Biogen (BIIB) 10-K risk factor changes: FY2020 vs FY2019

Our revenues depend upon continued sales of our [removed: products,] [added: products] as well as the financial rights we have in our anti-CD20 therapeutic [removed: programs, and, unless we develop, acquire rights to and/or commercialize new products and technologies, we will be substantially dependent on sales from our products and our financial rights in our anti-CD20 therapeutic programs for many years.][added: programs.]

[removed: Additionally, a] [added: A] significant portion of our revenues are concentrated on sales of our products in increasingly competitive [removed: markets.][added: markets and in markets affected directly and indirectly by the COVID-19 pandemic.]

[removed: | • |] [added: -] safety or efficacy issues; [removed: |]

[removed: | • |] [added: -] our ability to maintain a positive reputation among patients, healthcare providers and others, which may be impacted by our pricing and reimbursement decisions; [removed: |][added: or]

[removed: | • |] [added: -] the introduction or greater acceptance of competing products, including [added: new originator therapies,] generics, [removed: biosimilars,] prodrugs and [added: biosimilars of existing] products [added: and products] approved under abbreviated regulatory pathways; [removed: |]

[removed: | • |] [added: -] limitations and additional pressures on product pricing or price increases, including those resulting from governmental or regulatory [removed: requirements,] [added: requirements;] increased [removed: competition] [added: competition, including from generic] or [added: biosimilar versions of our products; or] changes in, or implementation of, reimbursement policies and practices of payors and other third parties; [removed: or |]

[removed: | • |] [added: -] adverse legal, administrative, regulatory or legislative [removed: developments. |][added: developments;]

Our inability to obtain and maintain adequate coverage, or a reduction in pricing or reimbursement, could have an adverse effect on our business, reputation, revenues and results of [removed: operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery and commercialization of new products or could cause a decline or volatility in our stock price.][added: operations.]

Sales of our products depend, to a significant extent, on [removed: the availability and extent of] adequate coverage, pricing and reimbursement from [removed: government health administration authorities, private health insurers and other organizations.][added: third-party payors.]

[removed: | • |] [added: -] changes in, and implementation of, federal, state or foreign government regulations or private third-party payors’ reimbursement policies; [removed: |]

[removed: | • |] [added: -] pressure by employers on private health insurance plans to reduce costs; [removed: |]

[added: - consolidation and increasing assertiveness of payors seeking price discounts or rebates in connection with the placement of our] products on their formularies and, in some cases, the imposition of restrictions on access or coverage of particular drugs or pricing determined based on perceived value; and

[removed: | • |] [added: -] our value-based contracting program pursuant to which we aim to tie the pricing of our products to their clinical values by either aligning price to patient outcomes or adjusting price for patients who discontinue therapy for any reason, including efficacy or tolerability concerns. [removed: |]

Our ability to set the price for our products varies significantly from country to country [removed: and] [added: and,] as a [removed: result] [added: result,] so can the price of our products.

[removed: Thus, our] [added: Our] inability to obtain and maintain adequate prices in a particular country may not only limit the revenues from our products within that country but may also adversely affect our ability to secure acceptable prices in existing and potential new [removed: markets.][added: markets, which may limit market growth.]

[removed: In addition, competition] [added: Competition] from current and future competitors may negatively impact our ability to maintain pricing and our market share.

New products [removed: or treatments brought to market] [added: marketed] by our competitors could cause [removed: revenues for] our [removed: products] [added: revenues] to decrease due to potential price reductions and lower sales volumes.

[removed: Such measures include] [added: Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including] more limited benefit plan designs, higher patient co-pay or co-insurance obligations and limitations on patients' use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs).

[removed: Significant consolidation in the health insurance industry] has resulted in a few large insurers and pharmacy benefit managers exerting greater pressure in pricing and usage negotiations with drug manufacturers, significantly increasing discounts and rebates required of manufacturers and limiting patient access and usage.

[removed: Ultimately, additional] [added: Additional] discounts, rebates, coverage or plan changes, restrictions or exclusions as described above could have a material adverse effect on sales of our affected products.

Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenues and results of [removed: operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery and commercialization of new products or could cause a decline or volatility in our stock price.][added: operations.]

Our [removed: success depends] [added: success, including our long-term viability and growth, depends,] in [removed: part] [added: part,] on our ability to obtain and defend patent and other intellectual property [removed: rights] [added: rights, including certain regulatory forms of exclusivity,] that are important to the commercialization of our products and product candidates.

[removed: The degree of patent] [added: Patent] protection [removed: afforded to our products and processes] [added: and/or regulatory exclusivity] in the U.S. and [removed: in] other important markets remains uncertain and depends, in part, upon decisions of the patent offices, courts, administrative bodies and lawmakers in these countries.

We may fail to [removed: successfully] obtain or preserve patent [removed: protection for the technologies incorporated into our products] and [removed: processes,] [added: other intellectual property rights, including certain regulatory forms of exclusivity,] or the protection we obtain may not be of sufficient breadth and degree to protect our commercial interests in all countries where we conduct [removed: business.][added: business, which could result in financial, business or reputational harm to us or could cause a decline or volatility in our stock price.]

[removed: The] [added: In many markets, including the U.S.,] manufacturers [removed: are] [added: may be] allowed to rely on the safety and efficacy data of the innovator's [removed: product, may] [added: product and do] not need to conduct clinical [removed: trials, can market] [added: trials before marketing] a competing version of a product after [removed: the expiration or loss of] [added: there is no longer] patent [removed: exclusivity] or [removed: the expiration or loss of] regulatory [removed: exclusivity and often charge significantly lower prices.][added: exclusivity.]

[removed: Litigation, interferences, oppositions, *inter partes* reviews,] [added: Legal proceedings,] administrative challenges or other [removed: similar] types of proceedings [removed: are, have been] [added: are] and may in the future be necessary [removed: in some instances] to determine the [removed: 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.

[removed: We also face challenges to our patent and regulatory protections covering our products by third parties, including] [added: In addition,] manufacturers of generics and biosimilars [removed: that] may choose to launch or attempt to launch their products before the expiration of our patent or [removed: regulatory exclusivity.][added: other intellectual property protections.]

[removed: Settlements] [added: In addition, settlements] of [removed: Hatch-Waxman litigation typically] [added: such proceedings often] result in reducing the period of patent [removed: protection, accelerating] [added: and other protections, resulting in a] reduction in revenue from affected products.

[removed: Adverse] [added: Negative] outcomes [removed: in intellectual property litigation also] [added: of such proceedings] could hinder [removed: our ability to manufacture] [added: or prevent us from manufacturing] and [removed: market] [added: marketing] our products, [added: could] require us to seek a license for the infringed product or technology or result in the assessment of significant monetary damages against us that may exceed amounts, if any, accrued in our financial statements.

[removed: An adverse determination in a judicial or administrative proceeding or a] [added: A] failure to obtain necessary licenses [added: for an infringed product or technology] could prevent us from manufacturing or selling our products.

Furthermore, payments under any licenses that we are able to obtain would reduce our profits [removed: derived] from the covered products and services.

Our long-term success depends upon the successful development of new products and additional indications for [added: our] existing products.

Our long-term [removed: viability and growth] [added: success] will depend upon the successful development of [removed: additional indications for our existing products as well as the successful development of] new products and technologies from our research and development [removed: activities, our biosimilars joint venture with Samsung BioLogics] [added: activities] or [added: our] licenses or acquisitions from third [removed: parties.][added: parties, including our commercialization agreements with Samsung Bioepis, as well as additional indications for our existing products.]

Product development is very expensive and involves a high degree of uncertainty and [removed: risk.][added: risk and may not be successful.]

[removed: Furthermore, the] [added: The] development of novel approaches for the treatment of diseases, including development efforts in new modalities such as those based on the ASO platform and gene therapy, may present additional challenges and risks, including obtaining [removed: regulatory] approval from [removed: the FDA and other] regulatory [removed: agencies] [added: authorities] that have limited experience with the development of such therapies.

