What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-02-15 compared with 2022-02-03 · 529 added, 469 removed, 688 unchanged (59% of the section changed)

Biogen is a global biopharmaceutical company focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and are providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease.

We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology.

Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics.

We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities.

Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases worldwide.

We have a broad portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and co-developed two treatments to address a defining pathology of Alzheimer’s disease.

We are focused on advancing our pipeline in neurology, neuropsychiatry, specialized immunology and rare diseases.

We support our drug discovery and development efforts through internal research and development programs and external collaborations.

Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS;

2 unchanged sentences

and FUMADERM for the treatment of severe plaque psoriasis.

We also collaborate with Eisai Co., Ltd.

(Eisai) on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted accelerated approval by the U.S.

Food and Drug Administration (FDA) in January 2023.

We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions;

2 unchanged sentences

OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS);

and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, Inc.

LUNSUMIO (mosunetuzumab), which was granted accelerated approval in the U.S.

during the fourth quarter of 2022 for the treatment of relapsed or refractory follicular lymphoma;

glofitamab, an investigational bispecific antibody for the potential treatment of non-Hodgkin's lymphoma;

and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, Inc.

(Genentech), a wholly-owned member of the Roche Group.

For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in this report.

For over two decades we have led in the research and development of new therapies to treat MS, resulting in our leading portfolio of MS treatments.

Now our research is focused on developing next generation treatments for MS.

We introduced the first approved treatment for SMA and are continuing to pursue research and development for potential advancements in the treatment of SMA.

We are also applying our scientific expertise to solve some of the most challenging and complex diseases, including Alzheimer's disease, ALS, Parkinson's disease, major depressive disorder (MDD), postpartum depression (PPD), systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), cognitive impairment associated with schizophrenia (CIAS), stroke and neuropathic pain.

Our innovative drug development and commercialization activities are complemented by our biosimilar business that expands access to medicines and reduces the cost burden for healthcare systems.

Through our agreements with Samsung Bioepis Co., Ltd.

(Samsung Bioepis), our joint venture with Samsung BioLogics Co., Ltd.

(Samsung BioLogics), we market and sell BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe.

We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was approved in the U.S., the European Union (E.U.) and the U.K.

during the third quarter of 2021.

For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in this report.

In addition to continuing to invest in new potential innovation in MS and SMA we are advancing our mid-to-late stage programs including zuranolone for major depressive disorder (MDD) and postpartum depression (PPD), BIIB080 for Alzheimer's disease, tofersen for amyotrophic lateral sclerosis (ALS) and both litifilimab and dapirolizumab pegol for certain forms of lupus.

We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S.

We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA.

For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.

Key Business Developments

The following is a summary of key developments affecting our business since the beginning of 2022.

For additional information on our acquisitions, collaborative and other relationships discussed below, please read Note 2, Acquisitions , Note 18, Collaborative and Other Relationships, and Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.

Acquisitions, Collaborative and Other Relationships

Bio-Thera Solutions

In April 2021 we entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA.

In connection with this agreement, we made an upfront payment of $30.0 million to Bio-Thera Solutions.

T a ble of Content s

InnoCare Pharma Limited

In August 2021 we closed a collaboration and license agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS.

Orelabrutinib is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS (RRMS).

Under the terms of this collaboration, we have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare retains exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan).

In connection with this agreement, we made an upfront payment of $125.0 million to InnoCare.

Mosunetuzumab

In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of mosunetuzumab, a late-stage bispecific antibody in development for B-cell non-Hodgkin’s lymphoma and other therapeutic areas.

For additional information on our collaborative and other relationships discussed below, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.

Developments in Key Collaborative Relationships

Eisai Collaboration Agreements

LEQEMBI (lecanemab) Collaboration Agreement

In January 2023 we and Eisai announced that the FDA granted accelerated approval of LEQEMBI, an anti-amyloid antibody for the treatment of Alzheimer's disease.

Additionally, in January 2023 we and Eisai announced the completed submission of a supplemental Biologics License Application (BLA) to the FDA for traditional approval of LEQEMBI.

In January 2023 the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for lecanemab.

In January 2023 Eisai completed the submission of a MAA to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for lecanemab, and was granted Priority Review by the Japanese Ministry of Health, Labor and Welfare.

Table of Conten ts

In December 2022 Eisai initiated a rolling submission of a BLA to the National Medicinal Products Administration (NMPA) of China for the approval of lecanemab.

In March 2022 we extended our supply agreement with Eisai related to LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance.

ADUHELM Collaboration Agreement

On March 14, 2022, we amended our ADUHELM Collaboration Agreement with Eisai.

As of the amendment date, we have sole decision making and commercialization rights worldwide on ADUHELM, and beginning January 1, 2023, Eisai receives only a tiered royalty based on net sales of ADUHELM, and no longer participates in sharing ADUHELM's global profits and losses.

Eisai's share of development, commercialization and manufacturing expense was limited to $335.0 million for the period from January 1, 2022 to December 31, 2022, which was achieved as of December 31, 2022.

Once this limit was achieved, we became responsible for all ADUHELM related costs.

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.

Zuranolone (BIIB125)

In June 2022 we and our collaboration partner Sage Therapeutics, Inc.

(Sage) announced that the Phase 3 SKYLARK study of zuranolone, for the potential treatment of MDD and PPD, met its primary and all key secondary endpoints.

In December 2022 we and Sage completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of zuranolone for the potential treatment of MDD and PPD.

This submission completes the NDA filing initiated earlier in 2022.

In February 2023 the FDA accepted the NDA and granted Priority Review for zuranolone, with a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.

For additional information on our collaboration arrangement with Sage, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.

LUNSUMIO (mosunetuzumab)

In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of LUNSUMIO (mosunetuzumab), a bispecific antibody for the treatment of relapsed or refractory follicular lymphoma.

In connection with this exercise, we recorded a $30.0 million option exercise fee payable to Genentech in December 2021.

BIIB115 Option Exercise

In December 2021 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115, a preclinical investigational ASO in development for SMA.

In connection with this option exercise, we made an opt-in payment of $60.0 million to Ionis.

In December 2022 Genentech announced that the FDA granted accelerated approval of LUNSUMIO, which was also approved by the European Commission (EC) in June 2022.

In December 2022 we reached an agreement with Genentech related to the commercialization and sharing of economics for glofitamab, an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 for the potential treatment of B-cell non-Hodgkin's lymphoma.

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.

Table of Conten ts

Other Collaborative Relationships

Alcyone Therapeutics

In December 2022 we entered into a license and collaboration agreement with Alcyone Therapeutics (Alcyone) to jointly develop the ThecaFlex DRx™ System, an implantable medical device intended for subcutaneous delivery of antisense oligonucleotide (ASO) therapies with a goal of improving the patient treatment experience and accessibility for people suffering from neurological disorders, such as SMA and ALS.

Under the terms of this collaboration, we and Alcyone will jointly develop the ThecaFlex DRx™ System and Alcyone will be solely responsible for its manufacture and commercialization.

In connection with this transaction, we made an upfront payment of $10.0 million to Alcyone.

Corporate Matters

Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics

In January 2022 we entered into an agreement to sell to Samsung Biologics our equity in Samsung Bioepis.

Under the terms of the proposed transaction, we would receive $1.0 billion in cash at closing and $1.3 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction.

We would also be eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.

Closing of the transaction is currently anticipated in mid-2022, contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions.

For additional information on the proposed transaction and our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in this report.

Other Key Developments

ADUHELM (aducanumab)

In June 2021 the U.S.

Food and Drug Administration (FDA) granted accelerated approval of ADUHELM, which we are developing and commercializing in collaboration with Eisai Co., Ltd.

(Eisai), based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.

As part of the accelerated approval, we will conduct a confirmatory trial to verify the clinical benefit of ADUHELM in patients with Alzheimer’s disease.

The FDA may withdraw approval if, among other things, the confirmatory trial fails to verify clinical benefit of ADUHELM, ADUHELM's benefit-risk is no longer positive or we fail to comply with the conditions of the accelerated approval.

In December 2021 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the Marketing Authorization Application (MAA) for aducanumab in Europe.

We are seeking a re-examination of the opinion by the CHMP.

In January 2022 the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memorandum stating the proposed NCD would cover FDA approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease for people with Medicare only if they are enrolled in qualifying clinical trials.

We expect a final Medicare NCD by the second quarter of 2022, which should clarify Medicare reimbursement for the class of antibodies directed against amyloid.

T a ble of Content s

BIIB125 (zuranolone)

In June 2021 we and Sage Therapeutics, Inc.

(Sage) announced positive Phase 3 results for BIIB125 (zuranolone) for the potential treatment of MDD and PPD.

In October 2021 we and Sage announced our plan to submit a New Drug Application (NDA) to the FDA for zuranolone in the second half of 2022, with rolling submission expected to start in the first half of 2022.

The planned initial submission package will seek approval of zuranolone for MDD and an additional filing for PPD is anticipated in the first half of 2023.

Lecanemab (BAN2401)

In June 2021 the FDA granted Breakthrough Therapy designation for lecanemab, an anti-amyloid antibody for the potential treatment of Alzheimer's disease, which we are developing in collaboration with Eisai.

In September 2021 Eisai initiated a rolling submission to the FDA of a Biologics License Application (BLA) for lecanemab.

The BLA is being submitted under the accelerated approval pathway and is primarily based in clinical, biomarker and safety data from the Phase 2b clinical trial in patients with early Alzheimer's disease and confirmed amyloid pathology.

BYOOVIZ (ranibizumab-nuna)

In September 2021 we announced that the FDA has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

In addition to the U.S.

approval, BYOOVIZ was approved in the E.U.

during the third quarter of 2021.

BIIB067 (tofersen)

In October 2021 we announced topline results from our pivotal Phase 3 VALOR study of BIIB067 (tofersen), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), indicating that the primary endpoint was not met.

Exchange Offer

In February 2021 we completed a private offer to exchange (Exchange Offer) our tendered 5.200% Senior Notes due September 15, 2045 (2045 Senior Notes) for a new series of 3.250% Senior Notes due February 15, 2051 (2051 Senior Notes) and cash, and an offer to purchase our tendered 2045 Senior Notes for cash.

North Carolina Gene Therapy Manufacturing Facility

In March 2021 we announced our plans to build a new gene therapy manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas.

The new facility will be approximately 175,000 square feet and is expected to be operational by the end of 2023.

Construction for this new facility began during the fourth quarter of 2021.

Solothurn, Switzerland Manufacturing Facility

In May 2021 we announced that a portion of our Solothurn manufacturing facility received a Good Manufacturing Practice (GMP) multi-product license from the Swiss Agency for Therapeutic Products (SWISSMEDIC).

In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics Co., Ltd.

(Samsung BioLogics).

Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction.

As part of this transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.

Our policy for contingent payments of this nature is to recognize the payments in the period that they become realizable, which is generally the same period in which the payments are earned.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, 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 that when completed we expect may yield approximately $1.0 billion in expense savings.

These savings are being achieved through a number of initiatives, including reductions to our workforce, the substantial elimination of our commercial ADUHELM infrastructure, the consolidation of certain real estate locations and operating efficiency gains across our selling, general and administrative and research and development functions.

Under these initiatives, we estimate we will incur total restructuring charges of approximately $131.0 million, primarily related to severance.

These amounts were substantially incurred during 2022.

As of December 31, 2022, approximately $35.9 million remained in our restructuring reserve and payments are expected to be made through 2026.

For additional information on our 2022 cost saving initiatives, please read Note 4, Restructuring , to our consolidated financial statements included in this report.

125 Broadway Sale and Leaseback Transaction

In September 2022 we completed the sale of our building and land parcel located at 125 Broadway, Cambridge, MA (125 Broadway) for an aggregate sales price of approximately $603.0 million, which is inclusive of a $10.8 million tenant allowance.

Simultaneously, with the close of this transaction we leased back the building for a term of approximately 5.5 years.

For additional information on our 125 Broadway sale and leaseback transaction, please read Note 11, Property, Plant and Equipment and Note 12, Leases , to our consolidated financial statements included in this report.

Management Changes

In July 2021 we announced the appointment of Rachid Izzar to the Executive Committee of the Company as well as Head of the Alzheimer's Disease and Dementia Business Unit.

In November 2021 we announced the retirement of Alfred Sandrock and the appointment of Priya Singhal, Head of Global Safety and Regulatory Sciences, as interim Head of Research and Development.

• In November 2022 we announced the appointment of Christopher A.

Viehbacher as President and Chief Executive Officer.

• In February 2022 we announced the appointment of Nicole Murphy as Executive Vice President, Pharmaceutical Operations and Technology.

• In January 2023 we announced the appointment of Priya Singhal as Executive Vice President, Head of Development.

Table of Conten ts

Board of Directors Update

• In June 2022 Nancy Leaming and Brian Posner retired from our Board of Directors.

• In November 2022 Christopher A.

Viehbacher joined our Board of Directors.

For additional information on our executive officers, please read the subsection entitled "Information about our Executive Officers" included in this report.

