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What changed in Biogen's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Biogen's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+673 added−589 removedSource: 10-K (2026-02-06) vs 10-K (2025-02-12)

Top changes in Biogen's 2025 10-K

673 paragraphs added · 589 removed · 431 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

244 edited+107 added−71 removed302 unchanged
Biggest changeAlzheimer's Disease and Dementia Lecanemab (Aβ mAb) (1)(2) - Early Alzheimer's Approved Lecanemab (Aβ mAb) (1) - Preclinical Alzheimer's Phase 3 Lecanemab (Aβ mAb) (1) - Subcutaneous autoinjector maintenance - Early Alzheimer's Regulatory Review Lecanemab (Aβ mAb) (1) - Subcutaneous autoinjector initiation - Early Alzheimer's Phase 3 BIIB080 (tau ASO) (1) - Alzheimer's Phase 2 Neuropsychiatry Zuranolone (GABA A PAM) (1)(3) - PPD Approved/Regulatory Review Specialized Immunology Felzartamab (anti-CD38 mAb) - AMR Phase 2 Felzartamab (anti-CD38 mAb) - IgAN Phase 2 Felzartamab (anti-CD38 mAb) - PMN Phase 2 Felzartamab (anti-CD38 mAb) - lupus nephritis Phase 1 Izastobart (C5aR1 mAb) - complement mediated disease Phase 1 Dapirolizumab pegol (anti-CD40L) (1) - SLE Phase 3 Litifilimab (anti-BDCA2) - SLE Phase 3 Litifilimab (anti-BDCA2) - CLE Phase 3 Neuromuscular Disorders Omaveloxolone (Nrf2 activator) - FA (4) Approved Omaveloxolone (Nrf2 activator) - Pediatric FA Phase 1 Tofersen (SOD1 ASO) (1)(5) - SOD1 ALS Approved HD Nusinersen (SMN2 splice modulator) - SMA Regulatory Review BIIB115 (SMN ASO) (1) - SMA Phase 1b Parkinson's and Movement Disorders BIIB122 (LRRK2 inhibitor) (1) - Parkinson's Phase 2 Multiple Sclerosis BIIB091 (peripheral BTK inhibitor) - MS Phase 2 (1) Collaboration program (2) Granted accelerated approval in the U.S. in January 2023 and traditional approval in the U.S. in July 2023.
Biggest changeNeurology Lecanemab (Aβ mAb) (1) - Preclinical Alzheimer's Phase 3 BIIB080 (tau ASO) (1) - Alzheimer's Phase 2 BIIB122 (LRRK2 inhibitor) (1) - Parkinson's Phase 2 BIIB091 (peripheral BTK inhibitor) - MS Phase 2 Immunology Dapirolizumab pegol (anti-CD40L) (1) - SLE Phase 3 Litifilimab (anti-BDCA2) - SLE Phase 3 Litifilimab (anti-BDCA2) - CLE Phase 3 BIIB142 (IRAK4 degrader) (1) Phase 1 BIIB145 (BTK degrader) (1) Phase 1 Rare Disease Felzartamab (anti-CD38 mAb) - AMR Phase 3 Felzartamab (anti-CD38 mAb) - IgAN Phase 3 Felzartamab (anti-CD38 mAb) - PMN Phase 3 Felzartamab (anti-CD38 mAb) - MVI Phase 2 Omaveloxolone (Nrf2 activator) - Pediatric FA Phase 3 Salanersen BIIB115 (SMN ASO) (1) - SMA Phase 3 Zorevunersen (SCN1A ASO) (1) - Dravet syndrome Phase 3 (1) Collaboration program For information about certain of our agreements with collaborators and other third parties, please read the subsection entitled Business Relationships below and Note 2, Acquisitions and Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
In addition, in some markets, when a generic or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time. Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA.
In addition, in some markets, when a generic or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time. TECFIDERA Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA.
RARE DISEASE SPINAL MUSCULAR ATROPHY We face competition from a gene therapy product ZOLGENSMA (onasemnogene abeparvovec-xioi) and an oral product EVRYSDI (risdiplam).
RARE DISEASE SPINAL MUSCULAR ATROPHY We face competition from an oral product EVRYSDI (risdiplam) and a gene therapy product ZOLGENSMA (onasemnogene abeparvovec-xioi).
The results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a BLA or a NDA. In response to a BLA or NDA, the FDA may grant marketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis for approval.
The results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a BLA or NDA. In response to a BLA or NDA, the FDA may grant marketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis for approval.
The agency may require the sponsor of a BLA or NDA to conduct additional clinical studies or to provide other scientific or technical information about the product, and these additional requirements may lead to unanticipated delays or expenses.
The agency may require the sponsor of a BLA or NDA to conduct additional clinical studies or to provide other scientific or technical information about the product, and these additional requirements may lead to unanticipated delays and/or expenses.
SPINRAZA has been granted ODD in the U.S., the E.U. and Japan; QALSODY and SKYCLARYS have been granted ODD in the U.S. and the E.U.; and felzartamab has been granted ODD in the U.S. for development in the treatment of PMN and AMR and in the E.U. in IgAN and solid organ transplantation.
SPINRAZA has been granted ODD in the U.S., the E.U. and Japan; QALSODY and SKYCLARYS have been granted ODD in the U.S. and the E.U.; and felzartamab has been granted ODD in the U.S. for development in the treatment of PMN and AMR and in the E.U. in PMN, IgAN and solid organ transplantation.
LEQEMBI is in the early stages of commercial launch in the U.S. and certain international markets and SKYCLARYS is in the early stages of commercial launch in the U.S. and certain European markets.
LEQEMBI is in the early stages of commercial launch in the U.S. and certain international markets and SKYCLARYS is in the early stages of commercial launch in certain European markets.
When such disclosures occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend the company or the public's legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our products.
When such disclosures occur, there is a risk that we may fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend the company or the public's legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our products.
While we continue to build and improve our systems and infrastructure, including our business continuity plans, there can be no assurance that our efforts will prevent cybersecurity threats or incidents in our systems and any such incidents could materially adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in material financial, legal, operational or reputational harm to us, loss of competitive advantage or loss of consumer confidence.
While we continue to build and improve our systems and infrastructure, including our business continuity plans, there can be no assurance that our efforts will detect and prevent cybersecurity threats or incidents in our systems and any such incidents could materially adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in material financial, legal, operational or reputational harm to us, loss of competitive advantage or loss of consumer confidence.
The result of these forthcoming changes for manufacturers, including us, may include: i) a material adverse effect on our revenue on drugs subject to “negotiation”; ii) new rebate liability for drugs subject to the inflation provisions, and iii) potential significant additional costs related to the Part D re-design. • Federal Agency Discounted Pricing : Our products are subject to discounted pricing when purchased by federal agencies via the FSS.
The result of these changes for manufacturers, including us, may include: i) a material adverse effect on our revenue on drugs subject to “negotiation”; ii) new rebate liability for drugs subject to the inflation provisions, and iii) potential significant additional costs related to the Part D re-design. • Federal Agency Discounted Pricing : Our products are subject to discounted pricing when purchased by federal agencies via the FSS.
Our ability to compete, maintain and grow our business may also be adversely affected due to a number of factors, including: • the introduction of other products, including products that may be more efficacious, safer, less expensive or more convenient alternatives to our products, including our own products and products of our collaborators; • the off-label use by physicians of therapies indicated for other conditions to treat patients; • patient dynamics, including the size of the patient population and our ability to identify, attract and maintain new and current patients to our therapies; • the reluctance of physicians to prescribe, and patients to use, our products without additional data on the efficacy and safety of such products; • damage to physician and patient confidence in any of our products, generic or biosimilars of our products or any other product from the same class as one of our products, or to our sales and reputation as a result of label changes, pricing and reimbursement decisions or adverse experiences or events that may occur with patients treated with our products or generic or biosimilars of our products; • inability to obtain and maintain appropriate pricing and adequate reimbursement for our products compared to our competitors in key markets; or • our ability to obtain and maintain patent, data or market exclusivity for our products.
Our ability to compete, maintain and grow our business may be adversely affected by a number of factors, including: • the introduction of other products, including products that may be more efficacious, safer, less expensive or more convenient alternatives to our products, including our own products and products of our collaborators; • the off-label use by physicians of therapies indicated for other conditions to treat patients; • patient dynamics, including the size of the patient population and our ability to identify, attract and maintain new and current patients to our therapies; • the reluctance of physicians to prescribe, and patients to use, our products without additional data on the efficacy and safety of such products; • damage to physician and patient confidence in any of our products, generic or biosimilars of our products or any other product from the same class as one of our products, or to our sales and reputation as a result of label changes, pricing and reimbursement decisions or adverse experiences or events that may occur with patients treated with our products or generic or biosimilars of our products; • inability to obtain and maintain appropriate pricing and adequate reimbursement for our products compared to our competitors in key markets; and • our ability to obtain and maintain patent, data or market exclusivity for our products.
In some countries, particularly in areas where we continue to expand into new geographic areas, we partner with third parties. RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are marketed by the Roche Group and its sublicensees. We commercialize BENEPALI, IMRALDI, FLIXABI and BYOOVIZ pursuant to our agreement with Samsung Bioepis in certain international markets.
In some countries, particularly in areas where we continue to expand into new geographic areas, we partner with third parties. RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are marketed by the Roche Group and its sublicensees. We commercialize BENEPALI, IMRALDI and FLIXABI pursuant to our agreement with Samsung Bioepis in certain international markets.
A MAA approved by the EC is valid in all member states of the E.U. The centralized procedure is required for all biological products, orphan medicinal products and new treatments for neurodegenerative disorders, and it is available for certain other products, including those which constitute a significant therapeutic, scientific or technical innovation.
An MAA approved by the EC is valid in all member states of the E.U. The centralized procedure is required for all biological products, orphan medicinal products and new treatments for neurodegenerative disorders, and it is available for certain other products, including those which constitute a significant therapeutic, scientific or technical innovation.
In addition, several U.S. jurisdictions have similar data privacy laws, such as the CCPA and California Privacy Rights Act. MANUFACTURING We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing capacity, capabilities, processes and facilities.
In addition, several U.S. state jurisdictions have similar data privacy laws, such as the CCPA and California Privacy Rights Act. MANUFACTURING We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing capacity, capabilities, processes and facilities.
SUCCESSION PLANNING Each year we conduct a talent review across our global enterprise that includes, among other important topics, a review of succession plans for many of our roles. To help ensure the long-term continuity of our business, we actively manage the development of talent to fill the roles that are most critical to the ongoing success of our Company.
SUCCESSION PLANNING Each year we conduct a talent review across our global enterprise that includes, among other important topics, a review of succession plans for many of our roles. To help ensure the long-term continuity of our business, we actively manage the development of talent to fill the roles that are most critical to our ongoing success.
We establish components and ranges of compensation based on market and benchmark data. Within this context, we strive to pay all employees fairly within a reasonable range, taking into consideration factors such as role; merit; market data; job location; relevant experience; and individual, business unit and company performance.
We establish components and ranges of compensation based on market and benchmark data. Within this context, we strive to pay all employees fairly within a reasonable range, taking into consideration factors such as role; market data; job location; relevant experience; and individual, business unit and company performance.
E.U. Relapsed or refractory follicular lymphoma U.S. Relapsed or refractory diffuse large B-cell lymphoma Large B-cell lymphoma arising from follicular lymphoma U.S. For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
Relapsed or refractory diffuse large B-cell lymphoma Large B-cell lymphoma arising from follicular lymphoma U.S. For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
In addition to risks associated with new product launches and the other factors described in these Risk Factors, Biogen’s and Eisai’s ability to successfully commercialize LEQEMBI and our ability to successfully commercialize SKYCLARYS may be adversely affected due to: • Eisai’s ability to obtain and maintain adequate reimbursement for LEQEMBI; • the effectiveness of Eisai's and Biogen’s commercial strategy for marketing LEQEMBI; • requirements such as participation in a registry and the use of imaging or other diagnostics for LEQEMBI; • our ability to obtain approval in other markets; • the approval of other new products for the same or similar indications; • Eisai’s and Biogen’s ability to maintain a positive reputation among patients, healthcare providers and others in the Alzheimer’s disease community, which may be impacted by pricing and reimbursement decisions relating to LEQEMBI, which are made by Eisai and/or third parties; • Biogen's ability to obtain and maintain adequate reimbursement for SKYCLARYS; and • the effectiveness of Biogen's commercial strategy for marketing SKYCLARYS.
In addition to risks associated with new product launches and the other factors described in these Risk Factors, Biogen’s and Eisai’s ability to successfully commercialize LEQEMBI and our ability to successfully commercialize SKYCLARYS may be adversely affected due to: • Eisai’s ability to obtain and maintain adequate reimbursement for LEQEMBI; • the effectiveness of Eisai's and Biogen’s commercial strategy for marketing LEQEMBI; • requirements such as participation in a registry and the use of imaging or other diagnostics for LEQEMBI; • our ability to obtain approval in other markets; • the approval and/or greater acceptance of other new products for the same or similar indications; • Eisai’s and Biogen’s ability to maintain a positive reputation among patients, healthcare providers and others in the Alzheimer’s disease community, which may be impacted by pricing and reimbursement decisions relating to LEQEMBI, which are made by Eisai and/or third parties; • Biogen's ability to obtain and maintain adequate reimbursement for SKYCLARYS; and • the effectiveness of Biogen's commercial strategy for marketing SKYCLARYS.
We may not be able to access the capital and credit markets on favorable terms, which could increase our financing costs. We may seek access to the capital and credit markets to supplement our existing funds and cash generated from operations for working capital, capital expenditure and debt service requirements and other business initiatives.
We may not be able to access the capital and credit markets on favorable terms, which could increase financing costs. We may seek access to the capital and credit markets to supplement our existing funds and cash generated from operations for working capital, capital expenditure, debt refinancing, debt service requirements and other business initiatives.
These third-parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations, and they may be unable or unwilling to increase production capacity commensurate with demand for our existing or future products.
Additionally, these third parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations, and they may be unable or unwilling to increase production capacity commensurate with demand for our existing or future products.
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 affected, including adversely affecting our expenses associated with such trials.
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.
Cybersecurity threats and incidents are often carried out by motivated, well-resourced, skilled and persistent actors, including nation states, organized crime groups, “hacktivists” and may include or target employees or contractors acting with careless or malicious intent.
Cybersecurity threats and incidents are often carried out by motivated, well-resourced, skilled and persistent threat actors, including nation states, organized crime groups, “hacktivists” and may include or target employees or contractors acting with careless or malicious intent.
General Risk Factors Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts in our financial statements. As a global biopharmaceutical company, we are subject to taxation in numerous countries, states and other jurisdictions.
General Risk Factors Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts in our financial statements. As a global company, we are subject to taxation in numerous countries, states and other jurisdictions.
Changes in credit ratings issued by nationally recognized credit rating agencies could also adversely affect our cost of financing and the market price of our securities. Our indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business.
Changes in credit ratings issued by nationally recognized credit rating agencies could also adversely affect our cost of financing and the market price of our securities. Our indebtedness could adversely affect us and limit our ability to plan for or respond to changes in our business.
Risks Related to Development, Clinical Testing and Regulation of Our Products and Product Candidates Successful preclinical work or early stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.
Risks Related to Development, Clinical Testing and Regulation of Our Products and Product Candidates Successful preclinical work or early/late stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.
The FDA may withdraw approval if, for instance, post-marketing studies fail to verify clinical benefit, it becomes clear that restrictions on the distribution of the product are inadequate to ensure its safe use or if a sponsor fails to comply with the conditions of the accelerated approval. • Fast Track : The FDA may grant "fast track" status to products that treat a serious condition and have data demonstrating the potential to address an unmet medical need or a drug that has been designated as a qualified infectious disease product. • Breakthrough Therapy : The FDA may grant “breakthrough therapy” status to drugs designed to treat, alone or in combination with another drug or drugs, a serious or life-threatening disease or condition and for which preliminary clinical evidence suggests a substantial improvement over existing therapies based on a clinically significant endpoint.
The FDA may withdraw approval if, for instance, post-marketing studies fail to verify clinical benefit, it becomes clear that 22 Table of Contents restrictions on the distribution of the product are inadequate to ensure its safe use or if a sponsor fails to comply with the conditions of the accelerated approval. • Fast Track : The FDA may grant "fast track" status to products that treat a serious condition and have data demonstrating the potential to address an unmet medical need or a drug that has been designated as a qualified infectious disease product. • Breakthrough Therapy : The FDA may grant “breakthrough therapy” status to drugs designed to treat, alone or in combination with another drug or drugs, a serious or life-threatening disease or condition and for which preliminary clinical evidence suggests a substantial improvement over existing therapies based on a clinically significant endpoint.
Our sales and operations are subject to the risks of doing business internationally, including: • the impact of public health epidemics on the global economy and the delivery of healthcare treatments; • less favorable intellectual property or other applicable laws; • the inability to obtain necessary foreign regulatory approvals of products in a timely manner; • limitations and additional pressures on our ability to obtain and maintain product pricing, reimbursement or receive price increases, including those resulting from governmental or regulatory requirements; • increased cost of goods due to factors such as inflation and supply chain disruptions; 48 Table o f Contents • additional complexity in manufacturing or conducting clinical research internationally, including materials manufactured in China or working with CROs in China; • delays in clinical trials relating to geopolitical instability related to Russia's invasion of Ukraine and the military conflict in the Middle East; • the inability to successfully complete subsequent or confirmatory clinical trials in countries where our experience is limited; • longer payment and reimbursement cycles and uncertainties regarding the collectability of accounts receivable; • fluctuations in foreign currency exchange rates that may adversely impact our revenue, net income and value of certain of our investments; • the imposition of governmental controls; • diverse data privacy and protection requirements; • increasingly complex standards for complying with foreign laws and regulations that may differ substantially from country to country and may conflict with corresponding U.S. laws and regulations; • the anti-bribery and anti-corruption legislation across the globe, including the U.K.
Our sales and operations are subject to the risks of doing business internationally, including: • the impact of public health epidemics on the global economy and the delivery of healthcare treatments; • less favorable intellectual property or other applicable laws; • the inability to obtain necessary foreign regulatory approvals of products in a timely manner; • limitations and additional pressures on our ability to obtain and maintain product pricing, reimbursement or receive price increases, including those resulting from governmental or regulatory requirements; • increased cost of goods due to factors such as inflation and supply chain disruptions; • additional complexity in manufacturing or conducting clinical research internationally, including materials manufactured in China or working with CROs in China; • delays in clinical trials relating to geopolitical instability related to Russia's invasion of Ukraine and the military conflict in the Middle East; • the inability to successfully complete subsequent or confirmatory clinical trials in countries where our experience is limited; • longer payment and reimbursement cycles and uncertainties regarding the collectability of accounts receivable; • fluctuations in foreign currency exchange rates that may adversely impact our revenue, net income and value of certain of our investments; • the imposition of governmental controls; • diverse data privacy and protection requirements; • increasingly complex standards for complying with foreign laws and regulations that may differ substantially from country to country and may conflict with corresponding U.S. laws and regulations; • the anti-bribery and anti-corruption legislation across the globe, including the U.K.
Alexander served as our Executive Vice President, Chief Legal and Corporate Services from March 2017 to March 2018, as our Executive Vice President, Chief Legal Officer and Secretary from December 2011 to March 2017 and as our Executive Vice President, General Counsel and Corporate Secretary from 2006 to December 2011. Prior to joining Biogen, Ms.
Prior to that, Ms. Alexander served as our Executive Vice President, Chief Legal and Corporate Services from March 2017 to March 2018, as our Executive Vice President, Chief Legal Officer and Secretary from December 2011 to March 2017 and as our Executive Vice President, General Counsel and Corporate Secretary from 2006 to December 2011. Prior to joining Biogen, Ms.
This may result in terminated programs, significant restrictions on use and safety warnings in an approved label, adverse placement within the treatment paradigm or significant reduction in the commercial potential of the product candidate.
