During the first quarter of 2022 we recorded approximately $275.0 million of gross charges associated with the write-off of inventory and purchase commitments in excess of forecasted demand related to ADUHELM. For the nine months ended September 30, 2022, we have also recorded approximately $76.0 million of aggregate gross idle capacity charges related to ADUHELM.

We have recognized approximately $177.0 million related to Eisai's 45.0% share of inventory and idle capacity charges in collaboration profit (loss) sharing within our condensed consolidated statements of income for the nine months ended September 30, 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 initiation of 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.

In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. Effective March 2022, we have sole decision making and commercialization rights worldwide on ADUHELM and beginning January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM, rather than sharing global profits and losses. Eisai's share of development, commercialization and manufacturing expense is limited to $335.0 million for the period from January 1, 2022 to December 31, 2022. As of September 30, 2022, Eisai's portion of these expenses was approximately $300.0 million. Once this limit is achieved, we will be responsible for all ADUHELM related development costs. After the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM’s economics beyond these royalties.

InnoCare Pharma Limited

In July 2021 we entered into a ~~license~~collaboration and ~~collaboration~~license agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule ~~Bruton's~~Bruton’s tyrosine kinase inhibitor for the potential treatment of MS. Orelabrutinib is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS. Under the terms of the 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 the closing of this transaction in August 2021 we made an upfront payment of $125.0 million that was recorded as research and development expense in our condensed consolidated statements of income. We may also pay InnoCare up to approximately $812.5 million in potential development milestones and potential commercial payments should this collaboration achieve certain development, commercial milestones and sales thresholds. In addition, we may pay InnoCare tiered royalties on potential net sales of any products developed under this collaboration in the low to high teen percentages.

Other Research and Discovery Arrangements

These arrangements may include the potential for future milestone payments based on the achievement of certain clinical and commercial development payable over a period of several years.

Other

For the three and nine months ended September 30, 2022, we recorded $14.0 million and $51.5 million, respectively, as research and development expense in our condensed consolidated statements of income related to other research and discovery related arrangements, compared to $7.7 million and $84.9 million, respectively, in the prior year comparative periods.

Samsung Bioepis Co., Ltd.

Joint Venture Agreement

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

In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction.

As part of the transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones. Our policy for contingent payments of this nature is to recognize them in the period that they become realizable, which is generally the same period in which they are earned.

Prior to this sale, we recognized our share of the results of operations related to our investment in Samsung Bioepis under the equity method of accounting one quarter in arrears when the results of the entity became available, which was reflected as equity in (income) loss of investee, net of tax in our condensed consolidated statements of income.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, continued)

Upon investment, the equity method of accounting required us to identify and allocate differences between the fair value of our investment and the carrying value of our interest in the underlying net assets of the investee. These basis differences were being amortized over their economic life until the completion of the sale in April 2022, as discussed above. The total basis difference was approximately $675.0 million and related to inventory, developed technology, IPR&D and deferred tax balances. The basis differences related to inventory were amortized, net of tax, over their estimated useful lives of 1.5 years, and the basis differences related to developed technology and IPR&D for marketed products were being amortized, net of tax, over their estimated useful lives of 15 years.

For the nine months ended September 30, 2022, we recognized net income on our investment of $2.6 million, reflecting our share of Samsung Bioepis' operating profits, net of tax totaling $17.0 million, offset by amortization of basis differences totaling $14.4 million. This amount reflects our share of results prior to the sale of Samsung Bioepis as the results are recognized one quarter in arrears. Following the sale of Samsung Bioepis we no longer recognize gains or losses associated with Samsung Bioepis' results of operations and amortization related to basis differences.

For the three and nine months ended September 30, 2021, we recognized net income on our investment of $1.1 million and $17.2 million, respectively, reflecting our share of Samsung Bioepis' operating profits, net of tax totaling $8.9 million and $39.5 million, respectively, offset by amortization of basis differences totaling $7.8 million and $22.3 million, respectively.

As of December 31, 2021, the carrying value of our investment in Samsung Bioepis totaled 713.3 billion South Korean won ($599.9 million), which is classified as a component of investments and other assets in our condensed consolidated balance sheets. In connection with the sale of Samsung Bioepis, the carrying value of our investment was reduced to zero.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements.

2019 Development and Commercialization Agreement

In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, BYOOVIZ (ranibizumab-nuna), a ranibizumab biosimilar referencing LUCENTIS, and SB15, a proposed aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia. Samsung Bioepis will be responsible for development and will supply both products to us at a pre-specified gross margin of approximately 45.0%.

In connection with this transaction, we made an upfront payment of $100.0 million to Samsung Bioepis in January 2020, of which $63.0 million was recorded as research and development expense in our condensed consolidated statements of income in 2019 and $37.0 million was recorded as intangible assets, net in our condensed consolidated balance sheets in 2019.

During the third quarter of 2021 we accrued $15.0 million in milestone payments related to the approval of BYOOVIZ in the U.S., the E.U. and the United Kingdom (U.K.), that were capitalized within intangible assets, net in our condensed consolidated balance sheets. We may also pay Samsung Bioepis up to approximately $180.0 million in additional development, regulatory and sales-based milestones.

We also acquired an option to extend the term of our 2013 commercial agreement for BENEPALI, IMRALDI and FLIXABI by an additional five years, subject to payment of an option exercise fee of $60.0 million, and obtained an option to acquire exclusive rights to commercialize these products in China.

2013 Commercial Agreement

We reflect revenue on sales of BENEPALI, IMRALDI and FLIXABI to third parties in product revenue, net in our condensed consolidated statements of income and record the related cost of revenue and sales and marketing expense in our condensed consolidated statements of income to their respective line items when these costs are incurred.

We share 50.0% of the profit or loss related to our commercial agreement with Samsung Bioepis, which is recognized in collaboration profit (loss) sharing in our condensed consolidated statements of income. For the three and nine months ended September 30, 2022, we recognized net profit-sharing expense of $48.7 million and $171.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits, compared to a net profit-sharing expense of $71.8 million and $210.2 million, respectively, in the prior year comparative periods.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, continued)

Other Services

Simultaneous with the formation of Samsung Bioepis, we also entered into a technical development services agreement, a manufacturing agreement and a license agreement with Samsung Bioepis. Revenue related to these services is reflected in revenue from collaborative and other relationships as a component of other revenue in our condensed consolidated statements of income.

Amounts receivable from Samsung Bioepis related to the agreements discussed above were $1.8 million and $4.1 million as of September 30, 2022 and December 31, 2021, respectively. Amounts payable to Samsung Bioepis related to the agreements discussed above were $53.8 million and $148.7 million as of September 30, 2022 and December 31, 2021, respectively.

For additional information on our ~~proposed~~ collaboration arrangements with ~~InnoCare,~~Samsung Bioepis and our other significant collaboration arrangements, please read Note ~~16,~~ 18,Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.

19. INVESTMENTS IN VARIABLE INTEREST ENTITIES

Consolidated Variable Interest Entities

Our condensed consolidated financial statements include the financial results of variable interest entities in which we are the primary beneficiary. The following are our significant variable interest entities.

Neurimmune SubOne AG

We have a collaboration and license agreement with Neurimmune for the development and commercialization of antibodies for the potential treatment of Alzheimer's disease, including ADUHELM (as amended, the Neurimmune Agreement). We are responsible for the development, manufacturing and commercialization of all collaboration products. The Neurimmune Agreement is effective for the longer of the duration of certain patents relating to a licensed product or 12 years from the first commercial sale of a licensed product.

We consolidate the results of Neurimmune as we determined that we are the primary beneficiary of Neurimmune because we have the power through the collaboration to direct the activities that most significantly impact the entity’s economic performance and we are required to fund 100.0% of the research and development costs incurred in support of the collaboration.

In June 2021 ADUHELM was granted accelerated approval by the FDA. Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $100.0 million related to the launch of ADUHELM in the U.S. During the second quarter of 2021 we made this $100.0 million payment, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our condensed consolidated statements of income. In addition, during the second quarter of 2021 we recognized net profit-sharing income of $45.0 million to reflect Eisai's 45.0% share of the $100.0 million milestone payment, which was recognized in collaboration profit (loss) sharing in our condensed consolidated statements of income.

During the second quarter of 2021 we recorded a net deferred tax asset in Switzerland of approximately $490.0 million on Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, we recorded a valuation allowance of approximately $390.0 million related to this deferred tax asset. During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an additional valuation allowance of approximately $85.0 million to reduce the net value of this deferred tax asset to zero. These adjustments to our deferred tax assets and their valuation allowances are each recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our condensed consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.

Excluding the impact of the Neurimmune deferred tax asset, the assets and liabilities of Neurimmune are not significant to our condensed consolidated financial position or results of operations as it is a research and development organization. We have provided no financing to Neurimmune other than contractually required amounts.

For additional information on our collaboration arrangements with Eisai, please read Note 18, Collaborative and Other Relationships, to these condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, continued)

Unconsolidated Variable Interest Entities

We have relationships with various variable interest entities that we do not consolidate as we lack the power to direct the activities that significantly impact the economic success of these entities. These relationships include investments in certain biotechnology companies and research collaboration agreements.

As of September 30, 2022 and December 31, 2021, the carrying value of our investments in certain biotechnology companies representing potential unconsolidated variable interest entities totaled $25.3 million and $24.6 million, respectively. Our maximum exposure to loss related to these variable interest entities is limited to the carrying value of our investments.

We have also entered into research collaboration agreements with certain variable interest entities where we are required to fund certain development activities. These development activities are included in research and development expense in our condensed consolidated statements of income as they are incurred. We have provided no financing to these variable interest entities other than previous contractually required amounts.

For additional information on our investments in Neurimmune and other variable interest entities, please read Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in our 2021 Form 10-K.

20. LITIGATION

We are currently involved in various claims and legal proceedings, including the matters described below. For information as to our accounting policies relating to claims and legal proceedings, including use of estimates and contingencies, please read Note 1, Summary of Significant Accounting Policies, to our consolidated financial statements included in our 2021 Form 10-K.

With respect to some loss contingencies, an estimate of the possible loss or range of loss cannot be made until management has further information, including, for example, (i) which claims, if any, will survive dispositive motion practice; (ii) information to be obtained through discovery; (iii) information as to the parties' damages claims and supporting evidence; (iv) the parties’ legal theories; and (v) the parties' settlement positions.

The claims and legal proceedings in which we are involved also include challenges to the scope, validity or enforceability of the patents relating to our products, pipeline or processes and challenges to the scope, validity or enforceability of the patents held by others. These include claims by third parties that we infringe their patents. An adverse outcome in any of these proceedings could result in one or more of the following and have a material impact on our business or consolidated results of operations and financial position: (i) loss of patent protection; (ii) inability to continue to engage in certain activities; and (iii) payment of significant damages, royalties, penalties and/or license fees to third parties.

Loss Contingencies

ADUHELM Securities Litigation

We and certain current and former officers are named as defendants in actions filed by shareholders in November 2020 (the November 2020 Securities Action) and February 2022 (the February 2022 Securities Action) and pending in the U.S. District Court for the District of Massachusetts. The actions allege violations of federal securities laws under 15 U.S.C §78j(b) and §78t(a) and 17 C.F.R. §240.10b-5 and seek declarations of the actions as class actions and monetary relief. In September 2022, the court dismissed the November 2020 Securities Action, and the plaintiff has appealed to the U.S. Court of Appeals for the First Circuit. Our motion to dismiss the February 2022 Securities Action is pending. An estimate of the possible loss or range of loss cannot be made at this time.

Derivative Action

We and members of the Board of Directors are named as defendants in derivative actions filed by shareholders on February 9 and July 21, 2022, in the U.S. District Court for the District of Massachusetts. The actions allege violations of federal securities laws under 15 U.S.C. §78n(a) and 17 C.F.R. §240 14.a-9, breaches of fiduciary duties and waste of corporate assets, and seek declaratory and injunctive relief, monetary relief payable to Biogen, and attorneys’ fees and costs payable to the plaintiffs. The court has stayed both cases. An estimate of the possible loss or range of loss cannot be made at this time.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, continued)

IMRALDI Patent Litigation

In September 2018 Fresenius Kabi Deutschland GmbH (Fresenius Kabi) commenced proceedings for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris and proceedings against Biogen GmbH in the Düsseldorf Regional Court, alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes national counterparts of European Patent No. 3 148 510 (the EP '510 Patent). In June 2022 Fresenius Kabi amended both actions to assert claims under European Patent 3 145 488 (the EP ‘488 Patent), which expires in May 2035. No hearing has been set in either action.

In June 2020 Fresenius Kabi commenced preliminary injunction proceedings in Denmark's Maritime and Commercial High Court alleging that IMRALDI infringes the Danish counterpart of the EP '488 Patent and a corresponding Danish utility model, DK 2020 00038 Y3. In September 2021 the Court refused Fresenius Kabi's request for a preliminary injunction, finding that the patent and utility model are invalid and not infringed. Fresenius Kabi has appealed to the High Court of Eastern Denmark, and a hearing is scheduled for January 2023.

In June 2022 the Technical Boards of Appeal (TBA) of the European Patent Office (EPO) affirmed the revocation of the EP '510 Patent, which resolves all pending infringement claims under the EP '510 Patent. The EPO has scheduled a hearing on the validity of the EP '488 Patent for October 26, 2022.

In July 2019 Gedeon Richter Nyrt commenced proceedings for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court, alleging infringement of the German counterpart of European Patent No. 3 212 667 (EP '667 Patent), which expires in October 2035. The case has been stayed pending proceedings in the EPO to invalidate the EP '667 Patent.

In July 2021 the Opposition Division of the EPO revoked the EP '667 Patent. Gedeon Richter Nyrt have appealed that decision to the TBA of the EPO. No hearing has been set in that appeal.

In November 2020 Gedeon Richter Nyrt commenced proceedings against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of a German utility model corresponding to EP '667. The proceeding has been stayed pending the outcome of proceedings that Biogen has filed in the German Patent and Trademark Office to cancel the utility model. No hearing has been set in the cancellation proceedings.

An estimate of the possible loss or range of loss in the IMRALDI patent litigation described above cannot be made at this time.

Qui Tam Litigation

In September 2022, without admitting any liability, we agreed to pay $900.0 million to settle previously disclosed litigation unsealed in July 2015 and filed by Michael Bawduniak on behalf of the U.S. and certain states in the U.S. District Court for the District of Massachusetts alleging violations of the federal False Claims Act and state law counterparts. In October 2022 the court dismissed the case with prejudice.

Dispute with Former Convergence Shareholders

In November and December 2019 Shareholder Representative Services LLC, on behalf of the former shareholders of Convergence, sent us correspondence asserting claims of $200.0 million for alleged breach of the contract under which we acquired Convergence. We dispute the claims.

ERISA Class Action Litigation

In September 2020 the U.S. District Court for the District of Massachusetts consolidated two cases filed against us in July and August 2020 by participants in the Biogen 401(k) Savings Plan, alleging breach of fiduciary duty under ERISA. Plaintiffs seek a declaration of the action as a class action and monetary and other relief. An estimate of the possible loss or range of loss cannot be made at this time.

Humana Patient Assistance Litigation

In September 2021 Humana Inc. (Humana) filed suit against us in the U.S. District Court for the District of Massachusetts, alleging damages related to our providing MS patients with free medications and making charitable contributions to non-profit organizations that assist MS patients. Humana alleges violation of the federal RICO Act and state laws and seeks statutory treble damages, attorneys' fees and costs. We filed a motion to dismiss, which is pending. An estimate of the possible loss cannot be made at this time.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, continued)

Other Matters

Government Investigations

The U.S. House of Representatives Committees on Oversight and Reform and Energy and Commerce and the Office of Inspector General of the U.S. Department of Health and Human Services have announced investigations relating to ADUHELM. The Company also received a civil investigative demand from the Federal Trade Commission (FTC) and a subpoena from the Securities and Exchange Commission seeking information relating to ADUHELM, including healthcare sites, ADUHELM’s approval and ADUHELM’s marketing. In July 2022 the FTC informed us that it had closed its investigation.

TECFIDERA Patent Matters

In October 2022 the U.S. Supreme Court denied our petition for writ of certiorari for review of the previously disclosed decision of the U.S. Court of Appeals for the Federal Circuit holding that the asserted claims of our U.S. Patent No. 8,399,514 (the '514 Patent) are invalid. Thereafter, we moved to dismiss our appeals from the judgments in the previously disclosed Delaware Actions, and we and Mylan Pharmaceuticals, Inc. (Mylan) agreed that the judgment in our favor in the previously reported inter partes review filed by Mylan in 2018 should be vacated.

TYSABRI Patent Matters

In September 2022 we filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc. and Polpharma Biologics S.A. under the Biologics Price Competition and Innovation Act, 42 U.S.C. §262, seeking a declaratory judgment of patent infringement, following our receipt of Sandoz inc.'s notice of intent to commercially market a biosimilar version of TYSABRI (natalizumab). No trial date has been set.

In November 2017 Swiss Pharma International AG, affiliated with the Polpharma Group, filed an action in the Commercial Court of Rome to invalidate the Italian counterpart of the European Patent No. 1 485 127 (the EP '127 Patent), which covers administration of natalizumab to treat MS and expires in February 2023. A hearing has been set for November 2022.

In August 2020 Polpharma Biologics S.A. brought an action in the Polish Patent Office to revoke our Polish Patent No. 215263, which corresponds to the EP '127 Patent and expires in February 2023. The action was suspended by the Polish Patent Office in April 2021 pending examination of our amended patent claims.

In June 2021 Polpharma Biologics S.A., Sandoz B.V. and Sandoz AG filed an action in the District Court of the Hague, Netherlands to invalidate the Dutch counterpart of our European Patent 2 676 967 (the EP '967 Patent), which expires in 2027 and covers methods of treatment using natalizumab (TYSABRI) and pre-treatment testing of patients. A hearing has not been scheduled.

In July 2021 the EPO revoked the EP ‘967 Patent. A hearing on our appeal to the TBA of the EPO is set for December 2022.

In September 2021 Polpharma Biologics S.A., Sandoz AG, Sandoz Limited and Sandoz GmbH filed an action in the English High Court to revoke the U.K. counterpart of the EP ‘967 Patent and seeking a declaration that the patent would not be infringed by the marketing of Polpharma’s proposed natalizumab biosimilar. A hearing has been set for February 2023.

Annulment Proceedings in the General Court of the European Union relating to TECFIDERA

Pharmaceutical Works Polpharma SA (Polpharma) and Mylan Ireland Ltd. (Mylan Ireland) each filed actions in the General Court of the European Union (Polpharma in October 2018 and Mylan Ireland in November 2020) to annul the European Medicines Agency's (EMA) decision not to validate their applications to market generic versions of TECFIDERA on the grounds that TECFIDERA benefits from regulatory data protection. On May 5, 2021, the European General Court annulled the EMA's non-validation decision with respect to Polpharma. We have appealed the decision to the European Court of Justice and the appeal is pending. The case brought by Mylan Ireland has been stayed.

Product Liability and Other Legal Proceedings

We are also involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial condition.

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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements (condensed consolidated financial statements) and the accompanying notes beginning on page 5 of this quarterly report on Form 10-Q and our audited consolidated financial statements and the accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2021 (2021 Form 10-K).

Executive Summary

Introduction

Biogen is a global biopharmaceutical company focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and developed the first and only approved treatment to address a defining pathology of Alzheimer's disease. We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology. Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities.

Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. 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); and other potential anti-CD20 therapies, 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 18,

Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.

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 collaboration with Samsung Bioepis Co., Ltd. (Samsung Bioepis) 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, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

~~Other Key Developments~~

~~Exchange Offer~~

We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we continually review our manufacturing capacity, capabilities, processes and facilities. In ~~February 2021~~order to support our future growth and drug development pipeline, we ~~completed~~are expanding our large molecule production capacity by building a private offer to exchange (Exchange Offer) our tendered 5.200% Senior Notes due September 15, 2045 (2045 Senior Notes) for a new series of 3.250% Senior Notes due February 15, 2051 (2051 Senior Notes) and cash, and an offer to purchase our tendered 2045 Senior Notes for cash.

~~For additional information on our Exchange Offer, please read~~ ~~Note 10, Indebtedness, to our condensed consolidated financial statements included in this report.~~

~~North Carolina Gene Therapy Manufacturing Facility~~

~~In March 2021 we announced our plans to build a new gene therapy~~large-scale biologics manufacturing facility in ~~Research Triangle Park, North Carolina to support our growing gene therapy pipeline across multiple therapeutic areas. The new~~Solothurn, Switzerland. In the second quarter of 2021 a portion of the facility received a Good Manufacturing Practice (GMP) multi-product license from the Swiss Agency for Therapeutic Products (SWISSMEDIC). In April 2022 the United States (U.S.) Food and Drug Administration (FDA) approved the Prior Approval Supplement for the Solothurn facility for ADUHELM. We estimate the second manufacturing suite at the Solothurn facility will be ~~175,000 square feet and is expected to be~~ operational ~~by 2023, with an estimated total investment of approximately $200.0 million.~~

~~Solothurn, Switzerland Manufacturing Facility~~

~~In May 2021 we announced that a portion of our Solothurn manufacturing facility received a GMP multi-product license from SWISSMEDIC.~~

~~For additional information on our Solothurn manufacturing facility, please read~~ ~~Note 9, Property, Plant and Equipment, to our condensed consolidated financial statements included in this report.~~

~~BIIB125 (zuranolone)~~

In June 2021 we and Sage Therapeutics, Inc. (Sage) announced positive Phase 3 results for BIIB125 (zuranolone) for the potential treatment of major depressive disorder (MDD) and postpartum depression (PPD). In October 2021 we and Sage announced our plan to submit an NDA to the FDA for zuranolone induring the second half of ~~2022, with rolling~~

~~submission expected~~2023. We believe that the Solothurn facility will support our anticipated near-term needs for the manufacturing of biologic assets. If we are unable to ~~start in early 2022. The planned initial submission package~~fully utilize our manufacturing facilities, due to lower than forecasted demand for our products, we will ~~seek approval of zuranolone for MDD, and an additional filing for PPD is anticipated in the first half of 2023.~~

~~For additional information~~incur excess capacity charges which will have a negative effect on our ~~collaboration arrangement with Sage, please read~~ ~~Note 16, Collaborative~~financial condition and ~~Other Relationships~~,results of operations.

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

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 ~~condensed consolidated financial statements included in this report.~~

~~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 on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early Alzheimer's disease and confirmed amyloid pathology.

~~BYOOVIZ (ranibizumab-nuna)~~

In September 2021 we and Samsung Bioepis 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 Europe in August 2021.

~~BIIB067 (tofersen)~~

In October 2021 we announced topline results from our pivotal Phase 3 VALOR study of BIIB067 (tofersen), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), indicating that the primary endpoint was not met. We are engaging with regulators and other key stakeholders to determine potential next steps.marketed

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~~Results~~

products, assets originating from our research and development efforts and/or successful execution of ~~Operations~~external business development opportunities.

~~Revenue~~Business Environment

~~Revenue~~The biopharmaceutical industry and the markets in which we operate are intensely competitive. Many of our competitors are working to develop or have commercialized products similar to those we market or are developing and have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. In addition, the commercialization of certain of our own approved products, products of our collaborators and pipeline product candidates may negatively impact future sales of our existing products.

Our products and revenue streams continue to face increasing competition in many markets from generic versions, prodrugs and biosimilars of existing products as well as products approved under abbreviated regulatory pathways. Such products are likely to be sold at substantially lower prices than branded products. Accordingly, the introduction of such products as well as other lower-priced competing products may significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which will negatively impact our revenue. In addition, in some markets, when a generic or biosimilar version of one of our products is ~~summarized~~commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time.

Sales of our products depend, to a significant extent, on the availability and extent of adequate coverage, pricing and reimbursement from government health administration authorities, private health insurers and other organizations. When a new pharmaceutical product is approved, the availability of government and private reimbursement for that product may be uncertain, as ~~follows:~~is the pricing and amount for which that product will be reimbursed.

For the Three Months Ended September 30,
(In millions, except percentages) 2021 2020 $ Change % Change
Product revenue, net:
United States $ 973.5 35.0 % $ 1,498.2 44.4 % $ (524.7) (35.0) %
Rest of world 1,232.2 44.4 1,192.1 35.3 40.1 3.4
Total product revenue, net 2,205.7 79.4 2,690.3 79.7 (484.6) (18.0)
Revenue from anti-CD20 therapeutic programs 415.4 14.9 560.1 16.6 (144.7) (25.8)
Other revenue 157.8 5.7 125.7 3.7 32.1 25.5
Total revenue $ 2,778.9 100.0 % $ 3,376.1 100.0 % $ (597.2) (17.7) %
Drug prices are under significant scrutiny in the markets in which our products are prescribed, for example the Inflation Reduction Act of 2022 (the IRA) has certain provisions related to drug pricing. We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis.

For the Nine Months Ended September 30,
(In millions, except percentages) 2021 2020 $ Change % Change
Product revenue, net:
United States $ 2,850.7 34.6 % $ 4,803.1 45.3 % $ (1,952.4) (40.6) %
Rest of world 3,802.7 46.1 3,587.5 33.9 215.2 6.0
Total product revenue, net 6,653.4 80.7 8,390.6 79.2 (1,737.2) (20.7)
Revenue from anti-CD20 therapeutic programs 1,244.4 15.1 1,558.8 14.7 (314.4) (20.2)
Other revenue 350.1 4.2 642.6 6.1 (292.5) (45.5)
Total revenue $ 8,247.9 100.0 % $ 10,592.0 100.0 % $ (2,344.1) (22.1) %
Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenue and results of operations, could curtail or eliminate our ability to adequately fund research and development programs for the discovery and commercialization of new products and/or could cause a decline or volatility in our stock price.