2 unchanged sentences

TECFIDERA (dimethyl fumerate)

• In April 2021 China's National Medical Products Administration approved TECFIDERA for the treatment of RMS.

T a ble of Content s

VUMERITY (diroximel fumarate;

• In November 2021 the European Commission (EC) granted marketing authorization for VUMERITY in the E.U.

for the treatment of RRMS.

PLEGRIDY (peginterferon beta-1a)

• In January 2021 the FDA approved a new intramuscular (IM) injection route of administration for PLEGRIDY for the treatment of RRMS.

TYSABRI (natalizumab)

• In April 2021 the EC granted marketing authorization for a new subcutaneous (SC) injection route of administration for TYSABRI for the treatment of RRMS.

• In April 2021, at the 2021 American Academy of Neurology (AAN) Virtual Annual Meeting, we presented new data on quality of life benefits and analyses of extended interval dosing with TYSABRI.

• In August 2021 we announced results from the two-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study.

NOVA was designed to estimate a potential difference between the efficacy of every six-weeks (Q6W) 300mg intravenous (IV) dosing compared to the efficacy of the approved every four-week (Q4W) dose in people treated with TYSABRI for RRMS.

• In June 2022 the European Patent Office (EPO) granted a patent that expires in February 2028 related to TECFIDERA.

• In October 2022 the Advocate General of the Court of Justice of the European Union (CJEU) issued a nonbinding advisory opinion in Biogen's favor relating to regulatory data protection for TECFIDERA.

This opinion recommends that the CJEU set aside the earlier judgement of the European General Court annulling the EMA's decision not to validate an application to market a generic version of TECFIDERA.

Alzheimer's Disease and Dementia

LEQEMBI (lecanemab)

• In January 2023 we and Eisai announced that the FDA granted accelerated approval of LEQEMBI, an anti-amyloid antibody for the treatment of Alzheimer's disease.

Additionally, in January 2023 we and Eisai announced the completed submission of a supplemental BLA to the FDA for traditional approval of LEQEMBI.

• In September 2022 we and Eisai announced positive topline results from the confirmatory Phase 3 CLARITY Alzheimer's disease study of LEQEMBI.

LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results.

• In November 2022 Eisai presented full results from the confirmatory Phase 3 CLARITY Alzheimer's disease study of LEQEMBI at the 2022 Clinical Trials on Alzheimer's Disease conference.

• In November 2022 The New England Journal of Medicine published full results from the confirmatory Phase 3 CLARITY Alzheimer's disease study of LEQEMBI.

ADUHELM (aducanumab)

• In June 2021 the FDA granted accelerated approval for ADUHELM as the first and only Alzheimer's disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.

• In July 2021 the FDA approved an updated label for ADUHELM injection 100 mg/mL solution.

• In July 2021, at the Alzheimer's Association International Conference (AAIC), we presented the design for the first real-world observational Phase 4 study of Alzheimer's disease called ICARE AD-US.

• In November 2021, at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, we announced that data from the ADUHELM Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer’s disease.

We also presented data from the Phase 3b redosing study, EMBARK, which examined the impact of patients with Alzheimer's disease stopping ADUHELM treatment for an extended period of time before re-initiating treatment.

• In November 2021 we received a negative trend vote on the aducanumab MAA in the E.U.

• In December 2021 the CHMP adopted a negative opinion on the MAA for aducanumab.

• In December 2021 the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare (MHLW) in Japan decided to continue deliberations on the application for the manufacturing and marketing approval of aducanumab for the treatment of Alzheimer's disease.

• In January 2022 the CMS released a proposed NCD decision memorandum, stating the proposed NCD would cover FDA approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease for people with Medicare only if they are enrolled in qualifying clinical trials.

BAN2401 (lecanemab)

• In June 2021 the FDA granted Breakthrough Therapy designation for lecanemab for the potential treatment of Alzheimer's disease.

• In July 2021, at the AAIC, Eisai presented results of a longitudinal preliminary assessment of the clinical effects of lecanemab following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer's disease.

• In September 2021 Eisai initiated a rolling submission to the FDA of a BLA for lecanemab.

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in patients with early Alzheimer's disease and confirmed amyloid pathology.

• In November 2021 Eisai presented results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer's disease from the

T a ble of Content s

lecanemab Phase 2b 201 and the OLE studies.

The findings were presented and discussed in a late-breaking roundtable session at the 2021 CTAD conference.

• In December 2021 we and Eisai announced that lecanemab was granted Fast Track designation by the FDA.

• In March 2022 we announced new data showing that after nearly two and a half years of treatment (128 weeks) with ADUHELM injection 100 mg/mL for intravenous use, patients in the long-term extension phase of the Phase 3 trials continued to experience significant reductions in two key Alzheimer's disease pathologies, amyloid beta plaques and plasma p-tau181.

• In March 2022 The Journal of Prevention of Alzheimer's Disease published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE studies of ADUHELM 100 mg/mL injection for intravenous use in early Alzheimer's disease.

The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

• In March 2022 we submitted the final study protocol for the confirmatory Phase 4 ENVISION study of ADUHELM to the FDA for review and approval.

• In April 2022 the Centers for Medicare and Medicaid Services (CMS) released a final NCD for the class of anti-amyloid treatments in Alzheimer's disease, including ADUHELM.

The final NCD confirmed coverage with evidence development, in which patients with Medicare can only access treatment if they are part of an approved clinical trial.

This decision effectively resulted in denying all Medicare beneficiaries access to ADUHELM.

• In April 2022 we announced our plans to offer a continuity of care plan for U.S.

patients currently treated with ADUHELM, as a result of the CMS decision.

Table of Conten ts

Neuropsychiatry

Zuranolone (BIIB125)

• In February 2022 we and Sage announced the Phase 3 CORAL study of zuranolone in people with MDD met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms at Day 3 and over the 2-week treatment period, achieving the primary and key secondary endpoints.

• In June 2022 we and Sage announced that the Phase 3 SKYLARK study of zuranalone in women with PPD met its primary and all key secondary endpoints.

• In October 2022 we and Sage presented additional data from the Phase 3 SKYLARK study of zuranalone in women with PPD.

This data was presented at the European College of Neuropsychopharmacology (ECNP) Congress.

• In December 2022 we and Sage completed the rolling submission of a NDA to the FDA for the approval of zuranolone for the potential treatment of MDD and PPD.

This submission completes the NDA filing initiated earlier in 2022.

• In February 2023 the FDA accepted the NDA and granted Priority Review for zuranolone, with a PDUFA action date of August 5, 2023.

Neuromuscular Disorders

SPINRAZA (nusinersen)

• In January 2021 the first patient was dosed in the global RESPOND study, which will examine the clinical benefit and assess the safety of SPINRAZA in infants and children with SMA.

• In April 2021, at the AAN 2021 Virtual Annual Meeting, we announced new data from the Phase 2/3 DEVOTE study.

Initial findings from the DEVOTE study suggest no new safety concerns and support continued development of a higher dose of SPINRAZA.

• In June 2021, at the virtual Cure SMA Research & Clinical Care Meeting, we announced new data on the long-term efficacy of SPINRAZA.

• In September 2021 we announced plans to initiate a global Phase 3b clinical study, ASCEND.

The ASCEND study is designed to evaluate the clinical outcomes and assess the safety of a higher dose of SPINRAZA in children, teens and adults with later-onset SMA following treatment of Evrysdi.

• In March 2022 we announced the first patient was treated in the global Phase 3b ASCEND study, which is designed to evaluate the clinical outcomes and assess the safety of a higher dose of SPINRAZA in children, teens and adults with later-onset SMA who were previously treated with Evrysdi.

• In October 2022 the first patient in the Phase 1 study of BIIB115, an investigational ASO in development for SMA, was dosed.

Tofersen (BIIB067)

• In June 2022 we announced new 12-month data for tofersen demonstrating that earlier initiation of tofersen compared to delayed initiation (six months later in the open-label extension study) slowed declines in clinical function, respiratory function, muscle strength and quality of life.

• In July 2022 the FDA accepted the NDA and granted Priority Review for tofersen, an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) ALS, which currently has a PDUFA action date of April 25, 2023.

• In September 2022 The New England Journal of Medicine published detailed results from the Phase 3 VALOR study of tofersen, including the combined analysis of the Phase 3 VALOR study and its open-label extension study evaluating tofersen for the potential treatment of SOD1 ALS.

• In December 2022 the EMA accepted for review the MAA for tofersen.

Movement Disorders

SAGE-324 (GABA A receptor PAM)

• In April 2021 we and Sage reported that the Phase 2 KINETIC study evaluating SAGE-324 in the treatment of patients with essential tremor (ET) met its primary endpoint.

Neuropsychiatry

BIIB125 (zuranolone)

• In June 2021 we and Sage announced positive results from the Phase 3 WATERFALL study for zuranolone, an investigational two-week, once-daily therapeutic being evaluated for MDD.

• In October 2021 we and Sage shared positive data from the LANDSCAPE and NEST clinical development program.

This study evaluated the efficacy and safety of zuranolone for the treatment of MDD and PPD.

The data was presented at the European College of Neuropsychopharmacology Congress.

• In October 2021 we and Sage announced plans to submit a NDA to the FDA for zuranolone for the potential treatment of MDD in the second half of 2022 with rolling submission expected to start in early 2022.

Plans also include the submission of a NDA to the FDA for zuranalone for the treatment of PPD, in the first half of 2023.

• In December 2021 we and Sage announced positive data from the 12-month Phase 3 open-label SHORELINE study for zuranolone.

The SHORELINE study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with MDD and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year.

Specialized Immunology

BIIB059 (anti-BDCA2) - SLE

• In June 2021 the first patient was dosed in the Phase 3 TOPAZ-1 study of BIIB059 for SLE.

The Phase 3 study will evaluate the clinical efficacy and assess the safety of BIIB059 in participants with active SLE.

Neuropathic Pain

BIIB074 (vixotrigine)

• In September 2021 we announced positive results that the Phase 2 CONVEY study of vixotrigine, a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy.

The CONVEY study 200 mg twice daily arm met its primary endpoint.

The CONVEY study 350 mg twice daily arm did not meet its primary endpoint.

T a ble of Content s

• In April 2021 we entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA (tocilizumab).

• In June 2021 we and Bio-Thera Solutions, Ltd.

(Bio-Thera) announced positive results that the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA (tocilizumab), met its primary endpoint.

Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics

• In June 2021 Samsung Bioepis announced that the CHMP adopted a positive opinion of BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS, and in August 2021 BYOOVIZ was approved by the EMA.

• In September 2021 Samsung Bioepis announced the FDA approval of BYOOVIZ.

Digital Health

• In January 2021 we announced a virtual research study, in collaboration with Apple Inc., to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health including mild cognitive impairment (MCI).

• In December 2021 we announced an expanded collaboration with TheraPanacea focused on multiple therapeutic areas in neuroscience.

The expanded collaboration aims to leverage machine learning and artificial intelligence analysis to develop digital health solutions that may improve patient care, accelerate drug development, and further the understanding of the underlying pathologies of neurological diseases.

Discontinued or Suspended Programs

• In May 2021 we announced that the Phase 2/3 XIRIUS study of cotoretigene toliparvovec (BIIB112), a gene therapy being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa, did not meet its primary endpoint.

Based on these results, we suspended further development based on the decision of management as part of its strategic review process.

• In June 2021 we announced that the Phase 3 STAR study of timrepigene emparvovec (BIIB111), an investigational gene therapy for the potential treatment of choroideremia, did not meet its primary endpoint.

Based on these results, we suspended further development based on the decision of management as part of its strategic review process.

• In June 2021 we announced that the Phase 2 TANGO study of BIIB092 (gosuranemab), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer's disease, did not meet its primary endpoint.

Based on these results, we discontinued development of gosuranemab.

T a ble of Content s

BIIB122 (DNL151)

• In May 2022 dosing commenced in the Phase 2b LUMA study of BIIB122, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2), evaluating the efficacy and safety of BIIB122 compared to placebo in approximately 640 patients with early stage Parkinson's disease.

• In October 2022 we and our collaboration partner Denali Therapeutics Inc.

(Denali) announced the initiation of the Phase 3 LIGHTHOUSE study of BIIB122 in patients with Parkinson's disease and a confirmed pathogenic mutation in the LRRK2 gene.

• In June 2022 we entered into a collaboration and license agreement with Alectos Therapeutics Inc.

(Alectos) to develop and commercialize ALO1811, a novel preclinical selective GBA2 inhibitor, for the potential oral disease modifying treatment for patients with Parkinson's disease.

Table of Conten ts

Litifilimab (BIIB059)

• In July 2022 The New England Journal of Medicine published positive results from the cutaneous lupus erythematosus (CLE) portion of the two-part Phase 2 LILAC study (Part B) evaluating litifilimab, an investigational drug for the treatment of lupus.

The study met its primary endpoint by demonstrating the enhanced efficacy of litifilimab compared to placebo in reducing skin disease activity.

