Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 02, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 0-19311 | ||
Entity Registrant Name | BIOGEN INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0112644 | ||
Entity Address, Address Line One | 225 Binney Street | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02142 | ||
City Area Code | 617 | ||
Local Phone Number | 679-2000 | ||
Title of 12(b) Security | Common Stock, $0.0005 par value | ||
Trading Symbol | BIIB | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 51,264,577,902 | ||
Entity Common Stock, Shares Outstanding | 146,962,793 | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2022 Annual Meeting of Stockholders are incorporated by reference into Part III of this report. | ||
Entity Central Index Key | 0000875045 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 238 |
Auditor Location | Boston, Massachusetts |
Auditor Name | PricewaterhouseCoopers LLP |
Consolidated Statements of Inco
Consolidated Statements of Income - USD ($) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Cost and expense: | |||
Cost of sales, excluding amortization and impairment of acquired intangible assets | 2,109.7 | 1,805.2 | 1,955.4 |
Research and development | 2,501.2 | 3,990.9 | 2,280.6 |
Selling, general and administrative | 2,674.3 | 2,504.5 | 2,374.7 |
Amortization and impairment of acquired intangible assets | 881.3 | 464.8 | 489.9 |
Collaboration profit (loss) sharing | 7.2 | 232.9 | 241.6 |
(Gain) loss on divestiture of Hillerød, Denmark manufacturing operations | 0 | (92.5) | 55.3 |
(Gain) loss on fair value remeasurement of contingent consideration | (50.7) | (86.3) | (63.7) |
Acquired in-process research and development | 18 | 75 | 0 |
Restructuring charges | 0 | 0 | 1.5 |
Total cost and expense | 8,141 | 8,894.5 | 7,335.3 |
Income from operations | 2,840.7 | 4,550.1 | 7,042.6 |
Other income (expense), net | (1,095.5) | 497.4 | 83.3 |
Income before income tax expense and equity in loss of investee, net of tax | 1,745.2 | 5,047.5 | 7,125.9 |
Income tax (benefit) expense | 52.5 | 992.3 | 1,158 |
Equity in (income) loss of investee, net of tax | (34.9) | (5.3) | 79.4 |
Net income | 1,727.6 | 4,060.5 | 5,888.5 |
Net income (loss) attributable to noncontrolling interests, net of tax | 171.5 | 59.9 | 0 |
Net income attributable to Biogen Inc. | $ 1,556.1 | $ 4,000.6 | $ 5,888.5 |
Net income per share: | |||
Basic earnings per share attributable to Biogen Inc. (in dollars per share) | $ 10.44 | $ 24.86 | $ 31.47 |
Diluted earnings per share attributable to Biogen Inc. (in dollars per share) | $ 10.40 | $ 24.80 | $ 31.42 |
Weighted-average shares used in calculating: | |||
Weighted average number of common shares outstanding (in shares) | 149.1 | 160.9 | 187.1 |
Diluted earnings per share attributable to Biogen Inc. (in shares) | 149.6 | 161.3 | 187.4 |
Product, net | |||
Revenues | $ 8,846.9 | $ 10,692.2 | $ 11,379.8 |
Revenue from anti-CD20 therapeutic programs | |||
Revenues | 1,658.5 | 1,977.8 | 2,290.4 |
Other | |||
Revenues | $ 476.3 | $ 774.6 | $ 707.7 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net income attributable to Biogen Inc. | $ 1,556.1 | $ 4,000.6 | $ 5,888.5 |
Other comprehensive income: | |||
Unrealized gains (losses) on securities available for sale, net of tax | (3.6) | (2.8) | 8.2 |
Unrealized gains (losses) on cash flow hedges, net of tax | 232.8 | (186.8) | (26.9) |
Gains (losses) on net investment hedges, net of tax | 34 | (33.6) | 21.6 |
Unrealized gains (losses) on pension benefit obligation, net of tax | 21.5 | (33.5) | (1.5) |
Currency translation adjustment | (92.4) | 92.9 | 103.8 |
Total other comprehensive income (loss), net of tax | 192.3 | (163.8) | 105.2 |
Comprehensive income attributable to Biogen Inc. | 1,748.4 | 3,836.8 | 5,993.7 |
Comprehensive income (loss) attributable to noncontrolling interests, net of tax | 172.1 | 60.9 | (0.4) |
Comprehensive income | $ 1,920.5 | $ 3,897.7 | $ 5,993.3 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 2,261.4 | $ 1,331.2 |
Marketable securities | 1,541.1 | 1,278.9 |
Accounts receivable, net | 1,549.4 | 1,913.8 |
Due from anti-CD20 therapeutic programs | 412.3 | 413.5 |
Inventory | 1,351.5 | 1,068.6 |
Other current assets | 740.8 | 881.1 |
Total current assets | 7,856.5 | 6,887.1 |
Marketable securities | 892 | 772.1 |
Property, plant and equipment, net | 3,416.4 | 3,411.5 |
Operating lease assets | 375.4 | 433.3 |
Intangible assets, net | 2,221.3 | 3,084.3 |
Goodwill | 5,761.1 | 5,762.1 |
Deferred tax asset | 1,415.1 | 1,369.5 |
Investments and other assets | 1,939.5 | 2,899 |
Total assets | 23,877.3 | 24,618.9 |
Current liabilities: | ||
Current portion of notes payable | 999.1 | 0 |
Taxes payable | 174.7 | 142 |
Accounts payable | 589.2 | 454.9 |
Accrued expense and other | 2,535.2 | 3,145.3 |
Total current liabilities | 4,298.2 | 3,742.2 |
Notes payable | 6,274 | 7,426.2 |
Deferred tax liability | 694.5 | 1,032.8 |
Long-term operating lease liabilities | 330.4 | 402 |
Other long-term liabilities | 1,320.5 | 1,329.6 |
Total liabilities | 12,917.6 | 13,932.8 |
Commitments, contingencies and guarantees (Notes 21 and 22) | ||
Biogen Inc. shareholders’ equity | ||
Preferred stock, par value $0.001 per share | 0 | 0 |
Common stock, par value $0.0005 per share | 0.1 | 0.1 |
Additional paid-in capital | 68.2 | 0 |
Accumulated other comprehensive loss | (106.7) | (299) |
Retained earnings | 13,911.7 | 13,976.3 |
Treasury stock, at cost; 23.8 million and 23.8 million shares, respectively | (2,977.1) | (2,977.1) |
Total Biogen Inc. shareholders’ equity | 10,896.2 | 10,700.3 |
Noncontrolling interests | 63.5 | (14.2) |
Total equity | 10,959.7 | 10,686.1 |
Total liabilities and equity | $ 23,877.3 | $ 24,618.9 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, par value (in dollars per share) | $ 0.0005 | $ 0.0005 |
Treasury stock at cost, shares (in shares) | 23.8 | 23.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flow from operating activities: | |||
Net income | $ 1,727.6 | $ 4,060.5 | $ 5,888.5 |
Adjustments to reconcile net income to net cash flow from operating activities: | |||
Depreciation and amortization | 487.7 | 457.2 | 464.7 |
Impairment of intangible assets | 629.3 | 209.7 | 215.9 |
Excess and obsolescence charges related to inventory | 167.6 | 26.6 | 52.2 |
Acquired in-process research and development | 18 | 75 | 0 |
Share-based compensation | 238.6 | 198.3 | 182.3 |
Changes in fair value | (50.7) | (86.3) | (63.7) |
(Gain)/loss on divestiture of Hillerød, Denmark manufacturing operations | 0 | (92.5) | 55.3 |
Deferred income taxes | (426.8) | 149 | 67.1 |
(Gain) loss on strategic investments | 826.8 | (681.8) | (147.3) |
(Gain) loss on equity method investment | (34.9) | (3.3) | 77.4 |
Other | 202.2 | 104.6 | 86.9 |
Changes in operating assets and liabilities, net: | |||
Accounts receivable | 324.8 | 2.8 | 68.8 |
Due from anti-CD20 therapeutic programs | 1.2 | 176.7 | (63.3) |
Inventory | (462.4) | (316.3) | (19.2) |
Accrued expense and other current liabilities | (95.4) | 154.2 | 240.2 |
Income tax assets and liabilities | 230.8 | (67.5) | 16.1 |
Other changes in operating assets and liabilities, net | (144.5) | (137.1) | (43.3) |
Net cash flow provided by operating activities | 3,639.9 | 4,229.8 | 7,078.6 |
Cash flow from investing activities: | |||
Purchases of property, plant and equipment | (258.1) | (424.8) | (514.5) |
Proceeds from sales and maturities of marketable securities | 3,405.4 | 7,299.4 | 6,007 |
Purchases of marketable securities | (3,808.7) | (6,397.7) | (5,252.6) |
Contingent consideration paid related to Fumapharm AG acquisition | 0 | 0 | (300) |
Acquisition of Nightstar Therapeutics plc, net of cash acquired | 0 | 0 | (744.4) |
Proceeds from divestiture of Hillerød, Denmark manufacturing operations | 28.1 | 0 | 923.7 |
Acquired in-process research and development | (18) | (75) | 0 |
Acquisitions of intangible assets | (18.8) | (52) | (155) |
Proceeds from sales of strategic investments | 93.5 | 74.9 | 479.3 |
Other | 12.9 | (26.9) | 27 |
Net cash flow (used in) provided by investing activities | (563.7) | (608.6) | 470.5 |
Cash flow from financing activities: | |||
Purchase of treasury stock | (1,800) | (6,679.1) | (5,868.3) |
Payments related to issuance of stock for share-based compensation arrangements, net | (0.7) | (4.6) | 0 |
Repayments of borrowings and premiums paid on debt exchange | (170) | 0 | 0 |
Proceeds from borrowings | 0 | 2,967.4 | 0 |
Repayments of borrowings | 0 | (1,500) | 0 |
Net (distribution) contribution to noncontrolling interest | (94.4) | (71) | 4.3 |
Other | (21.1) | 14.6 | 3.6 |
Net cash flow used in financing activities | (2,086.2) | (5,272.7) | (5,860.4) |
Net increase (decrease) in cash and cash equivalents | 990 | (1,651.5) | 1,688.7 |
Effect of exchange rate changes on cash and cash equivalents | (59.8) | 69 | 0.4 |
Cash and cash equivalents, beginning of the year | 1,331.2 | 2,913.7 | 1,224.6 |
Cash and cash equivalents, end of the year | 2,261.4 | 1,331.2 | 2,913.7 |
Sangamo Therapeutics, Inc. Agreement | |||
Cash flow from investing activities: | |||
Purchase of subsidiaries and affiliates | 0 | (141.8) | 0 |
Denali Therapeutics | |||
Cash flow from investing activities: | |||
Purchase of subsidiaries and affiliates | 0 | (423.7) | 0 |
Sage Therapeutics | |||
Cash flow from investing activities: | |||
Purchase of subsidiaries and affiliates | $ 0 | $ (441) | $ 0 |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) shares in Millions, $ in Millions | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Retained earnings | Treasury stock | Total Biogen Inc. shareholders’ equity | Noncontrolling interests | 2020 Share Repurchase Program | 2020 Share Repurchase ProgramCommon stock | 2020 Share Repurchase ProgramAdditional paid-in capital | 2020 Share Repurchase ProgramRetained earnings | 2020 Share Repurchase ProgramTreasury stock | 2020 Share Repurchase ProgramTotal Biogen Inc. shareholders’ equity | December 2019 Share Repurchase Program | December 2019 Share Repurchase ProgramCommon stock | December 2019 Share Repurchase ProgramAdditional paid-in capital | December 2019 Share Repurchase ProgramRetained earnings | December 2019 Share Repurchase ProgramTreasury stock | December 2019 Share Repurchase ProgramTotal Biogen Inc. shareholders’ equity | March 2019 Share Repurchase Program | March 2019 Share Repurchase ProgramCommon stock | March 2019 Share Repurchase ProgramAdditional paid-in capital | March 2019 Share Repurchase ProgramRetained earnings | March 2019 Share Repurchase ProgramTreasury stock | March 2019 Share Repurchase ProgramTotal Biogen Inc. shareholders’ equity | 2018 Share Repurchase Program | 2018 Share Repurchase ProgramCommon stock | 2018 Share Repurchase ProgramAdditional paid-in capital | 2018 Share Repurchase ProgramRetained earnings | 2018 Share Repurchase ProgramTreasury stock | 2018 Share Repurchase ProgramTotal Biogen Inc. shareholders’ equity |
Beginning balance (in shares) at Dec. 31, 2018 | 221 | 23.8 | ||||||||||||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ 13,031.6 | $ 0.1 | $ 0 | $ (240.4) | $ 16,257 | $ (2,977.1) | $ 13,039.6 | $ (8) | ||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||||||||||||
Net income | 5,888.5 | 5,888.5 | 5,888.5 | |||||||||||||||||||||||||||||
Other comprehensive income (loss), net of tax | 104.8 | 105.2 | 105.2 | (0.4) | ||||||||||||||||||||||||||||
Capital contribution from noncontrolling interest | 4.3 | 4.3 | ||||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost (in shares) | (14.7) | (14.7) | (8.9) | (8.9) | ||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost | $ (3,720.9) | $ (3,720.9) | $ (3,720.9) | $ (2,147.4) | $ (2,147.4) | $ (2,147.4) | ||||||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost (in shares) | 14.7 | 14.7 | 8.9 | 8.9 | ||||||||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost | $ 0 | $ (121.5) | $ (3,599.4) | $ 3,720.9 | $ 0 | $ (110.5) | $ (2,036.9) | $ 2,147.4 | ||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans (in shares) | 0.2 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 40.8 | 40.8 | 40.8 | |||||||||||||||||||||||||||||
Issuance of common stock under stock award plan (in shares) | 0.4 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (53.8) | (53.8) | (53.8) | |||||||||||||||||||||||||||||
Compensation expense related to share-based payments | 191.2 | 191.2 | 191.2 | |||||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 198 | 23.8 | ||||||||||||||||||||||||||||||
Ending balance at Dec. 31, 2019 | 13,339.1 | $ 0.1 | 0 | (135.2) | 16,455.4 | $ (2,977.1) | 13,343.2 | (4.1) | ||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||||||||||||
Net income | 4,060.5 | 4,000.6 | 4,000.6 | 59.9 | ||||||||||||||||||||||||||||
Other comprehensive income (loss), net of tax | (162.8) | (163.8) | (163.8) | 1 | ||||||||||||||||||||||||||||
Distribution to noncontrolling interest | (75) | (75) | ||||||||||||||||||||||||||||||
Capital contribution from noncontrolling interest | 4 | 4 | ||||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost (in shares) | (1.6) | (1.6) | (16.7) | (16.7) | (4.1) | (4.1) | ||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost | $ (400) | $ (400) | $ (400) | $ (5,000) | $ (5,000) | $ (5,000) | $ (1,279.1) | $ (1,279.1) | $ (1,279.1) | |||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost (in shares) | 1.6 | 1.6 | 16.7 | 16.7 | 4.1 | 4.1 | ||||||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost | $ 0 | $ (60.8) | $ (339.2) | $ 400 | $ 0 | $ (121.3) | $ (4,878.7) | $ 5,000 | $ 0 | $ (71) | $ (1,208.1) | $ 1,279.1 | ||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans (in shares) | 0.2 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 49.3 | 49.3 | 49.3 | |||||||||||||||||||||||||||||
Issuance of common stock under stock award plan (in shares) | 0.4 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (53.7) | (53.7) | (53.7) | |||||||||||||||||||||||||||||
Compensation expense related to share-based payments | 204.5 | 204.5 | 204.5 | |||||||||||||||||||||||||||||
