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Biogen

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FY2024 Annual Report · Biogen
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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, 2024
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 $33,709,755,067.
As of February 11, 2025, the registrant had 146,374,937 shares of common stock, $0.0005 par value, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive proxy statement for our 2025 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.

Table of Contents
BIOGEN INC.
ANNUAL REPORT ON FORM 10-K
For the Year Ended December 31, 2024
TABLE OF CONTENTS
 
 
Page
PART I
Item 1.
Business
1
Item 1A.
Risk Factors
38
Item 1B.
Unresolved Staff Comments
52
Item 1C.
Cybersecurity
52
Item 2.
Properties
54
Item 3.
Legal Proceedings
54
Item 4.
Mine Safety Disclosures
54
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
55
Item 6.
Reserved
56
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
57
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
87
Item 8.
Financial Statements and Supplementary Data
89
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
89
Item 9A.
Controls and Procedures
89
Item 9B.
Other Information
90
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
91
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
92
Item 11.
Executive Compensation
92
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
92
Item 13.
Certain Relationships and Related Transactions, and Director Independence
92
Item 14.
Principal Accountant Fees and Services
92
PART IV
Item 15.
Exhibits and Financial Statement Schedules
93
Item 16.
Form 10-K Summary
93
Signatures
96
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 PSLRA) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the PSLRA. These forward-looking
statements may be accompanied by such words as “aim,” “anticipate,” "assume," “believe,” “contemplate,” “continue," "could," “estimate,”
“expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “plan,” “possible,” "potential," “predict” “project,” “should,” “target,”
“will,” “would” or the negative of these words or other words and terms of similar meaning. Given their forward-looking nature, these
statements involve substantial risks and uncertainties and may be based on inaccurate assumptions. This report includes, among others,
forward-looking statements regarding:
•
our expected financial and operating performance;
•
our long-term strategy and supporting business plans, including our product pipeline;
•
our expectations about continued growth through acquisitions and key collaborative relationships;
•
our belief that our long-term competitive position depends upon our success in discovering and developing innovative, cost-effective
products that serve unmet medical needs, along with our ability to manufacture products efficiently and to launch and market them
effectively in a highly competitive environment;
•
our ability to obtain and maintain adequate coverage, pricing and reimbursement from third-party payors;
•
our expectations regarding certain legal and regulatory proceedings and investigations; and
•
our belief 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.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to
management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole
or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause
future events or results to be materially different from those stated or implied in this document, including, among others, factors relating to:
•
our substantial dependence on the anticipated amount, timing and accounting of revenue from our products, including from the
successful development of new products and approval of additional indications for our existing products, including but not limited to
LEQEMBI and SKYCLARYS;
•
the anticipated amount, timing and accounting of 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, approvals of additional indications for our existing products, sales,
pricing, growth, reimbursement and launch of our marketed and pipeline products all of which is subject to governmental and regulatory
oversight, and therefore subject to risks, including but not limited to those related to approvals, unfavorable or delayed reimbursements
and coverage determinations, and changes in reimbursement policies or practices of payors and other third-parties;
•
the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other 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, prodrugs or biosimilar versions of our
marketed products or competing products, including but not limited to increased competition from TECFIDERA generic entrants in the
U.S. market;
•
patent terms, patent term extensions, patent office actions and expected availability and periods of regulatory exclusivity, as well as our
ability to adequately enforce existing patents, including our European patent related to TECFIDERA;
•
our ability to effectively implement our corporate strategy which includes significant investment in product and pipeline candidates,
including but not limited to felzartamab and nusinersen;

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•
the successful execution of our strategic and growth initiatives, including acquisitions, and our ability to realize the anticipated benefits
from our acquisitions of Reata and HI-Bio, including future performance of the SKYCLARYS product and further development of the
felzartamab product and anticipated synergies;
•
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, including collaboration agreements, as well as the potential benefits
and results of, and the anticipated completion of, certain business development transactions, reorganizations 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 filing
approvals and/or discontinuation, of our products, drug candidates and pipeline programs, including collaborations with third-parties
including but not limited to Eisai and Sage, as well as the potential therapeutic scope of the development and commercialization of our
and our collaborators’ pipeline products, including ZURZUVAE;
•
the timing, outcome and impact of administrative, regulatory, legal and other proceedings, including those 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 commercialize biosimilars, which is subject to risks such as our reliance on third-parties, competitive challenges, regulatory
compliance, adequate supply, intellectual property and regulatory challenges and failure to gain market and patient acceptance;
•
our ability to finance our present and future operations and business initiatives and obtain funding for such activities on favorable terms;
•
our ability to attract, retain and motivate qualified individuals for management and other employee positions in a highly competitive
environment, including potential difficulty in retaining talent following acquisitions or following the discontinuation or underperformance
of one or more marketed, pre-clinical or clinical programs;
•
adverse safety events involving our marketed or pipeline products, generic, prodrugs 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
tensions between the U.S. and China, 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 or adverse weather events 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 technology systems and data and the potential impacts of any breakdowns, interruptions, invasions, corruptions,
data breaches, destructions and/or other cybersecurity incidents of such systems or those of our business partners;
•
our incorporation of technologies using AI into some of our processes;
•
the potential impact of healthcare reform in the U.S., including the IRA and the impact of the IRA Medicare Part D redesign, 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, as well as the potential impact of legislative and regulatory
changes and priorities;
•
our manufacturing capacity, including our ability to effectively manufacture biosimilars, reliance on third-party contract manufacturing
organizations, plans and timing relating to changes in our manufacturing capabilities, our ability to adequately address global bulk
supply risks, our ability to fully utilize our manufacturing facilities, including our Solothurn facility, activities in new or existing
manufacturing facilities and the expected timeline for the gene therapy, clinical packaging and other 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 ability to collect accounts
receivable in such countries;

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•
lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations;
•
changes in our effective tax rate and obligations in various jurisdictions in which we are subject to taxation; and
•
the impact of new laws, regulatory actions, judicial decisions and accounting standards, or tariffs or trade restrictions applicable to our
products or operations.
These forward-looking statements involve risks and uncertainties, including those that are described in Item 1A. Risk Factors and Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations included in this report and elsewhere in this report,
that could cause actual results to differ materially from those reflected in such statements. The factors identified above should not be
construed as an exhaustive list of factors that could affect our future results and should be read in conjunction with the other cautionary
statements that are included in this Annual Report on Form 10-K. 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™, OPUVIZ™ 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.
 

Table of Contents
DEFINED TERMS
2023 Form 10-K
Annual Report on Form 10-K for the year ended December 31, 2023
2020 Share Repurchase Program
Board of Directors authorized program to repurchase up to $5.0 billion of our common stock
2024 Omnibus Equity Plan
Biogen Inc. 2024 Omnibus Equity Plan
2017 Omnibus Equity Plan
Biogen Inc. 2017 Omnibus Equity Plan
2024 ESPP
Biogen Inc. 2024 Employee Stock Purchase Plan
2015 ESPP
Biogen Inc. 2015 Employee Stock Purchase Plan
2023 Term Loan
$1.5 billion term loan credit agreement
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
AMR
Antibody-Mediated Rejection
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
CISA
Cybersecurity and Infrastructure Security Agency
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
Denali
Denali Therapeutics Inc.
Directors Plan
Biogen Inc. 2015 Non-Employee Directors Equity Plan

Table of Contents
DEFINED TERMS (continued)
District Court
U.S. District Court for the District of Massachusetts
DOJ
U.S. Department of Justice
DPN
Diabetic Painful Neuropathy
EC
European Commission
EHS
Environment, Health and Safety
Eisai
Eisai Co., Ltd.
EMA
European Medicines Agency
EPO
European Patent Office
ERG
Employee Resource Group
ERISA
Employee Retirement Income Security Act of 1974
ERM
Enterprise Risk Management
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
HI-Bio
Human Immunology Biosciences, Inc.
Humana
Humana Inc.
IgAN
Immunoglobulin A. Nephropathy
Ionis
Ionis Pharmaceuticals Inc.
IPR&D
In-process Research and Development
IRA
Inflation Reduction Act of 2022
IT
Information Technology
IV
Intravenous
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
NCD
National Coverage Decision
NDA
New Drug Application
NDS
New Drug Submission

Table of Contents
DEFINED TERMS (continued)
Neurimmune
Neurimmune SubOne AG
NIST
National Institute of Standards and Technology
NMPA
National Medicinal Products Administration
ODD
Orphan Drug Designation
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
PMN
Primary Membranous Nephropathy
Polpharma
Polpharma Biologics S.A.
PPACA
Patient Protection and Affordable Care Act
PPD
Postpartum Depression
PPMS
Primary Progressive MS
PRV
Priority Review Voucher
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

Table of Contents
PART I
ITEM 1. BUSINESS
OVERVIEW
Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with
serious and complex diseases. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA,
co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a
genetic cause of ALS. We market the first and only drug approved in the U.S. and the E.U. for the treatment of FA in adults and adolescents
aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases. We support our
drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.
Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the
treatment of SMA; SKYCLARYS for the treatment of FA; QALSODY for the treatment of ALS; and FUMADERM for the treatment of severe
plaque psoriasis.
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the
commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the
treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL;
GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of
relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the
option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of
the Roche Group.
We commercialize a portfolio of biosimilars of advanced biologics including: BENEPALI, an etanercept biosimilar referencing ENBREL;
IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a
ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing
ACTEMRA, in the U.S. and certain international markets. We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar
referencing EYLEA.
On July 2, 2024, we completed the acquisition of HI-Bio. As a result of this transaction we acquired HI-Bio's lead asset, felzartamab, an anti-
CD38 antibody currently being evaluated for three leading indications, AMR, PMN and IgAN. For additional information on our acquisition of
HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in this report.
For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
1

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KEY BUSINESS DEVELOPMENTS
The following is a summary of key developments affecting our business since the beginning of 2024.
ACQUISITIONS AND DIVESTITURES
HUMAN IMMUNOLOGY BIOSCIENCES
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage
biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab,
an anti-CD38 antibody, is currently being evaluated for three leading indications, AMR, PMN and IgAN. Felzartamab has received
Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR. Subsequent to our
acquisition, felzartamab received ODD in the E.U. in IgAN and solid organ transplantation. The acquisition of HI-Bio is expected to augment
our pipeline and build on our expertise in immunology.
Under the terms of this acquisition, we paid shareholders of HI-Bio approximately $1.15 billion at closing and may pay up to an additional
$650.0 million in potential future development and regulatory milestone payments. We funded this acquisition through available cash on hand
and accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805,
Business Combinations, and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date. For
additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in this
report.
SALE OF PRIORITY REVIEW VOUCHER
In April 2024 we completed the sale of our rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third
party. In consideration for the PRV we received a cash payment of $103.0 million upon the closing of the PRV purchase, of which
approximately $14.4 million was paid to Ionis. Our net portion of approximately $88.6 million was recognized in gain on sale of priority review
voucher, net within our consolidated statements of income for the year ended December 31, 2024. For additional information on the sale of
our PRV, please read Note 3, Dispositions, to our consolidated financial statements included in this report.
DEVELOPMENTS IN KEY COLLABORATIVE RELATIONSHIPS
For additional information on our collaborative and other relationships discussed below, please read Note 19, Collaborative and Other
Relationships, to our consolidated financial statements included in this report.
LEQEMBI (lecanemab)
United States
Key developments related to LEQEMBI in the U.S. consisted of the following:
•
In January 2025 the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
•
In January 2025 the FDA accepted for review the BLA for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, with a
PDUFA action date set for August 31, 2025.
•
In July 2024 Eisai presented new clinical data from the CLARITY AD study open-label extension of LEQEMBI, demonstrating that three
years of continuous LEQEMBI treatment reduced clinical decline, resulting in a clinically meaningful benefit for early Alzheimer's disease
patients.
Rest of World
Key developments related to LEQEMBI (lecanemab) in rest of world markets consisted of the following:
•
In January 2025 we and Eisai announced an update regarding the ongoing regulatory review of the MAA for lecanemab in the E.U., which
the CHMP of the EMA previously adopted a positive opinion on in November 2024. The EC has asked the CHMP to consider information
on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may
require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to
ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.
2

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•
In December 2024 LEQEMBI was approved by the Federal Commission for the Protection Against Sanitary Risk in Mexico.
•
In November 2024 we and Eisai announced the launch of LEQEMBI in South Korea, which had been approved by the Ministry of Food
and Drug Safety in South Korea in May 2024.
•
In October 2024 the Therapeutic Goods Administration of Australia issued a public statement about the initial decision not to register
lecanemab. In December 2024 Eisai submitted a request for reconsideration of this decision.
•
In August 2024 LEQEMBI was approved by the Medicines and Healthcare products Regulatory Agency in Great Britain and by the
Ministry of Health and Prevention in the United Arab Emirates.
•
In July 2024 LEQEMBI was approved in Hong Kong and Israel.
•
In June 2024 we and Eisai announced the launch of LEQEMBI in China, which had been approved by the NMPA in China in January
2024.
UCB COLLABORATION
In September 2024 we and UCB announced positive topline data from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel
Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe SLE. The Phase 3 study met the primary endpoint
demonstrating clinical improvement in moderate-to-severe SLE with clinical improvements observed among key secondary endpoints. Based
on these results, UCB and Biogen initiated a second Phase 3 study in late 2024.
MANAGEMENT CHANGES
•
In October 2024 we announced that Michael R. McDonnell, Executive Vice President and Chief Financial Officer, plans to retire from
Biogen on March 1, 2025. Upon Mr. McDonnell's retirement, Robin C. Kramer, currently Senior Vice President and Chief Accounting
Officer at Biogen, will assume the role of Executive Vice President and Chief Financial Officer.
•
In January 2025 we announced the appointment of Sean Godbout as Vice President, Chief Accounting Officer and Global Corporate
Controller, effective March 1, 2025, upon the transition of Robin C. Kramer, currently Senior Vice President and Chief Accounting Officer
at Biogen, to the role of Executive Vice President and Chief Financial Officer.
BOARD OF DIRECTORS UPDATE
•
Effective October 1, 2024, Lloyd B. Minor, M.D. joined our Board of Directors.
•
Effective January 1, 2025, Sir Menelas (Mene) Pangalos, Ph.D. joined our Board of Directors.
For additional information on our executive officers, please read the subsection entitled "Information about our Executive Officers" included in
this report.
PRODUCT AND PIPELINE DEVELOPMENTS
NEUROLOGY
ALZHEIMER'S DISEASE
LEQEMBI (lecanemab)
•
In October 2024 Eisai presented data on benefits of long-term administration of dual-acting LEQEMBI at the 2024 CTAD conference. The
data presented additional measures resulting from the three years of continuous LEQEMBI treatment, showing that 46% of patients
improved or had no decline and 33% showed improvement from baseline on the CDR-SB. On the ADAS-Cog14 measurement scale,
46% of patients showed improvement or no decline and 43% showed improvement. On the ADCS MCI-ADL measurement scale, 51% of
patients showed improvement or no decline and 48% showed improvement.
•
In July 2024 Eisai announced the results of a detailed analysis of the Phase 3 CLARITY Alzheimer's disease study of LEQEMBI at the
2024 AAIC conference. The study provided further Phase 3 analysis showing three years of continuous LEQEMBI treatment reduced
clinical decline by -0.95 on CDR-SB showing continued clinically and personally meaningful benefit for early Alzheimer's disease
patients.
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IMMUNOLOGY
felzartamab
•
Felzartamab was granted ODD in the E.U. in IgAN and solid organ transplantation in November 2024 and December 2024, respectively.
•
In October 2024 we presented complete results from the Phase 2 IGNAZ study evaluating felzartamab, an investigational anti-CD38
monoclonal antibody, in people living with IgAN during the American Society of Nephrology Kidney Week 2024. The results from the
study showed substantial reductions in proteinuria, stabilization of kidney function and sustained treatment effect more than 18 months
after the last dose of felzartamab.
•
In October 2024 the FDA granted felzartamab Breakthrough Therapy Designation for the treatment of late AMR without T-cell mediated
rejection in kidney transplant patients.
RARE DISEASE
SPINRAZA (nusinersen)
•
In January 2025 the FDA accepted the supplemental NDA and the EMA validated the application for a higher dose regimen of nusinersen
for SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg-doses 14 days apart, and higher
maintenance regimen, 28 mg, every four months, compared to the currently approved dose of SPINRAZA.
•
In September 2024 we announced positive topline data from the Phase 2/3 DEVOTE study of nusinersen, which evaluated the safety and
efficacy of a higher dose regimen of nusinersen in treatment-naive symptomatic infants with SMA.
•
In March 2024 we announced new data from the Phase 4 RESPOND study for SPINRAZA. The study showed that neurofilament levels,
an indicator of neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA. The reductions in biomarker
complement previously reported RESPOND study efficacy results showing improved motor function in most participants treated with
SPINRAZA after gene therapy.
SKYCLARYS
•
In September 2024 SKYCLARYS was approved by SWISSMEDIC for the treatment of FA in adults and adolescents aged 16 years and
older.
•
In July 2024 the first pediatric patient was treated in the Phase 1 study of SKYCLARYS designed to identify the appropriate dose for the
pediatric population living with FA.
QALSODY
•
In December 2024 the Japanese Ministry of Health, Labor and Welfare approved QALSODY in Japan.
•
In October 2024 QALSODY was approved in China by the NMPA under the conditional approval pathway for the treatment of adults with
ALS associated with a mutation in the SOD1 gene.
•
In May 2024 the EC approved QALSODY in the E.U. for the treatment of adults with ALS associated with a mutation in the SOD1 gene.
QALSODY is the first treatment approved in the E.U. to target a genetic cause of ALS.
DISCONTINUED PROGRAMS AND STUDIES
SAGE COLLABORATION
zuranolone
In October 2024 we and Sage agreed to not pursue further development of zuranolone for the potential treatment of MDD. This decision was
based on the significant new investment and time we expect would be needed to conduct the additional studies required to support approval
of this indication.
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BIIB124
In July 2024 we and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124 did not meet its endpoints. Based on these
results, we discontinued our further development of BIIB124 and terminated our rights under the collaboration and license agreement specific
to BIIB124, effective February 17, 2025.
SAMSUNG BIOEPIS 2019 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
In October 2024 we notified Samsung Bioepis of our decision to terminate our 2019 Development and Commercialization Agreement (the
DCA Agreement) solely within the U.S. and Canada. Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S. and
Canada back to Samsung Bioepis over a period of up to 18 months. During this transition period, we will continue to commercialize
BYOOVIZ. The termination does not impact the other markets in the DCA Agreement.
IONIS COLLABORATION
BIIB105
In May 2024 we and Ionis announced that the Phase 1/2 ALSpire study of BIIB105, an investigational ASO for the potential treatment of ALS,
did not meet its endpoints. Based on these results, we discontinued our further development of BIIB105.
BIIB121
In May 2024 we announced that we have elected not to exercise our option to license and lead development of BIIB121, an ASO for the
potential treatment of Angelman syndrome.
MERZ THERAPEUTICS (PREVIOUSLY ACORDA THERAPEUTICS, INC.)
In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025, whereby
Acorda regained global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its
intention to sell substantially all of Acorda's assets to a third party. On July 10, 2024, Merz Therapeutics announced that its subsidiary Merz
Pharmaceuticals LLC had completed the acquisition of FAMPYRA, and related assets from Acorda. We are now working with Merz
Therapeutics on the transition of global commercialization rights of FAMPYRA and we expect to recognize minimal revenue in 2025.
BIIB143 (cemdomespib)
In early 2025 we discontinued further development of BIIB143 (cemdomespib) for the treatment of diabetic neuropathic pain, as part of our
ongoing pipeline prioritization efforts.
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MARKETED PRODUCTS
The following graph shows our product revenue, revenue from anti-CD20 therapeutic programs and Alzheimer's collaboration revenue for the
years ended December 31, 2024, 2023 and 2022.
MS includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA.
 Rare disease includes SPINRAZA, QALSODY, which became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U.
during the second quarter of 2024, and SKYCLARYS, which was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially
available in the U.S. during the second quarter of 2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our
acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024.
 Biosimilars includes BENEPALI, IMRALDI, FLIXABI, BYOOVIZ, which became commercially available in certain international markets in 2023, and TOFIDENCE, which
became commercially available in the U.S. during the second quarter of 2024.
 Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties.
 Anti-CD20 therapeutic programs include RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS and LUNSUMIO, which became commercially available in the U.S. during the
first quarter of 2023.
 Other includes FUMADERM, ADUHELM and ZURZUVAE, which became commercially available in the U.S. during the fourth quarter of 2023.
(1) 
(2)
(3)
(4)
(5)
(6)
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Product sales for TECFIDERA, TYSABRI and SPINRAZA each accounted for more than 10.0% of our total revenue for the years ended
December 31, 2024, 2023 and 2022. For additional financial information about our product and other revenue and geographic areas where
we operate, please read Note 5, Revenue and Note 25, Segment Information, to our consolidated financial statements included in this report
and Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations included in this report. A discussion of
the risks attendant to our operations is set forth in Item 1A. Risk Factors included in this report.
NEUROLOGY
MULTIPLE SCLEROSIS
We develop, manufacture and market a number of products designed to treat patients with MS. MS is a progressive disease in which the
body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death.
Patients with active RMS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by
flare-ups of the disease after which the patient may return to a lower baseline of functioning.
The MS products we market and our major markets are as follows:
Product
Indication
Collaborator
Major Markets
RMS

RRMS in the E.U.

Crohn's disease in the U.S.
None
U.S.

Brazil

France

Germany

Italy

U.K.
RMS in the U.S.

RRMS in the E.U.
None
U.S.

France

Germany

Italy

Japan

U.K.
RMS in the U.S.

RRMS in the E.U.
Alkermes Pharma Ireland Limited,
a subsidiary of Alkermes
U.S.

France

Germany

Netherlands

Spain

Switzerland
RMS
None
U.S.

Canada

France

Germany

Italy

Spain
RMS in the U.S.

RRMS in the E.U.
None
U.S.

France

Germany

Italy

Spain

U.K.
For additional information on our collaboration arrangements with Alkermes, please read Note 19, Collaborative and Other Relationships, to
our consolidated financial statements included in this report.
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ALZHEIMER'S DISEASE
Alzheimer's disease, the most common form of dementia, is a progressive neurological illness that causes a gradual decline in cognitive
abilities, usually during a span of seven to ten years. Nearly all brain functions, including memory, movement, language, judgement, behavior
and abstract thinking, are eventually affected. In the U.S., Alzheimer's disease is the seventh-leading cause of death, accounting for over
120,000 deaths each year.
Alzheimer's disease is characterized by two abnormalities in the brain: amyloid plaques and neurofibrillary tangles. Amyloid plaques, which
are found in the tissue between the nerve cells, are unusual clumps of a protein called beta amyloid along with degenerating bits of neurons
and other cells. Neurofibrillary tangles are bundles of twisted filaments found within neurons. These tangles are largely made up of a protein
called tau.
Our Alzheimer's disease products and major markets are as follows:
Product
Indication
Collaborator
Major Market
Alzheimer's disease
Eisai
U.S.

China

Great Britain

Israel

Japan

South Korea

United Arab Emirates
For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
NEUROPSYCHIATRY
Neuropsychiatry includes ZURZUVAE for PPD, which became commercially available in the U.S. during the fourth quarter of 2023. PPD
symptoms are estimated to affect approximately one in eight women who have given birth in the U.S. According to the Centers for Disease
Control and Prevention, mental health conditions are the leading cause of maternal mortality with PPD among the most common
complications during and after pregnancy.
Product
Indication
Collaborator
Major Markets
PPD in adults
Sage
U.S.
For additional information on our collaboration arrangements with Sage, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
RARE DISEASE
Rare disease includes SPINRAZA for SMA, QALSODY for ALS, which became commercially available in the U.S. during the second quarter
of 2023 and commercially available in the E.U. during the second quarter of 2024, and SKYCLARYS for FA, which was obtained as part of
our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and
we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS
was approved and became commercially available in the E.U. during the first quarter of 2024.
SMA is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy
and weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic
functions of life, like breathing and swallowing. Due to a deletion or mutations in the SMN1 gene, people with SMA do not produce enough
SMN protein, which is critical to the survival of the neurons that control muscles. The severity of SMA correlates with the amount of SMN
protein. People with Type 1 SMA, the most severe life-threatening form, produce very little SMN protein and do not achieve the ability to sit
without support, and typically do not live beyond two years of age without respiratory support and nutritional interventions. People with Type 2
and Type 3 SMA produce greater amounts of SMN protein and have less severe, but still life-altering, forms of SMA.
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FA is an inherited, debilitating and degenerative neuromuscular disorder that is typically diagnosed during adolescence and can ultimately
lead to premature death. Patients with FA experience progressive loss of coordination, muscle weakness and fatigue, which commonly
progresses to motor incapacitation, wheelchair reliance and eventually death.
ALS is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord that
are responsible for controlling voluntary muscle movement. People with ALS experience muscle weakness and atrophy, causing them to lose
independence as they steadily lose the ability to move, speak, eat and eventually breathe. Average life expectancy for people with ALS is
three to five years from time of symptom onset. Multiple genes have been implicated in ALS. Genetic testing helps determine if a person's
ALS is associated with a genetic mutation, even in individuals without a known family history of the disease. SOD1-ALS is a mutation in the
SOD1 gene, and this form of ALS is diagnosed in approximately two percent of all ALS cases.
Our Rare disease products and major markets are as follows:
Product
Indication
Collaborator
Major Markets
SMA
Ionis
U.S.

Brazil

France

Germany

Italy

Turkey
FA in adults and adolescents aged 16 years
and older
None
U.S.

France

Germany
ALS in adults with mutation in SOD1 gene
Ionis
U.S.

Germany
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
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BIOSIMILARS
Biosimilars are a group of biologic medicines that are highly similar to currently available biologic therapies developed by companies known
as "originators". We commercialize a portfolio of biosimilars of advanced biologics including: BENEPALI, an etanercept biosimilar referencing
ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and
BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar
referencing ACTEMRA, which became commercially available in the U.S. during the second quarter of 2024 and approved in the E.U. during
the second quarter of 2024. We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar referencing EYLEA, which
was approved in the E.U. during the fourth quarter of 2024.
Our current biosimilar products and major markets are as follows:
Product
Indication
Collaborator
Major Markets
Rheumatoid arthritis

Juvenile idiopathic arthritis

Psoriatic arthritis

Axial spondyloarthritis

Plaque psoriasis

Paediatric plaque psoriasis
Samsung Bioepis
France

Germany

Italy

Spain

Sweden

U.K.
Rheumatoid arthritis

Juvenile idiopathic arthritis

Axial spondyloarthritis

Psoriatic arthritis

Psoriasis
Paediatric plaque psoriasis

Hidradenitis suppurativa 

Adolescent hidradenitis suppurativa

Crohn’s disease

Paediatric Crohn's disease

Ulcerative colitis

Uveitis

Paediatric Uveitis
Samsung Bioepis
France

Germany

Italy

Spain

Sweden
Rheumatoid arthritis

Crohn’s disease

Paediatric Crohn’s disease

Ulcerative colitis

Paediatric ulcerative colitis

Ankylosing spondylitis

Psoriatic arthritis

Psoriasis
Samsung Bioepis
France

Germany

Italy

Norway
Spain

U.K.
Neovascular (wet) age-related macular degeneration

Macular edema following retinal vein occlusion

Myopic choroidal neovascularization
Samsung Bioepis
France

Germany

Switzerland

U.K.
Rheumatoid arthritis

Polyarticular juvenile idiopathic arthritis

Systemic juvenile idiopathic arthritis

Giant cell arteritis

COVID-19
Bio-Thera Solutions,
Ltd.
U.S.
For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other
Relationships, to our consolidated financial statements included in this report.
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GENENTECH RELATIONSHIPS
We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA,
GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
Our current anti-CD20 therapeutic programs and major markets are as follows:
Product
Indication
Major Markets
Non-Hodgkin's lymphoma

CLL

Rheumatoid arthritis

Two forms of ANCA-associated vasculitis

Pemphigus vulgaris
U.S.

Canada
Non-Hodgkin's lymphoma

CLL
U.S.
In combination with chlorambucil for previously untreated CLL

follicular lymphoma


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

PPMS
U.S.

E.U.
Relapsed or refractory follicular lymphoma
U.S.
Relapsed or refractory diffuse large B-cell lymphoma

Large B-cell lymphoma arising from follicular lymphoma
U.S.
For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to
our consolidated financial statements included in this report.
OTHER
Product
Indication
Collaborator
Major Markets
Moderate to severe plaque psoriasis
None
Germany
PATIENT SUPPORT AND ACCESS
We interact with patients, advocacy organizations and healthcare societies in order to gain insights into unmet needs. The insights gained
from these engagements help us support patients with services, programs and applications that are designed to help patients lead fuller,
healthier lives. Among other things, we provide customer service and other related programs for our products, such as disease and product
specific websites, insurance research services, financial assistance programs and the facilitation of the procurement of our marketed
products.
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We are dedicated to helping patients obtain access to our therapies. Our patient support representatives have access to a suite of financial
assistance tools. With those tools, we help patients understand their insurance coverage and, if needed, help patients compare insurance
options and programs. In the U.S., we have established programs that provide co-pay assistance or free product for qualified uninsured or
underinsured patients, based on specific eligibility criteria.
We believe all healthcare stakeholders have a shared responsibility to ensure patients have equitable access to new, innovative medicines.
We regularly review our pricing strategy and prioritize patient access to our therapies. We have a value-based contracting program designed
to align the price of our therapies to the value our therapies deliver to patients. We also work with regulators, clinical researchers, ethicists,
physicians and patient advocacy groups and communities, among others, to determine how best to address requests for access to our
investigational therapies in ways that are consistent with our patient-focused values and compliant with regulatory standards and protocols.
In appropriate situations, patients may have access to investigational therapies through clinical trials, early access programs, post-trial
access programs or compassionate use based on humanitarian grounds.
MARKETING AND DISTRIBUTION
SALES FORCE AND MARKETING
We promote our marketed products worldwide, including in the U.S., Europe and Japan, primarily through our own sales forces and
marketing groups. In some countries, particularly in areas where we continue to expand into new geographic areas, we partner with third
parties.
RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are marketed by the Roche Group and its sublicensees.
We commercialize BENEPALI, IMRALDI, FLIXABI and BYOOVIZ pursuant to our agreement with Samsung Bioepis in certain international
markets.
We focus our sales and marketing efforts on physicians in private practice or at major medical centers. We use customary industry practices
to market our products and to educate physicians. This includes our sales representatives calling on individual health care providers (in-
person and virtually), advertisements, professional symposia, direct mail, digital marketing, point of care marketing, public relations and other
methods. We focus on health care provider sales and marketing efforts on providers in both private practice and at major medical centers.
DISTRIBUTION ARRANGEMENTS
We distribute our products in the U.S. principally through wholesale and specialty distributors of pharmaceutical products and specialty
pharmacies, mail order specialty distributors or shipping service providers. In other countries, the distribution of our products varies from
country to country, including through wholesale distributors of pharmaceutical products and third-party distribution partners who are
responsible for most marketing and distribution activities.
RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are distributed by the Roche Group and its sublicensees.
We distribute BENEPALI, IMRALDI and FLIXABI in certain countries in Europe and have an option to acquire exclusive rights to distribute
these products in China. We also distribute BYOOVIZ in certain international markets and TOFIDENCE in the U.S.
Our product sales to two wholesale distributors each accounted for more than 10.0% of our total revenue for the years ended December 31,
2024, 2023 and 2022, and on a combined basis, accounted for approximately 39.3%, 36.9% and 37.9%, respectively, of our gross product
revenue. For additional information, please read Note 5, Revenue, to our consolidated financial statements included in this report.
PATENTS AND OTHER PROPRIETARY RIGHTS
Patents are important for obtaining and protecting exclusive rights in our products and product candidates. We regularly seek patent
protection in the U.S., the E.U. and Japan and in selected other countries for inventions originating from our research and development
efforts and those we license or acquire. In addition, we license rights to various patents and patent applications.
U.S. patents, as well as most foreign patents, are generally effective for 20 years from the date the earliest application was filed; however,
U.S. patents on applications filed before June 8, 1995, may be effective until
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17 years from the issue date, if that is later than the 20-year date. In some cases, the patent term may be extended to recapture a portion of
the term lost during regulatory review of the claimed therapeutic or, in the case of the U.S., additional patent term may be awarded due to
U.S. Patent and Trademark Office delays in prosecuting the application. In the U.S., under the Drug Price Competition and Patent Term
Restoration Act of 1984, commonly known as the Hatch-Waxman Act, a patent that covers a drug approved by the FDA may be eligible for
patent term extension (for up to 5 years, but not beyond a total of 14 years from the date of product approval) as compensation for patent
term lost during the FDA regulatory review process. The duration and extension of the term of foreign patents vary, in accordance with local
law. For example, in a number of European countries, SPCs can be granted to a product to compensate in part for delays in obtaining
marketing approval.
Regulatory exclusivity, which may consist of regulatory data protection and market protection, can also provide meaningful protection for our
products. Regulatory data protection provides to the holder of a drug or biologic marketing authorization, for a set period of time, the
exclusive use of the proprietary pre-clinical and clinical data that it created at significant cost and submitted to the applicable regulatory
authority to obtain approval of its product. After the period of exclusive use, third parties are permitted to reference such data in abbreviated
applications for approval and to market (subject to any applicable market protection) their generic drugs and biosimilars. Market protection
provides the holder of a drug or biologic marketing authorization the exclusive right to commercialize its product for a period of time, thereby
preventing the commercialization of another product containing the same active ingredient(s) during that period. Although the World Trade
Organization's agreement on trade-related aspects of intellectual property rights requires signatory countries to provide regulatory exclusivity
to innovative pharmaceutical products, implementation and enforcement varies widely from country to country.
We also rely upon other forms of unpatented confidential information to remain competitive. We protect such information principally through
refraining from public disclosure and utilizing confidentiality agreements with our employees, consultants, outside scientific collaborators,
scientists whose research we sponsor and other advisers. In the case of our employees, these agreements also provide, in compliance with
relevant law, that inventions and other intellectual property conceived by such employees during their employment are our exclusive property.
Our trademarks are important to us and are generally covered by trademark applications or registrations in the U.S. Patent and Trademark
Office and the patent or trademark offices of other countries. We also use trademarks licensed from third parties. Trademark protection varies
in accordance with local law, and continues in some countries as long as the trademark is used and in other countries as long as the
trademark is registered. Trademark registrations generally are for fixed but renewable terms.
OUR PATENT PORTFOLIO
The following table describes certain patents in the U.S. and Europe that we currently consider of primary importance to our marketed
products, including the territory, patent number, general subject matter and expected expiration dates. Except as otherwise noted, the
expected expiration dates include any granted patent term extensions and issued SPCs. In some instances, there may be additional later-
expiring patents relating to our products directed to, among other things, particular forms or compositions, methods of manufacturing or use
of the drug in the treatment of particular diseases or conditions. We also continue to pursue additional patents and patent term extensions in
the U.S. and other territories covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the
patents listed in the table.
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Table of Contents
Product
Territory
Patent No.
General Subject Matter
Patent
Expiration
TECFIDERA
Europe
2,653,873
Methods of use
2028
PLEGRIDY
U.S.
8,017,733
Polymer conjugates of interferon beta-1a
2027
Europe
1,476,181
Polymer conjugates of interferon-beta-1a and uses thereof
2023
TYSABRI
U.S.
8,124,350
Methods of treatment
2027
U.S.
8,871,449
Methods of treatment
2026
U.S.
9,316,641
Safety-related assay
2032
U.S.
9,493,567
Methods of treatment
2027
U.S.
9,709,575
Methods of treatment
2026
U.S.
10,119,976
Methods of evaluating patient risk
2034
U.S.
10,233,245
Methods of treatment
2027
U.S.
10,444,234
Safety-related assay
2031
U.S.
10,677,803
Methods of treatment
2034
U.S.
10,705,095
Methods of treatment
2026
U.S.
11,280,794
Methods of treatment
2034
U.S.
11,287,423
Safety-related assay
2031
U.S.
11,292,845
Methods of treatment
2027
U.S.
12,066,442
Methods of treatment
2032
Europe
1,872,136
Method of treatment
2026
Europe
2,170,390
Formulation
2028
Europe
2,645,106
Method of treatment
2026
Europe
3,264,094
Method of treatment
2026
Europe
3,339,865
Safety-related assay
2031
Europe
3,575,792
Safety-related assay
2032
Europe
4,152,004
Safety-related assay
2031
VUMERITY
U.S.
8,669,281
Compounds and pharmaceutical compositions
2033
U.S.
9,090,558
Methods of treatment
2033
U.S.
10,080,733
Crystalline forms, pharmaceutical compositions and methods of treatment
2033
Europe
2,970,101
Crystalline forms, pharmaceutical compositions and methods of treatment

Prodrugs of fumarates and their use in treating various diseases
2034
Europe
3,253,377
Formulation
2035
SPINRAZA
U.S.
7,838,657
SMA treatment via targeting of SMN2 splice site inhibitory sequences
2027
U.S.
8,110,560
SMA treatment via targeting of SMN2 splice site inhibitory sequences
2025
U.S.
8,361,977
Compositions and methods for modulation of SMN2 splicing
2030
U.S.
8,980,853
Compositions and methods for modulation of SMN2 splicing
2030
U.S.
9,717,750
Compositions and methods for modulation of SMN2 splicing
2030
U.S.
9,926,559
Compositions and methods for modulation of SMN2 splicing
2034
U.S.
10,266,822
SMA treatment via targeting of SMN2 splice site inhibitory sequences
2025
U.S.
10,436,802
Methods for Treating Spinal Muscular Atrophy
2035
U.S.
12,013,403
Methods for Treating Spinal Muscular Atrophy
2036
Europe
1,910,395
Compositions and methods for modulation of SMN2 splicing
2026
Europe
2,548,560
Compositions and methods for modulation of SMN2 splicing
2026
Europe
3,305,302
Compositions and methods for modulation of SMN2 splicing
2030
Europe
3,308,788
Compositions and methods for modulation of SMN2 splicing
2026
Europe
3,449,926
Compositions and methods for modulation of SMN2 splicing
2030
LEQEMBI
U.S.
8,025,878
Protofibril selective antibodies and the use thereof
2027
(1)
(2)
(3)
(4)
(6)
(1)(5)
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Table of Contents
Product
Territory
Patent No.
General Subject Matter
Patent
Expiration
QALSODY
U.S.
10,385,341
Compositions for modulating SOD-1 expression
2035
U.S.
10,669,546
Compositions for modulating SOD-1 expression
2035
U.S.
10,968,453
Compositions for modulating SOD-1 expression
2035
Europe
3,126,499
Compositions for modulating SOD-1 expression
2035
Europe
3,757,214
Compositions for modulating SOD-1 expression
2035
ZURZUVAE
U.S.
9,512,165
19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use
thereof
2034
U.S.
10,172,871
19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use
thereof
2034
U.S.
10,342,810
19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use
thereof
2034
U.S.
11,236,121
Crystalline 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroid
2034
SKYCLARYS
U.S.
8,124,799
Antioxidant Inflammation Modulators: Oleanolic Acid Derivatives with Amino
and other Modifications at C-17 (Composition)
2029
U.S.
8,440,854
Antioxidant Inflammation Modulators: Oleanolic Acid Derivatives with Amino
and other Modifications at C-17 (Composition)
2029
U.S.
8,993,640
2,2-Difluoropropionamide Derivatives of Bardoxolone Methyl, Polymorphic
Forms and Methods of Use Thereof (Composition)
2033
U.S.
9,670,147
Antioxidant Inflammation Modulators: Oleanolic Acid Derivatives with Amino
and other Modifications at C-17 (Composition)
2029
U.S.
9,701,709
2,2-Difluoropropionamide Derivatives of Bardoxolone Methyl, Polymorphic
Forms and Methods of Use Thereof (Composition)
2033
U.S.
11,091,430
Antioxidant Inflammation Modulators: Oleanolic Acid Derivatives with Amino
and other Modifications at C-17 (Treatment Method)
2029
Europe
2,276,493
Antioxidant Inflammation Modulators: Oleanolic Acid Derivatives with Amino
and other Modifications at C-17 (Composition)
2029
Europe
2,841,445
2,2-Difluoropropionamide Derivatives of Bardoxolone Methyl, Polymorphic
Forms and Methods of Use Thereof (Composition)
2033
Europe
3,444,261
2,2-Difluoropropionamide Derivatives of Bardoxolone Methyl, Polymorphic
Forms and Methods of Use Thereof (Composition)
2033
Footnotes follow on next page.
(1)
(1)(5)
(1)(8)
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(5)
(7)
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(1) In addition to patent protection, certain of our products are entitled to regulatory exclusivity in the U.S. and the E.U. expected until the dates set
forth below:
Product
Territory
Expected Expiration
PLEGRIDY
U.S.
2026
SPINRAZA
E.U.
2029
LEQEMBI
U.S.
2035
QALSODY
U.S.
2030
ZURZUVAE
U.S.
2028
SKYCLARYS
U.S.
2030
(2) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2028.
(3) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2031.
(4) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2031.
(5) A patent with this subject matter may be entitled to patent term extension in the U.S.
(6) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2032.
(7) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2038.
(8) This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries to 2039.
The existence of patents does not guarantee our right to practice the patented technology or commercialize the patented product. Patents
relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds and processes, such as those that cover our existing
products, compounds and processes and those that we will likely file in the future, do not always provide complete or adequate protection.
Litigation, interferences, oppositions, inter partes reviews, administrative challenges or other similar types of proceedings are, have been and
may in the future be necessary in some instances to determine the validity and scope of certain of our patents, regulatory exclusivities or
other proprietary rights, and in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third
parties to be pertinent to the manufacture, use or sale of our products. We also face challenges to our patents, regulatory exclusivities or
other proprietary rights covering our products by third-parties, such as manufacturers of generics, biosimilars, prodrugs and products
approved under abbreviated regulatory pathways. A discussion of certain risks and uncertainties that may affect our patent position,
regulatory exclusivities or other proprietary rights is set forth in Item 1A. Risk Factors included in this report, and the discussion of legal
proceedings related to certain patents described above is set forth in Note 21, Litigation, to our consolidated financial statements included in
this report.
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COMPETITION
Competition in the biopharmaceutical industry and the markets in which we operate is intense. There are many companies, including
biotechnology and pharmaceutical companies, engaged in developing products for the indications our approved products are approved to
treat and the therapeutic areas we are targeting with our research and development activities. Some of our competitors may have
substantially greater financial, marketing, research and development and other resources than we do.
We believe that competition and leadership in the industry is based on scientific, managerial and technological excellence and innovation, as
well as establishing patent and other proprietary positions through research and development. The achievement of a leadership position also
depends largely upon our ability to maximize the approval, acceptance and use of our product candidates and the availability of adequate
financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing. Another key aspect of remaining
competitive in the industry is recruiting and retaining leading scientists and technicians to conduct our research activities and advance our
development programs, including with the regulatory and commercial expertise to effectively advance and market our products.
Competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, patient
convenience, delivery devices, reliability, availability, reimbursement and price. In addition, early entry of a new pharmaceutical product into
the market may have important advantages in gaining product acceptance and market share. Accordingly, the relative speed with which we
can develop products, complete the testing and approval process and supply commercial quantities of products will have a significant impact
on our competitive position.
The introduction of new products or technologies, including the development of new processes or technologies by competitors or new
information about existing products or technologies, results in increased competition for our marketed products and pricing pressure on our
marketed products. The development of new or improved treatment options could eliminate the use of our products or may limit the utility and
application of ongoing clinical trials for our product candidates. Similarly, developments of new standards of care practices, treatment options
or cures for the diseases our products treat could have similar impacts.
We believe our long-term competitive position depends upon our success in discovering and developing innovative, cost-effective products
that serve unmet medical needs, along with our ability to manufacture products efficiently and to launch and market them effectively in a
highly competitive environment.
Additional information about the competition that our marketed products face is set forth below and in Item 1A. Risk Factors included in this
report.
GENERIC AND BIOSIMILARS COMPETITION
Certain of our products already face, or may face in the future, competition from the introduction of generic versions, prodrugs and biosimilars
of existing products and products approved under abbreviated regulatory pathways. Such products are likely to be sold at substantially lower
prices than branded products. 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 some jurisdictions a decrease in reimbursed price is mandated by law. 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.
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices
compared to TECFIDERA. We are defending the validity of our EP 2 653 873 patent related to TECFIDERA and expiring in 2028 in
opposition proceedings in the European Patent Office. We are also engaged in litigation in Europe to defend and enforce national
counterparts of our EP 2 653 873 patent, with mixed results. The generic competition for TECFIDERA has significantly reduced our
TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline.
Biosimilar products referencing RITUXAN 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.
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A biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that future sales of TYSABRI may be adversely
affected by the entrance of this biosimilar.
NEUROLOGY
MULTIPLE SCLEROSIS
Competition in the MS market is intense. Along with us, a number of companies are working to develop additional treatments for MS that may
in the future compete with our MS products. One competing product that was approved in the U.S. in 2017 and in the E.U. in 2018 is
OCREVUS, a treatment for RMS and PPMS that was developed by Genentech. Another competing product that was approved in the U.S. in
2020 and the E.U. in 2021 is KESIMPTA, a treatment for RMS that was developed by Novartis AG. While we have a financial interest in
OCREVUS, future sales of our MS products may be adversely affected if OCREVUS and KESIMPTA continue to gain market share, or if
other MS products that we or our competitors are developing are commercialized.
ALZHEIMER'S DISEASE
The market for the treatment of Alzheimer's disease is undeveloped and could be subject to rapid change in the future. Most current
treatments are symptomatic or intended to improve quality of life. Along with us, several companies are working to develop additional
treatments. We and our collaboration partner Eisai co-commercialize LEQEMBI, an anti-amyloid antibody for the treatment of Alzheimer's
disease. In 2024 a competing product, KISUNLA, a treatment for early symptomatic Alzheimer's disease that was developed by Eli Lilly and
Company, was approved in the U.S. We are aware of other products now in development that, if approved, may also compete with
LEQEMBI.
RARE DISEASE
SPINAL MUSCULAR ATROPHY
We face competition from a gene therapy product ZOLGENSMA (onasemnogene abeparvovec-xioi) and an oral product EVRYSDI
(risdiplam). We expect that we will experience competition from both products in additional jurisdictions in the future, as well as from the
launch of new formulations of those products, which may adversely affect our sales of SPINRAZA.
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RESEARCH AND DEVELOPMENT PROGRAMS
A commitment to research and development is fundamental to our mission. Our research efforts are focused on better understanding the
underlying biology of diseases so we can discover and deliver treatments that have the potential to make a real difference in the lives of
patients with high unmet medical needs. By applying our expertise in biologics and our capabilities in small molecule, antisense, gene
therapy and other technologies, we target specific medical needs where we believe new or better treatments are needed.
We intend to continue committing significant resources to targeted research and development opportunities where there is a significant
unmet need and where a drug candidate has the potential to be highly differentiated. As part of our ongoing research and development
efforts, we have devoted significant resources to conducting clinical studies to advance the development of new pharmaceutical products and
technologies and to explore the utility of our existing products in treating disorders beyond those currently approved in their labels.
For additional information on our research and development expense included in our consolidated statements of income, please read Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations included in this report.
The table below highlights our current research and development programs that are in clinical trials and the current phase of such programs.
Drug development involves a high degree of risk and investment, and the status, timing and scope of our development programs are subject
to change. Important factors that could adversely affect our drug development efforts are discussed in Item 1A. Risk Factors included in this
report.
Alzheimer's Disease and

Dementia
Lecanemab (Aβ mAb)
 - Early Alzheimer's
Approved
Lecanemab (Aβ mAb)  - Preclinical Alzheimer's
Phase 3
Lecanemab (Aβ mAb)  - Subcutaneous autoinjector maintenance -
Early Alzheimer's
Regulatory Review
Lecanemab (Aβ mAb)  - Subcutaneous autoinjector initiation -
Early Alzheimer's
Phase 3
BIIB080 (tau ASO)  - Alzheimer's
Phase 2
Neuropsychiatry
Zuranolone (GABA  PAM)
 - PPD
Approved/Regulatory Review
Specialized Immunology
Felzartamab (anti-CD38 mAb) - AMR
Phase 2
Felzartamab (anti-CD38 mAb) - IgAN
Phase 2
Felzartamab (anti-CD38 mAb) - PMN
Phase 2
Felzartamab (anti-CD38 mAb) - lupus nephritis
Phase 1
Izastobart (C5aR1 mAb) - complement mediated disease
Phase 1
Dapirolizumab pegol (anti-CD40L)  - SLE
Phase 3
Litifilimab (anti-BDCA2) - SLE
Phase 3
Litifilimab (anti-BDCA2) - CLE
Phase 3
Neuromuscular Disorders
Omaveloxolone (Nrf2 activator) - FA
Approved
Omaveloxolone (Nrf2 activator) - Pediatric FA
Phase 1
Tofersen (SOD1 ASO)
 - SOD1 ALS
Approved
HD Nusinersen (SMN2 splice modulator) - SMA
Regulatory Review
BIIB115 (SMN ASO)  - SMA
Phase 1b
Parkinson's and Movement Disorders
BIIB122 (LRRK2 inhibitor)  - Parkinson's
Phase 2
Multiple Sclerosis
BIIB091 (peripheral BTK inhibitor) - MS
Phase 2
 Collaboration program
 Granted accelerated approval in the U.S. in January 2023 and traditional approval in the U.S. in July 2023. Outside the U.S., LEQEMBI is now approved in Japan (September
2023), China (January 2024), South Korea (May 2024), Hong Kong (July 2024), Israel (July 2024), United Arab Emirates (August 2024), Great Britain (August 2024) and
Mexico (December 2024).
 Granted approval in the U.S. in August 2023, pending DEA scheduling, which was completed in October 2023, under the brand name ZURZUVAE.
 Granted approval in the U.S. in February 2023 and the E.U. in February 2024, under the brand name SKYCLARYS.
 Granted accelerated approval in the U.S. in April 2023, the E.U. in May 2024 and China in October 2024 under the brand name QALSODY.
# Option agreement
(1)(2)
(1)
(1)
(1)
(1)
A
(1)(3)
(1)
(4)
(1)(5)
(1)
(1)
(1)
(2)
(3)
(4)
(5)
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For information about certain of our agreements with collaborators and other third parties, please read the subsection entitled Business
Relationships below and Note 2, Acquisitions, Note 19, Collaborative and Other Relationships, and Note 20, Investments in Variable Interest
Entities, to our consolidated financial statements included in this report.
BUSINESS RELATIONSHIPS
As part of our business strategy, we establish business relationships, including entering into licenses, joint ventures and collaborative
arrangements with other companies, universities and medical research institutions, to assist in the clinical development and/or
commercialization of certain of our products and product candidates and to provide support for our research programs. We also evaluate
opportunities for acquiring products or rights to products and technologies that are complementary to our business from other companies,
universities and medical research institutions.
Below is a brief description of certain business relationships and collaborations that expand our pipeline and provide us with certain rights to
existing and potential new products and technologies. For additional information on certain of these relationships, including their ongoing
financial and accounting impact on our business, please read Note 19, Collaborative and Other Relationships, to our consolidated financial
statements included in this report.
EISAI
We have a collaboration agreement with Eisai to jointly develop and commercialize LEQEMBI (lecanemab), an anti-amyloid antibody for the
treatment of Alzheimer's disease. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both
companies co-commercializing and 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. We and Eisai co-promote LEQEMBI and share profits
and losses equally. We currently manufacture LEQEMBI drug substance and drug product and in March 2022 we extended our supply
agreement with Eisai related to LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance.
SAGE THERAPEUTICS, INC.
We have a global collaboration and license agreement with Sage to jointly develop and commercialize ZURZUVAE (zuranolone) for the
treatment of PPD.
Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for
commercialization in the U.S. Outside of the U.S., we are responsible for development and commercialization, excluding Japan, Taiwan and
South Korea.
IONIS
We have several exclusive, worldwide option and collaboration agreements with Ionis to develop and commercialize antisense therapeutics,
including SPINRAZA for the treatment of SMA and QALSODY for the treatment of ALS with SOD1 mutations, as well as other research
programs for a broad range of neurological diseases. Under these agreements, we have the option to license therapies arising out of these
collaborations and will be responsible for their development and commercialization. Ionis may receive potential milestones and royalties on
net sales if we successfully develop the product candidate after option exercise.
GENENTECH
We have agreements with Genentech that entitle us to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA,
GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
UCB
We have a collaboration agreement with UCB to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for
the potential treatment of SLE and other future agreed indications. Both companies will share equally costs incurred for agreed indications,
including research, development, sales and marketing expense. If marketing approval is obtained, both companies will jointly commercialize
dapirolizumab pegol and share profits and losses equally.
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DENALI
We have a collaboration and license agreement with Denali to co-develop and co-commercialize Denali's small molecule inhibitors of LRRK2
for Parkinson's disease. Under the LRRK2 Collaboration, both companies share responsibility and costs for global development based on
specified percentages as well as profits and losses for commercialization in the U.S. and China. Outside the U.S. and China we are
responsible for commercialization and may pay Denali potential tiered royalties.
SAMSUNG BIOEPIS
We have an agreement with Samsung Bioepis to commercialize three anti-TNF biosimilar product candidates in certain countries in
Europe. Under this agreement, we are commercializing BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab
biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE.
We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain
international markets, and OPUVIZ, an aflibercept biosimilar referencing EYLEA, which was approved in the E.U. during the fourth quarter of
2024. In addition to our commercialization agreements with Samsung Bioepis, we license certain of our proprietary technology to Samsung
Bioepis in connection with Samsung Bioepis' development, manufacture and commercialization of its biosimilar products.
REGULATORY
Our current and contemplated activities and the products, technologies and processes that result from such activities are subject to
substantial government regulation.
REGULATION OF PHARMACEUTICALS
PRODUCT APPROVAL AND POST-APPROVAL REGULATION IN THE U.S.
APPROVAL PROCESS
Before new pharmaceutical products may be sold in the U.S., preclinical studies and clinical trials of the products must be conducted and the
results submitted to the FDA for approval. With limited exceptions, the FDA requires companies to register both pre-approval and post-
approval clinical trials and disclose clinical trial results in public databases. Failure to register a trial or disclose study results within the
required time periods could result in penalties, including civil monetary penalties. Clinical trial programs must establish efficacy, determine an
appropriate dose and dosing regimen and define the conditions for safe use. This is a high-risk process that requires stepwise clinical studies
in which the candidate product must successfully meet predetermined endpoints. The results of the preclinical and clinical testing of a
product are then submitted to the FDA in the form of a BLA or a NDA. In response to a BLA or NDA, the FDA may grant marketing approval,
request additional information or deny the application if it determines the application does not provide an adequate basis for approval.
Product development and receipt of regulatory approval takes a number of years, involves the expenditure of substantial resources and
depends on a number of factors, including the severity of the disease in question, the availability of suitable alternative treatments, potential
safety signals observed in preclinical or clinical tests and the risks and benefits of the product as demonstrated in clinical trials. The FDA has
substantial discretion in the product approval process, and it is impossible to predict with any certainty whether and when the FDA will grant
marketing approval. The agency may require the sponsor of a BLA or NDA to conduct additional clinical studies or to provide other scientific
or technical information about the product, and these additional requirements may lead to unanticipated delays or expenses. Furthermore,
even if a product is approved, the approval may be subject to limitations based on the FDA's interpretation of the existing pre-clinical and/or
clinical data.
The FDA has developed four distinct approaches intended to facilitate the development and expedite the regulatory review of therapeutically
important drugs, especially when the drugs are the first available treatment or have advantages over existing treatments: accelerated
approval, fast track, breakthrough therapy and priority review.
•
Accelerated Approval: The FDA may grant “accelerated approval” to products that treat serious or life-threatening illnesses and that
provide meaningful therapeutic benefits to patients over existing treatments. Under this pathway, the FDA may approve a product based
on surrogate endpoints or clinical endpoints other than survival or irreversible morbidity. When approval is based on surrogate endpoints
or clinical endpoints other than survival or morbidity, the sponsor will be required to provide the FDA with confirmatory data post-
approval to verify and describe clinical benefit. Under the FDA's accelerated approval regulations, if the FDA
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concludes that a drug that has been shown to be effective can be safely used only if distribution or use is restricted, it may require
certain post-marketing restrictions to assure safe use. In addition, for products approved under accelerated approval, sponsors may be
required to submit all copies of their promotional materials, including advertisements, to the FDA at least 30 days prior to initial
dissemination. The FDA may withdraw approval if, for instance, post-marketing studies fail to verify clinical benefit, it becomes clear that
restrictions on the distribution of the product are inadequate to ensure its safe use or if a sponsor fails to comply with the conditions of
the accelerated approval.
•
Fast Track: The FDA may grant "fast track" status to products that treat a serious condition and have data demonstrating the potential to
address an unmet medical need or a drug that has been designated as a qualified infectious disease product.
•
Breakthrough Therapy: The FDA may grant “breakthrough therapy” status to drugs designed to treat, alone or in combination with
another drug or drugs, a serious or life-threatening disease or condition and for which preliminary clinical evidence suggests a
substantial improvement over existing therapies based on a clinically significant endpoint. Breakthrough therapy status entitles the
sponsor to earlier and more frequent meetings with the FDA regarding the development of nonclinical and clinical data and permits the
FDA to offer product development or regulatory advice for the purpose of shortening the time to product approval. Breakthrough therapy
status does not guarantee that a product will be eligible for priority review and does not ensure FDA approval.
•
Priority Review: “Priority review” only applies to applications (original or efficacy supplement) for a drug that treats a serious condition
and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, diagnosis or prevention of a
serious condition. Priority review may also be granted for any supplement that proposes a labeling change due to studies completed in
response to a written request from the FDA for pediatric studies, for an application for a drug that has been designated as a qualified
infectious disease product or for any application or supplement for a drug submitted with a PRV.
As part of our acquisition of Reata in September 2023 we obtained a rare pediatric disease PRV in connection with the approval of
SKYCLARYS, which was approved by the FDA in February 2023.
POST-MARKETING STUDIES
Regardless of the approval pathway employed, the FDA may require a sponsor to conduct additional post-marketing studies as a condition of
approval to provide data on safety and effectiveness. If a sponsor fails to conduct the required studies, the FDA may withdraw its approval. In
addition, if the FDA concludes that a drug that has been shown to be effective can be safely used only if distribution or use is restricted, it can
mandate post-marketing restrictions to assure safe use. In such a case, the sponsor may be required to establish rigorous systems to assure
use of the product under safe conditions. These systems are usually referred to as REMS. The FDA can impose financial penalties for failing
to comply with certain post-marketing commitments, including REMS. In addition, any changes to an approved REMS must be reviewed and
approved by the FDA prior to implementation.
ADVERSE EVENT REPORTING
We monitor information on side effects and adverse events reported during clinical studies and after marketing approval and report such
information and events to regulatory agencies. Non-compliance with the FDA's safety reporting requirements may result in civil or criminal
penalties. Side effects or adverse events that are reported during clinical trials can delay, impede or prevent marketing approval. Based on
new safety information that emerges after approval, the FDA can mandate product labeling changes, impose a new REMS or the addition of
elements to an existing REMS, require new post-marketing studies (including additional clinical trials) or suspend or withdraw approval of the
product. These requirements may affect our ability to maintain marketing approval of our products or require us to make significant
expenditures to obtain or maintain such approvals.
APPROVAL OF CHANGES TO AN APPROVED PRODUCT
If we seek to make certain types of changes to an approved product, such as adding a new indication, making certain manufacturing
changes or changing manufacturers or suppliers of certain ingredients or components, the FDA will need to review and approve such
changes in advance. In the case of a new indication, we are required to demonstrate with additional clinical data that the product is safe and
effective for a use other than what was initially approved. FDA regulatory review may result in denial or modification of the planned changes,
or requirements to conduct additional tests or evaluations that can substantially delay or increase the cost of the planned changes.
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REGULATION OF PRODUCT ADVERTISING AND PROMOTION
The FDA regulates all advertising and promotion activities and communications for products under its jurisdiction both before and after
approval. Pursuant to FDA guidance, a company can make safety and efficacy claims either in or consistent with the product label. However,
physicians may prescribe legally available drugs for uses that are not described in the drug's labeling. Such off-label prescribing is common
across medical specialties, and often reflects a physician's belief that the off-label use is the best treatment for patients. The FDA does not
regulate the behavior of physicians in their choice of treatments, but FDA regulations do impose stringent restrictions on manufacturers'
communications regarding off-label uses. Failure to comply with applicable FDA requirements may subject a company to adverse publicity,
enforcement action by the FDA, corrective advertising and the full range of civil and criminal penalties available to the government.
REGULATION OF COMBINATION PRODUCTS
Combination products are defined by the FDA to include products comprising two or more regulated components (e.g., a biologic and a
device). Biologics and devices each have their own regulatory requirements, and combination products may have additional requirements.
Some of our marketed products meet this definition and are regulated under this framework and similar regulations outside the U.S., and we
expect that some of our pipeline product candidates may be evaluated for regulatory approval under this framework as well.
In May 2017 new regulations governing medical devices and in-vitro diagnostic medical devices entered into force in the E.U. The medical
devices regulations became applicable in May 2021 and the in-vitro diagnostic medical devices regulations became applicable in May 2022.
All products covered by these regulations will be required to comply with them at the end of the transitional periods. These regulations
introduce new requirements, including for clinical investigation of certain classifications of medical devices, require increased regulatory
scrutiny, enhance the requirements for post market surveillance and vigilance and provide for greater transparency. These regulations also
change the requirements for assessment of the medical device components of integral drug-device combination products, necessitating
assessment of the device components under both the medical device and medicinal product regulatory regimes.
PRODUCT APPROVAL AND POST-APPROVAL REGULATION OUTSIDE THE U.S.
We market our products in numerous jurisdictions outside the U.S. Most of these jurisdictions have product approval and post-approval
regulatory processes that are similar in principle to those in the U.S. In Europe, for example, where a substantial part of our ex-U.S. efforts
are focused, there are several routes for marketing approval, depending on the type of product for which approval is sought. Under the
centralized procedure, a company submits a single application to the EMA. The MAA is similar to the NDA or BLA in the U.S. and is
evaluated by the CHMP, the expert scientific committee of the EMA responsible for human medicines. If the CHMP determines that the MAA
fulfills the requirements for quality, safety and efficacy and that the medicine has a positive benefit risk balance, it will adopt a positive opinion
recommending the granting of the marketing authorization by the EC. The CHMP opinion is not binding, but is typically adopted by the EC. A
MAA approved by the EC is valid in all member states of the E.U. The centralized procedure is required for all biological products, orphan
medicinal products and new treatments for neurodegenerative disorders, and it is available for certain other products, including those which
constitute a significant therapeutic, scientific or technical innovation.
In addition to the centralized procedure, the European regulatory framework includes the following options for regulatory review and approval
in the E.U. member states:
•
a national procedure, where the first application is made to the competent authority in one E.U. member state only;
•
a decentralized procedure, where applicants submit identical applications to several E.U. member states and receive simultaneous
approval, if the medicine has not yet been authorized in any E.U. member state; and
•
a mutual recognition procedure, where applicants that have a medicine authorized in one E.U. member state can apply for mutual
recognition of this authorization in other E.U. member states.
As in the U.S., the E.U. also has distinct approaches intended to optimize the regulatory pathways for therapeutically important drugs,
including the Priority Medicines Evaluation Scheme, accelerated assessment and conditional marketing authorization. Priority Medicines
Evaluation Scheme is intended to provide additional support to medicine developers throughout the development process. Regulatory review
timelines in the E.U. may be truncated under accelerated assessment for products that address an unmet medical need. In addition,
conditional marketing authorizations may be granted for products in the interest of public health, where the benefit of immediate availability
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outweighs the risk of having less comprehensive data than normally required. Conditional marketing authorizations are valid for one year and
can be renewed annually. The marketing authorization holder is required to complete specific obligations (ongoing or new studies and, in
some cases, additional activities) with a view to providing comprehensive data confirming that the benefit risk balance is positive. Once
comprehensive data on the product have been obtained, the marketing authorization may be converted into a standard marketing
authorization.
Aside from the U.S. and the E.U., there are countries in other regions where it is possible to receive an "accelerated" review whereby the
national regulatory authority will commit to truncated review timelines for products that meet specific medical needs.
In the E.U. there is detailed legislation on pharmacovigilance and extensive guidance on good pharmacovigilance practices. A failure to
comply with the E.U. pharmacovigilance obligations may result in significant financial penalties for the marketing authorization holder.
Regardless of the approval process employed, various parties share responsibilities for the monitoring, detection and evaluation of adverse
events post-approval, including national competent authorities, the EMA, the EC and the marketing authorization holder. The EMA’s
Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring the safety of human medicines and makes
recommendations on product safety issues. Marketing authorization holders have an obligation to inform regulatory agencies of any new
information which may influence the evaluation of benefits and risks of the medicinal product concerned.
In the U.S., the E.U. and other jurisdictions, regulatory agencies, including the FDA, conduct periodic inspections of NDA, BLA and marketing
authorization holders to assess their compliance with pharmacovigilance obligations.
GOOD MANUFACTURING PRACTICES
Regulatory agencies regulate and inspect equipment, facilities and processes used in the manufacturing and testing of pharmaceutical and
biologic products prior to approving a product. If, after receiving approval from regulatory agencies, a company makes a material change in
manufacturing equipment, location or process, additional regulatory review and approval may be required. We also must adhere to current
GMP and product-specific regulations enforced by regulatory agencies following product approval. The FDA, the EMA and other regulatory
agencies also conduct periodic visits to re-inspect equipment, facilities and processes following the initial approval of a product. If, as a result
of these inspections, it is determined that our equipment, facilities or processes do not comply with applicable regulations and conditions of
product approval, regulatory agencies may seek civil, criminal or administrative sanctions or remedies against us, including significant
financial penalties and the suspension of our manufacturing operations.
GOOD CLINICAL PRACTICES
The FDA, the EMA and other regulatory agencies promulgate regulations and standards for designing, conducting, monitoring, auditing and
reporting the results of clinical trials to ensure that the data and results are accurate and that the rights and welfare of trial participants are
adequately protected (commonly referred to as current GCP). Regulatory agencies enforce current GCP through periodic inspections of trial
sponsors, principal investigators and trial sites, CROs and institutional review boards. If our studies fail to comply with applicable current
GCP guidelines, the clinical data generated in our clinical trials may be deemed unreliable and relevant regulatory agencies may require us
to perform additional clinical trials before approving our marketing applications. Noncompliance can also result in civil or criminal sanctions.
We rely on third parties, including CROs, to carry out many of our clinical trial-related activities. Failure of such third parties to comply with
current GCP can likewise result in rejection of our clinical trial data or other sanctions.
In April 2014 the EC adopted a new Clinical Trial Regulation, which was entered into force in June 2014 but did not apply until January 2022.
There are transitional provisions for clinical trials which are ongoing at the date of application. Clinical trial applications could be made under
the Clinical Trial Directive (the existing regulatory framework) through January 2023. All clinical trials must fully comply with the Clinical Trial
Regulation by January 2025. The regulation harmonizes the procedures for assessment and governance of clinical trials throughout the E.U.
and will require that information on the authorization, conduct and results of each clinical trial conducted in the E.U. be publicly available.
APPROVAL OF BIOSIMILARS
In the U.S. the PPACA amended the PHS Act to authorize the FDA to approve biological products, referred to as biosimilars or follow-on
biologics, that are shown to be "highly similar" to previously approved biological products based upon potentially abbreviated data
packages. The biosimilar must show it has no clinically meaningful
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differences in terms of safety and effectiveness from the reference product, and only minor differences in clinically inactive components are
allowable in biosimilar products. The approval pathway for biosimilars does, however, grant a biologics manufacturer a 12-year period of
exclusivity from the date of approval of its biological product before biosimilar competition can be introduced. There is uncertainty, however,
as the approval framework for biosimilars originally was enacted as part of the PPACA. There have been, and there are likely to continue to
be, federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the PPACA. If the
PPACA is repealed, substantially modified or invalidated, it is unclear what, if any, impact such action would have on biosimilar regulation.
A biosimilars approval pathway has been in place in the E.U. since 2003. The EMA has issued a number of scientific and product specific
biosimilar guidelines, including requirements for approving biosimilars containing monoclonal antibodies. In the E.U., biosimilars are generally
approved under the centralized procedure. The approval pathway allows sponsors of a biosimilar to seek and obtain regulatory approval
based in part on reliance on the clinical trial data of an innovator product to which the biosimilar has been demonstrated, through
comprehensive comparability studies, to be “similar.” In many cases, this allows biosimilars to be brought to market without conducting the
full complement of clinical trials typically required for novel biologic drugs.
ORPHAN DRUG ACT
Under the U.S. Orphan Drug Act, the FDA may grant ODD to drugs or biologics intended to treat a “rare disease or condition,” which
generally is a disease or condition that affects fewer than 200,000 individuals in the U.S. If a product which has an ODD subsequently
receives an initial FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA
may not approve any other applications to market the same drug for the same indication for a period of seven years following marketing
approval, except in certain very limited circumstances, such as if the later product is shown to be clinically superior to the orphan product.
Legislation similar to the U.S. Orphan Drug Act has been enacted in other countries to encourage the research, development and marketing
of medicines to treat, prevent or diagnose rare diseases. In the E.U., medicinal products that receive and maintain an orphan designation are
entitled to 10 years of market exclusivity following approval, protocol assistance and access to the centralized procedure for marketing
authorization. SPINRAZA has been granted ODD in the U.S., the E.U. and Japan; QALSODY and SKYCLARYS have been granted ODD in
the U.S. and the E.U.; and felzartamab has been granted ODD in the U.S. for development in the treatment of PMN and AMR and in the E.U.
in IgAN and solid organ transplantation.
REGULATION PERTAINING TO PRICING AND REIMBURSEMENT
In both domestic and foreign markets, sales of our products depend, to a significant extent, on the availability and amount of reimbursement
by third-party payors, including governments, private health plans and other organizations. Substantial uncertainty exists regarding the
pricing and reimbursement of our products, and drug prices continue to receive significant scrutiny. Governments may regulate coverage,
reimbursement and pricing of our products to control cost or affect utilization of our products. Challenges to our pricing strategies, by either
government or private stakeholders, could harm our business. The U.S. and foreign governments have enacted and regularly consider
additional reform measures that affect health care coverage and costs. Private health plans may also seek to manage cost and utilization by
implementing coverage and reimbursement limitations. Other payors, including managed care organizations, health insurers, pharmacy
benefit managers, government health administration authorities and private health insurers, seek price discounts or rebates in connection
with the placement of our products on their formularies and, in some cases, may impose restrictions on access, coverage or pricing of
particular drugs based on perceived value.
WITHIN THE U.S.
•
Medicaid: Medicaid is a joint federal and state program that is administered by the states for low income and disabled beneficiaries.
Under the Medicaid Drug Rebate Program, we are required to pay a rebate for each unit of product reimbursed by the state Medicaid
programs. The amount of the rebate is established by law and is adjusted upward if the AMP increases more than inflation (measured
by the Consumer Price Index - Urban). The rebate amount is calculated each quarter based on our report of current AMP and best price
for each of our products to the CMS. The requirements for calculating AMP and best price are complex. We are required to report any
revisions to AMP or best price previously reported within a certain period, which revisions could affect our rebate liability for prior
quarters. In addition, if we fail to provide information timely or we are found to have knowingly submitted false information to the
government, the statute governing the Medicaid Drug Rebate Program provides for civil monetary penalties.
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•
Medicare: Medicare is a federal program that is administered by the federal government. The program covers individuals age 65 and
over as well as those with certain disabilities. Medicare Part B generally covers drugs that must be administered by physicians or other
health care practitioners, are provided in connection with certain durable medical equipment or are certain oral anti-cancer drugs and
certain oral immunosuppressive drugs. Medicare Part B pays for such drugs under a payment methodology based on the average sales
price of the drugs. Manufacturers, including us, are required to provide average sales price information to the CMS on a quarterly basis.
The manufacturer-submitted information is used to calculate Medicare payment rates. If a manufacturer is found to have made a
misrepresentation in the reporting of average sales price, the governing statute provides for civil monetary penalties.
Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a
physician). Medicare Part D is administered by private prescription drug plans approved by the U.S. government. Each drug plan
establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which the drug plan may modify from time-to-
time. The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the
availability of manufacturer discounts. In addition, manufacturers, including us, are required to provide to the CMS a discount of up to
70.0% on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reach the coverage gap in
their drug benefits.
On August 16, 2022, the IRA was signed into law, which provides for (i) the government to negotiate prices for select high-cost
Medicare Part D drugs (beginning in 2026) and Part B drugs (beginning in 2028), (ii) manufacturers to pay a rebate for Medicare Part B
and Part D drugs when prices increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) Medicare Part D
redesign which replaces the current coverage gap provisions and establishes a $2,000 cap for out-of-pocket costs for Medicare
beneficiaries beginning in 2025, with manufacturers being responsible for up to 10.0% of costs up to the $2,000 cap and up to 20.0%
after that cap is reached.
The result of these forthcoming changes for manufacturers, including us, may include: i) a material adverse effect on our revenue on
drugs subject to “negotiation”; ii) new rebate liability for drugs subject to the inflation provisions, and iii) potential significant additional
costs related to the Part D re-design.
•
Federal Agency Discounted Pricing: Our products are subject to discounted pricing when purchased by federal agencies via the FSS.
FSS participation is required for our products to be covered and reimbursed by the VA, Department of Defense, Coast Guard and PHS.
Coverage under Medicaid, Medicare and the PHS pharmaceutical pricing program is also conditioned upon FSS participation. FSS
pricing is intended not to exceed the price that we charge our most-favored non-federal customer for a product. In addition, prices for
drugs purchased by the VA, Department of Defense (including drugs purchased by military personnel and dependents through the
TriCare retail pharmacy program), Coast Guard and PHS are subject to a cap on pricing equal to 76.0% of the non-federal average
manufacturer price (non-FAMP). An additional discount applies if non-FAMP increases more than inflation (measured by the Consumer
Price Index - Urban). In addition, if we fail to provide information timely or we are found to have knowingly submitted false information to
the government, the governing statute provides for civil monetary penalties.
•
340B Discounted Pricing: To maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part B, we are
required to extend significant discounts to certain covered entities that purchase products under Section 340B of the PHS
pharmaceutical pricing program. Purchasers eligible for discounts include hospitals that serve a disproportionate share of financially
needy patients, community health clinics and other entities that receive certain types of grants under the PHS Act. For all of our
products, we must agree to charge a price that will not exceed the amount determined under statute (the “ceiling price”) when we sell
outpatient drugs to these covered entities. In addition, we may, but are not required to, offer these covered entities a price lower than the
340B ceiling price. The 340B discount formula is based on AMP and is generally similar to the level of rebates calculated under the
Medicaid Drug Rebate Program.
OUTSIDE THE U.S.
Outside the U.S., our products are paid for by a variety of payors, with governments being the primary source of payment. Governments may
determine or influence reimbursement of products and may also set prices or otherwise regulate pricing. Negotiating prices with
governmental authorities can delay commercialization of our products. Governments may use a variety of cost-containment measures to
control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing (i.e., referencing prices in
other countries and using those reference prices to set a price). Budgetary pressures in many countries are continuing to cause governments
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to consider or implement various cost-containment measures, such as price freezes, increased price cuts and rebates and expanded generic
substitution and patient cost-sharing.
REGULATION PERTAINING TO SALES AND MARKETING
We are subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims
laws. Anti-kickback laws generally prohibit a prescription drug manufacturer from soliciting, offering, receiving or paying any remuneration to
generate business, including the purchase or prescription of a particular drug. Although the specific provisions of these laws vary, their scope
is generally broad and there may be no regulations, guidance or court decisions that clarify how the laws apply to particular industry
practices. There is therefore a possibility that our practices might be challenged under anti-kickback or similar laws. False claims laws
prohibit anyone from knowingly and willingly presenting, or causing to be presented, for payment to third-party payors (including Medicare
and Medicaid), claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed or
claims for medically unnecessary items or services. Our activities relating to the sale and marketing of our products may be subject to
scrutiny under these laws. Violations of fraud and abuse laws may be punishable by criminal or civil sanctions, including fines and civil
monetary penalties, and exclusion from federal health care programs (including Medicare and Medicaid). In the U.S., federal and state
authorities are paying increased attention to enforcement of these laws within the pharmaceutical industry and private individuals have been
active in alleging violations of the laws and bringing suits on behalf of the government under the federal civil False Claims Act. If we were
subject to allegations concerning, or were convicted of violating, these laws, our business could be harmed.
Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of
pharmaceutical manufacturers. The laws and regulations generally limit financial interactions between manufacturers and health care
providers or require disclosure to the government and public of such interactions. The laws include federal “sunshine” provisions. The
sunshine provisions apply to pharmaceutical manufacturers with products reimbursed under certain government programs and require those
manufacturers to disclose annually to the federal government (for re-disclosure to the public) certain payments made to physicians and
certain other healthcare practitioners or to teaching hospitals. State laws may also require disclosure of pharmaceutical pricing information
and marketing expenditures. Many of these laws and regulations contain ambiguous requirements. Given the lack of clarity in laws and their
implementation, our reporting actions could be subject to the penalty provisions of the pertinent federal and state laws and regulations.
Outside the U.S., other countries have implemented requirements for disclosure of financial interactions with healthcare providers and
additional countries may consider or implement such laws.
OTHER LAWS AND REGULATIONS
FOREIGN ANTI-CORRUPTION
We are subject to various federal and foreign laws that govern our international business practices with respect to payments to government
officials. Those laws include the U.S. FCPA, which 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. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their
transactions and to devise and maintain an adequate system of internal accounting controls.
The laws to which we are subject also include the U.K. Bribery Act 2010 (Bribery Act), which proscribes giving and receiving bribes in the
public and private sectors, bribing a foreign public official and failing to have adequate procedures to prevent employees and other agents
from giving bribes. U.S. companies that conduct business in the U.K. generally will be subject to the Bribery Act. Penalties under the Bribery
Act include significant fines for companies and criminal sanctions for corporate officers under certain circumstances.
NIH GUIDELINES
We seek to conduct research at our U.S. facilities in compliance with the current U.S. National Institutes of Health Guidelines for Research
Involving Recombinant DNA Molecules (NIH Guidelines). By local ordinance, we are required to, among other things, comply with the NIH
Guidelines in relation to our facilities in RTP, North Carolina and are required to operate pursuant to certain permits.
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OTHER LAWS
Our present and future business has been and will continue to be subject to various other laws and regulations. Laws, regulations and
recommendations relating to data privacy and protection, safe working conditions, laboratory practices, the experimental use of animals and
the purchase, storage, movement, import, export and use and disposal of hazardous or potentially hazardous substances, including
radioactive compounds and infectious disease agents, used in connection with our research work are or may be applicable to our activities.
Certain agreements entered into by us involving exclusive license rights may be subject to national or international antitrust regulatory
control, the effect of which cannot be predicted. The extent of government regulation, which might result from future legislation or
administrative action, cannot accurately be predicted.
Data Privacy
Regulators currently impose data privacy and security requirements, which include monetary fines for privacy violations. For example, the
European Parliament and the Council of the E.U. adopted a comprehensive GDPR in 2016 to replace the current E.U. Data Protection
Directive and related country-specific legislation. The GDPR took effect in May 2018 and governs the collection and use of personal data in
the E.U. The GDPR, which is wide-ranging in scope, imposes several requirements relating to the consent of the individuals to whom the
personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification
and the use of third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the
transfer of personal data out of the E.U. to the U.S., provides an enforcement authority and imposes large penalties for noncompliance,
including the potential for fines of up to €20.0 million or 4.0% of the annual global revenue of the infringer, whichever is greater. In addition,
several U.S. jurisdictions have similar data privacy laws, such as the CCPA and California Privacy Rights Act.
MANUFACTURING
We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing
capacity, capabilities, processes and facilities. We believe that our manufacturing facilities, together with the third-party contract
manufacturing organizations we outsource to, currently provide sufficient capacity for our products and to Samsung Bioepis, our collaboration
partner that develops, manufactures and markets biosimilar products, and other strategic contract manufacturing partners.
In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North
Carolina to support our gene therapy pipeline across multiple therapeutic areas. We estimate the construction of this manufacturing facility
will be completed during 2025. As we continue to advance our research and development prioritization efforts, which includes refocusing our
investment in gene therapy, we are evaluating several alternative uses for this facility.
MANUFACTURING FACILITIES
Our manufacturing facilities include:
Facility
Product Manufactured
RTP, North Carolina
AVONEX
PLEGRIDY
TYSABRI
QALSODY
Other*
Solothurn, Switzerland
LEQEMBI

