What changed in this filing

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Item 1. Business

2021-02-03 compared with 2020-02-06 · 477 added, 434 removed, 571 unchanged (61% of the section changed)

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Our core growth areas include multiple sclerosis (MS) and neuroimmunology;

Alzheimer’s disease (AD) and dementia;

Alzheimer’s disease and dementia;

neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS);

movement disorders, including Parkinson's disease;

and ophthalmology.

ophthalmology;

and neuropsychiatry.

We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging growth areas of immunology;

neurocognitive disorders;

acute neurology;

and neuropathic pain.

In addition, we commercialize biosimilars of advanced biologics.

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

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

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

SPINRAZA for the treatment of SMA;

and FUMADERM for the treatment of severe plaque psoriasis.

We also 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;

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;

RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL;

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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 additional improvements in the treatment of MS, such as the development of next generation therapies for MS, with a goal to reverse or possibly repair damage caused by the disease.

We also introduced the first approved treatment for SMA and are continuing to pursue research and development for potential advancements in the treatment of SMA, including a muscle enhancement program, novel antisense oligonucleotide (ASO) drug candidates and an oral splicing modulator.

We are also applying our scientific expertise to solve some of the most challenging and complex diseases, including AD, ALS, Parkinson's disease, choroideremia (CHM), X-linked retinitis pigmentosa (XLRP), systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), cognitive impairment associated with schizophrenia (CIAS), stroke, epilepsy and pain.

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

Through Samsung Bioepis Co., Ltd.

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, choroideremia (CHM), major depressive disorder, postpartum depression, X-linked retinitis pigmentosa (XLRP), 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 and have exclusive rights to commercialize these products in China.

Additionally, we have exclusive rights to commercialize two potential ophthalmology biosimilar products, SB11 referencing LUCENTIS and SB15 referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

(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 and have an option to acquire exclusive rights to commercialize these products in China.

Additionally, we have exclusive rights to commercialize two potential ophthalmology biosimilar products, SB11, a proposed ranibizumab biosimilar referencing LUCENTIS, and SB15, a proposed aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

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.

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The following is a summary of key developments affecting our business since the beginning of 2020.

For additional information on our acquisitions, collaborative and other relationships discussed below, please read Note 2, Acquisitions , Note 3, Divestitures, Note 18, Collaborative and Other Relationships, and Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.

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

Skyhawk Therapeutics, Inc.

In January 2019 we entered into a collaboration and research and development services agreement with Skyhawk Therapeutics, Inc.

(Skyhawk) pursuant to which the companies are leveraging Skyhawk's SkySTAR technology platform with the goal of discovering innovative small molecule treatments for patients with neurological diseases, including MS and SMA.

We are responsible for the development and potential commercialization of any therapies resulting from this collaboration.

In October 2019 we amended this agreement to add an additional discovery program.

Nightstar Therapeutics plc

In June 2019 we completed our acquisition of all of the outstanding shares of Nightstar Therapeutics plc (NST), a clinical-stage gene therapy company focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.

As a result of this acquisition, we added two mid- to late-stage clinical assets, as well as preclinical programs, in ophthalmology.

Divestiture of Hillerød, Denmark Manufacturing Operations

In August 2019 we completed the sale of all of the outstanding shares of our subsidiary that owned our biologics manufacturing operations in Hillerød, Denmark to FUJIFILM Corporation (FUJIFILM).

Samsung Bioepis

In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, SB11 referencing LUCENTIS and SB15 referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

We also acquired an option to extend our existing commercial agreement with Samsung Bioepis for BENEPALI, IMRALDI and FLIXABI in Europe and obtained exclusive rights to commercialize these products in China.

BIIB080 Option Exercise

In December 2019 we exercised our option with Ionis Pharmaceuticals, Inc.

(Ionis) and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO), an investigational treatment for AD.

In January 2020 we entered into an agreement to acquire PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer Inc.

In particular, we plan to develop the Phase 1 asset for the treatment of sundowning in AD and irregular sleep wake rhythm disorder (ISWRD) in Parkinson’s disease.

This transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S.

We expect this transaction to close in the first quarter of 2020.

BIIB118 Acquisition

In March 2020 we acquired BIIB118 (CK1 inhibitor), a novel CNS-penetrant small molecule inhibitor of casein kinase 1, for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer Inc.

We are developing BIIB118 for the potential treatment of irregular sleep wake rhythm disorder (ISWRD) in Parkinson’s disease and plan to develop BIIB118 for the potential treatment of sundowning in Alzheimer's disease.

Sangamo Therapeutics, Inc.

In April 2020 we closed 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;

a third neuromuscular disease target;

and up to nine additional neurological disease targets to be identified and selected within a five-year period.

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.

In connection with the closing of this transaction, we purchased $225.0 million of Sangamo common stock, or approximately 24 million shares at approximately $9.21 per share.

Denali Therapeutics Inc.

In October 2020 we closed a collaboration and license agreement with Denali Therapeutics Inc.

(Denali) to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.

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 (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.

As part of this collaboration we purchased approximately $465.0 million of Denali common stock in September 2020, or approximately 13 million shares at approximately $34.94 per share.

Sage Therapeutics, Inc.

In December 2020 we closed a global collaboration and license agreement with Sage Therapeutics, Inc.

(Sage) to jointly develop and commercialize zuranolone (SAGE-217) 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.

In connection with the closing of this transaction we purchased $650.0 million of Sage common stock, or approximately 6.2 million shares at approximately $104.14 per share.

Other Key Developments

In October 2019 the U.S.

Food and Drug Administration (FDA) approved VUMERITY for the treatment of RMS.

The FDA approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.

It included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, Phase 3, single-arm, open label, two-year safety study evaluating VUMERITY in patients with relapsing remitting MS (RRMS), and data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalence, and relied, in part, on the FDA's findings of safety and efficacy for TECFIDERA.

In November 2019 VUMERITY became available in the U.S.

Aducanumab (Aβ mAb)

In October 2019 we and our collaboration partner Eisai Co., Ltd.

(Eisai) announced that we plan to pursue regulatory approval for aducanumab, our anti-amyloid beta antibody candidate for the potential treatment of AD, in the U.S.

In July 2020 we completed the submission of a Biologics License Application (BLA) to the U.S.

Food and Drug Administration (FDA) for the approval of aducanumab, an anti-amyloid beta antibody candidate for the potential treatment of Alzheimer's disease that we are developing in collaboration with Eisai Co., Ltd.

In August 2020 the FDA accepted the BLA and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021.

In November 2020 the FDA held a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (the Advisory Committee) to review data supporting the BLA for aducanumab and to vote on questions presented at the meeting.

A majority of the Advisory Committee members voted against each of the questions presented at the meeting.

In January 2021 the FDA extended the review period for the BLA for aducanumab by three months.

The updated PDUFA action date is June 7, 2021.

As part of the ongoing review, we submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review.

In October 2020 the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for aducanumab.

In December 2020 the Ministry of Health, Labor and Welfare accepted for review the Japanese New Drug Application for aducanumab.

SB11 (referencing LUCENTIS)

In October 2020 the EMA accepted for review the MAA for SB11 and in November 2020 the FDA accepted the BLA for SB11.

We have exclusive rights to commercialize SB11 in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia, pursuant to our 2019 agreement with Samsung Bioepis.

2020 Share Repurchase Programs

In March 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (March 2019 Share Repurchase Program).

Our March 2019 Share Repurchase Program does not have an expiration date.

All share repurchases under our March 2019 Share Repurchase Program will be retired.

In December 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (December 2019 Share Repurchase Program).

Our December 2019 Share Repurchase Program does not have an expiration date.

All share repurchases under our December 2019 Share Repurchase Program will be retired.

Board of Directors Update

In June 2019 stockholders elected two new independent directors, William A.

Hawkins and Jesus B.

Mantas, to Biogen's Board of Directors, who are each serving for a one-year term until the 2020 annual meeting of stockholders and their successors are duly elected and qualified.

In October 2020 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (2020 Share Repurchase Program).

Our 2020 Share Repurchase Program does not have an expiration date.

All share repurchases under our 2020 Share Repurchase Program will be retired.

Healthy Climate, Healthy Lives

In September 2020 we announced Healthy Climate, Healthy Lives, a $250.0 million, 20-year initiative to eliminate our fossil fuels across our operations and collaborate with renowned institutions with the aim to improve health, especially for the world's most vulnerable populations.

Management Changes

During 2019 we announced the following management changes:

The appointment of Alfred Sandrock, Jr., M.D., Ph.D.

as Executive Vice President, Research and Development;

The appointment of Alphonse Galdes, Ph.D., as Executive Vice President, Pharmaceutical Operations and Technology.

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

In July 2020 we announced the appointment of Michael R.

McDonnell as Executive Vice President and Chief Financial Officer.

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

Product and Pipeline Developments

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Multiple Sclerosis and Neuroimmunology

TECFIDERA (dimethyl fumarate)

In May 2019, at the 71 st annual meeting of the American Academy of Neurology (AAN) in Philadelphia, PA, we presented re-analyzed pooled images from the Phase 3 DEFINE and CONFIRM studies that showed that treatment with TECFIDERA significantly slowed the rate of whole brain volume loss by 35.9% during the second year of treatment compared to placebo.

