SEC Filing | Biogen

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biib-20230331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q


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

For the quarterly period ended March 31, 2023


☐			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

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

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. o

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

The number of shares of the issuer’s Common Stock, $0.0005 par value, outstanding as of April 24, 2023, was 144,742,305 shares.

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BIOGEN INC.

FORM 10-Q — Quarterly Report

For the Quarterly Period Ended March 31, 2023

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		Page
PART I — FINANCIAL INFORMATION

Item 1.	Financial Statements (unaudited)

	Condensed Consolidated Statements of Income — For the Three Months Ended March 31, 2023 and 2022	7

	Condensed Consolidated Statements of Comprehensive Income — For the Three Months Ended March 31, 2023 and 2022	8

	Condensed Consolidated Balance Sheets — As of March 31, 2023 and December 31, 2022	9

	Condensed Consolidated Statements of Cash Flow — For the Three Months Ended March 31, 2023 and 2022	10

	Condensed Consolidated Statements of Equity — For the Three Months Ended March 31, 2023 and 2022	11

	Notes to Condensed Consolidated Financial Statements	13

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	43

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	60

Item 4.	Controls and Procedures	62

PART II — OTHER INFORMATION

Item 1.	Legal Proceedings	64

Item 1A.	Risk Factors	64

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	79

Item 6.	Exhibits	80

Signatures		81

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NOTE REGARDING FORWARD-LOOKING STATEMENTS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

These forward-looking statements involve risks and uncertainties, including those that are described in Item 1A. Risk Factors included in this report and elsewhere in this report, that could cause actual results to differ materially from those reflected in such statements. You should not place undue reliance on these statements. Forward-looking statements speak only as of the date of this report. 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.

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®, PLEGRIDY®, RITUXAN®, RITUXAN HYCELA®, SPINRAZA®, TECFIDERA®, TYSABRI® and VUMERITY® are registered trademarks of Biogen.

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

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

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DEFINED TERMS


2022 Form 10-K			Annual Report on Form 10-K for the year ended December 31, 2022
2020 Share Repurchase Program			Board of Directors authorized program to repurchase up to $5.0 billion of our common stock
300 Binney Street			300 Binney Street, Cambridge, MA
Advisory Committee			Peripheral and Central Nervous System Drugs Advisory Committee
AI			Artificial Intelligence
ALS			Amyotrophic Lateral Sclerosis
AOCI			Accumulated Other Comprehensive Income (Loss)
ASO			Antisense Oligonucleotide
ASU			Accounting Standards Update
ATV			Antibody Transport Vehicle
BLA			Biologics License Application
CCPA			California Consumer Privacy Act
CEO			Chief Executive Officer
cGMP			current Good Manufacturing Practices
CHMP			Committee for Medicinal Products for Human Use
CJEU			Court of Justice of the European Union
CLE			Cutaneous Lupus Erythematosus
CLL			Chronic Lymphocytic Leukemia
CMS			Centers for Medicare & Medicaid Services
Convergence			Convergence Pharmaceuticals Ltd.
CROs			Contract Research Organizations
Denali			Denali Therapeutics Inc.
DPN			Diabetic Painful Neuropathy
EC			European Commission
Eisai			Eisai Co., Ltd.
EMA			European Medicines Agency
EPO			European Patent Office
ERISA			Employee Retirement Income Security Act of 1974
E.U.			European Union
FASB			Financial Accounting Standards Board
FCPA			Foreign Corrupt Practices Act
FDA			U.S. Food and Drug Administration
FDIC			Federal Deposit Insurance Corporation
Genentech			Genentech, Inc.
GILTI			Global Intangible Low Tax Income
GloBE			Global Anti-Base Erosion
GMP			Good Manufacturing Practice
Humana			Humana Inc.
IPR&D			In-process research and development
Ionis			Ionis Pharmaceuticals Inc.
IRA			Inflation Reduction Act of 2022
LRRK2			Leucine-Rich Repeat Kinase 2
MAA			Marketing Authorization Application
MDD			Major Depressive Disorder

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DEFINED TERMS (continued)


