Biogen (BIIB) 10-K risk factor changes: FY2022 vs FY2021

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

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

[removed: ADUHELM] [added: LEQEMBI] is in the early stages of commercial launch in the U.S. In addition to risks associated with new product launches and the other factors described in these Risk Factors, [removed: our] [added: Biogen’s and Eisai’s] ability to successfully commercialize [removed: ADUHELM] [added: LEQEMBI] may be adversely affected due to:

- [removed: our] [added: Eisai’s] ability to obtain and maintain [added: adequate] reimbursement for [removed: ADUHELM;][added: LEQEMBI;]

- the effectiveness of [removed: our] [added: Eisai's and Biogen’s] commercial strategy for marketing [removed: ADUHELM;][added: LEQEMBI; and]

- [removed: our] [added: Eisai’s and Biogen’s] ability to maintain a positive reputation among patients, healthcare providers and others in the Alzheimer’s disease community, which may be impacted by pricing and reimbursement decisions relating to [removed: ADUHELM.][added: LEQEMBI, which are made by Eisai.]

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

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

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

- inability to obtain appropriate pricing and [added: adequate] reimbursement for our products compared to our competitors in key international markets; or

- our ability to [removed: recieve] [added: receive] reimbursement for our [added: products or our ability to receive comparable reimbursement to that of competing] products; and

[added: This may create the opportunity for] third-party cross-border trade or influence our decision to sell or not to sell a product, thus adversely affecting our geographic expansion plans and revenue.

Drug prices are under significant scrutiny in the markets in which our products are [removed: prescribed.][added: prescribed; for example the IRA has certain provisions related to drug pricing.]

New products marketed by our competitors could cause our revenue to decrease due to potential price [removed: reductions and lower sales volumes.]

We depend on relationships with [removed: collaborators, joint venture partners] [added: collaborators] and other third-parties for revenue, and for the development, regulatory approval, commercialization and marketing of certain of our products and product candidates, which are outside of our full control.

We rely on a number of [removed: collaborative, joint venture] [added: collaborative] and other third-party relationships for revenue and the development, regulatory approval, commercialization and marketing of certain of our products and product candidates.

- we may be unable to control the resources our [removed: collaborators, joint venture partners] [added: collaborators] or third-parties devote to our programs, products or product candidates;

- disputes may arise under an agreement, including with respect to the achievement and payment of milestones, payment of development or commercial costs, ownership of rights to technology developed, and the underlying agreement may fail to provide us with significant protection or may fail to be effectively enforced if the [removed: collaborators, joint ventures partners] [added: collaborators] or third-parties fail to perform;

- the interests of our [removed: collaborators, joint venture partners] [added: collaborators] or third-parties may not always be aligned with our interests, and such parties may not pursue regulatory approvals or market a product in the same manner or to the same extent that we would, which could adversely affect our revenue, or may adopt tax strategies that could have an adverse effect on our business, results of operations or financial condition;

- any failure on the part of our [removed: collaborators, joint venture partners] [added: collaborators] or third-parties to comply with applicable laws, including tax laws, regulatory requirements and/or applicable contractual obligations or to fulfill any responsibilities they may have to protect and enforce any intellectual property rights underlying our products could have an adverse effect on our revenue as well as involve us in possible legal proceedings; and

- any improper conduct or actions on the part of our [removed: collaborators, joint venture partners] [added: collaborators] or third-parties could subject us to civil or criminal investigations and monetary and injunctive penalties, impact the accuracy and timing of our financial reporting and/or adversely impact our ability to conduct business, our operating results and our reputation.

Legislative and regulatory proposals, enactments to reform health care insurance programs [added: (including those contained in the IRA)] and increasing pressure from social sources could significantly [removed: influence the manner in which our products are prescribed and purchased.]

For example, two committees of the U.S. House of Representatives [removed: are investigating] [added: previously investigated] the approval and price of ADUHELM.

In addition, there have [removed: been,] [added: been (including elements of the IRA),] and are expected to continue to be, legislative proposals to address prescription drug pricing.

- *Reliance on Third-Parties.* We are dependent, in part, on the efforts of [removed: Samsung Bioepis,] collaboration partners and other third-parties over whom we have limited or no control in the development and manufacturing of biosimilars products.

- *Failure to Gain Market and Patient Acceptance.* Market success of biosimilar products will be adversely affected if patients, physicians and/or payors do not accept biosimilar products as safe and efficacious products offering a more competitive price or other benefit over existing therapies; [added: and]

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

[removed: We are dependent on a third-party for the manufacture of our biosimilar products and such third-party may not perform its obligations in a timely and] cost-effective manner or in compliance with applicable regulations and may be unable or unwilling to increase production capacity commensurate with demand for our existing or future biosimilar products; [removed: and]

- *Competitive Challenges.* Biosimilar products face significant competition, including from innovator products and biosimilar products offered by other [removed: companies.][added: companies that may receive greater acceptance or more favorable reimbursement.]

The number of competitors in a jurisdiction, the timing of approval and the ability to market biosimilar products successfully in a timely and cost-effective manner are additional factors that may impact our success [removed: and/or the success of Samsung Bioepis] in this business area.

In addition, settlements of such proceedings often result in reducing the period of [removed: patent] [added: exclusivity] and other protections, resulting in a reduction in revenue from affected products.

Such proceedings are unpredictable and are often [added: protracted and expensive.]

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

[removed: Even if later stage clinical trials are successful,] regulatory authorities may delay or decline approval of our product candidates.

Regulatory authorities may disagree with our view of the data, require additional [removed: studies or] [added: studies,] disagree with our trial design or [removed: endpoints.][added: endpoints or not approve adequate reimbursement.]

One CRO has responsibility for a substantial portion of our activities and reporting related to our clinical [added: trials, adversely affect our expense associated with such] trials and if such CRO does not adequately perform, many of our trials may be affected.

Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear and [removed: creates] [added: create] uncertainty and risk of noncompliance with regulations [removed: applicable to our business.]

The COVID-19 pandemic has caused us to modify our business practices in ways that heighten this dependence, including changing the requirement that most of our office-based employees in the U.S. and our other key markets work from the [removed: office.][added: office, with a number of our employees now working in hybrid or full-remote positions.]

Breakdowns, invasions, corruptions, destructions and/or breaches of our technology [removed: systems,] [added: systems or those of our business partners,] including our cloud technologies, and/or unauthorized access to our data and information could subject us to liability, negatively impact our business operations, and/or require replacement of technology and/or ransom payments.

[removed: Data] privacy or security breaches also pose a risk that sensitive data, including intellectual property, trade secrets or personal information belonging to us, patients, customers or other business partners, may be exposed to unauthorized persons or to the public.

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

Additionally and in part due to the impact of the COVID-19 pandemic, in certain jurisdictions governmental health agencies may adjust, retroactively and/or prospectively, reimbursement rates for our products.

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reductions and lower sales volumes.

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influence the manner in which our products are prescribed, purchased and reimbursed.

We are dependent on a third-party for the manufacture of our biosimilar products and such third-party may not perform its obligations in a timely and

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Legal proceedings may also be necessary to determine the rights, obligations and payments claimed during and after the expiration of intellectual property license agreements we have entered with third parties.

Even if later stage clinical trials are successful,

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Data

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Geopolitical instability, including that related to Russia's invasion of Ukraine may increase cyber-attacks.

Regulators are considering new cyber security regulations.

For example, the SEC has proposed amendments to its disclosure rules regarding cyber security risk management, strategy, governance and incident reporting by public companies.

These proposed regulations may impact the manner in which we operate.

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Our interactions with physicians and other health

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We may also be required

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- increased cost of goods due to factors such as inflation and supply chain disruptions;

- delays in clinical trials relating to geopolitical instability related to Russia's invasion of Ukraine;

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Customer-facing professionals interactions in healthcare settings have changed as a result of the COVID-19 pandemic and other global health outbreaks.

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applicable to our business.

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affect our earnings.

Additionally, the recently enacted IRA includes an excise tax on share repurchases, which will increase the cost of share repurchases.

Our effective tax rate may be different than experienced in the past or our current expectations due to many factors, including changes in the mix of our

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Additionally, regulators are considering new environmental disclosure rules.

For example, the SEC has proposed amendments to its disclosure rules regarding climate-related disclosure requirements.

These proposed regulations may impact the manner in which we operate.

- the lack of readiness of healthcare providers to initiate treatment as well as our ability to successfully identify eligible patients based on the information included in ADUHELM’s label;

- concern regarding the accelerated approval of ADUHELM and its data;

- the lack of market acceptance of ADUHELM;

- delays in the manufacturing, distribution and supply of ADUHELM;

- the approval of other new products for the same or similar indications; and

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

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This may create the opportunity for

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Certain officers and affiliates 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.

In addition, as Samsung Bioepis is a privately-held entity, our ability to liquidate our investment may be limited and we may realize significantly less than the value of such investment.

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protracted and expensive.

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

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providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption or loss of confidential or propriety information.

