), which expires in May 2035. In June 2022 2022, Fresenius Kabi filed a claim for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris alleging that IMRALDI, the adalimumab biosimilar product infringement of Samsung Bioepis that Biogen commercializes in Europe, infringes the French counterpart of EP ‘3 145 488 Patent (the EP '488 Patent) by a formulation of IMRALDI no longer commercialized in France. Fresenius Kabi alleges damages of € 13,450,000 plus interest and costs. Biogen disputes infringement and the EP ‘488 Patent. In March 2024 the Düsseldorf Regional Court dismissed Fresenius Kabi's claim of infringement validity of the German counterpart of the EP '488 Patent and Fresenius Kabi has appealed to the Higher Regional Court of Düsseldorf. patent. Trial is set for June 2026.
Source: Item 3, via Note 21 – Litigation, 10-K 0000875045-26-000013 vs Item 3, via Note 21 – Litigation, 10-K 0000875045-25-000009
Accounting Policies 79 words changed in this paragraph; it is 64% similar to last year's version.
At each reporting period we review our inventories for excess or obsolescence and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by us, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Additionally, our products are subject to strict quality control and monitoring that we perform throughout the manufacturing process. In the event that certain batches or units of product no longer meet quality specifications, we will record a charge to cost of sales to write-down any unmarketable inventory to its estimated net realizable value. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts written-down due to unmarketable inventory are charged to cost of sales in our consolidated statements of income.
Source: 10-K text, Note 1 – Summary of Significant Accounting Policies, 10-K 0000875045-26-000013 vs 10-K text, Note 1 – Summary of Significant Accounting Policies, 10-K 0000875045-25-000009
Every change, by type
Sentences and paragraphs of BIIB's Risk Factors and MD&A, 10-K 2026-02-06 against 10-K 2025-02-12. Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier
(may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
•disruptions, turnover or changes in strategy, priorities or capabilities at our collaborators resulting from, for example, a change in control, may impact the commercialization or manufacturing of our shared products and may result in loss of revenue or higher operating expense; and
AddedRisk Factors
In 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. The OBBBA implements additional eligibility rules on government health plans, expands administrative procedures around enrollment, modifies how states can obtain federal funding for Medicaid and no longer extends ACA premium subsidies. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028. At this time, we are unable to determine the overall impact that the OBBBA will have on our business, results of operations and financial condition, or the impact the OBBBA will have on the pharmaceutical industry as a whole because any such impact will depend upon developing interpretations of the OBBBA provisions and implementing regulations, which may be material.
AddedRisk Factors
Additionally, the current government administration has introduced various measures to address prescription drug pricing and access, including through issuance of an executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other developed countries. If 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. Additional proposals, regulations or initiatives related to drug pricing, such as the CMS-proposed MFN initiatives, the Global Benchmark for Efficient Drug Pricing for certain Medicare Part B drugs and the Guarding U.S. Medicare Against Rising Drug Costs for certain Medicare Part D drugs, continue to be debated, and additional executive orders or regulatory initiatives focused on drug pricing and competition may be adopted and implemented in some form. The timing and extent of implementation of any of the measures described above is uncertain and we cannot fully predict their impact on our product candidates and our business. The adoption of these and any other government controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could exclude or limit our product candidates from coverage, limit payments for
AddedRisk Factors
pharmaceuticals, limit our ability to launch products in certain markets and impact healthcare systems and drug markets in the U.S. and abroad, thereby negatively affecting our revenue and adversely impacting our business.
AddedRisk Factors
technology service providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption or loss of confidential or propriety information.
AddedRisk Factors
•the imposition of tariffs or reciprocal tariffs, trade protection measures, embargoes, import or export licensing requirements and the imposition of trade sanctions and other similar restrictions.
AddedRisk Factors
Our international operations are also subject to regulation under U.S. law. For example, the U.S. federal government has initiated Section 232 investigations including with respect to pharmaceutical imports into the U.S. The 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.