TYSABRI
* Other includes products manufactured for contract manufacturing partners.
In addition to our drug substance manufacturing facilities, we have a drug product manufacturing facility and supporting infrastructure in RTP,
North Carolina, including a parenteral facility and an oral solid dose products manufacturing facility.
The parenteral facility adds capabilities and capacity for filling biologics into vials and is used for filling product candidates. The oral solid
dose products facility can supplement our outsourced small molecule manufacturing capabilities.
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We have an oligonucleotide synthesis manufacturing facility in RTP, North Carolina. This facility gives us the capability to manufacture both
commercial and clinical ASOs, including QALSODY, and beginning in 2025 this facility will manufacture SPINRAZA.
In order to support our future growth and drug development pipeline, we built a large-scale biologics manufacturing facility in Solothurn,
Switzerland. In the second quarter of 2021 a portion of the facility (the first manufacturing suite) received a GMP multi-product license from
SWISSMEDIC and was placed into service. The second manufacturing suite, which was also licensed to operate by SWISSMEDIC, became
operational in the first quarter of 2024. Solothurn has been approved for the manufacture of LEQEMBI.
Genentech is responsible for all worldwide manufacturing activities for bulk RITUXAN, RITUXAN HYCELA and GAZYVA and has sourced
the manufacture of certain bulk requirements to a third party.
THIRD-PARTY SUPPLIERS AND MANUFACTURERS
We principally use third parties to manufacture the active pharmaceutical ingredient and the final product for our small molecule products and
product candidates, including TECFIDERA, VUMERITY and FUMADERM, and the final drug product for our large molecule products and, to
a lesser extent, product candidates.
We source the majority of our fill-finish and all of our final product assembly and storage operations for our products, along with a substantial
part of our label and packaging operations, to a concentrated group of third-party contract manufacturing organizations. Raw materials,
delivery devices, such as syringes and auto-injectors, and other supplies required for the production of our products and product candidates
are procured from various third-party suppliers and manufacturers in quantities adequate to meet our needs. We endeavor to assure
continuity of supply of such raw materials, devices and supplies through inventory management and dual sourcing as appropriate. Our third-
party service providers, suppliers and manufacturers may be subject to routine cGMP inspections by the FDA or comparable agencies in
other jurisdictions and undergo assessment and certification by our quality management group. In addition, one of our contract
manufacturers for IMRALDI and BENEPALI was acquired by a third party in December 2024. We have evaluated the impact this will have on
our biosimilars business and have mitigation activities in progress designed to ensure supply continuity.
CORPORATE RESPONSIBILITY
INTRODUCTION
Our Corporate Responsibility strategy and programs are designed to deliver meaningful results in the areas where we believe we can have
the greatest impact. We have bolstered our efforts in access and health equity and refocused our Biogen Foundation efforts in the
communities where we operate and to help deliver better health. Our environmental strategy is designed to balance impact in line with
investment and to drive sustainability into our core operations.
GOVERNANCE
Corporate Responsibility oversight is formally embedded into our Board of Directors' corporate governance principles. Our Board of Directors
annually reviews our Corporate Responsibility strategy, progress and goals. We also regularly review our environmental commitments within
the context of our business performance and external challenges. We remain committed to engaging employees and suppliers.
As part of our broader commitment to these priorities, we continue to tie a portion of our employees' and executive officers' compensation to
advancing our Corporate Responsibility priorities.
Our Executive Committee has responsibility for evaluating the impact of climate change on the business and overseeing actions taken by the
company to limit its adverse impact on the environment.
RISK MANAGEMENT
Our Board of Directors believes that a fundamental part of risk management is identifying and understanding the risks we face, monitoring
these risks and adopting appropriate controls and mitigation of such risks. Our Board of Directors and its committees are responsible for
reviewing our risk framework and governance and management's exercise of its responsibility to assess, monitor and manage our significant
risk exposures. Our Board of Directors oversees an enterprise-wide approach to risk management, which is designed to support execution of
our strategy and achievement of our objectives to improve long-term operational and financial performance and enhance stockholder value.
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We have a company-wide ERM program to identify, mitigate and monitor enterprise-level risks that may affect our ability to achieve our
objectives. The ERM program is overseen by our ERM Committee, a cross-functional group of business leaders representing all of our key
business functions. On an ongoing basis, we evaluate the greatest risks to our business, their underlying risk drivers and the associated
mitigation activities and controls.
CLIMATE RISK MANAGEMENT
We believe that the areas of risk that are fundamental to the success of our enterprise and rise to enterprise-level risks includes, among
other things, environmental matters. Our ERM framework is designed to ensure climate-related risks and opportunities are monitored and
integrated into our overall business strategy. Our ERM process includes evaluating identified risks, including any climate-related physical and
transition risks, by engaging leaders across the company.
We identify climate risk as the risk of loss arising from climate change which comprises both physical risk and transition risk. Physical risk
considers how the physical impacts of climate change (e.g., increased frequency and intensity of storms, drought, fires, floods) can directly
damage physical assets or otherwise impact their value or productivity. Transition risk considers how changes in policy, regulations, culture,
technology, business practices and market preferences to address climate change (e.g., carbon pricing policies, power generation shifts from
fossil fuels to renewable energy) can lead to changes in the value of assets and businesses. Disruption in supply chains, changing customer
expectations in the biosimilars market and potential shifts in the regulatory environment that disadvantage the use of fossil fuels, PFAS or
other materials may make it difficult for us to fulfill business obligations or cause us to incur substantial expense.
Identified climate-related material risks and opportunities are reported to our ERM team, which reports to our ERM Committee with oversight
by our Board of Directors. We endeavor to consider and address those risks and opportunities that are financially material and may impact
our business model, as well as mitigation measures that are in place or need to be adopted.
For additional information on our environment-related risks, please read Item 1A. Risk Factors included in this report.
CLIMATE-RELATED DISCLOSURES
We monitor global climate-related disclosure requirements to prepare for reporting, progress activities and publish materials designed to
ensure our compliance under applicable laws and regulations.
The E.U., California and certain other countries in which we do business have enacted legislation and regulations to enhance disclosures
related to the impacts of climate-related matters. The E.U.'s Corporate Sustainability Reporting Directive will require expansive disclosures
on various environmental and social matters for companies whose business and assets exceed certain thresholds within E.U. countries.
California's environmental disclosure laws will impose additional climate-related reporting requirements on large companies conducting
business in the state of California.
HUMAN CAPITAL
As of December 31, 2024, we had approximately 7,605 employees worldwide. Approximately 4,255 employees were employed in the U.S.
and approximately 3,350 employees were employed in foreign countries. As of December 31, 2024, 30.9% of Biogen’s U.S. manager-level
and above positions were held by ethnic or racial minorities. Globally, 48.3% of Biogen’s positions at the director-level and above were held
by women as of December 31, 2024.
CULTURE AND ENGAGEMENT
Our values and merit-based culture guide every action we take, from pioneering new therapies to promoting health access for all patients. To
continue to build on our strong culture, we implemented the New Biogen Way, aimed at maintaining our spirit of innovation and patient-
centricity while advancing a more entrepreneurial business mindset and results-focused approach.
These are the essentials that are designed to work together to help us successfully achieve our mission:
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Pioneer: We boldly advance rigorous science to
drive innovation in medicine.
Think broadly: We are humble and curious,
integrating external and internal advancements
to successfully compete.
Drive results: We achieve high performance and
have a greater impact by being decisive and
solution-oriented, while effectively managing
risk.
Ethical: We act with the highest integrity with
each other and all who place their trust in us.
Inclusive: We are open and embrace and
leverage differences, as well as treat everyone
with care and dignity.
We use an employee survey program to understand employee engagement, giving employees an opportunity for feedback. The survey is
designed to empower managers and leaders with anonymous information on their practices related to building culture, performance and an
engaged workforce, allowing them to create plans and measure efficacy for continuous improvement. We care about employee feedback and
are building an analytics community across Human Resources to bring more rigor and sophistication to the collection and analysis of
employee opinions. We use those employee perspectives to guide us to take actions that are designed to improve engagement and support
and help maintain our reputation as a great place to work for all our employees.
GLOBAL COMPETENCY
Many factors influence employee success and well-being. We work to foster a workplace to allow employees to deliver on our shared
mission. From career development to wellness to workplace environment, there are many opportunities to meet employee needs, and to
build a workplace where people are empowered to learn, grow and build rewarding careers. Our employees are encouraged to take
advantage of an array of professional development resources. Managers are trained to coach employees for performance, and to engage in
employee development discussions to support growth and learning.
Opportunities for ongoing learning can contribute to employee engagement and success. Development occurs through on-the-job learning,
challenging new assignments, leadership development programs, instructor-led training, online learning, mentoring and more. With some
employees continuing to work from home, virtual learning plays a key role. Virtual learnings are available through Biogen University as well
as Coursera.
To create and sustain an inclusive workplace reflective of the patients we serve, we offer programs that invest in our talent pipeline and in our
current leaders, including:
•
Global Leadership Summit: Immersing leaders in topics designed to help them shape culture and build resilience.
•
Advance Your Leadership Potential: Preparing high-potential individual contributors for first-level leadership roles.
•
Executive Coaching: Coaching program available to support individuals as they work toward enhancing their impact in the organization.
SUCCESSION PLANNING
Each year we conduct a talent review across our global enterprise that includes, among other important topics, a review of succession plans
for many of our roles. To help ensure the long-term continuity of our business, we actively manage the development of talent to fill the roles
that are most critical to the ongoing success of our Company. In addition, each year our Board of Directors reviews the succession plan for
our executives.
COMPENSATION AND BENEFITS
Our approach to employee compensation and benefits is designed to deliver merit-based cash, equity and benefit programs that are
competitive with those offered by leading companies in the biotechnology industry, and to attract, motivate and retain talent to build a strong,
engaged and productive workforce that is equipped to deliver forward-looking business priorities.
We establish components and ranges of compensation based on market and benchmark data. Within this context, we strive to pay all
employees fairly within a reasonable range, taking into consideration factors such as role; merit; market data; job location; relevant
experience; and individual, business unit and company performance. In addition, we are committed to providing flexible benefits designed to
allow our global workforce to have reward opportunities that meet their varied needs so that they are inspired to perform their best on behalf
of patients and stockholders each day. We regularly review our compensation practices and analyze the fairness of compensation decisions,
for individual employees and our workforce as a whole.
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RECRUITMENT AND RETENTION
We seek to recruit and retain highly qualified employees. A business-wide priority is to strengthen our culture and the employee experience.
We believe our wellness initiatives and flexible work arrangements empower employees, increasing workplace satisfaction and allowing us to
retain and attract key talent. We examine employee total rewards across four pillars: physical, financial, emotional and social well-being. We
regularly assess our global benefits, and we believe we remain competitive with other companies in terms of comprehensive total rewards.
We also conduct affordability analyses to benchmark whether our benefits program costs are appropriate and fair.
Our total rewards program is designed to meet the needs of employees in local markets and includes retirement savings plans, financial
advising, LTI plans and incentive grants, company-paid life insurance and disability coverage, tuition reimbursement and college-planning
services. Our global employee assistance program provides support to all employees and their family members worldwide.
WORKPLACE HEALTH AND SAFETY
The safety and well-being of our employees is a priority for Biogen, and we believe every employee plays a role in creating a safe and
healthy workplace. Our employees have varied roles and functions, which is why we empower them to promote a safe working environment,
regardless of whether work happens in the lab, in an office or in a manufacturing facility. Our EHS policies and practices are intended to
protect not only our employees, but also the surrounding communities where we operate.
We maintain an EHS management system, which documents our health and safety management practices, including the following elements:
•
risk and opportunity assessments to identify what could cause harm in the workplace;
•
prioritization and integration of action plans with quantified targets to address those risks;
•
integration of actions to prepare for and respond to emergency situations;
•
evaluation of progress in reducing/preventing health issues/risks against targets;
•
procedures to investigate work-related injuries, ill health, diseases and incidents; and
•
training to employees and contractors to raise awareness and reduce operational health and safety incidents.
We have also introduced safety criteria in our procurement and contractual requirements.
OUR CULTURE OF INCLUSION
We are committed to merit-based opportunities and believe discrimination is unacceptable. We believe an inclusive workplace fosters
innovation and helps us to better support patients. Our strategy outlines steps to build our talent and strengthen our leadership, improve
health outcomes for patients in the disease areas we treat and contribute to the communities where we live and work.
Our ERGs are formed by interested employees and sponsored by a senior leader of the company. Membership of each ERG is open to all
employees. Our ERGs provide opportunities for employees to build connections, foster leadership development and cultivate a sense of
belonging. Our current ERGs include:
• AccessAbility: Supports employees with disabilities and employees who are caregivers of individuals with disabilities and their allies.
• Biogen Veterans Network: Encourages veterans and allies to connect and support one another.
• IGNITE: Brings together early-career professionals and their allies.
• Mosaic: Fosters awareness and appreciation of different cultural backgrounds, in addition to promoting networking and development
opportunities for employees.
• ourIMPACT: Addresses environmental issues at work, in employees' personal lives and in the communities where we live and work.
• Parenting Network Group: Provides support, networking and development opportunities to working parents and caregivers, as well as
helping employees navigate the challenges of work-life balance.
• ReachOUT: Brings together LGBTQ+ employees and their allies.
• Women’s Impact Network: Creates networking, mentoring and learning opportunities for women and allies worldwide.
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INFORMATION ABOUT OUR EXECUTIVE OFFICERS (as of February 12, 2025)
Officer
Current Position
Age
Year
Joined
Biogen
Christopher A. Viehbacher
President, Chief Executive Officer
64
2022
Susan H. Alexander
Executive Vice President, Chief Legal Officer
68
2006
Michael R. McDonnell
Executive Vice President and Chief Financial Officer
61
2020
Nicole Murphy
Executive Vice President, Pharmaceutical Operations and Technology
52
2015
Ginger Gregory, Ph.D.
Executive Vice President and Chief Human Resources Officer
57
2017
Rachid Izzar
Executive Vice President, Global Product Strategy and Commercialization
50
2019
Priya Singhal, M.D., M.P.H.
Executive Vice President, Head of Development
57
2020
Jane Grogan, Ph.D.
Executive Vice President, Head of Research
58
2023
Adam Keeney, Ph.D.
Executive Vice President, Head of Corporate Development
48
2023
Robin C. Kramer
Senior Vice President, Chief Accounting Officer
59
2018
 Michael R. McDonnell, Executive Vice President and Chief Financial Officer, plans to retire from Biogen on March 1, 2025. Upon Mr. McDonnell's retirement, Robin C. Kramer,
currently Senior Vice President and Chief Accounting Officer at Biogen, will assume the role of Executive Vice President and Chief Financial Officer.
Christopher A. Viehbacher
Experience
Mr. Viehbacher has served as our President and Chief Executive Officer and member of our Board of Directors since November 2022. Prior
to joining Biogen, Mr. Viehbacher served as Managing Partner of Gurnet Point Capital, a Boston based investment fund from 2015 to 2022.
Prior to that, Mr. Viehbacher served as Global CEO of Sanofi, from 2008 to 2014. Prior to joining Sanofi, Mr. Viehbacher spent over 20 years
with GlaxoSmithKline in Germany, Canada, France and, latterly, the U.S. as president of its North American pharmaceutical division. Mr.
Viehbacher began his career with PricewaterhouseCoopers LLP and qualified as a chartered accountant. Mr. Viehbacher previously served
on the board of directors of Vedanta Biosciences, Inc. as chair, BEFORE Brands, Inc., and Crossover Health. He is also a trustee of
Northeastern University and a member of the board of fellows at Stanford Medical School.
Education
l Queen's University in Kingston, Ontario, Canada, B.A.
Susan H. Alexander
Experience
Ms. Alexander has served as our Executive Vice President, Chief Legal Officer since April 2018. Prior to that, Ms. Alexander served as our
Executive Vice President, Chief Legal and Corporate Services from March 2017 to March 2018, as our Executive Vice President, Chief
Legal Officer and Secretary from December 2011 to March 2017 and as our Executive Vice President, General Counsel and Corporate
Secretary from 2006 to December 2011. Prior to joining Biogen, Ms. Alexander served as the Senior Vice President, General Counsel and
Corporate Secretary of PAREXEL International Corporation, a biopharmaceutical services company, from 2003 to January 2006. From 2001
to 2003 Ms. Alexander served as General Counsel of IONA Technologies, a software company. From 1995 to 2001 Ms. Alexander served as
Counsel at Cabot Corporation, a specialty chemicals and performance materials company. Prior to that, Ms. Alexander was a partner at the
law firms of Hinckley, Allen & Snyder and Fine & Ambrogne.
Education
l Wellesley College, B.A.
l Boston University School of Law, J.D.
(1)
(1)
(1)
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Michael R. McDonnell
Experience
Mr. McDonnell has served as our Executive Vice President and Chief Financial Officer since August 2020. Prior to joining Biogen, Mr.
McDonnell served as Executive Vice President and Chief Financial Officer of IQVIA Holdings Inc., a leading global provider of advanced
analytics, technology solutions and contract research services to the life sciences industry, from December 2015 until July 2020. Prior to
that, Mr. McDonnell served as the Executive Vice President and Chief Financial Officer of Intelsat, a leading global provider of satellite
services, from November 2008 to December 2015, as Executive Vice President and Chief Financial Officer of MCG Capital Corporation, a
publicly-held commercial finance company, from September 2004 until October 2008 and as MCG Capital Corporation’s Chief Operating
Officer from August 2006 until October 2008. Before joining MCG Capital Corporation, Mr. McDonnell served as Executive Vice President
and Chief Financial Officer for EchoStar Communications Corporation (f/k/a DISH Network Corporation), a direct-to-home satellite television
operator, from July 2004 until August 2004 and as its Senior Vice President and Chief Financial Officer from August 2000 to July 2004. Mr.
McDonnell spent 14 years at PricewaterhouseCoopers LLP, including 4 years as a partner. Mr. McDonnell is a licensed certified public
accountant (CPA).
Public Company Boards
l Merit Medical Systems, Inc.
Education
l Georgetown University, B.S. Accounting
Nicole Murphy
Experience
Ms. Murphy has served as our Executive Vice President, Pharmaceutical Operations and Technology since February 2022. Prior to that, Ms.
Murphy has held senior executive positions at Biogen, including most recently as our Senior Vice President, Head of Global Manufacturing
& Technical Operations, from June 2019 to January 2022. In 2017, Ms. Murphy played a critical role during the successful spin-off of
Biogen's hemophilia franchise, as the Vice President and Head of Technical Operations of Bioverativ responsible for clinical and commercial
development, quality, regulatory, manufacturing and procurement. Prior to the spin-off Ms. Murphy was the General Manager and Head of
Cambridge Site Operations at Biogen from May 2015 to December 2016. Prior to joining Biogen, Ms. Murphy was Executive Director, Head
of Supply Chain at Amgen, a biopharmaceutical company, where her responsibilities included leadership of commercial manufacturing and
technical operations. Ms. Murphy also held numerous technical and operational roles during her time at Amgen from 2001 to 2015 where
she contributed significantly to various facility start-ups, business development integrations, strategic transformations and new product
introductions. Prior to Amgen, Ms. Murphy held a variety of process development and engineering positions at Immunex Pharmaceuticals
and the Monsanto Company.
Education
l University of Massachusetts Amherst, B.S. Engineering
l Rensselaer Polytechnic Institute, M.S. Engineering and a Masters of Business Administration
Ginger Gregory, Ph.D.
Experience
Dr. Gregory has served as our Executive Vice President and Chief Human Resources Officer since July 2017. Prior to joining Biogen, Dr.
Gregory served as Executive Vice President and Chief Human Resources Officer at Shire PLC, a global specialty biopharmaceutical
company, from February 2014 to April 2017. Prior to that, Dr. Gregory held executive-level human resources positions for several
multinational companies across a variety of industries, including Dunkin’ Brands Group Inc., a restaurant holding company, where she
served as Chief Human Resource Officer, Novartis AG, a pharmaceutical company, where she was the division head of Human Resources
for Novartis Vaccines and Diagnostics, Novartis Consumer Health and Novartis Institutes of BioMedical Research and Novo Nordisk A/S, a
pharmaceutical company, where she served as Senior Vice President, Corporate People & Organization at the company’s headquarters in
Copenhagen, Denmark. Earlier in her career, Dr. Gregory held a variety of human resources generalist and specialist positions at BMS, a
pharmaceutical company, and served as a consultant with Booz Allen & Hamilton, an information technology consulting company, in the
area of organization change and effectiveness.
Education
l University of Massachusetts, B.A. Psychology
l The George Washington University, Ph.D. Psychology
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Rachid Izzar
Experience
Mr. Izzar has served as our Executive Vice President, Head of Global Product Strategy and Commercialization since July 2021. Prior to that
Mr. Izzar served as our President for the Intercontinental Region, which includes Latin America, Australia, Asia, Japan, the Middle East and
Africa, Turkey and Russia, and the Global Biogen Biosimilars Unit. Prior to joining Biogen, Mr. Izzar was a Country President for
AstraZeneca in France, where his responsibilities included leadership for commercial and manufacturing operations. He held numerous
roles at his time with AstraZeneca, including the position of Global Vice President of the Cardiovascular Franchise where he contributed
significantly to the development of the franchise within the North American subsidiary, as well as in Europe and China. Prior to that, Mr. Izzar
was Vice President Strategic Transformation, also, China Portfolio for CEO based in Shanghai and Vice President Commercial International
covering China, Australia, Brazil, Russia, America Latin, Asia, Turkey, the Middle East and Africa.
Education
l University of Sherbrooke, Masters of Business Administration
l Harvard Business School, Enterprise Executive Transformation Program
Priya Singhal, M.D., M.P.H.
Experience
Dr. Singhal has served as our Executive Vice President and Head of Development since January 2023. Prior to that Dr. Singhal served as
our Interim Head of Research and Development since 2021 in addition to serving as Head of Global Safety and Regulatory Sciences,
including China and Japan Research and Development, since rejoining Biogen in 2020. Dr. Singhal was initially at Biogen from 2012 to
2018 and served in positions of increasing seniority as Vice President Clinical Trials Benefit-Risk Management, Global Head of Safety and
Benefit Risk Management and as the Interim Co-lead and Senior Vice President of Global Development. Prior to her 2020 return to Biogen,
Dr. Singhal served as Head of Research and Development and Manufacturing at Zafgen Inc. from 2019 to 2020. From 2008 to 2012 Dr.
Singhal held roles at Vertex Pharmaceuticals, including Vice President, Medical Affairs. Dr. Singhal began her drug-development career at
Millennium Pharmaceuticals, Inc. in 2005 and led benefit-risk management for Velcade and other compounds.
Education
l Harvard School of Public Health, M.P.H. in International Health
l University of Mumbai, Doctor of Medicine (M.D.)
Jane Grogan, Ph.D.
Experience
Dr. Grogan has served as our Executive Vice President and Head of Development since October 2023. Dr. Grogan most recently served as
the Chief Scientific Officer at Graphite Bio from 2021 to 2023 and ArsenalBio from 2019 to 2021, both cell and gene therapy companies.
From 2004 to 2019 Dr. Grogan held several roles in increasing seniority at Genentech across Immunology and Immuno-oncology, covering
research strategies and drug development across Rheumatoid Arthritis, Lupus, MS, Inflammatory Bowel Disease and Cancer.
Education
l Leiden University, Ph.D. in Immunology
l University of Melbourne, B.Sc in Biochemistry and Pharmacology
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Adam Keeney, Ph.D.
Experience
Dr. Keeney has served as our Executive Vice President and Head of Corporate Development since April 2023. Dr. Keeney brings more than
20 years of experience leading R&D, business development and strategy organizations at industry-leading companies within biotech and
large pharma, Dr. Keeney most recently served as the Chief Executive Officer of NodThera, a clinical stage biotech company focused on
chronic inflammation from 2018 to 2022. Prior to NodThera, Dr. Keeney was at Sanofi from 2014 to 2018 where he had responsibility for all
of Sanofi Gezyme's business development activities, including early- and late-stage deals across therapeutic areas and modalities,
successfully completing several significant transactions. From 2004 to 2013 Dr. Keeney worked at Johnson & Johnson where he held a
number of business development roles with increasing responsibility and started his career at Lundbeck as a discovery scientist.
Education
l University of Nottingham, UK, Ph.D. in Neuropharmacology
l University of Leeds, UK, BSc (Hons)
Robin C. Kramer
Experience
Ms. Kramer has served as our Senior Vice President, Chief Accounting Officer since December 2020. Prior to that, Ms. Kramer served as
our Vice President, Chief Accounting Officer from November 2018 to December 2020. Prior to joining Biogen, Ms. Kramer served as the
Senior Vice President and Chief Accounting Officer of Hertz Global Holdings, Inc., a car rental company, from May 2014 to November 2018.
Prior to that, Ms. Kramer was an audit partner at Deloitte & Touche LLP (Deloitte), a professional services firm, from 2007 to 2014, including
serving in Deloitte's National Office Accounting Standards and Communications Group from 2007 to 2010. From 2005 to 2007 Ms. Kramer
served as Chief Accounting Officer of Fisher Scientific International, Inc., a laboratory supply and biotechnology company, and from 2004 to
2005 Ms. Kramer served as Director, External Reporting, Accounting and Control for the Gillette Company, a personal care company. Ms.
Kramer also held partner positions in the public accounting firms of Ernst & Young LLP and Arthur Andersen LLP. Ms. Kramer is a licensed
CPA in Massachusetts. She is a member of the Massachusetts Society of CPAs and the American Institute of CPAs. Ms. Kramer previously
served as a Board Member for the Center for Women & Enterprise from August 2020 to November 2024, the Massachusetts State Board of
Accountancy from September 2011 to December 2015 and Probus Insurance Company Europe DAC from 2016 to 2018.
Public Company Boards
l Armata Pharmaceuticals, Inc., a biotechnology company
Education
l Salem State University, Bachelor of Science in Business Administration, Accounting
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AVAILABLE INFORMATION
Our principal executive offices are located at 225 Binney Street, Cambridge, MA 02142 and our telephone number is (617) 679-2000. Our
website address is www.biogen.com. We make available free of charge through the Investors section of our website our Annual Reports on
Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably
practicable after such material is electronically filed with or furnished to the SEC. We include our website address in this report only as an
inactive textual reference and do not intend it to be an active link to our website. The contents of our website are not incorporated into this
report.
USE OF WEBSITE TO PROVIDE INFORMATION
From time to time, we have used, and expect in the future to use, our website as a means of disclosing material information to the public in a
broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Financial and other material
information regarding the Company is routinely posted on our website and accessible at www.biogen.com. In order to receive notifications
regarding new postings to our website, investors are encouraged to enroll on our website to receive automatic email alerts. None of the
information on our website is incorporated into this report.
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ITEM 1A.    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. 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, 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 relating to inflation and those resulting from
governmental or regulatory requirements, including those relating to any future potential drug price negotiation under the IRA;
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;
•
adverse legal, administrative, geopolitical events, regulatory or legislative developments; or
•
our ability to maintain a positive reputation among patients, healthcare providers and others, which may be impacted by our pricing and
reimbursement decisions.
LEQEMBI is in the early stages of commercial launch in the U.S. and certain international markets and SKYCLARYS is in the early stages of
commercial launch in the U.S. and certain European markets. In addition to risks associated with new product launches and the other factors
described in these Risk Factors, Biogen’s and Eisai’s ability to successfully commercialize LEQEMBI and our ability to successfully
commercialize SKYCLARYS may be adversely affected due to:
•
Eisai’s ability to obtain and maintain adequate reimbursement for LEQEMBI;
•
the effectiveness of Eisai's and Biogen’s commercial strategy for marketing LEQEMBI;
•
requirements such as participation in a registry and the use of imaging or other diagnostics for LEQEMBI;
•
our ability to obtain approval in other markets;
•
the approval of other new products for the same or similar indications;
•
Eisai’s and Biogen’s ability to maintain a positive reputation among patients, healthcare providers and others in the Alzheimer’s disease
community, which may be impacted by pricing and reimbursement decisions relating to LEQEMBI, which are made by Eisai and/or
third parties;
•
Biogen's ability to obtain and maintain adequate reimbursement for SKYCLARYS; and
•
the effectiveness of Biogen's commercial strategy for marketing SKYCLARYS.
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, 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 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, presents additional challenges and risks,
including obtaining approval from regulatory authorities that have limited experience with the development of such therapies. For example,
we are currently seeking approval of LEQEMBI in Europe and the approval of a subcutaneous formulation of LEQEMBI in the U.S. and any
delays or challenges may impact our ability to realize the anticipated benefits from LEQEMBI.
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.
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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 or delay 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 prioritize
other opportunities in our pipeline.
Additionally, 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 has in the past and may in the future 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;
•
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 and maintain appropriate pricing and adequate reimbursement for our products compared to our competitors in key
markets; or
•
our ability to obtain and maintain patent, data or market exclusivity for our products.
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 depends upon internal development projects, commercial initiatives and
external opportunities, which may include the acquisition and in-licensing of products, technologies, companies, the entry into strategic
alliances and collaborations or our Fit for Growth program, as well as our ability to execute on strategic decisions and initiatives.
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.
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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 to make any such acquisition if suitable candidates are identified.
We may fail to initiate or complete transactions for many reasons, including failure to obtain regulatory or other approvals as well as a result
of disputes or litigation. Furthermore, we may not be able to achieve the full strategic and financial benefits expected to result from
transactions or strategic decisions, such as the decision to retain the biosimilars business, 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. For example, we recently acquired Reata and HI-Bio and are in the process of
integrating Reata and HI-Bio into our Company. The ultimate success of our acquisitions of Reata and HI-Bio and our ability to realize the
anticipated benefits from the acquisitions, including future performance of the SKYCLARYS product and further development of the
felzartamab product and anticipated synergies, depends on, among other things, how effective we are in integrating the Biogen, Reata and
HI-Bio operations.
We face risks associated with our Fit for Growth program that may impair our ability to achieve anticipated savings and operational
efficiencies or that may otherwise harm our business. These risks include delays in implementation of cost optimization actions, loss of
workforce capabilities, higher than anticipated separation expenses, litigation and the failure to meet financial and operational targets. In
addition, the calculation of the anticipated cost savings and other benefits resulting from our Fit for Growth program are subject to many
estimates and assumptions. These estimates and assumptions are subject to significant business, economic, competitive and other
uncertainties and contingencies, many of which are beyond our control. If these estimates and assumptions are incorrect or if we experience
delays or unforeseen events, our business and financial results could be adversely affected.
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, diagnosis of the condition it
treats and the cost to administer it 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.
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.
Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-
based pricing and reference pricing (i.e., referencing prices in other
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countries and using those reference prices to set a price). Drug prices are under significant scrutiny in the markets in which our products are
prescribed; for example the IRA has certain provisions related to drug pricing, including the ability for the U.S. government to set prices for
certain drugs in Medicare. 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 prices in existing and potential new markets, which may limit market growth and
result in reductions in revenue. 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, in certain jurisdictions governmental health
agencies may adjust, retroactively and/or prospectively, reimbursement rates for our products. Reimbursement for our products by
governments, including the timing of any reimbursements, may also be affected by budgetary or political constraints, particularly in
challenging economic environments. Government agencies often do not set their own budgets and therefore, have limited control over the
amount of money they can spend. In addition, these agencies experience political pressure that may dictate the manner in which they spend
money. There can be no assurance that the economic, budgeting or political issues will not worsen and adversely impact sales or
reimbursements of our products.
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 and other third-parties for revenue, and for the development, regulatory approval,
commercialization and marketing of certain of our products and product candidates, which are outside of our full control, and if
these relationships fail, our business may be adversely affected.
We rely on a number of collaborative and other third-party relationships for revenue and the development, regulatory approval,
commercialization and marketing of certain of our products and product candidates. We also outsource certain aspects of our regulatory
affairs and clinical development relating to our products and product candidates to third-parties. Reliance on third-parties subjects us to a
number of risks, including:
•
we may be unable to control the resources our collaborators or third-parties devote to our programs, products or product candidates,
which may affect our ability to achieve development goals or milestones;
•
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 or third-parties fail to perform;
•
the interests of our collaborators or third-parties may not always be aligned with our interests, and such parties may not protect and
enforce any intellectual property rights or 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,
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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 or third-parties to comply with applicable laws, including tax laws, regulatory requirements
and/or applicable contractual obligations or to fulfill any responsibilities they may have to protect and enforce any intellectual property
rights underlying our products could have an adverse effect on our revenue or reputation as well as involve us in possible legal
proceedings; and
•
any improper conduct or actions on the part of our collaborators or third-parties could subject us to civil or criminal investigations and
monetary and injunctive penalties, require management attention, impact the accuracy and timing of our financial reporting and/or
adversely impact our ability to conduct business, our operating results and our reputation.
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, purchased and
reimbursed. For example, provisions of the 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 under Section 340B of the Public Health Service Act and similar state legislation. 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 substantial 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. In addition, there have been (including elements of the IRA), and are
expected to continue to be, legislative proposals to address prescription drug pricing. We face uncertainties regarding potential healthcare
reforms, governmental policy and prioritization, 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, 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 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 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. We are dependent, in part, on the efforts of collaboration partners and other third-parties over whom we
have limited or no control in the development and manufacturing of biosimilars products. For example, a recently completed acquisition
of a contract development and manufacturing organization by a third party may impact its operational, strategic or financial risk. If these
third-parties fail to perform successfully, or reduce their third party manufacturing production, 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;
•
Competitive Challenges. Biosimilar products face significant competition, including from innovator products and biosimilar products
offered by other 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 in this business area;
•
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;
•
Ability to Provide Adequate Supply. Manufacturing biosimilars is complex. If we encounter any persistent manufacturing or supply chain
difficulties we may be unable to meet 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.
For example, one of our contract manufacturers for IMRALDI and BENEPALI was acquired by a third party in December 2024, which
may have an impact on our biosimilars business;
•
Intellectual Property and Regulatory Challenges. Biosimilar products may face extensive intellectual property clearances and
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; and
•
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.
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, administrative bodies and lawmakers in these countries. We may fail to obtain, defend 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 exclusivity 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.
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Furthermore, our products may be determined to infringe patents or other intellectual property rights held by third-parties. Legal proceedings,
administrative challenges or other types of proceedings are and may in the future be necessary to determine the validity, scope or non-
infringement of certain patent rights claimed by third-parties to be pertinent to the manufacture, use or sale of our products. Legal
proceedings may also be necessary to determine the rights, obligations and payments claimed during and after the expiration of intellectual
property license agreements we have entered with third parties. 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 could 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 have in the past and may not in the future 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, disagree with our trial
design or endpoints or not approve adequate reimbursement. 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 have in the past and may
in the future 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. 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 to carry out our clinical trial related activities and rely on such parties to accurately report their results. Our
reliance on 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, including adversely affecting our expenses associated with such trials. 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.
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.
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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.
Restrictions on use or safety warnings that may be required to be included in the label of our products may significantly reduce expected
revenue for those products and require significant expense and divert management time.
Risks Related to Our Operations
A breakdown or breach of our information systems could subject us to liability or interrupt the operation of our business.
We are increasingly dependent upon information systems and data to operate our business. Changes in how we operate have 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, with many of our employees now working in hybrid or full-remote
positions. As a result, we are increasingly dependent upon our information systems to operate our business and our ability to effectively
manage our business depends on the security, reliability and adequacy of our information 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). Breakdowns,
invasions, corruptions, destructions and/or breaches, which may include impacts such as, but not limited to, comprising the capacity,
reliability or security of our information systems or those of our business partners, including our cloud technologies, and/or unauthorized
access to our data and information could subject us to significant liability, negatively impact our business operations, and/or require
replacement of technology and/or sizeable ransom payments. Our information systems, including our cloud technologies, continue to
increase in multitude and complexity, increasing our vulnerability when breakdowns, malicious intrusions and random 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.
Cybersecurity threats and incidents are increasing in their frequency, sophistication and intensity, and are becoming increasingly difficult to
detect, particularly when they impact vendors, customers or suppliers, and other companies in our supply chain. Cybersecurity threats and
incidents are often carried out by motivated, well-resourced, skilled and persistent actors, including nation states, organized crime groups,
“hacktivists” and may include or target employees or contractors acting with careless or malicious intent. Recent developments in the threat
landscape include use of adversarial AI techniques and machine learning, as well as an increased number of cyber extortion attacks, with
higher financial ransom demand amounts and increasing sophistication and variety of ransomware techniques and methodology. Geopolitical
instability, including that related to Russia's invasion of Ukraine or the conflict in the Middle East, may increase the risk of cybersecurity
threats. Cybersecurity threats or incidents may include 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
information systems and data. Cybersecurity threats and incidents also include manufacturing, hardware or software supply chain attacks,
which could cause a delay in the manufacturing of products or products produced for contract 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 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.
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 cybersecurity threats or incidents in our systems and any such incidents could materially adversely affect our
business and operations and/or result in the loss of critical or sensitive information, which could result in material 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.
Regulations continue to change as regulators worldwide consider new rules. For example, the SEC has adopted additional disclosure rules
regarding cyber security risk management, strategy, governance and incident reporting by public companies. These new regulations or other
regulations being considered in Europe and around the world may impact the manner in which we operate.
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Regulators currently impose new data privacy and security requirements, including 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. U.S. data privacy and security laws, such as the 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.
The increasing use of AI-based software presents new risks and challenges and could adversely affect our business and
reputation.
The use of AI-based software is increasingly being used in the biopharmaceutical industry, including by us, such as for research, marketing,
manufacturing and commercialization, and we expect to use technology that uses AI in the future. As with many developing technologies, AI-
based software presents risks and challenges. For example, algorithms may be flawed; data sets may be insufficient, of poor quality or
contain biased information; and inappropriate or controversial data practices could impair results. If the analyses that AI-based software
assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability and brand or reputational
harm. Use of AI-based software may also lead to cybersecurity risks or the release of confidential proprietary information, including personal
data, which may impact our ability to realize the benefit of our intellectual property or violate our internal policies, data protection laws or
contractual requirements. The use of AI-based software may also result in unauthorized access of personal data or the intellectual property
of third parties. Since the use of AI is subject to new or evolving laws and regulations, compliance may impose operational costs and limit our
ability to use AI-based software, and failure to comply may result in potential government actions, litigation, fines, penalties or adverse
publicity.
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 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, strategic and financial risks that are outside of our control. For example, a
recently completed acquisition of a contract development and manufacturing organization by a third party may impact its operational,
strategic or financial risk. 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.
•
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, geopolitical
instability, public health epidemics, natural disasters, adverse weather events, power failures, cyber-attacks and many other factors.
•
Risks Relating to Compliance with current GMP (cGMP). We and our third-party providers are required to maintain compliance with
cGMP and other stringent requirements, as applicable, 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
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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.
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.
Furthermore, factors such as geopolitical events, global health outbreaks, adverse weather events, labor or raw material shortages,
imposition of tariffs or trade restrictions 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. 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, personnel and other organizational 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, which could disrupt our business and adversely affect our operations.
Changes in management, 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 other 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, integration related to the Reata and HI-Bio
acquisitions, the underperformance or discontinuation of one or more marketed, pre-clinical or clinical programs, recruitment by competitors
or changes in the overall labor market. In addition, 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 laws and 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 laws and
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 testing, 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 or other patient assistance 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 areas with different
patient populations, which
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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 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, staffing, resources 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.
Additionally, conditions and regulations governing the health care industry in the U.S. are subject to greater risk of change and uncertainty as
a result of changes in legislative and regulatory priorities and personnel.
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 or distributors 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 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, reimbursement 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;
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•
additional complexity in manufacturing or conducting clinical research internationally, including materials manufactured in China or
working with CROs in China;
•
delays in clinical trials relating to geopolitical instability related to Russia's invasion of Ukraine and the military conflict in the Middle
East;
•
the inability to successfully complete subsequent or confirmatory clinical trials in countries where our experience is limited;
•
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 anti-bribery and anti-corruption legislation across the globe, 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. 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 built a large-scale biologics manufacturing facility and are building a gene therapy, clinical packaging and other 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 have expanded 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.
Although the Solothurn facility was approved by the FDA for LEQEMBI, there can be no assurance that the regulatory authorities will approve
the Solothurn facility for the manufacturing of other products.
Additionally, we are building a new gene therapy, clinical packaging and other manufacturing facility in RTP, North Carolina with no assurance
that this investment will be fully utilized. If we are unable to fully utilize this gene therapy, clinical packaging and other manufacturing facility,
charges from excess capacity may occur and would have a negative effect on our financial condition and results of operations.
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.
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
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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 Holding Our Common Stock
Our operating results are subject to significant fluctuations.
Our quarterly revenue, expense and net income 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 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;
•
the costs associated with decisions to terminate research and development programs;
•
impairments with respect to investments, fixed assets and long-lived assets, including IPR&D and other intangible assets;
•
inventory write-downs for failed quality specifications, charges for excess capacity, charges for excess or obsolete inventory and
charges for inventory 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, 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 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
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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 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.
We may not be able to access the capital and credit markets on favorable terms, which could increase our financing costs.
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 which
could significantly increase our financing costs. 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
•
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.
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 has in the past and may in the future 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 news, biotechnology market sentiment, instability in the global financial markets
that reduces the liquidity of securities in our portfolio, 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 repurchase shares or that we will repurchase shares at favorable prices, which may
negatively affect our stock price.
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. Additionally, the recently enacted IRA includes an excise tax on share repurchases, which will
increase the cost of share repurchases. 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.
Some of our collaboration agreements contain change in control provisions that may discourage a 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
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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 in our financial
statements.
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 tax cases, changes in accounting for income taxes and
changes in tax laws, especially in the U.S. and Switzerland, and regulations (including the Global Tax Deal Executive Order issued on
January 20, 2025) either prospectively or retrospectively and the effects of the integrations of Reata and HI-Bio.
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 enactment of some or all of the recommendations set forth or that may be forthcoming in the OECD’s project on “Base Erosion and Profit
Shifting” 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.
Many countries have or are in the process of enacting legislation intended to implement the OECD GloBE Model Rules effective on January
1, 2024. The impact on the Company will depend on the timing of implementation, the exact nature of each country's GloBE legislation,
guidance and regulations (including the Global Tax Deal Executive Order issued on January 20, 2025) thereon and their application by tax
authorities either prospectively or retrospectively.
Our business involves environmental and operational 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 which make us subject to changing and evolving rules and interpretations, which could require us to incur
substantial costs associated with compliance or to alter one or more of our business practices. 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. Additionally, regulators have passed new environmental disclosure rules. For example, the E.U., California and certain
other countries we do business in have promulgated new climate disclosure rules that will generally require additional disclosure.
Additionally, other regulators are considering environmental disclosure rules. These new rules collectively will impose additional disclosure
requirements relating to climate-related risks and emissions disclosures. We expect to be subject to these new laws and regulations if or
when they go into effect, which would impose extensive reporting obligations about greenhouse gas emissions and climate-related financial
risks. These recently enacted and proposed regulations may require us to incur compliance and disclosure costs and will likely require
substantial management attention.
ITEM  1B. UNRESOLVED STAFF COMMENTS
None.
ITEM  1C. CYBERSECURITY
RISK MANAGEMENT AND STRATEGY
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We maintain a technology and cybersecurity program, which includes information security, as part of our overall risk management process
with the aim that our information systems, including those of our vendors and other third-parties, will be resilient, effective and capable of
safeguarding against emerging risks and cybersecurity threats. We endeavor to assure our program is appropriately resourced and to attract
and retain expert talent to execute it.
In designing, operating, evaluating and maintaining our program we use internal and external resources and frameworks, including
cybersecurity expert consultants, industry working groups, the U.S. NIST Cybersecurity Framework and the U.S. Cybersecurity Agency's
National Cyber Incident Scoring System model to benchmark, inform and evaluate the design of our program, our operational capabilities
and our program maturity.
Consistent with NIST 800-53, our technology and cybersecurity program and controls include a third party and vendor risk management
component. As part of our vendor risk management program, we conduct security assessments prior to engagement of high-risk vendors and
other third-party providers and have a monitoring program to evaluate ongoing compliance with our cybersecurity standards.
A key element of our technology and cybersecurity program strategy is fostering training and awareness. Our training and awareness
program includes annual cybersecurity awareness training and role-based phishing tests for our employees and for third parties with access
to our systems.
Our technology and cybersecurity program focuses on the defense, rapid detection and rapid remediation of cybersecurity threats and
incidents. Our program includes systems and processes designed based on defense-in-depth and zero-trust architectural principles and that
are intended to provide the control capabilities set forth in NIST's 800-53 Rev 5, Security and Privacy Controls for Information Systems and
Organizations. Our program also includes cybersecurity policies and a crisis response and management plan that is intended to allow rapid
management and response and appropriate communication of cybersecurity threats and incidents.
We staff a cybersecurity operations center to respond to threats and incidents. Our cybersecurity crisis management plan sets forth the
items, procedures and actions we expect to address and follow in the event of a cybersecurity incident, including detection, response,
mitigation and remediation. In addition to the cybersecurity operations center and our designated cybersecurity response team, we maintain
a cross-functional cybersecurity crisis core team, which includes our CISO and senior representatives from our Legal, Finance, IT and
Corporate Security teams.
When a potential threat or incident is identified, our cyber security incident response team will assign a risk level classification and initiate the
escalation and other steps called for by our plan. All incidents that are initially assessed by the cybersecurity incident response team as
potentially high-risk are escalated promptly to our CISO. Our CISO, Chief Legal Officer and Chief Financial Officer, will determine whether
and what elements of our cybersecurity crisis response and management plan should be activated, including escalation to other senior
management or our Executive Committee. Our Executive Committee will inform our Board of Directors of cybersecurity incidents, as
appropriate, considering a variety of factors, including financial, operational, legal or reputational impact.
Our program's maturity and operational readiness are regularly evaluated by independent experts using the U.S. NIST's CyberSecurity
Framework and penetration tests. Our program, and the results of these independent evaluations and testing, are regularly reviewed by our
senior management and members of our Board of Directors.
CYBERSECURITY RISK GOVERNANCE
We are committed to appropriate cybersecurity governance and oversight. Our technology and cybersecurity program is the principal
responsibility of our Chief Information Officer and CISO, each of whom have over 20 years of experience in information systems, including
cybersecurity training and experience. Additionally, we have a Cybersecurity steering committee that includes senior representatives from our
Legal, Finance and IT departments, which meets regularly to discuss cybersecurity matters.
Our Board of Directors oversees management's processes for identifying and mitigating risks, including cybersecurity and information
security risks. Our Board of Directors regularly reviews our technology and cybersecurity program and effectiveness, internal audits of our
program, independent external expert evaluations of our program's maturity and operational readiness and the results of penetration testing.
Our Board of Directors also receives cybersecurity updates and education on a broad range of topics, including:
•
Current cybersecurity landscape and emerging threats;
•
Status of ongoing cybersecurity initiatives and strategies;
•
Incident report and learnings from any cybersecurity events; and
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•
Compliance with regulatory requirements and industry standards.
We do not believe that any risks from cybersecurity threats have materially affected or are reasonably likely to materially affect our business
strategy, results of operations or financial condition during the period covered by this filing. For additional information on our cybersecurity
risks, please read Item 1A. Risk Factors - A breakdown or breach of our information systems could subject us to liability or interrupt the
operation of our business, included in this report.
ITEM  2. PROPERTIES
Below is a summary of our significant properties owned and leased as of December 31, 2024.
Location
Approximate Square
Feet
Use
Owned/Leased
U.S.
Cambridge, Massachusetts
263,000
Research laboratory and cogeneration plant
Owned
Cambridge, Massachusetts
729,000
Corporate headquarters and laboratory
Leased - Expires 2028
Weston, Massachusetts
357,000
Office
Leased - Expires 2025
RTP, North Carolina
1,040,000
Office, laboratory, manufacturing, warehouse
Owned
Durham, North Carolina
65,000
Warehouse
Leased - Expires 2025
Plano, Texas
327,000
Office and laboratory
Leased - Expires 2038
International
Solothurn, Switzerland
734,000
Manufacturing facility, warehouse and office
Owned
Baar, Switzerland
81,800
International headquarters
Leased - Expires 2028
 We also lease office space in other international regions including: the U.K.; Germany; France; Japan; Canada and numerous other countries. Our international lease
agreements expire at various dates through the year 2034.
In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North
Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new manufacturing facility will be approximately
197,000 square feet. We estimate the construction of this manufacturing facility will be completed during 2025.
We believe that our our existing properties, including both owned and leased sites, are adequate and suitable for the conduct of our
business. We believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our
expected long-term growth needs.
ITEM  3. LEGAL PROCEEDINGS
For a discussion of legal matters as of December 31, 2024, please read Note 21, Litigation, to our consolidated financial statements included
in this report, which is incorporated into this item by reference.
ITEM  4. MINE SAFETY DISCLOSURES
Not applicable.
(1)
(1)
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
MARKET AND STOCKHOLDER INFORMATION
Our common stock trades on The Nasdaq Global Select Market under the symbol “BIIB.” As of February 11, 2025, there were approximately
392 shareholders of record of our common stock.
DIVIDENDS
We have not paid cash dividends since our inception. While we historically have not paid cash dividends and do not have a current intention
to pay cash dividends, we continually review our capital allocation strategies, including, among other things, payment of cash dividends,
share repurchases and acquisitions.
ISSUER PURCHASES OF EQUITY SECURITIES
The following table summarizes our common stock repurchase activity during the fourth quarter of 2024:
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)
October 1, 2024 - October 31, 2024
— 
$
— 
— 
$
2,050.0 
November 1, 2024 - November 30, 2024
— 
$
— 
— 
$
2,050.0 
December 1, 2024 - December 31, 2024
— 
$
— 
— 
$
2,050.0 
Total
— 
$
— 
There were no share repurchases during the fourth quarter of 2024.
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 shares repurchased under our 2020 Share
Repurchase Program were retired. Under our 2020 Share Repurchase Program, we repurchased and retired approximately 3.6 million
shares of our common stock at a cost of approximately $750.0 million during the year ended December 31, 2022. There were no share
repurchases of our common stock during the years ended December 31, 2024 and 2023. Approximately $2.1 billion remained available
under our 2020 Share Repurchase Program as of December 31, 2024.
In August 2022 the IRA was signed into law. Among other things, the IRA levies a 1.0% excise tax on net stock repurchases after December
31, 2022. While we have historically made discretionary share repurchases, we had no share repurchases of our common stock during the
years ended December 31, 2024 and 2023.
(1)
(1) 
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PERFORMANCE GRAPH
The performance graph below compares the five-year cumulative total stockholder return on our common stock, the Nasdaq Pharmaceutical
Index, the S&P 500 Index and the Nasdaq Biotechnology Index. The performance graph below assumes the investment of $100.00 on
December 31, 2019, in our common stock and each of the three indexes, with dividends being reinvested.
The stock price performance in the graph below is not necessarily indicative of future price performance.
2019
2020
2021
2022
2023
2024
Biogen Inc.
$100.00
$82.52
$80.85
$93.31
$87.19
$51.52
Nasdaq Pharmaceutical Index
$100.00
$110.52
$137.47
$153.08
$159.01
$172.62
S&P 500 Index
$100.00
$118.40
$152.39
$124.79
$157.59
$197.02
Nasdaq Biotechnology Index
$100.00
$126.42
$126.45
$113.65
$118.87
$118.20
The information included under the heading Performance Graph is “furnished” and not “filed” for purposes of Section 18 of the Securities
Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A
or incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
ITEM 6.    RESERVED
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion should be read in conjunction with our consolidated financial statements and the accompanying notes beginning on
page F-1 of this report.
For our discussion of the year ended December 31, 2023, compared to the year ended December 31, 2022, please read Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations located in our Annual Report on Form 10-K for the
year ended December 31, 2023.
EXECUTIVE SUMMARY
INTRODUCTION
Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with
serious and complex diseases. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA,
co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a
genetic cause of ALS. We market the first and only drug approved in the U.S. and the E.U. for the treatment of FA in adults and adolescents
aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases. We support our
drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.
Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the
treatment of SMA; SKYCLARYS for the treatment of FA; QALSODY for the treatment of ALS; and FUMADERM for the treatment of severe
plaque psoriasis.
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the
commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the
treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL;
GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of
relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the
option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of
the Roche Group.
We commercialize a portfolio of biosimilars of advanced biologics including: BENEPALI, an etanercept biosimilar referencing ENBREL;
IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a
ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing
ACTEMRA, in the U.S. and certain international markets. We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar
referencing EYLEA.
On July 2, 2024, we completed the acquisition of HI-Bio. As a result of this transaction we acquired HI-Bio's lead asset, felzartamab, an anti-
CD38 antibody currently being evaluated for three leading indications, AMR, PMN and IgAN. For additional information on our acquisition of
HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in this report.
For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we regularly review our manufacturing
capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large
molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland. In the second quarter of 2021
a portion of the facility (the first manufacturing suite) received a GMP multi-product license from SWISSMEDIC and was placed into service.
The second manufacturing suite, which was also licensed to operate by SWISSMEDIC, became operational in the first quarter of 2024.
Solothurn has been approved for the manufacture of LEQEMBI. We believe that the Solothurn facility will support our anticipated near to mid-
term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity. If we
are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on
our financial condition and results of operations.
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In the longer term, our revenue growth will depend upon the successful clinical development, regulatory approval and launch of new
commercial products as well as additional indications for our existing products, our ability to obtain and maintain patents and other rights
related to our marketed products, assets originating from our research and development efforts and/or successful execution of external
business development opportunities.
BUSINESS ENVIRONMENT
For a detailed discussion on our business environment, please read Item 1. Business, included in this report. 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.
TECFIDERA
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices
compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that
TECFIDERA revenue will continue to decline. We are defending the validity of our EP 2 653 873 patent related to TECFIDERA and expiring
in 2028 in opposition proceedings in the European Patent Office. We are also engaged in litigation in Europe to defend and enforce national
counterparts of our EP 2 653 873 patent, with mixed results.
TYSABRI
A biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect the future sales of TYSABRI may be adversely
affected by the entrance of this biosimilar.
BUSINESS UPDATE REGARDING MACROECONOMIC CONDITIONS AND OTHER DISRUPTIONS
Significant portions of our business are conducted in Europe, Asia and other international geographies. Factors such as global health
outbreaks, adverse weather events, geopolitical events, tariffs, inflation, 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.
CURRENT ECONOMIC CONDITIONS
Economic conditions remain vulnerable as markets continue to be impacted in part by elevated inflation, higher interest rates, adverse
weather events, global supply chain uncertainties and risks associated with geopolitical conflicts.
ADVERSE WEATHER EVENTS
Adverse weather conditions, including hurricanes, earthquakes, wildfires and natural disaster damage, may affect our ability to do business.
We currently have operations in RTP, North Carolina, which were not impacted by recent hurricanes.
GLOBAL SUPPLY CHAIN DISRUPTIONS
Global supply chain disruptions, such as strikes, work stoppages, port congestion, port closures and other logistical problems, may affect our
ability to do business. For example, in 2024 major port strikes on the East and Gulf Coasts of the U.S. resulted in delayed cargo movement
for several days. As our primary shipping method for resources and finished goods is through air freight, the recent port strikes did not impact
our business; however, we will continue to assess any future port disruptions and if necessary, work to secure alternative transportation.
GEOPOLITICAL TENSIONS
Global disputes and interruptions in international relationships, including tariffs, trade protection measures, import or export licensing
requirements and the imposition of trade sanctions or similar restrictions, affect our ability to do business. For example, tensions between
China and Taiwan and tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on
imports from China mainland, retaliatory tariffs imposed by China on U.S. imports, as well as other business restrictions, with additional
restrictive measures being proposed.
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We, and the pharmaceutical industry, utilize China-based partners for certain raw materials, ingredients and components for our
pharmaceutical products and their delivery devices. Engaging alternative suppliers may involve seeking additional regulatory approvals and
be costly in terms of time and resources needed. For example, certain early processes related to our acquired SKYCLARYS product rely on
a single supplier based in China. We are continuing to evaluate SKYCLARYS' supply chain and prioritizing actions to mitigate risks
associated with its manufacturing and our ability to supply patients.
The ongoing geopolitical tensions related to Russia's invasion of Ukraine and the military conflict in the Middle East have resulted in global
business disruptions and economic volatility. For example, sanctions and other restrictions have been 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. 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 between Russia and Ukraine, its impact
on regional and global economic conditions and whether the conflict spreads or has effects on countries outside Ukraine and Russia.
We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East 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. Revenue generated from sales in Russia and Ukraine represent less than 2.0% of total revenue for the years ended
December 31, 2024, 2023 and 2022. Additionally, revenue generated from sales in the broader Middle East region represents less than 2.0%
of total revenue for the years ended December 31, 2024, 2023 and 2022.
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 are effective for periods after December 31, 2022. The
IRA did not result in any material adjustments to our income tax provision or other income tax balances as of December 31, 2024 and 2023.
Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods. We 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 the following:
(i)    allowing CMS to negotiate prices for select high-cost Medicare Part D drugs (beginning in 2026) and Part B drugs (beginning in 2028)
to reduce out-of-pocket prescription drug costs for beneficiaries, potentially resulting in higher contributions from plans and
manufacturers;
(ii)    drug inflationary rebate requirements to penalize manufacturers from raising the prices of Medicare covered single-source drugs and
biologics beyond the inflation-adjusted rate, beginning in 2022 for Part D drugs and 2023 for Part B drugs;
(iii)    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; and
(IV)    Medicare Part D redesign which replaces the current coverage gap provisions and establishes a $2,000 cap for out-of-pocket costs
for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for up to 10.0% of costs up to the $2,000 cap
and up to 20.0% after that cap is reached. Manufacturers that qualify as either specified or specified small manufacturers will phase-
in the new manufacturer liability for prescription drug costs over a 7-year period from 2025 to 2031 for certain Medicare Part D drugs
dispensed to certain beneficiaries.
In April 2024 CMS informed us that we qualified for the specified manufacturer exception pertaining to the Medicare Part D redesign. We
expect the IRA's drug pricing controls and Medicare Part D redesign may have an adverse impact on our sales, particularly for our products
that are more substantially reliant on Medicare reimbursement. We anticipate the IRA Medicare Part D redesign will have a modest net
unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and
MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
The degree of impact from this legislation on our business depends on a number of forthcoming implementation actions by regulatory
authorities, the full extent of the IRA's impacts on our sales and, in turn, our business, remains unclear.
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FINANCIAL HIGHLIGHTS
As described below under Results of Operations, our net income and diluted earnings per share attributable to Biogen Inc. for the year ended
December 31, 2024, compared to the year ended December 31, 2023, reflects the following:
TOTAL REVENUE
Decreased
$159.7 million or 1.6%
DILUTED EARNINGS PER SHARE
Increased
$3.21 or 40.3%
PRODUCT REVENUE, NET
Decreased
$33.2 million or 0.5%
• MS revenue decreased $312.1 million, or 6.7%
• Rare disease revenue increased $185.1 million, or 10.3%
• The decrease in MS product revenue was primarily due to a decrease in
Interferon demand due to competition as patients transition to higher
efficacy therapies and a decrease in global TYSABRI revenue driven by
increased competition.
• The increase in rare disease product revenue in 2024 was primarily due to
revenue from new product launches, including global SKYCLARYS
revenue of $382.5 million, $72.2 million for ZURZUVAE and $32.4 million
for QALSODY. This was partially offset by a decrease in rest of world
SPINRAZA revenue driven by the loss of an annual tender in Russia which
resulted in an unfavorable impact of approximately $45.0 million. The
decrease was also impacted by the timing of SPINRAZA shipments and
the unfavorable impact of foreign currency exchange.
TOTAL COST AND EXPENSE
Decreased
$768.9 million or 9.0%
• Cost of sales decreased $223.0 million, or 8.8%
• R&D expense decreased $420.2 million, or 17.1%
• SG&A expense decreased $146.0 million, or 5.7%
• Amortization and impairment of acquired intangible assets increased
$206.1 million, or 85.7%
• The decrease in cost of sales was primarily due to favorable product mix
from lower contract manufacturing revenue and lower idle capacity
charges, partially offset by approximately $181.5 million in SKYCLARYS
amortization costs.
• The decrease in R&D expense was primarily driven by approximately
$197.0 million of equity-based compensation expense recognized in 2023
related to our Reata acquisition, cost-reduction measures realized in 2024
in connection with our portfolio prioritization initiatives and our Fit for
Growth program, as well as higher spend on clinical trials and close out
costs incurred during 2023, partially offset by approximately $48.5 million
in SKYCLARYS amortization costs and approximately $42.5 million of
equity-based compensation expense recognized in 2024 related to our HI-
Bio acquisition.
• The decrease in SG&A expense was primarily due to approximately
$196.4 million of equity-based compensation expense recognized in 2023
related to our Reata acquisition.
• The increase in amortization and impairment of acquired intangible assets
was primarily due to amortization for the acquired intangible assets
associated with SKYCLARYS, as well as impairment charges of
approximately $60.2 million during 2024.
FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES
• Cash and cash equivalents totaled approximately $2.4 billion as of
December 31, 2024, compared to approximately $1.0 billion as of
December 31, 2023.
• We generated approximately $2,875.5 million of net cash flow from
operations for the year ended December 31, 2024.
• We received a net cash payment of $88.6 million from the sale of our rare
pediatric disease PRV in 2024.
• In April 2024 we received $437.5 million from Samsung BioLogics related
to the sale of our equity interest in Samsung Bioepis.
• In July 2024 we completed the acquisition of HI-Bio for $1.15 billion, which
was funded through available cash on hand.
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RECENT DEVELOPMENTS
ACQUISITIONS AND DIVESTITURES
HUMAN IMMUNOLOGY BIOSCIENCES
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage
biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab,
an anti-CD38 antibody, is currently being evaluated for three leading indications, AMR, PMN and IgAN. Felzartamab has received
Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR. Subsequent to our
acquisition, felzartamab received ODD in the E.U. in IgAN and solid organ transplantation. The acquisition of HI-Bio is expected to augment
our pipeline and build on our expertise in immunology.
Under the terms of this acquisition, we paid shareholders of HI-Bio approximately $1.15 billion at closing and may pay up to an additional
$650.0 million in potential future development and regulatory milestone payments. We funded this acquisition through available cash on hand
and accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805,
Business Combinations, and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date. For
additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in this
report.
SALE OF PRIORITY REVIEW VOUCHER
In April 2024 we completed the sale of our rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third
party. In consideration for the PRV we received a cash payment of $103.0 million upon the closing of the PRV purchase, of which
approximately $14.4 million was paid to Ionis. Our net portion of approximately $88.6 million was recognized in gain on sale of priority review
voucher, net within our consolidated statements of income for the year ended December 31, 2024. For additional information on the sale of
our PRV, please read Note 3, Dispositions, to our consolidated financial statements included in this report.
DEVELOPMENTS IN KEY COLLABORATIVE RELATIONSHIPS
LEQEMBI (lecanemab)
United States
Key developments related to LEQEMBI in the U.S. consisted of the following:
•
In January 2025 the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
•
In January 2025 the FDA accepted for review the BLA for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, with a
PDUFA action date set for August 31, 2025.
•
In July 2024 Eisai presented new clinical data from the CLARITY AD study open-label extension of LEQEMBI, demonstrating that three
years of continuous LEQEMBI treatment reduced clinical decline, resulting in a clinically meaningful benefit for early Alzheimer's disease
patients.
Rest of World
Key developments related to LEQEMBI (lecanemab) in rest of world markets consisted of the following:
•
In January 2025 we and Eisai announced an update regarding the ongoing regulatory review of the MAA for lecanemab in the E.U., which
the CHMP of the EMA previously adopted a positive opinion on in November 2024. The EC has asked the CHMP to consider information
on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may
require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to
ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.
•
In December 2024 LEQEMBI was approved by the Federal Commission for the Protection Against Sanitary Risk in Mexico.
•
In November 2024 we and Eisai announced the launch of LEQEMBI in South Korea, which had been approved by the Ministry of Food
and Drug Safety in South Korea in May 2024.
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•
In October 2024 the Therapeutic Goods Administration of Australia issued a public statement about the initial decision not to register
lecanemab. In December 2024 Eisai submitted a request for reconsideration of this decision.
•
In August 2024 LEQEMBI was approved by the Medicines and Healthcare products Regulatory Agency in Great Britain and by the
Ministry of Health and Prevention in the United Arab Emirates.
•
In July 2024 LEQEMBI was approved in Hong Kong and Israel.
•
In June 2024 we and Eisai announced the launch of LEQEMBI in China, which had been approved by the NMPA in China in January
2024.
OTHER KEY DEVELOPMENTS
felzartamab
In October 2024 the FDA granted felzartamab Breakthrough Therapy Designation for the treatment of late AMR without T-cell mediated
rejection in kidney transplant patients. Additionally, felzartamab was granted ODD in the E.U. in IgAN and solid organ transplantation in
November 2024 and December 2024, respectively.
UCB COLLABORATION
In September 2024 we and UCB announced positive topline data from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel
Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe SLE. The Phase 3 study met the primary endpoint
demonstrating clinical improvement in moderate-to-severe SLE with clinical improvements observed among key secondary endpoints. Based
on these results, UCB and Biogen initiated a second Phase 3 study in late 2024.
SPINRAZA (nusinersen)
In September 2024 we announced positive topline data from the Phase 2/3 DEVOTE study of nusinersen, which evaluated the safety and
efficacy of a higher dose regimen of nusinersen in treatment-naive symptomatic infants with SMA.
In January 2025 the FDA accepted the supplemental NDA and the EMA validated the application for a higher dose regimen of nusinersen for
SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg-doses 14 days apart, and higher
maintenance regimen, 28 mg, every four months, compared to the currently approved dose of SPINRAZA.
DISCONTINUED PROGRAMS AND STUDIES
SAGE COLLABORATION
zuranolone
In October 2024 we and Sage agreed to not pursue further development of zuranolone for the potential treatment of MDD. This decision was
based on the significant new investment and time we expect would be needed to conduct the additional studies required to support approval
of this indication.
BIIB124
In July 2024 we and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124 did not meet its endpoints. Based on these
results, we discontinued our further development of BIIB124 and terminated our rights under the collaboration and license agreement specific
to BIIB124, effective February 17, 2025.
SAMSUNG BIOEPIS 2019 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
In October 2024 we notified Samsung Bioepis of our decision to terminate our 2019 Development and Commercialization Agreement (the
DCA Agreement) solely within the U.S. and Canada. Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S. and
Canada back to Samsung Bioepis over a period of up to 18 months. During this transition period, we will continue to commercialize
BYOOVIZ. The termination does not impact the other markets in the DCA Agreement.
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IONIS COLLABORATION
BIIB105
In May 2024 we and Ionis announced that the Phase 1/2 ALSpire study of BIIB105, an investigational ASO for the potential treatment of ALS,
did not meet its endpoints. Based on these results, we discontinued our further development of BIIB105.
BIIB121
In May 2024 we announced that we have elected not to exercise our option to license and lead development of BIIB121, an ASO for the
potential treatment of Angelman syndrome.
MERZ THERAPEUTICS (PREVIOUSLY ACORDA THERAPEUTICS, INC.)
In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025, whereby
Acorda regained global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its
intention to sell substantially all of Acorda's assets to a third party. On July 10, 2024, Merz Therapeutics announced that its subsidiary Merz
Pharmaceuticals LLC had completed the acquisition of FAMPYRA, and related assets from Acorda. We are now working with Merz
Therapeutics on the transition of global commercialization rights of FAMPYRA and we expect to recognize minimal revenue in 2025.
BIIB143 (cemdomespib)
In early 2025 we discontinued further development of BIIB143 (cemdomespib) for the treatment of diabetic neuropathic pain, as part of our
ongoing pipeline prioritization efforts.
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RESULTS OF OPERATIONS
REVENUE
The following revenue discussion should be read in conjunction with Note 5, Revenue, to our consolidated financial statements included in
this report.
Revenue is summarized as follows:
 
For the Years Ended December 31,
% Change
$ Change
 
2024 

vs.