In September 2019, at the 35 th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24 th Annual Conference of Rehabilitation in MS in Stockholm, Sweden, we presented new 10-year results from the ongoing Phase 3 ENDORSE extension study and comparative effectiveness analyses of TECFIDERA that support the consistent, long-term benefits of treatment with TECFIDERA.

TYSABRI (natalizumab)

In January 2019 the first patient was enrolled in the global Phase 3b NOVA study evaluating the efficacy and safety of extended interval dosing (EID;

every six weeks) for natalizumab compared to standard interval dosing in patients with RMS.

In May 2019, at the 71 st annual meeting of the AAN in Philadelphia, PA, we presented updated safety analyses from the TOUCH database safety analysis evaluating EID of natalizumab (of approximately every six weeks) compared to every four-week dosing based on the TOUCH prescribing program database.

In September 2019, at the 35 th Congress of ECTRIMS and 24 th Annual Conference of Rehabilitation in MS in Stockholm, Sweden, we presented new data from the observational, open-label, single-arm STRIVE study that support the real-world long-term effectiveness of TYSABRI in patients with early RMS, who are within three years from diagnosis and are anti-JC virus antibody negative.

AVONEX (interferon beta-1a) and PLEGRIDY (peginterferon beta-1a)

In September 2019, at the 35 th Congress of ECTRIMS and 24 th Annual Conference of Rehabilitation in MS in Stockholm, Sweden, we presented new data from two real-world observational studies that provide further support that exposure to interferon beta treatment, including AVONEX and PLEGRIDY, before conception and/or during pregnancy is not expected to have an adverse effect on pregnancy or infant growth outcomes.

In October 2019 the European Medicines Agency (EMA) updated the summaries of product characteristics for AVONEX and PLEGRIDY to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with RMS.

• In March 2020 we made a regulatory submission to the EMA for a subcutaneous (SC) formulation of TYSABRI (natalizumab).

In June 2020 we submitted a Supplemental Biologics License Application for a SC formulation of natalizumab to the FDA.

The filings are supported by data from the DELIVER and REFINE studies, which demonstrated that natalizumab 300 mg SC every 4 weeks (Q4W) was comparable to standard 300 mg intravenous Q4W dosing with respect to clinical and magnetic resonance imaging (MRI) efficacy, pharmacokinetics/pharmacodynamics, immunogenicity and safety.

• In May 2020, through the 2020 American Academy of Neurology (AAN) Science Highlights virtual platform, an analysis of TYSABRI contributed to data demonstrating the reduced risk of progressive multifocal leukoencephalopathy (PML) through extended interval dosing (approximately every six weeks) as compared to the currently approved Q4W dosing.

• In September 2020, at MSVirtual2020, the eighth joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS), we presented new real-world MRI data suggesting that the effectiveness of extended interval dosing of TYSABRI is similar to the approved Q4W dosing.

VUMERITY (diroximel fumarate;

In May 2019, at the 71 st annual meeting of the AAN in Philadelphia, PA, we presented updated safety and exploratory efficacy results from the ongoing open-label EVOLVE-MS-1 study of VUMERITY in RMS.

In May 2019 we presented new interim data from the EVOLVE-MS-1 study at the annual meeting of the Consortium of Multiple Sclerosis Centers in Seattle, WA.

These data indicated that VUMERITY was generally well tolerated and significantly reduced disease activity in newly diagnosed RMS patients and those previously treated with interferons or glatiramer acetate.

Treatment discontinuations due to gastrointestinal events occurred at a low rate over one year.

In July 2019 we and Alkermes plc announced positive topline results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase 3 study of VUMERITY for RMS, compared to TECFIDERA.

VUMERITY was statistically superior to TECFIDERA on the study's pre-specified primary endpoint, with patients treated with VUMERITY self-reporting significantly fewer days of key gastrointestinal symptoms with intensity scores ≥ 2 on the Individual Gastrointestinal Symptom and Impact Scale, as compared to TECFIDERA (p=0.0003).

In September 2019, at the 35 th Congress of ECTRIMS and 24 th Annual Conference of Rehabilitation in MS in Stockholm, Sweden, we presented interim data from the Phase 3 EVOLVE-MS-1 study that support the potential of VUMERITY as a novel oral fumarate.

In November 2019, at the 27 th Annual Meeting of the European Charcot Foundation in Italy, we presented results from the Phase 3 EVOLVE-MS-2 study demonstrating the improved patient-assessed gastrointestinal tolerability of VUMERITY compared to TECFIDERA.

BIIB091 (BTK inhibitor)

In May 2019 the first participant was dosed in the Phase 1 study of BIIB091 in MS.

In December 2019 dosing began for the final multiple ascending dose cohort in the Phase 1 study of BIIB091 in MS.

• In May 2020, through the 2020 AAN Science Highlights virtual platform, we announced new data that support VUMERITY as an important oral treatment option in RMS.

• In September 2020, at MSVirtual2020, the eighth joint meeting of ACTRIMS-ECTRIMS, we presented new data further defining the effectiveness and safety profile of VUMERITY.

• In November 2020 we submitted a MAA for VUMERITY to the EMA.

PLEGRIDY (peginterferon beta-1a)

• In December 2020 the European Commission (EC) approved a new intramuscular (IM) injection route of administration for PLEGRIDY for the treatment of relapsing-remitting MS (RRMS).

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

Alzheimer's Disease and Dementia

Aducanumab (Aβ mAb)

In March 2019 we and our collaboration partner Eisai announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to AD and mild AD dementia.

In October 2019 we and our collaboration partner Eisai announced that we plan to pursue regulatory approval for aducanumab in the U.S.

and that the Phase 3 EMERGE study met its primary endpoint showing a significant reduction in clinical decline.

We believe that results from a subset of patients in the Phase 3 ENGAGE study who received sufficient exposure to high dose aducanumab support the findings from EMERGE.

The decision to file is based on a new analysis, conducted in consultation with the FDA, of a larger dataset from the Phase 3 EMERGE and ENGAGE trials that were discontinued in March 2019 following a futility analysis.

In December 2019, at the 12 th Clinical Trials on Alzheimer's Disease annual meeting in San Diego, CA, we presented topline results from the Phase 3 EMERGE and ENGAGE trials of aducanumab.

BAN2401 (Aβ mAb)

In May 2019 our collaboration partner Eisai dosed the first patient in the global Phase 3 study (Clarity AD) of BAN2401 in early AD.

BIIB092 (gosuranemab)

In September 2019 we completed enrollment of the Phase 2 study of gosuranemab for early AD.

• In March 2020 the first patient was dosed in the aducanumab re-dosing study, EMBARK, which is a global re-dosing clinical study designed to evaluate aducanumab in eligible Alzheimer’s disease patients who were actively enrolled in aducanumab studies (PRIME, EVOLVE, EMERGE and ENGAGE) in March 2019.

• In November 2020 we presented on the study design of the ongoing EMBARK re-dosing study of aducanumab at the 2020 Clinical Trials on Alzheimer's Disease digital conference.

BAN2401 (lecanemab)

• In September 2020 the first patient was dosed in the Phase 3 AHEAD 3-45 clinical study of BAN2401, an anti-amyloid beta antibody, in individuals with preclinical Alzheimer’s disease who have intermediate or elevated levels of amyloid in their brains.

We are collaborating with Eisai on the development of BAN2401.

Neuromuscular Disorders

SPINRAZA (nusinersen)

In February 2019 SPINRAZA was approved by the China National Medical Products Association for the treatment of 5q SMA.

In April 2019 we presented new data illustrating the rapidly progressive nature of SMA in adults, adolescents and older children.

We also presented data from the NURTURE study, highlighting the benefits of pre-symptomatic treatment and findings on the role of neurofilament as a potential biomarker for predicting motor function in SMA.

These data were presented at the Muscular Dystrophy Association Clinical and Scientific Conference in Orlando, FL.

In April 2019 data from CS2/CS12, an open-label study of the safety and tolerability of SPINRAZA in individuals with later-onset SMA, were published in the peer-reviewed journal Neurology , the medical journal of the AAN.

The data showed that individuals with later-onset SMA, treated with SPINRAZA, regained motor function that had been previously lost and that treatment stabilized their disease activity leading to improvements in activities of daily living.

In May 2019, at the 71 st annual meeting of the AAN in Philadelphia, PA, we presented data from the NURTURE study that demonstrated that pre-symptomatic infants with SMA treated with SPINRAZA over three years achieved motor milestones that are more consistent with normal childhood development, as well as interim results from the ENDEAR/CHERISH/SHINE open-label extension study that showed that treatment with SPINRAZA, particularly when initiated earlier, leads to progressive motor milestone improvements and increased survival rates for individuals with infantile-onset SMA.

In May 2019 The National Institute for Health and Care Excellence (NICE) in the U.K.

recommended funding for SPINRAZA on the National Health Service.

The positive recommendation is for the treatment of infants, children and adults with 5q SMA, including pre-symptomatic and symptomatic SMA Types 1, 2 and 3.

In June and July 2019 we presented new results from the NURTURE study, adding data to the longest study of SMA in pre-symptomatic infants (n=25).