If we, or our vendors or

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Although a portion of the Solothurn facility received a GMP multi-product license from SWISSMEDIC in May 2021, the manufacturing of a product or product candidate at the Solothurn facility must be approved by the applicable regulatory agencies, including the FDA.

If we do not receive the necessary regulatory approvals of the Solothurn facility or if our future growth and drug development plans increase, we may not have sufficient large-scale manufacturing capacity to meet our long-term manufacturing requirements.

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- *Risk Relating to Government Actions*.

We and/or our third-party providers may be required by the U.S. federal government to manufacture medical supplies needed to treat COVID-19 patients under the Defense Production Act or other acts or orders of government entities, which may result in delays in the manufacturing and supply of our products.

National, state and local governments have implemented and may continue to implement safety

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precautions.

These measures may disrupt normal business operations and may have significant negative impacts on businesses and financial markets worldwide.

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

In response to the COVID-19 pandemic, legislation has been enacted aimed at providing emergency assistance and health care for individuals, families and businesses and broadly supporting the U.S. economy.

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For our discussion of the year ended December 31, [removed: 2020,] [added: 2021,] compared to the year ended December 31, [removed: 2019,] [added: 2020,] please read *Item 7.* *Management's Discussion and Analysis of Financial Condition and Results of Operations* located in our Annual Report on Form 10-K for the year ended December 31, [removed: 2020.][added: 2021.]

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

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

We support our drug discovery and development efforts through [removed: the commitment of significant resources to discovery,] [added: internal] research and development programs and [removed: business development opportunities.][added: external collaborations.]

We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; [added: LUNSUMIO (mosunetuzumab), which was granted accelerated approval in the U.S. during the fourth quarter of 2022 for the treatment of relapsed or refractory follicular lymphoma; glofitamab, an investigational bispecific antibody for the potential treatment of non-Hodgkin's lymphoma;] and [added: have the option to add] other potential anti-CD20 therapies, [removed: including mosunetuzumab,] pursuant to our collaboration arrangements with Genentech, a [removed: wholly-][added: wholly-owned member of the Roche Group.]

For additional information on our collaboration arrangements with Genentech, please read *Note [removed: 18,] [added: 19,] Collaborative and Other Relationships*, to our consolidated financial statements included in this report.

[removed: We have also secured] [added: During] the [removed: exclusive rights to commercialize] [added: third quarter of 2021] BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, [removed: which] was approved in the U.S., the [removed: E.U.] [added: E.U] and the U.K. [removed: during] [added: BYOOVIZ launched in] the [removed: third quarter of 2021.][added: U.S. in June 2022 and became commercially available in July 2022 through major distributors in the U.S.]

For additional information on our collaboration arrangements with Samsung Bioepis, please read *Note [removed: 18,] [added: 19,] Collaborative and Other [removed: Relationships*,] [added: Relationships,*] to our consolidated financial statements included in this report.

We believe that the Solothurn facility will support our anticipated near-term needs for the manufacturing of [removed: ADUHELM and other] biologic assets.

[removed: In the longer term, our revenue growth will depend upon the successful clinical development, regulatory approval and launch of new commercial] products as well as additional indications for our existing products, our ability to obtain and maintain patents and other rights related to our marketed products, assets originating from our research and development efforts and/or successful execution of external business development opportunities.

In June 2021 the FDA granted accelerated approval of ADUHELM, [removed: which] [added: which, until March of 2022,] we [removed: are developing and commercializing in collaboration] [added: had been collaborating on] with Eisai, based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.

As part of the accelerated approval, we [removed: will] [added: are required to] conduct a confirmatory trial to verify the clinical benefit of ADUHELM in patients with Alzheimer’s disease.

In October 2020 the EMA accepted for review the [removed: Marketing Authorization Application] [added: MAA] for aducanumab and in December 2020 the [removed: MHLW] [added: Ministry of Health, Labor and Welfare (MHLW)] accepted for review the Japanese NDA for aducanumab.

We [removed: are seeking a] [added: sought] re-examination of the opinion by the CHMP.

Multiple TECFIDERA generic entrants are now in [removed: the U.S. market] [added: North America, Brazil] and [added: certain E.U. countries and] have deeply discounted prices compared to TECFIDERA.

The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and [removed: is expected to continue to have a substantial and increasing negative impact on our U.S.] [added: we expect that] TECFIDERA revenue [added: will continue to decline] in the future.

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

For additional information, please read [added: *Note 21, Litigation*, to our consolidated financial statements included in this report and] the discussion under [removed: Results] [added: *Results] of Operations - Product Revenue - Multiple Sclerosis (MS) - [removed: Fumarate] [added: Fumarate*] below.

*Business Update Regarding [removed: COVID-19*][added: COVID-19 and Other Disruptions*]

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, [removed: directly or indirectly, have a further impact on timing in the future.]

Factors such as the COVID-19 [removed: pandemic,] [added: pandemic and other global health outbreaks,] adverse weather events, [added: geopolitical events,] labor or raw material shortages and other supply chain disruptions could result in product shortages or other difficulties and delays [added: or increased costs] in manufacturing our products.

For additional information on the various risks posed by the COVID-19 [removed: pandemic,] [added: pandemic and the conflict in Ukraine,] please read *Item 1A.* *Risk [removed: Factors*] [added: Factors,*] included in this report.

Diluted earnings per share attributable to Biogen Inc. were [removed: $10.40] [added: $20.87] for [removed: 2021,] [added: 2022,] representing [removed: a decrease] [added: an increase] of [removed: 58.1%] [added: 100.7%] as compared to [removed: $24.80] [added: $10.40] in the same period in [removed: 2020.][added: 2021.]

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: 2021,] [added: 2022,] compared to the year ended December 31, [removed: 2020,] [added: 2021,] reflects the following:

- Total revenue was [removed: $10,981.7] [added: $10,173.4] million for [removed: 2021,] [added: 2022,] representing [removed: a $2,462.9] [added: an $808.3] million, or [removed: 18.3%,] [added: 7.4%,] decrease compared to [removed: $13,444.6] [added: $10,981.7] million in [removed: 2020.][added: 2021.]

- Product revenue, net totaled [removed: $8,846.9] [added: $7,987.8] million for [removed: 2021,] [added: 2022,] representing [removed: a $1,845.3] [added: an $859.1] million, or [removed: 17.3%,] [added: 9.7%,] decrease compared to [removed: $10,692.2] [added: $8,846.9] million in [removed: 2020.][added: 2021.]

- Revenue from anti-CD20 therapeutic programs totaled [removed: $1,658.5] [added: $1,700.5] million for [removed: 2021,] [added: 2022,] representing a [removed: $319.3] [added: $42.0] million, or [removed: 16.1%, decrease] [added: 2.5%, increase] compared to [removed: $1,977.8] [added: $1,658.5] million in [removed: 2020.][added: 2021.]

This [removed: decrease] [added: increase] was primarily due to a [removed: $480.2] [added: $144.6] million, or [removed: 45.5%, decrease] [added: 14.6%, increase] in [removed: RITUXAN revenue,] [added: royalty revenue on sales of OCREVUS,] partially offset by a [removed: $146.3] [added: $103.4] million, or [removed: 17.3%, increase] [added: 18.0%, decrease] in [removed: royalty revenue on sales of OCREVUS.][added: RITUXAN revenue.]

Sales of RITUXAN have been adversely affected by [removed: the onset of] biosimilar competition.

[removed: *•*Other] [added: - Other] revenue totaled [removed: $476.3] [added: $485.1] million for [removed: 2021,] [added: 2022,] representing a [removed: $298.3] [added: $8.8] million, or [removed: 38.5%, decrease] [added: 1.8%, increase] from [removed: $774.6] [added: $476.3] million in [removed: 2020.][added: 2021.]

- Total cost and expense was [removed: $8,141.0] [added: $6,581.6] million for [removed: 2021,] [added: 2022,] representing a [removed: $753.5] [added: $2,654.9] million, or [removed: 8.5%,] [added: 28.7%,] decrease compared to [removed: $8,894.5] [added: $9,236.5] million in [removed: 2020.][added: 2021.]

This decrease was primarily due to a [removed: $1,489.7] [added: $666.5] million, or [removed: 37.3%,] [added: 10.9%,] decrease in [removed: research and development expense.][added: MS product]

- We generated [removed: $3,639.9] [added: $1,384.3] million of net cash flow from operations for [removed: 2021.][added: 2022.]

- Cash, cash equivalents and marketable securities totaled approximately [removed: $4,694.5] [added: $5,598.5] million as of December 31, [removed: 2021.][added: 2022.]

- We repurchased and retired approximately [removed: 6.0] [added: 3.6] million shares of our common stock at a cost of approximately [removed: $1.8 billion] [added: $750.0 million] during [removed: 2021] [added: 2022] under our 2020 Share Repurchase Program.

Approximately [removed: $2.8] [added: $2.1] billion remained available under our 2020 Share Repurchase Program as of December 31, [removed: 2021.][added: 2022.]

