SEC Filing | Biogen

View:

biib-20220930

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 September 30, 2022


☐			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 October 24, 2022, was 144,001,404 shares.

Table of Contents

BIOGEN INC.

FORM 10-Q — Quarterly Report

For the Quarterly Period Ended September 30, 2022

TABLE OF CONTENTS


		Page
PART I — FINANCIAL INFORMATION

Item 1.	Financial Statements (unaudited)

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

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

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

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

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

	Notes to Condensed Consolidated Financial Statements	13

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	47

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	81

Item 4.	Controls and Procedures	83

PART II — OTHER INFORMATION

Item 1.	Legal Proceedings	84

Item 1A.	Risk Factors	84

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	99

Item 6.	Exhibits	100

Signatures		101

Table of Contents

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 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 United States (U.S.), including the Inflation Reduction Act of 2022 (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 Research Triangle Park (RTP), North Carolina to be operational;

Table of Contents

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

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

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

These forward-looking statements involve risks and uncertainties, including those that are described in Item 1A. Risk Factors included in this report and elsewhere in this report, that could cause actual results to differ materially from those reflected in such statements. 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

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

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

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

Table of Contents

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 September 30,				For the Nine Months Ended September 30,
	2022		2021		2022		2021
Revenue:
Product, net	$	1,962.1	$	2,205.7	$	6,083.3	$	6,653.4
Revenue from anti-CD20 therapeutic programs	416.9		415.4		1,252.6		1,244.4
Other	129.5		157.8		293.5		350.1
Total revenue	2,508.5		2,778.9		7,629.4		8,247.9
Cost and expense:
Cost of sales, excluding amortization and impairment of acquired intangible assets	469.5		511.8		1,707.4		1,449.6
Research and development	549.2		702.4		1,629.5		1,801.7
Selling, general and administrative	563.3		654.1		1,770.8		1,886.4
Amortization and impairment of acquired intangible assets	56.5		111.0		190.9		813.2
Collaboration profit (loss) sharing	45.3		21.2		(42.6)		74.5
(Gain) loss on fair value remeasurement of contingent consideration	(2.1)		(15.6)		(13.7)		(49.1)
Acquired in-process research and development	—		—		—		18.0
Restructuring charges	15.4		—		124.1		—
Gain on sale of building	(503.7)		—		(503.7)		—
Other (income) expense, net	(56.0)		502.9		(221.3)		913.4
Total cost and expense	1,137.4		2,487.8		4,641.4		6,907.7
Income before income tax expense and equity in loss of investee, net of tax	1,371.1		291.1		2,988.0		1,340.2
Income tax (benefit) expense	236.2		(25.9)		578.5		(390.7)
Equity in (income) loss of investee, net of tax	—		(1.1)		(2.6)		(17.2)
Net income	1,134.9		318.1		2,412.1		1,748.1
Net income (loss) attributable to noncontrolling interests, net of tax	0.2		(11.1)		(84.4)		560.2
Net income attributable to Biogen Inc.	$	1,134.7	$	329.2	$	2,496.5	$	1,187.9

Net income per share:
Basic earnings per share attributable to Biogen Inc.	$	7.86	$	2.22	$	17.12	$	7.93
Diluted earnings per share attributable to Biogen Inc.	$	7.84	$	2.22	$	17.07	$	7.90

Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc.	144.4		148.0		145.8		149.9
Diluted earnings per share attributable to Biogen Inc.	144.8		148.6		146.2		150.3

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(unaudited, in millions)


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

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in millions, except per share amounts)


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

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

BIOGEN INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

(unaudited, in millions)