RemovedRisk Factors
RemovedRisk Factors
RewordedRisk Factors
Our 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. and Switzerland, and regulations (including the Global Tax Deal Executive Order issued on January 20, 2025) either prospectively or retrospectively and the effects of the integrations of Reata and HI-Bio.
RewordedRisk Factors
In addition, our increased use of cloud technologies heightens these and other operational risks, and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption or loss of confidential or propriety information.
RewordedRisk Factors
Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenue and results of operations. operations, could curtail or eliminate our ability to adequately fund research and development programs and/or could cause a decline or volatility in our stock price.
RewordedRisk Factors
For example, a recently completed acquisition one of a our contract development manufacturers for IMRALDI and manufacturing organization BENEPALI was acquired by a third party in 2024 which may impact its the contract manufacturer's operational, strategic or financial risk.
RewordedRisk Factors
If we determine that the fair value of any of our owned properties is lower than their book value, we may not realize the full investment in these properties and incur significant impairment charges or additional depreciation when the expected useful lives of certain assets have been shortened due to the anticipated closing of facilities.
RewordedRisk Factors
Our ability to repurchase shares will depend upon, among other factors, our cash balances and potential future capital requirements for strategic transactions, our results of operations, our financial condition and other factors beyond our control that we may deem relevant.
RewordedRisk Factors
Additionally, we are building a new gene therapy, clinical packaging and other manufacturing facility as well as modernizing and automating our existing manufacturing facilities in RTP, North Carolina RTP with no assurance that this investment these investments will be fully utilized.
RewordedRisk Factors
Our reputation could be damaged by the negative publicity generated from false or if adverse information concerning us is posted on misleading social media platforms or similar mediums, posts concerning us, which we may not be able to reverse.
RewordedRisk Factors
Risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic areas with different patient populations, which may have different product distribution methods, marketing programs or patient assistance programs from those we currently utilize or support.
RewordedRisk Factors
The impact on the Company will depend on the timing of implementation, the exact nature of each country's GloBE legislation, guidance and regulations (including the Global Tax Deal Executive Order issued on Pillar Two side-by-side package announced by the OECD in January 20, 2025) 2026) thereon and their application by tax authorities either prospectively or retrospectively.
RewordedRisk Factors
Sales of our products depend, to a significant extent, on the availability and extent of adequate coverage, pricing and reimbursement from third-party payors, government health administration authorities, private health insurers and other organizations, which are subject to increasing and intense pressure from political, social, competitive and other sources.
RewordedRisk Factors
Sales of our products depend, to a significant extent, on the availability and extent of adequate coverage, pricing and reimbursement from third-party payors. governmental health administration authorities, private health insurers and other organizations.
Quiet changesRisk Factors
Product development is very expensive and involves a high degree of uncertainty and risk and may is not be always successful.
Quiet changesRisk Factors
Additionally, in certain jurisdictions governmental health agencies may are permitted to adjust, retroactively and/or prospectively, reimbursement rates for our products.
Quiet changesRisk Factors
Reimbursement for our products by governments, including the timing of any reimbursements, may are also be affected by budgetary or political constraints, particularly in challenging economic environments.
Quiet changesRisk Factors
One 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.
AddedMD&A
An interim goodwill impairment test based on quantitative factors may be required if adverse events indicate an impairment might be present. We monitor changes to our stock price between annual impairment tests, and we believe that general deterioration in macroeconomic and industry-specific conditions may not be indicators of a goodwill impairment, as such conditions may not represent a significant adverse change to our underlying operating performance, cash flows, financial condition or liquidity. Should our market capitalization decline below the carrying value of our net assets for a sustained period, we would consider the length and severity of the decline and the reason for the decline when assessing whether potential goodwill impairment exists.
AddedMD&A
The U.S. has imposed a baseline tariff on imports from all countries, subject to certain exceptions. Trade-related tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China and retaliatory tariffs imposed by China on U.S. imports.