In addition, clinical trial data are subject to differing interpretations [removed: and,] [added: and] even if we view data as sufficient to support the safety, effectiveness and/or approval of an investigational therapy, regulatory authorities may disagree and may require additional data, [removed: may] limit the scope of the approval or [removed: may] deny approval altogether.

[removed: Consequently, it may be] [added: It is] difficult to predict the [added: success and the] time and cost of product development of novel approaches for the treatment of diseases.

[removed: In addition, success] [added: Success] in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful.

Even if we could successfully develop new products or indications, we may make a strategic decision to discontinue development of a product candidate or indication if, for example, we believe commercialization will be difficult relative to the standard of care or [added: we prefer to pursue] other opportunities in our pipeline.

We compete with biotechnology and pharmaceutical companies that have a greater number of products on the market and in the product pipeline, substantially greater financial, [removed: marketing and] [added: marketing,] research and development and other resources and other technological or competitive advantages.

Risks Related to Our Business

- the inability or reluctance of patients to receive a diagnosis, prescription or administration of our products or a decision to prescribe and administer competitive therapies as a direct or indirect result of the COVID-19 pandemic.

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For instance, demand and price for TECFIDERA declined significantly as a result of multiple TECFIDERA generic entrants entering the U.S. market during the year ended December 31, 2020.

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Additionally, the introduction of generic or biosimilar versions of our products, follow-on products, prodrugs or products approved under abbreviated regulatory pathways may significantly reduce the price that we are able to charge for our products and the volume of products we sell.

Significant consolidation in the health insurance industry

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and the expansion of the number of hospitals eligible for discounts under Section 340B of the PHSA.

There is increasing public attention on the costs of prescription drugs and there have been, are expected to continue to be, legislative proposals to address prescription drug pricing.

Some of these proposals could have significant effects on our business, including an executive order issued in September 2020 to test a “most favored nation” model for Part B and Part D drugs that tie reimbursement rates to international drug pricing metrics.

If Samsung Bioepis or other third parties fail to perform successfully, we may not realize the anticipated benefits of our investment in Samsung Bioepis;

- *Ability to Provide Adequate Supply.* Manufacturing biosimilars is complex.

If we encounter any manufacturing or supply chain difficulties we may be unable to meet higher than anticipated demand.

We are dependent on a third-party for the manufacture of biosimilar products and such third-party may not perform its obligations in a timely and cost-effective manner or in compliance with applicable regulations and may be

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unable or unwilling to increase production capacity commensurate with demand for our existing or future biosimilar products;

- *Competitive Challenges.* Biosimilar products face significant competition, including from innovator products and biosimilar products offered by other companies.

Local tendering processes may restrict biosimilar products from being marketed and sold in some jurisdictions.

The former chief executive officer (the incumbent chairman of the board) and the chief financial officer of our joint venture partner, Samsung BioLogics, are currently subject to ongoing criminal proceedings that may impact its operations and business or divert the attention of the Samsung Bioepis management team from its ongoing operations.

Risks Related to Development, Clinical Testing and Regulation of Our Products and Product Candidates

Discovery of safety issues with our products could create product liability and could cause additional regulatory scrutiny and

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Any of these could result in adverse impacts on our results of operations.

Risks Related to Intellectual Property

In such cases, manufacturers often charge significantly lower prices and a major portion of the company's revenues may be reduced in a short period of time.

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Furthermore, our products may be determined to infringe patents or other intellectual property rights held by third parties.

Such proceedings are unpredictable and are often protracted and expensive.

Risks Related to Our Operations

The ongoing COVID-19 pandemic may, directly or indirectly, adversely affect our business, results of operations and financial condition.

Our business could be materially adversely affected, directly or indirectly, by the ongoing COVID-19 pandemic.

National, state and local governments in affected regions have implemented and may continue to implement safety precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter in place orders and shutdowns, business closures and other measures.

These measures may disrupt normal business operations both in and outside of affected areas and may have significant negative impacts on businesses and financial markets worldwide.

We continue to monitor our operations and applicable government recommendations, and we have made modifications to our normal operations because of the COVID-19 pandemic, including limiting travel and working from home.

We have also suspended the vast majority of our in-person interactions by our customer-facing professionals in healthcare settings.

This limits our ability to market our products and educate physicians, which, in turn, could have an adverse effect on our ability to compete in the marketing and sales of our products.

Prolonged remote working arrangements could impact employees’ productivity and morale, strain our technology resources and introduce operational risks.

Operating requirements may continually change due to the COVID-19 pandemic and we may experience unpredictability in our expenses, employee productivity and employee work culture.

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SPINRAZA has been approved by, among others, the FDA, the EC and the Japanese Ministry of Health, Labor and Welfare, and is in the early stages of commercial launch in certain markets.

In addition to risks associated with new product launches and the other factors described in these *Risk Factors*, our ability to successfully commercialize SPINRAZA may be adversely affected due to:

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| • | the introduction of a new gene therapy product that was approved in the U.S. in May 2019 for the treatment of SMA, and other products in development that, if successfully developed and approved, may compete with SPINRAZA in the SMA market, including potential oral products; |

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| • | our limited marketing experience within certain SMA markets, which may impact our ability to develop additional relationships with the associated medical and scientific community; and |

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| • | the lack of readiness of healthcare providers within certain SMA markets to treat patients with SMA. |

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| • | consolidation and increasing assertiveness of payors, including managed care organizations, health insurers, pharmacy benefit managers, government health administration authorities, private health insurers and other organizations, seeking price discounts or rebates in connection with the placement of our |

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Payors, including managed care organizations, health insurers, pharmacy benefit managers, government health administration authorities, private health insurers and other organizations, increasingly seek ways to reduce their costs.

Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients.

Payors also increasingly seek price discounts or rebates in connection with the placement of our products on their formularies or those they manage and control costs by imposing restrictions on access to or usage of our products, such as by requiring prior authorization or step therapy.

Under the Hatch-Waxman Act, a manufacturer may file an Abbreviated New Drug Application, seeking approval of a generic copy of an approved innovator product, or a NDA under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, which may be for a new or improved version of the original innovator product.

Upon the expiration or loss of patent protection or the expiration or loss of regulatory exclusivity for a product, a major portion of revenues for that product may be reduced in a short period of time.

When others exploit our inventions, the expected benefit from them are reduced.

Furthermore, our products may be determined to

infringe patents or other intellectual property rights held by third parties, which could result in financial, legal, business or reputational harm to us.

We also rely on regulatory exclusivity for protection of our products.

Implementation and enforcement of regulatory exclusivity, which may consist of regulatory data protection and market protection, varies widely from country to country.

For our discussion of the year ended December 31, [removed: 2018,] [added: 2019,] compared to the year ended December 31, [removed: 2017,] [added: 2018,] please read [removed: Item 7.][added: *Item 7.* *Management's Discussion and Analysis of Financial Condition and Results of Operations* located in our Annual Report on Form 10-K for the year ended December 31, 2019.]

Our core growth areas include MS and neuroimmunology; [removed: AD] [added: Alzheimer's disease] and dementia; neuromuscular disorders, including SMA and ALS; movement disorders, including Parkinson's disease; [added: ophthalmology;] and [removed: ophthalmology.][added: neuropsychiatry.]

We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging growth areas of immunology; [removed: neurocognitive disorders;] acute neurology; and [added: neuropathic] pain.

Our marketed products include TECFIDERA, [added: VUMERITY,] AVONEX, PLEGRIDY, [removed: TYSABRI, VUMERITY] [added: TYSABRI] and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; and FUMADERM for the treatment of severe plaque psoriasis.

We [removed: also] have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; and other potential anti-CD20 therapies pursuant to our collaboration arrangements with Genentech.

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

Our innovative drug development and commercialization activities are complemented by our biosimilar [removed: products] [added: business] that [removed: expand] [added: expands] access to medicines [added: and reduces the cost burden for healthcare systems.]

Through [added: our agreements with] Samsung Bioepis, our joint venture with Samsung [removed: BioLogics Co., Ltd.,] [added: 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 [added: an option to acquire] exclusive rights to commercialize these products in China.