2023
2023

vs.

2022
2024 

vs.

2023
2023

vs.

2022
(In millions, except percentages)
2024
2023
2022
Product revenue, net:
United States
$
3,237.3 
$
3,141.4 
$
3,469.3 
3.1 %
(9.5)%
$
95.9 
$
(327.9)
Rest of world
3,976.2 
4,105.3 
4,518.5 
(3.1)
(9.1)
(129.1)
(413.2)
Total product revenue, net
7,213.5 
7,246.7 
7,987.8 
(0.5)
(9.3)
(33.2)
(741.1)
Revenue from anti-CD20 therapeutic programs
1,749.9 
1,689.6 
1,700.5 
3.6 
(0.6)
60.3 
(10.9)
Alzheimer's collaboration revenue
59.9 
— 
— 
nm
— 
59.9 
— 
Contract manufacturing, royalty and other revenue
652.6 
899.3 
485.1 
(27.4)
85.4 
(246.7)
414.2 
Total revenue
$
9,675.9 
$
9,835.6 
$
10,173.4 
(1.6)%
(3.3)%
$
(159.7)
$
(337.8)
 Not meaningful
 Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties.
PRODUCT REVENUE
Product revenue is summarized as follows:
 
For the Years Ended December 31,
% Change
$ Change
 
2024 

vs.

2023
2023

vs.

2022
2024 

vs.

2023
2023

vs.

2022
(In millions, except percentages)
2024
2023
2022
Multiple Sclerosis
$
4,349.8 
$
4,661.9 
$
5,430.2 
(6.7)%
(14.1)%
$
(312.1)
$
(768.3)
Rare disease
1,988.1 
1,803.0 
1,793.5 
10.3 
0.5 
185.1 
9.5 
Biosimilars
793.1 
770.0 
751.1 
3.0 
2.5 
23.1 
18.9 
Other
82.5 
11.8 
13.0 
599.2 
(9.2)
70.7 
(1.2)
Total product revenue, net
$
7,213.5 
$
7,246.7 
$
7,987.8 
(0.5)%
(9.3)%
$
(33.2)
$
(741.1)
 Other includes FUMADERM, ADUHELM and ZURZUVAE, which became commercially available in the U.S. during the fourth quarter of 2023.
(1)
nm
(1)
(1)
(1)
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MULTIPLE SCLEROSIS
• Global TYSABRI revenue decreased $161.9 million, from $1,876.9
million in 2023 to $1,715.0 million in 2024, or 8.6%, primarily due to
increased competition and a decrease in pricing in rest of world
TYSABRI.
• Global TECFIDERA revenue decreased $45.4 million, from $1,012.5
million in 2023 to $967.1 million in 2024, or 4.5%, driven by a
decrease in demand as a result of multiple TECFIDERA generic
entrants in North America, Brazil and certain E.U. countries.
• Global Interferon revenue decreased $137.7 million, from $1,105.7
million in 2023 to $968.0 million in 2024, or 12.5%, driven by a
decrease is demand as patients transition to higher efficacy
therapies.
• Global VUMERITY revenue increased $51.7 million, from $576.3
million in 2023 to $628.0 million in 2024, or 9.0%, primarily due to an
increase in global demand.
MS revenue includes sales from TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective January 1, 2025, our
collaboration and license agreement for FAMPYRA global commercialization rights was terminated. We expect to recognize minimal revenue
in 2025.
In 2025 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the
U.S. and rest of world markets. Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We expect that
future sales of TYSABRI may be adversely affected by the entrance of this biosimilar.
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RARE DISEASE
•
U.S. SPINRAZA revenue increased $15.2 million, from $610.5 million
in 2023 to $625.7 million in 2024, or 2.5%, primarily due to favorable
net pricing, offset by a decrease in demand.
•
Rest of world SPINRAZA revenue decreased $183.2 million, from
$1,130.7 million in 2023 to $947.5 million in 2024, or 16.2%,
primarily driven by the loss of an annual tender in Russia which
resulted in an unfavorable impact of approximately $45.0 million. The
decrease was also impacted by the timing of shipments and the
unfavorable impact of foreign currency exchange.
•
Global SKYCLARYS revenue was $382.5 million in 2024, including
$301.1 million of U.S. SKYCLARYS revenue, which we began
recognizing during the fourth quarter of 2023, subsequent to our
acquisition of Reata, and $81.4 million of rest of world SKYCLARYS
revenue, which was approved in the E.U. and became commercially
available during the first quarter of 2024.
•
Global QALSODY revenue was $32.4 million in 2024.
Rare disease revenue includes sales from SPINRAZA, QALSODY, which became commercially available in the U.S. during the second
quarter of 2023 and commercially available in the E.U. during the second quarter of 2024, and SKYCLARYS, which was obtained as part of
our acquisition of Reata in September 2023.
SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and we began recognizing revenue from
SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition of Reata. SKYCLARYS was also approved in the
E.U. and became commercially available during the first quarter of 2024.
In 2025 we expect growth in rare disease revenue as we continue to launch SKYCLARYS in the U.S. and the E.U. We anticipate global
SPINRAZA revenue to be relatively flat in 2025.
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BIOSIMILARS
•
For 2024 compared to 2023, the increase in biosimilar revenue was
primarily due to an increase in sales volumes related to BENEPALI,
partially offset by a decrease in pricing due to competitive pressures.

Biosimilars revenue includes sales from BENEPALI, IMRALDI, FLIXABI, BYOOVIZ and TOFIDENCE. In 2023 BYOOVIZ became
commercially available in certain international markets. During the third quarter of 2023 the FDA approved TOFIDENCE, a tocilizumab
biosimilar referencing ACTEMRA, which became commercially available in the U.S. during the second quarter of 2024 and approved in the
E.U. during the second quarter of 2024.
We continue to work with our third-party contract manufacturers for IMRALDI and BENEPALI to address supply constraints. If not resolved
these supply constraints could have an adverse impact on 2025 sales. In addition, one of our contract manufacturers for IMRALDI and
BENEPALI was acquired by a third party in December 2024. We have evaluated the impact this will have on our biosimilars business and
have mitigation activities in progress designed to ensure supply continuity.
After evaluating our strategic options, we have made the decision to retain our biosimilars business.
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REVENUE FROM ANTI-CD20 THERAPEUTIC PROGRAMS
Our share of RITUXAN, including RITUXAN HYCELA, GAZYVA and LUNSUMIO collaboration operating profits in the U.S., royalty revenue
on sales of OCREVUS 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.
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Royalty revenue on sales of OCREVUS
$
1,339.5 
$
1,266.2 
$
1,136.3 
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO
392.0 
409.4 
547.0 
Other revenue from anti-CD20 therapeutic programs
18.4 
14.0 
17.2 
Total revenue from anti-CD20 therapeutic programs
$
1,749.9 
$
1,689.6 
$
1,700.5 
 LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
ROYALTY REVENUE ON SALES OF OCREVUS
For 2024 compared to 2023, the increase in royalty revenue on sales of OCREVUS was primarily due to sales growth of OCREVUS in the
U.S.
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.
BIOGEN'S SHARE OF PRE-TAX PROFITS IN THE U.S. FOR RITUXAN, GAZYVA AND LUNSUMIO
The following table provides a summary of amounts comprising our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and
LUNSUMIO:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Product revenue, net
$
1,531.0 
$
1,581.3 
$
1,729.2 
Cost and expense
404.1 
419.9 
253.6 
Pre-tax profits in the U.S.
$
1,126.9 
$
1,161.4 
$
1,475.6 
Biogen's share of pre-tax profits
$
392.0 
$
409.4 
$
547.0 
For 2024 compared to 2023, the decrease in U.S. product revenue, net was primarily due to a decrease in sales volumes of RITUXAN in the
U.S. of 7.9%, resulting from competition from multiple biosimilar products, partially offset by an increase in sales volumes of GAZYVA of
11.8%.
In April 2023 our pre-tax profit share for RITUXAN, GAZYVA and LUNSUMIO decreased from 37.5% to 35.0%.
Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in
research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated
statements of income. After an anti-CD20 product is approved, we record our share of the development and sales and marketing expense
related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs.
We are aware of several other anti-CD20 molecules, including biosimilar products, that have been approved and are competing with
RITUXAN and GAZYVA in the oncology and other markets. Biosimilar products referencing RITUXAN 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.
(1)
(1)
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OTHER REVENUE FROM ANTI-CD20 THERAPEUTIC PROGRAMS
Other revenue from anti-CD20 therapeutic programs consists of our share of pre-tax co-promotion profits from RITUXAN in Canada, royalty
revenue on sales of LUNSUMIO outside the U.S. and royalty revenue on net sales of COLUMVI in the U.S., which became commercially
available during the second quarter of 2023.
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 19, Collaborative and Other Relationships,
to our consolidated financial statements included in this report.
ALZHEIMER'S COLLABORATION REVENUE
Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we
are not the principal. We began recognizing Alzheimer's collaboration revenue upon the accelerated approval of LEQEMBI in the U.S. during
the first quarter of 2023.
For the year ended December 31, 2024, we recognized approximately $59.9 million of Alzheimer's collaboration revenue within our
consolidated statements of income. For the year ended December 31, 2023, our share of LEQEMBI product revenue, net, was fully offset by
our share of cost of sales, including royalties, resulting in a zero net impact to Alzheimer's collaboration revenue within our consolidated
statements of income.
For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
CONTRACT MANUFACTURING, ROYALTY AND OTHER REVENUE
Contract manufacturing, royalty and other revenue is summarized as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Contract manufacturing revenue
$
592.1 
$
848.2 
$
417.7 
Royalty and other revenue
60.5 
51.1 
67.4 
Total contract manufacturing, royalty and other revenue
$
652.6 
$
899.3 
$
485.1 
CONTRACT MANUFACTURING REVENUE
Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers.
For 2024 compared to 2023, the decrease in contract manufacturing revenue was primarily driven by higher volumes in 2023 due to the
timing of batch production, which includes batches related to LEQEMBI that we began recognizing in the first quarter of 2023 upon the
accelerated approval of LEQEMBI in the U.S.
In addition, as part of the 2020 sale of our Hillerød, Denmark manufacturing operations to FUJIFILM, we provided FUJIFILM with certain
minimum batch production commitment guarantees, including batches related to our contract manufacturing arrangements. These batch
commitments were satisfied as of December 31, 2023. As a result, we recognized lower contract manufacturing revenue in 2024, compared
to 2023, as we are no longer supplying contract manufacturing customers using Hillerød in this manner.
ROYALTY AND OTHER REVENUE
Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and
royalties we receive from net sales on products related to patents that we have out-licensed.
For additional information on our license arrangements with Samsung Bioepis and our collaborative arrangements with Eisai, please read
Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
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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.
In August 2022 the IRA was signed into law in the U.S. and contains substantial drug pricing reforms. We expect the IRA's drug pricing
controls and Medicare Part D redesign may have an adverse impact on our sales, particularly for our products that are more substantially
reliant on Medicare reimbursement. We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025
revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue,
approximately a third of which could be associated with SKYCLARYS.
Reserves for discounts, contractual adjustments and returns that reduced gross product revenue are summarized as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Contractual adjustments
$
2,648.8 
$
2,681.7 
$
2,716.9 
Discounts
832.2 
735.2 
663.9 
Returns
37.8 
38.2 
5.1 
Total discounts and allowances
$
3,518.8 
$
3,455.1 
$
3,385.9 
For the years ended December 31, 2024, 2023 and 2022, reserves for discounts and allowances as a percentage of gross product revenue
were 32.6%, 32.0% and 30.1%, respectively.
CONTRACTUAL ADJUSTMENTS
Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay)
assistance, VA, 340B discounts, specialty pharmacy program fees and other government rebates or applicable allowances.
For 2024 compared to 2023, the decrease in contractual adjustments was primarily due to lower government rebates in rest of world and
biosimilars, partially offset by higher government rebates in the U.S.
DISCOUNTS
Discounts include trade term discounts, wholesaler incentives and volume related discounts.
For 2024 compared to 2023, the increase in discounts was primarily driven by higher purchase and volume discounts for biosimilars and rest
of world, as well as higher purchase discounts in the U.S.
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 estimated product returns are recognized in the period the related revenue is recognized, resulting in a reduction to product sales.
For 2024 compared to 2023, return reserves were relatively consistent.
For additional information on our revenue reserves, please read Note 5, Revenue, to our 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 Years Ended December 31,
% Change
$ Change
 
2024 

vs.

2023
2023

vs.

2022
2024 

vs.

2023
2023

vs.

2022
(In millions, except percentages)
2024
2023
2022
Cost of sales, excluding amortization and impairment of
acquired intangible assets
$
2,310.4 
$
2,533.4 
$
2,278.3 
(8.8)%
11.2 %
$
(223.0)
$
255.1 
Research and development
2,041.8 
2,462.0 
2,231.1 
(17.1)
10.3 
(420.2)
230.9 
Selling, general and administrative
2,403.7 
2,549.7 
2,403.6 
(5.7)
6.1 
(146.0)
146.1 
Amortization and impairment of acquired intangible assets
446.7 
240.6 
365.9 
85.7 
(34.2)
206.1 
(125.3)
Collaboration profit sharing/(loss reimbursement)
254.4 
218.8 
(7.4)
16.3 
nm
35.6 
226.2 
(Gain) loss on fair value remeasurement of contingent
consideration
27.7 
— 
(209.1)
nm
nm
27.7 
209.1 
Restructuring charges
30.2 
218.8 
131.1 
(86.2)
66.9 
(188.6)
87.7 
Gain on sale of priority review voucher, net
(88.6)
— 
— 
nm
— 
(88.6)
— 
Gain on sale of building, net
— 
— 
(503.7)
— 
nm
— 
503.7 
Other (income) expense, net
343.6 
315.5 
(108.2)
8.9 
(391.6)
28.1 
423.7 
Total cost and expense
$
7,769.9 
$
8,538.8 
$
6,581.6 
(9.0)%
29.7 %
$
(768.9)
$
1,957.2 
 Not meaningful
COST OF SALES, EXCLUDING AMORTIZATION AND IMPAIRMENT OF ACQUIRED INTANGIBLE ASSETS
For the Years Ended December 31,
(In millions)
2024
2023
2022
Product
$
1,604.2 
$
1,787.2 
$
1,504.8 
Royalty
706.2 
746.2 
773.5 
Total cost of sales
$
2,310.4 
$
2,533.4 
$
2,278.3 
Cost of sales, as a percentage of total revenue, were 23.9%, 25.8% and 22.4% for the years ended December 31, 2024, 2023 and 2022,
respectively.
PRODUCT COST OF SALES
For 2024 compared to 2023, the decrease in product cost of sales was primarily due to favorable product mix from decreased contract
manufacturing revenue and lower idle capacity charges, offset in part by approximately $181.5 million in SKYCLARYS amortization costs.
Contract manufacturing revenue includes LEQEMBI inventory produced for Eisai, beginning in the first quarter of 2023 upon the accelerated
approval of LEQEMBI in the U.S. Cost of sales as a percentage of revenue was adversely affected by LEQEMBI batches due to minimal
margins.
As a result of our acquisition of Reata in September 2023 we recorded a fair value step-up adjustment related to the acquired inventory of
SKYCLARYS of approximately $1.3 billion. This fair value step-up adjustment is being amortized to cost of sales within our consolidated
statements of income as the inventory is sold, which is expected to be sold over a period of approximately 4 years from the acquisition date.
For the years ended December 31, 2024 and 2023, amortization from the fair value step-up adjustment was approximately $181.5 million
and $31.5 million, respectively. For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our consolidated
financial statements included in this report.
Write Downs and Other Charges
Inventory amounts written down as a result of excess, obsolescence or unmarketability totaled $101.9 million, $124.4 million and $336.2
million for the years ended December 31, 2024, 2023 and 2022, respectively.
For the years ended December 31, 2024, 2023 and 2022, we recorded approximately $4.8 million, $165.2 million and $119.0 million,
respectively, of aggregate gross idle capacity charges.
ROYALTY COST OF SALES
For 2024 compared to 2023, the decrease in royalty cost of sales was primarily due to lower royalties payable associated with lower sales of
SPINRAZA and TYSABRI, partially offset by higher royalties payable associated with higher sales of SKYCLARYS.
nm
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RESEARCH AND DEVELOPMENT
Research and development expense, as a percentage of total revenue,
was 21.1%, 25.0% and 21.9% for the years ended December 31, 2024,
2023 and 2022, respectively.
For 2024 compared to 2023, the decrease in research and development
was primarily driven by approximately $197.0 million of equity-based
compensation expense recognized in 2023 related to our acquisition of
Reata, cost-reduction measures realized in 2024 in connection with our
portfolio prioritization initiatives and our Fit for Growth program, as well
as higher spend on clinical trials and close out costs incurred during
2023, partially offset by approximately $48.5 million of step-up
amortization related to SKYCLARYS inventory and approximately
$42.5 million of equity based compensation expense recognized in
2024 related to our acquisition of HI-Bio.
EARLY STAGE PROGRAMS
2024 vs. 2023
The decrease in early stage programs was driven by a decrease in
costs associated with:
• advancement of BIIB059 for the treatment of CLE into late stage;
• discontinuation of BIIB121 for the treatment of Angelman syndrome; and
• discontinuation of BIIB131 for the treatment of acute ischemic stroke.
The decrease was partially offset by an increase in costs associated
with:
• development of BIIB080 for the treatment of Alzheimer's disease;
• development of cemdomespib for the treatment of diabetic neuropathic
pain; and
• development of BIIB091 for the treatment of MS.
LATE STAGE PROGRAMS
2024 vs. 2023
The decrease in late stage programs was driven by a decrease in costs
associated with:
• advancement of ZURZUVAE from late stage to marketed upon the
approval of ZURZUVAE for PPD in the U.S.;
• advancement of QALSODY from late stage to marketed upon the
accelerated approval of QALSODY in the U.S.;
• advancement of TOFIDENCE from late stage to marketed upon the
approval of TOFIDENCE in the U.S.; and
• discontinuation of BIIB093 for LHI.
The decrease was partially offset by an increase in costs associated
with:
• advancement of BIIB059 for the treatment of CLE into late stage; and
• development of BIIB059 for the treatment of SLE.
MARKETED PROGRAMS
2024 vs. 2023
The decrease in marketed programs was driven by a decrease in costs
associated with:
• discontinuation of ADUHELM for the treatment of Alzheimer's disease;
• decreased spend on LEQEMBI for the treatment of Alzheimer's disease;
and
• decreased spend on ZURZUVAE for MDD.
The decrease was partially offset by an increase in costs associated
with:
• increased spend in SKYCLARYS as a result of our acquisition of Reata
in 2023;
• advancement of QALSODY from late stage to marketed upon the
accelerated approval of QALSODY in the U.S.; and
• advancement of TOFIDENCE from late stage to marketed upon the
approval of TOFIDENCE in the U.S.
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MILESTONE AND UPFRONT EXPENSE
Research and development expense for 2024 includes:
•
$20.0 million in charges to research and development expense in connection with the upfront payment associated with entering into our
collaboration with Neomorph in the fourth quarter of 2024;
•
$16.0 million in charges to research and development expense in connection with milestone payments to C4;
•
$12.0 million in charges to research and development expense in connection with milestone payments to Alcyone; and
•
$7.5 million in charges to research and development expense in connection with a milestone payment to Ionis.
Research and development expense for 2023 includes:
•
$7.5 million charge to research and development expense in connection with a milestone payment to Ionis; and
•
$5.0 million charge to research and development expense in connection with exercising our option with Denali to license the ATV-
enabled anti-amyloid beta program.
Research and development expense is reported above based on the following classifications. The development stage reported is 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.
•
Research and discovery: represents costs incurred to support our discovery research and translational science efforts.
•
Early stage programs: are programs in Phase 1 or Phase 2 development.
•
Late stage programs: are programs in Phase 3 development or in registration stage.
•
Marketed products: includes costs associated with product lifecycle management activities including, if applicable, costs associated
with the development of new indications for existing products.
•
Other research and development costs: A significant amount of our research and development costs consist 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. For 2023
other research and development costs also includes approximately $197.0 million of equity-based compensation expense incurred as
a result of our acquisition of Reata in 2023.
Excluding any milestone and upfront payments, we expect our core research and development expense to decrease in 2025, while
continuing to invest in our pipeline, such as our acquisition of HI-Bio in July 2024. This is primarily due to the continued realization of our cost
savings initiatives. We intend to continue committing significant resources to targeted research and development opportunities where there is
a significant unmet need and where a drug candidate has the potential to be highly differentiated.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements
included in this report.
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SELLING, GENERAL AND ADMINISTRATIVE
For 2024 compared to 2023, selling, general and administrative expense decreased by approximately 5.7% primarily due to equity-based
compensation expense recognized in 2023 of approximately $196.4 million related to our acquisition of Reata. Selling, general and
administrative expense for 2024 also includes higher operational spending on sales and marketing activities in support of LEQEMBI and
SKYCLARYS as we continue to expand our U.S. and international product launches, which was partially offset by cost-reduction measures
realized in connection with our Fit for Growth program.
In 2024, selling, general and administrative expense included the recognition of approximately $13.9 million in equity-based compensation
expense related to our acquisition of HI-Bio that was associated with the accelerated vesting of stock options and RSUs previously granted to
HI-Bio employees and required no future services to vest. Additionally, we incurred transaction and integration-related expense of
approximately $3.6 million related to our acquisition of HI-Bio.
In 2023, selling, general and administrative expense included the recognition of approximately $196.4 million in equity-based compensation
expense related to our acquisition of Reata that was associated with the accelerated vesting of stock options and RSUs previously granted to
Reata employees and required no future services to vest. Additionally, we incurred transaction and integration-related expense of
approximately $34.6 million related to our acquisition of Reata. In 2023, selling, general and administrative expense also included a
$31.0 million obligation to Eisai related to the termination of the co-promotion agreement for our MS products in Japan and approximately
$11.5 million of accelerated depreciation.
GENERAL AND ADMINISTRATIVE EXPENSE
In 2024 compared to 2023, general and administrative expense decreased by approximately $173.2 million, or 19.6%, due to the recognition
of approximately $196.4 million in equity-based compensation expense in 2023 related to our acquisition of Reata.
We expect selling, general and administrative costs to continue to decline in 2025 due to the continued realization of our cost-reduction
measures in connection with our Fit for Growth program.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements
included in this report.
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 TYSABRI, AVONEX, SPINRAZA, VUMERITY and SKYCLARYS, which was obtained as part of our
acquisition of Reata in September 2023. For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our
consolidated financial statements included in this report.
For the year ended December 31, 2024, amortization and impairment of acquired intangible assets reflects the impact of a $40.0 million
impairment charge related to intangible assets from other clinical programs we acquired from Reata, reducing the remaining book value of
these IPR&D intangible assets to zero, and a $20.2 million impairment charge related to intangible assets associated with Samsung Bioepis
commercialization rights terminated during the third quarter of 2024. For the year ended December 31, 2023, we had no impairment charges.
Amortization of acquired intangible assets, excluding impairment charges, totaled $386.5 million, $240.6 million and $246.3 million for the
years ended December 31, 2024, 2023 and 2022, respectively. For 2024 compared to 2023, the increase in amortization of acquired
intangible assets, excluding impairment charges, was primarily due to amortization for the Reata acquisition acquired intangible assets
associated with SKYCLARYS.
For additional information on the amortization and impairment of our acquired intangible assets, please read Note 7, Intangible Assets and
Goodwill, to our consolidated financial statements included in this report. For additional information on our 2019 Development and
Commercialization Agreement with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our consolidated
financial statements included in this report.
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COLLABORATION PROFIT SHARING/(LOSS REIMBURSEMENT)
Collaboration profit sharing/(loss reimbursement) includes Samsung Bioepis' 50.0% share of the profit or loss related to our biosimilars 2013
commercial agreement with Samsung Bioepis and, beginning in the third quarter of 2023, collaboration profit sharing/(loss reimbursement)
related to Sage's 50.0% share of the profit or loss in the U.S. related to ZURZUVAE for PPD.
For the years ended December 31, 2024, 2023 and 2022, we recognized net profit-sharing expense of approximately $227.4 million, $223.5
million and $217.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits.
For the years ended December 31, 2024 and 2023, we recognized net profit-sharing expense of approximately $27.0 million and net loss
reimbursement of approximately $4.7 million, respectively, to reflect Sage's 50.0% share of net collaboration results in the U.S. for
ZURZUVAE for PPD.
For additional information on our collaboration and license arrangements with Samsung Bioepis and Sage, please read Note 19,
Collaborative and Other Relationships, to our consolidated financial statements included in this report.
(GAIN) LOSS ON FAIR VALUE REMEASUREMENT OF CONTINGENT CONSIDERATION
Consideration payable for certain of our business combinations include 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. In connection with our acquisition of HI-Bio in July 2024 we recorded contingent
consideration obligations related to potential milestone payments.
For the year ended December 31, 2024, the changes in the fair value of our contingent consideration obligations were primarily due to
changes in interest rates used to revalue our contingent consideration liabilities, the passage of time and updates to the expected timing of
achieving certain milestones which will trigger contingent consideration payments.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in
this report.
RESTRUCTURING CHARGES
2023 FIT FOR GROWTH RESTRUCTURING PROGRAM
In 2023 we initiated additional cost saving measures as part of our Fit for Growth program to reduce operating costs, while improving
operating efficiency and effectiveness. The Fit for Growth program is expected to generate approximately $1.0 billion in gross operating
expense savings by the end of 2025, some of which will be reinvested in various initiatives. The Fit for Growth program is currently estimated
to include net headcount reductions of approximately 1,000 employees and we expect to incur restructuring charges ranging from
approximately $260.0 million to $280.0 million.
Total charges incurred from our 2023 Fit for Growth program are summarized as follows:
For the Years Ended December 31,
2024
2023
(In millions)
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Severance

Costs
Accelerated
Depreciation and
Other Costs
Total
Selling, general and administrative
$
— 
$
13.8 
$
13.8 
$
— 
$
23.3 
$
23.3 
Research and development
— 
11.7 
11.7 
— 
1.2 
1.2 
Restructuring charges
24.2 
— 
24.2 
153.4 
34.6 
188.0 
Total charges
$
24.2 
$
25.5 
$
49.7 
$
153.4 
$
59.1 
$
212.5 
Other Costs: includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pretax gains and losses
resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs.
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REATA INTEGRATION
Following the close of our Reata acquisition in September 2023, we implemented an integration plan designed to realize operating synergies
through cost savings and avoidance. Under this initiative, we estimate we will incur total integration charges of approximately $35.0 million,
related to severance and employment costs. These severance and employment costs were substantially incurred during 2023.
Total charges incurred from our Reata integration are summarized as follows:
For the Years Ended December 31,
2024
2023
(In millions)
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Selling, general and administrative
$
— 
$
6.3 
$
6.3 
$
— 
$
— 
$
— 
Research and development
— 
11.9 
11.9 
— 
— 
— 
Restructuring charges
3.4 
— 
3.4 
30.4 
— 
30.4 
Total charges
$
3.4 
$
18.2 
$
21.6 
$
30.4 
$
— 
$
30.4 
In connection with our acquisition of Reata we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400
square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years. We do not intend to occupy this
building and are evaluating opportunities to sublease the property. For additional information on our acquisition of Reata, please read Note 2,
Acquisitions, to our consolidated financial statements included in this report.
HI-BIO INTEGRATION
Following the close of our HI-Bio acquisition in July 2024, we implemented an integration plan designed to realize operating synergies
through cost savings and avoidance. Under this initiative, we incurred approximately $2.6 million of severance and employment costs, which
are reflected in restructuring charges within our consolidated statements of income for the year ended December 31, 2024. For additional
information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in this report.
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, deprioritization of certain research and development programs, the consolidation of certain real estate locations
and operating efficiencies across our selling, general and administrative and research and development functions. Charges related to our
2022 cost saving initiatives were substantially incurred during 2022 with remaining payments expected to be made through 2026.
Total charges incurred from our 2022 cost saving initiatives are summarized as follows:
For the Years Ended December 31,
2023
2022
(In millions)
Severance

Costs
Accelerated
Depreciation and
Other Costs
Total
Severance
Costs
Accumulated
Depreciation and
Other Costs
Total
Restructuring charges
$
(2.2)
$
2.6 
$
0.4 
$
112.6 
$
18.5 
$
131.1 
Total charges
$
(2.2)
$
2.6 
$
0.4 
$
112.6 
$
18.5 
$
131.1 
 Amounts reflect a gain recorded during the third quarter of 2022 of approximately $5.3 million related to the partial termination of a portion of our lease located at 300 Binney
Street. For additional information on our 300 Binney Street lease modification, please read Note 12, Leases, to our consolidated financial statements included in this report.
For additional information on our cost saving initiatives, please read Note 4, Restructuring, to our consolidated financial statements included
in this report.
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OTHER (INCOME) EXPENSE, NET
For 2024 compared to 2023, the change in other (income) expense, net primarily reflects lower interest income driven by lower cash
balances in 2024, compared to 2023, partially offset by higher net losses on our holdings in equity securities in 2023.
NET (GAINS) LOSSES IN EQUITY SECURITIES
For the year ended December 31, 2024, net unrealized losses and realized gains on our holdings in equity securities were approximately
$102.4 million and $2.0 million, respectively, compared to net unrealized and realized losses of approximately $270.0 million and $5.2 million,
respectively, in 2023.
•
The net unrealized losses recognized during the year ended December 31, 2024, primarily reflect a decrease in the aggregate fair value
of our investments in Sage common stock of approximately $101.4 million, partially offset by an increase in the fair value of Denali and
Sangamo common stock of approximately $7.5 million.
•
The net unrealized losses recognized during the year ended December 31, 2023, primarily reflect a decrease in the aggregate fair value
of our investments in Sage, Denali, Sangamo and Ionis common stock of approximately $248.5 million.
INTEREST INCOME AND EXPENSE
For the year ended December 31, 2024, net interest expense was approximately $182.7 million, compared to net interest income of
$29.6 million in 2023. The change was primarily due to lower interest income driven by lower cash balances in 2024, compared to 2023, due
to use of cash on hand for business development transactions.
For 2025 compared to 2024, we anticipate lower net interest expense as a result of higher cash balances, somewhat offset by lower interest
rates, leading to more interest income.
INCOME TAX PROVISION
For the Years Ended December 31,
(In millions, except percentages)
2024
2023
2022
Income before income tax (benefit) expense
$
1,906.0 
$
1,296.8 
$
3,591.8 
Income tax (benefit) expense
273.8 
135.3 
632.8 
Effective tax rate
14.4 %
10.4 %
17.6 %
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 2024 compared to 2023, the increase in our effective tax rate was partially driven by the relative deferred tax effects of the changes in the
value of our equity investments and amortization of purchased intangible assets and inventory. Further, 2023 benefited from the combined
impacts of Reata acquisition-related expenses and the resolution of an uncertain tax matter related to tax credits. This was partially offset by
a 2024 benefit related to a decrease in our valuation allowance related to projected future foreign taxable income.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our consolidated financial statements included in
this report.
As a result of decreases in our stock price between the grant date of certain share-based compensation awards and the vesting date in 2025,
we expect that we will record an income tax expense of approximately $15.0 million during the first quarter of 2025, upon the vesting of these
awards. The exact amount of the income tax expense will depend on our stock price at the time of vesting.
PILLAR TWO
The OECD has issued model rules, which generally provide for a jurisdictional minimum effective tax rate of 15.0% as defined in those rules.
Various countries have or are in the process of enacting legislation intended to implement the principles effective January 1, 2024. Our
income tax provision for the year ended December 31, 2024, reflects currently enacted legislation and guidance related to the OECD model
rules. This enacted legislation and guidance related to the OECD model rules did not result in any material adjustments to our income tax
provision or income tax balances as of December 31, 2024. On January 20, 2025, the Global Tax Deal Executive Order was issued. At this
stage, we do not believe this Executive Order impacts our financial results as of December 31, 2024.
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For additional information on our income taxes, uncertain tax positions and income tax rate reconciliation, please read Note 17, Income
Taxes, to our consolidated financial statements included in this report.
NONCONTROLLING INTERESTS, NET OF TAX
Our consolidated financial statements include the financial results of a variable interest entity, Neurimmune, as we determined that we were
the primary beneficiary.
In November 2023 we notified Neurimmune of our decision to terminate the Neurimmune Agreement. Subsequent to the termination, we
reconsidered our relationship with Neurimmune and determined that we were no longer the primary beneficiary of the variable interest entity.
As a result, we recorded a net gain on the deconsolidation of Neurimmune of approximately $3.0 million, which was recorded in other
(income) expense, net within our consolidated statements of income for the year ended December 31, 2023.
For additional information on the deconsolidation and our collaboration agreement with Neurimmune, please read Note 20, Investments in
Variable Interest Entities, to our consolidated financial statements included in this report.
FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES
Our financial condition is summarized as follows:
 
As of December 31,
(In millions, except percentages)
2024
2023
% Change
$ Change
Financial assets:
Cash and cash equivalents
$
2,375.0 
$
1,049.9 
126.2 %
$
1,325.1 
Total cash and cash equivalents
$
2,375.0 
$
1,049.9 
126.2 %
$
1,325.1 
Borrowings:
Current portion of notes payable and term loan
$
1,748.6 
$
150.0 
nm
$
1,598.6 
Notes payable and term loan
4,547.2 
6,788.2 
(33.0)
(2,241.0)
Total borrowings
$
6,295.8 
$
6,938.2 
(9.3)%
$
(642.4)
Working Capital:
Current assets
$
7,456.8 
$
6,859.3 
8.7 %
$
597.5 
Current liabilities
(5,528.8)
(3,434.3)
61.0 
(2,094.5)
Total working capital
$
1,928.0 
$
3,425.0 
(43.7)%
$
(1,497.0)
 Not meaningful
OVERVIEW
We have historically financed and expect to continue to fund our operating and capital expenditures primarily through cash flow earned
through our operations, as well as our existing cash resources. We believe that generic and biosimilar competition for many of our key
products, the continued overall decline of our MS business and our investments in the launch of key new products and the development of
our pipeline will have a significant adverse impact on our future cash flow from operations.
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 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.
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio. Under the terms of this acquisition, we
paid shareholders of HI-Bio approximately $1.15 billion as well as an additional $43.7 million related to working capital adjustments as of the
transaction close date. These amounts were funded through available cash on hand. For additional information on our acquisition of HI-Bio,
please read Note 2, Acquisitions, to our 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 read Item
1A. Risk Factors and Item 7A. Quantitative and Qualitative Disclosures About Market Risk included in this report.
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LIQUIDITY
WORKING CAPITAL
Working capital is defined as current assets less current liabilities. Our working capital was $1.9 billion as of December 31, 2024, compared
to $3.4 billion as of December 31, 2023. The change in working capital reflects an increase in total current assets of approximately $597.5
million and an increase in total current liabilities of approximately $2.1 billion. The changes in total current assets and total current liabilities
were primarily driven by the following:
CURRENT ASSETS
•
$1.3 billion increase in cash and cash equivalents;
•
$259.3 million decrease in accounts receivable, net related to our ongoing operations; and
•
$429.5 million decrease in other current assets primarily due to the receipt of $437.5 million from Samsung BioLogics related to the sale
of our 49.9% equity interest in Samsung Bioepis.
CURRENT LIABILITIES
•
$184.1 million increase in accrued expense and other primarily due to $279.3 million of short-term contingent consideration recognized
from our acquisition of HI-Bio, offset in part by the timing of our annual incentive compensation payment and other benefits-related
payments; and
•
$1.6 billion increase in current portion of debt primarily due to the reclassification of our $1.75 billion aggregate principal amount of 4.05%
Senior Notes due September 15, 2025, from long-term to short-term and the repayment of our 2023 Term Loan.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our consolidated financial statements included in
this report. For additional information on the sale of our equity interest in Samsung Bioepis and the sale of our PRV, please read Note 3,
Dispositions, to our consolidated financial statements included in this report. For additional information on our 2023 Term Loan, please read
Note 13, Indebtedness, to our consolidated financial statements included in this report.
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES
As of December 31, 2024, we had cash and cash equivalents totaling approximately $2.4 billion compared to approximately $1.0 billion as of
December 31, 2023. The increase in the balance was primarily due to cash generated by our operations, the receipt of $437.5 million in April
2024 from Samsung BioLogics related to the sale of our 49.9% equity interest in Samsung Bioepis, the net cash receipt of $88.6 million from
the sale of one of our two PRV's and proceeds from the sale of a portion of our Denali common stock and our remaining Sangamo common
stock during 2024. The increase was offset in part by $1.15 billion of cash and cash equivalents used to fund our acquisition of HI-Bio in July
2024 and $650.0 million of cash used for the repayment of our 2023 Term Loan.
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 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. We have experienced no significant limitations in our liquidity resulting from uncertainties in the banking sector.
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The following table summarizes the fair value of our significant common stock investments in our strategic investment portfolio:
As of December 31,
(In millions)
2024
2023
Denali
$
145.8 
$
273.6 
Sage
33.9 
135.3 
Sangamo
— 
7.9 
Total
$
179.7 
$
416.8 
During 2024 we sold a portion of our Denali common stock and the remaining shares of our Sangamo common stock.
Our ability to liquidate our investments in Denali and Sage may be limited by the size of our interest, the volume of market related activity, our
concentrated level of ownership and potential restrictions resulting from our status as a collaborator. Therefore, we may realize significantly
less than the current value of such investments.
For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
CASH FLOW
The following table summarizes our cash flow activity:
% Change
 
For the Years Ended December 31,
2024 

vs.

2023
2023

vs.

2022
(In millions, except percentages)
2024
2023
2022
Net cash flow provided by (used in) operating activities
$
2,875.5 
$
1,547.2 
$
1,384.3 
85.9 %
11.8 %
Net cash flow provided by (used in) investing activities
(799.2)
(4,101.0)
1,576.6 
(80.5)
(360.1)
Net cash flow provided by (used in) financing activities
(683.5)
149.3 
(1,747.3)
(557.8)
108.5 
OPERATING ACTIVITIES
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
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
•
(gains) losses on the disposal of assets, deferred income taxes, changes in the fair value of contingent payments associated with our
acquisitions of businesses and acquired IPR&D.
For 2024 compared to 2023, the increase in net cash flow provided by operating activities was primarily due to higher net income, lower
employee-benefit payments made during the first quarter of 2024, as compared to the same period in 2023, lower estimated federal tax
payments made during 2024, as compared to 2023, and changes in non-cash adjustments to net income. The increase was partially offset
by the timing of working capital, which includes higher inventory levels, primarily associated with our contract manufacturing for LEQEMBI.
INVESTING ACTIVITIES
For 2024 compared to 2023, the change in net cash flow in investing activities was primarily due to cash payments made associated with our
acquisition of HI-Bio in 2024 and with our acquisition of Reata in 2023. Additionally, cash outlay in 2023 was partially offset by net proceeds
received from the sale of our marketable securities.
FINANCING ACTIVITIES
For 2024 compared to 2023, the change in net cash flow in financing activities was primarily due to the repayment of our 2023 Term Loan for
$650.0 million during 2024 compared to the issuance of term loans totaling $1.0 billion under our 2023 Term Loan which were used to
partially fund our acquisition of Reata in 2023, partially offset by repayments of borrowings and debt premiums paid in 2023 totaling
$809.9 million.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our consolidated financial statements included in
this report.
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CAPITAL RESOURCES
DEBT AND CREDIT FACILITIES
LONG-TERM DEBT AND TERM LOAN CREDIT AGREEMENTS
Our long-term obligations primarily consist of long-term debt related to our Senior Notes with final maturity dates ranging between 2030 and
2051. As of December 31, 2024, our outstanding balance related to long-term debt was $4,547.2 million.
In connection with our acquisition of Reata in September 2023 we entered into a $1.5 billion term loan credit agreement. On the closing date
of the Reata acquisition we drew $1.0 billion from the 2023 Term Loan, comprised of a $500.0 million floating rate 364-day tranche and a
$500.0 million floating rate three-year tranche. The remaining unused commitment of $500.0 million was terminated. As of December 31,
2023, we repaid $350.0 million of the 364-day tranche. The remaining $150.0 million portion of the 364-day tranche was repaid during the
first quarter of 2024.
Additionally, during the first quarter of 2024 we repaid $250.0 million of the three-year tranche, with the remaining $250.0 million portion
being subsequently repaid in full during the second quarter of 2024.
2024 REVOLVING CREDIT FACILITY
In August 2024 we entered into a $1.5 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. This revolving credit facility replaced the revolving credit facility that we entered into in
January 2020. As of December 31, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.
For a summary of the fair values of our outstanding borrowings as of December 31, 2024 and 2023, please read Note 8, Fair Value
Measurements, to our consolidated financial statements included in this report.
For additional information on our Senior Notes, 2023 Term Loan and credit facility please read, Note 13, Indebtedness, to our consolidated
financial statements included in this report.
SHARE REPURCHASE PROGRAMS
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 shares repurchased under our 2020 Share
Repurchase Program were retired. There were no share repurchases of our common stock during the years ended December 31, 2024 and
2023. Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of December 31, 2024.
CAPITAL EXPENDITURES
In the fourth quarter of 2021 we began construction of a new gene therapy, clinical packaging and other manufacturing facility in RTP, North
Carolina to support our gene therapy pipeline across multiple therapeutic areas. The new manufacturing facility will be approximately
197,000 square feet with an estimated total investment of approximately $195.0 million. We estimate the construction of this manufacturing
facility will be completed during 2025. As we continue to advance our research and development prioritization efforts, which includes
refocusing our investment in gene therapy, we are evaluating several alternative uses for this facility.
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CONTRACTUAL OBLIGATIONS AND OFF-BALANCE SHEET ARRANGEMENTS
CONTRACTUAL OBLIGATIONS
The following table summarizes our contractual obligations as of December 31, 2024, 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.
 
Payments Due by Period
(In millions)
Total
Less than

1 Year
1 to 3

Years
3 to 5

Years
After

5 Years
Non-cancelable operating leases 
$
459.6 
$
88.7 
$
152.5 
$
66.0 
$
152.4 
Long-term debt obligations 
9,797.0 
1,965.0 
323.7 
323.7 
7,184.6 
Purchase and other obligations 
566.7 
406.2 
135.3 
20.7 
4.5 
Defined benefit obligation
107.1 
— 
— 
— 
107.1 
Total contractual obligations
$
10,930.4 
$
2,459.9 
$
611.5 
$
410.4 
$
7,448.6 
 We lease properties and equipment for use in our operations. Amounts reflected within the table above detail future minimum rental commitments under non-cancelable
operating leases as of December 31 for each of the periods presented. In addition to the minimum rental commitments, these leases may require us to pay additional
amounts for taxes, insurance, maintenance and other operating expense.
 Obligations are presented net of sublease income expected to be received for our vacated portions of our Weston, Massachusetts facility and other facilities throughout the
world.
 In connection with our acquisition of Reata in September 2023 we assumed operating lease commitments, including the responsibility for a single-tenant, built-to-suit building
with a total net present value of rental expense of approximately $154.4 million over the next 15 years. For additional information on our acquisition of Reata, please read
Note 2, Acquisitions, to our consolidated financial statements included in this report.
 Long-term debt obligations are related to our 2021 Exchange Offer Senior Notes, our 2020 Senior Notes and our 2015 Senior Notes, including principal and interest
payments. For additional information on our long-term debt obligations, please read Note 13, Indebtedness, to our consolidated financial statements included in this report.
 Purchase and other obligations include $234.0 million related to the remaining payments on the Transition Toll Tax and $11.7 million related to the fair value of net liabilities on
derivative contracts.
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 consolidated statements of
income.
SPINRAZA
We make royalty payments to Ionis 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 consolidated statements of income.
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
QALSODY
We make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0% and 15.0%, which
are recognized as cost of sales in our consolidated statements of income.
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships, to our
consolidated financial statements included in this report.
VUMERITY
We make royalty payments to Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0%, which are recognized as cost of
sales in our consolidated statements of income. Royalties payable on net sales of VUMERITY are subject, under certain circumstances, to
tiered minimum annual payment requirements for a period of five years following FDA approval.
In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes for
VUMERITY. We have elected to initiate a technology transfer and, following a transition period, to
(1)(2)(3)
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(5)
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manufacture VUMERITY or have VUMERITY manufactured by a third party we have engaged in exchange for paying an increased royalty
rate to Alkermes on any portion of future worldwide net commercial sales of VUMERITY that is manufactured by us or our designee.
For additional information on our collaboration arrangement with Alkermes, please read Note 19, Collaborative and Other Relationships, to
our consolidated financial statements included in this report.
SKYCLARYS
In connection with our acquisition of Reata in September 2023 we assumed additional contractual obligations related to royalty payments.
Reata entered into agreements to pay royalties on future sales of SKYCLARYS, which will cumulatively range in the low- to mid-single digits.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our consolidated financial statements included in
this report.
CONTINGENT CONSIDERATION RELATED TO BUSINESS COMBINATIONS
In connection with our acquisition of HI-Bio in July 2024 we may make additional payments based upon the achievement of certain milestone
events. We recognized the contingent consideration obligations associated with this acquisition at its fair value on the acquisition date and
we revalue this obligation each reporting period. We may pay up to an additional $650.0 million in potential future development and
regulatory milestone payments. The acquisition-date fair value of these milestones was approximately $485.1 million. We anticipate that we
may trigger the first and second milestone payments of approximately $150.0 million each in 2025.
For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our condensed consolidated financial statements
included in this report.
CONTINGENT DEVELOPMENT, REGULATORY AND COMMERCIAL MILESTONE PAYMENTS
Based on our development plans as of December 31, 2024, we could trigger potential future milestone payments to third parties of up to
approximately $3.8 billion, including approximately $0.5 billion in development milestones, approximately $0.5 billion in regulatory milestones
and approximately $2.8 billion in commercial milestones, as part of our various collaborations, including licensing and development programs
and HI-Bio's pre-existing commitments, as discussed below. Payments under these agreements generally become due and payable upon
achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones was not
considered probable as of December 31, 2024, 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 approximately $73.6 million in milestones in 2025 under our current
agreements, excluding opt-in payments.
We acquired HI-Bio's pre-existing in-license commitments under third-party agreements, which include tiered royalties on potential future
sales of felzartamab and izastobart/HIB210, ranging from high-single digit to mid-teen percentages, as well as potential future development,
regulatory and commercial milestone payments related to felzartamab and izastobart/HIB210 of up to $130.0 million, $230.0 million and
$640.0 million, respectively. This amount includes potential milestone payments due upon the first patient dosed in a phase 3 clinical trial of
felzartamab in a first and second indication of $35.0 million and $30.0 million, respectively, which we anticipate will be triggered in 2025.
OTHER FUNDING COMMITMENTS
As of December 31, 2024, we have several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial
expenditures are to CROs. The contracts with CROs are generally cancellable, with notice, at our option. We recorded accrued expense of
approximately $21.7 million in our consolidated balance sheets for expenditures incurred by CROs as of December 31, 2024. We have
approximately $509.2 million in cancellable future commitments based on existing CRO contracts as of December 31, 2024.
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 December 31, 2024, we have approximately $173.8 million of
liabilities associated with uncertain tax positions.
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As of December 31, 2024 and 2023, we have accrued income tax liabilities of approximately $234.0 million and $419.5 million, respectively,
under the Transition Toll Tax. The amount accrued as of December 31, 2024, is expected to be paid within one year. The Transition Toll Tax
is being paid in installments over an eight--year period, which started in 2018, and will not accrue interest.
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 consolidated financial
statements included in this report.
LEGAL MATTERS
For a discussion of legal matters as of December 31, 2024, please read Note 21, Litigation, to our consolidated financial statements included
in this report.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of our consolidated financial statements, which have been prepared in accordance with U.S. GAAP, 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 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. Other significant accounting policies are outlined in Note 1, Summary of Significant Accounting Policies, to our
consolidated financial statements included in this report.
REVENUE RECOGNITION
We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which
we expect to receive in exchange for those goods or services. We recognize revenue following the five-step model prescribed under FASB
ASC 606, Revenue from Contracts with Customers: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v)
recognize revenue when (or as) we satisfy the performance obligations.
PRODUCT REVENUE
In the U.S., we sell our products primarily to wholesale and specialty distributors and specialty pharmacies. In other countries, we sell our
products primarily to wholesale distributors, hospitals, pharmacies and other third-party distribution partners. These customers subsequently
resell our products to health care providers and patients. In addition, we enter into arrangements with health care providers and payors that
provide for government-mandated or privately-negotiated discounts and allowances related to our products.
Product revenue is recognized when the customer obtains control of our product, which occurs at a point in time, typically upon delivery to
the customer. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset
that we would have recognized is one year or less or the amount is immaterial.
RESERVES FOR DISCOUNTS AND ALLOWANCES
Product revenue is recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our
customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the
international markets in which we operate. Our process for
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estimating reserves established for these variable consideration components do not differ materially from our historical practices.
Product revenue reserves, which are classified as a reduction in product revenue, are generally characterized in the following categories:
discounts, contractual adjustments and returns.
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). Our
estimates of reserves established for variable consideration are calculated based upon a consistent application of our methodology utilizing
the expected value method. 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. The transaction price, which includes
variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price
only to the extent that it is probable that a significant reversal of the amount of the cumulative revenue recognized will not occur in a future
period. 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.
As of December 31, 2024 and 2023, a 10.0% change in our discounts, contractual adjustments and reserves would have resulted in a
decrease of our pre-tax earnings by approximately $351.9 million and $345.5 million, respectively.
In addition to discounts, rebates and product returns, we also maintain certain customer service contracts with distributors and other
customers in the distribution channel that provide us with inventory management, data and distribution services, which are generally reflected
as a reduction of revenue. To the extent we can demonstrate a separable benefit and fair value for these services we classify these
payments in selling, general and administrative expense in our consolidated statements of income.
For additional information on our revenue, please read Note 5, Revenue, to our consolidated financial statements included in this report.
ACQUIRED INTANGIBLE ASSETS, INCLUDING IPR&D
When we purchase a business, the acquired IPR&D is measured at fair value, capitalized as an intangible asset and tested for impairment at
least annually, as of October 31, until commercialization, after which time the IPR&D is amortized over its estimated useful life. If we acquire
an asset or group of assets that do not meet the definition of a business under applicable accounting standards, then the acquired IPR&D is
expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense within our
consolidated statements of income as they are incurred.
We have acquired, and expect to continue to acquire, intangible assets through the acquisition of biotechnology companies or through the
consolidation of variable interest entities. These intangible assets primarily consist of technology associated with human therapeutic
products, IPR&D product candidates and priority review vouchers. When significant identifiable intangible assets are acquired, we generally
engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date.
Management will determine the fair value of less significant identifiable intangible assets acquired. Discounted cash flow models are typically
used in these valuations, and these models require the use of significant estimates and assumptions including but not limited to:
•
estimating the timing of and expected costs to complete the in-process projects;
•
projecting regulatory approvals;
•
estimating future cash flow from product sales resulting from completed products and in process projects; and
•
developing appropriate discount rates and probability rates by project.
We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available
facts and circumstances as of the acquisition dates.
If these projects are not successfully developed, the sales and profitability of the company may be adversely affected in future periods.
Additionally, the value of the acquired intangible assets may become impaired. No assurance can be given that the underlying assumptions
used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as
estimated.
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INVENTORY
At each reporting period we review our inventories for excess or obsolescence and write-down obsolete or otherwise unmarketable inventory
to its estimated net realizable value. The determination of obsolete or excess inventory requires management to make estimates based on
assumptions about the future demand of our products, product expiration dates, estimated future sales and our general future plans. If
customer demand subsequently differs from our forecasts, we may be required to record additional charges for excess inventory.
Although we believe that the assumptions we use in estimating inventory write-downs are reasonable, no assurance can be given that
significant future changes in these assumptions or changes in future events and market conditions could result in different estimates.
IMPAIRMENT AND AMORTIZATION OF LONG-LIVED ASSETS
Long-lived assets to be held and used include property, plant and equipment as well as intangible assets, including IPR&D and trademarks.
Property, plant and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount
of the assets may not be recoverable. We review our intangible assets with indefinite lives for impairment annually, as of October 31, and
whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
When performing our impairment assessment, we calculate the fair value using the same methodology as described above under Acquired
Intangible Assets, including IPR&D. If the carrying value of our acquired IPR&D exceeds its fair value, then the intangible asset is written
down to its fair value. Changes in estimates and assumptions used in determining the fair value of our acquired IPR&D could result in an
impairment. Impairments are recorded within amortization and impairment of acquired intangible assets in our consolidated statements of
income.
Based on our most recent impairment assessment we incurred impairment charges of approximately $60.2 million for the year ended
December 31, 2024, related to the impairment of other clinical programs we acquired from Reata and Samsung Bioepis commercialization
rights terminated during the third quarter of 2024. For the year ended December 31, 2023, we had no impairment charges. For additional
information on our impairments, please read Note 7, Intangible Assets and Goodwill, to our consolidated financial statements included in this
report.
Our most significant intangible assets relate to SKYCLARYS and TYSABRI. We amortize the intangible assets related to our marketed
products using the economic consumption method, which is based on revenue generated from the products underlying the related intangible
assets. An analysis of the anticipated lifetime revenue of our marketed products is performed annually during our long-range planning cycle
and whenever events or changes in circumstances would significantly affect anticipated lifetime revenue of the relevant products.
For additional information on the impairment charges related to our long-lived assets during 2024, 2023 and 2022, please read Note 7,
Intangible Assets and Goodwill, to our consolidated financial statements included in this report.
CONTINGENT CONSIDERATION
We record contingent consideration resulting from a business combination at its fair value on the acquisition date. Each reporting period
thereafter, we revalue the remaining obligations and record changes in the fair value as an adjustment to (gain) loss on fair value
remeasurement of contingent consideration in our consolidated statements of income. Changes in the fair value of the contingent
consideration obligations can result from changes to one or multiple inputs, including adjustments to the discount rates, changes in the
amount or timing of expected expenditures associated with product development, changes in the amount or timing of cash flow and reserves
associated with products upon commercialization, changes in the assumed achievement or timing of any cumulative sales-based and
development milestones, changes in the probability of certain clinical events and changes in the assumed probability associated with
regulatory approval. These fair value measurements represent Level 3 measurements as they are based on significant inputs that are not
observable in the market.
Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each
subsequent period. Accordingly, changes in assumptions described above, could have a material impact on the amount of contingent
consideration expense we record in any given period.
INCOME TAXES
We prepare and file income tax returns based on our interpretation of each jurisdiction’s tax laws and regulations. In preparing our
consolidated financial statements, we estimate our income tax liability in each of the jurisdictions in which we operate by estimating our
actual current tax expense together with assessing temporary differences resulting from differing treatment of items for tax and financial
reporting purposes. These differences result in
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deferred tax assets and liabilities, which are included in our consolidated balance sheets. Upon our election in the fourth quarter of 2018 to
record deferred taxes for GILTI, we have included amounts related to GILTI taxes within temporary difference.
Significant management judgment is required in assessing the realizability of our deferred tax assets. In performing this assessment, we
consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of
deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences
become deductible. In making this determination, under the applicable financial accounting standards, we are allowed to consider the
scheduled reversal of deferred tax liabilities, projected future taxable income and the effects of tax planning strategies. In the event that
actual results differ from our estimates, we adjust our estimates in future periods and we may need to establish a valuation allowance, which
could materially impact our consolidated financial position and results of operations.
We account for uncertain tax positions using a “more likely than not” threshold for recognizing and resolving uncertain tax positions. We
evaluate uncertain tax positions on a quarterly basis and consider various factors including, but not limited to, changes in tax law, the
measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, information
obtained during in process audit activities and changes in facts or circumstances related to a tax position. We adjust the level of the liability to
reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Our liabilities for uncertain tax positions can be
relieved only if the contingency becomes legally extinguished, through either payment to the taxing authority or the expiration of the statute of
limitations, the recognition of the benefits associated with the position meet the “more likely than not” threshold or the liability becomes
effectively settled through the examination process. We consider matters to be effectively settled once the taxing authority has completed all
of its required or expected examination procedures, including all appeals and administrative reviews, we have no plans to appeal or litigate
any aspect of the tax position and we believe that it is highly unlikely that the taxing authority would examine or re-examine the related tax
position. We also accrue for potential interest and penalties related to unrecognized tax benefits in income tax (benefit) expense in our
consolidated statements of income.
BUSINESS COMBINATIONS
Business combinations are recorded using the acquisition method of accounting. The results of operations of the acquired company are
included in our results of operations beginning on the acquisition date, and assets acquired and liabilities assumed are recognized on the
acquisition date at their respective fair values. Any excess of consideration transferred over the net carrying value of the assets acquired and
liabilities assumed as of the acquisition date is recognized as goodwill.
We use the multi-period excess earnings method, which is a form of the income approach, utilizing post-tax cash flow and discount rates in
estimating the fair value of identifiable intangible assets acquired when allocating the purchase consideration paid for the acquisition. The
estimates of the fair value of identifiable intangible assets involve significant judgment by management and include assumptions with
measurement uncertainty, such as the amount and timing of projected cash flow, long-term sales forecasts, discount rates and additionally
for IPR&D intangible assets, the timing and probability of regulatory and commercial success.
We use the net realizable value method in estimating the fair value of acquired finished goods and work-in-process inventory. Raw materials
acquired are valued using the replacement cost method.
Transaction and restructuring costs related to business combinations are expensed as incurred. The fair value of assets acquired and
liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to
exceed 12 months from the acquisition date. If we determine the assets acquired do not meet the definition of a business, the transaction will
be accounted for as an asset acquisition rather than a business combination.
ITEM 7A. 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 equity price exposure as well as changes in economic conditions in the
markets in which we operate as a result of the conflict between Russia and Ukraine and the military conflict in the Middle East. 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, foreign currency options, interest rate lock contracts and interest rate swap contracts.
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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 and Swiss franc.
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 December 31, 2024, and is not expected
to have a material impact on our results of operations or financial position in the future. In December 2023 the Argentinian Peso experienced
a substantial devaluation following a presidential election. The devaluation resulted in a $16.0 million charge recorded during the fourth
quarter of 2023 in other (income) expense, net within our consolidated statements of income for the year ended December 31, 2023.
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 expense
transactions denominated in foreign currencies in the next 12 months. We do not engage in currency speculation. For a more detailed
disclosure of our revenue and operating expense hedging program, please read Note 10, Derivative Instruments, to our 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 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 these contracts are reported as operating activities in our 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 December 31, 2024 and 2023, 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 $191.7 million and $249.4 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
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different. The quantitative information about market risk is limited because it does not take into account all foreign currency operating
transactions.
CREDIT RISK
Financial instruments that potentially subject us to concentrations of credit risk include cash and cash equivalents, investments, derivatives
and accounts receivable. We attempt to minimize the risks related to cash and cash equivalents and investments by investing in a broad and
diverse range of financial instruments. We have established guidelines related to credit ratings and maturities intended to safeguard principal
balances and maintain liquidity. Our investment portfolio is maintained in accordance with our 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 counterparties.
We operate in certain countries where weakness in economic conditions, including the effects of the conflict between Russia and Ukraine
and the military conflict in the Middle East, 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 December 31, 2024 and 2023.
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 in the fair
value of equity investments. We may sell such equity securities based on our business considerations, which may include limiting our price
risk.
Changes in the fair value of these 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 December 31, 2024 and 2023, a hypothetical adverse 10.0% movement would result in a hypothetical
decrease in fair value of approximately $18.0 million and $41.7 million, respectively.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this Item 8 is contained on pages F-1 through F-83 of this report and is incorporated herein by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. 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) or 15d-15(e) under the Securities Exchange Act of 1934, as amended), as of December 31, 2024. 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
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(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 December 31, 2024, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
MANAGEMENT'S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over
financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act as a process designed by, or under the
supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management
and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and
procedures that:
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our
assets;
•
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and
directors; and
•
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that
could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this
assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in
its 2013 Internal Control — Integrated Framework.
Based on our assessment, our management has concluded that, as of December 31, 2024, our internal control over financial reporting is
effective based on those criteria.
The effectiveness of our internal control over financial reporting as of December 31, 2024, has been audited by PricewaterhouseCoopers
LLP, an independent registered public accounting firm, as stated in their attestation report, which is included herein.
ITEM 9B. OTHER INFORMATION
RULE 10b5-1 TRADING ARRANGEMENTS
From time to time, our officers (as defined in Rule 16a-1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading
arrangements (as each such term is defined in Item 408 of Regulation S-K). During the fourth quarter of 2024 our officers and directors took
the following actions with respect to 10b5-1 trading arrangements:
Trading Arrangement
Name and Position
Action
Date
Rule

10b5-1
Non-Rule
10b5-1
Total Shares to
be Sold
Expiration Date
Stephen A. Sherwin, Director
Adopt
11/7/2024
X
—
8,760
05/08/2025
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ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS
Not Applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information concerning our executive officers is set forth under the heading Information about our Executive Officers in Item 1 of this
report.
Code of Business Conduct and Ethics: The text of our code of business conduct, which includes the code of ethics that applies to our
principal executive officer, principal financial officer, principal accounting officer or controller, and persons performing similar functions, is
posted on our website, www.biogen.com, under the “Corporate Governance” subsection of the “Investors” section of the site. We intend to
make all required disclosures regarding any amendments to, or waivers from, provisions of our code of business conduct at the same
location of our website.
Insider Trading Policy: We have adopted an insider trading policy governing the purchase, sale and/or other dispositions of our securities and
those of public companies in which we do business with by our directors, executive officers, employees and temporary staff, that we believe
is reasonably designed to promote compliance with insider trading laws, rules and regulations and applicable NASDAQ listing standards. A
copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
The response to the remainder of this item is incorporated by reference from the discussion responsive thereto in the sections entitled
“Proposal 1 - Election of Directors,” “Corporate Governance” and “Miscellaneous - Stockholder Proposals” contained in the proxy statement
for our 2025 annual meeting of stockholders.
ITEM 11. EXECUTIVE COMPENSATION
The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled “Executive
Compensation Tables,” "Compensation Discussion and Analysis" and “Corporate Governance” contained in the proxy statement for our 2025
annual meeting of stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled “Stock Ownership” and
“Equity Compensation Plan Information” contained in the proxy statement for our 2025 annual meeting of stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The response to this item is incorporated by reference from the discussion responsive thereto in the sections entitled “Certain Relationships
and Related Person Transactions” and “Corporate Governance” contained in the proxy statement for our 2025 annual meeting of
stockholders.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The response to this item is incorporated by reference from the discussion responsive thereto in the section entitled “Proposal 2 - Ratification
of the Selection of our Independent Registered Public Accounting Firm” contained in the proxy statement for our 2025 annual meeting of
stockholders.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
a. (1) Consolidated Financial Statements:
The following financial statements are filed as part of this report:
Financial Statements
Page Number
Consolidated Statements of Income
F-2
Consolidated Statements of Comprehensive Income
F-3
Consolidated Balance Sheets
F-4
Consolidated Statements of Cash Flow
F-5
Consolidated Statements of Equity
F-6
Notes to Consolidated Financial Statements
F-8
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)
F-81
Certain totals may not sum due to rounding.
(2) Exhibits
The exhibits listed on the Exhibit Index beginning on page 95, which is incorporated herein by reference, are filed or furnished as part of this
report or are incorporated into this report by reference.
(3) Financial Statement Schedules
Schedules are omitted because they are not applicable, or are not required, or because the information is included in the consolidated
financial statements and notes thereto.
ITEM 16. FORM 10-K SUMMARY
Not applicable.
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EXHIBIT INDEX
Exhibit No.
  
Description
2.1
Agreement and Plan of Merger by and among Reata Pharmaceuticals, Inc., Biogen Inc. and River Acquisition, Inc. dated as of July
28, 2023. Filed as Exhibit 2.1 to our current report on Form 8-K filed July 31, 2023.
3.1
   Amended and Restated Certificate of Incorporation, as amended. Filed as Exhibit 3.1 to our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2012.
3.2
Certificate of Amendment to the Certificate of Incorporation. Filed as Exhibit 3.1 to our Current Report on Form 8-K filed on March
27, 2015.
3.3
Certificate of Amendment of Biogen Inc.'s Amended and Restated Certificate of Incorporation, as amended. Filed as Exhibit 3.1 to
our Current Report on Form 8-K filed on June 8, 2021.
3.4
Certificate of Amendment of Biogen Inc.'s Amended and Restated Certificate of Incorporation, as amended. Filed as Exhibit 3.1 to
our Current Report on Form 8-K filed on June 25, 2024.
3.5
   Fifth Amended and Restated Bylaws of Biogen Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K filed on December 12,
2023.
4.1
Second Supplemental Indenture, dated April 30, 2020, between Biogen Inc. and U.S. Bank National Association, including the
forms of Global Notes attached as Exhibit A and Exhibit B, respectively, thereto. Filed as Exhibit 4.2 to our Current Report on Form
8-K filed on April 30, 2020.
4.2
   Reference is made to Exhibit 3.1 for a description of the rights, preferences and privileges of our Series A Preferred Stock and
Series X Junior Participating Preferred Stock.
4.3
Indenture between Biogen Inc. and U.S. Bank National Association, dated as of September 15, 2015. Filed as Exhibit 4.1 to our
Current Report on Form 8-K filed on September 16, 2015.
4.4
First Supplemental Indenture between Biogen Inc. and U.S. Bank National Association, dated September 15, 2015. Filed as Exhibit
4.2 to our Current Report on Form 8-K filed on September 16, 2015.
4.5
Third Supplemental Indenture, dated February 16, 2021, between Biogen Inc. and U.S. Bank National Association. Filed as Exhibit
4.2 to our Current Report on Form 8-K filed on February 16, 2021.
4.6+
Description of Securities. Filed as Exhibit 4.6 to our Annual Report on Form 10-K for the year ended December 31, 2023.
10.1
Credit Agreement, dated as of August 12, 2024, among Biogen Inc., Bank of America, N.A., as administrative agent, swing line
lender and the L/C issuer, and the other lenders party thereto. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on
August 14, 2024.
10.2
Credit Agreement, dated as of August 28, 2023, among Biogen Inc., JPMorgan Chase Bank N.S., as administrative agent and the
other lenders party thereto. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on September 1, 2023.
10.3†
   Second Amended and Restated Collaboration Agreement between Biogen Idec Inc. and Genentech, Inc., dated as of October 18,
2010. Filed as Exhibit 10.5 to our Annual Report on Form 10-K for the year ended December 31, 2010.
10.4†
   Letter Agreement regarding GA101 financial terms between Biogen Idec Inc. and Genentech, Inc., dated October 18, 2010. Filed as
Exhibit 10.6 to our Annual Report on Form 10-K for the year ended December 31, 2010.
10.5
Form of performance share award agreement under the Biogen Inc. 2024 Omnibus Equity Plan. Filed as Exhibit 10.3 to our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
10.6
Form of restricted stock award agreement under the Biogen Inc. 2024 Omnibus Equity Plan. Filed as Exhibit 10.4 to our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024.
10.7
Form of non-employee director restricted stock unit award agreement under the Biogen Inc. 2024 Omnibus Equity Plan. Filed as
Exhibit 10.5 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
10.8*
   Biogen Inc. 2017 Omnibus Equity Plan. Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 26,
2017.
10.9*
   Form of restricted stock unit award agreement under the Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.2 to our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.
10.10*
Form of performance stock units award agreement under the Biogen Inc. 2017 Omnibus Equity Plan (for grants commencing in July
2019). Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.
10.11*
Form of nonqualified stock option award agreement under Biogen Inc. 2017 Omnibus Equity Plan. Filed as Exhibit 10.20 to our
Annual Report on Form 10-K for the year ended December 31, 2022.
10.12*
   Biogen Idec Inc. 2008 Performance-Based Management Incentive Plan. Filed as Appendix B to our Definitive Proxy Statement on
Schedule 14A filed on May 8, 2008.
10.13*
Biogen Inc. 2019 Form of Performance-Based Management Incentive Plan, as amended. Filed as Exhibit 10.1 to our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021.
10.14+
Voluntary Board of Directors Savings Plan.
10.15+
Biogen Inc. Supplemental Savings Plan.
10.16*
Biogen Inc. Executive Severance Policy - U.S. Executive Vice President, as amended effective July 13, 2020. Filed as Exhibit 10.1
to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.
94

Table of Contents
Exhibit No.
  