MS			Multiple Sclerosis
Mylan Ireland			Mylan Ireland Ltd.
NDA			New Drug Application
Neurimmune			Neurimmune SubOne AG
NMPA			National Medicinal Products Administration
OECD			Organization for Economic Co-operation and Development
OIG			Office of Inspector General
PDUFA			Prescription Drug User Fee Act
PMDA			Pharmaceuticals and Medical Devices Agency
Polpharma			Polpharma SA
PPACA			Patient Protection and Affordable Care Act
PPD			Postpartum Depression
PPMS			Primary Progressive MS
RMS			Relapsing MS
RRMS			Relapsing-Remitting MS
RTP			Research Triangle Park
Sage			Sage Therapeutics, Inc.
Samsung Bioepis			Samsung Bioepis Co., Ltd.
Samsung BioLogics			Samsung BioLogics Co., Ltd.
Sangamo			Sangamo Therapeutics, Inc.
SG&A			Selling, General and Administrative
SLE			Systemic Lupus Erythematosus
SMA			Spinal Muscular Atrophy
SOD1			Superoxide Dismutase 1
SVB			Silicon Valley Bank
SWISSMEDIC			Swiss Agency for Therapeutic Products
TBA			Technical Boards of Appeal
TGN			Trigeminal Neuralgia
Transition Toll Tax			A one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign earnings
U.K.			United Kingdom
U.S.			United States
U.S. GAAP			Accounting Principles Generally Accepted in the U.S.
VA			Veterans Administration

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PART I FINANCIAL INFORMATION

BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(unaudited, in millions, except per share amounts)


	For the Three Months Ended March 31,
	2023		2022
Revenue:
Product, net	$	1,763.3	$	2,066.3
Revenue from LEQEMBI Collaboration	(18.9)		—
Revenue from anti-CD20 therapeutic programs	399.5		399.4
Contract manufacturing, royalty and other revenue	319.1		66.1
Total revenue	2,463.0		2,531.8
Cost and expense:
Cost of sales, excluding amortization and impairment of acquired intangible assets	662.8		753.9
Research and development	570.6		551.7
Selling, general and administrative	605.0		634.9
Amortization and impairment of acquired intangible assets	50.2		66.9
Collaboration profit sharing/(loss reimbursement)	57.1		(117.3)
(Gain) loss on fair value remeasurement of contingent consideration	—		(7.1)

Restructuring charges	9.6		38.1

Other (income) expense, net	69.4		263.3
Total cost and expense	2,024.7		2,184.4
Income before income tax expense and equity in loss of investee, net of tax	438.3		347.4
Income tax (benefit) expense	50.7		125.6
Equity in (income) loss of investee, net of tax	—		3.3
Net income	387.6		218.5
Net income (loss) attributable to noncontrolling interests, net of tax	(0.3)		(85.3)
Net income attributable to Biogen Inc.	$	387.9	$	303.8

Net income per share:
Basic earnings per share attributable to Biogen Inc.	$	2.69	$	2.06
Diluted earnings per share attributable to Biogen Inc.	$	2.67	$	2.06

Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc.	144.4		147.1
Diluted earnings per share attributable to Biogen Inc.	145.2		147.6

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(unaudited, in millions)


	For the Three Months Ended March 31,
	2023		2022
Net income attributable to Biogen Inc.	$	387.9	$	303.8
Other comprehensive income:
Unrealized gains (losses) on securities available for sale, net of tax	5.7		(9.7)
Unrealized gains (losses) on cash flow hedges, net of tax	(35.4)		15.9
Gains (losses) on net investment hedges, net of tax	—		6.2
Unrealized gains (losses) on pension benefit obligation, net of tax	0.5		0.9
Currency translation adjustment	22.1		(21.8)
Total other comprehensive income (loss), net of tax	(7.1)		(8.5)
Comprehensive income (loss) attributable to Biogen Inc.	380.8		295.3
Comprehensive income (loss) attributable to noncontrolling interests, net of tax	(0.3)		(85.3)
Comprehensive income (loss)	$	380.5	$	210.0

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in millions, except per share amounts)