The data reported, after up to 45.1 months of analysis, continued to demonstrate efficacy and safety in patients treated pre-symptomatically with SPINRAZA in comparison to the natural history of SMA.

These new data also showed that patients treated with SPINRAZA had continuous improvement, with the majority of patients achieving motor milestones within timeframes consistent with normal development.

These data were presented at the Cure SMA Annual SMA Conference in Anaheim, CA and the 5 th Congress of the European Academy of Neurology in Oslo, Norway.

In September 2019 we announced that we plan to initiate DEVOTE, a new Phase 2/3 study evaluating whether a higher dose of SPINRAZA can offer even greater efficacy in treating SMA, as well as the safety and tolerability of SPINRAZA, when administered at a higher dose.

In September 2019 we presented new data further demonstrating the safety and efficacy of treatment with SPINRAZA in individuals with later-onset SMA at the 13 th Congress of the European Paediatric Neurology Society in Athens, Greece.

An integrated analysis from SHINE, an open-label extension study for patients with SMA who participated in prior SPINRAZA studies, found that children with later-onset SMA (Type 2 or Type 3) experienced improvements or stabilization in one or more measures of motor function for up to nearly six years, in contrast to the expected decline observed in natural history cohorts.

In October 2019 the journal Neuromuscular Disorders published data from NURTURE, the first study investigating a treatment targeting the underlying cause of SMA in infants treated pre-symptomatically.

Data from the NURTURE study demonstrated that infants who initiated treatment with SPINRAZA prior to the onset of clinical symptoms attained unparalleled results compared to the natural history of the disease.

These published results from the NURTURE study were previously presented at the 2019 Cure SMA Annual

SMA Conference in Anaheim, CA and the 5 th Congress of the European Academy of Neurology in Oslo, Norway.

• In March 2020 the first patient was dosed in the global DEVOTE study, which is evaluating the safety, tolerability and potential for even greater efficacy of SPINRAZA when administered at a higher dose than currently approved for the treatment of SMA.

• In March 2020 a study on the efficacy and safety of SPINRAZA in teen and adult patients was published in Lancet Neurology , showing clinically meaningful improvements in motor function in a real-world cohort.

This study included 139 teens and adults with later-onset SMA (age 16-65 years) from 10 neuromuscular treatment centers in Germany.

Patients were followed for 6-14 months and experienced statistically significant increases in HFMSE (Hammersmith Functional Motor Scale Expanded) scores compared to baseline at 6 months, 10 months and 14 months.

Clinically meaningful improvements (≥3 points increase) in HFMSE scores were seen in 28% of patients at 6 months, 35% of patients at 10 months and 40% of patients at 14 months.

The most frequent adverse events were headache, back pain and nausea.

• In June 2020 we announced new results from NURTURE, the longest study of presymptomatic patients with SMA.

In infants genetically diagnosed with SMA, new data demonstrated that early and sustained treatment with SPINRAZA for up to 4.8 years enabled unprecedented survival.

Patients continued to maintain and make progressive gains in motor function compared to the natural course of the disease.

These results were presented at the virtual Cure SMA Research & Clinical Care Meeting.

• In May 2020, through the 2020 AAN Science Highlights virtual platform, we announced additional data from the SPINRAZA clinical development program that further demonstrated the sustained efficacy and longer-term safety of SPINRAZA in a broad range of patients with SMA.

The SHINE open-label extension study (NCT02594124) has enrolled 292 patients (infants through teenagers) from 5 previous SPINRAZA clinical studies, including ENDEAR.

New findings from the SHINE study show that treatment with SPINRAZA resulted in motor function improvement or disease stabilization in toddlers, children and young adults who were treated continuously, some for up to six and a half years.

BIIB067 (tofersen) - ALS

In March 2019 the first patient was dosed in the Phase 3 VALOR study of tofersen in adults with ALS with a confirmed superdioxide dismutate 1 (SOD1) mutation.

In May 2019 we presented interim results of the Phase 1/2 study of tofersen.

The data demonstrated a statistically significant reduction in SOD1 protein levels and a numerical trend towards slowing of clinical decline in SOD1-ALS patients treated with tofersen compared to placebo.

The data were presented at the 71 st annual meeting of the AAN in Philadelphia, PA and The European Network for the Cure of ALS meeting in Tours, France.

BIIB100 (XPO1 inhibitor) - ALS

In June 2019 the first patient was dosed in the Phase 1 study of BIIB100 in sporadic ALS.

• In July 2020 positive results from a Phase 1/2 study of tofersen for the potential treatment of superoxide dismutase 1 (SOD1) ALS were published in The New England Journal of Medicine .

Final Phase 1/2 study results demonstrated proof-of-concept and proof-of-biology of tofersen.

BIIB105 (ataxin-2 ASO) - ALS

• In September 2020 the first patient in a Phase 1 study of BIIB105, an antisense oligonucleotide (ASO) targeting ataxin-2 in ALS, was dosed.

Movement Disorders

BIIB054 (cinpanemab) - Parkinson's Disease

In May 2019 we completed enrollment of the Phase 2 study of BIIB054 for Parkinson's disease.

BIIB094 (ION859) - Parkinson's Disease

In August 2019 the first patient in the Phase 1 study of BIIB094, an ASO targeting leucine-rich repeat kinase 2 (LRRK2) for Parkinson's disease, was dosed.

Ophthalmology

BIIB111 (timrepigene emparvovec) - CHM

In November 2019 we completed enrollment of the Phase 3 STAR study of timrepigene emparvovec for CHM.

BIIB101 (ION464) - Multiple System Atrophy

• In July 2020 the first patient in the Phase 1 study of BIIB101, an ASO targeting alpha synuclein in multiple system atrophy, was dosed.

Emerging Growth Areas

Dapirolizumab Pegol (anti-CD40L) - SLE

In June 2019 our collaboration partner UCB presented interim results from the Phase 2b study of dapirolizumab pegol (DZP) in patients with active SLE despite standard-of-care treatment.

The primary endpoint of the study, which was to demonstrate a dose response at 24 weeks on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (p=0.07), was not met.

The study did demonstrate consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with DZP compared with placebo.

In addition, biomarker data demonstrated evidence of proof of biology.

DZP was well tolerated and demonstrated an acceptable safety profile.

The data were presented at the European Congress of Rheumatology (EULAR) 2019 in Madrid, Spain.

• In August 2020 the first patient was dosed in the Phase 3 program for dapirolizumab pegol in patients with active SLE despite being treated by standard of care therapies.

Dapirolizumab pegol is being developed in collaboration with UCB Pharma S.A.

BIIB059 (anti-BDCA2) - CLE/SLE

In May 2019 we completed enrollment of the Phase 2 LILAC study of BIIB059 for CLE and SLE.

In December 2019 we announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059 in CLE and SLE.

The CLE part of the study met its primary endpoint (p<0.001) by demonstrating a dose response of BIIB059 on the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 16 in individuals with CLE.

Study participants with CLE treated with 50 mg, 150 mg and 450 mg of BIIB059 experienced reductions in CLASI-A scores of 40.9% (p=0.008), 48.0% (p=0.001) and 42.5% (p=0.001), respectively, versus 14.5% with placebo.

CLASI-A is a well-defined and reliable outcome measure that has been shown to detect meaningful change in CLE skin disease activity.

The SLE part of the study also met its primary endpoint of reducing disease activity in individuals with SLE as measured by change from baseline in total active joint count at week 24 (treatment difference = -3.4 for BIIB059 450 mg versus placebo, p=0.037).

Total active joint count is the total number of tender or swollen

joints, with joint involvement being a common symptom in people with SLE.

In addition, improvements in skin disease and overall disease activity were consistently observed across multiple secondary endpoints.

Neurocognitive Disorders

BIIB104 (AMPA) - CIAS

In June 2019 the FDA granted BIIB104 fast track designation for CIAS.

Acute Neurology

BIIB093 (glibenclamide IV) - Brain Contusion

In October 2019 we dosed the first patient in the Phase 2 study of BIIB093 for brain contusion.

• In June 2020 we shared positive data from the 16-week CLE portion of the Phase 2 LILAC study.

The study evaluated the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells (pDCs).

The data were presented at the European E-Congress of Rheumatology (EULAR).

• In November 2020 we shared positive data from the 24-week SLE portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 was associated with a statistically significant reduction in total active joint count.

These data, along with the previously reported findings from the CLE portion of the LILAC study, were presented at the American College of Rheumatology’s virtual ACR Convergence 2020.

Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics

In June 2019 we presented real-world evidence confirming the safety and efficacy of BENEPALI, IMRALDI and FLIXABI and the high adherence of patients to treatment.

The data were presented at EULAR 2019 in Madrid, Spain.

In October 2019 we presented new data highlighting real-world evidence confirming the safety and efficacy of IMRALDI and FLIXABI for patients with inflammatory bowel disease.

These data were presented at the United European Gastroenterology Week 2019 in Barcelona, Spain.

Genentech Relationship

Anti-CD20 Therapies

GAZYVA (obinutuzumab)

In June 2019 Roche announced positive topline results for NOBILITY, a Phase 2 study investigating the safety and efficacy of GAZYVA for adults with proliferative lupus nephritis.

The study met its primary endpoint, showing GAZYVA, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

In addition, GAZYVA met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.

