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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

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

For the fiscal year ended December 31, 2023

or

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

Commission file number: 0-19311

BIOGEN INC.

(Exact name of registrant as specified in its charter)

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

225 Binney Street, Cambridge, MA 02142

(617) 679-2000

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class						Trading Symbol(s)						Name of Each Exchange on Which Registered
Common Stock, $0.0005 par value						BIIB						The			Nasdaq Global Select Market

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

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer			x						Accelerated filer			☐
Non-accelerated filer			☐						Smaller reporting company			☐
									Emerging growth company			☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No x

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was $41,190,868,800.

As of February 12, 2024, the registrant had 145,360,798 shares of common stock, $0.0005 par value, outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the definitive proxy statement for our 2024 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.

BIOGEN INC.

ANNUAL REPORT ON FORM 10-K

For the Year Ended December 31, 2023

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						Page
PART I
Item 1.			Business			1
Item 1A.			Risk Factors			40
Item 1B.			Unresolved Staff Comments			54
Item 1C.			Cybersecurity			54
Item 2.			Properties			55
Item 3.			Legal Proceedings			57
Item 4.			Mine Safety Disclosures			57
PART II
Item 5.			Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities			58
Item 6.			Reserved			59
Item 7.			Management’s Discussion and Analysis of Financial Condition and Results of Operations			60
Item 7A.			Quantitative and Qualitative Disclosures About Market Risk			91
Item 8.			Financial Statements and Supplementary Data			93
Item 9.			Changes in and Disagreements with Accountants on Accounting and Financial Disclosure			93
Item 9A.			Controls and Procedures			93
Item 9B.			Other Information			94
Item 9C.			Disclosure Regarding Foreign Jurisdictions that Prevent Inspections			95
PART III
Item 10.			Directors, Executive Officers and Corporate Governance			96
Item 11.			Executive Compensation			96
Item 12.			Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters			96
Item 13.			Certain Relationships and Related Transactions, and Director Independence			96
Item 14.			Principal Accountant Fees and Services			96
PART IV
Item 15.			Exhibits and Financial Statement Schedules			97
Item 16.			Form 10-K Summary			97
Signatures						100
Consolidated Financial Statements						F- 1

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NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the Act) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the Act. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” "contemplate," "continue," “estimate,” “expect,” “forecast,” "goal," “intend,” “may,” “plan,” “potential,” “possible,” "predict," "project", "should," "target," “will,” “would” or the negative of these words or other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding:

• the anticipated amount, timing and accounting of revenue; contingent, milestone, royalty and other payments under licensing, collaboration, acquisition or divestiture agreements; tax positions and contingencies; collectability of receivables; pre-approval inventory; cost of sales; research and development costs; compensation and other selling, general and administrative expense; amortization of intangible assets; foreign currency exchange risk; estimated fair value of assets and liabilities; and impairment assessments;

• expectations, plans and prospects relating to product approvals, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products;

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

• patent terms, patent term extensions, patent office actions and expected availability and periods of regulatory exclusivity;

• our plans and investments in our portfolio as well as implementation of our corporate strategy;

• the execution of our strategic and growth initiatives, including the ultimate success of our acquisition of Reata and our ability to realize the anticipated benefits from the acquisition, including future performance of the SKYCLARYS product and anticipated synergies, as well as the exploration of strategic options for our biosimilars business;

• the drivers for growing our business, including our plans and intention to commit resources relating to discovery, research and development programs and business development opportunities as well as the potential benefits and results of, and the anticipated completion of, certain business development transactions and cost-reduction measures, including our Fit for Growth program;

• the expectations, development plans and anticipated timelines, including costs and timing of potential clinical trials, regulatory filings and approvals, of our products, drug candidates and pipeline programs, including collaborations with third-parties, as well as the potential therapeutic scope of the development and commercialization of our and our collaborators’ pipeline products;

• the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our patents and other proprietary and intellectual property rights, tax audits, assessments and settlements, pricing matters, sales and promotional practices, product liability, investigations and other matters;

• our ability to finance our operations and business initiatives and obtain funding for such activities;