~~Product Revenue~~

~~Product revenue is summarized~~In addition to the impact of competition, pricing actions and other measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, our sales and operations could also be affected by other risks of doing business internationally, including the impact of public health epidemics, such as ~~follows:~~

For the Three Months Ended September 30,
(In millions, except percentages) 2021 2020 $ Change % Change
Multiple Sclerosis:
Fumarate* $ 619.5 28.1 % $ 967.5 36.0 % $ (348.0) (36.0) %
Interferon** 387.5 17.6 474.1 17.6 (86.6) (18.3)
TYSABRI 522.8 23.7 516.5 19.2 6.3 1.2
FAMPYRA 26.2 1.2 26.8 1.0 (0.6) (2.2)
Subtotal: MS product revenue 1,556.0 70.5 1,984.9 73.8 (428.9) (21.6)
Spinal Muscular Atrophy:
SPINRAZA 444.1 20.1 494.4 18.4 (50.3) (10.2)
Alzheimer's disease:
ADUHELM*** 0.3 — — — 0.3 nm
Biosimilars:
BENEPALI 120.8 5.5 124.2 4.6 (3.4) (2.7)
IMRALDI 57.4 2.6 56.2 2.1 1.2 2.1
FLIXABI 24.6 1.1 27.5 1.0 (2.9) (10.5)
Subtotal: Biosimilar product revenue 202.8 9.2 207.9 7.7 (5.1) (2.5)
Other:
FUMADERM 2.5 0.1 3.1 0.1 (0.6) (19.4)
Total product revenue, net $ 2,205.7 100.0 % $ 2,690.3 100.0 % $ (484.6) (18.0) %

*Fumarate includes TECFIDERAthe COVID-19 pandemic, on employees, the global economy and ~~VUMERITY.~~

**Interferon includes AVONEXthe delivery of healthcare treatments, geopolitical events, supply chain disruptions, foreign currency exchange fluctuations, changes in intellectual property legal protections and ~~PLEGRIDY.~~changes in trade regulations and procedures.

~~***~~For a detailed discussion on our business environment, please read Item 1. Business, in our 2021 Form 10-K. For additional information on our competition and pricing risks that could negatively impact our product sales, please read Item 1A. Risk Factors included in this report.

ADUHELM (aducanumab)

U.S.

In June 2021 the FDA granted accelerated approval of ADUHELM, which ~~became commercially available in the U.S. during the second quarter of 2021~~. ~~For additional information, please read~~ ~~Note 16, Collaborative and Other Relationships~~-we are collaborating on with Eisai Co., Ltd. ~~- ADUHELM Collaboration Agreement~~(Eisai), ~~to our condensed consolidated financial statements included~~based on reduction in ~~this report.~~

nm ~~Not meaningful~~

~~Table~~amyloid beta plaques observed in patients treated with ADUHELM. As part of ~~Contents~~

For the Nine Months Ended September 30,
(In millions, except percentages) 2021 2020 $ Change % Change
Multiple Sclerosis:
Fumarate* $ 1,750.9 26.3 % $ 3,258.6 38.9 % $ (1,507.7) (46.3) %
Interferon** 1,188.4 17.9 1,421.5 17.0 (233.1) (16.4)
TYSABRI 1,550.4 23.3 1,470.9 17.5 79.5 5.4
FAMPYRA 78.8 1.2 78.1 0.9 0.7 0.9
Subtotal: MS product revenue 4,568.5 68.7 6,229.1 74.3 (1,660.6) (26.7)
Spinal Muscular Atrophy:
SPINRAZA 1,464.4 22.1 1,554.0 18.5 (89.6) (5.8)
Alzheimer's disease:
ADUHELM*** 2.0 — — — 2.0 nm
Biosimilars:
BENEPALI 363.9 5.5 363.9 4.3 — —
IMRALDI 170.9 2.6 162.6 1.9 8.3 5.1
FLIXABI 75.4 1.1 71.8 0.9 3.6 5.0
Subtotal: Biosimilar product revenue 610.2 9.2 598.3 7.1 11.9 2.0
Other:
FUMADERM 8.3 0.1 9.2 0.1 (0.9) (9.8)
Total product revenue, net $ 6,653.4 100.0 % $ 8,390.6 100.0 % $ (1,737.2) (20.7) %

*Fumarate includes TECFIDERA and VUMERITY.

**Interferon includes AVONEX and PLEGRIDY.

***In June 2021 the ~~FDA granted~~ accelerated approval, we are required to 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.

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 ~~became commercially available~~was studied in clinical trials.

In January 2022 the ~~U.S. during~~Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memorandum, stating the ~~second quarter~~proposed NCD would cover FDA approved monoclonal antibodies that target amyloid for the treatment of ~~2021. For additional information, please read~~ ~~Note 16, Collaborative and Other Relationships- Eisai Co., Ltd. -~~Alzheimer's disease for people with Medicare only if they are enrolled in qualifying clinical trials.

In April 2022 CMS released the 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. We expect that this decision will reduce future demand for ADUHELM ~~Collaboration Agreement~~, to ~~our condensed consolidated financial statements included in this report.~~a minimal level.

nm ~~Not meaningful~~

5248

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~~Multiple Sclerosis (MS)~~

~~Fumarate~~

~~Fumarate revenue includes sales from TECFIDERA~~During the first quarter of 2022 we recorded approximately $275.0 million of gross charges associated with the write-off of inventory and ~~VUMERITY. In October 2019 the FDA approved VUMERITY for the treatment~~purchase commitments in excess of ~~RMS and VUMERITY became commercially available in the U.S. in November 2019.~~

forecasted demand related to ADUHELM. For the ~~three and nine~~months ended September 30, 2021, compared to the same periods in 2020, the decreases of 56% and 66%, respectively, in U.S. Fumarate revenue were primarily due to a decrease in TECFIDERA demand as a result of multiple TECFIDERA generic entrants in the U.S. market. The decrease was partially offset by an increase in VUMERITY sales volume.

~~For the three and~~ nine months ended September 30, ~~2021, compared~~2022, we have also recorded approximately $76.0 million of aggregate gross idle capacity charges related to ADUHELM.

Rest of World

In October 2020 the ~~increases~~European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for aducanumab and in December 2020 the Ministry of ~~13%~~Health, Labor and ~~8%, respectively, in rest of world Fumarate revenue were primarily due to increases in TECFIDERA sales volumes of 10% and 7%, respectively.~~

~~In June 2020 and September 2020 judgments were entered in favor of~~Welfare accepted for review the ~~defendants in the patent~~Japanese New Drug Application (NDA) for aducanumab.

~~infringement proceedings relating~~In December 2021 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a negative opinion on the MAA for aducanumab in Europe. We sought re-examination of the opinion by the CHMP. In April 2022 we announced our decision to ~~TECFIDERA Orange-Book listed patents pursuant to the Hatch-Waxman Act~~withdraw our MAA for aducanumab in ~~West Virginia and Delaware. We have appealed the judgments in both actions.~~Europe.

TECFIDERA

Multiple TECFIDERA generic entrants are now in the U.S. ~~market~~and European Union (E.U.) markets and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and is expected to continue to have a substantial and increasing negative impact on our TECFIDERA revenue ~~for as long as there~~in the future.

In the U.S., the U.S. Supreme Court declined in October 2022 to review the appellate decision holding that claims of our U.S. Patent No. 8,399,514, related to TECFIDERA, are invalid.

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 ~~generic competition.~~

~~We anticipate an increase in TECFIDERA sales volume in rest~~entitled to regulatory data and market protection until at least February 2024. Our Company, the EMA and the European Commission (EC) have each appealed the May 2021 decision of ~~world in 2021, compared to 2020, notwithstanding the increasing competition from additional treatments for MS and potential disruptions due, directly or indirectly, to the COVID-19 pandemic.~~

~~On May 5, 2021,~~ the European General Court, which annulled the EMA's ~~non-validation~~ decision ~~with respect~~not to validate an application for approval of a TECFIDERA generic ~~application related to TECFIDERA in~~on the ~~E.U. This generic application is now before~~basis that the EMA ~~which is reassessing~~and EC conducted the wrong assessment when determining TECFIDERA's entitlement to regulatory data ~~protection by performing a scientific assessment pursuant to the European General Court's decision. The result of the scientific assessment of~~and marketing protection. Our Company, the EMA ~~is expected in~~and the ~~fourth quarter of 2021. We~~EC have each appealed the ~~European~~ General ~~Court's~~Court’s decision ~~to the European Court of Justice~~as wrongly decided and the appeal is pending.

On October 6, 2022, the Advocate General of the Court of Justice of the European Union (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 ~~will face TECFIDERA generic competition in~~are awaiting the ~~E.U. if regulatory data protection is not upheld and we expect that this would have an adverse impact on our TECFIDERA sales and our results~~decision of ~~operations.~~the CJEU.

For additional information, please read Note 20, Litigation, to our condensed consolidated financial statements included in this report and the discussion under Results of Operations - Product Revenue - Multiple Sclerosis (MS) - Fumarate below.

Business Update Regarding COVID-19 and Other Disruptions

COVID-19

The COVID-19 pandemic continues to present a substantial public health and economic challenge around the world. The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, the supply chain, manufacturing, clinical trials, research and development costs and

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employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets.

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

While we are currently continuing the clinical trials we have underway in sites across the globe, COVID-19 precautions have impacted the timeline for some of our clinical trials and these precautions may, directly or indirectly, have a further impact on timing in the future.

Conflict in Ukraine

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. For example, the development of orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor for the potential treatment of MS, that we are developing with InnoCare Pharma Limited (InnoCare) has been delayed and will require the establishment of new clinical sites in other geographies. 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. Revenue generated from sales in these regions represented less than 2.0% of total product revenue for the three and nine months ended September 30, 2022 and the year ended December 31, 2021.

We will continue to monitor the ongoing conflict between Russia and Ukraine and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations.

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

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

Inflation Reduction Act of 2022

In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA will be effective for periods after December 31, 2022. The enactment of the IRA did not result in any material adjustments to our income tax provision or net deferred tax assets as of September 30, 2022. We expect additional guidance and regulations to be issued in future periods and will continue to assess its potential impact on our business and results of operations as further information becomes available.

The IRA also contains substantial drug pricing reforms that may have a significant impact on the pharmaceutical industry in the U.S. This includes allowing CMS to negotiate a maximum fair price for certain high-priced single source Medicare drugs, as well as redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, potentially resulting in higher contributions from plans and manufacturers. The IRA also establishes drug inflationary rebate requirements to penalize manufacturers from raising the prices of Medicare covered single-source drugs and biologics beyond the inflation-adjusted rate. Further, to incentivize biosimilar development, the IRA provides an 8.0% Medicare Part B add-on payment for qualifying biosimilar products for a five-year period.

The overall impact that the IRA will have on our business, results of operations and financial condition, and the impact on the pharmaceutical industry as a whole is not yet known. We will continue to assess as further information becomes available.

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Financial Highlights

Diluted earnings per share attributable to Biogen Inc. was $7.84 for the three months ended September 30, 2022, representing an increase of 253.2% compared to $2.22 in the same period in 2021.

As described below under Results of Operations, our net income and diluted earnings per share attributable to Biogen Inc. for the three months ended September 30, 2022, compared to the three months ended September 30, 2021, reflects the following:

Revenue

•Total revenue was $2,508.5 million for the third quarter of 2022, representing a $270.4 million, or 9.7%, decrease compared to $2,778.9 million in the same period in 2021.

•Product revenue, net totaled $1,962.1 million for the third quarter of 2022, representing a $243.6 million, or 11.0%, decrease compared to $2,205.7 million in the same period in 2021. This decrease was primarily due to a $215.7 million, or 13.9%, decrease in MS product revenue and a $13.0 million, or 2.9%, decrease in SPINRAZA product revenue.

◦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 and a decrease in Interferon demand due to competition.

◦The decrease in SPINRAZA revenue was primarily due to the unfavorable impact of foreign currency exchange, as well as a decrease in demand as a result of increased competition in certain established markets, particularly Germany and Japan, and the timing of shipments.

◦The decrease was also due to a decrease in biosimilar revenue primarily due to unfavorable pricing and the unfavorable impact of foreign currency exchange.

•Revenue from anti-CD20 therapeutic programs totaled $416.9 million for the third quarter of 2022, representing a $1.5 million, or 0.4%, increase compared to $415.4 million in the same period in 2021. This increase was primarily due to a $16.9 million, or 6.4%, increase in royalty revenue on sales of OCREVUS, partially offset by a $14.9 million, or 11.8%, decrease in RITUXAN revenue. Sales of RITUXAN have been adversely

affected by the onset of biosimilars competition.

•Other revenue totaled $129.5 million for the third quarter of 2022, representing a $28.3 million, or 17.9%, decrease compared to $157.8 million in the same period in 2021.

Expense

•Total cost and expense was $1,137.4 million for the third quarter of 2022, representing a $1,350.4 million, or 54.3%, decrease compared to $2,487.8 million in the same period in 2021.

◦Research and development expense for the third quarter of 2021 included a $125.0 million upfront payment to InnoCare and $39.1 million of estimated clinical trial closeout costs and manufacturing commitments associated with BIIB111 (timrepigene emparvovec) and BIIB112 (cotoretigene toliparvovec).

◦Selling, general and administrative expense for the third quarter of 2022 decreased $90.8 million, or 13.9%, compared to the same period in 2021, primarily driven by cost savings initiatives, including the substantial elimination of the ADUHELM commercial infrastructure.

◦A pre-tax gain of approximately $503.7 million recognized during the third quarter of 2022 related to the sale of one of our buildings.

As described below under Financial Condition, Liquidity and Capital Resources:

•We generated $1,559.3 million of net cash flow from operations for the nine months ended September 30, 2022.

•Cash, cash equivalents and marketable securities totaled approximately $5,771.4 million as of September 30, 2022.

•We repurchased and retired approximately 1.2 million shares of our common stock at a cost of approximately $250.0 million during the third quarter of 2022 under a program authorized by our Board of Directors in October 2020 to repurchase up to $5.0 billion of our common stock (2020 Share Repurchase Program). Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of September 30, 2022.

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Collaborative and Other Relationships

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

Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics

In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics. Under the terms of this transaction, we received approximately $1.0 billionin cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction.

We are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones.Our policy for contingent payments of this nature is to recognize them in the period that they become realizable, which is generally the same period in which they are earned.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to our condensed consolidated financial statements included in this report.

Eisai Collaboration Agreements

ADUHELM Collaboration Agreement

Lecanemab Collaboration

In March 2022 we extended our supply agreement related to lecanemab from five years to ten years for the manufacture of lecanemab drug substance and drug product.

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

Other Key Developments

2022 Cost Saving Initiatives

In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures during 2022. These savings are expected to be achieved through a number of initiatives, including reductions to our workforce, primarily within our global Alzheimer's 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 expect to incur restructuring charges ranging from approximately $130.0 million to $150.0 million. These amounts are primarily related to severance and are expected to be substantially incurred and paid by the end of 2022.

For additional information on our 2022 cost saving initiatives, please read Note 3, Restructuring, to our condensed consolidated financial statements included in this report.

BIIB125 (zuranolone)

In May 2022 we and our collaboration partner Sage Therapeutics, Inc. (Sage) initiated a rolling submission of a NDA to the FDA for BIIB125 (zuranolone) for the potential treatment of major depressive disorder (MDD).

In June 2022 we and Sage announced that the Phase 3 SKYLARK study of zuranolone, which is being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Subsequently, we decided to submit a single NDA seeking approval of zuranolone for the treatment of both MDD and PPD. We expect to complete the submission of this single NDA by the end of 2022, and to seek priority review of the filing.

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

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Lecanemab

In May 2022 we and our collaboration partner Eisai announced the completed submission of a Biologics License Application (BLA) to the FDA for the accelerated approval of lecanemab, an anti-amyloid antibody candidate for the potential treatment of Alzheimer's disease. In July 2022 the FDA accepted the BLA and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.

In September 2022 we and Eisai announced that the Phase 3 Clarity AD confirmatory study for lecanemab met its primary and all key secondary endpoints.

Mosunetuzumab

In June 2022 our collaboration partner Genentech announced that mosunetuzumab, a late-stage bispecific antibody in development for B-cell non-Hodgkin's lymphoma and other therapeutic areas, was approved in the E.U.

In July 2022 Genentech announced that the FDA accepted the company's BLA and granted Priority Review for mosunetuzumab, with a PDUFA action date of December 29, 2022.

For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.

BIIB067 (tofersen)

In July 2022 we announced that the FDA accepted our NDA and granted Priority Review for BIIB067 (tofersen), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), with a PDUFA action date of April 25, 2023.

Senior Note Redemption

In July 2022 we redeemed our 3.625% Senior Notes totaling $1.0 billion in aggregate principal amount prior to their maturity on September 15, 2022.

For additional information on our Senior Note redemption, please read Note 12, Indebtedness, to our condensed consolidated financial statements included in this report.

125 Broadway Sale and Leaseback Transaction

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

Cambridge, MA (125 Broadway) for an aggregate sales price of approximately $603.0 million, which is inclusive of a $10.8 million tenant allowance.

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

For additional information on the sale of our building, please read Note 10, Property, Plant and Equipment, to our condensed consolidated financial statements included in this report.

BIIB800

In September 2022 we and our collaboration partner Bio-Thera Solutions announced that the EMA accepted the MAA for BIIB800, a biosimilar referencing ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, for the treatment of severe, active and progressive rheumatoid arthritis.

BIIB122 (DNL151)

In October 2022 we and our collaboration partnerDenali Therapeutics Inc. (Denali) announced the initiation of the Phase 3 LIGHTHOUSE study for BIIB122 (DNL151), a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) for the potential treatment of Parkinson's disease.

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

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RESULTS OF OPERATIONS

Revenue

Revenue is summarized as follows:


	For the Three Months Ended September 30,
(In millions, except percentages)	2022				2021				$ Change		% Change
Product revenue, net:
United States	$	850.4	33.9	%	$	973.5	35.0	%	$	(123.1)	(12.6)	%
Rest of world	1,111.7		44.3		1,232.2		44.4		(120.5)		(9.8)
Total product revenue, net	1,962.1		78.2		2,205.7		79.4		(243.6)		(11.0)
Revenue from anti-CD20 therapeutic programs	416.9		16.6		415.4		14.9		1.5		0.4
Other revenue	129.5		5.2		157.8		5.7		(28.3)		(17.9)
Total revenue	$	2,508.5	100.0	%	$	2,778.9	100.0	%	$	(270.4)	(9.7)	%

	For the Nine Months Ended September 30,
(In millions, except percentages)	2022				2021				$ Change		% Change
Product revenue, net:
United States	$	2,619.7	34.3	%	$	2,850.7	34.6	%	$	(231.0)	(8.1)	%
Rest of world	3,463.6		45.4		3,802.7		46.1		(339.1)		(8.9)
Total product revenue, net	6,083.3		79.7		6,653.4		80.7		(570.1)		(8.6)
Revenue from anti-CD20 therapeutic programs	1,252.6		16.4		1,244.4		15.1		8.2		0.7
Other revenue	293.5		3.9		350.1		4.2		(56.6)		(16.2)
Total revenue	$	7,629.4	100.0	%	$	8,247.9	100.0	%	$	(618.5)	(7.5)	%

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Product Revenue

Product revenue is summarized as follows:


	For the Three Months Ended September 30,
(In millions, except percentages)	2022				2021				$ Change		% Change
Multiple Sclerosis (MS):
TECFIDERA	$	339.0	17.3	%	$	498.6	22.6	%	$	(159.6)	(32.0)	%
VUMERITY(1)	137.8		7.0		120.9		5.5		16.9		14.0
Total Fumarate	476.8		24.3		619.5		28.1		(142.7)		(23.0)
AVONEX	255.1		13.0		301.3		13.7		(46.2)		(15.3)
PLEGRIDY	80.9		4.1		86.2		3.9		(5.3)		(6.1)
Total Interferon	336.0		17.1		387.5		17.6		(51.5)		(13.3)
TYSABRI	505.5		25.8		522.8		23.7		(17.3)		(3.3)
FAMPYRA	22.0		1.1		26.2		1.2		(4.2)		(16.0)
Subtotal: MS	1,340.3		68.3		1,556.0		70.6		(215.7)		(13.9)

Spinal Muscular Atrophy:
SPINRAZA	431.1		22.0		444.1		20.1		(13.0)		(2.9)

Biosimilars:
BENEPALI	110.2		5.6		120.8		5.5		(10.6)		(8.8)
IMRALDI	57.7		2.9		57.4		2.6		0.3		0.5
FLIXABI	19.0		1.0		24.6		1.1		(5.6)		(22.8)
BYOOVIZ(2)	0.7		—		—		—		0.7		nm
Subtotal: Biosimilars	187.6		9.5		202.8		9.2		(15.2)		(7.5)

Other:
FUMADERM	1.5		0.1		2.5		0.1		(1.0)		(40.0)
ADUHELM	1.6		0.1		0.3		—		1.3		nm
Total product revenue, net	$	1,962.1	100.0	%	$	2,205.7	100.0	%	$	(243.6)	(11.0)	%

(1) VUMERITY became commercially available in the E.U. during the fourth quarter of 2021.

(2) BYOOVIZ launched in the U.S. in June 2022 and became commercially available during the third quarter of 2022.

nm Not meaningful

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	For the Nine Months Ended September 30,
(In millions, except percentages)	2022				2021				$ Change		% Change
Multiple Sclerosis (MS):
TECFIDERA	$	1,146.8	18.9	%	$	1,465.4	22.0	%	$	(318.6)	(21.7)	%
VUMERITY(1)	402.6		6.6		285.5		4.3		117.1		41.0
Total Fumarate	1,549.4		25.5		1,750.9		26.3		(201.5)		(11.5)
AVONEX	743.4		12.2		923.3		13.9		(179.9)		(19.5)
PLEGRIDY	252.4		4.1		265.1		4.0		(12.7)		(4.8)
Total Interferon	995.8		16.3		1,188.4		17.9		(192.6)		(16.2)
TYSABRI	1,542.5		25.4		1,550.4		23.3		(7.9)		(0.5)
FAMPYRA	73.7		1.2		78.8		1.2		(5.1)		(6.5)
Subtotal: MS	4,161.4		68.4		4,568.5		68.7		(407.1)		(8.9)

Spinal Muscular Atrophy:
SPINRAZA	1,334.7		21.9		1,464.4		22.0		(129.7)		(8.9)

Biosimilars:
BENEPALI	340.7		5.6		363.9		5.5		(23.2)		(6.4)
IMRALDI	172.4		2.9		170.9		2.6		1.5		0.9
FLIXABI	62.0		1.0		75.4		1.1		(13.4)		(17.8)
BYOOVIZ(2)	1.2		—		—		—		1.2		nm
Subtotal: Biosimilars	576.3		9.5		610.2		9.2		(33.9)		(5.6)

Other:
FUMADERM	6.4		0.1		8.3		0.1		(1.9)		(22.9)
ADUHELM	4.5		0.1		2.0		—		2.5		nm
Total product revenue, net	$	6,083.3	100.0	%	$	6,653.4	100.0	%	$	(570.1)	(8.6)	%

(1) VUMERITY became commercially available in the E.U. during the fourth quarter of 2021.

(2) BYOOVIZ launched in the U.S. in June 2022 and became commercially available during the third quarter of 2022.

nm Not meaningful

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Multiple Sclerosis (MS)

Fumarate

Fumarate revenue includes sales from TECFIDERA and VUMERITY. During the fourth quarter of 2021 VUMERITY was approved for the treatment of relapsing-remitting MS (RRMS) in the E.U., Switzerland and the United Kingdom (U.K.).

For the three and nine months ended September 30, 2022, compared to the same periods in 2021, the decreases of 26.5% and 11.4%, respectively, in U.S. Fumarate revenue were primarily due to decreases in TECFIDERA demand as a result of multiple TECFIDERA generic entrants in the U.S. market, partially offset by increases in VUMERITY sales volumes.

For the three and nine months ended September 30, 2022, compared to the same periods in 2021, the decreases of 19.8% and 11.6%, respectively, in rest of world Fumarate revenue were primarily due to TECFIDERA pricing reductions in certain European countries, the unfavorable impact of foreign currency exchange and decreases in TECFIDERA demand as

multiple TECFIDERA generic entrants entered into markets such as Germany and Canada, partially offset by increases in VUMERITY sales volumes.

Multiple TECFIDERA generic entrants are now in the U.S. and European Union (E.U.) markets and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and is expected to continue to have a substantial and increasing negative impact on our TECFIDERA revenue in the future.

In the U.S., the U.S. Supreme Court declined in October 2022 to review the appellate decision holding that claims of our U.S. Patent No. 8,399,514, related to TECFIDERA, are invalid.

In the E.U., we are seeking to enforce a patent granted in June 2022 that relates to TECFIDERA and expires in 2028. In addition, we are litigating to affirm that TECFIDERA is entitled to regulatory data and market protection until at least February 2024. Our Company, the EMA and the European Commission (EC) have each appealed the May 2021 decision of the European General Court, which annulled the EMA's decision not to validate an application for approval of a TECFIDERA generic on the basis that the EMA and EC conducted the wrong assessment when determining TECFIDERA's entitlement to regulatory data and marketing protection. Our Company, the EMA and the EC have each appealed the General Court’s decision as wrongly decided and the appeal is pending. On October 6, 2022, the Advocate General of the Court of Justice of the European Union (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.

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

We expect that TECFIDERA revenue will continue to decline in 2022, compared to 2021, as a result of generic competition.

We expect an increase in VUMERITY sales ~~volume driven by~~volumes in 2022, compared to 2021, mostly due to demand ~~growth.~~growth in the U.S. and 14 other markets. We continue to work with our contract manufacturing supplier to address potential supply constraints for VUMERITY. We do not anticipate a supply shortage in 2022 and are currently focused on rebuilding adequate inventory with the goal of re-initiating new country launches in 2023.

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Interferon

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the decreases of ~~23%~~15.0% and ~~22%~~19.1%, respectively, in U.S. Interferon revenue were primarily due to decreases in Interferon sales volumes of ~~19%~~15.5% and ~~19%~~15.2%, respectively. The net declines in sales volumes reflect the continued decline of the Interferon market as patients transition to other higher efficacy and oral MS therapies.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the decreases of 8%10.1% and 4%11.2%, respectively, in rest of world Interferon revenue were primarily due to decreases in Interferon sales volumes resulting from the continued decline of ~~11%~~the Interferon market and ~~5%, respectively.~~the unfavorable impact of foreign currency exchange.

We expect that Interferon revenue will continue to decline in both the U.S. and rest of world markets in ~~2021,~~2022, compared to ~~2020,~~2021, as a result of increasing competition from ~~our~~ other MS products, ~~as well as other treatments for MS,~~ including biosimilars, and further pricing reductions in certain European markets.

TYSABRI

For the three months ended September 30, 2021, compared to the same period in 2020, the decrease of 8% in U.S. TYSABRI revenue was primarily due to a decrease in sales volume of 13%, partially offset by an increase in pricing.