Additionally, we have exclusive rights to commercialize two potential ophthalmology biosimilar products, [removed: SB11] [added: SB11, a proposed ranibizumab biosimilar] referencing [removed: LUCENTIS] [added: LUCENTIS,] and [removed: SB15] [added: 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 [removed: Note] [added: *Note] 18, [removed: *Collaborative] [added: Collaborative] and Other Relationships*, to our consolidated financial statements included in this report.

Our revenues depend upon continued sales of our [removed: products,] [added: products] as well as the financial rights we have in our anti-CD20 therapeutic programs, and, unless we develop, acquire rights to and/or commercialize new products and technologies, we will be substantially dependent on sales from our products and our financial rights in our anti-CD20 therapeutic programs for many years.

For additional information on our competition and pricing risks that could negatively impact our product sales, please read [removed: Item] [added: *Item] 1A.

[removed: *Risk] [added: Risk] Factors* and [removed: Item] [added: *Item] 7A.

[removed: *Quantitative] [added: Quantitative] and Qualitative Disclosures About Market Risk* included in this report.

We do [removed: not, however,] [added: not] expect Brexit to have a material impact on our consolidated results of operations as [removed: approximately 3.5%, 3.3% and 3.2%] [added: less than 4.0%] of our total product revenues in [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017, respectively,] [added: 2018] were derived from U.K. sales.

[removed: We have implemented measures to meet E.U. legal and regulatory requirements and to continue to modify our business operations to prepare for the finalization of the terms of the U.K.'s separation from the E.U.] However, we cannot predict the direction Brexit-related developments will take nor the impact of those developments on our European operations and the economies of the markets where we operate.

Therefore, we will continue to monitor for developments in this area and assess any potential [removed: impact] [added: impacts] on our business and results of operations.

[removed: ][added: Research and Development]

Diluted earnings per share attributable to Biogen Inc. were [removed: $31.42] [added: $24.80] for [removed: 2019,] [added: 2020,] representing [removed: an increase] [added: a decrease] of [removed: 45.6% over $21.58] [added: 21.1% as compared to $31.42] in the same period in [removed: 2018.][added: 2019.]

As described below under *Results of Operations*, our net income and diluted earnings per share attributable to Biogen Inc. for the year ended December 31, [removed: 2019,] [added: 2020,] compared to the year ended December 31, [removed: 2018,] [added: 2019,] reflects the following:

[removed: | • |] [added: -] Total revenues were [removed: $14,377.9] [added: $13,444.6] million for [removed: 2019,] [added: 2020,] representing [removed: an increase] [added: a decrease] of [removed: 6.9% over $13,452.9] [added: 6.5% as compared to $14,377.9] million in [removed: 2018. |][added: 2019.]

[removed: | • | Revenues] [added: For 2020 compared to 2019, the increase in other revenues] from anti-CD20 therapeutic programs [removed: totaled $2,290.4 million for 2019, representing an increase of 15.7% over $1,980.2 million in 2018. This increase] was primarily due to [removed: an increase in royalty revenues on] sales [added: growth] of OCREVUS. [removed: |]

This [removed: decrease] [added: increase] was partially offset by:

[removed: | • |] [added: -] We generated [removed: $7,078.6] [added: $4,229.8] million of net cash flows from operations for [removed: 2019, which were primarily driven by earnings. |][added: 2020.]

[removed: | • |] [added: -] Cash, cash equivalents and marketable securities totaled approximately [removed: $5,884.0] [added: $3,382.2] million as of December 31, [removed: 2019. |][added: 2020.]

[removed: | • |] [added: -] We repurchased and retired approximately [removed: 23.6] [added: 22.4] million shares of our common stock at a cost of approximately [removed: $5.8] [added: $6.7] billion during [removed: 2019] [added: 2020] under our [removed: March] [added: 2020, December] 2019 [removed: Share Repurchase Program] and [removed: our 2018] [added: March 2019] Share Repurchase [removed: Program. |][added: Programs.]

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

[removed: *Skyhawk] [added: *Sangamo] Therapeutics, Inc.*

[removed: *Divestiture] [added: (Gain) Loss on Divestiture] of Hillerød, Denmark Manufacturing [removed: Operations*][added: Operations]

In [removed: August] [added: March] 2019 we [removed: completed the sale of] [added: entered into a share purchase agreement with FUJIFILM to sell] all of the outstanding shares of our subsidiary that owned our biologics manufacturing operations in Hillerød, [removed: Denmark to FUJIFILM.][added: Denmark.]

[removed: In addition, we sold to FUJIFILM $41.8] [added: - $923.7] million [added: in proceeds received on the divestiture] of [added: our Hillerød, Denmark manufacturing operations, including the sale of] raw materials that were remaining at the Hillerød facility on the closing date of this [removed: transaction.][added: transaction;]

In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology [added: biosimilars, SB11, a proposed ranibizumab] biosimilar [removed: products, SB11] referencing [removed: LUCENTIS] [added: LUCENTIS,] and [removed: SB15] [added: 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 [removed: Europe and obtained exclusive rights to commercialize these products] [added: certain countries] in [removed: China.]

In [removed: January] [added: March] 2020 we [removed: entered into an agreement to acquire PF-05251749,] [added: acquired BIIB118,] a novel CNS-penetrant small molecule inhibitor of [removed: CK1,] [added: casein kinase 1,] for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer.

[removed: In particular, we plan to develop the Phase 1 asset] [added: We are developing BIIB118] for the [added: potential] treatment of [removed: sundowning in AD and] ISWRD in Parkinson’s [removed: disease.][added: disease and plan to develop]

In October 2019 the FDA approved VUMERITY for the treatment of [removed: RMS.][added: RMS and VUMERITY became commercially available in the U.S. in November 2019.]

[removed: Under the terms of the license and collaboration agreement with Alkermes, we made milestone payments totaling] [added: -] $155.0 million [added: in payments made] to Alkermes following the FDA's approval of VUMERITY.

[removed: In November 2019] VUMERITY became [added: commercially] available in the U.S. [added: in November 2019.]

[removed: *Aducanumab*][added: *Aducanumab (AB mAb)*]

In [removed: March 2019] [added: October 2020] our Board of Directors authorized our [removed: March 2019] [added: 2020] Share Repurchase Program, which is a program to repurchase up to $5.0 billion of our common stock.

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

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

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, which we expect to be partially operational during the first half of 2021.

We believe that the Solothurn manufacturing facility will provide us with the ability to further expand if our future growth and drug development plans increase.

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For a detailed discussion on our business environment, please read *Item 1.

Business* included in this report.

In June 2020 and September 2020 judgments were entered in favor of the defendants in the patent infringement proceedings relating to TECFIDERA Orange-Book listed patents pursuant to the Hatch-Waxman Act in West Virginia and Delaware.

We have appealed the judgments in both actions.

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.

For additional information, please read the discussion under *Results of Operations - Product Revenues - Multiple Sclerosis (MS) - Fumarate* below.

*Business Update Regarding COVID-19*

The COVID-19 pandemic continues to present a substantial public health and economic challenge around the world.

The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets.

We are monitoring the demand for our products, including the duration and degree to which we may see delays in starting new patients on a product due to hospitals diverting the resources that are necessary to administer certain of our products to care for COVID-19 patients, including products, such as TYSABRI and SPINRAZA, that are administered in a physician's office or hospital setting.

We may also see reduced demand for immunosuppressant therapies during the COVID-19 pandemic.

While we are currently continuing the clinical trials we have underway in sites across the globe,

COVID-19 precautions have impacted the timeline for some of our clinical trials and these precautions may, directly or indirectly, have a further impact on timing in the future.

For example, our Phase 3 study of BIIB093 for LHI, a severe form of ischemic stroke, has been delayed as this study involves administration of BIIB093 in an acute hospital setting.

To help mitigate the impact of the COVID-19 pandemic to our clinical trials, we are pursuing innovative approaches such as remote monitoring, remote patient visits and supporting home infusions.