Description
10.17*
Annual Retainer Summary for Board of Directors (effective January 1, 2020). Filed as Exhibit 10.1 to our Quarterly Report on Form
10-Q for the quarter ended September 30, 2019.
10.18*
Form of indemnification agreement for directors and executive officers. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed
on June 7, 2011.
10.19*
Employment Agreement, dated November 10, 2022, by and between Biogen Inc. and Christopher A. Viehbacher. Filed as Exhibit
10.1 to our Current Report on Form 8-K filed on November 10, 2022.
10.20*
Letter regarding employment arrangement of Michael McDonnell dated July 16, 2020. Filed as Exhibit 10.2 to our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2020.
10.21*
Letter regarding employment arrangement of Susan Alexander dated December 13, 2005. Filed as Exhibit 10.58 to our Annual
Report on Form 10-K for the year ended December 31, 2009.
10.22*
Letter amending employment arrangement of Susan Alexander dated February 28, 2020. Filed as Exhibit 10.32 to our Annual
Report on Form 10-K for the year ended December 31, 2023.
10.23*
Letter regarding employment arrangement of Rachid Izzar dated August 1, 2019. Filed as Exhibit 10.33 to our Annual Report on
Form 10-K for the year ended December 31, 2023.
10.24*
Letter regarding employment arrangement of Nicole Murphy dated January 28, 2022. Filed as Exhibit 10.3 to our Quarterly Report
on Form 10-Q for the quarter ended March 31, 2023.
10.25*
Letter regarding employment arrangement of Robin Kramer dated October 28, 2024. Filed as Exhibit 10.1 to our Current Report on
Form 8-K filed on October 30, 2024.
10.26
Amended and Restated Collaboration Agreement, dated October 22, 2017, between Biogen MA Inc. and Eisai Co., LTD. Filed as
Exhibit 10.45 to our Annual Report on Form 10-K for the year ended December 31, 2022.
10.27
First Amendment to Amended and Restated Collaboration Agreement, dated March 13, 2022, between Biogen MA Inc. and Eisai
Co., LTD. Filed as Exhibit 10.46 to our Annual Report on Form 10-K for the year ended December 31, 2022.
19.1+
Policy relating to insider trading.
21+
   Subsidiaries.
23+
   Consent of PricewaterhouseCoopers LLP, an Independent Registered Public Accounting Firm.
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 of the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
97.1
Policy relating to recovery of erroneously awarded compensation. Filed as Exhibit 97.1 to our Annual Report on Form 10-K for the
year ended December 31, 2023.
101++
   The following materials from Biogen Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in iXBRL
(Inline Extensible Business Reporting Language): (i) the Consolidated Statements of Income, (ii) the Consolidated Statements of
Comprehensive Income, (iii) the Consolidated Balance Sheets, (iv) the Consolidated Statements of Cash Flow, (v) the Consolidated
Statements of Equity and (vi) Notes to Consolidated Financial Statements.
104
Cover Page Interactive Data File (contained in Exhibit 101)
*
Management contract or compensatory plan or arrangement.
†
Confidential treatment has been granted or requested with respect to portions of this exhibit.
+
Filed herewith.
 ++
Furnished herewith.
95

Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
By:
/S/    CHRISTOPHER A. VIEHBACHER
Christopher A. Viehbacher
Chief Executive Officer
Date: February 12, 2025
96

Table of Contents
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf
of the registrant and in the capacities and on the dates indicated.
Name
  
Capacity
 
Date
/S/    CHRISTOPHER A. VIEHBACHER
  
Director and Chief Executive Officer (principal executive officer)  
February 12, 2025
Christopher A. Viehbacher
/S/    MICHAEL R. MCDONNELL
  
Executive Vice President and Chief Financial Officer (principal
financial officer)
 
February 12, 2025
Michael R. McDonnell
/S/    ROBIN C. KRAMER
Senior Vice President, Chief Accounting Officer (principal
accounting officer)
February 12, 2025
Robin C. Kramer
/S/    CAROLINE D. DORSA
  
Director and Chair of the Board of Directors
 
February 12, 2025
Caroline D. Dorsa
/S/    MARIA C. FREIRE
Director
February 12, 2025
Maria C. Freire
/S/    WILLIAM A. HAWKINS
Director
February 12, 2025
William A. Hawkins
/S/    SUSAN LANGER
Director
February 12, 2025
Susan Langer
/S/    JESUS B. MANTAS
Director
February 12, 2025
Jesus B. Mantas
/S/    LLOYD B. MINOR
Director
February 12, 2025
Lloyd B. Minor
/S/    SIR MENELAS PANGALOS
Director
February 12, 2025
Sir Menelas Pangalos
/S/    MONISH PATOLAWALA
Director
February 12, 2025
Monish Patolawala
/S/    ERIC K. ROWINSKY
Director
February 12, 2025
Eric K. Rowinsky
/S/    STEPHEN A. SHERWIN
Director
February 12, 2025
Stephen A. Sherwin
97

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
 
  
Page Number
Consolidated Statements of Income
  
F-2
Consolidated Statements of Comprehensive Income
F-3
Consolidated Balance Sheets
  
F-4
Consolidated Statements of Cash Flow
  
F-5
Consolidated Statements of Equity
  
F-6
Notes to Consolidated Financial Statements
  
F-8
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)
F-81
F-1

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per share amounts)
For the Years Ended December 31,
2024
2023
2022
Revenue:
Product revenue, net
$
7,213.5 
$
7,246.7 
$
7,987.8 
Revenue from anti-CD20 therapeutic programs
1,749.9 
1,689.6 
1,700.5 
Alzheimer's collaboration revenue
59.9 
— 
— 
Contract manufacturing, royalty and other revenue
652.6 
899.3 
485.1 
Total revenue
9,675.9 
9,835.6 
10,173.4 
Cost and expense:
Cost of sales, excluding amortization and impairment of acquired intangible assets
2,310.4 
2,533.4 
2,278.3 
Research and development
2,041.8 
2,462.0 
2,231.1 
Selling, general and administrative
2,403.7 
2,549.7 
2,403.6 
Amortization and impairment of acquired intangible assets
446.7 
240.6 
365.9 
Collaboration profit sharing/(loss reimbursement)
254.4 
218.8 
(7.4)
(Gain) loss on fair value remeasurement of contingent consideration
27.7 
— 
(209.1)
Restructuring charges
30.2 
218.8 
131.1 
Gain on sale of priority review voucher, net
(88.6)
— 
— 
Gain on sale of building, net
— 
— 
(503.7)
Other (income) expense, net
343.6 
315.5 
(108.2)
Total cost and expense
7,769.9 
8,538.8 
6,581.6 
Income before income tax (benefit) expense and equity in (income) loss of investee, net of
tax
1,906.0 
1,296.8 
3,591.8 
Income tax (benefit) expense
273.8 
135.3 
632.8 
Equity in (income) loss of investee, net of tax
— 
— 
(2.6)
Net income
1,632.2 
1,161.5 
2,961.6 
Net income (loss) attributable to noncontrolling interests, net of tax
— 
0.4 
(85.3)
Net income attributable to Biogen Inc.
$
1,632.2 
$
1,161.1 
$
3,046.9 
Net income per share:
Basic earnings per share attributable to Biogen Inc.
$
11.21 
$
8.02 
$
20.96 
Diluted earnings per share attributable to Biogen Inc.
$
11.18 
$
7.97 
$
20.87 
Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc.
145.6 
144.7 
145.3 
Diluted earnings per share attributable to Biogen Inc.
145.9 
145.6 
146.0 
See accompanying notes to these consolidated financial statements.
F-2

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
 
For the Years Ended December 31,
 
2024
2023
2022
Net income attributable to Biogen Inc.
$
1,632.2 
$
1,161.1 
$
3,046.9 
Other comprehensive income (loss):
Unrealized gains (losses) on securities available for sale, net of tax
— 
15.7 
(13.5)
Unrealized gains (losses) on cash flow hedges, net of tax
76.6 
(40.1)
(38.7)
Gains (losses) on net investment hedges, net of tax
— 
— 
(25.5)
Unrealized gains (losses) on pension benefit obligation, net of tax
(14.0)
(1.5)
43.7 
Currency translation adjustments, net of tax
(45.1)
37.1 
(24.2)
Total other comprehensive income (loss), net of tax
17.5 
11.2 
(58.2)
Comprehensive income (loss) attributable to Biogen Inc.
1,649.7 
1,172.3 
2,988.7 
Comprehensive income (loss) attributable to noncontrolling interests, net of tax
— 
0.4 
(85.3)
Comprehensive income (loss)
$
1,649.7 
$
1,172.7 
$
2,903.4 
See accompanying notes to these consolidated financial statements.
F-3

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In millions, except per share amounts)
As of December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
2,375.0 
$
1,049.9 
Accounts receivable, net of allowance for doubtful accounts of $2.2 and $2.4, respectively
1,404.8 
1,664.1 
Due from anti-CD20 therapeutic programs
464.0 
435.9 
Inventory
2,460.5 
2,527.4 
Other current assets
752.5 
1,182.0 
Total current assets
7,456.8 
6,859.3 
Property, plant and equipment, net
3,181.3 
3,309.7 
Operating lease assets
356.4 
420.0 
Intangible assets, net
9,691.2 
8,363.0 
Goodwill
6,478.9 
6,219.2 
Deferred tax asset
324.2 
928.6 
Investments and other assets
560.5 
745.0 
Total assets
$
28,049.3 
$
26,844.8 
LIABILITIES AND EQUITY
Current liabilities:
Current portion of notes payable and term loan
$
1,748.6 
$
150.0 
Taxes payable
548.3 
257.4 
Accounts payable
424.2 
403.3 
Accrued expense and other
2,807.7 
2,623.6 
Total current liabilities
5,528.8 
3,434.3 
Notes payable and term loan
4,547.2 
6,788.2 
Deferred tax liability
190.5 
641.8 
Long-term operating lease liabilities
334.5 
400.0 
Other long-term liabilities
732.3 
781.1 
Total liabilities
11,333.3 
12,045.4 
Commitments, contingencies and guarantees (Notes 22 and 23)
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
569.4 
302.5 
Accumulated other comprehensive income (loss)
(136.2)
(153.7)
Retained earnings
19,259.8 
17,627.6 
Treasury stock, at cost; 23.8 million and 23.8 million shares, respectively
(2,977.1)
(2,977.1)
Total equity
16,716.0 
14,799.4 
Total liabilities and equity
$
28,049.3 
$
26,844.8 
See accompanying notes to these consolidated financial statements.
F-4

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOW
(In millions)
For the Years Ended December 31,
 
2024
2023
2022
Cash flow from operating activities:
Net income
$
1,632.2 
$
1,161.5 
$
2,961.6 
Adjustments to reconcile net income to net cash flow from operating activities:
Depreciation and amortization
673.2 
494.8 
518.4 
Impairment of intangible assets
60.2 
— 
119.6 
Excess and obsolescence charges related to inventory
101.9 
124.4 
336.2 
Amortization of acquired inventory step-up
230.0 
31.5 
— 
Share-based compensation
291.2 
264.2 
254.1 
Contingent consideration
27.7 
— 
(209.1)
Deferred income taxes
(158.1)
(305.8)
(168.6)
(Gain) loss on strategic investments
101.4 
277.1 
265.9 
(Gain) loss on equity method investment
— 
— 
(2.6)
Gain on sale of equity interest in Samsung Bioepis
— 
— 
(1,505.4)
Gain on sale of building, net
— 
— 
(503.7)
Gain on sale of priority review voucher, net
(88.6)
— 
— 
Other
159.6 
148.2 
208.2 
Changes in operating assets and liabilities, net of effects of business acquired:
Accounts receivable
222.3 
61.3 
(203.4)
Due from anti-CD20 therapeutic programs
(28.1)
(4.6)
(19.0)
Inventory
(273.8)
(130.9)
(320.2)
Accrued expense and other current liabilities
24.6 
(201.6)
(113.4)
Income tax assets and liabilities
78.5 
(299.0)
(142.3)
Other changes in operating assets and liabilities, net
(178.7)
(73.9)
(92.0)
Net cash flow provided by (used in) operating activities
2,875.5 
1,547.2 
1,384.3 
Cash flow from investing activities:
Purchases of property, plant and equipment
(153.7)
(277.0)
(240.3)
Proceeds from sales and maturities of marketable securities
— 
7,380.8 
3,671.0 
Purchases of marketable securities
— 
(5,140.7)
(3,448.5)
Acquisition of Reata, net of cash acquired
— 
(6,926.1)
— 
Acquisition of HI-Bio, net of cash acquired
(1,074.8)
— 
— 
Proceeds from sale of equity interest in Samsung Bioepis
406.8 
788.1 
990.3 
Proceeds from sale of building
— 
— 
582.6 
Proceeds from sale of priority review voucher, net
88.6 
— 
— 
Acquisitions of intangible assets
(206.1)
(34.4)
(2.9)
Proceeds from sales of strategic investments
144.7 
119.6 
— 
Other
(4.7)
(11.3)
24.4 
Net cash flow provided by (used in) investing activities
(799.2)
(4,101.0)
1,576.6 
Cash flow from financing activities:
Purchase of treasury stock
— 
— 
(750.0)
Payments related to issuance of stock for share-based compensation arrangements, net
(31.3)
(44.3)
(1.9)
Repayments of borrowings and premiums paid
(650.0)
(809.9)
(1,002.2)
Proceeds from borrowings
— 
997.2 
— 
Net (distribution) contribution to noncontrolling interest
— 
12.3 
12.4 
Other
(2.2)
(6.0)
(5.6)
Net cash flow provided by (used in) financing activities
(683.5)
149.3 
(1,747.3)
Net increase (decrease) in cash and cash equivalents
1,392.8 
(2,404.5)
1,213.6 
Effect of exchange rate changes on cash and cash equivalents
(67.7)
35.1 
(55.7)
Cash and cash equivalents, beginning of the year
1,049.9 
3,419.3 
2,261.4 
Cash and cash equivalents, end of the year
$
2,375.0 
$
1,049.9 
$
3,419.3 
See accompanying notes to these consolidated financial statements.
F-5

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EQUITY
(In millions)
For the Year Ended December 31, 2024
 
Preferred stock
Common stock
Additional

paid-in

capital
Accumulated

other

comprehensive

income (loss)
Retained
earnings
Treasury stock
Total

equity
 
Shares
Amount
Shares
Amount
Shares
Amount
Balance, December 31, 2023
— 
$
— 
168.7 
$
0.1 
$
302.5 
$
(153.7)
$
17,627.6 
(23.8)
$(2,977.1)
$
14,799.4 
Net income
— 
— 
— 
— 
— 
— 
1,632.2 
— 
— 
1,632.2 
Other comprehensive income (loss), net of
tax
— 
— 
— 
— 
— 
17.5 
— 
— 
— 
17.5 
Issuance of common stock under stock
option and stock purchase plans
— 
— 
0.2 
— 
36.3 
— 
— 
— 
— 
36.3 
Issuance of common stock under stock
award plan
— 
— 
0.6 
— 
(67.7)
— 
— 
— 
— 
(67.7)
Compensation related to share-based
payments
— 
— 
— 
— 
301.5 
— 
— 
— 
— 
301.5 
Other
— 
— 
— 
— 
(3.2)
— 
— 
— 
— 
(3.2)
Balance, December 31, 2024
— 
$
— 
169.5 
$
0.1 
$
569.4 
$
(136.2)
$
19,259.8 
(23.8)
$(2,977.1)
$
16,716.0 
For the Year Ended December 31, 2023
 
Preferred stock
Common stock
Additional

paid-in

capital
Accumulated
other
comprehensive
income (loss)
Retained

earnings
Treasury stock
Total

Biogen Inc.

shareholders’

equity
Noncontrolling

interests
Total

equity
Shares
Amount
Shares
Amount
Shares
Amount
Balance, December 31,
2022
— 
$
— 
167.9 
$
0.1 
$
73.3 
$
(164.9)
$16,466.5 
(23.8)
$(2,977.1)
$
13,397.9 
$
(9.5)
$13,388.4 
Net income
— 
— 
— 
— 
— 
— 
1,161.1 
— 
— 
1,161.1 
0.4 
1,161.5 
Other comprehensive
income (loss), net of tax
— 
— 
— 
— 
— 
11.2 
— 
— 
— 
11.2 
— 
11.2 
Capital contribution from
noncontrolling interest
— 
— 
— 
— 
— 
— 
— 
— 
— 
— 
12.3 
12.3 
Deconsolidation of
noncontrolling interest
— 
— 
— 
— 
— 
— 
— 
— 
— 
— 
(3.2)
(3.2)
Issuance of common stock
under stock option and
stock purchase plans
— 
— 
0.2 
— 
45.1 
— 
— 
— 
— 
45.1 
— 
45.1 
Issuance of common stock
under stock award plan
— 
— 
0.6 
— 
(89.5)
— 
— 
— 
— 
(89.5)
— 
(89.5)
Compensation related to
share-based payments
— 
— 
— 
— 
274.4 
— 
— 
— 
— 
274.4 
— 
274.4 
Other
— 
— 
— 
— 
(0.8)
— 
— 
— 
— 
(0.8)
— 
(0.8)
Balance, December 31,
2023
— 
$
— 
168.7 
$
0.1 
$
302.5 
$
(153.7)
$17,627.6 
(23.8)
$(2,977.1)
$
14,799.4 
$
— 
$14,799.4 
See accompanying notes to these consolidated financial statements.
F-6

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF EQUITY - (Continued)
(In millions)
For the Year Ended December 31, 2022
Preferred stock
Common stock
Additional

paid-in

capital
Accumulated
other
comprehensive
income (loss)
Retained

earnings
Treasury stock
Total

Biogen Inc.

shareholders’

equity
Noncontrolling

interests
Total

equity
Shares
Amount
Shares
Amount
Shares
Amount
Balance, December 31,
2021
— 
$
— 
170.8 
$
0.1 
$
68.2 
$
(106.7)
$ 13,911.7 
(23.8)
$(2,977.1)
$
10,896.2 
$
63.5 
$10,959.7 
Net income
— 
— 
— 
— 
— 
— 
3,046.9 
— 
— 
3,046.9 
(85.3)
2,961.6 
Other comprehensive
income (loss), net of tax
— 
— 
— 
— 
— 
(58.2)
— 
— 
— 
(58.2)
— 
(58.2)
Capital contribution from
noncontrolling interest
— 
— 
— 
— 
— 
— 
— 
— 
— 
— 
12.3 
12.3 
Repurchase of common
stock pursuant to the 2020
Share Repurchase
Program, at cost
— 
— 
— 
— 
— 
— 
— 
(3.6)
(750.0)
(750.0)
— 
(750.0)
Retirement of common
stock pursuant to the 2020
Share Repurchase
Program, at cost
— 
— 
(3.6)
— 
(257.9)
— 
(492.1)
3.6 
750.0 
— 
— 
— 
Issuance of common stock
under stock option and
stock purchase plans
— 
— 
0.2 
— 
44.2 
— 
— 
— 
— 
44.2 
— 
44.2 
Issuance of common stock
under stock award plan
— 
— 
0.5 
— 
(46.0)
— 
— 
— 
— 
(46.0)
— 
(46.0)
Compensation related to
share-based payments
— 
— 
— 
— 
263.5 
— 
— 
— 
— 
263.5 
— 
263.5 
Other
— 
— 
— 
— 
1.3 
— 
— 
— 
— 
1.3 
— 
1.3 
Balance, December 31,
2022
— 
$
— 
167.9 
$
0.1 
$
73.3 
$
(164.9)
$16,466.5 
(23.8)
$(2,977.1)
$
13,397.9 
$
(9.5)
$13,388.4 
See accompanying notes to these consolidated financial statements.
F-7

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1:
Summary of Significant Accounting Policies
References in these notes to "Biogen," the "company," "we," "us" and "our" refer to Biogen Inc. and its consolidated subsidiaries.
Business Overview
Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with
serious and complex diseases. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA,
co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a
genetic cause of ALS. We market the first and only drug approved in the U.S. and the E.U. for the treatment of FA in adults and adolescents
aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases. We support our
drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.
Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the
treatment of SMA; SKYCLARYS for the treatment of FA; QALSODY for the treatment of ALS; and FUMADERM for the treatment of severe
plaque psoriasis.
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the
commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the
treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL;
GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of
relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the
option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of
the Roche Group.
We commercialize a portfolio of biosimilars of advanced biologics including: BENEPALI, an etanercept biosimilar referencing ENBREL;
IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a
ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing
ACTEMRA, in the U.S. and certain international markets. We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar
referencing EYLEA.
On July 2, 2024, we completed the acquisition of HI-Bio. As a result of this transaction we acquired HI-Bio's lead asset, felzartamab, an anti-
CD38 antibody currently being evaluated for three leading indications, AMR, PMN and IgAN. For additional information on our acquisition of
HI-Bio, please read Note 2, Acquisitions, to these consolidated financial statements.
For additional information on our collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
Consolidation
Our consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries and variable interest entities
where we are the primary beneficiary. For consolidated entities where we own or are exposed to less than 100.0% of the economics, we
record net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income equal to the percentage
of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and
transactions are eliminated in consolidation.
In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether
we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right
to receive benefits from, the entity that could potentially be significant to that entity. We continuously assess whether we are the primary
beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or
deconsolidating one or more of our collaborators or partners. In November 2023 we terminated the Neurimmune Agreement, which resulted
in the deconsolidation of our variable interest entity, Neurimmune.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Use of Estimates
The preparation of our consolidated financial statements 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 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.
Revenue Recognition
We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which
we expect to receive in exchange for those goods or services. We recognize revenue following the five-step model prescribed under FASB
ASC 606, Revenue from Contracts with Customers: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v)
recognize revenue when (or as) we satisfy the performance obligations.
Product Revenue
In the U.S., we sell our products primarily to wholesale and specialty distributors and specialty pharmacies. In other countries, we sell our
products primarily to wholesale distributors, hospitals, pharmacies and other third-party distribution partners. These customers subsequently
resell our products to health care providers and patients. In addition, we enter into arrangements with health care providers and payors that
provide for government-mandated or privately-negotiated discounts and allowances related to our products.
Product revenue is recognized when the customer obtains control of our product, which occurs at a point in time, typically upon delivery to
the customer. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset
that we would have recognized is one year or less or the amount is immaterial.
Reserves for Discounts and Allowances
Product revenue is recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our
customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the
international markets in which we operate.
Product revenue reserves, which are classified as a reduction in product revenue, are generally characterized in the following categories:
discounts, contractual adjustments and returns.
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). Our
estimates of reserves established for variable consideration are calculated based upon a consistent application of our methodology utilizing
the expected value method. 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. The transaction price, which includes
variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price
only to the extent that it is probable that a significant reversal of the amount of the cumulative revenue recognized will not occur in a future
period. 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.
Discounts include trade term discounts, wholesaler incentives and volume related discounts. Trade term discounts and wholesaler incentives
primarily relate to estimated obligations for credits to be granted to wholesalers for remitting payment on their purchases within established
incentive periods and credits to be granted to wholesalers for compliance with various contractually-defined inventory management practices,
respectively. We determine these reserves based on our historical experience, including the timing of customer payments. Volume related
discounts primarily relate to incentives offered to downstream customers who earn discounts based upon the quarterly or annual volume of
units purchased.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay)
assistance, VA and PHS discounts, specialty pharmacy program fees and other governmental rebates or applicable allowances.
•
Medicaid rebates: relate to our estimated obligations to states under established reimbursement arrangements. Rebate accruals are
recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a
liability which is included in accrued expense and other current liabilities in our consolidated balance sheets. Our liability for Medicaid
rebates consists of estimates for claims that a state will make for the current quarter, claims for prior quarters that have been estimated
for which an invoice has not been received, invoices received for claims from the prior quarters that have not been paid and an estimate
of potential claims that will be made for inventory that exists in the distribution channel at period end.
•
Governmental rebates: or chargebacks, including VA and PHS discounts, represent our estimated obligations resulting from contractual
commitments to sell products to qualified healthcare providers at prices lower than the list prices we charge to wholesalers which provide
those products. The wholesaler charges us for the difference between what the wholesaler pays for the products and the ultimate selling
price to the qualified healthcare providers. Rebate and chargeback reserves are established in the same period as the related revenue is
recognized, resulting in a reduction of product revenue and a reduction in the net accounts receivable. Chargeback amounts are
generally determined at the time of resale to the qualified healthcare provider from the wholesaler, and we generally issue credits for
such amounts within a few weeks of the wholesaler notifying us about the resale. Our reserves for VA, PHS and other chargebacks
consist of amounts for inventory that exists at the wholesalers that we expect will be sold to qualified healthcare providers and
chargebacks that wholesalers have claimed for which we have not issued a credit.
•
Managed care rebates: represent our estimated obligations to third parties, primarily pharmacy benefit managers. Rebate accruals are
recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a
liability which is included in accrued expense and other current liabilities in our consolidated balance sheets. These rebates result from
performance-based goals, formulary position and price increase limit allowances (price protection). The calculation of the accrual for
these rebates is based on an estimate of the coverage patterns and the resulting applicable contractual rebate rate(s) to be earned over
a contractual period.
•
Copay assistance: represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by
insurance. The calculation of the accrual for copay is based on an estimate of claims and the cost per claim that we expect to receive
associated with inventory that exists in the distribution channel at period end.
•
Pharmacy rebates: represent our estimated obligations resulting from contractual commitments to sell products to specific pharmacies.
Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the
establishment of a liability which is included in accrued expense and other current liabilities in our consolidated balance sheets. These
rebates result from contracted discounts on product purchased or product dispensed. The calculation of the accrual for these rebates is
based on an estimate of the pharmacy’s buying or dispensing patterns and the resulting applicable contractual rebate rate(s) to be
earned over the contractual period.
•
Other governmental rebates: non-U.S. pharmaceutical taxes or applicable allowances primarily relate to mandatory rebates and discounts
in international markets where government-sponsored healthcare systems are the primary payors for healthcare.
Product return reserves are established for returns made by wholesalers and are recorded in the period the related revenue is recognized,
resulting in a reduction to product revenue. 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. Expired product return reserves are
estimated through a comparison of historical return data to their related sales on a production lot basis. Historical rates of return are
determined for each product and are adjusted for known or expected changes in the marketplace specific to each product.
In addition to discounts, rebates and product returns, we also maintain certain customer service contracts with distributors and other
customers in the distribution channel that provide us with inventory management, data and distribution services, which are generally reflected
as a reduction of revenue. To the extent we can demonstrate a
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
separable benefit and fair value for these services we classify these payments in selling, general and administrative expense in our
consolidated statements of income.
Revenue from Anti-CD20 Therapeutic Programs
Our collaboration with Genentech is within the scope of ASC 808, Collaborative Agreements, which provides guidance on the presentation
and disclosure of collaborative arrangements. For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as
RITUXAN.
Our share of the pre-tax co-promotion profits on RITUXAN, GAZYVA and LUNSUMIO and royalty revenue on sales of OCREVUS, resulted
from an exchange of a license. As we do not have future performance obligations under the license or collaboration agreement, revenue is
recognized as the underlying sales occur.
Revenue from anti-CD20 therapeutic programs consist of:
(i)     our share of pre-tax profits and losses in the U.S. for RITUXAN, GAZYVA and LUNSUMIO;
(ii)    royalty revenue on sales of OCREVUS; and
(ii)     other revenue from anti-CD20 therapeutic programs, which consists of our share of pre-tax co-promotion profits on RITUXAN in
Canada, royalties on net sales of COLUMVI in the U.S. and royalties on sales of LUNSUMIO outside the U.S.
Pre-tax co-promotion profits on RITUXAN, GAZYVA and LUNSUMIO are calculated and paid to us by Genentech and the Roche Group. Pre-
tax co-promotion profits consist of net sales to third-party customers less applicable costs to manufacture, third-party royalty expense,
distribution, selling and marketing expense and joint development expense incurred by Genentech and the Roche Group. Our share of the
pre-tax profits on RITUXAN, GAZYVA and LUNSUMIO include estimates that are based on information received from Genentech and the
Roche Group. These estimates are subject to change and actual results may differ.
We recognize royalty revenue on sales of OCREVUS 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.
Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products
within research and development expense and pre-commercialization costs within selling, general and administrative expense in our
consolidated statements of income. After an anti-CD20 product is approved, we record our share of the development and sales and
marketing expense related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs.
Accordingly, Biogen recorded its share of the expense incurred in connection with the development of LUNSUMIO within research and
development expense and its share of pre-commercialization costs within selling, general and administrative expense through December
2022, when regulatory approval was granted by the FDA. Beginning in January 2023 our share of pre-tax profits and losses in the U.S. for
LUNSUMIO was reflected as a component of revenue from anti-CD20 therapeutic programs within our consolidated statements of income.
For additional information on our relationship with Genentech, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
Alzheimer's Collaboration Revenue
Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we
are not the principal. We began recognizing Alzheimer's collaboration revenue upon the accelerated approval of LEQEMBI in the U.S. during
the first quarter of 2023.
Contract Manufacturing, Royalty and Other Revenue
Contract Manufacturing Revenue
We record contract manufacturing revenue primarily from amounts earned under contract manufacturing agreements with our strategic
customers. Revenue under contract manufacturing agreements is recognized when the customer obtains control of the product, which may
occur at a point in time or over time depending on the terms and conditions of the agreement. During the first quarter of 2023 we began
recognizing contract manufacturing revenue
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
for LEQEMBI, upon accelerated approval of LEQEMBI in the U.S. Prior to accelerated approval, our share of contract manufacturing
amounts related to LEQEMBI were recognized in research and development expense within our consolidated statements of income.
Royalty and Other Revenue
Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and
royalties we receive from net sales on products related to patents that we have out-licensed.
As the royalties we receive relate to arrangements that resulted from an exchange of a license and utilize the sales and usage based royalty
exception, the royalties are recognized as the underlying sales occur.
Collaborative and Other Relationships
We also have a number of significant collaborative and other third-party relationships for revenue and for the development, regulatory
approval, commercialization and marketing of certain of our products and product candidates. Where we are the principal on sales
transactions with third parties, we recognize revenue, cost of sales and operating expense on a gross basis in their respective lines in our
consolidated statements of income. Where we are not the principal on sales transactions with third parties, our share of the revenue, cost of
sales and operating expense is recorded on a net basis as a component of other revenue in our consolidated statements of income.
Our development and commercialization arrangements with Genentech, Eisai, Sage and Samsung Bioepis represent collaborative
arrangements as each party is an active participant in one or more joint operating activities and is exposed to significant risks and rewards of
these arrangements. These arrangements resulted from an exchange of a license and utilize the sales and usage based royalty exception,
as applicable. Therefore, revenue relating to royalties or profit-sharing amounts received is recognized as the underlying sales occur.
For additional information on our collaboration arrangements with Genentech, Eisai, Sage and Samsung Bioepis, please read Note 19,
Collaborative and Other Relationships, to these consolidated financial statements.
Fair Value Measurements
We have certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value
hierarchy as described in the accounting standards for fair value measurements.
•
Level 1 — Fair values are determined utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that we have
the ability to access;
•
Level 2 — Fair values are determined by utilizing quoted prices for identical or similar assets and liabilities in active markets or other
market observable inputs such as interest rates, yield curves, foreign currency spot rates and option pricing valuation models; and
•
Level 3 — Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
The majority of our financial assets have been classified as Level 2, and have been initially valued at the transaction price and subsequently
valued, at the end of each reporting period, utilizing third-party pricing services or option pricing valuation models. The pricing services utilize
industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value.
These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot
rates and other industry and economic events.
We validate the prices provided by our third-party pricing services by understanding the models used, obtaining market values from other
pricing sources and analyzing pricing data in certain instances. The option pricing valuation models use assumptions within the model,
including the term, stock price volatility, constant maturity risk-free interest rate and dividend yield. After completing our validation
procedures, we did not adjust or override any fair value measurements provided by our pricing services as of December 31, 2024 and 2023.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Other Assets and Liabilities
The carrying amounts reflected in our consolidated balance sheets for current accounts receivable, due from anti-CD20 therapeutic
programs, other current assets, accounts payable and accrued expense and other, approximate fair value due to their short-term maturities.
Cash and Cash Equivalents
We consider only those investments that are highly liquid, readily convertible to cash and that mature within three months from date of
purchase to be cash equivalents. As of December 31, 2024 and 2023, cash equivalents were comprised of money market funds with
maturities less than three months from the date of purchase.
Accounts Receivable
The majority of our accounts receivable arise from product sales and primarily represent amounts due from our wholesale and other third-
party distributors, public hospitals, pharmacies and other government entities and have standard payment terms that generally require
payment within 30 to 90 days.
We do not adjust our receivables for the effects of a significant financing component at contract inception if we expect to collect the
receivables in one year or less from the time of sale.
We provide reserves against accounts receivable for estimated losses that may result from a customer's inability to pay. Amounts determined
to be uncollectible are charged or written-off against the reserve.
Receivables from Samsung BioLogics
In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics, which resulted in a receivable of
approximately $1.3 billion in cash to be deferred over two payments. The first deferred payment of $812.5 million was received in April 2023
and the second deferred payment of $437.5 million was received in April 2024. The payments due to us from Samsung BioLogics were
recorded at their estimated fair values through the use of risk-adjusted discount rates. For additional information on the accounting for the
sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these consolidated financial statements.
Concentration of Credit Risk
Financial instruments that potentially subject us to concentrations of credit risk include cash and cash equivalents, investments, derivatives
and accounts receivable. We attempt to minimize the risks related to cash and cash equivalents and investments by investing in a broad and
diverse range of financial instruments as previously defined by us. We have established guidelines related to credit ratings and maturities
intended to safeguard principal balances and maintain liquidity. Our investment portfolio is maintained in accordance with our 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 counterparties.
Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the wide variety of
customers and markets using our products, as well as their dispersion across many different geographic areas. We monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We
continue to monitor these conditions and assess their possible impact on our business.
Marketable Securities and Other Investments
Marketable Debt Securities
Available-for-sale marketable debt securities are recorded at fair market value and unrealized gains and losses are included in AOCI in
equity, net of related tax effects, unless the security has experienced a credit loss, we have determined that we have the intent to sell the
security or we have determined that it is more likely than not that we will have to sell the security before its expected recovery. Realized gains
and losses are reported in other (income) expense, net on a specific identification basis.
During the third quarter of 2023 we sold all of our marketable debt securities and used the proceeds to partially fund our acquisition of Reata.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to these consolidated financial statements.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Marketable Equity Securities and Venture Capital Funds
Our marketable equity securities are recorded at fair market value and unrealized gains and losses are included in other (income) expense,
net in our consolidated statements of income. Our marketable equity securities represent investments in publicly traded equity securities and
are included in investments and other assets in our consolidated balance sheets.
Our investments in venture capital funds are recorded at net asset value, which approximates fair value, and unrealized gains and losses are
included in other (income) expense, net in our consolidated statements of income. The underlying investments of the venture capital funds in
which we invest are in equity securities of certain biotechnology companies and are included in investments and other assets in our
consolidated balance sheets.
Non-Marketable Equity Securities
We also invest in equity securities of companies whose securities are not publicly traded and where fair value is not readily available. These
investments are recorded using either the equity method of accounting or the cost minus impairment adjusted for observable price changes,
depending on our ownership percentage and other factors that suggest we have significant influence. We monitor these investments to
evaluate whether any increase or decline in their value has occurred, based on the implied value of recent company financings, public market
prices of comparable companies and general market conditions. These investments are included in investments and other assets in our
consolidated balance sheets.
Evaluating Marketable Debt Securities for Other-than-Temporary Impairments
When we hold marketable debt securities, we conduct periodic reviews to identify and evaluate each investment that has an unrealized loss,
in accordance with the meaning of other-than-temporary impairment. An unrealized loss exists when the current fair value of an individual
security is less than its amortized cost basis. Unrealized losses on available-for-sale debt securities that are determined to be temporary, and
not related to credit loss, are recorded, net of tax, in AOCI.
For available-for-sale debt securities with unrealized losses, management performs an analysis to assess whether we intend to sell or
whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we
intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full
amount of the unrealized loss is reflected in earnings as an impairment loss.
Regardless of our intent to sell a security, we perform additional analysis on all securities with unrealized losses to evaluate losses
associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to
recover the amortized cost basis of a security.
Equity Method of Accounting
In circumstances where we have the ability to exercise significant influence over the operating and financial policies of a company in which
we have an investment, we utilize the equity method of accounting for recording investment activity. In assessing whether we exercise
significant influence, we consider the nature and magnitude of our investment, the voting and protective rights we hold, any participation in
the governance of the other company and other relevant factors such as the presence of a collaborative or other business relationship. Under
the equity method of accounting, we record in our consolidated statements of income our share of income or loss of the other company. If our
share of losses exceeds the carrying value of our investment, we will suspend recognizing additional losses and will continue to do so unless
we commit to providing additional funding.
Inventory
Inventories are stated at the lower of cost or net realizable value with cost based on the first-in, first-out method. We classify our inventory
costs as long-term when we expect to utilize the inventory beyond our normal operating cycle and include these costs in investments and
other assets in our consolidated balance sheets. Inventory that can be used in either the production of clinical or commercial products is
expensed as research and development costs when identified for use in a clinical manufacturing campaign.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Capitalization of Inventory Costs
We capitalize inventory costs associated with our products prior to regulatory approval, when, based on management’s judgment, future
commercialization is considered probable and the future economic benefit is expected to be realized. We consider numerous attributes in
evaluating whether the costs to manufacture a particular product should be capitalized as an asset. We assess the regulatory approval
process and where the particular product stands in relation to that approval process, including any known safety or efficacy concerns,
potential labeling restrictions and other impediments to approval. We evaluate our anticipated research and development initiatives and
constraints relating to the product and the indication in which it will be used. We consider our manufacturing environment including our supply
chain in determining logistical constraints that could hamper approval or commercialization. We consider the shelf life of the product in
relation to the expected timeline for approval and we consider patent related or contract issues that may prevent or delay commercialization.
We also base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria. Finally, we
consider the reimbursement strategies that may prevail with respect to the product and assess the economic benefit that we are likely to
realize. We expense previously capitalized costs related to pre-approval inventory upon changes in such judgments, due to, among other
potential factors, a denial or significant delay of approval by necessary regulatory bodies.
Obsolescence and Unmarketable Inventory
At each reporting period we review our inventories for excess or obsolescence and write-down obsolete or otherwise unmarketable inventory
to its estimated net realizable value. If the actual net realizable value is less than that estimated by us, or if it is determined that inventory
utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Additionally, our products
are subject to strict quality control and monitoring that we perform throughout the manufacturing process. In the event that certain batches or
units of product no longer meet quality specifications, we will record a charge to cost of sales to write-down any unmarketable inventory to its
estimated net realizable value. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts
written-down due to unmarketable inventory are charged to cost of sales in our consolidated statements of income.
Property, Plant and Equipment
Property, plant and equipment are carried at cost, subject to reviews for impairment whenever events or changes in circumstances indicate
that the carrying amount of the asset may not be recoverable. The cost of normal, recurring or periodic repairs and maintenance activities
related to property, plant and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related
acquisition or construction of assets, is capitalized if the repair will result in future economic benefits.
Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use,
at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. We also capitalize certain direct
and incremental costs associated with the validation effort required for licensing by regulatory agencies of new manufacturing equipment for
the production of a commercially approved drug. These costs primarily include direct labor and material and are incurred in preparing the
equipment for its intended use. The validation costs are either amortized over the life of the related equipment or expensed as cost of sales
when the product produced in the validation process is sold.
In addition, we capitalize certain internal use computer software development costs. If the software is an integral part of production assets,
these costs are included in machinery and equipment and are amortized on a straight-line basis over the estimated useful lives of the related
software, which generally range from three to five years.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
We generally depreciate or amortize the cost of our property, plant and equipment using the straight-line method over the estimated useful
lives of the respective assets, which are summarized as follows:
Asset Category
Useful Lives
Land
Not depreciated
Buildings
15 to 40 years
Leasehold Improvements
Lesser of the useful life or the term of the respective lease
Furniture and Fixtures
5 to 7 years
Machinery and Equipment
5 to 20 years
Computer Software and Hardware
3 to 5 years
When we dispose of property, plant and equipment, we remove the associated cost and accumulated depreciation from the related accounts
in our consolidated balance sheets and include any resulting gain or loss in our consolidated statements of income.
Leases
We determine if an arrangement is a lease at contract inception. Operating lease assets represent our right to use an underlying asset for the
lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease assets and
liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When
determining the lease term, we include options to extend or terminate the lease when it is reasonably certain that they will be exercised.
We use the implicit rate when readily determinable and use our incremental borrowing rate when the implicit rate is not readily determinable
based upon the information available at the commencement date in determining the present value of the lease payments. Our incremental
borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease.
The lease payments used to determine our operating lease assets may include lease incentives, stated rent increases and escalation
clauses linked to rates of inflation when determinable and are recognized in our operating lease assets in our consolidated balance sheets.
Our lease agreements may include both lease and non-lease components, which we account for as a single lease component when the
payments are fixed. Variable payments included in the lease agreement are expensed as incurred. For certain equipment leases, such as
vehicles, we apply a portfolio approach to effectively account for the operating lease assets and liabilities.
Our operating leases are reflected in operating lease assets, accrued expense and other and long-term operating lease liabilities in our
consolidated balance sheets. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
We also have real estate lease agreements which are subleased to third parties. Operating leases for which we are the sublessor are
included in accrued expense and other and other long-term liabilities in our consolidated balance sheets. We recognize sublease income on
a straight-line basis over the lease term in our consolidated statements of income.
For additional information on our leases, please read Note 12, Leases, to these consolidated financial statements.
Intangible Assets
Our intangible assets primarily consist of completed technology (comprising of acquired and in-licensed rights and patents, and developed
technology), IPR&D acquired after January 1, 2009, acquired priority review vouchers and trademarks and trade names. Our intangible
assets are recorded at fair value at the time of their acquisition and are stated in our consolidated balance sheets net of accumulated
amortization and impairments, if applicable.
Intangible assets related to completed technology are amortized over their estimated useful lives using the economic consumption method if
anticipated future revenue can be reasonably estimated. The straight-line method is used when revenue cannot be reasonably estimated.
Amortization is recorded within amortization and impairment of acquired intangible assets in our consolidated statements of income.
The economic consumption method is based on revenue generated from the products underlying the related intangible assets. An analysis of
the anticipated lifetime revenue of our marketed products is performed annually
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
during our long-range planning cycle and whenever events or changes in circumstances would significantly affect anticipated lifetime revenue
of the relevant products.
Intangible assets related to trademarks, trade names, IPR&D prior to commercialization and priority review vouchers are not amortized
because they have indefinite lives; however, they are subject to review for impairment. We review our intangible assets with indefinite lives
for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset
may not be recoverable.
Acquired In-process Research and Development
Acquired IPR&D represents the fair value assigned to research and development assets that have not reached technological feasibility. The
value assigned to acquired IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable
products, estimating the resulting revenue from the projects and discounting the net cash flow to present value. The revenue and cost
projections used to value acquired IPR&D are, as applicable, reduced based on the probability of success of developing a new drug.
Additionally, the projections consider the relevant market sizes and growth factors, expected trends in technology and the nature and
expected timing of new product introductions by us and our competitors. The rates utilized to discount the net cash flow to present value are
commensurate with the stage of development of the projects and uncertainties in the economic estimates used in the projections. Upon the
acquisition of IPR&D, we complete an assessment of whether our acquisition constitutes the purchase of a single asset or a group of assets.
We consider multiple factors in this assessment, including the nature of the technology acquired, the presence or absence of separate cash
flow, the development process and stage of completion, quantitative significance and our rationale for entering into the transaction.
If we acquire a business as defined under applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If
we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, then the
acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development
expense within our consolidated statements of income as they are incurred.
When performing our impairment assessment, we calculate the fair value using the same methodology as described above. If the carrying
value of our acquired IPR&D exceeds its fair value, then the intangible asset is written down to its fair value. Changes in estimates and
assumptions used in determining the fair value of our acquired IPR&D could result in an impairment. Impairments are recorded within
amortization and impairment of acquired intangible assets in our consolidated statements of income.
Goodwill
Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets when
accounted for using the purchase method of accounting. Goodwill is not amortized, but is reviewed for impairment annually, as of October 31,
and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.
We compare the fair value of our reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit
exceeds the fair value of our reporting unit, we would record an impairment loss equal to the difference. As described in Note 25, Segment
Information, to these consolidated financial statements, we operate as one operating segment, which is our only reporting unit.
Impairment of Long-Lived Assets
Long-lived assets to be held and used, including property, plant and equipment, and definite-lived intangible assets are reviewed for
impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be
recoverable.
Determination of recoverability is based on an estimate of undiscounted future cash flow resulting from the use of the asset and its eventual
disposition. In the event that such cash flow is not expected to be sufficient to recover the carrying amount of the assets, the assets are
written-down to their fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingent Consideration
The consideration for our acquisitions often includes future payments that are contingent upon the occurrence of a particular event or events.
We record an obligation for such contingent payments at fair value on the acquisition date. We estimate the fair value of contingent
consideration obligations through valuation models that incorporate probability-adjusted assumptions related to the achievement of the
milestones and thus likelihood of making related payments. We revalue our contingent consideration obligations each reporting period.
Changes in the fair value of our contingent consideration obligations are recognized in our consolidated statements of income. Changes in
the fair value of the contingent consideration obligations can result from changes to one or multiple inputs, including adjustments to the
discount rates, changes in the amount or timing of expected expenditures associated with product development, changes in the amount or
timing of cash flow and reserves associated with products upon commercialization, changes in the assumed achievement or timing of any
cumulative sales-based and development milestones, changes in the probability of certain clinical events and changes in the assumed
probability associated with regulatory approval.
Discount rates in our valuation models represent a measure of the credit risk associated with settling the liability. The period over which we
discount our contingent obligations is based on the current development stage of the product candidates, our specific development plan for
that product candidate adjusted for the probability of completing the development step and when the contingent payments would be
triggered. In estimating the probability of success, we utilize data regarding similar milestone events from several sources, including industry
studies and our own experience. These fair value measurements are based on significant inputs not observable in the market. Significant
judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period.
Derivative Instruments and Hedging Activities
Cash Flow and Fair Value Derivative Instruments
We recognize all derivative instruments as either assets or liabilities at fair value in our consolidated balance sheets. Changes in the fair
value of our derivative instruments are recognized each period in current earnings or AOCI, depending on whether the derivative instrument
is designated as part of a hedge transaction and, if so, the type of hedge transaction. We classify the cash flow from these instruments in the
same category as the cash flow from the hedged items. We do not hold or issue derivative instruments for trading or speculative purposes.
We assess at inception and on an ongoing basis, whether the derivative instruments that are used in hedging transactions are highly
effective in offsetting the changes in cash flow or fair values of the hedged items. We exclude the forward points portion of the derivative
instruments used in a hedging transaction from the effectiveness test and record the fair value gain or loss related to this portion each period
in our consolidated statements of income in the same line as the underlying hedged item. If we determine that a forecasted transaction is no
longer probable of occurring, we discontinue hedge accounting for the affected portion of the hedge instrument, and any related unrealized
gain or loss on the contract is recognized in current earnings.
Net Investment Derivative Instruments
Designated net investment hedges are recognized as either assets or liabilities, at fair value, in our consolidated balance sheets. We hedge
the changes in the spot exchange rate in AOCI and exclude changes to the forward rate and amortize the forward points in other (income)
expense, net in our consolidated statements of income over the term of the contract. We classify the cash flow from these instruments in the
same category as the cash flow from the hedged items.
Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9% equity
interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note
3, Dispositions, to these consolidated financial statements.
For additional information on our derivative instruments and hedging activities, please read Note 10, Derivative Instruments, to these
consolidated financial statements.
Translation of Foreign Currencies
The functional currency for most of our foreign subsidiaries is their local currency. For our non-U.S. subsidiaries that transact in a functional
currency other than the U.S. dollar, assets and liabilities are translated at current rates of
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
exchange at the balance sheet date. Income and expense items are translated at the average foreign currency exchange rates for the
period. Adjustments resulting from the translation of the financial statements of our foreign operations into U.S. dollars are excluded from the
determination of net income and are recorded in AOCI, as a separate component of equity. For subsidiaries where the functional currency of
the assets and liabilities differ from the local currency, non-monetary assets and liabilities are translated at the rate of exchange in effect on
the date assets were acquired while monetary assets and liabilities are translated at current rates of exchange as of the balance sheet date.
Income and expense items are translated at the average foreign currency rates for the period. Translation adjustments of these subsidiaries
are included in other (income) expense, net in our consolidated statements of income.
Royalty Cost of Sales
We make royalty payments to a number of third parties under license or purchase agreements associated with our acquisition of intellectual
property. These royalty payments are typically calculated as a percentage (royalty rate) of the sales of our products in a particular year. That
royalty rate may remain constant, increase or decrease within each year based on the total amount of sales during the annual period. Each
quarterly period, we estimate our total royalty obligation for the full year and recognize the proportional amount as cost of sales based on
actual quarterly sales as a percentage of full year estimated sales. For example, if the level of net sales in any calendar year increases the
royalty rate within the year, we will record our cost of sales at an even rate over the year, based on the estimated blended royalty rate.
Accounting for Share-Based Compensation
Our share-based compensation programs grant awards that have included stock options, restricted stock units that vest based on stock
performance known as MSUs, time-vested RSUs, performance-vested stock units that settle in stock or cash (PSUs) and shares issued
under our ESPP. Compensation expense is recognized based on the estimated fair value of the awards at grant date. We recognize
compensation expense for the number of awards expected to vest after taking into consideration an estimate of award forfeitures over the
requisite service period, which is generally the vesting period. Where awards are made with non-substantive vesting periods (for instance,
where a portion of the award vests upon retirement eligibility), we estimate and recognize expense based on the period from the grant date to
the date the employee becomes retirement eligible.
The fair values of our stock option grants are estimated as of the date of grant using a Black-Scholes option valuation model. The estimated
fair values of the stock options are then expensed over the options' vesting periods.
The fair values of our MSUs and PSUs that settle in stock and have market-based metrics are estimated using a lattice model with a Monte
Carlo simulation. We apply an accelerated attribution method to recognize share-based compensation expense over the applicable service
period for these awards. The probability of actual shares expected to be earned is considered in the grant date valuation, therefore the
expense is not adjusted to reflect the actual units earned.
The fair values of our RSUs are based on the market value of our stock on the date of grant. Compensation expense for RSUs is recognized
straight-line over the applicable service period.
We apply an accelerated attribution method to recognize share-based compensation expense when accounting for our PSUs that settle in
cash, and the fair value of the liability is remeasured at the end of each reporting period through expected settlement. Compensation
expense associated with PSUs that settle in cash are based upon the stock price and the number of units expected to be earned after
assessing the probability that certain performance criteria will be met and the targeted payout level associated with the performance criteria
expected to be achieved. Cumulative adjustments are recorded each quarter to reflect changes in the stock price and estimated outcome of
the performance-related conditions until the date results are determined and settled. If performance criteria are not met or not expected to be
met, any compensation expense previously recognized to date associated with the awards will be reversed.
The fair values of PSUs that settle in stock and do not have market-based metrics are based upon the stock price on the date of grant.
Compensation expense is recognized for the number of units expected to be earned after assessing the probability that certain performance
criteria will be met and the targeted payout level associated with the performance criteria expected to be achieved. Cumulative adjustments
are recorded each quarter to reflect the estimated outcome of the performance-related conditions until the date results are determined and
settled. If
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
performance criteria are not met or not expected to be met, any compensation expense previously recognized to date associated with the
awards will be reversed.
Research and Development Expense
Research and development expense consists of expenses incurred in performing research and development activities, which include
compensation and benefits, facilities and overhead expense, clinical trial expense and fees paid to CROs, clinical supply and manufacturing
expense, write-offs of inventory that was previously capitalized in anticipation of product launch and determined to no longer be realizable
and other outside expense and upfront fees and milestones paid to third-party collaborators. Research and development expense is
expensed as incurred. Upfront and milestone payments made to third-party collaborators are expensed as incurred up to the point of
regulatory approval. Milestone payments made upon regulatory approval are capitalized and amortized over the remaining useful life of the
related product. Payments we make for research and development services prior to the services being rendered are recorded as prepaid
assets in our consolidated balance sheets and are expensed as the services are provided. We also accrue the costs of ongoing clinical trials
associated with programs that have been terminated or discontinued for which there is no future economic benefit at the time the decision is
made to terminate or discontinue the program.
From time to time, we enter into development agreements in which we share expenses with a collaborative partner. We record payments
received from our collaborative partners for their share of the development costs as a reduction of research and development expense,
except as discussed in Note 19, Collaborative and Other Relationships, to these consolidated financial statements. Expenses incurred by
Genentech in the ongoing development of RITUXAN, GAZYVA, LUNSUMIO and other products for which an initial indication has been
approved are not recorded as research and development expense, but rather reduce our share of profits recorded as a component of
revenue from anti-CD20 therapeutic programs.
Selling, General and Administrative Expense
Selling, general and administrative expense is primarily comprised of compensation and benefits associated with sales and marketing,
finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal
expense and other general and administrative costs.
Advertising costs are expensed as incurred. For the years ended December 31, 2024, 2023 and 2022, advertising costs totaled $66.8 million,
$71.4 million and $54.1 million, respectively.
Income Taxes
The provision for income taxes includes federal, state, local and foreign taxes. Income taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences of temporary differences between the
financial statement carrying amounts and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. We evaluate the
realizability of our deferred tax assets and establish a valuation allowance when it is more likely than not that all or a portion of deferred tax
assets will not be realized. We recognize deferred taxes associated with our GILTI tax calculations.
The income tax consequences from the intra-entity transfers of inventory within our consolidated group, both current and deferred, are
recorded as a prepaid tax or deferred charge and recognized through our consolidated statements of income when the inventory is sold to a
third party. The income tax consequences from the intra-entity transfer of assets other than inventory and associated changes to deferred
taxes are recognized when the transfer occurs.
We account for uncertain tax positions using a “more likely than not” threshold for recognizing and resolving uncertain tax positions. We
evaluate uncertain tax positions on a quarterly basis and consider various factors including, but not limited to, changes in tax law, the
measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, information
obtained during in process audit activities and changes in facts or circumstances related to a tax position. We also accrue for potential
interest and penalties related to unrecognized tax benefits in income tax (benefit) expense in our consolidated statements of income.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Contingencies
We are currently involved in various claims and legal proceedings. Loss contingency provisions are recorded if the potential loss from any
claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated or a range of loss
can be determined. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is
reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision.
On a quarterly basis, we review the status of each significant matter and assess its potential financial exposure. Significant judgment is
required in both the determination of probability and as to whether an exposure is reasonably estimable. Because of uncertainties related to
these matters, accruals are based only on the best information available at the time. As additional information becomes available, we
reassess the potential liability related to pending claims and litigation and may change our estimates. Legal costs associated with legal
proceedings are expensed when incurred.
Earnings per Share
Basic earnings per share is computed by dividing undistributed net income attributable to Biogen Inc. by the weighted-average number of
common shares outstanding during the period. Diluted earnings per share is computed based on the treasury method by dividing net income
by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares
outstanding.
Business Combinations
Business combinations are recorded using the acquisition method of accounting. The results of operations of the acquired company are
included in our results of operations beginning on the acquisition date, and assets acquired and liabilities assumed are recognized on the
acquisition date at their respective fair values. Any excess of consideration transferred over the net carrying value of the assets acquired and
liabilities assumed as of the acquisition date is recognized as goodwill.
We use the multi-period excess earnings method, which is a form of the income approach, utilizing post-tax cash flow and discount rates in
estimating the fair value of identifiable intangible assets acquired when allocating the purchase consideration paid for the acquisition. The
estimates of the fair value of identifiable intangible assets involve significant judgment by management and include assumptions with
measurement uncertainty, such as the amount and timing of projected cash flow, long-term sales forecasts, discount rates and additionally
for IPR&D intangible assets, the timing and probability of regulatory and commercial success.
We use the net realizable value method in estimating the fair value of acquired finished goods and work-in-process inventory. Raw materials
acquired are valued using the replacement cost method.
Transaction and restructuring costs related to business combinations are expensed as incurred. The fair value of assets acquired and
liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to
exceed 12 months from the acquisition date. If we determine the assets acquired do not meet the definition of a business, the transaction will
be accounted for as an asset acquisition rather than a business combination.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the
specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have or may
have a material impact on our consolidated financial statements or disclosures.
Standard
Description
Effective Date
Effects on the financial statements
ASU No. 2023-07, Segment
Reporting (Topic 280):
Improvements to Reportable
Segment Disclosure
This standard requires disclosure of significant segment
expenses that are regularly provided to the CODM and
included within each reported measure of segment profit or
loss, an amount and description of its composition for other
segment items to reconcile to segment profit or loss and the
title and position of the entity's CODM. The amendments in
this update also expand the interim segment disclosure
requirements. All disclosure requirements under this standard
are also required for public entities with a single reportable
segment. The amendments in this update are required to be
applied on a retrospective basis.
Annual reporting for fiscal
years beginning after
December 15, 2023, and
interim periods within fiscal
years beginning after
December 15, 2024. Early
adoption is permitted.
This standard became effective for us for
our annual reporting period ended
December 31, 2024, using the retrospective
method. The adoption of this standard
resulted in additional disclosure on the
significant expenses reviewed by our
CODM. The adoption did not have a
material impact on our consolidated financial
position or results of operations. Refer to
Note 25, Segment Information, for our
updated segment presentation.
ASU No. 2023-09, Income
Taxes (Topic 740):
Improvements to Income Tax
Disclosures
This standard establishes incremental disaggregation of
income tax disclosures pertaining to the effective tax rate
reconciliation and income taxes paid. The amendments in this
update are required to be applied on a prospective basis with
the option to apply it retrospectively.
Annual reporting for fiscal
years beginning after
December 15, 2024. Early
adoption is permitted.
We are currently evaluating the potential
impact that this new standard will have on
our consolidated financial statements and
related disclosures.
ASU No. 2024-03, Income
Statement (Subtopic 220-40):
Reporting Comprehensive
Income - Expense
Disaggregation Disclosures
This standard requires disclosure in the notes to the financial
statements, at each interim and annual reporting period, of
specified information about certain costs and expense
including purchases of inventory, employee compensation,
depreciation and intangible asset amortization included in each
relevant expense caption. This standard also requires a
qualitative description of the amounts remaining in relevant
expense captions that are not separately disaggregated, as
well as disclosure of the total amount of selling expenses, and,
in annual reporting periods, an entity’s definition of selling
expenses.
Annual reporting for fiscal
years beginning after
December 15, 2026, and
interim periods within fiscal
years beginning after
December 15, 2027. Early
adoption is permitted.
We are currently evaluating the potential
impact that this new standard will have on
our consolidated financial statements and
related disclosures.
SEC Release No. 33-11275,
The Enhancement and
Standardization of Climate-
Related Disclosures for
Investors
This new rule will require large accelerated filers to disclose
material climate-related risks that are reasonably likely to have
a material impact on their business, results of operations or
financial condition. The required information about climate-
related risks will also include disclosure of material direct
greenhouse gas emissions from operations owned or
controlled (Scope 1) and/or material indirect greenhouse gas
emissions from purchased energy consumed in owned or
controlled operations (Scope 2). Additionally, the new rules will
require disclosure within the notes to the financial statements
of the effects of severe weather events and other natural
conditions and information on any climate-related targets or
goals, subject to certain materiality thresholds.
Phased-in compliance period
beginning with annual
reporting for fiscal years as of
December 31, 2025.
In April 2024 the SEC
voluntarily stayed
implementation of the new
climate-related disclosure
requirements pending judicial
review. Once the litigation is
resolved, and if the rule
remains in effect, the SEC will
announce a new effective date.
We are currently evaluating the potential
impact that this new rule may have on our
company's disclosures.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 2:
Acquisitions
Human Immunology Biosciences
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage
biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab,
an anti-CD38 antibody, is currently being evaluated for three leading indications, AMR, PMN and IgAN. Felzartamab has received
Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR. Subsequent to our
acquisition, felzartamab received ODD in the E.U. in IgAN and solid organ transplantation. The acquisition of HI-Bio is expected to augment
our pipeline and build on our expertise in immunology.
Under the terms of this acquisition, we paid shareholders of HI-Bio approximately $1.15 billion at closing and may pay up to an additional
$650.0 million in potential future development and regulatory milestone payments. The $1.15 billion paid includes approximately $74.5 million
related to HI-Bio's outstanding, non-vested equity awards, inclusive of employer taxes, of which $56.4 million was recognized as share-based
compensation payments to settle non-vested equity awards attributable to the post-acquisition service period and therefore not reflected as a
component of total purchase price paid. Of the total $56.4 million, we recognized approximately $42.5 million as a charge to research and
development expense with the remaining $13.9 million as a charge to selling, general and administrative expense within our consolidated
statements of income for the year ended December 31, 2024. These amounts were associated with the accelerated vesting of stock options
and RSUs previously granted to HI-Bio employees and required no future services to vest.
Upon closing we also paid an additional $43.7 million related to working capital adjustments as of the transaction close date, which was
included as a component of total purchase price paid.
We funded this acquisition through available cash on hand and accounted for this acquisition as a business combination using the acquisition
method of accounting in accordance with ASC Topic 805, Business Combinations, and recorded assets acquired and liabilities assumed at
their respective fair values as of the acquisition date.
In addition to the lead program felzartamab, the HI-Bio pipeline acquired includes izastobart/HIB210, an anti-C5aR1 antibody currently in a
Phase 1 trial, and the potential for continued development in a range of complement-mediated diseases.
Purchase Price Consideration
Total consideration transferred for the acquisition of HI-Bio is summarized as follows:
(In millions)
As of July 2, 2024
Cash consideration paid to HI-Bio shareholders
$
1,137.3 
Contingent consideration
485.1 
Total consideration
$
1,622.4 
 Represents total consideration paid to shareholders of HI-Bio of $1.15 billion, plus an additional $43.7 million related to working capital adjustments as of the transaction close
date, less $56.4 million of cash paid for HI-Bio's outstanding, non-vested equity awards, inclusive of employer taxes, which were recognized as compensation attributable to
the post-acquisition service period and therefore not reflected as a component of total consideration.
Contingent Consideration: We may make certain contingent payments to the former shareholders of HI-Bio upon the achievement of
certain development and regulatory milestones. As of the acquisition date, the maximum aggregate amount payable for these potential
milestones was $650.0 million. The acquisition-date fair value of these milestones was approximately $485.1 million and was estimated
utilizing a probability-adjusted discounted cash flow calculation using an appropriate discount rate dependent on the nature and timing of the
milestone payments, which ranged from 6.2% to 7.0%, and probabilities of technological and regulatory success ranging from 67.0% to near-
certain probability. Of the total contingent consideration, approximately $279.3 million related to milestones classified as short-term and
reflected as a component of accrued expense and other with the remaining $205.8 million reflected as a component of other long-term
liabilities within our consolidated balance sheets. The short-term liability relates to the fourth patient dosed in a phase 3 clinical trial of
felzartamab in a first and second indication, which would trigger milestone payments of $150.0 million each.
(1)
(1)
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Subsequent changes in the fair value of the contingent consideration obligation will be recognized as (gain) loss on fair value remeasurement
of contingent consideration within our consolidated statements of income. This fair value measurement was based on significant inputs that
are not observable in the market and thus represent Level 3 fair value measurements. For additional information related to the fair value of
this obligation, please read Note 8, Fair Value Measurements, to these consolidated financial statements.
Other Contractual Commitments: We acquired HI-Bio's pre-existing in-license commitments under third-party agreements, which include
tiered royalties on potential future sales of felzartamab and izastobart/HIB210, ranging from high-single digit to mid-teen percentages, as well
as potential future development, regulatory and commercial milestone payments related to felzartamab and izastobart/HIB210 of up to
$130.0 million, $230.0 million and $640.0 million, respectively. Because the achievement of these milestones was not considered probable as
of the transaction close date, such contingencies have not been recorded in our financial statements.
Preliminary Purchase Price Allocation
The following table summarizes the preliminary purchase price allocation of the separately identifiable assets acquired and liabilities
assumed as of July 2, 2024:
(In millions)
Estimated Fair Value
as of
July 2, 2024
Cash and cash equivalents
$
62.5 
Intangible assets:
IPR&D - felzartamab (IgAN)
920.0 
IPR&D - felzartamab (AMR)
450.0 
IPR&D - felzartamab (PMN)
265.0 
Other clinical programs
7.9 
Prepaid expense and other assets
1.0 
Operating lease assets
1.2 
Accounts payable
(1.1)
Accrued liabilities
(35.0)
Deferred tax liability
(304.4)
Operating lease liabilities
(1.2)
Total identifiable net assets
1,365.9 
Goodwill
256.5 
Total assets acquired and liabilities assumed
$
1,622.4 
There were no material purchase price allocation adjustments for the year ended December 31, 2024.
Intangible assets: Intangible assets comprised of $1.6 billion of IPR&D related to HI-Bio's lead asset felzartamab. This includes
$920.0 million of IPR&D related to felzartamab indication for IgAN, $450.0 million of IPR&D related to felzartamab indication for AMR and
$265.0 million of IPR&D related to felzartamab indication for PMN. The estimated fair values of the program related intangible assets were
determined using a multi-period excess earnings method, a form of the income approach, utilizing cash flow analyses and a discount rate of
14.5%. These fair value measurements were based on significant inputs that are not observable in the market and thus represent Level 3 fair
value measurements.
Goodwill: Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future
economic benefits arising from the other assets acquired that could not be individually identified and separately recognized. We recognized
goodwill of approximately $256.5 million, which is not deductible for tax purposes. The goodwill recognized from our acquisition of HI-Bio is
primarily the result of the deferred tax consequences from the transaction recorded for financial statement purposes.
Acquisition-related expense: Acquisition-related expense, primarily comprised of advisory and legal fees, and other transaction costs,
totaled approximately $2.8 million and were recorded within selling, general and administrative expense within our consolidated statements
of income for the year ended December 31, 2024.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Assumptions in the Allocations of Purchase Price
The results of operations of HI-Bio, along with the estimated fair values of the assets acquired and liabilities assumed in the HI-Bio
acquisition, have been included in our consolidated financial statements since the closing of the HI-Bio acquisition on July 2, 2024.
Our preliminary estimate of the fair value of the specifically identifiable assets acquired and liabilities assumed as of the date of acquisition is
subject to the finalization of management's analysis related to certain matters, such as finalizing our assessment of income taxes. The final
determination of these fair values will be completed as additional information becomes available but no later than one year from the
acquisition date. The final determination may result in asset and liability fair values that are different than the preliminary estimates.
Subsequent to the acquisition date, our results of operations include the results of operations of HI-Bio. HI-Bio operations had an immaterial
impact on our results of operations for the year ended December 31, 2024. Due to the immateriality of HI-Bio's historic revenue and
expenses, additional pro forma information combining the results of operations of Biogen and HI-Bio have not been included.
Reata Pharmaceuticals, Inc.
On September 26, 2023, we completed the acquisition of all of the issued and outstanding shares of Reata, a biopharmaceutical company
focused on developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. As a result of this
transaction we acquired SKYCLARYS (omaveloxolone), the first and only drug approved in the U.S. and the E.U. for the treatment of FA in
adults and adolescents aged 16 years and older, as well as other clinical and preclinical pipeline programs. The acquisition of Reata is
expected to complement our global portfolio of neuromuscular and rare disease therapies. The addition of SKYCLARYS is anticipated to
provide potential operating synergies with SPINRAZA and QALSODY.
Under the terms of this acquisition, we paid Reata shareholders $172.50 in cash for each issued and outstanding Reata share, which totaled
approximately $6.6 billion. In addition, we agreed to pay approximately $983.9 million in cash for Reata's outstanding equity awards,
inclusive of employer taxes, of which approximately $590.5 million was attributable to pre-acquisition services and is therefore reflected as a
component of total purchase price paid. Of the $983.9 million paid to Reata's equity award holders, we recognized approximately
$393.4 million as compensation attributable to the post-acquisition service period, of which $196.4 million was recognized as a charge to
selling, general and administrative expense with the remaining $197.0 million as a charge to research and development expense within our
consolidated statements of income for the year ended December 31, 2023. These amounts were associated with the accelerated vesting of
stock options and RSUs previously granted to Reata employees that required no future services to vest.
We funded this acquisition through available cash, cash equivalents and marketable securities, supplemented by the issuance of a
$1.0 billion term loan under our 2023 Term Loan. For additional information on our 2023 Term Loan, please read Note 13, Indebtedness, to
these consolidated financial statements.
We accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805,
Business Combinations, and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date.
Purchase Price Consideration
Total consideration transferred for the acquisition of Reata is summarized as follows:
(In millions)
As of September 26, 2023
Cash consideration paid to Reata shareholders
$
6,602.9 
Fair value of Reata equity compensation pre-acquisition services and related taxes
590.5 
Total consideration
$
7,193.4 
 Represents cash consideration transferred of $172.50 per outstanding Reata ordinary share based on 38.3 million Reata shares outstanding at closing.
 Represents the fair value of Reata stock options and stock units issued to Reata equity award holders and the related taxes attributable to pre-acquisition vesting services.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Purchase Price Allocation
We finalized purchase accounting for this acquisition in the third quarter of 2024. The following table summarizes the amounts recognized for
assets acquired and liabilities assumed as of the acquisition date, and reflects measurement period adjustments made to the amounts
initially recorded as of the acquisition date on September 26, 2023. The measurement period adjustments summarized below resulted from
updates to our valuation assumptions related to the estimated amounts and timing of future cash flows associated with certain intangible
assets, updates of our assumptions related to the quantities, selling location and remaining manufacturing and selling costs of acquired
inventory, and other assets and liabilities. The related impact to our consolidated statements of income that would have been recognized in
previous periods if the adjustments were recognized as of the acquisition date is immaterial.
(In millions)
Amounts Recognized as of Acquisition
Date

(as adjusted)
Cash and cash equivalents
$
267.3 
Accounts receivable
15.9 
Inventory
1,259.0 
Other current assets
54.6 
Intangible assets:
Completed technology for SKYCLARYS (U.S.)
4,200.0 
In-process research and development (omaveloxolone)
2,300.0 
Priority review voucher
100.0 
Other clinical programs
40.0 
Operating lease assets
121.2 
Accrued expense and other
(110.3)
Debt payable
(159.9)
Contingent payable to Blackstone
(300.0)
Deferred tax liability
(909.3)
Operating lease liabilities
(151.8)
Other assets and liabilities, net
(2.5)
Total identifiable net assets
6,724.2 
Goodwill
469.2 
Total assets acquired and liabilities assumed
$
7,193.4 
 Includes measurement period adjustments recorded in 2024 that increased other current assets by $1.0 million, accrued expense and other by $8.8 million and goodwill by
$4.7 million, and decreased deferred tax liability by $3.1 million.
Inventory: Total inventory acquired was approximately $1.3 billion, which reflects a step-up in the fair value of finished goods and work-in-
process inventory for SKYCLARYS. The fair value was determined based on the estimated selling price of the inventory, less the remaining
manufacturing and selling costs and a normal profit margin on those manufacturing and selling efforts. This fair value step-up adjustment is
being amortized to cost of sales within our consolidated statements of income as the inventory is sold, which is expected to be sold over a
period of approximately 4 years from the acquisition date. For the years ended December 31, 2024 and 2023, amortization from the fair value
step-up adjustment was approximately $230.0 million and $31.5 million, respectively. For the year ended December 31, 2024, amortization
from the fair value step-up adjustment includes approximately $48.5 million of inventory used for clinical purposes, which is reflected within
research and development expense within our consolidated statements of income.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Intangible assets: Intangible assets are comprised of $4.2 billion related to SKYCLARYS commercialization rights in the U.S., $2.3 billion of
IPR&D related to the omaveloxolone program outside the U.S., which had not yet received regulatory approval in the E.U. as of the
acquisition date, $100.0 million related to a rare pediatric disease PRV which may be used to obtain priority review by the FDA for a future
regulatory submission or sold to a third party and $40.0 million related to other clinical programs. The estimated fair values of the program
related intangible assets were determined using a multi-period excess earnings method, a form of the income approach, utilizing a discount
rate of 14.3% and the estimated fair value of the PRV was based on recent external purchase and sale transactions of similar vouchers.
Our valuation of the SKYCLARYS commercialization rights reflects the assumption that, using an economic consumption model, the related
$4.2 billion intangible asset will be amortized over its expected economic life. Upon SKYCLARYS receiving regulatory approval in the E.U. in
February 2024, we began selling the product in certain countries in Europe, and began amortizing the $2.3 billion IPR&D asset related to the
program outside the U.S. over its expected economic life using an economic consumption model.
These fair value measurements were based on significant inputs not observable in the market and thus represent Level 3 fair value
measurements.
Leases: We assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory
space located in Plano, Texas, with an initial lease term of 16 years. We recorded a lease liability of approximately $151.8 million, which
represents the net present value of rental expense over the remaining lease term of approximately 15 years, with a corresponding right-of-
use asset of approximately $121.2 million, which represents our estimate of the fair value for a market participant of the current rental market
in the Dallas, Texas area. Included in our estimate of the market rental rate is the value of any leasehold improvements or tenant allowances
related to the building. We do not intend to occupy this building and are evaluating opportunities to sublease the property.
Goodwill: Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future
economic benefits arising from the other assets acquired that could not be individually identified and separately recognized. We recognized
goodwill of approximately $469.2 million, which includes measurement period adjustments, and is not deductible for tax purposes. The
goodwill recognized from our acquisition of Reata is primarily the result of the deferred tax consequences from the transaction recorded for
financial statement purposes.
Acquisition-related expense: Acquisition-related expense, primarily comprised of regulatory, advisory and legal fees, and other transaction
costs, totaled approximately $28.4 million and were recorded in selling, general and administrative expense within our consolidated
statements of income for the year ended December 31, 2023.
Note 3:
Dispositions
Sale of Joint Venture Equity Interest in Samsung Bioepis
In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in exchange for total
consideration of approximately $2.3 billion. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing, with
approximately $1.3 billion in cash to be deferred over two payments. The first deferred payment of $812.5 million was received in April 2023
and the second deferred payment of $437.5 million was received in April 2024.
Prior to the sale, the carrying value of our investment in Samsung Bioepis totaled $581.6 million. For the year ended December 31, 2022, we
recognized a pre-tax gain of approximately $1.5 billion related to this transaction, which was recorded in other (income) expense, net in our
consolidated statements of income. This pre-tax gain included reclassifications from AOCI to net income of approximately $58.9 million in
cumulative translation losses, partially offset by approximately $57.0 million in gains resulting from the termination of our net investment
hedge.
We concluded that the divestment of Samsung Bioepis did not meet the criteria to be reported as discontinued operations in our consolidated
financial statements, as our decision to divest this business did not represent a strategic shift that would have a major effect on our
operations and financial results.
We elected the fair value option and measured the payments due to us from Samsung BioLogics at fair value. As of December 31, 2023, the
estimated fair value of the remaining second deferred payment using a risk-adjusted discount rate of 5.8% was approximately $430.0 million.
This payment has been classified as a Level 3 fair value
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
measurement and is reflected in other current assets within our consolidated balance sheets as of December 31, 2023.
For the year ended December 31, 2024, we recognized a gain of approximately $7.5 million to reflect the change in fair value associated with
the passage of time related to the second deferred payment due to us, which was received in April 2024. For the year ended December 31,
2023, we recognized gains of approximately $13.7 million and $24.6 million to reflect the changes in fair value associated with changes in
interest rates and the passage of time related to the first and second deferred payments due to us, respectively, which were received in April
2023 and April 2024, respectively. For the year ended December 31, 2022, we recognized a gain of approximately $10.7 million and a loss of
approximately $1.4 million to reflect the changes in fair value associated with changes in interest rates and the passage of time related to the
first and second deferred payments due to us, respectively, which were received in April 2023 and April 2024, respectively. These changes
were recorded in other (income) expense, net within our consolidated statements of income.
As part 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 the payments in the period the payments become realizable,
which is generally the same period in which the payments are earned.
Additionally, for the year ended December 31, 2022, we recorded a discrete tax expense of approximately $257.9 million related to this
transaction, which is reflected in income tax (benefit) expense in our consolidated statements of income.
Sale of Priority Review Voucher
In April 2024 we completed the sale of our rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third
party. In consideration for the PRV we received a cash payment of $103.0 million upon the closing of the PRV purchase, of which
approximately $14.4 million was paid to Ionis. Our net portion of approximately $88.6 million was recognized in gain on sale of priority review
voucher, net within our consolidated statements of income for the year ended December 31, 2024.
Note 4:
Restructuring
2023 Fit for Growth Restructuring Program
In 2023 we initiated additional cost saving measures as part of our Fit for Growth program to reduce operating costs, while improving
operating efficiency and effectiveness. The Fit for Growth program is expected to generate approximately $1.0 billion in gross operating
expense savings by the end of 2025, some of which will be reinvested in various initiatives. The Fit for Growth program is currently estimated
to include net headcount reductions of approximately 1,000 employees and we expect to incur restructuring charges ranging from
approximately $260.0 million to $280.0 million.
Total charges incurred from our 2023 Fit for Growth program are summarized as follows:
For the Years Ended December 31,
2024
2023
(In millions)
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Severance