AddedMD&A
The U.S. Secretary of Commerce has further initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, key starting materials and derivative products of those items, under Section 232 of the Trade Expansion Act of 1962.
AddedMD&A
There is a high degree of uncertainty concerning what future steps countries and economic blocs will take in response to changes in global trade rules and economics.
AddedMD&A
Key products that are currently manufactured mainly outside the U.S. are TECFIDERA, VUMERITY and LEQEMBI. In 2024 we initiated a technology transfer process to enable us to manufacture LEQEMBI in the U.S., which was approved in January 2026.
AddedMD&A
Although certain starting materials for SKYCLARYS rely on a single supplier based in China, the manufacturing process, including active pharmaceutical ingredients and drug substance, is primarily conducted in the U.S.
AddedMD&A
As of the date of this filing, we do not expect the tariffs currently applicable to our business to result in a material adverse effect on our operations in 2026. This is based on existing tariffs either in place or potential tariffs as previously announced by the U.S. Administration, our manufacturing footprint, and our inventory levels and positioning. Should significant additional tariffs be enacted, our business could be impacted in the future and differ materially from our current expectations. We will continue to monitor the current and future global tariff landscape as it evolves.
AddedMD&A
Additionally, in May 2025 the U.S. government issued an executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other developed countries. If HHS sets MFN pricing targets for prescription drugs, including the use of international reference pricing to set drug prices in the U.S., it could result in reduced prices and reimbursement for certain of the Company's products in the U.S. We continue to evaluate the potential impact of this executive order. This executive order and any additional legislation, regulations or initiatives related to drug pricing, such as the CMS-proposed MFN initiatives, the Global Benchmark for Efficient Drug Pricing for certain Medicare Part B drugs and the Guarding U.S. Medicare Against Rising Drug Costs for certain Medicare Part D drugs, could create additional uncertainty around the timing and prioritization around worldwide commercial efforts and adversely impact our business and results of operations.
AddedMD&A
On July 4, 2025, the U.S. signed into law the H.R.1 legislation formally titled "An Act to Provide for Reconciliation Pursuant to Title II of H. Con. Res. 14", commonly referred to as the OBBBA.
AddedMD&A
The OBBBA contains tax provisions, such as the permanent extension or revision of certain expiring provisions of the Tax Cuts and Jobs Act enacted in 2017, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The provisions of the OBBBA have multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.
AddedMD&A
The OBBBA did not result in any material adjustments to our total income tax provision for the year ended December 31, 2025, and we have adjusted our deferred tax balances to reflect the impacts of the OBBBA enactment. However, given the complexity of tax laws, related regulations and interpretations, our current estimates may require revision as additional information becomes available regarding the application of the OBBBA provisions.
AddedMD&A
The OBBBA also enacts significant potential changes to Medicaid funding and rescinds or does not continue elements of the PPACA. The OBBBA implements additional eligibility rules on government health plans, expands administrative procedures around enrollment, modifies how states can obtain federal funding for Medicaid and no longer extends ACA premium subsidies. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028.
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RemovedMD&A
RewordedMD&A
For 2024 2025 compared to 2023, 2024, the decrease in research and development was primarily driven by approximately $197.0 million of equity-based compensation expense recognized in 2023 related to our acquisition of Reata, continued cost-reduction measures realized in 2024 in connection with our portfolio prioritization initiatives and our Fit for Growth program, as well as higher spend on clinical trials and close out costs incurred during 2023, partially offset by approximately $48.5 $23.9 million of step-up amortization related to SKYCLARYS inventory recorded in 2025, compared to $48.5 million in 2024, and approximately $42.5 million of equity based equity-based compensation expense recognized in 2024 related to our acquisition of HI-Bio.