• In September 2022 The New England Journal of Medicine published a second manuscript detailing positive results from the systemic lupus erythematosus (SLE) portion of the two-part Phase 2 LILAC study (Part A) evaluating litifilimab.

The study met its primary endpoint by demonstrating that litifilimab was associated with a statistically significant reduction in total active joint count compared to placebo.

• In October 2022 the first patient was dosed in the Phase 2/3 AMETHYST study of litifilimab, evaluating the efficacy and safety of litifilimab compared to placebo in patients with CLE.

BIIB801 (referencing CIMZIA)

• In February 2022 we entered into a commercialization and license agreement with Xbrane Biopharma AB (Xbrane) to develop, manufacture and commercialize BIIB801, a proposed certolizumab pegol biosimilar referencing CIMZIA.

BYOOVIZ (referencing LUCENTIS)

• In June 2022 we and Samsung Bioepis announced that BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, launched in the U.S.

BIIB800 (referencing ACTEMRA)

• In June 2022 we and our collaboration partner Bio-Thera Solutions, Ltd.

(Bio-Thera) presented positive results from the Phase 3 study of BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, for the treatment of severe, active and progressive rheumatoid arthritis.

The data was presented at the 2022 Annual European Congress of Rheumatology.

• In September 2022 the EMA accepted for review the MAA for BIIB800.

• In December 2022 the FDA accepted for review the abbreviated BLA for BIIB800.

Discontinued Programs

• In March 2022 we and Ionis Pharmaceuticals Inc.

(Ionis) announced that the Phase 1 study of BIIB078 in ALS did not meet any secondary efficacy endpoints and it did not demonstrate clinical benefit.

Based on these results, we discontinued development of BIIB078.

• In June 2022 we discontinued further development of BIIB100 for the potential treatment of certain neurological and neurodegenerative diseases, primarily in ALS, based on the decision by management as part of its strategic review process.

• In July 2022 we announced that the Phase 2 TALLY study of BIIB104 in cognitive impairment associated with schizophrenia did not meet its primary or secondary efficacy endpoints.

Given the consistent lack of efficacy observed across the primary and secondary measures of cognition and functioning, we decided to discontinue the BIIB104 program.

• In 2022 we discontinued further development of BIIB118 (CK1 inhibitor) for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases, based on the decision by management as part of its strategic review process.

• In December 2022 we discontinued further development of vixotrigine (BIIB074) for the potential treatment of trigeminal neuralgia (TGN) and diabetic painful neuropathy (DPN), based on regulatory, development and commercialization challenges.

• In February 2023 we terminated our license and collaboration agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS.

Table of Conten ts

Marketed Products

The following graph shows our revenue by product and revenue from anti-CD20 therapeutic programs for the years ended December 31, 2022, 2021 and 2020.

(1) Fumarate includes TECFIDERA and VUMERITY.

(1) MS includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA.

VUMERITY became commercially available in the E.U.

during the fourth quarter of 2021.

(2) Interferon includes AVONEX and PLEGRIDY.

(3) In June 2021 the FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S.

during the second quarter of 2021.

For additional information, please read Note 18, Collaborative and Other Relationships - Eisai Co., Ltd.

- ADUHELM Collaboration Agreement , to our consolidated financial statements included in this report.

(4) Other includes FAMPYRA, FUMADERM, BENEPALI, IMRALDI and FLIXABI.

(2) SMA includes SPINRAZA.

(3) Alzheimer's disease includes ADUHELM.

(4) Biosimilars includes BENEPALI, IMRALDI, FLIXABI and BYOOVIZ.

BYOOVIZ launched in the U.S.

in June 2022 and became commercially available during the third quarter of 2022.

(5) Anti-CD20 therapeutic programs include RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS.

Product sales for TECFIDERA, AVONEX, TYSABRI and SPINRAZA each accounted for more than 10.0% of our total revenue for the years ended December 31, 2021, 2020 and 2019.

(6) Other includes FUMADERM.

Product sales for TECFIDERA, TYSABRI and SPINRAZA each accounted for more than 10.0% of our total revenue for the years ended December 31, 2022, 2021 and 2020.

For additional financial information about our product and other revenue and geographic areas where we operate, please read Note 5, Revenue and Note 25, Segment Information, to our consolidated financial statements included in this report and Item 7.

2 unchanged sentences

Risk Factors included in this report.

T a ble of Content s

Multiple Sclerosis and Neuroimmunology

Table of Conten ts

Multiple Sclerosis

We develop, manufacture and market a number of products designed to treat patients with MS.

MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death.

MS is a progressive disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death.

Patients with active RMS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by flare-ups of the disease after which the patient may return to a lower baseline of functioning.

2 unchanged sentences

RMS in the U.S.

RRMS in the E.U.

Relapsing-remitting MS (RRMS) in the E.U.

RMS in the U.S.

15 unchanged sentences

People with Type 1 SMA, the most severe life-threatening form, produce very little SMN protein and do not

T a ble of Content s

Table of Conten ts

achieve the ability to sit without support, and typically do not live beyond two years of age without respiratory support and nutritional interventions.

2 unchanged sentences

Product Indication Collaborator Major Markets

SMA Ionis Pharmaceuticals Inc.

SMA Ionis U.S.

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.

3 unchanged sentences

Amyloid plaques, which are found in the tissue between the nerve cells, are unusual clumps of a protein called beta amyloid along with degenerating bits of neurons and other cells.

Our Alzheimer's disease product and major market is as follows:

Our Alzheimer's disease products and major markets are as follows:

Product Indication Collaborator Major Market

Alzheimer's disease Eisai U.S.

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.

Biosimilars are a group of biologic medicines that are similar to currently available biologic therapies developed by companies known as "originators".

Biosimilars are a group of biologic medicines that are highly similar to currently available biologic therapies developed by companies known as "originators".

Under our agreements with Samsung Bioepis, we commercialize three anti-tumor necrosis factor (TNF) biosimilars in certain countries in Europe:

1 unchanged sentence

We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was approved in the U.S., the E.U.

during the third quarter of 2021.

T a ble of Content s

and the United Kingdom (U.K.) during the third quarter of 2021.

BYOOVIZ launched in the U.S.

in June 2022 and became commercially available during the third quarter of 2022.

Table of Conten ts

Our current biosimilar products and major markets are as follows:

25 unchanged sentences

Psoriasis France

Neovascular (wet) age-related macular degeneration

Macular edema following retinal vein occlusion

Myopic choroidal neovascularization U.S.

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.

T a ble of Content s

Table of Conten ts

Genentech Relationships

We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS and other potential anti-CD20 therapies, including mosunetuzumab.

We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO, which was granted accelerated approval in the U.S.

during the fourth quarter of 2022, glofitamab and options to add other potential anti-CD20 therapies.

Our current anti-CD20 therapeutic programs and major markets are as follows:

8 unchanged sentences

In combination with chemotherapy followed by GAZYVA alone for previously untreated follicular lymphoma U.S.

Relapsed or refractory 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.

4 unchanged sentences

The insights gained from these engagements help us support patients with services, programs and applications that are designed to help patients lead better lives.

Among other things, we provide customer service and other related programs for our products, such as disease and product specific websites, insurance research services, financial assistance programs and the facilitation of the procurement of our marketed products.

facilitation of the procurement of our marketed products.

We are dedicated to helping patients obtain access to our therapies.

Our patient representatives have access to a suite of financial assistance tools.

With those tools, we help patients understand their

insurance coverage and, if needed, help patients compare and select new insurance options and programs.

In the U.S., we have established programs that provide co-pay assistance or free marketed product for qualified uninsured or underinsured patients, based on specific eligibility criteria.

We also provide charitable contributions to independent charitable organizations that assist patients with out-of-pocket expenses associated with their therapy.

With those tools, we help patients understand their insurance coverage and, if needed, help patients compare insurance options and programs.

In the U.S., we have established programs that provide co-pay assistance or free product for qualified uninsured or underinsured patients, based on specific eligibility criteria.

We also provide charitable contributions to

Table of Conten ts

independent charitable organizations that assist patients with out-of-pocket expenses associated with their therapy.

We believe all healthcare stakeholders have a shared responsibility to ensure patients have equitable access to new, innovative medicines.

1 unchanged sentence

We have a value-based contracting program designed to align the price of our therapies to the value our therapies deliver to patients.

We also work with regulators, clinical researchers, ethicists, physicians and patient

T a ble of Content s

advocacy organizations and communities, among others, to determine how best to address requests for access to our investigational therapies in a manner that is consistent with our patient-focused values and compliant with regulatory standards and protocols.

We also work with regulators, clinical researchers, ethicists, physicians and patient advocacy organizations and communities, among others, to determine how best to address requests for access to our investigational therapies in a manner that is consistent with our patient-focused values and compliant with regulatory standards and protocols.

In appropriate situations, patients may have access to investigational therapies through Early Access Programs, single patient access or emergency use based on humanitarian or compassionate grounds.

3 unchanged sentences

In some countries, particularly in areas where we continue to expand into new geographic areas, we partner with third parties.

We and Eisai co-promote AVONEX, TYSABRI and TECFIDERA in Japan in certain settings.

We and Eisai co-promote ADUHELM with a region-based profit split.

RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS are marketed by the Roche Group and its sublicensees.

We commercialize BENEPALI, IMRALDI and FLIXABI pursuant to our agreement with Samsung Bioepis in certain countries in Europe.

RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS and LUNSUMIO are marketed by the Roche Group and its sublicensees.

We commercialize BENEPALI, IMRALDI and FLIXABI pursuant to our agreement with Samsung Bioepis in certain countries in Europe, as well as BYOOVIZ in the U.S.

We focus our sales and marketing efforts on specialist physicians in private practice or at major medical centers.

We use customary industry practices to market our products and to educate physicians, such as sales representatives calling on individual physicians, advertisements, professional symposia, direct mail, public relations and other methods.

We use customary industry practices to market our products and to educate physicians.

This includes our sales representatives calling on individual health care providers (in-person and virtually), advertisements, professional symposia, direct mail, digital marketing, point of care marketing, public relations and other methods.

We focus on health care provider sales and marketing efforts on specialty providers in both private practice and at major medical centers.

Distribution Arrangements

1 unchanged sentence

principally through wholesale and specialty distributors of pharmaceutical products and specialty pharmacies, mail order specialty distributors or shipping service providers.

In other countries, the distribution of our products varies from country to country, including through wholesale distributors of pharmaceutical products and third-party distribution partners who are responsible for most marketing and distribution activities.

In other countries, the distribution of our

products varies from country to country, including through wholesale distributors of pharmaceutical products and third-party distribution partners who are responsible for most marketing and distribution activities.

Eisai distributes AVONEX, TYSABRI, TECFIDERA and PLEGRIDY in India and other Asia-Pacific markets, excluding China.

RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS are distributed by the Roche Group and its sublicensees.

We distribute BENEPALI, IMRALDI and FLIXABI in certain countries in Europe and have an option to acquire exclusive rights to distribute these products in China.

Our product sales to two wholesale distributors each accounted for more than 10.0% of our total revenue for the years ended December 31, 2021, 2020 and 2019, and on a combined basis, accounted for approximately 38.9%, 45.8% and 47.0% of our gross product revenue for the years ended December 31, 2021, 2020 and 2019, respectively.

RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS and LUNSUMIO are distributed by the Roche Group and its sublicensees.

We distribute BENEPALI, IMRALDI and FLIXABI in certain countries in Europe and have an option to acquire exclusive rights to distribute these products in China, as well as BYOOVIZ in the U.S.

Our product sales to two wholesale distributors each accounted for more than 10.0% of our total revenue for the years ended December 31, 2022, 2021 and 2020, and on a combined basis, accounted for approximately 37.9%, 38.9% and 45.8%, respectively, of our gross product revenue.

For additional information, please read Note 5, Revenue , to our consolidated financial statements included in this report.

Patents and Other Proprietary Rights

Patents are important to obtaining and protecting exclusive rights in our products and product candidates.

Patents are important for obtaining and protecting exclusive rights in our products and product candidates.

We regularly seek patent protection in the U.S.

4 unchanged sentences

however, U.S.

patents that issue on applications filed before June 8, 1995, may be effective until 17 years from the issue date, if that is later than the 20-year date.

patents on applications filed before June 8, 1995, may be effective until 17 years from the issue date, if that is later than the 20-year date.

In some cases, the patent term may be extended to recapture a portion of the term lost during regulatory review of the claimed therapeutic or, in the case of the U.S., because of U.S.

2 unchanged sentences

The duration and extension of the term of foreign patents varies, in accordance with local law.

For example, supplementary protection certificates (SPCs) on some of our products have been granted in a number of European countries, compensating in part for delays in obtaining marketing approval.

For example, supplementary protection certificates (SPCs) on some of our products have

Table of Conten ts

been granted in a number of European countries, compensating in part for delays in obtaining marketing approval.

Regulatory exclusivity, which may consist of regulatory data protection and market protection, also can provide meaningful protection for our products.