These alternative measures have resulted in an immaterial increase to the cost of the clinical trials underway.

For additional information on the various risks posed by the COVID-19 pandemic, please read *Item 7A.

Quantitative and Qualitative Disclosures About Market Risk* and *Item 1A.* *Risk Factors* included in this report.

Effective January 31, 2020, the U.K. ceased to be a member state of the E.U., a process known as Brexit, and began a transition period, which expired on December 31, 2020.

In December 2020 the U.K. and the E.U. agreed on a trade and cooperation agreement, under which the E.U. and the U.K. will now form two separate markets governed by two distinct regulatory and legal regimes.

The trade and cooperation agreement covers the general objectives and framework of the relationship between the U.K. and the E.U., including as it relates to trade, transport and visas.

Notably, under the trade and cooperation agreement, U.K. service suppliers no longer benefit from automatic access to the entire E.U. single market, U.K. goods no longer benefit from the free movement of goods and there is no longer the free movement of people between the U.K. and the E.U. Depending on the application of the terms of the trade and cooperation agreement, we could face new regulatory costs and challenges.

Brexit could lead to legal uncertainty and potentially divergent national laws and regulations as the U.K. determines which E.U. laws to replace or replicate, including U.K. competition laws.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

*Revenues*

- Product revenues, net totaled $10,692.2 million for 2020, representing a decrease of 6.0% as compared to $11,379.8 million in 2019.

This decrease was primarily due to a $697.2 million, or 8.2%, decrease in MS product revenues and a $44.9 million, or 2.1%, decrease in revenues from SPINRAZA, partially offset by a $57.5 million, or 7.8%, increase in revenues from our biosimilar business.

Product revenues, net, compared to the same period in 2019, further reflects the unfavorable impact of foreign currency exchange of $111.6 million.

◦The decrease in MS product revenues was primarily due to a decrease in TECFIDERA demand and price as a result of multiple TECFIDERA generic entrants entering the U.S. market during the year ended December 31, 2020.

- Revenues from anti-CD20 therapeutic programs totaled $1,977.8 million for 2020, representing a decrease of 13.6% as compared to $2,290.4 million in 2019.

This decrease was primarily due to a $490.7 million, or 31.7%, decrease in RITUXAN revenues, partially offset by a $157.9 million, or 23.0%, increase in royalty revenues on sales of OCREVUS.

Sales of RITUXAN have been adversely affected primarily by the onset of biosimilars competition in the U.S.

*•*Other revenues totaled $774.6 million for 2020, representing an increase of 9.5% over $707.7 million in 2019.

This increase was due to higher contract manufacturing revenues, primarily resulting from $346.2 million in revenues related to the delivery of the license for certain of our manufacturing-related intellectual property to a contract manufacturing customer.

*Management's Discussion and Analysis of Financial Condition and Results of Operations* located in our 2018 Form 10-K.

and reduce the cost burden for healthcare systems.

The biopharmaceutical industry and the markets in which we operate are intensely competitive.

Many of our competitors are working to develop or have commercialized products similar to 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.

Our products continue to face increasing competitive pressures from the introduction of generic versions, prodrugs and biosimilars of existing products as well as 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.

Sales of our products depend, to a significant extent, on the availability and extent of adequate coverage, pricing and reimbursement from government health administration authorities, private health insurers and other organizations.

When a new pharmaceutical product is approved, the availability of government and private reimbursement for that product may be uncertain, as is the pricing and amount for which that product will be reimbursed.

Drug prices are under significant scrutiny in the markets in which our products are prescribed.

We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis.

Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenues and results of operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery and commercialization of new products or could cause a decline or volatility in our stock price.

In addition to the impact of competition, pricing actions and other measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, our sales and operations could also be affected by other risks of doing business internationally, including the impact of foreign currency exchange fluctuations, changes in intellectual property legal protections and changes in trade regulations and procedures as well as the impact of the continued uncertainty of the credit and economic conditions in certain countries in Europe.

In June 2016 the U.K. electorate voted in a referendum to voluntarily depart from the E.U., known as Brexit.

In March 2017 the U.K. government formally notified the European Council of its intention to leave the E.U. and began to negotiate the terms of its withdrawal and outline the future relationship between the U.K. and the E.U. upon exit, which occurred on January 31, 2020.

Following the U.K.’s departure, there is now a transition period during which existing arrangements will remain in place until the end of 2020, allowing detailed discussions on the future relationship between the U.K. and the E.U. to take place.

The potential impact on our results of operations and liquidity resulting from Brexit remains unclear.

The actual effects of Brexit will depend upon many factors and significant uncertainty remains with respect to the future relationship between the U.K. and the E.U. The final outcome of the discussions during the transition period may impact certain of our research, commercial and general business operations in the U.K. and the E.U., including the approval and supply of our products.

Compliance with any resulting regulatory mandates may prove challenging and the macroeconomic impact on our sales and consolidated results of operations from these developments remains unknown.

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| • | Product revenues, net totaled $11,379.8 million for 2019, representing an increase of 4.5% over $10,886.8 million in 2018. This increase was primarily due to a 21.6% increase in revenues from SPINRAZA and a 35.4% increase in revenues from our biosimilar business. Product revenues, net, compared to the same period in 2018, further reflects the unfavorable impact of foreign currency exchange of $53.0 million. |

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| • | Other revenues totaled $707.7 million for 2019, representing an increase of 20.8% over $585.9 million in 2018. This increase was primarily due to higher revenues from our manufacturing and supply agreement with Bioverativ, partially offset by lower revenues from other contract manufacturing agreements. |

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| --- | --- |

| • | Total cost and expenses totaled $7,335.3 million for 2019, representing a decrease of 3.0% from $7,564.3 million in 2018. This decrease was primarily due to: |

| | |

| --- | --- |

| ◦ | a 12.2% decrease in research and development expense, primarily due to the $482.6 million net charge recognized in 2018 upon the closing of the 2018 Ionis Agreement; |

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| --- | --- |

| ◦ | a 34.4% decrease in amortization and impairment of acquired intangible assets, primarily due to the $366.1 million impairment charges recognized in 2018, which lowered amortization expense in subsequent periods, partially offset by the $215.9 million impairment charges recognized in 2019; and |

We are subject to certain risks that may affect our results of operations, cash flows and fair values of assets and liabilities, including volatility in foreign currency exchange rates, interest rate [removed: movements,] [added: movements and] pricing pressures worldwide [removed: and weak] [added: as well as changes in] economic conditions in the [removed: foreign] markets in which we [removed: operate.]

During the second quarter of 2018 the International Practices Task Force of the Center for Audit Quality categorized Argentina as a country with a projected three-year cumulative inflation rate greater than [removed: 100%,] [added: 100.0%,] which indicated that Argentina’s economy is highly inflationary.

This categorization did not have a material impact on our results of operations or financial position as of December 31, [removed: 2019,] [added: 2020,] and is not expected to have a material impact on our results of operations or financial position in the future.

We use foreign currency forward contracts to manage foreign currency risk, with the majority of our forward contracts used to hedge certain forecasted revenue and operating expense transactions denominated in foreign currencies in the next [removed: 15] [added: 24] months.

For a more detailed disclosure of our revenue and operating expense hedging program, please read [removed: Note] [added: *Note] 9, [removed: *Derivative] [added: Derivative] Instruments,* to our consolidated financial statements included in this report.

The cash flows from these contracts [added: are reported as operating activities in our consolidated statements of cash flows.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] a hypothetical adverse [removed: 10%] [added: 10.0%] movement in foreign currency exchange rates compared to the U.S. dollar across all maturities would result in a hypothetical decrease in the fair value of forward contracts of approximately [removed: $265.0] [added: $458.2] million and [removed: $290.0] [added: $265.0] million, respectively.