In September 2019 Roche announced that the FDA granted breakthrough therapy designation to GAZYVA for adults with lupus nephritis.

This designation was granted based on data from the Phase 2 NOBILITY study in adult patients with proliferative lupus nephritis, as discussed above.

• In May 2020 Samsung Bioepis announced that the primary endpoints were met in the randomized, double-masked, Phase 3 trial comparing the efficacy, safety and immunogenicity of SB11 to the reference product (LUCENTIS).

Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.

• In June 2020 Samsung Bioepis initiated a Phase 3 study for SB15, a proposed aflibercept biosimilar referencing EYLEA.

EYLEA is widely used to treat ophthalmologic conditions such as neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME) and diabetic retinopathy in patients with DME.

Discontinued Programs

In August 2019 we discontinued the Phase 2b study of BG00011 (STX-100) for the potential treatment of idiopathic pulmonary fibrosis (IPF) due to safety concerns.

In September 2019 we and our collaboration partner Eisai announced the decision to discontinue the global Phase 3 studies (MISSION AD1 and MISSION AD2) of the investigational oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code:

E2609) in patients with early AD.

In December 2019 we announced that the Phase 2 PASSPORT study investigating gosuranemab in individuals with progressive supranuclear palsy (PSP) did not meet its primary endpoint.

Based on these results, we discontinued development of gosuranemab in PSP and other primary tauopathies.

Safety results of the Phase 2 PASSPORT study were generally consistent with previous studies of gosuranemab.

We will continue our ongoing Phase 2 TANGO study of gosuranemab for mild cognitive impairment due to AD or mild AD, given differences in disease pathology.

• In March 2020 we announced that the Phase 2 OPUS study investigating natalizumab as an adjunctive therapy in adults with drug-resistant focal epilepsy did not meet its primary endpoint.

Safety data were in-line with the known safety profile of natalizumab.

Based on these results, we discontinued development of natalizumab in drug-resistant focal epilepsy.

• In October 2020 we announced that the Phase 2 AFFINITY study of opicinumab (anti-LINGO) in MS did not meet its primary or secondary endpoints.

Based on these results, we discontinued development of opicinumab.

• In February 2021 we announced that the Phase 2 SPARK study of BIIB054 (cinpanemab) in Parkinson's disease did not meet its primary or secondary endpoints.

Based on these results, we discontinued development of BIIB054.

Marketed Products

The following graph shows our revenues by product and revenues from anti-CD20 therapeutic programs for the years ended December 31, 2020, 2019 and 2018.

Interferon includes product revenues from AVONEX and PLEGRIDY.

For 2019, 2018 and 2017 other includes product revenues from FAMPYRA, FUMADERM, BENEPALI and FLIXABI.

For 2019 and 2018 other also includes product revenues from IMRALDI, which was launched in Europe in October 2018.

For 2019 other also includes product revenues from VUMERITY, which was available in the U.S.

(1) Fumarate includes TECFIDERA and VUMERITY.

VUMERITY became commercially available in the U.S.

in November 2019.

For 2018 and 2017 other also includes product revenues from ZINBRYTA, which was voluntary withdrawn from the market in March 2018.

For 2017 other also includes product revenues from ALPROLIX and ELOCTATE through January 31, 2017.

No product revenues for ALPROLIX and ELOCTATE were recognized subsequent to February 1, 2017, the effective date of the spin-off of our hemophilia business.

Anti-CD20 therapeutic programs include revenues from RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS.

Product sales for TECFIDERA, AVONEX and TYSABRI as well as our share of pre-tax profits in the U.S.

for RITUXAN each accounted for more than 10% of our total revenues for the years ended December 31, 2019 , 2018 and 2017 .

Product sales for SPINRAZA also accounted for more than 10% of our total revenues for the years ended December 31, 2019 and 2018 .

(2) Interferon includes AVONEX and PLEGRIDY.

(3) For 2020, 2019 and 2018 other includes FAMPYRA, FUMADERM, BENEPALI, IMRALDI and FLIXABI.

For 2020 and 2019 other also includes VUMERITY, which became commercially available in the U.S.

in November 2019.

For 2018 other also includes ZINBRYTA, which was voluntary withdrawn from the market in March 2018.

(4) 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 revenues for the years ended December 31, 2020, 2019 and 2018.

For additional financial information about our product and other revenues and geographic areas where we operate, please read Note 4, Revenues, and Note 24, Segment Information, to our consolidated financial statements included in this report and Item 6.

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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.

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 returns to a new baseline of functioning.

Our MS products and major markets are as follows:

Major Markets

The MS products we market and our major markets are as follows:

Product Indication Collaborator Major Markets

RMS in the U.S.

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RMS in the U.S.

Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc (Alkermes) U.S.

RMS None U.S.

RMS in the U.S.

RRMS in the E.U.

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Crohn's disease in the U.S.

RMS in the U.S.

Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc (Alkermes)

Walking ability for patients with MS

Acorda Therapeutics, Inc.

Walking ability for patients with MS Acorda Therapeutics, Inc.

(Acorda) France

Neuromuscular Disorders

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Our SMA product and major markets are as follows:

Major Markets

Product Indication Collaborator Major Markets

SMA Ionis Pharmaceuticals Inc.

For additional information on our collaboration arrangements with Ionis, please read Note 18, 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 known as originators.

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

Biosimilars are a group of biologic medicines that are 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:

BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE.

Additionally, we have exclusive rights to commercialize BENEPALI, IMRALDI and FLIXABI in China and two potential ophthalmology biosimilar products, SB11 referencing LUCENTIS and SB15 referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

We also have an option to acquire exclusive rights to commercialize BENEPALI, IMRALDI and FLIXABI in China.

Our current biosimilar products and major markets are as follows:

Major Markets

Product Indication Major Markets

Rheumatoid arthritis

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Plaque psoriasis

Paediatric plaque psoriasis

Paediatric plaque psoriasis France

Rheumatoid arthritis

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Ulcerative colitis

Paediatric Uveitis

Paediatric Uveitis France

Rheumatoid arthritis

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Psoriatic arthritis

Psoriasis France

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.

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

Major Markets

Product Indication Major Markets

Non-Hodgkin's lymphoma

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Two forms of ANCA-associated vasculitis

Pemphigus vulgaris

Pemphigus vulgaris U.S.

Non-Hodgkin's lymphoma

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Follicular lymphoma

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

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

For additional information on our collaboration arrangements with Genentech, please read Note 1, Summary of Significant Accounting Policies, and Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in this report.

Major Markets

Moderate to severe plaque psoriasis

Product Indication Collaborator Major Markets

Moderate to severe plaque psoriasis None

Patient Support and Access

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We also provide charitable contributions to 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.

We regularly review our pricing strategy and prioritize patient access to our therapies.

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 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.

Marketing and Distribution

Sales Force and Marketing

We promote our products worldwide, including in the U.S., most of the major countries of the E.U.

and Japan, primarily through our own sales forces and marketing groups.

We promote our marketed products worldwide, including in the U.S., Europe and Japan, primarily through our own sales forces and marketing groups.

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

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

We commercialize BENEPALI, IMRALDI and FLIXABI in collaboration with Samsung Bioepis in certain countries in Europe.

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

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

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We distribute our products in the U.S.

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

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.

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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 exclusive rights to distribute these products in China.

Our product sales to two wholesale distributors, AmerisourceBergen and McKesson, each accounted for more than 10% of our total revenues for the years ended December 31, 2019 , 2018 and 2017 , and on a combined basis, accounted for approximately 47%, 50% and 56% of our gross product revenues for the years ended December 31, 2019 , 2018 and 2017 , respectively.

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 revenues for the years ended December 31, 2020, 2019 and 2018, and on a combined basis, accounted for approximately 45.8%, 47.0% and 50.0% of our gross product revenues for the years ended December 31, 2020, 2019 and 2018, respectively.

For additional information, please read Note 4, Revenues , to our consolidated financial statements included in this report.

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and in selected countries outside the U.S.

for inventions originating from our research and development efforts.

for inventions originating from our research and development efforts and those we license or acquire.

In addition, we license rights to various patents and patent applications.

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Patent and Trademark Office (USPTO) delays in prosecuting the application.

14 years from the date of product approval) as compensation for patent term lost during the FDA regulatory review process.

Specifically, in the U.S., under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, a patent that covers a drug approved by the FDA may be eligible for patent term extension (for up to 5 years, but not beyond a total of 14 years from the date of product approval) as compensation for patent term lost during the FDA regulatory review process.

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

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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 regulatory authority to obtain approval of its product.

After the applicable set period of time, third parties are then permitted to rely upon such data to file for approval of their abbreviated applications for, and to market (subject to any applicable market protection), their generic drugs and biosimilars referencing such data.

Market protection provides to the holder of a drug or biologic marketing authorization the exclusive right to commercialize its product for a set period of time, thereby preventing the commercialization of another product containing the same active ingredient(s) during that period.

significant cost and submitted to the applicable 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.

Market protection provides the holder of a drug or biologic marketing authorization the exclusive right to commercialize its product for a period of time, thereby preventing the commercialization of another product containing the same active ingredient(s) during that period.