• adverse safety events involving our marketed or pipeline products, generic or biosimilar versions of our marketed products or any other products from the same class as one of our products;

• the current and potential impacts of geopolitical tensions, acts of war and other large-scale crises, including impacts to our operations, sales and the possible disruptions or delay in our plans to conduct clinical trial activities in areas of geopolitical tension, including regions affected by Russia's invasion of Ukraine and the military conflict in the Middle East;

• the direct and indirect impact of global health outbreaks on our business and operations, including sales, expense, reserves and allowances, the supply chain, manufacturing, research and development costs, clinical trials and employees;

• our use of information systems and data and the potential impacts of any breakdowns, invasions, corruptions, destructions and/or breaches of such systems or those of our business partners;

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• the potential impact of healthcare reform in the U.S., including the IRA, and measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;

• our manufacturing capacity, use of third-party contract manufacturing organizations, plans and timing relating to changes in our manufacturing capabilities, activities in new or existing manufacturing facilities and the expected timeline for the gene therapy manufacturing facility in RTP, North Carolina to be operational;

• the impact of the continued uncertainty of the credit and economic conditions in certain countries and our collection of accounts receivable in such countries;

• lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations; and

• the impact of new laws (including tax), regulatory requirements, judicial decisions and accounting standards.

These forward-looking statements involve risks and uncertainties, including those that are described in Item 1A. Risk Factors included in this report and elsewhere in this report, that could cause actual results to differ materially from those reflected in such statements. Because some of these risks and uncertainties cannot be predicted or quantified and some are beyond our control, you should not rely on our forward-looking statements as predictions of future events and you should not place undue reliance on these statements. Moreover, we operate in a very competitive and rapidly changing environment, new risks and uncertainties may emerge from time to time and it is not possible for us to predict all risks nor identify all uncertainties. Forward-looking statements speak only as of the date of this report and are based on information and estimates available to us at this time. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. You should read this report with the understanding that our actual future results, performance, events and circumstances might be materially different from what we expect.

NOTE REGARDING COMPANY AND PRODUCT REFERENCES

References in this report to:

• “Biogen,” the “company,” “we,” “us” and “our” refer to Biogen Inc. and its consolidated subsidiaries; and

• “RITUXAN” refers to both RITUXAN (the trade name for rituximab in the U.S., Canada and Japan) and MabThera (the trade name for rituximab outside the U.S., Canada and Japan).

NOTE REGARDING TRADEMARKS

ADUHELM®, AVONEX®, BYOOVIZ®, PLEGRIDY®, QALSODY®, RITUXAN®, RITUXAN HYCELA®, SKYCLARYS®, SPINRAZA®, TECFIDERA®, TYSABRI® and VUMERITY® are registered trademarks of Biogen.

BENEPALI™, FLIXABI™, FUMADERM™, IMRALDI™ and TOFIDENCE™ are trademarks of Biogen.

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

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DEFINED TERMS

2022 Form 10-K			Annual Report on Form 10-K for the year ended December 31, 2022
2020 Share Repurchase Program			Board of Directors authorized program to repurchase up to $5.0 billion of our common stock
125 Broadway			125 Broadway, Cambridge, MA
300 Binney Street			300 Binney Street, Cambridge, MA
AAIC			Alzheimer's Association International Conference
AbbVie			AbbVie Inc.
Acorda			Acorda Therapeutics, Inc.
AI			Artificial Intelligence
Alkermes			Alkermes plc
ALS			Amyotrophic Lateral Sclerosis
AMP			Average Manufacturer Price
AOCI			Accumulated Other Comprehensive Income (Loss)
ASO			Antisense Oligonucleotide
ASU			Accounting Standards Update
ATV			Antibody Transport Vehicle
BLA			Biologics License Application
Blackstone			Blackstone Life Sciences
CCDAA			Climate Corporate Data Accountability Act
CCPA			California Consumer Privacy Act
CEO			Chief Executive Officer
CHMP			Committee for Medicinal Products for Human Use
CISO			Chief Information Security Officer
CJEU			Court of Justice of the European Union
CLE			Cutaneous Lupus Erythematosus
CLL			Chronic Lymphocytic Leukemia
CMS			Centers for Medicare & Medicaid Services
CODM			Chief Operating Decision Maker
Convergence			Convergence Pharmaceuticals Ltd.
CRFRA			Climate-Related Financial Risk Act
CRL			Complete Response Letter
CROs			Contract Research Organizations
CTAD			Clinical Trials on Alzheimer's Disease
DEA			Drug Enforcement Agency
DE&I			Diversity, Equity and Inclusion
Denali			Denali Therapeutics Inc.
DOJ			U.S. Department of Justice
DPN			Diabetic Painful Neuropathy
EC			European Commission
Eisai			Eisai Co., Ltd.
EMA			European Medicines Agency
EPO			European Patent Office
ERISA			Employee Retirement Income Security Act of 1974
ERM			Enterprise Risk Management