	As of March 31, 2023		As of December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents	$	2,898.2	$	3,419.3
Marketable securities	2,143.1		1,473.5
Accounts receivable, net	1,634.4		1,705.0
Due from anti-CD20 therapeutic programs	393.8		431.4
Inventory	1,281.0		1,344.4
Other current assets	1,412.0		1,417.6
Total current assets	9,762.5		9,791.2
Marketable securities	978.2		705.7
Property, plant and equipment, net	3,300.9		3,298.6
Operating lease assets	399.1		403.9
Intangible assets, net	1,813.3		1,850.1
Goodwill	5,751.8		5,749.0
Deferred tax asset	1,211.8		1,226.4
Investments and other assets	1,380.8		1,529.2
Total assets	$	24,598.4	$	24,554.1
LIABILITIES AND EQUITY
Current liabilities:

Taxes payable	$	235.5	$	259.9
Accounts payable	491.2		491.5
Accrued expense and other	2,288.2		2,521.4
Total current liabilities	3,014.9		3,272.8
Notes payable	6,282.7		6,281.0
Deferred tax liability	251.3		334.7
Long-term operating lease liabilities	327.0		333.0
Other long-term liabilities	935.5		944.2
Total liabilities	10,811.4		11,165.7
Commitments, contingencies and guarantees
Equity:
Biogen Inc. shareholders’ equity:
Preferred stock, par value $0.001 per share	—		—
Common stock, par value $0.0005 per share	0.1		0.1
Additional paid-in capital	91.2		73.3
Accumulated other comprehensive income (loss)	(172.0)		(164.9)
Retained earnings	16,854.4		16,466.5
Treasury stock, at cost	(2,977.1)		(2,977.1)
Total Biogen Inc. shareholders’ equity	13,796.6		13,397.9
Noncontrolling interests	(9.6)		(9.5)
Total equity	13,787.0		13,388.4
Total liabilities and equity	$	24,598.4	$	24,554.1

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

(unaudited, in millions)


	For the Three Months Ended March 31,
	2023		2022
Cash flow from operating activities:
Net income	$	387.6	$	218.5
Adjustments to reconcile net income to net cash flow from operating activities:
Depreciation and amortization	112.3		143.1

Excess and obsolescence charges related to inventory	17.4		281.5

Share-based compensation	75.6		67.6
Contingent consideration	—		(7.1)
Deferred income taxes	(64.5)		1.0
(Gain) loss on strategic investments	79.6		191.1
(Gain) loss on equity method investments	—		3.3


Other	31.4		43.3
Changes in operating assets and liabilities, net:
Accounts receivable	77.2		(87.5)
Due from anti-CD20 therapeutic programs	37.6		22.9
Inventory	27.9		(142.6)
Accrued expense and other current liabilities	(295.0)		(461.6)
Income tax assets and liabilities	65.0		101.9
Other changes in operating assets and liabilities, net	(96.8)		(213.6)
Net cash flow provided by (used in) operating activities	455.3		161.8
Cash flow from investing activities:
Purchases of property, plant and equipment	(66.6)		(57.9)
Proceeds from sales and maturities of marketable securities	406.7		543.6
Purchases of marketable securities	(1,321.2)		(1,133.5)




Acquisitions of intangible assets	(5.0)		—
Proceeds from sales of strategic investments	33.8		—
Other	(0.7)		(0.2)
Net cash flow provided by (used in) investing activities	(953.0)		(648.0)
Cash flow from financing activities:

Payments related to issuance of stock for share-based compensation arrangements, net	(60.1)		(20.8)



Net (distribution) contribution to noncontrolling interest	0.2		0.2
Other	16.5		4.1
Net cash flow provided by (used in) financing activities	(43.4)		(16.5)
Net increase (decrease) in cash and cash equivalents	(541.1)		(502.7)
Effect of exchange rate changes on cash and cash equivalents	20.0		(9.4)
Cash and cash equivalents, beginning of the period	3,419.3		2,261.4
Cash and cash equivalents, end of the period	$	2,898.2	$	1,749.3