Although the World Trade Organization's agreement on trade-related aspects of intellectual property rights (TRIPS) requires signatory countries to provide regulatory exclusivity to innovative pharmaceutical products, implementation and enforcement varies widely from country to country.

We also rely upon other forms of unpatented confidential information to remain competitive.

We protect such information principally through

confidentiality agreements with our employees, consultants, outside scientific collaborators, scientists whose research we sponsor and other advisers.

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 shall be 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.

We protect such information principally through refraining from public disclosure and confidentiality agreements with our employees, consultants, outside scientific collaborators, scientists whose research we sponsor and other advisers.

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.

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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.

General Subject Matter

Product Territory Patent No.

General Subject Matter Patent

Expiration (1)

Methods of treatment

TECFIDERA U.S.

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

Formulations of dialkyl fumarates and their use for treating autoimmune diseases

Methods of use

AVONEX and PLEGRIDY

Use of recombinant beta interferon for immunomodulation

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

Europe 2137537 Methods of use 2028 (4)

PLEGRIDY U.S.

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

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8,017,733 Polymer conjugates of interferon beta-1a 2027

Polymer conjugates of interferon-beta-1a and uses thereof

Humanized recombinant antibodies;

nucleic acids and host cells;

processes for production;

therapeutic compositions;

methods of use

Europe 1656952 Polymer conjugates of interferon-beta-1a and uses thereof 2024 (5)

Europe 1476181 Polymer conjugates of interferon-beta-1a and uses thereof 2023 (6)

7,807,167 Methods of treatment 2023

9,493,567 Methods of treatment 2027

Humanized immunoglobulins;

nucleic acids;

pharmaceutical compositions;

Methods of use

Sustained-release aminopyridine compositions for increasing walking speed in patients with MS

Sustained-release aminopyridine compositions for treating MS

Europe 1485127 Methods of use 2023 (2)

Europe 2676967 Methods of use 2027

FAMPYRA Europe 1732548 Sustained-release aminopyridine compositions for increasing walking speed in patients with MS 2025 (7)

Europe 2377536 Sustained-release aminopyridine compositions for treating MS 2025 (8)

VUMERITY U.S.

8,669,281 Compounds and pharmaceutical compositions 2033

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10,080,733 Crystalline forms, pharmaceutical compositions and methods of treatment 2033

SPINRAZA U.S.

7,101,993 Oligonucleotides containing 2’-O-modified purines 2023

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10,436,802 Methods for Treating Spinal Muscular Atrophy 2035

Compositions and methods for modulation of SMN2 splicing

Europe 1910395 Compositions and methods for modulation of SMN2 splicing 2026 (9)

Europe 2548560 Compositions and methods for modulation of SMN2 splicing 2026 (10)

Europe 3305302 Compositions and methods for modulation of SMN2 splicing 2030

Europe 3308788 Compositions and methods for modulation of SMN2 splicing 2026

Europe 3449926 Compositions and methods for modulation of SMN2 splicing 2030

Footnotes follow on next page.

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expected until the dates set forth below:

Expected Expiration

For additional information, please read Note 20, Litigation , to our consolidated financial statements included in this report.

Product Territory Expected Expiration

TECFIDERA E.U.

PLEGRIDY U.S.

SPINRAZA U.S.

(2) For additional information as to the validity of this patent, please read Note 20, Litigation , to our consolidated financial statements included in this report.

(3) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2024.

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(6) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2028.

Reflects SPCs granted in most European countries and pediatric extension in some countries.

(7) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2026.

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Litigation, interferences, oppositions, inter partes reviews, administrative challenges or other similar types of proceedings are, have been and may in the future be necessary in some instances to determine the validity and scope of certain of our patents, regulatory exclusivities or other proprietary rights, and in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products.

We also face challenges to our patents, regulatory exclusivities or other proprietary rights covering our products by manufacturers of generics, biosimilars, prodrugs and products approved under abbreviated regulatory pathways.

We also face challenges to our patents, regulatory exclusivities or other proprietary rights covering our products by third-parties, such as manufacturers of generics, biosimilars, prodrugs and products approved under abbreviated regulatory pathways.

A discussion of certain risks and uncertainties that may affect our patent position, regulatory exclusivities or other proprietary rights is set forth in Item 1A.

Risk Factors included in this report, and a discussion of legal proceedings related to certain patents described above is set forth in Note 20, Litigation, to our consolidated financial statements included in this report.

Competition in the biopharmaceutical industry is intense and comes from many sources, including biotechnology and pharmaceutical companies.

Many of our competitors, certain of whom have substantially greater financial, marketing, research and development and other resources than we do, are working to develop or have commercialized products similar to or competitive with those we market or are developing and have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products.

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.

Risk Factors included in this report, and the discussion of legal proceedings related to certain patents described above is set forth in Note 20, Litigation, to our consolidated financial statements included in this report.

Competition in the biopharmaceutical industry 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.

Some of our competitors may have substantially greater financial, marketing, research and development and other resources than we do.

We believe that competition and leadership in the industry is based on managerial and technological excellence and innovation as well as establishing patent and other proprietary positions through research and development.

The achievement of a leadership position also depends largely upon our ability to maximize the approval, acceptance and use of products resulting from research and the availability of adequate financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing.

Another key aspect of remaining competitive within the industry is recruiting and retaining leading scientists and technicians.

We believe that we have been successful in attracting and retaining skilled and experienced scientific personnel.

Competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, convenience/delivery devices, reliability, availability and price.

The achievement of a leadership position also depends largely upon our ability to maximize the approval, acceptance and use of our product candidates and the availability of adequate financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing.

Another key aspect of remaining competitive in the industry is recruiting and retaining leading scientists and technicians to conduct our research activities and advance our development programs, including with the commercial expertise to effectively market our products.

Competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, patient convenience, delivery devices, reliability, availability, reimbursement and price.

In addition, early entry of a new pharmaceutical product into the market may have important advantages in gaining product acceptance and market share.

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The development of new or improved treatment options or standards of care or cures for the diseases our products treat reduces and could eliminate the use of our products or may limit the utility and application of ongoing clinical trials for our product candidates.

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

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.

In addition, when a generic version of one of our products is commercialized, it may, in some cases, be automatically substituted for our product and reduce our revenues in a short period of time.

Additional information about the competition that our marketed products face is set forth below.

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 revenues in a short period of time.

We believe our long-term competitive position depends upon our success in discovering and developing innovative, cost-effective products that serve unmet medical needs, along with our ability to manufacture products efficiently and to launch and market them effectively in a highly competitive environment.

Additional information about the competition that our marketed products face is set forth below and in Item 1A.

Risk Factors included in this report.

Multiple Sclerosis

TECFIDERA, AVONEX, PLEGRIDY, TYSABRI and VUMERITY each compete with one or more of the following products as well as generic and biosimilar versions of such products:

Competing Product

AUBAGIO (teriflunomide)

Sanofi Genzyme

BETASERON/BETAFERON (interferon-beta-1b)

(glatiramer acetate)

Teva Pharmaceuticals Industries Ltd.

(interferon-beta-1b)

GILENYA (fingolimod)

GLATOPA (glatiramer acetate)

Sandoz, a division of Novartis AG

LEMTRADA (alemtuzumab)

Sanofi Genzyme

MAVENCLAD (cladribine)

MAYZENT (siponimod)

OCREVUS (ocrelizumab)

(interferon-beta-1)

Competing Product Competitor

AUBAGIO (teriflunomide) Sanofi Genzyme

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

(glatiramer acetate) Teva Pharmaceuticals Industries Ltd.

(interferon-beta-1b) Novartis AG

GILENYA (fingolimod) Novartis AG

GLATOPA (glatiramer acetate) Sandoz, a division of Novartis AG

LEMTRADA (alemtuzumab) Sanofi Genzyme

MAVENCLAD (cladribine) EMD Serono

MAYZENT (siponimod) Novartis AG

OCREVUS (ocrelizumab) Genentech

(interferon-beta-1) EMD Serono

ZEPOSIA (ozanimod) BMS

BAFIERTAM (monomethyl fumarate) Banner Life Sciences

KESIMPTA (ofatumumab) Novartis AG

In addition, multiple TECFIDERA generic entrants are now in the U.S.

market and have deeply discounted prices compared to TECFIDERA.

The generic competition for TECFIDERA significantly reduced our TECFIDERA revenues during the year ended December 31, 2020, and is expected to have a

substantial negative impact on our TECFIDERA revenues for as long as there is generic competition.

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.

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in 2018 is OCREVUS, a treatment for RMS and PPMS that was developed by Genentech.

While we have a financial interest in OCREVUS, future sales of our MS products may be adversely affected if

OCREVUS continues to gain market share, or if other MS products that we or our competitors are developing are commercialized .

Future sales may also be negatively impacted by the introduction of generics, prodrugs of existing therapies, biosimilars of existing products or products approved under abbreviated regulatory pathways.

While we have a financial interest in OCREVUS, future sales of our MS products may be adversely affected if OCREVUS continues to gain market share, or if other MS products that we or our competitors are developing are commercialized .

Spinal Muscular Atrophy

We face competition from a new gene therapy product that was approved in the U.S.

in May 2019 for the treatment of SMA.