This may result in terminated programs, significant restrictions on use, safety warnings in an approved label, adverse placement within the treatment paradigm or significant reduction in the commercial potential of the product candidate.
Adverse safety events involving our marketed products, generic or biosimilar versions of our marketed products or products from the same class as one of our products may have a negative impact on our business.
Adverse safety events involving our products, generic or biosimilar versions of our products or products from the same class as one of our products may have a negative impact on our business.
Restrictions on use or safety warnings that may be required to be included in the label of our products may significantly reduce expected revenue for those products and require significant expense and divert management time. Risks Related to Our Operations A breakdown or breach of our information systems could subject us to liability or interrupt the operation of our business.
Restrictions on use or safety warnings that may be required to be included in the label of our products may significantly reduce expected revenue for those products or require significant expense or divert management time. Risks Related to Our Operations A breakdown or breach of our information systems could subject us to liability or interrupt our business operations.
Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient co-pay or co-insurance obligations and limitations on patients' use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs).
Many third-party payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient co-pay or co-insurance obligations and limitations on patients' use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs).
We have a global collaboration and license agreement with Sage to jointly develop and commercialize ZURZUVAE (zuranolone) for the treatment of PPD. Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S.
SUPERNUS (PREVIOUSLY SAGE) We have a global collaboration and license agreement with Supernus to jointly develop and commercialize ZURZUVAE (zuranolone) for the treatment of PPD. Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S.
Charges resulting from excess capacity may continue to occur and would have a negative effect on our financial condition and results of operations. The illegal distribution and sale by third-parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
Charges resulting from excess capacity may occur and would have a negative effect on our financial condition and results of operations. The illegal distribution and sale by third parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.
According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality with PPD among the most common complications during and after pregnancy. Product Indication Collaborator Major Markets PPD in adults Sage U.S.
According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality with PPD among the most common complications during and after pregnancy. Product Indication Collaborator Major Markets PPD in adults Supernus U.S.
In addition to our drug substance manufacturing facilities, we have a drug product manufacturing facility and supporting infrastructure in RTP, North Carolina, including a parenteral facility and an oral solid dose products manufacturing facility. The parenteral facility adds capabilities and capacity for filling biologics into vials and is used for filling product candidates.
In addition to our drug substance manufacturing facilities, we have a drug product manufacturing facility and supporting infrastructure in RTP, including a parenteral facility and an oral solid dose products manufacturing facility. The parenteral facility adds capabilities and capacity for filling biologics into vials and is used for filling product candidates.
Keeney was at Sanofi from 2014 to 2018 where he had responsibility for all of Sanofi Gezyme's business development activities, including early- and late-stage deals across therapeutic areas and modalities, successfully completing several significant transactions. From 2004 to 2013 Dr.
Keeney was at Sanofi from 2014 to 2018 where he had responsibility for all of Sanofi Genzyme's business development activities, including early- and late-stage deals across therapeutic areas and modalities, successfully completing several significant transactions. From 2004 to 2013 Dr.
Our global bulk supply of these products and product candidates depends on the uninterrupted and efficient operation of these facilities, which could be adversely affected by equipment failures, labor or raw material shortages, geopolitical instability, public health epidemics, natural disasters, adverse weather events, power failures, cyber-attacks and many other factors. • Risks Relating to Compliance with current GMP (cGMP).
Our global bulk supply of these products and product candidates depends on the uninterrupted and efficient operation of these facilities, which could be adversely affected by equipment failures, labor or raw material shortages, geopolitical instability, public health epidemics, natural disasters, adverse weather events, power failures, cyber-attacks and many other factors. 47 Table of Contents • Risks Relating to Compliance with current GMP (cGMP).
Any of the following negative developments relating to any of our products or any of our anti-CD20 therapeutic programs may adversely affect our revenue and results of operations or could cause a decline in our stock price: • the introduction, greater acceptance or more favorable reimbursement of competing products, including new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; • safety or efficacy issues; • limitations and additional pressures on product pricing or price increases, including those relating to inflation and those resulting from governmental or regulatory requirements, including those relating to any future potential drug price negotiation under the IRA; increased competition, including from generic or biosimilar versions of our products; or changes in, or implementation of, reimbursement policies and practices of payors and other third-parties; • adverse legal, administrative, geopolitical events, regulatory or legislative developments; or • our ability to maintain a positive reputation among patients, healthcare providers and others, which may be impacted by our pricing and reimbursement decisions.
Any of the following negative developments relating to any of our products or any of our anti-CD20 therapeutic programs may adversely affect our revenue and results of operations or our stock price: • the introduction, greater acceptance or more favorable reimbursement of competing products, including new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; • safety or efficacy issues; • limitations and additional pressures on product pricing or price increases, including those relating to inflation and those resulting from governmental or regulatory requirements, including those relating to any future potential drug price negotiation under the IRA or other legislative or executive acts; increased competition, including from generic or biosimilar versions of our products; or changes in, or implementation of, reimbursement policies and practices of payors and other third parties; • adverse legal, administrative, geopolitical, regulatory or legislative developments; and • our ability to maintain a positive reputation among patients, healthcare providers and others, which may be impacted by our pricing and reimbursement decisions.
The reporting of adverse safety events involving our products or products similar to ours and public rumors about such events may increase claims against us and may also cause our product sales to decline or our stock price to experience periods of volatility.
The reporting of adverse safety events involving our products or products similar to ours and public rumors about such events may increase claims against us and may also cause our product sales to decline or lead to periods of stock price volatility.
We face uncertainties regarding potential healthcare reforms, governmental policy and prioritization, and the uncertainty about the future of the PPACA and healthcare laws may put downward pressure on pharmaceutical pricing and increase our regulatory burdens and operating costs.
We face uncertainties regarding potential healthcare reforms, governmental policy and prioritization. The uncertainty about the future of the PPACA and healthcare laws may put downward pressure on drug pricing and increase our regulatory burdens and operating costs.
Such off-label prescribing is common across medical specialties, and often reflects a physician's belief that the off-label use is the best treatment for patients. The FDA does not regulate the behavior of physicians in their choice of treatments, but FDA regulations do impose stringent restrictions on manufacturers' communications regarding off-label uses.
Such off-label prescribing is common across medical specialties, and often reflects a physician's belief that the off-label use is the best treatment for patients. The FDA does not regulate the behavior of physicians in their choice of treatments, but FDA regulations do impose stringent restrictions on manufacturers' 23 Table of Contents communications regarding off-label uses.
If we or our third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical trials or the potential regulatory approval of a product candidate may be delayed or denied. We have opened clinical trial sites and are enrolling patients in a number of countries where our experience is limited.
If we or our third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical trials or the potential regulatory approval of a product candidate may be delayed or denied. 45 Table of Contents We have opened clinical trial sites and are enrolling patients in a number of countries where our experience is limited.
We compete with biotechnology and pharmaceutical companies that have a greater number of products on the market and in the product pipeline, substantially greater financial, marketing, research and development and other resources and other technological or competitive advantages.
We compete with companies that have a greater number of products on the market and in the product pipeline, substantially greater financial, marketing, research and development and other resources, and other technological or competitive advantages.
Reimbursement for our products by governments, including the timing of any reimbursements, may also be affected by budgetary or political constraints, particularly in challenging economic environments. Government agencies often do not set their own budgets and therefore, have limited control over the amount of money they can spend.
Reimbursement for our products by governments, including the timing of any reimbursements, are also affected by budgetary or political constraints, particularly in challenging economic environments. Government agencies often do not set their own budgets and therefore, have limited control over the amount of money they can spend.
We expect that future sales of TYSABRI may be adversely affected by the entrance of this biosimilar. NEUROLOGY MULTIPLE SCLEROSIS Competition in the MS market is intense. Along with us, a number of companies are working to develop additional treatments for MS that may in the future compete with our MS products.
We expect that future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar worldwide. NEUROLOGY MULTIPLE SCLEROSIS Competition in the MS market is intense. Along with us, a number of companies are working to develop additional treatments for MS that may in the future compete with our MS products.
Our long-term success depends upon the successful development of new products and additional indications for our existing products. Our long-term success will depend upon the successful development of new products from our research and development activities or our licenses or acquisitions from third parties, as well as additional indications for our existing products.
Our long-term success depends upon the successful development of new products and additional indications for our existing products. Our long-term success depends upon the successful development of new products from our research and development activities or our licenses or acquisitions from third parties, as well as the development of additional indications for our existing products.
As part of our broader commitment to these priorities, we continue to tie a portion of our employees' and executive officers' compensation to advancing our Corporate Responsibility priorities. Our Executive Committee has responsibility for evaluating the impact of climate change on the business and overseeing actions taken by the company to limit its adverse impact on the environment.
As part of our broader commitment to these priorities, we continue to link a portion of our employees' and executive officers' compensation to advancing our Corporate Responsibility goals. Our Executive Committee has responsibility for evaluating the impact of climate change on the business and overseeing actions taken by the company to limit its adverse impact on the environment.
Pricing and reimbursement for our products may be adversely affected by a number of factors, including: • changes in, and implementation of, federal, state or foreign government regulations or private third-party payors’ reimbursement policies; • pressure by employers on private health insurance plans to reduce costs; • consolidation and increasing assertiveness of payors seeking price discounts or rebates in connection with the placement of our products on their formularies and, in some cases, the imposition of restrictions on access or coverage of particular drugs or pricing determined based on perceived value; • our ability to receive reimbursement for our products or our ability to receive comparable reimbursement to that of competing products; and • our value-based contracting program pursuant to which we aim to tie the pricing of our products to their clinical values by either aligning price to patient outcomes or adjusting price for patients who discontinue therapy for any reason, including efficacy or tolerability concerns.
Pricing and reimbursement for our products may be adversely affected by a number of factors, including: • changes in, and implementation of, federal, state or foreign government regulations or private third-party payors’ reimbursement policies; • pressure by employers on private health insurance plans to reduce costs; • consolidation and increasing assertiveness of governmental health administration authorities, private health insurers and other organizations seeking price discounts or rebates in connection with the placement of our products on their formularies and, in some cases, the imposition of restrictions on access or coverage of particular drugs or pricing determined based on perceived value; • our ability to receive reimbursement for our products or our ability to receive comparable reimbursement to that of competing products; and • our value-based contracting program pursuant to which we aim to tie the pricing of our products to their clinical values by either aligning price to patient outcomes or adjusting price for patients who discontinue therapy for any reason, including efficacy or tolerability concerns.
By applying our expertise in biologics and our capabilities in small molecule, antisense, gene therapy and other technologies, we target specific medical needs where we believe new or better treatments are needed.
By applying our expertise in biologics and our capabilities in small molecule, antisense and other technologies, we target specific medical needs where we believe new or better treatments are needed.
Even if we could successfully develop new products or indications, we may make a strategic decision to discontinue development of a product candidate or indication if, for example, we believe commercialization will be difficult relative to the standard of care or we prioritize other opportunities in our pipeline.
Even if we could successfully develop new products or additional indications for our existing products, we may make a strategic decision to discontinue development of a product candidate or an additional indication for our existing products if, for example, we believe commercialization will be difficult relative to the standard of care or we prioritize other opportunities in our pipeline.
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.
In addition, our increased use of cloud technologies heightens these and other operational risks, and any failure by cloud or other 46 Table of Contents 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.
The approval pathway for biosimilars does, however, grant a biologics manufacturer a 12-year period of exclusivity from the date of approval of its biological product before biosimilar competition can be introduced. There is uncertainty, however, as the approval framework for biosimilars originally was enacted as part of the PPACA.
The approval pathway for biosimilars does, however, grant a biologics manufacturer a 12-year period of exclusivity from the date of approval of its biological product before 25 Table of Contents biosimilar competition can be introduced. There is uncertainty, however, as the approval framework for biosimilars originally was enacted as part of the PPACA.
The ERM program is overseen by our ERM Committee, a cross-functional group of business leaders representing all of our key business functions. On an ongoing basis, we evaluate the greatest risks to our business, their underlying risk drivers and the associated mitigation activities and controls.
The ERM program is overseen by our ERM Committee, a cross-functional group of 30 Table of Contents business leaders representing all of our key business functions. On an ongoing basis, we evaluate the greatest risks to our business, their underlying risk drivers and the associated mitigation activities and controls.
In recent years, some states have considered legislation and ballot initiatives that would control the prices of drugs, including laws to allow importation of pharmaceutical products from lower cost jurisdictions outside the U.S. and laws intended to impose price controls on state drug purchases.
Some states have considered legislation and ballot initiatives that would control the prices of drugs, including laws to allow importation of pharmaceutical products from lower cost jurisdictions outside the U.S. and laws intended to impose price controls on state drug purchases.
For additional information on our collaboration arrangements with Sage, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
For additional information on our collaboration arrangements with Supernus, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
Furthermore, even if a product is approved, the approval may be subject to limitations based on the FDA's interpretation of the existing pre-clinical and/or clinical data.
Furthermore, even if a product is approved, the approval may be subject to limitations based on the FDA's interpretation of the existing preclinical and/or clinical data.
Product development is very expensive and involves a high degree of uncertainty and risk and may not be successful. Only a small number of research and development programs result in the commercialization of a product. It is difficult to predict the success and the time and cost of product development of novel approaches for the treatment of diseases.
Product development is very expensive and involves a high degree of uncertainty and risk and is not always successful. Only a small number of research and development programs result in the commercialization of a product. It is difficult to predict the success and the time and cost of product development of novel approaches for the treatment of diseases.
If these third-parties fail to perform successfully, or reduce their third party manufacturing production, our biosimilar product development or commercialization of biosimilar products could be delayed, revenue from biosimilar products could decline and/or we may not realize the anticipated benefits of these arrangements; • Competitive Challenges.
If these third parties fail to perform, or reduce their third-party manufacturing production, our biosimilar product development or commercialization of biosimilars could be delayed, revenue from biosimilars could decline and/or we may not realize the anticipated benefits of these arrangements; • Competitive Challenges.
Our current ERGs include: • AccessAbility: Supports employees with disabilities and employees who are caregivers of individuals with disabilities and their allies. • Biogen Veterans Network: Encourages veterans and allies to connect and support one another. • IGNITE: Brings together early-career professionals and their allies. • Mosaic: Fosters awareness and appreciation of different cultural backgrounds, in addition to promoting networking and development opportunities for employees. • ourIMPACT: Addresses environmental issues at work, in employees' personal lives and in the communities where we live and work. • Parenting Network Group: Provides support, networking and development opportunities to working parents and caregivers, as well as helping employees navigate the challenges of work-life balance. • ReachOUT: Brings together LGBTQ+ employees and their allies. • Women’s Impact Network: Creates networking, mentoring and learning opportunities for women and allies worldwide. 32 Table o f Contents INFORMATION ABOUT OUR EXECUTIVE OFFICERS (as of February 12, 2025) Officer Current Position Age Year Joined Biogen Christopher A.
Our current ERGs include: • AccessAbility: Supports employees with disabilities and employees who are caregivers of individuals with disabilities and their allies. • Biogen Veterans Network: Encourages veterans and allies to connect and support one another. • IGNITE: Brings together early-career professionals and their allies. • Mosaic: Fosters awareness and appreciation of different cultural backgrounds, in addition to promoting networking and development opportunities for employees. • ourIMPACT: Addresses environmental issues at work, in employees' personal lives and in the communities where we live and work. • Parenting Network Group: Provides support, networking and development opportunities to working parents and caregivers, as well as helping employees navigate the challenges of work-life balance. • ReachOUT: Brings together LGBTQ+ employees and their allies. • Women’s Impact Network: Creates networking, mentoring and learning opportunities for women and allies worldwide. 33 Table of Contents INFORMATION ABOUT OUR EXECUTIVE OFFICERS (as of February 6, 2026) Officer Current Position Age Year Joined Biogen Christopher A.
The introduction of such products as well as other lower-priced competing products has reduced, and may in the future, significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which will negatively impact our revenue.
The introduction of such products as well as other lower-priced competing products has in the past reduced, and may in the future significantly reduce, both the price that we are able to charge for our products and the volume of products we sell, which has and may continue to negatively impact our revenue.
Our interactions with physicians and other health care 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 companies.
Our interactions with physicians and other 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 healthcare companies.
On August 16, 2022, the IRA was signed into law, which provides for (i) the government to negotiate prices for select high-cost Medicare Part D drugs (beginning in 2026) and Part B drugs (beginning in 2028), (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) Medicare Part D redesign which replaces the current coverage gap provisions and establishes a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for up to 10.0% of costs up to the $2,000 cap and up to 20.0% after that cap is reached.
On August 16, 2022, the IRA was signed into law, which provides for (i) the government to negotiate prices for select high-cost Medicare Part D drugs (beginning in 2026) and Part B drugs (beginning in 2028), (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) Medicare Part D redesign which replaces the previous coverage gap provisions and establishes a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025 (indexed to increase in future years), with manufacturers being responsible for up to 10.0% of costs up to the patient's out-of-pocket cap and up to 20.0% after that cap is reached.
Grogan held several roles in increasing seniority at Genentech across Immunology and Immuno-oncology, covering research strategies and drug development across Rheumatoid Arthritis, Lupus, MS, Inflammatory Bowel Disease and Cancer. Education l Leiden University, Ph.D. in Immunology l University of Melbourne, B.Sc in Biochemistry and Pharmacology 35 Table o f Contents Adam Keeney, Ph.D. Experience Dr.
Grogan held several roles in increasing seniority at Genentech across Immunology and Immuno-oncology, covering research strategies and drug development across Rheumatoid Arthritis, Lupus, MS, Inflammatory Bowel Disease and Cancer. Education l Leiden University, Ph.D. in Immunology l University of Melbourne, B.Sc in Biochemistry and Pharmacology 36 Table of Contents Adam Keeney, Ph.D. Experience Dr.
For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report. 10 Table o f Contents GENENTECH RELATIONSHIPS We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report. 11 Table of Contents GENENTECH RELATIONSHIPS We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
Conditional marketing authorizations are valid for one year and can be renewed annually. The marketing authorization holder is required to complete specific obligations (ongoing or new studies and, in some cases, additional activities) with a view to providing comprehensive data confirming that the benefit risk balance is positive.
Conditional marketing authorizations are valid for one year and can be renewed annually. The marketing authorization holder is required to complete specific obligations (ongoing or new studies and, in some cases, additional activities) with a view to providing 24 Table of Contents comprehensive data confirming that the benefit risk balance is positive.
We 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.
We 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; • Intellectual Property and Regulatory Challenges.
THIRD-PARTY SUPPLIERS AND MANUFACTURERS We principally use third parties to manufacture the active pharmaceutical ingredient and the final product for our small molecule products and product candidates, including TECFIDERA, VUMERITY and FUMADERM, and the final drug product for our large molecule products and, to a lesser extent, product candidates.
THIRD-PARTY SUPPLIERS AND MANUFACTURERS We principally use third parties to manufacture the active pharmaceutical ingredient and the final product for our small molecule products and product candidates, including TECFIDERA, VUMERITY, SKYCLARYS and ZURZUVAE, and the final drug product for our large molecule products and, to a lesser extent, product candidates.
The program covers individuals age 65 and over as well as those with certain disabilities. Medicare Part B generally covers drugs that must be administered by physicians or other health care practitioners, are provided in connection with certain durable medical equipment or are certain oral anti-cancer drugs and certain oral immunosuppressive drugs.
The program covers individuals age 65 and over as well as those with certain disabilities. Medicare Part B generally covers drugs that must be administered by physicians or other health care practitioners, are provided in connection with 26 Table of Contents certain durable medical equipment or are certain oral anti-cancer drugs and certain oral immunosuppressive drugs.
We make available free of charge through the Investors section of our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC.
Our website address is www.biogen.com. We make available free of charge through the Investors section of our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC.
This may create the opportunity for third-party cross-border trade or influence our decision to sell or not to sell a product, thus adversely affecting our geographic expansion plans and revenue. Additionally, in certain jurisdictions governmental health agencies may adjust, retroactively and/or prospectively, reimbursement rates for our products.