Other | (0.7) | (0.7) | (0.7) | |||||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 176.2 | 23.8 | ||||||||||||||||||||||||||||||
Ending balance at Dec. 31, 2020 | 10,686.1 | $ 0.1 | 0 | (299) | 13,976.3 | $ (2,977.1) | 10,700.3 | (14.2) | ||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||||||||||||
Net income | 1,727.6 | 1,556.1 | 1,556.1 | 171.5 | ||||||||||||||||||||||||||||
Other comprehensive income (loss), net of tax | 192.9 | 192.3 | 192.3 | 0.6 | ||||||||||||||||||||||||||||
Distribution to noncontrolling interest | (100) | (100) | ||||||||||||||||||||||||||||||
Capital contribution from noncontrolling interest | 5.6 | 5.6 | ||||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost (in shares) | (6) | (6) | ||||||||||||||||||||||||||||||
Repurchase of common stock pursuant to the share repurchase program, at cost | $ (1,800) | $ (1,800) | $ (1,800) | |||||||||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost (in shares) | 6 | 6 | ||||||||||||||||||||||||||||||
Retirement of common stock pursuant to the share repurchase program, at cost | $ 0 | $ (231.9) | $ (1,568.1) | $ 1,800 | ||||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans (in shares) | 0.2 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 54.4 | 54.4 | 0 | 54.4 | ||||||||||||||||||||||||||||
Issuance of common stock under stock award plan (in shares) | 0.4 | |||||||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (55) | (2.4) | (52.6) | (55) | ||||||||||||||||||||||||||||
Compensation expense related to share-based payments | 246.6 | 246.6 | 246.6 | |||||||||||||||||||||||||||||
Other | 1.5 | 1.5 | 1.5 | |||||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 170.8 | 23.8 | ||||||||||||||||||||||||||||||
Ending balance at Dec. 31, 2021 | $ 10,959.7 | $ 0.1 | $ 68.2 | $ (106.7) | $ 13,911.7 | $ (2,977.1) | $ 10,896.2 | $ 63.5 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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 worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and are providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology. Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group. For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Our innovative drug development and commercialization activities are complemented by our biosimilar business that expands access to medicines and reduces the cost burden for healthcare systems. Through our agreements with Samsung Bioepis Co., Ltd. (Samsung Bioepis), our joint venture with Samsung BioLogics Co., Ltd. (Samsung BioLogics), we market and sell BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe. We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was approved in the U.S., the E.U. and the U.K. during the third quarter of 2021. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, 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 those of 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 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 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. We have made estimates of the impact of the COVID-19 pandemic within our consolidated financial statements and there may be changes to those estimates in future periods. 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 the FASB Accounting Standards Codification (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 distributors and specialty pharmacy providers. 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 and wholesaler incentives. 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. Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay) assistance, Veterans Administration (VA) and Public Health Service (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 chargebacks consist of amounts that we expect to issue 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 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 and GAZYVA and royalty revenue on the sale 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 and GAZYVA; and (ii) other revenue from anti-CD20 therapeutic programs, which primarily consist of our share of pre-tax co-promotion profits on RITUXAN in Canada and royalty revenue on sales of OCREVUS. Pre-tax co-promotion profits on RITUXAN and GAZYVA 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 and GAZYVA 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. For additional information on our relationship with Genentech, please read Note 18, Collaborative and Other Relationships, to these consolidated financial statements. Other Revenue Royalty Revenue We recognize royalty revenue related to sales by our licensees of products covered under patents that we own. Collaborative and Other Relationships We 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, we record our share of the revenue, cost of sales and operating expense on a net basis in collaborative and other relationships included in other revenue in our consolidated statements of income. Our development and commercialization arrangements with Genentech 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. 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 and Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Other Corporate Revenue We record other corporate revenue primarily from amounts earned under contract manufacturing agreements. 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. 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. Our financial assets (which include our cash equivalents, marketable debt securities and certain of our marketable equity securities, derivative contracts and plan assets for deferred compensation) 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, 2021 and 2020. 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, 2021 and 2020, cash equivalents were comprised of money market funds, commercial paper, overnight reverse repurchase agreements and other debt securities with maturities less than 90 days 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. In countries where we have experienced a pattern of payments extending beyond our contractual payment term and we expect to collect receivables greater than one year from the time of sale, we have assessed whether the customer has a significant financing component and discounted our receivables and reduced related revenue over the period of time that we estimate those amounts will be paid using the country’s market-based borrowing rate for such period. The related receivables are classified at the time of sale as non-current assets. We accrete interest income on these receivables, which is recorded as a component of other income (expense), net in our consolidated statements of income. 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. 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 accumulated other comprehensive income (loss) 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. 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 changes in observable prices, 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 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 accumulated other comprehensive income (loss). 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. 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 a change in such judgment, 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 c |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2021 | |
Business Combinations [Abstract] | |
Acquisitions | ACQUISITIONS BIIB118 Acquisition In March 2020 we acquired BIIB118 (CK1 inhibitor) for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases from Pfizer Inc. (Pfizer). We are developing BIIB118 for the potential treatment of irregular sleep wake rhythm disorder in Parkinson’s disease and plan to develop BIIB118 for the potential treatment of sundowning in Alzheimer's disease. In connection with this acquisition, we made an upfront payment of $75.0 million to Pfizer, which was accounted for as an asset acquisition and recorded as acquired IPR&D in our consolidated statements of income as BIIB118 has not yet reached technological feasibility. We may also pay Pfizer up to $635.0 million in potential additional development and commercialization milestone payments as well as tiered royalties in the high single digits to sub-teens. Acquisition of Nightstar Therapeutics plc In June 2019 we completed our acquisition of all of the outstanding shares of Nightstar Therapeutics plc (NST), a clinical-stage gene therapy company focused on adeno-associated virus treatments for inherited retinal disorders. As a result of this acquisition, we added two mid- to late-stage clinical assets, as well as preclinical programs, in ophthalmology. These assets included BIIB111 (timrepigene emparvovec), for the potential treatment of choroideremia, and BIIB112 (cotoretigene toliparvovec), for the potential treatment of X-linked retinitis pigmentosa. Under the terms of the acquisition, we paid NST shareholders $25.50 in cash for each issued and outstanding NST share, which totaled $847.6 million. In addition, we paid $4.6 million in cash for equity compensation, which was attributable to pre-combination services and was reflected as a component of the total purchase price paid. The fair value of equity compensation attributable to the post-combination service period was $26.2 million, of which $18.4 million was recognized as a charge to selling, general and administrative expense with the remaining $7.8 million as a charge to research and development expense in our consolidated statements of income. These amounts were associated with the accelerated vesting of stock options previously granted to NST employees and were fully paid in cash as of June 30, 2019. We funded this acquisition through available cash and accounted for it as an acquisition of a business. We finalized purchase accounting for this acquisition in the fourth quarter of 2019. The fair value of the IPR&D programs acquired was determined through a probability adjusted discounted cash flow analysis utilizing a discount rate of 12.5%. We recorded IPR&D assets for BIIB111 and BIIB112 at their initial fair values of $480.0 million and $220.0 million, respectively. Some of the more significant assumptions utilized in our asset valuations included the estimated net cash flows for each year for each asset or product, including net revenue, cost of sales, research and development and other operating expense, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream as well as other factors. These fair value measurements were based on significant inputs not observable in the market and thus represent Level 3 fair value measurements. We recognized goodwill in relation to the fair value associated with NST workforce's expertise and early research in retinal disorders. We also recognized goodwill in relation to the establishment of a deferred tax liability for the acquired IPR&D intangible assets, which have no tax basis. This deferred tax liability is net of the related impacts on the deferred taxes for GILTI. Goodwill that is tax deductible for GILTI purposes was approximately $60.9 million. There is no remaining book value associated with either BIIB111 or BIIB112 as of December 31, 2021, as we have fully impaired both of these IPR&D assets. For additional information, please read Note 6, Intangible Assets and Goodwill, to these consolidated financial statements. |
Divestitures
Divestitures | 12 Months Ended |
Dec. 31, 2021 | |
Divestitures [Abstract] | |
Divestitures | DIVESTITURES Divestiture of Hillerød, Denmark Manufacturing Operations In August 2019 we completed the sale of all of the outstanding shares of our subsidiary that owned our biologics manufacturing operations in Hillerød, Denmark to FUJIFILM Corporation (FUJIFILM). Upon the closing of this transaction, we received approximately $881.9 million in cash, which may be adjusted based on other contractual terms, which are discussed below. We determined that the operations disposed of in this transaction did not meet the criteria to be classified as discontinued operations under the applicable guidance. As part of this transaction, we provided FUJIFILM with certain minimum batch production commitment guarantees. There is a risk that the minimum contractual batch production commitments will not be met. Based upon current estimates we do not expect to incur an adverse commitment obligation associated with such guarantees. We may further adjust this estimate based upon changes in business conditions, which may result in the increase or reduction of this adverse commitment obligation in subsequent periods. We also may be obligated to indemnify FUJIFILM for liabilities that existed relating to certain business activities incurred prior to the closing of this transaction. In addition, we may earn certain contingent payments based on future manufacturing activities at the Hillerød facility. For the disposition of a business, our policy is to recognize contingent consideration when the consideration is realizable. We currently believe the probability of earning these payments is remote and therefore we did not include these contingent payments in our calculation of the fair value of the operations. As part of this transaction, we entered into certain manufacturing services agreements with FUJIFILM pursuant to which FUJIFILM will use the Hillerød facility to produce commercial products for us, such as TYSABRI, as well as other third-party products. For the year ended December 31, 2019, we recognized a total net loss of approximately $124.2 million related to the transaction in our consolidated statements of income. This loss included a pre-tax loss of $55.3 million, which was recorded in loss on divestiture of Hillerød, Denmark manufacturing operations. The loss recognized was based on exchange rates and business conditions on the closing date of this transaction, and included costs to sell our Hillerød, Denmark manufacturing operations of approximately $11.2 million and our estimate of the fair value of adverse commitments of approximately $74.0 million, primarily associated with the guarantee of future minimum batch production at the Hillerød facility. We also recorded a tax expense of $68.9 million related to this transaction. During the year ended December 31, 2020, we reduced our estimate of the fair value of the adverse commitment associated with the guarantee of future batch production by approximately $62.0 million based on our current manufacturing forecasts. Additionally, we recorded a reduction to our pre-tax loss of approximately $30.5 million due to a refund of interest paid associated with a tax matter. Our estimate of the fair value of the adverse commitments is a Level 3 measurement and is based on forecasted batch production at the Hillerød facility. |