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EQUITY

(unaudited, in millions)


	Preferred stock			Common stock			Additional paid-in capital		Accumulated other comprehensive loss		Retained earnings		Treasury stock			Total Biogen Inc. shareholders’ equity		Noncontrolling interests		Total equity
	Shares	Amount		Shares	Amount								Shares	Amount
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	—	—		—	—		—		—		387.9		—	—		387.9		(0.3)		387.6
Other comprehensive income (loss), net of tax	—	—		—	—		—		(7.1)		—		—	—		(7.1)		—		(7.1)

Capital contribution from noncontrolling interest	—	—		—	—		—		—		—		—	—		—		0.2		0.2


Issuance of common stock under stock option and stock purchase plans	—	—		0.1	—		20.1		—		—		—	—		20.1		—		20.1
Issuance of common stock under stock award plan	—	—		0.6	—		(80.2)		—		—		—	—		(80.2)		—		(80.2)
Compensation related to share-based payments	—	—		—	—		78.9		—		—		—	—		78.9		—		78.9
Other	—	—		—	—		(0.9)		—		—		—	—		(0.9)		—		(0.9)
Balance, March 31, 2023	—	$	—	168.6	$	0.1	$	91.2	$	(172.0)	$	16,854.4	(23.8)	$	(2,977.1)	$	13,796.6	$	(9.6)	$	13,787.0

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EQUITY - (Continued)

(unaudited, in millions)


	Preferred stock			Common stock			Additional paid-in capital		Accumulated other comprehensive loss		Retained earnings		Treasury stock			Total Biogen Inc. shareholders’ equity		Noncontrolling interests		Total equity
	Shares	Amount		Shares	Amount								Shares	Amount
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	—	—		—	—		—		—		303.8		—	—		303.8		(85.3)		218.5
Other comprehensive income (loss), net of tax	—	—		—	—		—		(8.5)		—		—	—		(8.5)		—		(8.5)

Capital contribution from noncontrolling interest	—	—		—	—		—		—		—		—	—		—		0.2		0.2


Issuance of common stock under stock option and stock purchase plans	—	—		0.1	—		18.9		—		—		—	—		18.9		—		18.9
Issuance of common stock under stock award plan	—	—		0.4	—		(39.7)		—		—		—	—		(39.7)		—		(39.7)
Compensation related to share-based payments	—	—		—	—		70.4		—		—		—	—		70.4		—		70.4
Other	—	—		—	—		1.2		—		—		—	—		1.2		—		1.2
Balance, March 31, 2022	—	$	—	171.3	$	0.1	$	119.0	$	(115.2)	$	14,215.5	(23.8)	$	(2,977.1)	$	11,242.3	$	(21.6)	$	11,220.7

See accompanying notes to these unaudited condensed consolidated financial statements.

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BIOGEN INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)


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 worldwide. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA and co-developed two treatments to address a defining pathology of Alzheimer's disease. We are focused on advancing our pipeline in neurology, neuropsychiatry, specialized immunology and rare diseases. We support our drug discovery and development efforts through internal research and development programs and external collaborations.

Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We also collaborate with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted accelerated approval by the FDA in January 2023. 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, which was granted accelerated approval in the U.S. during the fourth quarter of 2022 for the treatment of relapsed or refractory follicular lymphoma; glofitamab, an investigational bispecific antibody for the potential treatment of non-Hodgkin's lymphoma; and 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.

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

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

For additional information on our collaboration arrangements, please read Note 16, Collaborative and Other Relationships, to these unaudited condensed consolidated financial statements (condensed consolidated financial statements). For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our audited consolidated financial statements included in our 2022 Form 10-K.

Basis of Presentation

In the opinion of management, our condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair statement of our financial statements for interim periods in accordance with U.S. GAAP. The information included in this quarterly report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our 2022 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2022 Form 10-K and updated, as necessary, in this report. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three months ended March 31, 2023, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period.

We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

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Consolidation

Our condensed consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries and certain 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 condensed 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.

Use of Estimates

The preparation of our condensed 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.