	For the Nine Months Ended September 30,
	2022		2021
Cash flow from operating activities:
Net income	$	2,412.1	$	1,748.1
Adjustments to reconcile net income to net cash flow from operating activities:
Depreciation and amortization	398.6		353.0
Impairment of intangible assets	—		629.3
Excess and obsolescence charges related to inventory	321.6		36.5
Acquired in-process research and development	—		18.0
Share-based compensation	186.9		179.8
Contingent consideration	(13.7)		(49.1)
Deferred income taxes	(139.8)		(750.1)
(Gain) loss on strategic investments	160.3		710.5
(Gain) loss on equity method investments	(2.6)		(17.2)
Gain on sale of equity interest in Samsung Bioepis	(1,505.4)		—
Gain on sale of building	(503.7)		—
Other	147.8		164.5
Changes in operating assets and liabilities, net:
Accounts receivable	(109.5)		157.8
Due from anti-CD20 therapeutic programs	(3.0)		13.5
Inventory	(338.3)		(322.6)
Accrued expense and other current liabilities	632.3		(243.3)
Income tax assets and liabilities	(100.2)		260.5
Other changes in operating assets and liabilities, net	15.9		(87.6)
Net cash flow provided by (used in) operating activities	1,559.3		2,801.6
Cash flow from investing activities:
Purchases of property, plant and equipment	(153.9)		(206.5)
Proceeds from sales and maturities of marketable securities	3,104.7		2,028.1
Purchases of marketable securities	(2,805.9)		(2,372.6)
Proceeds from sale of equity interest in Samsung Bioepis	990.3		—
Proceeds from sale of building	582.6		—
Proceeds from divestiture of Hillerød, Denmark manufacturing operations	—		28.1
Acquired in-process research and development	—		(18.0)
Acquisitions of intangible assets	(1.9)		(1.9)
Proceeds from sales of strategic investments	—		91.2
Other	1.8		0.6
Net cash flow provided by (used in) investing activities	1,717.7		(451.0)
Cash flow from financing activities:
Purchases of treasury stock	(750.0)		(1,800.0)
Payments related to issuance of stock for share-based compensation arrangements, net	(5.8)		(8.3)
Repayment of borrowings and premiums paid	(1,002.2)		(170.0)


Net (distribution) contribution to noncontrolling interest	12.2		(94.8)
Other	5.9		(22.9)
Net cash flow provided by (used in) financing activities	(1,739.9)		(2,096.0)
Net increase (decrease) in cash and cash equivalents	1,537.1		254.6
Effect of exchange rate changes on cash and cash equivalents	(122.9)		(44.0)
Cash and cash equivalents, beginning of the period	2,261.4		1,331.2
Cash and cash equivalents, end of the period	$	3,675.6	$	1,541.8

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

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, June 30, 2022	—	$	—	169.0	$	0.1	$	—	$	(110.4)	$	14,959.9	(23.8)	$	(2,977.1)	$	11,872.5	$	(9.1)	$	11,863.4
Net income	—	—		—	—		—		—		1,134.7		—	—		1,134.7		0.2		1,134.9
Other comprehensive income (loss), net of tax	—	—		—	—		—		(53.2)		—		—	—		(53.2)		—		(53.2)

Capital contribution from noncontrolling interest	—	—		—	—		—		—		—		—	—		—		0.2		0.2
Repurchase of common stock pursuant to the 2020 Share Repurchase Program, at cost	—	—		—	—		—		—		—		(1.2)	(250.0)		(250.0)		—		(250.0)
Retirement of common stock pursuant to the 2020 Share Repurchase Program, at cost	—	—		(1.2)	—		(71.5)		—		(178.5)		1.2	250.0		—		—		—
Issuance of common stock under stock option and stock purchase plans	—	—		—	—		8.6		—		—		—	—		8.6		—		8.6
Issuance of common stock under stock award plan	—	—		—	—		(2.8)		—		—		—	—		(2.8)		—		(2.8)
Compensation related to share-based payments	—	—		—	—		65.7		—		—		—	—		65.7		—		65.7
Other	—	—		—	—		—		—		—		—	—		—		—		—
Balance, September 30, 2022	—	$	—	167.8	$	0.1	$	—	$	(163.6)	$	15,916.1	(23.8)	$	(2,977.1)	$	12,775.5	$	(8.7)	$	12,766.8

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

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	—	—		—	—		—		—		2,496.5		—	—		2,496.5		(84.4)		2,412.1
Other comprehensive income (loss), net of tax	—	—		—	—		—		(56.9)		—		—	—		(56.9)		—		(56.9)

Capital contribution from noncontrolling interest	—	—		—	—		—		—		—		—	—		—		12.2		12.2
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	—		37.5		—		—		—	—		37.5		—		37.5
Issuance of common stock under stock award plan	—	—		0.4	—		(43.2)		—		—		—	—		(43.2)		—		(43.2)
Compensation related to share-based payments	—	—		—	—		194.1		—		—		—	—		194.1		—		194.1
Other	—	—		—	—		1.3		—		—		—	—		1.3		—		1.3
Balance, September 30, 2022	—	$	—	167.8	$	0.1	$	—	$	(163.6)	$	15,916.1	(23.8)	$	(2,977.1)	$	12,775.5	$	(8.7)	$	12,766.8

See accompanying notes to these unaudited condensed consolidated financial statements.

Table of Contents

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