Additionally, we are aware of other products in development that, if successfully developed and approved, may compete with SPINRAZA in the SMA market, including potential oral products.

We face competition from a gene therapy product that was approved in the U.S.

and a new oral product that was approved in the U.S.

and has been accepted for review in the E.U.

We expect that we will experience competition from both products in additional jurisdictions in the future.

Additionally, we are aware of other products now in development that, if launched, may also compete with SPINRAZA.

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

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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 anti-CD20 molecules, including biosimilar products, in development that if successfully developed and approved, could compete with RITUXAN, RITUXAN HYCELA and GAZYVA in the oncology market.

The introduction of a biosimilar product can result in a significant reduction in net sales for the relevant product, as other manufacturers typically offer their versions at lower prices.

In November 2019 and January 2020 biosimilar products referencing

RITUXAN were launched in the U.S.

and this could adversely affect the pre-tax profits of our collaboration arrangements with Genentech, which could, in turn adversely 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 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 future years.

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Risk Factors included in this report.

Core Growth Areas

MS and Neuroimmunology

Opicinumab (anti-LINGO) - MS

BIIB061 (oral remyelination) - MS

BIIB091 (BTK inhibitor) - MS

Alzheimer's Disease and Dementia

Aducanumab (Aβ mAb) * - Alzheimer's

BAN2401 (Aβ mAb) * - Alzheimer's

BIIB092 (gosuranemab) - Alzheimer's

BIIB076 (anti-tau mAb) - Alzheimer's

BIIB080 (tau ASO) - Alzheimer's

Core Growth Areas MS and Neuroimmunology 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 U.S., E.U.

BAN2401 (lecanemab) * - Alzheimer's

BIIB092 (gosuranemab) - Alzheimer's Phase 2

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

BIIB080 (tau ASO) - Alzheimer's Phase 1

Neuromuscular Disorders,

including SMA and ALS

BIIB067 (tofersen) - ALS

including SMA and ALS BIIB067 (tofersen) - ALS Phase 3

BIIB078 (IONIS-C9 Rx ) # - ALS

BIIB110 (ActRIIA/B ligand trap) - SMA

BIIB100 (XP01 inhibitor) - ALS

Movement Disorders,

including Parkinson's Disease

BIIB054 (cinpanemab) - Parkinson's

BIIB105 (ataxin-2 ASO) # - ALS

BIIB100 (XP01 inhibitor) - ALS Phase 1

BIIB110 (ActRIIA/B ligand trap) - SMA Phase 1

Parkinson's Disease and

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

BIIB094 (ION859) # - Parkinson's

Ophthalmology

BIIB111 (timrepigene emparvovec) - CHM

BIIB112 (RPGR gene therapy) - XLRP

Emerging Growth Areas

Immunology / Other

Dapirolizumab pegol (anti-CD40L)* - SLE

BIIB059 (anti-BDCA2) - CLE/SLE

Neurocognitive Disorders

BIIB104 (AMPA) - CIAS

Acute Neurology

BIIB093 (glibenclamide IV) - LHI ^ Stroke

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

BIIB101 (ION464) # - Multiple System Atrophy

BIIB122 (DNL151) * - Parkinson's

Ophthalmology BIIB111 (timrepigene emparvovec) - CHM Phase 3

BIIB112 (RPGR gene therapy) - XLRP Phase 2/3

Neuropsychiatry BIIB125 (zuranolone)* - PPD Phase 3

BIIB125 (zuranolone)* - MDD Phase 3

BIIB104 (AMPA PAM) - CIAS Phase 2

Emerging Growth Areas Immunology Dapirolizumab pegol (anti-CD40L)* - SLE Phase 3

BIIB059 (anti-BDCA2) - CLE/SLE Phase 2

Acute Neurology BIIB093 (glibenclamide IV) - LHI ^ Stroke

TMS-007 # - Acute Ischemic Stroke

Natalizumab - Epilepsy

BIIB093 (glibenclamide IV) - Brain Contusion

BIIB074 (vixotrigine) - Trigeminal Neuralgia

BIIB074 (vixotrigine) - Small Fiber Neuropathy

BIIB095 (Nav 1.7) - Neuropathic Pain

SB11 (referencing LUCENTIS)

BIIB093 (glibenclamide IV) - Brain Contusion Phase 2

Neuropathic Pain BIIB074 (vixotrigine) - Trigeminal Neuralgia Phase 2

BIIB074 (vixotrigine) - Small Fiber Neuropathy Phase 2

BIIB095 (Nav 1.7) - Neuropathic Pain Phase 1

Biosimilars SB11 (referencing LUCENTIS) *

Filed in U.S.

SB15 (referencing EYLEA) *

* Collaboration program

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^ 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 18, Collaborative and Other Relationships, and Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in this report.

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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 available in the U.S.

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

in November 2019.

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

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

Bristol-Myers Squibb Company

We have an exclusive license agreement with Bristol-Myers Squibb Company (BMS) for the development and potential commercialization of BIIB092 (gosuranemab), a phase 2 investigational therapy with potential in AD.

Under this agreement, we received worldwide rights to gosuranemab and are responsible for the full development and potential commercialization of gosuranemab in AD.

We have an exclusive license agreement with Bristol-Myers Squibb Company (BMS) for the development and potential commercialization of BIIB092 (gosuranemab), a Phase 2 investigational therapy in Alzheimer's disease.

Under this agreement, we received worldwide rights to gosuranemab and are responsible for the full development and potential commercialization of gosuranemab in Alzheimer's disease.

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.

Eisai Co., Ltd.

We have a collaboration agreement with Eisai to jointly develop and commercialize BAN2401, an Eisai product candidate for the potential treatment of AD.

Eisai serves as the global operational and regulatory

lead for BAN2401 and all costs, including research, development, sales and marketing expenses, are shared equally between us and Eisai.

Upon marketing approval, we and Eisai will co-promote BAN2401 and share profits equally.

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

Eisai serves as the global operational and regulatory lead for BAN2401 and all costs, including research, development, sales and marketing expenses, are shared equally between us and Eisai.

If BAN2401 receives marketing approval, we and Eisai will co-promote BAN2401 and share profits equally.

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

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We have an exclusive, worldwide option and collaboration agreement with Ionis relating to the development and commercialization of antisense therapeutics for up to three gene targets.

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 ASO drug candidates for a broad range of neurological diseases, which we refer to as the 2018 Ionis Agreement.

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 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 or other therapeutics for the potential treatment of neurological diseases.

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 AD, including aducanumab (as amended, the Neurimmune Agreement).

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 aducanumab (as amended, the Neurimmune Agreement).

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

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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 Europe and, in the case of BENEPALI, Japan.

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.

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 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.

We also provide technical development and technology transfer services to Samsung Bioepis.

Skyhawk Therapeutics, Inc.

We have a collaboration and research and development services agreement with Skyhawk pursuant to which the companies are leveraging Skyhawk’s SkySTAR technology platform with the goal of discovering innovative small molecule treatments for patients with neurological diseases, including MS and SMA.

We are responsible for the development and potential commercialization of any therapies resulting from this collaboration.

TMS Co., Ltd.

We have an exclusive option agreement with TMS Co., Ltd.

(TMS) granting us the option to acquire TMS-007, a plasminogen activator with a novel mechanism of action associated with breaking down blood clots which is in Phase 2 development in Japan, and backup compounds for the treatment of stroke.

Our current and contemplated activities and the products, technologies and processes that result from

such activities are subject to substantial government regulation.

In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, SB11, a proposed ranibizumab biosimilar referencing LUCENTIS, and SB15, a proposed aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

We also acquired an option to extend our existing commercial agreement with Samsung Bioepis for BENEPALI, IMRALDI and FLIXABI in certain countries in Europe and obtained an option to acquire exclusive rights to commercialize these products in China.

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.

Sangamo Therapeutics, Inc.

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

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

a third neuromuscular disease target;

and up to nine additional neurological disease targets to be identified and selected within a five-year period.

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.

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

Regulation of Pharmaceuticals

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Failure to register a trial or disclose study results within the required time periods could result in penalties, including civil monetary penalties.

Clinical trial programs must establish efficacy, determine an appropriate dose and dosing regimen and define the conditions for safe use.

Clinical trial programs must establish efficacy, determine an

appropriate dose and dosing regimen and define the conditions for safe use.

This is a high-risk process that requires stepwise clinical studies in which the candidate product must successfully meet predetermined endpoints.

The results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a Biologics License Application (BLA) or a NDA.

The results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a BLA or a New Drug Application (NDA).

In response to a BLA or NDA, the FDA may grant marketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis for approval.

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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

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

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When approval is based on surrogate endpoints or clinical endpoints other than survival or morbidity, the sponsor will be required to provide the FDA with confirmatory data post-approval to verify and describe clinical benefit.

Under the FDA's accelerated approval regulations, if the FDA concludes that a drug that has been shown to be effective can be safely used only if distribution or use is restricted, it may require certain post-marketing restrictions to assure safe use.

Under the FDA's accelerated approval regulations, if the FDA concludes that a drug that has been shown to be effective can be safely used only if distribution or use is restricted, it may require

certain post-marketing restrictions to assure safe use.

In addition, for products approved under accelerated approval, sponsors may be required to submit all copies of their promotional materials, including advertisements, to the FDA at least 30 days prior to initial dissemination.