This has created, or may create, the opportunity for third-party cross-border trade or influence our decision to sell or not to sell a product, thus adversely affecting our geographic expansion plans and revenue. Additionally, in certain jurisdictions governmental health agencies are permitted to adjust, retroactively and/or prospectively, reimbursement rates for our products.
In the E.U. and some other international markets, the government provides health care at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored health care system.
In the E.U. and some other international markets, the government provides healthcare at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored healthcare system.
Risk Factors included in this report, and the discussion of legal proceedings related to certain patents described above is set forth in Note 21, Litigation, to our consolidated financial statements included in this report. 16 Table o f Contents COMPETITION Competition in the biopharmaceutical industry and the markets in which we operate is intense.
Risk Factors included in this report, and the discussion of legal proceedings related to certain patents described above is set forth in Note 21, Litigation, to our consolidated financial statements included in this report. 17 Table of Contents COMPETITION Competition in the biopharmaceutical industry and the markets in which we operate is intense.
Furthermore, the approval of a product candidate by one regulatory agency does not mean that other regulatory agencies will also approve such product candidate. 38 Table o f Contents Success in preclinical work or early-stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful.
Furthermore, the approval of a product candidate by one regulatory agency does not mean that other regulatory agencies will also approve such product candidate. 39 Table of Contents Success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful.
General Subject Matter Patent Expiration (1) TECFIDERA Europe 2,653,873 Methods of use 2028 PLEGRIDY U.S. 8,017,733 Polymer conjugates of interferon beta-1a 2027 Europe 1,476,181 Polymer conjugates of interferon-beta-1a and uses thereof 2023 (2) TYSABRI U.S. 8,124,350 Methods of treatment 2027 U.S. 8,871,449 Methods of treatment 2026 U.S. 9,316,641 Safety-related assay 2032 U.S. 9,493,567 Methods of treatment 2027 U.S. 9,709,575 Methods of treatment 2026 U.S. 10,119,976 Methods of evaluating patient risk 2034 U.S. 10,233,245 Methods of treatment 2027 U.S. 10,444,234 Safety-related assay 2031 U.S. 10,677,803 Methods of treatment 2034 U.S. 10,705,095 Methods of treatment 2026 U.S. 11,280,794 Methods of treatment 2034 U.S. 11,287,423 Safety-related assay 2031 U.S. 11,292,845 Methods of treatment 2027 U.S. 12,066,442 Methods of treatment 2032 Europe 1,872,136 Method of treatment 2026 Europe 2,170,390 Formulation 2028 Europe 2,645,106 Method of treatment 2026 Europe 3,264,094 Method of treatment 2026 Europe 3,339,865 Safety-related assay 2031 Europe 3,575,792 Safety-related assay 2032 Europe 4,152,004 Safety-related assay 2031 VUMERITY U.S. 8,669,281 Compounds and pharmaceutical compositions 2033 U.S. 9,090,558 Methods of treatment 2033 U.S. 10,080,733 Crystalline forms, pharmaceutical compositions and methods of treatment 2033 Europe 2,970,101 Crystalline forms, pharmaceutical compositions and methods of treatment Prodrugs of fumarates and their use in treating various diseases 2034 Europe 3,253,377 Formulation 2035 SPINRAZA U.S. 7,838,657 SMA treatment via targeting of SMN2 splice site inhibitory sequences 2027 U.S. 8,110,560 SMA treatment via targeting of SMN2 splice site inhibitory sequences 2025 U.S. 8,361,977 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 8,980,853 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 9,717,750 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 9,926,559 Compositions and methods for modulation of SMN2 splicing 2034 U.S. 10,266,822 SMA treatment via targeting of SMN2 splice site inhibitory sequences 2025 U.S. 10,436,802 Methods for Treating Spinal Muscular Atrophy 2035 U.S. 12,013,403 Methods for Treating Spinal Muscular Atrophy 2036 Europe 1,910,395 Compositions and methods for modulation of SMN2 splicing 2026 (3) Europe 2,548,560 Compositions and methods for modulation of SMN2 splicing 2026 (4) Europe 3,305,302 Compositions and methods for modulation of SMN2 splicing 2030 Europe 3,308,788 Compositions and methods for modulation of SMN2 splicing 2026 Europe 3,449,926 Compositions and methods for modulation of SMN2 splicing 2030 (6) LEQEMBI U.S. 8,025,878 Protofibril selective antibodies and the use thereof 2027 (1)(5) 14 Table o f Contents Product Territory Patent No.
General Subject Matter Patent Expiration (1) PLEGRIDY U.S. 8,017,733 Polymer conjugates of interferon beta-1a 2027 Europe 1,476,181 Polymer conjugates of interferon-beta-1a and uses thereof 2023 (2) TYSABRI U.S. 8,124,350 Methods of treatment 2027 U.S. 8,871,449 Methods of treatment 2026 U.S. 9,316,641 Safety-related assay 2032 U.S. 9,493,567 Methods of treatment 2027 U.S. 9,709,575 Methods of treatment 2026 U.S. 10,119,976 Methods of evaluating patient risk 2034 U.S. 10,233,245 Methods of treatment 2027 U.S. 10,444,234 Safety-related assay 2031 U.S. 10,677,803 Methods of treatment 2034 U.S. 10,705,095 Methods of treatment 2026 U.S. 11,280,794 Methods of treatment 2034 U.S. 11,287,423 Safety-related assay 2031 U.S. 11,292,845 Methods of treatment 2027 U.S. 12,066,442 Methods of treatment 2032 Europe 1,872,136 Method of treatment 2026 Europe 2,170,390 Formulation 2028 Europe 2,645,106 Method of treatment 2026 Europe 3,264,094 Method of treatment 2026 Europe 3,339,865 Safety-related assay 2031 Europe 3,575,792 Safety-related assay 2032 Europe 4,152,004 Safety-related assay 2031 VUMERITY U.S. 8,669,281 Compounds and pharmaceutical compositions 2033 U.S. 9,090,558 Methods of treatment 2033 U.S. 10,080,733 Crystalline forms, pharmaceutical compositions and methods of treatment 2033 Europe 2,970,101 Crystalline forms, pharmaceutical compositions and methods of treatment Prodrugs of fumarates and their use in treating various diseases 2034 Europe 3,253,377 Formulation 2035 SPINRAZA U.S. 7,838,657 SMA treatment via targeting of SMN2 splice site inhibitory sequences 2027 U.S. 8,361,977 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 8,980,853 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 9,717,750 Compositions and methods for modulation of SMN2 splicing 2030 U.S. 9,926,559 Compositions and methods for modulation of SMN2 splicing 2034 U.S. 10,436,802 Methods for Treating Spinal Muscular Atrophy 2035 U.S. 12,013,403 Methods for Treating Spinal Muscular Atrophy 2036 Europe 1,910,395 Compositions and methods for modulation of SMN2 splicing 2026 (3) Europe 2,548,560 Compositions and methods for modulation of SMN2 splicing 2026 (4) Europe 3,305,302 Compositions and methods for modulation of SMN2 splicing 2030 Europe 3,308,788 Compositions and methods for modulation of SMN2 splicing 2026 Europe 3,449,926 Compositions and methods for modulation of SMN2 splicing 2030 (6) Europe 3,999,643 Methods of Treating or Preventing Spinal Muscular Atrophy 2040 LEQEMBI U.S. 8,025,878 Protofibril selective antibodies and the use thereof 2027 (1)(5) Europe 2,004,688 Improved protofibril selective antibodies and the use thereof 2027 (1)(9) 15 Table of Contents Product Territory Patent No.
We also continue to pursue additional patents and patent term extensions in the U.S. and other territories covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the patents listed in the table. 13 Table o f Contents Product Territory Patent No.
We also continue to pursue additional patents and patent term extensions in the U.S. and other territories covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the patents listed in the table. 14 Table of Contents Product Territory Patent No.
We regularly review our compensation practices and analyze the fairness of compensation decisions, for individual employees and our workforce as a whole. 31 Table o f Contents RECRUITMENT AND RETENTION We seek to recruit and retain highly qualified employees. A business-wide priority is to strengthen our culture and the employee experience.
We regularly review our compensation practices and analyze the fairness of compensation decisions, for individual employees and our workforce as a whole. 32 Table of Contents RECRUITMENT AND RETENTION We seek to recruit and retain highly qualified employees. A business-wide priority is to strengthen our culture and the employee experience.
The successful execution of our strategic and growth initiatives depends upon internal development projects, commercial initiatives and external opportunities, which may include the acquisition and in-licensing of products, technologies, companies, the entry into strategic alliances and collaborations or our Fit for Growth program, as well as our ability to execute on strategic decisions and initiatives.
The successful execution of our strategic and growth initiatives depends upon internal development projects, commercial initiatives and external opportunities, which may include the acquisition and in-licensing of products, technologies, companies, the entry into strategic alliances and collaborations, as well as our ability to execute on strategic decisions and initiatives.
Our Board of Directors oversees an enterprise-wide approach to risk management, which is designed to support execution of our strategy and achievement of our objectives to improve long-term operational and financial performance and enhance stockholder value. 29 Table o f Contents We have a company-wide ERM program to identify, mitigate and monitor enterprise-level risks that may affect our ability to achieve our objectives.
Our Board of Directors oversees an enterprise-wide approach to risk management, which is designed to support execution of our strategy and achievement of our objectives to improve long-term operational and financial performance and enhance stockholder value. We have a company-wide ERM program to identify, mitigate and monitor enterprise-level risks that may affect our ability to achieve our objectives.
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 50 Table o f Contents impairment charges or additional depreciation when the expected useful lives of certain assets have been shortened due to the anticipated closing of facilities.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changePRODUCT REVENUE Product revenue is summarized as follows: For the Years Ended December 31, % Change $ Change 2024 vs. 2023 2023 vs. 2022 2024 vs. 2023 2023 vs. 2022 (In millions, except percentages) 2024 2023 2022 Multiple Sclerosis $ 4,349.8 $ 4,661.9 $ 5,430.2 (6.7) % (14.1) % $ (312.1) $ (768.3) Rare disease 1,988.1 1,803.0 1,793.5 10.3 0.5 185.1 9.5 Biosimilars 793.1 770.0 751.1 3.0 2.5 23.1 18.9 Other (1) 82.5 11.8 13.0 599.2 (9.2) 70.7 (1.2) Total product revenue, net $ 7,213.5 $ 7,246.7 $ 7,987.8 (0.5) % (9.3) % $ (33.2) $ (741.1) (1) Other includes FUMADERM, ADUHELM and ZURZUVAE, which became commercially available in the U.S. during the fourth quarter of 2023. 64 Table o f Contents MULTIPLE SCLEROSIS • Global TYSABRI revenue decreased $161.9 million, from $1,876.9 million in 2023 to $1,715.0 million in 2024, or 8.6%, primarily due to increased competition and a decrease in pricing in rest of world TYSABRI. • Global TECFIDERA revenue decreased $45.4 million, from $1,012.5 million in 2023 to $967.1 million in 2024, or 4.5%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants in North America, Brazil and certain E.U. countries. • Global Interferon revenue decreased $137.7 million, from $1,105.7 million in 2023 to $968.0 million in 2024, or 12.5%, driven by a decrease is demand as patients transition to higher efficacy therapies. • Global VUMERITY revenue increased $51.7 million, from $576.3 million in 2023 to $628.0 million in 2024, or 9.0%, primarily due to an increase in global demand.
Biggest changePRODUCT REVENUE Product revenue is summarized as follows: For the Years Ended December 31, % Change $ Change 2025 vs. 2024 2024 vs. 2023 2025 vs. 2024 2024 vs. 2023 (In millions, except percentages) 2025 2024 2023 Multiple Sclerosis $ 4,038.9 $ 4,349.8 $ 4,661.9 (7.1) % (6.7) % $ (310.9) $ (312.1) Rare disease 2,154.2 1,988.1 1,803.0 8.4 10.3 166.1 185.1 Biosimilars 729.1 793.1 770.0 (8.1) 3.0 (64.0) 23.1 Other (1) 197.2 82.5 11.8 139.0 nm 114.7 70.7 Total product revenue, net $ 7,119.4 $ 7,213.5 $ 7,246.7 (1.3) % (0.5) % $ (94.1) $ (33.2) nm Not meaningful (1) Other includes ZURZUVAE, FUMADERM and ADUHELM. 69 Table of Contents MULTIPLE SCLEROSIS • Global VUMERITY revenue increased $118.8 million, from $628.0 million in 2024 to $746.8 million in 2025, or 18.9%, primarily due to an increase in global demand and a favorable change in estimate of approximately $20.3 million related to rebates and discounts in the U.S., partially offset by charges related to the IRA redesign. • Global TYSABRI revenue decreased $49.6 million, from $1,715.0 million in 2024 to $1,665.4 million in 2025, or 2.9%, primarily due to increased competition in rest of world, including the impacts from a biosimilar entrant of TYSABRI in Europe. • Global Interferon revenue decreased $22.4 million, from $968.0 million in 2024 to $945.6 million in 2025, or 2.3%, driven by a decrease in demand as patients transition to higher efficacy therapies, offset in part by a favorable change in estimate of approximately $19.3 million related to rebates and discounts in the U.S. • Global TECFIDERA revenue decreased $287.4 million, from $967.1 million in 2024 to $679.7 million in 2025, or 29.7%, driven by a decrease in global demand as a result of multiple TECFIDERA generic entrants.
The IRA did not result in any material adjustments to our income tax provision or other income tax balances as of December 31, 2024 and 2023. Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods.
The IRA did not result in any material adjustments to our income tax provision or other income tax balances as of December 31, 2025 and 2024. Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods.
We are aware of several other anti-CD20 molecules, including biosimilar products, that have been approved and are competing with RITUXAN and GAZYVA in the oncology and other markets. B i osimilar products referencing RITUXAN have launched in the U.S and are being offered at lower prices.
We are aware of several other anti-CD20 molecules, including biosimilar products, that have been approved and are competing with RITUXAN and GAZYVA in the oncology and other markets. B i osimilar products referencing RITUXAN are available in the U.S and are being offered at lower prices.
Revenue generated from sales in Russia and Ukraine represent less than 2.0% of total revenue for the years ended December 31, 2024, 2023 and 2022. Additionally, revenue generated from sales in the broader Middle East region represents less than 2.0% of total revenue for the years ended December 31, 2024, 2023 and 2022.
Revenue generated from sales in Russia and Ukraine represent less than 2.0% of total revenue for the years ended December 31, 2025, 2024 and 2023. Additionally, revenue generated from sales in the broader Middle East region represents less than 2.0% of total revenue for the years ended December 31, 2025, 2024 and 2023.
For additional information on our collaboration and license arrangements with Samsung Bioepis and Sage, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
For additional information on our license arrangements with Samsung Bioepis and our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.
Changes in the fair value of our contingent consideration obligations, other than changes due to payments, are recognized as a (gain) loss on fair value remeasurement of contingent consideration in our condensed consolidated statements of income. In connection with our acquisition of HI-Bio in July 2024 we recorded contingent consideration obligations related to potential milestone payments.
Changes in the fair values of our contingent consideration obligations, other than changes due to payments, are recognized as a (gain) loss on fair value remeasurement of contingent consideration within our consolidated statements of income. In connection with our acquisition of HI-Bio in July 2024 we recorded contingent consideration obligations related to potential milestone payments.
For the year ended December 31, 2024 , amortization and impairment of acquired intangible assets reflects the impact of a $40.0 million impairment charge related to intangible assets from other clinical programs we acquired from Reata, reducing the remaining book value of these IPR&D intangible assets to zero, and a $20.2 million impairment charge related to intangible assets associated with Samsung Bioepis commercialization rights terminated during the third quarter of 2024.
For the year ended December 31, 2024, amortization and impairment of acquired intangible assets reflects the impact of a $40.0 million impairment charge related to intangible assets from other clinical programs we acquired from Reata, reducing the remaining book value of these IPR&D intangible assets to zero, and a $20.2 million impairment charge related to intangible assets associated with the termination of Samsung Bioepis' commercialization rights during the third quarter of 2024.
Item 1A. Risk Factors, included in this report. TECFIDERA Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline.
Item 1A. Risk Factors, included in this report. 59 Table of Contents TECFIDERA Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline.
We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations.
We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and other global geopolitical developments and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
Research and development expense is reported above based on the following classifications. The development stage reported is based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same year. For several of our programs, the research and development activities are part of our collaborative and other relationships.
The development stage reported is based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same year. For several of our programs, the research and development activities are part of our collaborative and other relationships.
For the years ended December 31, 2024, 2023 and 2022, we recognized net profit-sharing expense of approximately $227.4 million, $223.5 million and $217.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits.
For the years ended December 31, 2025, 2024 and 2023, we recognized net profit-sharing expense of approximately $219.2 million, $227.4 million and $223.5 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits.
This competition has had a significant adverse impact on the pre-tax profits of our collaboration arrangements with Genentech, as the sales of RITUXAN have decreased substantially compared to prior periods.
This competition has had a significant adverse impact on the pre-tax profits of our collaboration arrangements with Genentech, as the sales of RITUXAN have decreased substantially compared to prior periods and we expect sales to continue to decrease.
For the years ended December 31, 2024 and 2023, we recognized net profit-sharing expense of approximately $27.0 million and net loss reimbursement of approximately $4.7 million, respectively, to reflect Sage's 50.0% share of net collaboration results in the U.S. for ZURZUVAE for PPD.
For the years ended December 31, 2025, 2024 and 2023, we recognized net profit-sharing expense of approximately $71.0 million and $27.0 million, and net loss reimbursement of approximately $4.7 million, respectively, to reflect Supernus' 50.0% share of net collaboration results in the U.S.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. RESTRUCTURING CHARGES 2023 FIT FOR GROWTH RESTRUCTURING PROGRAM In 2023 we initiated additional cost saving measures as part of our Fit for Growth program to reduce operating costs, while improving operating efficiency and effectiveness.
For additional information on our leases, please read Note 12, Leases , to our consolidated financial statements included in this report. RESTRUCTURING CHARGES 2023 FIT FOR GROWTH RESTRUCTURING PROGRAM In 2023 we initiated cost saving measures as part of our Fit for Growth program to reduce operating costs, while improving operating efficiency and effectiveness.
We expect the IRA's drug pricing controls and Medicare Part D redesign may have an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement.
The IRA's drug pricing controls and Medicare Part D redesign had an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
NET (GAINS) LOSSES IN EQUITY SECURITIES For the year ended December 31, 2024, net unrealized losses and realized gains on our holdings in equity securities were 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. • The net unrealized losses recognized during the year ended December 31, 2024, primarily reflect a decrease in the aggregate fair value of our investments in Sage common stock of approximately $101.4 million, partially offset by an increase in the fair value of Denali and Sangamo common stock of approximately $7.5 million. • The net unrealized losses recognized during the year ended December 31, 2023, primarily reflect a decrease in the aggregate fair value of our investments in Sage, Denali, Sangamo and Ionis common stock of approximately $248.5 million.
NET (GAINS) LOSSES IN EQUITY SECURITIES For the year ended December 31, 2025, net unrealized and realized 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, in 2024. • The net unrealized losses recognized during the year ended December 31, 2025, primarily reflect a decrease in the aggregate fair value of our investment in Denali common stock of approximately $27.7 million, partially offset by an increase in the fair value of Sage common stock of approximately $23.0 million. • The net unrealized losses recognized during the year ended December 31, 2024, primarily reflect a decrease in the aggregate fair value of our investment in Sage common stock of approximately $101.4 million, partially offset by an increase in the fair value of Denali and Sangamo common stock of approximately $7.5 million.