[removed: Acquisitions,] [added: *Other] Collaborative [removed: and Other Relationships][added: Relationships*]

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

[added: For additional information on our collaboration arrangements,] please read *Note [removed: 2, Acquisitions*, *Note 18,] [added: 19,] Collaborative and Other [removed: Relationships,* and *Note 19, Investments in Variable Interest Entities*,] [added: Relationships*,] to our consolidated financial statements included in this report.

In connection with this [removed: agreement,] [added: transaction,] we made an upfront payment of [removed: $30.0] [added: $10.0] million to [removed: Bio-Thera Solutions.][added: Alcyone.]

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

We also collaborate with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted accelerated approval by the FDA in January 2023.

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

We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S. We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA.

In February 2023 we announced that we are exploring strategic options for our biosimilars business.

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

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

In the longer term, our revenue growth will depend upon the successful clinical development, regulatory approval and launch of new commercial

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In April 2022 the CMS released a final NCD for the class of anti-amyloid treatments in Alzheimer's disease, including ADUHELM.

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

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

We expect that this decision will reduce future demand for ADUHELM to a minimal level.

Additionally, for the year ended December 31, 2022, we recorded approximately $111.0 million of aggregate gross idle capacity charges related to ADUHELM.

These charges were recorded in cost of sales within our consolidated statements of income for the year ended December 31, 2022.

We have recognized approximately $197.0 million related to Eisai's 45.0% share of inventory, idle capacity charges and contractual commitments in collaboration profit (loss) sharing

within our consolidated statements of income for the year ended December 31, 2022.

Additionally, as a result of the final NCD we have substantially eliminated our commercial infrastructure supporting ADUHELM, retaining minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the U.S.

We expect to continue funding certain regulatory and research and development activities for ADUHELM, including the continuation of the EMBARK re-dosing study and the Phase 4 post-marketing requirement study, ENVISION.

Additional actions regarding ADUHELM may be informed by upcoming data readouts expected for this class of antibodies, as well as further engagement with the FDA and CMS.

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

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

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

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

In April 2022 we announced our decision to withdraw our MAA for aducanumab in Europe.

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

In addition, we are litigating to affirm that TECFIDERA is entitled to regulatory data and

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market protection until at least February 2024.

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

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

We are awaiting the decision of the CJEU.

*COVID-19*

directly or indirectly, have a further impact on timing in the future.

*Geopolitical Tensions*

The ongoing geopolitical tensions related to Russia's invasion of Ukraine have resulted in global business disruptions and economic volatility, including sanctions and other restrictions levied on the government and businesses in Russia.

Although we do not have affiliates or employees, in either Russia or Ukraine, we do provide various therapies to patients in Russia through a distributor and are currently involved in clinical trials with sites in Ukraine and Russia.

The timing and costs of these trials may be impacted as a result of the conflict.

In addition, new government sanctions on the export of certain manufacturing materials to Russia may delay or limit our ability to get new products approved.

The impact of the conflict on our operations and financial performance remains uncertain and will depend on future developments, including the severity and duration of the conflict, its impact on regional and global economic conditions and whether the conflict spreads or has effects on countries outside Ukraine and Russia.

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

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

owned member of the Roche Group.

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

Through our agreements with Samsung Bioepis, our joint venture with 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.

In addition, we believe that the Solothurn site may provide us with the ability to further expand if we need additional large scale manufacturing capacity to support future clinical and commercial manufacturing requirements.

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The U.S. ADUHELM product label states that treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population which was studied in clinical trials.

We expect patient uptake will be gradual and we do not expect all eligible patients will be treated with ADUHELM for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway, the lack of readiness of healthcare providers and institutions to initiate treatment, concern regarding the accelerated approval of ADUHELM and its data and the ability to obtain and maintain adequate reimbursement for ADUHELM.

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

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

If the final

NCD is not broader than the proposed NCD, our future operating results may be negatively impacted.

Under our collaboration agreement with Eisai (ADUHELM Collaboration Agreement), we and Eisai will co-promote ADUHELM with a region-based profit split, with Eisai reimbursing us for 45.0% of development and commercialization costs incurred by the collaboration for the advancement of ADUHELM in the U.S. Shipments of ADUHELM commenced during the second quarter of 2021.

We have made, and may continue to make, commercial, medical and infrastructure investments in support of activities associated with the launch of ADUHELM in the U.S.

If we do not receive regulatory approval or are unable to successfully commercialize aducanumab in other jurisdictions, our financial condition, business and operations may be adversely affected.

In 2020 U.S. federal courts in West Virginia and Delaware entered judgments in favor of the defendants in patent infringement proceedings relating to TECFIDERA Orange-Book listed patents.

We appealed both decisions.

In late 2021 the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) affirmed the judgment of the West Virginia federal court.

The appeals in the Delaware cases were stayed and we expect will remain so until the decision in the West Virginia case becomes final.

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

If data and market protection is not upheld, we could face generic competition in the E.U. as early as the first half of 2022, which would have an adverse impact on our TECFIDERA sales in the E.U. and our results of operations.

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.

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This decrease was primarily due to a $1,735.4 million, or 22.2%, decrease in MS product revenue and a $147.0 million, or 7.2%, decrease in SPINRAZA product revenue, partially offset by a $35.3 million, or 4.4%, increase in revenue from our biosimilar business.

◦The decrease in MS product revenue was primarily due to a decrease in U.S. TECFIDERA demand as a result of multiple TECFIDERA generic entrants in the U.S. market.

◦The decrease in SPINRAZA revenue was primarily due to a decrease in demand as a result of increased competition in the U.S. and Germany as well as a decrease in pricing in the U.S. and rest of world markets, partially offset by an increase in sales volumes in Latin America and certain distributor markets.

◦The decrease in other revenue was primarily due to higher contract manufacturing revenue in 2020, resulting from $346.2 million in revenue related to the delivery of the license for certain of our manufacturing-related intellectual property to a contract manufacturing customer.

◦The decrease in research and development expense was primarily due to $1,893.3 million in upfront payments recognized in 2020 in connection with our collaborations with Sangamo, Denali and Sage, partially offset by a $125.0 million upfront payment recognized in connection with our collaboration with InnoCare in 2021.

*◦*The decrease was partially offset by a $304.5 million, or 16.9%, increase in cost of sales, which was primarily driven by $164.0 million of charges associated with inventory and purchase commitments in excess of forecasted demand related to ADUHELM during 2021 as well as higher impairment charges recorded during 2021 as compared to 2020.

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*Bio-Thera Solutions*

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

*InnoCare Pharma Limited*

In July 2021 we entered into a collaboration and license agreement with InnoCare for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS. In connection with this agreement, we made an upfront payment of $125.0 million to InnoCare.

*BIIB115 Option Exercise*

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

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

We are subject to certain risks that may affect our results of operations, cash flow and fair values of assets and liabilities, including volatility in foreign currency exchange rates, interest rate movements and equity price exposure as well as changes in economic conditions in the markets in which we operate as a result of the COVID-19 [removed: pandemic.][added: pandemic and the conflict in Ukraine.]

As a result, our consolidated financial position, results of operations and cash flow can be affected by market fluctuations in foreign currency exchange rates, primarily with respect to the Euro, British pound sterling, Canadian dollar, Swiss [removed: franc, Japanese yen] [added: franc] and [removed: South Korean won.][added: Japanese yen.]

[removed: The impact to net income as a result of a strengthening U.S. dollar will be partially] mitigated by the value of non-U.S. expense, which will also decline when reported in U.S. dollars.

We have established revenue and operating expense hedging and balance sheet risk management programs to protect against volatility of future foreign currency cash [removed: flows] [added: flow] and changes in fair value caused by volatility in foreign currency exchange rates.

This categorization did not have a material impact on our results of operations or financial position as of December 31, [removed: 2021,] [added: 2022,] 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 [added: and foreign currency options] 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: 12] months.

For a more detailed disclosure of our revenue and operating expense hedging program, please read *Note [removed: 9,] [added: 10,] Derivative Instruments,* to our consolidated financial statements included in this report.

In these instances, we principally utilize currency forward [removed: contracts.]

As of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] a hypothetical adverse 10.0% movement in foreign currency exchange rates compared to the U.S. dollar across all maturities [added: would result in a hypothetical decrease in the fair value of forward contracts of approximately $293.7 million and $333.1 million, respectively.]

[added: As of December 31, 2022 and 2021, a hypothetical adverse 10.0% movement] would result in a hypothetical decrease in [removed: the] fair value of [removed: forward contracts of] approximately [removed: $333.1] [added: $79.1] million and [removed: $458.2] [added: $104.8] million, respectively.

As of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we estimate that such hypothetical 100 basis point adverse movement would result in a hypothetical loss in fair value of approximately [removed: $14.3] [added: $11.7] million and [removed: $13.2] [added: $14.3] million, respectively, to our interest rate sensitive instruments.