For the nine months ended September 30, 2021, compared to the same period in 2020, the increase of 3% in U.S. TYSABRI revenue was primarily due to an increase in pricing, partially offset by a decrease in sales volume.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the ~~increases of 14%~~decreases in U.S. TYSABRI revenue were primarily due to decreases in sales volumes.

For the three and ~~8%, respectively,~~nine months ended September 30, 2022, compared to the same periods in 2021, the decreases in rest of world TYSABRI revenue were primarily due to ~~favorable volume impacts,~~decreases in pricing and the unfavorable impact of foreign currency exchange, partially offset by ~~decreases~~increases in ~~pricing.~~sales volumes.

We anticipate TYSABRI ~~sales volume~~revenue to ~~modestly increase~~be relatively flat on a global basis in ~~2021,~~2022, compared to ~~2020,~~2021, despite increasing competition from additional treatments for ~~MS, including OCREVUS.~~MS. We expect to continue to face price reductions in certain European markets. We are also aware of a potential biosimilar entrant of TYSABRI that may enter the U.S. and European markets as early as 2023.

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Spinal Muscular Atrophy

SPINRAZA

For the three and nine months ended September 30, 2021, compared to the same periods in 2020, the decreases of 23% and 30%, respectively, in U.S. SPINRAZA revenue were primarily due to decreases in sales volumes resulting from increased competition.

For the three months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, U.S. SPINRAZA revenue remained flat.

For the nine months ended September 30, 2022, compared to the same period in 2021, the increase of 1.3% in U.S. SPINRAZA revenue was primarily due to an increase in sales volumes resulting from favorable channel dynamics, partially offset by a decrease in net pricing.

For the three months ended September 30, 2022, compared to the same period in 2021, the decrease of 2%4.4% in rest of world SPINRAZA revenue was primarily due to the unfavorable impact of foreign currency exchange.

For the nine months ended September 30, 2022, compared to the same periods in 2021, the decrease of 13.2% in rest of world SPINRAZA revenue was primarily due to a decrease in ~~sales volume resulting from increased competition as well as a decrease in pricing.~~pricing and the unfavorable impact of foreign currency exchange.

For the three and nine months ended September 30, ~~2021, compared to the same period in 2020, the increase of 11% in~~2022, rest of world SPINRAZA ~~revenue was primarily due to an increase~~reflects decreases in ~~sales volume~~demand as a result of ~~10% due~~increased competition in ~~part to~~certain established markets, particularly Germany and Japan, and the timing of shipments, partially offset by sales volume growth in ~~developing markets~~certain Asian markets.

We face competition from a gene therapy product and ~~increases in patients. The increase was also due to the favorable impact of foreign currency exchange of 4%.~~

an oral product. In ~~2021~~2022 we expect that SPINRAZA revenue will be subject to increased competition likely resulting in ~~higher~~continued patient discontinuations and a lower rate of new patient starts combined with the impact of loading dose dynamics as patients transition to dosing once every four months and lower prices in certain rest of world countries.

We face competition from a gene therapy product and an oral product. We expect that we will experience competition from both products in additional jurisdictions in the future, which may adversely affect our sales of SPINRAZA.

For additional information on our collaboration arrangements with Ionis Pharmaceuticals, Inc. (Ionis), please read Note 18, Collaborative and Other

Relationships, to our consolidated financial statements included in our ~~2020~~2021 Form 10-K.

Alzheimer's Disease

ADUHELM

In June 2021 the FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S. during the second quarter of 2021. ~~For the three and nine months ended September 30, 2021, U.S. ADUHELM revenue was approximately $0.3 million and $2.0 million, respectively.~~

In ~~2021~~April 2022 the CMS released the 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. We expect that this decision will reduce future demand for ADUHELM to a minimal level.

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

For additional information on our collaboration arrangements with Eisai, please read Note ~~16,~~18, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

~~Biosimilars~~

~~BENEPALI, IMRALDI and FLIXABI~~

For the three months ended September 30, 2021, compared to the same period in 2020, the decrease of 2% in biosimilar revenue was primarily due to decreases in pricing, partially offset by the favorable impact of higher volumes.

For the nine months ended September 30, 2021, compared to the same period in 2020, the increase of 2% in biosimilar revenue was primarily due to the favorable impact of higher volumes and foreign currency exchange, partially offset by decreases in pricing.

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InBiosimilars

BENEPALI, IMRALDI, FLIXABI and BYOOVIZ

During the third quarter of 2021 ~~we expect~~BYOOVIZ, a biosimilar referencing LUCENTIS, was approved in the U.S., the E.U. and the U.K. BYOOVIZ launched in the U.S. in June 2022 and became commercially available in July 2022 through major distributors in the U.S.

For the three and nine months ended September 30, 2022, compared to the same periods in 2021, the decreases of 7.5% and 5.6%, respectively, in biosimilar revenue ~~for~~were primarily due to unfavorable pricing and the unfavorable impact of foreign currency exchange, partially offset by increases in sales volumes.

We anticipate a slight decline in revenue from our biosimilars business ~~to be flat~~in 2022, despite the launch of BYOOVIZ in the U.S., and an anticipated modest

increase in sales volumes as ~~compared to 2020. We expect to~~we continue to face price reductions in certain ~~European countries.~~markets.

We are currently working with our contract manufacturer for IMRALDI to address facility regulatory inspection deficiencies at two filling locations, which could impact supply and have an adverse impact on 2023 IMRALDI sales, if not resolved. Manufacturing of BENEPALI also utilizes one of these facilities and therefore could have an adverse impact on 2023 BENEPALI sales. We are working with our existing secondary supplier for BENEPALI with the aim to secure additional capacity.

For additional information on our collaboration arrangements with Samsung Bioepis, please read Note ~~16,~~18, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

Revenue from Anti-CD20 Therapeutic Programs

Genentech (Roche Group)

Our share of RITUXAN, including RITUXAN HYCELA, and GAZYVA collaboration operating profits in the U.S. and other revenue from anti-CD20 therapeutic programs are summarized in the table below. For purposes of this discussion, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.

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Biogen’s Share of Pre-tax Profits in the U.S. for RITUXAN and GAZYVA

The following tables provide a summary of amounts comprising our share of pre-tax profits in the U.S. for RITUXAN and GAZYVA:


		For the Three Months Ended September 30,					For the Three Months Ended September 30,
(In millions)	(In millions)	2021		2020		(In millions)	2022		2021
Product revenue, net	Product revenue, net	$	457.0	$	814.4	Product revenue, net	$	409.8	$	457.0
Cost and expense	Cost and expense	70.8		81.1		Cost and expense	56.7		70.8
Pre-tax profits in the U.S.	Pre-tax profits in the U.S.	386.2		733.3		Pre-tax profits in the U.S.	353.1		386.2
Biogen's share of pre-tax profits	Biogen's share of pre-tax profits	$	145.8	$	275.0	Biogen's share of pre-tax profits	$	131.1	$	145.8

							For the Nine Months Ended September 30,
(In millions)						(In millions)	2022		2021
Product revenue, net						Product revenue, net	$	1,307.9	$	1,562.5
Cost and expense						Cost and expense	186.6		222.9
Pre-tax profits in the U.S.						Pre-tax profits in the U.S.	1,121.3		1,339.6
Biogen's share of pre-tax profits						Biogen's share of pre-tax profits	$	414.2	$	498.7

For the Nine Months Ended September 30,
(In millions) 2021 2020
Product revenue, net $ 1,562.5 $ 2,700.5
Cost and expense 222.9 350.0
Pre-tax profits in the U.S. 1,339.6 2,350.5
Biogen's share of pre-tax profits $ 498.7 $ 873.8

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the decreases in U.S. product revenue, net were primarily due to decreases in sales volumes of RITUXAN in the U.S. of ~~43.3%~~26.1% and ~~41.0%~~29.3%, respectively, primarily due to the onset of competition from multiple biosimilar ~~products.~~products.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same ~~periods~~periods in ~~2020, product revenue, net also reflected increases in GAZYVA sales volume of 5.1% and 10.5%, respectively.~~

~~For~~2021, the ~~three and nine months ended September 30, 2021, compared to the same periods in 2020, the~~ decreases in collaboration costs and expense were primarily due to lower cost of sales, onselling and marketing expense, distribution costs and other expenses related to RITUXAN.

We are aware of several other anti-CD20 molecules, including biosimilar products, that have ~~recently~~ been approved and are competing with RITUXAN and GAZYVA in the oncology and other markets. ~~In November 2019, January 2020 and January 2021 biosimilar~~Biosimilar products referencing RITUXAN ~~were~~have launched in the U.S. and are being offered at lower prices. This

competition has had a significant adverse impact on the pre-tax profits of our collaboration arrangements with Genentech, as the sales of RITUXAN have decreased substantially compared to prior periods. We expect that biosimilar competition will continue to increase as these products capture additional market share and that this will have a significant adverse impact on our co-promotion profits in the U.S. in future years.

Other Revenue from Anti-CD20 Therapeutic Programs

Other revenue from anti-CD20 therapeutic programs consists of royalty revenue on sales of OCREVUS and our share of pre-tax co-promotion profits from RITUXAN in Canada.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same ~~period~~periods in ~~2020,~~2021, the ~~increase~~increases in other revenue from anti-CD20 therapeutic programs ~~was~~were primarily due to sales growth of OCREVUS.

Royalty revenue recognized on sales of OCREVUS for the three and nine months ended September 30, ~~2021,~~2022, totaled $281.1 million and $825.2 million, respectively, compared to $264.2 million and $730.5 ~~million, respectively, compared to $272.5~~

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~~million and $643.0~~ million, respectively, in the prior year comparative periods.

OCREVUS royalty revenue is based on our estimates from third party and market research data of OCREVUS sales occurring during the corresponding period. Differences between actual and estimated royalty revenue will be adjusted for in the period in which they become known, which is generally expected to be the following quarter.

For additional information on our collaboration arrangements with Genentech, including information regarding the pre-tax profit-sharing formula and its impact on future revenue from anti-CD20 therapeutic programs, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our ~~2020~~2021 Form 10-K.

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Other Revenue

Other revenue is summarized as follows:


		For the Three Months Ended September 30,													For the Three Months Ended September 30,
(In millions, except percentages)	(In millions, except percentages)	2021				2020				% Change		$ Change		(In millions, except percentages)	2022				2021				$ Change		% Change
Revenue from collaborative and other relationships	Revenue from collaborative and other relationships	$	6.3	4.0	%	$	5.4	4.3	%	16.7	%	$	0.9	Revenue from collaborative and other relationships	$	6.5	5.0	%	$	6.3	4.0	%	$	0.2	3.2	%
Other royalty and corporate revenue	Other royalty and corporate revenue	151.5		96.0		120.3		95.7		25.9		31.2		Other royalty and corporate revenue	123.0		95.0		151.5		96.0		(28.5)		(18.8)
Total other revenue	Total other revenue	$	157.8	100.0	%	$	125.7	100.0	%	25.5	%	$	32.1	Total other revenue	$	129.5	100.0	%	$	157.8	100.0	%	$	(28.3)	(17.9)	%

															For the Nine Months Ended September 30,
(In millions, except percentages)														(In millions, except percentages)	2022				2021				$ Change		% Change
Revenue from collaborative and other relationships														Revenue from collaborative and other relationships	$	20.9	7.1	%	$	15.7	4.5	%	$	5.2	33.1	%
Other royalty and corporate revenue														Other royalty and corporate revenue	272.6		92.9		334.4		95.5		(61.8)		(18.5)
Total other revenue														Total other revenue	$	293.5	100.0	%	$	350.1	100.0	%	$	(56.6)	(16.2)	%

For the Nine Months Ended September 30,
(In millions, except percentages) 2021 2020 % Change $ Change
Revenue from collaborative and other relationships $ 15.7 4.5 % $ 14.3 2.2 % 9.8 % $ 1.4
Other royalty and corporate revenue 334.4 95.5 628.3 97.8 (46.8) (293.9)
Total other revenue $ 350.1 100.0 % $ 642.6 100.0 % (45.5) % $ (292.5)

Revenue from Collaborative and Other Relationships

Revenue from collaborative and other relationships primarily includes royalty revenue on biosimilar products from Samsung Bioepis.

For additional information on our collaborative arrangements with Samsung Bioepis, please read Note ~~16,~~18, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

Other Royalty and Corporate Revenue

We receive royalties from net sales on products related to patents that we have out-licensed and we

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record other corporate revenue primarily from amounts earned under contract manufacturing agreements.

For the three ~~months ended September 30, 2021, compared to the same period in 2020, the increase in other corporate revenue was primarily due to higher revenue related to contract manufacturing agreements.~~

~~For the~~and nine months ended September 30, ~~2021,~~2022, compared to the same ~~period~~periods in ~~2020,~~ 2021,

the ~~decrease~~decreases in other corporate revenue ~~was~~were primarily due to ~~higher~~lower contract manufacturing ~~revenue during the second quarter of 2020, resulting from $329.4 million in~~ revenue related to the ~~delivery~~timing of ~~a license for certain of our manufacturing-related intellectual property to a contract manufacturing customer.~~batch releases.

Reserves for Discounts and Allowances

Revenue from product sales is recorded net of reserves established for applicable discounts and allowances, including those associated with the implementation of pricing actions in certain international markets where we operate.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). These estimates reflect our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.

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Reserves for discounts, contractual adjustments and returns that reduced gross product revenue are summarized as follows:

For the three and nine months ended September 30, ~~2021,~~2022, reserves for discounts and allowances as a percentage of gross product revenue were ~~26.5%~~31.2% and ~~27.9%~~29.1%, respectively, compared to ~~27.3%~~26.5% and ~~26.3%~~27.9%, respectively, in the prior year comparative periods.

Discounts

Discounts include trade term discounts and wholesaler incentives.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~ 2021,

the decreases in discounts were primarily driven by ~~a decrease~~decreases in gross sales, primarily driven by lower TECFIDERA sales.

Contractual Adjustments

Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay) assistance, Veterans Administration, 340B discounts, specialty pharmacy program fees and other government rebates or applicable allowances.

For the three ~~and~~months ended September 30, 2022, compared to the same period in 2021, the increase in contractual adjustments was primarily driven by higher co-pay assistance in the U.S.

For the nine months ended September 30, ~~2021,~~2022, compared to the same ~~periods~~period in ~~2020,~~2021, the ~~decreases~~decrease in contractual adjustments ~~were~~was primarily ~~caused~~driven by lower TECFIDERA sales in the U.S., resulting in lower pharmacy rebates, Medicaid rebates and managed care rebates, ~~partially offset~~as well as lower Medicaid rebates in the U.S. driven by ~~pharmacy rebates.~~a favorable change in estimates for VUMERITY.

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Returns

Product return reserves are established for returns made by wholesalers. In accordance with contractual terms, wholesalers are permitted to return product for reasons such as damaged or expired product. The majority of wholesaler returns are due to product expiration. Provisions for product returns are recognized in the period the related revenue is recognized, resulting in a reduction to product sales.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, return reserves were relatively consistent.

For additional information on our revenue reserves, please read Note 3,4, Revenue, to our condensed consolidated financial statements included in this report.

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Cost and Expense

A summary of total cost and expense is as follows:

For the Three Months Ended September 30,
(In millions, except percentages) 2021 2020 % Change $ Change
Cost of sales, excluding amortization and impairment of acquired intangible assets $ 511.8 $ 449.1 14.0 % $ 62.7
Research and development 702.4 1,140.9 (38.4) (438.5)
Selling, general and administrative 654.1 573.1 14.1 81.0
Amortization and impairment of acquired intangible assets 111.0 82.6 34.4 28.4
Collaboration profit sharing 21.2 73.0 (71.0) (51.8)
(Gain) loss on fair value remeasurement of contingent consideration (15.6) (29.0) (46.2) 13.4
Acquired in-process research and development — — nm —
Total cost and expense $ 1,984.9 $ 2,289.7 (13.3) % $ (304.8)


		For the Nine Months Ended September 30,								For the Three Months Ended September 30,
(In millions, except percentages)	(In millions, except percentages)	2021		2020		% Change		$ Change			(In millions, except percentages)	2022		2021		% Change		$ Change
Cost of sales, excluding amortization and impairment of acquired intangible assets	Cost of sales, excluding amortization and impairment of acquired intangible assets	$	1,449.6	$	1,314.6	10.3	%	$	135.0		Cost of sales, excluding amortization and impairment of acquired intangible assets	$	469.5	$	511.8	(8.3)	%	$	(42.3)
Research and development	Research and development	1,801.7		2,264.8		(20.4)		(463.1)			Research and development	549.2		702.4		(21.8)		(153.2)
Selling, general and administrative	Selling, general and administrative	1,886.4		1,698.3		11.1		188.1			Selling, general and administrative	563.3		654.1		(13.9)		(90.8)
Amortization and impairment of acquired intangible assets	Amortization and impairment of acquired intangible assets	813.2		215.6		277.2		597.6			Amortization and impairment of acquired intangible assets	56.5		111.0		(49.1)		(54.5)
Collaboration profit sharing		74.5		166.5		(55.3)		(92.0)

Collaboration profit (loss) sharing											Collaboration profit (loss) sharing	45.3		21.2		113.7		24.1
(Gain) loss on fair value remeasurement of contingent consideration	(Gain) loss on fair value remeasurement of contingent consideration	(49.1)		(23.5)		108.9		(25.6)			(Gain) loss on fair value remeasurement of contingent consideration	(2.1)		(15.6)		(86.5)		13.5

Restructuring charges											Restructuring charges	15.4		—		nm		15.4
Gain on sale of building											Gain on sale of building	(503.7)		—		—		(503.7)
Other (income) expense, net											Other (income) expense, net	(56.0)		502.9		(111.1)		(558.9)
Total cost and expense											Total cost and expense	$	1,137.4	$	2,487.8	(54.3)	%	$	(1,350.4)

												For the Nine Months Ended September 30,
(In millions, except percentages)											(In millions, except percentages)	2022		2021		% Change		$ Change
Cost of sales, excluding amortization and impairment of acquired intangible assets											Cost of sales, excluding amortization and impairment of acquired intangible assets	$	1,707.4	$	1,449.6	17.8	%	$	257.8
Research and development											Research and development	1,629.5		1,801.7		(9.6)		(172.2)
Selling, general and administrative											Selling, general and administrative	1,770.8		1,886.4		(6.1)		(115.6)
Amortization and impairment of acquired intangible assets											Amortization and impairment of acquired intangible assets	190.9		813.2		(76.5)		(622.3)
Collaboration profit (loss) sharing											Collaboration profit (loss) sharing	(42.6)		74.5		(157.2)		(117.1)
(Gain) loss on fair value remeasurement of contingent consideration											(Gain) loss on fair value remeasurement of contingent consideration	(13.7)		(49.1)		(72.1)		35.4
Acquired in-process research and development	Acquired in-process research and development	18.0		75.0		(76.0)		(57.0)			Acquired in-process research and development	—		18.0		nm		(18.0)
Restructuring charges											Restructuring charges	124.1		—		nm		124.1
Gain on sale of building											Gain on sale of building	(503.7)		—		—		(503.7)
Other (income) expense, net											Other (income) expense, net	(221.3)		913.4		(124.2)		(1,134.7)
Total cost and expense	Total cost and expense	$	5,994.3	$	5,711.3	5.0	%	$	283.0		Total cost and expense	$	4,641.4	$	6,907.7	(32.8)	%	$	(2,266.3)

nm Not meaningful

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Cost of Sales, Excluding Amortization and Impairment of Acquired Intangible Assets

Product Cost of Sales

For the nine months ended September 30, 2022, compared to the same period in 2021, the increase in product cost of sales was primarily due to the write-off of ADUHELM inventory during the first quarter of 2022. During the first quarter of 2022 we recorded approximately $275.0 million of gross charges associated with inventory and purchase commitments in excess of forecasted demand related to ADUHELM. For the nine months ended September 30, 2022, we have also recorded approximately $83.0 million of aggregate gross idle capacity charges.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the ~~increases in product cost of sales were primarily due to product mix and higher cost of sales associated with contract manufacturing agreements.~~

~~Royalty Cost of Sales~~

~~For the three and nine months ended September 30, 2021, compared to the same periods in 2020, the increases~~decreases in royalty cost of sales were primarily due to lower royalties payable on lower sales of SPINRAZA, TYSABRI and AVONEX, partially offset by higher royalties payable on higher sales of ~~TYSABRI and~~ VUMERITY.

Research and Development

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

A significant amount of our research and development costs consists of indirect costs incurred in support of overall research and development activities and non-specific programs, including activities that benefit multiple programs, such as

management costs, as well as depreciation, information technology and facility-based expenses. These costs are considered other research and development costs in the table above and are not allocated to a specific program or stage.

Research and development expense incurred in support of our marketed products includes costs associated with product lifecycle management activities including, if applicable, costs associated with the development of new indications for existing products. Late stage programs are programs in Phase 3 development or in registration stage. Early stage programs are programs in Phase 1 or Phase 2 development. Research and discovery represents costs incurred to support our discovery research and translational science efforts. Costs are reflected in the development stage based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same year. For several of our programs, the research and development activities are part of our collaborative and other relationships. Our costs reflect our share of the total costs incurred.

For the three months ended September 30, 2022, compared to the same period in 2021, the decrease in research and development expense was primarily due to higher milestone payments in 2021 and a decrease in spending in late stage programs, primarily due to the discontinuation of BIIB111 (timrepigene emparvovec) in choroideremia.

For the nine months ended September 30, ~~2021,~~2022, compared to the same ~~periods~~period in ~~2020,~~2021, the ~~decreases~~decrease in research and development expense ~~were~~was primarily due to ~~$601.3 million~~higher milestone payments in ~~upfront payments recognized upon the closing of our collaboration with Denali in the third quarter of 2020,~~2021, partially offset by ~~a $125.0 million upfront payment recognized upon closing~~the advancement of ~~our collaboration with InnoCare in the third quarter of 2021, the development of zuranolone~~BIIB059 (anti-BDCA2) for the potential treatment of ~~MDD~~systemic lupus erytheatosus (SLE), the development of mosunetuzumab, a late-stage bispecific antibody in development for B-cell non-Hodgkin's lymphoma and ~~PPD,~~other therapeutic areas, the development of BIIB124 (SAGE-324) for the potential treatment of essential tremor, which we are developing in collaboration with Sage, the development of BIIB122 (DNL151) for the potential treatment of Parkinson's disease, which we are developing in collaboration with Denali, and ~~closeout costs associated~~the development of BIIB135 (orelabrutinib) for the potential treatment of MS.

In 2021 we recorded significant upfront payments related to our new collaborations as part of research and development expense. Excluding upfront payments, we expect our core research and development expense in 2022 to be consistent with ~~BIIB111 (timrepigene emparvovec)~~2021 as we continue to invest in our pipeline. We intend to continue committing significant resources to targeted research and ~~BIIB112 (cotoretigene toliparvovec).~~development opportunities where there is a significant unmet need and where a

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drug candidate has the potential to be highly differentiated.

Early Stage Programs

For the three ~~and nine~~ months ended September 30, ~~2021,~~2022, compared to the same ~~periods~~period in ~~2020,~~2021, the ~~decreases~~decrease in spending related to our early stage programs ~~were~~was primarily due to ~~decreases~~a decrease in costs associated with:

•the discontinuation of ~~opicinumab (anti-LINGO) in MS;~~

•~~the discontinuation of~~ BIIB054 (cinpanemab) in Parkinson's ~~disease and~~ disease;

•the discontinuation of gosuranemab (BIIB092) in Alzheimer's disease; and

•the ~~advancement~~discontinuation of ~~dapirolizumab pego, an anti-CD40L pegylated Fab that we are developing~~BIIB112 (cotoretigene toliparvovec) in ~~collaboration with UCB, for the~~

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~~potential treatment of systemic lupus erytheatosus (SLE) into late stage; and~~

•~~the advancement of BIIB059 (anti-BDCA2) for the potential treatment of SLE into late stage.~~X-linked retinitis pigmentosa.

~~These decreases were~~The decrease was partially offset by ~~increases~~an increase in costs associated with:

•an increase in spending in the development of BIIB124 for the potential treatment of essential tremor;

•an increase in spending in the development of ~~BIIB122 (DNL151)~~BIIB059 for the potential treatment of ~~Parkinson's disease, which we are developing in collaboration with Denali;~~cutaneous lupus erythematosus (CLE); and

•~~close out costs~~an increase in spending in the development of BIIB113 for the potential treatment of Alzheimer's disease.

For the nine months ended September 30, 2022, compared to the same period in 2021, the decrease in spending related to our early stage programs was primarily due to a decrease in costs associated with:

•the discontinuation of BIIB054 (cinpanemab) in Parkinson's disease;

•the discontinuation of gosuranemab (BIIB092) in Alzheimer's disease;

•the discontinuation of BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa; and

•the advancement of BIIB059 for the potential treatment of SLE into late stage, which had the first patient dosed in a phase 3 study in the second quarter of 2021.

The decrease was partially offset by an increase in costs associated with:

•an increase in spending in the development of BIIB124 for the potential treatment of essential tremor;

•an increase in spending in the development of BIIB135 ~~(Orelabrutinib)~~ for the potential treatment of MS; ~~and~~

•~~closeout costs related to BIIB112.~~

~~Late Stage Programs~~

~~For the three and nine months ended September 30, 2021, compared to the same periods in 2020, the increases~~an increase in spending ~~associated with our late stage programs were primarily due to:~~in the development of BIIB059 for the potential treatment of cutaneous lupus erythematosus (CLE); and

•an increase in spending in the development of ~~zuranolone~~BIIB113 for the potential treatment of ~~MDD~~Alzheimer's disease.

Late Stage Programs

For the three months ended September 30, 2022, compared to the same period in 2021, the decrease in spending associated with our late stage programs was primarily due to a decrease in costs associated with:

•the decrease in spending related to lecanemab; and ~~PPD;~~

•the discontinuation of BIIB111 (timrepigene emparvovec) in choroideremia.

The decrease was partially offset by an increase in costs associated with:

•an increase in spending related to mosunetuzumab, a late-stage bispecific antibody in development for B-cell non-Hodgkin's lymphoma and other therapeutic areas; and

•the advancement of ~~dapirolizumab pegol~~BIIB122 for the potential treatment of ~~SLE~~Parkinson's disease into late ~~stage;~~stage.