Regulatory data protection provides to the holder of a drug or biologic marketing authorization, for a set period of time, the exclusive use of the proprietary pre-clinical and clinical data that it created at significant cost and submitted to the applicable

T a ble of Content s

regulatory authority to obtain approval of its product.

After the period of exclusive use, third parties are permitted to reference such data in abbreviated applications for approval and to market (subject to any applicable market protection) their generic drugs and biosimilars.

4 unchanged sentences

In the case of our employees, these agreements also provide, in compliance with relevant law, that inventions and other intellectual property conceived by such employees during their employment are our exclusive property.

Our trademarks are important to us and are generally covered by trademark applications or

registrations in the USPTO and the patent or trademark offices of other countries.

Our trademarks are important to us and are generally covered by trademark applications or registrations in the USPTO and the patent or trademark offices of other countries.

We also use trademarks licensed from third parties, such as the trademark FAMPYRA, which we license from Acorda.

2 unchanged sentences

Our Patent Portfolio

The following table describes our patents in the U.S.

The following table describes certain patents in the U.S.

and Europe that we currently consider of primary importance to our marketed products, including the territory, patent number, general subject matter and expected expiration dates.

Except as otherwise noted, the expected expiration dates include any granted patent term extensions and issued SPCs.

In some instances, there are later-expiring patents relating to our products directed to, among other things, particular forms or compositions, methods of manufacturing or use of the drug in the treatment of particular diseases or conditions.

Except as otherwise noted, the expected expiration dates

include any granted patent term extensions and issued SPCs.

In some instances, there are additional later-expiring patents relating to our products directed to, among other things, particular forms or compositions, methods of manufacturing or use of the drug in the treatment of particular diseases or conditions.

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.

T a ble of Content s

Table of Conten ts

Product Territory Patent No.

1 unchanged sentence

Expiration (1)

TECFIDERA U.S.

8,399,514 Methods of treatment 2028 (2)

Europe 1131065 Formulations of dialkyl fumarates and their use for treating autoimmune diseases 2024 (3)

TECFIDERA Europe 1,131,065 Formulations of dialkyl fumarates and their use for treating autoimmune diseases 2024 (3)

Europe 2,653,873 Methods of use 2028

PLEGRIDY U.S.

7,446,173 Polymer conjugates of interferon beta-1a 2022

8,524,660 Methods of treatment 2023

3 unchanged sentences

8,124,350 Methods of treatment 2027

8,349,321 Formulation 2024

8,815,236 Formulation 2024

8,871,449 Methods of treatment 2026

8,900,577 Formulation 2024

9,316,641 Safety-related assay 2032

9,493,567 Methods of treatment 2027

9,709,575 Methods of treatment 2026

10,119,976 Methods of evaluating patient risk 2034

10,233,245 Methods of treatment 2027

10,444,234 Safety-related assay 2031

10,677,803 Methods of treatment 2034

10,705,095 Methods of treatment 2026

11,280,794 Methods of treatment 2034

11,287,423 Safety-related assay 2031

11,292,845 Methods of treatment 2027

Europe 1,485,127 Methods of use 2023 (2)

Europe 2,170,390 Formulation 2028

Europe 2,236,154 Formulation 2024

Europe 2,676,967 Methods of use 2027

Europe 3,339,865 Safety-related assay 2031

Europe 3,417,875 Formulation 2024

Europe 3,575,792 Safety-related assay 2032

FAMPYRA Europe 1,732,548 Sustained-release aminopyridine compositions for increasing walking speed in patients with MS 2025 (6)

14 unchanged sentences

9,926,559 Compositions and methods for modulation of SMN2 splicing 2034

Table of Conten ts

10,266,822 SMA treatment via targeting of SMN2 splice site inhibitory sequences 2025

7 unchanged sentences

10,131,708 Methods of treating Alzheimer's disease 2028

8,025,878 Protofibril selective antibodies and the use thereof 2027 (1)(10)

Footnotes follow on next page.

T a ble of Content s

(1) In addition to patent protection, certain of our products are entitled to regulatory exclusivity in the U.S.

Table of Conten ts

(1) I n addition to patent protection, certain of our products are entitled to regulatory exclusivity in the U.S.

expected until the dates set forth below:

1 unchanged sentence

TECFIDERA E.U.

Subject to appeal

PLEGRIDY U.S.

15 unchanged sentences

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.

T a ble of Content s

Competition in the biopharmaceutical industry is intense.

Table of Conten ts

Competition in the biopharmaceutical industry and the markets in which we operate is intense.

There are many companies, including biotechnology and pharmaceutical companies, engaged in developing products for the indications our approved products are approved to treat and the therapeutic areas we are targeting with our research and development activities.

9 unchanged sentences

In addition, the commercialization of certain of our own approved products, products of our collaborators and pipeline product candidates may negatively impact future sales of our existing products.

We also face increased competitive pressures from the introduction of generic versions, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways.

Such products are likely to be sold at substantially lower prices than branded products, which may significantly reduce both the price that we are able to charge for our products and the volume of products we sell.

Our products and revenue streams continue to face increasing competition in many markets from the introduction of generic versions, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways.

Such products are likely to be sold at substantially lower prices than branded products.

Accordingly, the introduction of such products as well as other lower-priced competing products may 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.

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.

7 unchanged sentences

BETASERON/BETAFERON (interferon-beta-1b) Bayer Group

BRIUMVI (ublituximab-xiiy) TG Therapeutics, Inc.

(glatiramer acetate) Teva Pharmaceuticals Industries Ltd.

11 unchanged sentences

KESIMPTA (ofatumumab) Novartis AG

Multiple TECFIDERA generic entrants are now in the U.S.

market and have deeply discounted prices compared to TECFIDERA.

The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and is expected to continue to have a substantial and increasing negative impact on our U.S.

TECFIDERA revenue in the future.

T a ble of Content s

In May 2021 the European General Court annulled the EMA's decision not to validate applications for approval of TECFIDERA generics on the basis that the EMA conducted the wrong assessment when determining TECFIDERA's entitlement to regulatory data and marketing protection.

Multiple TECFIDERA generic entrants are now in North America, Brazil and certain E.U.

countries and have deeply discounted prices compared to

Table of Conten ts

The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline in the future.

In the E.U., we are seeking to enforce a patent granted in June 2022 that relates to TECFIDERA and expires in 2028.

In addition, we are litigating to affirm that TECFIDERA is entitled to regulatory data and market protection until at least February 2024.

Our Company, the EMA and the EC have each appealed the May 2021 decision of the European General Court, which annulled the EMA's decision not to validate an application for approval of a TECFIDERA generic on the basis that the EMA and EC conducted the wrong assessment when determining TECFIDERA's entitlement to regulatory data and marketing protection.

Our Company, the EMA and the EC have each appealed the General Court’s decision as wrongly decided and the appeal is pending.

In November 2021 the CHMP of the EMA issued an ad hoc opinion referencing the General Court’s decision which concluded that "the totality of the available data cannot establish that [monoethyl fumarate] exerts a clinically relevant therapeutic contribution within FUMADERM." The EC will decide TECFIDERA’s entitlement to regulatory data and market protection.

If data and market protection is not upheld, we could face generic competition in the E.U.

as early as the first half of 2022, which would have an adverse impact on our TECFIDERA sales in the E.U.

and our results of operations.

On October 6, 2022, the Advocate General of the CJEU issued a nonbinding advisory opinion in Biogen's favor.

This opinion recommends that the CJEU set aside the judgment of the European General Court.

We are awaiting the decision of the CJEU.

FAMPYRA is indicated as a treatment to improve walking in adult patients with MS who have a walking disability and is the first treatment that addresses this unmet medical need with demonstrated efficacy in people with all types of MS.

11 unchanged sentences

Future sales of SPINRAZA may be adversely affected by the commercialization of competing products.

FUMADERM competes with several different types of therapies in the psoriasis market within

Germany, including oral systemics such as methotrexate and cyclosporine.

BENEPALI, IMRALDI and FLIXABI, the three biosimilar products we currently commercialize in certain countries in Europe for Samsung Bioepis, compete with their reference products, ENBREL, HUMIRA and REMICADE, respectively, as well as other biosimilars of those reference products.

FUMADERM competes with several different types of therapies in the psoriasis market within Germany, including oral systemics such as methotrexate and cyclosporine.

BENEPALI, IMRALDI and FLIXABI, the three biosimilar products we currently commercialize in certain countries in Europe pursuant to an agreement with Samsung Bioepis, compete with their reference products, ENBREL, HUMIRA and REMICADE, respectively, as well as other biosimilars of those reference products.

In addition, BYOOVIZ, a biosimilar product we currently commercialize in the U.S.

pursuant to an agreement with Samsung Bioepis, competes with its reference product LUCENTIS, as well as other biosimilars of this reference product.

Genentech Relationships in Other Indications

2 unchanged sentences

We also expect that over time RITUXAN HYCELA and GAZYVA will increasingly compete with RITUXAN in the oncology market.

In addition, we are aware of several other anti-CD20 molecules, including biosimilar products, that have recently been approved and are expected to compete with RITUXAN, RITUXAN HYCELA and GAZYVA in the oncology market.

In November 2019, January 2020 and Janu ary 2021 bi osimilar products referencing RITUXAN were launched in the U.S and are being offered at lower prices.

This competition has adversely affected the pre-tax profits of our collaboration arrangements with Genentech and could have a significant adverse affect our co-promotion profits in the U.S.

In addition, we are aware of several other anti-CD20 molecules, including biosimilar products, that have been approved and are competing with RITUXAN, RITUXAN HYCELA 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.

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.

We expect that biosimilar competition will continue to increase as these products capture additional market share and that this will have a significant adverse impact on our co-promotion profits in the U.S.

in future years.

1 unchanged sentence

RITUXAN competes with several different types of therapies in the rheumatoid arthritis market, including, among others, traditional disease-modifying anti-rheumatic drugs such as steroids, methotrexate and cyclosporine, TNF inhibitors, ORENCIA (abatacept), ACTEMRA (tocilizumab) and XELJANZ (tofacitinib).

We are also aware of other products, including biosimilars, in development that, if approved, may compete with RITUXAN in the rheumatoid arthritis market.

We are also aware of other products, including biosimilars, in development that, if approved, may

Table of Conten ts

compete with RITUXAN in the rheumatoid arthritis market.

Research and Development Programs

1 unchanged sentence

Our research efforts are focused on better understanding the underlying biology of diseases so we can discover and deliver treatments that have the potential to make a real difference in the lives of patients with high unmet medical needs.

By applying our expertise in biologics and our growing capabilities in small molecule, antisense, gene therapy, gene editing and other technologies, we target specific

T a ble of Content s

medical needs where we believe new or better treatments are needed.

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.

As part of our ongoing research and development efforts, we have devoted significant resources to conducting clinical studies to advance the development of new pharmaceutical products and

technologies and to explore the utility of our existing products in treating disorders beyond those currently approved in their labels.

By applying our expertise in biologics and our growing capabilities in small molecule, antisense, gene therapy, gene editing and other technologies, we target specific medical needs where we believe new or better treatments are needed.

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.

As part of our ongoing research and development efforts, we have devoted significant resources to conducting clinical studies to advance the development of new pharmaceutical products and technologies and to explore the utility of our existing products in treating disorders beyond those currently approved in their labels.

For additional information on our research and development expense included in our consolidated statements of income, please read Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations included in this report.

T a ble of Content s

Table of Conten ts

The table below highlights our current research and development programs that are in clinical trials and the current phase of such programs.

2 unchanged sentences

Risk Factors included in this report.

MS and Neuroimmunology BIIB135 (orelabrutinib)* Phase 2

BIIB061 (oral remyelination) - MS Phase 1

BIIB091 (BTK inhibitor) - MS Phase 1

BIIB107 (anti-VLA4) - MS Phase 1

Alzheimer's Disease and Dementia Aducanumab (Aβ mAb)* - Alzheimer's Filed in E.U., Japan, Other Markets

Lecanemab (Aβ mAb)* - Alzheimer's Phase 3

Alzheimer's Disease and

Dementia Lecanemab (Aβ mAb)*** - Alzheimer's Filed in the U.S., E.U.

Lecanemab (Aβ mAb)* - Preclinical Alzheimer's Phase 3

Aducanumab (Aβ mAb)** - Alzheimer's Filed in Japan and Other Markets

BIIB080 (tau ASO)* - Alzheimer's Phase 2

BIIB076 (anti-tau mAb) - Alzheimer's Phase 1

Neuromuscular Disorders,

including SMA and ALS Tofersen (SOD1 ASO) - ALS Phase 3

BIIB078 (IONIS-C9 Rx ) # - ALS

BIIB113 (OGA inhibitor) - Alzheimer's Phase 1

Neuropsychiatry Zuranolone (GABA A PAM)* - MDD

Filed in the U.S.

Zuranolone (GABA A PAM)* - PPD

Filed in the U.S.

Specialized Immunology Dapirolizumab pegol (anti-CD40L)* - SLE Phase 3

Litifilimab (anti-BDCA2) - SLE Phase 3

Litifilimab (anti-BDCA2) - CLE Phase 2/3

Neuromuscular Disorders Tofersen (SOD1 ASO)* - SOD1 ALS Filed in the U.S.