The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, the supply chain, manufacturing, clinical trials, research and development costs and employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets. Additionally, the ongoing geopolitical tensions related to the conflict in Ukraine, and the related sanctions and other penalties imposed, are creating substantial uncertainty in the global economy. The extent and duration of the conflict, sanctions and resulting market disruptions are highly unpredictable. We have made estimates of the impact of the COVID-19 pandemic and the ongoing geopolitical conflict within our condensed consolidated financial statements and there may be changes to those estimates in future periods.

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 had or may have a material impact on our condensed consolidated financial statements or disclosures.

Fair Value Measurements

In June 2022 the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for us on January 1, 2024. We elected to early adopt this standard on a prospective basis during the third quarter of 2022. Upon adoption, we recorded an immaterial amount in other (income) expense, net in our condensed consolidated statements of income, as a result of removing the impact of the remaining contractual sale restrictions from the fair value measurement of certain shares in Sage.

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Note 2:			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. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments. The first payment of approximately $812.5 million was received in April 2023 and the second payment of approximately $437.5 million is due at the second anniversary of the closing of this transaction.

Prior to the sale, the carrying value of our investment in Samsung Bioepis totaled $581.6 million. During the second quarter of 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 condensed 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 elected the fair value option and measured the payments due to us from Samsung BioLogics at fair value. As of March 31, 2023, the estimated fair values of the first and second payments using risk-adjusted discount rates of 5.9% and 5.8%, respectively, were approximately $809.9 million and $411.6 million, respectively. These payments have been classified as Level 3 measurements and are reflected in other current assets and investments and other assets, respectively, in our condensed consolidated balance sheets.

For the three months ended March 31, 2023, we recognized a gain of approximately $11.1 million and $6.2 million to reflect the changes in fair value related to the first and second payments due to us, respectively. These changes were recorded in other (income) expense, net in our condensed 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 that they become realizable, which is generally the same period in which the payments are earned.


Note 3:			Restructuring

2022 Cost Saving Initiatives

In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures during 2022. These savings are being achieved through a number of initiatives, including reductions to our workforce, the substantial elimination of our commercial ADUHELM infrastructure, the consolidation of certain real estate locations and operating efficiencies across our selling, general and administrative and research and development functions.

Under these initiatives, we estimate we will incur total restructuring charges of approximately $135.0 million, primarily related to severance. These amounts were substantially incurred during 2022. As of March 31, 2023, $28.0 million remained in our restructuring reserve and payments are expected to be made through 2026.

For the three months ended March 31, 2023 and 2022, we recognized $9.6 million and $38.1 million, respectively, of net pre-tax restructuring charges, of which approximately $7.1 million and $27.7 million, respectively, consisted of employee severance costs. These costs were recorded in restructuring charges in our condensed consolidated statements of income. Our restructuring reserve is included in accrued expense and other in our condensed consolidated balance sheets.

In September 2022 we entered into an agreement to partially terminate a portion of our lease located at 300 Binney Street, as well as to reduce the lease term for the majority of the remaining space. This resulted in a gain of approximately $5.3 million, which was recorded within restructuring charges in our condensed consolidated statements of income during the third quarter of 2022. For additional information on our 300 Binney Street lease modification, please read Note 12, Leases, to our consolidated financial statements included in our 2022 Form 10-K.

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Following an evaluation of our current capacity needs, in March 2022 we ceased using a patient services office space in Durham, North Carolina. Our decision to cease use of the facility resulted in the immediate expense of certain leasehold improvements and other assets at this facility. As a result, we recognized approximately $10.4 million of accelerated depreciation expense, which was recorded in restructuring charges in our condensed consolidated statements of income for the three months ended March 31, 2022. In May 2022 we entered into a lease assignment agreement whereby we assigned our remaining lease obligations to an external third party. As a result of the lease assignment, we derecognized the related operating lease obligation and right-of-use asset during the second quarter of 2022.

For the three months ended March 31, 2023, we recognized other restructuring costs of approximately $2.5 million, which were recorded in restructuring charges in our condensed consolidated statements of income. Other restructuring costs include items such as facility closure costs, employee non-severance expense, asset write-offs and other costs.