FOR RITUXAN, GAZYVA AND LUNSUMIO The following table provides a summary of amounts comprising our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO: For the Years Ended December 31, (In millions) 2024 2023 2022 Product revenue, net $ 1,531.0 $ 1,581.3 $ 1,729.2 Cost and expense 404.1 419.9 253.6 Pre-tax profits in the U.S. $ 1,126.9 $ 1,161.4 $ 1,475.6 Biogen's share of pre-tax profits $ 392.0 $ 409.4 $ 547.0 For 2024 compared to 2023, the decrease in U.S. product revenue, net was primarily due to a decrease in sales volumes of RITUXAN in the U.S. of 7.9%, resulting from competition from multiple biosimilar products, partially offset by an increase in sales volumes of GAZYVA of 11.8%.
FOR RITUXAN, GAZYVA AND LUNSUMIO The following table provides a summary of amounts comprising our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO: For the Years Ended December 31, (In millions) 2025 2024 2023 Product revenue, net $ 1,655.9 $ 1,531.0 $ 1,581.3 Cost and expense 448.3 404.1 419.9 Pre-tax profits in the U.S. $ 1,207.6 $ 1,126.9 $ 1,161.4 Biogen's share of pre-tax profits $ 420.2 $ 392.0 $ 409.4 For 2025 compared to 2024, the increase in our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO was primarily due to an increase in sales volumes of GAZYVA of approximately 14.4%, partially offset by a decrease in sales volumes of RITUXAN of approximately 4.1%, resulting from competition from multiple biosimilar products.
Reserves for discounts, contractual adjustments and returns that reduced gross product revenue are summarized as follows: For the Years Ended December 31, (In millions) 2024 2023 2022 Contractual adjustments $ 2,648.8 $ 2,681.7 $ 2,716.9 Discounts 832.2 735.2 663.9 Returns 37.8 38.2 5.1 Total discounts and allowances $ 3,518.8 $ 3,455.1 $ 3,385.9 For the years ended December 31, 2024, 2023 and 2022, reserves for discounts and allowances as a percentage of gross product revenue were 32.6%, 32.0% and 30.1%, respectively.
Reserves for discounts, contractual adjustments and returns that reduced gross product revenue are summarized as follows: For the Years Ended December 31, (In millions) 2025 2024 2023 Contractual adjustments $ 2,689.7 $ 2,648.8 $ 2,681.7 Discounts 834.6 832.2 735.2 Returns 32.6 37.8 38.2 Total discounts and allowances $ 3,556.9 $ 3,518.8 $ 3,455.1 For the years ended December 31, 2025, 2024 and 2023, reserves for discounts and allowances as a percentage of gross product revenue were 33.0%, 32.6% and 32.0%, respectively.
We intend to continue committing significant resources to targeted research and development opportunities where there is a significant unmet need and where a drug candidate has the potential to be highly differentiated.
We intend to continue committing significant resources to targeted research and development opportunities while continuing to invest in our pipeline, where there is a significant unmet need and where a drug candidate has the potential to be highly differentiated.
INCOME TAX PROVISION For the Years Ended December 31, (In millions, except percentages) 2024 2023 2022 Income before income tax (benefit) expense $ 1,906.0 $ 1,296.8 $ 3,591.8 Income tax (benefit) expense 273.8 135.3 632.8 Effective tax rate 14.4 % 10.4 % 17.6 % Our effective tax rate fluctuates from year to year due to the global nature of our operations.
INCOME TAX PROVISION For the Years Ended December 31, (In millions, except percentages) 2025 2024 2023 Income before income tax (benefit) expense $ 1,556.5 $ 1,906.0 $ 1,296.8 Income tax (benefit) expense 263.6 273.8 135.3 Effective tax rate 16.9 % 14.4 % 10.4 % Our effective tax rate fluctuates from year to year due to the global nature of our operations.
INFLATION REDUCTION ACT OF 2022 In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA are effective for periods after December 31, 2022.
FACTORS AFFECTING PHARMACEUTICAL PRICING AND OTHER DEVELOPMENTS In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA are effective for periods after December 31, 2022.
This enacted legislation and guidance related to the OECD model rules did not result in any material adjustments to our income tax provision or income tax balances as of December 31, 2024. On January 20, 2025, the Global Tax Deal Executive Order was issued.
This enacted legislation and guidance related to the OECD model rules did not result in any material adjustments to our income tax provision or income tax balances as of December 31, 2025 and 2024.
Revenue is summarized as follows: For the Years Ended December 31, % Change $ Change 2024 vs. 2023 2023 vs. 2022 2024 vs. 2023 2023 vs. 2022 (In millions, except percentages) 2024 2023 2022 Product revenue, net: United States $ 3,237.3 $ 3,141.4 $ 3,469.3 3.1 % (9.5) % $ 95.9 $ (327.9) Rest of world 3,976.2 4,105.3 4,518.5 (3.1) (9.1) (129.1) (413.2) Total product revenue, net 7,213.5 7,246.7 7,987.8 (0.5) (9.3) (33.2) (741.1) Revenue from anti-CD20 therapeutic programs 1,749.9 1,689.6 1,700.5 3.6 (0.6) 60.3 (10.9) Alzheimer's collaboration revenue (1) 59.9 — — nm — 59.9 — Contract manufacturing, royalty and other revenue 652.6 899.3 485.1 (27.4) 85.4 (246.7) 414.2 Total revenue $ 9,675.9 $ 9,835.6 $ 10,173.4 (1.6) % (3.3) % $ (159.7) $ (337.8) nm Not meaningful (1) Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties.
Revenue is summarized as follows: For the Years Ended December 31, % Change $ Change 2025 vs. 2024 2024 vs. 2023 2025 vs. 2024 2024 vs. 2023 (In millions, except percentages) 2025 2024 2023 Product revenue, net: United States $ 3,547.9 $ 3,237.3 $ 3,141.4 9.6 % 3.1 % $ 310.6 $ 95.9 Rest of world 3,571.5 3,976.2 4,105.3 (10.2) (3.1) (404.7) (129.1) Total product revenue, net 7,119.4 7,213.5 7,246.7 (1.3) (0.5) (94.1) (33.2) Revenue from anti-CD20 therapeutic programs 1,860.6 1,749.9 1,689.6 6.3 3.6 110.7 60.3 Alzheimer's collaboration revenue (1) 177.7 59.9 — 196.7 nm 117.8 59.9 Contract manufacturing, royalty and other revenue 732.9 652.6 899.3 12.3 (27.4) 80.3 (246.7) Total revenue $ 9,890.6 $ 9,675.9 $ 9,835.6 2.2 % (1.6) % $ 214.7 $ (159.7) nm Not meaningful (1) Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties.
GEOPOLITICAL TENSIONS Global disputes and interruptions in international relationships, including tariffs, trade protection measures, import or export licensing requirements and the imposition of trade sanctions or similar restrictions, affect our ability to do business.
INTERNATIONAL TRADE Global disputes and interruptions in international relationships, including tariffs, trade protection measures, embargoes, import or export licensing requirements and the imposition of trade sanctions or similar restrictions, may affect our ability to do business and the costs that we incur in providing products to our patients.
AMORTIZATION AND IMPAIRMENT OF ACQUIRED INTANGIBLE ASSETS Our amortization expense is based on the economic consumption and impairment of intangible assets. Our most significant amortizable intangible assets are related to TYSABRI, AVONEX, SPINRAZA, VUMERITY and SKYCLARYS, which was obtained as part of our acquisition of Reata in September 2023.
AMORTIZATION AND IMPAIRMENT OF ACQUIRED INTANGIBLE ASSETS Our amortization expense is based on the economic consumption and impairment of intangible assets. Our most significant amortizable intangible assets are related to TYSABRI, AVONEX, SPINRAZA, VUMERITY and SKYCLARYS.
CONTRACT MANUFACTURING, ROYALTY AND OTHER REVENUE Contract manufacturing, royalty and other revenue is summarized as follows: For the Years Ended December 31, (In millions) 2024 2023 2022 Contract manufacturing revenue $ 592.1 $ 848.2 $ 417.7 Royalty and other revenue 60.5 51.1 67.4 Total contract manufacturing, royalty and other revenue $ 652.6 $ 899.3 $ 485.1 CONTRACT MANUFACTURING REVENUE Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers.
CONTRACT MANUFACTURING, ROYALTY AND OTHER REVENUE Contract manufacturing, royalty and other revenue is summarized as follows: For the Years Ended December 31, (In millions) 2025 2024 2023 Contract manufacturing revenue $ 679.4 $ 592.1 $ 848.2 Royalty and other revenue 53.5 60.5 51.1 Total contract manufacturing, royalty and other revenue $ 732.9 $ 652.6 $ 899.3 CONTRACT MANUFACTURING REVENUE Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers and batches of LEQEMBI related to our collaboration with Eisai.
The decrease was partially offset by an increase in costs associated with: • development of BIIB080 for the treatment of Alzheimer's disease; • development of cemdomespib for the treatment of diabetic neuropathic pain; and • development of BIIB091 for the treatment of MS.
The decrease was partially offset by an increase in costs associated with: • development of salanersen for the treatment of SMA; and • development of BIIB080 for the treatment of Alzheimer's disease.
Total charges incurred from our 2023 Fit for Growth program are summarized as follows: For the Years Ended December 31, 2024 2023 (In millions) Severance Costs Accelerated Depreciation and Other Costs Total Severance Costs Accelerated Depreciation and Other Costs Total Selling, general and administrative $ — $ 13.8 $ 13.8 $ — $ 23.3 $ 23.3 Research and development — 11.7 11.7 — 1.2 1.2 Restructuring charges 24.2 — 24.2 153.4 34.6 188.0 Total charges $ 24.2 $ 25.5 $ 49.7 $ 153.4 $ 59.1 $ 212.5 Other Costs: includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pretax gains and losses resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs. 75 Table o f Contents REATA INTEGRATION Following the close of our Reata acquisition in September 2023, we implemented an integration plan designed to realize operating synergies through cost savings and avoidance.
Total charges incurred from our 2023 Fit for Growth program are summarized as follows: For the Years Ended December 31, 2025 2024 2023 (In millions) Severance Costs Accelerated Depreciation and Other Total Severance Costs Accelerated Depreciation and Other Total Severance Costs Accelerated Depreciation and Other Total 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 Other Costs: Includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pre-tax gains and losses resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs.
In April 2023 our pre-tax profit share for RITUXAN, GAZYVA and LUNSUMIO decreased from 37.5% to 35.0%. Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated statements of income.
Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated statements of income.
For 2024 compared to 2023, the increase in discounts was primarily driven by higher purchase and volume discounts for biosimilars and rest of world, as well as higher purchase discounts in the U.S. RETURNS Product return reserves are established for returns made by wholesalers.
DISCOUNTS Discounts include trade term discounts, wholesaler incentives and volume related discounts. For 2025 compared to 2024, the increase in discounts was primarily driven by higher volume discounts in the U.S. for TYSABRI, offset by lower purchase discounts in rest of world and lower volume discounts for U.S. biosimilars. RETURNS Product return reserves are established for returns made by wholesalers.
For additional information on our collaboration arrangements with Genentech, including information regarding the pre-tax profit-sharing formula and its impact on future revenue from anti-CD20 therapeutic programs, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
OTHER REVENUE FROM ANTI-CD20 THERAPEUTIC PROGRAMS Other revenue from anti-CD20 therapeutic programs consists of our share of pre-tax co-promotion profits from RITUXAN in Canada, royalty revenue on sales of LUNSUMIO outside the U.S. and royalty revenue on net sales of COLUMVI in the U.S. 73 Table of Contents For additional information on our collaboration arrangements with Genentech, including information regarding the pre-tax profit-sharing formula and its impact on future revenue from anti-CD20 therapeutic programs, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
Differences between actual and estimated royalty revenue will be adjusted for in the period in which they become known, which is generally expected to be the following quarter. BIOGEN'S SHARE OF PRE-TAX PROFITS IN THE U.S.
OCREVUS royalty revenue is based on our estimates from third party and market research data of OCREVUS sales occurring during the corresponding period. Differences between actual and estimated royalty revenue will be adjusted for in the period in which they become known, which is generally expected to be the following quarter. BIOGEN'S SHARE OF PRE-TAX PROFITS IN THE U.S.
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, which was obtained as part of our acquisition of Reata in September 2023.
Rare disease revenue includes sales from SPINRAZA, QALSODY, which became commercially available in the E.U. during the second quarter of 2024, and SKYCLARYS which became commercially available in the E.U. during the first quarter of 2024.
For 2024 compared to 2023, 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, 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 million of step-up amortization related to SKYCLARYS inventory and approximately $42.5 million of equity based compensation expense recognized in 2024 related to our acquisition of HI-Bio.
For 2025 compared to 2024, the decrease in research and development was primarily driven by continued cost-reduction measures realized in connection with our portfolio prioritization initiatives and our Fit for Growth program, approximately $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 compensation expense recognized in 2024 related to our acquisition of HI-Bio.
For the Years Ended December 31, (In millions) 2024 2023 2022 Royalty revenue on sales of OCREVUS $ 1,339.5 $ 1,266.2 $ 1,136.3 Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO (1) 392.0 409.4 547.0 Other revenue from anti-CD20 therapeutic programs 18.4 14.0 17.2 Total revenue from anti-CD20 therapeutic programs $ 1,749.9 $ 1,689.6 $ 1,700.5 (1) LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
For the Years Ended December 31, (In millions) 2025 2024 2023 Royalty revenue on sales of OCREVUS $ 1,414.9 $ 1,339.5 $ 1,266.2 Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO 420.2 392.0 409.4 Other revenue from anti-CD20 therapeutic programs 25.5 18.4 14.0 Total revenue from anti-CD20 therapeutic programs $ 1,860.6 $ 1,749.9 $ 1,689.6 ROYALTY REVENUE ON SALES OF OCREVUS For 2025 compared to 2024, the increase in royalty revenue on sales of OCREVUS was primarily due to sales growth of OCREVUS in the U.S.
INTEREST INCOME AND EXPENSE For the year ended December 31, 2024, net interest expense was approximately $182.7 million, compared to net interest income of $29.6 million in 2023. The change was primarily due to lower interest income driven by lower cash balances in 2024, compared to 2023, due to use of cash on hand for business development transactions.
INTEREST INCOME AND EXPENSE For the year ended December 31, 2025, net interest expense was approximately $142.5 million, compared to net interest expense of $182.7 million in 2024. The change was primarily due to higher interest income driven by higher cash balances in 2025.
EARLY STAGE PROGRAMS 2024 vs. 2023 The decrease in early stage programs was driven by a decrease in costs associated with: • advancement of BIIB059 for the treatment of CLE into late stage; • discontinuation of BIIB121 for the treatment of Angelman syndrome; and • discontinuation of BIIB131 for the treatment of acute ischemic stroke.
EARLY STAGE PROGRAMS 2025 vs. 2024 The decrease in early stage programs was driven by a decrease in costs associated with: • discontinuation of BIIB143 for the treatment of diabetic neuropathic pain; • discontinuation of BIIB121 for the treatment of Angelman syndrome; • advancement of litifilimab for the treatment of CLE into late stage; and • discontinuation of BIIB105 for the treatment of ALS.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. For additional information on certain risks that could negatively impact our financial position or future results of operations, please read Item 1A. Risk Factors and
For additional information on certain risks that could negatively impact our financial position or future results of operations, please read Item 1A. Risk Factors and
For additional information on our revenue reserves, please read Note 5, Revenue, to our consolidated financial statements included in this report. 70 Table o f Contents COST AND EXPENSE A summary of total cost and expense is as follows: For the Years Ended December 31, % Change $ Change 2024 vs. 2023 2023 vs. 2022 2024 vs. 2023 2023 vs. 2022 (In millions, except percentages) 2024 2023 2022 Cost of sales, excluding amortization and impairment of acquired intangible assets $ 2,310.4 $ 2,533.4 $ 2,278.3 (8.8) % 11.2 % $ (223.0) $ 255.1 Research and development 2,041.8 2,462.0 2,231.1 (17.1) 10.3 (420.2) 230.9 Selling, general and administrative 2,403.7 2,549.7 2,403.6 (5.7) 6.1 (146.0) 146.1 Amortization and impairment of acquired intangible assets 446.7 240.6 365.9 85.7 (34.2) 206.1 (125.3) Collaboration profit sharing/(loss reimbursement) 254.4 218.8 (7.4) 16.3 nm 35.6 226.2 (Gain) loss on fair value remeasurement of contingent consideration 27.7 — (209.1) nm nm 27.7 209.1 Restructuring charges 30.2 218.8 131.1 (86.2) 66.9 (188.6) 87.7 Gain on sale of priority review voucher, net (88.6) — — nm — (88.6) — Gain on sale of building, net — — (503.7) — nm — 503.7 Other (income) expense, net 343.6 315.5 (108.2) 8.9 (391.6) 28.1 423.7 Total cost and expense $ 7,769.9 $ 8,538.8 $ 6,581.6 (9.0) % 29.7 % $ (768.9) $ 1,957.2 nm Not meaningful COST OF SALES, EXCLUDING AMORTIZATION AND IMPAIRMENT OF ACQUIRED INTANGIBLE ASSETS For the Years Ended December 31, (In millions) 2024 2023 2022 Product $ 1,604.2 $ 1,787.2 $ 1,504.8 Royalty 706.2 746.2 773.5 Total cost of sales $ 2,310.4 $ 2,533.4 $ 2,278.3 Cost of sales, as a percentage of total revenue, were 23.9%, 25.8% and 22.4% for the years ended December 31, 2024, 2023 and 2022, respectively.
For additional information on our revenue reserves, please read Note 5, Revenue, to our consolidated financial statements included in this report. 75 Table of Contents COST AND EXPENSE A summary of total cost and expense is as follows: For the Years Ended December 31, % Change $ Change 2025 vs. 2024 2024 vs. 2023 2025 vs. 2024 2024 vs. 2023 (In millions, except percentages) 2025 2024 2023 Cost of sales, excluding amortization and impairment of acquired intangible assets $ 2,404.2 $ 2,310.4 $ 2,533.4 4.1 % (8.8) % $ 93.8 $ (223.0) Research and development 1,778.6 1,980.3 2,445.4 (10.2) (19.0) (201.7) (465.1) Acquired in-process research and development, upfront and milestone expense 471.8 61.5 16.6 667.2 270.5 410.3 44.9 Selling, general and administrative 2,433.6 2,403.7 2,549.7 1.2 (5.7) 29.9 (146.0) Amortization and impairment of acquired intangible assets 515.0 446.7 240.6 15.3 85.7 68.3 206.1 Collaboration profit sharing/(loss reimbursement) 290.2 254.4 218.8 14.1 16.3 35.8 35.6 (Gain) loss on fair value remeasurement of contingent consideration 33.6 27.7 — 21.3 nm 5.9 27.7 Impairment of ROU asset 52.9 — — nm — 52.9 — Restructuring charges 48.6 30.2 218.8 60.9 (86.2) 18.4 (188.6) Gain on sale of priority review voucher, net — (88.6) — nm nm 88.6 (88.6) Other (income) expense, net 305.6 343.6 315.5 (11.1) 8.9 (38.0) 28.1 Total cost and expense $ 8,334.1 $ 7,769.9 $ 8,538.8 7.3 % (9.0) % $ 564.2 $ (768.9) nm Not meaningful COST OF SALES, EXCLUDING AMORTIZATION AND IMPAIRMENT OF ACQUIRED INTANGIBLE ASSETS For the Years Ended December 31, (In millions) 2025 2024 2023 Product $ 1,587.2 $ 1,604.2 $ 1,787.2 Royalty 817.0 706.2 746.2 Total cost of sales $ 2,404.2 $ 2,310.4 $ 2,533.4 Cost of sales, as a percentage of total revenue, were 24.3%, 23.9% and 25.8% for the years ended December 31, 2025, 2024 and 2023, respectively.
We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
The IRA Medicare Part D redesign had a 61 Table of Contents modest net unfavorable impact to our 2025 revenue of approximately $90.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a quarter of which was associated with SKYCLARYS.