BIIB105 (ataxin-2 ASO) # - ALS

BIIB100 (XP01 inhibitor) - ALS Phase 1

BIIB115 (SMN ASO)* - SMA Phase 1

Parkinson's Disease and

Movement Disorders BIIB124 (SAGE-324)* - Essential Tremor Phase 2

Movement Disorders BIIB122 (DNL151) * - LRRK2 Parkinson's

BIIB122 (DNL151) * - Parkinson's

BIIB124 (SAGE-324)* - Essential Tremor Phase 2

BIIB094 (ION859) # - Parkinson's

BIIB118 (CK1 inhibitor) - ISWRD in Parkinson's Phase 1

BIIB101 (ION464) # - Multiple System Atrophy

BIIB122 (DNL151) * - Parkinson's

Neuropsychiatry BIIB125 (zuranolone)* - PPD Phase 3

BIIB125 (zuranolone)* - MDD Phase 3

BIIB104 (AMPA PAM) - CIAS Phase 2

Neurovascular BIIB093 (glibenclamide IV) - LHI^ Stroke Phase 3

BIIB093 (glibenclamide IV) - Brain Contusion Phase 2

BIIB132 (ATXN-3 ASO) # - SCA3

Multiple Sclerosis BIIB091 (peripheral BTK inhibitor) - MS Phase 1

BIIB107 (anti-VLA4) - MS Phase 1

Neurovascular Glibenclamide IV (SUR1-TRPM4 Inhibitor) - LHI^ Stroke Phase 3

Glibenclamide IV (SUR1-TRPM4 Inhibitor) - Brain Contusion Phase 2

BIIB131 (TMS-007) - Acute Ischemic Stroke Phase 2

Neuropathic Pain BIIB074 (vixotrigine) - Trigeminal Neuralgia Phase 2

BIIB074 (vixotrigine) - Small Fiber Neuropathy Phase 2

Genetic Neurodevelopmental Disorders BIIB121 (UBE3A ASO) # - Angelman Syndrome

Specialized Immunology Dapirolizumab pegol (anti-CD40L)* - SLE Phase 3

BIIB059 (anti-BDCA2) - SLE Phase 3

BIIB059 (anti-BDCA2) - CLE Phase 2

Biosimilars BYOOVIZ (referencing LUCENTIS®) *

SB15 (referencing EYLEA®) *

BIIB800 (referencing ACTEMRA®)* Phase 3

* Collaboration program

**Not yet commercially available

** Granted accelerated approval in the U.S.

in June 2021 under the brand name ADUHELM.

*** Granted accelerated approval in the U.S.

in January 2023 under the brand name LEQEMBI and filed for traditional approval in the U.S., E.U.

# Option agreement

^ Large Hemispheric Infarction (LHI)

postpartum depression (PPD);

major depressive disorder (MDD)

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 , Note 19, Collaborative and Other Relationships, and Note 20, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.

T a ble of Content s

Table of Conten ts

Business Relationships

2 unchanged sentences

Below is a brief description of certain business relationships and collaborations that expand our pipeline and provide us with certain rights to existing and potential new products and technologies.

For additional information on certain of these relationships, including their ongoing financial and accounting impact on our business, please read Note 18, Collaborative and Other Relationships, and Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.

Acorda Therapeutics, Inc.

We have a collaboration and license agreement with Acorda to develop and commercialize products containing fampridine, such as FAMPYRA, in markets outside the U.S.

We are responsible for all regulatory activities and the future clinical development of related products in those markets.

We have an exclusive license and collaboration agreement with Alkermes for VUMERITY, which was approved for the treatment of RMS in the U.S.

in October 2019 and became commercially available in the U.S.

in November 2019.

During the fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in the E.U., Switzerland and the U.K.

Under this agreement, we have an exclusive, worldwide license to develop and commercialize VUMERITY.

Denali Therapeutics Inc.

We have a collaboration and license agreement with Denali to co-develop and co-commercialize Denali’s small molecule inhibitors of LRRK2 for Parkinson’s disease.

In the LRRK2 collaboration, we and Denali share responsibility and costs for global development as well as profits and losses for commercialization in the U.S.

Outside the U.S.

and China, we are responsible for commercialization and pay Denali tiered royalties.

In addition to the LRRK2 program, we also have an exclusive option to license two preclinical programs from Denali’s Transport Vehicle platform, including its

Antibody Transport Vehicle:

Abeta program and a second program utilizing its Transport Vehicle technology.

Further, we have a right of first negotiation on two additional Transport Vehicle-enabled therapeutics, should Denali decide to seek a collaboration for such programs.

For additional information on certain of these relationships, including their ongoing financial and accounting impact on our business, please read Note 19, Collaborative and Other Relationships , to our consolidated financial statements included in this report.

Eisai Co., Ltd.

We have a collaboration agreement with Eisai to jointly develop and commercialize lecanemab (BAN2401), an Eisai product candidate for the potential treatment of Alzheimer's disease.

Eisai serves as the global operational and regulatory lead for lecanemab and all costs, including research, development, sales and marketing expense, are shared equally between us and Eisai.

If lecanemab receives marketing approval, we and Eisai will co-promote lecanemab and share profits equally.

We also have a collaboration agreement with Eisai to jointly develop and commercialize ADUHELM (aducanumab) (the ADUHELM Collaboration Agreement).

Under the ADUHELM Collaboration Agreement, the two companies will co-promote ADUHELM with a region-based profit split and we lead the ongoing development and commercialization of ADUHELM.

We and Eisai co-promote AVONEX, TYSABRI and TECFIDERA in Japan in certain settings and Eisai distributes AVONEX, TYSABRI, TECFIDERA and PLEGRIDY in India and other Asia-Pacific markets, excluding China.

Genentech, Inc.

(Roche Group)

We have collaboration arrangements with Genentech which entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS and other potential anti-CD20 therapies, including mosunetuzumab.

We have a collaboration agreement with Eisai to jointly develop and commercialize LEQEMBI (lecanemab), an anti-amyloid antibody for the treatment of Alzheimer's disease.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority.

All costs, including research, development, sales and marketing expense, are shared equally between us and Eisai.

Upon LEQEMBI marketing approval, we and Eisai will co-promote LEQEMBI and share profits and losses equally.

We currently manufacture LEQEMBI drug substance and drug product and in March 2022 we extended our supply agreement with Eisai related to LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance.

We also have a collaboration agreement with Eisai for ADUHELM.

Under our initial ADUHELM Collaboration Agreement, we would lead the ongoing development of ADUHELM, and we and Eisai would co-promote ADUHELM with a region-based profit split.

On March 14, 2022, we amended our ADUHELM Collaboration Agreement with Eisai.

Eisai's share of development, commercialization and manufacturing expense was limited to $335.0 million for the period from January

1, 2022 to December 31, 2022, which was achieved as of December 31, 2022.

Once this limit was achieved, we became responsible for all ADUHELM related costs.

In addition, we and Eisai co-promote AVONEX, TYSABRI and TECFIDERA in Japan in certain settings and Eisai distributes AVONEX, TYSABRI, TECFIDERA and PLEGRIDY in India and other Asia-Pacific markets, excluding China.

Sage Therapeutics, Inc.

We have a global collaboration and license agreement with Sage to jointly develop and commercialize zuranolone for the potential treatment of MDD and PPD and BIIB124 (SAGE-324) for the potential treatment of essential tremor with potential in other neurological conditions such as epilepsy.

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.

Outside the U.S., we are responsible for development and commercialization, excluding Japan, Taiwan and South Korea, with respect to zuranolone and may pay Sage potential tiered royalties in the high teens to low twenties.

Ionis Pharmaceuticals, Inc .

1 unchanged sentence

Under a separate collaboration and license agreement with Ionis, we have an exclusive, worldwide license to develop and commercialize SPINRAZA for the treatment of SMA.

We also have a 10-year exclusive collaboration agreement with Ionis to develop novel antisense oligonucleotide (ASO) drug candidates for a broad range of neurological diseases.

In addition, we have research collaboration agreements with Ionis under which both companies perform discovery level research and will develop and commercialize new ASO drug candidates for the potential treatment of SMA and additional antisense

T a ble of Content s

or other therapeutics for the potential treatment of neurological diseases.

InnoCare Pharma Limited

We have a collaboration and license agreement with InnoCare for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS.

Orelabrutinib is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

Neurimmune SubOne AG

We have a collaboration and license agreement with Neurimmune SubOne AG (Neurimmune) for the development and commercialization of antibodies for the potential treatment of Alzheimer's disease, including ADUHELM (as amended, the Neurimmune Agreement).

We are responsible for the development, manufacturing and commercialization of all licensed products.

We also have a 10-year exclusive collaboration agreement with Ionis to develop novel ASO drug candidates for a broad range of neurological diseases.

Genentech, Inc.

(Roche Group)

during the fourth quarter of 2022, glofitamab and options to add other potential anti-CD20 therapies.

Table of Conten ts

Denali Therapeutics Inc.

We have a collaboration and license agreement with Denali to co-develop and co-commercialize Denali’s small molecule inhibitors of LRRK2 for Parkinson’s disease.

Under this collaboration, both companies share responsibility and costs for global development based on specified percentages as well as profits and losses for commercialization in the U.S.

Outside the U.S.

and China, we are responsible for commercialization and may pay Denali potential tiered royalties.

In addition to the LRRK2 program, we also have an exclusive option to license two preclinical programs from Denali’s Transport Vehicle platform, including its Antibody Transport Vehicle (ATV):

ATV enabled anti-amyloid beta program and a second program utilizing its Transport Vehicle technology.

Further, we have the right of first negotiation on two additional ATV-enabled therapeutics for indications within specific neurodegenerative diseases, should Denali decide to seek a collaboration for such programs.

Samsung Bioepis Co., Ltd.

We and Samsung BioLogics established a joint venture, Samsung Bioepis, to develop, manufacture and market biosimilar products.

We also have an agreement with Samsung Bioepis to commercialize, over a 10-year term, 3 anti-TNF biosimilar product candidates in certain countries in Europe and, in the case of BENEPALI, Japan.

In February 2012 we entered into a joint venture agreement with Samsung BioLogics establishing an entity, Samsung Bioepis, to develop, manufacture and market biosimilar products.

We also have an agreement with Samsung Bioepis to commercialize, over a 10-year term, three anti-TNF biosimilar product candidates in certain countries in Europe and, in the case of BENEPALI, Japan.

Under this agreement, we are commercializing BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe.

In January 2022 we entered into an agreement to sell to Samsung Biologics our equity in Samsung Bioepis.

We would also be eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.

In December 2019 we completed a transaction with Samsung Bioepis and acquired an option to extend our existing commercial agreement with Samsung Bioepis for BENEPALI, IMRALDI and FLIXABI in certain countries in Europe.

1 unchanged sentence

during the third quarter of 2021.

In addition to our joint venture and commercialization agreements with Samsung Bioepis, we license certain of our proprietary technology to Samsung Bioepis in connection with Samsung Bioepis' development, manufacture and commercialization of its biosimilar products.

Sage Therapeutics, Inc.

We have a global collaboration and license agreement with Sage to jointly develop and commercialize zuranolone for the potential treatment of major depressive disorder, postpartum depression and other psychiatric disorders and SAGE-324 for the potential treatment of essential tremor and other neurological disorders.

We and Sage share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S.

Outside the U.S., we are responsible for development and commercialization, excluding Japan, Taiwan and South Korea with respect to zuranolone, and will pay Sage tiered royalties.

BYOOVIZ launched in the U.S.

in June 2022 and became commercially available during the third quarter of 2022.

In addition to our commercialization agreements with Samsung Bioepis, we license certain of our proprietary technology to Samsung Bioepis in connection with Samsung Bioepis' development, manufacture and commercialization of its biosimilar products.

In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics.

Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately

$1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction.

As part of this transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.

Our policy for contingent payments of this nature is to recognize the payments in the period that they become realizable, which is generally the same period in which the payments are earned.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to our consolidated financial statements included in this report.

We have a collaboration agreement with UCB to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for the potential treatment of SLE and other future agreed indications.

Both companies will share equally costs incurred for agreed indications, including research, development, sales and marketing expense.

If marketing approval is obtained, both companies will co-promote dapirolizumab pegol and share profits and losses equally.

Sangamo Therapeutics, Inc.

We have a collaboration and license agreement with Sangamo to develop and commercialize ST-501 for tauopathies, including Alzheimer’s disease;

We have a collaboration and license agreement with Sangamo Therapeutics, Inc.

(Sangamo) to develop and commercialize ST-501 for tauopathies, including Alzheimer’s disease;

ST-502 for synucleinopathies, including Parkinson’s disease;

2 unchanged sentences

The companies are leveraging Sangamo's proprietary zinc finger protein technology delivered via adeno-associated virus to modulate the expression of key genes involved in neurological diseases.