Revenues
Revenues | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | REVENUE Product Revenue Revenue by product are summarized as follows: For the Years Ended December 31, 2021 2020 2019 (In millions) United Rest of Total United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate (1) $ 1,089.5 $ 1,272.8 $ 2,362.3 $ 2,742.0 $ 1,163.4 $ 3,905.4 $ 3,312.0 $ 1,126.2 $ 4,438.2 Interferon (2) 983.1 583.0 1,566.1 1,273.5 604.0 1,877.5 1,426.6 675.2 2,101.8 TYSABRI 1,142.2 920.9 2,063.1 1,096.8 849.3 1,946.1 1,041.8 850.4 1,892.2 FAMPYRA — 105.2 105.2 — 103.1 103.1 — 97.1 97.1 Subtotal: MS 3,214.8 2,881.9 6,096.7 5,112.3 2,719.8 7,832.1 5,780.4 2,748.9 8,529.3 Spinal Muscular Atrophy: SPINRAZA 587.9 1,317.2 1,905.1 787.8 1,264.3 2,052.1 933.4 1,163.6 2,097.0 Alzheimer's disease: ADUHELM (3) 3.0 — 3.0 — — — — — — Biosimilars: BENEPALI — 498.3 498.3 — 481.6 481.6 — 486.2 486.2 IMRALDI — 233.4 233.4 — 216.3 216.3 — 184.0 184.0 FLIXABI — 99.4 99.4 — 97.9 97.9 — 68.1 68.1 Subtotal: Biosimilars — 831.1 831.1 — 795.8 795.8 — 738.3 738.3 Other: FUMADERM — 11.0 11.0 — 12.2 12.2 — 15.2 15.2 Total product revenue $ 3,805.7 $ 5,041.2 $ 8,846.9 $ 5,900.1 $ 4,792.1 $ 10,692.2 $ 6,713.8 $ 4,666.0 $ 11,379.8 (1) Fumarate includes TECFIDERA and VUMERITY. VUMERITY became commercially available in the E.U. during the fourth quarter of 2021. (2) Interferon includes AVONEX and PLEGRIDY. (3) In June 2021 the FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S. during the second quarter of 2021. For additional information, please read Note 18, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these consolidated financial statements. We recognized revenue from two wholesalers accounting for 28.8% and 10.1% of gross product revenue in 2021, 30.5% and 15.3% of gross product revenue in 2020 and 30.0% and 17.2% of gross product revenue in 2019, respectively. As of December 31, 2021, two wholesale distributors individually accounted for approximately 21.9% and 10.2% of net accounts receivable associated with our product sales, as compared to 21.1% and 8.5% as of December 31, 2020, respectively. An analysis of the change in reserves for discounts and allowances is summarized as follows: December 31, 2021 (In millions) Discounts Contractual Returns Total Beginning balance $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 Current provisions relating to sales in current year 736.7 2,948.7 15.2 3,700.6 Adjustments relating to prior years (4.0) (96.1) (3.3) (103.4) Payments/credits relating to sales in current year (599.3) (2,283.1) (0.4) (2,882.8) Payments/credits relating to sales in prior years (137.1) (902.9) (15.1) (1,055.1) Ending balance $ 137.7 $ 759.6 $ 38.0 $ 935.3 December 31, 2020 (In millions) Discounts Contractual Returns Total Beginning balance $ 131.1 $ 1,027.3 $ 40.5 $ 1,198.9 Current provisions relating to sales in current year 774.7 3,308.8 19.0 4,102.5 Adjustments relating to prior years (1.0) (54.0) 1.3 (53.7) Payments/credits relating to sales in current year (635.1) (2,426.1) — (3,061.2) Payments/credits relating to sales in prior years (128.3) (763.0) (19.2) (910.5) Ending balance $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 December 31, 2019 (In millions) Discounts Contractual Returns Total Beginning balance $ 127.8 $ 888.8 $ 34.7 $ 1,051.3 Current provisions relating to sales in current year 666.2 3,011.5 20.9 3,698.6 Adjustments relating to prior years 0.3 (54.1) 5.5 (48.3) Payments/credits relating to sales in current year (535.5) (2,242.9) (0.2) (2,778.6) Payments/credits relating to sales in prior years (127.7) (576.0) (20.4) (724.1) Ending balance $ 131.1 $ 1,027.3 $ 40.5 $ 1,198.9 The total reserves above, which are included in our consolidated balance sheets, are summarized as follows: As of December 31, (In millions) 2021 2020 Reduction of accounts receivable $ 133.2 $ 195.4 Component of accrued expense and other 802.1 1,080.6 Total revenue-related reserves $ 935.3 $ 1,276.0 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) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 Approximately 15.1%, 14.7% and 15.9% of our total revenue in 2021, 2020 and 2019, respectively, was derived from our collaboration arrangements with Genentech. For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Other Revenue Other revenue is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Revenue from collaborative and other relationships: Revenue earned under our technical development agreement, manufacturing services agreements and royalty revenue on biosimilar products with Samsung Bioepis $ 20.7 $ 20.9 $ 106.2 Other revenue from collaborative and other relationships — 0.7 — Other royalty and corporate revenue: Royalty 27.9 33.9 17.0 Other corporate 427.7 719.1 584.5 Total other revenue $ 476.3 $ 774.6 $ 707.7 Other corporate revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers, including Bioverativ Inc. (Bioverativ). During the years ended December 31, 2021, 2020 and 2019, we recognized $18.2 million, $48.6 million and $383.2 million, respectively, in revenue under the manufacturing and supply agreement with Bioverativ entered into in connection with the spin-off of our hemophilia business. 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 first payment became due upon a regulatory approval of such product and was received during the second quarter of 2020. The second payment became due upon the first anniversary of the regulatory approval and was received during the second quarter of 2021. The third payment is due on the second anniversary of the regulatory approval. Other corporate revenue for the year ended December 31, 2020, reflects $346.2 million related to the delivery of the license for certain of our manufacturing-related intellectual property under the amended agreement, as discussed above, and the performance of manufacturing product supply services for such customer. We have allocated the remaining $153.8 million of the $500.0 million transaction price to the performance of manufacturing product supply services for the customer, which we expect to perform through 2026. The value allocated to the manufacturing services was based on expected demand for supply and the fair value of comparable manufacturing and development services. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY The components of inventory are summarized as follows: As of December 31, (In millions) 2021 2020 Raw materials $ 349.6 $ 314.9 Work in process 814.0 544.5 Finished goods 187.9 209.2 Total inventory $ 1,351.5 $ 1,068.6 Inventory amounts written down as a result of excess, obsolescence or unmarketability are charged to cost of sales, and totaled $167.6 million, $26.6 million and $52.2 million for the years ended December 31, 2021, 2020 and 2019, respectively. Upon review of the ADUHELM inventory it was determined that a portion of the inventory will not be consumed prior to product expiration based on our latest estimates of forecasted demand. During the fourth quarter of 2021 we wrote-off approximately $120.0 million of inventory in excess of forecasted demand related to ADUHELM, which was recognized in cost of sales within our consolidated statements of income. As of December 31, 2021, we had approximately $223.0 million of inventory related to ADUHELM. For additional information please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | INTANGIBLE ASSETS AND GOODWILL Intangible Assets Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: As of December 31, 2021 As of December 31, 2020 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,413.1 $ (5,388.5) $ 2,024.6 $ 7,394.3 $ (5,136.5) $ 2,257.8 In-process research and development Indefinite until commercialization 132.7 — 132.7 762.5 — 762.5 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,609.8 $ (5,388.5) $ 2,221.3 $ 8,220.8 $ (5,136.5) $ 3,084.3 Amortization and Impairments Amortization and impairment of acquired intangible assets totaled $881.3 million, $464.8 million and $489.9 million for the years ended December 31, 2021, 2020 and 2019, respectively. Amortization of acquired intangible assets, excluding impairment charges, totaled $252.0 million, $255.1 million and $274.0 million for the years ended December 31, 2021, 2020 and 2019, respectively. The decrease in amortization of acquired intangible assets, excluding impairment charges, over the three years was primarily due to a low er rate of amortization for acquired intangible assets. For the year ended December 31, 2021, amortization and impairment of acquired intangible assets reflects the impact of a $365.0 million impairment charge related to BIIB111, a $220.0 million impairment charge related to BIIB112 and a $44.3 million impairment charge related to vixotrigine (BIIB074) for the potential treatment of trigeminal neuralgia (TGN). For the year ended December 31, 2020, amortization and impairment of acquired intangible assets reflects the impact of a $115.0 million impairment charge related to BIIB111, a $75.4 million impairment charge related to BIIB054 (cinpanemab) and a $19.3 million impairment charge related to one of our other IPR&D intangible assets. For the year ended December 31, 2019, amortization and impairment of acquired intangible assets reflects the impact of a $215.9 million impairment charge related to certain IPR&D assets associated with the Phase 2b study of BG00011 (STX-100) for the potential treatment of idiopathic pulmonary fibrosis (IPF), which was discontinued in the third quarter of 2019. Completed Technology Completed technology primarily relates to our acquisition of all remaining rights to TYSABRI as well as other amounts related to our other marketed products and programs acquired through business combinations. 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, 2021, relates to the IPR&D programs we acquired in connection with our acquisition of Convergence Pharmaceuticals Holdings Ltd. (Convergence). Vixotrigine In the periods since we acquired vixotrigine, there have been numerous delays in the initiation of Phase 3 studies for the potential treatment of TGN and for the potential treatment of DPN, another form of neuropathic pain. We have engaged with the U.S. Food and Drug Administration (FDA) regarding the design of the Phase 3 studies of vixotrigine for the potential treatment of TGN and DPN and are now performing an additional clinical trial of vixotrigine. The performance of this additional clinical trial delayed the initiation of the Phase 3 studies of vixotrigine for the potential treatment of TGN, and, as a result, we recognized an impairment charge of $44.3 million related to vixotrigine for the potential treatment of TGN during the first quarter of 2021. As of December 31, 2021, the carrying value associated with the remaining IPR&D asset for DPN was $132.7 million and the fair value of this asset was not significantly in excess of its carrying value. BIIB111 and BIIB112 During the fourth quarter of 2020 we recognized an impairment charge of $115.0 million related to BIIB111 as a result of third-party manufacturing delays that impacted the timing and increased the costs associated with advancing BIIB111 through Phase 3 development. During the second quarter of 2021 we announced that our Phase 3 STAR study of BIIB111 and our Phase 2/3 XIRIUS study of BIIB112 did not meet their primary endpoints. In the third quarter of 2021 we suspended further development on these programs based on the decision by management as part of its strategic review process. For the year ended December 31, 2021, we recognized an impairment charge of $365.0 million related to BIIB111 and an impairment charge of $220.0 million related to BIIB112, reducing the remaining book values of these IPR&D intangible assets to zero. In addition, for the year ended December 31, 2021 , as a result of our decision to suspend further development of BIIB111 and BIIB112, we recognized charges of approximately $39.1 million related to our manufacturing arrangements and other costs that we expect to incur as a result of suspending these programs, which were recorded as research and development expense in our consolidated statements of income. BIIB054 In February 2021 we announced that we discontinued development of BIIB054 as a potential treatment of Parkinson's disease as our Phase 2 SPARK study did not meet its primary or secondary endpoints. Although we made this determination in February 2021, it was based on conditions that existed as of December 31, 2020. As a result, we recognized an impairment charge of approximately $75.4 million during the fourth quarter of 2020 to reduce the fair value of the related IPR&D intangible asset to zero. The IPR&D impairment charges were included in amortization and impairment of acquired intangible assets and the gain resulting from the remeasurement of our contingent consideration obligation was recorded in (gain) loss on fair value remeasurement of contingent consideration in our consolidated statements of income. The fair value of the intangible assets and contingent consideration obligations were based on a probability-adjusted discounted cash flow calculation using Level 3 fair value measurements and inputs including estimated revenue, costs and probabilities of success. 