[added: We attempt] to [added: minimize the risks related to] cash and cash equivalents and investments by investing in a broad and diverse range of financial instruments.

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

We believe that our allowance for doubtful accounts was adequate as of December 31, [removed: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

The impact to net income as a result of a strengthening U.S. dollar will be partially

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contracts.

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*Net Investment Hedge Program*

Our net investment hedging program is designed to mitigate currency fluctuations between the U.S. dollar and the South Korean won as a result of our approximately 49.9% ownership interest in Samsung Bioepis.

We entered into foreign currency forward contracts to hedge changes in the spot rate over the next 10 months.

As of December 31, 2021 and 2020, a hypothetical adverse 10.0% movement would result in a hypothetical decrease in fair value of approximately $58.7 million and $56.9 million, respectively.

The estimated fair value was determined by measuring the impact of the hypothetical spot rate movement on outstanding forward contracts.

We plan to unwind our foreign currency forward contracts in conjunction with the closing of our proposed sale of our ownership interest in Samsung Bioepis to Samsung Biologics.

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

We attempt to minimize the risks related

As of December 31, 2021 and 2020, a hypothetical adverse 10.0% movement would result in a hypothetical decrease in fair value of approximately $104.8 million and $188.8 million, respectively.

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

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

We support our drug discovery and development efforts through [removed: the commitment of significant resources to discovery,] [added: internal] research and development programs and [removed: business development opportunities.][added: external collaborations.]

We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); [added: LUNSUMIO (mosunetuzumab), which was granted accelerated approval in the U.S. during the fourth quarter of 2022 for the treatment of relapsed or refractory follicular lymphoma; glofitamab, an investigational bispecific antibody for the potential treatment of non-Hodgkin's lymphoma;] and [added: have the option to add] other potential anti-CD20 therapies, [removed: including mosunetuzumab,] pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group.

For additional information on our collaboration arrangements with Genentech, please read *Note [removed: 18,] [added: 19,] Collaborative and Other Relationships*, to our consolidated financial statements included in this report.

We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was approved in the U.S., the [removed: European Union (E.U.)] [added: E.U.] and the [removed: U.K.] [added: United Kingdom (U.K.)] during the third quarter of 2021.

For additional information on our collaboration arrangements with Samsung Bioepis, please read *Note [removed: 18,] [added: 19,] Collaborative and Other [removed: Relationships*,] [added: 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: 2021.][added: 2022.]

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

[removed: Acquisitions,] [added: *Other] Collaborative [removed: and Other Relationships][added: Relationships*]

In connection with this [removed: agreement,] [added: transaction,] we made an upfront payment of [removed: $30.0] [added: $10.0] million to [removed: Bio-Thera Solutions.][added: Alcyone.]

[added: -] In [removed: August 2021] [added: February 2023] we [removed: closed a collaboration and] [added: terminated our] license [added: and collaboration] agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS. [removed: Orelabrutinib is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS (RRMS).]

[removed: *Mosunetuzumab*][added: *LUNSUMIO (mosunetuzumab)*]

In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of [removed: mosunetuzumab,] [added: LUNSUMIO (mosunetuzumab),] a [removed: late-stage] bispecific antibody [removed: in development] for [removed: B-cell non-Hodgkin’s lymphoma and other therapeutic areas.][added: the treatment of relapsed or refractory follicular lymphoma.]

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

[removed: We would] [added: As part of this transaction, we are] also [removed: be] eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.

For additional information on [removed: the proposed transaction and] our collaboration arrangements with [removed: Samsung Bioepis,] [added: Eisai,] please read *Note [removed: 18,] [added: 19,] Collaborative and Other Relationships,* to our consolidated financial statements included in this report.

[removed: Other] [added: *Developments in] Key [removed: Developments][added: Collaborative Relationships*]

[removed: *BIIB125 (zuranolone)*][added: *Zuranolone (BIIB125)*]

[removed: *BIIB067 (tofersen)*][added: *Tofersen (BIIB067)*]

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

The new [added: manufacturing] facility will be approximately [removed: 175,000] [added: 197,000] square feet and is expected to be operational by the end of [removed: 2023.][added: 2023, with an estimated total investment of approximately $195.0 million.]

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

[removed: -] In [removed: September 2021] [added: December 2022] Eisai initiated a rolling submission [removed: to the FDA] of a BLA [added: to the National Medicinal Products Administration (NMPA) of China] for [added: the approval of] lecanemab.

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

[removed: *BIIB125 (zuranolone)*][added: *Zuranolone (BIIB125)*]

[removed: The] [added: This] data was presented at the European College of Neuropsychopharmacology [added: (ECNP)] Congress.

- In [removed: October 2021] [added: December 2022] we and Sage [removed: announced plans to submit] [added: completed the rolling submission of] a NDA to the FDA for [added: the approval of] zuranolone for the potential treatment of MDD [removed: in the second half of 2022 with rolling submission expected to start in early 2022.][added: and PPD.]

[removed: *BIIB059] [added: | | | | Litifilimab] (anti-BDCA2) - [removed: SLE*][added: SLE | | | | | | Phase 3 | | | | | | | | | | | | | | |]

[removed: Biosimilars][added: *Biosimilars*]

- In June [removed: 2021] [added: 2022 we and] Samsung Bioepis announced that [removed: the CHMP adopted a positive opinion of BYOOVIZ (ranibizumab-nuna),] [added: BYOOVIZ,] a [added: ranibizumab] biosimilar referencing LUCENTIS, [removed: and] [added: launched] in [removed: August 2021 BYOOVIZ was approved by] the [removed: EMA.][added: U.S.]

[removed: Discontinued or Suspended Programs][added: *Discontinued Programs*]

Based on these results, we discontinued development of [removed: gosuranemab.][added: BIIB078.]

The following graph shows our revenue by product and revenue from anti-CD20 therapeutic programs for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019.][added: 2020.]

For additional [removed: information,] [added: information on our collaboration arrangements with Eisai,] please read *Note [removed: 18,] [added: 19,] Collaborative and Other [removed: Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement*,] [added: Relationships,*] to our consolidated financial statements included in this report.

Product sales for TECFIDERA, [removed: AVONEX,] TYSABRI and SPINRAZA each accounted for more than 10.0% of our total revenue for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019.][added: 2020.]

For additional financial information about our product and other revenue and geographic areas where we operate, please read *Note [removed: 4, Revenue,*] [added: 5, Revenue*] and *Note [removed: 24,] [added: 25,] Segment Information,* to our consolidated financial statements included in this report and *Item 7.

[removed: Multiple Sclerosis and Neuroimmunology][added: *Multiple Sclerosis*]

We develop, manufacture and market a number of products designed to treat patients with MS. MS is a progressive [removed: neurological] disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death.

| [removed: ] [added: ] | | | | | | RMS in the U.S. [removed: RRMS] [added: Relapsing-remitting MS (RRMS)] in the E.U. | | | | | | None | | | | | | U.S. France Germany Italy Japan Spain U.K. | | |

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

We also collaborate with Eisai Co., Ltd. (Eisai) on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2023.

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

We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S. We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA.

*Eisai Collaboration Agreements*

*LEQEMBI (lecanemab) Collaboration Agreement*

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

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

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

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

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

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

*ADUHELM Collaboration Agreement*

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

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

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

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

In June 2022 we and our collaboration partner Sage Therapeutics, Inc. (Sage) announced that the Phase 3 SKYLARK study of zuranolone, for the potential treatment of MDD and PPD, met its primary and all key secondary endpoints.

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

This submission completes the NDA filing initiated earlier in 2022.

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

*Genentech*

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

*Glofitamab*

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

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

*Alcyone Therapeutics*

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

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

*Corporate Matters*

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

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

*2022 Cost Saving Initiatives*

In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures that when completed we expect may yield approximately $1.0 billion in expense savings.

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

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

These amounts were substantially incurred during 2022.

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

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

*125 Broadway Sale and Leaseback Transaction*

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

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

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

Now our research is focused on developing next generation treatments for MS. We introduced the first approved treatment for SMA and are continuing to pursue research and development for potential advancements in the treatment of SMA.

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

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

Through our agreements with Samsung Bioepis Co., Ltd. (Samsung Bioepis), our joint venture with Samsung BioLogics Co., Ltd. (Samsung BioLogics), we market and sell BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe.

*Bio-Thera Solutions*

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

[T](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[a](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[ble of Content](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[s](#ia2a6167b9c3f4c10903e8786984aa4d2_7)

*InnoCare Pharma Limited*

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

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

*BIIB115 Option Exercise*

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

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

*Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics*

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

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

*ADUHELM (aducanumab)*

In June 2021 the U.S. Food and Drug Administration (FDA) granted accelerated approval of ADUHELM, which we are developing and commercializing in collaboration with Eisai Co., Ltd. (Eisai), based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.