We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
The IRA Medicare Part D redesign had a 74 Table of Contents modest net unfavorable impact to our 2025 revenue of approximately $90.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a quarter of which was associated with SKYCLARYS.
For additional information on the sale of our PRV, please read Note 3, Dispositions , to our consolidated financial statements included in this report.
For additional information on our Senior Notes, please read Note 13, Indebtedness , to our consolidated financial statements included in this report.
As a result of our acquisition of Reata in September 2023 we recorded a fair value step-up adjustment related to the acquired inventory of SKYCLARYS of approximately $1.3 billion.
Cost of sales as a percentage of revenue was adversely affected by LEQEMBI batches due to lower margins associated with this business. As a result of our acquisition of Reata in September 2023 we recorded a fair value step-up adjustment related to the acquired inventory of SKYCLARYS of approximately $1.3 billion.
After evaluating our strategic options, we have made the decision to retain our biosimilars business. 67 Table o f Contents REVENUE FROM ANTI-CD20 THERAPEUTIC PROGRAMS Our share of RITUXAN, including RITUXAN HYCELA, GAZYVA and LUNSUMIO collaboration operating profits in the U.S., royalty revenue on sales of OCREVUS and other revenue from anti-CD20 therapeutic programs are summarized in the table below.
ZURZUVAE revenue as we expect total patients to continue to increase in 2026. 72 Table of Contents REVENUE FROM ANTI-CD20 THERAPEUTIC PROGRAMS Our share of RITUXAN, including RITUXAN HYCELA, GAZYVA and LUNSUMIO collaboration operating profits in the U.S., royalty revenue on sales of OCREVUS and other revenue from anti-CD20 therapeutic programs are summarized in the table below.
For 2025 compared to 2024, we anticipate lower net interest expense as a result of higher cash balances, somewhat offset by lower interest rates, leading to more interest income.
For 2026 compared to 2025, we anticipate lower net interest expense as a result of higher interest income driven by higher cash balances, partially offset by higher interest expense as a result of the issuance of our 2025 Senior Notes.
FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES Our financial condition is summarized as follows: As of December 31, (In millions, except percentages) 2024 2023 % Change $ Change Financial assets: Cash and cash equivalents $ 2,375.0 $ 1,049.9 126.2 % $ 1,325.1 Total cash and cash equivalents $ 2,375.0 $ 1,049.9 126.2 % $ 1,325.1 Borrowings: Current portion of notes payable and term loan $ 1,748.6 $ 150.0 nm $ 1,598.6 Notes payable and term loan 4,547.2 6,788.2 (33.0) (2,241.0) Total borrowings $ 6,295.8 $ 6,938.2 (9.3) % $ (642.4) Working Capital: Current assets $ 7,456.8 $ 6,859.3 8.7 % $ 597.5 Current liabilities (5,528.8) (3,434.3) 61.0 (2,094.5) Total working capital $ 1,928.0 $ 3,425.0 (43.7) % $ (1,497.0) nm Not meaningful OVERVIEW We have historically financed and expect to continue to fund our operating and capital expenditures primarily through cash flow earned through our operations, as well as our existing cash resources.
FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES Our financial condition is summarized as follows: As of December 31, (In millions, except percentages) 2025 2024 % Change $ Change Financial assets: Cash and cash equivalents $ 3,008.5 $ 2,375.0 26.7 % $ 633.5 Marketable securities — current 807.2 — nm 807.2 Marketable securities — non-current 431.9 — nm 431.9 Total cash, cash equivalents and marketable securities $ 4,247.6 $ 2,375.0 78.8 % $ 1,872.6 Borrowings: Current portion of notes payable $ — $ 1,748.6 nm $ (1,748.6) Notes payable 6,286.8 4,547.2 38.3 1,739.6 Total borrowings $ 6,286.8 $ 6,295.8 (0.1) % $ (9.0) Working Capital: Current assets $ 8,974.1 $ 7,456.8 20.3 % $ 1,517.3 Current liabilities (3,349.4) (5,528.8) (39.4) 2,179.4 Total working capital $ 5,624.7 $ 1,928.0 191.7 % $ 3,696.7 nm Not meaningful OVERVIEW We have historically financed and expect to continue to fund our operating and capital expenditures primarily through cash flow earned through our operations and borrowings, as well as our existing cash resources.
In August 2022 the IRA was signed into law in the U.S. and contains substantial drug pricing reforms. We expect the IRA's drug pricing controls and Medicare Part D redesign may have an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement.
The IRA's drug pricing controls and Medicare Part D redesign had an adverse impact on our sales, particularly for our products that are more substantially reliant on Medicare reimbursement.
MS revenue includes sales from TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated. We expect to recognize minimal revenue in 2025.
MS revenue includes sales from TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated. In 2026 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets.
For the year ended December 31, 2024, we recognized approximately $59.9 million of Alzheimer's collaboration revenue within our consolidated statements of income.
For the years ended December 31, 2025 and 2024, we recognized Alzheimer's collaboration revenue of approximately $177.7 million and $59.9 million, respectively.
For additional information on our 300 Binney Street lease modification, please read Note 12, Leases , to our consolidated financial statements included in this report.
For additional information on goodwill, please read Note 7, Intangible Assets and Goodwill , to our consolidated financial statements included in this report.
Write Downs and Other Charges Inventory amounts written down as a result of excess, obsolescence or unmarketability totaled $101.9 million, $124.4 million and $336.2 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Write Downs and Other Charges Inventory amounts written down as a result of excess, obsolescence or unmarketability totaled $29.2 million, $101.9 million and $124.4 million for the years ended December 31, 2025, 2024 and 2023, respectively. 76 Table of Contents ROYALTY COST OF SALES For 2025 compared to 2024 , the increase in royalty cost of sales was primarily due to a charge recorded during 2025 of approximately $104.9 million related to a litigation matter.
In addition, new government sanctions on the export of certain manufacturing materials to Russia may delay or limit our ability to get new products approved.
Although we do not have affiliates or employees in either Russia or Ukraine, we do provide various therapies to patients in Russia through a distributor. Government sanctions on the export of certain manufacturing materials to Russia may delay or limit our ability to get new products approved.
For additional information on the deconsolidation and our collaboration agreement with Neurimmune, please read Note 20, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.
For additional information on our collaboration arrangement with Stoke, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
We anticipate global SPINRAZA revenue to be relatively flat in 2025. 66 Table o f Contents BIOSIMILARS • For 2024 compared to 2023, the increase in biosimilar revenue was primarily due to an increase in sales volumes related to BENEPALI, partially offset by a decrease in pricing due to competitive pressures.
We anticipate global SPINRAZA revenue growth to be relatively flat in 2026. 71 Table of Contents BIOSIMILARS • For 2025 compared to 2024, the decrease in biosimilar revenue was primarily due to a decrease in sales volumes, decreases in pricing due to competitive pressures in Europe and the unfavorable impact of foreign currency exchange.
TYSABRI A biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect the future sales of TYSABRI may be adversely affected by the entrance of this biosimilar. BUSINESS UPDATE REGARDING MACROECONOMIC CONDITIONS AND OTHER DISRUPTIONS Significant portions of our business are conducted in Europe, Asia and other international geographies.
TYSABRI A biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect the future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar.
DEVELOPMENTS IN KEY COLLABORATIVE RELATIONSHIPS LEQEMBI (lecanemab) United States Key developments related to LEQEMBI in the U.S. consisted of the following: • In January 2025 the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease. • In January 2025 the FDA accepted for review the BLA for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025. • In July 2024 Eisai presented new clinical data from the CLARITY AD study open-label extension of LEQEMBI, demonstrating that three years of continuous LEQEMBI treatment reduced clinical decline, resulting in a clinically meaningful benefit for early Alzheimer's disease patients.
DEVELOPMENTS IN KEY COLLABORATIVE RELATIONSHIPS LEQEMBI (lecanemab) United States Key developments related to LEQEMBI in the U.S. consisted of the following: • In January 2026 the FDA accepted for review the supplemental BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for weekly starting dose, with a PDUFA action date of May 24, 2026. • In August 2025 the FDA approved the BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for weekly maintenance dosing. • In January 2025 the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
For the year ended December 31, 2023, we had no impairment charges. Amortization of acquired intangible assets, excluding impairment charges, totaled $386.5 million, $240.6 million and $246.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Amortization of acquired intangible assets, excluding impairment charges, totaled $507.1 million, $386.5 million and $240.6 million for the years ended December 31, 2025, 2024 and 2023, respectively. The increase in amortization of acquired intangible assets, excluding impairment charges, was primarily due to amortization for the acquired intangible assets associated with SKYCLARYS and TYSABRI.
In 2025 we expect growth in rare disease revenue as we continue to launch SKYCLARYS in the U.S. and the E.U.
In 2026 we expect growth in rare disease revenue due to the continued launch of SKYCLARYS in the U.S., Europe and other international markets as well as the continued launch of QALSODY in Europe.
BIIB143 (cemdomespib) In early 2025 we discontinued further development of BIIB143 (cemdomespib) for the treatment of diabetic neuropathic pain, as part of our ongoing pipeline prioritization efforts. 63 Table o f Contents RESULTS OF OPERATIONS REVENUE The following revenue discussion should be read in conjunction with Note 5, Revenue , to our consolidated financial statements included in this report.
FELZARTAMAB - LUPUS NEPHRITIS In November 2025 we discontinued the open label Phase 1b study of felzartamab for the treatment of lupus nephritis. 68 Table of Contents RESULTS OF OPERATIONS REVENUE The following revenue discussion should be read in conjunction with Note 5, Revenue , to our consolidated financial statements included in this report.
We do not intend to occupy this building and are evaluating opportunities to sublease the property. For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report. For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our license arrangements with Samsung Bioepis and our collaborative arrangements with Eisai, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report. 69 Table o f Contents RESERVES FOR DISCOUNTS AND ALLOWANCES Revenue from product sales is recorded net of reserves established for applicable discounts and allowances, including those associated with the implementation of pricing actions in certain international markets where we operate.
RESERVES FOR DISCOUNTS AND ALLOWANCES Revenue from product sales is recorded net of reserves established for applicable discounts and allowances, including those associated with the implementation of pricing actions in certain international markets where we operate.
For 2024 compared to 2023, the decrease 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.
For 2025 compared to 2024, the increase in contract manufacturing revenue was primarily driven by higher volumes due to the timing of batch production.
For 2024 compared to 2023, the decrease in contractual adjustments was primarily due to lower government rebates in rest of world and biosimilars, partially offset by higher government rebates in the U.S. DISCOUNTS Discounts include trade term discounts, wholesaler incentives and volume related discounts.
For 2025 compared to 2024, the decrease in returns was primarily driven by lower returns in the U.S., partially offset by higher returns in rest of world.
For additional information on our 2019 Development and Commercialization Agreement with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report. 74 Table o f Contents COLLABORATION PROFIT SHARING/(LOSS REIMBURSEMENT) Collaboration profit sharing/(loss reimbursement) includes Samsung Bioepis' 50.0% share of the profit or loss related to our biosimilars 2013 commercial agreement with Samsung Bioepis and, beginning in the third quarter of 2023, collaboration profit sharing/(loss reimbursement) related to Sage's 50.0% share of the profit or loss in the U.S. related to ZURZUVAE for PPD.
COLLABORATION PROFIT SHARING/(LOSS REIMBURSEMENT) Collaboration profit sharing/(loss reimbursement) includes Samsung Bioepis' 50.0% share of the profit or loss related to our biosimilars 2013 commercial agreement with Samsung Bioepis and collaboration profit sharing/(loss reimbursement) related to Supernus' 50.0% share of the profit or loss in the U.S. related to ZURZUVAE for PPD.
The Fit for Growth program is expected to generate approximately $1.0 billion in gross operating expense savings by the end of 2025, some of which will be reinvested in various initiatives.
The Fit for Growth program generated approximately $1.0 billion in gross operating expense savings by the end of 2025, some of which has been reinvested in various initiatives. The Fit for Growth program included net headcount reductions of approximately 1,400 employees and we incurred total restructuring charges of approximately $320.0 million by the end of 2025.
The exact amount of the income tax expense will depend on our stock price at the time of vesting. PILLAR TWO The OECD has issued model rules, which generally provide for a jurisdictional minimum effective tax rate of 15.0% as defined in those rules.
PILLAR TWO The OECD has issued model rules, which generally provide for a jurisdictional minimum effective tax rate of 15.0% as defined in those rules. Various countries have or are in the process of enacting legislation intended to implement the principles.
Various countries have or are in the process of enacting legislation intended to implement the principles effective January 1, 2024. Our income tax provision for the year ended December 31, 2024, reflects currently enacted legislation and guidance related to the OECD model rules.
Our income tax provision for the years ended December 31, 2025 and 2024, reflects currently enacted legislation and guidance related to the OECD model rules including the Pillar Two side-by-side package announced by the OECD in January 2026.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. 2022 COST SAVING INITIATIVES In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures during 2022.
For additional information on our cost saving initiatives, please read Note 4, Restructuring, to our consolidated financial statements included in this report.
PRODUCT COST OF SALES For 2024 compared to 2023, the decrease in product cost of sales was primarily due to favorable product mix from decreased contract manufacturing revenue and lower idle capacity charges, offset in part by approximately $181.5 million in SKYCLARYS amortization costs.
PRODUCT COST OF SALES For 2025 compared to 2024, the decrease in product cost of sales was primarily due to lower inventory write-offs, partially offset by product mix, including higher contract manufacturing revenue driven by the timing of batch releases and higher SKYCLARYS inventory step-up amortization costs. Contract manufacturing revenue includes LEQEMBI inventory produced for Eisai.
TOTAL COST AND EXPENSE Decreased $768.9 million or 9.0% • Cost of sales decreased $223.0 million, or 8.8% • R&D expense decreased $420.2 million, or 17.1% • SG&A expense decreased $146.0 million, or 5.7% • Amortization and impairment of acquired intangible assets increased $206.1 million, or 85.7% • The decrease in cost of sales was primarily due to favorable product mix from lower contract manufacturing revenue and lower idle capacity charges, partially offset by approximately $181.5 million in SKYCLARYS amortization costs. • The decrease in R&D expense was primarily driven by approximately $197.0 million of equity-based compensation expense recognized in 2023 related to our Reata acquisition, 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 million in SKYCLARYS amortization costs and approximately $42.5 million of equity-based compensation expense recognized in 2024 related to our HI-Bio acquisition. • The decrease in SG&A expense was primarily due to approximately $196.4 million of equity-based compensation expense recognized in 2023 related to our Reata acquisition. • The increase in amortization and impairment of acquired intangible assets was primarily due to amortization for the acquired intangible assets associated with SKYCLARYS, as well as impairment charges of approximately $60.2 million during 2024.
TOTAL COST AND EXPENSE Increased $564.2 million or 7.3% • Cost of sales increased $93.8 million, or 4.1% • R&D expense decreased $201.7 million, or 10.2% • SG&A expense increased $29.9 million, or 1.2% • Acquired IPR&D, upfront and milestone expense increased $410.3 million • Impairment of ROU asset of $52.9 million • The increase in cost of sales was primarily due to a charge recorded during 2025 of approximately $104.9 million related to a litigation matter and product mix, including higher contract manufacturing revenue driven by the timing of batch releases. • The decrease in R&D expense was primarily driven by continued cost reduction measures realized in connection with our portfolio prioritization initiatives and our Fit for Growth program, offset in part by higher spend on clinical trials, including litifilimab and felzartamab.
For the years ended December 31, 2024 and 2023, amortization from the fair value step-up adjustment was approximately $181.5 million and $31.5 million, respectively. For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our litigation matters, please read Note 21, Litigation , to our consolidated financial statements included in this report. 77 Table of Contents RESEARCH AND DEVELOPMENT Research and development expense, as a percentage of total revenue, was 18.0%, 20.5% and 24.9% for the years ended December 31, 2025, 2024 and 2023, respectively.
In 2025 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets. Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023.
We expect TECFIDERA revenue will be adversely impacted by accelerating generic competition in certain markets in the E.U. Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that future sales of TYSABRI will continue to be adversely affected by the entrance of this biosimilar worldwide.
Total charges incurred from our Reata integration are summarized as follows: For the Years Ended December 31, 2024 2023 (In millions) Severance Costs Accelerated Depreciation and Other Costs Total Severance Costs Accelerated Depreciation and Other Costs Total Selling, general and administrative $ — $ 6.3 $ 6.3 $ — $ — $ — Research and development — 11.9 11.9 — — — Restructuring charges 3.4 — 3.4 30.4 — 30.4 Total charges $ 3.4 $ 18.2 $ 21.6 $ 30.4 $ — $ 30.4 In connection with our acquisition of Reata we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years.
IMPAIRMENT OF RIGHT-OF-USE ASSET As part of our acquisition of Reata, we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years. We recorded a lease liability of approximately $151.8 million, with a corresponding right-of-use asset of approximately $121.2 million.
These costs are considered other research and development costs in the table above and are not allocated to a specific program or stage. For 2023 other research and development costs also includes approximately $197.0 million of equity-based compensation expense incurred as a result of our acquisition of Reata in 2023.
These costs are considered other research and development costs in the table above and are not allocated to a specific program or stage. We expect our core research and development expense to increase slightly in 2026 with most investments in our late-stage programs.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. 73 Table o f Contents SELLING, GENERAL AND ADMINISTRATIVE For 2024 compared to 2023, selling, general and administrative expense decreased by approximately 5.7% primarily due to equity-based compensation expense recognized in 2023 of approximately $196.4 million related to our acquisition of Reata.
For additional information on our acquisition of Alcyone, please read Note 2, Acquisitions, to our consolidated financial statements included in this report. 79 Table of Contents SELLING, GENERAL AND ADMINISTRATIVE For 2025 compared to 2024, selling, general and administrative expense increased by approximately 1.2% primarily due to an increase in operational spending on sales and marketing activities in support of LEQEMBI and SKYCLARYS as we continue to expand our U.S. and international product launches.
As a result, we recorded a net gain on the deconsolidation of Neurimmune of approximately $3.0 million, which was recorded in other (income) expense, net within our consolidated statements of income for the year ended December 31, 2023.
As a result of this impairment assessment, we recorded an impairment charge of approximately $52.9 million related to this Reata lease, which is included in impairment of ROU asset within our consolidated statements of income for the year ended December 31, 2025.
We are continuing to evaluate SKYCLARYS' supply chain and prioritizing actions to mitigate risks associated with its manufacturing and our ability to supply patients. The ongoing geopolitical tensions related to Russia's invasion of Ukraine and the military conflict in the Middle East have resulted in global business disruptions and economic volatility.
GEOPOLITICAL TENSIONS The ongoing geopolitical tensions related to Russia's invasion of Ukraine and the military conflict in the Middle East and other global geopolitical developments have resulted in global business disruptions and economic volatility. For example, sanctions and other restrictions have been levied on the government and businesses in Russia.
MARKETED PROGRAMS 2024 vs. 2023 The decrease in marketed programs was driven by a decrease in costs associated with: • discontinuation of ADUHELM for the treatment of Alzheimer's disease; • decreased spend on LEQEMBI for the treatment of Alzheimer's disease; and • decreased spend on ZURZUVAE for MDD.
MARKETED PROGRAMS 2025 vs. 2024 The decrease in marketed programs was driven by a decrease in costs associated with: • decreased spend on LEQEMBI for the treatment of Alzheimer's disease; and • $23.9 million of step-up amortization related to SKYCLARYS inventory recorded in 2025, compared to $48.5 million in 2024. 78 Table of Contents Research and development expense is reported above based on the following classifications.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur technology and cybersecurity program is the principal responsibility of our Chief Information Officer and CISO, each of whom have over 20 years of experience in information systems, including cybersecurity training and experience. Additionally, we have a Cybersecurity steering committee that includes senior representatives from our Legal, Finance and IT departments, which meets regularly to discuss cybersecurity matters.