Sangamo will perform early research activities, costs for which will be shared by the companies, and we will assume responsibility and costs beyond the early research activities.

Under this collaboration, we may pay Sangamo tiered royalties on potential net sales of any products developed under this collaboration in the high single digit to sub-teen percentages.

Table of Conten ts

Our current and contemplated activities and the products, technologies and processes that result from such activities are subject to substantial government regulation.

T a ble of Content s

Regulation of Pharmaceuticals

12 unchanged sentences

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.

The FDA has developed four distinct approaches intended to facilitate the development and expedite the regulatory review of therapeutically important drugs, especially when the drugs are the first available treatment or have advantages over existing treatments:

The FDA has developed four distinct approaches intended to facilitate the development and expedite the regulatory review of therapeutically important drugs, especially when the drugs are the first

available treatment or have advantages over existing treatments:

accelerated approval, fast track, breakthrough therapy and priority review.

• Accelerated Approval :

The FDA may grant “accelerated approval” to products that treat serious or life-threatening illnesses and that

provide meaningful therapeutic benefits to patients over existing treatments.

The FDA may grant “accelerated approval” to products that treat serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments.

Under this pathway, the FDA may approve a product based on surrogate endpoints or clinical endpoints other than survival or irreversible morbidity.

9 unchanged sentences

Breakthrough therapy status does not guarantee that a product will be eligible for priority review and does not ensure FDA approval.

Table of Conten ts

• Priority Review :

“Priority review” only applies to applications (original or efficacy supplement) for a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.

Priority review may also be granted for

T a ble of Content s

any supplement that proposes a labeling change due to studies completed in response to a written request from the FDA for pediatric studies, for an application for a drug that has been designated as a qualified infectious disease product or for any application or supplement for a drug submitted with a priority review voucher.

Priority review may also be granted for any supplement that proposes a labeling change due to studies completed in response to a written request from the FDA for pediatric studies, for an application for a drug that has been designated as a qualified infectious disease product or for any application or supplement for a drug submitted with a priority review voucher.

In December 2016 the FDA issued a rare pediatric disease priority review voucher to us in connection with the approval of SPINRAZA.

12 unchanged sentences

Based on new safety information that emerges after approval, the FDA can mandate product labeling changes, impose a new REMS or the addition of elements to an existing REMS, require new post-marketing studies (including additional clinical trials) or suspend or withdraw approval of the product.

These requirements may affect our ability to maintain marketing approval of our products or require us to make significant expenditures to obtain or maintain such approvals.

These requirements may affect our ability to maintain marketing approval of our products or require us to

make significant expenditures to obtain or maintain such approvals.

APPROVAL OF CHANGES TO AN APPROVED PRODUCT

If we seek to make certain types of changes to an approved product, such as adding a new indication, making certain manufacturing changes or

changing manufacturers or suppliers of certain ingredients or components, the FDA will need to review and approve such changes in advance.

If we seek to make certain types of changes to an approved product, such as adding a new indication, making certain manufacturing changes or changing manufacturers or suppliers of certain ingredients or components, the FDA will need to review and approve such changes in advance.

In the case of a new indication, we are required to demonstrate with additional clinical data that the product is safe and effective for a use other than what was initially approved.

12 unchanged sentences

In May 2017 new regulations governing medical devices (MDR) and in-vitro diagnostic medical devices (IVDR) entered into force in the E.U.

The MDR became applicable in May 2021.

The IVDR regulations are not expected to fully apply until May 2022.

The MDR regulations became applicable in May 2021 and the

Table of Conten ts

IVDR regulations became applicable in May 2022.

All products covered by these regulations will be required to comply with them at the end of the transitional periods.

These regulations introduce new requirements, including for clinical investigation of certain classifications of medical devices, require increased regulatory scrutiny, enhance the requirements for post market surveillance and

T a ble of Content s

vigilance and provide for greater transparency.

These regulations also change the requirements for assessment of the medical device components of integral drug-device combination products, necessitating assessment of the device components under both the medical device and medicinal product regulatory regimes.

7 unchanged sentences

and is evaluated by the CHMP, the expert scientific committee of the EMA responsible for human medicines.

If the CHMP determines that the marketing authorization application fulfills the requirements for quality, safety and efficacy and that the medicine has a positive benefit risk balance, it will adopt a positive opinion recommending the granting of the marketing authorization by the EC.

If the CHMP determines that the MAA fulfills the requirements for quality, safety and efficacy and that the medicine has a positive benefit risk balance, it will adopt a positive opinion recommending the granting of the marketing authorization by the EC.

The CHMP opinion is not binding, but is typically adopted by the EC.

12 unchanged sentences

As in the U.S., the E.U.

also has distinct approaches intended to optimize the regulatory

pathways for therapeutically important drugs, including the Priority Medicines Evaluation Scheme (PRIME), accelerated assessment and conditional marketing authorization.

also has distinct approaches intended to optimize the regulatory pathways for therapeutically important drugs, including the Priority Medicines Evaluation Scheme (PRIME), accelerated assessment and conditional marketing authorization.

PRIME is intended to provide additional support to medicine developers throughout the development process.

13 unchanged sentences

Marketing authorization holders have an obligation to inform regulatory agencies of any new information which may influence the evaluation of benefits and risks of the medicinal product concerned.

Table of Conten ts

In the U.S., the E.U.

and other jurisdictions, regulatory agencies, including the FDA, conduct periodic inspections of NDA, BLA and marketing authorization holders to assess their compliance with pharmacovigilance obligations.

T a ble of Content s

Good Manufacturing Practices

11 unchanged sentences

Failure of such third-parties to comply with cGCP can likewise result in rejection of our clinical trial data or other sanctions.

In April 2014 the EC adopted a new Clinical Trial Regulation, which was entered into force in June 2014 but will not apply until January 2022.

In April 2014 the EC adopted a new Clinical Trial Regulation, which was entered into force in June 2014 but did not apply until January 2022.

There are transitional provisions for clinical trials which are ongoing at the date of application.

Clinical trial applications may also continue to be made under the Clinical Trial Directive (the existing regulatory framework) until January 2023.

Clinical trial applications may also continue to be made under the

Clinical Trial Directive (the existing regulatory framework) until January 2023.

All clinical trials must fully comply with the Clinical Trial Regulation by January 2025.

The regulation harmonizes the procedures for assessment and governance of clinical trials throughout the E.U.

and will require that

information on the authorization, conduct and results of each clinical trial conducted in the E.U.

and will require that information on the authorization, conduct and results of each clinical trial conducted in the E.U.

be publicly available.

13 unchanged sentences

Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a “rare disease or condition,” which generally is a disease or condition that affects fewer than 200,000 individuals in the U.S.

If a product which has an orphan drug designation subsequently receives an initial FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years

T a ble of Content s

following marketing approval, except in certain very limited circumstances, such as if the later product is shown to be clinically superior to the orphan product.

Table of Conten ts

which has an orphan drug designation subsequently receives an initial FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years following marketing approval, except in certain very limited circumstances, such as if the later product is shown to be clinically superior to the orphan product.

Legislation similar to the U.S.

14 unchanged sentences

The amount of the rebate is established by law and is adjusted upward if the average manufacturer price (AMP) increases more than inflation (measured by the Consumer Price Index - Urban).

The rebate amount is calculated each quarter based on our report of current AMP and best price for each of our products to the Centers for Medicare & Medicaid Services (CMS).

The rebate amount is calculated each quarter based on our report of current AMP and best price for each of our products to the CMS.

The requirements for calculating AMP and best price are complex.

We are required to report any

revisions to AMP or best price previously reported within a certain period, which revisions could affect our rebate liability for prior quarters.

We are required to report any revisions to AMP or best price previously reported within a certain period, which revisions could affect our rebate liability for prior quarters.

In addition, if we fail to provide information timely or we are found to have knowingly submitted false information to the government, the statute governing the Medicaid Drug Rebate Program provides for civil monetary penalties.

11 unchanged sentences

In addition, manufacturers, including us, are required to provide to the CMS a discount of up to 70.0% on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reach the coverage gap in their drug benefits.

Legislation is pending in Congress that includes significant modifications to Medicare Part B and Medicare Part D.

Specifically, the Build Back Better Act includes provisions that would, among other things:

1) allow CMS to directly negotiate the prices of certain drugs paid for by Medicare and impose a significantly discounted maximum price;

T a ble of Content s

2) impose inflation penalties (in the form of rebates) for price increases that exceed the rate of inflation;

3) re-design the Medicare Part D benefit in a way that increases the financial liability of manufacturers.

If enacted, this legislation could harm our business.

On August 16, 2022, President Biden signed into law the IRA, 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

Table of Conten ts

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 10.0% of costs up to the $2,000 cap and 20.0% after that cap is reached.

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.

However, as the degree of impact from this legislation on our business depends on a number of forthcoming implementation actions by regulatory authorities, the full extent of the IRA’s impact on our sales and, in turn, our business, remains unclear.

• Federal Agency Discounted Pricing :

9 unchanged sentences

Purchasers eligible for discounts include hospitals that serve a disproportionate share of financially needy patients, community health clinics and other entities that receive certain types of grants under the PHSA.

For all of our products, we must agree to charge a price that will not exceed the amount determined under statute (the “ceiling price”) when we sell outpatient drugs to these covered entities.

our products, we must agree to charge a price that will not exceed the amount determined under statute (the “ceiling price”) when we sell outpatient drugs to these covered entities.

In addition, we may, but are not required to, offer these covered entities a price lower than the 340B ceiling price.

14 unchanged sentences

Violations of fraud and abuse laws may be punishable by criminal or civil sanctions, including fines and civil monetary penalties, and exclusion from federal health care programs (including Medicare and Medicaid).

In the U.S., federal and state authorities are paying increased attention to enforcement of these laws within the pharmaceutical industry and private individuals have been active in alleging violations of the laws and bringing suits on behalf of the government under the federal civil False Claims Act.

In the U.S., federal and state authorities are paying increased attention to enforcement of these laws

Table of Conten ts

within the pharmaceutical industry and private individuals have been active in alleging violations of the laws and bringing suits on behalf of the government under the federal civil False Claims Act.

If we were subject to allegations concerning, or were convicted of violating, these laws, our business could be harmed.

Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical

T a ble of Content s

manufacturers.

Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical manufacturers.

The laws and regulations generally limit financial interactions between manufacturers and health care providers or require disclosure to the government and public of such interactions.

14 unchanged sentences

The laws to which we are subject also include the U.K.

Bribery Act 2010 (Bribery Act), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official and failing to have adequate procedures to prevent employees and other agents from giving bribes.

Bribery Act 2010 (Bribery Act), which proscribes giving and receiving bribes in the public

and private sectors, bribing a foreign public official and failing to have adequate procedures to prevent employees and other agents from giving bribes.

companies that conduct business in the U.K.

17 unchanged sentences

to the U.S., provides an enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20.0 million or 4.0% of the annual global revenue of the infringer, whichever is greater.

Table of Conten ts

Manufacturing

1 unchanged sentence

To that end, we continually review our manufacturing capacity, capabilities, processes and facilities.

We believe that our manufacturing facilities, together with the third-party contract manufacturing organizations we

T a ble of Content s

outsource to, currently provide sufficient capacity for our products and to Samsung Bioepis, our joint venture that develops, manufactures and markets biosimilar products, and other strategic contract manufacturing partners.

In order to support our future growth and drug development pipeline, we are expanding our large molecule production capacity by building a large-scale biologics manufacturing facility in Solothurn, Switzerland.

In the second quarter of 2021 a portion of the facility received a GMP multi-product license from SWISSMEDIC.

In March 2021 we announced our plans to build a new gene therapy manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas.

The new facility will be approximately 175,000 square feet and is expected to be operational by the end of 2023.

We believe that our manufacturing facilities, together with the third-party contract manufacturing organizations we outsource to, currently provide sufficient capacity for our products and to Samsung Bioepis, our collaboration partner that develops, manufactures and markets biosimilar products, and other strategic contract manufacturing partners.

In March 2021 we announced our plans to build a new gene therapy manufacturing facility in RTP, NC to support our gene therapy pipeline across multiple therapeutic areas.

The new manufacturing facility will be approximately 197,000 square feet and is expected to be operational by the end of 2023, with an estimated total investment of approximately $195.0 million.

Construction for this new facility began during the fourth quarter of 2021.

Manufacturing Facilities

Our drug substance manufacturing facility includes:

Our drug substance manufacturing facilities include:

Facility Drug Substance Manufactured

RTP, NC AVONEX

RTP, North Carolina AVONEX

Solothurn, Switzerland ADUHELM

* Other includes products manufactured for contract manufacturing partners.

In addition to our drug substance manufacturing facility, we have a drug product manufacturing facility and supporting infrastructure in RTP, NC, including a parenteral facility and an oral solid dose products manufacturing facility.

In addition to our drug substance manufacturing facilities, we have a drug product manufacturing facility and supporting infrastructure in RTP, NC, 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.

The oral solid dose products facility can supplement our outsourced small molecule manufacturing capabilities, including the manufacture of TECFIDERA.