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

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

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

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

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

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

[T](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[a](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[ble of Content](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[s](#ia2a6167b9c3f4c10903e8786984aa4d2_7)

In June 2021 we and Sage Therapeutics, Inc. (Sage) announced positive Phase 3 results for BIIB125 (zuranolone) for the potential treatment of MDD and PPD.

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

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

*Lecanemab (BAN2401)*

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

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

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

*BYOOVIZ (ranibizumab-nuna)*

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

In addition to the U.S. approval, BYOOVIZ was approved in the E.U. and the U.K. during the third quarter of 2021.

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

*Exchange Offer*

For a discussion of legal matters as of December 31, [removed: 2021,] [added: 2022,] please read *Note [removed: 20,] [added: 21,] Litigation,* to our consolidated financial statements included in this report, which is incorporated into this item by reference.

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For the fiscal year ended December 31, [removed: 2021][added: 2022]

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

Securities registered pursuant to Section 12(g) of the Act: [added: None]

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: $51,264,577,902.][added: $29,397,964,818.]

As of February [removed: 2, 2022,] [added: 14, 2023,] the registrant had [removed: 146,962,793] [added: 144,485,646] shares of common stock, $0.0005 par value, outstanding.

Portions of the definitive proxy statement for our [removed: 2022] [added: 2023] Annual Meeting of Stockholders are incorporated by reference into Part III of this report.

For the Year Ended December 31, [removed: 2021][added: 2022]

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| [Item [removed: 11.](#ia2a6167b9c3f4c10903e8786984aa4d2_193)] [added: 11.](#i0cbadda4abfc4b4b9c7e5be15680d793_196)] | | | [Executive [removed: Compensation](#ia2a6167b9c3f4c10903e8786984aa4d2_193)] [added: Compensation](#i0cbadda4abfc4b4b9c7e5be15680d793_196)] | | | [removed: [91](#ia2a6167b9c3f4c10903e8786984aa4d2_193)] [added: [83](#i0cbadda4abfc4b4b9c7e5be15680d793_196)] | | |

| [Item [removed: 12.](#ia2a6167b9c3f4c10903e8786984aa4d2_196)] [added: 12.](#i0cbadda4abfc4b4b9c7e5be15680d793_199)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ia2a6167b9c3f4c10903e8786984aa4d2_196)] [added: Matters](#i0cbadda4abfc4b4b9c7e5be15680d793_199)] | | | [removed: [91](#ia2a6167b9c3f4c10903e8786984aa4d2_196)] [added: [83](#i0cbadda4abfc4b4b9c7e5be15680d793_199)] | | |

| [Item [removed: 13.](#ia2a6167b9c3f4c10903e8786984aa4d2_199)] [added: 13.](#i0cbadda4abfc4b4b9c7e5be15680d793_202)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#ia2a6167b9c3f4c10903e8786984aa4d2_199)] [added: Independence](#i0cbadda4abfc4b4b9c7e5be15680d793_202)] | | | [removed: [91](#ia2a6167b9c3f4c10903e8786984aa4d2_199)] [added: [83](#i0cbadda4abfc4b4b9c7e5be15680d793_202)] | | |

| [Item [removed: 14.](#ia2a6167b9c3f4c10903e8786984aa4d2_202)] [added: 14.](#i0cbadda4abfc4b4b9c7e5be15680d793_205)] | | | [Principal Accountant Fees and [removed: Services](#ia2a6167b9c3f4c10903e8786984aa4d2_202)] [added: Services](#i0cbadda4abfc4b4b9c7e5be15680d793_205)] | | | [removed: [91](#ia2a6167b9c3f4c10903e8786984aa4d2_202)] [added: [83](#i0cbadda4abfc4b4b9c7e5be15680d793_205)] | | |

| [Item [removed: 15.](#ia2a6167b9c3f4c10903e8786984aa4d2_208)] [added: 15.](#i0cbadda4abfc4b4b9c7e5be15680d793_211)] | | | [Exhibits and Financial Statement [removed: Schedules](#ia2a6167b9c3f4c10903e8786984aa4d2_208)] [added: Schedules](#i0cbadda4abfc4b4b9c7e5be15680d793_211)] | | | [removed: [92](#ia2a6167b9c3f4c10903e8786984aa4d2_208)] [added: [84](#i0cbadda4abfc4b4b9c7e5be15680d793_211)] | | |

| [Item [removed: 16.](#ia2a6167b9c3f4c10903e8786984aa4d2_211)] [added: 16.](#i0cbadda4abfc4b4b9c7e5be15680d793_214)] | | | [Form 10-K [removed: Summary](#ia2a6167b9c3f4c10903e8786984aa4d2_211)] [added: Summary](#i0cbadda4abfc4b4b9c7e5be15680d793_214)] | | | [removed: [92](#ia2a6167b9c3f4c10903e8786984aa4d2_211)] [added: [84](#i0cbadda4abfc4b4b9c7e5be15680d793_214)] | | |

| [Consolidated Financial [removed: Statements](#ia2a6167b9c3f4c10903e8786984aa4d2_220)] [added: Statements](#i0cbadda4abfc4b4b9c7e5be15680d793_223)] | | | | | | F- [removed: [1](#ia2a6167b9c3f4c10903e8786984aa4d2_220)] [added: [1](#i0cbadda4abfc4b4b9c7e5be15680d793_223)] | | |

- expectations, plans and prospects relating to sales, pricing, [removed: growth] [added: growth, reimbursement] and launch of our marketed and pipeline products;

- the potential impact of increased product competition in the markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways, including generic or biosimilar versions of our [added: products or competing] products;

- the drivers for growing our business, including our plans and intention to commit resources relating to discovery, research and development programs and business development opportunities as well as the potential benefits and results of, and the anticipated completion of, certain business development [removed: transactions;][added: transactions and cost-reduction measures;]

- the direct and indirect impact of the COVID-19 pandemic [added: and other global health outbreaks] on our business and operations, including sales, expense, reserves and allowances, the supply chain, manufacturing, cyber-attacks or other privacy or data security incidents, research and development costs, clinical trials and employees;

- the potential impact of healthcare reform in the United States [removed: (U.S.)] [added: (U.S.), including the Inflation Reduction Act of 2022 (IRA),] and measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;

- our manufacturing capacity, use of third-party contract manufacturing organizations, plans and timing relating to changes in our manufacturing capabilities, activities in new or existing manufacturing facilities and the expected timeline for the [added: remaining portion of the] Solothurn manufacturing facility to begin manufacturing products or product candidates and for the gene therapy manufacturing facility in Research Triangle Park (RTP), [removed: North Carolina] [added: NC] to be operational;

[added: ADUHELM®,] AVONEX®, PLEGRIDY®, RITUXAN®, RITUXAN HYCELA®, SPINRAZA®, TECFIDERA®, TYSABRI® and VUMERITY® are registered trademarks of Biogen.

[removed: ADUHELM™,] BENEPALI™, BYOOVIZ™, FLIXABI™, FUMADERM™, IMRALDI™ and Healthy [removed: Climate] [added: Climate,] Healthy Lives™ are trademarks of Biogen.

[added: ACTEMRA®, CIMZIA®,] ENBREL®, EYLEA®, FAMPYRA™, GAZYVA®, HUMIRA®, [added: LEQEMBI™,] LUCENTIS®, [added: LUNSUMIO™,] OCREVUS®, REMICADE® and other trademarks referenced in this report are the property of their respective owners.

| [PART I](#i0cbadda4abfc4b4b9c7e5be15680d793_19) | | | | | | | | |

| [PART II](#i0cbadda4abfc4b4b9c7e5be15680d793_82) | | | | | | | | |

| [PART III](#i0cbadda4abfc4b4b9c7e5be15680d793_190) | | | | | | | | |

| [PART IV](#i0cbadda4abfc4b4b9c7e5be15680d793_208) | | | | | | | | |

| [Signatures](#i0cbadda4abfc4b4b9c7e5be15680d793_220) | | | | | | [88](#i0cbadda4abfc4b4b9c7e5be15680d793_220) | | |

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- the current and potential impacts of the conflict in Ukraine, including impacts on our operations, sales and the possible disruptions or delays in our plans to conduct clinical trial activities in affected regions;

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None

| [PART I](#ia2a6167b9c3f4c10903e8786984aa4d2_19) | | | | | | | | |

| [PART II](#ia2a6167b9c3f4c10903e8786984aa4d2_82) | | | | | | | | |

| [PART III](#ia2a6167b9c3f4c10903e8786984aa4d2_187) | | | | | | | | |

| [PART IV](#ia2a6167b9c3f4c10903e8786984aa4d2_205) | | | | | | | | |

| [Signatures](#ia2a6167b9c3f4c10903e8786984aa4d2_217) | | | | | | [96](#ia2a6167b9c3f4c10903e8786984aa4d2_217) | | |

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Below is a summary of our owned and leased properties as of December 31, [removed: 2021.][added: 2022.]