Biggest changeOur technology and cybersecurity program is the principal responsibility of our Chief Information Officer and CISO, each of whom have over 20 years of 54 Table of Contents experience in information systems, including cybersecurity training and experience.
Risk Factors - A breakdown or breach of our information systems could subject us to liability or interrupt the operation of our business , included in this report.
Risk Factors - A breakdown or breach of our information systems could subject us to liability or interrupt the operation of our business operations , included in this report.
Our Executive Committee will inform our Board of Directors of cybersecurity incidents, as appropriate, considering a variety of factors, including financial, operational, legal or reputational impact. Our program's maturity and operational readiness are regularly evaluated by independent experts using the U.S. NIST's CyberSecurity Framework and penetration tests.
Our Executive Committee will inform our Board of Directors of cybersecurity incidents, as appropriate, considering a variety of factors, including financial, operational, legal or reputational impact. Our program's maturity and operational readiness are regularly evaluated by internal audit and independent experts using the U.S. NIST's CyberSecurity Framework and penetration tests.
ITEM 1C. CYBERSECURITY RISK MANAGEMENT AND STRATEGY 52 Table o f Contents We maintain a technology and cybersecurity program, which includes information security, as part of our overall risk management process with the aim that our information systems, including those of our vendors and other third-parties, will be resilient, effective and capable of safeguarding against emerging risks and cybersecurity threats.
ITEM 1C. CYBERSECURITY RISK MANAGEMENT AND STRATEGY We maintain a technology and cybersecurity program, which includes information security, as part of our overall risk management process with the aim that our information systems, including those of our vendors and other third parties, will be resilient, effective and capable of safeguarding against emerging risks and cybersecurity threats.
Our Board of Directors oversees management's processes for identifying and mitigating risks, including cybersecurity and information security risks. Our Board of Directors regularly reviews our technology and cybersecurity program and effectiveness, internal audits of our program, independent external expert evaluations of our program's maturity and operational readiness and the results of penetration testing.
Our Board of Directors regularly reviews our technology and cybersecurity program and effectiveness, internal audits of our program, independent external expert evaluations of our program's maturity and operational readiness and the results of penetration testing.
Our Board of Directors also receives cybersecurity updates and education on a broad range of topics, including: • Current cybersecurity landscape and emerging threats; • Status of ongoing cybersecurity initiatives and strategies; • Incident report and learnings from any cybersecurity events; and 53 Table o f Contents • Compliance with regulatory requirements and industry standards.
Our Board of Directors also receives cybersecurity updates and education on a broad range of topics, including: • Current cybersecurity landscape and emerging threats; • Status of ongoing cybersecurity initiatives and strategies; • Incident report and learnings from any cybersecurity events; and • Compliance with regulatory requirements and industry standards, including international regulations such as the NIS2 Directive in the E.U.
Cybersecurity Agency's National Cyber Incident Scoring System model to benchmark, inform and evaluate the design of our program, our operational capabilities and our program maturity. Consistent with NIST 800-53, our technology and cybersecurity program and controls include a third party and vendor risk management component.
Cybersecurity Agency's National Cyber Incident Scoring System model to benchmark, inform and evaluate the design of our program, our operational capabilities and our program maturity. We have designed our cybersecurity policies and procedures to align with international regulatory frameworks, including the NIS2 Directive in the E.U.
Added
Our program integrates periodic reviews and updates to ensure our controls remain effective and compliant with evolving international regulations. Consistent with NIST 800-53, our technology and cybersecurity program and controls include a third party and vendor risk management component.
Added
Additionally, we have a Cybersecurity steering committee that includes senior representatives from our Legal, Finance and IT departments, which meets regularly to discuss cybersecurity matters. Our Board of Directors oversees management's processes for identifying and mitigating risks, including cybersecurity and information security risks.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe estimate the construction of this manufacturing facility will be completed during 2025. We believe that our our existing properties, including both owned and leased sites, are adequate and suitable for the conduct of our business. We believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs.
Biggest changeWe believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs.
ITEM 2. PROPERTIES Below is a summary of our significant properties owned and leased as of December 31, 2024. Location Approximate Square Feet Use Owned/Leased U.S.
ITEM 2. PROPERTIES Below is a summary of our significant properties owned and leased as of December 31, 2025. Location Approximate Square Feet Use Owned/Leased U.S.
Our international lease agreements expire at various dates through the year 2034. In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new manufacturing facility will be approximately 197,000 square feet.
Our international lease agreements expire at various dates through the year 2047. In the fourth quarter of 2021 we began construction of a new clinical packaging and other manufacturing facility in RTP, North Carolina to support our R&D pipeline across multiple therapeutic areas. The new manufacturing facility is approximately 197,000 square feet.
Cambridge, Massachusetts 263,000 Research laboratory and cogeneration plant Owned Cambridge, Massachusetts 729,000 Corporate headquarters and laboratory Leased - Expires 2028 Weston, Massachusetts 357,000 Office Leased - Expires 2025 RTP, North Carolina 1,040,000 Office, laboratory, manufacturing, warehouse Owned Durham, North Carolina 65,000 Warehouse Leased - Expires 2025 Plano, Texas 327,000 Office and laboratory Leased - Expires 2038 International (1) Solothurn, Switzerland 734,000 Manufacturing facility, warehouse and office Owned Baar, Switzerland 81,800 International headquarters Leased - Expires 2028 (1) We also lease office space in other international regions including: the U.K.; Germany; France; Japan; Canada and numerous other countries.
Cambridge, Massachusetts 263,000 Research laboratory and cogeneration plant Owned Cambridge, Massachusetts 729,000 Corporate headquarters and laboratory Leased - Expires 2028 RTP, North Carolina 1,237,000 Office, laboratory, manufacturing, warehouse Owned Durham, North Carolina 40,000 Warehouse Leased - Expires 2030 Plano, Texas 327,000 Office and laboratory Leased - Expires 2038 International (1) Solothurn, Switzerland 734,000 Manufacturing facility, warehouse and office Owned Baar, Switzerland 81,800 International headquarters Leased - Expires 2028 Athlone, Ireland 47,500 Fill finish manufacturing facility Leased - Expires 2047 (1) We also lease office space in other international regions including: the U.K.; Germany; France; Japan; Canada and numerous other countries.
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The construction of this manufacturing facility was completed during 2025 and the majority of the facility was placed in service during the fourth quarter of 2025.
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NEW CORPORATE HEADQUARTERS LEASE In March 2025 we entered into a lease agreement with MIT Investment Management Company and BioMed Realty for the lease of approximately 580,000 square feet of office and research and development space located at 75 Broadway, Cambridge, Massachusetts, which will be used as our new global corporate headquarters, as well as integrating our research and development and technical operations teams alongside our North American commercial organization.
Added
As part of a multi-year real estate consolidation plan that is expected to result in a reduction of approximately 40% of our real estate footprint in Massachusetts, this new lease is intended to replace two existing leases, both in Cambridge, Massachusetts, including our current corporate headquarters.
Added
We expect the initial lease term of approximately 15.5 years to commence on May 31, 2028. 55 Table of Contents We believe that our existing properties, including both owned and leased sites, are adequate and suitable for the conduct of our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS For a discussion of legal matters as of December 31, 2024, please read Note 21, Litigation, to our consolidated financial statements included in this report, which is incorporated into this item by reference. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 54 Table o f Contents PART II
Biggest changeITEM 3. LEGAL PROCEEDINGS For a discussion of legal matters as of December 31, 2025, please read Note 21, Litigation, to our consolidated financial statements included in this report, which is incorporated into this item by reference. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 56 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

6 edited+14 added−1 removed2 unchanged
Biggest changeUnder our 2020 Share Repurchase Program, we repurchased and retired approximately 3.6 million shares of our common stock at a cost of approximately $750.0 million during the year ended December 31, 2022 . There were no share repurchases of our common stock during the years ended December 31, 2024 and 2023.
Biggest changeThere were no repurchases of our common stock during the years ended December 31, 2025, 2024 and 2023.
ISSUER PURCHASES OF EQUITY SECURITIES The following table summarizes our common stock repurchase activity during the fourth quarter of 2024: Period Total Number of Shares Purchased (#) Average Price Paid per Share ($) Total Number of Shares Purchased as Part of Publicly Announced Programs (#) Approximate Dollar Value of Shares That May Yet Be Purchased Under Our Programs ($ in millions) October 1, 2024 - October 31, 2024 — $ — — $ 2,050.0 November 1, 2024 - November 30, 2024 — $ — — $ 2,050.0 December 1, 2024 - December 31, 2024 — $ — — $ 2,050.0 Total (1) — $ — (1) There were no share repurchases during the fourth quarter of 2024.
ISSUER PURCHASES OF EQUITY SECURITIES The following table summarizes our common stock repurchase activity during the fourth quarter of 2025: Period Total Number of Shares Purchased (#) Average Price Paid per Share ($) Total Number of Shares Purchased as Part of Publicly Announced Programs (#) Approximate Dollar Value of Shares That May Yet Be Purchased Under Our Programs ($ in millions) October 1, 2025 - October 31, 2025 — $ — — $ 2,050.0 November 1, 2025 - November 30, 2025 — $ — — $ 2,050.0 December 1, 2025 - December 31, 2025 — $ — — $ 2,050.0 Total (1) — $ — (1) There were no share repurchases during the fourth quarter of 2025.
The performance graph below assumes the investment of $100.00 on December 31, 2019, in our common stock and each of the three indexes, with dividends being reinvested.
The performance graph below assumes the investment of $100.00 on December 31, 2020, in our common stock and each of the three indexes, with dividends being reinvested.
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES MARKET AND STOCKHOLDER INFORMATION Our common stock trades on The Nasdaq Global Select Market under the symbol “BIIB.” As of February 11, 2025, there were approximately 392 shareholders of record of our common stock. DIVIDENDS We have not paid cash dividends since our inception.
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES MARKET AND STOCKHOLDER INFORMATION Our common stock trades on The Nasdaq Global Select Market under the symbol “BIIB.” As of February 4, 2026, there were approximately 372 shareholders of record of our common stock. DIVIDENDS We have not paid cash dividends since our inception.
The stock price performance in the graph below is not necessarily indicative of future price performance. 2019 2020 2021 2022 2023 2024 Biogen Inc. $100.00 $82.52 $80.85 $93.31 $87.19 $51.52 Nasdaq Pharmaceutical Index $100.00 $110.52 $137.47 $153.08 $159.01 $172.62 S&P 500 Index $100.00 $118.40 $152.39 $124.79 $157.59 $197.02 Nasdaq Biotechnology Index $100.00 $126.42 $126.45 $113.65 $118.87 $118.20 The information included under the heading Performance Graph is “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A or incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
The stock price performance in the graph below is not necessarily indicative of future price performance. 2020 2021 2022 2023 2024 2025 Biogen Inc. $100.00 $97.98 $113.08 $105.65 $62.43 $71.84 Nasdaq Pharmaceutical Index $100.00 $124.39 $138.51 $143.88 $156.19 $200.89 S&P 500 Index $100.00 $128.71 $105.40 $133.10 $166.40 $196.16 Nasdaq Biotechnology Index $100.00 $100.02 $89.90 $94.03 $93.49 $124.75 The information included under the heading Performance Graph is “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A or incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
While we have historically made discretionary share repurchases, we had no share repurchases of our common stock during the years ended December 31, 2024 and 2023. 55 Table o f Contents PERFORMANCE GRAPH The performance graph below compares the five-year cumulative total stockholder return on our common stock, the Nasdaq Pharmaceutical Index, the S&P 500 Index and the Nasdaq Biotechnology Index.
Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2025. 57 Table of Contents PERFORMANCE GRAPH The performance graph below compares the five-year cumulative total stockholder return on our common stock, the Nasdaq Pharmaceutical Index, the S&P 500 Index and the Nasdaq Biotechnology Index.
Removed
Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2024. In August 2022 the IRA was signed into law. Among other things, the IRA levies a 1.0% excise tax on net stock repurchases after December 31, 2022.
Added
ITEM 6. RESERVED 58 Table of Contents ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion should be read in conjunction with our consolidated financial statements and the accompanying notes beginning on page F-1 of this report.
Added
For our discussion of the year ended December 31, 2024, compared to the year ended December 31, 2023, please read Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations located in our Annual Report on Form 10-K for the year ended December 31, 2024.
Added
EXECUTIVE SUMMARY INTRODUCTION Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases.
Added
We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS.
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We market the first and only drug approved in the U.S., the E.U. and certain international markets for the treatment of FA in adults and adolescents aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases.
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We support our drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions. Our marketed products include VUMERITY, TYSABRI, TECFIDERA, AVONEX and PLEGRIDY for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of FA; and QALSODY for the treatment of ALS.
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We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Supernus on the commercialization of ZURZUVAE for the treatment of PPD.
Added
We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL, follicular lymphoma and, following its approval in October 2025, lupus nephritis; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly owned member of the Roche Group.
Added
We commercialize a portfolio of biosimilars of advanced biologics including: BENEPALI, an etanercept biosimilar referencing ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; and FLIXABI, an infliximab biosimilar referencing REMICADE. For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.
Added
We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland.
Added
The Solothurn facility is operational and has been approved for the manufacture of LEQEMBI and TYSABRI. We believe that the Solothurn facility will support our anticipated near to mid-term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity.
Added
Additionally, we continue to invest to modernize, automate and support the capacity requirements for our pipeline and existing products at our existing manufacturing facilities in RTP. If we are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on our financial condition and results of operations.
Added
In the longer term, our revenue growth will depend upon the successful clinical development, regulatory approval and launch of new commercial products as well as additional indications for our existing products, our ability to obtain and maintain patents and other rights related to our marketed products, assets originating from our research and development efforts and/or successful execution of external business development opportunities.
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BUSINESS ENVIRONMENT For a detailed discussion on our business environment, please read Item 1. Business, included in this report. For additional information on our competition and pricing risks that could negatively impact our product sales, please read

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

10 edited+2 added−2 removed6 unchanged
Biggest changeIPR&D In-process Research and Development IRA Inflation Reduction Act of 2022 IT Information Technology IV Intravenous LHI Large Hemispheric Infarction LRRK2 Leucine-Rich Repeat Kinase 2 MAA Marketing Authorization Application MDD Major Depressive Disorder MHRA Medicines and Healthcare products Regulatory Agency MS Multiple Sclerosis NCD National Coverage Decision NDA New Drug Application NDS New Drug Submission Table o f Contents DEFINED TERMS (continued) Neurimmune Neurimmune SubOne AG NIST National Institute of Standards and Technology NMPA National Medicinal Products Administration ODD Orphan Drug Designation OECD Organization for Economic Co-operation and Development OIE Other (Income) Expense, Net PDUFA Prescription Drug User Fee Act PFAS Per- and Polyfluoroalkyl Substances PHS Public Health Service PMDA Pharmaceuticals and Medical Devices Agency PMN Primary Membranous Nephropathy Polpharma Polpharma Biologics S.A.
Biggest changeIPR&D In-process Research and Development IRA Inflation Reduction Act of 2022 IT Information Technology IV Intravenous LEQEMBI Collaboration Agreement Amended and Restated Collaboration Agreement entered into by Biogen MA Inc. and Eisai Co., Ltd. on October 22, 2017, as amended on March 13, 2022 LRRK2 Leucine-Rich Repeat Kinase 2 LTI Long-term Incentive MAA Marketing Authorization Application MFN Most-Favored-Nation MHRA Medicines and Healthcare products Regulatory Agency MorphoSys MorphoSys AG MS Multiple Sclerosis MVI Microvascular Inflammation in Kidney Transplant Patients NDA New Drug Application NDS New Drug Submission Neurimmune Neurimmune SubOne AG NIST National Institute of Standards and Technology NMPA National Medical Products Administration OBBBA One Big Beautiful Bill Act ODD Orphan Drug Designation OECD Organization for Economic Co-operation and Development OIE Other (Income) Expense, Net Organon Organon LLC PDUFA Prescription Drug User Fee Act PFAS Per- and Polyfluoroalkyl Substances PHS Public Health Service PMN Primary Membranous Nephropathy Polpharma Polpharma Biologics S.A.
NOTE REGARDING TRADEMARKS ADUHELM®, AVONEX®, BYOOVIZ®, PLEGRIDY®, QALSODY®, RITUXAN®, RITUXAN HYCELA®, SKYCLARYS®, SPINRAZA®, TECFIDERA®, TYSABRI® and VUMERITY® are registered trademarks of Biogen. BENEPALI™, FLIXABI™, FUMADERM™, IMRALDI™, OPUVIZ™ and TOFIDENCE™ are trademarks of Biogen. ACTEMRA®, COLUMVI®, ENBREL®, EYLEA®, FAMPYRA™, GAZYVA®, LEQEMBI®, HUMIRA®, LUCENTIS®, LUNSUMIO®, OCREVUS®, REMICADE®, ZURZUVAE™ and other trademarks referenced in this report are the property of their respective owners.
NOTE REGARDING TRADEMARKS ADUHELM®, AVONEX®, PLEGRIDY®, QALSODY®, RITUXAN®, RITUXAN HYCELA®, SKYCLARYS®, SPINRAZA®, TECFIDERA®, THECAFLEX DRX®, TYSABRI® and VUMERITY® are registered trademarks of Biogen. BENEPALI™, FLIXABI™, FUMADERM™ and IMRALDI™ are trademarks of Biogen. ACTEMRA®, COLUMVI®, ENBREL®, EYLEA®, FAMPYRA™, GAZYVA®, LEQEMBI®, HUMIRA®, LUCENTIS®, LUNSUMIO®, OCREVUS®, REMICADE®, TOFIDENCE®, ZURZUVAE® and other trademarks referenced in this report are the property of their respective owners.
Table o f Contents DEFINED TERMS 2023 Form 10-K Annual Report on Form 10-K for the year ended December 31, 2023 2020 Share Repurchase Program Board of Directors authorized program to repurchase up to $5.0 billion of our common stock 2024 Omnibus Equity Plan Biogen Inc. 2024 Omnibus Equity Plan 2017 Omnibus Equity Plan Biogen Inc. 2017 Omnibus Equity Plan 2024 ESPP Biogen Inc. 2024 Employee Stock Purchase Plan 2015 ESPP Biogen Inc. 2015 Employee Stock Purchase Plan 2023 Term Loan $1.5 billion term loan credit agreement 125 Broadway 125 Broadway, Cambridge, MA 300 Binney Street 300 Binney Street, Cambridge, MA AAIC Alzheimer's Association International Conference AbbVie AbbVie Inc.
Table of Contents DEFINED TERMS 2024 Form 10-K Annual Report on Form 10-K for the year ended December 31, 2024 2020 Share Repurchase Program Board of Directors authorized program to repurchase up to $5.0 billion of our common stock 2024 Omnibus Equity Plan Biogen Inc. 2024 Omnibus Equity Plan 2017 Omnibus Equity Plan Biogen Inc. 2017 Omnibus Equity Plan 2024 ESPP Biogen Inc. 2024 Employee Stock Purchase Plan 2015 ESPP Biogen Inc. 2015 Employee Stock Purchase Plan 2023 Term Loan $1.5 billion term loan credit agreement AAIC Alzheimer's Association International Conference AbbVie AbbVie Inc.
AI Artificial Intelligence Alkermes Alkermes plc ALS Amyotrophic Lateral Sclerosis AMP Average Manufacturer Price AMR Antibody-Mediated Rejection AOCI Accumulated Other Comprehensive Income (Loss) ASO Antisense Oligonucleotide ASU Accounting Standards Update ATV Antibody Transport Vehicle BLA Biologics License Application Blackstone Blackstone Life Sciences CCDAA Climate Corporate Data Accountability Act CCPA California Consumer Privacy Act CEO Chief Executive Officer CHMP Committee for Medicinal Products for Human Use CISA Cybersecurity and Infrastructure Security Agency CISO Chief Information Security Officer CJEU Court of Justice of the European Union CLE Cutaneous Lupus Erythematosus CLL Chronic Lymphocytic Leukemia CMS Centers for Medicare & Medicaid Services CODM Chief Operating Decision Maker Convergence Convergence Pharmaceuticals Ltd.