For the nine months ended September 30, 2022, compared to the same period in 2021, the decrease in spending associated with our late stage programs was primarily due to a decrease in costs associated with:

•the advancement of ADUHELM from late stage to marketed upon the accelerated approval of ADUHELM in the U.S.; and

•the discontinuation of BIIB111 (timrepigene emparvovec) in choroideremia.

The decrease was partially offset by an increase in costs associated with:

•the advancement of BIIB059 for the potential treatment of SLE into late stage;

•an increase in spending related to ~~lecanemab;~~mosunetuzumab; and

•~~closeout~~the advancement of BIIB122 for the potential treatment of Parkinson's disease into late stage.

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Marketed Programs

For the nine months ended September 30, 2022, compared to the same period in 2021, the increase in spending associated with our marketed programs was primarily due to an increase in costs ~~related~~associated with:

•the advancement of ADUHELM from late stage to ~~BIIB111.~~marketed upon the accelerated approval of ADUHELM in the U.S.

Other Research and Development

In March 2019 Eisai initiated a global Phase 3 trial for the development of lecanemab in early Alzheimer's disease. Under our collaboration arrangement, Eisai serves as the ~~global operational~~lead of lecanemab development and regulatory ~~lead for lecanemab~~submissions globally with both companies co-commercializing and ~~all~~co-promoting the product, and Eisai having final decision-making authority. All costs, including research, development, sales and marketing expense, are shared equally between us and Eisai. In July 2022 Eisai completed the submission of a BLA to the FDA for the accelerated approval of lecanemab.

As of September 30, 2022, we had approximately $118.0 million of work-in-process inventory related to lecanemab. We plan to continue producing inventory and are also procuring raw materials associated with this production. If the program does not receive regulatory approval, we would expect to expense inventory on hand at that time as research and development expense and, under the terms of the collaboration arrangement with Eisai to jointly develop and commercialize lecanemab, we and Eisai would share the costs equally.

Selling, General and Administrative

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, selling, general and administrative expense ~~increased 14.1%~~decreased by approximately 13.9% and ~~11.1%~~6.1%, respectively, primarily due to ~~increases in personnel in support~~cost-reduction measures realized during 2022, partially offset by gross ADUHELM commercialization expense of approximately $4.0 million and $111.0 million, respectively.

As a result of the ~~launch of~~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.

Beginning in the second quarter of 2021 reimbursement from Eisai for its share of U.S. ADUHELM selling, general and administrative expense is ~~reflected within~~recognized in collaboration profit ~~sharing.~~(loss) sharing in our condensed consolidated statements of income.

We expect selling, general and administrative costs to decline in 2022, compared to 2021, primarily driven by the implementation of our cost savings initiatives, which include the substantial elimination of our commercial infrastructure supporting ADUHELM as well as other cost-reduction measures.

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Amortization and Impairment of Acquired Intangible Assets

Our amortization expense is based on the economic consumption and impairment of intangible assets. Our most significant amortizable intangible assets are related to our TYSABRI, AVONEX, SPINRAZA, VUMERITY and TECFIDERA (rest of world)

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products and other programs acquired through business combinations.

For the three and nine months ended September 30, 2022, compared to the same periods in 2021, the decreases in amortization and impairment of acquired intangible assets ~~reflects~~were primarily related to impairment charges of ~~$15.0~~approximately $629.3 million recorded in 2021. For the three and ~~$365.0 million, respectively,~~nine ~~related to BIIB111~~months ended September 30, 2022, we had no ~~for the potential treatment of choroideremia,~~ ~~and charges of $28.4 million and $220.0 million, respectively,~~ ~~related to BIIB112for the potential treatment of X-linked retinitis pigmentosa.~~impairment charges.

For the three and nine months ended September 30, 2021, amortization and impairment of acquired intangible assets reflects impairment charges of $15.0 million and $365.0 million, respectively, related to BIIB111 (timrepigene emparvovec) for the ~~impact~~potential treatment of choroideremia and impairment charges of $28.4 million and $220.0 million, respectively, related to BIIB112 (cotoretigene toliparvovec) for the potential treatment of X-linked retinitis pigmentosa.

For the nine months ended September 30, 2021, amortization and impairment of acquired intangible assets also reflects a $44.3 million impairment charge related to vixotrigine (BIIB074) for the potential treatment of trigeminal neuralgia (TGN).

For the three and nine months ended September 30, 2020, amortization and impairment of acquired intangible assets reflects the impact of a $19.3 million impairment charge related to one of our in-process research and development (IPR&D) intangible assets.

We monitor events and expectations regarding product performance. If new information indicates that the assumptions underlying our most recent analysis

are substantially different than those utilized in our current estimates, our analysis would be updated and may result in a significant change in the anticipated lifetime revenue of the relevant products. The occurrence of an adverse event could substantially increase the amount of amortization expense related to our acquired intangible assets as compared to previous periods or our current expectations, which may result in a significant negative impact on our future results of operations.

IPR&D Related to Business Combinations

~~IPR&D~~In-process research and development (IPR&D) represents the fair value assigned to research and development assets that we acquired as part of a business combination and had not yet reached technological feasibility at the date of acquisition. We review amounts capitalized as acquired IPR&D for impairment annually, as of October 31, and whenever events or changes in circumstances indicate to us that the carrying value of the assets might not be recoverable.

Overall, the value of our acquired IPR&D assets is dependent upon several variables, including estimates of future revenue and the effects of competition, our ability to secure sufficient pricing in a competitive market, our ability to confirm safety and efficacy based on data from clinical trials and regulatory feedback, the level of anticipated development costs and the probability and timing of successfully advancing a particular research program from one clinical trial phase to the next. We are

continually reevaluating our estimates concerning these and other variables, including our life cycle management strategies, research and development priorities and development risk, changes in program and portfolio economics and related impact of foreign currency exchange rates and economic trends and evaluating industry and company data regarding the productivity of clinical research and the development process. Changes in our estimates may result in a significant change to our valuation of our IPR&D assets.

Vixotrigine

In the periods since we acquired vixotrigine, there have been numerous delays in the initiation of Phase 3 studies for the potential treatment of TGN and for the potential treatment of diabetic painful neuropathy (DPN), another form of neuropathic pain. We have engaged with the FDA regarding the design of the Phase 3 studies of vixotrigine for the potential treatment of TGN and DPN and are now performing an additional clinical trial of ~~vixotrigine.~~vixotrigine, which is expected to be completed by the end of 2022.

The performance of this additional clinical trial has delayed the initiation of the Phase 3 studies of

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vixotrigine for the potential treatment of TGN, and, as a result, we recognized an impairment charge of $44.3 million related to vixotrigine for the potential treatment of TGN during the ~~first~~first quarter of 2021.

As of September 30, ~~2021,~~2022, the carrying value associated with the remaining vixotrigine IPR&D intangible asset for DPN was ~~$132.0 million.~~$109.3 million and the fair value of this asset was not significantly in excess of its carrying value. We will reassess the carrying value of this program upon conclusion of the ongoing clinical trial, or sooner if there is a reevaluation event, and may record an impairment charge related to this asset.

BIIB111 and BIIB112

~~During the fourth quarter of 2020 we recognized an impairment charge of $115.0 million~~ ~~related to BIIB111 as a result of third-party manufacturing delays that impacted the timing and increased the costs associated with advancing BIIB111 through Phase 3 development.~~

During the second quarter of 2021 we announced that our Phase 3 STAR study of BIIB111 and our Phase 2/3 XIRIUS study of BIIB112 did not meet their primary endpoints. In the third quarter of 2021 we suspended further development on these programs based on the decision by management as part of its strategic review process. For the three and nine months ended September 30, 2021, we ~~recorded~~recognized impairment charges of $15.0 million and $365.0 million, respectively, related to BIIB111, and impairment charges of $28.4 million and $220.0 million, respectively, related to ~~BIIB112. As a result,~~BIIB112, reducing the remaining book values ~~associated with~~of these ~~programs were reduced~~IPR&D intangible assets to zero.

In addition, ~~for the three months ended September 30, 2021,~~ as a result of our decision to suspend further development of BIIB111 and BIIB112, we recorded charges of approximately $39.1 million during the third quarter of 2021 related to our manufacturing arrangements and

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other costs that we expect to incur as a result of suspending these programs.

For additional information on the amortization and impairment of our acquired intangible assets, please read Note 6, Intangible Assets and Goodwill, to our condensed consolidated financial statements included in this report.

Collaboration Profit (Loss) Sharing

Collaboration profit (loss) sharing primarily includes Samsung Bioepis' 50.0% share of the profit or loss related to our biosimilars commercial agreement with Samsung Bioepis and, beginning in the second quarter of 2021, Eisai's 45.0% share of income and ~~expenses~~expense in the U.S. related to the ADUHELM Collaboration Agreement.

For the three and nine months ended September 30, ~~2021,~~2022, we recognized net profit-sharing expense of ~~$71.8~~$48.7 million and ~~$210.2~~$171.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits compared to a net ~~profit sharing~~profit-sharing expense of ~~$72.9~~$71.8 million and ~~$200.1~~$210.2 million, respectively, in the prior year comparative periods.

For the three and nine months ended September 30, ~~2021,~~2022, we recognized a net ~~profit-sharing income~~reduction to our operating expense of$3.4 million and $214.0 million, respectively, to reflect Eisai's 45.0% share of net collaboration losses in the U.S., compared to $50.6 million and $90.7 million, respectively, ~~to reflect Eisai's 45.0% share of loss related to~~in the ~~ADUHELM Collaboration Agreement.~~ prior year comparative periods.

For the nine months ended September 30, 2021, we also recognized net profit-sharing income of $45.0 million to reflect Eisai's 45.0% share of the $100.0 million milestone payment made to Neurimmune related to the launch of ADUHELM in the U.S.

~~For~~ during the ~~nine months ended September 30, 2020, we also recognized net profit-sharing income~~second quarter of ~~$33.8 million to reflect Eisai's 45.0% share of the $75.0 million milestone payment made to Neurimmune related to the submission of the BLA for the approval of ADUHELM to the FDA.~~2021.

For additional information on our collaboration arrangements with Samsung Bioepis and Eisai, please read Note ~~16,~~18, Collaborative and Other Relationships, to

our condensed consolidated financial statements included in this report.

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(Gain) Loss on Fair Value Remeasurement of Contingent Consideration

Consideration payable for certain of our business combinations includes future payments that are contingent upon the occurrence of a particular event or events. We record an obligation for such contingent consideration payments at fair value on the acquisition date. We then revalue our contingent consideration obligations each reporting period. Changes in the fair value of our contingent consideration obligations, other than changes due to payments, are recognized as a (gain) loss on fair value remeasurement of contingent consideration in our condensed consolidated statements of income.

For the three and ninemonths ended September 30, ~~2021,~~2022, the ~~decrease~~changes in the fair value of our contingent consideration obligations ~~was~~were primarily due to increases in the discount rates used to revalue these obligations and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs.

For the three and ninemonths ended September 30, 2021, the changes in the fair value of our contingent consideration obligations were primarily due to reductions in the probability of technical and regulatory success and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs.

Restructuring Charges

2022 Cost Saving Initiatives

In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures during 2022. 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 efficiencies across our selling, general and administrative and research and development functions.

For the three and ninemonths ended September 30, 2022, we recognized approximately $15.4 million and $124.1 million, respectively, of net pre-tax restructuring charges related to our 2022 cost saving initiatives, of which approximately $21.6 million and $110.2 million, respectively, consisted of employee severance costs. These costs were recorded in restructuring charges in our condensed consolidated statements of income. Our restructuring reserve is included in accrued expense and other in our condensed consolidated balance sheets.

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. This resulted in a gain of approximately $5.3 million, which was recorded within restructuring charges in our condensed consolidated statements of income for the three and nine months ended September 30, 2022.

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For additional information on our 300 Binney Street lease modification, please read Note 11, Leases, to our condensed consolidated financial statements included in this report.

Following an evaluation of our current capacity needs, in March 2022 we ceased using a patient services office space in Durham, North Carolina. Our decision to cease use of the facility resulted in the immediate expense of certain leasehold improvements and other assets at this facility. As a result, for the nine months ended September 30, 2022, we recognized approximately $10.4 million of accelerated depreciation expense, which was recorded in restructuring charges in our condensed consolidated statements of income. In May 2022 we entered into a lease assignment agreement whereby we assigned our remaining lease obligations to an external third party. As a result of the lease assignment, we derecognized the related operating lease obligation and right-of-use asset during the second quarter of 2022.

For the ninemonths ended September 30, 2022, we recognized other restructuring costs of approximately $8.8 million, which were recorded in restructuring charges in our condensed consolidated statements of income. Other restructuring costs include items such as facility closure costs, employee non-severance expense, asset write-offs and other costs.

The following table summarizes the charges and spending related to our 2022 workforce reductions for the three and ninemonths ended September 30, 2022:


(In millions)	Total
Restructuring reserve as of December 31, 2021	$	—
Expense	27.7
Payment	(6.2)

Restructuring reserve as of March 31, 2022	21.5
Expense	60.9
Payment	(29.7)
Foreign currency and other adjustments	(0.5)
Restructuring reserve as of June 30, 2022	52.2
Expense	21.6
Payment	(32.3)
Foreign currency and other adjustments	(1.3)
Restructuring reserve as of September 30, 2022	$	40.2

Gain on Sale of Building

In September 2022 we completed the sale of our building and land parcel located at 125 Broadway for an aggregate sales price of approximately $603.0 million, which is inclusive of a $10.8 million tenant allowance. This sale resulted in a pre-tax gain on sale of approximately $503.7 million, net of transaction costs, which is reflected within gain on sale of building in our condensed consolidated statements of income for the three and nine months ended September 30, 2022. Simultaneously, with the close of this transaction we immediately 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 condensed consolidated balance sheets as of September 30, 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 on the sale of our building, please read Note 10, Property, Plant and Equipment, to our condensed consolidated financial statements included in this report.

For additional information on our 300 Binney Street lease modification, please read Note 11, Leases, to these condensed consolidated financial statements.

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~~Acquired In-Process Research and Development~~Other (Income) Expense, Net

~~BIIB118 Acquisition~~

~~In March 2020 we acquired BIIB118 (CK1 inhibitor) for~~For the ~~potential treatment~~nine months ended September 30, 2022, compared to the same period in 2021, the change in other (income) expense, net primarily reflects a pre-tax gain of ~~patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer Inc. (Pfizer). In~~approximately $1.5 billion related to the sale of our 49.9%equity interest in Samsung Bioepis during the second quarter of 2022, partially offset by a pre-tax charge of $900.0 million in connection with ~~this acquisition,~~a litigation settlement agreement, as discussed below.

During the second quarter of 2022 we ~~made an upfront payment~~recorded a pre-tax charge of ~~$75.0~~$900.0 million, plus estimated fees and expenses, related to ~~Pfizer, which was accounted for as an asset acquisition and recorded as acquired IPR&D~~a litigation settlement agreement to resolve a qui tam litigation relating to conduct prior to 2015. This charge is included within other (income) expense, net in our condensed consolidated statements of income ~~as BIIB118 has not yet reached technological feasibility.~~

for the nine months ended September 30, 2022.For additional information on ~~our acquisition of BIIB118,~~the litigation settlement agreement, please read Note ~~2, Acquisitions,~~20, Litigation, to our condensed consolidated financial statements included in this report.

~~Other Income (Expense), Net~~

For the three months ended September 30, ~~2021, compared to the same period in 2020, the~~

~~change in other income (expense), net primarily reflects~~2022, net unrealized ~~losses on our holdings in equity securities.~~

For the nine months ended September 30, 2021, compared to the same period in 2020, the change in other income (expense), net primarily reflects net unrealized losses on our holdings in equity securities.

~~For the three months ended September 30, 2021, net unrealized losses~~gains and realized gains on our holdings in equity securities were approximately ~~$426.9~~$109.3 million and ~~$2.7~~$0.5 million, respectively, compared to net unrealized losses and realized gains ~~(losses)~~ of ~~$82.3~~approximately $426.9 million and ~~zero,~~$2.7 million, respectively, in the prior year comparative period. The net unrealized ~~losses~~gains recognized during the three months ended September 30, ~~2021,~~2022, primarily reflect ~~decreases~~an increase in the aggregate fair value of our investments in ~~Denali,~~Sage, Ionis, ~~Sage~~Sangamo Therapeutics, Inc. (Sangamo) and ~~Sangamo~~Denali common stock of approximately ~~$424.3~~$112.5 million.

For the nine months ended September 30, ~~2021,~~2022, net unrealized losses and realized ~~gains~~(gains) losses on our holdings in equity securities were approximately ~~$715.2~~$158.1 million and ~~$9.3 million,~~zero, respectively, compared to net unrealized losses and realized gains ~~(losses)~~

of ~~$40.3~~$715.2 million and ~~zero,~~$9.3 million, respectively, in the prior year comparative period. The net unrealized losses recognized during the nine months ended September 30, ~~2021,~~2022, primarily reflect ~~decreases~~a decrease in the aggregate fair value of our investments in Denali ~~Ionis, Sage~~ and Sangamo common stock of approximately ~~$709.1~~$198.0 million.

~~We expect a moderate increase~~For additional information on the sale of our equity interest in ~~interest expense for 2021, compared~~Samsung Bioepis, please read Note 2, Dispositions, to ~~2020, primarily due to lower interest being capitalized as a result of assets being placed into service during 2021.~~

our condensed consolidated financial statements included in this report.

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Income Tax ~~(Benefit)~~ Provision

Our effective tax rate fluctuates from year to year due to the global nature of our operations. The factors that most significantly impact our effective tax rate include changes in tax laws, variability in the allocation of our taxable earnings among multiple jurisdictions, the amount and characterization of our research and development expense, the levels of certain deductions and credits, acquisitions and licensing transactions.

For the three and nine months ended September 30, ~~2021,~~2022, compared to the same periods in ~~2020,~~2021, the ~~decreases~~increases in our effective tax ~~rate, excluding~~rates include the ~~impact~~tax

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impacts on the ~~Neurimmune deferred tax asset discussed below, were primarily due to the change in the territorial mix~~sale of one of our ~~profitability, which included the adverse effect of generic competition for TECFIDERA in the U.S. market; the tax impacts of the BIIB111 and BIIB112 impairment charges;~~buildings and the ~~impact of the non-cash~~favorable prior year tax effects of changes in the value of our equity investments, where we recorded unrealized losses, ~~in 2021.~~and the BIIB111 and BIIIB112 impairment charges. The tax effects of this change in value of our equity investments were recorded ~~in the current period,~~discretely as ~~the~~ changes in value of equity investments cannot be ~~reliably~~ forecasted. Our 2020 effective tax rate also reflected an income tax expense related to the establishment of a valuation allowance against certain deferred tax assets, the realization of which is dependent on future sales of TECFIDERA in the U.S.

~~In addition, for~~For the nine months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, the ~~decrease~~increase in our effective tax rate ~~was primarily due to a current year deferred tax benefit in Switzerland resulting from~~also reflects the ~~accelerated approval~~net effects of ~~ADUHELM by~~ the ~~FDA in~~Neurimmune SubOne AG (Neurimmune) matters, as discussed below, and the ~~U.S. recognized during~~litigation settlement agreement.

During the second quarter of ~~2021. We~~2021 we recorded a net deferred tax asset in Switzerland of approximately ~~$500.0 million. The net deferred tax asset is comprised of approximately $875.0~~$490.0 million ~~of gross deferred tax asset, reduced by approximately $375.0 million of unrecognized tax benefit discussed below. The deferred tax benefit relates to~~on Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, ~~and approval~~we recorded a valuation allowance of approximately $390.0 million.

During the first quarter of 2022, upon issuance of the ~~Swiss cantonal~~final NCD related to ADUHELM, we recorded an additional valuation allowance of approximately $85.0 million to reduce the net value of this deferred tax ~~authorities,~~asset to zero. These adjustments to our deferred tax assets and their valuation allowances are each recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our condensed consolidated statements of income, resulting in a zero net impact to net income attributable to Biogen Inc.

Inflation Reduction Act

For additional information on the litigation settlement agreement, please read Note 20, Litigation, to our condensed consolidated financial statements included in this report.

For additional information on our collaboration arrangement with Neurimmune, please read Note ~~17,~~19, Investments in Variable Interest Entities, to ~~our~~these condensed consolidated financial ~~statements included in this report~~statements.

For additional information on our income taxes please read Note ~~14,~~16, Income Taxes, to our condensed consolidated financial statements included in this report.

Equity in (Income) Loss of Investee, Net of Tax

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

In ~~June 2018~~April 2022 we ~~exercised~~completed the sale of our ~~option under our joint venture agreement to increase our ownership~~

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~~percentage~~49.9% equity interest in Samsung Bioepis ~~from approximately 5.0%~~ to ~~approximately 49.9%. The share purchase transaction was completed in November 2018. As~~Samsung BioLogics. Following the sale of ~~September 30, 2021, our ownership percentage remained at approximately 49.9%.~~Samsung Bioepis we no longer recognize gains or losses associated with Samsung Bioepis' results of operations and amortization related to basis differences.

~~We recognize~~Prior to this sale, we recognized our share of the results of operations related to our investment in Samsung Bioepis under the equity method of accounting one quarter in arrears when the results of the entity ~~become~~became available, which iswas reflected as equity in (income) loss of investee, net of tax in our condensed consolidated statements of income. We ~~recognize~~recognized amortization on certain basis differences resulting from our November 2018 investment.

~~Certain officers and affiliates~~For the nine months ended September 30, 2022, we recognized net income on our investment of $2.6 million, reflecting our ~~joint venture partner,~~share of Samsung ~~BioLogics, are currently subject~~Bioepis' operating profits, net of tax totaling $17.0 million, offset by amortization of basis differences totaling $14.4 million. This amount reflects our share of results prior to ~~ongoing criminal proceedings that we continue to monitor. While these proceedings could impact~~ the ~~operations~~sale of Samsung Bioepis ~~and its business, we have assessed~~as the ~~value of our investment~~results are recognized one quarter in ~~Samsung Bioepis and continue to believe that the fair value of the investment is in excess of its net book value.~~arrears.

For the three and nine months ended September 30, 2021, we recognized net income on our investment of $1.1 million and $17.2 million, respectively, reflecting our share of Samsung Bioepis' operating ~~results~~profits, net of tax totaling $8.9 million and $39.5 million, respectively, offset by amortization of basis differences ~~net of tax, compared to net losses on our investment of $13.1~~totaling $7.8 million and ~~$12.7~~$22.3 million, ~~respectively,~~respectively.

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For additional information on the sale of our equity interest in ~~the prior year comparative periods.~~

~~Net income on~~Samsung Bioepis, please read Note 2, Dispositions, to our investment for the nine months ended September 30, 2021, reflects a $31.2 million benefit related to the release of a valuation allowance on deferred tax assets associated with Samsung Bioepis. The valuation allowance was releasedcondensed consolidated financial statements included in ~~the second quarter of 2021 based on a consideration of the positive and negative evidence, including the historic earnings of Samsung Bioepis.~~this report.

Noncontrolling Interests, Net of Tax

Our condensed consolidated financial statements include the financial results of our variable interest entity, Neurimmune, as we determined that we are the primary beneficiary.

For the nine months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, the ~~increase is~~change in net income (loss) attributable to noncontrolling interests, net of tax was primarily due to ~~the recognition of~~ a ~~current year~~ deferred tax benefit ~~associated with the accelerated approval of ADUHELM by the FDA~~recorded in the ~~U.S.~~ second quarter of 2021, as discussed below.

During the second quarter of 2021 we recorded a net deferred tax asset in Switzerland of approximately ~~$500.0~~$490.0 million ~~related to~~on Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, ~~and approval~~we recorded a valuation allowance of approximately $390.0 million related to this deferred tax asset.

For the nine months ended September 30, 2021, ~~compared to the same period in 2020,~~ the change in net income (loss) attributable to noncontrolling interests, net of tax was also due to the $100.0 million milestone payment to Neurimmune related to the launch of ADUHELM in the U.S. during the second quarter of 2021.

For the nine months ended September 30, 2020, net income (loss) attributable to noncontrolling interests, net of tax was primarily related to the $75.0 million milestone payment to Neurimmune related to the submission of the BLA for the approval of ADUHELM to the FDA.

For additional information on our collaboration agreement with Neurimmune, please read Note ~~17,~~19, Investments in Variable Interest Entities, to our condensed consolidated financial statements included in this report.

For additional information on our income taxes please read Note ~~14,~~16, Income Taxes, to our condensed consolidated financial statements included in this report.

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~~Financial Condition, Liquidity and Capital Resources~~FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Our financial condition is summarized as follows:


(In millions, except percentages)	(In millions, except percentages)	As of September 30, 2021		As of December 31, 2020		Change %		(In millions, except percentages)	As of September 30, 2022		As of December 31, 2021		% Change		$ Change
Financial assets:	Financial assets:							Financial assets:
Cash and cash equivalents	Cash and cash equivalents	$	1,541.8	$	1,331.2	15.8	%	Cash and cash equivalents	$	3,675.6	$	2,261.4	62.5	%	$	1,414.2
Marketable securities — current	Marketable securities — current	1,413.3		1,278.9		10.5		Marketable securities — current	1,235.5		1,541.1		(19.8)		(305.6)
Marketable securities — non-current	Marketable securities — non-current	968.3		772.1		25.4		Marketable securities — non-current	860.3		892.0		(3.6)		(31.7)
Total cash, cash equivalents and marketable securities	Total cash, cash equivalents and marketable securities	$	3,923.4	$	3,382.2	16.0	%	Total cash, cash equivalents and marketable securities	$	5,771.4	$	4,694.5	22.9	%	$	1,076.9
Borrowings:	Borrowings:							Borrowings:
Current portion of notes payable	Current portion of notes payable	$	998.8	$	—	—	%	Current portion of notes payable	$	—	$	999.1	(100.0)	%	$	(999.1)
Notes payable	Notes payable	$	6,272.3	$	7,426.2	(15.5)	%	Notes payable	6,279.2		6,274.0		0.1		5.2
Total borrowings	Total borrowings	$	7,271.1	$	7,426.2	(2.1)	%	Total borrowings	$	6,279.2	$	7,273.1	(13.7)	%	$	(993.9)
Working capital:	Working capital:							Working capital:
Current assets	Current assets	$	7,162.3	$	6,887.1	4.0	%	Current assets	$	9,765.8	$	7,856.5	24.3	%	$	1,909.3
Current liabilities	Current liabilities	(4,211.6)		(3,742.2)		12.5		Current liabilities	(3,926.4)		(4,298.2)		(8.7)		371.8
Total working capital	Total working capital	$	2,950.7	$	3,144.9	(6.2)	%	Total working capital	$	5,839.4	$	3,558.3	64.1	%	$	2,281.1

For the nine months ended September 30, ~~2021,~~2022, certain significant cash flows were as follows:

•$~~2,801.6~~1,559.3 million in net cash flow provided by operating ~~activities, which reflected an upfront payment of $125.0 million made in connection with entering into our collaboration with InnoCare and recognized as research and development expense;~~activities;

•$~~1,800.0~~990.3 million in net proceeds received from the sale of our equity interest in Samsung Bioepis;

•$582.6 million in net proceeds received from the sale of one of our buildings;

•$1.0 billion payment made for the redemption of our 3.625% Senior Notes due September 15, 2022;

•$806.5 million in total net payments for income taxes;

•$750.0 million used for share repurchases; and

•$~~170.0 million used in connection with our Exchange Offer;~~

•~~$206.5~~153.9 million used for purchases of property, plant and ~~equipment;~~

•~~$100.1 million in total net payments of income taxes; and~~

•~~$100.0 million milestone payment to Neurimmune.~~equipment.