Our net investment hedging program is designed to mitigate currency fluctuations between the U.S. dollar and [added: the] South Korean won as a result of [removed: exercising] our [removed: option to increase our] [added: approximately 49.9%] ownership [removed: percentage] [added: interest] in Samsung [removed: Bioepis to approximately 49.9%.][added: Bioepis.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] a hypothetical adverse [removed: 10%] [added: 10.0%] movement would result in a hypothetical decrease in fair value of approximately [removed: $43.0] [added: $56.9] million and [removed: $64.0] [added: $43.0] million, respectively.

The fair value of our marketable securities is subject to change as a result of potential changes in market [added: interest rates, including changes resulting from the impact of the COVID-19 pandemic.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] we estimate that such hypothetical 100 basis point adverse movement would result in a hypothetical loss in fair value of approximately [removed: $21.0] [added: $13.2] million and [removed: $19.0] [added: $21.0] million, respectively, to our interest rate sensitive instruments.

[removed: Thus, our] [added: Our] inability to obtain and maintain adequate prices in a particular country may [added: not only limit the revenues from our products within that country but may also] adversely affect our ability to secure acceptable prices in existing and potential new markets, which may limit market growth.

[removed: The continued implementation of pricing actions] throughout Europe may also lead to higher levels of parallel trade.

[added: There is also] significant economic pressure on state budgets that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for our drugs.

Our products [removed: are also susceptible] [added: continue] to [added: face] increasing competition in many markets from [removed: generic versions, biosimilars and] [added: new originator therapies, generics,] prodrugs [added: and biosimilars] of existing products [removed: as well as] [added: and] products approved under abbreviated regulatory pathways.

In addition, [added: in some markets,] when a generic [added: or biosimilar] version of one of our products is commercialized, it [removed: may, in some cases,] [added: may] be automatically substituted for our product and [added: significantly] reduce our revenues in a short period of time.

The majority of our accounts receivable arise from product sales in the U.S. and Europe with concentrations of credit risk limited due to the wide variety of customers and markets using our [removed: products,] [added: products] as well as their dispersion across many different geographic areas.

Our accounts receivable are primarily due from wholesale and other [removed: third-party distributors, public hospitals, pharmacies and other government entities.]

We operate in certain countries where weakness in economic [removed: conditions] [added: conditions, including as a result of the COVID-19 pandemic,] can result in extended collection periods.

We believe that our allowance for doubtful accounts was adequate as of December 31, [removed: 2019] [added: 2020] and [removed: 2018.][added: 2019.]

operate as a result of the COVID-19 pandemic.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

The continued implementation of pricing actions

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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.

third-party distributors, public hospitals, pharmacies and other government entities.

are reported as operating activities in our consolidated statements of cash flows.

interest rates.

To achieve a desired mix of fixed and floating interest rate debt, we entered into interest rate swap contracts during 2015 for certain of our fixed-rate debt.

These derivative contracts effectively converted a fixed-rate interest coupon to a floating-rate LIBOR-based coupon over the life of the respective note.

As of December 31, 2019 and 2018, a 100 basis-point adverse movement (increase in LIBOR) would increase annual interest expense by approximately $6.8 million.

There is also

Our core growth areas include multiple sclerosis (MS) and neuroimmunology; Alzheimer’s disease [removed: (AD)] and dementia; neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS); movement disorders, including Parkinson's disease; [added: ophthalmology;] and [removed: ophthalmology.][added: neuropsychiatry.]

We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging growth areas of immunology; [removed: neurocognitive disorders;] acute neurology; and [added: neuropathic] pain.

Our marketed products include TECFIDERA, [added: VUMERITY,] AVONEX, PLEGRIDY, [removed: TYSABRI, VUMERITY] [added: TYSABRI] and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; and FUMADERM for the treatment of severe plaque psoriasis.

We [removed: 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; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); and other potential anti-CD20 therapies pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group.

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

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

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

Through [added: 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 [added: an option to acquire] exclusive rights to commercialize these products in China.

Additionally, we have exclusive rights to commercialize two potential ophthalmology biosimilar products, [removed: SB11] [added: SB11, a proposed ranibizumab biosimilar] referencing [removed: LUCENTIS] [added: LUCENTIS,] and [removed: SB15] [added: 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 [removed: Note] [added: *Note] 18, [removed: *Collaborative] [added: Collaborative] and Other Relationships*, to our consolidated financial statements included in this report.

The following is a summary of key developments affecting our business since the beginning of [removed: 2019.][added: 2020.]

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

[removed: *Skyhawk] [added: *Sangamo] Therapeutics, Inc.*

In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, [removed: SB11] [added: SB11, a proposed ranibizumab biosimilar] referencing [removed: LUCENTIS] [added: LUCENTIS,] and [removed: SB15] [added: 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 [added: certain countries in] Europe and obtained [added: an option to acquire] exclusive rights to commercialize these products in China.

In [removed: January] [added: March] 2020 we [removed: entered into an agreement to acquire PF-05251749,] [added: acquired BIIB118 (CK1 inhibitor),] a novel CNS-penetrant small molecule inhibitor of casein kinase [removed: 1 (CK1),] [added: 1,] for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer Inc. (Pfizer).

[removed: In particular, we plan to develop the Phase 1 asset] [added: We are developing BIIB118] for the [added: potential] treatment of [removed: sundowning in AD and] irregular sleep wake rhythm disorder (ISWRD) in Parkinson’s [added: disease and plan to develop BIIB118 for the potential treatment of sundowning in Alzheimer's] disease.

[removed: In November 2019] VUMERITY became [added: commercially] available in the U.S. [added: in November 2019.]

In [removed: October 2019 we and our collaboration partner Eisai Co., Ltd. (Eisai) announced that] [added: July 2020] we [removed: plan] [added: completed the submission of a Biologics License Application (BLA)] to [removed: pursue regulatory approval] [added: the U.S. Food and Drug Administration (FDA)] for [added: the approval of] aducanumab, [removed: our] [added: an] anti-amyloid beta antibody candidate for the potential treatment of [removed: AD,] [added: Alzheimer's disease that we are developing] in [removed: the U.S.][added: collaboration with Eisai Co., Ltd. (Eisai).]

[removed: *2019] [added: *2020] Share Repurchase Programs*

In [removed: March 2019] [added: October 2020] our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock [removed: (March 2019] [added: (2020] Share Repurchase Program).

Our [removed: March 2019] [added: 2020] Share Repurchase Program does not have an expiration date.

All share repurchases under our [removed: March 2019] [added: 2020] Share Repurchase Program will be retired.

| [removed: • | The appointment of Alfred] [added: Alfred W.] Sandrock, Jr., M.D., [removed: Ph.D. as] [added: Ph.D. | | | | | |] Executive Vice President, Research and [removed: Development; and] [added: Development] | [added: | | | | | 63 | | | | | | 1998 | | |]

| [removed: • | The appointment of Alphonse] [added: Alphonse] Galdes, [removed: Ph.D., as] [added: Ph.D. | | | | | |] Executive Vice President, Pharmaceutical Operations and [removed: Technology.] [added: Technology] | [added: | | | | | 68 | | | | | | 1995 | | |]

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

[removed: *AVONEX (interferon beta-1a) and PLEGRIDY] [added: *PLEGRIDY] (peginterferon beta-1a)*

[removed: *BIIB091] [added: | | | | BIIB091] (BTK [removed: inhibitor)*][added: inhibitor) - MS | | | | | | Phase 1 | | | | | | | | | | | | | | | | | |]

[removed: *BIIB092 (gosuranemab)*][added: | | | | BIIB092 (gosuranemab) - Alzheimer's | | | | | | Phase 2 | | | | | | | | | | | | | | | | | |]

[removed: *BIIB100 (XPO1] [added: | | | | BIIB100 (XP01] inhibitor) - [removed: ALS*][added: ALS | | | | | | Phase 1 | | | | | | | | | | | | | | | | | |]

[removed: *BIIB094 (ION859) - Parkinson's Disease*][added: | | | | BIIB094 (ION859)# - Parkinson's | | | | | | Phase 1 | | | | | | | | | | | | | | | | | |]

[removed: *BIIB111] [added: | Ophthalmology | | | | | | BIIB111] (timrepigene emparvovec) - [removed: CHM*][added: CHM | | | | | | Phase 3 | | | | | | | | | | | | | | |]

[removed: *BIIB104 (AMPA)] [added: | | | | | | | BIIB104 (AMPA PAM)] - [removed: CIAS*][added: CIAS | | | | | | Phase 2 | | | | | | | | | | | | | | |]

[removed: *BIIB093] [added: | | | | BIIB093] (glibenclamide IV) - Brain [removed: Contusion*][added: Contusion | | | | | | Phase 2 | | | | | | | | | | | | | | | | | |]

The following graph shows our revenues by product and revenues from anti-CD20 therapeutic programs for the years ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017.][added: 2018.]