We also have an oligonucleotide synthesis manufacturing facility in RTP, North Carolina.

This facility gives us the capability to manufacture ASO drugs like SPINRAZA as well as our other ASO candidates currently in our clinical pipeline.

The oral solid dose products facility can supplement our outsourced small molecule manufacturing capabilities.

We also have an oligonucleotide synthesis manufacturing facility in RTP, NC.

This facility gives us the capability to manufacture ASO candidates currently in our clinical pipeline.

In order to support our future growth and drug development pipeline, we are building a large-scale biologics manufacturing facility in Solothurn, Switzerland.

In the second quarter of 2021 a portion of the facility received a GMP multi-product license from SWISSMEDIC.

In the second quarter of 2021 a portion of the facility received a Good Manufacturing Practice (GMP) multi-product license from the Swiss Agency for

Therapeutic Products (SWISSMEDIC).

Solothurn has been approved for the manufacture of ADUHELM and LEQEMBI by the FDA.

We estimate the second manufacturing suite at the Solothurn facility will be operational by the end of 2023.

Genentech is responsible for all worldwide manufacturing activities for bulk RITUXAN, RITUXAN HYCELA and GAZYVA and has sourced the manufacture of certain bulk RITUXAN, RITUXAN HYCELA and GAZYVA requirements to a third party.

Acorda supplies FAMPYRA to us pursuant to its supply agreement with Alkermes, Inc.

and Ionis supplies the active pharmaceutical ingredient (API) for SPINRAZA.

Alkermes currently supplies VUMERITY to us pursuant to a supply agreement.

In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes.

Ionis supplies the active pharmaceutical ingredient (API) for SPINRAZA.

Alkermes currently supplies both VUMERITY and FAMPYRA to us pursuant to separate supply agreements.

In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes for VUMERITY.

We have elected to initiate a technology transfer and, following a transition period, to 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.

In October 2022 we entered into a new supply agreement with Alkermes for FAMPYRA.

Acorda previously supplied FAMPYRA to us pursuant to a sublicensing arrangement with Alkermes, which was terminated in October 2022 as a result of an arbitration outcome between Acorda and Alkermes.

Third-Party Suppliers and Manufacturers

4 unchanged sentences

Our third-party service providers, suppliers and manufacturers may be subject to routine cGMP inspections by the FDA or comparable agencies in other jurisdictions and undergo assessment and certification by our quality management group.

Environmental Matters

Table of Conten ts

ESG and Climate-Related Matters

Our environmental, social and governance (ESG) efforts prioritize climate, health and equity, with a focus on vulnerable populations, as well as ongoing leadership in sustainability, governance, transparency and disclosure.

We remain committed to reducing our environmental footprint by eliminating harmful emissions and by minimizing resources used to manufacture our products.

Since 2014 we have taken responsibility for our impact on climate change by matching 100% of our electricity usage with renewable energy, credits and offsets, driving efficiency initiatives internally and working with our suppliers.

Green chemistry is embraced throughout our company, continually exploring new ways to make our

T a ble of Content s

drug development processes safer, more efficient and more sustainable while also saving resources.

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.

In 2020 we launched our Healthy Climate, Healthy Lives initiative, which is our 20-year, $250 million initiative to address climate, health and equity.

We aim to eliminate fossil fuel emissions across our operations by 2040, engage employees and suppliers and collaborate with renowned institutions to advance the science and action to improve health outcomes.

As part of our commitment, we have tied a portion of our employees' and executive officers' 2021 compensation to advancing our Environmental, Social and Governance strategy.

Green chemistry is embraced throughout our company, continually exploring new ways to make our drug development processes safer, more efficient and more sustainable while also saving resources.

ESG oversight is formally embedded into our Board of Director's governance principles and includes an annual review of our ESG strategy and short-and long-term goals.

We regularly review our environmental commitments within the landscape of our business performance, rising costs and supply chain challenges.

We remain committed to engaging employees and suppliers and collaborating with renowned institutions to advance the science and action to improve health outcomes.

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 ESG efforts.

We strive to comply in all material respects with applicable laws and regulations concerning the environment.

While it is impossible to predict accurately the future costs associated with environmental compliance and potential remediation activities, compliance with environmental laws is not expected to require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our operations or competitive position.

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.

Our Enterprise Risk Management (ERM) framework is designed to ensure climate-related risks and opportunities are integrated into our overall business strategy.

Our ERM team monitors strategic climate-related risks across all aspects of our business and utilizes climate scenarios as part of its

On an annual basis, the ERM team evaluates identified risks, including any climate-related physical and transitional risks, by engaging leaders across the company.

The ERM team provides annual updates on their findings and activities to our Executive Committee and Board of Directors.

Risk Management

Addressing ESG matters is part of our long-term global strategy and investment in our future and we have seen increased interest from stakeholders and investors on our ESG practices.

While we continue to to advance our ESG efforts, there is no certainty that we will manage ESG matters in ways that successfully meet rapidly changing expectations from investors, regulators, third party rankings firms, customers and society as a whole.

Our inability to manage ESG matters in accordance with expectations can negatively impact our reputation and business.

Climate Risk Management

We identify climate risk as the risk of loss arising from climate change and is comprised of both physical risk and transition risk.

Physical risk considers how the physical impacts of climate change (e.g., increased storms, drought, fires, floods) can directly damage physical assets or otherwise impact their value or productivity.

Transition risk considers how changes in policy.

regulations, culture, technology, business practices and market preferences to address climate change (e.g., carbon pricing policies, power generation shifts from fossil fuels to renewable energy) can lead to changes in the value of assets and businesses.

Disruption in supply chains, changing customer expectations in the biosimilar market and potential shifts in the regulatory environment that disadvantage the use of fossil fuels, may make it difficult for us to fulfill business obligations or cause us to incur substantial expense.

Identified material risks and opportunities are reported to our ERM team, which reports to our Executive Committee and Board of Directors.

We consider and address those risks and opportunities that are financially material and may impact our business model, as well as mitigation measures that are in place or need to be adopted.

For additional information on our environment-related risks, please read Item 1A.

Risk Factors included in this report.

Human Capital

2 unchanged sentences

and approximately 3,755 employees were employed in foreign countries.

Table of Conten ts

Diversity, Equity and Inclusion

At Biogen, prejudice, racism and intolerance are unacceptable.

We are committed to Diversity, Equity and Inclusion (DE&I) across all aspects of our organization, including hiring, promotion and development practices.

As of December 31, 2021, 25.8% of Biogen’s director-level and above positions were held by ethnic or racial minorities in the U.S.

We are committed to Diversity, Equity and Inclusion (DE&I) across all aspects of our organization, including recruitment, hiring, promotion, retention and development practices.

As of December 31, 2022, 30.4% of Biogen’s manager-level and above positions were held by ethnic or racial minorities in the U.S.

Our policies and practices are global, but the laws in many countries outside the U.S.

1 unchanged sentence

Globally, 47.4% of Biogen’s positions at director-level and above were held by women as of December 31, 2022.

In 2020 we introduced an updated DE&I strategy that outlines actionable steps to deepen our commitment across the business, building upon a strong foundation.

This plan includes a four-part strategy to build our talent and leadership pipeline, improve health outcomes for minority communities in the disease areas we treat and expand sourcing with

minority-owned businesses.

Our DE&I strategy outlines actionable steps to deepen our commitment across the business, building upon a strong foundation.

This plan includes the strategy to build our talent and strengthen our leadership, improve health outcomes for underserved communities in the disease areas we treat and contribute to the communities impacting our employees and patients.

We plan to create greater awareness and capability in our organization through leadership accountability and transparency.

To establish and progress this strategy, we rely on a cross-company governing body of employees known as the Diversity, Equity & Inclusion Strategic Council.

We are honored to be recognized as a company of choice.

For the fourth consecutive year, we scored 100.0% on the 2021 Disability Equality Index, which measures our policies and practices related to disability inclusion.

Additionally, for the second consecutive year, we were awarded by Disability:IN North Carolina with the 2021 DI-NC Employer Award for our commitment to champion and invest in disability inclusion at the affiliate and national levels.

For the eighth consecutive year, we were recognized as a Best Place to Work for LGBTQ Equality by the Human Rights Campaign, scoring 100.0% on their Corporate Equality Index.

In 2021 we were also ranked in the top five of Fortune 500's Measure Up initiative, which highlights the most progressive companies on DE&I efforts.

In January 2021 we shared the results of a global pay equity analysis.

The analysis confirmed that fairness and equity are embedded in our compensation practices around the globe with respect to gender and additionally in the U.S.

with respect to race.

In 2021 we also committed to strengthen the DE&I awareness and capability of our employees.

We ended 2021 with close to 90.0% of people managers trained on inclusive recruiting and hiring, and a majority of global employees trained on DE&I curriculum.

We are honored to be recognized as an employer of choice.

For the fifth consecutive year, we scored 100% on the Disability:IN's Disability Equality Index, which measures our policies and practices related to disability inclusion.

Additionally, for the third consecutive year, we were awarded the DI-NC Employer Award by Disability:IN North Carolina for our commitment to champion and invest in disability inclusion at the affiliate and national levels.

For the ninth consecutive year, we were recognized as a Best Place to Work for LGBTQ+ Equality by the Human Rights Campaign, scoring 100% on their Corporate Equality Index.

Strengthening our Global Competency

We are committed to strengthening the DE&I awareness and capability of our employees.

We have focused on ensuring that our employees have the resources and learning they need to contribute to our strategy.

Our people managers are trained on inclusive recruiting and hiring and our global employees are trained on DE&I curriculum.

In 2022 we introduced GlobeSmart®, a tool to enhance cross-cultural collaboration, increase cultural agility and further connect our global teams.

Our people leaders have used GlobeSmart®, allowing them to explore different working styles, perspectives and approaches that exist around the globe, getting actionable, personalized advice for better collaboration and teamwork across cultures, and

exploring new ways for teams to build trust, strengthen collaboration and leverage diversity.

Philosophy on Pay Equity

8 unchanged sentences

We regularly review our compensation practices and analyze the equity of compensation decisions, for individual employees and our workforce as a whole.

If we identify employees with pay gaps, we review and take action to attain fidelity between our stated philosophy and actions.

T a ble of Content s

In 2022 we shared the results of a global gender pay assessment, analyzing pay at the executive, management and other professional levels.

We institute measures, such as communications and trainings, to recognize, interrupt and prevent bias in hiring, performance management and compensation decisions and we provide resources to further develop managers and leaders to help them make equitable decisions about pay.

Talent and Development

Many factors influence employee success and well-being.

We foster a workplace to allow employees to deliver on our shared mission while helping to mitigate their challenges.

From career development to wellness to workplace environment, there are many opportunities to meet employee needs, and to build a workplace where people are empowered to learn, grow and build rewarding careers.

Our employees are encouraged to take advantage of an array of professional development resources.

Managers coach employees for performance, and also engage in employee development discussions to support growth and learning.

We provide our employees access to over 17,000 on-demand learning modules in English, French, German, Spanish, Japanese, Portuguese and Mandarin.

Additionally, we have a wide selection of courses and trainings that are offered through Biogen University, our global validated learning management system.

Opportunities for ongoing learning can contribute to employee related engagement and success.

At Biogen, development occurs through on-the-job learning, challenging new assignments, formal training, online learning, mentoring and more.

With many employees continuing to work from home, virtual learning plays a key role.

Virtual learnings are available through Biogen University as well as LinkedIn Learning.

Through Biogen University we offer more than 1,200 instructor-based courses, of which approximately 300 are available virtually.

Through LinkedIn Learning we provided employees with access

Table of Conten ts

to more than 20,000 on-demand learning modules in 11 languages:

English, German, French, Spanish, Japanese, Portuguese, Italian, Dutch, Polish, Turkish and Mandarin.

To create and sustain a workplace as diverse and inclusive as the patients we serve, we offer programs that invest in our talent pipeline and in our current leaders, including:

7 unchanged sentences

To continue to bolster our talent pipeline with a diverse mix of leaders, high potential, mid-career, underrepresented minorities participate in this program, which we helped create.

• Women on the Rise:

Addressing the unique challenges faced by mid-level female leaders to increase influence and impact.

• Emerging Leaders:

Preparing high-potential individual contributors for first-level leadership roles.

Coaching program available to support individuals as they work toward enhancing their impact in the organization.

Our Employee Resource Networks (ERNs) provide invaluable opportunities for employees to share knowledge and build connections.

Our current ERNs include:

• Parenting Network Group:

Biogen's newest ERN provides support, networking and development opportunities to working parents and caregivers, as well as helping employees navigate the challenges of work-life balance.

Brings together early-career professionals and their advocates.

3 unchanged sentences

Encourages veterans and allies of veterans to connect and support one another.

Fosters awareness and appreciation of different cultural backgrounds, in addition

to promoting networking and development opportunities for members.

Fosters awareness and appreciation of different cultural backgrounds, in addition to promoting networking and development opportunities for members.

Supports a best-in-class working environment for LGBTQ+ employees and embraces all LGBTQ+ employees and their allies.