Overview

We have historically financed and expect to continue to fund our operating and capital expenditures primarily through cash flow earned through our operations. We expect our operating expenditures, particularly those related to research and development, clinical trials, commercialization of new products and international expansion to continue to grow. However, we expect to continue funding our current and planned operating requirements primarily through our cash flow earned from our operations as well as our existing cash resources. We believe generic competition for TECFIDERA in the U.S. and other key markets will continue to reduce our cash flow from operations in ~~2021~~2022 and will have a

significant adverse impact on our future cash flow from operations.

During the second quarter of 2022 we recorded a pre-tax charge of $900.0 million, plus estimated fees and expenses, related to a litigation settlement agreement to resolve a qui tam litigation relating to conduct prior to 2015. In October 2022 we made the $900.0 million payment related to the litigation settlement agreement. In July 2022 we redeemed our

3.625% Senior Notes due September 15, 2022, with an aggregate principal amount of $1.0 billion. In September 2022 we received $582.6 million in net proceeds from the sale of one of our buildings.

We believe that our existing funds, when combined with cash generated from operations and our access to additional financing resources, if needed, are sufficient to satisfy our operating, working capital, strategic alliance, milestone payment, capital expenditure and debt service requirements for the foreseeable future. In addition, we may choose to opportunistically return cash to shareholders and pursue other business initiatives, including acquisition and licensing activities. We may, from time to time, also seek additional funding through a combination of new collaborative agreements, strategic alliances and additional equity and debt financings or from other sources should we identify a significant new ~~opportunity~~opportunity.

For additional information on the litigation settlement agreement, please read .Note 20, Litigation, to our condensed consolidated financial statements included in this report.

For additional information on certain risks that could negatively impact our financial position or future results of operations, please readItem 1A. Risk Factors and Item 3. Quantitative and Qualitative Disclosures About Market Risk ~~and~~ ~~Item 1A.Risk Factors~~ included in this report.

Cash, Cash Equivalents and Marketable Securities

Until required for another use in our business, we typically invest our cash reserves in bank deposits, certificates of deposit, commercial paper, corporate notes, U.S. and foreign government instruments, overnight reverse repurchase agreements and other interest-bearing marketable debt instruments in accordance with our investment policy. It is our policy

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to mitigate credit risk in our cash reserves and marketable securities by maintaining a well-diversified portfolio that limits the amount of exposure as to institution, maturity and investment type.

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As of September 30, ~~2021,~~2022, we had cash, cash equivalents and marketable securities totaling approximately ~~$3.9~~$5.8 billion compared to approximately ~~$3.4~~$4.7 billion as of December 31, ~~2020.~~2021. The change in cash, cash equivalents and marketable securities at September 30, ~~2021,~~2022, from December 31, ~~2020,~~2021, was primarily due to net cash flow provided by operating activities and $990.3 million in net proceeds received from the sale of our equity interest in Samsung Bioepis and $582.6 million in net proceeds received from the sale of one of our buildings, partially offset by $1.0 billion of cash used for the redemption of our 3.625% Senior Notes due September 15, 2022, and share ~~repurchases and capital expenditures, cash payments made in connection with our Exchange Offer and a milestone payment made to Neurimmune.~~repurchases.

Investments and other assets in our condensed consolidated balance sheets as of ~~September 30, 2021 and~~ December 31, ~~2020,~~2021, include the carrying value of our investment in Samsung Bioepis of ~~$586.1 million and $620.2 million, respectively. As~~$599.9 million. In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis ~~is a privately-held entity, our ability~~ to ~~liquidate our investment may~~Samsung BioLogics. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be ~~limited~~deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction.

We are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones. If any payments due to us remain outstanding after the second anniversary of the closing of this transaction, we may ~~realize significantly less than the value of such investment. This investment is also subject~~elect to ~~foreign currency exchange fluctuations.~~

~~In connection with our collaboration with Sangamo, we purchased approximately 24 million~~receive shares of ~~Sangamo~~Samsung BioLogics common stock at a 5.0% discount in ~~April 2020. As~~lieu of ~~September 30, 2021 and December 31, 2020,~~a cash payment for the remaining amount due. Currently, we believe that the likelihood of Samsung BioLogics failing to make timely payments to us for the amounts due is remote.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to our condensed consolidated financial statements included in this report.

The following table summarizes the fair value of ~~this investment was $210.5 million and $333.7 million, respectively.~~

~~In connection with~~ our ~~collaboration with Denali, we purchased approximately 13 million shares of Denali~~significant common stock ~~in September 2020. As of September 30, 2021 and December 31, 2020, the fair value of this investment was $612.9 million and $935.7 million, respectively.~~investments:

In connection with our collaboration with Sage, we purchased approximately 6.2 million shares of Sage common stock in December 2020. As of September 30, 2021 and December 31, 2020, the fair value of this investment was $236.9 million and $433.9 million, respectively.


(In millions)	September 30, 2022		December 31, 2021
Denali	$	408.5	$	550.7
Sangamo	115.9		173.7
Sage	244.4		231.9
Ionis	127.2		87.5
	$	896.0	$	1,043.8

Our investment in Ionis common stock had a fair value of $96.4 million and $249.1 million as of September 30, 2021 and December 31, 2020, respectively. The decrease was partially due to the sale of a portion of our investment in Ionis common stock during the first quarter of 2021.

For additional information on our collaboration arrangements with Samsung Bioepis, Sangamo, Denali and Sage, please read Note ~~16,~~18, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

For additional information on our collaboration arrangements with Ionis, please read Note 18, Collaborative and Other Relationships, to our

consolidated financial statements included in our ~~2020~~2021 Form 10-K.

Capital Expenditures

In March 2021 we announced our plans to build a new gene therapy manufacturing facility in RTP, North Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new facility is expected to be operational by the end of 2023, with an estimated total investment of approximately $200.0 million. Construction for this new facility began during the fourth quarter of 2021.

Borrowings

In February 2021 we completed our Exchange Offer, consisting of the following:

•$624.6 million aggregate principal amount of our 2045 Senior Notes was exchanged for $700.7 million aggregate principal amount of our 2051 Senior Notes and approximately $151.8 million of aggregate cash payments; and

•$8.9 million aggregate principal amount of our 2045 Senior Notes was redeemed for approximately $12.1 million of aggregate cash payments, excluding accrued and unpaid interest.

~~In April 2020 we issued~~The following is a summary of our currently outstanding senior unsecured notes ~~for an aggregate principal amount of $3.0 billion~~issued in 2020 (2020 Senior Notes)~~, consisting of the following:~~:

•$1.5 billion aggregate principal amount of 2.25% Senior Notes due May 1, 2030; and

•$1.5 billion aggregate principal amount of 3.15% Senior Notes due May 1, 2050.

The following is a summary of our currently outstanding senior unsecured notes issued in 2015 (2015 Senior Notes):

•$~~1.0 billion aggregate principal amount of 3.625% Senior Notes due September 15, 2022;~~

•$1.75 billion aggregate principal amount of 4.05% Senior Notes due September 15, 2025; and

•$1.12 billion aggregate principal amount of 5.20% Senior Notes due September 15, 2045.

Our 2020 Senior Notes and our 2015 Senior Notes were issued at a discount, which are amortized

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as additional interest expense over the period from issuance through maturity.

In July 2022 we redeemed our 3.625% Senior Notes due September 15, 2022, with an aggregate principal amount of $1.0 billion.

For a summary of the fair and carrying values of our outstanding borrowings as of September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, please read Note 6,7, Fair Value Measurements, to our condensed consolidated financial statements included in this report.

Credit Facility

In January 2020 we entered into a $1.0 billion, five-year senior unsecured revolving credit facility under which we are permitted to draw funds for working capital and general corporate purposes. The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio. As of September 30,

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2022 and December 31, 2021, we had no outstanding borrowings and were in compliance with all covenants under this facility.

Working Capital

Working capital is defined as current assets less current liabilities. ~~Total~~Working capital was $5.8 billion and $3.6 billion as of September 30, 2022 and December 31, 2021, respectively. The change in working capital ~~decreased by $194.2 million, or 6.2%, primarily driven by~~reflects an increase in total current assets of approximately $1.9 billion and a decrease in total current liabilities ~~partially offset by an increase in current liabilities.~~of approximately $371.8 million.

The increase in current liabilities was primarily due to the reclassification of our $1.0 billion aggregate principal amount of 3.625% Senior Notes due September 15, 2022 from long-term to short-term, partially offset by a reduction in accounts payable as well as accrued expense and other, which was primarily related to decreases in the accrual of contingent payments, the accrual for employee compensation and benefits and the fair values of derivative liabilities.Current Assets

The increase in total current assets was primarily driven by anthe following:

•net increase in ~~net~~ cash, cash equivalents and marketable securities due to ~~$2,801.6~~net cash flow provided by operating activities;

•receipt of approximately $990.3 million in cash, net of expenses, from the sale of our equity interest in Samsung Bioepis;

•recording of a receivable from Samsung BioLogics for approximately $790.8 million as part of the sale of our equity interest in Samsung Bioepis; and

•cash ~~generated from operations,~~receipt of approximately $582.6 million related to the sale of one of our buildings.

The increase was partially offset by cash used for the redemption of our 3.625% Senior Notes due September 15, 2022, of approximately $1.0 billion and for share repurchases ~~capital expenditures~~of $750.0 million.

Current Liabilities

The decrease in current liabilities was primarily due to the following:

•redemption of our 3.625% Senior Notes due September 15, 2022, of approximately $1.0 billion, which were classified within current liabilities as of December 31, 2021; and

•a ~~Neurimmune milestone payment as well as cash payments made~~reduction in ~~conjunction~~our accounts payable.

The decrease was partially offset by an increase in accrued expense and other resulting from an accrual recorded during the second quarter of 2022 for a pre-tax charge of $900.0 million in connection with ~~our Exchange Offer.~~a litigation settlement agreement reached during 2022.

Share Repurchase Programs

repurchases under our 2020 Share Repurchase Program will be retired. Under our 2020 Share Repurchase Program, we repurchased and retired approximately 1.2 million and 3.6 million shares of our common stock at a cost of approximately $250.0 million and $750.0 million during the three and nine months ended September 30, 2022, respectively. During the three and nine months ended September 30, 2021, we repurchased and retired approximately 2.2 million and 6.0 million shares of our common stock at a cost of approximately $750.0 million and $1.8 billion, ~~during the three and nine months ended September 30, 2021,~~ respectively. Approximately ~~$2.8~~$2.1 billion remained available under our 2020 Share Repurchase Program as of September 30, ~~2021.~~2022.

In December 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (December 2019 Share Repurchase Program), which was completed as of September 30, 2020. All shares repurchased under our December 2019 Share Repurchase Program were retired. Under our December 2019 Share Repurchase Program, we repurchased and retired approximately 4.5 million and 16.7 million shares of our common stock at a cost of approximately $1.3 billion and $5.0 billion during the three and nine months ended September 30, 2020, respectively.

In March 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (March 2019 Share Repurchase Program), which was completed as of March 31, 2020. All shares repurchased under our March 2019 Share Repurchase Program were retired. Under our March 2019 Share Repurchase Program, we repurchased and retired approximately 4.1 million shares of our common stock at a cost of approximately $1.3 billion during the nine months ended September 30, 2020.

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Cash Flow

The following table summarizes our cash flow activity:

For the Nine Months Ended September 30,
(In millions, except percentages) 2021 2020 % Change
Net cash flow provided by operating activities $ 2,801.6 $ 4,596.9 (39.1) %
Net cash flow used in investing activities (451.0) (442.2) (2.0)
Net cash flow used in financing activities (2,096.0) (4,871.6) 57.0


	For the Nine Months Ended September 30,
(In millions, except percentages)	2022		2021		% Change
Net cash flow provided by (used in) operating activities	$	1,559.3	$	2,801.6	(44.3)	%
Net cash flow provided by (used in) investing activities	1,717.7		(451.0)		480.9
Net cash flow provided by (used in) financing activities	(1,739.9)		(2,096.0)		(17.0)

Operating Activities

Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. We expect cash provided from operating activities will continue to be our primary source of funds to finance operating needs and capital expenditures for the foreseeable future.

Operating cash flow is derived by adjusting our net income for:

•non-cash operating items such as depreciation and amortization, impairment charges, unrealized gain (loss) on strategic investments, acquired IPR&D and share-based compensation;

•changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations; and

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•changes in the fair value of contingent payments associated with our acquisitions of businesses and payments related to collaborations.

For the nine months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, the decrease in net cash flow provided by operating activities was primarily due to lower revenue in 2022, timing of payments and higher net ~~income.~~income tax payments in 2022 as compared to the same period in 2021.

Investing Activities

For the nine months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, the increase in net cash flow ~~used in~~provided by investing activities was primarily due to ~~higher~~proceeds received from the sale of our 49.9% equity interest in Samsung Bioepis of $990.3 million, net of expenses, during the second quarter of 2022 as well as $582.6 million in net proceeds received from the sale of ~~marketable securities in 2020 as compared to~~one of our buildings during the ~~current year, partially offset by higher capital expenditures and acquisitions~~third quarter of ~~IPR&D and other intangible assets in 2020 as well as the upfront payments made to Sangamo and Denali.~~2022.

Financing Activities

For the nine months ended September 30, ~~2021,~~2022, compared to the same period in ~~2020,~~2021, the decrease in net cash flow used in financing activities was primarily due to ~~the greater number of shares repurchased~~$1.1 billion in ~~2020 as compared to the comparative period~~lower share

repurchases in ~~2021,~~2022, partially offset by ~~cash used~~$832.2 million in ~~connection with our Exchange Offer and a milestone payment to Neurimmune~~higher debt repayments in ~~2021.~~2022.

Contractual Obligations and Off-Balance Sheet Arrangements

Contractual Obligations

Our contractual obligations primarily consist of our obligations under non-cancellable operating leases, long-term debt obligations and defined benefit and other purchase obligations, excluding amounts related to uncertain tax positions, funding commitments, contingent development, regulatory and commercial milestone payments, contingent payments and contingent consideration related to our business combinations, as described below.

There have been no material changes in our contractual obligations since December 31, ~~2020.~~2021, aside from our new lease commitment as a result of our sale-leaseback transaction during the third quarter of 2022. For additional information, please read Note 11, Leases, to our condensed consolidated financial statements included in this report.

Royalty Payments

TYSABRI

We are obligated to make contingent payments of 18.0% on annual worldwide net sales of TYSABRI up to $2.0 billion and 25.0% on annual worldwide net sales of TYSABRI that exceed $2.0 billion. Royalty payments are recognized as cost of sales in our condensed consolidated statements of income.

SPINRAZA

We make royalty payments on annual worldwide net sales of SPINRAZA using a tiered royalty rate between 11.0% and 15.0%, which are recognized as cost of sales in our condensed consolidated statements of income.

VUMERITY

In October 2019 the FDA approved VUMERITY for the treatment of RMS. During the fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in the E.U., Switzerland and the U.K. Under our agreement with Alkermes Pharma Ireland Limited, a

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subsidiary of Alkermes plc (Alkermes), we make royalty payments to Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0%, which are ~~recorded~~recognized as cost of sales in our condensed consolidated statements of income.

In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes. We have elected to initiate a technology transfer and, following a transition period, to manufacture VUMERITY or have VUMERITY manufactured by a third party we have engaged in exchange for paying an increased royalty rate to Alkermes on any portion of future worldwide net sales of VUMERITY that is manufactured by us or our designee. For additional information on our collaboration arrangement with Alkermes, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our ~~2020~~2021 Form 10-K.

Contingent Consideration related to Business Combinations

In connection with our acquisition of Convergence Pharmaceuticals Holdings Ltd., we agreed to make additional payments based upon the achievement of certain milestone events.

We recognized the contingent consideration liabilities associated with this acquisition at ~~its~~their fair value on the acquisition date and revalue ~~this obligation~~these obligations each reporting period. We may pay up to approximately $400.0 million in remaining milestones related to this acquisition.

Contingent Development, Regulatory and Commercial Milestone Payments

Based on our development plans as of September 30, ~~2021,~~2022, we could trigger potential future milestone payments to third parties of up to approximately ~~$10.9~~$9.5 billion, including approximately ~~$2.1~~$1.9 billion in development milestones, approximately ~~$1.2 billion~~$700.0 million in regulatory milestones and approximately ~~$7.6~~$6.9 billion in commercial milestones, as part of our various collaborations, including licensing and development programs. Payments under these agreements generally become due and payable

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upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones was not considered probable as of September 30, ~~2021,~~2022, such contingencies have not been recorded in our financial statements. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones.

If certain clinical and commercial milestones are met, we may pay up to ~~$20.5~~approximately $24.3 million in milestones in ~~2021~~2022 under our current agreements. In addition, if aducanumab receives regulatory approval in the jurisdictions where we have submitted filings, we may pay up to $100.0 million in additional milestones to Neurimmune, which includes $50.0 million if launched in three or more countries in the E.U. and $50.0 million if launched in Japan. Milestones payable to Neurimmune are shared expenses under the ADUHELM Collaboration Agreement.

~~For additional information on our collaboration arrangements with Eisai, please read~~ ~~Note 16, Collaborative and Other Relationships,~~ ~~to our condensed consolidated financial statements included in this report.~~

~~For additional information on our collaboration arrangement with Neurimmune, please read~~ ~~Note 17, Investments in Variable Interest Entities,~~ ~~to our condensed consolidated financial statements included in this report.~~

Other Funding Commitments

As of September 30, ~~2021,~~2022, we have several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial expenditures are to contract research organizations (CROs). The contracts with CROs are generally cancellable, with notice, at our option. We recorded accrued expense of approximately ~~$47.0~~$15.8 million in our condensed consolidated balance ~~sheet~~sheets for expenditures incurred by CROs as of September 30, ~~2021.~~2022. We have approximately ~~$644.1~~$943.5 million in cancellable future commitments based on existing CRO contracts as of September 30, ~~2021.~~2022.

As part of the sale of our Hillerød, Denmark manufacturing operations to FUJIFILM Corporation (FUJIFILM), we provided FUJIFILM with certain minimum batch production commitment guarantees. There is a risk that the minimum contractual batch production commitments will not be met. Based upon current estimates we do not expect to incur an adverse commitment obligation associated with such guarantees. We developed this estimate using a probability-weighted estimate of future manufacturing activity and may further adjust this estimate based upon changes in business conditions, which may

result in the increase or reduction of this adverse commitment obligation in subsequent periods.

For additional information on the divestiture of our Hillerød, Denmark manufacturing operations, please read Note 3, Divestitures, to our consolidated financial statements included in our ~~2020~~2021 Form 10-K.

Tax Related Obligations

We exclude liabilities pertaining to uncertain tax positions from our summary of contractual obligations as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. As of September 30, ~~2021,~~2022, we have approximately ~~$102.4~~$155.1 million of liabilities associated with uncertain tax positions.

As of September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, we have accrued income tax liabilities of approximately ~~$633.0~~$558.0 million and ~~$697.0~~$633.0 million, respectively, under a one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings (the Transition Toll Tax). Of the amounts accrued as of September 30, ~~2021,~~2022, approximately ~~$72.7~~$137.8 million is expected to be paid within one year. The Transition Toll Tax will be paid in installments over an eight-year period, which started in 2018, and will not accrue interest.

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Other Off-Balance Sheet Arrangements

We do not have any relationships with entities often referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships. We consolidate variable interest entities if we are the primary beneficiary.

New Accounting Standards

For a discussion of new accounting standards please read Note 1, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included in this report.

Critical Accounting Estimates

The preparation of our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S., requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical

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experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates.

For a discussion of our critical accounting estimates, please read Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our ~~2020~~2021 Form 10-K. There have been no material changes to our critical accounting estimates since our ~~2020~~2021 Form 10-K.

~~Item~~ITEM 3. ~~Quantitative and Qualitative Disclosures About Market Risk~~QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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 ~~pricing pressures worldwide~~equity price exposure as well as changes in economic conditions in the markets in which we operate as a result of the COVID-19 ~~pandemic.~~pandemic and the conflict in Ukraine. We manage the impact of foreign currency exchange rates and interest rates through various financial instruments, including derivative instruments such as foreign currency forward contracts, interest rate lock contracts and interest rate swap contracts.

We do not enter into financial instruments for trading or speculative purposes. The counterparties to these contracts are major financial institutions, and there is no significant concentration of exposure with any one counterparty.

Foreign Currency Exchange Risk

Our results of operations are subject to foreign currency exchange rate fluctuations due to the global nature of our operations. As a result, our consolidated financial position, results of operations and cash flow can be affected by market fluctuations in foreign currency exchange rates, primarily with respect to the Euro, British pound sterling, Canadian dollar, Swiss franc, Japanese yen and South Korean won.

While the financial results of our global activities are reported in U.S. dollars, the functional currency for most of our foreign subsidiaries is their respective local currency. Fluctuations in the foreign currency exchange rates of the countries in which we do business will affect our operating results, often in ways that are difficult to predict. In particular, as the U.S. dollar strengthens versus other currencies, the value of the non-U.S. revenue will decline when reported in U.S. dollars. 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. As the U.S. dollar weakens versus other currencies, the value of

the non-U.S. revenue and expense will increase 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 flow and changes in fair value caused by volatility in foreign currency exchange rates.

During the second quarter of 2018 the International Practices Task Force of the Center for Audit Quality categorized Argentina as a country with a projected three-year cumulative inflation rate greater than 100.0%, which indicated that Argentina's economy is highly inflationary. This categorization did not have a material impact on our results of operations or financial position as of September 30, ~~2021,~~2022, and is not expected to have a material impact on our results of operations or financial position in the future.

Revenue and Operating Expense Hedging Program

Our foreign currency hedging program is designed to mitigate, over time, a portion of the impact resulting from volatility in exchange rate changes on revenue and operating expense. We use foreign currency forward contracts and foreign currency options to manage foreign currency risk, with the majority of our forward contracts and options used to hedge certain forecasted revenue and operating

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expense transactions denominated in foreign currencies in the next 1815 months. We do not engage in currency speculation. For a more detailed disclosure of our revenue and operating expense hedging program, please read Note 8,9, Derivative Instruments, to our condensed consolidated financial statements included in this report.

Our ability to mitigate the impact of foreign currency exchange rate changes on revenue and net income diminishes as significant foreign currency exchange rate fluctuations are sustained over extended periods of time. In particular, devaluation or significant deterioration of foreign currency exchange rates are difficult to mitigate and likely to negatively impact earnings. The cash flow from these contracts are reported as operating activities in our condensed consolidated statements of cash flow.

Balance Sheet Risk Management Hedging Program

We also use forward contracts to mitigate the foreign currency exposure related to certain balance sheet items. The primary objective of our balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets and liabilities of foreign affiliates. In these instances, we principally utilize currency forward contracts. We have not elected hedge accounting for the balance sheet related items. The cash flow from

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these contracts are reported as operating activities in our condensed consolidated statements of cash flow.

The following quantitative information includes the impact of currency movements on forward contracts used in our revenue, operating expense and balance sheet hedging programs. As of September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, a hypothetical adverse 10.0% movement in foreign currency exchange rates compared to the U.S. dollar across all maturities would result in a hypothetical decrease in the fair value of forward contracts of approximately ~~$344.1~~$227.2 million and ~~$458.2~~$333.1 million, respectively. The estimated fair value change was determined by measuring the impact of the hypothetical exchange rate movement on outstanding forward contracts. Our use of this methodology to quantify the market risk of such instruments is subject to assumptions and actual impact could be significantly different. The quantitative information about market risk is limited because it does not take into account all foreign currency operating transactions.

Net Investment Hedge Program

Our net investment hedging program iswas 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~~In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis

to Samsung BioLogics and closed these foreign currency forward ~~contracts~~ contracts.

For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to ~~manage the foreign currency risk with~~ our ~~forward contracts used to hedge changes~~condensed consolidated financial statements included in the spot rate over the next one month. As of September 30, 2021 and December 31, 2020, a hypothetical adverse 10.0% movement would result in a hypothetical decrease in fair value of approximately $52.4 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.this report.

Interest Rate Risk

Our investment portfolio includes cash equivalents and short-term investments. The fair value of our marketable securities is subject to change as a result of potential changes in market interest rates. The potential change in fair value for interest rate sensitive instruments has been assessed on a hypothetical 100 basis point adverse movement across all maturities. As of September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, we estimate that such hypothetical 100 basis point adverse movement would result in a hypothetical loss in fair value of approximately ~~$15.0~~$12.7 million and ~~$13.2~~$14.3 million, respectively, to our interest rate sensitive instruments. The fair values of our investments were determined using third-party pricing services or other market observable data.

~~Pricing Pressure~~

Governments in certain international markets in which we operate have implemented measures, and may in the future implement new or additional measures, to reduce health care costs to limit the overall level of government expenditures. These measures vary by country and may include, among other things, patient access restrictions, suspensions on price increases, prospective and possible retroactive price reductions and other recoupments and increased mandatory discounts or rebates, recoveries of past price increases and greater importation of drugs from lower-cost countries. In addition, certain countries set prices by reference to the prices in other countries where our products are marketed. Our inability to obtain and maintain adequate prices in a particular country may not only limit the revenue from our products within that country but may also adversely affect our ability to secure acceptable prices in existing and potential new markets, which may limit market growth. The continued implementation of pricing actions throughout Europe may also lead to higher levels of parallel trade.