[removed: | (1) |] [added: (2)] Interferon includes [removed: product revenues from] AVONEX and PLEGRIDY. [removed: |]

[removed: | (3) |] [added: (4)] Anti-CD20 therapeutic programs include [removed: revenues from] RITUXAN, RITUXAN HYCELA, GAZYVA and OCREVUS. [removed: |]

Product sales for TECFIDERA, [removed: AVONEX and] [added: AVONEX,] TYSABRI [removed: as well as our share of pre-tax profits in the U.S. for RITUXAN] [added: and SPINRAZA] each accounted for more than [removed: 10%] [added: 10.0%] of our total revenues for the years ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017.][added: 2018.]

[removed: Product] [added: Our product] sales [removed: for SPINRAZA also] [added: to two wholesale distributors each] accounted for more than [removed: 10%] [added: 10.0%] of our total revenues for the years ended December 31, [added: 2020,] 2019 and [removed: 2018.][added: 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 financial information about our product and other revenues and geographic areas where we operate, please read [removed: Note] [added: *Note] 4, [removed: *Revenues*,] [added: Revenues,*] and [removed: Note] [added: *Note] 24, [removed: *Segment] [added: Segment] Information,* to our consolidated financial statements included in this report and [removed: Item] [added: *Item] 6.

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.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

*BIIB118 Acquisition*

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.

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.

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.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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.

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

*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.

In July 2020 we announced the appointment of Michael R.

McDonnell as Executive Vice President and Chief Financial Officer.

- 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.

- 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.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

- 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.

- 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.


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.

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*

*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.

*Pfizer Inc.*

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.

*VUMERITY*

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 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.

During 2019 we announced the following management changes:

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*TECFIDERA (dimethyl fumarate)*

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| • | In May 2019, at the 71st 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. |

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| • | In September 2019, at the 35th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24th 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. |

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For a discussion of legal matters as of December 31, [removed: 2019,] [added: 2020,] please read [removed: Note] [added: *Note] 20, [removed: *Litigation,*] [added: Litigation,*] to our consolidated financial statements included in this report, which is incorporated into this item by reference.

[removed: Form 10-K][added: Form 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the fiscal year [removed: ended December] [added: ended December] 31, [removed: 2019][added: 2020]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

Commission file [removed: number: 0-19311][added: number: 0-19311]

| Delaware | | [added: | | | |] 33-0112644 | [added: | |]

| *(State or other jurisdiction of incorporation or organization)* | | [added: | | | |] *(I.R.S. Employer Identification No.)* | [added: | |]

225 Binney [removed: Street, Cambridge, MA 02142][added: Street, Cambridge, MA 02142]

[removed: (617) 679-2000][added: (617) 679-2000]

| Title of Each Class | | [added: | | | |] Trading Symbol(s) | | [added: | | | |] Name of Each Exchange Where Registered | | [added: | | | |]

| Common Stock, $0.0005 par value | | [added: | | | |] BIIB | | [added: | | | |] The | [added: | |] Nasdaq Global Select Market | [added: | |]

| Large accelerated filer | [added: | |] x | | [added: | | | |] Accelerated filer | [added: | |] ☐ | [added: | |]

| Non-accelerated filer | [added: | |] ☐ | | [added: | | | |] Smaller reporting company | [added: | |] ☐ | [added: | |]

| | | | [added: | | | | | |] Emerging growth company | [added: | |] ☐ | [added: | |]

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was [removed: $43,010,112,437.][added: $42,102,640,463.]

As of February [removed: 4, 2020,] [added: 2, 2021,] the registrant had [removed: 174,064,011] [added: 152,335,731] shares of common stock, $0.0005 par value, outstanding.

Portions of the definitive proxy statement for our [removed: 2020] [added: 2021] Annual Meeting of Stockholders are incorporated by reference into Part III of this report.

For the Year [removed: Ended December] [added: Ended December] 31, [removed: 2019][added: 2020]

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Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

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| [PART I](#iefe8f1adeafa45df8da4a5beded16de5_19) | | | | | | | | |

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| [PART II](#iefe8f1adeafa45df8da4a5beded16de5_79) | | | | | | | | |

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| [PART IV](#iefe8f1adeafa45df8da4a5beded16de5_199) | | | | | | | | |

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[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

- the direct and indirect impact of the COVID-19 pandemic on our business and operations, including sales, expenses, supply chain, manufacturing, cyber-attacks or other privacy or data security incidents, research and development costs, clinical trials and employees;

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

BENEPALI™, FLIXABI™, FUMADERM™, IMRALDI™ and Healthy Climate, Healthy Lives™ are trademarks of Biogen.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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| [PART IV](#sACD2232777E05562B9938EF24C78D202) | | |

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| [Signatures](#s16FDF2DBB88E58939B769B4367E8A1AE) | | [95](#s16FDF2DBB88E58939B769B4367E8A1AE) |

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Below is a summary of our owned and leased properties as of December 31, [removed: 2019.][added: 2020.]

In addition, we lease a total of approximately [removed: 1,157,000] [added: 1,169,000] square feet in Massachusetts, which is summarized as follows:

[removed: | • |] [added: -] 800,000 square feet in Cambridge, MA, which is comprised of offices for our corporate headquarters and other administrative and development functions and laboratories, of which [removed: 289,000] [added: 265,000] square feet is subleased by multiple companies for general office space, laboratories and manufacturing facilities; [removed: and |]

[removed: | • |] [added: -] 357,000 square feet of office space in Weston, MA, of which 174,000 square feet is subleased through the remaining term of our lease [removed: agreement. |][added: agreement; and]

In RTP, NC we own approximately [removed: 1,022,000] [added: 1,040,000] square feet of real estate space, which is summarized as follows:

[removed: | • |] [added: -] 357,000 square feet of laboratory and office space; [removed: |]

[removed: | • | 188,000] [added: - 206,000] square foot multi-purpose facility, including an ASO manufacturing suite and administrative space; [removed: |]

[removed: | • |] [added: -] 175,000 square feet related to a large-scale biologics manufacturing facility; [removed: |]

[removed: | • |] [added: -] 105,000 square feet related to a small-scale biologics manufacturing facility; [removed: |]

[removed: | • |] [added: -] 84,000 square feet of warehouse space and utilities; [removed: |]

[removed: | • |] [added: -] 70,000 square feet related to a parenteral fill-finish facility; and [removed: |]

[removed: | • |] [added: -] 43,000 square feet related to a large-scale purification facility. [removed: |]

In addition, we lease approximately [removed: 40,000] [added: 65,000] square feet of warehouse space [added: and 103,000 square feet of office space] in Durham, NC.

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

We expect this facility to be partially operational [removed: by] [added: during] the [removed: end] [added: first half] of [removed: 2020.][added: 2021.]

We lease office space in Baar, Switzerland, our international headquarters; the U.K.; Germany; France; [removed: Denmark] [added: Japan; Canada] and numerous other countries.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

- 12,000 square feet of office space in Waltham, MA.

Our North Carolina lease agreements expire at various dates through the year 2031.

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[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

Our common stock trades on The Nasdaq Global Select Market under the symbol “BIIB.” As of February [removed: 4, 2020,] [added: 2, 2021,] there were approximately [removed: 540] [added: 505] shareholders of record of our common stock.