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, 2021 2022 $ 255.0 2023 210.0 2024 195.0 2025 195.0 2026 180.0 Goodwill The following table provides a roll forward of the changes in our goodwill balance: As of December 31, (In millions) 2021 2020 Goodwill, beginning of year $ 5,762.1 $ 5,757.8 Other (1.0) 4.3 Goodwill, end of year $ 5,761.1 $ 5,762.1 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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: As of December 31, 2021 (In millions) Total Quoted Prices in Significant Other Significant Assets: Cash equivalents $ 1,632.2 $ — $ 1,632.2 $ — Marketable debt securities: Corporate debt securities 1,108.2 — 1,108.2 — Government securities 1,192.7 — 1,192.7 — Mortgage and other asset backed securities 132.2 — 132.2 — Marketable equity securities 1,048.5 181.7 866.8 — Derivative contracts 80.9 — 80.9 — Plan assets for deferred compensation 33.4 — 33.4 — Total $ 5,228.1 $ 181.7 $ 5,046.4 $ — Liabilities: Derivative contracts $ 10.8 $ — $ 10.8 $ — Contingent consideration obligations 209.1 — — 209.1 Total $ 219.9 $ — $ 10.8 $ 209.1 As of December 31, 2020 (In millions) Total Quoted Prices Significant Significant Assets: Cash equivalents $ 626.9 $ — $ 626.9 $ — Marketable debt securities: Corporate debt securities 1,301.5 — 1,301.5 — Government securities 627.1 — 627.1 — Mortgage and other asset backed securities 122.4 — 122.4 — Marketable equity securities 1,974.3 271.1 1,703.2 — Derivative contracts 20.5 — 20.5 — Plan assets for deferred compensation 28.2 — 28.2 — Total $ 4,700.9 $ 271.1 $ 4,429.8 $ — Liabilities: Derivative contracts $ 217.2 $ — $ 217.2 $ — Contingent consideration obligations 259.8 — — 259.8 Total $ 477.0 $ — $ 217.2 $ 259.8 There have been no material impairments of our assets measured and carried at fair value during the years ended December 31, 2021 and 2020. In addition, there have been no changes in valuation techniques during the years ended December 31, 2021 and 2020. The fair value of Level 2 instruments classified as cash equivalents and marketable debt securities was determined through third-party pricing services. The fair value of Level 2 instruments classified as marketable equity securities represents our investments in the common stock of Sangamo Therapeutics, Inc. (Sangamo), Denali Therapeutics Inc. (Denali) and Sage Therapeutics, Inc. (Sage) and are valued using an option pricing valuation model as the investments are each subject to certain holding period restrictions. The holding period restrictions for a portion of our Sangamo investment expired during the second quarter of 2021. The fair value of this portion of our Sangamo investment was a Level 1 measurement as of December 31, 2021. For additional information on our investments in Sangamo, Denali and Sage common stock, please read Note 8, Financial Instruments , to these consolidated financial statements. For a description of our validation procedures related to prices provided by third-party pricing services and our option pricing valuation model, please read the Fair Value Measurements section within Note 1, Summary of Significant Accounting Policies, to these consolidated financial statements. The following tables summarize the significant unobservable inputs in the fair value measurement of our contingent consideration obligations as of December 31, 2021 and 2020: As of December 31, 2021 (In millions) Fair Value Valuation Technique Unobservable Input Range Weighted Average Liabilities: Contingent consideration obligation $209.1 Discounted cash flow Discount rate 1.30% 1.30% Expected timing of achievement of development milestones 2023 to 2027 — As of December 31, 2020 (In millions) Fair Value Valuation Technique Unobservable Input Range Weighted Average Liabilities: Contingent consideration obligation $259.8 Discounted cash flow Discount rate 0.60% 0.60% Expected timing of achievement of development milestones 2021 to 2025 — The weighted average discount rate was calculated based on the relative fair value of our contingent consideration obligations. In addition, we apply various probabilities of technological and regulatory success, ranging from 10.9% to certain probability as of December 31, 2021, to the valuation models to estimate the fair values of our contingent consideration obligations. Nonrecurring Fair Value Measurements For the year ended December 31, 2021, we recorded impairment charges of $365.0 million related to BIIB111 and $220.0 million related to BIIB112. As a result, the remaining book values associated with these programs were reduced to zero. For additional information, please read Note 6, Intangible Assets and Goodwill , to these consolidated financial statements. Debt Instruments The fair values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of December 31, (In millions) 2021 2020 3.625% Senior Notes due September 15, 2022 $ 1,020.0 $ 1,054.1 4.050% Senior Notes due September 15, 2025 1,895.2 2,003.1 2.250% Senior Notes due May 1, 2030 1,475.9 1,557.2 5.200% Senior Notes due September 15, 2045 (1) 1,463.0 2,365.1 3.150% Senior Notes due May 1, 2050 1,457.7 1,536.4 3.250% Senior Notes due February 15, 2051 (1) 692.9 — Total $ 8,004.7 $ 8,515.9 (1) In February 2021 we completed a private offer to exchange (Exchange Offer) our tendered 5.200% Senior Notes due September 15, 2045 (2045 Senior Notes), whereby approximately $624.6 million of our 2045 Senior Notes were exchanged for approximately $700.7 million of a new series of 3.250% Senior Notes due February 15, 2051 (2051 Senior Notes). For additional information on our Exchange Offer, please read Note 12, 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. For additional information related to our Senior Notes, please read Note 12, Indebtedness , to these consolidated financial statements. Contingent Consideration Obligations In connection with our acquisitions of Convergence and Biogen International Neuroscience GmbH (BIN) , we agreed to make additional payments based upon the achievement of certain milestone events. The following table provides a roll forward of the fair values of our contingent consideration obligations, which includes Level 3 measurements: As of December 31, (In millions) 2021 2020 Fair value, beginning of year $ 259.8 $ 346.1 Changes in fair value (50.7) (86.3) Fair value, end of year $ 209.1 $ 259.8 As of December 31, 2021 and 2020, approximately $209.1 million and $110.3 million, respectively, of the fair value of our total contingent consideration obligations was reflected as a component of other long-term liabilities in our consolidated balance sheets with the remaining balance reflected as a component of accrued expense and other. For the year ended December 31, 2021, changes in the fair value of our contingent consideration obligations were primarily due to reductions in the probability of technical and regulatory success and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs. For the year ended December 31, 2020, changes in the fair value of our contingent consideration obligations were primarily due to our discontinuing development of BIIB054 for the potential treatment of Parkinson's disease, resulting in a reduction of our contingent consideration obligations of $51.0 million as well as other changes in the probability and the expected timing of the achievement of certain remaining developmental milestones, changes in the interest rates used to revalue our contingent consideration liabilities and the passage of time. 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. Convergence Pharmaceuticals Holdings Limited In connection with our acquisition of Convergence in February 2015 we recorded a contingent consideration obligation of $274.5 million. As of December 31, 2021 and 2020, the fair value of this contingent consideration obligation was $209.1 million and $259.8 million, respectively. Our most recent valuation was determined based upon net cash flow projections of $400.0 million, probability weighted and discounted using a rate of 1.3%, which is a measure of the credit risk associated with settling the liability. Biogen International Neuroscience GmbH In connection with our acquisition of BIN in December 2010 we recorded a contingent consideration obligation of $81.2 million. We discontinued further development of BIIB054 for the potential treatment of Parkinson's disease based on the results of a Phase 2 study of BIIB054. Additionally, during the third and fourth quarters of 2020 we discontinued other programs related to our acquisition of BIN for which we had immaterial contingent consideration obligations. As a result, the fair value of the contingent consideration obligations related to our acquisition of BIN was adjusted to zero, resulting in a gain of $101.5 million for the year ended December 31, 2020. Acquired IPR&D The fair values of the acquired IPR&D assets were based on a probability-adjusted discounted cash flow calculation using Level 3 fair value measurements and inputs including estimated revenue and probabilities of success. These assets are tested for impairment annually until commercialization, after which time the acquired IPR&D will be amortized over its estimated useful life using the economic consumption method. In connection with our acquisition of NST, we recognized $480.0 million and $220.0 million of acquired IPR&D intangible assets for BIIB111 and BIIB112, respectively. During the fourth quarter of 2020 we recognized an impairment charge of $115.0 million related to BIIB111. During the third quarter of 2021 we suspended further development on these programs and recognized an impairment charge of $365.0 million related to BIIB111 and an impairment charge of $220.0 million related to BIIB112, reducing the fair value of these IPR&D intangible assets to zero. In connection with our acquisition of BIN, we recognized a $110.9 million acquired IPR&D intangible asset. During the fourth quarter of 2020 we discontinued further development of BIIB054 for the potential treatment of Parkinson's disease and recognized an impairment charge of $75.4 million to reduce the fair value of the IPR&D intangible asset to zero. In connection with our acquisition of Stromedix Inc., we recognized a $219.2 million acquired IPR&D intangible asset. During the third quarter of 2019 we discontinued the Phase 2b study of BG00011 for the potential treatment of IPF and recognized an impairment charge of $215.9 million to reduce the fair value of the IPR&D intangible asset to zero. For additional information on our IPR&D intangible assets, including a discussion of our most significant assumptions, please read Note 6, Intangible Assets and Goodwill , to these consolidated financial statements. |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Investments, All Other Investments [Abstract] | |
Financial Instruments | 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) 2021 2020 Commercial paper $ 247.6 $ 61.1 Overnight reverse repurchase agreements 200.0 37.4 Money market funds 901.6 505.1 Short-term debt securities 283.0 23.3 Total $ 1,632.2 $ 626.9 The carrying values of our commercial paper, including accrued interest, overnight reverse repurchase agreements, money market funds and our short-term debt securities approximate fair value due to their short-term maturities. Our marketable equity securities gains (losses) are recorded in other income (expense), net in our consolidated statements of income. The following tables summarize our marketable debt and equity securities, classified as available for sale: As of December 31, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities: Corporate debt securities: Current $ 723.6 $ 0.1 $ (0.3) $ 723.4 Non-current 385.4 0.2 (0.8) 384.8 Government securities: Current 817.0 — (0.4) 816.6 Non-current 377.0 0.1 (1.0) 376.1 Mortgage and other asset backed securities: Current 1.1 — — 1.1 Non-current 131.8 — (0.7) 131.1 Total marketable debt securities $ 2,435.9 $ 0.4 $ (3.2) $ 2,433.1 Marketable equity securities: Marketable equity securities, current $ 33.9 $ 9.9 $ — $ 43.8 Marketable equity securities, non-current 1,133.1 151.0 (279.4) 1,004.7 Total marketable equity securities $ 1,167.0 $ 160.9 $ (279.4) $ 1,048.5 As of December 31, 2020 (In millions) Amortized Gross Gross Fair Marketable debt securities: Corporate debt securities: Current $ 897.8 $ 0.4 $ (0.2) $ 898.0 Non-current 402.5 1.1 (0.1) 403.5 Government securities: Current 380.6 0.1 — 380.7 Non-current 245.9 0.5 — 246.4 Mortgage and other asset backed securities: Current 0.2 — — 0.2 Non-current 122.1 0.2 (0.1) 122.2 Total marketable debt securities $ 2,049.1 $ 2.3 $ (0.4) $ 2,051.0 Marketable equity securities: Marketable equity securities, current $ 70.6 $ 15.9 $ — $ 86.5 Marketable equity securities, non-current 1,168.9 733.8 (14.9) 1,887.8 Total marketable equity securities $ 1,239.5 $ 749.7 $ (14.9) $ 1,974.3 Summary of Contractual Maturities: Available-for-Sale Debt Securities The estimated fair value and amortized cost of our marketable debt securities available-for-sale by contractual maturity are summarized as follows: As of December 31, 2021 As of December 31, 2020 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,541.1 $ 1,541.7 $ 1,278.9 $ 1,278.6 Due after one year through five years 868.2 870.2 722.6 721.3 Due after five years 23.8 24.0 49.5 49.2 Total marketable debt securities $ 2,433.1 $ 2,435.9 $ 2,051.0 $ 2,049.1 The average maturity of our marketable debt securities available-for-sale as of December 31, 2021 and 2020, was approximately 10 months and 11 months, respectively. 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) 2021 2020 2019 Proceeds from maturities and sales $ 3,405.4 $ 7,299.4 $ 6,007.0 Realized gains 0.2 17.7 6.0 Realized losses 4.0 26.0 1.5 Realized losses for the year ended December 31, 2021, 2020 and 2019, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed securities. Strategic Investments As of December 31, 2021 and 2020, our strategic investment portfolio was comprised of investments totaling $1,110.3 million and $2,024.6 million, respectively, which are included in other current assets and investments and other assets in our consolidated balance sheets. Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies, which are reflected within our disclosures included in Note 7, Fair Value Measurements , to these consolidated financial statements, venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities. The decrease in our strategic investment portfolio for the year ended December 31, 2021, was primarily due to decreases in the fair value of our investments in Denali, Ionis Pharmaceuticals, Inc. (Ionis), Sage and Sangamo common stock. Sage Therapeutics, Inc. In November 2020 we entered into a global collaboration and license agreement with Sage. 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 are subject to transfer restrictions. This investment is classified as a Level 2 marketable equity security due to certain holding period restrictions and is remeasured each reporting period and carried at fair value. The effects of certain holding period restrictions on the investment are estimated using an option pricing valuation model. The most significant assumptions within the model are the term of the restrictions and the stock price volatility, which is based upon historical volatility of similar companies. We also use a constant maturity risk free-interest rate to match the remaining term of the restrictions on our investment in Sage's common stock and a dividend yield of zero based upon the fact that Sage and similar companies generally have not historically granted cash dividends. For additional information on our collaboration arrangement with Sage, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Denali Therapeutics Inc. In August 2020 we entered into a collaboration and license agreement with Denali. 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 are subject to transfer restrictions. This investment is classified as a Level 2 marketable equity security due to certain holding period restrictions and is remeasured each reporting period and carried at fair value. The effects of certain holding period restrictions on the investment are estimated using an option pricing valuation model. The most significant assumptions within the model are the term of the restrictions and the stock price volatility, which is based upon historical volatility of similar companies. We also use a constant maturity risk free-interest rate to match the remaining term of the restrictions on our investment in Denali's common stock and a dividend yield of zero based upon the fact that Denali and similar companies generally have not historically granted cash dividends. For additional information on our collaboration agreement with Denali, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Sangamo Therapeutics, Inc. In February 2020 we entered into a collaboration and license agreement with Sangamo. 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, of which approximately 12 million shares remain subject to transfer restrictions as of December 31, 2021. This equity method investment will be remeasured each reporting period and carried at fair value due to our election of the fair value option. The effects of certain holding period restrictions on the investment are estimated using an option pricing valuation model. The most significant assumptions within the model are the term of the restrictions and the stock price volatility, which is based upon historical volatility of similar companies. We also use a constant maturity risk free-interest rate to match the remaining term of the restrictions on our investment in Sangamo's common stock and a dividend yield of zero based upon the fact that Sangamo and similar companies generally have not historically granted cash dividends. For additional information on our collaboration agreement with Sangamo, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Samsung Bioepis In June 2018 we exercised our option under our joint venture agreement with Samsung BioLogics to increase our ownership percentage in Samsung Bioepis from approximately 5.0% 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. As of December 31, 2021 and 2020, the carrying value of our equity method investment in Samsung Bioepis totaled 713.3 billion South Korean won ($599.9 million) and 673.8 billion South Korean won ($620.2 million), respectively, which is classified as a component of investments and other assets within our consolidated balance sheets. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. |
Derivative Instruments
Derivative Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Instruments | 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. In order to mitigate these changes, we use foreign currency forward contracts to lock in exchange rates associated with a portion of our forecasted international revenue and operating expense. Foreign currency forward contracts in effect as of December 31, 2021 and 2020, had durations of 1 to 15 months and 1 to 24 months, respectively. These contracts have been designated as cash flow hedges and unrealized gains or losses on the portion of these foreign currency forward contracts that are included in the effectiveness test are reported in accumulated other comprehensive income (loss) (referred to as AOCI in the table below). Realized gains and losses of such contracts 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 accumulated other comprehensive income (loss) and fair value changes of excluded portions in the same line item in our consolidated statements of income that has been impacted by the hedged item. The notional value of foreign currency forward contracts that were entered into to hedge forecasted revenue and operating expense is summarized as follows: Notional Amount (In millions) 2021 2020 Euro $ 1,828.0 $ 2,979.1 British pound 166.2 250.6 Japanese yen 72.7 — Canadian dollar 59.9 — Total foreign currency forward contracts $ 2,126.8 $ 3,229.7 The pre-tax portion of the fair value of these foreign currency forward contracts that were included in accumulated other comprehensive income (loss) in total equity is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Unrealized gains $ 60.8 $ — $ 6.9 Unrealized (losses) (7.0) (212.5) (6.4) Net unrealized gains (losses) $ 53.8 $ (212.5) $ 0.5 We expect the net unrealized gains of $53.8 million to be settled over the next 15 months, of which $48.2 million of these unrealized gains are expected to be settled over the next 12 months, with any amounts in accumulated other comprehensive income (loss) 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, 2021 and 2020, credit risk did not materially change the fair value of our foreign currency forward contracts. The following table summarizes the effect of foreign currency forward contracts 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) Location 2021 2020 2019 Location 2021 2020 2019 Revenue $ (60.0) $ 18.3 $ 118.6 Revenue $ (8.4) $ (9.9) $ 2.9 Operating expense (0.8) 3.3 (3.3) Operating expense — — 0.2 Interest Rate Contracts - Hedging Instruments We have entered into interest rate lock contracts or interest rate swap contracts on certain borrowing transactions to manage our exposure to interest rate changes and to reduce our overall cost of borrowing. Interest Rate Swap Contracts In connection with the issuance of our 2.90% Senior Notes due September 15, 2020, we entered into interest rate swaps with an aggregate notional amount of $675.0 million, which were originally set to expire on September 15, 2020. The interest rate swap contracts were designated as hedges of the fair value changes in our 2.90% Senior Notes attributable to changes in interest rates. In May 2020 we settled our interest rate swap contracts, in conjunction with our early redemption of our 2.90% Senior Notes, resulting in a gain of approximately $3.3 million, which was recorded as a component of interest expense in our consolidated statements of income during the year ended December 31, 2020. 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. In June 2018 we exercised our option under our joint venture agreement to increase our ownership percentage in Samsung Bioepis from approximately 5.0% 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. Our investment in the equity of Samsung Bioepis is exposed to the currency fluctuations in the South Korean won. In order to mitigate these currency fluctuations between the U.S. dollar and South Korean won, we have entered into foreign currency forward contracts. Foreign currency forward contracts in effect as of December 31, 2021, had remaining durations of 10 months. These contracts have been designated as net investment hedges. We recognize changes in the spot exchange rate in accumulated other comprehensive income (loss). The pre-tax portion of the fair value of these foreign currency forward contracts that were included in accumulated other comprehensive income (loss) in total equity reflected net gains of $10.6 million and net losses of $21.2 million as of December 31, 2021 and 2020, respectively. We exclude fair value changes related to the forward rate from our hedging relationship and will amortize the forward points in other income (expense), net in our consolidated statements of income over the term of the contract. The pre-tax portion of the fair value of the forward points that were included in accumulated other comprehensive income (loss) in total equity reflected net losses of $3.6 million and net gains of $0.2 million as of December 31, 2021 and 2020, respectively. The following table summarizes the effect of our net investment hedges in our consolidated financial statements: For the Years Ended December 31, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 2019 Location 2021 2020 2019 Location 2021 2020 2019 Gains (losses) on net investment hedge $ 46.0 $ (35.1) $ 25.3 Gains (losses) on net investment hedge $ (3.2) $ 4.5 $ 3.3 Other income (expense) $ (0.6) $ 2.9 $ 7.0 For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, 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 $1,268.0 million and $1,158.0 million as of December 31, 2021 and 2020, respectively. Net losses of $43.3 million, net gains of $30.1 million and net losses of $5.9 million related to these contracts were recorded as a component of other income (expense), net for the years ended December 31, 2021, 2020 and 2019, 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 2021 2020 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 66.2 $ — Investments and other assets 5.5 — Liability derivative instruments Accrued expense and other 6.6 157.1 Other long-term liabilities — 35.7 Net Investment Hedging Instruments: Asset derivative instruments Other current assets 4.1 — Liability derivative instruments Accrued expense and other — 19.7 Other Derivative Instruments: Asset derivative instruments Other current assets 5.1 20.5 Liability derivative instruments Accrued expense and other 4.2 4.7 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | 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) 2021 2020 Land $ 207.5 $ 119.8 Buildings 1,699.7 1,025.3 Leasehold improvements 121.0 104.6 Machinery and equipment 1,585.5 1,027.8 Computer software and hardware 971.6 903.0 Furniture and fixtures 67.4 62.5 Construction in progress 770.3 1,950.8 Total cost 5,423.0 5,193.8 Less: accumulated depreciation (2,006.6) (1,782.3) Total property, plant and equipment, net $ 3,416.4 $ 3,411.5 Depreciation expense totaled $235.3 million, $201.9 million and $190.6 million for the years ended December 31, 2021, 2020 and 2019, respectively. For the years ended December 31, 2021, 2020 and 2019, we capitalized interest costs related to construction in progress totaling approximately $36.3 million, $65.2 million and $68.8 million, respectively. Solothurn, Switzerland Manufacturing Facility In order to support our future growth and drug development pipeline, we are building a large-scale biologics manufacturing facility in Solothurn, Switzerland. Upon completion, this facility will include 393,000 square feet |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 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 nine 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 one year to six years. In addition, we sublease certain real estate to third-parties. Our sublease portfolio consists of operating leases, with remaining lease terms ranging from three years to seven years. Our subleases do not include an option to renew as they are coterminous with our operating leases. 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 2021 2020 Assets: Operating lease assets Operating lease assets $ 375.4 $ 433.3 Liabilities Current operating lease liabilities Accrued expense and other $ 89.1 $ 83.2 Non-current operating lease liabilities Long-term operating lease liabilities 330.4 402.0 Total operating lease liabilities $ 419.5 $ 485.2 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 2021 2020 Operating lease cost Research and development $ 3.4 $ 5.2 Selling, general and administrative 95.9 93.1 Variable lease cost Research and development 0.8 1.1 Selling, general and administrative 25.7 21.1 Sublease income Selling, general and administrative (23.9) (24.2) Other (income) expense, net (4.0) (3.9) Net lease cost $ 97.9 $ 92.4 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 is expected to be as follows: (In millions) As of December 31, 2021 2022 $ 99.6 2023 89.7 2024 79.7 2025 57.2 2026 44.8 Thereafter 84.0 Total lease payments $ 455.0 Less: interest 35.5 Present value of operating lease liabilities $ 419.5 The weighted average remaining lease term and weighted average discount rate of our operating leases are as follows: As of December 31, 2021 2020 Weighted average remaining lease term in years 5.43 6.30 Weighted average discount rate 2.9 % 2.9 % 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) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities $ 105.8 $ 100.2 Operating lease assets obtained in exchange for lease obligations 18.1 59.0 |
Indebtedness