In the U.S., federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance programs and increasing pressure from social sources could significantly influence the way our products are prescribed and purchased. It is possible that additional federal health care reform measures will be adopted in the future, which could result in increased pricing pressure and reduced reimbursement for our products and otherwise have an adverse impact on our consolidated financial position or results of operations. There is also significant economic pressure on state budgets that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for our drugs. Managed care organizations are also continuing to seek price discounts and, in some cases, impose restrictions on the coverage of certain drugs.

Our products continue to face increasing competition in many markets from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways. Such products are likely to be sold at substantially lower prices than branded products. Accordingly, the introduction of such products as well as other lower-priced competing products may significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which will negatively impact our revenue. In addition, in some markets, when a generic

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~~or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time.~~

Multiple TECFIDERA generic entrants are now in the U.S. market and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and is expected to have a substantial negative impact on our TECFIDERA revenue for as long as there is generic competition.

On May 5, 2021, the European General Court annulled the EMA's non-validation decision with respect to a generic application related to TECFIDERA in the E.U. This generic application is now before the EMA, which is reassessing TECFIDERA's regulatory data protection by performing a scientific assessment pursuant to the European General Court's decision. The result of the scientific assessment of the EMA is expected in the fourth quarter of 2021. We have appealed the European General Court's decision to the European Court of Justice and the appeal is pending.

We will face TECFIDERA generic competition in the E.U. if regulatory data protection is not upheld and we expect that this would have an adverse impact on our TECFIDERA sales and our results of operations.

Credit Risk

~~We are~~Financial instruments that potentially subject us to ~~credit risk from our accounts receivable related to our product sales. The majority of our accounts receivable arise from product sales in the U.S. and Europe with~~ concentrations of credit risk ~~limited due~~include cash and cash equivalents, investments, derivatives and accounts receivable. We attempt to minimize the ~~wide variety~~risks related to cash and cash equivalents and investments by investing in a broad and diverse range of ~~customers~~financial instruments. We have established guidelines related to credit ratings and ~~markets using~~maturities intended to safeguard principal balances and maintain liquidity. Our investment portfolio is maintained in accordance with our ~~products~~investment policy, which defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. We minimize credit risk resulting from derivative instruments by choosing only highly rated financial institutions as well as their dispersion across many different geographic areas. Our accounts receivable are primarily due from wholesale and other third-party distributors, public hospitals, pharmacies and other government entities. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. counterparties.

We operate in certain countries where weakness in economic conditions, including ~~as a result~~the effects of the COVID-19 pandemic and the conflict in Ukraine, can result in extended collection periods. We continue to monitor these conditions, including the volatility associated with international economies and the relevant financial markets, and assess their possible impact on our business. To date, we have not experienced any significant losses with respect to the collection of our accounts receivable.

We believe that our allowance for doubtful accounts was adequate as of September 30, ~~2021~~2022 and December 31, ~~2020. However, if significant~~2021.

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Equity Price Risk

Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies. While we are holding such securities, we are subject to equity price risk, and this may increase the volatility of our income in future periods due to changes ~~occur~~ in the ~~availability~~fair value of ~~government funding or~~equity investments. We may sell such equity securities based on our business considerations, which may include limiting our price risk.

Changes in the ~~reimbursement practices~~fair value of these or

equity securities are impacted by the volatility of the stock market and changes in general economic conditions, among other factors. The potential change in fair value for equity price sensitive instruments has been assessed on a hypothetical 10.0% adverse movement. As of September 30, 2022 and December 31, 2021, a hypothetical adverse 10.0% movement would result in a hypothetical decrease in fair value of approximately $89.6 million and $104.8 million, respectively.

~~other governments, we may not be able to collect on amounts due to us from customers in such countries and our results of operations could be adversely affected.~~

~~Item~~ITEM 4. ~~Controls and Procedures~~CONTROLS AND PROCEDURES

Disclosure Controls and Procedures and Internal Control over Financial Reporting

Controls and Procedures

We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended), as of September 30, ~~2021.~~2022. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that:

(a) the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms; and

(b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well

designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, ~~2021,~~2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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~~Part~~PART II — OTHER INFORMATION

~~Item~~ITEM 1. ~~Legal Proceedings~~LEGAL PROCEEDINGS

For a discussion of legal proceedings as of September 30, ~~2021,~~2022, please read Note ~~18,~~20, Litigation, to our condensed consolidated financial statements included in this report, which is incorporated into this item by reference.

~~Item~~ITEM 1A. ~~Risk Factors~~RISK FACTORS

Risks Related to Our Business

We are substantially dependent on revenue from our products.

Our revenue depends upon continued sales of our products as well as the financial rights we have in our anti-CD20 therapeutic programs. A significant portion of our revenue is concentrated on sales of our products in increasingly competitive markets and in markets affected directly and indirectly by the COVID-19 pandemic. Any of the following negative developments relating to any of our products or any of our anti-CD20 therapeutic programs may adversely affect our revenue and results of operations or could cause a decline in our stock price:

•the introduction, or greater acceptance or more favorable reimbursement of competing products, including new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways;

•safety or efficacy issues;

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

•adverse legal, administrative, regulatory or legislative developments;

•our ability to maintain a positive reputation among patients, healthcare providers and others, which may be impacted by our pricing and reimbursement decisions; or

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

~~ADUHELM is in~~In June 2021 the ~~early stages~~FDA granted accelerated approval of ~~commercial launch~~ADUHELM in the U.S. In addition to risks associated with new ~~product launches~~products and the other factors described in these Risk Factors, our ability to successfully commercialize ADUHELM may be adversely affected due to:

•~~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;

•our ability to obtain and maintain ~~adequate~~ reimbursement for ADUHELM;

•the impact of the final NCD by CMS for the class of anti-amyloid treatments in Alzheimer's disease, including ADUHELM; and

•the lack of market acceptance of ~~ADUHELM;~~

•~~the effectiveness of our commercial strategy for marketing ADUHELM;~~

•~~delays in the manufacturing, distribution and supply of ADUHELM;~~

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

•our 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 ADUHELM.

As part of the accelerated approval, we ~~will~~are required to 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, ADUHELM's benefit-risk is no longer positive or we fail to comply with the conditions of the accelerated approval.

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

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

Product development is very expensive and involves a high degree of uncertainty and risk and may not be successful. Only a small number of research and development programs result in the commercialization of a product. It is difficult to predict the success and the time and cost of product development of novel approaches for the

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treatment of diseases. The development of novel approaches for the treatment of diseases, including development efforts in new modalities such as those based on the antisense oligonucleotide platform and gene therapy, may present additional challenges and risks, including obtaining approval from regulatory authorities that have limited experience with the development of such therapies.

Clinical trial data are subject to differing interpretations and even if we view data as sufficient to support the safety, effectiveness and/or approval of an investigational therapy, regulatory authorities may disagree and may require additional data, limit the scope of the approval or deny approval altogether. Furthermore, the approval of a product candidate by one regulatory agency does not mean that other regulatory agencies will also approve such product candidate.

Success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. Clinical trials may indicate that our product candidates lack efficacy, have harmful side effects, result in unexpected adverse events or raise other concerns that may significantly reduce the likelihood of regulatory approval. This may result in terminated programs, significant restrictions on use and safety warnings in an approved label, adverse placement within the treatment paradigm or significant reduction in the commercial potential of the product candidate.

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

Sales of new products or products with additional indications may not meet investor expectations.

If we fail to compete effectively, our business and market position would suffer.

The biopharmaceutical industry and the markets in which we operate are intensely competitive. We compete in the marketing and sale of our products, the development of new products and processes, the acquisition of rights to new products with commercial potential and the hiring and retention of personnel. We compete with biotechnology and pharmaceutical companies that have a greater number of products on the market and in the product pipeline, substantially greater financial, marketing, research and development and other resources and other technological or competitive advantages.

Our products continue to face increasing competition from the introduction of new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways. Some of these products are likely to be sold at substantially lower prices than our branded products. The introduction of such products as well as other lower-priced competing products has reduced, and may in the future, significantly reduce both the price that we are able to charge for our products and the volume of products we sell, which will negatively impact our revenue. For instance, demand and price for TECFIDERA declined significantly as a result of multiple TECFIDERA generic entrants entering the U.S. market in 2020. In addition, in some markets, when a generic or biosimilar version of one of our products is commercialized, it may be automatically substituted for our product and significantly reduce our revenue in a short period of time.

Our ability to compete, maintain and grow our business may also be adversely affected due to a number of factors, including:

•the introduction of other products, including products that may be more efficacious, safer, less expensive or more convenient alternatives to our products, including our own products and products of our collaborators;

•the off-label use by physicians of therapies indicated for other conditions to treat patients;

•patient dynamics, including the size of the patient population and our ability to identify, attract and maintain new and current patients to our therapies;

•the reluctance of physicians to prescribe, and patients to use, our products without additional data on the efficacy and safety of such products;

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•damage to physician and patient confidence in any of our products, generic or biosimilars of our products or any other product from the same class as one of our products, or to our sales and reputation as a result of label changes, pricing and reimbursement decisions or adverse experiences or events that may occur with patients treated with our products or generic or biosimilars of our products;

•inability to obtain appropriate pricing and reimbursement for our products compared to our competitors in key international markets; or

•our ability to obtain and maintain patent, data or market exclusivity for our products.

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Our business may be adversely affected if we do not successfully execute or realize the anticipated benefits of our strategic and growth initiatives.

The successful execution of our strategic and growth initiatives may depend upon internal development projects, commercial initiatives and external opportunities, which may include the acquisition and in-licensing of products, technologies and companies or the entry into strategic alliances and collaborations.

While we believe we have a number of promising programs in our pipeline, failure or delay of internal development projects to advance or difficulties in executing on our commercial initiatives could impact our current and future growth, resulting in additional reliance on external development opportunities for growth.

Supporting the further development of our existing products and potential new products in our pipeline will require significant capital expenditures and management resources, including investments in research and development, sales and marketing, manufacturing capabilities and other areas of our business. We have made, and may continue to make, significant operating and capital expenditures for potential new products prior to regulatory approval with no assurance that such investment will be recouped, which may adversely affect our financial condition, business and operations.

The availability of high quality, fairly valued external product development is limited and the opportunity for their acquisition is highly competitive. As such, we are not certain that we will be able to identify suitable candidates for acquisition or if we will be able to reach agreement.

We may fail to initiate or complete transactions for many reasons, including failure to obtain regulatory or other approvals as well as disputes or litigation. Furthermore, we may not be able to achieve the full strategic and financial benefits expected to result from transactions, or the benefits may be delayed or not occur at all. We may also face additional costs or liabilities in completed transactions that were not contemplated prior to completion.

Any failure in the execution of a transaction, in the integration of an acquired asset or business or in achieving expected synergies could result in slower growth, higher than expected costs, the recording of asset impairment charges and other actions which could adversely affect our business, financial condition and results of operations.

Sales of our products depend, to a significant extent, on adequate coverage, pricing and reimbursement from third-party payors, which are subject to increasing and intense pressure from political, social, competitive and other sources. Our inability to obtain and maintain adequate coverage, or a reduction in pricing or reimbursement, could have an adverse effect on our business, reputation, revenue and results of operations.

Sales of our products depend, to a significant extent, on adequate coverage, pricing and reimbursement from third-party payors. When a new pharmaceutical product is approved, the availability of government and private reimbursement for that product may be uncertain, as is the pricing and amount for which that product will be reimbursed.

Pricing and reimbursement for our products may be adversely affected by a number of factors, including:

•changes in, and implementation of, federal, state or foreign government regulations or private third-party payors’ reimbursement policies;

•pressure by employers on private health insurance plans to reduce costs;

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

•our ability to receive reimbursement for our products or our ability to receive comparable reimbursement to that of competing products; and

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

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Our ability to set the price for our products varies significantly from country to country and, as a result, so can the price of our products. Drug prices are under significant scrutiny in the markets in which our products are prescribed; for example the Inflation Reduction Act of 2022 (the IRA) has certain provisions related to drug pricing. We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis. Certain countries set prices by reference to the prices in other countries where our products are marketed. Our inability to obtain and maintain adequate prices in a particular country may not only limit the revenue from our products within that country but may also adversely affect our ability to secure acceptable

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prices in existing and potential new markets, which may limit market growth. This may create the opportunity for third-party cross-border trade or influence our decision to sell or not to sell a product, thus adversely affecting our geographic expansion plans and revenue. Additionally 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.

Drug prices are under significant scrutiny in the markets in which our products are prescribed. We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis. Competition from current and future competitors may negatively impact our ability to maintain pricing and our market share. New products marketed by our competitors could cause our revenue to decrease due to potential price reductions and lower sales volumes. Additionally, the introduction of generic or biosimilar versions of our products, follow-on products, prodrugs or products approved under abbreviated regulatory pathways may significantly reduce the price that we are able to charge for our products and the volume of products we sell.

Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient co-pay or co-insurance obligations and limitations on patients' use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs). Significant consolidation in the health insurance industry has resulted in a few large insurers and pharmacy benefit managers exerting greater pressure in pricing and usage negotiations with drug manufacturers, significantly increasing discounts and rebates required of manufacturers and limiting patient access and usage. Further consolidation among insurers, pharmacy benefit managers and other payors would increase the negotiating leverage such entities have over us and other drug manufacturers. Additional discounts, rebates, coverage or plan changes, restrictions or exclusions as described above could have a material adverse effect on sales of our affected products.

Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business, reputation, revenue and results of operations.

We depend on relationships with collaborators, joint venture partners and other ~~third parties~~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 collaborative, joint venture and other third-party relationships for revenue and the development, regulatory approval, commercialization and marketing of certain of our products and product candidates. We also outsource certain aspects of our regulatory affairs and clinical development relating to our products and product candidates to ~~third parties.~~third-parties. Reliance on ~~third parties~~third-parties subjects us to a number of risks, including:

•we may be unable to control the resources our collaborators, joint venture partners or ~~third parties~~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 collaborators, joint ventures partners or ~~third parties~~third-parties fail to perform;

•the interests of our collaborators, joint venture partners or ~~third parties~~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;

•third-party relationships require the parties to cooperate, and failure to do so effectively could adversely affect product sales or the clinical development or regulatory approvals of product candidates under joint control, could result in termination of the research, development or commercialization of product candidates or could result in litigation or arbitration;

•any failure on the part of our collaborators, joint venture partners or ~~third parties~~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

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•any improper conduct or actions on the part of our collaborators, joint venture partners or ~~third parties~~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.

~~Certain officers and affiliates~~

Table 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.Contents

Given these risks, there is considerable uncertainty regarding the success of our current and future collaborative efforts. If these efforts fail, our product development or commercialization of new products could be delayed, revenue from products could decline and/or we may not realize the anticipated benefits of these arrangements.

Our results of operations may be adversely affected by current and potential future healthcare reforms.

In the U.S., federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance programs (including those contained in the IRA) and increasing pressure from social sources could significantly influence the manner in which our products are prescribed and purchased. For example, provisions of the Patient Protection and Affordable Care Act (PPACA) have resulted in changes in the way health care is paid for by both governmental and private insurers, including increased rebates owed by manufacturers under the Medicaid Drug Rebate Program, annual fees and taxes on manufacturers of certain branded prescription drugs, the requirement that manufacturers participate in a discount program for certain outpatient drugs under Medicare Part D and the expansion of the number of hospitals eligible for discounts under Section 340B of the Public Health Service Act. These changes have had and are expected to continue to have a significant impact on our business.

We may face uncertainties as a result of efforts to repeal, substantially modify or invalidate some or all of the provisions of the PPACA. There is no assurance that the PPACA, as currently enacted or as amended in the future, will not adversely affect our business and financial results, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

There is increasing public attention on the costs of prescription drugs and we expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis. For example, two committees of the U.S. House of Representatives are investigating the approval and price of ADUHELM. In addition, there have been, and are expected to continue to be, legislative proposals to address prescription drug pricing. Some of these proposals could have significant effects on our business, including an executive order issued in September 2020 to test a “most favored nation” model for Part B and Part D drugs that tie reimbursement rates to international drug pricing metrics. These actions and the uncertainty about the future of the PPACA and healthcare laws may put downward pressure on pharmaceutical pricing and increase our regulatory burdens and operating costs.

There is also significant economic pressure on state budgets, including as a result of the COVID-19 pandemic, that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for our drugs. In recent years, some states have considered legislation and ballot initiatives that would control the prices of drugs, including laws to allow importation of pharmaceutical products from lower cost jurisdictions outside the U.S. and laws intended to impose price controls on state drug purchases. State Medicaid programs are increasingly requesting manufacturers to pay supplemental rebates and requiring prior authorization by the state program for use of any drug for which supplemental rebates are not being paid. Government efforts to reduce Medicaid ~~expenses~~expense may lead to increased use of managed care organizations by Medicaid programs. This may result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding limitation on prices and reimbursement for our products.

In the E.U. and some other international markets, the government provides health care at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored health care system. Many countries have announced or implemented measures, and may in the future implement new or additional measures, to reduce health care costs to limit the overall level of government expenditures. These measures vary by country and may include, among other things, patient access restrictions, suspensions on price increases, prospective and possible retroactive price reductions and other recoupments and increased mandatory discounts or rebates, recoveries of past price increases and greater importation of drugs from lower-cost countries. These measures have negatively impacted our revenue and may continue to adversely affect our revenue and results of operations in the future.

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Our success in commercializing biosimilars is subject to risks and uncertainties inherent in the development, manufacture and commercialization of biosimilars. If we are unsuccessful in such activities, our business may be adversely affected.

The development, manufacture and commercialization of biosimilar products require specialized expertise and are very costly and subject to complex regulation. Our success in commercializing biosimilars is subject to a number of risks, including:

•Reliance on ~~Third Parties.~~Third-Parties. We are dependent, in part, on the efforts of Samsung Bioepis, collaboration partners and other ~~third parties~~third-parties over whom we have limited or no control in the development and

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manufacturing of biosimilars products. If these ~~third parties~~third-parties fail to perform successfully, our biosimilar product development or commercialization of biosimilar products could be delayed, revenue from biosimilar products could decline and/or we may not realize the anticipated benefits of these arrangements;

•Regulatory Compliance. Biosimilar products may face regulatory hurdles or delays due to the evolving and uncertain regulatory and commercial pathway of biosimilars products in certain jurisdictions;

•Intellectual Property and Regulatory Challenges. Biosimilar products may face extensive patent clearances, patent infringement litigation, injunctions or regulatory challenges, which could prevent the commercial launch of a product or delay it for many years or result in imposition of monetary damages, penalties or other civil sanctions and damage our reputation;

•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;

•Ability to Provide Adequate Supply. Manufacturing biosimilars is complex. If we encounter any manufacturing or supply chain difficulties we may be unable to meet ~~higher than anticipated~~ demand. We are dependent on a third-party for the manufacture of 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; and

•Competitive Challenges. Biosimilar products face significant competition, including from innovator products and biosimilar products offered by other ~~companies.~~companies that may receive greater acceptance or more favorable reimbursement. Local tendering processes may restrict biosimilar products from being marketed and sold in some jurisdictions. 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 and/or the success of Samsung Bioepis in this business area.

The illegal distribution and sale by third-parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.

Third-parties might illegally distribute and sell counterfeit or unfit versions of our products, which do not meet our rigorous manufacturing, distribution and testing standards. A patient who receives a counterfeit or unfit drug may be at risk for a number of dangerous health consequences. Our reputation and business could suffer harm as a result of counterfeit or unfit drugs sold under our brand name. Inventory that is stolen from warehouses, plants or while in-transit, and that is subsequently improperly stored and sold through unauthorized channels, could adversely impact patient safety, our reputation and our business.

The increasing use of social media platforms presents new risks and challenges.

Social media is increasingly being used to communicate about our products and the diseases our therapies are designed to treat. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear and create uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to comment on the effectiveness of a product or to report an alleged adverse event. When such disclosures occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend the company or the public's legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our products. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on social media. We may also encounter criticism on social media regarding our company, management, product candidates or products. The immediacy of social media precludes us from having real-time control over postings made regarding us via social media, whether matters of fact or opinion. Our reputation could be damaged by negative publicity or if adverse information concerning us is posted on social media platforms or similar mediums, which we may not be able to reverse. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face restrictive regulatory actions or incur other harm to our business.

Risks Related to Intellectual Property

If we are unable to obtain and maintain adequate protection for our data, intellectual property and other proprietary rights, our business may be harmed.

Our success, including our long-term viability and growth, depends, in part, on our ability to obtain and defend patent and other intellectual property rights, including certain regulatory forms of exclusivity, that are important to the commercialization of our products and product candidates. Patent protection and/or regulatory exclusivity in the U.S. and other important markets remains uncertain and depends, in part, upon decisions of the patent offices, courts,

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administrative bodies and lawmakers in these countries. We may fail to obtain or preserve patent and other intellectual property rights, including certain regulatory forms of exclusivity, or the protection we obtain may not be of sufficient breadth and degree to protect our commercial interests in all countries where we conduct business, which could result in financial, business or reputational harm to us or could cause a decline or volatility in our stock price. In addition, settlements of such proceedings often result in reducing the period of patent and other protections, resulting in a reduction in revenue from affected products.

In many markets, including the U.S., manufacturers may be allowed to rely on the safety and efficacy data of the innovator's product and do not need to conduct clinical trials before marketing a competing version of a product after there is no longer patent or regulatory exclusivity. In such cases, manufacturers often charge significantly lower prices and a major portion of the company's revenue may be reduced in a short period of time. In addition, manufacturers of generics and biosimilars may choose to launch or attempt to launch their products before the expiration of our patent or other intellectual property protections.

Furthermore, our products may be determined to infringe patents or other intellectual property rights held by ~~third parties.~~third-parties. Legal proceedings, administrative challenges or other types of proceedings are and may in the future

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be necessary to determine the validity, scope or non-infringement of certain patent rights claimed by ~~third parties~~third-parties to be pertinent to the manufacture, use or sale of our products. Such proceedings are unpredictable and are often protracted and expensive. Negative outcomes of such proceedings could hinder or prevent us from manufacturing and marketing our products, require us to seek a license for the infringed product or technology or result in the assessment of significant monetary damages against us that may exceed amounts, if any, accrued in our financial statements. A failure to obtain necessary licenses for an infringed product or technology could prevent us from manufacturing or selling our products. Furthermore, payments under any licenses that we are able to obtain would reduce our profits from the covered products and services. Any of these circumstances could result in financial, business or reputational harm to us or could cause a decline or volatility in our stock price.

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

Successful preclinical work or early stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product.

Positive results in a clinical trial may not be replicated in subsequent or confirmatory trials. Additionally, success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained. 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 studies or disagree with our trial design or endpoints. Regulatory authorities may also fail to approve the facilities or processes used to manufacture a product candidate, our dosing or delivery methods or companion devices. Regulatory authorities may grant marketing approval that is more restricted than anticipated, including limiting indications to narrow patient populations and the imposition of safety monitoring, educational requirements, requiring confirmatory trials and risk evaluation and mitigation strategies. 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. The occurrence of any of these events could result in significant costs and expense, have an adverse effect on our business, financial condition and results of operations and/or cause our stock price to decline or experience periods of volatility.

Clinical trials and the development of biopharmaceutical products is a lengthy and complex process. If we fail to adequately manage our clinical activities, our clinical trials or potential regulatory approvals may be delayed or denied.

Conducting clinical trials is a complex, time-consuming and expensive process. Our ability to complete clinical trials in a timely fashion depends on a number of key factors, including protocol design, regulatory and institutional review board approval, patient enrollment rates and compliance with current Good Clinical Practices. If we or our third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical trials or the potential regulatory approval of a product candidate may be delayed or denied.

We have opened clinical trial sites and are enrolling patients in a number of countries where our experience is limited. In most cases, we use the services of ~~third parties~~third-parties to carry out our clinical trial related activities and rely on such parties to accurately report their results. Our reliance on ~~third parties~~third-parties for these activities may impact our ability to control the timing, conduct, expense and quality of our clinical trials. One CRO has responsibility for a substantial portion of our activities and reporting related to our clinical trials and if such CRO does not adequately perform, many of our trials may be affected. We may need to replace our CROs, which may result in the delay of the affected trials or otherwise adversely affect our efforts to obtain regulatory approvals and commercialize our product candidates.

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Adverse safety events or restrictions on use and safety warnings for our products can negatively affect our business, product sales and stock price.

Adverse safety events involving our marketed products, generic or biosimilar versions of our marketed products or products from the same class as one of our products may have a negative impact on our business. Discovery of safety issues with our products could create product liability and could cause additional regulatory scrutiny and requirements for additional labeling or safety monitoring, withdrawal of products from the market and/or the imposition of fines or criminal penalties. Adverse safety events may also damage physician, patient and/or investor confidence in our products and our reputation. Any of these could result in adverse impacts on our results of operations.

Regulatory authorities are making greater amounts of stand-alone safety information directly available to the public through periodic safety update reports, patient registries and other reporting requirements. The reporting of adverse safety events involving our products or products similar to ours and public rumors about such events may increase claims against us and may also cause our product sales to decline or our stock price to experience periods of volatility.

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Restrictions on use or ~~significant~~ safety warnings that may be required to be included in the label ~~of our products, such as the risk of developing progressive multifocal leukoencephalopathy (PML) in the label for certain~~ of our products may significantly reduce expected revenue for those products and require significant expense and management time.

~~The illegal distribution and sale by third parties of counterfeit or unfit versions of our products or stolen products could have a negative impact on our reputation and business.~~

Third parties might illegally distribute and sell counterfeit or unfit versions of our products, which do not meet our rigorous manufacturing, distribution and testing standards. A patient who receives a counterfeit or unfit drug may be at risk for a number of dangerous health consequences. Our reputation and business could suffer harm as a result of counterfeit or unfit drugs sold under our brand name. Inventory that is stolen from warehouses, plants or while in-transit, and that is subsequently improperly stored and sold through unauthorized channels, could adversely impact patient safety, our reputation and our business.