The following table summarizes our common stock repurchase activity during the fourth quarter of [removed: 2019:][added: 2020:]

| Period | [added: | |] Total Number [removed: of Shares Purchased (#)] [added: of Shares Purchased (#)] | | | [added: | | |] Average [removed: Price Paid] [added: Price Paid] per [removed: Share ($)] [added: Share ($)] | | | | [added: | |] Total Number [removed: of Shares Purchased as] [added: of Shares Purchased as] Part of [removed: Publicly Announced Programs (#)] [added: Publicly Announced Programs (#)] | | | [added: | | |] Approximate Dollar [removed: Value of] [added: Value of] Shares That May Yet [removed: Be Purchased Under Our] [added: Be Purchased Under Our] Programs ($ in millions) | | |

In [removed: December 2019] [added: October 2020] our Board of Directors authorized our [removed: December 2019] [added: 2020] Share Repurchase Program, which is a program to repurchase up to $5.0 billion of our common stock.

Our [removed: December 2019] [added: 2020] Share Repurchase Program does not have an expiration date.

All share repurchases under our [removed: December 2019] [added: 2020] Share Repurchase Program will be retired.

[removed: We did not repurchase shares of our common stock under] [added: Under] our December 2019 Share Repurchase [removed: Program] [added: Program, we repurchased and retired approximately 16.7 million shares of our common stock at a cost of approximately $5.0 billion] during the year ended December 31, [removed: 2019.][added: 2020.]

In March 2019 our Board of Directors authorized [removed: our March 2019 Share Repurchase Program, which is] a program to repurchase up to $5.0 billion of our common [removed: stock.][added: stock (March 2019 Share Repurchase Program), which was completed as of March 31, 2020.]

All [removed: share repurchases] [added: shares repurchased] under our March 2019 Share Repurchase Program [removed: will be] [added: were] retired.

Under our March 2019 Share Repurchase Program, we repurchased and retired approximately [added: 4.1 million and] 14.7 million shares of our common stock at a cost of approximately [added: $1.3 billion and] $3.7 billion during the [removed: year] [added: years] ended December 31, [removed: 2019.][added: 2020 and 2019, respectively.]

Under our 2018 Share Repurchase Program, we repurchased and retired approximately 8.9 million [added: and 4.3 million] shares of our common stock at a cost of approximately $2.1 billion [added: and $1.4 billion] during the [removed: year] [added: years] ended December 31, [removed: 2019.][added: 2019 and 2018, respectively.]

For additional information on the spin-off of our hemophilia business, please read [removed: Note] [added: *Note] 3, [removed: *Hemophilia] [added: Hemophilia] Spin-Off*, to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, [removed: 2018 (2018 Form 10-K).][added: 2018.]

The performance graph below assumes the investment of $100.00 on December 31, [removed: 2014,] [added: 2015,] in our common stock and each of the three indexes, with dividends being reinvested.

| | | [removed: 2014] | | [added: | |] 2015 | | [added: | | | |] 2016 | | [added: | | | |] 2017 | | [added: | | | |] 2018 | | [added: | | | |] 2019 | [added: | | | | | 2020 | | |]

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| October 2020 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 5,000.0 | |

| November 2020 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 5,000.0 | |

| December 2020 | | | 1,620,969 | | | | | | $ | 246.77 | | | | | — | | | | | | $ | 4,600.0 | |

| Total | | | 1,620,969 | | | | | | $ | 246.77 | | | | | | | | | | | | | |

Under our 2020 Share Repurchase Program, we repurchased and retired approximately 1.6 million shares of our common stock at a cost of approximately $400.0 million during the year ended December 31, 2020.

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), which was completed as of September 30, 2020.

All shares repurchased under our December 2019 Share Repurchase Program were retired.

In July 2016 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (2016 Share Repurchase Program), which was completed as of June 30, 2018.

All share repurchases under our 2016 Share Repurchase Program were retired.

Under our 2016 Share Repurchase Program, we repurchased and retired approximately 10.5 million shares of common stock at a cost of approximately $3.0 billion during the year ended December 31, 2018.

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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| Biogen Inc. | | | | | | $100.00 | | | | | | $92.57 | | | | | | $112.74 | | | | | | $106.49 | | | | | | $105.01 | | | | | | $86.65 | | |

| Nasdaq Pharmaceutical Index | | | | | | $100.00 | | | | | | $98.91 | | | | | | $117.83 | | | | | | $127.20 | | | | | | $145.65 | | | | | | $160.97 | | |

| S&P 500 Index | | | | | | $100.00 | | | | | | $111.96 | | | | | | $136.40 | | | | | | $130.42 | | | | | | $171.49 | | | | | | $203.04 | | |

| Nasdaq Biotechnology Index | | | | | | $100.00 | | | | | | $78.65 | | | | | | $95.69 | | | | | | $87.21 | | | | | | $109.11 | | | | | | $137.94 | | |

[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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| October 2019 | 3,215,407 | | | $ | 238.71 | | | 3,215,407 | | | $ | 2,604.7 | |

| November 2019 | 1,550,825 | | | $ | 292.01 | | | 1,550,825 | | | $ | 2,151.8 | |

| December 2019 | 2,928,634 | | | $ | 297.99 | | | 2,928,634 | | | $ | 6,279.1 | |

| Total | 7,694,866 | | | $ | 272.01 | | | | | | | | |

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


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| Biogen Inc. | | $100.00 | | $90.25 | | $83.54 | | $101.74 | | $96.11 | | $94.77 |

| Nasdaq Pharmaceutical Index | | $100.00 | | $105.43 | | $104.29 | | $124.23 | | $134.11 | | $153.57 |

| S&P 500 Index | | $100.00 | | $101.38 | | $113.51 | | $138.29 | | $132.23 | | $173.86 |

| Nasdaq Biotechnology Index | | $100.00 | | $111.77 | | $87.91 | | $106.95 | | $97.47 | | $121.94 |

| Our results of operations are summarized as follows: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| | [added: | |] For the Years Ended December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| [added: (In millions)] | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| (In millions, except per share amounts) | | | [added: 2020] | | | | | | [added: 2019] | | | | | | [added: 2018] | | | | | [added: | 2017 | | | | | | 2016 | | |]

| Results of Operations [removed: (1)] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Product revenues, net [removed: (2)] | [added: | |] $ | [removed: 11,379.8] [added: 10,692.2] | | | [added: | |] $ | [removed: 10,886.8] [added: 11,379.8] | | | [added: | |] $ | [removed: 10,354.7] [added: 10,886.8] | | | [added: | |] $ | [removed: 9,817.9] [added: 10,354.7] | | | [added: | |] $ | [removed: 9,188.5] [added: 9,817.9] | |

| Revenues from anti-CD20 therapeutic programs | [added: | | 1,977.8 | | | | | |] 2,290.4 | | | | [added: | |] 1,980.2 | | | | [removed: 1,559.2] | | [added: 1,559.2] | | [removed: 1,314.5] | | | | [removed: 1,339.2] [added: 1,314.5] | | |

| Other revenues | [added: | | 774.6 | | | | | |] 707.7 | | | | [added: | |] 585.9 | | | | [removed: 360.0] | | [added: 360.0] | | [removed: 316.4] | | | | [removed: 236.1] [added: 316.4] | | |

| Total revenues | [added: | | 13,444.6 | | | | | |] 14,377.9 | | | | [added: | |] 13,452.9 | | | | [removed: 12,273.9] | | [added: 12,273.9] | | [removed: 11,448.8] | | | | [removed: 10,763.8] [added: 11,448.8] | | |

| Total cost and expenses [removed: (3)] | [added: | | 8,894.5 | | | | | |] 7,335.3 | | | | [added: | |] 7,564.3 | | | | [removed: 6,928.1] | | [added: 6,928.1] | | [removed: 6,297.1] | | | | [removed: 5,872.8] [added: 6,297.1] | | |

| Income from operations | [added: | | 4,550.1 | | | | | |] 7,042.6 | | | | [added: | |] 5,888.6 | | | | [removed: 5,345.8] | | [added: 5,345.8] | | [removed: 5,151.7] | | | | [removed: 4,891.0] [added: 5,151.7] | | |