Costs
Accelerated
Depreciation and
Other Costs
Total
Selling, general and administrative
$
— 
$
13.8 
$
13.8 
$
— 
$
23.3 
$
23.3 
Research and development
— 
11.7 
11.7 
— 
1.2 
1.2 
Restructuring charges
24.2 
— 
24.2 
153.4 
34.6 
188.0 
Total charges
$
24.2 
$
25.5 
$
49.7 
$
153.4 
$
59.1 
$
212.5 
Other Costs: includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pretax gains and losses
resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reata Integration
Following the close of our Reata acquisition in September 2023, we implemented an integration plan designed to realize operating synergies
through cost savings and avoidance. Under this initiative, we estimate we will incur total integration charges of approximately $35.0 million,
related to severance and employment costs. These severance and employment costs were substantially incurred during 2023.
Total charges incurred from our Reata integration are summarized as follows:
For the Years Ended December 31,
2024
2023
(In millions)
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Severance
Costs
Accelerated
Depreciation and
Other Costs
Total
Selling, general and administrative
$
— 
$
6.3 
$
6.3 
$
— 
$
— 
$
— 
Research and development
— 
11.9 
11.9 
— 
— 
— 
Restructuring charges
3.4 
— 
3.4 
30.4 
— 
30.4 
Total charges
$
3.4 
$
18.2 
$
21.6 
$
30.4 
$
— 
$
30.4 
In connection with our acquisition of Reata we assumed responsibility for a single-tenant, build-to-suit building of approximately 327,400
square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years. We do not intend to occupy this
building and are evaluating opportunities to sublease the property. For additional information on our acquisition of Reata, please read Note 2,
Acquisitions, to these consolidated financial statements.
HI-Bio Integration
Following the close of our HI-Bio acquisition in July 2024, we implemented an integration plan designed to realize operating synergies
through cost savings and avoidance. Under this initiative, we incurred approximately $2.6 million of severance and employment costs, which
are reflected in restructuring charges within our consolidated statements of income for the year ended December 31, 2024. For additional
information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to these consolidated financial statements.
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, deprioritization of certain research and development programs, the consolidation of certain real estate locations
and operating efficiencies across our selling, general and administrative and research and development functions. Charges related to our
2022 cost saving initiatives were substantially incurred during 2022 with remaining payments expected to be made through 2026.
Total charges incurred from our 2022 cost saving initiatives are summarized as follows:
For the Years Ended December 31,
2023
2022
(In millions)
Severance

Costs
Accelerated
Depreciation and
Other Costs
Total
Severance
Costs
Accumulated
Depreciation and
Other Costs
Total
Restructuring charges
$
(2.2)
$
2.6 
$
0.4 
$
112.6 
$
18.5 
$
131.1 
Total charges
$
(2.2)
$
2.6 
$
0.4 
$
112.6 
$
18.5 
$
131.1 
 Amounts reflect a gain recorded during the third quarter of 2022 of approximately $5.3 million related to the partial termination of a portion of our lease located at 300 Binney
Street. For additional information on our 300 Binney Street lease modification, please read Note 12, Leases, to these consolidated financial statements.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Charges and spending related to workforce reductions are summarized as follows:
(In millions)
Workforce Reductions
Restructuring reserve, December 31, 2022
$
35.9 
Expense
181.6 
Payment
(140.5)
Foreign currency and other adjustments
(1.6)
Restructuring reserve, December 31, 2023
75.4 
Expense
30.2 
Payment
(73.8)
Foreign currency and other adjustments
0.1 
Restructuring reserve, December 31, 2024
$
31.9 
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 5:
Revenue
Product Revenue
Revenue by product are summarized as follows:
 
For the Years Ended December 31,
 
2024
2023
2022
(In millions)
United

States
Rest of

World
Total
United

States
Rest of

World
Total
United

States
Rest of

World
Total
Multiple Sclerosis:
TECFIDERA
$
169.2 
$
797.9 
$
967.1 
$
263.1 
$
749.4 
$
1,012.5 
$
417.7 
$
1,026.2 
$
1,443.9 
VUMERITY
538.6 
89.4 
628.0 
512.1 
64.2 
576.3 
521.3 
32.1 
553.4 
Total Fumarate
707.8 
887.3 
1,595.1 
775.2 
813.6 
1,588.8 
939.0 
1,058.3 
1,997.3 
AVONEX
451.3 
256.2 
707.5 
536.7 
274.3 
811.0 
649.2 
324.3 
973.5 
PLEGRIDY
111.4 
149.1 
260.5 
126.2 
168.5 
294.7 
148.4 
183.5 
331.9 
Total Interferon
562.7 
405.3 
968.0 
662.9 
442.8 
1,105.7 
797.6 
507.8 
1,305.4 
TYSABRI
920.0 
795.0 
1,715.0 
997.9 
879.0 
1,876.9 
1,123.4 
907.5 
2,030.9 
FAMPYRA
— 
71.7 
71.7 
— 
90.5 
90.5 
— 
96.6 
96.6 
Subtotal: Multiple Sclerosis
2,190.5 
2,159.3 
4,349.8 
2,436.0 
2,225.9 
4,661.9 
2,860.0 
2,570.2 
5,430.2 
Rare Disease:
SPINRAZA
625.7 
947.5 
1,573.2 
610.5 
1,130.7 
1,741.2 
600.2 
1,193.3 
1,793.5 
SKYCLARYS
301.1 
81.4 
382.5 
55.9 
— 
55.9 
— 
— 
— 
QALSODY
20.9 
11.5 
32.4 
5.8 
0.1 
5.9 
— 
— 
— 
Subtotal: Rare Disease
947.7 
1,040.4 
1,988.1 
672.2 
1,130.8 
1,803.0 
600.2 
1,193.3 
1,793.5 
Biosimilars:
BENEPALI
— 
479.1 
479.1 
— 
438.8 
438.8 
— 
441.0 
441.0 
IMRALDI
— 
213.1 
213.1 
— 
222.1 
222.1 
— 
224.5 
224.5 
FLIXABI
— 
63.2 
63.2 
— 
77.4 
77.4 
— 
81.3 
81.3 
BYOOVIZ
23.0 
13.6 
36.6 
29.2 
2.5 
31.7 
4.3 
— 
4.3 
TOFIDENCE
1.1 
— 
1.1 
— 
— 
— 
— 
— 
— 
Subtotal: Biosimilars
24.1 
769.0 
793.1 
29.2 
740.8 
770.0 
4.3 
746.8 
751.1 
Other:
ZURZUVAE
72.2 
— 
72.2 
1.6 
— 
1.6 
— 
— 
— 
Other
2.8 
7.5 
10.3 
2.4 
7.8 
10.2 
4.8 
8.2 
13.0 
Subtotal: Other
75.0 
7.5 
82.5 
4.0 
7.8 
11.8 
4.8 
8.2 
13.0 
Total product revenue, net
$
3,237.3 
$
3,976.2 
$
7,213.5 
$
3,141.4 
$
4,105.3 
$
7,246.7 
$
3,469.3 
$
4,518.5 
$
7,987.8 
 SKYCLARYS was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of
2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS was approved and
became commercially available in the E.U. during the first quarter of 2024.
 QALSODY became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024.
 BYOOVIZ became commercially available in certain international markets in 2023.
 TOFIDENCE became commercially available in the U.S. during the second quarter of 2024.
 ZURZUVAE became commercially available in the U.S. during the fourth quarter of 2023.
 Other includes FUMADERM and ADUHELM.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
We recognized revenue from two wholesalers accounting for 25.9% and 13.4% of gross product revenue in 2024, 27.0% and 9.9% of gross
product revenue in 2023 and 26.8% and 11.1% of gross product revenue in 2022, respectively.
As of December 31, 2024, two wholesale distributors individually accounted for approximately 27.2% and 11.7% of net accounts receivable
associated with our product sales, as compared to 24.6% and 11.6% as of December 31, 2023, respectively.
An analysis of the change in reserves for discounts and allowances is summarized as follows:
December 31, 2024
(In millions)
Discounts
Contractual
Adjustments
Returns
Total
Balance, December 31, 2023
$
173.3 
$
857.1 
$
31.6 
$
1,062.0 
Current provisions relating to sales in current year
824.2 
2,687.5 
23.6 
3,535.3 
Adjustments relating to prior years
8.0 
(38.7)
14.2 
(16.5)
Payments/credits relating to sales in current year
(670.9)
(1,989.7)
(0.6)
(2,661.2)
Payments/credits relating to sales in prior years
(171.9)
(635.4)
(20.7)
(828.0)
Balance, December 31, 2024
$
162.7 
$
880.8 
$
48.1 
$
1,091.6 
December 31, 2023
(In millions)
Discounts
Contractual

Adjustments
Returns
Total
Balance, December 31, 2022
$
153.8 
$
857.7 
$
23.5 
$
1,035.0 
Current provisions relating to sales in current year
735.6 
2,720.1 
19.0 
3,474.7 
Adjustments relating to prior years
(0.4)
(38.4)
19.2 
(19.6)
Payments/credits relating to sales in current year
(572.9)
(1,944.8)
(2.1)
(2,519.8)
Payments/credits relating to sales in prior years
(142.8)
(737.5)
(28.0)
(908.3)
Balance, December 31, 2023
$
173.3 
$
857.1 
$
31.6 
$
1,062.0 
December 31, 2022
(In millions)
Discounts
Contractual

Adjustments
Returns
Total
Balance, December 31, 2021
$
137.7 
$
759.6 
$
38.0 
$
935.3 
Current provisions relating to sales in current year
666.6 
2,715.5 
12.3 
3,394.4 
Adjustments relating to prior years
(2.8)
1.4 
(7.2)
(8.6)
Payments/credits relating to sales in current year
(514.9)
(2,060.7)
(1.2)
(2,576.8)
Payments/credits relating to sales in prior years
(132.8)
(558.1)
(18.4)
(709.3)
Balance, December 31, 2022
$
153.8 
$
857.7 
$
23.5 
$
1,035.0 
The total reserves above, which are included in our consolidated balance sheets, are summarized as follows:
 
As of December 31,
(In millions)
2024
2023
Reduction of accounts receivable
$
154.1 
$
135.5 
Component of accrued expense and other
937.5 
926.5 
Total revenue-related reserves
$
1,091.6 
$
1,062.0 
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Revenue from Anti-CD20 Therapeutic Programs
Revenue from anti-CD20 therapeutic programs is summarized in the table below. For purposes of this footnote, we refer to RITUXAN and
RITUXAN HYCELA collectively as RITUXAN.
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Royalty revenue on sales of OCREVUS
$
1,339.5 
$
1,266.2 
$
1,136.3 
Biogen's share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO
392.0 
409.4 
547.0 
Other revenue from anti-CD20 therapeutic programs
18.4 
14.0 
17.2 
Total revenue from anti-CD20 therapeutic programs
$
1,749.9 
$
1,689.6 
$
1,700.5 
 LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
Approximately 18.1%, 17.2% and 16.7% of our total revenue in 2024, 2023 and 2022, respectively, was derived from our collaboration
arrangements with Genentech. For additional information on our collaboration arrangements with Genentech, please read Note 19,
Collaborative and Other Relationships, to these consolidated financial statements.
Alzheimer's Collaboration Revenue
Alzheimer's collaboration revenue consists of our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we
are not the principal. We began recognizing Alzheimer's collaboration revenue upon the accelerated approval of LEQEMBI in the U.S. during
the first quarter of 2023.
For the year ended December 31, 2024, we recognized approximately $59.9 million of Alzheimer's collaboration revenue within our
consolidated statements of income. For the year ended December 31, 2023, our share of LEQEMBI product revenue, net, was fully offset by
our share of cost of sales, including royalties, resulting in a zero net impact to Alzheimer's collaboration revenue within our consolidated
statements of income.
For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
Contract Manufacturing, Royalty and Other Revenue
Contract manufacturing, royalty and other revenue is summarized as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Contract manufacturing revenue
$
592.1 
$
848.2 
$
417.7 
Royalty and other revenue
60.5 
51.1 
67.4 
Total contract manufacturing, royalty and other revenue
$
652.6 
$
899.3 
$
485.1 
Contract Manufacturing Revenue
Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers.
During the first quarter of 2023 we began recognizing contract manufacturing revenue for LEQEMBI, upon accelerated approval of LEQEMBI
in the U.S. Prior to accelerated approval, our share of contract manufacturing amounts related to LEQEMBI were recognized in research and
development expense within our consolidated statements of income.
During the third quarter of 2019, we amended our agreement with a contract manufacturing customer pursuant to which we licensed certain
of our manufacturing-related intellectual property to the customer. In the second quarter of 2020, the customer received regulatory approval
for its product that is being manufactured using certain of our manufacturing-related intellectual property. As a result we were entitled to
$500.0 million in a series of three payments. The third and final payment became due upon the second anniversary of the regulatory
approval and was received during the second quarter of 2022.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Royalty and Other Revenue
Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and
royalties we receive from net sales on products related to patents that we have out-licensed.
For additional information on our license arrangements with Samsung Bioepis and our collaboration arrangements with Eisai, please read
Note 19, Collaborative and Other Relationships, to these consolidated financial statements.
Note 6:
Inventory
The components of inventory are summarized as follows:
 
As of December 31,
(In millions)
2024
2023
Raw materials
$
317.8 
$
426.9 
Work in process
1,882.8 
1,926.8 
Finished goods
353.8 
255.4 
Total inventory
$
2,554.4 
$
2,609.1 
Balance Sheet Classification:
Inventory
$
2,460.5 
$
2,527.4 
Investments and other assets
93.9 
81.7 
Total inventory
$
2,554.4 
$
2,609.1 
Long-term inventory is included in investments and other assets within our consolidated balance sheets.
We recorded approximately $1.3 billion of acquired inventory, which includes measurement period adjustments, related to SKYCLARYS as a
result of our acquisition of Reata in September 2023. The fair value was determined based on the estimated selling price of the inventory,
less the remaining manufacturing and selling costs and a normal profit margin on those manufacturing and selling efforts. This fair value
step-up adjustment is being amortized to cost of sales within our consolidated statements of income as the inventory is sold, which is
expected to be sold over a period of approximately 4 years from the acquisition date. For the years ended December 31, 2024 and 2023,
amortization from the fair value step-up adjustment was approximately $230.0 million and $31.5 million, respectively. For the year ended
December 31, 2024, amortization from the fair value step-up adjustment includes approximately $48.5 million of inventory used for clinical
purposes, which is reflected within research and development expense within our consolidated statements of income. For additional
information on our acquisition of Reata, please read Note 2, Acquisitions, to these consolidated financial statements.
Write Downs and Other Charges
Inventory amounts written down as a result of excess, obsolescence or unmarketability are charged to cost of sales, and totaled $101.9
million, $124.4 million and $336.2 million for the years ended December 31, 2024, 2023 and 2022, respectively.
During the first quarter of 2022 we wrote-off approximately $275.0 million of inventory related to ADUHELM, as a result of the final NCD,
which was recognized in cost of sales within our consolidated statements of income for the year ended December 31, 2022. We recognized
approximately $136.0 million related to Eisai's 45.0% share of these charges in collaboration profit sharing/(loss reimbursement) within our
consolidated statements of income for the year ended December 31, 2022.
For additional information on our collaboration with Eisai, please read Note 19, Collaborative and Other Relationships, to these consolidated
financial statements.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 7:
Intangible Assets and Goodwill
Intangible Assets
Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows:
 
 
As of December 31, 2024
As of December 31, 2023
(In millions)
Estimated Life
Cost
Accumulated

Amortization
Net
Cost
Accumulated

Amortization
Net
Completed technology
1-31 years
$
14,138.4 
$
(6,254.1)
$
7,884.3 
$
11,728.8 
$
(5,869.8)
$
5,859.0 
In-process research and development
Indefinite until
commercialization
1,642.9 
— 
1,642.9 
2,340.0 
— 
2,340.0 
Priority review voucher
Indefinite
100.0 
— 
100.0 
100.0 
— 
100.0 
Trademarks and trade names
Indefinite
64.0 
— 
64.0 
64.0 
— 
64.0 
Total intangible assets
$
15,945.3 
$
(6,254.1)
$
9,691.2 
$
14,232.8 
$
(5,869.8)
$
8,363.0 
Amortization and Impairments
Amortization and impairment of acquired intangible assets totaled $446.7 million, $240.6 million and $365.9 million for the years ended
December 31, 2024, 2023 and 2022, respectively.
Amortization of acquired intangible assets, excluding impairment charges, totaled $386.5 million, $240.6 million and $246.3 million for the
years ended December 31, 2024, 2023 and 2022, respectively. The increase in amortization of acquired intangible assets, excluding
impairment charges, was primarily due to amortization for the Reata acquisition acquired intangible assets associated with SKYCLARYS.
For the year ended December 31, 2024, amortization and impairment of acquired intangible assets reflects the impact of a $40.0 million
impairment charge related to intangible assets from other clinical programs we acquired from Reata, reducing the remaining book value of
these IPR&D intangible assets to zero, and a $20.2 million impairment charge related to intangible assets associated with Samsung Bioepis
commercialization rights terminated during the third quarter of 2024. For the year ended December 31, 2023, we had no impairment charges.
For the year ended December 31, 2022, amortization and impairment of acquired intangible assets reflects the impact of a $119.6 million
impairment charge related to vixotrigine (BIIB074) for the potential treatment of DPN, which was discontinued during the fourth quarter of
2022 based on regulatory, development and commercialization challenges, reducing the remaining book value of this IPR&D intangible asset
to zero. We also adjusted the value of our contingent consideration obligations related to this asset resulting in a pre-tax gain of
approximately $209.1 million, which was recognized in (gain) loss on fair value remeasurement of contingent consideration within our
consolidated statements of income for the year ended December 31, 2022.
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.
Completed Technology
Completed technology primarily relates to our other marketed products and programs acquired through asset acquisitions, licenses and
business combinations. Completed technology intangible assets are amortized over their estimated useful lives, which range between 1 to 31
years, with a remaining weighted average useful life of 13 years. In connection with our acquisition of Reata in September 2023 we acquired
SKYCLARYS, a commercially-approved product in the U.S., with an estimated fair value of approximately $4.2 billion, which includes
measurement period adjustments. During the first quarter of 2024 SKYCLARYS was approved in the E.U. and became commercially
available, which resulted in the reclassification of the related intangible asset, with an estimated fair value of approximately $2.3 billion, from
IPR&D to completed technology.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
IPR&D Related to Business Combinations
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. Included in IPR&D balances are adjustments related to foreign currency
exchange rate fluctuations. 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.
The carrying value associated with our IPR&D assets as of December 31, 2024, relates to the IPR&D programs we acquired in connection
with our acquisition of HI-Bio in July 2024, with an estimated fair value of approximately $1.6 billion.
The carrying value associated with our IPR&D assets as of December 31, 2023, relates to the IPR&D programs we acquired in connection
with our acquisition of Reata in September 2023 with an estimated fair value of approximately $2.3 billion, which includes measurement
period adjustments. During the first quarter of 2024 SKYCLARYS was approved in the E.U. and became commercially available, which
resulted in the reclassification of the related intangible asset from IPR&D to completed technology.
Priority Review Voucher
In connection with our acquisition of Reata in September 2023 we acquired a rare pediatric disease PRV which may be used to obtain priority
review by the FDA for a future regulatory submission or sold to a third party. We recorded the PRV based on its estimated fair value of
$100.0 million as an intangible asset. The estimated fair value of the PRV was based on recent external purchase and sale transactions of
similar vouchers.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions, to these consolidated financial
statements.
Estimated Future Amortization of Intangible Assets
The estimated future amortization of finite-lived intangible assets for the next five years is expected to be as follows:
(In millions)
As of December 31, 2024
2025
$
525.0 
2026
560.0 
2027
600.0 
2028
630.0 
2029
665.0 
Goodwill
The following table provides a roll forward of the changes in our goodwill balance:
 
As of December 31,
(In millions)
2024
2023
Goodwill, January 1
$
6,219.2 
$
5,749.0 
Goodwill resulting from HI-Bio acquisition
256.5 
— 
Goodwill resulting from Reata acquisition
4.7 
464.5 
Other
(1.5)
5.7 
Goodwill, December 31
$
6,478.9 
$
6,219.2 
 Goodwill resulting from Reata acquisition for the year ended December 31, 2024, relates to Reata measurement period adjustments recognized during 2024.
For additional information on our acquisitions of Reata and HI-Bio, please read Note 2, Acquisitions, to these consolidated financial
statements.
As of December 31, 2024 and 2023, we had no accumulated impairment losses related to goodwill. Other includes adjustments related to
foreign currency exchange rate fluctuations.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 8:
Fair Value Measurements
The tables below present information about our assets and liabilities that are regularly measured and carried at fair value and indicate the
level within the fair value hierarchy of the valuation techniques we utilized to determine such fair value:
Fair Value Measurements on a Recurring Basis
As of December 31, 2024
(In millions)
Total
Quoted Prices

in Active

Markets

(Level 1)
Significant

Other Observable

Inputs

(Level 2)
Significant

Unobservable

Inputs

(Level 3)
Assets:
Cash equivalents
$
1,664.9 
$
— 
$
1,664.9 
$
— 
Marketable equity securities
179.7 
179.7 
— 
— 
Other current assets:
Derivative contracts
62.5 
— 
62.5 
— 
Other non-current assets:
Plan assets for deferred compensation
42.8 
— 
42.8 
— 
Total
$
1,949.9 
$
179.7 
$
1,770.2 
$
— 
Liabilities:
Other current liabilities:
Derivative contracts
$
11.7 
$
— 
$
11.7 
$
— 
Contingent consideration obligations
291.2 
— 
— 
291.2 
Other non-current liabilities:
Contingent consideration obligations
221.6 
— 
— 
221.6 
Total
$
524.5 
$
— 
$
11.7 
$
512.8 
Fair Value Measurements on a Recurring Basis
As of December 31, 2023
(In millions)
Total
Quoted Prices

in Active
Markets

(Level 1)
Significant

Other Observable

Inputs

(Level 2)
Significant

Unobservable

Inputs

(Level 3)
Assets:
Cash equivalents
$
610.7 
$
— 
$
610.7 
$
— 
Marketable equity securities
416.8 
416.8 
— 
— 
Other current assets:
Receivable from Samsung BioLogics
430.0 
— 
— 
430.0 
Derivative contracts
11.9 
— 
11.9 
— 
Other non-current assets:
Plan assets for deferred compensation
37.5 
— 
37.5 
— 
Total
$
1,506.9 
$
416.8 
$
660.1 
$
430.0 
Liabilities:
Derivative contracts
$
31.6 
$
— 
$
31.6 
$
— 
Total
$
31.6 
$
— 
$
31.6 
$
— 
 Represents the fair value of the second deferred payment due from Samsung BioLogics as a result of the sale of our 49.9% equity interest in Samsung Bioepis to Samsung
BioLogics during the second quarter of 2022, for which we elected the fair value option. For additional information on the sale of our equity interest in Samsung Bioepis,
please read Note 3, Dispositions, to these consolidated financial statements.
Our marketable equity securities represent investments in publicly traded equity securities. Our ability to liquidate our investments in Denali
and Sage may be limited by the size of our interest, the volume of market related activity, our
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
concentrated level of ownership and potential restrictions resulting from our status as a collaborator. Therefore, we may realize significantly
less than the current value of such investments.
For additional information on our investments in Denali, Sangamo and Sage common stock, please read Note 19, Collaborative and Other
Relationships, to these consolidated financial statements.
There have been no material impairments of our assets measured and carried at fair value as of December 31, 2024 and 2023. In addition,
there have been no changes to our valuation techniques as of December 31, 2024 and 2023.
For a description of our validation procedures related to prices provided by third-party pricing services and our option pricing valuation model,
please read Note 1, Summary of Significant Accounting Policies - Fair Value Measurements, to these consolidated financial statements.
Level 3 Assets and Liabilities Held at Fair Value
The following table presents quantitative information, as of the dates indicated, about the valuation techniques and significant unobservable
inputs used in the valuation of our Level 3 financial assets and liabilities measured at fair value on a recurring basis:
Quantitative Information about Level 3 Fair Value Measurements
As of December 31, 2024
(In millions)
Fair Value
Valuation Technique
Significant

Unobservable Input(s)
Range
Weighted

Average
Liabilities:
Contingent consideration obligations
$
512.8 
Discounted cash flow
Discount rate
6.2% - 6.3%
6.2%
Expected timing of
achievement of development
milestones
2025 - 2030
—
The weighted average discount rates were calculated based on the relative fair values of each distinct contingent consideration obligation
related to our acquisition of HI-Bio in July 2024. In addition, we apply various probabilities of technological and regulatory success to the
valuation models to estimate the fair values of these contingent consideration obligations, which ranged from 68.3% to near certain
probability as of December 31, 2024.
There were no transfers of assets or liabilities into or out of Level 3 as of December 31, 2024 and 2023.
Contingent Consideration Obligations
In connection with our acquisition of HI-Bio in July 2024 we agreed to make additional payments based upon the achievement of certain
milestone events. The following table provides a roll forward of the fair value of our contingent consideration obligations, which were
classified as Level 3 measurements:
(In millions)
As of December 31, 2024
Fair value, beginning of year
$
— 
Contingent consideration resulting from HI-Bio acquisition
485.1 
Changes in fair value
27.7 
Fair value, end of year
$
512.8 
Changes in the fair values of our contingent consideration obligations are recorded in (gain) loss on fair value remeasurement of contingent
consideration in our consolidated statements of income. The fair values of the contingent consideration liabilities were based on a probability-
adjusted discounted cash flow calculation using Level 3 fair value measurements and inputs. For additional information on the valuation
techniques and inputs utilized in the valuation of our financial assets and liabilities, please read Note 1, Summary of Significant Accounting
Policies, to these consolidated financial statements.
As of December 31, 2024, approximately $291.2 million of the fair value of the total contingent consideration obligation was classified as
short-term and reflected as a component of accrued expense and other within our consolidated balance sheets with the remaining
$221.6 million reflected as a component of other long-term liabilities in our consolidated balance sheets.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
For the year ended December 31, 2024, the changes in the fair value of our contingent consideration obligations were primarily due to
changes in interest rates used to revalue our contingent consideration liabilities, the passage of time and updates to the expected timing of
achieving certain milestones which will trigger contingent consideration payments.
Financial Instruments Not Carried at Fair Value
Other Financial Instruments
Due to the short-term nature of certain financial instruments, the carrying value reflected in our consolidated balance sheets for current
accounts receivable, due from anti-CD20 therapeutic programs, other current assets, accounts payable and accrued expense and other,
approximates fair value.
Debt Instruments
The fair values of our debt instruments, which are Level 2 liabilities, are summarized as follows:
 
Fair Value

As of December 31,
(In millions)
2024
2023
Current portion:
2023 Term Loan 364-day tranche
$
— 
$
150.0 
4.050% Senior Notes due September 15, 2025
1,741.0 
— 
Current portion of notes payable and term loan
1,741.0 
150.0 
Non-current portion:
2023 Term Loan three-year tranche
— 
500.0 
4.050% Senior Notes due September 15, 2025
— 
1,721.5 
2.250% Senior Notes due May 1, 2030
1,295.6 
1,279.3 
5.200% Senior Notes due September 15, 2045
1,008.0 
1,089.7 
3.150% Senior Notes due May 1, 2050
943.7 
1,049.0 
3.250% Senior Notes due February 15, 2051
448.9 
498.2 
Non-current portion of notes payable and term loan
3,696.2 
6,137.7 
Total notes payable and term loan
$
5,437.2 
$
6,287.7 
In connection with our acquisition of Reata we drew $1.0 billion from our 2023 Term Loan, comprised of a $500.0 million floating rate 364-day
tranche and a $500.0 million floating rate three-year tranche. As of December 31, 2024, our 2023 Term Loan was repaid in full. For additional
information on our 2023 Term Loan, please read Note 13, Indebtedness, to these consolidated financial statements.
The fair values of each of our series of Senior Notes were determined through market, observable and corroborated sources. The changes in
the fair values of our Senior Notes as of December 31, 2024, compared to 2023, are primarily related to increases in U.S. treasury yields
partially offset by a decrease in credit spreads used to value our Senior Notes since December 31, 2023. For additional information related to
our Senior Notes, please read Note 13, Indebtedness, to these consolidated financial statements.
Note 9:
Financial Instruments
The following table summarizes our financial assets with maturities of less than 90 days from the date of purchase included in cash and cash
equivalents in our consolidated balance sheets:
 
As of December 31,
(In millions)
2024
2023
Money market funds
$
1,664.9 
$
610.7 
Total
$
1,664.9 
$
610.7 
The carrying value of our money market funds approximates fair value due to their short-term maturities.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our marketable equity securities gains (losses) are recorded in other (income) expense, net in our consolidated statements of income. The
following tables summarize our available-for-sale marketable equity securities:
As of December 31, 2024
(In millions)
Amortized
Cost
Gross
Unrealized

Gains
Gross
Unrealized

Losses
Fair
Value
Marketable equity securities:
Marketable equity securities, non-current
$
668.7 
$
— 
$
(489.0)
$
179.7 
Total marketable equity securities
$
668.7 
$
— 
$
(489.0)
$
179.7 
As of December 31, 2023
(In millions)
Amortized

Cost
Gross

Unrealized

Gains
Gross

Unrealized

Losses
Fair

Value
Marketable equity securities:
Marketable equity securities, current
$
31.6 
$
— 
$
(21.0)
$
10.6 
Marketable equity securities, non-current
948.3 
— 
(542.1)
406.2 
Total marketable equity securities
$
979.9 
$
— 
$
(563.1)
$
416.8 
Proceeds from Marketable Debt Securities
The proceeds from maturities and sales of marketable debt securities and resulting realized gains and losses are summarized as follows:
 
For the Years Ended December 31,
(In millions)
2023
2022
Proceeds from maturities and sales
$
7,380.8 
$
3,671.0 
Realized gains
1.4 
— 
Realized losses
18.4 
12.6 
We partially funded our Reata acquisition through available cash, cash equivalents and marketable securities. As of December 31, 2023, we
had sold all of our marketable debt securities. For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to
these consolidated financial statements.
Realized losses for the year ended December 31, 2023, primarily relate to sales of U.S. treasuries and corporate bonds. Realized losses for
the year ended December 31, 2022, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed
securities.
Strategic Investments
Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies, which are reflected within our
disclosures included in Note 8, Fair Value Measurements, to these consolidated financial statements, as well as venture capital funds where
the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities.
As of December 31, 2024, our strategic investment portfolio was comprised of investments totaling $226.7 million which are included in
investments and other assets in our consolidated balance sheets. As of December 31, 2023, our strategic investment portfolio was
comprised of investments totaling $460.7 million which are included in other current assets and investments and other assets in our
consolidated balance sheets.
The decrease in our strategic investment portfolio for the year ended December 31, 2024, was primarily due to the decrease in the fair value
of our investment in Sage common stock, partially offset by an increase in the fair value of our investment in Denali common stock.
Additionally, during 2024 we sold a portion of our Denali common stock and the remaining portion of our Sangamo common stock.
For additional information on our investments in Denali, Sangamo and Sage common stock, please read Note 19, Collaborative and Other
Relationships, to these consolidated financial statements.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 10:
Derivative Instruments
Foreign Currency Forward Contracts - Hedging Instruments
Due to the global nature of our operations, portions of our revenue and operating expense are recorded in currencies other than the
U.S. dollar. The value of revenue and operating expense measured in U.S. dollars is therefore subject to changes in foreign currency
exchange rates. We enter into foreign currency forward contracts and foreign currency options with financial institutions with the primary
objective to mitigate the impact of foreign currency exchange rate fluctuations on our international revenue and operating expense.
Foreign currency forward contracts and foreign currency options in effect as of December 31, 2024 and 2023, had durations of 1 to 12
months. These contracts have been designated as cash flow hedges and unrealized gains and losses on the portion of these foreign
currency forward contracts and foreign currency options that are included in the effectiveness test are reported in AOCI. Realized gains and
losses of such contracts and options are recognized in revenue when the sale of product in the currency being hedged is recognized and in
operating expense when the expense in the currency being hedged is recorded. We recognize all cash flow hedge reclassifications from
AOCI and fair value changes of excluded portions in the same line item in our consolidated statements of income that have been impacted
by the hedged item.
The notional amount of foreign currency forward contracts and foreign currency options that were entered into to hedge forecasted revenue
and operating expense is summarized as follows:
 
Notional Amount

As of December 31,
(In millions)
2024
2023
Euro
$
1,062.6 
$
1,169.0 
British pound
133.8 
— 
Canadian dollar
38.6 
— 
Total foreign currency forward contracts and options
$
1,235.0 
$
1,169.0 
The pre-tax portion of the fair value of these foreign currency forward contracts and foreign currency options that were included in AOCI in
total equity is summarized as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Unrealized gains
$
50.6 
$
— 
$
29.9 
Unrealized (losses)
(0.3)
(34.8)
(21.3)
Net unrealized gains (losses)
$
50.3 
$
(34.8)
$
8.6 
We expect the net unrealized gains of approximately $50.3 million to be settled over the next 12 months, with any amounts in AOCI to be
reported as an adjustment to revenue or operating expense. We consider the impact of our and our counterparties’ credit risk on the fair
value of the contracts as well as the ability of each party to execute its contractual obligations. As of December 31, 2024 and 2023, credit risk
did not materially change the fair value of our foreign currency forward contracts and forward currency options.
The following table summarizes the effect of foreign currency forward contracts and forward currency options designated as hedging
instruments in our consolidated statements of income:
For the Years Ended December 31,
Net Gains/(Losses)
Reclassified from AOCI into Operating Income (in millions)
Net Gains/(Losses) Excluded from Effectiveness Testing and

Recognized in Operating Income (in millions)
Location
2024
2023
2022
Location
2024
2023
2022
Revenue
$
18.1 
$
11.6 
$
201.6 
Revenue
$
(0.8)
$
(2.4)
$
(8.6)
Operating expense
(12.9)
3.7 
(5.5)
Operating expense
— 
— 
— 
F-41

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Net Investment Hedges - Hedging Instruments
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. Our investment in the equity of Samsung Bioepis related to this transaction was exposed to the
currency fluctuations in the South Korean won.
In order to mitigate the currency fluctuations between the U.S. dollar and South Korean won, we entered into foreign currency forward
contracts. These contracts were designated as net investment hedges. 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. Upon completing this sale, the cumulative
gains on our net investment hedges of $57.0 million were reclassified from AOCI and reflected within the total pre-tax gain recognized from
the sale, which was recorded in other (income) expense, net in our consolidated statements of income for the year ended December 31,
2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these
consolidated financial statements.
The following table summarizes the effect of our net investment hedges in our consolidated financial statements:
For the Year Ended December 31, 2022
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
2022
Location
2022
Location
2022
Gains (losses) on net investment hedge
$
20.4 
Gains (losses) on net investment hedge
$
(3.2)
Other (income) expense
$
(4.6)
Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April
2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these consolidated financial statements.
For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other
Relationships, to these consolidated financial statements.
Foreign Currency Forward Contracts - Other Derivative Instruments
We also enter into other foreign currency forward contracts, usually with durations of one month or less, to mitigate the foreign currency risk
related to certain balance sheet positions. We have not elected hedge accounting for these transactions.
The aggregate notional amount of these outstanding foreign currency forward contracts was $738.7 million and $1,301.5 million as of
December 31, 2024 and 2023, respectively. Net losses of $49.7 million, net gains of $3.8 million and net losses of $34.7 million related to
these contracts were recorded as a component of other (income) expense, net for the years ended December 31, 2024, 2023 and 2022,
respectively.
Summary of Derivative Instruments
While certain of our derivative instruments are subject to netting arrangements with our counterparties, we do not offset derivative assets and
liabilities in our consolidated balance sheets. The amounts in the table below would not be substantially different if the derivative assets and
liabilities were offset.
The following table summarizes the fair value and presentation in our consolidated balance sheets of our outstanding derivative instruments,
including those designated as hedging instruments:
As of December 31,
(In millions)
Balance Sheet Location
2024
2023
Cash Flow Hedging Instruments:
Asset derivative instruments
Other current assets
$
58.4 
$
0.3 
Liability derivative instruments
Accrued expense and other
0.3 
26.5 
Other Derivative Instruments:
Asset derivative instruments
Other current assets
4.1 
11.6 
Liability derivative instruments
Accrued expense and other
11.4 
5.1 
(1)
(1)
(1)
(1) 
F-42

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 11:
Property, Plant and Equipment
Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Components of property, plant and
equipment, net are summarized as follows:
 
As of December 31,
(In millions)
2024
2023
Land
$
202.4 
$
202.4 
Buildings
1,963.7 
1,601.3 
Leasehold improvements
137.8 
135.7 
Machinery and equipment
2,109.8 
1,703.8 
Computer software and hardware
1,070.5 
1,032.1 
Furniture and fixtures
59.5 
61.5 
Construction in progress
308.4 
975.4 
Total cost
5,852.1 
5,712.2 
Less: accumulated depreciation
(2,670.8)
(2,402.5)
Total property, plant and equipment, net
$
3,181.3 
$
3,309.7 
Depreciation expense totaled $286.7 million, $254.2 million and $272.4 million for the years ended December 31, 2024, 2023 and 2022,
respectively.
For the years ended December 31, 2024, 2023 and 2022, we capitalized interest costs related to construction in progress totaling
approximately $3.2 million, $21.7 million and $17.1 million, respectively.
Solothurn, Switzerland Manufacturing Facility
In order to support our future growth and drug development pipeline, we built a large-scale biologics manufacturing facility in Solothurn,
Switzerland. This facility includes 393,000 square feet related to a large-scale biologics manufacturing facility, 290,000 square feet of
warehouse, utilities and support space and 51,000 square feet of administrative space. As of December 31, 2023, we had approximately
$728.8 million capitalized as construction in progress related to this facility. In the second quarter of 2021 a portion of this facility (the first
manufacturing suite) received a GMP multi-product license from SWISSMEDIC and was placed into service. The second manufacturing
suite, which was also licensed to operate by SWISSMEDIC, became operational in the first quarter of 2024, resulting in approximately
$717.3 million of fixed assets being placed into service. Solothurn has been approved for the manufacture of LEQEMBI.
125 Broadway Building Sale
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, net in our consolidated statements of
income for the year ended December 31, 2022. This transaction included approximately $79.2 million of property, plant and equipment, net,
which comprised of approximately $72.6 million for buildings, approximately $1.6 million for land and approximately $5.0 million for
machinery and equipment.
Note 12:
Leases
We lease real estate, including laboratory and office space, and certain equipment.
Our leases have remaining lease terms ranging from less than one year to fourteen years. Certain leases include one or more options to
renew, exercised at our sole discretion, with renewal terms that can extend the lease term from less than one year to ten years.
In addition, we sublease certain real estate to third parties. Our sublease portfolio consists of operating leases, with remaining lease terms
ranging from less than one year to five years.
F-43

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
All of our leases qualify as operating leases. The following table summarizes the presentation in our consolidated balance sheets of our
operating leases:
As of December 31,
(In millions)
Balance sheet location
2024
2023
Assets:
Operating lease assets
Operating lease assets
$
356.4 
$
420.0 
Liabilities
Current operating lease liabilities
Accrued expense and other
$
86.4 
$
90.3 
Non-current operating lease liabilities
Long-term operating lease liabilities
334.5 
400.0 
Total operating lease liabilities
$
420.9 
$
490.3 
The following table summarizes the effect of lease costs in our consolidated statements of income:
For the Years Ended December 31,
(In millions)
Income Statement Location
2024
2023
2022
Operating lease cost
Research and development
$
2.4 
$
2.0 
$
2.0 
Selling, general and administrative
110.1 
128.1 
95.9 
Variable lease cost
Research and development
0.4 
0.5 
0.4 
Selling, general and administrative
31.2 
37.3 
25.4 
Sublease income
Selling, general and administrative
(14.8)
(23.5)
(24.0)
Other (income) expense, net
(4.0)
(4.1)
(4.1)
Net lease cost
$
125.3 
$
140.3 
$
95.6 
Variable lease cost primarily related to operating expense, taxes and insurance associated with our operating leases. As these costs are
generally variable in nature, they are not included in the measurement of the operating lease asset and related lease liability.
The minimum lease payments for the next five years and thereafter are expected to be as follows:

(In millions)
As of December 31, 2024
2025
$
103.4 
2026
88.5 
2027
88.3 
2028
50.2 
2029
21.9 
Thereafter
152.4 
Total lease payments
$
504.7 
Less: interest
83.8 
Present value of operating lease liabilities
$
420.9 
The weighted average remaining lease term and weighted average discount rate of our operating leases are as follows:
As of December 31,
2024
2023
Weighted average remaining lease term in years
7.20
7.37
Weighted average discount rate
4.5 %
4.5 %
F-44

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Supplemental disclosure of cash flow information related to our operating leases included in cash flow provided by operating activities in our
consolidated statements of cash flow is as follows:
As of December 31,
(In millions)
2024
2023
2022
Cash paid for amounts included in the measurement of lease liabilities
$
115.8 
$
116.4 
$
107.4 
Operating lease assets obtained in exchange for lease obligations
16.9 
146.0 
108.3 
6100 Legacy Drive Lease
In connection with our acquisition of Reata in September 2023 we assumed responsibility for a single-tenant, build-to-suit building of
approximately 327,400 square feet of office and laboratory space located in Plano, Texas, with an initial lease term of 16 years. We recorded
a lease liability of approximately $151.8 million, which represents the net present value of rental expense over the remaining lease term of
approximately 15 years, with a corresponding right-of-use asset of approximately $121.2 million, which represents our estimate of the fair
value for a market participant of the current rental market in the Dallas, Texas area. Included in our estimate of the market rental rate is the
value of any leasehold improvements or tenant allowances related to the building. We do not intend to occupy this building and are
evaluating opportunities to sublease the property.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to these consolidated financial statements.
125 Broadway Building Sale and Leaseback Transaction
In connection with the sale of our 125 Broadway building during the third quarter of 2022, we simultaneously leased back the building for a
term of approximately 5.5 years, which resulted in the recognition of approximately $168.2 million in a new lease liability and right-of-use
asset recorded within our consolidated balance sheets as of December 31, 2022. The sale and immediate leaseback of this building qualified
for sale and leaseback treatment and is classified as an operating lease. For additional information on the sale of our 125 Broadway building,
please read Note 11, Property, Plant and Equipment, to these consolidated financial statements.
300 Binney Street Lease Modification
In September 2022 we entered into an agreement to partially terminate a portion of our lease located at 300 Binney Street, as well as to
reduce the lease term for the majority of the remaining space. The agreement was driven by our 2022 efforts to reduce costs by
consolidating real estate locations. The transaction was treated as a lease modification as of the effective date and resulted in the
derecognition of a right-of-use asset of approximately $47.4 million and a lease liability of approximately $52.7 million, which resulted in a
gain of approximately $5.3 million, which was recorded within restructuring charges in our consolidated statements of income for the year
ended December 31, 2022. As of December 31, 2024, we no longer lease any portion of this space.
F-45

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 13:
Indebtedness
Our indebtedness is summarized as follows:
 
As of December 31,
(In millions)
2024
2023
Current portion:
2023 Term Loan 364-day tranche
$
— 
$
150.0 
4.050% Senior Notes due September 15, 2025
1,748.6 
— 
Current portion of notes payable and term loan
$
1,748.6 
$
150.0 
Non-current portion:
2023 Term Loan three-year tranche
$
— 
$
500.0 
4.050% Senior Notes due September 15, 2025
— 
1,746.6 
2.250% Senior Notes due May 1, 2030
1,494.7 
1,493.8 
5.200% Senior Notes due September 15, 2045
1,101.1 
1,100.7 
3.150% Senior Notes due May 1, 2050
1,475.0 
1,474.3 
3.250% Senior Notes due February 15, 2051
476.4 
472.8 
Non-current portion of notes payable and term loan
$
4,547.2 
$
6,788.2 
In connection with our acquisition of Reata we drew $1.0 billion from our 2023 Term Loan, comprised of a $500.0 million floating rate 364-day
tranche and a $500.0 million floating rate three-year tranche. As of December 31, 2024, our 2023 Term Loan was repaid in full.
As of December 31, 2024, we were in compliance with our senior note covenants and term loan covenants.
2023 Term Loan Credit Agreement
In connection with our acquisition of Reata in September 2023 we entered into a $1.5 billion term loan credit agreement. On the closing date
of the Reata acquisition we drew $1.0 billion from the 2023 Term Loan, comprised of a $500.0 million floating rate 364-day tranche and a
$500.0 million floating rate three-year tranche. The remaining unused commitment of $500.0 million was terminated. As of December 31,
2023, we repaid $350.0 million of the 364-day tranche. The remaining $150.0 million portion of the 364-day tranche was repaid during the
first quarter of 2024.
Additionally, during the first quarter of 2024 we repaid $250.0 million of the three-year tranche, with the remaining $250.0 million portion
being subsequently repaid in full during the second quarter of 2024. For additional information on our acquisition of Reata, please read Note
2, Acquisitions, to these consolidated financial statements.
2021 Exchange Offer Senior Notes
The following is a summary of our currently outstanding senior unsecured notes issued in 2021 as part of our Exchange Offer (the 2021
Exchange Offer Senior Notes), consisting of the following:
•
$700.7 million aggregate principal amount of 3.25% Senior Notes due February 15, 2051, valued at 99.298% of par.
Our 2021 Exchange Offer Senior Notes are senior unsecured obligations and may be redeemed at our option at any time at 100.0% of the
principal amount plus accrued interest and a specified make-whole amount. Our 2021 Exchange Offer Senior Notes contain a change of
control provision that may require us to purchase the notes at a price equal to 101.0% of the principal amount plus accrued and unpaid
interest to the date of purchase under certain circumstances.
The costs associated with this exchange offer of approximately $5.4 million have been recorded as a reduction to the carrying amount of the
debt in our consolidated balance sheets. These costs along with the discounts will be amortized as additional interest expense using the
effective interest rate method over the period from issuance through maturity. Interest on our 2021 Exchange Offer Senior Notes is payable
February 15 and August 15 of each year, commencing August 15, 2021.
F-46

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
2020 Senior Notes
The following is a summary of our currently outstanding senior unsecured notes 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, valued at 99.973% of par; and
•
$1.5 billion aggregate principal amount of 3.15% Senior Notes due May 1, 2050, valued at 99.174% of par.
Our 2020 Senior Notes are senior unsecured obligations and may be redeemed at our option at any time at 100.0% of the principal amount
plus accrued interest and, until a specified period before maturity, a specified make-whole amount. Our 2020 Senior Notes contain a change-
of-control provision that, under certain circumstances, may require us to purchase our 2020 Senior Notes at a price equal to 101.0% of the
principal amount plus accrued and unpaid interest to the date of repurchase.
The original costs associated with this offering of approximately $24.4 million have been recorded as a reduction to the carrying amount of
the debt in our consolidated balance sheets. These costs along with the discounts will be amortized as additional interest expense using the
effective interest rate method over the period from issuance through maturity. Interest on our 2020 Senior Notes is payable May 1 and
November 1 of each year, commencing November 1, 2020.
2015 Senior Notes
The following is a summary of our currently outstanding senior unsecured notes issued in 2015 (the 2015 Senior Notes), consisting of the
following:
•
$1.75 billion aggregate principal amount of 4.05% Senior Notes due September 15, 2025, valued at 99.764% of par; and
•
$1.12 billion aggregate principal amount of 5.20% Senior Notes due September 15, 2045, valued at 99.294% of par.
Our 2015 Senior Notes are senior unsecured obligations and may be redeemed at our option at any time at 100.0% of the principal amount
plus accrued interest and a specified make-whole amount. Our 2015 Senior Notes contain a change of control provision that may require us
to purchase the notes at a price equal to 101.0% of the principal amount plus accrued and unpaid interest to the date of purchase under
certain circumstances.
The original costs associated with this offering of approximately $47.5 million, of which approximately $23.6 million pertains to our currently
outstanding notes, have been recorded as a reduction to the carrying amount of the debt in our consolidated balance sheets. These costs
along with the discounts will be amortized as additional interest expense using the effective interest rate method over the period from
issuance through maturity. Interest on our 2015 Senior Notes is payable March 15 and September 15 of each year, commencing March 15,
2016.
3.625% Senior Notes due September 15, 2022
On September 15, 2015, we issued $1.0 billion aggregate principal amount of our 3.625% Senior Notes due September 15, 2022, at
99.920% of par. Our 3.625% Senior Notes were senior unsecured obligations. In July 2022 we redeemed our 3.625% Senior Notes prior to
their maturity and recognized a net pre-tax charge of approximately $2.4 million upon the extinguishment of these Senior Notes, which
primarily reflects the payment of an early call premium as well as the write-off of remaining unamortized original debt issuance costs and
discount balances. These charges were recognized as interest expense in other (income) expense, net in our consolidated statements of
income for the year ended December 31, 2022.
2024 Revolving Credit Facility
In August 2024 we entered into a $1.5 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. This revolving credit facility replaced the revolving credit facility that we entered into in
January 2020. As of December 31, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.
F-47

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Debt Maturity
The total gross payments due under our debt arrangements are as follows:
(In millions)
As of December 31, 2024
2025
$
1,750.0 
2026
— 
2027
— 
2028
— 
2029
— 
2030 and thereafter
4,817.3 
Total current and non-current debt
6,567.3 
Less: debt discount and issuance fees
(271.5)
Total current and non-current debt, net
$
6,295.8 
The fair value of our debt is disclosed in Note 8, Fair Value Measurements, to these consolidated financial statements.
Note 14:
Equity
Preferred Stock
We have 8.0 million shares of Preferred Stock authorized, of which 1.75 million shares are authorized as Series A, 1.0 million shares are
authorized as Series X junior participating and 5.25 million shares are undesignated. Shares may be issued without a vote or action of
shareholders from time to time in classes or series with the designations, powers, preferences and the relative, participating, optional or other
special rights of the shares of each such class or series and any qualifications, limitations or restrictions thereon as set forth in the
instruments governing such shares. Any such Preferred Stock may rank prior to common stock as to dividend rights, liquidation preference or
both, and may have full or limited voting rights and may be convertible into shares of common stock. No shares of Preferred Stock were
issued and outstanding during 2024, 2023 and 2022.
Common Stock
The following table describes the number of shares authorized, issued and outstanding of our common stock as of December 31, 2024, 2023
and 2022:
 
As of December 31, 2024
As of December 31, 2023
As of December 31, 2022
(In millions)
Authorized
Issued
Outstanding
Authorized
Issued
Outstanding
Authorized
Issued
Outstanding
Common stock
1,000.0 
169.5 
145.8 
1,000.0 
168.7 
144.9 
1,000.0 
167.9 
144.0 
Share Repurchases
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 shares repurchased under our 2020 Share
Repurchase Program were retired. Under our 2020 Share Repurchase Program, we repurchased and retired approximately 3.6 million
shares of our common stock at a cost of approximately $750.0 million during the year ended December 31, 2022. There were no share
repurchases of our common stock during the years ended December 31, 2024 and 2023. Approximately $2.1 billion remained available
under our 2020 Share Repurchase Program as of December 31, 2024.
Amounts paid to repurchase shares in excess of their par value are allocated between additional paid-in-capital and retained earnings, with
payments in excess of our additional paid-in-capital balance recorded as a reduction to retained earnings.
F-48

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Accumulated Other Comprehensive Income (Loss)
The following tables summarize the changes in AOCI, net of tax by component:
December 31, 2024
(In millions)
Unrealized Gains (Losses)
on Cash Flow Hedges,

Net of Tax
Unrealized Gains (Losses)
on Pension Benefit
Obligation, 

Net of Tax
Currency

Translation

Adjustments,

Net of Tax
Total
Balance, December 31, 2023
$
(25.0)
$
(2.6)
$
(126.1)
$
(153.7)
Other comprehensive income (loss) before
reclassifications
80.8 
(14.0)
(45.1)
21.7 
Amounts reclassified from AOCI
(4.2)
— 
— 
(4.2)
Net current period other comprehensive
income (loss)
76.6 
(14.0)
(45.1)
17.5 
Balance, December 31, 2024
$
51.6 
$
(16.6)
$
(171.2)
$
(136.2)
December 31, 2023
(In millions)
Unrealized Gains
(Losses) on
Securities Available
for Sale, Net of Tax
Unrealized Gains
(Losses) on Cash
Flow Hedges,

Net of Tax
Unrealized Gains
(Losses) on Pension
Benefit Obligation,

Net of Tax
Currency Translation
Adjustments,

Net of Tax
Total
Balance, December 31, 2022
$
(15.7)
$
15.1 
$
(1.1)
$
(163.2)
$
(164.9)
Other comprehensive income (loss) before
reclassifications
2.3 
(26.8)
(1.5)
37.1 
11.1 
Amounts reclassified from AOCI
13.4 
(13.3)
— 
— 
0.1 
Net current period other comprehensive
income (loss)
15.7 
(40.1)
(1.5)
37.1 
11.2 
Balance, December 31, 2023
$
— 
$
(25.0)
$
(2.6)
$
(126.1)
$
(153.7)
December 31, 2022
(In millions)
Unrealized Gains
(Losses) on
Securities
Available for Sale,

Net of Tax
Unrealized Gains
(Losses) on Cash
Flow Hedges,

Net of Tax
Gains (Losses) on
Net Investment
Hedges,
Net of Tax
Unrealized Gains
(Losses) on
Pension Benefit
Obligation,

Net of Tax
Currency
Translation
Adjustments,

Net of Tax
Total
Balance, December 31, 2021
$
(2.2)
$
53.8 
$
25.5 
$
(44.8)
$
(139.0)
$
(106.7)
Other comprehensive income (loss) before
reclassifications
(23.5)
137.3 
12.6 
43.7 
(83.1)
87.0 
Amounts reclassified from AOCI
10.0 
(176.0)
(38.1)
— 
58.9 
(145.2)
Net current period other comprehensive
income (loss)
(13.5)
(38.7)
(25.5)
43.7 
(24.2)
(58.2)
Balance, December 31, 2022
$
(15.7)
$
15.1 
$
— 
$
(1.1)
$
(163.2)
$
(164.9)
Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April
2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these consolidated financial statements.
(1)
(1) 
F-49

Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following table summarizes the amounts reclassified from AOCI:
(In millions)
Amounts Reclassified from AOCI
Income Statement Location
For the Years Ended December 31,
2024
2023
2022
Gains (losses) on securities available for sale
$
— 
$
(17.0)
$
(12.6)
Other (income) expense, net
— 
3.6 
2.6 
Income tax (benefit) expense
Gains (losses) on cash flow hedges
18.1 
11.6 
201.6 
Revenue
(12.9)
3.7 
(5.5)
Operating expense
(0.4)
(0.3)
(0.3)
Other (income) expense, net
(0.6)
(1.7)
(19.8)
Income tax (benefit) expense
Gains (losses) on net investment hedges
— 
— 
38.1 
Other (income) expense, net
Currency translation adjustments
— 
— 
(58.9)
Other (income) expense, net
Total reclassifications, net of tax
$
4.2 
$
(0.1)
$
145.2 
Beginning in the second quarter of 2022 we no longer held net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April
2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these consolidated financial statements.
Note 15:
Earnings per Share
Basic and diluted shares outstanding used in our earnings per share calculation are calculated as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Numerator:
Net income attributable to Biogen Inc.
$
1,632.2 
$
1,161.1 
$
3,046.9 
Denominator:
Weighted-average number of common shares outstanding
145.6 
144.7 
145.3 
Effect of dilutive securities:
Time-vested restricted stock units
0.3 
0.7 
0.5 
Market stock units
— 
— 
0.1 
Performance stock units settled in stock
— 
0.2 
0.1 
Dilutive potential common shares
0.3 
0.9 
0.7 
Shares used in calculating diluted earnings per share
145.9 
145.6 
146.0 
Amounts excluded from the calculation of net income per diluted share because their effects were anti-dilutive were insignificant.
Earnings per share for the year ended December 31, 2022, reflects the repurchase of approximately 3.6 million shares of our common stock,
respectively, under our 2020 Share Repurchase Program. There were no share repurchases of our common stock during the years ended
December 31, 2024 and 2023. For additional information on our 2020 Share Repurchase Program, please read Note 14, Equity, to these
consolidated financial statements.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 16:
Share-Based Payments
Share-Based Compensation Expense
The following table summarizes share-based compensation expense included in our consolidated statements of income:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Research and development
$
154.1 
$
296.7 
$
98.5 
Selling, general and administrative
198.6 
371.7 
175.1 
Subtotal
352.7 
668.4 
273.6 
Capitalized share-based compensation costs
(10.3)
(10.2)
(9.3)
Share-based compensation expense included in total cost and expense
342.4 
658.2 
264.3 
Income tax effect
(63.4)
(132.6)
(49.2)
Share-based compensation expense included in net income attributable to Biogen Inc.
$
279.0 
$
525.6 
$
215.1 
In connection with our acquisition of Reata in September 2023 we recognized Reata equity-based compensation expense, inclusive of
employer taxes, of approximately $393.4 million attributable to the post-acquisition service period, of which $196.4 million was recognized as
a charge to selling, general and administrative expense with the remaining $197.0 million as a charge to research and development expense
within our consolidated statements of income for the year ended December 31, 2023. These amounts were associated with the accelerated
vesting of stock options and RSUs previously granted to Reata employees that required no future services to vest.
In connection with our acquisition of HI-Bio in July 2024 we recognized HI-Bio equity-based compensation expense, inclusive of employer
taxes, of approximately $56.4 million attributable to the post-acquisition service period, of which $42.5 million was recognized as a charge to
research and development expense with the remaining $13.9 million as a charge to selling, general and administrative expense within our
consolidated statements of income for the year ended December 31, 2024. These amounts were associated with the accelerated vesting of
stock options and RSUs previously granted to HI-Bio employees and required no future services to vest.
For additional information on our acquisitions of HI-Bio and Reata, please read Note 2, Acquisitions, to these consolidated financial
statements.
The following table summarizes share-based compensation expense associated with each of our share-based compensation programs:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Time-vested restricted stock units
$
236.4 
$
220.0 
$
202.3 
Performance stock units settled in stock
48.4 
35.5 
35.0 
Performance stock units settled in cash
(2.5)
6.8 
10.1 
Employee stock purchase plan
9.7 
10.5 
12.7 
Stock options
3.7 
3.7 
0.3 
Market stock units
0.6 
4.9 
13.2 
Reata equity awards
— 
387.0 
— 
HI-Bio equity awards
56.4 
— 
— 
Subtotal
352.7 
668.4 
273.6 
Capitalized share-based compensation costs
(10.3)
(10.2)
(9.3)
Share-based compensation expense included in total cost and expense
$
342.4 
$
658.2 
$
264.3 
Relates to the Reata and HI-Bio equity-based compensation expense attributable to the post-acquisition service period, associated with the accelerated vesting of stock
options and RSUs previously granted to Reata and HI-Bio employees that required no future services to vest. For additional information on our acquisitions of Reata and HI-
Bio, please read Note 2, Acquisitions, to these consolidated financial statements.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
As of December 31, 2024, unrecognized compensation cost related to unvested share-based compensation was approximately $292.2
million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.8 years.
Share-Based Compensation Plans
We have two share-based compensation plans pursuant to which awards are currently being made: (i) the Biogen Inc. 2024 Omnibus Equity
Plan (2024 Omnibus Equity Plan); and (ii) the Biogen Inc. 2024 Employee Stock Purchase Plan (2024 ESPP).
We have three share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards
can or will be made: (i) the Biogen Inc. 2006 Non-Employee Directors Equity Plan (2006 Directors Plan); (ii) the Biogen Inc. 2017 Omnibus
Equity Plan (2017 Omnibus Equity Plan); and (iii) the Biogen Inc. 2015 Employee Stock Purchase Plan (2015 ESPP).
2024 Omnibus Equity Plan
In June 2024 our shareholders approved the 2024 Omnibus Equity Plan for share-based awards to our prospective and current employees,
non-employee directors, officers or consultants. Awards granted from the 2024 Omnibus Equity Plan may include stock options, shares of
restricted stock, restricted stock units, performance shares, stock appreciation rights and other awards in such amounts and with such terms
and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common
stock available for grant under the 2024 Omnibus Equity Plan consist of 3.7 million shares reserved for this purpose, plus shares of common
stock that remained available for grant under our 2017 Omnibus Equity Plan (including shares available by reason of a predecessor plan) on
the date that our shareholders approved the 2024 Omnibus Equity Plan, plus shares that were subject to awards under the 2017 Omnibus
Equity Plan (including shares available by reason of a predecessor plan) that remain unissued upon the cancellation, surrender, exchange,
termination or forfeiture of such awards. The 2024 Omnibus Equity Plan provides that awards other than stock options and stock appreciation
rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
We have not made any awards pursuant to the 2017 Omnibus Equity Plan or the Directors Plan since our shareholders approved the 2024
Omnibus Equity Plan, and do not intend to make any awards pursuant to the 2017 Omnibus Equity Plan or the Directors Plan in the future,
except that unused shares under the 2017 Omnibus Equity Plan have been carried over for use under the 2024 Omnibus Equity Plan.
Awards outstanding under the 2017 Omnibus Equity Plan and the Directors Plan as of the date our shareholders approved the 2024
Omnibus Equity Plan will remain outstanding and subject to the terms and conditions of the 2017 Omnibus Equity Plan and the Directors
Plan, as applicable, and the relevant award agreements.
Stock Options
In 2022 we granted approximately 81,000 stock options to our CEO (2022 CEO Grant) under the 2017 Omnibus Plan with a grant date fair
value of $139.10 per option for a total of approximately $11.2 million. The fair value of the stock option grant is estimated as of the date of
grant using a Black-Scholes option valuation model. The estimated fair value of the stock option is then expensed over the options' vesting
periods. The 2022 CEO Grant is eligible to vest in equal annual installments over a three-year period from the grant date, subject to the
CEO’s continued employment. The outstanding stock option has a 10-year term and is exercisable at a price per share not less than the fair
market value of the underlying common stock on the date of grant.
December 31, 2024
Shares
Weighted Average
Exercise Price
Weighted Average Remaining
Contractual Term
Outstanding at December 31, 2023
81,000 
$
301.85 
8.9 years
Granted
— 
— 
Exercised
— 
— 
Forfeited
— 
— 
Outstanding at December 31, 2024
81,000 
$
301.85 
7.9 years
Exercisable at December 31, 2024
54,000 
$
301.85 
7.9 years
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Market Stock Units
MSUs awarded to employees in 2014 and thereafter vest in three equal annual increments beginning on the first anniversary of the grant
date, and participants may ultimately earn between zero and 200.0% of the target number of units granted based on actual stock
performance.
The vesting of these awards is subject to the respective employee’s continued employment. The number of MSUs granted represents the
target number of units that are eligible to be earned based on the attainment of certain market-based criteria involving our stock price. The
number of MSUs earned is calculated at each annual anniversary from the date of grant over the respective vesting periods, resulting in
multiple performance periods. Accordingly, additional MSUs may be issued or currently outstanding MSUs may be cancelled upon final
determination of the number of awards earned.
Beginning in 2022 we no longer grant MSUs as part of our long term incentive program and have replaced with granting performance-vested
RSUs.
The following table summarizes our MSU activity:
December 31, 2024
Shares
Weighted Average

Grant Date Fair Value
Unvested at December 31, 2023
34,000 
$
359.77 
Granted
— 
— 
Vested
(29,000)
375.59 
Forfeited
(5,000)
375.20 
Unvested at December 31, 2024
— 
$
— 
The fair values of MSUs vested in 2024, 2023 and 2022 totaled $6.3 million, $20.7 million and $18.8 million, respectively.
Performance Stock Units
PSUs Settled in Stock
During the first quarter of 2018 we began granting awards for performance-vested RSUs that will settle in stock. PSUs awarded to
employees have a three-year performance period and vest on the third anniversary of the grant date. The vesting of these awards is subject
to the respective employee’s continued employment. The number of PSUs granted represents the target number of units that are eligible to
be earned based on the achievement of cumulative three-year performance measures established at the beginning of the performance
period, which ends on December 31 of the third year of the performance period.
Participants may ultimately earn between zero and 200.0% of the target number of PSUs granted based on the degree of achievement of the
applicable performance metric. Accordingly, additional PSUs may be issued or currently outstanding PSUs may be cancelled upon final
determination of the number of units earned.
Beginning in 2022 we no longer grant MSUs as part of long term incentive program and have replaced with granting PSUs with a
performance metric based on a three-year cumulative relative total shareholder return (rTSR) metric. Beginning in 2024 we began granting
PSUs with a performance metric based on the three-year cumulative aggregate growth rate of our earnings per share during the performance
period.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following table summarizes our PSUs that settle in stock activity:
December 31, 2024
Shares
Weighted Average

Grant Date Fair Value
Unvested at December 31, 2023
389,000 
$
325.73 
Granted 
266,000 
280.60 
Vested
(59,000)
277.05 
Forfeited
(46,000)
308.84 
Unvested at December 31, 2024
550,000 
$
310.61 
 PSUs settled in stock granted in 2024 include awards granted in conjunction with our annual awards made in February 2024 and PSUs granted in conjunction with the hiring
of employees. These grants reflect the target number of shares eligible to be earned at the time of grant.
PSUs settled in stock granted in 2023 and 2022 had weighted average grant date fair values of $383.61 and $294.43, respectively.
We value grants of PSUs with a performance metric based on a three-year cumulative rTSR metric using a lattice model with a Monte Carlo
simulation. This valuation methodology utilizes several key assumptions, the 30 calendar day average closing stock price on the date of grant
for PSUs, expected volatility of our stock price, risk-free rates of return and expected dividend yield.
The assumptions used in our valuation are summarized as follows:
 
For the Years Ended December 31,
 
2024
2023
2022
Expected dividend yield
—%
—%
—%
Range of expected stock price volatility
35.1%
44.7%
44.0% - 45.9%
Range of risk-free interest rates
4.1%
4.1%
1.8% - 3.9%
30 calendar day average stock price on grant date
$251.69
$283.93
$231.31 - $294.86
Weighted-average per share grant date fair value
$280.60
$383.61
$294.43
The fair values of PSUs settled in stock that vested in 2024, 2023 and 2022 totaled $13.2 million, $28.6 million and $9.5 million, respectively.
PSUs Settled in Cash
During the first quarter of 2018 we began granting awards for performance-vested restricted stock units that will settle in cash. PSUs
awarded to employees have three performance periods and vest on the third anniversary of the grant date. The vesting of these awards is
subject to the respective employee’s continued employment. The number of PSUs granted represents the target number of units that are
eligible to be earned based on the achievement of three annual performance measures established when the performance objectives are
defined, which will be at the beginning of each year and will end on December 31 of such year.
Participants may ultimately earn between zero and 200.0% of the target number of PSUs granted based on the degree of achievement of the
applicable performance metric. Accordingly, additional PSUs may be issued or currently outstanding PSUs may be cancelled upon final
determination of the number of units earned. PSUs are classified as liability awards and will be settled in cash based on the 30 calendar day
average closing stock price through the vesting date, once the actual vested and earned number of PSUs is determined. Since no shares are
issued, these awards do not dilute equity.
Beginning in 2022 we no longer grant this type of PSUs as part of our long term incentive program and have replaced with granting time-
vested RSUs.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following table summarizes our PSUs that settle in cash activity:
December 31, 2024
Shares
Unvested at December 31, 2023
41,000 
Granted
— 
Vested
(39,000)
Forfeited
(2,000)
Unvested at December 31, 2024
— 
The fair values of PSUs settled in cash that vested in 2024, 2023 and 2022 totaled $9.5 million, $11.7 million and $11.0 million, respectively.
Time-Vested Restricted Stock Units
RSUs awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or
upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us, except as otherwise
provided in the plan. Shares of our common stock will be delivered to the employee upon vesting, subject to payment of applicable
withholding taxes. RSUs awarded to directors for service on our Board of Directors vest on the first anniversary of the date of grant, provided
in each case that the director continues to serve on our Board of Directors through the vesting date. Shares of our common stock will be
delivered to the director upon vesting and are not subject to any withholding taxes.
The following table summarizes our RSU activity:
Shares
Weighted Average

Grant Date Fair Value
Unvested at December 31, 2023
1,856,000 
$
256.74 
Granted 
1,300,000 
235.82 
Vested
(830,000)
254.33 
Forfeited
(275,000)
249.22 
Unvested at December 31, 2024
2,051,000 
$
246.22 
 RSUs granted in 2024 primarily represent RSUs granted in conjunction with our annual awards made in February 2024 and awards made in conjunction with the hiring of new
employees. RSUs granted in 2024 also include approximately 11,200 RSUs granted to our Board of Directors.
RSUs granted in 2023 and 2022 had weighted average grant date fair values of $282.92 and $221.28, respectively.
The fair values of RSUs vested in 2024, 2023 and 2022 totaled $193.6 million, $232.1 million and $116.3 million, respectively.
Employee Stock Purchase Plan
2024 Employee Stock Purchase Plan
In June 2024 our shareholders approved the 2024 ESPP. The 2024 ESPP, which became effective on July 1, 2024, replaced the 2015 ESPP,
which expired on June 30, 2024. The maximum number of shares of our common stock that may be purchased under the 2024 ESPP is
2.5 million.
The following table summarizes our ESPP activity:
 
For the Years Ended December 31,
(In millions, except share amounts)
2024
2023
2022
Shares issued under the 2024 ESPP
40,000 
— 
— 
Shares issued under the 2015 ESPP
175,000 
199,000 
241,000 
Cash received under the 2024 ESPP
$
5.1 
$
— 
$
— 
Cash received under the 2015 ESPP
$
31.2 
$
45.1 
$
44.2 
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 17:
Income Taxes
Income Tax Expense
Income before income tax (benefit) expense and the income tax (benefit) expense consist of the following:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Income before income tax (benefit) expense:
Domestic
$
853.4 
$
192.4 
$
1,842.0 
Foreign
1,052.6 
1,104.4 
1,749.8 
Total income before income tax (benefit) expense
$
1,906.0 
$
1,296.8 
$
3,591.8 
Income tax (benefit) expense:
Current:
Federal
$
448.9 
$
377.6 
$
694.5 
State
50.5 
15.1 
39.0 
Foreign
(67.5)
48.4 
67.9 
Total current
431.9 
441.1 
801.4 
Deferred:
Federal
(154.5)
(587.4)
(328.3)
State
(17.3)
(12.7)
2.5 
Foreign
13.7 
294.3 
157.2 
Total deferred
(158.1)
(305.8)
(168.6)
Total income tax (benefit) expense
$
273.8 
$
135.3 
$
632.8 
Transition Toll Tax
The Tax Cuts and Jobs Act of 2017 eliminated the deferral of U.S. income tax on the historical unrepatriated earnings by imposing the one-
time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings. The Transition Toll Tax
was assessed on our share of our foreign corporations' accumulated foreign earnings that were not previously taxed. Earnings in the form of
cash and cash equivalents were taxed at a rate of 15.5% and all other earnings were taxed at a rate of 8.0%.
As of December 31, 2024 and 2023, we have accrued income tax liabilities of $234.0 million and $419.5 million, respectively, under the
Transition Toll Tax. The amount accrued as of December 31, 2024, is expected to be paid within one year. The Transition Toll Tax is being
paid in installments over an eight--year period, which started in 2018, and will not accrue interest.
Unremitted Earnings
At December 31, 2024, we considered our earnings not to be permanently reinvested outside the U.S. and therefore recorded deferred tax
liabilities associated with an estimate of the total withholding taxes expected as a result of our repatriation of earnings. Other than for
earnings, we are permanently reinvested for book/tax basis differences of approximately $1.5 billion as of December 31, 2024, primarily
arising through the impacts of purchase accounting. These permanently reinvested basis differences could reverse through sales of the
foreign subsidiaries, as well as various other events, none of which were considered probable as of December 31, 2024. The residual U.S.
tax liability, if these differences reverse, would be between $300.0 million and $400.0 million as of December 31, 2024.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Deferred Tax Assets and Liabilities
Significant components of our deferred tax assets and liabilities are summarized as follows:
 