The FDA may withdraw approval if, for instance, post-marketing studies fail to verify clinical benefit, it becomes clear that restrictions on the distribution of the product are inadequate to ensure its safe use or if a sponsor fails to comply with the conditions of the accelerated approval.

• Fast Track :

The FDA may grant "fast track" status to products that treat a serious condition and have data demonstrating the potential to address an unmet medical need or a drug that has been designated as a qualified infectious disease product.

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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

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The FDA regulates all advertising and promotion activities and communications for products under its jurisdiction both before and after approval.

Pursuant to FDA guidance, a company can make safety and efficacy claims from data either in or consistent with the label.

Pursuant to FDA guidance, a company can make safety and efficacy claims either in or consistent with the product label.

However, physicians may prescribe legally available drugs for uses that are not described in the drug's labeling.

Such off-label prescribing is common across medical specialties, and often reflect a physician's belief that the off-label use is the best treatment for patients.

Such off-label prescribing is common across medical specialties, and often reflects a physician's belief that the off-label use is the best treatment for patients.

The FDA does not regulate the behavior of physicians in their choice of treatments, but FDA regulations do impose stringent restrictions on manufacturers' communications regarding off-label uses.

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

although these

are not expected to fully apply until May 2020 with respect to the MDR regulations and May 2022 with respect to the IVDR regulations.

although these are not expected to fully apply until May 2021 with respect to the MDR regulations and May 2022 with respect to the IVDR regulations.

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

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and is evaluated by the Committee for Medicinal Products for Human Use (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 European Commission (EC).

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

A marketing authorization application approved by the EC is valid in all member states of the E.U.

A MAA approved by the EC is valid in all member states of the E.U.

The centralized procedure is required for all biological products, orphan medicinal products and new treatments for neurodegenerative disorders, and it is available for certain other products, including those which constitute a significant therapeutic, scientific or technical innovation.

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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.

PRIME is intended to provide additional support to medicine developers throughout the

development process.

Regulatory review timelines in the E.U.

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The EMA’s Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring the safety of human medicines and makes recommendations on product safety issues.

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.

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.

In the U.S., E.U.

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

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.

Good Manufacturing Practices

Regulatory agencies regulate and inspect equipment, facilities and processes used in the manufacturing and testing of pharmaceutical and biologic products prior to approving a product.

If, after receiving approval from regulatory agencies, a company makes a material change in manufacturing equipment, location or process, additional regulatory review and approval may be required.

If, after receiving approval from regulatory agencies, a

company makes a material change in manufacturing equipment, location or process, additional regulatory review and approval may be required.

We also must adhere to current Good Manufacturing Practices (cGMP) and product-specific regulations enforced by regulatory agencies following product approval.

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The Patient Protection and Affordable Care Act (PPACA) amended the Public Health Service Act (PHSA) to authorize the FDA to approve biological products, referred to as biosimilars or follow-on biologics, that are shown to be "highly similar" to previously approved biological products based upon potentially abbreviated data packages.

The biosimilar must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product, and only minor differences in clinically inactive components are allowable in biosimilar products.

The biosimilar

must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product, and only minor differences in clinically inactive components are allowable in biosimilar products.

The approval pathway for biosimilars does, however, grant a biologics manufacturer a 12-year period of exclusivity from the date of approval of its biological product before biosimilar competition can be introduced.

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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 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.

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 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.

Orphan Drug Act has been enacted in other countries to encourage the research, development and marketing of medicines to treat, prevent or diagnose rare diseases.

In the E.U., medicinal products that receive and maintain an orphan designation are entitled to 10 years of market exclusivity following approval, protocol assistance and access to the centralized procedure for marketing authorization.

authorization.

SPINRAZA has been granted orphan drug designation in the U.S., E.U.

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Under the Medicaid Drug Rebate Program, we are required to pay a rebate for each unit of product reimbursed by the state Medicaid programs.

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 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).

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If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the governing statute provides for civil monetary penalties.

In November 2020 CMS issued an interim final rule that seeks to lower prescription drug costs by paying no more for certain Medicare Part B drugs than the lowest price paid for such drugs in certain other countries (the "most favored nation" rule).

One of the drugs subject to the rule is TYSABRI.

Under the rule, the lower payment rates for affected drugs would be phased in over a period of four years, beginning in 2021.

Although the rule is being challenged by industry associations on a number of grounds, if the challenges are unsuccessful, the rule could harm our business.

In addition, if the rule were expanded to include other drugs or to include Medicare Part D, such expansions could cause additional harm.

Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician).

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• Federal Agency Discounted Pricing :

Our products are subject to discounted pricing when purchased by federal agencies via the Federal

Supply Schedule (FSS).

Our products are subject to discounted pricing when

purchased by federal agencies via the Federal Supply Schedule (FSS).

FSS participation is required for our products to be covered and reimbursed by the Veterans Administration (VA), Department of Defense, Coast Guard and Public Health Service (PHS).

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Negotiating prices with governmental authorities can delay commercialization of our products.

Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing (i.e., referencing prices in other countries and using

those reference prices to set a price).

Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing

(i.e., referencing prices in other countries and using those reference prices to set a price).

Budgetary pressures in many countries are continuing to cause governments to consider or implement various cost-containment measures, such as price freezes, increased price cuts and rebates and expanded generic substitution and patient cost-sharing.

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The laws include federal “sunshine” provisions.

The sunshine provisions apply to pharmaceutical manufacturers with products reimbursed under certain government programs and require those manufacturers to disclose annually to the federal government (for re-disclosure to the public) certain payments made to physicians and certain other healthcare practitioners or to teaching hospitals.

State laws may also require

disclosure of pharmaceutical pricing information and marketing expenditures.

teaching hospitals.

State laws may also require disclosure of pharmaceutical pricing information and marketing expenditures.

Many of these laws and regulations contain ambiguous requirements.

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By local ordinance, we are required to, among other things, comply with the NIH Guidelines in relation to our facilities in Research Triangle Park (RTP), NC and are required to operate pursuant to certain permits.

Our present and future business has been and will continue to be subject to various other laws and

Our present and future business has been and will continue to be subject to various other laws and regulations.

Various laws, regulations and recommendations relating to data privacy and protection, safe working conditions, laboratory practices, the experimental use of animals and the purchase, storage, movement, import, export and use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work are or may be applicable to our activities.

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Manufacturing

We are committed to ensuring an uninterrupted supply of medicines to patients around the world.

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 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 drug development pipeline, we are expanding our large molecule production capacity by building a large-scale biologics manufacturing facility in Solothurn, Switzerland.

We expect this facility to be partially operational by the end of 2020.

We seek to ensure an uninterrupted supply of medicines to patients around the world.

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 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.

We expect this facility to be partially operational during the first half of 2021.

Manufacturing Facilities

Our drug substance manufacturing facility includes:

Drug Substance Manufactured

Facility Drug Substance Manufactured

RTP, NC AVONEX

* Other includes products manufactured for contract manufacturing partners.

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

In order to support our drug development pipeline, we are building a large-scale biologics manufacturing facility in Solothurn, Switzerland, which we expect to be partially operational by the end of 2020.

In order to support our future growth and drug development pipeline, we are building a large-scale biologics manufacturing facility in Solothurn, Switzerland, which we expect to be partially operational during the first half of 2021.

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.

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

Alkermes currently supplies VUMERITY to us pursuant to our supply agreement with Alkermes.

In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes pursuant to which we have the election,

following a transition period, to manufacture VUMERITY or have manufacturing transitioned to a third party.

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.

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.

Third-Party Suppliers and Manufacturers

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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.

Our Employees

Human Capital

As of December 31, 2020, we had approximately 9,100 employees worldwide.

Approximately 5,675 employees were employed in the U.S.

and approximately 3,425 employees were employed in foreign countries.

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, 2020, 28% of Biogen’s director-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.

do not permit us to collect ethnic or racial data on our employees.

Globally, 48%

of Biogen’s positions at director-level and above were held by women.

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 the African American, Black, Latinx and other minority communities in the disease areas we treat and expand sourcing with minority-owned businesses.

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.

We scored 100.0% on the 2020 Disability Equality Index, which measures our policies and practices related to disability inclusion, for the third consecutive year.

Additionally, for the seventh 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.

Philosophy on Pay Equity

We are committed to ensuring our employees receive equal pay for equal work.

We establish components and ranges of compensation based on market and benchmark data.

Within this context, we strive to pay all employees equitably within a reasonable range, taking into consideration factors such as role;

internal equity;

job location;

relevant experience;

and individual, business unit and company performance.

In addition, we are committed to providing flexible benefits designed to allow our diverse global workforce to have reward opportunities that meet their varied needs so that they are inspired to perform their best on behalf of patients and stockholders each day.

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 appropriate action to ensure fidelity between our stated philosophy and actions.

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

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 8,000 on-demand learning modules in English, French, German, Spanish, Japanese and Portuguese.

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

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:

• Activate, Reflect and Co-Create:

Preparing top talent for the rigors of executive roles.

• Women’s Leadership Program:

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

• Executive Leadership Retreat:

Immersing leaders in topics designed to help them shape culture and build resilience.

• The Partnership, Inc's BioDiversity Fellows Program:

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.