[removed: Massachusetts][added: *Massachusetts*]

In Cambridge, MA we own approximately [removed: 508,000] [added: 263,000] square feet of real estate space, consisting of a building that houses a research laboratory and a cogeneration [removed: plant totaling approximately 263,000 square feet and a building that contains research, development and quality laboratories totaling approximately 245,000 square feet.][added: plant.]

In addition, we lease a total of approximately [removed: 1,157,000] [added: 1,429,000] square feet in Massachusetts, which is summarized as follows:

- [removed: 800,000] [added: 1,072,000] square feet in Cambridge, MA, which is comprised of offices for our corporate headquarters and other administrative and development functions and laboratories, of which 289,000 square feet is subleased by multiple companies for general office space, laboratories and manufacturing facilities; and

[removed: North Carolina][added: *North Carolina*]

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

Our North Carolina lease agreements expire at various dates through the year [removed: 2031.][added: 2025.]

The new [added: manufacturing] facility will be [removed: 175,000] [added: approximately 197,000] square feet and is expected to be operational by the end of 2023, with an estimated total investment of [removed: $200.0] [added: approximately $195.0] million.

[removed: Switzerland][added: *Switzerland*]

Upon completion, [removed: the] [added: this] facility will include 393,000 square feet related to a large-scale biologics manufacturing facility, 290,000 square feet of warehouse, utilities and support space and 51,000 square feet of administrative space.

U.S.

*125 Broadway Building Sale and Leaseback*

In September 2022 we completed the sale of our building and land parcel located at 125 Broadway.

In connection with this sale, we simultaneously leased back the building for a term of approximately 5.5 years, which resulted in the recognition of approximately $168.2 million in new lease liabilities and right-of-use assets recorded within our consolidated balance sheets as of December 31, 2022.

The sale and immediate leaseback of this building qualified for sale and leaseback treatment and is classified as an operating lease.

For additional information

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

*300 Binney Street Lease Modification*

In September 2022 we entered into an agreement to partially terminate a portion of our lease located at 300 Binney Street, Cambridge, MA (300 Binney Street), as well as to reduce the lease term for the majority of the remaining space.

The agreement was driven by our 2022 efforts to reduce costs by consolidating real estate locations.

For additional information on our 300 Binney Street lease modification, please read *Note 12, Leases*, to our consolidated financial statements included in this report.

International

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

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

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Our common stock trades on The Nasdaq Global Select Market under the symbol “BIIB.” As of February [removed: 2, 2022,] [added: 14, 2023,] there were approximately [removed: 479] [added: 448] shareholders of record of our common stock.

The following table summarizes our common stock repurchase activity during the fourth quarter of [removed: 2021:][added: 2022:]

(1) There were no share repurchases during the fourth quarter of [removed: 2021.][added: 2022.]

Under our 2020 Share Repurchase Program, we repurchased and retired approximately [added: 3.6 million,] 6.0 million and 1.6 million shares of our common stock at a cost of approximately [added: $750.0 million,] $1.8 billion and $400.0 million during the years ended December 31, [added: 2022,] 2021 and 2020, respectively.

Approximately [removed: $2.8] [added: $2.1] billion remained available under our 2020 Share Repurchase Program as of December 31, [removed: 2021.][added: 2022.]

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

The performance graph below assumes the investment of $100.00 on December 31, [removed: 2016,] [added: 2017,] in our common stock and each of the three indexes, with dividends being reinvested.

| | | | | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | |

| October 2022 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,050.0 | |

| November 2022 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,050.0 | |

| December 2022 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,050.0 | |

In August 2022 the IRA was signed into law.

Among other things, the IRA levies a 1.0% excise tax on net stock repurchases after December 31, 2022.

Historically, we have made discretionary share repurchases.

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| Biogen Inc. | | | | | | $100.00 | | | | | | $94.46 | | | | | | $93.14 | | | | | | $76.86 | | | | | | $75.31 | | | | | | $86.92 | | |

| Nasdaq Pharmaceutical Index | | | | | | $100.00 | | | | | | $107.95 | | | | | | $123.62 | | | | | | $136.62 | | | | | | $169.94 | | | | | | $189.23 | | |

| S&P 500 Index | | | | | | $100.00 | | | | | | $95.62 | | | | | | $125.72 | | | | | | $148.85 | | | | | | $191.58 | | | | | | $156.88 | | |

| Nasdaq Biotechnology Index | | | | | | $100.00 | | | | | | $91.14 | | | | | | $114.02 | | | | | | $144.15 | | | | | | $144.18 | | | | | | $129.59 | | |

| October 2021 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,800.0 | |

| November 2021 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,800.0 | |

| December 2021 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 2,800.0 | |

In August 2018 our Board of Directors authorized a program to repurchase up to $3.5 billion of our common stock (2018 Share Repurchase Program), which was completed as of June 30, 2019.

All share repurchases under our 2018 Share Repurchase Program were retired.

Under our 2018 Share Repurchase Program, we repurchased and retired approximately 8.9 million shares of our common stock at a cost of approximately $2.1 billion during the year ended December 31, 2019.

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On February 1, 2017, we completed the spin-off of our hemophilia business, Bioverativ Inc. (Bioverativ), as an independent, publicly traded company.

In connection with the spin-off, each Biogen shareholder received one share of Bioverativ common stock for every two shares of Biogen common stock they owned.

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

Our stock prices have been adjusted for the effect of the spin-off of our hemophilia business.

The five-year cumulative total stockholder return for Biogen does not reflect the reinvestment by Biogen shareholders of the distribution they received in connection with the spin-off of our hemophilia business or any subsequent increase or decrease in value of Bioverativ stock subsequent to the spin-off.

| Biogen Inc. | | | | | | $100.00 | | | | | | $121.79 | | | | | | $115.04 | | | | | | $113.44 | | | | | | $93.61 | | | | | | $91.72 | | |

| Nasdaq Pharmaceutical Index | | | | | | $100.00 | | | | | | $119.12 | | | | | | $128.60 | | | | | | $147.25 | | | | | | $162.74 | | | | | | $202.43 | | |

| S&P 500 Index | | | | | | $100.00 | | | | | | $121.83 | | | | | | $116.49 | | | | | | $153.17 | | | | | | $181.35 | | | | | | $233.41 | | |

| Nasdaq Biotechnology Index | | | | | | $100.00 | | | | | | $121.66 | | | | | | $110.88 | | | | | | $138.72 | | | | | | $175.38 | | | | | | $175.41 | | |

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The information required by this Item 8 is contained on pages F-1 through [removed: F-78] [added: F-79] of this report and is incorporated herein by reference.

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[removed: We have carried out an evaluation, under] the [removed: 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) [removed: and] [added: or] 15d-15(e) under the Securities Exchange Act of 1934, as amended), as of December 31, [removed: 2021.][added: 2022.]

There were no changes in our internal control over financial reporting during the quarter ended December 31, [removed: 2021,] [added: 2022,] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

[added: Internal control over financial] reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

Based on our assessment, our management has concluded that, as of December 31, [removed: 2021,] [added: 2022,] our internal control over financial reporting is effective based on those criteria.

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their attestation report, which is included herein.

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

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Internal control over financial

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The response to the remainder of this item is incorporated by reference from the discussion responsive thereto in the sections entitled “*Proposal 1 - Election of Directors,” “Corporate Governance at Biogen”* and “*Miscellaneous - Stockholder Proposals*” contained in the proxy statement for our [removed: 2022] [added: 2023] annual meeting of stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled “*Executive Compensation Matters*” and *“Corporate Governance at Biogen”* contained in the proxy statement for our [removed: 2022] [added: 2023] annual meeting of stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled *“Stock Ownership”* and *“Equity Compensation Plan Information”* contained in the proxy statement for our [removed: 2022] [added: 2023] annual meeting of stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled “*Certain Relationships and Related Person Transactions*” and *“Corporate Governance at Biogen*” contained in the proxy statement for our [removed: 2022] [added: 2023] annual meeting of stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto in the section entitled “*Proposal 2 - Ratification of the Selection of our Independent Registered Public Accounting Firm*” contained in the proxy statement for our [removed: 2022] [added: 2023] annual meeting of stockholders.