~~The increasing use of social media platforms presents new risks and challenges.~~

Social media is increasingly being used to communicate about our products and the diseases our therapies are designed to treat. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear and creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to comment on the effectiveness of a product or to report an alleged adverse event. When such disclosures occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend the company or the public's legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our products. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on social media. We may also encounter criticism on social media regarding our company, management, product candidates or products. The immediacy of social media precludes us from having real-time control over postings made regarding us via social media, whether matters of fact or opinion. Our reputation could be damaged by negative publicity or if adverse information concerning us is posted on social media platforms or similar mediums, which we may not be able to reverse. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face overly restrictive regulatory actions or incur other harm to our business.

Risks Related to Our Operations

A breakdown or breach of our technology systems could subject us to liability or interrupt the operation of our business.

We are increasingly dependent upon technology systems and data to operate our business. ~~Further, the~~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 ~~office.~~office, with a number of our employees now working in hybrid or full-remote positions. As a result, we are increasingly dependent upon our technology systems to operate our business and our ability to effectively manage our business depends on the security, reliability and adequacy of our technology systems and data, which includes use of cloud technologies, including Software as a Service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS). ~~A breakdown, invasion, corruption, destruction~~ Breakdowns, invasions, corruptions, destructions and/or ~~breach~~breaches of our technology 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, or negatively impact ~~the operation~~our business operations, and/or require replacement of ~~our business.~~technology and/or ransom payments. Our technology systems, including our cloud technologies, continue to increase in multitude and complexity, ~~making them potentially vulnerable to breakdown,~~increasing our vulnerability when breakdowns, malicious ~~intrusion~~intrusions and random ~~attack.~~attacks occur. 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.

Cyber-attacks are increasing in their frequency, sophistication and intensity, and are becoming increasingly difficult to ~~detect.~~detect, when they impact vendors, customers or companies, including vendors, suppliers and other companies in our supply chain. They are often carried out by motivated, well-resourced, skilled and persistent actors, including nation states, organized crime groups, “hacktivists” and employees or contractors acting with careless or malicious intent. Geopolitical instability, including that related to Russia's invasion of Ukraine may increase cyber-attacks. Cyber-attacks ~~could~~ include ~~the~~ deployment of harmful malware and key loggers, ransomware, a denial-of-service attack, a malicious website, the use of social engineering and other means to affect the confidentiality, integrity and availability of our technology systems and data. Cyber-attacks ~~could~~ also include manufacturing, hardware or software supply chain attacks, which could cause a delay in the manufacturing of ~~our~~ products or products produced for contract ~~manufacturing.~~manufacturing or lead to a data privacy or security breach. Our key business partners face similar risks and any security breach of their systems could adversely affect our security posture. In addition, our increased use of cloud technologies ~~could heighten~~heightens these and other operational risks, and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption or loss of confidential or propriety information.

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While we continue to build and improve our systems and infrastructure, including our business continuity plans, there can be no assurance that our efforts will prevent breakdowns or breaches in our systems that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in financial, legal, operational or reputational harm to us, loss of competitive advantage or loss of consumer confidence. Our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyber-attacks and other related breaches.

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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.

Regulators are imposing new data privacy and security requirements, including new and greater monetary fines for privacy violations. For example, the E.U.’s General Data Protection Regulation established regulations regarding the handling of personal data, and provides an enforcement authority and imposes large penalties for noncompliance. New U.S. data privacy and security laws, such as the California Consumer Privacy Act (CCPA), and others that may be passed, similarly introduce requirements with respect to personal information, and non-compliance with the CCPA may result in liability through private actions (subject to statutorily defined damages in the event of certain data breaches) and enforcement. Failure to comply with these current and future laws, policies, industry standards or legal obligations or any security incident resulting in the unauthorized access to, or acquisition, release or transfer of personal information may result in governmental enforcement actions, litigation, fines and penalties or adverse publicity and could cause our customers to lose trust in us, which could have a material adverse effect on our business and results of operations.

Manufacturing issues could substantially increase our costs, limit supply of our products and/or reduce our revenue.

The process of manufacturing our products is complex, highly regulated and subject to numerous risks, including:

•Risks of Reliance on Third-Parties and Single Source Providers. We rely on third-party suppliers and manufacturers for many aspects of our manufacturing process for our products and product candidates including VUMERITY. In some cases, due to the unique manner in which our products are manufactured, we rely on single source providers of raw materials and manufacturing supplies. These third-parties are independent entities subject to their own unique operational and financial risks that are outside of our control. These third-parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations, and they may be unable or unwilling to increase production capacity commensurate with demand for our existing or future products. Finding alternative providers could take a significant amount of time and involve significant expense due to the specialized nature of the services and the need to obtain regulatory approval of any significant changes to our suppliers or manufacturing methods. We cannot be certain that we could reach agreement with alternative providers or that the FDA or other regulatory authorities would approve our use of such alternatives. Furthermore, factors such as the COVID-19 pandemic, weather events, labor or raw material shortages and other supply chain disruptions could result in difficulties and delays in manufacturing our products, which could have an adverse impact on our results in operations or result in product shortages.

•Global Bulk Supply Risks. We rely on our manufacturing facilities for the production of drug substance for our large molecule products and product candidates. Our global bulk supply of these products and product candidates depends on the uninterrupted and efficient operation of these facilities, which could be adversely affected by equipment failures, labor or raw material shortages, public health epidemics, natural disasters, power failures, cyber-attacks and many other factors.

•Risks Relating to Compliance with current GMP (cGMP). We and our third-party providers are generally required to maintain compliance with cGMP and other stringent requirements and are subject to inspections by the FDA and other regulatory authorities to confirm compliance. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging or storage of our products as a result of a failure of our facilities or operations or those of third-parties to receive regulatory approval or pass any regulatory agency inspection could significantly impair our ability to develop and commercialize our products. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions and damage our reputation.

•Risk of Product Loss. The manufacturing process for our products is extremely susceptible to product loss due to contamination, oxidation, equipment failure or improper installation or operation of equipment or vendor or operator error. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our products or manufacturing facilities, we may need to close our manufacturing facilities for an extended period of time to investigate and remediate the contaminant.

•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.

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Any adverse developments affecting our manufacturing operations or the operations of our third-party suppliers and manufacturers may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the commercial supply of our products. We may also have to take inventory write-offs and incur other charges and expense for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase our manufacturing costs, cause us to lose revenue or market share as patients and physicians turn to competing therapeutics, diminish our profitability or damage our reputation.

In addition, although we have business continuity plans to reduce the potential for manufacturing disruptions or delays and reduce the severity of a disruptive event, there is no guarantee that these plans will be adequate, which could adversely affect our business and operations.

Management and other personnel changes may disrupt our operations, and we may have difficulty retaining personnel or attracting and retaining qualified replacements on a timely basis for the management and other personnel who may leave the Company.

Changes in management (including our CEO), other personnel and our overall retention rate may disrupt our business, and any such disruption could adversely affect our operations, programs, growth, financial condition or results of operations. New members of management may have different perspectives on programs and opportunities for our business, which may cause us to focus on new opportunities or reduce or change emphasis on our existing programs.

Our success is dependent upon our ability to attract and retain qualified management and key personnel in a highly competitive environment. Qualified individuals are in high demand, and we may incur significant costs to attract or retain them. We may face difficulty in attracting and retaining talent for a number of reasons, including management changes, the underperformance or discontinuation of one or more ~~late-stage~~marketed or late stage programs, recruitment by competitors or changes in the overall labor ~~market favoring flexible working arrangements.~~market. In addition, ~~additional~~ changes in our organizational structure or in our flexible working arrangements could impact employees' productivity and morale as well as our ability to attract, retain and motivate employees. We cannot ensure that we will be able to hire or retain the personnel necessary for our operations or that the loss of any personnel will not have a material impact on our financial condition and results of operations.

If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.

Our activities, and the activities of our collaborators, distributors and other third-party providers, are subject to extensive government regulation and oversight in the U.S. and in foreign jurisdictions, and are subject to change and evolving interpretations, which could require us to incur substantial costs associated with compliance or to alter one or more of our business practices. The FDA and comparable foreign agencies directly regulate many of our most critical business activities, including the conduct of preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse event reporting, product risk management and our compliance with good practice quality guidelines and regulations. Our interactions with physicians and other health care providers that prescribe or purchase our products are also subject to government regulation designed to prevent fraud and abuse in the sale and use of products and place significant restrictions on the marketing practices of health care companies. Health care companies are facing heightened scrutiny of their relationships with health care providers and have been the target of lawsuits and investigations alleging violations of government regulation, including claims asserting submission of incorrect pricing information, impermissible off-label promotion of pharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, antitrust violations or violations related to environmental matters. There is also enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay assistance programs and donations to third-party charities that provide such assistance. The U.S. government has challenged some of our donations to third-party charities that provide patient assistance. If we, or our vendors or donation recipients, are found to fail to comply with relevant laws, regulations or government guidance in the operation of these programs, we could be subject to significant fines or penalties. Risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic

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areas with different patient populations, which may have different product distribution methods, marketing programs or patient assistance programs from those we currently utilize or support.

Conditions and regulations governing the health care industry are subject to change, with possible retroactive effect, including:

•new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or judicial decisions, related to health care availability, pricing or marketing practices, compliance with employment

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practices, method of delivery, payment for health care products and services, compliance with health information and data privacy and security laws and regulations, tracking and reporting payments and other transfers of value made to physicians and teaching hospitals, extensive anti-bribery and anti-corruption prohibitions, product serialization and labeling requirements and used product take-back requirements;

•changes in the FDA and foreign regulatory approval processes or perspectives that may delay or prevent the approval of new products and result in lost market opportunity;

•government shutdowns or relocations may result in delays to the review and approval process, slowing the time necessary for new drug candidates to be reviewed and/or approved, which may adversely affect our business;

•requirements that provide for increased transparency of clinical trial results and quality data, such as the EMA's clinical transparency policy, which could impact our ability to protect trade secrets and competitively-sensitive information contained in approval applications or could be misinterpreted leading to reputational damage, misperception or legal action, which could harm our business; and

•changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products or otherwise adversely affect the market for our products.

Violations of governmental regulation may be punishable by criminal and civil sanctions, including fines and civil monetary penalties and exclusion from participation in government programs, including Medicare and Medicaid, as well as against executives overseeing our business. We could also be required to repay amounts we received from government payors or pay additional rebates and interest if we are found to have miscalculated the pricing information we submitted to the government. In addition, legal proceedings and investigations are inherently unpredictable, and large judgments or settlements sometimes occur. While we believe that we have appropriate compliance controls, policies and procedures in place to comply with the laws or regulations of the jurisdictions in which we operate, there is a risk that acts committed by our employees, agents, distributors, collaborators or third-party providers might violate such laws or regulations. Whether or not we have complied with the law, an investigation or litigation related to alleged unlawful conduct could increase our expense, damage our reputation, divert management time and attention and adversely affect our business.

Our sales and operations are subject to the risks of doing business internationally.

We are increasing our presence in international markets, subjecting us to many risks that could adversely affect our business and revenue. There is no guarantee that our efforts and strategies to expand sales in international markets will succeed. Emerging market countries may be especially vulnerable to periods of global and local political, legal, regulatory and financial instability and may have a higher incidence of corruption and fraudulent business practices. Certain countries may require local clinical trial data as part of the drug registration process in addition to global clinical trials, which can add to overall drug development and registration timelines. We may also be required to increase our reliance on third-party agents and unfamiliar operations and arrangements previously utilized by companies we collaborate with or acquire in emerging markets.

Our sales and operations are subject to the risks of doing business internationally, including:

•the impact of public health epidemics, such as the COVID-19 pandemic, on the global economy and the delivery of healthcare treatments;

•less favorable intellectual property or other applicable laws;

•the inability to obtain necessary foreign regulatory approvals of products in a timely manner;

•limitations and additional pressures on our ability to obtain and maintain product pricing or receive price increases, including those resulting from governmental or regulatory requirements;

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

•additional complexity in manufacturing internationally;

~~Table~~•delays in clinical trials relating to geopolitical instability related to Russia's invasion of ~~Contents~~Ukraine;

•the inability to successfully complete subsequent or confirmatory clinical trials in countries where our experience is limited;

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•longer payment and reimbursement cycles and uncertainties regarding the collectability of accounts receivable;

•fluctuations in foreign currency exchange rates that may adversely impact our revenue, net income and value of certain of our investments;

•the imposition of governmental controls;

•diverse data privacy and protection requirements;

•increasingly complex standards for complying with foreign laws and regulations that may differ substantially from country to country and may conflict with corresponding U.S. laws and regulations;

•the far-reaching anti-bribery and anti-corruption legislation in the ~~United Kingdom (U.K.)~~U.K., including the U.K. Bribery Act 2010, and elsewhere and escalation of investigations and prosecutions pursuant to such laws;

•compliance with complex import and export control laws;

•changes in tax laws; and

•the imposition of tariffs or embargoes and other trade restrictions.

In addition, our international operations are subject to regulation under U.S. law. For example, the U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. companies and their representatives from paying, offering to pay, promising to pay or authorizing the payment of anything of value to any foreign government official, government staff member, political party or political candidate for the purpose of obtaining or retaining business or to otherwise obtain favorable treatment or influence a person working in an official capacity. In many countries, the health care professionals we regularly interact with may meet the FCPA's definition of a foreign government official. Failure to comply with domestic or foreign laws could result in various adverse consequences, including possible delay in approval or refusal to approve a product, recalls, seizures or withdrawal of an approved product from the market, disruption in the supply or availability of our products or suspension of export or import privileges, the imposition of civil or criminal sanctions, the prosecution of executives overseeing our international operations and damage to our reputation. Any significant impairment of our ability to sell products outside of the U.S. could adversely impact our business and financial results. In addition, while we believe that we have appropriate compliance controls, policies and procedures in place to comply with the FCPA, there is a risk that acts committed by our employees, agents, distributors, collaborators or third-party providers might violate the FCPA and we might be held responsible. If our employees, agents, distributors, collaborators or third-party providers are found to have engaged in such practices, we could suffer severe penalties and may be subject to other liabilities, which could negatively affect our business, operating results and financial condition.

We are building a large-scale biologics manufacturing facility, which will result in the incurrence of significant investment with no assurance that such investment will be recouped.

In order to support our future growth and drug development pipeline, we are expanding our large molecule production capacity by building a large-scale biologics manufacturing facility in Solothurn, Switzerland with no assurance that the additional capacity will be required or this investment will be recouped.

If we are unable to fully utilize our manufacturing facilities, our business may be harmed. Charges resulting from excess capacity may continue to occur and would have a negative effect on our financial condition and results of operations.

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~~was approved by the ~~applicable regulatory agencies, including the FDA. There~~FDA for ADUHELM, there can be no assurance that the regulatory authorities will approve the Solothurn facility for the manufacturing of a product or a product candidate. 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.

~~Manufacturing issues could substantially increase our costs, limit supply of our products and/or reduce our revenue.~~

~~The process of manufacturing our products is complex, highly regulated and subject to numerous risks, including:~~

•~~Risks of Reliance on Third Parties and Single Source Providers.~~ ~~We rely on third-party suppliers and manufacturers for many aspects of our manufacturing process for our products and product candidates. In~~

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some cases, due to the unique manner in which our products are manufactured, we rely on single source providers of raw materials and manufacturing supplies. These third parties are independent entities subject to their own unique operational and financial risks that are outside of our control. These third parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations, and they may be unable or unwilling to increase production capacity commensurate with demand for our existing or futureother products. Finding alternative providers could take a significant amount of time and involve significant expense due to the specialized nature of the services and the need to obtain regulatory approval of any significant changes to our suppliers or manufacturing methods. We cannot be certain that we could reach agreement with alternative providers or that the FDA or other regulatory authorities would approve our use of such alternatives. Furthermore, factors such as the COVID-19 pandemic, weather events, labor or raw material shortages and other supply chain disruptions could result in difficulties and delays in manufacturing our products, which could have an adverse impact on our results in operations or result in product shortages.

•~~Risks Relating to Compliance with current GMP (cGMP).~~ We and our third-party providers are generally required to maintain compliance with cGMP and other stringent requirements and are subject to inspections by the FDA and other regulatory authorities to confirm compliance. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging or storage of our products as a result of a failure of our facilities or operations or those of third parties to receive regulatory approval or pass any regulatory agency inspection could significantly impair our ability to develop and commercialize our products. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions and damage our reputation.

•~~Global Bulk Supply Risks.~~ We rely on our manufacturing facilities for the production of drug substance for our large molecule products and product candidates. Our global bulk supply of these products and product candidates depends on the uninterrupted and efficient operation of these facilities, which could be adversely affected by equipment failures, labor shortages, public health epidemics, natural disasters, power failures, cyber-attacks and many other factors.

•~~Risk of Product Loss.~~ The manufacturing process for our products is extremely susceptible to product loss due to contamination, oxidation, equipment failure or improper installation or operation of equipment or vendor or operator error. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our products or manufacturing facilities, we may need to close our manufacturing facilities for an extended period of time to investigate and remediate the contaminant.

•~~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.

~~Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts.~~

As a global biopharmaceutical company, we are subject to taxation in numerous countries, states and other jurisdictions. As a result, our effective tax rate is derived from a combination of applicable tax rates, including withholding taxes, in the various places that we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of such places. 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 profitability from country to country, the results of examinations and audits of our tax filings, adjustments to the value of our uncertain tax positions, interpretations by tax authorities or other bodies with jurisdiction, the result of

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~~tax cases, changes in accounting for income taxes and changes in tax laws and regulations either prospectively or retrospectively.~~

Our inability to secure or sustain acceptable arrangements with tax authorities and future changes in the tax laws, among other things, may result in tax obligations in excess of amounts accrued in our financial statements.

The Tax Cuts and Jobs Act of 2017 (2017 Tax Act) resulted in significant changes to the U.S. corporate income tax system. Our estimates concerning the impact of the 2017 Tax Act on our accounting and on our business remain subject to developing interpretations of the provisions of the 2017 Tax Act, which may require further adjustments and changes in our estimates, which could have a material adverse effect on our business, results of operations or financial condition. Further, the current administration could introduce new tax laws or revise or issue new interpretations of the 2017 Tax Act.

The Swiss Federal Act on Tax Reform and AHV Financing (TRAF) resulted in significant changes to the Swiss cantonal income tax system. Final interpretation of the transitional and new regimes of the TRAF may require further adjustments and changes in our estimates, which could have a significant adverse effect on our business, results of operations or financial condition.

The enactment of some or all of the recommendations set forth or that may be forthcoming in the Organization for Economic Cooperation and Development’s project on “Base Erosion and Profit Shifting” (BEPS) by tax authorities and economic blocs in the countries in which we operate, could unfavorably impact our effective tax rate. These initiatives focus on common international principles for the entitlement to taxation of global corporate profits and minimum global tax rates.

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

Our business has and could continue to be adversely affected, directly or indirectly, by the ongoing COVID-19 pandemic. National, state and local governments have implemented and may continue to implement safety ~~precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter in place orders and shutdowns and other measures.~~precautions. These measures may disrupt normal business operations and may have significant negative impacts on businesses and financial markets worldwide.

We continue to monitor our operations and applicable government recommendations, and we have made modifications to our normal operations because of the COVID-19 pandemic, including limiting travel and working from home. ~~We have also suspended the vast majority of our in-person~~Customer-facing professionals interactions ~~by our customer-facing professionals~~ in healthcare ~~settings.~~settings have changed as a result of the COVID-19 pandemic. This limits our ability to market our products and educate physicians, which, in turn, could have an adverse effect on our ability to compete in the marketing and sales of our products.

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Changes in flexible working arrangements could impact employee retention, ~~employees’~~employees' productivity and morale, strain our technology resources and introduce operational risks. Additionally, the risk of cyber-attacks or other privacy or data security incidents may be heightened as a result of our moving increasingly towards a remote working environment, which may be less secure and more susceptible to hacking attacks.

The COVID-19 pandemic could affect the health and availability of our workforce as well as those of the ~~third parties~~third-parties we rely on. Furthermore, delays and disruptions experienced by our collaborators, joint venture partners or other ~~third parties~~third-parties due to the COVID-19 pandemic could adversely impact the ability of such parties to fulfill their obligations, which could affect product sales or the clinical development or regulatory approvals of product candidates under joint control.

Our ability to continue our existing clinical trials or to initiate new clinical trials has been and may continue to be adversely affected, directly or indirectly, by the COVID-19 pandemic. ~~For example, our Phase 3 study of BIIB093 for LHI has been delayed as this study involves administration of BIIB093 in an acute hospital setting.~~ Restrictions on travel and/or transport of clinical materials as well as diversion of hospital staff and resources to COVID-19 infected patients could disrupt trial operations and recruitment, possibly resulting in a slowdown in enrollment and/or deviations from or disruptions in key clinical trial activities, such as clinical trial site monitoring. These challenges may lead to difficulties in meeting protocol-specified procedures. We may need to make certain adjustments to the operation of clinical trials in an effort to minimize risks to trial data integrity during the COVID-19 pandemic. In addition, the impact of the COVID-19 pandemic on the operations of the FDA and other health authorities may delay potential approvals of our product candidates.

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. Additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that

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federal and state governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures and have a financial impact on our business that we cannot predict.

While it is not possible at this time to estimate the entirety of the impact that the COVID-19 pandemic will continue to have on our business, operations, employees, customers, suppliers or collaboration partners, continued spread of COVID-19, measures taken by governments, actions taken to protect employees and the broad impact of the pandemic on all business activities may materially and adversely affect our business, supply chain and distribution systems, results of operations and financial condition.

Risks Related to Holding Our Common Stock

Our operating results are subject to significant fluctuations.

Our quarterly revenue, expense and net income (loss) have fluctuated in the past and are likely to fluctuate significantly in the future due to the risks described in these Risk Factors as well as the timing of charges and ~~expenses~~expense that we may take. We have recorded, or may be required to record, charges that include:

•the cost of restructurings or other initiatives to streamline our operations and reallocate resources;

•impairments with respect to investments, fixed assets and long-lived assets, including ~~IPR&D~~in-process research and development (IPR&D) and other intangible assets;

•inventory write-downs for failed quality specifications, recurring charges for excess or obsolete inventory and charges for inventory ~~write downs~~write-downs relating to product suspensions, expirations or recalls;

•changes in the fair value of contingent consideration or our equity investments;

•bad debt expense and increased bad debt reserves;

•outcomes of litigation and other legal or administrative proceedings, regulatory matters and tax matters;

•payments in connection with acquisitions, divestitures and other business development activities and under license and collaboration agreements;

•failure to meet certain contractual commitments; and

•the impact of public health epidemics, such as the COVID-19 pandemic, on employees, the global economy and the delivery of healthcare treatments.

Our revenue and certain assets and liabilities are also subject to foreign currency exchange rate fluctuations due to the global nature of our operations. Our efforts to mitigate the impact of fluctuating currency exchange rates may not be successful. As a result, currency fluctuations among our reporting currency, the U.S. dollar, and other currencies in which we do business will affect our operating results, often in unpredictable ways. Our net income may

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also fluctuate due to the impact of charges we may be required to take with respect to foreign currency hedge transactions. In particular, we may incur higher than expected charges from early termination of a hedge relationship.

Our operating results during any one period do not necessarily suggest the anticipated results of future periods.

Our investments in properties may not be fully realized.

We own or lease real estate primarily consisting of buildings that contain research laboratories, office space and manufacturing operations. We may decide to consolidate or co-locate certain aspects of our business operations or dispose of one or more of our properties, some of which may be located in markets that are experiencing high vacancy rates and decreasing property values. If we determine that the fair value of any of our owned properties is lower than their book value, we may not realize the full investment in these properties and incur significant impairment charges or additional depreciation when the expected useful lives of certain assets have been shortened due to the anticipated closing of facilities. If we decide to fully or partially vacate a property, we may incur significant cost, including facility closing costs, employee separation and retention ~~expenses,~~expense, lease termination fees, rent expense in excess of sublease income and impairment of leasehold improvements and accelerated depreciation of assets. Any of these events may have an adverse impact on our results of operations.

Our investment portfolio is subject to market, interest and credit risk that may reduce its value.

We maintain a portfolio of marketable securities for investment of our cash as well as investments in equity securities of certain biotechnology companies. Changes in the value of our investment portfolio could adversely affect our earnings. The value of our investments may decline due to, among other things, increases in interest rates, downgrades of the bonds and other securities in our portfolio, negative ~~company specific~~company-specific news, biotechnology market sentiment, instability in the global financial markets that reduces the liquidity of securities in our portfolio,

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declines in the value of collateral underlying the securities in our portfolio and other factors. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost. Although we attempt to mitigate these risks through diversification of our investments and continuous monitoring of our portfolio's overall risk profile, the value of our investments may nevertheless decline.

There can be no assurance that we will continue to repurchase shares or that we will repurchase shares at favorable prices.

From time to time our Board of Directors authorizes share repurchase programs. The amount and timing of share repurchases are subject to capital availability and our determination that share repurchases are in the best interest of our shareholders and are in compliance with all respective laws and our applicable agreements. Our ability to repurchase shares will depend upon, among other factors, our cash balances and potential future capital requirements for strategic transactions, our results of operations, our financial condition and other factors beyond our control that we may deem relevant. A reduction in repurchases under, or the completion of, our share repurchase programs could have a negative effect on our stock price. We can provide no assurance that we will repurchase shares at favorable prices, if at all.

We may not be able to access the capital and credit markets on terms that are favorable to us.

We may seek access to the capital and credit markets to supplement our existing funds and cash generated from operations for working capital, capital expenditure and debt service requirements and other business initiatives. The capital and credit markets are experiencing, and have in the past experienced, extreme volatility and disruption, which leads to uncertainty and liquidity issues for both borrowers and investors. In the event of adverse market conditions, we may be unable to obtain capital or credit market financing on favorable terms. Changes in credit ratings issued by nationally recognized credit rating agencies could also adversely affect our cost of financing and the market price of our securities.

Our indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business.

Our indebtedness, together with our significant contingent liabilities, including milestone and royalty payment obligations, could have important consequences to our business; for example, such obligations could:

•increase our vulnerability to general adverse economic and industry conditions;

•limit our ability to access capital markets and incur additional debt in the future;

•require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flow for other purposes, including business development, research and development and mergers and acquisitions; and

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•limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate, thereby placing us at a disadvantage compared to our competitors that have less debt.

Some of our collaboration agreements contain change in control provisions that may discourage a ~~third party~~third-party from attempting to acquire us.