Indebtedness | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Indebtedness | INDEBTEDNESS Our indebtedness is summarized as follows: As of December 31, (In millions) 2021 2020 Current portion: 3.625% Senior Notes due September 15, 2022 $ 999.1 $ — Current portion of notes payable $ 999.1 $ — Non-current portion: 3.625% Senior Notes due September 15, 2022 $ — $ 997.9 4.050% Senior Notes due September 15, 2025 1,742.9 1,741.2 2.250% Senior Notes due May 1, 2030 1,492.0 1,491.1 5.200% Senior Notes due September 15, 2045 (1) 1,099.9 1,723.4 3.150% Senior Notes due May 1, 2050 1,473.2 1,472.6 3.250% Senior Notes due February 15, 2051 (1) 466.0 — Non-current portion of notes payable $ 6,274.0 $ 7,426.2 (1) In February 2021 we completed our Exchange Offer of our tendered 2045 Senior Notes, whereby approximately $624.6 million of our 2045 Senior Notes were exchanged for approximately $700.7 million of our 2051 Senior Notes. Exchange Offer In February 2021 we completed our Exchange Offer of our tendered 2045 Senior Notes for our 2051 Senior Notes and cash, and an offer to purchase our tendered 2045 Senior Notes for cash. An aggregate principal amount of approximately $624.6 million of our 2045 Senior Notes was exchanged for an aggregate principal amount of approximately $700.7 million of our 2051 Senior Notes and aggregate cash payments of approximately $151.8 million. Our Exchange Offer has been accounted for as a debt modification; as such, the cash component has been reflected as additional debt discount and is amortized as an adjustment to interest expense over the term of our 2051 Senior Notes. In addition, we redeemed an aggregate principal amount of approximately $8.9 million of our 2045 Senior Notes for aggregate cash payments of approximately $12.1 million, excluding accrued and unpaid interest. The redemption has been accounted for as a debt extinguishment; as such, we recognized a pre-tax charge of $3.2 million upon the extinguishment of such 2045 Senior Notes. This charge, which was recognized in interest expense in other income (expense), net in our consolidated statements of income for the year ended December 31, 2021, reflects the payment of an early call premium and the write-off of the remaining unamortized original debt issuance costs and discount balances associated with such 2045 Senior Notes. Upon settlement, we also made aggregate cash payments of approximately $13.8 million to settle all accrued and unpaid interest from the last interest payment date on our 2045 Senior Notes that were exchanged or redeemed. We incurred approximately $6.1 million of costs associated with our Exchange Offer, which was recognized in interest expense in other income (expense), net in our consolidated statements of income for the year ended December 31, 2021. 2020 Senior Notes On April 30, 2020, we issued senior unsecured notes for an aggregate principal amount of $3.0 billion (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. We incurred approximately $24.4 million of costs associated with this offering, which have been recorded as a reduction to the carrying amount of the debt on our consolidated balance sheet. These costs will be amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity. The discounts will be amortized as additional interest expense over the period from issuance through maturity using the effective interest rate method. 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 secured notes issued in 2015 (the 2015 Senior Notes), consisting of the following: • $1.0 billion aggregate principal amount of 3.625% Senior Notes due September 15, 2022, valued at 99.920% of par; • $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. The original costs associated with this offering of approximately $47.5 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. 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. On September 15, 2015, we issued $1.5 billion aggregate principal amount of 2.90% Senior Notes due September 15, 2020, at 99.792% of par. Our 2.90% Senior Notes were senior unsecured obligations. In connection with the 2.90% Senior Notes, we entered into interest rate swap contracts where we received a fixed rate and paid a variable rate. In May 2020 we used the net proceeds from the sale of our 2020 Senior Notes to redeem our 2.90% Senior Notes prior to their maturity and recognized a net pre-tax charge of $9.4 million upon the extinguishment of these notes. This charge, which was recognized in interest expense in other income (expense), net in our consolidated statements of income for the year ended December 31, 2020, reflects the payment of a $12.7 million early call premium and the write off of remaining unamortized original debt issuance costs and discount balances, partially offset by a $3.3 million gain related to the settlement of the associated interest rate swap contracts. For additional information on our interest rate contracts, please read Note 9, Derivative Instruments, to these consolidated financial statements. 2020 Credit Facility In January 2020 we entered into a $1.0 billion, five-year senior unsecured revolving credit facility under which we are permitted to draw funds for working capital and general corporate purposes. The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio. This revolving credit facility replaced the revolving credit facility that we entered into in August 2015. As of December 31, 2021, we had no outstanding borrowings and were in compliance with all covenants under this facility. Debt Maturity The total gross payments due under our debt arrangements are as follows: (In millions) As of December 31, 2021 2022 $ 1,000.0 2023 — 2024 — 2025 1,750.0 2026 — 2027 and thereafter 4,817.3 Total $ 7,567.3 The fair value of our debt is disclosed in Note 7, Fair Value Measurements, to these consolidated financial statements. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Equity | 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 2021, 2020 and 2019. Common Stock The following table describes the number of shares authorized, issued and outstanding of our common stock as of December 31, 2021, 2020 and 2019: As of December 31, 2021 As of December 31, 2020 As of December 31, 2019 (In millions) Authorized Issued Outstanding Authorized Issued Outstanding Authorized Issued Outstanding Common stock 1,000.0 170.8 147.0 1,000.0 176.2 152.4 1,000.0 198.0 174.2 Share Repurchases In October 2020 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (2020 Share Repurchase Program). Our 2020 Share Repurchase Program does not have an expiration date. All share repurchases under our 2020 Share Repurchase Program will be retired. Under our 2020 Share Repurchase Program, we repurchased and retired approximately 6.0 million and 1.6 million shares of our common stock at a cost of approximately $1.8 billion and $400.0 million during the years ended December 31, 2021 and 2020, respectively. Approximately $2.8 billion remained available under our 2020 Share Repurchase Program as of December 31, 2021. In December 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (December 2019 Share Repurchase Program), which was completed as of September 30, 2020. All shares repurchased under our December 2019 Share Repurchase Program were retired. Under our December 2019 Share Repurchase Program, we repurchased and retired approximately 16.7 million shares of our common stock at a cost of approximately $5.0 billion during the year ended December 31, 2020. In March 2019 our Board of Directors authorized a program to repurchase up to $5.0 billion of our common stock (March 2019 Share Repurchase Program), which was completed as of March 31, 2020. All shares repurchased under our March 2019 Share Repurchase Program were retired. Under our March 2019 Share Repurchase Program, we repurchased and retired approximately 4.1 million and 14.7 million shares of our common stock at a cost of approximately $1.3 billion and $3.7 billion during the years ended December 31, 2020 and 2019, respectively. In August 2018 our Board of Directors authorized a program to repurchase up to $3.5 billion of our common stock (2018 Share Repurchase Program), which was completed as of June 30, 2019. All share repurchases under our 2018 Share Repurchase Program were retired. Under our 2018 Share Repurchase Program, we repurchased and retired approximately 8.9 million shares of our common stock at a cost of approximately $2.1 billion during the year ended December 31, 2019. 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. Accumulated Other Comprehensive Income (Loss) The following tables summarize the changes in accumulated other comprehensive income (loss), net of tax by component: December 31, 2021 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) Other comprehensive income (loss) before reclassifications (6.6) 178.2 33.4 21.5 (92.4) 134.1 Amounts reclassified from accumulated other comprehensive income (loss) 3.0 54.6 0.6 — — 58.2 Net current period other comprehensive income (loss) (3.6) 232.8 34.0 21.5 (92.4) 192.3 Balance, December 31, 2021 $ (2.2) $ 53.8 $ 25.5 $ (44.8) $ (139.0) $ (106.7) December 31, 2020 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2019 $ 4.2 $ 7.8 $ 25.1 $ (32.8) $ (139.5) $ (135.2) Other comprehensive income (loss) before reclassifications (9.3) (165.0) (30.7) (33.5) 92.9 (145.6) Amounts reclassified from accumulated other comprehensive income (loss) 6.5 (21.8) (2.9) — — (18.2) Net current period other comprehensive income (loss) (2.8) (186.8) (33.6) (33.5) 92.9 (163.8) Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) December 31, 2019 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2018 $ (4.0) $ 34.7 $ 3.5 $ (31.3) $ (243.3) $ (240.4) Other comprehensive income (loss) before reclassifications 11.8 88.1 28.6 (1.5) 103.8 230.8 Amounts reclassified from accumulated other comprehensive income (loss) (3.6) (115.0) (7.0) — — (125.6) Net current period other comprehensive income (loss) 8.2 (26.9) 21.6 (1.5) 103.8 105.2 Balance, December 31, 2019 $ 4.2 $ 7.8 $ 25.1 $ (32.8) $ (139.5) $ (135.2) The following table summarizes the amounts reclassified from accumulated other comprehensive income (loss): (In millions) Income Statement Location Amounts Reclassified from For the Years Ended December 31, 2021 2020 2019 Gains (losses) on securities available for sale Other income (expense) $ (3.8) $ (8.2) $ 4.5 Income tax benefit (expense) 0.8 1.7 (0.9) Gains (losses) on cash flow hedges Revenue (60.0) 18.3 118.6 Operating expense (0.8) 3.3 (3.3) Other income (expense) 0.2 0.3 0.3 Income tax benefit (expense) 6.0 (0.1) (0.6) Gains (losses) on net investment hedge Other income (expense) (0.6) 2.9 7.0 Total reclassifications, net of tax $ (58.2) $ 18.2 $ 125.6 |
Earnings per Share
Earnings per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Earnings per Share | 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) 2021 2020 2019 Numerator: Net income attributable to Biogen Inc. $ 1,556.1 $ 4,000.6 $ 5,888.5 Denominator: Weighted average number of common shares outstanding 149.1 160.9 187.1 Effect of dilutive securities: Time-vested restricted stock units 0.3 0.2 0.2 Market stock units 0.1 0.1 0.1 Performance stock units settled in stock 0.1 0.1 — Dilutive potential common shares 0.5 0.4 0.3 Shares used in calculating diluted earnings per share 149.6 161.3 187.4 Amounts excluded from the calculation of net income per diluted share because their effects were anti-dilutive were insignificant. Earnings per share for the years ended December 31, 2021, 2020 and 2019, reflects the repurchase of approximately 6.0 million shares, 22.4 million shares and 23.6 million shares of our common stock, respectively, under our share repurchase programs. For additional information on our share repurchase programs, please read Note 13, Equity , to these consolidated financial statements. |
Share-Based Payments
Share-Based Payments | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | 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) 2021 2020 2019 Research and development $ 89.3 $ 80.0 $ 77.1 Selling, general and administrative 169.5 131.3 148.3 Subtotal 258.8 211.3 225.4 Capitalized share-based compensation costs (8.0) (6.2) (8.9) Share-based compensation expense included in total cost and expense 250.8 205.1 216.5 Income tax effect (46.7) (33.5) (35.7) Share-based compensation expense included in net income attributable to Biogen Inc. $ 204.1 $ 171.6 $ 180.8 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) 2021 2020 2019 Market stock units $ 45.6 $ 40.5 $ 30.4 Time-vested restricted stock units 159.8 142.6 134.0 Cash settled performance units — (1.7) 0.7 Performance units — (0.1) 1.6 Performance stock units settled in stock 23.9 7.9 15.5 Performance stock units settled in cash 12.2 8.6 5.5 Employee stock purchase plan 17.3 13.5 11.5 NST stock options — — 26.2 Subtotal 258.8 211.3 225.4 Capitalized share-based compensation costs (8.0) (6.2) (8.9) Share-based compensation expense included in total cost and expense $ 250.8 $ 205.1 $ 216.5 As of December 31, 2021, unrecognized compensation cost related to unvested share-based compensation was approximately $235.5 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.9 years. Share-Based Compensation Plans We have three share-based compensation plans pursuant to which awards are currently being 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). Directors Plan In May 2006 our shareholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include stock options, shares of restricted stock, RSUs, 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 2006 Directors Plan. We have reserved a total of 1.6 million shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio. In June 2015 our shareholders approved an amendment to extend the term of the 2006 Directors Plan until June 2025. Omnibus Plan In June 2017 our shareholders approved the 2017 Omnibus Equity Plan for share-based awards to our employees. Awards granted from the 2017 Omnibus Equity Plan may include stock options, shares of restricted stock, RSUs, 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 2017 Omnibus Equity Plan. Shares of common stock available for grant under the 2017 Omnibus Equity Plan consist of 8.0 million shares reserved for this purpose, plus shares of common stock that remained available for grant under the Biogen Idec Inc. 2008 Omnibus Equity Plan (2008 Omnibus Equity Plan) as of June 7, 2017, or that could again become available for grant if outstanding awards under the 2008 Omnibus Equity Plan as of June 7, 2017, are cancelled, surrendered or terminated in whole or in part. The 2017 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 2008 Omnibus Equity Plan since our shareholders approved the 2017 Omnibus Equity Plan, and do not intend to make any awards pursuant to the 2008 Omnibus Equity Plan in the future, except that unused shares under the 2008 Omnibus Equity Plan have been carried over for use under the 2017 Omnibus Equity Plan. Stock Options We currently do not grant stock options to our employees or directors. Outstanding stock options previously granted to our employees and directors generally have a 10-year term and vest over a period of between one The total intrinsic values of options exercised in 2020 and 2019 totaled $2.9 million and $4.2 million, respectively. The following table summarizes the amount of tax benefit realized for stock options and cash received from the exercise of stock options: For the Years Ended December 31, (In millions) 2020 2019 Tax benefit realized for stock options $ 2.9 $ 2.5 Cash received from the exercise of stock options 0.7 0.4 Market Stock Units (MSUs) MSUs awarded to employees prior to 2014 vested in four equal annual increments beginning on the first anniversary of the grant date. Participants may ultimately earn between zero and 150.0% of the target number of units granted based on actual stock performance. 