As of December 31,
(In millions)
2024
2023
Deferred tax assets:
Tax credits
$
294.0 
$
252.8 
Inventory, other reserves and accruals
219.2 
203.7 
Intangibles, net
989.6 
1,153.9 
IRC Section 174 capitalized research and development
733.9 
570.8 
Net operating loss
1,357.2 
1,700.4 
Share-based compensation
34.4 
36.1 
Other
318.4 
293.3 
Valuation allowance
(1,013.7)
(1,278.7)
Total deferred tax assets
$
2,933.0 
$
2,932.3 
Deferred tax liabilities:
Purchased inventory valuation step-up and intangible assets
$
(1,529.6)
$
(1,257.4)
Samsung Bioepis investment installments
— 
(35.5)
GILTI
(1,054.8)
(1,136.9)
Depreciation, amortization and other
(214.9)
(215.7)
Total deferred tax liabilities
$
(2,799.3)
$
(2,645.5)
As of December 31, 2024, 2023, 2022 and 2021, we had a valuation allowance of $1,013.7 million, $1,278.7 million, $2,003.3 million and
$1,961.3 million, respectively, related to net operating losses in Switzerland and Neurimmune's tax basis in ADUHELM.
The change in the valuation allowance between December 31, 2024 and 2023, was primarily driven by movements in net operating loss
deferred tax assets in Switzerland. The net income tax impact of the changes in the valuation allowance was a benefit of approximately
$56.8 million for the year ended December 31, 2024.
The change in the valuation allowance between December 31, 2023 and 2022, was primarily driven by a reduction of approximately
$470.3 million related to the elimination of Neurimmune's tax basis in ADUHELM as a result of its deconsolidation and reduction of
approximately $230.3 million due to movements in net operating loss deferred tax assets in Switzerland. The net income tax impact of the
changes in the valuation allowance was an expense of approximately $7.4 million for the year ended December 31, 2023.
The change in the valuation allowance between December 31, 2022 and 2021, was primarily driven by an addition of $85.0 million related to
Neurimmune's tax basis in ADUHELM. For additional information on the deconsolidation and our collaboration arrangement with
Neurimmune, please read Note 20, Investments in Variable Interest Entities, to these consolidated financial statements.
In addition to deferred tax assets and liabilities, we have recorded deferred charges related to intra-entity sales of inventory. As of December
31, 2024 and 2023, the total deferred charges were $273.1 million and $69.3 million, respectively.
Inflation Reduction Act
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 are effective for periods after December 31, 2022. The
IRA did not result in any material adjustments to our income tax provision or income tax balances as of December 31, 2024 and 2023.
Preliminary guidance has been issued by the IRS and we expect additional guidance and regulations to be issued in future periods. We will
continue to assess its potential impact on our business and results of operations as further information becomes available.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Pillar Two
The OECD has issued model rules, which generally provide for a jurisdictional minimum effective tax rate of 15.0% as defined in those rules.
Various countries have or are in the process of enacting legislation intended to implement the principles effective January 1, 2024. Our
income tax provision for the year ended December 31, 2024, reflects currently enacted legislation and guidance related to the OECD model
rules. This enacted legislation and guidance related to the OECD model rules did not result in any material adjustments to our income tax
provision or income tax balances as of December 31, 2024.
Tax Rate
A reconciliation between the U.S. federal statutory tax rate and our effective tax rate is summarized as follows:
 
For the Years Ended December 31,
 
2024
2023
2022
Statutory rate
21.0 %
21.0 %
21.0 %
State taxes
1.8 
1.1 
1.1 
Taxes on foreign earnings, including valuation allowances
(7.6)
(5.9)
(4.9)
Tax credits
(2.2)
(7.3)
(1.7)
Purchased inventory valuation step-up and intangible assets
2.1 
0.7 
0.3 
GILTI
(1.6)
(0.6)
0.7 
Sale of Samsung Bioepis
— 
— 
(1.6)
Litigation settlement agreement
— 
— 
2.6 
Neurimmune tax impacts
— 
— 
2.3 
Internal reorganization
— 
(0.1)
(1.4)
Other, including permanent items
0.9 
1.5 
(0.8)
Effective tax rate
14.4 %
10.4 %
17.6 %
Changes in Tax Rate
For the year ended December 31, 2024, compared to 2023, the increase in our effective tax rate was partially driven by the relative deferred
tax effects of the changes in the value of our equity investments and amortization of purchased intangible assets and inventory. Further, 2023
benefited from the combined impacts of Reata acquisition-related expenses and the resolution of an uncertain tax matter related to tax
credits. This was partially offset by a 2024 benefit related to a decrease in our valuation allowance related to projected future foreign taxable
income, as discussed in the Deferred Tax Assets and Liabilities section above.
For the year ended December 31, 2023, compared to 2022, the decrease in our effective tax rate was driven by the impact of the non-cash
changes in the value of our equity investments, the impact of Fit for Growth related expenses and Reata acquisition-related expenses, as
well as the combined net unfavorable tax rate impacts in 2022 related to a litigation settlement agreement, the sale of our equity interest in
Samsung Bioepis, the impact of a Neurimmune valuation allowance, as discussed below, and an international reorganization to align with
global tax developments. The change also benefits from the resolution of an uncertain tax matter during the first quarter of 2023 related to tax
credits.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to these consolidated financial statements.
For additional information on the litigation settlement agreement, please read Note 18, Other Consolidated Financial Statement Detail, to
these consolidated financial statements.
Neurimmune Deferred Tax Asset
During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of
approximately $85.0 million to reduce the net value of a previously recorded deferred tax asset in Switzerland on Neurimmune's tax basis in
ADUHELM, the realization of which was dependent on future sales of ADUHELM, to zero.
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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
This adjustment to our net deferred tax asset was recorded with an equal and offsetting amount assigned to net income (loss) attributable to
noncontrolling interests, net of tax in our consolidated statements of income, resulting in a zero net impact to net income attributable to
Biogen Inc.
During the fourth quarter of 2023 Neurimmune was deconsolidated from our consolidated financial statements. For additional information on
the deconsolidation and our collaboration arrangement with Neurimmune, please read Note 20, Investments in Variable Interest Entities, to
these consolidated financial statements.
Tax Attributes
As of December 31, 2024, we had credit carry forwards for U.S. federal income tax purposes of approximately $163.0 million that begin to
expire in 2030 and net operating losses of approximately $513.4 million that do not expire. For U.S. state income tax purposes, we had
research and investment credit carry forwards of approximately $165.5 million that begin to expire in 2027 and net operating losses of
approximately $220.9 million that begin to expire in 2028. For foreign income tax purposes, we had $10.7 billion of federal net operating loss
carryforwards that begin to expire in 2027 and $10.1 billion of Swiss cantonal net operating loss carryforwards that begin to expire in 2027.
In assessing the realizability of our deferred tax assets, we have considered whether it is more likely than not that some portion or all of the
deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable
income during the periods in which those temporary differences become deductible. In making this determination, under the applicable
financial reporting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income
and tax planning strategies. Based upon the level of historical taxable income and income tax liability and projections for future taxable
income over the periods in which the deferred tax assets are utilizable, we believe it is more likely than not that we will realize the net benefits
of the deferred tax assets of our wholly owned subsidiaries, net of the recorded valuation allowance. In the event that actual results differ
from our estimates or we adjust our estimates in future periods, we may need to adjust or establish a valuation allowance, which could
materially impact our consolidated financial position and results of operations.
Accounting for Uncertainty in Income Taxes
A reconciliation of the beginning and ending amount of our unrecognized tax benefits is summarized as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Beginning balance
$
173.4 
$
606.4 
$
563.4 
Additions based on tax positions related to the current period
1.2 
5.2 
36.3 
Additions for tax positions of prior periods
31.5 
60.2 
23.4 
Reductions for tax positions of prior periods
(3.1)
(485.0)
(14.9)
Statute expirations
(12.7)
(2.1)
(1.6)
Settlement refund (payment)
(4.0)
(11.3)
(0.2)
Ending balance
$
186.3 
$
173.4 
$
606.4 
As of December 31, 2022, the unrecognized tax benefits related to a deferred tax asset for Swiss tax purposes for Neurimmune's tax basis in
ADUHELM was approximately $450.0 million. This unrecognized tax benefit was recorded as a reduction to the gross deferred tax asset,
resulting in the net deferred tax asset, as discussed above, and not as a separate liability on our consolidated balance sheets. During the
year ended December 31, 2023, we decreased our gross unrecognized tax benefits by approximately $450.0 million related to this item as a
result of the deconsolidation of Neurimmune.
We file income tax returns in various U.S. states and in U.S. federal and other foreign jurisdictions. With few exceptions, we are no longer
subject to U.S. federal tax examination for years before 2021 or state, local or non-U.S. income tax examinations for years before 2013.
The U.S. Internal Revenue Service and other national tax authorities routinely examine our intercompany transfer pricing with respect to
intellectual property related transactions and it is possible that they may disagree with one or more positions we have taken with respect to
such valuations.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Included in the balance of unrecognized tax benefits as of December 31, 2024, 2023 and 2022, are $139.3 million, $147.6 million and $134.0
million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective
income tax rate in future periods.
We recognize potential interest and penalties related to unrecognized tax benefits in income tax (benefit) expense within our consolidated
statements of income. During the years ended December 31, 2024, 2023 and 2022, we recognized total interest and penalty expense of
$13.8 million, $5.1 million and $0.7 million, respectively. We have accrued $40.7 million and $30.2 million for the payment of interest and
penalties as of December 31, 2024 and 2023, respectively.
It is reasonably possible that we will adjust the value of our uncertain tax positions related to certain transfer pricing, collaboration matters,
withholding taxes and other issues as we receive additional information from various taxing authorities, including reaching settlements with
such authorities.
We estimate that it is reasonably possible that our gross unrecognized tax benefits, exclusive of interest, could decrease by up to
approximately $45.0 million in the next 12 months as a result of various audit closures, settlements and expiration of the statute of limitations.
Note 18:
Other Consolidated Financial Statement Detail
Supplemental Cash Flow Information
Supplemental disclosure of cash flow information is summarized as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Cash paid during the year for:
Interest
$
245.4 
$
252.2 
$
262.5 
Income taxes
355.1 
740.7 
932.9 
Other (Income) Expense, Net
Components of other (income) expense, net, are summarized as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Interest income
$
(67.6)
$
(276.5)
$
(89.3)
Interest expense
250.3 
246.9 
246.6 
(Gains) losses on investments, net
100.4 
291.2 
277.3 
Foreign exchange (gains) losses, net
30.9 
50.4 
35.5 
Gain on sale of equity interest in Samsung Bioepis
— 
— 
(1,505.4)
Litigation settlement agreement and settlement fees
— 
— 
917.0 
Other, net
29.6 
3.5 
10.1 
Total other (income) expense, net
$
343.6 
$
315.5 
$
(108.2)
 Reflects the pre-tax gain, net of transaction costs, recognized from the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in April 2022. For
additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these consolidated financial statements.
The (gains) losses on investments, net, as reflected in the table above, relate to debt securities, equity securities of certain biotechnology
companies, venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-
marketable equity securities.
During the second quarter of 2022 we recorded a pre-tax charge of $900.0 million, plus settlement fees and expenses, related to 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 consolidated statements of income for the year ended December 31, 2022.
(1)
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following table summarizes our (gains) losses on investments, net that relates to our equity securities held during the following periods:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Net (gains) losses recognized on equity securities
$
100.4 
$
275.2 
$
264.7 
Less: Net (gains) losses realized on equity securities
(2.0)
5.2 
— 
Net unrealized (gains) losses recognized on equity securities
$
102.4 
$
270.0 
$
264.7 
The net unrealized losses recognized during the year ended December 31, 2024, primarily reflect a decrease in the aggregate fair value of
our investments in Sage common stock of approximately $101.4 million, partially offset by an increase in the fair value of Denali and
Sangamo common stock of approximately $7.5 million.
The net unrealized losses recognized during the year ended December 31, 2023, primarily reflect a decrease in the aggregate fair value of
our investments in Sage, Denali, Sangamo and Ionis common stock of approximately $248.5 million.
The net unrealized losses recognized during the year ended December 31, 2022, primarily reflect a decrease in the aggregate fair value of
our investments in Denali and Sangamo common stock of approximately $278.0 million, partially offset by an increase in the fair value of
Ionis and Sage common stock of approximately $27.3 million.
Accrued Expense and Other
Accrued expense and other consists of the following:
 
As of December 31,
(In millions)
2024
2023
Revenue-related reserves for discounts and allowances
$
937.5 
$
926.5 
Employee compensation and benefits
375.8 
335.1 
Collaboration expense
309.0 
214.6 
Royalties and licensing fees
190.2 
191.5 
Current portion of contingent consideration obligations
291.2 
— 
Other
704.0 
955.9 
Total accrued expense and other
$
2,807.7 
$
2,623.6 
Other long-term liabilities were $732.3 million and $781.1 million as of December 31, 2024 and 2023, respectively, and included accrued
income taxes totaling $156.7 million and $403.2 million, respectively.
Note 19:
Collaborative and Other Relationships
In connection with our business strategy, we have entered into various collaboration agreements that provide us with rights to develop,
produce and market products using certain know-how, technology and patent rights maintained by our collaborative partners. Terms of the
various collaboration agreements may require us to make milestone payments upon the achievement of certain product research and
development objectives and pay royalties on future sales, if any, of commercial products resulting from the collaboration.
Depending on the collaborative arrangement, we may record funding receivable or payable balances with our collaboration partners, based
on the nature of the cost-sharing mechanism and activity within the collaboration. Our significant collaborative arrangements are discussed
below.
Genentech, Inc. (Roche Group)
We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other
conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular
lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma;
COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma, which was granted accelerated approval by the FDA during
the second quarter of 2023; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Genentech, a wholly-owned member of the Roche Group. For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA
collectively as RITUXAN.
If we undergo a change in control, as defined in our collaboration agreement, Genentech has the right to present an offer to buy the rights to
RITUXAN and we must either accept Genentech’s offer or purchase Genentech’s rights on the same terms as its offer. Genentech will also
be deemed concurrently to have purchased our rights to the remaining products in the collaboration on the terms set forth below.
Our collaboration with Genentech was created through a contractual arrangement and not through a joint venture or other legal entity.
RITUXAN
Genentech and its affiliates are responsible for the worldwide manufacture of RITUXAN as well as all development and commercialization
activities as follows:
•
U.S.: We have co-exclusively licensed our rights to develop, commercialize and market RITUXAN in the U.S.
•
Canada: We have co-exclusively licensed our rights to develop, commercialize and market RITUXAN in Canada.
GAZYVA
The Roche Group and its sub-licensees maintain sole responsibility for the development, manufacture and commercialization of GAZYVA in
the U.S. The level of gross sales of GAZYVA in the U.S. has impacted our percentage of the co-promotion profits for RITUXAN and
LUNSUMIO, as summarized in the table below.
If we undergo a change in control, as defined in our collaboration agreement, Genentech will be deemed to have purchased our rights to
GAZYVA in exchange for the continued payment of the current compensation payable for GAZYVA under the collaboration arrangement until
the 11 year anniversary of the first commercial sale of GAZYVA in the U.S.
OCREVUS
Pursuant to the terms of our collaboration arrangements with Genentech, we receive a tiered royalty on U.S. net sales from 13.5% and
increasing up to 24.0% if annual net sales exceed $900.0 million. There will be a 50.0% reduction to these royalties upon the first entry of an
FDA approved biosimilar to OCREVUS.
In addition, we receive a gross 3.0% royalty on net sales of OCREVUS outside the U.S., with the royalty period lasting 11 years from the first
commercial sale of OCREVUS on a country-by-country basis.
The commercialization of OCREVUS does not impact the percentage of the co-promotion profits we receive for RITUXAN, LUNSUMIO or
GAZYVA. Genentech is solely responsible for development and commercialization of OCREVUS and funding future costs. Genentech cannot
develop OCREVUS in CLL, non-Hodgkin's lymphoma or rheumatoid arthritis.
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.
If we undergo a change in control, as defined in our collaboration agreement, Genentech will be deemed to have purchased our rights to
OCREVUS in exchange for the continued payment of the current royalties on net sales (as defined in our collaboration agreement and
summarized above) in the U.S. only, until the 11 year anniversary of the first commercial sale of OCREVUS in the U.S.
LUNSUMIO (mosunetuzumab)
In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of LUNSUMIO. Under
our collaboration with Genentech, we were responsible for 30.0% of development costs for LUNSUMIO prior to FDA approval and will be
entitled to a tiered share of co-promotion operating profits and losses in the U.S., as summarized in the table below. In addition, we receive
low-single digit royalties on sales of LUNSUMIO outside the U.S. In December 2022 LUNSUMIO was granted accelerated approval by the
FDA for the treatment of relapsed or refractory follicular lymphoma.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in
research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated
statements of income. After an anti-CD20 product is approved, we record our share of the development and sales and marketing expense
related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs.
For the year ended December 31, 2022, we recorded approximately $28.4 million in research and development expense and approximately
$13.0 million in sales and marketing expense in our consolidated statements of income related to this collaboration. For the year ended
December 31, 2023, we began to record our share of LUNSUMIO development and sales and marketing expense as a reduction of our
share of pre-tax profits in revenue from anti-CD20 therapeutic programs within our consolidated statements of income.
If we undergo a change in control, as defined in our collaboration agreement, Genentech will be deemed to have purchased our rights to
LUNSUMIO in exchange for 30.0% of the U.S. co-promotion operating profits or losses until the 11 year anniversary of the first commercial
sale of LUNSUMIO in the U.S.
COLUMVI (glofitamab)
In December 2022 we entered into an agreement with Genentech related to the commercialization and sharing of economics for COLUMVI,
a bispecific antibody for the treatment of B-cell non-Hodgkin's lymphoma, which was subsequently granted accelerated approval by the FDA
in June 2023. Under the terms of this agreement, we will have no payment obligations. Genentech will have sole decision-making rights on
the commercialization of COLUMVI within the U.S. and we will receive tiered royalties in the mid-single digit range on net sales of COLUMVI
in the U.S. The commercialization of COLUMVI does not impact the percentage of the co-promotion profits we receive for RITUXAN,
LUNSUMIO or GAZYVA.
If we undergo a change in control, as defined in our collaboration agreement, Genentech will be deemed to have purchased our rights to
COLUMVI in exchange for a mid-single digit royalty on net sales (as defined in our collaboration agreement) in the U.S. only, until the 11 year
anniversary of the first commercial sale of the product in the U.S.
Profit-sharing Formulas
RITUXAN and LUNSUMIO Profit Share
Our current pretax co-promotion profit-sharing formula for RITUXAN and LUNSUMIO in the U.S. provides for a 30.0% share on the first
$50.0 million of combined co-promotion operating profits earned each calendar year. As a result of the FDA approval of LUNSUMIO our
share of the combined annual co-promotion profits for RITUXAN and LUNSUMIO in excess of $50.0 million varies upon the following events,
as summarized in the table below:
After LUNSUMIO Approval until the First Threshold Date
37.5 %
After First Threshold Date until the Second Threshold Date
35.0 %
After Second Threshold Date
30.0 %
First Threshold Date means the earlier of (i) the first day of the calendar quarter following the date U.S. gross sales of GAZYVA within
any consecutive 12-month period have reached $500.0 million or (ii) the first date in any calendar year in which U.S. gross sales of
LUNSUMIO have reached $150.0 million.
Second Threshold Date means the later of (i) the first date the gross sales in any calendar year in which U.S. gross sales of LUNSUMIO
reach $350.0 million or (ii) January 1 of the calendar year following the calendar year in which the First Threshold Date occurs.
In March 2023 the First Threshold Date was achieved. As a result, beginning in April 2023 the pre-tax profit share for RITUXAN and
LUNSUMIO was 35.0%. Our share of RITUXAN pre-tax profits in the U.S. in excess of $50.0 million for the year ended December 31, 2022,
was 37.5%.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
GAZYVA Profit Share
Our current pretax profit-sharing formula for GAZYVA provides for a 35.0% share on the first $50.0 million of operating profits earned each
calendar year. Our share of annual co-promotion profits in excess of $50.0 million varies upon the following events, as summarized in the
table below:
Until Second GAZYVA Threshold Date
37.5 %
After Second GAZYVA Threshold Date
35.0 %
Second GAZYVA Threshold Date means the first day of the calendar quarter following the date U.S. gross sales of GAZYVA within any
consecutive 12-month period have reached $500.0 million. The Second GAZYVA Threshold Date can be achieved regardless of
whether GAZYVA has been approved in a non-CLL indication.
In March 2023 the Second GAZYVA Threshold Date was achieved. As a result, beginning in April 2023 the pre-tax profit share for GAZYVA
was 35.0%. Our share of GAZYVA pre-tax profits in excess of $50.0 million for the year ended December 31, 2022, was 37.5%.
Revenue from Anti-CD20 Therapeutic Programs
Revenue from anti-CD20 therapeutic programs is summarized as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Royalty revenue on sales of OCREVUS
$
1,339.5 
$
1,266.2 
$
1,136.3 
Biogen's share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO
392.0 
409.4 
547.0 
Other revenue from anti-CD20 therapeutic programs
18.4 
14.0 
17.2 
Total revenue from anti-CD20 therapeutic programs
$
1,749.9 
$
1,689.6 
$
1,700.5 
 LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in
research and development expense and pre-commercialization costs within selling, general and administrative expense in our consolidated
statements of income. After an anti-CD20 product is approved, we record our share of the development and sales and marketing expense
related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs.
Ionis Pharmaceuticals, Inc.
SPINRAZA
In January 2012 we entered into a collaboration and license agreement with Ionis pursuant to which we have an exclusive, worldwide license
to develop and commercialize SPINRAZA for the treatment of SMA.
Under our agreement with Ionis, we make royalty payments to Ionis on annual worldwide net sales of SPINRAZA using a tiered royalty rate
between 11.0% and 15.0%, which are recognized in cost of sales within our consolidated statements of income. Royalty cost of sales related
to sales of SPINRAZA for the years ended December 31, 2024, 2023 and 2022, totaled approximately $216.1 million, $240.2 million and
$243.1 million, respectively.
2018 Ionis Agreement
In June 2018 we entered into a 10-year exclusive collaboration agreement with Ionis to develop novel ASO drug candidates for a broad
range of neurological diseases for a total payment of $1.0 billion, consisting of an upfront payment of $375.0 million and the purchase of
approximately 11.5 million shares of Ionis common stock at a cost of $625.0 million.
We have the option to license therapies arising out of this agreement and will be responsible for the development and commercialization of
such therapies. We may pay development milestones to Ionis of up to $125.0 million or $270.0 million for each program, depending on the
indication plus an annual license fee, as well as royalties on potential net commercial sales.
(1)
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
During the years ended December 31, 2024, 2023 and 2022, we incurred milestones of $7.5 million, $7.5 million and $10.0 million,
respectively, related to the advancement of neurological targets identified under this agreement, which were recorded as research and
development expense in our consolidated statements of income.
2017 SMA Collaboration Agreement
In December 2017 we entered into a collaboration agreement with Ionis to identify new ASO drug candidates for the potential treatment of
SMA. Under this agreement, we have the option to license therapies arising out of this collaboration and will be responsible for their
development and commercialization of such therapies.
We may pay Ionis up to $260.0 million in additional development and regulatory milestone payments if new drug candidates advance to
marketing approval. Upon commercialization, we may also pay Ionis up to $800.0 million in additional performance-based milestone
payments and tiered royalties on potential net sales of such therapies.
In December 2021 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and
commercialize BIIB115, an investigational ASO in development for SMA.
2013 Long-term Strategic Research Agreement
In September 2013 we entered into a six-year research collaboration agreement with Ionis under which both companies collaborate to
perform discovery level research and subsequent development and commercialization activities of antisense or other therapeutics for the
potential treatment of neurological diseases. Under this agreement, Ionis performs research on a set of neurological targets identified within
the agreement.
Ionis is eligible to receive milestone payments, license fees and royalty payments for all product candidates developed through this
collaboration, with the specific amount dependent upon the modality of the product candidate advanced by us under the terms of the
agreement.
For non-ALS antisense product candidates, Ionis is responsible for global development through the completion of a Phase 2 trial and we
provide advice on the clinical trial design and regulatory strategy. For ALS antisense product candidates, we are responsible for global
development, clinical trial design and regulatory strategy. We have an option to license a product candidate until completion of the Phase 2
trial. If we exercise our option, we will pay Ionis up to a $70.0 million license fee and assume global development, regulatory and
commercialization responsibilities. Ionis could receive additional milestone payments upon the achievement of certain regulatory milestones
of up to $130.0 million, plus additional amounts related to the cost of clinical trials conducted by Ionis under the collaboration, and royalties
on future sales if we successfully develop the product candidate after option exercise.
In December 2018 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and
commercialize QALSODY (tofersen), for the treatment of ALS with SOD1 mutations. Following the option exercise, we are solely responsible
for the costs and expense related to the development, manufacturing and commercialization of QALSODY.
In April 2023 the FDA approved QALSODY for the treatment of ALS in adults who have a mutation in the SOD1 gene. This indication is
approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with QALSODY.
Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Under this agreement, we
make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0% and 15.0%, which are
recognized in cost of sales within our consolidated statements of income.
During the year ended December 31, 2024, we incurred a milestone payment of $20.0 million to Ionis following the approval of QALSODY in
the E.U., which was recorded within intangible assets, net in our consolidated balance sheets. Additionally, during the year ended December
31, 2024, we accrued a milestone payment of $10.0 million to Ionis following the approval of QALSODY in Japan, which was recorded within
intangible assets, net in our consolidated balance sheets, and is expected to be paid during the first quarter of 2025.
During the year ended December 31, 2023, we incurred a milestone payment of $16.0 million to Ionis following the FDA's approval of
QALSODY, which was recorded within intangible assets, net in our consolidated balance sheets.
During the year ended December 31, 2022, we incurred a milestone payment of $17.0 million related to the advancement of a program under
this agreement, which was recorded in research and development expense within our consolidated statements of income.
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2012 Ionis Agreement
In December 2012 we entered into an agreement with Ionis for the development and commercialization of up to three gene targets.
Under this agreement, Ionis is responsible for global development of any product candidate through the completion of a Phase 2 trial and we
will provide advice on the clinical trial design and regulatory strategy. We have an option to license the product candidate until completion of
the Phase 2 trial. If we exercise our option, we will pay a license fee of up to $70.0 million to Ionis and assume global development,
regulatory and commercialization responsibilities. Ionis is eligible to receive up to $130.0 million in additional milestone payments upon the
achievement of certain regulatory milestones as well as royalties on future sales if we successfully develop the product candidate after option
exercise.
In December 2019 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and
commercialize BIIB080 (tau ASO), which is currently in Phase 2 development for the potential treatment of Alzheimer's disease. In
connection with the option exercise, we made a payment of $45.0 million to Ionis, which was recorded in research and development expense
within our consolidated statements of income. Future payments may include additional milestone payments of up to $155.0 million and
royalties on future sales in the low- to mid-teens if we successfully develop the product candidate after option exercise.
During the year ended December 31, 2022, we incurred a milestone payment of $10.0 million, related to the advancement of BIIB080 under
this agreement, which was recorded in research and development expense within our consolidated statements of income.
Eisai Co., Ltd.
During the first quarter of 2023 we accrued a $31.0 million payable to Eisai related to the termination of an agreement whereby Eisai co-
promoted or distributed our MS products in certain Asia-Pacific markets and settings. As of December 31, 2023, we paid approximately
$16.0 million of the $31.0 million payable. The remaining portion was subsequently paid in January 2024. This termination fee is included in
selling, general and administrative expense in our consolidated statements of income for the year ended December 31, 2023.
LEQEMBI (lecanemab) Collaboration
We have a collaboration agreement with Eisai to jointly develop and commercialize LEQEMBI (lecanemab), an anti-amyloid antibody for the
treatment of Alzheimer's disease (the LEQEMBI Collaboration).
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and 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. We and Eisai co-promote LEQEMBI and share profits and losses equally. We currently
manufacture LEQEMBI drug substance and drug product and in March 2022 we extended our supply agreement with Eisai related to
LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance.
The LEQEMBI Collaboration also provided Eisai with an option to jointly develop and commercialize ADUHELM (aducanumab) (ADUHELM
Option), and an option to jointly develop and commercialize one of our anti-tau monoclonal antibodies (Anti-Tau Option). In October 2017
Eisai exercised its ADUHELM Option and we entered into a new collaboration agreement for the joint development and commercialization of
ADUHELM (aducanumab) (the ADUHELM Collaboration Agreement).
In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. As of the amendment date, we have sole decision making
and commercialization rights worldwide on ADUHELM, and beginning January 1, 2023, Eisai receives only a tiered royalty based on net
sales of ADUHELM, and no longer participates in sharing ADUHELM's global profits and losses. In March 2022 we also amended the
LEQEMBI Collaboration Agreement with Eisai to eliminate the Anti-Tau Option.
If either company undergoes a change of control, as defined in our LEQEMBI Collaboration Agreement, the non-acquired party may elect to
initiate an operational separation, as defined in the LEQEMBI Collaboration Agreement. In the event of an operational separation, we would
work with Eisai to effect a timely transition of any development, manufacturing or commercial responsibilities regarding LEQEMBI from us to
Eisai. In this scenario, as of six months following the change of control, our ongoing responsibility for LEQEMBI related cost-sharing would be
reduced to an
 
 
 
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
amount equal to 80.0% of what we would have owed prior to the operational separation, and all other economic rights would remain
unchanged.
In addition, in the event either company undergoes a change of control in which the acquirer is engaged in commercialization of a competing
product, as defined in the LEQEMBI Collaboration Agreement, the non-acquired party may also request that the acquired party cease
commercializing the competing product. Should the acquired party elect to continue commercializing the competing product, the non-
acquired party may terminate the LEQEMBI Collaboration Agreement. Furthermore, in the event we are the non-acquired party, we may
choose either to sell our interest in LEQEMBI to Eisai or purchase Eisai's interest in LEQEMBI, subject to the parameters set forth in the
LEQEMBI Collaboration Agreement.
In July 2023 the FDA granted traditional approval of LEQEMBI. Prior to receiving traditional approval, LEQEMBI had been granted
accelerated approval by the FDA in January 2023, at which time it became commercially available in the U.S. Outside of the U.S., LEQEMBI
is now approved in Japan (September 2023), China (January 2024), South Korea (May 2024), Hong Kong (July 2024), Israel (July 2024),
United Arab Emirates (August 2024), Great Britain (August 2024) and Mexico (December 2024). Additionally, in January 2025 the FDA
approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
Upon commercialization of LEQEMBI in the U.S., we began recognizing our 50.0% share of LEQEMBI product revenue, net and cost of
sales, including royalties, within Alzheimer's collaboration revenue in our consolidated statements of income, as we are not the principal.
Our share of LEQEMBI sales and marketing expense and development expense are recorded within selling, general and administrative
expense and research and development expense, respectively, within our consolidated statements of income.
A summary of development and sales and marketing expense related to the LEQEMBI Collaboration is as follows:
 
For the Years Ended December 31,
(In millions)
2024
2023
2022
Total development expense incurred by the collaboration related to the advancement of LEQEMBI
$
329.6 
$
371.9 
$
347.2 
Biogen's share of the LEQEMBI Collaboration development expense reflected in research and development
expense in our consolidated statements of income
164.8 
186.0 
173.6 
Total sales and marketing expense incurred by the LEQEMBI Collaboration
647.0 
304.4 
104.6 
Biogen's share of the LEQEMBI Collaboration sales and marketing expense reflected in selling, general and
administrative expense in our consolidated statements of income
323.5 
152.2 
52.3 
ADUHELM Collaboration Agreement
The LEQEMBI Collaboration also provided Eisai with an option to jointly develop and commercialize ADUHELM (aducanumab) (ADUHELM
Option). In October 2017 Eisai exercised its ADUHELM Option and we entered into a new collaboration agreement for the joint development
and commercialization of ADUHELM (the ADUHELM Collaboration Agreement).
Under our initial ADUHELM Collaboration Agreement, we would lead the ongoing development of ADUHELM, and we and Eisai would co-
promote ADUHELM with a region-based profit split. Beginning in 2019, Eisai was reimbursing us for 45.0% of development and sales and
marketing expense incurred by the collaboration for the advancement of ADUHELM.
In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. As of the amendment date, we have sole decision making
and commercialization rights worldwide on ADUHELM, and beginning January 1, 2023, Eisai receives only a tiered royalty based on net
sales of ADUHELM, and no longer participates in sharing ADUHELM's global profits and losses. Eisai's share of development,
commercialization and manufacturing expense was limited to $335.0 million for the period from January 1, 2022 to December 31, 2022,
which was achieved as of December 31, 2022. Once this limit was achieved, we became responsible for all ADUHELM related costs.
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A summary of development expense, sales and marketing expense and milestone payments related to our initial ADUHELM Collaboration
Agreement is as follows:
(In millions)
For the Year Ended December
31, 2022
Total ADUHELM Collaboration development expense
$
149.4 
Biogen's share of the ADUHELM Collaboration development expense reflected in research and development expense in our consolidated
statements of income
82.2 
Total sales and marketing expense incurred by the ADUHELM Collaboration
134.2 
Biogen's share of the ADUHELM Collaboration sales and marketing expense reflected in selling, general and administrative expense and
collaboration profit sharing/(loss reimbursement) in our consolidated statements of income
71.5 
ADUHELM Co-promotion Profits and Losses
Under our initial ADUHELM Collaboration Agreement, we recognized revenue on sales of ADUHELM in the U.S. to third parties as a
component of product revenue, net in our consolidated statements of income. We also recorded the related cost of revenue and sales and
marketing expense in our consolidated statements of income as these costs were incurred. Payments made to and received from Eisai for its
45.0% share of the co-promotion profits or losses in the U.S. were recognized in collaboration profit sharing/(loss reimbursement) in our
consolidated statements of income. For the year ended December 31, 2022, we recognized net reductions to our operating expense of
approximately $224.7 million to reflect Eisai's 45.0% share of net collaboration losses in the U.S. for ADUHELM.
During the first quarter of 2022, as a result of the final NCD, we recorded approximately $275.0 million of charges associated with the write-
off of inventory and purchase commitments in excess of forecasted demand related to ADUHELM. Additionally, for the year ended December
31, 2022, we recorded approximately $111.0 million of aggregate gross idle capacity charges related to ADUHELM. These charges were
recorded in cost of sales within our consolidated statements of income for the year ended December 31, 2022.
We recognized approximately $197.0 million related to Eisai's 45.0% share of inventory, idle capacity charges and contractual commitments
in collaboration profit sharing/(loss reimbursement) within our consolidated statements of income for the year ended December 31, 2022.
Amounts receivable from Eisai related to the agreements discussed above were approximately $16.7 million and $1.4 million as of December
31, 2024 and 2023, respectively. Amounts payable to Eisai related to the agreements discussed above were approximately $138.0 million
and $118.4 million as of December 31, 2024 and 2023, respectively.
UCB
We have a collaboration agreement with UCB, effective November 2003, to jointly develop and commercialize dapirolizumab pegol, an anti-
CD40L pegylated Fab, for the potential treatment of SLE and other future agreed indications. Either we or UCB may propose development of
dapirolizumab pegol in additional indications. If the parties do not agree to add an indication as an agreed indication to the collaboration, we
or UCB may, at the sole expense of the applicable party, pursue development in such excluded indication(s), subject to an opt-in right of the
non-pursuing party after proof of clinical activity.
All costs incurred for agreed indications, including research, development, sales and marketing expense, are shared equally between us and
UCB. If marketing approval is obtained, both companies will jointly commercialize dapirolizumab pegol and share profits and losses equally.
A summary of development expense related to the UCB collaboration agreement is as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Total UCB collaboration development expense
$
77.5 
$
60.7 
$
68.0 
Biogen's share of the UCB collaboration development expense reflected in research and
development expense in our consolidated statements of income
38.7 
30.3 
34.0 
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Merz Therapeutics (previously Acorda Therapeutics, Inc.)
In June 2009 we entered into a collaboration and license agreement with Acorda to develop and commercialize products containing
fampridine, such as FAMPYRA, in markets outside the U.S.
Under this agreement, we pay tiered royalties based on the level of ex-U.S. net sales and we may pay potential milestone payments based
on the successful achievement of certain regulatory and commercial milestones.
In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025, whereby
Acorda regained global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its
intention to sell substantially all of Acorda's assets to a third party. On July 10, 2024, Merz Therapeutics announced that its subsidiary Merz
Pharmaceuticals LLC had completed the acquisition of FAMPYRA, and related assets from Acorda. We are now working with Merz
Therapeutics on the transition of global commercialization rights of FAMPYRA and we expect to recognize minimal revenue in 2025.
For the years ended December 31, 2024, 2023 and 2022, total cost of sales related to royalties and commercial supply of FAMPYRA
reflected in our consolidated statements of income were approximately $52.4 million, $55.2 million and $46.1 million, respectively.
Sage Therapeutics, Inc.
In November 2020 we entered into a global collaboration and license agreement with Sage to jointly develop and commercialize ZURZUVAE
(zuranolone) for the treatment of PPD and potential treatment of MDD and BIIB124 (SAGE-324) for the potential treatment of essential
tremor with potential in other neurological conditions such as epilepsy. In July 2024 we and Sage announced that the Phase 2 KINETIC 2
dose-range study of BIIB124 did not meet its endpoints. Based on these results, we discontinued our further development of BIIB124 and
terminated our rights under the collaboration and license agreement specific to BIIB124, effective February 17, 2025.
In connection with the closing of this transaction in December 2020 we purchased $650.0 million of Sage common stock, or approximately
6.2 million shares at approximately $104.14 per share, which were initially subject to transfer restrictions. We may pay Sage development
and commercial milestone payments that could total up to approximately $700.0 million if all the specified milestones set forth in this
collaboration are achieved.
In August 2023 the FDA approved ZURZUVAE for adults with PPD, pending DEA scheduling, which was completed in October 2023. Upon
approval, ZURZUVAE became the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive
symptoms by day 15 for women with PPD. ZURZUVAE for PPD became commercially available in the U.S. during the fourth quarter of 2023.
Additionally, the FDA issued a CRL for the NDA for zuranolone in the treatment of adults with MDD. In October 2024 we and Sage agreed to
not pursue further development of zuranolone for the potential treatment of MDD. This decision was based on the significant new investment
and time we expect would be needed to conduct the additional studies required to support approval of this indication.
Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for
commercialization in the U.S. Outside of the U.S., we are responsible for development and commercialization, excluding Japan, Taiwan and
South Korea, with respect to zuranolone and may pay Sage potential tiered royalties in the high teens to low twenties. During the fourth
quarter of 2023 we accrued a milestone payment due to Sage of $75.0 million upon the first commercial sale of ZURZUVAE for PPD in the
U.S., which was recorded within intangible assets, net in our consolidated balance sheets, and subsequently paid in January 2024.
We reflect revenue on sales of ZURZUVAE to third parties in product revenue, net in our consolidated statements of income and record the
related cost of revenue and sales and marketing expense in our 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 global collaboration and license agreement with Sage, which is
recognized in collaboration profit sharing/(loss reimbursement) in our consolidated statements of income.
For the years ended December 31, 2024 and 2023, we recognized net profit-sharing expense of approximately $27.0 million and net loss
reimbursement of approximately $4.7 million, respectively, to reflect Sage's 50.0% share
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
of net collaboration losses in the U.S., which are recognized in collaboration profit sharing/(loss reimbursement) in our consolidated
statements of income.
A summary of development and sales and marketing expense related to the Sage collaboration is as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Total Sage collaboration development expense
$
34.2 
$
176.7 
$
173.3 
Biogen's share of the Sage collaboration development expense reflected in research and
development expense in our consolidated statements of income
17.1 
88.3 
86.7 
Total sales and marketing expense incurred by the Sage collaboration
118.5 
187.0 
109.9 
Biogen's share of the Sage collaboration sales and marketing expense reflected in selling,
general and administrative expense and collaboration profit sharing/(loss reimbursement) in
our consolidated statements of income
59.2 
93.5 
55.0 
Denali Therapeutics Inc.
In August 2020 we entered into a collaboration and license agreement with Denali to co-develop and co-commercialize Denali's small
molecule inhibitors of LRRK2 for Parkinson's disease (LRRK2 Collaboration) and also entered into a separate agreement to obtain an
exclusive option to license two preclinical programs from Denali's Transport Vehicle platform, including its ATV-enabled anti-amyloid beta
program and a second program utilizing its Transport Vehicle technology. In July 2024 we terminated our license with Denali for the ATV-
enabled anti-amyloid beta program. This termination also resulted in the termination of the exclusive option agreement, as discussed above.
As part of this collaboration we purchased $465.0 million of Denali common stock in September 2020, or approximately 13 million shares at
approximately $34.94 per share, which were initially subject to transfer restrictions. We may pay Denali development and commercial
milestone payments that could total up to approximately $1.1 billion if the milestones related to the LRRK2 Collaboration are achieved.
Under the LRRK2 Collaboration, both companies share responsibility and costs for global development based on specified percentages as
well as profits and losses for commercialization in the U.S. and China. Outside the U.S. and China we are responsible for commercialization
and may pay Denali potential tiered royalties.
A summary of development expense related to the Denali collaboration is as follows:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Total Denali collaboration development expense
$
53.1 
$
65.0 
$
75.1 
Biogen's share of the Denali collaboration development expense reflected in research and
development expense in our consolidated statements of income
31.9 
39.0 
43.8 
Sangamo Therapeutics, Inc.
In February 2020 we entered into a collaboration and license agreement with Sangamo to pursue certain neurological targets leveraging
Sangamo’s proprietary zinc finger protein technology delivered via adeno-associated virus to modulate the expression of key genes involved
in neurological diseases.
In connection with the closing of this transaction in April 2020 we purchased $225.0 million of Sangamo common stock, or approximately
24 million shares at approximately $9.21 per share, which were initially subject to transfer restrictions. These restrictions have now lapsed.
In March 2023 we terminated our collaboration and license agreement with Sangamo.
A summary of development expense related to the Sangamo collaboration is as follows:
For the Years Ended December 31,
(In millions)
2023
2022
Total Sangamo collaboration development expense
$
4.1 
$
19.1 
Biogen's share of the Sangamo collaboration development expense reflected in research and development expense in
our consolidated statements of income
2.4 
12.1 
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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 years ended December 31, 2024, 2023 and 2022, we recorded approximately $54.0 million, $4.1 million and $39.2 million,
respectively, as research and development expense in our consolidated statements of income related to other research and discovery related
arrangements.
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. Samsung BioLogics contributed 280.5 billion South Korean won (approximately $250.0 million)
for an 85.0% ownership interest in Samsung Bioepis and we contributed 49.5 billion South Korean won (approximately $45.0 million) for the
remaining 15.0% ownership interest. In June 2018 we exercised our option under our joint venture agreement to increase our ownership
percentage in Samsung Bioepis from approximately 5.0%, which reflected the effect of previous equity financings in which we did not
participate, to approximately 49.9%. The share purchase transaction was completed in November 2018 and, upon closing, we paid 759.5
billion South Korean won ($676.6 million) to Samsung BioLogics.
In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in exchange for total
consideration of approximately $2.3 billion. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing, with
approximately $1.3 billion in cash to be deferred over two payments. The first deferred payment of $812.5 million was received in April 2023
and the second deferred payment of $437.5 million was received in April 2024.
As part 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 the payments in the period that they become realizable, which is
generally the same period in which the payments 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 consolidated statements of income.
Upon our November 2018 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 year ended December 31, 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. 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 additional information on the sale of our equity interest in Samsung Bioepis, please read Note 3, Dispositions, to these 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, a ranibizumab biosimilar referencing LUCENTIS, and OPUVIZ, an aflibercept biosimilar
referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia. The agreement established that
Samsung Bioepis will be responsible for development and will supply both products to us at a pre-specified gross margin of approximately
45.0%.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In October 2024 we notified Samsung Bioepis of our decision to terminate our 2019 Development and Commercialization Agreement (the
DCA Agreement) solely within the U.S. and Canada. As a result of this termination we recognized impairment charges of approximately
$20.2 million, which were recorded within amortization and impairment of acquired intangible assets within our consolidated statements of
income for the year ended December 31, 2024. Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S. and
Canada back to Samsung Bioepis over a period of up to 18 months. During this transition period, we will continue to commercialize
BYOOVIZ. The termination does not impact the other markets in the DCA Agreement.
In the fourth quarter of 2024 we made a milestone payment of $15.0 million to Samsung Bioepis related to the approval of OPUVIZ in the
E.U., which was recorded within intangible assets, net in our consolidated balance sheets. We may also pay Samsung Bioepis up to
approximately $150.0 million in additional development, regulatory and sales-based milestones associated with the remaining major markets
covered by the agreement.
We reflect revenue on sales of BYOOVIZ to third parties in product revenue, net in our consolidated statements of income and record the
related cost of revenue and sales and marketing expense in our consolidated statements of income to their respective line items when these
costs are incurred.
2013 Commercial Agreement
In December 2013 we entered into an agreement with Samsung Bioepis to commercialize, over a 10-year term, 3 anti-TNF biosimilar product
candidates which includes IMRALDI, an adalimumab biosimilar referencing HUMIRA, FLIXABI, an infliximab biosimilar referencing
REMICADE, and BENEPALI, an etanercept biosimilar referencing ENBREL, in Europe. 
In July 2024 we exercised an option to extend this agreement by an additional five years, and paid Samsung Bioepis an option exercise fee
of $60.0 million, which was recorded within intangible assets, net within our consolidated balance sheets as of December 31, 2024.
We reflect revenue on sales of BENEPALI, IMRALDI and FLIXABI to third parties in product revenue, net in our consolidated statements of
income and record the related cost of revenue and sales and marketing expense in our consolidated statements of income to their respective
line items when these costs are incurred. Royalty payments to AbbVie on sales of IMRALDI are recognized in cost of sales within our
consolidated statements of income.
We share 50.0% of the profit or loss related to our 2013 commercial agreement with Samsung Bioepis, which is recognized in collaboration
profit sharing/(loss reimbursement) in our consolidated statements of income. For the years ended December 31, 2024, 2023 and 2022, we
recognized net profit-sharing expense of approximately $227.4 million, $223.5 million and $217.4 million, respectively, to reflect Samsung
Bioepis' 50.0% sharing of the net collaboration profits.
Other Services
Simultaneous with the formation of Samsung Bioepis, we also entered into a license agreement with Samsung Bioepis. Under this license
agreement, we granted Samsung Bioepis an exclusive license to use, develop, manufacture and commercialize biosimilar products created
by Samsung Bioepis using Biogen product-specific technology. In exchange, we receive single digit royalties on biosimilar products
developed and commercialized by Samsung Bioepis. Royalty revenue under the license agreement is recognized as a component of contract
manufacturing, royalty and other revenue in our consolidated statements of income.
For the years ended December 31, 2024, 2023 and 2022, we recognized approximately $14.4 million, $13.6 million and $20.6 million,
respectively, as a component of contract manufacturing, royalty and other revenue in our consolidated statements of income related to the
license agreement and other services performed under our collaboration with Samsung Bioepis.
Amounts receivable from Samsung Bioepis related to the agreements discussed above were approximately $7.6 million and $9.9 million as
of December 31, 2024 and 2023, respectively. Amounts payable to Samsung Bioepis related to the agreements discussed above were
approximately $60.8 million and $73.7 million as of December 31, 2024 and 2023, respectively.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 20:
Investments in Variable Interest Entities
Consolidated Variable Interest Entities
Our 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
Beginning in 2007 we consolidated the results of Neurimmune as we determined we were the primary beneficiary because we had the power
through the collaboration to direct the activities that most significantly impacted the entity's economic performance and we were required to
fund 100.0% of the research and development costs incurred in support of the collaboration. The collaboration and license agreement with
Neurimmune was for the development and commercialization of antibodies for the potential treatment of Alzheimer's disease, including
ADUHELM (as amended, the Neurimmune Agreement).
In November 2023 we notified Neurimmune of our decision to terminate the Neurimmune Agreement. Subsequent to the termination, we
reconsidered our relationship with Neurimmune and determined that we were no longer the primary beneficiary of the variable interest entity.
As a result, we recorded a net gain on the deconsolidation of Neurimmune of approximately $3.0 million, which was recorded in other
(income) expense, net within our consolidated statements of income for the year ended December 31, 2023.
During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of
approximately $85.0 million to reduce the net value of a previously recorded deferred tax asset in Switzerland on Neurimmune's tax basis in
ADUHELM, the realization of which was dependent on future sales of ADUHELM, to zero. This adjustment to our net deferred tax asset was
recorded with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our
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 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.
Research and development costs for which we reimbursed Neurimmune are reflected in research and development expense in our
consolidated statements of income. For the years ended December 31, 2023 and 2022, amounts reimbursed were immaterial.
For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
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 December 31, 2024 and 2023, the carrying value of our investments in certain biotechnology companies representing potential
unconsolidated variable interest entities totaled $23.6 million and $16.4 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 consolidated statements of
income as they are incurred. We have provided no financing to these variable interest entities other than previous contractually required
amounts.
Note 21:
Litigation
We are currently involved in various claims, investigations and legal proceedings, including the matters described below. For information as
to our accounting policies relating to claims and legal proceedings, including use of
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
estimates and contingencies, please read Note 1, Summary of Significant Accounting Policies, to these consolidated financial statements.
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. If an estimate of the possible loss or range of loss can be made at this time, it is included in the potential loss
contingency description below.
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
Securities Litigation asserted against Biogen
We and certain current and former officers are defendants in three securities actions pending in the District Court, one filed by Nadia Shash
and Amjad Khan in November 2020 and related to statements about ADUHELM, one filed by the Oklahoma Firefighters Pension and
Retirement System in February 2022 and related to statements about ADUHELM, and one filed by Thomas Allen Gray in June 2024 and
related to statements about LEQEMBI, TECFIDERA and VUMERITY. All 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.
Derivative Actions
We and members of the Board of Directors are named as defendants in five derivative actions pending in the District Court, one filed by The
Booth Family Trust in February 2022, one filed by Elaine Wang in July 2022, one filed by Jonathan Blaufarb (Blaufarb I) in July 2024, one
filed by Lawrence Hollin in October 2024 and one filed by Jonathan Blaufarb (Blaufarb II) in October 2024. The Booth, Wang and Blaufarb II
actions relate to ADUHELM and other matters, and the Blaufarb I and Hollin actions relate to statements about LEQEMBI, our compliance
controls, 2023 earnings guidance and other matters. The actions allege breach of fiduciary duty, waste of corporate assets and other
common law claims, and violations of the Securities Exchange Act of 1934, 15 U.S.C. §78a et seq. The actions seek declaratory and
injunctive relief, monetary relief payable to Biogen, and attorneys’ fees and costs payable to the plaintiffs. The Booth and Wang actions are
stayed.
IMRALDI Patent Litigation
In June 2024, the Technical Boards of Appeal of the European Patent Office upheld the validity of Fresenius Kabi Deutschland GmbH's
(Fresenius Kabi's) European Patent 3 145 488 (the EP '488 Patent), which expires in May 2035. In June 2022 Fresenius Kabi filed a claim for
damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris alleging that IMRALDI, the
adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes the French counterpart of the EP ‘488
Patent. In March 2024 the Düsseldorf Regional Court dismissed Fresenius Kabi's claim of infringement of the German counterpart of the EP
'488 Patent and Fresenius Kabi has appealed to the Higher Regional Court of Düsseldorf.
Litigation with Former Convergence Shareholders
In 2015 Biogen acquired Convergence, a U.K. company. In 2019 Shareholder Representative Services LLC, on behalf of the former
shareholders of Convergence, asserted claims of $200.0 million for alleged breaches of the contract pursuant to which we acquired
Convergence. In June 2023 Shareholder Representative Services LLC and 24 former shareholders filed a suit against us in the High Court of
Justice of England and Wales asserting one of the 2019 claims and seeking payment of $49.9 million, interest and costs.
Humana Patient Assistance Litigation
In March 2023 the District Court dismissed the previously disclosed action filed against us by Humana in September 2020. Humana had
alleged damages related to our providing MS patients with free medications and making
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
charitable contributions to non-profit organizations that assist MS patients and had alleged violations of the federal RICO Act and state laws.
In January 2025 the United States Court of Appeals for the First Circuit affirmed the District Court's dismissal of this action.
Genentech Litigation
In February 2023 Genentech, Inc. filed suit against us in the U.S. District Court for the Northern District of California and claims that it is owed
royalties of approximately $92.7 million on sales of TYSABRI that occurred after the expiration of a patent licensed by Genentech to Biogen,
plus interest and costs.
Lender Litigation
In April 2024, BioPharma Credit PLC, BPCR Limited Partnership, and BioPharma Credit Investments V (Master) LP filed suit against us and
Reata Pharmaceuticals, Inc. in the Supreme Court of the State of New York alleging breach of a loan agreement with Reata and seeking
payment of approximately $23.2 million, plus interest, costs and attorneys' fees.
Antitrust Litigation
In August and September 2024, four suits were filed against us in the U.S. District Court for the Northern District of Illinois and have been
consolidated for pretrial purposes. Plaintiffs are Local No. 1 Health Fund, the Mayor and City Council of Baltimore, Teamsters Local 237
Welfare Fund and Teamsters Local 237 Retirees' Benefit Fund, New York State Teamsters Council Health and Hospital Fund, and UFCW
Local 1500 Welfare Fund. Plaintiffs allege violations of federal antitrust laws including 15 U.S.C. §§ 1, 2 and 13(c) and of various state laws,
based on contracts with pharmacy benefit managers related to TECFIDERA and VUMERITY. Plaintiffs seek declarations of the actions as
class actions, monetary, declaratory and equitable relief, and attorneys' fees and costs.
Other Matters
Government Investigations
We have received subpoenas from the SEC seeking information relating to ADUHELM and its launch, and our equity plans. We have also
received subpoenas from the DOJ and SEC seeking information relating to our business operations in several foreign countries. The Italian
Competition Authority is investigating Biogen and other companies in relation to our biosimilar product BYOOVIZ.
TYSABRI Biosimilar Patent Matter
In September 2022 we filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc., other Sandoz entities 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.
Hatch-Waxman Act Litigation relating to VUMERITY Orange-Book Listed Patents
In July 2023 Biogen and Alkermes Pharma Ireland Limited filed patent infringement proceedings relating to VUMERITY Orange-Book listed
patents (U.S. Patent Nos. 8,669,281, 9,090,558 and 10,080,733) pursuant to the Drug Price Competition and Patent Term Restoration Act of
1984 (the Hatch-Waxman Act) in the U.S. District Court for the District of Delaware against Zydus Worldwide DMCC.
Product Liability and Other Legal Proceedings
We are also involved in product liability claims and other legal proceedings 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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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Note 22:
Commitments and Contingencies
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 consolidated statements of
income.
SPINRAZA
We make royalty payments to Ionis 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 consolidated statements of income.
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
QALSODY
We make royalty payments to Ionis on annual worldwide net sales of QALSODY using a tiered royalty rate between 11.0% and 15.0%, which
are recognized as cost of sales in our consolidated statements of income.
For additional information on our collaboration arrangements with Ionis, please read Note 19, Collaborative and Other Relationships, to these
consolidated financial statements.
VUMERITY
We make royalty payments to Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0%, which are recognized as cost of
sales in our consolidated statements of income. Royalties payable on net sales of VUMERITY are subject, under certain circumstances, to
tiered minimum annual payment requirements for a period of five years following FDA approval.
In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes for
VUMERITY. We have elected to initiate a technology transfer and, following a transition period, to manufacture VUMERITY or have
VUMERITY manufactured by a third party we have engaged in exchange for paying an increased royalty rate to Alkermes on any portion of
future worldwide net commercial sales of VUMERITY that is manufactured by us or our designee.
For additional information on our collaboration arrangement with Alkermes, please read Note 19, Collaborative and Other Relationships, to
these consolidated financial statements.
SKYCLARYS
In connection with our acquisition of Reata in September 2023 we assumed additional contractual obligations related to royalty payments.
Reata entered into agreements to pay royalties on future sales of SKYCLARYS, which will cumulatively range in the low- to mid-single digits.
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to these consolidated financial statements.
Contingent Consideration related to Business Combinations
In connection with our acquisition of HI-Bio in July 2024 we may make additional payments based upon the achievement of certain milestone
events. We recognized the contingent consideration obligations associated with this acquisition at its fair value on the acquisition date and
we revalue this obligation each reporting period. We may pay up to an additional $650.0 million in potential future development and
regulatory milestone payments. The acquisition-date fair value of these milestones was approximately $485.1 million.
Regulatory and Commercial Milestone Payments
Based on our development plans as of December 31, 2024, we could trigger potential future milestone payments to third parties of up to
approximately $3.8 billion, including approximately $0.5 billion in development milestones, approximately $0.5 billion in regulatory milestones
and approximately $2.8 billion in commercial milestones, as part
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
of our various collaborations, including licensing and development programs and HI-Bio's pre-existing commitments, as discussed below.
Payments under these agreements generally become due and payable upon achievement of certain development, regulatory or commercial
milestones. Because the achievement of these milestones was not considered probable as of December 31, 2024, 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 approximately $73.6 million in milestones in 2025 under our current
agreements, excluding opt-in payments.
We acquired HI-Bio's pre-existing in-license commitments under third-party agreements, which include tiered royalties on potential future
sales of felzartamab and izastobart/HIB210, ranging from high-single digit to mid-teen percentages, as well as potential future development,
regulatory and commercial milestone payments related to felzartamab and izastobart/HIB210 of up to $130.0 million, $230.0 million and
$640.0 million, respectively. This amount includes potential milestone payments due upon the first patient dosed in a phase 3 clinical trial of
felzartamab in a first and second indication of $35.0 million and $30.0 million, respectively.
Other Funding Commitments
As of December 31, 2024, we have several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial
expenditures are to CROs. The contracts with CROs are generally cancellable, with notice, at our option. We recorded accrued expense of
approximately $21.7 million in our consolidated balance sheets for expenditures incurred by CROs as of December 31, 2024. We have
approximately $509.2 million in cancellable future commitments based on existing CRO contracts as of December 31, 2024.
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 December 31, 2024, we have approximately $173.8 million of
liabilities associated with uncertain tax positions.
As of December 31, 2024 and 2023, we have accrued income tax liabilities of approximately $234.0 million and $419.5 million, respectively,
under the Transition Toll Tax. The amount accrued as of December 31, 2024, is expected to be paid within one year. The Transition Toll Tax
is being paid in installments over an eight--year period, which started in 2018, and will not accrue interest. For additional information on the
Transition Toll Tax, please read Note 17, Income Taxes, to these consolidated financial statements.
Note 23:
Guarantees
As of December 31, 2024 and 2023, we did not have significant liabilities recorded for guarantees.
We enter into indemnification provisions under our agreements with other companies in the ordinary course of business, typically with
business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the
indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions
generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make
under these indemnification provisions is unlimited. However, to date we have not incurred material costs to defend lawsuits or settle claims
related to these indemnification provisions. As a result, the estimated fair value of these agreements is minimal. Accordingly, we have no
liabilities recorded for these agreements as of December 31, 2024 and 2023.
Note 24:
Employee Benefit Plans
We sponsor various retirement and pension plans. Our estimates of liabilities and expense for these plans incorporate a number of
assumptions, including expected rates of return on plan assets and interest rates used to discount future benefits.
401(k) Savings Plan
We maintain a 401(k) Savings Plan, which is available to substantially all regular employees in the U.S. over the age of 21. Participants may
make voluntary contributions. We make matching contributions according to the 401(k)
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Savings Plan’s matching formula. All matching contributions and participant contributions vest immediately. The 401(k) Savings Plan also
holds certain transition contributions on behalf of participants who previously participated in the Biogen, Inc. Retirement Plan. The expense
related to our 401(k) Savings Plan primarily consists of our matching contributions.
Expense related to our 401(k) Savings Plan totaled approximately $51.5 million, $55.9 million and $56.0 million for the years ended
December 31, 2024, 2023 and 2022, respectively.
Deferred Compensation Plan
We maintain a non-qualified deferred compensation plan, known as the SSP, which allows a select group of management employees in the
U.S. to defer a portion of their compensation. The SSP also provides certain credits to highly compensated U.S. employees that are paid by
the company. These credits are known as the Restoration Match. The deferred compensation amounts are accrued when earned. Such
deferred compensation is distributable in cash in accordance with the rules of the SSP. Deferred compensation amounts under such plan as
of December 31, 2024 and 2023, totaled approximately $140.6 million and $134.6 million, respectively, and are included in other long-term
liabilities in our consolidated balance sheets. The SSP also holds certain transition contributions on behalf of participants who previously
participated in the Biogen, Inc. Retirement Plan. The Restoration Match and participant contributions vest immediately. Distributions to
participants can be either in one lump sum payment or annual installments as elected by the participants.
Pension Plans
Our retiree benefit plans include defined benefit plans for employees in our affiliates in Switzerland and Germany as well as other
insignificant defined benefit plans in certain other countries where we maintain an operating presence.
Our Swiss plan is a government-mandated retirement fund that provides employees with a minimum investment return. The minimum
investment return is determined annually by the Swiss government and was 1.00% in 2024, 1.75% in 2023 and 2.00% in 2022. Under the
Swiss plan, both we and certain of our employees with annual earnings in excess of government determined amounts are required to make
contributions into a fund managed by an independent investment fiduciary. Employer contributions must be in an amount at least equal to the
employee’s contribution. Minimum employee contributions are based on the respective employee’s age, salary and gender. As of December
31, 2024 and 2023, the Swiss plan had an unfunded net pension obligation of $61.5 million and $51.5 million, respectively, and plan assets
that totaled $224.7 million and $239.6 million, respectively. In 2024, 2023 and 2022 we recognized net expense totaling $17.5 million, $17.6
million and $20.0 million, respectively, related to our Swiss plan, of which $6.0 million, $5.1 million and $5.3 million, respectively, was
included in other (income) expense, net in our consolidated statements of income.
The obligations under the German plans are unfunded and totaled $45.6 million and $46.5 million as of December 31, 2024 and 2023,
respectively. Net periodic pension cost related to the German plans totaled $3.8 million, $3.6 million and $5.9 million for the years ended
December 31, 2024, 2023 and 2022, respectively, of which $1.1 million, $0.8 million and $1.8 million, respectively, was included in other
(income) expense, net in our consolidated statements of income.
Note 25:
Segment Information
We operate and are managed as one operating segment, and derive revenue from activities related to the discovery, development and
delivery of innovative therapies for people living with serious and complex diseases.
Our research and development organization is responsible for the research and discovery of new product candidates and supports
development and registration efforts for potential future products. Our pharmaceutical, operations and technology organization manages the
development of the manufacturing processes, clinical trial supply, commercial product supply, distribution, buildings and facilities. Our
commercial organization is responsible for U.S. and international development of our commercial products. We are also supported by
corporate staff functions.
Our CEO, as the CODM, manages and allocates resources to the operations of our company on a total company basis by assessing the
overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and
development projects that are in line with our long-term company-wide strategic goals. In making these decisions, our CEO uses
consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and
setting incentive targets. The
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
CODM performs this assessment based on the segment’s net income. Through this analysis, which includes a comparison to budgeted
results, the CODM assesses performance and how to allocate resources across the functions discussed above. The measure of segment
assets used in determining how to manage and allocate resources is reported within our consolidated balance sheets as total assets.
The tables presented below, which were prepared in accordance with the accounting policies discussed in Note 1, Summary of Significant
Accounting Policies, contain additional information on enterprise-wide disclosures about product revenue, other revenue and long-lived
assets, as well as our segment’s revenue and profits, including significant segment expense and other segment items. Revenue is primarily
attributed to individual countries based on location of the customer or licensee.
Geographic Information
The following tables contain certain financial information by geographic area:
December 31, 2024
(In millions)
U.S.
Europe
Germany
Asia
Other
Total
Product revenue from external customers
$
3,237.3 
$
2,171.5 
$
955.6 
$
366.9 
$
482.2 
$
7,213.5 
Revenue from anti-CD20 therapeutic programs
1,673.6 
0.6 
— 
— 
75.7 
1,749.9 
Contract manufacturing, royalty and other revenue
395.0 
0.4 
— 
257.2 
— 
652.6 
Long-lived assets
1,366.1 
2,139.2 
13.3 
8.5 
10.6 
3,537.7 
December 31, 2023
(In millions)
U.S.
Europe
Germany
Asia
Other
Total
Product revenue from external customers
$
3,141.4 
$
2,127.4 
$
868.0 
$
649.4 
$
460.5 
$
7,246.7 
Revenue from anti-CD20 therapeutic programs
1,618.5 
0.4 
— 
— 
70.7 
1,689.6 
Contract manufacturing, royalty and other revenue
673.6 
11.7 
— 
214.0 
— 
899.3 
Long-lived assets
1,443.0 
2,248.0 
17.5 
8.3 
12.9 
3,729.7 
December 31, 2022
(In millions)
U.S.
Europe
Germany
Asia
Other
Total
Product revenue from external customers
$
3,469.3 
$
2,401.3 
$
926.2 
$
672.1 
$
518.9 
$
7,987.8 
Revenue from anti-CD20 therapeutic programs
1,636.4 
0.1 
— 
— 
64.0 
1,700.5 
Contract manufacturing, royalty and other revenue
425.8 
11.7 
— 
47.6 
— 
485.1 
Long-lived assets
1,369.4 
2,275.8 
21.0 
13.7 
22.6 
3,702.5 
 Represents amounts related to Europe less those attributable to Germany.
Long-Lived Assets
As of December 31, 2024, 2023 and 2022, approximately $2,056.2 million, $2,156.4 million and $2,198.5 million, respectively, of our long-
lived assets were related to the construction of our large-scale biologics manufacturing facility in Solothurn, Switzerland.
For additional information on our Solothurn manufacturing facility, please read Note 11, Property, Plant and Equipment, to these consolidated
financial statements.
(1)
(1)
(1)
(1)
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Additional Segment Information
The following table includes additional information about reported segment revenue, significant segment expense and segment measure of
profitability:
For the Years Ended December 31,
(In millions)
2024
2023
2022
Total revenue
$
9,675.9 
$
9,835.6 
$
10,173.4 
Less cost and expense:
Cost of sales, excluding amortization and impairment of acquired intangible assets:
Product cost of sales
1,604.2 
1,787.2 
1,504.8 
Royalty cost of sales
706.2 
746.2 
773.5 
Research and development:
Milestone and upfront expense
61.5 
16.6 
76.2 
Research and discovery
201.5 
212.5 
289.4 
Early stage programs
286.6 
361.0 
289.9 
Late stage programs
209.7 
250.5 
484.5 
Marketed products
534.7 
766.1 
361.5 
Other research and development costs
747.8 
855.3 
729.6 
Selling, general and administrative
2,403.7 
2,549.7 
2,403.6 
Other segment expense
1,287.8 
1,129.4 
213.5 
Net Income attributable to Biogen Inc.
$
1,632.2 
$
1,161.1 
$
3,046.9 
 Other research and development costs primarily consist 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 and are not
allocated to a specific program or stage.
 Other segment expense includes: amortization and impairment of acquired intangible assets; collaboration profit sharing/(loss reimbursement); (gain) loss on fair value
remeasurement of contingent consideration; restructuring charges; gain on sale of priority review voucher, net; gain on sale of building, net; other (income) expense, net;
income tax (benefit) expense; equity in (income) loss of investee, net of tax; and net income (loss) attributable to noncontrolling interests, net of tax.
Note 26:
Subsequent Events
In February 2025 we entered into an arrangement with Royalty Pharma under which we will receive up to $200.0 million in 2025 and up to
$50.0 million in 2026 to co-fund our development costs for the litifilimab program.
Following potential regulatory approval, Royalty Pharma will be eligible for regulatory milestones and royalties of a mid-single digits
percentage of the applicable net sales.
(1)
(2)
(1)
(2)
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Biogen Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Biogen Inc. and its subsidiaries (the “Company”) as of December 31, 2024
and 2023, and the related consolidated statements of income, of comprehensive income, of equity and of cash flow for each of the three years
in the period ended December 31, 2024, including the related notes (collectively referred to as the “consolidated financial statements”). We
also have audited the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal
Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the
Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period
ended December 31, 2024 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion,
the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on
criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over
financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual
Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s
consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be
independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the
Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to
obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or
fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the
consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also
included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an
understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the
design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures
as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of
records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally
accepted accounting principles, and that receipts and expenditures of the company are being made
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only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or
that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that
were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to
the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of
critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by
communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to
which they relate.
Reserves for Medicaid and Managed Care Rebates in the U.S.
As described in Notes 1 and 5 to the consolidated financial statements, the Company recognized revenue from product sales, net of reserves,
including contractual adjustments related to Medicaid and managed care rebates in the U.S. Within accrued expense and other, revenue-
related reserves amounted to $937.5 million as of December 31, 2024. A portion of this balance includes contractual adjustments for
Medicaid and managed care rebates in the U.S. Medicaid rebates relate to the Company’s estimated obligations to states under established
reimbursement arrangements. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make for the
current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, invoices received for claims
from the prior quarters that have not been paid and an estimate of potential claims that will be made for inventory that exists in the
distribution channel at period end. Managed care rebates in the U.S. represent the Company’s estimated obligations to third-parties,
primarily pharmacy benefit managers. These rebates result from performance-based goals, formulary position and price increase limit
allowances (price protection). The calculation of the accrual for these rebates is based on an estimate of the coverage patterns and the
resulting applicable contractual rebate rate(s) to be earned over a contractual period. Rebate accruals for Medicaid and managed care in the
U.S. are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a
liability which is included in accrued expense and other current liabilities. The estimates of the reserves for Medicaid and managed care in the
U.S. reflect historical experience, current contractual and statutory requirements, specific known market events and trends, industry data
and forecasted customer buying and payment patterns.
The principal considerations for our determination that performing procedures relating to reserves for Medicaid and managed care rebates in
the U.S. is a critical audit matter are (i) the significant judgment by management due to the significant measurement uncertainty when
developing the estimate of the reserves and (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and
evaluating management's significant assumptions related to historical experience, current contractual requirements, specific known market
events, and forecasted customer buying and payment patterns.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the
consolidated financial statements. These procedures included testing the effectiveness of controls relating to management's estimate of the
reserves for Medicaid and managed care rebates in the U.S. These procedures also included, among others (i) developing an independent
estimate of the reserves for Medicaid and managed care rebates in the U.S. by utilizing third-party data related to product demand, data
related to price changes, the terms of the specific rebate programs, the historical trend of actual rebate claims paid and consideration of
contractual requirement changes and market events; (ii) comparing the independent estimate to management’s estimate to evaluate the
reasonableness of management's estimate; and (iii) testing, on a sample basis, rebate claims paid by the Company, including evaluating the
claims for consistency with the contractual terms of the Company’s rebate agreements.
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Acquisition of Human Immunology Biosciences, Inc. (HI-Bio) - Valuation of In-Process Research and Development Intangible Assets
As described in Notes 1 and 2 to the consolidated financial statements, on July 2, 2024, the Company completed the acquisition of HI-Bio for
total consideration of $1,622.4 million. In-process research and development (IPR&D) intangible assets of $1,635.0 million were recorded,
which include $920.0 million related to felzartamab indication for immunoglobulin A. nephropathy (IgAN), $450.0 million related to
felzartamab indication for antibody-mediated rejection (AMR), and $265.0 million related to felzartamab indication for primary
membranous nephropathy (PMN). Management uses the multi-period excess earnings method, which is a form of the income approach,
utilizing post-tax cash flows and discount rates in estimating the fair value of identifiable intangible assets acquired when allocating the
purchase consideration paid for the acquisition. The estimates of the fair value of identifiable intangible assets involve significant judgment
by management and include assumptions with measurement uncertainty, such as the amount and timing of projected cash flow, long-term
sales forecasts, discount rates, and the timing and probability of regulatory and commercial success.
The principal considerations for our determination that performing procedures relating to the valuation of IPR&D intangible assets acquired
in the acquisition of HI-Bio is a critical audit matter are (i) the significant judgment by management due to the significant measurement
uncertainty when developing the fair value estimate of the IPR&D intangible assets acquired; (ii) a high degree of auditor judgment,
subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to long-term sales forecasts,
discount rate, and the probability of regulatory and commercial success for the IPR&D intangible assets acquired; and (iii) the audit effort
involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the
consolidated financial statements. These procedures included testing the effectiveness of controls relating to the acquisition accounting,
including controls over management’s valuation of the IPR&D intangible assets acquired. These procedures also included, among others (i)
reading the purchase agreement; (ii) testing management’s process for developing the fair value estimate of the IPR&D intangible assets
acquired; (iii) evaluating the appropriateness of the multi-period excess earnings method used by management; (iv) testing the completeness
and accuracy of certain of the data used in the multi-period excess earnings method; and (v) evaluating the reasonableness of the significant
assumptions used by management related to long-term sales forecasts, discount rate, and the probability of regulatory and commercial
success for the IPR&D intangible assets acquired. Evaluating management's assumptions related to long-term sales forecasts and the
probability of regulatory and commercial success for the IPR&D intangible assets acquired involved evaluating whether the assumptions used
by management were reasonable considering (i) the current and past performance of the acquired business and (ii) whether the assumptions
were consistent with evidence obtained in other areas of the audit. Evaluating management’s assumption related to long-term sales forecasts
also involved considering the consistency with external market and industry data. Professionals with specialized skill and knowledge were
used to assist in evaluating (i) the appropriateness of the multi-period excess earnings method and (ii) the reasonableness of the discount rate
significant assumption for the IPR&D intangible assets acquired.
/s/PricewaterhouseCoopers LLP
Boston, Massachusetts
February 12, 2025
We have served as the Company's auditor since 2003.
F-83

EXHIBIT 10.14
BIOGEN INC.
VOLUNTARY BOARD OF DIRECTORS SAVINGS PLAN
(Plan Provisions as in Effect on January 1, 2024)

TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS...........................................................................................................1
1.1 Purpose and Effective Date..............................................................................................1
ARTICLE 2 DEFINITIONS...........................................................................................................1
2.1 Biogen………………………….………………………………………………………... 1
2.2 Board..................................................................................................................................1
2.3 Change in Control…………………………………………………………………….....1
2.4 Committee……………………………………………………………………………......1
2.5 Director..............................................................................................................................2
2.6 Equity Plan Award............................................................................................................2
2.7 Fees.....................................................................................................................................2
2.8 Participant..........................................................................................................................2
2.9 Plan.....................................................................................................................................2
2.10 Plan Year............................................................................................................................2
2.11 Retainer…………………………………………………………………………………..2
2.12 Savings Plan……………………………………………………………………………...2
ARTICLE 3 PARTICIPATION.....................................................................................................2
3.1 Eligibility and Participation.............................................................................................2
3.2 End of Participation..........................................................................................................2
ARTICLE 4 VOLUNTARY DEFERRALS BY PARTICIPANTS................................................2
4.1 Voluntary Deferrals..........................................................................................................2
4.2 Election Procedures...........................................................................................................3
ARTICLE 5 PARTICIPANT ACCOUNTS....................................................................................5
5.1 Participant Accounts…………….……………………………………………………....5
5.2 Vesting…….................…………………………………………………………………...6
ARTICLE 6 DISTRIBUTION TO PARTICIPANT……….……………………………………..7
6.1 Distributions for Unforeseeable Emergency……………………………………….......7
6.2. In-Service Distribution(s) at a Time Specified by Participant……………………......7
6.3 Distribution Upon a Change in Control……………………………………………......8
6.4 Distribution upon Death of a Participant.......................................................................8
6.5 Other Distributions……………………………………………………………………...8
6.6 Installment Distributions in Certain Cases………………………………………….....8
6.7 Certain Other Distributions.............................................................................................9
6.8 Delay in Distributions……………………………………………………….................10
6.9 Compliance with Code Section 409A.............................................................................10
ARTICLE 7 MISCELLANEOUS.................................................................................................10
7.1 Amendment or Termination of Plan.............................................................................10
7.2 Benefits Not Currently Funded……………………………………………………......11
7.3 No Assignment………………………………………………………………………….11
7.4 Effect of Change in Control............................................................................................11
7.5 Responsibilities and Authority of Committee...............................................................12
7.6 Limitation on Rights Created by Plan………………………………………………...12
7.7. Tax Withholding………………………………………………………………………..12
7.8. Text Controls...................................................................................................................12
7.9. Applicable State Law......................................................................................................13
7.10. Paperless Administration...............................................................................................13

APPENDIX A ...........................................................................................................................A-1

ARTICLE 1
INTRODUCTION

1.1    Purpose and Effective Date. The purpose of this plan is to provide members of the Board of Directors of Biogen with a tax-deferred
savings opportunity. This plan allows participants to defer all or a portion of their cash directors’ fees and retainer by so electing before such
fees and retainer have been earned.