2 unchanged sentences

Advances climate, health and equity at work, in employees' personal lives and in the communities where we live and work.

Creating a culture where all colleagues feel supported and valued is paramount to our corporate mission.

The ongoing COVID-19 pandemic has led to unique challenges, and we are striving to ensure the health, safety and general well-being of our employees.

We continue to evolve our programs to meet our employees’ health and wellness needs, which we believe is essential to attract and retain employees of the highest caliber.

For example, we have refreshed our flexible working arrangement policies to allow for more flexibility around work hours to help employees balance the demands of their work and home lives, shifted many of our on-site wellness services to virtual, including virtual behavior health, nutrition, fitness and overall well-being classes and counseling, rolled out the Headspace meditation app globally at no cost, provided workshops and programming to help employees cope with stress, isolation and building resilience, along with financial planning workshops and counseling sessions, expanded our child- and back-up care services to meet the growing childcare needs of our employees and provided additional holidays and time off for recharging, voting and volunteering.

We have refreshed our flexible working arrangement policies to allow for more flexibility around work hours to help employees balance the demands of their work and home lives, shifted many of our on-site wellness services to virtual, including virtual behavior health, nutrition, fitness and overall well-being classes and counseling, rolled out the Headspace meditation app globally at no cost, provided workshops and programming to help employees cope with stress, isolation and building resilience, along with financial planning workshops and counseling sessions, expanded our caregiver services to meet the growing needs of our employees and provided additional holidays and time off for recharging, voting and volunteering.

Employee Surveys

2 unchanged sentences

We care deeply about employee feedback and are building an analytics community across Human Resources to bring more rigor and sophistication to the collection and analysis of employee opinions.

We use their perspectives to guide us to take actions that improve engagement and support and help maintain our reputation as a great place to work for all of our employees.

We use their perspectives to guide us to take actions that improve engagement and support and help maintain our reputation as a great place to work for all our employees.

An example of such an action was our 2022 Wellness Week, a weeklong mid-year shutdown.

Succession Planning

T a ble of Content s

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 on-going success of our company.

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

Table of Conten ts

ongoing success of our company.

In addition, each year our Board of Directors reviews the succession plan for our executives.

Workplace Health and Safety

The well-being of our employees is a top priority, and we believe each and every employee plays a role in creating a safe and healthy workplace.

The well-being of our employees is the priority, and we believe every employee plays a role in creating a safe and healthy workplace.

Our employees have varied roles and functions, which is why we empower them to promote a safe working environment, regardless of whether work happens in the lab, in an office or in a manufacturing plant.

Our policies and practices are intended to protect not only our employees, but also the surrounding communities in which we operate.

Our policies and practices are intended to protect not only our employees, but also the surrounding communities where we operate.

In 2022 we continued to make significant progress integrating Human Performance into our Environment, Health and Safety programs.

3 unchanged sentences

The actions we implement as a result of these evaluations reduce the risks associated with these essential activities and ensure our operational systems are safer and more resilient for employees.

We also utilize “After Action Reviews” following the completion of a project.

We also use “After Action Reviews” following the completion of a project.

These reviews enable us to not only focus on areas for improvement, but also to learn and apply good practices from what goes well.

By engaging and empowering our employees through such programs, we believe that we can help change how the entire industry approaches safety performance and risk management.

T a ble of Content s

Table of Conten ts

Information about our Executive Officers (as of February 15, 2023)

Officer Current Position Age Year Joined Biogen

Michel Vounatsos Chief Executive Officer 60 2016

Christopher A.

Viehbacher President, Chief Executive Officer 62 2022

Alexander Executive Vice President, Chief Legal Officer and Secretary 66 2006

McDonnell Executive Vice President and Chief Financial Officer 59 2020

Alphonse Galdes, Ph.D.

Executive Vice President, Pharmaceutical Operations and Technology 69 1995

Nicole Murphy Executive Vice President, Pharmaceutical Operations and Technology 50 2015

Ginger Gregory, Ph.D.

Executive Vice President and Chief Human Resources Officer 55 2017

Chirfi Guindo Executive Vice President, Global Product Strategy and Commercialization 56 2017

Rachid Izzar Executive Vice President, Head of Alzheimer's and Dementia Business Unit 47 2019

Rachid Izzar Executive Vice President, Global Product Strategy and Commercialization 48 2019

Priya Singhal, M.D., M.P.H.

Executive Vice President, Head of Development 55 2020

Kramer Senior Vice President, Chief Accounting Officer 57 2018

Michel Vounatsos

Vounatsos has served as our Chief Executive Officer and as a member of our Board of Directors since January 2017.

Prior to that, from April 2016 to December 2016, Mr.

Vounatsos served as our Executive Vice President, Chief Commercial Officer.

Christopher A.

Viehbacher has served as our President and Chief Executive Officer and member of our Board of Directors since November 2022.

Prior to joining Biogen, Mr.

Vounatsos spent 20 years at Merck & Co., Inc.

(Merck), a pharmaceutical company, where he most recently served as President, Primary Care, Customer Business Line and Merck Customer Centricity.

In this role, he led Merck’s global primary care business unit, a role which encompassed Merck’s cardiology-metabolic, general medicine, women’s health and biosimilars groups and developed and instituted a strategic framework for enhancing the company’s relationships with key constituents, including the most significant providers, payors and retailers and the world’s largest governments.

Vounatsos previously held leadership positions across Europe and in China for Merck.

Viehbacher served as Managing Partner of Gurnet Point Capital, a Boston based investment fund from 2015 to 2022.

Prior to that, Mr.

Vounatsos held management positions at Ciba-Geigy, a pharmaceutical company.

Vounatsos currently serves on the advisory board of Tsinghua University School of Pharmaceutical Sciences, on the Supervisory Board of Liryc, the Electrophysiology and Heart Modeling Institute at the University of Bordeaux, as a member of the MIT Presidential CEO Advisory Board and as a member of NetZero International Leadership Counsel.

Viehbacher served as Global CEO of Sanofi, from 2008 to 2014.

Prior to joining Sanofi, Mr.

Viehbacher spent over 20 years with GlaxoSmithKline in Germany, Canada, France and, latterly, the U.S.

as president of its North American pharmaceutical division.

Viehbacher began his career with PricewaterhouseCoopers LLP and qualified as a chartered accountant.

Viehbacher previously served on the board of directors of Vedanta Biosciences, Inc.

as chair, BEFORE Brands, Inc., and Crossover Health.

He is also a trustee of Northeastern University and a member of the board of fellows at Stanford Medical School.

Public Company Boards

l PerkinElmer, Inc., a global scientific technology and life science research company

l Universite Victor Segalen, Bordeaux II, France, C.S.C.T.

Certificate in Medicine

l HEC School of Management - Paris, M.B.A.

l PureTech Health Plc.

l Queen's University in Kingston, Ontario, Canada, B.A.

Alexander has served as our Executive Vice President, Chief Legal Officer and Secretary since April 2018.

9 unchanged sentences

Alexander was a partner at the law firms of Hinckley, Allen & Snyder and Fine & Ambrogne.

Public Company Boards

l Invacare Corporation, a medical and healthcare product company

l Wellesley College, B.A.

l Boston University School of Law, J.D.

T a ble of Content s

Table of Conten ts

McDonnell has served as our Executive Vice President and Chief Financial Officer since August 2020.

7 unchanged sentences

McDonnell is a licensed certified public accountant (CPA).

Public Company Boards

l Merit Medical Systems, Inc.

l Georgetown University, B.S.

Alphonse Galdes, Ph.D.

Galdes has served as our Executive Vice President, Pharmaceutical Operations and Technology since September 2019.

Since joining Biogen in 1995, Dr.

Galdes has held several senior executive positions, including most recently as Senior Vice President, Asset Development and Portfolio Management from November 2015 to September 2019 and Senior Vice President, Technical Development from October 2010 to November 2015.

Galdes was a Rhodes Scholar at Oxford University and performed post-doctoral research work at the Department of Biological Chemistry at Harvard Medical School.

l University of Malta, B.Sc.

Chemistry and Biology

l University of Malta, M.Sc.

l Oxford University, Ph.D.

Nicole Murphy

Murphy has served as our Executive Vice President, Pharmaceutical Operations and Technology since February 2022.

Prior to that, Ms.

Murphy has held senior executive positions at Biogen, including most recently as our Senior Vice President, Head of Global Manufacturing & Technical Operations, from June 2019 to January 2022.

Murphy played a critical role during the successful spin-off of Biogen's hemophilia franchise, as the Vice President and Head of Technical Operations of Bioverativ responsible for clinical and commercial development, quality, regulatory, manufacturing and procurement.

Prior to the spin-off Ms.

Murphy was the General Manager and Head of Cambridge Site Operations at Biogen from May 2015 to December 2016.

Prior to joining Biogen, Ms.

Murphy was Executive Director, Head of Supply Chain at Amgen, a biopharmaceutical company, where her responsibilities included leadership of commercial manufacturing and technical operations.

Murphy also held numerous technical and operational roles during her time at Amgen from 2001 to 2015 where she contributed significantly to various facility start-ups, business development integrations, strategic transformations and new product introductions.

Prior to Amgen, Ms.

Murphy held a variety of process development and engineering positions at Immunex Pharmaceuticals and the Monsanto Company.

l University of Massachusetts Amherst, B.S.

l Rensselaer Polytechnic Institute, M.S.

Engineering and a Masters of Business Administration

Ginger Gregory, Ph.D.

8 unchanged sentences

l The George Washington University, Ph.D.

T a ble of Content s

Chirfi Guindo

Guindo has served as our Executive Vice President, Global Product Strategy and Commercialization since February 2019.

Prior to that, Mr.

Guindo served as our Executive Vice President and Head of Global Marketing, Market Access and Customer Innovation from November 2017 to February 2019.

Prior to joining Biogen, Mr.

Guindo spent 27 years in the global pharmaceutical industry and held several leadership positions at Merck, a pharmaceutical company, in Canada, the U.S., France, Africa and the Netherlands.

He worked in several disciplines including Finance, Sales & Marketing, General Management and Global Strategy/Product Development in specialty, acute and hospital care.

Most recently Mr.

Guindo was Vice President and Managing Director and President and Managing Director of Merck Canada from October 2014 to November 2017.

From January 2011 to October 2014 he was Vice President and General Manager, Global HIV Franchise at Merck.

l Ecole Central de Paris (France), Engineering

l Stern School of Business, New York University, M.B.A.

Finance/Economics

Izzar has served as our Executive Vice President, Head of Alzheimer’s Disease and Dementia Business Unit since July 2021.

Table of Conten ts

Izzar has served as our Executive Vice President, Head of Global Product Strategy and Commercialization since July 2021.

Prior to that Mr.

7 unchanged sentences

l Harvard Business School, Enterprise Executive Transformation Program

Priya Singhal, M.D., M.P.H.

Singhal has served as our Executive Vice President and Head of Development since January 2023.

Prior to that Dr.

Singhal served as our Interim Head of Research and Development since 2021 in addition to serving as Head of Global Safety and Regulatory Sciences, including China and Japan Research and Development, since rejoining Biogen in 2020.

Singhal was initially at Biogen from 2012 to 2018 and served in positions of increasing seniority as Vice President Clinical Trials Benefit-Risk Management, Global Head of Safety and Benefit Risk Management and as the Interim Co-lead and Senior Vice President of Global Development.

Prior to her 2020 return to Biogen, Dr.

Singhal served as Head of Research and Development and Manufacturing at Zafgen Inc.

from 2019 to 2020.

From 2008 to 2012 Dr.

Singhal held roles at Vertex Pharmaceuticals, including Vice President, Medical Affairs.

Singhal began her drug-development career at Millennium Pharmaceuticals, Inc.

in 2005 and led benefit-risk management for Velcade and other compounds.

l Harvard School of Public Health, M.P.H.

in International Health

l University of Mumbai, Doctor of Medicine (M.D.)

Kramer has served as our Senior Vice President, Chief Accounting Officer since December 2020.

8 unchanged sentences

Kramer served as Director, External Reporting, Accounting and Control for the Gillette Company, a personal care company.

Kramer also held partner positions in the public accounting firms of Ernst & Young LLP and Arthur Anderson LLP.

Kramer also held partner positions in the public accounting firms of Ernst & Young LLP and Arthur Andersen LLP.

Kramer is a licensed CPA in Massachusetts.

She is a member of the Massachusetts Society of CPAs and the American Institute of CPAs.

Kramer currently serves on the board of directors of Samsung Bioepis and on the board of directors of the Center for Women and Enterprise.

Kramer currently serves on the board of directors of the Center for Women and Enterprise.

Kramer previously served as a Board Member for the Massachusetts State Board of Accountancy from September 2011 to December 2015 and Probus Insurance Company Europe DAC from 2016 to 2018.

2 unchanged sentences

l Salem State University, B.B.A.

T a ble of Content s

Table of Conten ts

Available Information

5 unchanged sentences

The contents of our website are not incorporated into this report.

T a ble of Content s

Table of Conten ts

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business