Alkermes Alkermes plc ALS Amyotrophic Lateral Sclerosis AMP Average Manufacturer Price AMR Antibody-Mediated Rejection AOCI Accumulated Other Comprehensive Income (Loss) ASO Antisense Oligonucleotide ASU Accounting Standards Update BLA Biologics License Application Blackstone Blackstone Life Sciences CCPA California Consumer Privacy Act CEO Chief Executive Officer CHMP Committee for Medicinal Products for Human Use CISO Chief Information Security Officer CLE Cutaneous Lupus Erythematosus CLL Chronic Lymphocytic Leukemia CMS Centers for Medicare & Medicaid Services CNS Central Nervous System CODM Chief Operating Decision Maker Convergence Convergence Pharmaceuticals Ltd.
PPACA Patient Protection and Affordable Care Act PPD Postpartum Depression PPMS Primary Progressive MS PRV Priority Review Voucher R&D Research and Development Reata Reata Pharmaceuticals, Inc. REMS Risk Evaluation and Mitigation Strategies RMS Relapsing MS RRMS Relapsing-Remitting MS RTP Research Triangle Park SAG Scientific Advisory Group Sage Sage Therapeutics, Inc. Samsung Bioepis Samsung Bioepis Co., Ltd.
PPACA Patient Protection and Affordable Care Act PPD Postpartum Depression PPMS Primary Progressive MS PRV Priority Review Voucher R&D Research and Development Reata Reata Pharmaceuticals, Inc. REMS Risk Evaluation and Mitigation Strategies RMS Relapsing MS RNAi RNA Interference Table of Contents DEFINED TERMS (continued) RRMS Relapsing-Remitting MS RTP Research Triangle Park, North Carolina Sage Sage Therapeutics, Inc.
CRFRA Climate-Related Financial Risk Act CRL Complete Response Letter CROs Contract Research Organizations CTAD Clinical Trials on Alzheimer's Disease DEA Drug Enforcement Agency Denali Denali Therapeutics Inc. Directors Plan Biogen Inc. 2015 Non-Employee Directors Equity Plan Table o f Contents DEFINED TERMS (continued) District Court U.S. District Court for the District of Massachusetts DOJ U.S.
CRL Complete Response Letter CROs Contract Research Organizations CTAD Clinical Trials on Alzheimer's Disease Dayra Dayra Therapeutics, Inc. Denali Denali Therapeutics Inc. Directors Plan Biogen Inc. 2015 Non-Employee Directors Equity Plan District Court U.S. District Court for the District of Massachusetts DOJ U.S.
Department of Justice DPN Diabetic Painful Neuropathy EC European Commission EHS Environment, Health and Safety Eisai Eisai Co., Ltd. EMA European Medicines Agency EPO European Patent Office ERG Employee Resource Group ERISA Employee Retirement Income Security Act of 1974 ERM Enterprise Risk Management E.U.
Department of Justice DPN Diabetic Painful Neuropathy EC European Commission EHS Environment, Health and Safety Eisai Eisai Co., Ltd. EMA European Medicines Agency EPO European Patent Office ERG Employee Resource Group ERM Enterprise Risk Management E.U. European Union FA Friedreich Ataxia FASB Financial Accounting Standards Board FCPA Foreign Corrupt Practices Act FDA U.S.
European Union FA Friedreich's Ataxia FASB Financial Accounting Standards Board FCPA Foreign Corrupt Practices Act FDA U.S. Food and Drug Administration FDIC Federal Deposit Insurance Corporation Fit for Growth Cost saving program initiated in 2023 FSS Federal Supply Schedule GCP Good Clinical Practices GDPR General Data Privacy Regulation Genentech Genentech, Inc.
Food and Drug Administration Table of Contents DEFINED TERMS (continued) Fit for Growth Cost saving program initiated in 2023 FSS Federal Supply Schedule GCP Good Clinical Practices GDPR General Data Protection Regulation Genentech Genentech, Inc. GILTI Global Intangible Low-Taxed Income GloBE Global Anti-Base Erosion GMP Good Manufacturing Practices HHS U.S.
Securities and Exchange Commission SG&A Selling, General and Administrative SLE Systemic Lupus Erythematosus SMA Spinal Muscular Atrophy SMN Survival Motor Neuron SOD1 Superoxide Dismutase 1 SPC Supplementary Protection Certificate SSP Supplemental Savings Plan SWISSMEDIC Swiss Agency for Therapeutic Products TBA Technical Boards of Appeal TGN Trigeminal Neuralgia TNF Anti-tumor Necrosis Factor Transition Toll Tax A one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings U.K.
Samsung Bioepis Samsung Bioepis Co., Ltd. Samsung BioLogics Samsung BioLogics Co., Ltd. Sangamo Sangamo Therapeutics, Inc. SEC U.S. Securities and Exchange Commission SG&A Selling, General and Administrative SLE Systemic Lupus Erythematosus SMA Spinal Muscular Atrophy SMN Survival Motor Neuron SOD1 Superoxide Dismutase 1 SPC Supplementary Protection Certificate SSP Supplemental Savings Plan Supernus Supernus Pharmaceuticals, Inc.
GILTI Global Intangible Low Tax Income GloBE Global Anti-Base Erosion GMP Good Manufacturing Practices HI-Bio Human Immunology Biosciences, Inc. Humana Humana Inc. IgAN Immunoglobulin A. Nephropathy Ionis Ionis Pharmaceuticals Inc.
Department of Health and Human Services HI-Bio Human Immunology Biosciences, Inc. Humana Humana Inc. IgAN Immunoglobulin A Nephropathy IND Investigational New Drug Ionis Ionis Pharmaceuticals Inc.
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Samsung BioLogics Samsung BioLogics Co., Ltd. Sangamo Sangamo Therapeutics, Inc. SEC U.S.
Added
Acorda Acorda Therapeutics, Inc. AI Artificial Intelligence Alcyone Alcyone Therapeutics, Inc.
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United Kingdom U.S. United States U.S. GAAP Accounting Principles Generally Accepted in the U.S. VA Veterans Administration Table o f Contents PART I
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SWISSMEDIC Swiss Agency for Therapeutic Products TNF Anti-tumor Necrosis Factor Transition Toll Tax A one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings U.K. United Kingdom U.S. United States U.S. GAAP Accounting Principles Generally Accepted in the U.S. VA U.S. Department of Veterans Affairs Vanqua Vanqua Bio, Inc. VAT Value-added Tax Table of Contents PART I

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

68 edited+14 added−17 removed56 unchanged
Biggest changeFor 2024 compared to 2023, the increase in net cash flow provided by operating activities was primarily due to higher net income, lower employee-benefit payments made during the first quarter of 2024, as compared to the same period in 2023, lower estimated federal tax payments made during 2024, as compared to 2023, and changes in non-cash adjustments to net income.
Biggest changeFor 2025 compared to 2024, the decrease in net cash flow provided by operating activities was primarily due to lower net income in 2025, which included higher acquired in-process research and development, upfront and milestone payments in 2025, higher worldwide tax payments in 2025, compared to 2024, of approximately $864.0 million and $355.1 million, respectively, driven by the timing of estimated tax payments, the timing of customer payments and higher employee-benefit payments made during the first quarter of 2025, compared to the same period in 2024.
Discounted cash flow models are typically used in these valuations, and these models require the use of significant estimates and assumptions including but not limited to: • estimating the timing of and expected costs to complete the in-process projects; • projecting regulatory approvals; • estimating future cash flow from product sales resulting from completed products and in process projects; and • developing appropriate discount rates and probability rates by project.
Discounted cash flow models are typically used in these valuations, and these models require the use of significant estimates and assumptions including but not limited to: • estimating the timing of and expected costs to complete the in-process projects; • projecting the timing and likelihood of regulatory approvals; • estimating future cash flow from product sales resulting from completed products and in process projects; and • developing appropriate discount rates and probability rates by project.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. (4) Long-term debt obligations are related to our 2021 Exchange Offer Senior Notes, our 2020 Senior Notes and our 2015 Senior Notes, including principal and interest payments.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. (4) Long-term debt obligations are related to our 2025 Senior Notes, our 2021 Exchange Offer Senior Notes, our 2020 Senior Notes and our 2015 Senior Notes, including principal and interest payments.
For additional information on the impairment charges related to our long-lived assets during 2024, 2023 and 2022, please read Note 7, Intangible Assets and Goodwill, to our consolidated financial statements included in this report. CONTINGENT CONSIDERATION We record contingent consideration resulting from a business combination at its fair value on the acquisition date.
For additional information on the impairment charges related to our long-lived assets during 2025, 2024 and 2023, please read Note 7, Intangible Assets and Goodwill, to our consolidated financial statements included in this report. CONTINGENT CONSIDERATION We record contingent consideration resulting from a business combination at its fair value on the acquisition date.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our condensed consolidated financial statements included in this report.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio. This revolving credit facility replaced the revolving credit facility that we entered into in January 2020. As of December 31, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.
The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio. This revolving credit facility replaced the revolving credit facility that we entered into in January 2020. As of December 31, 2025, we had no outstanding borrowings and were in compliance with all covenants under this facility.
LEGAL MATTERS For a discussion of legal matters as of December 31, 2024, please read Note 21, Litigation, to our consolidated financial statements included in this report. CRITICAL ACCOUNTING POLICIES AND ESTIMATES The preparation of our consolidated financial statements, which have been prepared in accordance with U.S.
LEGAL MATTERS For a discussion of legal matters as of December 31, 2025, please read Note 21, Litigation, to our consolidated financial statements included in this report. CRITICAL ACCOUNTING POLICIES AND ESTIMATES The preparation of our consolidated financial statements, which have been prepared in accordance with U.S.
Payments under these agreements generally become due and payable upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones was not considered probable as of December 31, 2024, such contingencies have not been recorded in our financial statements.
Payments under these agreements generally become due and payable upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones was not considered probable as of December 31, 2025, such contingencies have not been recorded in our financial statements.
We use foreign currency forward contracts and foreign currency options to manage foreign currency risk, with the majority of our forward contracts and options used to hedge certain forecasted revenue and operating expense transactions denominated in foreign currencies in the next 12 months. We do not engage in currency speculation.
We use foreign currency forward contracts and foreign currency options to manage foreign currency risk, with the majority of our forward contracts and options used to hedge certain forecasted revenue and operating expense transactions denominated in foreign currencies in the next 21 months. We do not engage in currency speculation.
SPINRAZA We make royalty payments to Ionis on annual worldwide net sales of SPINRAZA using a tiered royalty rate between 11.0% and 15.0%, which are recognized as cost of sales in our consolidated statements of income.
SPINRAZA We make royalty payments to Ionis on annual worldwide net sales of SPINRAZA using a tiered royalty rate between 11.0% and 15.0%, which are recognized in cost of sales within our consolidated statements of income.
QALSODY We make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0% and 15.0%, which are recognized as cost of sales in our consolidated statements of income.
QALSODY We make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0% and 15.0%, which are recognized in cost of sales within our consolidated statements of income.
For a summary of the fair values of our outstanding borrowings as of December 31, 2024 and 2023, please read Note 8, Fair Value Measurements, to our consolidated financial statements included in this report.
For a summary of the fair values of our outstanding borrowings as of December 31, 2025 and 2024, please read Note 8, Fair Value Measurements, to our consolidated financial statements included in this report.
If we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense within our consolidated statements of income as they are incurred.
If we acquire an asset or group of assets with no alternative future use that do not meet the definition of a business under applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense within our consolidated statements of income as they are incurred.
As 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 and Swiss franc.
As 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.
For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report .
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.
These fair value measurements represent Level 3 measurements as they are based on significant inputs that are not observable in the market. Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period.
These fair value measurements represent Level 3 measurements as they are based on significant inputs that are not observable in the market. 91 Table of Contents Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period.
As of December 31, 2024 and 2023, a hypothetical adverse 10.0% movement in foreign currency exchange rates compared to the U.S. dollar across all maturities would result in a hypothetical decrease in the fair value of forward contracts of approximately $191.7 million and $249.4 million, respectively.
As of December 31, 2025 and 2024, a hypothetical adverse 10.0% movement in foreign currency exchange rates compared to the U.S. dollar across all maturities would result in a hypothetical decrease in the fair value of forward contracts of approximately $278.0 million and $191.7 million, respectively.
The estimated fair value change was determined by measuring the impact of the hypothetical exchange rate movement on outstanding forward contracts. Our use of this methodology to quantify the market risk of such instruments is subject to assumptions and actual impact could be significantly 88 Table o f Contents different.
The estimated fair value change was determined by measuring the impact of the hypothetical exchange rate movement on outstanding forward contracts. Our use of this methodology to quantify the market risk of such instruments is subject to assumptions and the actual impact could be significantly different.
Our process for 84 Table o f Contents estimating reserves established for these variable consideration components do not differ materially from our historical practices. Product revenue reserves, which are classified as a reduction in product revenue, are generally characterized in the following categories: discounts, contractual adjustments and returns.
Our process for estimating reserves established for these variable consideration components do not differ materially from our historical practices. Product revenue reserves, which are classified as a reduction in product revenue, are generally characterized in the following categories: discounts, contractual adjustments and returns.
We manage the impact of foreign currency exchange rates and interest rates through various financial instruments, including derivative instruments such as foreign currency forward contracts, foreign currency options, interest rate lock contracts and interest rate swap contracts. 87 Table o f Contents We do not enter into financial instruments for trading or speculative purposes.
We manage the impact of foreign currency exchange rates and interest rates through various financial instruments, including derivative instruments such as foreign currency forward contracts, foreign currency options, interest rate lock contracts and interest rate swap contracts. We do not enter into financial instruments for trading or speculative purposes.
BALANCE SHEET RISK MANAGEMENT HEDGING PROGRAM We also use forward contracts to mitigate the foreign currency exposure related to certain balance sheet items. The primary objective of our balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets and liabilities of foreign affiliates. In these instances, we principally utilize currency forward contracts.
BALANCE SHEET RISK MANAGEMENT HEDGING PROGRAM We also use forward contracts to mitigate the foreign currency exposure related to certain balance sheet items. The primary objective of our balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets and liabilities of foreign affiliates.
We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts and circumstances as of the acquisition dates. If these projects are not successfully developed, the sales and profitability of the company may be adversely affected in future periods. Additionally, the value of the acquired intangible assets may become impaired.
We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts and circumstances as of the acquisition dates. 90 Table of Contents If these projects are not successfully developed, the sales and profitability of the company may be adversely affected in future periods.
As of December 31, 2024 and 2023, a 10.0% change in our discounts, contractual adjustments and reserves would have resulted in a decrease of our pre-tax earnings by approximately $351.9 million and $345.5 million, respectively.
As of December 31, 2025 and 2024, a 10.0% change in our discounts, contractual adjustments and reserves would have resulted in a decrease of our pre-tax earnings by approximately $355.7 million and $351.9 million, respectively.
We have approximately $509.2 million in cancellable future commitments based on existing CRO contracts as of December 31, 2024. TAX RELATED OBLIGATIONS We exclude liabilities pertaining to uncertain tax positions from our summary of contractual obligations as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities.
We have approximately $524.9 million in cancellable future commitments based on existing CRO contracts as of December 31, 2025. 88 Table of Contents TAX RELATED OBLIGATIONS We exclude liabilities pertaining to uncertain tax positions from our summary of contractual obligations as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities.
The change in working capital reflects an increase in total current assets of approximately $597.5 million and an increase in total current liabilities of approximately $2.1 billion.
The change in working capital reflects an increase in total current assets of approximately $1.5 billion and a decrease in total current liabilities of approximately $2.2 billion.
For additional information on our 2023 Term Loan, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES As of December 31, 2024, we had cash and cash equivalents totaling approximately $2.4 billion compared to approximately $1.0 billion as of December 31, 2023.
For additional information on our Senior Notes, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES As of December 31, 2025, we had cash, cash equivalents and marketable securities totaling approximately $4.2 billion compared to approximately $2.4 billion as of December 31, 2024.
Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones. If certain clinical and commercial milestones are met, we may pay up to approximately $73.6 million in milestones in 2025 under our current agreements, excluding opt-in payments.
Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones. If certain research milestones are met, we may pay up to approximately $67.5 million in additional milestones in 2026 under our current agreements, excluding opt-in payments.
Our 2020 Share Repurchase Program does not have an expiration date. All shares repurchased under our 2020 Share Repurc hase Program were retired. There were no share repurchases of our common stock during the years ended December 31, 2024 and 2023. Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2024.
Our 2020 Share Repurchase Program does not have an expiration date. All shares repurchased under our 2020 Share Repurc hase Program were retired. There were no repurchases of our common stock during the years ended December 31, 2025 and 2024.
We amortize the intangible assets related to our marketed products using the economic consumption method, which is based on revenue generated from the products underlying the related intangible assets.
Our most significant intangible assets relate to SKYCLARYS and TYSABRI. We amortize the intangible assets related to our marketed products using the economic consumption method, which is based on revenue generated from the products underlying the related intangible assets.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk included in this report. 78 Table o f Contents LIQUIDITY WORKING CAPITAL Working capital is defined as current assets less current liabilities. Our working capital was $1.9 billion as of December 31, 2024, compared to $3.4 billion as of December 31, 2023.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk included in this report. 83 Table of Contents LIQUIDITY WORKING CAPITAL Working capital is defined as current assets less current liabilities. Our working capital was $5.6 billion as of December 31, 2025, compared to $1.9 billion as of December 31, 2024.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. 80 Table o f Contents CAPITAL RESOURCES DEBT AND CREDIT FACILITIES LONG-TERM DEBT AND TERM LOAN CREDIT AGREEMENTS Our long-term obligations primarily consist of long-term debt related to our Senior Notes with final maturity dates ranging between 2030 and 2051.
For additional information on our Senior Notes and 2023 Term Loan, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. 85 Table of Contents CAPITAL RESOURCES DEBT AND CREDIT FACILITIES LONG-TERM DEBT AND TERM LOAN CREDIT AGREEMENTS Our long-term obligations primarily consist of long-term debt related to our Senior Notes with final maturity dates ranging between 2030 and 2055.
CASH FLOW The following table summarizes our cash flow activity: % Change For the Years Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In millions, except percentages) 2024 2023 2022 Net cash flow provided by (used in) operating activities $ 2,875.5 $ 1,547.2 $ 1,384.3 85.9 % 11.8 % Net cash flow provided by (used in) investing activities (799.2) (4,101.0) 1,576.6 (80.5) (360.1) Net cash flow provided by (used in) financing activities (683.5) 149.3 (1,747.3) (557.8) 108.5 OPERATING ACTIVITIES Operating cash flow is derived by adjusting our net income for: • non-cash operating items such as depreciation and amortization, impairment charges, unrealized (gain) loss on strategic investments and share-based compensation; • changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations; and • (gains) losses on the disposal of assets, deferred income taxes, changes in the fair value of contingent payments associated with our acquisitions of businesses and acquired IPR&D.
For additional information on our 2025 Senior Notes, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. 84 Table of Contents CASH FLOW The following table summarizes our cash flow activity: % Change For the Years Ended December 31, 2025 vs. 2024 2024 vs. 2023 (In millions, except percentages) 2025 2024 2023 Net cash flow provided by (used in) operating activities $ 2,204.6 $ 2,875.5 $ 1,547.2 (23.3) % 85.9 % Net cash flow provided by (used in) investing activities (1,371.1) (799.2) (4,101.0) 71.6 (80.5) Net cash flow provided by (used in) financing activities (301.9) (683.5) 149.3 (55.8) (557.8) OPERATING ACTIVITIES Operating cash flow is derived by adjusting our net income for: • non-cash operating items such as depreciation and amortization, impairment charges, unrealized (gain) loss on strategic investments and share-based compensation; • changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations; and • (gains) losses on the disposal of assets, deferred income taxes, changes in the fair value of contingent payments associated with our acquisitions of businesses and acquired IPR&D.