The plan was amended and restated effective as of January 1, 2012 to expand the tax-deferred savings opportunities by allowing
members of the Board of Directors to defer certain equity based awards granted under the Biogen Inc. 2006 Non-Employee Directors Equity
Plan (or successor plan). This amended and restated plan is effective as of January 1, 2024. Certain historical information about the plan and
any amendments thereto is set forth in Appendix A.
ARTICLE 2 
DEFINITIONS

This section contains definitions of terms used in the plan. Where the context so requires, the masculine includes the feminine, the
singular includes the plural, and the plural includes the singular.
2.1    Biogen means Biogen Inc., a Delaware corporation, or any successor to all or the major portion of its assets or business which assumes
the obligations of Biogen Inc. under this plan.

2.2    Board means the Board of Directors of Biogen.

2.3    Change in Control

(a)
For purposes of Section 7.4, a change in control means a “Corporate Change in Control” or a “Corporate Transaction” as
each is defined in the Biogen Inc. Omnibus Equity Plan, as in effect at the time of the corporate event.
(b)
For purposes of Section 4.2(b) and Section 6.3, a change in control means (i) the acquisition by a person or group of stock of
Biogen that, together with stock previously held by such person or group, constitutes more than 50 percent of the total fair market value or
total voting power of the stock of Biogen; (ii) a change in the effective control of Biogen resulting from either the acquisition by any person
or group during a 12-month period of stock of Biogen possessing 30 percent or more of the total voting power of Biogen stock; or the
replacement of a majority of the members of the Board during any 12-month period by directors whose appointment or election was not
endorsed by a majority of the members of the Board in office immediately before the start of such 12-month period; or (iii) the acquisition by
any person or group (during any 12-month period) of assets having a gross fair market value equal to or greater than 40 percent of the total
gross fair market value of all assets of Biogen. This subsection (b) and terms used herein will be interpreted in accordance with the
regulations under Code Section 409A relating to a change in the ownership or effective control of a corporation or a change in the ownership
of a substantial portion of the assets of a corporation.
2.4    Committee means the Retirement Committee, or such other committee designated by the Board to administer this Plan.
1

2.5    Director means an individual serving as a non-employee director of Biogen in accordance with its articles and by-laws.
2.6    Equity Plan Award means an award granted pursuant to the Biogen Inc. 2006 Non-Employee Directors Equity Plan, or successor plan
thereto.
2.7    Fees means the cash amounts payable to a director as compensation for his or her attendance at a meeting of the Board or a committee
of the Board or for other special services.
2.8    Participant means a director who has made a voluntary deferral hereunder or for whom an amount has been transferred to this plan.
2.9    Plan means the Biogen Inc. Voluntary Board of Directors Savings Plan, as set forth in this plan instrument, and as it may be amended
from time to time.

2.10    Plan year means the 12-month periods commencing on each January 1 while this plan remains in effect.

2.11    Retainer means the cash amount payable to a director as an annual retainer for service in such capacity, as in effect from time to time.

2.12    Savings Plan means the Biogen 401(k) Savings Plan, as amended from time to time. Any term defined in the Savings Plan will have
the same meaning when used in this plan unless otherwise defined herein.
2

ARTICLE 3
PARTICIPATION

3.1    Eligibility and Participation. Each director will be eligible to be a participant in this plan as long as he is a director. A director will
become a participant hereunder when he makes a voluntary deferral to this plan or when his account balance under the Biogen, Inc. Voluntary
Board of Directors Savings Plan (the “Biogen Directors Plan”) is transferred to this plan. Voluntary deferrals under this plan are voluntary
and no director will be required to make such deferrals.

3.2    End of Participation. A participant’s participation in this plan will end upon the termination of his service as a director of Biogen
because of death, retirement, resignation, failure of reelection, or any other reason. Upon the termination of a participant’s participation in
this plan in accordance with this section, the participant may make no further voluntary deferrals hereunder. However, the participant will be
entitled to receive any amounts in his account in accordance with this plan.
ARTICLE 4

VOLUNTARY DEFERRALS BY PARTICIPANTS

4.1    Voluntary Deferrals. Each director may make voluntary deferrals to the plan from his fees, retainer, or equity plan award in any whole
percentage of such fees, retainer, and/or equity plan award from a minimum of 1% to a maximum of 100%, by electing to reduce his fees,
retainer, and/or equity plan award by such amount in accordance with this plan. If a director’s fees include separately identified types of fees
(for example, meeting fees or special service fees), the Committee may permit separate elections to defer with respect to different categories
of fees. Deferrals of any equity plan awards shall not include any partial shares of common stock of Biogen.
All amounts by which a participant reduces his fees, retainer, and/or equity plan award hereunder are referred to herein as the
participant’s voluntary deferrals.
Notwithstanding anything in this plan to contrary, no director may elect to defer to this plan any equity plan award granted on or after
January 1, 2015 under the Biogen Inc. Non-Employee Directors Equity Plan.
4.2    Election Procedures.

(a)    Voluntary Deferrals. A director who wishes to reduce his fees, retainer, and or equity plan award to be earned during a particular
plan year in order to make voluntary deferrals under Section 4.1 must complete an enrollment form specifying the amount of his voluntary
deferrals (with separate percentages for his meeting fees, special service fees (if any) and/or retainer, if desired), agreeing to reduce such fees,
retainer, and/or equity plan award by the amount(s) he specifies, and providing such other information as the Committee may require.
Elections made with respect to equity plan awards shall apply to all tranches of such awards regardless of the date such award becomes
nonforfeitable and shall apply with respect to any and all dividends or dividend equivalents provided with respect to such awards. All deferral
elections hereunder must be made on an enrollment form approved by the Committee, specifying the amount he elects to defer, agreeing to
reduce his fees, retainer, and/or equity plan award by such amount. And providing such other information as the Committee may require. If a
director elects to defer an equity plan award, he or she shall not be permitted to diversify the investment of such awards other than in Biogen
stock or stock equivalent
3

A director’s enrollment form electing voluntary deferrals for any plan year must be filed with the Committee by such deadline as the
Committee specifies, but in any event before the start of such plan year. In addition, in the case of an individual who anticipates being elected
as a director during a plan year, such person may make an election hereunder in anticipation of his or her election and such election will be
effective with respect to fees, retainer, and/or equity plan award to be earned after the date of such election; such an election will be effective
as of the date when it is made but will be subject to such individual’s actual election as a director. Further, in the case of a newly elected
director, who did not make an election under the preceding sentence, such person may elect to defer his fees, retainer, and/or equity plan
award for the plan year of his election to office, within 30 days after the Committee sends him an enrollment form, provided that such
election will relate only to fees, retainer, and equity plan awards to be earned after the date of filing his completed enrollment form, and
provided further that such person had not previously been eligible to make voluntary deferrals under this plan for a period of at least 24
months. Any filing deadline will comply with the timing of election requirements of the regulations under Code Section 409A. Accordingly,
with respect to the initial election to defer payment of any equity plan awards or any other forfeitable rights that requires the participant to
provide services for at least 12 months from the date the award is granted, the election to defer such compensation may be made within 30
days after the date of grant or, if earlier, 12 months in advance of the date such award or right becomes nonforfeitable provided that if death,
disability or a change in control occurs which accelerates the vesting before the end of such 12-month period, the deferral election will not be
effective. The Committee’s written procedures will be deemed to constitute part of this plan for purposes of the written plan document
requirements of the regulations under Code Section 409A. A participant may change the amount of his voluntary deferrals with respect to any
subsequent plan year by filing a new enrollment form before the start of such subsequent plan year, and the change will become effective as
of the first day of such subsequent plan year. Once a participant has elected to defer fees, retainer, and/or equity plan awards his enrollment
form will remain in effect for future plan years unless the participant changes or terminates his prior elections by filing a new enrollment
form in accordance with the preceding sentence.
After a plan year has begun, a participant may not change the amount of voluntary deferrals (if any) he had elected for such plan
year. However, if during a plan year a participant has an unforeseeable emergency (as defined in Section 6.1) and receives a distribution
under Section 6.1, the participant’s voluntary deferral election for the balance of that year will automatically be cancelled.
Notwithstanding anything in this plan to contrary, no director may elect to defer to this plan any equity plan award granted on or after
January 1, 2015 under the Biogen Inc. Non-Employee Directors Equity Plan.
(b)
Form and Time of Payment.
(i)
Initial Election. Each participant in the initial enrollment form filed hereunder or another form designated by the
Committee must specify the form of payment (lump sum or installments in accordance with Section 6.4(a), 6.5 and/or 6.6(a) below,
as applicable) of his account hereunder in the event of the participant’s death or other termination of service as a director (including
as a result of disability). In addition, effective as of the date of execution of this amended and restated plan document, a participant
may elect payment of his account under Section 6.3 in the event of a change in control (as defined in Section 2.3(b)).
In addition, a participant may (but is not required to) specify one or more in-service distributions to the participant in
accordance with Section 6.2 if desired by the participant.
4

The time and form payments under the plan are governed by the provisions of Article 6 and participant elections must
conform to the requirements of such provisions. Any election as to medium of payment with respect to equity plan award (i.e.,
whether such award will be settled in stock or cash) shall be subject to the terms of the Biogen Inc. Non-Employee Directors Equity
Plan (or successor plan) and/or award agreement thereunder. Any such election shall not be considered an election as to time or form
of payment and shall not be subject to the restrictions under this Section.
(ii)
Change of Election. Notwithstanding subsection (i) above, the following changes of election will be permitted. If
such a subsequent election becomes effective as provided below, then the participant’s account will be payable at the time and in the
form specified in his subsequent election.
(A)
 In-Service Distributions. In the case of a participant who elected an in-service distribution, at any time that
is at least one year prior to the date for payment originally elected by the participant, if the participant is still
a director of Biogen at such time, the participant may make one subsequent election to defer the time when
any previously elected in-service distribution under Section 6.2 from his account would otherwise be
payable (or installment payments would otherwise begin) to a subsequent date specified by him, and/or may
elect another form of payment or a different number of installments with respect to the in-service
distribution of his account, subject in all cases to the requirements of this section and to the requirements of
Section 6.2.
(B)
Death or Termination of Employment. A participant who is still a director of Biogen may make one
subsequent election to change the form of payment hereunder that will be used following his death or other
termination of employment. Such an election must comply with the applicable requirements of Sections 6.4,
6.5 and 6.6 (as applicable).
(C)
Effectiveness of Subsequent Election. A participant’s subsequent election under this subsection (ii) will
become effective only if the following requirements are satisfied: (1) the subsequent election does not take
effect until one year after the date of the subsequent election and the participant remains a director of Biogen
during such one year period, (2) the election extends the date for payment, or the start date for installment
payments, by at least five years, and (3) in the case of a subsequent election to defer a previously elected in-
service distribution (under subsection (A) above), the subsequent election is made at least 12 months before
the date previously elected for such in-service distribution.
No election under this subsection (c)(i) may operate to accelerate any payment or distribution hereunder or violate any
requirement of Code Section 409A or the regulations and rulings thereunder.
A participant may make only one subsequent election under subsection (ii) (A) and only one subsequent election under
subsection (ii)(B). Such subsequent election(s) may be made at the
5

same or at different times. Also, the Committee may permit additional election opportunities (in accordance with the transition or
other rules under the regulations or other Internal Revenue Service guidance under Code Section 409A or in such other
circumstances as the Committee deems appropriate). Any such additional subsequent elections under subsection (ii) must satisfy all
the requirements of this section and any other applicable requirements under the plan or, alternatively, must satisfy such requirements
as the Committee may impose in connection with a new election under a Code Section 409A transition or other rule.
ARTICLE 5

PARTICIPANT ACCOUNTS
5.1    Participant Accounts.

(a)
Voluntary Deferrals Accounts. Voluntary deferrals by a participant from his fees and/or retainer hereunder will be credited to
an account in the name of such participant. Such account will be called his voluntary deferrals account.
(b)
Participant’s Account Value. Except as otherwise provided below, a participant’s account will be credited with deemed
investment results as if his voluntary deferrals account were invested in one or more designated investment funds (as described below) and
all dividends and distributions on shares of a particular investment fund were reinvested in such fund. The investment funds available for this
purpose will be those determined in the discretion of the Committee.
In addition to the investment funds described in the preceding paragraph, a participant may elect to have his account credited with the
deemed investment results as if such amounts were invested in a fixed income option earning a rate of return specified by the Committee.
The rate of return of the fixed rate option will be determined each year by the Committee.
Notwithstanding the foregoing, with respect to the portion of a participant’s voluntary deferred compensation account attributable to
the equity plan awards, such portion will be deemed to be invested in shares of common stock of Biogen, and the participant shall not be
permitted to designate any other investment fund for this purpose.
Investment funds hereunder are for the sole purpose of providing a basis for crediting deemed investment results to participants’
accounts, and do not represent any actual funds or assets held hereunder for the benefit of participants.
Each participant will indicate with his initial enrollment form (or other form specified by the Committee) the investment fund or
funds (and the proportion in each fund when the participant designates more than one) he wishes to designate for this purpose. Thereafter, a
participant may change his designation either with respect to the deemed investment of future voluntary deferrals or the deemed transfer of
amounts from a previously designated investment fund to another fund. The Committee shall establish the frequency by which such a change
may be made, the method of making such a change, and the effective date of such a change and shall prescribe such other rules and
procedures as it deems appropriate. Such designation will remain in effect until subsequently changed by the participant in accordance with
this paragraph. Following a participant’s death and before the payment of any amount due to the participant’s beneficiary hereunder has been
completed, the beneficiary will exercise the participant’s designation powers under this section.
6

Notwithstanding the preceding paragraph, the Committee may establish one or more default investment funds that will be used to
determine deemed investment results in the case of any participant or group of participants who have not made a designation under the
preceding paragraph. Such default investment fund(s) will be used to determine deemed investment results applicable to the account of such
participant or participants until any such participant makes a designation of investment fund(s) in accordance with the plan.
Deemed investment results under this subsection will be credited to a participant’s account effective as of the last day of each plan
year (and as of such other valuation dates during a plan year as the Committee may establish).
The value of a participant’s account at any point in time will be his voluntary deferrals (plus, if applicable, his transferred account
balance from the Biogen Directors Plan), increased or decreased by deemed investment results as provided in this subsection (b) through the
end of the most recent valuation date, and reduced by any distributions from the participant’s account.
Notwithstanding the foregoing, in connection with the transfer of participants’ Biogen Directors Plan account balances to this plan,
transferred account balances will be initially credited with deemed investment results as if the participant had selected the money market fund
investment option under the Savings Plan. Deemed investment results in accordance with the preceding sentence will apply to such
transferred account balances until a participant changes such designation in accordance with this section.
(c)
Bookkeeping Accounts. Participants’ accounts and subaccounts will be maintained on Biogen’s books for bookkeeping
purposes only; such accounts will not represent any property or any secured or priority interest in any trust or in any segregated asset.
In order to facilitate the administration of the plan, the Committee may arrange for a participant’s voluntary deferrals account to be
divided for recordkeeping purposes into two or more subaccounts, in accordance with procedures established by the Committee.
5.2    Vesting. A participant will have a fully vested interest in his voluntary deferrals account at all times except that any equity plan awards
deferred hereunder shall be subject to such vesting requirements as provided under the Biogen Inc. 2006 Non-Employee Directors Equity
Plan (or successor plan) and/or award agreement applicable to such award. For this purpose, “fully vested” means that such account is not
subject to forfeiture; however, all participant accounts are subject to (i) fluctuation as a result of the crediting of deemed investment results
(including losses) to such accounts as provided in the plan and (ii) the possibility of the insolvency or bankruptcy of Biogen (see Section
7.2(a)).
7

ARTICLE 6
DISTRIBUTIONS TO PARTICIPANT
6.1    Distributions for Unforeseeable Emergency. If a participant has an unforeseeable emergency prior to his termination of service as a
director, he may apply to the Committee for a distribution from his vested account. If such application for an unforeseeable emergency
distribution is approved by the Committee, distribution of the approved amount will be made on the date of approval by the Committee. The
amount of the distribution will be the amount reasonably needed to alleviate the participant’s unforeseeable emergency (including the amount
necessary to pay any federal, state or local income taxes and penalties reasonably anticipated to result from the distribution), as determined
by the Committee, up to a maximum of the participant’s account balance. Such a distribution will be made from the participant’s account in a
single lump sum payment. If such a participant’s account has two or more subaccounts, the Committee will determine which subaccount(s)
will be debited to reflect the unforeseeable emergency distribution.

An unforeseeable emergency is a severe financial hardship affecting the participant resulting from illness of the participant or spouse,
dependent or designated beneficiary, need to rebuild the participant’s principal residence following damage not covered by insurance, or
other similar extraordinary and unforeseeable circumstances arising as a result of events beyond the participant’s control. A circumstance or
exigency of the participant does not constitute an unforeseeable emergency to the extent that the participant’s financial need is or may be
relieved through reimbursement or compensation by insurance or otherwise, by liquidation of assets (to the extent that such liquidation would
not itself cause severe hardship), or by cessation of voluntary deferrals in accordance with Section 4.1.
The Committee will determine whether a participant has incurred an unforeseeable emergency and the amount needed to alleviate the
unforeseeable emergency. A participant is not entitled to a distribution under this section regardless of the participant’s circumstances or
exigencies, and all such distributions and the amounts thereof are subject to the determination of the Committee.
6.2    In-Service Distribution(s) at a Time Specified by Participant. A participant shall be permitted, in accordance with this section, to
elect an in-service distribution at a specified date (but not earlier than five years after the date he is making such election) of the portion of his
vested account that is not invested in the fixed income option described in the second paragraph of Section 5.1(b). If, in his initial enrollment
or other election form (or, if applicable, a subsequent election under Section 4.2(b)(ii)), the participant elected payment of such portion of his
vested account (or a specified part of such portion) at a specified time(s) and he is still a director at such time(s), the participant will receive
payment of the amount elected, payable on the designated date(s). A participant’s election for in-service distributions under this Section 6.2
may be for a single payment or up to five annual payments (with the first payment on the date specified by the participant and subsequent
payments on anniversaries of such date), in each case in an amount or portion specified by the participant in his enrollment or other election
form. Each payment will be the amount specified (or the entire balance remaining in the participant’s account, if less). Payments with respect
to an in-service distribution election of a flat dollar amount (as opposed to a percentage of the participant’s vested account) by a participant
who has deferred equity plan awards shall be paid from the portion of the participant’s vested account that is not attributable to such equity
based awards.

Any amount in a participant’s vested account hereunder not distributed to the participant under this Section 6.2 will be distributed under
Section 6.3, 6.4 or 6.5, whichever may be applicable, and Section 6.6 (if applicable). If a participant is receiving multiple payments under this
Section 6.2 and dies or otherwise
8

terminates service as a director, payments under this subsection will cease and subsequent payments will be governed by Section 6.4 or 6.5,
as the case may be.
6.3    Distribution Upon a Change in Control. In the event of a change in control (as defined in Section 2.3(b)), a participant who elected
payment of his account under Section 4.2(b)(i) will receive a lump sum payment equal to the amount credited to his account hereunder. Such
payment will be made 30 days after the occurrence of the change in control.
6.4    Distribution upon Death of a Participant.
(a)
In general. If a participant dies before his entire vested account balance has been distributed, his beneficiary will receive the
amount remaining in the participant’s vested account. Except as provided in Section 6.6, distribution will be made in a single sum payment
on the first day of the month after the Committee receives appropriate evidence of the participant’s death and of the right of any beneficiary
to receive such payment (and in the case of payment to the participant’s estate, the appointment of a personal representative).
(b)
Beneficiary. A participant may designate one or more beneficiaries to receive a distribution payable under subsection (a)
above and may revoke or change such a designation at any time. If the participant names two or more beneficiaries, distribution to them will
be in such proportions as the participant designates or, if the participant does not so designate, in equal shares. Any designation of beneficiary
will be made in accordance with such procedures or in such form as the Committee may prescribe or deem acceptable.
Any portion of a distribution payable upon the death of a participant that is not disposed of by a designation of beneficiary under the
preceding paragraph, for any reason whatsoever, will be paid to the participant’s spouse if living at his death, otherwise equally to the
participant’s natural and adopted children (and the issue of a deceased child by right of representation), otherwise to the participant’s estate.
The Committee may direct payment in accordance with a prior designation of beneficiary (and will be fully protected in so doing) if
such direction (i) is given before a later designation is received, or (ii) is due to the Committee’s inability to verify the authenticity of a later
designation. Such a distribution will discharge all liability therefor under the plan.
6.5    Other Distributions. Except in the case of the participant’s death (in which case distribution is made in accordance with Section 6.4),
distribution of a participant’s account will be made at the time elected by the participant in accordance with Section 4.2. In the absence of
such an election, distribution of the participant’s account will be made on the first day of the month after the participant’s termination of
service as a director. Distribution will be made in a single lump sum payment.

In applying the distribution provisions of this Article 6, in the case of a participant who terminates service as a director but thereupon
becomes an employee of Biogen (or a subsidiary or other affiliate of Biogen), such participant will be deemed not to have a termination of
service as a director until he terminates employment with Biogen (or subsidiary or other affiliate).
6.6    Installment Distributions in Certain Cases.

(a)
Participant. Notwithstanding the provisions of Section 6.5, a participant may, at the time of filing his initial enrollment form
under Section 4.2(b)(i) (or, if applicable, in a subsequent election under Section 4.2(b)(ii)), designate that the amount payable to him
hereunder upon termination of service
9

as a director will be paid in a number (minimum of two and maximum of fifteen) of annual installment payments, as specified by the
participant. However, in the event the participant’s account balance as of the date that installment distribution would begin in accordance
with Section 6.5 is equal to or less than the limit under Code Section 402(g)(1)(B) and (g)(4) as in effect when installments would begin (for
example, $23,000 for 2024), such account balance will automatically be paid in the form of a lump sum payment to the extent not prohibited
by the regulations under Code Section 409A.
(b)
Beneficiary. Notwithstanding Section 6.4, a participant may at the time of filing his initial enrollment form under Section 4.2
(or, if applicable, in a subsequent election) designate that, if the participant dies before receiving the entire amount payable to him hereunder,
the beneficiary will receive either:
    (i)    A number of annual installment payments equal to:
        (A)    the number the participant elected for himself under subsection (a) above (if the participant dies before receiving any
installment payments), or
        (B)    the number of remaining installment payments due to the participant under subsection (a) above (if the participant dies
after receiving one or more installment payments); or
    (ii)    a single payment.
Payment to the beneficiary (or the first installment) will be made or begin as provided in Section 6.4(a).
If the participant fails to designate the form of payment to the beneficiary, the default form of payment will be a single payment
under (ii) above.
(c)
Installment Payments. Where installment payments are due, the first annual installment payment will be made on the date
specified in Section 6.4 or 6.5 (whichever is applicable) and subsequent annual installments will be paid on succeeding anniversaries of the
first payment date. The amount of each annual installment payment will be determined by multiplying the amount then remaining to be paid
by a fraction whose numerator is one and whose denominator is the number of remaining annual installment payments. Installment payments
with respect to the portion of a participant’s vested account equity based awards shall be made in shares and shall not include any fractional
shares.
(d)
Death of Beneficiary. If a participant’s designated beneficiary is receiving installment payments and dies before receiving
payment of all the annual installments, the designated beneficiary’s estate will receive a lump sum payment of the amount remaining to the
distributed to such deceased beneficiary. Such payment will be made on the first day of the month next following the Committee’s receipt of
satisfactory evidence of the death of the designated beneficiary and the appointment of a personal representative.
(e)
Deemed Single Payment. As provided in the regulations under Code Section 409A, installment payments to a participant will
be deemed a single payment on the date of the first installment for purposes of the anti-acceleration rule (Section 4.2(b) and Section 6.9) and
the rules governing the timing of changes in elections with respect to time and form of payment hereunder (Section 4.2(b)).
10

6.7    Certain Other Distributions. In addition to the distributions provided for in the preceding sections of this Article 6, the Committee
may provide for a distribution from a participant’s account under the following circumstances:

(a)
Domestic Relations Order. Distribution of the amount necessary to fulfill the requirements of a domestic relations order (as
defined in Code Section 414(p)) requiring the payment of all or a portion of participant’s account to another individual (see Section 7.3(b)).
(b)
Conflicts of Interest. Distribution to the extent reasonably necessary to comply with a federal government ethics agreement
or a federal, state, local or foreign ethics or conflicts of interest law (as described in the regulations under Code Section 409A).
(c)
Violation of Code Section 409A. In the event that, notwithstanding the intent that this plan satisfy in form and operation the
requirements of Code Section 409A, it is determined that the requirements of Code Section 409A have been violated with respect to any
participant or group of participants, distribution of the amount determined to be includable in taxable income of such participant or
participants as a result of such violation of Code Section 409A.
(d)
Other Circumstances. Distribution of any amount specifically permitted by Code Section 409A and the regulations
thereunder.
6.8    Delay in Distributions. Notwithstanding the provisions of any of the foregoing sections in this Article 6, the Committee may delay the
making of any payment to a subsequent date, provided that the delayed payment is made not later than the latest time permitted under Code
Section 409A and the regulations and rulings thereunder (generally, the later of the end of the calendar year in which the specified payment
date occurs or the 15th day of the third month after the specified payment date).

6.9    Compliance with Code Section 409A. Notwithstanding any other provision of this plan (including, without limitation, Section 6.7(c)),
distributions and elections respecting distributions are intended to be and will be administered in accordance with the provisions of Code
Section 409A and the regulations and rulings thereunder (including the provisions prohibiting acceleration of payment unless specifically
permitted by such regulations and rulings).
ARTICLE 7
MISCELLANEOUS

7.1    Amendment or Termination of Plan. Biogen, by action of the Board or of the Compensation Committee (or such committee thereof
or officer or officers of Biogen to whom the Board has delegated this authority), at any time and from time to time, may amend or modify
any or all of the provisions of this plan or may terminate this plan without the consent of any participant (or beneficiary or other person
claiming through a participant). In addition, any amendment may be made by the Committee, or the Executive Vice President - Chief
Financial Officer, or the Executive Vice President - Human Resources of Biogen except for an amendment that would materially increase or
reduce the benefits of the plan to participants or materially increase the cost of maintaining the plan to Biogen; such committee or specified
officers may not terminate the plan.

No termination or amendment of the plan may reduce the amount credited to the account of any participant under the plan (including
a participant whose service as a director terminated before such plan termination or amendment). However, Biogen may change the deemed
investment options under Section
11

5.1(b), and Biogen may upon termination of this plan pay participants’ account balances to the participants regardless of the times elected for
payment (or the start of installment payments) elected by the participants and may pay such amounts in single sum payments regardless of
whether installment distributions would otherwise be payable under Section 6.6; provided that any such distributions upon plan termination
must be permitted by Code Section 409A and the regulations and rulings thereunder. In addition, Biogen may, from time to time, make any
amendment that it deems necessary or desirable to satisfy the applicable requirements of the tax laws and rulings and regulations thereunder
in order to preserve, if possible, the tax deferral features of this plan for participants. No diminution or restriction on a participant’s
opportunity to make elections or withdrawals, or exercise other privileges or rights hereunder pursuant to the preceding sentence will be
deemed to violate the rights of any participant or beneficiary hereunder so long as such change does not render a participant’s account
balance forfeitable. Any amendment that is required by Code Section 409A and the regulations and rulings thereunder to have a delayed
effective date will be effective no earlier than such required date.
7.2    Benefits Not Currently Funded.

(a)
Nothing in this plan will be construed to create a trust or to obligate Biogen to segregate a fund, purchase an insurance
contract or other investment, or in any other way currently to fund the future payment of any benefits hereunder, nor will anything herein be
construed to give any participant or any other person rights to any specific assets of Biogen or any other entity. However, in order to make
provision for its obligations hereunder, Biogen may in its discretion purchase an insurance contract or other investment; any such contract or
investment will be a general asset belonging to Biogen, and no participant or beneficiary will have any rights to any such asset. The rights of
a participant or beneficiary hereunder will be solely those of a general, unsecured creditor of Biogen.
(b)
Notwithstanding subsection (a) above, Biogen in its sole discretion may establish a grantor trust of which it is treated as the
owner under Code Section 671 to provide for the payment of benefits hereunder, subject to such terms and conditions as Biogen may deem
necessary or advisable to ensure that trust assets and benefit payments hereunder are not includable, by reason of the trust, in the taxable
income of trust beneficiaries before actual distribution and that the existence of the trust does not cause the plan or any other arrangement to
be considered funded for purposes of Title I of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”) or for
purposes of the Internal Revenue Code of 1986, as amended. Biogen may terminate any such trust in accordance with its terms.
7.3    No Assignment.

(a)
No participant or beneficiary will have any power or right to transfer, assign, anticipate or otherwise encumber any benefit or
amount payable under this plan, nor shall any such benefit or amount payable be subject to seizure or attachment by any creditor of a
participant or a beneficiary, or to any other legal, equitable or other process, or be liable for, or subject to, the debts, liabilities or other
obligations of a participant or beneficiary except as otherwise required by law.
(b)
Notwithstanding subsection (a) above, all or a portion of a participant’s account balance may be assigned to the participant’s
spouse, former spouse, or other dependent (for purposes of this section, an “alternate recipient”) in connection with a domestic relations order
(as defined in Code Section 414(p)) awarding such portion to the alternate recipient. However, no such order may award an alternate
recipient greater rights than the participant has with respect to his account. Upon receipt of a copy of the relevant provisions of any such
order or property settlement agreement, certified to be accurate and in effect by the participant, and an acknowledgment by the alternate
recipient that such alternate recipient
12

will be responsible for income taxes on such amounts when distributed or made available to such alternate recipient and that such amounts
are subject to income tax withholding as provided in this plan, and such other information (including the alternate recipient’s social security
number) as the Committee may reasonably request, the Committee will assign such amount to a separate account hereunder and will
distribute such account to the alternate recipient in the form of a single sum payment as soon as administratively possible, as permitted by
Reg. 1.409A-3(j)(4)(ii) (except for any unvested amounts).
7.4    Effect of Change in Control.

(a)
Amendments. Notwithstanding Section 7.1, following the occurrence of a change in control (as defined in Section 2.3(a)), no
amendment will be made following a change in control without the consent of the affected participant (or beneficiary or other person
claiming through a participant) that adversely affects the rights of a participant (or beneficiary or other person claiming through a participant)
under the plan as in effect immediately before such change in control, including (i) the right to make elections concerning the form and time
of payment of distributions in accordance with Section 4.2(b) and the right to receive distributions in the form elected by the participant
thereunder; and (ii) the right to the investment funds or options specified herein for the determination of deemed investment results
applicable to participants’ accounts, as in effect immediately before such change in control. In particular, for purposes of clause (ii) of the
preceding sentence (i) the Committee may not set the rate of return of the fixed income option under Section 5.1(b) at a rate lower than that
available under life insurance or annuity contracts obtained by a vendor or service provider (currently, The Newport Group) for purposes of
the plan; and (ii) the Committee will maintain a menu of investment funds under Section 5.1(b) that is substantially similar (in terms of
investment styles and ability to position an account on a risk/reward spectrum) to the array of funds available immediately prior to the change
in control.
(b)
Termination. The plan will not be terminated before the payment of all benefits hereunder in accordance with the terms of the
plan as in effect immediately before such change in control without the consent of a majority of the participants (including, in the case of the
deceased participant, the beneficiary or other person claiming through such deceased participant). This subsection (b) will not preclude the
merger of this plan into a nonqualified deferred compensation plan maintained by a successor to Biogen provided that the benefits and rights
of participants hereunder (including this Section 7.4) are preserved in such successor plan.
7.5    Responsibilities and Authority of Committee. The Committee will control and manage the operation and administration of the plan
except to the extent that such responsibilities are specifically assigned hereunder to Biogen, the Board, the Compensation Committee (or a
delegatee of the Board or the Compensation Committee).

The Committee will have all powers and authority necessary or appropriate to carry out its responsibilities for the operation and
administration of the plan. It will have discretionary authority to interpret and apply all plan provisions and to correct any defect, supply any
omission or reconcile any inconsistency or ambiguity in such manner as it deems advisable. It will make all final determinations concerning
eligibility, benefits and rights hereunder, and all other matters concerning plan administration and interpretation. All determinations and
actions of the Committee will be conclusive and binding upon all persons, except as otherwise provided herein or by law, and except that the
Committee may revoke or modify a determination or action previously made in error. It is intended that any action or inaction by the
Committee will be given the maximum possible deference by any reviewing body (whether a court or other reviewing body) and will be
reversed by such reviewing court or other body only if found to be arbitrary and capricious.
13

Biogen will be the “plan administrator” and the “named fiduciary” for purposes of ERISA.
7.6    Limitation on Rights Created by Plan. Nothing appearing in the plan will be construed (a) to give any person any benefit, right or
interest except as expressly provided herein, or (b) to create a contract of employment or to give any director the right to continue in such
capacity or to affect or modify the terms of his service as a director in any way.
7.7    Tax Withholding. Any payment hereunder to a participant, beneficiary or alternate recipient will be subject to withholding of income
and other taxes to the extent required by law.
7.8    Text Controls. Headings and titles are for convenience only, and the text will control in all matters.
7.9    Applicable State Law. To the extent that state law applies, the provisions of the plan will be construed, enforced and administered
according to the laws of the Commonwealth of Massachusetts.
7.10        Paperless Administration. The Committee may establish procedures whereby an electronic, internet or voice recognized
authorization or election will or may be utilized under the plan in lieu a written form or document otherwise required by the terms of the plan.
In such event, any reference herein to a written election, authorization or other form shall be deemed to include such other authorization or
election.

                            BIOGEN INC.
                        By:                            
                            
                        Dated:                     
14

APPENDIX A
Historical Information; Amendments
A.1    Adoption of Plan Document. This plan document was approved by the Board of Directors of the Corporation (Biogen Idec Inc.),
effective as of January 1, 2004.
By appropriate votes, the account balances of certain directors who previously were participants under the Biogen, Inc. Voluntary
Board of Directors Savings Plan, maintained by Biogen, Inc. prior to the merger transaction, were transferred to and merged into this plan.
A.2    2005 Amendment and Restatement. The plan was amended and restated in its entirety, effective as of January 1, 2005 (except as
otherwise specified), primarily to comply with the requirements of Code Section 409A and regulations thereunder. During the period from
January 1, 2005 until the date of execution of the amended and restated plan document, the plan was interpreted and administered in
accordance with a good faith interpretation of the requirements of Code Section 409A and applicable guidance of the Internal Revenue
Service thereunder.
A.3    2012 Amendment and Restatement. The plan was amended and restated in its entirety, effective as of January 1, 2012 to expand the
tax-deferred savings opportunities by allowing members of the Board of Directors to defer certain equity based awards granted under the
Biogen Inc. 2006 Non-Employee Directors Equity Plan (or successor plan).
A.4    2015 Amendments to the 2013 Amendment and Restatement. The 2012 Amendment and Restatement of the plan was amended by
the First Amendment thereto to eliminate the ability to defer any equity based awards that may be granted beginning on or after January 1,
2015 under the Biogen Idec Inc Non-Employee Directors Equity Plan. The 2012 Amendment and Restatement was further amended by the
Second Amendment thereto, effective March 23, 2015, to reflect the change in the name of the plan from the ‘Biogen Idec. Inc. Voluntary
Board of Directors Savings Plan’ to the ‘Biogen Inc. Voluntary Board of Directors Savings Plan.’
A.5    January 2024 Restatement. The plan was amended and restated in its entirety effective January 1, 2024 to incorporate all previously
adopted amendments, to remove certain historical references and clarify investment options available under the plan.
A-1

EXHIBIT 10.15
BIOGEN INC.
SUPPLEMENTAL SAVINGS PLAN
(Plan Provisions as in Effect on
January 1, 2024)

TABLE OF CONTENTS
 
 
Page
ARTICLE 1
INTRODUCTION
1
    1.1
Purpose and Effective Date
1
ARTICLE 2
DEFINITIONS
1
    2.1
401(k) restoration
1
    2.2
Applicable compensation
1
    2.3
Base salary
1
    2.4
Biogen
1
    2.5
Biogen SERP
2
    2.6
Board
2
    2.7
Change in Control
2
    2.8
Code
2
    2.9
Committee
2
    2.10
Compensation Committee
2
    2.11
Disability
2
    2.12
Employee
2
    2.13
Employer
3
    2.14
ERISA
3
    2.15
Excess applicable compensation
3
    2.16
Non-recurring bonus amounts
3
    2.17
Participant.
3
    2.18
Plan
3
    2.19
Plan year
3
    2.20
Prior plan
3
    2.21
Recurring bonus amounts
3
    2.22
Savings Plan
4
    2.23
Service
4
    2.24
Transition credit
4
    2.25
Voluntary deferred compensation
4
    2.26
Years of service
4
ARTICLE 3
PARTICIPATION
4
    3.1
Eligibility and Participation
4
    3.2
End of Participation
5
ARTICLE 4
VOLUNTARY DEFERRALS BY PARTICIPANTS; EMPLOYER CREDITS
6
    4.1
401(k) Restoration
6
    4.2
Voluntary Deferrals
6
    4.3
Transition Credit
7
    4.4
Election Procedures
7
ARTICLE 5
PARTICIPANT ACCOUNTS
11
    5.1
Participant Accounts.
11
    5.2
Participant’s Account Value.
12
    5.3
Vesting.
13
ARTICLE 6
DISTRIBUTIONS TO PARTICIPANT
14
    6.1
Distributions for Unforeseeable Emergency
14
    6.2
Distributions Upon Change in Control
14
    6.3
In-Service Distribution(s) at a Time Specified by Participant
14
    6.4
Distribution upon Death of a Participant
15
    6.5
Distribution upon Participant’s Termination of Employment
16
    6.6
Installment Distributions in Certain Cases.
16

    6.7
Certain Other Distributions……………………………………………………………………….
17
    6.8
Delay in Distributions..
17
    6.9
Compliance with Code Section 409A.
18
ARTICLE 7
MISCELLANEOUS
18
    7.1
Amendment or Termination of Plan
18
    7.2
Benefits Not Currently Funded.
19
    7.3
No Assignment
19
    7.4
Effect of Change in Control
20
    7.5
Responsibilities and Authority of Committee
20
    7.6
Limitation on Rights Created by Plan.
21
    7.7
Tax Withholding.
21
    7.8
Text Controls
21
    7.9
Applicable State Law.
21
    7.10
Paperless Administration
21
 
APPENDIX A.
A-1
 
APPENDIX B.
B-1
ii

ARTICLE 1
INTRODUCTION
1.1    Purpose and Effective Date. The purpose of this plan is to provide certain key executives and managers of Biogen (or its
subsidiaries) with additional tax-deferred savings opportunities supplementing those available under the Savings Plan. This plan
allows certain eligible participants to make voluntary deferrals from base salary or recurring and/or non-recurring bonus amounts,
if elected by a participant in accordance with the terms of the plan. In addition, certain participants whose compensation exceeds
the Code Section 401(a)(17) limit applicable to the Savings Plan will receive an employer 401(k) restoration credit in accordance
with Section 4.1 and certain participants received transition credits in accordance with Section 4.3.
This plan also contains certain account balances or benefits previously maintained under the amended and restated IDEC
Pharmaceuticals Corporation Deferred Compensation Plan, the Biogen. Inc. Voluntary Executive Supplemental Savings Plan, and
the Biogen, Inc. Supplemental Executive Retirement Plan.
The plan was amended and restated effective January 1, 2005 to comply with Code Section 409A and restated again
effective February 1, 2008, October 1, 2008, January 1, 2010 and January 1, 2012. This amended and restated plan document is
effective as of January 1, 2024. Certain historical information about the plan and any amendments thereto is set forth in Appendix
A.
ARTICLE 2 

DEFINITIONS
This section contains definitions of certain terms used in the plan. Where the context so requires, the masculine includes
the feminine, the singular includes the plural, and the plural includes the singular.
2.1        401(k) restoration means that component of the plan under which an eligible participant’s account will receive an
employer 401(k) restoration credit under Section 4.1 with respect to applicable compensation in excess of the limit imposed by
Section 401(a)(17) of the Code.
2.2    Applicable compensation shall have the same meaning as in the Savings Plan except that applicable compensation under
this plan shall also include voluntary deferrals made under Section 4.2 in addition to other salary reductions included in
applicable compensation under the Savings Plan.
2.3    Base salary means the base salary established for any participant by his employer as in effect from time to time; the entire
amount of a participant’s base salary will be taken into account in accordance with the terms of this plan without regard to any
dollar limitation on applicable compensation that may be imposed under the Savings Plan; base salary includes all
1

components of a participant’s applicable compensation other than recurring and nonrecurring bonus amounts.
2.4    Biogen means Biogen Inc., a Delaware corporation, or any successor to it or to all or the major portion of its assets or
business which assumes the obligations of Biogen Inc. under this plan.
2.5    Biogen SERP means the Biogen, Inc. Supplemental Executive Retirement Plan, as in effect immediately prior to January 1,
2004 (or other date of transfer referred to in Section 3.1(c)).
2.6    Board means the Board of Directors of Biogen.
2.7    Change in Control
(a)    For purposes of Section 5.3(f) and Section 7.4, a change in control means a “Corporate Change in Control”
or a “Corporate Transaction” as each is defined in the Biogen Inc. Omnibus Equity Plan, as in effect at the time of the
corporate event.
(b)    For purposes of Section 4.4(b) and Section 6.2, a change in control means (i) the acquisition by a person or
group of stock of Biogen that, together with stock previously held by such person or group, constitutes more than 50
percent of the total fair market value or total voting power of the stock of Biogen; (ii) a change in the effective control of
Biogen resulting from either the acquisition by any person or group during a 12-month period of stock of Biogen
possessing 30 percent or more of the total voting power of Biogen stock; or the replacement of a majority of the members
of the Board during any 12-month period by directors whose appointment or election was not endorsed by a majority of
the members of the Board in office immediately before the start of such 12-month period; or (iii) the acquisition by any
person or group (during any 12-month period) of assets having a gross fair market value equal to or greater than 40
percent of the total gross fair market value of all assets of Biogen. This subsection (b) and terms used herein will be
interpreted in accordance with the regulations under Code Section 409A relating to a change in the ownership or effective
control of a corporation or a change in the ownership of a substantial portion of the assets of a corporation.
2.8    Code means the Internal Revenue Code of 1986, as amended, or any successor statute enacted in its place. Reference to any
provision of the Code includes reference to any successor provision thereto.
2.9    Committee means the Retirement Committee, or such other committee designated by the Board to administer this Plan.
2.10    Compensation Committee means the Compensation and Management Development Committee of the Board (or any
successor committee, however named, carrying out its functions).
2

2.11    Disability means “disability” as defined under the long-term disability program of Biogen or another employer covering a
participant, or, if no such program is in effect with respect to such participant, then “disability” means “total and permanent
disability” as defined in Code Section 22(e)(3).
2.12    Employee means a person who is classified as a regular, common law employee of Biogen (or other employer) under the
regular personnel classifications and practices of his employer. An individual will not be considered an employee for purposes of
this plan if the individual is classified as a consultant or contractor under Biogen’s (or other employer’s) regular personnel
classifications and practices or he is a party to an agreement to provide services to Biogen (or other employer) without
participating in this plan, notwithstanding that such individual may be treated as a common law employee for payroll tax or other
legal purposes.
2.13    Employer means Biogen and each direct or indirect subsidiary or other affiliate of Biogen that employs persons who are
or may be eligible to participate in this plan. Employees of a subsidiary or other affiliate of Biogen may be eligible to participate
in this plan only if approved by Biogen or the Committee.
2.14    ERISA means the Employee Retirement Income Security Act of 1974, as amended, or any successor statute enacted in its
place. Reference to any provision of ERISA includes reference to any successor provision thereto.
2.15    Excess applicable compensation means, for any plan year, the amount of a participant’s applicable compensation in
excess of the limit under Section 401(a)(17) of the Code applicable to such year and which therefore could not be considered
under the Savings Plan, plus, if applicable, the amount by which a participant’s applicable compensation is reduced below such
Code Section 401(a)(17) limit by reason of an election to reduce base salary or recurring and/or non-recurring bonus amounts
under Section 4.2.
2.16    Non-recurring bonus amounts means any portion(s) of a participant’s compensation which constitutes a bonus payable
in cash (including any equity-based compensation awards that are settled in cash) other than a recurring bonus amount. Any
component of a participant’s compensation which is a non-recurring bonus amount will be designated as such by the Committee.
The entire amount of any such non-recurring bonus amount will be taken into account in accordance with the terms of this plan
without regard to any dollar limitation on applicable compensation that may be imposed under the Savings Plan.
2.17    Participant means an employee of Biogen (or other employer) who is eligible to participate in this plan in accordance
with Section 3.1 and who has an account described in Section 5.1 or for whom an amount has been transferred to this plan from a
prior plan or from the Biogen SERP.
2.18    Plan means the Biogen Inc. Supplemental Savings Plan, as set forth in this plan instrument, and as it may be amended
from time to time.
3

2.19    Plan year means the 12-month periods commencing each January 1 while the plan remains in effect.
2.20    Prior plan means the amended and restated IDEC Pharmaceuticals Corporation Deferred Compensation Plan and the
Biogen, Inc. Voluntary Executive Supplemental Savings Plan, each as in effect immediately prior to January 1, 2004 (or other
date of transfer referred to in Section 3.1(c)).
2.21    Recurring bonus amounts means any portion(s) of a participant’s compensation which is (i) not base salary, (ii) is
payable in cash (excluding any equity-based compensation awards that are settled in cash), and (iii) is a recurring and/or
predictable component of the participant’s compensation for a calendar year such that the participant will know before the start of
such calendar year that he is or may be eligible to receive such bonus if the criteria applicable to such bonus are satisfied (in full
or in part). Recurring bonus amounts include (but are not limited to) a participant’s annual bonus, sales incentive compensation
plan bonuses (if applicable to a participant), and similar bonuses (if any) but does not include any long term incentive award
payments. The entire amount of any such recurring bonus amount will be taken into account in accordance with the terms of this
plan without regard to any dollar limitation on applicable compensation that may be imposed under the Savings Plan.
2.22    Savings Plan means the Biogen 401(k) Savings Plan, as amended from time to time. Any term defined in the Savings Plan
will have the same meaning when used in this plan unless otherwise defined herein.
2.23    Service means the sum of a participant’s employment (a) with Biogen since November 12, 2003 and (b) with either
Biogen, Inc. or IDEC Pharmaceuticals Corporation prior to November 12, 2003 (including in each case service with any
subsidiary or other affiliate of such entity).
2.24    Transition credit means an amount credited by Biogen to a participant’s account under this plan that is equal to (a) the
additional amount that would be contributed on behalf of the participant under the Savings Plan, as determined under Appendix C
of the Savings Plan but without regard to the nondiscrimination limits or the Code Section 401(a)(17) or Code Section 415 limits
that restrict additions to the participant’s account(s) under the Savings Plan, reduced by (b) the amount of the actual additional
contribution on the participant’s behalf to the Savings Plan in accordance with Appendix C thereof.
2.25    Voluntary deferred compensation means that component of the plan which permits an eligible participant to defer from
1% to 80% of his base salary and from 1% to 100% of his recurring bonus and/or non-recurring bonus amounts in accordance
with Section 4.2.
2.26    Years of service means full years of completed continuous service as a regular employee, determined in accordance with
the personnel policies and practices of a participant’s employer.
4

ARTICLE 3
PARTICIPATION
    3.1    Eligibility and Participation.
(a)    Voluntary Deferred Compensation. An employee (i) who has the job title of Senior Director or Vice President or
more senior officer of Biogen (or other employer which is participating hereunder) or (ii) who is designated as eligible by the
Compensation Committee will be eligible to be a participant in the voluntary deferred compensation component of the plan.
Participation in this component of the plan is voluntary and no eligible employee will be required to participate.
(b)
Transition Credit. An employee (i) whose “additional employer contribution” as determined under Appendix C of
the Savings Plan was limited because of limits on compensation, limits on annual additions or nondiscrimination requirements
applicable to qualified plans under the Code and (ii) who was designated by the Committee (either individually or by class) is
eligible to be a participant in the transition contribution component of this plan (see Section 4.3).
(c)
Prior Plans and Biogen SERP. Each employee who is not eligible to be a participant under subsection (a) or (b)
above or (d) below, or who is eligible but declines to participate under subsection (a) above, but who was a prior plan participant
and/or Biogen SERP participant and whose prior plan and/or Biogen SERP account balance (or supplemental pension formula
benefit under Section 4.1 of the Biogen SERP, if applicable) was transferred to this plan effective as of January 1, 2004 (or such
later date as the Committee specified) is a participant solely with respect to such transferred prior plan and/or Biogen SERP
account balance (or supplemental pension formula benefit, if applicable). This will not include a person who is a vested
participant under the Biogen SERP but not an employee (i.e., a person who terminated employment from Biogen, Inc. or from
Biogen on or before the date of transfer referred to in the preceding sentence); such a person’s benefits under the Biogen SERP
are governed by the provisions of Section 5.1(f) and Appendix B.
(d)
401(k) Restoration. An employee who satisfies the requirements of Section 4.1(a) below will be eligible to be a
participant with respect to the employer 401(k) restoration component of the plan.
(e)
Time of Eligibility and Participation. An employee who is newly hired or promoted into a position described in
subsection (a)(i) above, or who is newly designated as eligible under subsection (a)(ii) above, will be deemed to be eligible on
the date the Committee (or its delegatee) sends him an enrollment form (see Section 4.4).
An eligible employee under subsection (a) above will become a participant hereunder when he makes a voluntary
deferral under this plan. An eligible employee under subsection (b), (c) or (d) above will become a participant hereunder when
Biogen (or other employer) credits an amount to his account(s) hereunder.
5

(f)    Top Hat Plan. Notwithstanding the preceding subsections (or any other provisions of the plan), no employee will be
eligible to participate in any component of this plan at any time when he or she is not a member of a select group of management
or highly compensated employees (within the meaning of ERISA Sections 201(2), 301(a)(3) and 401(a)(1)), as determined by
the Committee.
3.2    End of Participation. A participant’s participation in this plan (or a particular component of this plan) will end upon the
termination of his service as an employee of Biogen (or other employer) because of death or any other reason, or upon his
transfer to or reclassification as an employee who is not eligible to participate in the plan (or in such component).
In addition, in the case of a participant who was designated as eligible for a component of the plan by the Compensation
Committee, his participation in such component will end upon the Compensation Committee’s specifying that he is no longer
eligible to participate. In such event, his participation will end effective as of the later of the date of the Compensation
Committee’s action or the date specified by the Compensation Committee; provided that no such action will retroactively
deprive a participant of any amount credited to his account or any amount he was entitled to under this plan determined as of the
effective date of his termination of participation.
Upon the termination of a participant’s participation in this plan (or in a particular component of this plan) in accordance
with this section, there will be no additional voluntary deferrals or employer credits to such participant’s account(s) (or the
account(s) related to such component), except to the extent required by Code Section 409A or the regulations or any rulings
thereunder with respect to the balance of the plan year in which such termination of participation occurred. However, the
participant will be entitled to receive amounts credited to his account(s) in accordance with this plan.
ARTICLE 4

VOLUNTARY DEFERRALS BY PARTICIPANTS; EMPLOYER CREDITS
4.1    401(k) Restoration.
(a)
Eligibility. Each employee who has excess applicable compensation during a plan year will receive employer
credits under this section, but only if the individual is still an employee as of the end of the plan year (or other period—for
example, quarterly) for which an amount is to be credited under subsection (c) below.
(b)
Amount of Employer 401(k) Restoration Credits. For each plan year (or a shorter period of time specified by the
Committee), each employer will credit a 401(k) restoration amount to the account of each eligible participant (under subsection
(a) above) employed by such employer who has excess applicable compensation during such plan year (or such shorter period of
time). The employer’s credits on behalf of such a participant will be equal to six percent of his excess applicable compensation
during the plan year (or such shorter period of time).
6

(c)
Time for Making Employer 401(k) Restoration Credits. Employer credit amounts under subsection (b) will be
credited to participants’ accounts at such time(s) as the Committee determines after the end of each plan year (or such shorter
periods of time-for example, quarterly—specified by the Committee).
4.2    Voluntary Deferrals. Each eligible employee (under Section 3.1(a)) may make voluntary deferrals under the plan from his
base salary in any whole percentage of his base salary from a minimum of 1% to a maximum of 80% by electing to reduce his
base salary by such amount. In addition, each such eligible employee may make voluntary deferrals under the plan from his
recurring bonus amounts (as defined in Section 2.21) in any whole percentage of his recurring bonus amounts from a minimum
of 1% to a maximum of 100% by electing to reduce his recurring bonus amounts by such amount. Elections to reduce base salary
and/or recurring bonus amounts will be in accordance with the requirements of Section 4.4(a)(i). Finally, each such eligible
employee may make voluntary deferrals under the plan from his non-recurring bonus amounts (as defined in Section 2.16), if any,
in any whole percentage of his non-recurring bonus amounts from a minimum of 1% to a maximum of 100%, by electing to
reduce his non-recurring bonus amounts by such amount. Deferrals of any equity based awards shall not include any partial
shares of common stock of Biogen. Elections to reduce non-recurring bonus amounts must be made in accordance with the
requirements of Section 4.4(a)(ii).
Notwithstanding the first sentence of the preceding paragraph, the Committee (or its designee) may reduce the maximum
base salary deferral an eligible employee may elect from 80% to such smaller percentage as the Committee (or its designee)
deems advisable, in the case of any participant or group of participants, so that all employee contributions (by salary reduction or
otherwise) for benefit plan coverages applicable to such participant(s), withholding tax obligations applicable to such
participant(s), and any other elective or non-elective application of the base salary of such participant(s) (such as, by way of
illustration and not by way of limitation, charitable deductions) will be accommodated. Any such reduction applicable to a
participant for a plan year will be made before the start of such plan year.
4.3    Transition Credit. Each eligible employee (under Section 3.1(b)) will receive a transition credit hereunder. The amount of
such credit will be the amount the participant would have received under the terms and conditions of Appendix C of the Savings
Plan if Code Section 401(a) nondiscrimination requirements and/or Code Section 401(a)(17) or 415 limits did not apply, reduced
by any amount actually contributed to the Savings Plan on his behalf under such Appendix C. Any such transition credit amount
hereunder will be credited at a time determined by the Committee.
4.4    Election Procedures.
(a)(i)    Voluntary Deferrals from Base Salary or Recurring Bonus Amounts. An eligible employee under Section 3.1(a)
who wishes to reduce his base salary and/or recurring bonus amounts to be earned during a particular plan year in order to make
voluntary deferrals under Section 4.2 must complete an enrollment form specifying the amount of his voluntary deferrals (with
separate percentages for his base salary and recurring bonus amounts, if desired),
7

agreeing to reduce his base salary and/or recurring bonus amounts by the amount(s) he specifies, and providing such other
information as the Committee may require.
A participant’s enrollment form electing such voluntary deferrals for any plan year must be filed with the Committee by
such deadline as the Committee specifies, but in any event before the start of such plan year. A participant may change the
amount of his voluntary deferrals with respect to any subsequent plan year by filing a new enrollment form before the start of
such subsequent plan year, and the change will become effective as of the first day of such subsequent plan year. Once a
participant has elected to defer base salary and/or recurring bonus amounts, his enrollment form will remain in effect for future
plan years unless the participant changes or terminates his prior elections by filing a new enrollment form in accordance with
the preceding sentence.
An individual who first becomes eligible under Section 3.1(a) during a plan year may make an initial election by filing an
enrollment form with the Committee not later than 30 days after the Committee (or its delegatee) sends him an enrollment form.
However, such a newly eligible employee may elect to defer only base salary and/or that portion of any recurring bonus amounts
to be earned after the date of filing his completed enrollment form. An individual is considered first eligible only if either: (i) he
had not during the preceding 24-month period been eligible to make voluntary deferrals under this plan or under another non-
qualified deferred compensation plan maintained by Biogen (or another employer or other subsidiary or affiliate of Biogen); or
(ii) he had received a complete distribution of his entire interest under the plan and subsequently, through rehire, promotion,
transfer or designation, again becomes eligible to participate in this plan under Section 3.1.
After a plan year has begun, a participant may not change the amount of voluntary deferrals of base salary and/or
recurring bonus amounts (if any) he had elected for such plan year. However, if during a plan year a participant either (i) has an
unforeseeable emergency (as defined in Section 6.1) and receives a distribution under Section 6.1 or (ii) has a financial hardship
(as defined in the Savings Plan) and receives a financial hardship withdrawal from the Savings Plan, the participant’s deferral
election will automatically be cancelled. For distributions referred to in (i) above, deferrals shall be cancelled for the balance of
the year in which any such distribution is made. For distributions referred to in (ii) above, deferrals shall be cancelled through
the end of the year in which falls the six-month anniversary of the hardship withdrawal.
(ii) Voluntary Deferrals From Non-Recurring Bonus Amounts. If an eligible employee (under Section 3.1(a)) becomes
eligible to receive a non-recurring bonus amount (as designated by the Committee in accordance with Section 2.16), such
eligible employee may elect to make voluntary deferrals under Section 4.2 equal to all or a specified portion of such non-
recurring bonus amount in accordance with such procedures as established by the Committee. Elections made with respect to
equity based awards shall apply to all tranches of such awards regardless of the date such award becomes nonforfeitable and
shall apply with respect to any and all dividends or dividend equivalents provided with respect to such awards. All deferral
elections hereunder must be made on an enrollment form approved by the Committee, specifying the
8

amount he elects to defer, agreeing to reduce his non-recurring bonus amount(s) by such amount, and providing such other
information as the Committee may require. If an eligible employee elects to defer restricted stock or market stock unit awards,
such employee shall not be permitted to diversify the investment of such awards other than in Biogen stock or stock equivalent.
A participant’s enrollment form must be filed with the Committee by such deadline as the Committee specifies in written
procedures approved by the Committee (or its delegatee) governing deferral elections for nonrecurring bonus amounts. Any
filing deadline will comply with the timing of elections requirements of the regulations under Code Section 409A. Accordingly,
if the Committee determines that a particular non-recurring bonus amount constitutes “performance-based compensation,” the
timing requirements for electing to defer performance-based compensation may be applied. Furthermore, with respect to the
initial election to defer payment of any equity based awards such as restricted stock unit awards, market stock unit awards or any
other forfeitable rights that requires the participant to provide services for at least 12 months from the date the award is granted,
the election to defer such compensation may be made within 30 days after the date of grant or, if earlier, 12 months in advance of
the date such award or right becomes nonforfeitable provided that if death, disability or a change in control occurs which
accelerates the vesting before the end of such 12-month period, the deferral election will not be effective. The Committee’s
written procedures will be deemed to constitute part of this plan for purposes of the written plan document requirements of the
regulations under Code Section 409A.
If an individual first becomes eligible under Section 3.1(a) during a plan year and after the deadline provided in the
preceding paragraph, he may make an election to defer his non-recurring bonus amounts (if any) for such plan year in
accordance with the rules specified in the third paragraph of subsection (i) above. In addition, the rules in the fourth paragraph of
subsection (i) above will apply to any non-recurring bonus amounts deferral election the participant made for any plan year in
which he receives a distribution under Section 6.1 or a financial hardship withdrawal from the Savings Plan.
Notwithstanding anything in this Plan to the contrary, no eligible employee shall be permitted to elect to defer equity
grants, including, but not limited to, restricted stock or market stock unit awards that are granted under the Biogen Inc. Omnibus
Equity Plan, or any predecessor or successor plans, beginning on or after January 1, 2015.
(b)    Form and Time of Payment.
(i)
Initial Election. Each participant must specify the form of payment (lump sum or installments in
accordance with Section 6.4(a), 6.5(a) and/or Section 6.6(a) below, as applicable) of his accounts hereunder in the event
of the participant’s death or other termination of employment (including as a result of disability). The time and form of
payments under the plan are governed by the provisions of Article 6 and participant elections must conform to the
requirements of such provisions. Any election as to medium of payment with respect to equity based awards (i.e., whether
such award will be settled in stock or cash) shall be subject to the terms of the Biogen Inc. Omnibus Equity
9

Plan (or successor plan) and/or award agreement under which it was granted. Any such election shall not be considered an
election as to time or form of payment and shall not be subject to the restrictions under this Section.
In addition, a participant may elect payment of his accounts under Section 6.2 in the event of a change in control
(as defined in Section 2.7(b)).
In addition, a participant who is an active Employee may (but is not required to) specify one or more in-service
distributions to the participant in accordance with Section 6.3 if desired by the participant. A participant who declines to
elect such an in-service distribution is deemed to have elected payment only after death (Section 6.4) or termination of
employment (Section 6.5) or, if applicable, a change in control (Section 6.2); such a participant may not thereafter make a
change of election under subsection (ii) with respect to an in-service distribution from the plan.
A participant’s initial election of a time and form of payment hereunder must be made by whichever of the
following dates applies to the participant (or the earlier of such dates, if both apply to a particular participant): (A) the
deadline for filing the participant’s initial enrollment form under subsection (a) above; or (B) January 30 of the year
following the year for which an amount is first credited to the participant under Section 3.1(c), Section 4.1 or Section 4.3
(provided that this clause (B) will not apply to a participant if he was previously eligible for employer credits or
contributions (as opposed to voluntary deferrals) under this plan or under any other account balance non-qualified
deferred compensation plan maintained by Biogen (or another employer or other subsidiary or affiliate of Biogen).
(ii)
Change of Election. Notwithstanding subsection (i) above, the following changes of election will be
permitted. If such a subsequent election becomes effective as provided below, then the participant’s account(s) will be
payable at the time and in the form specified in his subsequent election.
(A)
In-Service Distributions. In the case of an eligible participant who elected an in-service distribution, at any
time that is at least one year prior to the date for payment originally elected by the participant, if the
participant is still an employee of Biogen (or another employer or other subsidiary or affiliate) at such
time, the participant may make one subsequent election to defer the time when any previously elected in-
service distribution under Section 6.3 from his account(s) would otherwise be payable (or installment
payments would otherwise begin) to a subsequent date specified by him, and/or may elect another form of
payment or a different number of installments with respect to the in-service distribution of his account(s),
subject in all cases to the requirements of this section and to the requirements of Section 6.3.
(B)
Death or Termination of Employment. A participant who is still an employee of Biogen (or another
employer or other subsidiary or affiliate)
10

may make one subsequent election to change the form of payment hereunder that will be used following
his death or other termination of employment. Such an election must comply with the applicable
requirements of Sections 6.4(a), 6.5(a) and 6.6(a) (as applicable).
(C)
Effectiveness of Subsequent Election. A participant’s subsequent election under this subsection (ii) will
become effective only if the following requirements are satisfied: (1) the subsequent election does not take
effect until one year after the date of the subsequent election and the participant remains an employee of
Biogen (or another employer or other subsidiary or affiliate) during such one year period, (2) the election
extends the date for payment, or the start date for installment payments, by at least five years, and (3) in
the case of a subsequent election to defer a previously elected in-service distribution (under subsection (A)
above), the subsequent election is made at least 12 months before the date previously elected for such in-
service distribution.
No election under this subsection (ii) may operate to accelerate any payment or distribution hereunder or violate
any requirement of Code Section 409A or the regulations and rulings thereunder.
A participant may make only one subsequent election under subsection (ii)(A) and only one subsequent election
under subsection (ii)(B). Such subsequent election(s) may be made at the same or at different times. Also, the Committee
may permit additional election opportunities (in accordance with the transition or other rules under the regulations or
other Internal Revenue Service guidance under Code Section 409A or in such other circumstances as the Committee
deems appropriate). Any such additional subsequent elections under subsection (ii) must satisfy all the requirements of
this section and any other applicable requirements under the plan or, alternatively, must satisfy such requirements as the
Committee may impose in connection with a new election under a Code Section 409A transition or other rule.
ARTICLE 5

PARTICIPANT ACCOUNTS
5.1    Participant Accounts.
(a)
Employer 401(k) Restoration Accounts. Employer credits on a participant’s behalf under Section 4.1 will be
credited to an account in the name of such participant. Such account will be called his employer 401(k) restoration account.
(b)
Voluntary Deferred Compensation Accounts. Voluntary deferrals by a participant under Section 4.2 will be
credited to an account in the name of such participant. Such account will be called his voluntary deferred compensation account.
11

(c)
Transition Accounts. Transition credits on a participant’s behalf under Section 4.3 will be credited to an account in
the name of such participant. Such account will be called his transition account.
(d)
Prior Plan Account. Account balances as of December 31, 2003 (or such later date as the Committee specified) for
a participant in a prior plan were transferred to this plan from such prior plan and the transferred amount was credited to an
account in the name of such participant. Such account is called his prior plan account.
(e)
Biogen SERP Account. Amounts transferred to this plan from the Biogen SERP on behalf of a participant were
credited to an account in the name of such participant. Such account is called his Biogen SERP account. The amount so
transferred on behalf of a participant in the excess benefit formulas in Section 4.2 of the Biogen SERP was the amount credited to
such participant’s Biogen SERP cash balance account as of December 31, 2003 (or such later date of transfer as the Committee
specified). The amount so transferred on behalf of a participant in the supplemental pension formula in Section 4.1 of the SERP
was the present value as of December 31, 2003 (or such later date of transfer as the Committee specified) of the participant’s
SERP accrued supplemental pension as of such date (calculated in accordance with the terms of the SERP in effect on such date).
(f)
Certain Special Provisions. Participants’ prior plan accounts and Biogen SERP accounts will be governed by the
applicable provisions of this plan as in effect from time to time.
For persons who were participants in the Biogen SERP before the transfer date referred to in subsection (e) above and are
entitled to a vested SERP benefit thereunder, but who are not active participants under this plan and therefore, do not have an
account hereunder, the amount transferred to this plan in respect of their Biogen SERP benefit will be governed by Appendix B
hereto, as in effect from time to time.
(g)    409A. For purposes of applying Code Section 409A, as provided in the regulations thereunder, a participant’s
voluntary deferred compensation account is disaggregated from his or her other accounts hereunder.
5.2    Participant’s Account Value.
(a)
Deemed Investment Results. Except as otherwise provided below, a participant’s accounts will be credited with
deemed investment results as if the amounts credited to his accounts were invested in one or more designated investment funds
(as described below) and all dividends and distributions on shares or other interests of a particular investment fund were
reinvested in such fund. The investment funds available for this purpose will be those determined in the discretion of the
Committee, plus the investment funds specified in subsections (b) and (c) below (in the case of eligible participants).
Notwithstanding the foregoing, with respect to the portion of a participant’s voluntary deferred compensation account attributable
to restricted stock or market stock units or other equity based awards, such portion will be deemed to be invested in shares of
common stock of Biogen as described in the long term incentive plan sponsored by Biogen. Investment funds hereunder are for
the sole purpose of providing the basis for crediting
12

deemed investment results to participants’ accounts, and do not represent any actual funds or assets held hereunder for the benefit
of participants.
Each participant will indicate with his initial enrollment form (or another form specified by the Committee) the
investment fund or funds (and the proportion in each fund when the participant designates more than one) he wishes to designate
for this purpose. Thereafter, a participant may change his designation with respect to either the deemed investment of future
credits to his account(s) hereunder or the deemed transfer of amounts from a previously designated investment fund to another
fund. The Committee shall establish the frequency with which such a change may be made, the method of making such a change,
and the effective date of such a change, and shall prescribe such other rules and procedures as it deems appropriate. Such
designation will remain in effect until subsequently changed by the participant in accordance with this paragraph. Following a
participant’s death and before the payment of any amount due to the participant’s beneficiary hereunder has been completed, the
beneficiary will exercise the participant’s designation powers under this section.
Notwithstanding the preceding paragraph, the Committee may establish one or more default investment funds that will be
used to determine deemed investment results in the case of any participant or group of participants who have not made a
designation under the preceding paragraph. Such default investment fund(s) will be used to determine deemed investment results
applicable to the account of such participant or participants until any such participant makes a designation of investment fund(s)
in accordance with the plan.
Deemed investment results under this subsection will be credited to a participant’s accounts effective as of the last day of
each plan year (and as of such other valuation dates during a plan year as the Committee may establish).
The value of a participant’s accounts at any point in time will be his voluntary deferrals, employer 401(k) restoration
credits, transition credits on his behalf, and prior plan and/or Biogen SERP transfer amounts, increased or decreased by deemed
investment results as provided in this section through the most recent valuation date, and reduced by any distributions from the
participant’s accounts.
(b)
Fixed Rate Option. In addition to the investment funds offered under the Savings Plan as described in (a) above, a
participant who is an active Employee may elect to have his accounts credited with the deemed investment results as if they were
invested in a fixed rate option earning a rate of return specified by the Committee. The rate of return of the fixed rate option will
be determined each year by the Committee.
(c)
Exception for Certain Prior Plan Accounts. Former participants in the IDEC Pharmaceuticals Corporation
Deferred Compensation Plan whose accounts were credited with interest under the fixed rate option available under that plan
immediately prior to the date such account was transferred to this plan may continue to have such transferred amount credited
with deemed investment results equal to the interest rate under that fixed rate option. Any additional contributions made under
this plan will be credited with deemed investment results as described in subsection (a) or (b) above. Amounts being credited
with interest under this subsection (c)
13

may be transferred to an option described in subsection (a) or (b) above, but no amounts credited to a participant’s accounts may
be transferred into the fixed rate option under this subsection (c) (even if such amounts had previously been invested in such
investment fund and then transferred to another investment fund).
(d)
Special Rule for Transferred Prior Plan Accounts and Transferred Biogen SERP Accounts. In connection with the
transfer of participants’ prior plan account balances and Biogen SERP account balances to this plan, transferred account
balances were initially credited with deemed investment results as if the participant had selected the money market fund
investment option under the Savings Plan. Deemed investment results in accordance with the preceding sentence will apply to
such transferred account balances until a participant changes such designation in accordance with subsection (a) above.
(e)
Bookkeeping Accounts. Participants’ accounts and subaccounts will be maintained on the books of the
participant’s employer for bookkeeping purposes only; such accounts will not represent any property or any secured or priority
interest in any trust or in any segregated asset.
In order to facilitate the administration of the plan, the Committee may arrange for a participant’s account to be divided
for recordkeeping purposes into two or more subaccounts, in accordance with procedures established by the Committee.
5.3    Vesting.
Each participant will have a fully vested interest in his or her plan accounts at all times, provided, however, that any
equity based awards deferred hereunder shall be subject to such vesting requirements as provided under the Biogen Inc.
Omnibus Equity Plan (or successor plan) and/or any award agreement applicable to such award.
Reference to any account of a participant as “fully vested” means that such account is not subject to forfeiture; however,
all participant accounts, including fully vested accounts, are subject to (i) fluctuation as a result of the crediting of deemed
investment results (including losses) to such accounts as provided in the plan and (ii) the possibility of the insolvency or
bankruptcy of Biogen (or other employer) (see Section 7.2(a)).
ARTICLE 6