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

Our current ERNs include:

Brings together early-career professionals and their advocates.

• AccessAbility:

Supports employees with disabilities and employees who are caretakers of individuals with disabilities.

• Biogen Veterans Network:

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.

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

• Women’s Innovation Network:

Creates networking, mentoring and learning opportunities for women and allies worldwide.

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.

Employee surveys

We utilize an employee survey program to pulse employees through email and mobile apps as well as provide an opportunity for commentary and facilitate feedback to questions.

The survey is designed to empower managers and leaders with anonymous information on their practices related to building culture, performance and an engaged workforce, allowing them to create plans and measure efficacy for continuous improvement.

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.

Succession planning

Each year we conduct a talent review across our global enterprise that includes, among other important topics, a review of succession plans for many of our roles.

To help ensure the long-term continuity of our business, we actively manage the development of

talent to fill the roles that are most critical to the on-going 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.

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.

In 2020 we continued to make significant progress integrating Human Performance into our Environment, Health and Safety programs.

We believe that, when it comes to safety, workers are part of the solution.

We encourage employees to collaboratively engage in proactive problem solving through practices such as Open Reporting and Work Observation and Risk Conversations.

We also utilize “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.

Information about our Executive Officers (as of February 3, 2021)

Current Position

Year Joined Biogen

Michel Vounatsos

Chief Executive Officer

Executive Vice President, Chief Legal Officer and Secretary

Executive Vice President and Chief Financial Officer

Officer Current Position Age Year Joined Biogen

Michel Vounatsos Chief Executive Officer 59 2016

Alexander Executive Vice President, Chief Legal Officer and Secretary 64 2006

McDonnell Executive Vice President and Chief Financial Officer 57 2020

Alphonse Galdes, Ph.D.

2 unchanged sentences

Executive Vice President and Chief Human Resources Officer 53 2017

Chirfi Guindo

Executive Vice President, Global Product Strategy and Commercialization

Executive Vice President, Corporate Development

Vice President, Chief Accounting Officer

Chirfi Guindo Executive Vice President, Global Product Strategy and Commercialization 55 2017

Kramer Senior Vice President, Chief Accounting Officer 55 2018

Sandrock, Jr., M.D., Ph.D.

12 unchanged sentences

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, on the board of directors of N-Lorem Foundation and as a member of the MIT Presidential CEO Advisory Board.

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

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

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

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

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

10 unchanged sentences

Public Company Boards

Invacare Corporation, a medical and healthcare product company

Wellesley College, B.A.

Boston University School of Law, J.D.

Capello has served as our Executive Vice President and Chief Financial Officer since December 2017 and served as our Chief Accounting Officer from July 2018 to November 2018.

l Invacare Corporation, a medical and healthcare product company

l Wellesley College, B.A.

l Boston University School of Law, J.D.

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

Prior to joining Biogen, Mr.

Capello served as the Chief Financial Officer of Beacon Health Options, Inc., a behavioral health company, with responsibility for finance, human resources, information technology, real estate and procurement from October 2016 until November 2017.

From July 2015 until September 2016 Mr.

Capello was the founder and Chief Executive Officer of Monomoy Advisors, which focuses on helping companies drive shareholder value.

From July 2014 until June 2015 Mr.

Capello served as the Executive Vice President and Chief Financial Officer of Ortho-Clinical Diagnostics, an in-vitro diagnostics company that was acquired by the Carlyle Group from Johnson & Johnson, with responsibility for global finance and business development.

From March 2010 to December 2013 Mr.

Capello served as Chief Financial Officer and Executive Vice President of Boston Scientific Corporation (Boston Scientific), a medical device company, where he was responsible for the worldwide management of Boston Scientific’s finance, information systems, business development and corporate strategy functions.

Capello joined Boston Scientific in June 2008 and served as Senior Vice President and Chief Accounting Officer until March 2010.

From 2006 to 2008 he was the Senior Vice President and Chief Financial Officer with responsibilities for global finance and business development at PerkinElmer, Inc.

(PerkinElmer), a life sciences tool company.

Previously, he served as PerkinElmer’s Vice President of Finance, Corporate Controller, Treasurer and Chief Accounting Officer from 2001 to 2006.

Prior to his tenure at PerkinElmer, Mr.

Capello was a Partner at PricewaterhouseCoopers LLP, both in the U.S.

and in the Netherlands.

University of Vermont, B.S.

Business Administration

Harvard Business School, M.B.A.

McDonnell served as Executive Vice President and Chief Financial Officer of IQVIA Holdings Inc., a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry, from December 2015 until July 2020.

Prior to that, Mr.

McDonnell served as the Executive Vice President and Chief Financial Officer of Intelsat, a leading global provider of satellite services, from November 2008 to December 2015, as Executive Vice President and Chief Financial Officer of MCG Capital Corporation, a publicly-held commercial finance company, from September 2004 until October 2008 and as MCG Capital Corporation’s Chief Operating Officer from August 2006 until October 2008.

Before joining MCG Capital Corporation, Mr.

McDonnell served as Executive Vice President and Chief Financial Officer for EchoStar Communications Corporation (f/k/a DISH Network Corporation), a direct-to-home satellite television operator, from July 2004 until August 2004 and as its Senior Vice President and Chief Financial Officer from August 2000 to July 2004.

McDonnell spent 14 years at PricewaterhouseCoopers LLP, including 4 years as a partner.

McDonnell has a Bachelor of Science degree in accounting from Georgetown University and is a certified public accountant.

l Georgetown University, B.S.

Alphonse Galdes, Ph.D.

3 unchanged sentences

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

University of Malta, B.Sc.

l University of Malta, B.Sc.

Chemistry and Biology

University of Malta, M.Sc.

Oxford University, Ph.D.

l University of Malta, M.Sc.

l Oxford University, Ph.D.

Ginger Gregory, Ph.D.

6 unchanged sentences

Gregory held a variety of human resources generalist and specialist positions at BMS, a pharmaceutical company, and served as a consultant with Booz Allen & Hamilton, an information technology consulting company, in the area of organization change and effectiveness.

University of Massachusetts, B.A.

The George Washington University, Ph.D.

l University of Massachusetts, B.A.

l The George Washington University, Ph.D.

Chirfi Guindo

3 unchanged sentences

Prior to joining Biogen, Mr.

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

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.

2 unchanged sentences

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

Ecole Central de Paris (France), Engineering

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

l Ecole Central de Paris (France), Engineering

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

Finance/Economics

Karp has served as our Executive Vice President, Corporate Development since June 2018.

Prior to joining Biogen, Mr.

Karp held a number of positions of increasing responsibility at Pfizer, a biopharmaceutical company, including as Vice President, Worldwide Business Development and Head of Business Development for Worldwide Research and Development from May 2016 to June 2018, as Vice President, Worldwide Business Development and BD Lead for Pfizer Vaccines, Oncology and Consumer Healthcare from January 2014 to May 2016, as Senior Director, Worldwide Business Development from December 2010 to December 2013, as Director, Worldwide Business Development from January 2008 to December 2010, as Senior Manager, Worldwide Business Development from May 2007 to December 2007 and as Manager, U.S.

Business Development from July 2006 to April 2007.

Prior to that, Mr.

Karp held roles in healthcare and life sciences strategy consulting.

Duke University, B.S.

Wharton School of the University of Pennsylvania, M.B.A.

Kramer has served as our Vice President, Chief Accounting Officer since November 2018.

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

Prior to that, Ms.

Kramer served as our Vice President, Chief Accounting Officer from November 2018 to December 2020.

Prior to joining Biogen, Ms.

7 unchanged sentences

Kramer is a licensed certified public accountant (CPA) in Massachusetts.

She is a member of the Massachusetts Society of CPAs and the American Institute of CPAs and served as a Board Member for the Massachusetts State Board of Accountancy from September 2011 to December 2015.

Salem State University, B.B.A.

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 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.

Public Company Boards

l Armata Pharmaceuticals, Inc., a biotechnology company

l Salem State University, B.B.A.

Sandrock, Jr., M.D., Ph.D.

4 unchanged sentences

Sandrock held several other senior executive positions since joining Biogen in 1998, including Senior Vice President of Neurology Research and Development and Vice President of Clinical Development, Neurology.

Public Company Boards

Neurocrine Biosciences, Inc., a life sciences company

Stanford University, B.A.

l Stanford University, B.A.

Human Biology

Harvard Medical School, M.D.

Harvard University, Ph.D.

Massachusetts General Hospital, internship in Medicine, residency and chief residency in Neurology and clinical fellowship in Neuromuscular Disease and Clinical Neurophysiology (electromyography)

l Harvard Medical School, M.D.

l Harvard University, Ph.D.

l Massachusetts General Hospital, internship in Medicine, residency and chief residency in Neurology and clinical fellowship in Neuromuscular Disease and Clinical Neurophysiology (electromyography)

Available Information

1 unchanged sentence

Our website address is www.biogen.com.

We make available free of charge through the Investors section of our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the U.S.

Securities and Exchange Commission (SEC).

electronically filed with or furnished to the U.S.

Securities and Exchange Commission.

We include our website address in this report only as an inactive textual reference and do not intend it to be an active link to our website.

1 unchanged sentence

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