| Other income (expense), net | [added: | | 497.4 | | | | | |] 83.3 | | | | [added: | |] 11.0 | | | | [removed: (217.0] | | [removed: )] [added: (217.0)] | | [removed: (218.7] | | [removed: )] | | [removed: (123.7] [added: (218.7)] | | [removed: )] |

| Income before income tax expense and equity in loss of investee, net of tax | [added: | | 5,047.5 | | | | | |] 7,125.9 | | | | [added: | |] 5,899.6 | | | | [removed: 5,128.8] | | [added: 5,128.8] | | [removed: 4,933.0] | | | | [removed: 4,767.3] [added: 4,933.0] | | |

| Income tax expense [removed: (4)] | [added: | | 992.3 | | | | | |] 1,158.0 | | | | [added: | |] 1,425.6 | | | | [removed: 2,458.7] | | [added: 2,458.7] | | [removed: 1,237.3] | | | | [removed: 1,161.6] [added: 1,237.3] | | |

| Equity in loss of investee, net of tax | [removed: 79.4] | | [added: (5.3)] | | [removed: —] | | | | [added: 79.4 | | | | | |] — | | | | [added: | |] — | | | | [removed: 12.5] | | [added: —] | [added: | |]

| Net income | [added: | | 4,060.5 | | | | | |] 5,888.5 | | | | [added: | |] 4,474.0 | | | | [removed: 2,670.1] | | [added: 2,670.1] | | [removed: 3,695.7] | | | | [removed: 3,593.2] [added: 3,695.7] | | |

| Net income (loss) attributable to noncontrolling interests, net of tax [removed: (5)] | [added: | | 59.9 | | | | | |] — | | | | [added: | |] 43.3 | | | | [removed: 131.0] | | [added: 131.0] | | [removed: (7.1] | | [removed: )] | | [removed: 46.2] [added: (7.1)] | | |

| Net income attributable to Biogen Inc. | [added: | |] $ | [removed: 5,888.5] [added: 4,000.6] | | | [added: | |] $ | [removed: 4,430.7] [added: 5,888.5] | | | [added: | |] $ | [removed: 2,539.1] [added: 4,430.7] | | | [added: | |] $ | [removed: 3,702.8] [added: 2,539.1] | | | [added: | |] $ | [removed: 3,547.0] [added: 3,702.8] | |

| Diluted Earnings Per Share [removed: (6)] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Diluted earnings per share attributable to Biogen Inc. | [added: | |] $ | [removed: 31.42] [added: 24.80] | | | [added: | |] $ | [removed: 21.58] [added: 31.42] | | | [added: | |] $ | [removed: 11.92] [added: 21.58] | | | [added: | |] $ | [removed: 16.93] [added: 11.92] | | | [added: | |] $ | [removed: 15.34] [added: 16.93] | |

| Weighted-average shares used in calculating diluted earnings per share attributable to Biogen Inc. | [added: | | 161.3 | | | | | |] 187.4 | | | | [added: | |] 205.3 | | | | [removed: 213.0] | | [added: 213.0] | | [removed: 218.8] | | | | [removed: 231.2] [added: 218.8] | | |

| Our financial condition is summarized as follows: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| | [added: | |] As of December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Financial Condition [removed: (1)] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Cash, cash equivalents and marketable securities | [added: | |] $ | [removed: 5,884.0] [added: 3,382.2] | | | [added: | |] $ | [removed: 4,913.9] [added: 5,884.0] | | | [added: | |] $ | [removed: 6,746.3] [added: 4,913.9] | | | [added: | |] $ | [removed: 7,724.5] [added: 6,746.3] | | | [added: | |] $ | [removed: 6,188.9] [added: 7,724.5] | |

| Total assets | [added: | |] $ | [removed: 27,234.3] [added: 24,618.9] | | | [added: | |] $ | [removed: 25,288.9] [added: 27,234.3] | | | [added: | |] $ | [removed: 23,652.6] [added: 25,288.9] | | | [added: | |] $ | [removed: 22,876.8] [added: 23,652.6] | | | [added: | |] $ | [removed: 19,504.8] [added: 22,876.8] | |

| Notes payable, less current portion [removed: (7)] | [added: | |] $ | [removed: 4,459.0] [added: 7,426.2] | | | [added: | |] $ | [removed: 5,936.5] [added: 4,459.0] | | | [added: | |] $ | [removed: 5,935.0] [added: 5,936.5] | | | [added: | |] $ | [removed: 6,512.7] [added: 5,935.0] | | | [added: | |] $ | [removed: 6,521.5] [added: 6,512.7] | |

| Total Biogen Inc. shareholders’ equity [removed: (6)] | [added: | |] $ | [removed: 13,343.2] [added: 10,700.3] | | | [added: | |] $ | [removed: 13,039.6] [added: 13,343.2] | | | [added: | |] $ | [removed: 12,612.8] [added: 13,039.6] | | | [added: | |] $ | [removed: 12,140.1] [added: 12,612.8] | | | [added: | |] $ | [removed: 9,372.8] [added: 12,140.1] | |

[removed: In addition to the following notes, the] [added: The] financial data included within the tables above should be read in conjunction with our consolidated financial statements and related notes and [removed: Item] [added: *Item] 7.

[removed: *Management’s] [added: Management’s] Discussion and Analysis of Financial Condition and Results of Operations* included in this report and our previously filed Annual Reports on Form 10-K.

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[Table of](#iefe8f1adeafa45df8da4a5beded16de5_7) [Contents](#iefe8f1adeafa45df8da4a5beded16de5_7)

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| (In millions) | 2019 | | | | 2018 | | | | 2017 | | | | 2016 | | | | 2015 | | |

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| (1) | On February 1, 2017, we completed the spin-off of our hemophilia business. Our consolidated results of operations and financial condition reflect the financial results of our hemophilia business for all periods through January 31, 2017. |

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| (2) | Product revenues, net reflect the impact of the following product launches: |

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| • | Commercial sales of VUMERITY in the U.S. began in the fourth quarter of 2019. |

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| • | Commercial sales of SPINRAZA in the U.S. began in the fourth quarter of 2016 and in rest of world markets beginning in the first quarter of 2017. |

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| • | Under our collaboration agreement with AbbVie Inc. (AbbVie), we began to recognize revenues on sales of ZINBRYTA to third parties in the E.U. in the third quarter of 2016. In March 2018 we and AbbVie announced the voluntary worldwide withdrawal of ZINBRYTA for RMS. |

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| • | Under our commercial agreement with Samsung Bioepis, we began to recognize revenues on sales of BENEPALI and FLIXABI to third parties in certain countries in Europe in the first and third quarters of 2016, respectively, and began to recognize revenues on sales of IMRALDI to third parties in certain countries in Europe in the fourth quarter of 2018. |

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| • | We stopped recognizing revenues from ALPROLIX and ELOCTATE effective February 1, 2017, upon the completion of the spin-off of our hemophilia business. |

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| (3) | Total cost and expenses included the following charges: |

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| • | Pre-tax research and development expenses related to upfront and milestone payments made upon entering into strategic agreements or achievement of specified development milestones totaling $253.8 million, $602.7 million, $494.0 million, $167.6 million and $158.2 million in 2019, 2018, 2017, 2016 and 2015, respectively. |

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| • | Impairment charges related to certain acquired intangible assets totaling $215.9 million, $366.1 million, $359.4 million and $12.2 million in 2019, 2018, 2017 and 2016, respectively. For additional information, please read Note 6, *Intangible Assets and Goodwill*, to our consolidated financial statements included in this report. |

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| • | Pre-tax research and development expenses of $486.2 million in 2018 related to the 2018 Ionis Agreement. 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. |

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The information required by this Item 8 is contained on pages F-1 through [removed: F-82] [added: F-80] of this report and is incorporated herein by reference.

We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended), as of December 31, [removed: 2019.][added: 2020.]

Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring [removed: that (a) the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.][added: that:]

There were no changes in our internal control over financial reporting during the quarter ended December 31, [removed: 2019,] [added: 2020,] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.