Some of our collaboration agreements include change in control provisions that could reduce the potential acquisition price an acquirer is willing to pay or discourage a takeover attempt that could be viewed as beneficial to shareholders. Upon a change in control, some of these provisions could trigger reduced milestone, profit or royalty payments to us or give our collaboration partner rights to terminate our collaboration agreement, acquire operational control or force the purchase or sale of the programs that are the subject of the collaboration.

General Risk Factors

Our effective tax rate fluctuates, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

As a global biopharmaceutical company, we are subject to taxation in numerous countries, states and other jurisdictions. As a result, our effective tax rate is derived from a combination of applicable tax rates, including withholding taxes, in the various places that we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of such places. 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 profitability from country to country, the results of examinations and audits of our tax filings (including those related to the impact of the Tax Cuts and Jobs Act of 2017), adjustments to the value of our uncertain tax positions, interpretations by tax authorities or other bodies with jurisdiction, the result of tax cases, changes in accounting for income taxes and changes in tax laws and regulations either prospectively or retrospectively (including those related to the IRA).

Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury.

Our business and the business of several of our strategic partners involve the controlled use of hazardous materials, chemicals, biologics and radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply with state, federal and foreign standards, there will always be the risk of accidental contamination or injury. If we were to become liable for an accident, or if we were to suffer an extended facility shutdown, we could incur significant costs, damages and penalties that could harm our business. Manufacturing of our products and product candidates also requires permits from government agencies for water supply and wastewater discharge. If we do not obtain appropriate permits, including permits for sufficient quantities of water and wastewater, we could incur significant costs and limits on our manufacturing volumes that could harm our business.

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~~Item~~ITEM 2. ~~Unregistered Sales of Equity Securities and Use of Proceeds~~UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

The following table summarizes our common stock repurchase activity under our 2020 Share Repurchase Program during the third quarter of ~~2021:~~2022:

Period Total Number of
Shares Purchased
(#) Average Price
Paid per Share
($) Total Number of
Shares Purchased
as Part of Publicly
Announced Programs
(#) Approximate Dollar Value
of Shares That May Yet Be Purchased Under
Our Programs
($ in millions)
July 2021 — $ — — $ 3,550.0
August 2021 2,100,000 $ 340.89 2,100,000 $ 2,834.1
September 2021 99,230 $ 344.06 99,230 $ 2,800.0
Total 2,199,230 $ 341.03


Period	Total Number of Shares Purchased (#)	Average Price Paid per Share ($)		Total Number of Shares Purchased as Part of Publicly Announced Programs (#)	Approximate Dollar Value of Shares That May Yet Be Purchased Under Our Programs ($ in millions)
July 2022	300,000	$	209.94	300,000	$	2,237.0
August 2022	870,002	$	214.96	870,002	$	2,050.0
September 2022	—	$	—	—	$	2,050.0
Total	1,170,002	$	213.67

In October 2020 our Board of Directors authorized our 2020 Share Repurchase Program, which is a program to repurchase up to $5.0 billion of our common stock. Our 2020 Share Repurchase Program does not have an expiration date. All share repurchases under our 2020 Share Repurchase Program will be retired. Under our 2020 Share Repurchase Program, we repurchased and retired approximately 1.2 million and 3.6 million shares of our common stock at a cost of approximately $250.0 million and $750.0 million during the three and nine months ended September 30, 2022, respectively. During the three and nine months ended September 30, 2021, we repurchased and retired approximately 2.2 million and 6.0 million shares of our common stock at a cost of approximately $750.0 million and $1.8 billion, ~~during the three and ninemonths ended September 30, 2021,~~ respectively. Approximately ~~$2.8~~$2.1 billion remained available under our 2020 Share Repurchase Program as of September 30, ~~2021.~~

In December 2019 our Board of Directors authorized our December 2019 Share Repurchase Program, which was a program to repurchase up to $5.0 billion of our common stock that was completed as of September 30, 2020. All shares repurchased under our December 2019 Share Repurchase Program were retired. Under our December 2019 Share Repurchase Program, we repurchased and retired approximately 4.5 million and 16.7 million shares of our common stock at a cost of approximately $1.3 billion and $5.0 billion during the three and nine months ended September 30, 2020, respectively.

In March 2019 our Board of Directors authorized our March 2019 Share Repurchase Program, which was a program to repurchase up to $5.0 billion of our common stock that was completed as of March 31, 2020. All shares repurchased under our March 2019 Share Repurchase Program were retired. Under our March 2019 Share Repurchase Program, we repurchased and retired approximately 4.1 million shares of our common stock at a cost of approximately $1.3 billion during the nine months ended September 30, 2020.2022.

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~~Item~~ITEM 6. ~~Exhibits~~EXHIBITS

The exhibits listed below are filed or furnished as part of this Quarterly Report on Form 10-Q.

EXHIBIT INDEX


Exhibit Number						Description of Exhibit
31.1+						Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2+						Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1++						Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101++						The following materials from Biogen Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, ~~2021,~~2022, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Income, (ii) the Condensed Consolidated Statements of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheets, (iv) the Condensed Consolidated Statements of Cash Flow, (v) the Condensed Consolidated Statements of Equity and (vi) Notes to Condensed Consolidated Financial Statements.

104++						The cover page from this Quarterly Report on Form 10-Q for the quarter ended September 30, ~~2021,~~2022, formatted in Inline XBRL.

+ Filed herewith

++ Furnished herewith

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



BIOGEN INC.

/s/ Michael R. McDonnell
Michael R. McDonnell

Chief Financial Officer
(principal financial officer)

October ~~20, 2021~~25, 2022

93101


Delaware						33-0112644
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)


		For the Three Months Ended September 30,				For the Nine Months Ended September 30,					For the Three Months Ended September 30,				For the Nine Months Ended September 30,
		2021		2020		2021		2020			2022		2021		2022		2021
Net income attributable to Biogen Inc.	Net income attributable to Biogen Inc.	$	329.2	$	701.5	$	1,187.9	$	3,642.7	Net income attributable to Biogen Inc.	$	1,134.7	$	329.2	$	2,496.5	$	1,187.9
Other comprehensive income:	Other comprehensive income:									Other comprehensive income:
Unrealized gains (losses) on securities available for sale, net of tax	Unrealized gains (losses) on securities available for sale, net of tax	0.1		0.1		(1.4)		1.0		Unrealized gains (losses) on securities available for sale, net of tax	(1.0)		0.1		(19.0)		(1.4)
Unrealized gains (losses) on cash flow hedges, net of tax	Unrealized gains (losses) on cash flow hedges, net of tax	66.2		(83.7)		205.0		(101.1)		Unrealized gains (losses) on cash flow hedges, net of tax	5.9		66.2		79.0		205.0
Gains (losses) on net investment hedges		15.1		(11.3)		35.2		5.5
Gains (losses) on net investment hedges, net of tax										Gains (losses) on net investment hedges, net of tax	—		15.1		(25.5)		35.2
Unrealized gains (losses) on pension benefit obligation, net of tax	Unrealized gains (losses) on pension benefit obligation, net of tax	1.5		(0.5)		3.9		0.4		Unrealized gains (losses) on pension benefit obligation, net of tax	1.5		1.5		4.2		3.9
Currency translation adjustment	Currency translation adjustment	(47.7)		50.9		(80.3)		3.9		Currency translation adjustment	(59.6)		(47.7)		(95.6)		(80.3)
Total other comprehensive income (loss), net of tax	Total other comprehensive income (loss), net of tax	35.2		(44.5)		162.4		(90.3)		Total other comprehensive income (loss), net of tax	(53.2)		35.2		(56.9)		162.4
Comprehensive income attributable to Biogen Inc.		364.4		657.0		1,350.3		3,552.4
Comprehensive income (loss) attributable to Biogen Inc.										Comprehensive income (loss) attributable to Biogen Inc.	1,081.5		364.4		2,439.6		1,350.3
Comprehensive income (loss) attributable to noncontrolling interests, net of tax	Comprehensive income (loss) attributable to noncontrolling interests, net of tax	(11.1)		1.5		560.8		61.1		Comprehensive income (loss) attributable to noncontrolling interests, net of tax	0.2		(11.1)		(84.4)		560.8
Comprehensive income		$	353.3	$	658.5	$	1,911.1	$	3,613.5
Comprehensive income (loss)										Comprehensive income (loss)	$	1,081.7	$	353.3	$	2,355.2	$	1,911.1


	As of September 30, 2022		As of December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	3,675.6	$	2,261.4
Marketable securities	1,235.5		1,541.1
Accounts receivable, net	1,568.8		1,549.4
Due from anti-CD20 therapeutic programs	415.4		412.3
Inventory	1,375.0		1,351.5
Other current assets	1,495.5		740.8
Total current assets	9,765.8		7,856.5
Marketable securities	860.3		892.0
Property, plant and equipment, net	3,266.4		3,416.4
Operating lease assets	424.5		375.4
Intangible assets, net	2,008.9		2,221.3
Goodwill	5,741.2		5,761.1
Deferred tax asset	1,174.5		1,415.1
Investments and other assets	1,612.6		1,939.5
Total assets	$	24,854.2	$	23,877.3
LIABILITIES AND EQUITY
Current liabilities:
Current portion of notes payable	$	—	$	999.1
Taxes payable	237.3		174.7
Accounts payable	383.2		589.2
Accrued expense and other	3,305.9		2,535.2
Total current liabilities	3,926.4		4,298.2
Notes payable	6,279.2		6,274.0
Deferred tax liability	328.9		694.5
Long-term operating lease liabilities	354.8		330.4
Other long-term liabilities	1,198.1		1,320.5
Total liabilities	12,087.4		12,917.6
Commitments, contingencies and guarantees
Equity:
Biogen Inc. shareholders’ equity:
Preferred stock, par value $0.001 per share	—		—
Common stock, par value $0.0005 per share	0.1		0.1
Additional paid-in capital	—		68.2
Accumulated other comprehensive income (loss)	(163.6)		(106.7)
Retained earnings	15,916.1		13,911.7
Treasury stock, at cost	(2,977.1)		(2,977.1)
Total Biogen Inc. shareholders’ equity	12,775.5		10,896.2
Noncontrolling interests	(8.7)		63.5
Total equity	12,766.8		10,959.7
Total liabilities and equity	$	24,854.2	$	23,877.3


	As of September 30, 2021		As of December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	1,541.8	$	1,331.2
Marketable securities	1,413.3		1,278.9
Accounts receivable, net	1,723.0		1,913.8
Due from anti-CD20 therapeutic programs	400.0		413.5
Inventory	1,347.9		1,068.6
Other current assets	736.3		881.1
Total current assets	7,162.3		6,887.1
Marketable securities	968.3		772.1
Property, plant and equipment, net	3,410.7		3,411.5
Operating lease assets	389.1		433.3
Intangible assets, net	2,286.8		3,084.3
Goodwill	5,760.5		5,762.1
Deferred tax asset	1,810.4		1,369.5
Investments and other assets	2,018.6		2,899.0
Total assets	$	23,806.7	$	24,618.9
LIABILITIES AND EQUITY
Current liabilities:
Current portion of notes payable	$	998.8	$	—
Taxes payable	$	234.2	$	142.0
Accounts payable	427.9		454.9
Accrued expense and other	2,550.7		3,145.3
Total current liabilities	4,211.6		3,742.2
Notes payable	6,272.3		7,426.2
Deferred tax liability	774.7		1,032.8
Long-term operating lease liabilities	348.2		402.0
Other long-term liabilities	1,318.2		1,329.6
Total liabilities	12,925.0		13,932.8
Commitments and contingencies	0		0
Equity:
Biogen Inc. shareholders’ equity:
Preferred stock, par value $0.001 per share	—		—
Common stock, par value $0.0005 per share	0.1		0.1
Additional paid-in capital	—		—
Accumulated other comprehensive loss	(136.6)		(299.0)
Retained earnings	13,543.5		13,976.3
Treasury stock, at cost	(2,977.1)		(2,977.1)
Total Biogen Inc. shareholders’ equity	10,429.9		10,700.3
Noncontrolling interests	451.8		(14.2)
Total equity	10,881.7		10,686.1
Total liabilities and equity	$	23,806.7	$	24,618.9


	For the Nine Months Ended September 30,
	2021		2020
Cash flow from operating activities:
Net income	$	1,748.1	$	3,702.9
Adjustments to reconcile net income to net cash flow from operating activities:
Depreciation and amortization	353.0		347.5
Impairment of intangible assets	629.3		19.3
Acquired in-process research and development	18.0		75.0
Share-based compensation	179.8		149.3

Contingent consideration	(49.1)		(23.5)
Deferred income taxes	(750.1)		211.9
(Gain) loss on strategic investments	710.5		41.8
(Gain) loss on equity method investment	(17.2)		14.7
Other	201.0		110.1
Changes in operating assets and liabilities, net:
Accounts receivable	157.8		(135.7)
Due from anti-CD20 therapeutic programs	13.5		63.0
Inventory	(322.6)		(270.6)
Accrued expense and other current liabilities	(243.3)		372.9
Income tax assets and liabilities	260.5		15.3
Other changes in operating assets and liabilities, net	(87.6)		(97.0)
Net cash flow provided by operating activities	2,801.6		4,596.9
Cash flow from investing activities:
Purchases of property, plant and equipment	(206.5)		(338.8)
Proceeds from sales and maturities of marketable securities	2,028.1		5,240.7
Purchases of marketable securities	(2,372.6)		(4,649.1)
Purchase of Sangamo Therapeutics, Inc. stock	—		(141.8)
Purchase of Denali Therapeutics Inc. stock	—		(423.7)
Proceeds from divestiture of Hillerød, Denmark manufacturing operations	28.1		—
Acquired in-process research and development	(18.0)		(75.0)
Acquisitions of intangible assets	(1.9)		(37.0)


Proceeds from sales of strategic investments	91.2		0.5
Other	0.6		(18.0)
Net cash flow used in investing activities	(451.0)		(442.2)
Cash flow from financing activities:
Purchases of treasury stock	(1,800.0)		(6,279.1)
Payments related to issuance of stock for share-based compensation arrangements, net	(8.3)		(11.8)
Repayment of borrowings and premiums paid on debt exchange	(170.0)		—
Proceeds from borrowings	—		2,967.3
Repayment of borrowings	—		(1,500.0)
Cash proceeds from settlement of swap	—		—
Net distribution to noncontrolling interest	(94.8)		(70.9)
Other	(22.9)		22.9
Net cash flow used in financing activities	(2,096.0)		(4,871.6)
Net increase (decrease) in cash and cash equivalents	254.6		(716.9)
Effect of exchange rate changes on cash and cash equivalents	(44.0)		28.0
Cash and cash equivalents, beginning of the period	1,331.2		2,913.7
Cash and cash equivalents, end of the period	$	1,541.8	$	2,224.8


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


		Page
PART I — FINANCIAL INFORMATION

Item 1.	Financial Statements (unaudited)

	Condensed Consolidated Statements of Income — For the Three and Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021	5

	Condensed Consolidated Statements of Comprehensive Income — For the Three and Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021	6

	Condensed Consolidated Balance Sheets — As of September 30, ~~2021~~2022 and December 31, ~~2020~~2021	7

	Condensed Consolidated Statements of Cash Flow — For the Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021	8

	Condensed Consolidated Statements of Equity — For the Three and Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021	9

	Notes to Condensed Consolidated Financial Statements	13

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4647

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	7381

Item 4.	Controls and Procedures	7583

PART II — OTHER INFORMATION

Item 1.	Legal Proceedings	7684

Item 1A.	Risk Factors	7684

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	9199

Item 6.	Exhibits	92100

Signatures		93101


		Preferred stock			Common stock			Additional paid-in capital				Accumulated other comprehensive loss			Retained earnings		Treasury stock				Total Biogen Inc. shareholders’ equity			Noncontrolling interests					Total equity					Preferred stock							Common stock				Additional paid-in capital				Accumulated other comprehensive loss			Retained earnings			Treasury stock						Total Biogen Inc. shareholders’ equity			Noncontrolling interests		Total equity
		Shares	Amount		Shares	Amount								Shares			Amount						Shares									Amount				Shares			Amount								Shares						Amount
Balance, June 30, 2021		—	$	—	172.9	$	0.1			$	—				$	(171.8)	$	13,900.7	(23.8)		$	(2,977.1)				$	10,751.9				$	462.9			$	11,214.8
Balance, June 30, 2022																										Balance, June 30, 2022		—					$	—			169.0			$	0.1	$	—	$		(110.4)			$	14,959.9		(23.8)			$	(2,977.1)		$	11,872.5		$	(9.1)		$	11,863.4
Net income	Net income	—	—		—	—		—				—			329.2		—		—		329.2			(11.1)					318.1			Net income		—				—			—		—		—				—			1,134.7			—			—			1,134.7			0.2		1,134.9
Other comprehensive income (loss), net of tax	Other comprehensive income (loss), net of tax	—	—		—	—		—				35.2			—		—		—		35.2			—					35.2			Other comprehensive income (loss), net of tax		—				—			—		—		—				(53.2)			—			—			—			(53.2)			—		(53.2)
Capital contribution by noncontrolling interest		—	—		—	—		—				—			—		—		—		—			—					—
Distribution to noncontrolling interest		—	—		—	—		—				—			—		—		—		—			—					—

Capital contribution from noncontrolling interest																										Capital contribution from noncontrolling interest		—					—				—			—		—		—				—			—			—			—			0.2			0.2
Repurchase of common stock pursuant to the 2020 Share Repurchase Program, at cost	Repurchase of common stock pursuant to the 2020 Share Repurchase Program, at cost	—	—		—	—		—				—			—		(2.2)		(750.0)		(750.0)			—					(750.0)			Repurchase of common stock pursuant to the 2020 Share Repurchase Program, at cost		—				—			—		—		—				—			—			(1.2)			(250.0)			(250.0)			—		(250.0)
Retirement of common stock pursuant to the 2020 Share Repurchase Program, at cost	Retirement of common stock pursuant to the 2020 Share Repurchase Program, at cost	—	—		(2.2)	—		(68.6)				—			(681.4)		2.2		750.0		—			—					—			Retirement of common stock pursuant to the 2020 Share Repurchase Program, at cost		—				—			(1.2)		—		(71.5)				—			(178.5)			1.2			250.0			—			—		—
Issuance of common stock under stock option and stock purchase plans	Issuance of common stock under stock option and stock purchase plans	—	—		—	—		11.0				—			—		—		—		11.0			—					11.0			Issuance of common stock under stock option and stock purchase plans		—				—			—		—		8.6				—			—			—			—			8.6			—		8.6
Issuance of common stock under stock award plan	Issuance of common stock under stock award plan	—	—		—	—		—				—			(5.0)		—		—		(5.0)			—					(5.0)			Issuance of common stock under stock award plan		—				—			—		—		(2.8)				—			—			—			—			(2.8)			—		(2.8)
Compensation related to share-based payments	Compensation related to share-based payments	—	—		—	—		57.6				—			—		—		—		57.6			—					57.6			Compensation related to share-based payments		—				—			—		—		65.7				—			—			—			—			65.7			—		65.7
Other	Other	—	—		—	—		—				—			—		—		—		—			—					—			Other		—				—			—		—		—				—			—			—			—			—			—		—
Balance, September 30, 2021		—	$	—	170.7	$	0.1	$	—			$	(136.6)		$	13,543.5	(23.8)		$	(2,977.1)	$	10,429.9		$	451.8				$	10,881.7
Balance, September 30, 2022																										Balance, September 30, 2022		—					$	—			167.8			$	0.1	$	—	$	(163.6)			$	15,916.1		(23.8)			$	(2,977.1)		$	12,775.5		$	(8.7)		$	12,766.8


(In millions)	As of September 30, ~~2021~~2022
Goodwill, December 31, ~~2020~~2021	$	~~5,762.1~~5,761.1

Other	~~(1.6)~~(19.9)
Goodwill, September 30, ~~2021~~2022	$	~~5,760.5~~5,741.2


											Fair Value Measurements on a Recurring Basis
		As of September 30, 2021									As of September 30, 2022
(In millions)	(In millions)	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		(In millions)	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:	Assets:									Assets:
Cash equivalents	Cash equivalents	$	978.9	$	—	$	978.9	$	—	Cash equivalents	$	3,191.8	$	—	$	3,191.8	$	—
Marketable debt securities:	Marketable debt securities:									Marketable debt securities:
Corporate debt securities	Corporate debt securities	1,486.8		—		1,486.8		—		Corporate debt securities	1,219.1		—		1,219.1		—
Government securities	Government securities	712.9		—		712.9		—		Government securities	702.0		—		702.0		—
Mortgage and other asset backed securities	Mortgage and other asset backed securities	181.9		—		181.9		—		Mortgage and other asset backed securities	174.7		—		174.7		—
Marketable equity securities	Marketable equity securities	1,166.2		215.9		950.3		—		Marketable equity securities	896.0		896.0		—		—
Other current assets:										Other current assets:
Receivable from Samsung BioLogics(1)										Receivable from Samsung BioLogics(1)	790.8		—		—		790.8
Other assets:										Other assets:
Derivative contracts	Derivative contracts	80.0		—		80.0		—		Derivative contracts	195.9		—		195.9		—
Plan assets for deferred compensation	Plan assets for deferred compensation	33.7		—		33.7		—		Plan assets for deferred compensation	32.2		—		32.2		—
Receivable from Samsung BioLogics(1)										Receivable from Samsung BioLogics(1)	402.8		—		—		402.8
Total	Total	$	4,640.4	$	215.9	$	4,424.5	$	—	Total	$	7,605.3	$	896.0	$	5,515.7	$	1,193.6
Liabilities:	Liabilities:									Liabilities:
Derivative contracts	Derivative contracts	$	27.7	$	—	$	27.7	$	—	Derivative contracts	$	22.8	$	—	$	22.8	$	—
Contingent consideration obligations	Contingent consideration obligations	210.7		—		—		210.7		Contingent consideration obligations	195.4		—		—		195.4
Total	Total	$	238.4	$	—	$	27.7	$	210.7	Total	$	218.2	$	—	$	22.8	$	195.4


		Notional Amount					Notional Amount
(In millions)	(In millions)	As of September 30, 2021		As of December 31, 2020		(In millions)	As of September 30, 2022		As of December 31, 2021
Euro	Euro	$	1,901.5	$	2,979.1	Euro	$	1,089.2	$	1,828.0
British pound	British pound	63.6		250.6		British pound	43.5		166.2
Swiss franc	Swiss franc	60.4		—		Swiss franc	37.8		—
Japanese yen	Japanese yen	30.1		—		Japanese yen	23.5		72.7
Canadian dollar	Canadian dollar	25.2		—		Canadian dollar	14.7		59.9
Total foreign currency forward contracts	Total foreign currency forward contracts	$	2,080.8	$	3,229.7	Total foreign currency forward contracts	$	1,208.7	$	2,126.8


For the Nine Months Ended September 30,
Net Gains/(Losses) Reclassified from AOCI into Operating Income (in millions)					Net Gains/(Losses) Recognized in Operating Income (in millions)
Location	2021		2020		Location	2021		2020
Revenue	$	(68.7)	$	41.6	Revenue	$	(4.5)	$	(1.0)
Operating expense	(0.3)		1.4		Operating expense	(0.4)		(0.7)


For the Nine Months Ended September 30,
Net Gains/(Losses) Recognized in Other Comprehensive Income (Effective Portion) (in millions)					Net Gains/(Losses) Recognized in Other Comprehensive Income (Amounts Excluded from Effectiveness Testing) (in millions)					Net Gains/(Losses) Recognized in Net Income (Amounts Excluded from Effectiveness Testing) (in millions)
Location	2021		2020		Location	2021		2020		Location	2021		2020
Gains (losses) on net investment hedge	$	46.1	$	5.0	Gains (losses) on net investment hedge	$	(1.1)	$	3.1	Other income (expense)	$	0.1	$	2.6


(In millions)	(In millions)	Balance Sheet Location	As of September 30, 2021		As of December 31, 2020		(In millions)	Balance Sheet Location	As of September 30, 2022		As of December 31, 2021
Cash Flow Hedging Instruments:	Cash Flow Hedging Instruments:						Cash Flow Hedging Instruments:
Asset derivative instruments	Asset derivative instruments	Other current assets	$	34.5	$	—	Asset derivative instruments	Other current assets	$	158.2	$	66.2
		Investments and other assets	14.1		—			Investments and other assets	5.0		5.5
Liability derivative instruments	Liability derivative instruments	Accrued expense and other	11.8		157.1		Liability derivative instruments	Accrued expense and other	2.6		6.6
		Other long-term liabilities	—		35.7

Net Investment Hedging Instruments:(1)	Net Investment Hedging Instruments:(1)						Net Investment Hedging Instruments:(1)
Asset derivative instruments	Asset derivative instruments	Other current assets	25.3		—		Asset derivative instruments	Other current assets	21.4		4.1
Liability derivative instruments		Accrued expense and other	—		19.7

Other Derivative Instruments:	Other Derivative Instruments:						Other Derivative Instruments:
Asset derivative instruments	Asset derivative instruments	Other current assets	6.1		20.5		Asset derivative instruments	Other current assets	11.3		5.1
Liability derivative instruments	Liability derivative instruments	Accrued expense and other	15.9		4.7		Liability derivative instruments	Accrued expense and other	20.2		4.2


(In millions)	(In millions)	As of September 30, 2021		(In millions)	As of September 30, 2022
2021 (remaining three months)		$	70.0
2022		255.0
2022 (remaining three months)				2022 (remaining three months)	$	55.0
2023	2023	210.0		2023	215.0
2024	2024	195.0		2024	195.0
2025	2025	195.0		2025	190.0
2026	2026	180.0		2026	175.0
2027				2027	165.0


(In millions)	Income Statement Location	Amounts Reclassified from Accumulated Other Comprehensive Income (Loss)
		For the Three Months Ended September 30,				For the Nine Months Ended September 30,
		2021		2020		2021		2020
Gains (losses) on securities available for sale	Other income (expense)	$	(0.4)	$	0.1	$	(1.3)	$	(12.4)
	Income tax benefit (expense)	0.1		—		0.3		2.6

Gains (losses) on cash flow hedges	Revenue	(14.9)		(9.1)		(68.7)		41.6
	Operating expense	(0.3)		1.5		(0.3)		1.4
	Other income (expense)	—		—		0.1		0.2
	Income tax benefit (expense)	1.5		0.1		6.8		(0.1)

Gains (losses) on net investment hedge	Other income (expense)	—		0.8		0.1		2.6


Total reclassifications, net of tax		$	(14.0)	$	(6.6)	$	(63.0)	$	35.9