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

[T](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[a](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[ble of Content](#ia2a6167b9c3f4c10903e8786984aa4d2_7)[s](#ia2a6167b9c3f4c10903e8786984aa4d2_7)

| Report of Independent Registered Public Accounting Firm (PCAOB ID 238) | | | | | | [removed: F-77] [added: F-78] | | |

The exhibits listed on the Exhibit Index beginning on page [removed: 93,] [added: 85,] which is incorporated herein by reference, are filed or furnished as part of this report or are incorporated into this report by reference.

| 4.8+ | | | | | | [Description of [removed: Securities.](https://www.sec.gov/Archives/edgar/data/875045/000087504522000007/biib-20211231xex48.htm)] [added: Securities.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/biib-20211231xex48.htm)] | | |

| 10.2 | | | | | | [Credit Agreement, dated as of January 28, 2020, among Biogen Inc., Bank of America, N.A., as administrative agent, swing [removed: ling] [added: line] lender and the L/C issuer, and the other lenders party thereto. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on February 3, [removed: 2020.](http://www.sec.gov/Archives/edgar/data/875045/000119312520022940/d854655dex101.htm)] [added: 2020.](https://www.sec.gov/Archives/edgar/data/875045/000119312520022940/d854655dex101.htm)] | | |

| [removed: 10.3†] [added: 10.4†] | | | | | | [Second Amended and Restated Collaboration Agreement between Biogen Idec Inc. and Genentech, Inc., dated as of October 18, 2010. Filed as Exhibit 10.5 to our Annual Report on Form 10-K for the year ended December 31, 2010.](http://www.sec.gov/Archives/edgar/data/875045/000095012311009300/b83162exv10w5.htm) | | |

| [removed: 10.4†] [added: 10.5†] | | | | | | [Letter Agreement regarding GA101 financial terms between Biogen Idec Inc. and Genentech, Inc., dated October 18, 2010. Filed as Exhibit 10.6 to our Annual Report on Form 10-K for the year ended December 31, 2010.](http://www.sec.gov/Archives/edgar/data/875045/000095012311009300/b83162exv10w6.htm) | | |

| [removed: 10.5] [added: 10.6] | | | | | | [Settlement and License Agreement, dated January 17, 2017, between Biogen Swiss Manufacturing GmbH, Biogen International Holdings ltd., Forward Pharma A/S and other parties thereto. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on February 1, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000095015717000082/ex10-1.htm) | | |

| [removed: 10.6*] [added: 10.7*] | | | | | | [Biogen Inc. 2017 Omnibus Equity Plan. Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 26, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000119312517139450/d43428ddef14a.htm#toc43428_63) | | |

| [removed: 10.7*] [added: 10.8*] | | | | | | [Form of restricted stock unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504517000024/biib-2017630xexhibit102.htm) | | |

| [removed: 10.8*] [added: 10.9*] | | | | | | [Form of market stock unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504517000024/biib-2017630xexhibit103.htm) | | |

| [removed: 10.9*] [added: 10.10*] | | | | | | [Form of performance unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.4 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504517000024/biib-2017630xexhibit104.htm) | | |

| [removed: 10.10*] [added: 10.11*] | | | | | | [Form of cash-settled performance unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.5 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504517000024/biib-2017630xexhibit105.htm) | | |

| [removed: 10.11*] [added: 10.12*] | | | | | | [Form of performance stock units award agreement (cash-settled) under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.10 to our Annual Report on Form 10-K for the year ended December 31, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000005/biib-20171231xex1010.htm) | | |

| [removed: 10.12*] [added: 10.13*] | | | | | | [Form of performance stock units award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.11 to our Annual Report on Form 10-K for the year ended December 31, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000005/biib-20171231xex1011.htm) | | |

| [removed: 10.13*] [added: 10.14*] | | | | | | [Form of performance stock units award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000010/biib-2018331xex101.htm) | | |

| [removed: 10.14*] [added: 10.15*] | | | | | | [Form of performance stock units award agreement (cash settled) under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000010/biib-2018331xex102.htm) | | |

| [removed: 10.15*] [added: 10.16*] | | | | | | [Form of restricted stock unit award agreement (2018 one-time transition grant) under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000010/biib-2018331xex103.htm) | | |

| [removed: 10.16*] [added: 10.17*] | | | | | | [Form of market stock unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan (for grants commencing in July 2019). Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000029/biib-2019630xex101.htm) | | |

| [removed: 10.17*] [added: 10.18*] | | | | | | [Form of performance stock units award agreement under the Biogen Inc. 2017 Omnibus Equity Plan (for grants commencing in July 2019). Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000029/biib-2019630xex102.htm) | | |

| [removed: 10.18*] [added: 10.19*] | | | | | | [Form of performance stock units award agreement (cash settled) under the Biogen Inc. 2017 Omnibus Equity Plan (for grants commencing in July 2019). Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000029/biib-2019630xex103.htm) | | |

| [removed: 10.19*] [added: 10.21*] | | | | | | [Biogen Idec Inc. 2008 Amended and Restated Omnibus Equity Plan. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.](http://www.sec.gov/Archives/edgar/data/875045/000087504514000011/biib-2014331xex101.htm) | | |

| [removed: 10.20*] [added: 10.22*] | | | | | | [Form of performance unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.](http://www.sec.gov/Archives/edgar/data/875045/000087504514000011/biib-2014331xex102.htm) | | |

| [removed: 10.21*] [added: 10.23*] | | | | | | [Form of market stock unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.](http://www.sec.gov/Archives/edgar/data/875045/000087504514000011/biib-2014331xex103.htm) | | |

| [removed: 10.22*] [added: 10.24*] | | | | | | [Form of restricted stock unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on August 1, 2008.](http://www.sec.gov/Archives/edgar/data/875045/000095013508005246/b71469biexv10w1.htm) | | |

| [removed: 10.23*] [added: 10.25*] | | | | | | [Form of nonqualified stock option award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Current Report on Form 8-K filed on August 1, 2008.](http://www.sec.gov/Archives/edgar/data/875045/000095013508005246/b71469biexv10w2.htm) | | |

| [removed: 10.24*] [added: 10.26*] | | | | | | [Form of cash-settled performance shares award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.](http://www.sec.gov/Archives/edgar/data/875045/000095012310036233/b79987exv10w1.htm) | | |

| [removed: 10.25*] [added: 10.27*] | | | | | | [Biogen Inc. 2006 Non-Employee Directors Equity Plan, as amended. Filed as Exhibit [removed: 10.1] [added: 10.2] to our Quarterly Report on Form 10-Q for the quarter ended March 31, [removed: 2015.](http://www.sec.gov/Archives/edgar/data/875045/000087504515000014/biib-2015331xex101.htm)] [added: 2022.](https://www.sec.gov/Archives/edgar/data/875045/000087504522000016/exhibit102biogeninc2006non.htm)] | | |

| [removed: 10.26*] [added: 10.28*] | | | | | | [Biogen Inc. 2015 Employee Stock Purchase Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 30, 2015.](http://www.sec.gov/Archives/edgar/data/875045/000119312515159387/d786327ddef14a.htm#toc786327_57) | | |

| [removed: 10.27*] [added: 10.29*] | | | | | | [Biogen Idec Inc. 2008 Performance-Based Management Incentive Plan. Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on May 8, 2008.](http://www.sec.gov/Archives/edgar/data/875045/000095013508003542/b67068dfdefc14a.htm#152) | | |

| [removed: 10.28*] [added: 10.30*] | | | | | | [Biogen Inc. 2019 Form of Performance-Based Management Incentive Plan, as amended. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000017/biib-2019331xex101.htm) | | |

| [removed: 10.29*] [added: 10.31*] | | | | | | [Biogen Idec Inc. Voluntary Executive Supplemental Savings Plan, as amended and restated effective January 1, 2004. Filed as Exhibit 10.13 to our Annual Report on Form 10-K for the year ended December 31, 2003.](http://www.sec.gov/Archives/edgar/data/875045/000095013504001180/b48790biexv10w13.txt) | | |

| [removed: 10.30*] [added: 10.32*] | | | | | | [Biogen Idec Inc. Supplemental Savings Plan, as amended. Filed as Exhibit 10.23 to our Annual Report on Form 10-K for the year ended December 31, 2015.](http://www.sec.gov/Archives/edgar/data/875045/000087504516000042/biib-20151231xex1023.htm) | | |

| [removed: 10.31*] [added: 10.33*] | | | | | | [Biogen Idec Inc. Voluntary Board of Directors Savings Plan, as amended. Filed as Exhibit 10.24 to our Annual Report on Form 10-K for the year ended December 31, 2015.](http://www.sec.gov/Archives/edgar/data/875045/000087504516000042/biib-20151231xex1024.htm) | | |

| [removed: 10.32*] [added: 10.34*] | | | | | | [Biogen Inc. Executive Severance Policy - U.S. Executive Vice President, as amended effective June 19, 2019. Filed as Exhibit 10.4 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000029/biib-2019630xex104.htm) | | |

| [removed: 10.33*] [added: 10.35*] | | | | | | [Biogen Inc. Executive Severance Policy - U.S. Executive Vice President, as amended effective July 13, 2020. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.](https://www.sec.gov/Archives/edgar/data/875045/000087504520000036/exhibit101-severancepo.htm) | | |

| [removed: 10.34*] [added: 10.36*] | | | | | | [Annual Retainer Summary for Board of Directors (effective January 1, 2020). Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019.](http://www.sec.gov/Archives/edgar/data/875045/000087504519000041/biib-2019930xex101.htm) | | |

| [removed: 10.35*] [added: 10.37*] | | | | | | [Form of indemnification agreement for directors and executive officers. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on June 7, 2011.](http://www.sec.gov/Archives/edgar/data/875045/000095012311057276/b86869exv10w1.htm) | | |