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DEFINED TERMS (continued)

ERN			Employee Resource Network
ESG			Environmental, Social and Governance
E.U.			European Union
FA			Friedreich's Ataxia
FASB			Financial Accounting Standards Board
FCPA			Foreign Corrupt Practices Act
FDA			U.S. Food and Drug Administration
FDIC			Federal Deposit Insurance Corporation
Fit for Growth			Cost saving program initiated in 2023
FSS			Federal Supply Schedule
GCP			Good Clinical Practices
GDPR			General Data Privacy Regulation
Genentech			Genentech, Inc.
GILTI			Global Intangible Low Tax Income
GloBE			Global Anti-Base Erosion
GMP			Good Manufacturing Practices
Humana			Humana Inc.
IPR&D			In-process Research and Development
Ionis			Ionis Pharmaceuticals Inc.
IRA			Inflation Reduction Act of 2022
IT			Information Technology
LHI			Large Hemispheric Infarction
LRRK2			Leucine-Rich Repeat Kinase 2
MAA			Marketing Authorization Application
MDD			Major Depressive Disorder
MHRA			Medicines and Healthcare products Regulatory Agency
MS			Multiple Sclerosis
Mylan Ireland			Mylan Ireland Ltd.
NCD			National Coverage Decision
NDA			New Drug Application
NDS			New Drug Submission
Neurimmune			Neurimmune SubOne AG
NIST			National Institute of Standards and Technology
NMPA			National Medicinal Products Administration
OECD			Organization for Economic Co-operation and Development
OIE			Other (Income) Expense, Net
PDUFA			Prescription Drug User Fee Act
PFAS			Per- and Polyfluoroalkyl Substances
PHS			Public Health Service
PMDA			Pharmaceuticals and Medical Devices Agency
Polpharma			Polpharma Biologics S.A.
PPACA			Patient Protection and Affordable Care Act
PPD			Postpartum Depression
PPMS			Primary Progressive MS

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DEFINED TERMS (continued)

R&D			Research and Development
Reata			Reata Pharmaceuticals, Inc.
REMS			Risk Evaluation and Mitigation Strategies
RMS			Relapsing MS
RRMS			Relapsing-Remitting MS
RTP			Research Triangle Park
SAG			Scientific Advisory Group
Sage			Sage Therapeutics, Inc.
Samsung Bioepis			Samsung Bioepis Co., Ltd.
Samsung BioLogics			Samsung BioLogics Co., Ltd.
Sangamo			Sangamo Therapeutics, Inc.
SEC			U.S. Securities and Exchange Commission
SG&A			Selling, General and Administrative
SLE			Systemic Lupus Erythematosus
SMA			Spinal Muscular Atrophy
SMN			Survival Motor Neuron
SOD1			Superoxide Dismutase 1
SPC			Supplementary Protection Certificate
SSP			Supplemental Savings Plan
SWISSMEDIC			Swiss Agency for Therapeutic Products
TBA			Technical Boards of Appeal
TGN			Trigeminal Neuralgia
TNF			Anti-tumor Necrosis Factor
Transition Toll Tax			A one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings
U.K.			United Kingdom
U.S.			United States
U.S. GAAP			Accounting Principles Generally Accepted in the U.S.
VA			Veterans Administration

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PART I