Charges and spending related to our workforce reductions is summarized as follows:


	For the Three Months Ended March 31,
(In millions)	2023			2022
Restructuring reserve as of December 31	$	35.9		$	—
Expense	7.1			27.7
Payment	(15.6)			(6.2)
Foreign currency and other adjustments	0.6			—
Restructuring reserve as of March 31	$	28.0	—	$	21.5

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Note 4:			Revenue

Product Revenue

Revenue by product is summarized as follows:


	For the Three Months Ended March 31,
	2023						2022
(In millions)	United States		Rest of World		Total		United States		Rest of World		Total
Multiple Sclerosis (MS):
TECFIDERA	$	74.7	$	199.8	$	274.5	$	117.1	$	292.8	$	409.9
VUMERITY	93.5		14.7		108.2		125.2		2.8		128.0
Total Fumarate	168.2		214.5		382.7		242.3		295.6		537.9
AVONEX	102.6		69.8		172.4		148.0		81.6		229.6
PLEGRIDY	29.9		43.3		73.2		34.3		45.7		80.0
Total Interferon	132.5		113.1		245.6		182.3		127.3		309.6
TYSABRI	245.4		227.4		472.8		284.5		236.3		520.8
FAMPYRA	—		24.1		24.1		—		26.2		26.2
Subtotal: MS	546.1		579.1		1,125.2		709.1		685.4		1,394.5

Spinal Muscular Atrophy:
SPINRAZA	146.7		296.6		443.3		163.3		309.2		472.5

Biosimilars:
BENEPALI	—		109.0		109.0		—		114.7		114.7
IMRALDI	—		54.4		54.4		—		57.1		57.1
FLIXABI	—		20.4		20.4		—		22.5		22.5
BYOOVIZ	8.2		0.4		8.6		—		—		—
Subtotal: Biosimilars	8.2		184.2		192.4		—		194.3		194.3




Other(1)	0.4		2.0		2.4		2.8		2.2		5.0
Total product revenue	$	701.4	$	1,061.9	$	1,763.3	$	875.2	$	1,191.1	$	2,066.3

(1) Other includes FUMADERM and ADUHELM.

We recognized revenue from two wholesalers accounting for 27.3% and 7.4% of gross product revenue for the three months ended March 31, 2023, and 26.3% and 10.5% of gross product revenue for the three months ended March 31, 2022.

An analysis of the change in reserves for discounts and allowances is summarized as follows:


(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	182.3		638.0		3.5		823.8
Adjustments relating to prior years	(1.1)		(8.1)		1.0		(8.2)
Payments/credits relating to sales in current year	(94.0)		(261.8)		(1.0)		(356.8)
Payments/credits relating to sales in prior years	(73.3)		(368.1)		(7.4)		(448.8)
Balance, March 31, 2023	$	167.7	$	857.7	$	19.6	$	1,045.0

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The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:


(In millions)	As of March 31, 2023		As of December 31, 2022
Reduction of accounts receivable	$	137.8	$	143.4
Component of accrued expense and other	907.2		891.6
Total revenue-related reserves	$	1,045.0	$	1,035.0

Revenue from LEQEMBI Collaboration

In January 2023 the FDA granted accelerated approval of LEQEMBI, which became commercially available in the U.S. during the first quarter of 2023. Upon commercialization, we began recognizing commercial profits and losses related to the LEQEMBI Collaboration Agreement on a net basis as a separate component of total revenue within our condensed consolidated income statements, as we are not the principal.

For the three months ended March 31, 2023, we recognized a reduction to revenue of approximately $18.9 million, reflecting our net profit-share of the LEQEMBI Collaboration results in the U.S.

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

Revenue from Anti-CD20 Therapeutic Programs

Revenue from anti-CD20 therapeutic programs is summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.


	For the Three Months Ended March 31,
(In millions)	2023		2022
Royalty revenue on sales of OCREVUS	$	283.6	$	252.3
Biogen’s share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO	112.5		143.2
Other revenue from anti-CD20 therapeutic programs	3.4