| [removed: 10.36*] [added: 10.38*] | | | | | | [Employment Agreement between Biogen Inc. and Michel Vounatsos dated December 18, 2016 and effective as of January 6, 2017. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on December 19, 2016.](http://www.sec.gov/Archives/edgar/data/875045/000087504516000076/biogenemploymentagreementf.htm) | | |

| [removed: 10.37*] [added: 10.41*] | | | | | | [Letter regarding employment arrangement of Michael McDonnell dated July 16, 2020. Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.](https://www.sec.gov/Archives/edgar/data/875045/000087504520000036/exhibit102-mcdonnellof.htm) | | |

| [removed: 10.38*] [added: 10.42*] | | | | | | [Letter regarding employment arrangement of Susan Alexander dated December 13, 2005. Filed as Exhibit 10.58 to our Annual Report on Form 10-K for the year ended December 31, 2009.](http://www.sec.gov/Archives/edgar/data/875045/000095012310010528/b77985exv10w58.htm) | | |

| 10.39* | | | | | | [Letter regarding employment arrangement of [removed: Alfred W. Sandrock, Jr.] [added: Michel Vounatsos] dated May [removed: 7, 2013.] [added: 2, 2022.] Filed as [removed: Exhibit 10.1] [added: Exhibit](https://www.sec.gov/Archives/edgar/data/875045/000087504522000013/exhibit101letteragreement.htm) [10.1] to [removed: our Quarterly] [added: our](https://www.sec.gov/Archives/edgar/data/875045/000087504522000013/exhibit101letteragreement.htm) [Current] Report on Form [removed: 10-Q for the quarter ended June 30, 2013.](https://www.sec.gov/Archives/edgar/data/875045/000087504513000027/biib-2013630xex101.htm)] [added: 8-K filed on May 3, 2022.](https://www.sec.gov/Archives/edgar/data/875045/000087504522000013/exhibit101letteragreement.htm)] | | |

| [removed: 10.40*] [added: 10.43*] | | | | | | [Letter regarding employment arrangement of [removed: Alfred Sandrock] [added: Chirfi Guindo] dated October [removed: 19, 2015.] [added: 12, 2017.] Filed as Exhibit [removed: 10.37] [added: 10.41] to our Annual Report on Form 10-K for the year ended December 31, [removed: 2015.](https://www.sec.gov/Archives/edgar/data/875045/000087504516000042/biib-20151231xex1037.htm)] [added: 2020.](https://www.sec.gov/Archives/edgar/data/0000875045/000087504521000010/biib-20201231xex1041.htm)] | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| 10.3+ | | | | | | [Amendment to Credit Agreement, dated as of February 7, 2023, by and among Biogen Inc., Bank of America, N.A., as administrative agent, swing line lender and the L&C issuer, and the other lenders party thereto.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit103amendmenttocredi.htm) | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| 10.20+ | | | | | | [Form of nonqualified](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [stock option](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [award agreement](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [under Biogen](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [Inc.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [2017](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) [Omnibus Equity Plan.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit10ormofnonqualified.htm) | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| 10.40* | | | | | | [Employment Agreement, dated November 10, 2022, by and between Biogen Inc. and Christopher A. Viehbacher. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on November 10, 2022.](https://www.sec.gov/Archives/edgar/data/875045/000119312522281950/d419645dex101.htm) | | |

| 10.45+ | | | | | | [Amended and Restated Collaboration Agreement, dated October 22, 2017, between Biogen MA Inc. and Eisai Co., LTD.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit1045amendedandresta.htm) | | |

| 10.46+ | | | | | | [First Amendment to Amended and Restated Collaboration Agreement, dated March 13, 2022, between Biogen MA Inc. and Eisai Co., LTD.](https://www.sec.gov/Archives/edgar/data/875045/000087504523000009/exhibit1046firstamendmentt.htm) | | |

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| By: | | | /S/ CHRISTOPHER A. VIEHBACHER | | |

| | | | Christopher A. Viehbacher | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| Christopher A. Viehbacher | | | | | | | | | | | | | | |

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[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| Gain on sale of building | | | | | | (503.7) | | | | | | — | | | | | | — | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| | | | 2022 | | | | | | 2021 | | |

| Goodwill | | | 5,749.0 | | | | | | 5,761.1 | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| Gain on sale of equity interest in Samsung Bioepis | | | (1,505.4) | | | | | | — | | | | | | — | | |

| Gain on sale of building | | | (503.7) | | | | | | — | | | | | | — | | |

| Proceeds from sale of equity interest in Samsung Bioepis | | | 990.3 | | | | | | — | | | | | | — | | |

| Proceeds from sale of building | | | 582.6 | | | | | | — | | | | | | — | | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| Net income | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 3,046.9 | | | | | | — | | | | | | — | | | | | | 3,046.9 | | | | | | (85.3) | | | | | | 2,961.6 | | |

| Distribution to noncontrolling interest | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| Balance, December 31, 2022 | | | — | | | | | | $ | — | | | | | 167.9 | | | | | | $ | 0.1 | | | | | $ | 73.3 | | | | | $ | (164.9) | | | | | $ | 16,466.5 | | | | | (23.8) | | | | | | $ | (2,977.1) | | | | | $ | 13,397.9 | | | | | $ | (9.5) | | | | | $ | 13,388.4 | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

| Balance, December 31, 2021 | | | — | | | | | | $ | — | | | | | 170.8 | | | | | | $ | 0.1 | | | | | $ | 68.2 | | | | | $ | (106.7) | | | | | $ | 13,911.7 | | | | | (23.8) | | | | | | $ | (2,977.1) | | | | | $ | 10,896.2 | | | | | $ | 63.5 | | | | | $ | 10,959.7 | |

[Table of](#i0cbadda4abfc4b4b9c7e5be15680d793_7) [Conten](#i0cbadda4abfc4b4b9c7e5be15680d793_7)[ts](#i0cbadda4abfc4b4b9c7e5be15680d793_7)

We also collaborate with Eisai Co., Ltd. (Eisai) on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2023.

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

We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S. We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA.

Additionally, the ongoing geopolitical tensions related to the conflict in Ukraine, and the related sanctions and other penalties imposed, are creating substantial uncertainty in the global economy.

The extent and duration of the conflict, sanctions and resulting market disruptions are highly unpredictable.

estimates.

The majority of

(ii) royalty revenue on sales of OCREVUS; and

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| 10.41* | | | | | | [Letter regarding employment arrangement of Chirfi Guindo dated October 12, 2017. Filed as Exhibit 10.41 to our Annual Report on Form 10-K for the year ended December 31, 2020.](https://www.sec.gov/Archives/edgar/data/0000875045/000087504521000010/biib-20201231xex1041.htm) | | |

| 10.42* | | | | | | [Letter regarding employment arrangement of Jeffrey Capello dated November 14, 2017. Filed as Exhibit 10.31 to our Annual Report on Form 10-K for the year ended December 31, 2017.](http://www.sec.gov/Archives/edgar/data/875045/000087504518000005/biib-20171231xex1031.htm) | | |

| 10.43* | | | | | | [Separation Agreement between Biogen Inc. and Jeffrey Capello dated July 16, 2020. Filed as Exhibit 10.3 to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.](https://www.sec.gov/Archives/edgar/data/875045/000087504520000036/exhibit103-capellosepa.htm) | | |

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| By: | | | /S/ MICHEL VOUNATSOS | | |

| | | | Michel Vounatsos | | |

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| Michel Vounatsos | | | | | | | | | | | | | | |

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| /S/ NANCY L. LEAMING | | | | | | Director | | | | | | February 3, 2022 | | |

| Nancy L. Leaming | | | | | | | | | | | | | | |

| /S/ BRIAN S. POSNER | | | | | | Director | | | | | | February 3, 2022 | | |

| Brian S. Posner | | | | | | | | | | | | | | |

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| Income from operations | | | | | | 2,840.7 | | | | | | 4,550.1 | | | | | | 7,042.6 | | |

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| Contingent consideration paid related to Fumapharm AG acquisition | | | — | | | | | | — | | | | | | (300.0) | | |

| Acquisition of Nightstar Therapeutics plc, net of cash acquired | | | — | | | | | | — | | | | | | (744.4) | | |

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| Balance, December 31, 2019 | | | — | | | | | | $ | — | | | | | 198.0 | | | | | | $ | 0.1 | | | | | $ | — | | | | | $ | (135.2) | | | | | $ | 16,455.4 | | | | | (23.8) | | | | | | $ | (2,977.1) | | | | | $ | 13,343.2 | | | | | $ | (4.1) | | | | | $ | 13,339.1 | |

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| Balance, December 31, 2018 | | | — | | | | | | $ | — | | | | | 221.0 | | | | | | $ | 0.1 | | | | | $ | — | | | | | $ | (240.4) | | | | | $ | 16,257.0 | | | | | (23.8) | | | | | | $ | (2,977.1) | | | | | $ | 13,039.6 | | | | | $ | (8.0) | | | | | $ | 13,031.6 | |