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. The following table summarizes our MSU activity: December 31, 2021 Shares Weighted Average Unvested at December 31, 2020 201,000 $ 388.98 Granted (1) 151,000 358.77 Vested (80,000) 382.95 Forfeited (15,000) 383.72 Unvested at December 31, 2021 257,000 $ 372.08 (1) MSUs granted during 2021 include awards granted in conjunction with our annual awards made in February 2021 and MSUs 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. MSUs granted in 2021 also reflect an adjustment based upon the final performance multiplier in relation to shares granted in 2020, 2019 and 2018. We value grants of MSUs 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 MSUs, 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, 2021 2020 2019 Expected dividend yield —% —% —% Range of expected stock price volatility 54.8% - 61.6% 37.8% - 44.1% 31.2% - 33.6% Range of risk-free interest rates 0.06% - 0.21% 1.41% - 1.48% 2.46% - 2.53% 30 calendar day average stock price on grant date $262.23 - $360.31 $257.83 - $325.40 $228.59 - $331.18 Weighted-average per share grant date fair value $358.77 $398.61 $378.08 The fair values of MSUs vested in 2021, 2020 and 2019 totaled $22.5 million, $26.9 million and $32.5 million, respectively. Cash Settled Performance Units (CSPUs) CSPUs awarded to employees vest in three equal annual increments beginning on the first anniversary of the grant date. The vesting of these awards is subject to the respective employee’s continued employment with such awards settled in cash. The number of CSPUs granted represents the target number of units that are eligible to be earned based on the attainment of certain performance measures established at the beginning of the performance period, which ends on December 31 of each year. Participants may ultimately earn between zero and 200.0% of the target number of units granted based on the degree of actual performance metric achievement. Accordingly, additional CSPUs may be issued or currently outstanding CSPUs may be cancelled upon final determination of the number of units earned. CSPUs are classified as liability awards and will be settled in cash based on the 30 calendar day average closing stock price through each vesting date, once the actual vested and earned number of units is known. Since no shares are issued, these awards do not dilute equity. All remaining CSPUs were fully vested as of December 31, 2020. The cash paid in settlement of CSPUs vested in 2020 and 2019 totaled $3.8 million and $10.6 million, respectively. Performance-vested Restricted Stock Units (PUs) PUs are granted to certain employees in the form of RSUs that may be settled in cash or shares of our common stock at the sole discretion of the Compensation and Management Development Committee of our Board of Directors. These awards are structured and accounted for the same way as the CSPUs, and vest in three equal annual increments beginning on the first anniversary of the grant date. The number of PUs granted represents the target number of units that are eligible to be earned based on the attainment of certain performance measures established at the beginning of the performance period, which ends on December 31 of each year. Participants may ultimately earn between zero and 200.0% of the target number of units granted based on the degree of actual performance metric achievement. Accordingly, additional PUs may be issued or currently outstanding PUs may be cancelled upon final determination of the number of units earned. PUs settling in cash are based on the 30 calendar day average closing stock price through each vesting date once the actual vested and earned number of units is known. All remaining PUs were fully vested as of December 31, 2020. All PUs that vested in 2020 and 2019 were settled in cash totaling $3.4 million and $10.4 million, respectively. Performance Stock Units (PSUs) 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. The following table summarizes our PSUs that settle in stock activity: Shares Weighted Unvested at December 31, 2020 155,000 $ 304.19 Granted (1) 110,000 276.61 Vested (56,000) 316.66 Forfeited (13,000) 287.55 Unvested at December 31, 2021 196,000 $ 289.94 (1) PSUs settled in stock granted in 2021 include awards granted in conjunction with our annual awards made in February 2021 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 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 three 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. The following table summarizes our PSUs that settle in cash activity: Shares Unvested at December 31, 2020 120,000 Granted (1) 60,000 Vested (37,000) Forfeited (9,000) Unvested at December 31, 2021 134,000 (1) PSUs settled in cash granted in 2021 include awards granted in conjunction with our annual awards made in February 2021 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. Time-Vested Restricted Stock Units (RSUs) 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 Unvested at December 31, 2020 1,018,000 $ 314.46 Granted (1) 826,000 276.90 Vested (466,000) 313.99 Forfeited (176,000) 294.34 Unvested at December 31, 2021 1,202,000 $ 291.54 (1) RSUs granted in 2021 primarily represent RSUs granted in conjunction with our annual awards made in February 2021 and awards made in conjunction with the hiring of new employees. RSUs granted in 2021 also include approximately 10,000 RSUs granted to our Board of Directors. RSUs granted in 2020 and 2019 had weighted average grant date fair values of $318.87 and $304.44, respectively. The fair values of RSUs vested in 2021, 2020 and 2019 totaled $132.2 million, $140.5 million and $131.5 million, respectively. Employee Stock Purchase Plan (ESPP) In June 2015 our shareholders approved the 2015 ESPP. The maximum aggregate number of shares of our common stock that may be purchased under the 2015 ESPP is 6.2 million. The following table summarizes our ESPP activity: For the Years Ended December 31, (In millions, except share amounts) 2021 2020 2019 Shares issued under the 2015 ESPP 248,000 212,000 204,000 Cash received under the 2015 ESPP $ 54.4 $ 48.6 $ 40.4 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES Income Tax Expense Income before income tax expense and the income tax expense consist of the following: For the Years Ended December 31, (In millions) 2021 2020 2019 Income before income taxes (benefit): Domestic $ 448.3 $ 3,290.0 $ 4,725.3 Foreign 1,296.9 1,757.5 2,400.6 Total $ 1,745.2 $ 5,047.5 $ 7,125.9 Income tax expense (benefit): Current: Federal $ 319.1 $ 647.0 $ 947.4 State 23.1 41.2 59.1 Foreign 137.1 155.1 84.4 Total 479.3 843.3 1,090.9 Deferred: Federal $ (242.5) $ (1,749.9) $ 1,143.9 State (11.9) (6.8) (2.3) Foreign (172.4) 1,905.7 (1,074.5) Total (426.8) 149.0 67.1 Total income tax expense $ 52.5 $ 992.3 $ 1,158.0 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). 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, 2021 and 2020, we have accrued income tax liabilities of $633.0 million and $697.0 million, respectively, under the Transition Toll Tax. Of the amounts accrued as of December 31, 2021, approximately $72.7 million is expected to be paid within one year. The Transition Toll Tax will be paid in installments over an eight--year period, which started in 2018, and will not accrue interest. Unremitted Earnings At December 31, 2021, 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, 2021, 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, 2021. The residual U.S. tax liability, if these differences reverse, would be between $300.0 million and $400.0 million as of December 31, 2021. TECFIDERA In 2020 U.S. federal courts in West Virginia and Delaware entered judgments in favor of the defendants in patent infringement proceedings relating to TECFIDERA Orange-Book listed patents. We appealed both decisions. In late 2021 the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) affirmed the judgment of the West Virginia federal court. The appeals in the Delaware cases were stayed and we expect will remain so until the decision in the West Virginia case becomes final. For additional information, please read Note 20, Litigation , to these consolidated financial statements. Multiple TECFIDERA generic entrants are now in the U.S. market and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and is expected to continue to have a substantial and increasing negative impact on our U.S. TECFIDERA revenue in the future. As of December 31, 2020, we assessed the realizability of our deferred tax assets that are dependent on future expected sales of TECFIDERA in the U.S. and reduced the net value of certain deferred tax assets by approximately $1.7 billion and reduced the net value of deferred tax liabilities associated with GILTI and tax credits by approximately $1.6 billion. For the year ended December 31, 2020, the income tax expense associated with these reductions was approximately $90.3 million. We continue to assess the realizability of these deferred tax assets and have recorded an increase in these deferred tax assets of approximately $108.5 million and an increase in these deferred tax liabilities of approximately $103.9 million for the year ended December 31, 2021. Deferred Tax Assets and Liabilities Significant components of our deferred tax assets and liabilities are summarized as follows: As of December 31, (In millions) 2021 2020 Deferred tax assets: Tax credits $ 121.0 $ 113.4 Inventory, other reserves and accruals 199.4 165.9 Intangibles, net 1,477.5 1,546.0 Neurimmune's tax basis in ADUHELM 475.8 — Net operating loss 1,973.0 2,080.3 Share-based compensation 31.7 23.3 Other 208.8 103.1 Valuation allowance (1,961.3) (1,753.9) Total deferred tax assets $ 2,525.9 $ 2,278.1 Deferred tax liabilities: Purchased intangible assets $ (256.6) $ (396.2) GILTI (1,037.6) (1,143.7) Tax credits (260.2) (174.6) Depreciation, amortization and other (250.9) (227.0) Total deferred tax liabilities $ (1,805.3) $ (1,941.5) The change in the valuation allowance between December 31, 2021 and 2020, was primarily related to the establishment of a valuation allowance against the deferred tax asset related to Neurimmune SubOne AG's (Neurimmune) tax basis in ADUHELM, as discussed below, and the adjustment of a valuation against certain deferred tax assets, the realization of which is dependent on future sales of TECFIDERA in the U.S., as discussed above. In addition to deferred tax assets and liabilities, we have recorded deferred charges related to intra-entity sales of inventory. As of December 31, 2021 and 2020, the total deferred charges were $39.6 million and $142.2 million, respectively. As of December 31, 2021 and 2020, the carrying value of our investment in Samsung Bioepis totaled 713.3 billion South Korean won ($599.9 million) and 673.8 billion South Korean won ($620.2 million), respectively, which is classified as a component of investments and other assets within our consolidated balance sheets. As of December 31, 2021, we have not recorded deferred taxes related to this investment as it is not apparent that the basis difference will reverse in the foreseeable future. 