These differences result in 86 Table o f Contents deferred tax assets and liabilities, which are included in our consolidated balance sheets. Upon our election in the fourth quarter of 2018 to record deferred taxes for GILTI, we have included amounts related to GILTI taxes within temporary difference.
These differences result in deferred tax assets and liabilities, which are included in our consolidated balance sheets. Upon our election in the fourth quarter of 2018 to record deferred taxes for GILTI, we have included amounts related to GILTI taxes within temporary difference. Significant management judgment is required in assessing the realizability of our deferred tax assets.
If the carrying value of our acquired IPR&D exceeds its fair value, then the intangible asset is written down to its fair value. Changes in estimates and assumptions used in determining the fair value of our acquired IPR&D could result in an impairment. Impairments are recorded within amortization and impairment of acquired intangible assets in our consolidated statements of income.
Changes in estimates and assumptions used in determining the fair value of our acquired IPR&D could result in an impairment. Acquired IPR&D impairments are recorded within amortization and impairment of acquired intangible assets in our consolidated statements of income.
CONTINGENT DEVELOPMENT, REGULATORY AND COMMERCIAL MILESTONE PAYMENTS Based on our development plans as of December 31, 2024, we could trigger potential future milestone payments to third parties of up to approximately $3.8 billion, including approximately $0.5 billion in development milestones, approximately $0.5 billion in regulatory milestones and approximately $2.8 billion in commercial milestones, as part of our various collaborations, including licensing and development programs and HI-Bio's pre-existing commitments, as discussed below.
CONTINGENT DEVELOPMENT, REGULATORY AND COMMERCIAL MILESTONE PAYMENTS Based on our development plans as of December 31, 2025, we could make potential future milestone payments to third parties of up to approximately $5.3 billion, including approximately $0.7 billion in development milestones, approximately $0.8 billion in regulatory milestones and approximately $3.8 billion in commercial milestones, as part of our various collaborations, including licensing and development programs.
It is our policy to mitigate credit risk in our cash reserves and marketable securities by maintaining a well-diversified portfolio that limits the amount of exposure as to institution, maturity and investment type.
It is our policy to mitigate credit risk in our cash reserves and marketable securities by maintaining a well-diversified portfolio that limits the amount of exposure as to institution, maturity and investment type. We have experienced no significant limitations in our liquidity resulting from uncertainties in the banking sector.
For additional information on our long-term debt obligations, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. (5) Purchase and other obligations include $234.0 million related to the remaining payments on the Transition Toll Tax and $11.7 million related to the fair value of net liabilities on derivative contracts.
For additional information on our long-term debt obligations, please read Note 13, Indebtedness , to our consolidated financial statements included in this report. (5) Purchase and other obligations includes approximately $58.9 million related to the fair value of net liabilities on derivative contracts.
This categorization did not have a material impact on our results of operations or financial position as of December 31, 2024, and is not expected to have a material impact on our results of operations or financial position in the future. In December 2023 the Argentinian Peso experienced a substantial devaluation following a presidential election.
This categorization did not have a material impact on our results of operations or financial position as of December 31, 2025, and is not expected to have a material impact on our results of operations or financial position in the future.
We review our intangible assets with indefinite lives for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. When performing our impairment assessment, we calculate the fair value using the same methodology as described above under Acquired Intangible Assets, including IPR&D .
We review our intangible assets with indefinite lives for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Although we believe that the assumptions we use in estimating inventory write-downs are reasonable, no assurance can be given that significant future changes in these assumptions or changes in future events and market conditions could result in different estimates.
If customer demand subsequently differs from our forecasts, we may be required to record additional charges for excess inventory. Although we believe that the assumptions we use in estimating inventory write-downs are reasonable, no assurance can be given that significant future changes in these assumptions or changes in future events and market conditions could result in different estimates.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. In making this determination, under the applicable financial accounting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income and the effects of tax planning strategies.
In making this determination, under the applicable financial accounting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income and the effects of tax planning strategies.
We may pay up to an additional $650.0 million in potential future development and regulatory milestone payments. The acquisition-date fair value of these milestones was approximately $485.1 million. We anticipate that we may trigger the first and second milestone payments of approximately $150.0 million each in 2025.
We may pay up to a total of $650.0 million in contingent development and regulatory milestone payments. The acquisition-date fair value of these milestones was approximately $485.1 million.
To date, we have not experienced any significant losses with respect to the collection of our accounts receivable. We believe that our allowance for doubtful accounts was adequate as of December 31, 2024 and 2023. EQUITY PRICE RISK Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies.
To date, we have not experienced any significant losses with respect to the collection of our accounts receivable. We believe that our allowance for doubtful accounts was adequate as of December 31, 2025 and 2024. ITEM 8.
RESERVES FOR DISCOUNTS AND ALLOWANCES Product revenue is recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the international markets in which we operate.
We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. 89 Table of Contents RESERVES FOR DISCOUNTS AND ALLOWANCES Product revenue is recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the international markets in which we operate.
We have not elected hedge accounting for the balance sheet related items. The cash flow from these contracts are reported as operating activities in our consolidated statements of cash flow. The following quantitative information includes the impact of currency movements on forward contracts used in our revenue, operating expense and balance sheet hedging programs.
In these instances, we principally utilize 93 Table of Contents currency forward contracts. We have not elected hedge accounting for the balance sheet related items. The cash flow from these contracts are reported as operating activities in our consolidated statements of cash flow.
If we determine the assets acquired do not meet the definition of a business, the transaction will be accounted for as an asset acquisition rather than a business combination. ITEM 7A.
If we determine the assets acquired do not meet the definition of a business, the transaction will be accounted for as an asset acquisition rather than a business combination. 92 Table of Contents For additional information on our acquisitions, please read Note 2, Acquisitions, to our consolidated financial statements included in this report. ITEM 7A.
IMPAIRMENT AND AMORTIZATION OF LONG-LIVED ASSETS Long-lived assets to be held and used include property, plant and equipment as well as intangible assets, including IPR&D and trademarks. Property, plant and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable.
IMPAIRMENT AND AMORTIZATION OF LONG-LIVED ASSETS Long-lived assets to be held and used include property, plant and equipment as well as intangible assets, including IPR&D and trademarks.
The changes in total current assets and total current liabilities were primarily driven by the following: CURRENT ASSETS • $1.3 billion increase in cash and cash equivalents ; • $259.3 million decrease in accounts receivable, net related to our ongoing operations; and • $429.5 million decrease in other current assets primarily due to the receipt of $437.5 million from Samsung BioLogics related to the sale of our 49.9% equity interest in Samsung Bioepis.
The changes in total current assets and total current liabilities were primarily driven by the following: CURRENT ASSETS • $1.4 billion increase in cash, cash equivalents and current marketable securities ; • $62.4 million decrease in accounts receivable, net related to our ongoing operations; and • $292.4 million decrease in inventory primarily due to timing of production.
Payments Due by Period (In millions) Total Less than 1 Year 1 to 3 Years 3 to 5 Years After 5 Years Non-cancelable operating leases (1)(2)(3) $ 459.6 $ 88.7 $ 152.5 $ 66.0 $ 152.4 Long-term debt obligations (4) 9,797.0 1,965.0 323.7 323.7 7,184.6 Purchase and other obligations (5) 566.7 406.2 135.3 20.7 4.5 Defined benefit obligation 107.1 — — — 107.1 Total contractual obligations $ 10,930.4 $ 2,459.9 $ 611.5 $ 410.4 $ 7,448.6 (1) We lease properties and equipment for use in our operations.
Payments Due by Period (In millions) Total Less than 1 Year 1 to 3 Years 3 to 5 Years After 5 Years Non-cancelable operating leases (1)(2)(3) $ 414.8 $ 81.9 $ 135.5 $ 49.1 $ 148.3 Long-term debt obligations (4) 11,359.7 264.6 529.1 2,006.5 8,559.5 Purchase and other obligations (5) 352.0 243.1 96.7 7.7 4.5 Defined benefit obligation 118.7 — — — 118.7 Total contractual obligations $ 12,245.2 $ 589.6 $ 761.3 $ 2,063.3 $ 8,831.0 (1) We lease properties and equipment for use in our operations.
As of December 31, 2024, we have approximately $173.8 million of liabilities associated with uncertain tax positions. 83 Table o f Contents As of December 31, 2024 and 2023, we have accrued income tax liabilities of approximately $234.0 million and $419.5 million, respectively, under the Transition Toll Tax.
As of December 31, 2025, we have approximately $166.8 million of liabilities associated with uncertain tax positions. As of December 31, 2024, we accrued income tax liabilities of approximately $234.0 million under the Transition Toll Tax, which was subsequently paid in full in April 2025.
Significant management judgment is required in assessing the realizability of our deferred tax assets. In performing this assessment, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.
In performing this assessment, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.
The determination of obsolete or excess inventory requires management to make estimates based on assumptions about the future demand of our products, product expiration dates, estimated future sales and our general future plans. If customer demand subsequently differs from our forecasts, we may be required to record additional charges for excess inventory.
INVENTORY 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. The determination of obsolete or excess inventory requires management to make estimates based on assumptions about the future demand of our products, product expiration dates, estimated future sales and our general future plans.
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report. VUMERITY We make royalty payments to Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0%, which are recognized as cost of sales in our consolidated statements of income.
Royalty payments are recognized as cost of sales in our consolidated statements of income. For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
For additional information on our collaboration arrangement with Alkermes, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report. SKYCLARYS In connection with our acquisition of Reata in September 2023 we assumed additional contractual obligations related to royalty payments.
Prior to this acquisition, we disposed of all of our shares of Sage common stock in a block trade. For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report .
Our most significant clinical trial expenditures are to CROs. The contracts with CROs are generally cancellable, with notice, at our option. We recorded accrued expense of approximately $21.7 million in our consolidated balance sheets for expenditures incurred by CROs as of December 31, 2024.
We recorded accrued expense of approximately $39.3 million in our consolidated balance sheets for expenditures incurred by CROs as of December 31, 2025.
As we continue to advance our research and development prioritization efforts, which includes refocusing our investment in gene therapy, we are evaluating several alternative uses for this facility. 81 Table o f Contents CONTRACTUAL OBLIGATIONS AND OFF-BALANCE SHEET ARRANGEMENTS CONTRACTUAL OBLIGATIONS The following table summarizes our contractual obligations as of December 31, 2024, 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.
Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2025. 86 Table of Contents CONTRACTUAL OBLIGATIONS AND OFF-BALANCE SHEET ARRANGEMENTS CONTRACTUAL OBLIGATIONS The following table summarizes our contractual obligations as of December 31, 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.
Based on our most recent impairment assessment we incurred impairment charges of approximately $60.2 million for the year ended December 31, 2024, related to the impairment of other clinical programs we acquired from Reata and Samsung Bioepis commercialization rights terminated during the third quarter of 2024. For the year ended December 31, 2023, we had no impairment charges.
For the year ended December 31, 2024, we incurred impairment charges of approximately $60.2 million related to the impairment of other clinical programs we acquired from Reata and the termination of Samsung Bioepis' commercialization rights. For additional information on our impairments, please read Note 7, Intangible Assets and Goodwill , to our consolidated financial statements included in this report.
(3) In connection with our acquisition of Reata in September 2023 we assumed operating lease commitments, including the responsibility for a single-tenant, built-to-suit building with a total net present value of rental expense of approximately $154.4 million over the next 15 years.
(2) Obligations are presented net of sublease income expected to be received for our vacated portions of various facilities throughout the world. (3) In connection with our acquisition of Reata in September 2023 we assumed operating lease commitments, including the responsibility for a single-tenant, built-to-suit building.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report. For additional information on the sale of our equity interest in Samsung Bioepis and the sale of our PRV, please read Note 3, Dispositions , to our consolidated financial statements included in this report.
Additionally, net cash flow used in financing activities during 2024 included the repayment of our 2023 Term Loan for $650.0 million. For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
The increase in the balance was primarily due to cash generated by our operations, the receipt of $437.5 million in April 2024 from Samsung BioLogics related to the sale of our 49.9% equity interest in Samsung Bioepis, the 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 of our Denali common stock and our remaining Sangamo common stock during 2024.
In 2024, net cash flow in investing activities included the acquisition of HI-Bio for $1.15 billion, partially offset by the receipt of $437.5 million from Samsung BioLogics related to the sale of our 49.9% equity interest in Samsung Bioepis and the net cash receipt of $88.6 million from the sale of one of our two PRVs.
We have experienced no significant limitations in our liquidity resulting from uncertainties in the banking sector. 79 Table o f Contents The following table summarizes the fair value of our significant common stock investments in our strategic investment portfolio: As of December 31, (In millions) 2024 2023 Denali (1) $ 145.8 $ 273.6 Sage 33.9 135.3 Sangamo (1) — 7.9 Total $ 179.7 $ 416.8 (1) During 2024 we sold a portion of our Denali common stock and the remaining shares of our Sangamo common stock.
The following table summarizes the fair value of our significant common stock investments in our strategic investment portfolio: As of December 31, (In millions) 2025 2024 Denali $ 118.1 $ 145.8 Sage (1) — 33.9 Total $ 118.1 $ 179.7 (1) In July 2025 Sage was acquired by Supernus.
No assurance can be given that the underlying assumptions used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as estimated. 85 Table o f Contents INVENTORY 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.
Additionally, the value of the acquired intangible assets may become impaired. No assurance can be given that the underlying assumptions used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as estimated.
This amount includes potential milestone payments due upon the first patient dosed in a phase 3 clinical trial of felzartamab in a first and second indication of $35.0 million and $30.0 million, respectively, which we anticipate will be triggered in 2025. OTHER FUNDING COMMITMENTS As of December 31, 2024, we have several ongoing clinical studies in various clinical trial stages.
This amount includes a $45.0 million milestone payment due upon the initiation of a Phase 3 trial of salanersen. OTHER FUNDING COMMITMENTS As of December 31, 2025, we have several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial expenditures are to CROs. The contracts with CROs are generally cancellable, with notice, at our option.
As of December 31, 2024 and 2023, a hypothetical adverse 10.0% movement would result in a hypothetical decrease in fair value of approximately $18.0 million and $41.7 million, respectively. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The information required by this Item 8 is contained on pages F-1 through F-83 of this report and is incorporated herein by reference.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The information required by this Item 8 is contained on pages F-1 through F-79 of this report and is incorporated herein by reference. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.
As of December 31, 2024, our outstanding balance related to long-term debt was $4,547.2 million. In connection with our acquisition of Reata in September 2023 we entered into a $1.5 billion term loan credit agreement.
In June 2025 we used the net proceeds from the sale of our 2025 Senior Notes to redeem our 4.050% Senior Notes due September 15, 2025, prior to maturity. 2023 TERM LOAN In connection with our acquisition of Reata in September 2023 we entered into a $1.5 billion term loan credit agreement.
INVESTING ACTIVITIES For 2024 compared to 2023, the change in net cash flow in investing activities was primarily due to cash payments made associated with our acquisition of HI-Bio in 2024 and with our acquisition of Reata in 2023. Additionally, cash outlay in 2023 was partially offset by net proceeds received from the sale of our marketable securities.
The decrease was offset in part by lower inventory levels and $200.0 million of research and development funding received from Royalty Pharma in 2025. INVESTING ACTIVITIES For 2025 compared to 2024, the change in net cash flow in investing activities was primarily due to purchases of marketable securities in 2025 of $1.3 billion.
Reata entered into agreements to pay royalties on future sales of SKYCLARYS, which will cumulatively range in the low- to mid-single digits. For additional information on our acquisition of Reata, please read Note 2, Acquisitions , to our consolidated financial statements included in this report.
SKYCLARYS In connection with our acquisition of Reata in September 2023 we assumed additional contractual obligations related to royalty payments. Reata entered into agreements to pay royalties on annual worldwide net sales of 87 Table of Contents SKYCLARYS, which will cumulatively range in the low to mid-single digit percentages.
We have elected to initiate a technology transfer and, following a transition period, to 82 Table o f Contents manufacture VUMERITY or have VUMERITY manufactured by a third party we have engaged in exchange for paying an increased royalty rate to Alkermes on any portion of future worldwide net commercial sales of VUMERITY that is manufactured by us or our designee.
VUMERITY We make royalty payments to Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0% on product that Alkermes has manufactured and 16.0% on product manufactured by us or a third-party designee, which are recognized as cost of sales in our consolidated statements of income.
Removed
CURRENT LIABILITIES • $184.1 million increase in accrued expense and other primarily due to $279.3 million of short-term contingent consideration recognized from our acquisition of HI-Bio, offset in part by the timing of our annual incentive compensation payment and other benefits-related payments; and • $1.6 billion increase in current portion of debt primarily due to the reclassification of our $1.75 billion aggregate principal amount of 4.05% Senior Notes due September 15, 2025, from long-term to short-term and the repayment of our 2023 Term Loan.
Added
CURRENT LIABILITIES • $1.7 billion decrease in the current portion of notes payable due to the redemption of our 4.050% Senior Notes due September 15, 2025, during the second quarter of 2025; and • $433.5 million decrease in taxes payable primarily due to the timing of tax payments.
Removed
The increase was offset in part by $1.15 billion of cash and cash equivalents used to fund our acquisition of HI-Bio in July 2024 and $650.0 million of cash used for the repayment of our 2023 Term Loan.
Added
The increase in the balance was primarily due to cash generated by our operations, which includes $200.0 million of 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 connection with the closing of our collaboration and license agreement, milestone payments made to the former shareholders of HI-Bio totaling $300.0 million, a payment of $50.0 million in connection with our acquisition of Alcyone and total payments of $166.0 million in connection with our agreements with City Therapeutics, Dayra and Vanqua.
Removed
Our ability to liquidate our investments in Denali and Sage may be limited by the size of our interest, the volume of market related activity, our concentrated level of ownership and potential restrictions resulting from our status as a collaborator. Therefore, we may realize significantly less than the current value of such investments.
Added
During the second quarter of 2025 we received $1.75 billion in net proceeds from the issuance of our 2025 Senior Notes, which was offset by a $1.75 billion payment made for the redemption of our 4.050% Senior Notes due September 15, 2025.
Removed
The increase was partially offset by the timing of working capital, which includes higher inventory levels, primarily associated with our contract manufacturing for LEQEMBI.
Added
FINANCING ACTIVITIES For 2025 compared to 2024, the change in net cash flow in financing activities was primarily due to $1.75 billion in net proceeds received from the issuance of our 2025 Senior Notes, which was offset by a $1.75 billion payment made for the redemption of our 4.050% Senior Notes due September 15, 2025, as well as $300.0 million of milestone payments made to the former shareholders of HI-Bio, of which approximately $280.0 million was reflected within financing activities.
Removed
FINANCING ACTIVITIES For 2024 compared to 2023, the change in net cash flow in financing activities was primarily due to the repayment of our 2023 Term Loan for $650.0 million during 2024 compared to the issuance of term loans totaling $1.0 billion under our 2023 Term Loan which were used to partially fund our acquisition of Reata in 2023, partially offset by repayments of borrowings and debt premiums paid in 2023 totaling $809.9 million.
Added
As of December 31, 2025, our outstanding balance related to long-term debt was $6.3 billion, net of discounts and debt offering costs. 2025 SENIOR NOTES On May 12, 2025, we issued our 2025 Senior Notes for an aggregate principal amount of $1.75 billion.
Removed
CAPITAL EXPENDITURES In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new manufacturing facility will be approximately 197,000 square feet with an estimated total investment of approximately $195.0 million.
Added
LEASE COMMITMENTS In March 2025 we entered into a lease agreement with MIT Investment Management Company and BioMed Realty for the lease of approximately 580,000 square feet of office and research and development space located at 75 Broadway, Cambridge, Massachusetts, which will be used as our new global corporate headquarters, as well as integrating our research and development and technical operations teams alongside our North American commercial organization.

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