RewordedMD&A
The following table summarizes our contractual obligations as of December 31, 2024, 2025, excluding amounts related to uncertain tax positions, funding commitments, contingent development, regulatory and commercial milestone payments, contingent payments and contingent consideration related to our business combinations, as described below.Payments Due by Period (In millions) Total Less than 1 to 3 3 to 5 After 1 Year Years Years 5 Years Non-cancelable operating leases (1)(2)(3) leases(1)(2)(3) $ 459.6 414.8 $ 88.7 81.9 $ 152.5 135.5 $ 66.0 49.1 $ 152.4 148.3 Long-term debt obligations (4) 9,797.0 1,965.0 323.7 323.7 7,184.6 obligations(4) 11,359.7 264.6 529.1 2,006.5 8,559.5 Purchase and other obligations (5) 566.7 406.2 135.3 20.7 obligations(5) 352.0 243.1 96.7 7.7 4.5 Defined benefit obligation 107.1 118.7 — — — 107.1 118.7 Total contractual obligations $ 10,930.4 12,245.2 $ 2,459.9 589.6 $ 611.5 761.3 $ 410.4 2,063.3 $ 7,448.6 8,831.0
RewordedMD&A
RewordedMD&A
For the year ended December 31, 2024, 2025, net unrealized losses and realized gains losses on our holdings in equity securities were approximately $18.2 million and $1.5 million, respectively, compared to net unrealized losses and realized gains of approximately $102.4 million and $2.0 million, respectively, compared to net unrealized and realized losses of approximately $270.0 million and $5.2 million, respectively, in 2023. 2024.
RewordedMD&A
The degree of impact from this legislation on our business depends on a number of forthcoming implementation actions by regulatory authorities, which may be further impacted by other legislative acts that may modify or replace the full extent of IRA, such as the IRA's impacts on our sales and, in turn, our business, remains unclear. OBBBA, as discussed below.
RewordedMD&A
Rare disease revenue includes sales from SPINRAZA, QALSODY, which became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024, and SKYCLARYS, SKYCLARYS which was obtained as part became commercially available in the E.U. during the first quarter of our acquisition of Reata in September 2023. 2024.
RewordedMD&A
For 2024 2025 compared to 2023, 2024, the decrease increase in contract manufacturing revenue was primarily driven by higher volumes in 2023 due to the timing of batch production, which includes batches related to LEQEMBI that we began recognizing in the first quarter of 2023 upon the accelerated approval of LEQEMBI in the U.S. production.
RewordedMD&A
For 2024 2025 compared to 2023, 2024, the change in other (income) expense, net primarily reflects lower higher interest income in 2025 driven by lower higher cash balances as well as higher litigation related expense in 2024, 2025 compared to 2023, partially offset by higher net losses on our holdings in equity securities in 2023. 2024.
RewordedMD&A
RewordedMD&A
The degree of impact from this legislation on our business depends on a number of forthcoming implementation actions by regulatory authorities, which may be further impacted by other legislative acts that may modify or replace the full extent of IRA, such as the IRA's impacts on our sales and, in turn, our business, remains unclear. OBBBA.
RewordedMD&A
For 2025 2026 compared to 2024, 2025, we anticipate lower net interest expense as a result of higher interest income driven by higher cash balances, somewhat partially offset by lower higher interest rates, leading to more interest income. expense as a result of the issuance of our 2025 Senior Notes.
RewordedMD&A
For the Years Ended December 31, 2025 2024 2023 (In millions) Severance Costs Accelerated Depreciation and Other Costs Total Severance Costs Accelerated Depreciation and Other Total Severance Costs Accelerated Depreciation and Other Total Costs Selling, general and administrative $ — $ (1.4) $ (1.4) $ — $ 13.8 $ 13.8 $ — $ 23.3 $ 23.3 Research and development — 10.1 10.1 — 11.7 11.7 — 1.2 1.2 Restructuring charges 48.7 — 48.7 24.2 — 24.2 153.4 34.6 188.0 Total charges $ 48.7 $ 8.7 $ 57.4 $ 24.2 $ 25.5 $ 49.7 $ 153.4 $ 59.1 $ 212.5
Quiet changesMD&A
We expect the future sales of TYSABRI may will continue to be adversely affected by the entrance of this biosimilar.
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