DISTRIBUTIONS TO PARTICIPANT
6.1    Distributions for Unforeseeable Emergency. If a participant has an unforeseeable emergency prior to his termination of
employment with his employer, he may apply to the Committee for a distribution from the plan. If such application for an
unforeseeable emergency distribution is approved by the Committee, distribution of the approved amount will be made on the
date of approval by the Committee. The amount of the distribution will be the amount reasonably needed to alleviate the
participant’s unforeseeable emergency (including the amount necessary to pay any federal, state or local income taxes and
penalties reasonably anticipated to result from the distribution), as determined by the Committee, up to a maximum of the
14

participant’s vested account balances. Such a distribution will be made from the participant’s vested accounts in a single lump
sum payment.
An unforeseeable emergency is a severe financial hardship affecting the participant resulting from illness or accident of
the participant or the participant’s spouse, dependent or designated beneficiary, the need to rebuild the participant’s principal
residence following damage not covered by insurance, or other similar extraordinary and unforeseeable circumstances arising as
a result of events beyond the participant’s control. A circumstance or exigency of the participant does not constitute an
unforeseeable emergency to the extent that the participant’s financial need is or may be relieved through reimbursement or
compensation by insurance or otherwise, or by liquidation of assets (to the extent that such liquidation would not itself cause
severe hardship).
The Committee will determine whether a participant has incurred an unforeseeable emergency and the amount needed to
alleviate the unforeseeable emergency. A participant is not entitled to a distribution under this section regardless of the
participant’s circumstances or exigencies, and all such distributions and the amounts thereof are subject to the determination of
the Committee.
6.2    Distribution Upon a Change in Control. In the event of a change in control (as defined in Section 2.7(b)), a participant
who elected payment of his accounts under the second paragraph of Section 4.4(b)(i) will receive a lump sum payment equal to
the amount credited to his accounts hereunder. Such payment will be made 30 days after the occurrence of the change in control.
6.3        In-Service Distribution(s) at a Time Specified by Participant. A participant who is an active Employee may, in
accordance with this section and Section 4.4, elect an in-service distribution at a specified future date (but not earlier than five
years after the time the participant is making such election) of all or any portion of his vested accounts. If, in his initial
enrollment or subsequent change of election form, the participant designated payment of all or any portion of his vested
account(s) at a specified time(s) and he is still an employee of Biogen (or another employer or other subsidiary or affiliate) at
such time(s), the participant will receive payment of the amount elected, payable on the designated date(s). A participant’s
election for in-service distributions under this Section 6.3 may be for a single payment or up to five annual payments (with the
first payment on the date specified by the participant and subsequent payments made in each subsequent calendar year until all
such annual payments have been distributed), in each case in an amount or portion specified by the participant in his initial
enrollment or other subsequent change of election form (whichever applies). Each payment will be the amount specified (or the
entire vested balance remaining in the participant’s accounts, if less). Payments with respect to an in-service distribution election
of a flat dollar amount (as opposed to a percentage of the participant’s vested account) by a participant who has deferred equity
based awards shall be paid from the portion of the participant’s vested account that is not attributable to such equity based
awards.
Any amount in a participant’s accounts hereunder not distributed to the participant under this Section 6.3 will be
distributed under Section 6.2 or under Section 6.4 or 6.5, whichever may
15

be applicable, and Section 6.6, if applicable. If a participant is receiving multiple payments under this Section 6.3 and dies or
otherwise terminates employment, or (if applicable) there is a change in control, payments under this subsection will cease and
subsequent payments will be governed by Section 6.4 or 6.5, or Section 6.2, as the case may be.
6.4    Distribution upon Death of a Participant.
(a)
In general. If a participant dies while still an employee of Biogen (or another employer or other subsidiary or
affiliate) or after termination of such employment, but before the complete distribution of his vested accounts hereunder, his
beneficiary will receive the total amount remaining in his vested accounts. Except as otherwise provided in Section 6.6,
distribution will be made in a single sum payment within 90 days of the date of death.
(b)
Beneficiary. Each participant may designate one or more beneficiaries to receive a distribution payable under
subsection (a) above and may revoke or change such a designation at any time. If the participant names two or more
beneficiaries, distribution to them will be in such proportions as the participant designates or, if the participant does not so
designate, in equal shares. Any such designation of beneficiary will be made in accordance with such procedures or in such form
as the Committee may prescribe or deem acceptable.
Any portion of a distribution payable upon the death of a participant that is not disposed of by a designation of
beneficiary under the preceding paragraph, for any reason whatsoever, will be paid to the beneficiary determined under the
following rules:
(i)
If at the participant’s death the participant has an account under the Savings Plan and there is a valid
designation of beneficiary under the Savings Plan, the beneficiary(ies) will be the same person(s) who is (are) the
Savings Plan beneficiary(ies) (in the same proportions, if more than one).
(ii)
If subsection (a) does not apply, the participant’s account(s) hereunder will be paid to the participant’s
spouse if living at his death, otherwise equally to the participant’s natural and adopted children living at his death (and
the issue of a deceased child by right of representation), otherwise to the participant’s estate. For all purposes under the
plan, “spouse” shall have the same meaning as under the Savings Plan.
The Committee may direct payment in accordance with a prior designation of beneficiary (and will be fully protected in
so doing) if such direction (i) is given before a later designation is received, or (ii) is due to the Committee’s inability to verify
the authenticity of a later designation. Such a distribution will discharge all liability therefor under the plan.
6.5    Distribution upon Participant’s Termination of Employment.
(a)
Time and Form of Payment. Following a participant’s termination of employment (including as a result of
disability) for any reason other than death, except as otherwise provided in Section 6.6, the participant will receive a single sum
payment equal to his vested account
16

balance, payable on the first business day following the six-month anniversary of the participant’s termination of employment.
(b)
Termination of Employment. For purposes of this plan, a participant will have a termination of employment only
if the provisions of the regulations under Code Section 409A defining “separation from service” are satisfied.
6.6    Installment Distributions in Certain Cases.
(a)
Participant. Notwithstanding the provisions of Section 6.5, a participant may, at the time of filing his initial
enrollment form under Section 4.4(b)(i) (or, if applicable, in a subsequent election under Section 4.4(b)(ii)), designate that the
amount payable to him hereunder upon termination of employment will be paid in a number (minimum of two and maximum of
fifteen) of annual installment payments, as specified by the participant. However, in the event the participant’s vested account
balance as of the date that installment distributions would begin in accordance with Section 6.5 is equal to or less than the limit
under Code Section 402(g)(1)(B) and (g)(4) (as in effect at such time-for example, $23,000 during 2024), such vested account
balance will be automatically paid in the form of a lump sum payment to the extent not prohibited by the regulations under Code
Section 409A.
(b)
Beneficiary. Notwithstanding Section 6.4, a participant may at the time of filing his initial enrollment form under
Section 4.4 (or, if applicable, in a subsequent election), designate that, if the participant dies before receiving the entire amount
payable to him hereunder, the beneficiary will receive either:
(i)    A number of annual installment payments equal to:
(A)
the number the participant elected for himself under subsection (a) above (if the participant dies
before receiving any installment payments), or
(B)
the number of remaining installment payments due to the participant under subsection (a) above (if
the participant dies after receiving one or more installment payments).
(ii) A single payment.
Payment to the beneficiary (or the first installment) will be made at the time provided in Section 6.4(a).
If the participant fails to designate the form of payment to the beneficiary, the default form of payment will be a single
payment under (ii) above.
(c)
Installment Payments. Where installment payments are due, the first annual installment payment will be made on
the date specified in Section 6.4 or 6.5 (whichever is applicable) and subsequent annual installments will be made in each
subsequent calendar year until all such annual payments have been distributed. The amount of each annual installment
17

payment will be determined by multiplying the then amount of the participant’s vested account balances by a fraction whose
numerator is one and whose denominator is the number of remaining annual installment payments. Installment payments with
respect to equity based awards shall be made in shares and shall not include any fractional shares.
(d)
Death of Beneficiary. If a participant’s designated beneficiary is receiving installment payments and dies before
receiving payment of all the annual installments, the deceased beneficiary’s estate will receive a lump sum payment of the
amount remaining to be distributed to such beneficiary. Such payment will be made within 90 days of the date of death.
(e)
Deemed Single Payment. As provided in the regulations under Code Section 409A, installment payments to a
participant will be deemed a single payment on the date of the first installment for purposes of the anti-acceleration rule
(Section 4.4(b) and Section 6.9) and the rules governing the timing of changes in elections with respect to time and form of
payment hereunder (Section 4.4(b)).
6.7    Certain Other Distributions. In addition to the distributions provided for in the preceding sections of this Article 6, the
Committee may provide for a distribution from a participant’s account(s) under the following circumstances:
(a)
Domestic Relations Order. Distribution of the amount necessary to fulfill the requirements of a domestic relations
order (as defined in Code Section 414(p)) requiring the payment of all or a portion of the participant’s vested account(s) to
another individual (see Section 7.3(b)).
(b)
Conflicts of Interest. Distribution to the extent reasonably necessary to comply with a federal government ethics
agreement or a federal, state, local or foreign ethics or conflicts of interest law (as described in the regulations under Code
Section 409A).
(c)
Violation of Code Section 409A. In the event that, notwithstanding the intent that this plan satisfy in form and
operation the requirements of Code Section 409A, it is determined that the requirements of Code Section 409A have been
violated with respect to one or more accounts of any participant or group of participants, distribution of the amount determined
to be includable in taxable income of such participant or participants as a result of such a violation of Code Section 409A shall
be made to such participant(s).
(d)
Other Circumstances. Distribution of any amount specifically permitted by Code Section 409A and the regulations
thereunder.
6.8    Delay in Distributions. Notwithstanding the provisions of any of the foregoing sections in this Article 6, the Committee
may delay the making of any payment due to a subsequent date, provided that the delayed payment is made not later than the
latest time permitted under Code Section 409A and the regulations and rulings thereunder (generally, the later of the end of the
calendar year in which the specified payment date occurs or the 15  day of the third month after the specified payment date).
th
18

6.9    Compliance with Code Section 409A. Notwithstanding any other provision of this plan (including, without limitation,
Section 6.7(c)), distributions and elections respecting distributions are intended to be and will be administered in accordance
with the provisions of Code Section 409A and the regulations and rulings thereunder (including the provisions prohibiting
acceleration of payment unless specifically permitted by such regulations and rulings).
ARTICLE 7

MISCELLANEOUS
7.1    Amendment or Termination of Plan. Biogen, by action of the Board or of the Compensation Committee (or such other
committee thereof or officer or officers of Biogen to whom the Board or Compensation Committee has delegated this authority),
at any time and from time to time, may amend or modify any or all of the provisions of this plan or may terminate this plan
without the consent of any participant (or beneficiary or other person claiming through a participant). In addition, any
amendment may be made by the Committee, or by the Executive Vice President — Chief Financial Officer, or the Executive
Vice President — Human Resources of Biogen except for an amendment that would materially increase or reduce the benefits of
the plan to participants or materially increase the cost of maintaining the plan to the employers; such committee or specified
officer(s) may not terminate the plan.
Notwithstanding the preceding paragraph, no termination or amendment of the plan may reduce the amounts credited to
the accounts of any participant under the plan (including a participant whose employment with the employer was terminated
before such plan termination or amendment) or the vested percentages of such accounts. However, Biogen may change the
deemed investment options under Section 5.2, and Biogen may upon termination of this plan pay participants’ account balances
to the participants regardless of the times elected for payment (or the start of installment payments) elected by the participants
and may pay such amounts in single sum payments regardless of whether installment distributions would otherwise be payable
under Section 6.6; provided that any such distributions upon plan termination must be permitted by Code Section 409A and the
regulations and rulings thereunder. In addition, Biogen may, from time to time, make any amendment that it deems necessary or
desirable to satisfy the applicable requirements of the tax laws and rulings and regulations thereunder in order to preserve, if
possible, the tax deferral features of this plan for participants. No diminution or restriction on a participant’s opportunity to make
elections or withdrawals, or exercise other privileges or rights hereunder, pursuant to the preceding sentence will be deemed to
violate the rights of any participant or beneficiary hereunder so long as such change does not effect a forfeiture of any of a
participant’s account balances hereunder or render an account balance (or portion thereof) which previously was nonforfeitable
forfeitable. Any amendment that is required by Code Section 409A and the regulations and rulings thereunder to have a delayed
effective date will be effective no earlier than such required date.
    7.2    Benefits Not Currently Funded.
(a)
Nothing in this plan will be construed to create a trust or to obligate Biogen to segregate a fund, purchase an
insurance contract or other investment, or in any other way
19

currently fund the future payment of any benefits hereunder, nor will anything herein be construed to give any participant or any
other person rights to any specific assets of Biogen or any other entity. However, in order to make provision for its obligations
hereunder, Biogen (or other employer) may in its discretion purchase an insurance contract or other investment; any such
contract or investment will be a general asset belonging to Biogen (or other employer), and no participant or beneficiary will
have any rights to any such asset. The rights of a participant or beneficiary hereunder will be solely those of a general, unsecured
creditor of his employer.
(b)
Notwithstanding subsection (a) above, Biogen (or other employer) in its sole discretion may establish a grantor
trust of which it is treated as the owner under Code Section 671 to provide for the payment of benefits hereunder, subject to such
terms and conditions as Biogen (or other employer) may deem necessary or advisable to ensure that trust assets and benefit
payments are not includable, by reason of the trust, in the taxable income of trust beneficiaries before actual distribution and that
the existence of the trust does not cause the plan or any other arrangement to be considered funded for purposes of Title I of
ERISA. Biogen may terminate any such trust in accordance with its terms.
7.3    No Assignment.
(a)
No participant or beneficiary will have any power or right to transfer, assign, anticipate or otherwise encumber any
benefit or amount payable under this plan, nor shall any such benefit or amount payable be subject to seizure or attachment by
any creditor of a participant or a beneficiary, or to any other legal, equitable or other process, or be liable for, or subject to, the
debts, liabilities or other obligations of a participant or beneficiary except as otherwise required by law.
(b)
Notwithstanding subsection (a) above, all or a portion of a participant’s account balances may be assigned to the
participant’s spouse, former spouse, or other dependent (for purposes of this section, an “alternate recipient”) in connection
with a domestic relations order (as defined in Code Section 414(p)) awarding such portion(s) to the alternate recipient.
However, no such order may award to an alternate recipient greater rights than the participant has with respect to his account. If
any portion of an account so assigned is not fully vested at such time, such portion will vest only in accordance with the
applicable provisions of this plan based upon the participant’s years of service. Upon receipt of a copy of the relevant
provisions of any such order or property settlement agreement, certified or represented to the committee’s satisfaction to be
accurate and in effect, and an acknowledgment by the alternate recipient that such alternate recipient will be responsible for
income taxes on such amounts when distributed or made available to such alternate recipient and that such amounts are subject
to income tax withholding as provided in this plan, and such other information (including the alternate recipient’s social
security number) as the Committee may reasonably request, the Committee will assign such amount to a separate account
hereunder and will distribute such account to the alternate recipient in the form of a single sum payment as soon as
administratively possible, as permitted by Reg. 1.409A-3(j)(4)(ii) (except for any unvested amounts) as provided in Section
6.7(a).
    7.4    Effect of Change in Control.
20

(a)
Amendments. Notwithstanding Section 7.1, following the occurrence of a change in control (as defined in Section
2.7(a)), no amendment will be made following a change in control without the consent of the affected participant (or beneficiary
or other person claiming through a participant) that adversely affects the rights of a participant (or beneficiary or other person
claiming through a participant) under the plan as in effect immediately before such change in control, including (i) the right to
make elections concerning the form and time of payment of distributions in accordance with Section 4.4(b) and the right to
receive distributions in the form elected by the participant thereunder; and (ii) the right to the investment funds or options
specified herein for the determination of deemed investment results applicable to participants’ accounts, as in effect
immediately before such change in control. In particular, for purposes of clause (ii) of the preceding sentence: (i) the Committee
may not set the rate of return under Section 5.2(b) at a rate lower than that available under life insurance or annuity contracts
obtained by a vendor or service provider (currently, The Newport Group) for purposes of the plan; and (ii) the Committee will
maintain a menu of investment funds under Section 5.2(a) that is substantially similar (in terms of investment styles and ability
to position account(s) on a risk/reward spectrum) to the array of funds available immediately prior to the change in control.
(b)
Termination. The plan will not be terminated before the payment of all benefits hereunder in accordance with the
terms of the plan as in effect immediately before such change in control without the consent of a majority of the participants
(including, in the case of the deceased participant, the beneficiary or other person claiming through such deceased participant).
This subsection (b) will not preclude the merger of this plan into a nonqualified deferred compensation plan maintained by a
successor to Biogen provided that the benefits and rights of participants hereunder (including this Section 7.4) are preserved in
such successor plan.
7.5    Responsibilities and Authority of Committee. The Committee will control and manage the operation and administration
of the plan except to the extent that such responsibilities are specifically assigned hereunder to Biogen, the Board or the
Compensation Committee, or to a specified officer of Biogen.
The Committee will have all powers and authority necessary or appropriate to carry out its responsibilities for the
operation and administration of the plan. It will have discretionary authority to interpret and apply all plan provisions and may
correct any defect, supply any omission or reconcile any inconsistency or ambiguity in such manner as it deems advisable. It will
make all final determinations concerning eligibility, benefits and rights hereunder, and all other matters concerning plan
administration and interpretation. All determinations and actions of the Committee will be conclusive and binding upon all
persons, except as otherwise provided herein or by law, and except that the Committee may revoke or modify a determination or
action previously made in error. It is intended that any action or inaction by the Committee will be given the maximum possible
deference by any reviewing body (whether a court or other reviewing body) and will be reversed by such reviewing court or other
body only if found to be arbitrary and capricious.
21

Biogen will be the “plan administrator” and the “named fiduciary” for purposes of ERISA.
7.6    Limitation on Rights Created by Plan. Nothing appearing in the plan will be construed (a) to give any person any benefit,
right or interest except as expressly provided herein, or (b) to create a contract of employment or to give any employee the right
to continue as an employee or to affect or modify his terms of employment in any way.
7.7    Tax Withholding. Any payment hereunder to a participant, beneficiary or alternate recipient will be subject to withholding
of income and other taxes to the extent required by law. In addition, amounts that were owed as FICA or other withholding on
amounts previously credited to a participant’s account hereunder, but that were not correctly paid at the time owed, may in the
discretion of the Committee be deducted from the participant’s account.
7.8    Text Controls. Headings and titles are for convenience only, and the text will control in all matters.
7.9    Applicable State Law. To the extent that state law applies, the provisions of the plan will be construed, enforced and
administered according to the laws of the Commonwealth of Massachusetts.
7.10    Paperless Administration. The Committee may establish procedures whereby an electronic, internet or voice recognized
authorization or election will or may be utilized under the plan in lieu a written form or document otherwise required by the terms
of the plan. In such event, any reference herein to a written election, authorization or other form shall be deemed to include such
other authorization or election.
BIOGEN INC.
By: _________________________________
Dated: ______________________________
22

23

APPENDIX A
Historical Information; Amendments
    A.1    Adoption of Plan Document. This plan document, effective as of January 1, 2004, was approved by the Corporation
(Biogen Idec Inc.) under the initial name of “Biogen Idec Inc. Voluntary Executive Supplemental Savings Plan.” Prior to
execution of the plan document, the name of the plan was changed to “Biogen Idec Inc. Supplemental Savings Plan.”
By appropriate votes, (i) the IDEC Pharmaceuticals Corporation Deferred Compensation Plan maintained by IDEC
Pharmaceuticals Corporation, (ii) the Biogen, Inc. Voluntary Executive Supplemental Savings Plan maintained by Biogen, Inc..
and (iii) the Biogen, Inc. Supplemental Executive Retirement Plan maintained by Biogen, Inc. prior to the merger transaction,
were merged into this plan.
    A.2    2005 Amendment and Restatement. The plan was amended and restated in its entirety, effective as of January 1, 2005
(except as otherwise specified), primarily to comply with the requirements of Code Section 409A and regulations thereunder.
During the period from January 1, 2005 until the date of execution of this amended and restated plan document, the plan was
interpreted and administered in accordance with a good faith interpretation of the requirements of Code Section 409A and
applicable guidance of the Internal Revenue Service thereunder.
The provisions herein relating to distributions and other changes upon the occurrence of a change in control (primarily
Sections 2.7(b), 4.4(b), 6.2 and 7.4) are effective as of the date of execution of this amended and restated plan document. The
provisions relating to full vesting of all accounts (subsections 5.3(a) and (c)) and the increase in the threshold for the payment of
a lump sum in place of installments from $10,000 to the Code Section 402(g)(1)(B) and (g)(4) limit (the last sentence of
subsection 6.6(a)) are effective as of January 1, 2008.
A.3         February 2008 Restatement. The plan was amended and restated in its entirety effective as of February 1, 2008,
primarily to provide for the deferral of non-recurring bonus amounts.
A.4        October 2008 Restatement. The plan was amended and restated in its entirety effective October 1, 2008, to update the
reference in the Change in Control definition to the Biogen Inc. 2008 Omnibus Equity Plan and to modify the distribution
provisions applicable to inactive participants with Biogen SERP accounts whereby distributions shall be made as of July 1, 2009
in either a lump sum payment or in installments. For a participant who elects installments, the participant’s account shall no
longer be credited with interest credits under Section B.3 but shall be invested in the same manner as other plan participants.
A.5        January 2010 Restatement. The plan was amended and restated in its entirety effective January 1, 2010, to allow an
employee who is eligible under Section 3.1(a) to elect to defer
A-1

payments made under Biogen’s long term incentive award program which are settled in cash. Such amounts are considered non-
recurring bonus amounts hereunder.
A.6         January 2012 Restatement. The plan was amended and restated in its entirety effective as of January 1, 2012 to
expand the tax-deferred savings opportunities by allowing eligible participants to defer certain equity based awards granted
under the Biogen Inc. 2008 Omnibus Equity Plan whether or not settled in cash or shares. Such amounts are considered non-
recurring bonus amounts hereunder.
A.7         2015 Amendments to the January 2012 Restatement. The January 2012 restatement of the plan was amended by the
First Amendment thereto to eliminate the ability to defer any restricted stock units, market stock units, or other equity based
awards that may be granted beginning on or after January 1, 2015 under the Biogen Inc. 2008 Omnibus Equity Plan or any
successor plan. The January 2012 Restatement of the plan was further amended by the Second Amendment thereto, effective
March 23, 2015, to reflect the change in the name of the plan from the ‘Biogen Idec Inc. Supplemental Savings Plan’ to the
‘Biogen Inc. Supplemental Savings Plan’ and to reflect the Employer’s change of name from ‘Biogen Idec Inc.’ to ‘Biogen Inc.’
A.8     January 2024 Restatement. The plan was amended and restated in its entirety effective January 1, 2024 to incorporate
all previously adopted amendments, to remove certain historical references and clarify eligibility provisions for related
employers and investment options available under the plan.
A-2

APPENDIX B
Biogen, Inc. Supplemental Executive Retirement Plan
B.1    Applicability.
(a)
The provisions of this Appendix B will govern the treatment of transferred Biogen SERP account balances (or
supplemental pension benefit formula benefit under Section 4.1(a) of the Biogen SERP, if applicable) of persons who were
entitled to a benefit under the Biogen SERP but who were not active employees of Biogen or any of its subsidiaries or other
affiliates as of the date of transfer. To the extent that the provisions of this Appendix B are applicable, they will govern over
any other provisions of this plan.
A participant whose Biogen SERP account (or supplemental pension formula benefit, if applicable) is
governed by this Appendix will be referred to as an “Appendix B participant.”
(b)
This Appendix B will not apply to any transferred Biogen SERP account balances of any person who was an
active employee of Biogen (or any of its subsidiaries or other affiliates) as of the date of transfer as described in Section 3.1(c)
and 5.1(e). The other provisions of this plan (including, without limitation, the crediting of deemed investment experience and
the distribution provisions) will govern such transferred SERP account balance.
(c)
For purposes of Code Section 409A, prior to the changes made to this Appendix B effective October 1, 2008,
this Appendix B will be treated as a separate grandfathered non-qualified deferred compensation plan not subject to the
requirements of such section.
B.2    Amount Transferred.
For an Appendix B participant in the excess benefit formulas in Section 4.2 of the Biogen SERP, the amount transferred
from the Biogen SERP to this plan on behalf of an Appendix B participant was the vested amount in the Appendix B
participant’s Biogen SERP account as of his or her date of termination of employment, with subsequent interest credits on such
amounts in accordance with the terms of the Biogen SERP. The full vesting provisions of Section 5.3(e) of this plan will not
apply to an Appendix B participant.
B.3    Interest Credits.
For periods prior to July 1, 2009, interest credits shall continue to be added to each Appendix B participant’s Biogen
SERP account as of the last day of the plan year based on the amount of the participant’s Biogen SERP account balance as of
the first day of the plan year in the same manner as interest credits were added before such transfer.
The annual rate of interest used to determine the interest credit shall be the annual average of the yield on the one-year
Treasury Bill constant maturity rate for the preceding plan year plus 100 basis points. However, in no event shall the annual
interest rate be less than 5.25% or more than 10.0%.
B-1

Notwithstanding the foregoing, for any plan year in which a plan benefit commences, an interest credit shall be added on
the amount of the participant’s Biogen SERP account balance as of the first day of the plan year for the period from the first day
of such plan year until the participant’s expected date of distribution. The interest rate shall be the annual interest rate as
described above multiplied by the number of complete months since the end of the prior plan year divided by 12. Interest credits
shall continue to be made during any period in which payment of an Appendix B participant’s benefit is being deferred. In no
event will interest credits be made after benefits have commenced.
Effective July 1, 2009, for any Appendix B participant who elects to receive his distribution in installments rather than
a lump sum payment commencing as of such date in accordance with Section B.4, the participant’s Biogen SERP account
balance shall no longer be credited with interest credits under this Section B.3 but shall be invested in accordance with Section
5.2.
B.4    Distributions.
(a)
With respect to an Appendix B participant who has not commenced distribution of his Biogen SERP account by
October 1, 2008, distribution of such participant’s Biogen SERP account shall be made, or commence, as of July 1, 2009. Such
a participant shall be furnished a distribution election form whereby the participant may elect to receive his Biogen SERP
account as of such date in either a single lump sum payment or in installments as prescribed in Section 6.6. If a participant fails
to make an election, the default form of payment will be a single lump sum payment. The lump sum payment amount shall be
the amount credited to the participant’s account as of such date of payment including interest credits, as described in Section
B.3, to such date. If the participant elects payment of his Biogen SERP account in installments, Section 6.6 shall apply in
determining the amount and timing of the annual installments and payment in the event of death.
(b)
Prior to October 1, 2008, an Appendix B participant’s Biogen SERP account (or supplemental pension formula
benefit, if applicable) will be paid in the same form and beginning at approximately the same time that his benefit under the
Retirement Plan is payable, subject to the following rules. Notwithstanding the preceding sentence, if a participant elects a lump
sum form of payment under the Retirement Plan, payment in such form under this plan will be subject to the approval of the
Committee.
(i)
Annuity Options. If an Appendix B participant’s Biogen SERP account balance (or supplemental
pension formula benefit, if applicable) is payable in any form other than a lump sum, the actuarial factors used to
convert his Biogen SERP account balance to such other form of payment will be the same as the factors used for such
purpose in the Retirement Plan.
(ii)
Lump Sum. If an Appendix B participant’s Biogen SERP account is payable in a single sum, the payment
amount is the amount credited to the participant’s account as of the date of payment, with interest credits hereunder to
such date (or as close thereto as is practicable). For a participant with a supplemental pension benefit under Section
4.1(a) of the Biogen SERP, the amount of lump sum payment shall be the
B-2

supplemental pension amount converted to a single lump sum using the assumptions set forth in the Biogen Retirement
Plan for such purpose.
(iii)
Lump Sum Override. Notwithstanding the preceding provisions of this section, if an Appendix B
participant’s Biogen SERP account balance (or lump sum value of his supplemental pension benefit, if applicable) is
$10,000 or less as of the date that distribution would be made, such amount will be paid in the form of a lump sum
payment.
B.5    Death Benefits.
(a)
Applicability of this Section. This section specifies the benefits payable upon the death of an Appendix B
participant, either before or after the date his benefit payments hereunder begin. Except as specified in this section, no benefits
are payable upon the death of an Appendix B participant.
(b)
Preretirement Death Benefits. If an Appendix B participant dies before the date when his Biogen SERP account
balance is converted to an annuity (or installments) or paid to such participant, his beneficiary will receive payment of the
participant’s Biogen SERP account balance (or value of supplemental pension benefit, if applicable). Such amount will be paid
in a single payment to the beneficiary.
(c)
Death After Benefit Payments Begin. If a participant dies while receiving installment payments hereunder, his
beneficiary will receive the death benefit as described in Section 6.6.
B-3

Exhibit 19.1
Global Insider Trading and Information Policy
Purpose
1.1
Introduction. U.S. federal and state securities laws prohibit the purchase or sale of a company’s securities by persons who possess
Material, Nonpublic Information. These laws also prohibit persons from making Selective Disclosure. Many countries in addition to the U.S. also have
laws prohibiting Insider Trading.
1.2
Purpose. The Company has adopted this Policy to establish guidelines that prohibit (a) the purchase or sale of securities by persons who
possess Material, Nonpublic Information and (b) making Selective Disclosure.
Scope
1.3
Covered Persons. This Policy is applicable to all Covered Persons. Temporary staff are not Biogen employees, and nothing in this Policy
should be construed to the contrary. This Policy is applicable globally, inside and outside the U.S. alike, and applies to Covered Persons who are citizens of
countries other than the U.S. Even if the activities prohibited by this Policy are not prohibited in the country where the Covered Person is located, the
Company’s requirements for Insider Trading compliance and the disclosure of Material, Nonpublic Information apply to all Covered Persons regardless of
geographic location.
Policy
2.0     Insider Trading and Unauthorized or Selective Disclosure Prohibited
2.1
Policy Statement. It is the Company’s policy to comply with all U.S. and international securities laws and regulations, including Insider
Trading laws and regulations and Regulation FD. This Policy sets forth the requirements for Covered Persons’ compliance with (a) Insider Trading laws
and regulations and (b) the disclosure of Material, Nonpublic Information, including Regulation FD. Covered Persons may not:
2.1.1
purchase or sell any type of security while possessing Material, Nonpublic Information relating to the issuer of the security,
whether the issuer of that security is the Company or any Other Company;
2.1.2
directly or indirectly pass along, disclose or provide Material, Nonpublic Information concerning the Company or any Other
Company to anyone who may purchase or sell that company’s securities while possessing such Material, Nonpublic
Information;
2.1.3
recommend to any other person (including Immediate Family members) to purchase, sell, or hold securities while in possession
of Material, Nonpublic Information about the issuer of the security, whether the issuer of that security is the Company or any
Other Company; and
2.1.4
make unauthorized disclosure of Material, Nonpublic Information concerning the Company or any Other Company or Selective
Disclosure.
2.2
Individual Responsibility. Each Covered Person is responsible for ensuring that he or she does not violate Insider Trading laws and
regulations, the Company’s requirements for the disclosure of Material, Nonpublic Information, Regulation FD, and/or this Policy
3.0    Prohibited Transactions and Actions
3.1
No Short Sales. Covered Persons may not engage in short sales of the Company’s securities (i.e., sale of stock that the seller does not
own or a sale that is completed by delivery of borrowed stock).
3.2
No Margin Accounts or Pledges. Covered Persons may not purchase Company stock on margin (using a loan from your brokerage firm
to invest in more securities than the cash in your brokerage account would

allow), or borrow against any account in which Company securities are held, or pledge Company securities as collateral for a loan.
3.3
No Hedging Transactions. Covered Persons may not engage in hedging transactions with respect to the Company’s equity securities
held by the Covered Person.
3.4
No Derivative Transactions. Covered Persons may not engage in any derivative or similar transactions with respect to Company
securities, including, but not limited to, purchases or sales of puts and calls (whether written or purchased or sold), options (whether covered or not),
forward contracts, including, but not limited to prepaid variable forward contracts, put and call collars (European or American), equity or performance
swap or exchange fund agreements, or any similar agreements or arrangements however denominated in Company securities.
3.5
No Unauthorized or Selective Disclosure. Covered Persons may not make unauthorized disclosure of Material, Nonpublic Information
concerning the Company or any Other Company or Selective Disclosure.
4.0     Permitted Transactions and Actions
4.1
Employee Stock Purchase Plan. This Policy does not apply to purchases of Company stock through the ESPP. This Policy’s trading
restrictions do apply to sales of Company securities purchased under the ESPP.
4.2
Stock Option Exercises; Tax Withholding. This Policy does not apply to the withholding of shares subject to an option or other equity
award to satisfy tax withholding requirements. However, this Policy does apply to any sale of stock as part of a broker-assisted cashless exercise of an
option, or any other market sale for the purpose of generating the cash needed to pay the exercise price of an option.
4.3
Gifts. For Covered Persons who are Trading Group A members or Trading Group B members, gifts of Company stock must be made
only during the Company’s open Trading Window periods. All Covered Persons are prohibited from making gifts of Company stock while in possession of
Material, Nonpublic Information concerning the Company to (i) public charities or (ii) when such Covered Person has actual knowledge that the recipient
intends to sell the Company’s stock.
4.4
Authorized Disclosures. Covered Persons who are authorized to speak for the Company may disclose Material, Nonpublic Information
concerning the Company if such disclosure complies with the requirements of Regulation FD. Following Regulation FD compliant disclosure, such
information shall no longer be considered Nonpublic Information. People who are authorized to speak for the Company include the Company’s CEO; CFO;
Head of Research; Head of Development; members of the Investor Relations department; members of the Global Corporate Affairs department; and such
other persons who may from time to time be authorized to speak by the Company’s CEO or CFO.
4.5
Financial Guidance. The Company may from time to time, with the approval of the CEO and CFO, after consultation with the Audit
Committee, provide Guidance. All disclosures of Guidance must be in compliance with Regulation FD. The Company’s most recent Guidance will be
posted on the Investor Relations section of the Company’s website accompanied by a forward-looking safe harbor statement that includes a statement that
the Guidance is as of the date it was first given and has not been updated. An Investor Relations Spokesperson may inform investors that the Company’s
most recent Guidance is available on the Company’s website. In addition, Investor Relations Spokespeople may repeat the Company’s most recent
Guidance during the period extending from the time the Guidance is given until the earlier of (a) the closing of the next Trading Window and (b) the next
Special Blackout Period. Repetition of Guidance must be accompanied by a clear statement that the Guidance is as of the date it was given and is not being
updated at the time of its repetition and otherwise be in accordance with the requirements of Regulation FD. Under no circumstances shall any Covered
Person, including authorized

spokespersons, provide Material, Nonpublic Information or additional financial guidance at any time except in compliance with this Policy and U.S. and
international securities laws, including, without limitation, Regulation FD.
4.6
Limitations on the Company. The Company may not, directly or indirectly, buy or sell Company securities while in possession of
Material, Nonpublic Information related to the Company unless such trading activity otherwise complies with all applicable securities laws.
5.0     10b5-1 Trading Plans
5.1
Rule 10b5-1 Affirmative Defense. Rule 10b5-1 provides a person with an affirmative defense against Insider Trading liability for
transactions made pursuant to a qualifying written plan that is adopted prior to possessing Material, Nonpublic Information. Once a 10b5-1 Trading Plan is
adopted, the Rule 10b5-1 affirmative defense may be lost if the plan is altered without satisfying the amendment requirements set forth in Section 5.3 of
this Policy or otherwise fails to satisfy the requirements of Rule 10b5-1.
5.2
Approved 10b5-1 Trading Plan. This Policy allows Covered Persons to buy or sell Company stock when they possess Material,
Nonpublic Information if the purchase or sale is made pursuant to a 10b5-1 Trading Plan that is adopted while the Covered Person does not possess
Material, Nonpublic Information and otherwise satisfies the requirements for a 10b5-1 Trading Plan. The procedures for establishing a 10b5-1 Trading Plan
are set forth in the 10b5-1 Trading Plan Guidelines, attached as Attachment 1 to this Policy.
5.3
10b5-1 Trading Plan Requirements.
5.3.1
10b5-1 Trading Plans and all amendments must be in writing and entered into with a broker. The form of the contract, instruction,
plan, or trust document will be provided to the Covered Person by the Covered Person’s broker and must, in each case, be
approved by the Company’s Legal Department prior to implementation. It is the Covered Person’s responsibility to seek and
obtain approval from the Legal Department of a 10b5-1 Trading Plan and any amendments thereto, prior to implementation.
5.3.2
10b5-1 Trading Plans must be adopted (or amended, as the case may be) only when a Covered Person does not possess Material,
Nonpublic Information concerning the Company and must entered into and operated in good faith.
5.3.3
Cooling-Off Period
5.3.3.1
For Covered Persons who are not D&Os, the first trade under a 10b5-1 Trading Plan shall not occur until at least 30
days after adoption of the 10b5-1 Trading Plan.
5.3.3.2
For Covered Persons who are D&Os, the first trade under a 10b5-1 Trading Plan shall not occur prior to the expiration
of the D&O Cooling-off Period.
5.3.4
A single trade 10b5-1 Trading Plan cannot be put into place if the Covered Person has entered into another 10b5-1 Trading Plan
within the past 12 months.
5.3.5
10b5-1 Trading Plans may be amended only when a Covered Person does not possess Material, Nonpublic Information. For all
Covered Persons other than D&Os, the first trade under an amended 10b5-1 Trading Plan shall not occur before 30 days after the
amendment. For D&Os, the first trade under an amended 10b5-1 Trading Plan shall not occur until after the expiration of the
D&O Cooling-off Period). For purposes of this Section 5.1.3, modifications to a 10b5-1 Trading Plan that do not change the sales
or purchase prices or price ranges, the amount of securities to be sold or purchased, or the timing of transactions under a Rule
10b5-1 plan (such as an adjustment for stock splits or a change in account information) shall not be deemed amendments to the
applicable 10b5-1 Trading Plan. The number and timing of amendments should be reviewed carefully so as

to avoid any implication that the 10b5-1 Trading Plan was not entered into in good faith or was part of a scheme to evade Insider
Trading laws. The Company also discourages Covered Persons from repeatedly amending their 10b5-1 Trading Plans, because
such frequent amendments can create the appearance of wrongdoing and may weaken the affirmative defense against Insider
Trading liability. Any modification or change to the amount, price or timing of the purchase or sale of Company Securities
underlying a 10b5-1 Trading Plan is considered a termination of such 10b5-1 Trading Plan and the adoption of a new 10b5-1
Trading Plan. Such a new 10b5-1 plan must comply with the applicable cooling-off period in Section 5.3.3.
5.3.6
All 10b5-1 Trading Plans must include a representation in the 10b5-1 Trading Plan certifying that, on the date of adoption of the
plan, such person is not aware of Material Nonpublic Information about the Company or its securities and such person is
adopting the 10b5-1 Trading Plan in good faith and not as part of a plan or scheme to evade the prohibitions of Exchange Act
Section 10(b) and Exchange Act Rule 10b-5.
5.3.7
10b5-1 Trading Plans may have provisions that allow Covered Persons to terminate the 10b5-1 Trading Plan. Termination of a
plan could affect the availability of the affirmative defense for previous purchases or sales of Company stock under the 10b5-1
Trading Plan if the facts and circumstances surrounding the termination call into question whether the 10b5-1 Trading Plan was
entered into in good faith and not as part of a scheme to evade Insider Trading laws. All D&Os must notify the Legal
Department of any termination of any 10b5-1 Trading Plan. The Company prohibits Covered Persons from entering into
multiple 10b5-1 Trading Plans, except in the case of (i) trades conducted by multiple brokers, when taken together, satisfy the
requirements for a 10b5-1 Trading Plan, (ii) a 10b5-1 Trading Plan that will only commence only after the first 10b5-1 Trading
Plan expires or all transactions under the first 10b5-1 Trading Plan have been completed and (iii) a 10b5-1 Trading Plan that is
only in place to satisfy tax withholding obligations upon vesting of compensatory awards and such person does not exercise
control over the timing of such sales.
5.3.8
10b5-1 Trading Plans should have suspension provisions which automatically suspend the plan in the event a transaction would
violate applicable law, including Section 16 of the Exchange Act or if the Board of Directors suspends trading.
5.3.9
Additional information regarding the procedures and requirements for establishing a 10b5-1 Trading Plan are set forth in 10b5-1
Trading Plan Guidelines, attached as Attachment 1 to this Policy.
6.0     Trading Groups and Applicable Trading Restrictions
6.1
Trading Groups. The Company has identified on Attachment 2 to this Policy (as may be updated from time to time, the “Trading Group
Designations Criteria”) three distinct trading groups (Trading Group A, B, and C), the applicable descriptions of the trading restrictions that apply to each
trading group, and the titles or other description of those Covered Persons who have been designated as members of each of the Trading Groups. The
trading restrictions applicable to each trading group are summarized below:
6.1.1
Trading Group A.
•
Prior Legal Department Review. Trading Group A members are required to obtain Legal Department review at least 48
hours prior to any transaction in Company stock (including purchases, sales or gifts) not covered by a 10b5-1 Trading
Plan, or entering into or amending a 10b5-1 Trading Plan.
•
Transactions by Trading Group A Members.  Members of Trading Group A (except for members of the Board of
Directors who are permitted to purchase

Company stock outside of a 10b5-1 Trading Plan)are limited to selling or buying Company stock only under a 10b5-1
Trading Plan, which plan may only be entered into or amended during the Company’s open Trading Window periods
and when not in possession of Material, Nonpublic Information concerning the Company.   All other transactions
(including gifting) in Company stock may only be effected during the Company’s open Trading Window periods and
when they are not in possession of Material, Nonpublic Information concerning the Company.
6.1.2
Trading Group B. Trading Group B members are limited to trading in, and gifting, Company stock only during the Company’s
quarterly open Trading Window periods and when they are not in possession of Material, Nonpublic Information concerning the
Company. At their discretion, members of Trading Group B may choose to adopt and trade under a 10b5-1 Trading Plan.
Members of Trading Group B may only enter into or amend a 10b5-1 Trading Plan during the Company’s quarterly open
Trading Window periods and when they are not in possession of Material, Nonpublic Information concerning the Company.
6.1.3
Trading Group C. Trading Group C members may trade in, and gift, Company stock at any time that they are not in possession
of Material, Nonpublic Information concerning the Company. At their discretion, members of Trading Group C may choose to
adopt and trade under a 10b5-1 Trading Plan. Members of Trading Group C may only enter into or amend a 10b5-1 Trading Plan
when they are not in possession of Material, Nonpublic Information concerning the Company.
6.1.4
Trading Group Designations. Trading group designations are made based on the Trading Group Designation Criteria listed in
Attachment 2 to this Policy, as may be updated from time to time. The Legal Department will maintain the list of those Covered
Persons who have been designated as members of Trading Group A and Trading Group B. Each department is responsible for
notifying the Legal Department of any changes that are made to the Trading Groups’ membership list from time to time to add
or remove Covered Persons as appropriate. If a Covered Person is added to Trading Group A or Trading Group B, they will be
notified by the Legal Department or its designee.
6.2
Trading Window Periods. The Trading Window in any fiscal quarter (a) opens one full Trading Day after the Company’s quarterly,
periodic, or fiscal year-end earnings release information has been filed or furnished with the SEC, and (b) ends at the close of business on the day that is
fifteen (15) days prior to the close of each fiscal quarter. The Legal Department will provide Trading Groups A and B with email notification of when the
Trading Window period opens and closes.

For Example:    If the Company publicly announces earnings via a press release, a live webcast, or an SEC filing on Tuesday morning before the
Nasdaq Stock Market opens, and provided that the Covered Person is not in possession of Material, Nonpublic Information
concerning the Company,
Trading Group A
•
Covered Person may establish or amend a 10b5-1 Trading Plan when the Nasdaq Stock Market opens after one
full trading day (in this example after Wednesday morning), subject to compliance with the requirements for
establishing or amending a 10b5-1 Trading Plan as set forth in Section 5.3 of this Policy.
•
Covered Person who is a member of the Board of Directors may begin buying (but not selling) or gifting
Company stock after one full trading day (in this case when the Nasdaq Stock Market opens on Wednesday
morning, subject to prior Legal Department review as set forth in Section 6.1.1 of this Policy.
Trading Group B
o
Covered Person may begin buying, selling or gifting Company stock after one full trading day after
the above disclosure (in this example when the Nasdaq Stock Market opens on Wednesday
morning).
o
Covered Person may establish or amend a 10b5-1 Trading Plan when the Nasdaq Stock Market
opens after one full trading day (in this example after Wednesday morning), subject to compliance
with the requirements for establishing or amending a 10b5-1 Trading Plan as set forth in Section
5.3 of this Policy.
Trading Group C
o Covered Person may buy, sell or gift Company stock at any time.
o Covered Person may establish or amend a 10b5-1 Trading Plan at any time.
6.3
Special Blackout Periods. From time to time, there may be Material, Nonpublic Information concerning the Company that is known by
only certain Covered Persons. So long as this information remains Material and nonpublic, it is against this Policy for those Covered Persons who
possesses the information that is being subject to a Special Blackout Period (a) to establish or amend a 10b5-1 Trading Plan during a Special Blackout
Period, (b) to purchase, gift or sell Company securities during a Special Blackout Period, unless the purchase or sale is made pursuant to a pre-established
10b5-1 Trading Plan, or (c) to make an election or change to a contribution election under the ESPP. No Covered Persons, whether or not subject to a
Special Blackout Period, may disclose to any outside third party that a Special Blackout Period exists. Covered Persons that are subject to a Special
Blackout Period will be notified by the Legal Department by email as promptly as practical when the Special Blackout Period begins and ends.
6.4
Hardship Exceptions. A Covered Person who is subject to the Trading Window requirements and who has an extraordinary,
unanticipated, and urgent need to sell Company stock in order to generate cash may, in appropriate circumstances, be permitted to sell Company stock even
if the Trading Window period has closed. A hardship exception may be granted only by the unanimous decision of the CEO, the CLO, and the CFO and
must be requested at least two business days in advance of the proposed trade. Such officers are under no obligation to approve a hardship exception, and
neither the Company nor such officers will have any liability for any refusal to grant a hardship exception or for any delay in making or communicating a
decision. Under no circumstance will a hardship exception be granted during a Special Blackout Period, or for ordinary, anticipated, and non-urgent events,
such as purchasing a home or paying college tuition. All requests for a hardship exception should be submitted by email or in writing to the CLO.
7.0     Post-Employment Transactions
7.1
If a Covered Person possesses Material, Nonpublic Information when the Covered Person’s employment, service as a director, or service
relationship with the Company terminates, the Covered Person may not

purchase, gift or sell Company securities or disclose such Material, Nonpublic Information until that information has been made public by the Company or
it is no longer Material.
7.2
If a Covered Person is subject to the Trading Window or Special Blackout Period restrictions imposed by this Policy and the Covered
Person’s employment terminates or, service as a director or service relationship with the Company terminates during a closed Trading Window or a Special
Blackout Period, the Covered Person will continue to be subject to this Policy and the ongoing prohibition against purchasing selling or gifting Company
securities, until the Trading Window period opens or the Special Blackout Period ends.
7.3
If a Covered Person has questions as to whether the Covered Person possesses Material, Nonpublic Information or if the Covered Person
is subject to the Trading Window or a Special Blackout Period restrictions after the Covered Person’s employment or service as a director of the Company
terminates, the Covered Person should direct questions to the Chief Corporation Counsel.
8.0     Penalties for Noncompliance
8.1
Potential Civil and Criminal Penalties. The penalties for violating U.S. and international securities laws and regulations, including
Insider Trading laws and regulations and Regulation FD may include imprisonment for up to 20 years, criminal fines up to U.S. $5 million, and civil fines
of up to three times the profit gained or loss avoided.
8.2
Company Disciplinary Actions. Failure to comply with this Policy or U.S. or international securities laws and regulations, including
Insider Trading laws and regulations and Regulations FD by any Covered Person may also subject the Covered Person to disciplinary action by the
Company up to and including termination of the Covered Person’s employment, whether or not the Covered Person’s failure to comply with this Policy
results in a violation of U.S. or International securities laws and regulations, including Insider Trading laws and regulations and Regulation FD. Failure to
comply with this Policy or U.S. and international securities laws and regulations, including Insider Trading laws and regulations and Regulation FD may
also be deemed to be a violation of the Biogen Code of Business Conduct.
8.3
Reporting Insider Trading and Information Violations. Any Covered Person who violates this Policy or any U.S. or international
securities laws and regulations, including Insider Trading laws and regulations and Regulation FD, or who knows of any actual or potential violation by any
other Covered Person, must report the violation immediately to the Compliance Helpline, Human Resource Department, Corporate Compliance
Department, the Chief Compliance Officer, the CLO, the Head of Hurman Resources, the Chief Corporation Counsel, or the Chair of the Audit Committee.

9.0     Definitions
9.1
10b5-1 Trading Plan. A written, pre-planned trading plan entered into with a broker, in which the broker is instructed to purchase or sell
Company securities at a future date according to instructions meeting certain requirements at the time the plan is put in place.
9.2
10b5-1 Trading Plan Guidelines. The procedures for establishing a 10b5-1 Trading Plan as set forth in Attachment 1 to this Policy, as
updated from time to time.
9.3
Audit Committee. Audit Committee of the Board of Directors.
9.4
Biogen. Biogen Inc. and its subsidiaries.
9.5
CEO. The Company’s Chief Executive Officer.
9.6
CFO. The Company’s Chief Financial Officer.
9.7
CLO. The Company’s Chief Legal Officer.
9.8
Company. Biogen Inc. and its subsidiaries.
9.9
Covered Persons. All Company employees, officers, directors, and temporary staff worldwide and members of their Immediate Family
and family trusts (or similar entities) controlled by or benefiting individuals subject to this Policy.
9.10
D&O. All members of the Board of Directors, executive officers and the Chief Accounting Officer.
9.11
D&O Cooling-Off Period. A period not shorter than the later of (i) 90 days after adoption of the 10b5-1 Trading Plan or (ii) two business
days after the filing by the Company of a 10-Q or 10-K (not including the day of filing; e.g. if a 10-K is filed on Monday the first sale
could occur no earlier than Thursday, assuming no federal holidays), but in no event longer than 120 days after the adoption or
modification of such 10b5-1 Trading Plan.
9.12
Exchange Act. Securities Exchange Act of 1934, as amended.
9.13
ESPP. Company’s Employee Stock Purchase Plan, as amended from time to time.
9.14
Guidance. Guidance as to the Company’s expected future financial performance.
9.15
Immediate Family. The following persons are considered members of a Covered Person’s “Immediate Family”: the Covered Person’s
spouse, parents, children, and siblings, including any such relationship that arises through marriage or by adoption. A Covered Person’s “Immediate
Family” also includes anyone else who lives in the Covered Person’s household, whether or not they are related to the Covered Person, and any family
members who do not live in the Covered Person’s household but whose transactions in Company securities are directed by the Covered Person or are
subject to the Covered Person’s influence and control (such as parents or children who consult with the Covered Person before they buy or sell Company
securities). The applicable Covered Person is responsible for ensuring that these other individuals and entities comply with this Policy.
9.16
Insider Trading. The purchase or sale of a company’s securities by persons who possess Material, Nonpublic Information.
9.17
Investor Relations Spokespeople. Covered Persons in the Company’s Investor Relations department who are authorized to speak for the
Company and the CFO.
9.18
Legal Department. The Company’s legal department.
9.19
Material, Nonpublic Information. Material, Nonpublic Information is Material information concerning the Company or Another
Company that has not been previously disclosed to the general public through

press releases, live webcasts, SEC filings or furnished to the SEC and is otherwise not available to the general public.
9.19.1
Material. Information (positive or negative) is “Material” if there is a substantial likelihood that a reasonable investor would
consider it important in deciding whether to buy or sell a company’s securities. In making a determination as to whether information is “Material”, Covered
Persons should consider whether the information would significantly alter the total mix of information available to an investor considering trading in
company stock. Any information that could reasonably be expected to affect the price of the security is Material. Examples of categories of information
that may be considered Material include:
•
earnings results
•
the results of clinical trials
•
significant developments regarding a major product or program
•
the acquisition of significant technology or new products
•
major licensing deals
•
significant information about a partner or other third party with whom we do business
•
significant litigation or patent-related events
•
restatements of financial results or significant impairments, write-offs or changes in reserves
•
significant cybersecurity incidents, such as a data breach, or any other significant disruption in the Company’s operations or loss, potential
loss, breach, or unauthorized access of its property or assets, whether at its facilities or through its information technology infrastructure
•
receipt of regulatory approval, failure to obtain regulatory approval, or significant change in existing regulatory approval for products, new
formulations of products, or devices to administer products
•
label changes that may affect prescribing behavior
•
reimbursement decisions
•
pending or proposed merger, acquisition, tender offer, or other significant transaction
•
the offering or sale of additional securities
•
changes in top management
•
the gain or loss of a substantial customer or supplier
•
problems with a product that may result in significant financial consequences for the Company or involve serious product safety,
manufacturing, or supply issues
9.19.2
Nonpublic Information. Nonpublic Information is information that is not generally known or available to the public. The
Company generally discloses information to the public either via press releases, live webcasts, or in its SEC filings. Information is considered “public” only
after it has been publicly available through press releases, live webcasts, SEC filings or furnished to the SEC, or otherwise, for at least 24 hours.
9.20
Nasdaq. The National Association of Securities Dealers Automated Quotation System.
9.21
Other Company. Any other public company with which the Company does business.
9.22
Regulation FD. Regulation Fair Disclosure of the Exchange Act prohibits the Selective Disclosure of Material, Nonpublic Information to
certain specified persons, including: (a) broker/dealers and persons associated with them, including investment analysts, (b) investment advisors, certain
institutional investment managers, and their associated staff, (c) investment companies, hedge funds, and affiliated persons, and (d) any

security holder of the Company, including employees, under circumstances in which it is reasonably foreseeable that the security holder would purchase or
sell securities on the basis of the information.
9.23
Rule 10b5-1. SEC Rule 10b5-1, promulgated under the Securities Exchange Act of 1934, amended.
9.24
SEC. The U.S. Securities and Exchange Commission.
9.25
Securities. Any stock, preferred stock, bonds, debentures, notes, or other debt securities, options, warrants, or other derivative or
financial instrument issued by or based upon the performance of a company.
9.26
Selective Disclosure. Any disclosure of Material, Nonpublic Information concerning the Company or any Other Company that does not
comply with the requirements of Regulation FD.
9.27
Special Blackout Period. A certain period of time designated by the Company during which certain Covered Persons have been notified
that because they possess certain Material, Nonpublic Information they may not (a) create or amend a 10b5-1 Trading Plan, (b) purchase, sell or gift
Company securities even though the Trading Window may otherwise be open, or (c) make an election or change to contribution elections under the ESPP.
9.28
Trading Day. A business day on which national stock exchanges and the Nasdaq Stock Market are open for business.
9.29
Trading Window. The period of time during which the Company permits Covered Persons to purchase, gift or sell Company securities
or enter into or amend 10b5-1 Trading Plans. See Section 6.2 of this Policy.
9.30
U.S. The United States.
10.0     Questions
10.1
Please direct questions as to any of the matters discussed in this Policy to the Company’s Chief Corporation Counsel.

Attachment 1 - 10b5-1 Trading Plan Guidelines
Contacts
To Set Up 10b5-1 Trading Plan
Questions for the Legal Department
Fidelity
Phone:
(800) 823-0217
Email:
[ ]
[ ]
[ ]
Procedures for Establishing a 10b5-1 Trading Plan
o
Contact a broker. Biogen has worked with Fidelity (the administrator of Biogen’s equity plans) to create a form of 10b5-1 Trading Plan that
meets the requirements of this Policy and there is some benefit in working with Fidelity if a Covered Person intends to include Biogen equity plan
awards or shares to be purchased under the Biogen ESPP in their 10b5-1 Trading Plan. Covered Persons should contact Fidelity if they would like
to use Fidelity as their broker. Other brokerage firms may also be able to provide Covered Persons with assistance in establishing a 10b5-1
Trading Plan. If you choose to use a broker other than Fidelity, the Covered Person should work with such other broker to follow the procedures
and requirements described in these guidelines and this Policy.
o
Develop a 10b5-1 Trading Plan. Once a Covered Person has contacted Fidelity, the Covered Person should work with Fidelity to establish a
10b5-1 Trading Plan that meets the Covered Person’s needs and fulfills the requirements and criteria set forth in this Policy.
o
Trading Schedules. The key parts of the 10b5-1 Trading Plan are the Trading Schedules attached to the 10b5-1 Trading Plan. The Trading
Schedules contain the details of the Covered Person’s planned trades (number of shares to be purchased or sold, desired price, date(s) of sale, etc.).
o
Fidelity has access to each Covered Persons’ equity award records, and Covered Persons should work directly with Fidelity on their
Trading Schedules. To expedite the process, Covered Persons should think about their trading goals prior to calling Fidelity and keep
their Trading Schedules simple.
o
Execute a written 10b5-1 Trading Plan; Approval by Legal Department and Fidelity. Once a Covered Person reviews the 10b5-1 Trading
Plan and agrees with its content, including the Trading Schedules, the 10b5-1 Trading Plan will need to be signed by both the Covered Person, a
representative of the Legal Department and Fidelity, and will need to be reviewed and approved by the Legal Department. It is the Covered
Person’s responsibility to seek and obtain approval from the Legal Department of a 10b5-1 Trading Plan and any amendments thereto, prior to
implementation.
o
File Form 144. If a Covered Person is a D&O, the Covered Person will need to sign and the Covered Person’s broker will need to file a Form 144
simultaneously with the first purchase or sale under the 10b5-1 Trading Plan. The Form 144 should report all purchases or sales expected to take
place within the next three (3) months. Additional Forms 144 should be filed by the Covered Person’s broker on a rolling basis simultaneously
with the first purchase or sale in each subsequent three-month period.
o
File Form 4. If a Covered Person is a member of Trading Group A-I, the Covered Person or the Covered Person’s broker must notify Biogen’s
Legal Department within 24 hours of a purchase, gift or sale under the 10b5-1 Trading Plan so that a Form 4 can be timely prepared and filed with
the SEC. The Legal Department will prepare and file the Covered Person’s Form 4, unless the Covered Person elects to have his/her own
representative prepare and file the Form 4 on the Covered Person’s behalf.

10b5-1 Trading Plan Key Requirements and Information
o
Two key 10b5-1 Trading Plan requirements are as follows: (a) at the time a Covered Person enters into or amends a 10b5-1 Trading Plan, the Covered
Person cannot be in possession of Material, Nonpublic Information concerning the Company, and (b) the first trade under a 10b5-1 Trading Plan may
not occur until at least 30 days (or the D&O Cooling-off Period for Covered Persons who are D&Os)
o
after a Covered Person adopts or amends (excluding modifications that do not change the sales or purchase prices or price ranges, the amount of
securities to be sold or purchased, or the timing of transactions under a Rule 10b5-1 plan) a 10b5-1 Trading Plan. Please refer to this Policy for
additional requirements for 10b5-1 Trading Plans.
o
10b5-1 Trading Plans may include unvested equity awards. Please note that, upon vesting, only Biogen employees will have the option of paying
required tax withholdings through the netting of vested shares. The remaining shares would then be delivered to the Covered Person’s account at
Fidelity. This “netting” of shares is not subject to Insider Trading laws and, therefore, knowledge of Material, Nonpublic Information on the
vesting date will not impact a Covered Person’s ability to take advantage of the netting procedure. As a result, a Covered Person may want to
reconsider entering into a 10b5-1 Trading Plan if the primary reason for doing so is to cover the Covered Person’s tax obligations upon vesting of
restricted stock and restricted stock units. Members of the Board of Directors who are not Biogen employees may not pay required tax
withholdings through the netting of vested shares.
o
10b5-1 Trading Plans may not include equity awards that a Covered Person has not yet received, e.g., awards not yet granted.
o
There may be up to a 3-5 day time lag between the vesting of restricted stock and restricted stock units or the purchase of shares under the ESPP
and the delivery of the shares (either gross or net) into a Covered Person’s account at Fidelity. As a result, sales of vested restricted stock, shares
purchased under the ESPP, or shares delivered in settlement of restricted stock units may not be completed by Fidelity or your broker for up to 10
days after the vesting date or the ESPP purchase date, as the case may be.
o
10b5-1 Trading Plan Trading Schedules are very flexible in terms of the types of selling or buying orders that may be established, the number of
shares that may be sold or bought at any given time and the like. Please work directly with Fidelity or your broker on the trading details.

Attachment 2 - Trading Groups
Trading Group
Trading Restrictions
Members of Trading Group

Trading Group A

•
Legal Department prior review required of all transactions in
Company stock not covered by a 10b5-1 Trading Plan. See
Section 6.1.1 of this Policy.

•
Sell Company stock only under a 10b5-1 Trading Plan, which
plan must be entered into or amended only (i) during an open
Trading Window period, and (ii) when not in possession of any
Material, Nonpublic Information concerning the Company, and
(iii) subject to compliance with the requirements set forth in
Section 5.3 of this Policy.

•
Except for Members of the Board of Directors, buy Company
Stock only under a 10b5-1 Trading Plan, which plan must be
entered into or amended only (i) during an open Trading
Window period, and (ii) when not in possession of any Material,
Nonpublic Information concerning the Company, and (iii)
subject to compliance with the requirements set forth in Section
5.3 of this Policy.

•
All other transactions in Company stock to be effected only (i)
during open an Trading Window period and (ii) when not in
possession of any Material, Nonpublic Information concerning
the Company. Optional use of 10b5-1 Trading Plans (which is
only optional for Members of the Board of Directors who want
to put into place a 10b5-1 Trading Plan that only relates to the
purchase (but not sale) of Company stock) for other transactions
in Company stock, which plan must be entered into or amended
only (x) during an open Trading Window period and (y) when
not in possession of any Material, Nonpublic Information
concerning the Company, and (z) subject to compliance with the
requirements set forth in Section 5.3 of this Policy.

•
Members of the Board of Directors
•
All Executive Officers (Executive Committee),
Chief Accounting Officer, and Treasurer
•
All Executive Vice Presidents (EVPs)
•
All Senior Vice Presidents (SVPs)
•
Chiefs of Staff to Executive Officers
•
All members of the Legal Department
•
Executive Assistants to Trading Group A
Members
•
Other Covered Persons designated by the CEO or
CLO


Trading Group B

•
Buy or sell Company stock only during open Trading Window
periods and when not in possession of any Material, Nonpublic
Information concerning the Company.

•
Optional use of 10b5-1 Trading Plans. Enter into or amend a
10b5-1 Trading Plan
only (i) during an open Trading Window period, and (ii) when
not in possession of any Material, Nonpublic Information
concerning the Company, and (iii) subject to compliance with
the requirements set forth in Section 5.3 of this Policy.

•
All Vice Presidents
•
All members of the Finance Department
•
Business Development and External Innovation
Group
•
Customer & Market Insights Group
•
Customer Information Management
•
Senior Directors and above in Corporate Affairs
•
Administrative Assistants of Trading Group B
Members
•
Other Covered Persons designated by the CEO or
CLO

Trading Group C

•
Buying or selling Company stock is allowed at any time in
compliance with this Policy (i.e., at any time when the Covered
Person is not in possession of any Material, Nonpublic
Information concerning the Company).

•
Optional use of 10b5-1 Trading Plans. Enter into or amend a
10b5-1 Trading Plan when not in possession of any Material,
Nonpublic Information concerning the Company and subject to
compliance with the requirements set forth in Section 5.3 of this
Policy.

•
All other Covered Persons
Implementation
Corporate
The Company will implement a global education program for all Company directors, officers, employees, and temporary staff, including:
•
Training as part of the onboarding process for a new director, officer, employee, or temporary staff;
•
Annual distribution of this Policy; and
•
Annual certification of receipt, read, understood, and compliance with this Policy.
Management
Management of each of the Company’s affiliates or other organizational units must:
•
Ensure that this Policy is embedded in the business and adhered to;
•
Oversee and supervise the activities of Covered Persons; and
•
Implement processes, awareness, training and controls, in line with the minimum corporate standards set forth in this Policy.
Enforcement
Failure to follow the principles and steps set out in this Policy may result in disciplinary action, up to and including termination.


Exhibit 21
BIOGEN INC.
The following is a list of subsidiaries of Biogen Inc. as of December 31, 2024, omitting some subsidiaries which,
considered in the aggregate, would not constitute a significant subsidiary.
SUBSIDIARY
STATE OR OTHER JURISDICTION OF

INCORPORATION OR ORGANIZATION
Biogen Foundation Inc.
Massachusetts
Biogen MA Inc.
Massachusetts
Biogen Realty Corporation
Massachusetts
Biogen Realty Limited Partnership
Massachusetts
Biogen U.S. Corporation
Massachusetts
Biogen U.S. Limited Partnership
Massachusetts
Biogen (RTP) Realty LLC
Delaware
Biogen Chesapeake LLC
Delaware
Biogen Digital Health Inc.
Delaware
Biogen Digital Health Global LLC
Delaware
Biogen Holding I LLC
Delaware
Biogen Holding II LLC
Delaware
Biogen OUS Holding Inc.
Delaware
Biogen Manufacturing Holding LLC
Delaware
Biogen New Ventures Inc.
Delaware
Biogen SRO Inc.
Delaware
Biogen Therapeutics Inc.
Delaware
Biogen U.S. Pacific LLC
Delaware
Biogen U.S. West Corporation
Delaware
Conforma Therapeutics Corporation
Delaware
Human Immunology Biosciences, Inc.
Delaware
Stromedix, LLC
Delaware
Nightstar, Inc.
Delaware
Reata Pharmaceuticals Global, Inc.
Delaware
Reata Pharmaceuticals Holdings, LLC.
Delaware
Reata Pharmaceuticals, Inc.
Delaware
Biogen (Argentina) SRL
Argentina
Biogen Australia PTY Ltd
Australia
Reata Australia PTY Ltd
Australia
Biogen Austria GmbH
Austria
Biogen Belgium N.V./S.A.
Belgium
Biogen International Holding Limited
Bermuda
Biogen (Bermuda) Technologies Ltd.
Bermuda
Biogen Brasil Produtos Farmaceuticos LTDA
Brazil
Biogen Canada Inc.
Canada
Biogen Chile SpA
Chile
Biogen Biotechnology (Shanghai) Co., Ltd
China
BIIB Colombia S.A.S.
Colombia

Biogen Pharma d.o.o.
Croatia
Biogen (Czech Republic) s.r.o.
Czech Republic
Biogen (Denmark) A/S
Denmark

SUBSIDIARY
STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION
Biogen Estonia OU
Estonia
Biogen Finland OY
Finland
Biogen France S.A.S.
France
Reata France S.A.S.
France
Biogen GmbH
Germany
Reata Germany GmbH
Germany
Biogen Hong Kong Limited
Hong Kong
Biogen Hungary KFT
Hungary
Biogen Idec Biotech India Pvt. Ltd.
India
Biogen Capability Center India Private Limited
India
Biogen Idec (Ireland) Ltd.
Ireland
Nightstar Europa Limited
Ireland
Reata Ireland Limited
Ireland
Human Immunology Biosciences Ireland Limited
Ireland
Biogen Italia S.R.L.
Italy
Reata Italy S.R.L.
Italy
Biogen Japan Ltd.
Japan
Biogen Korea LLC
Korea
Biogen Latvia SIA
Latvia
Biogen Lithuania UAB
Lithuania
Biogen Luxembourg Holding S.a.r.l.
Luxembourg
Biogen Mexico S. de R.L. de C.V.
Mexico
Biogen NZ Biopharma Ltd.
New Zealand
Biogen Norway AS
Norway
Biogen Poland Sp. z.o.o.
Poland
Biogen Portugal Sociedade Farmaceutica, Unipessoal Lda.
Portugal
Biogen Arabia Limited
Saudi Arabia
Biogen Regional Headquarters LLC
Saudi Arabia
Biogen Slovakia s.r.o.
Slovak Republic
Biogen Pharma, farmacevtska in biotehnoloska druzba, d.o.o.
Slovenia
Biogen Spain, S.L.
Spain
Biogen Sweden AB
Sweden
Biogen Digital Health International GmbH
Switzerland
Biogen International GmbH
Switzerland
Biogen International Neuroscience GmbH
Switzerland
Biogen Management Services GmbH
Switzerland
Biogen Switzerland AG
Switzerland
Eidetica Biopharma GmbH
Switzerland
Biogen Taiwan Limited
Taiwan
Biogen Turkey Ilac Ticaret Limited Sirketi
Turkey
Biogen B.V.
The Netherlands
Biogen Netherlands B.V.
The Netherlands
Biogen Idec Limited
United Kingdom
Biogen Idec Research Ltd.
United Kingdom
Convergence Pharmaceuticals Limited
United Kingdom
Convergence Pharmaceuticals Holdings Ltd.
United Kingdom
Old Convergence Pharmaceuticals Limited
United Kingdom
Reata U.K. Limited
United Kingdom

SUBSIDIARY
STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION
Silver Acquisition Co. Ltd.
United Kingdom
Nightstar Therapeutics Limited
United Kingdom
NightstaRx Limited
United Kingdom
Tungsten Bidco Limited
United Kingdom
Biogen Idec Uruguay SA
Uruguay

Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (Nos. 333-280360
and 333-218799) of Biogen Inc. of our report dated February 12, 2025, relating to the financial statements and the
effectiveness of internal control over financial reporting, which appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 12, 2025
    
 

Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Christopher A. Viehbacher, certify that:
1.
I have reviewed this annual report of Biogen Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with
respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the
equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: February 12, 2025
 
/s/ Christopher A. Viehbacher
 
Christopher A. Viehbacher
 
President and Chief Executive Officer

Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael R. McDonnell, certify that:
1.
I have reviewed this annual report of Biogen Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with
respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the
equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: February 12, 2025
/s/ Michael R. McDonnell
Michael R. McDonnell
Executive Vice President and
Chief Financial Officer

Exhibit 32.1
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States
Code), each of the undersigned officers of Biogen Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s
knowledge, that:
The Annual Report on Form 10-K for the year ended December 31, 2024 (the “Form 10-K”) of the Company fully complies with the
requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly
presents, in all material respects, the financial condition and results of operations of the Company.
Date: February 12, 2025
 
/s/ Christopher A. Viehbacher
 
Christopher A. Viehbacher
 
President and Chief Executive Officer
 
[principal executive officer]
 
Date: February 12, 2025
 
/s/ Michael R. McDonnell
 
Michael R. McDonnell
 
Executive Vice President and
 
Chief Financial Officer
 
[principal financial officer]
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.