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, 2021 2020 2019 Statutory rate 21.0 % 21.0 % 21.0 % State taxes 0.8 0.7 0.8 Taxes on foreign earnings (10.5) (3.3) (4.5) Tax credits (3.8) (1.2) (1.1) Purchased intangible assets (1.6) 0.7 0.4 Divestiture of Denmark manufacturing operations — (0.4) 1.0 Internal reorganization of certain intellectual property rights — — (2.1) TECFIDERA impairment — 1.8 — GILTI 1.3 1.3 1.5 Swiss tax reform — — (0.8) Neurimmune tax impacts (5.3) (0.1) — Other 1.1 (0.8) 0.1 Effective tax rate 3.0 % 19.7 % 16.3 % Changes in Tax Rate For the year ended December 31, 2021, compared to 2020, the decrease in our effective tax rate, excluding the impact of the Neurimmune deferred tax asset, as discussed below, was primarily due to the change in the territorial mix of our profitability, which included the adverse effect of generic competition for TECFIDERA in the U.S. market, the tax impacts of the BIIB111 and BIIB112 impairment charges and the impact of the non-cash tax effects of changes in the value of our equity investments, where we recorded net unrealized losses in 2021 and net unrealized gains in 2020. Our 2020 effective tax rate also reflected an income tax expense related to the establishment of a valuation allowance against certain deferred tax assets, the realization of which is dependent on future sales of TECFIDERA in the U.S. In addition, for the year ended December 31, 2021, compared to 2020, the decrease in our effective tax rate was significantly impacted by a current year deferred tax benefit in Switzerland resulting from the accelerated approval of ADUHELM by the FDA in the U.S., recognized during the second quarter of 2021. We recorded a net deferred tax asset of approximately $490.0 million during the second quarter of 2021. The net deferred tax asset is comprised of approximately $945.0 million of gross deferred tax asset, reduced by approximately $455.0 million of unrecognized tax benefit, as discussed below. During the fourth quarter of 2021 we recorded a valuation allowance of approximately $390.0 million related to this deferred tax asset. The deferred tax benefit relates to Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM and approval of the Swiss cantonal tax authorities, 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. For additional information on our collaboration arrangement with Neurimmune, please read Note 19, Investments in Variable Interest Entities , to these consolidated financial statements. For the year ended December 31, 2020, compared to 2019, the increase in our effective tax rate was primarily due to the income tax expense related to the establishment of a valuation allowance against certain deferred tax assets, the realization of which is dependent on future sales of TECFIDERA in the U.S., as discussed above, and partially offset by the benefit recognized on the effective settlement of certain tax matters. Additionally, our 2019 effective tax rate benefited from an internal reorganization of certain intellectual property rights and the enactment of a new taxing regime in the country and certain cantons of Switzerland, which we refer to as Swiss Tax Reform, partially offset by tax expense related to the divestiture of our Hillerød, Denmark manufacturing operations. Although we recognized a loss on the divestiture of our Hillerød, Denmark manufacturing operations, the divestiture required us to write-off certain deferred tax assets and resulted in a taxable gain in certain jurisdictions. For additional information on the divestiture of our Hillerød, Denmark manufacturing operations, please read Note 3, Divestitures , to these consolidated financial statements. Tax Attributes As of December 31, 2021, we had net operating losses and general business credit carry forwards for U.S. federal income tax purposes of approximately $0.6 million and $4.8 million, respectively, which begin to expire in 2022 and 2027, respectively. For U.S. state income tax purposes, we had research and investment credit carry forwards of approximately $147.6 million that begin to expire in 2022. For foreign income tax purposes, we had $16.7 billion of Swiss federal net operating loss carryforwards that begin to expire in 2025 and $16.2 billion of Swiss cantonal net operating loss carryforwards that begin to expire in 2025. 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: (In millions) 2021 2020 2019 Beginning balance $ 75.7 $ 129.9 $ 114.2 Additions based on tax positions related to the current period 4.2 1.5 5.3 Additions for tax positions of prior periods 509.9 51.7 17.2 Reductions for tax positions of prior periods (18.8) (63.6) (10.3) Statute expirations (3.2) (7.9) (0.1) Settlement refund (payment) (4.4) (35.9) 3.6 Ending balance $ 563.4 $ 75.7 $ 129.9 During the year ended December 31, 2021, we increased our gross unrecognized tax benefits by approximately $455.0 million, related to a deferred tax asset for Swiss tax purposes for Neurimmune's tax basis in ADUHELM, as discussed above. 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. Our 2020 activity reflects the impact of the effective settlement of certain tax matters. We and our subsidiaries are routinely examined by various taxing authorities. 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 2017 or state, local or non-U.S. income tax examinations for years before 2012. 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. Included in the balance of unrecognized tax benefits as of December 31, 2021, 2020 and 2019, are $87.5 million, $68.8 million and $122.7 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 expense. During the years ended December 31, 2021, 2020 and 2019 we recognized total interest and penalty expense of $2.7 million, $1.0 million and $4.7 million, respectively. We have accrued $24.8 million and $21.2 million for the payment of interest and penalties as of December 31, 2021 and 2020, respectively. It is reasonably possible that we will adjust the value of our uncertain tax positions related to certain transfer pricing, collaboration matters 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 $475.0 million, including approximately $455.0 million related to the unrecognized tax benefits related to Neurimmune's tax basis in ADUHELM, as discussed above, in the next 12 months as a result of various audit closures, settlements and expiration of the statute of limitations. |
Other Consolidated Financial St
Other Consolidated Financial Statement Detail | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Other Consolidated Financial Statement Detail | OTHER CONSOLIDATED FINANCIAL STATEMENT DETAIL Supplemental Cash Flow Information Supplemental disclosure of cash flow information for the years ended December 31, 2021, 2020 and 2019, is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Cash paid during the year for: Interest $ 280.8 $ 272.7 $ 244.2 Income taxes 247.9 906.7 1,064.5 Non-cash Operating, Investing and Financing Activity In the fourth quarter of 2018 we accrued $300.0 million upon reaching $20.0 billion in total cumulative sales of FUMADERM and TECFIDERA (together, the Fumapharm Products), which was paid in the first quarter of 2019. These amounts, net of tax benefit, were accounted for as increases to goodwill in accordance with the accounting standard applicable to business combinations when we acquired Fumapharm AG. Other Income (Expense), Net Components of other income (expense), net, are summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Interest income $ 11.0 $ 42.0 $ 120.0 Interest expense (253.6) (222.5) (187.4) Gain (loss) on investments, net (824.9) 685.7 204.7 Foreign exchange gains (losses), net (22.4) (10.7) (7.0) Other, net (5.6) 2.9 (47.0) Total other income (expense), net $ (1,095.5) $ 497.4 $ 83.3 Gain (loss) 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. The following table summarizes our gain (loss) on investments, net that relates to our equity securities held as of December 31, 2021, 2020 and 2019: For the Years Ended December 31, (In millions) 2021 2020 2019 Net gains (losses) recognized during the period on equity securities $ (821.1) $ 693.9 $ 200.1 Less: Net gains (losses) realized during the period and on equity securities 10.3 12.1 50.0 Unrealized gains (losses) recognized during the period on equity securities $ (831.4) $ 681.8 $ 150.1 The net unrealized losses recognized during the year ended December 31, 2021, primarily reflect decreases in the aggregate fair value of our investments in Denali, Sage, Sangamo and Ionis common stock of approximately $819.6 million. Accrued Expense and Other Accrued expense and other consists of the following: As of December 31, (In millions) 2021 2020 Revenue-related reserves for discounts and allowances $ 802.1 $ 1,080.6 Collaboration expense 324.7 389.9 Employee compensation and benefits 345.1 333.8 Royalties and licensing fees 234.7 218.5 Derivative liabilities 10.8 181.5 Current portion of contingent consideration obligations — 149.6 Other 817.8 791.4 Total accrued expense and other $ 2,535.2 $ 3,145.3 Other Long-term Liabilities Other long-term liabilities were $1,320.5 million and $1,329.6 million as of December 31, 2021 and 2020, respectively, and included accrued income taxes totaling $664.5 million and $709.9 million, respectively. |
Collaborative and Other Relatio
Collaborative and Other Relationships | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative and Other Relationships | 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; and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group. For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. Our collaboration arrangements will continue in effect until we mutually agree to terminate the collaboration, except that 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 OCREVUS and any other collaboration anti-CD20 products in development in exchange for a royalty as well as our rights to GAZYVA in exchange for the compensation described in the collaboration arrangement. 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. We recognize our share of the development and commercialization expense of GAZYVA as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs. Commercialization of GAZYVA impacts our percentage of the co-promotion profits for RITUXAN, as summarized in the table below. OCREVUS In March 2017 the FDA approved OCREVUS for the treatment of RMS and PPMS. 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 if a biosimilar to OCREVUS is approved in the U.S. 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. OCREVUS has been approved for the treatment of RMS and PPMS in the E.U. and certain other countries. The commercialization of OCREVUS does not impact the percentage of the co-promotion profits we receive for RITUXAN 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 was 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. Mosunetuzumab In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of mosunetuzumab, a late-stage bispecific antibody in development for B-cell non-Hodgkin’s lymphoma and other therapeutic areas. In connection with this exercise, we recorded a $30.0 million option exercise fee payable to Genentech in December 2021, which was recognized in research and development expense in our consolidated statements of income. We also recorded a charge of approximately $20.0 million to reimburse Genentech for our 30.0% of the costs incurred in developing this product candidate during 2021, which was recognized in research and development expense in our consolidated statements of income. Under our collaboration with Genentech, we will be responsible for 30.0% of development costs for mosunetuzumab prior to FDA approval and will be entitled to 30.0% - 37.5% of mosunetuzumab co-promotion operating profits and losses in the U.S. based on certain events and low single-digit royalties on sales of mosunetuzumab outside the U.S. Profit-sharing Formulas RITUXAN and Mosunetuzumab Profit Share Our current pretax co-promotion profit-sharing formula for RITUXAN and mosunetuzumab provides for a 30.0% share on the first $50.0 million of co-promotion operating profits earned each calendar year. Our share of annual co-promotion profits in excess of $50.0 million varies, as summarized in the table below, upon the following events: After First GAZYVA Threshold Date until Second GAZYVA Threshold Date 37.5 % After Second GAZYVA Threshold Date 35.0 % First GAZYVA Threshold Date means the earlier of (i) the date of the First Non-CLL GAZYVA FDA approval if U.S. gross sales of GAZYVA for the preceding consecutive 12-month period were at least $150.0 million or (ii) the first day of the calendar quarter after the date of the First Non-CLL GAZYVA FDA Approval that U.S. gross sales of GAZYVA within any consecutive 12-month period have reached $150.0 million. Second GAZYVA Threshold Date means the first day of the calendar quarter after 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. Our share of RITUXAN pre-tax profits in the U.S. in excess of $50.0 million for the years ended December 31, 2021, 2020 and 2019, was 37.5%. In addition, should the FDA approve mosunetuzumab or any other anti-CD20 product other than OCREVUS or GAZYVA that is acquired or developed by Genentech and subject to the collaboration agreement, the above table would no longer apply and our share of the co-promotion operating profits of RITUXAN and the new product would be between 30.0% and 37.5% based on certain events. 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 profits in excess of $50.0 million varies, as summarized in the table below, upon the following events: After First GAZYVA Threshold Date until Second GAZYVA Threshold Date 37.5 % After Second GAZYVA Threshold Date 35.0 % Our share of GAZYVA pre-tax profits in excess of $50.0 million for the years ended December 31, 2021, 2020 and 2019, 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) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 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 in our consolidated statements of income. After an anti-CD20 product is approved, we record our share of the development 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, 2021, 2020 and 2019, totaled $267.1 million, $286.6 million and $293.0 million, respectively. 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 1 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 as research and development expense in 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. 2018 Ionis Agreement In June 2018 we closed a 10-year exclusive collaboration agreement with Ionis to develop novel antisense oligonucleotide (ASO) drug candidates for a broad range of neurological diseases (2018 Ionis Agreement) 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. Upon closing, we recorded $50.9 million of the $375.0 million upfront payment as prepaid services in our consolidated balance sheets and recognized the remaining $324.1 million as research and development expense in our consolidated statements of income. The amount recorded as prepaid services represented the value of the employee resources committed to the arrangement to provide research and discovery services over the term of the agreement. The 11.5 million shares of Ionis common stock were purchased at a premium to their fair value at the transaction closing date. The premium consisted of acquiring the shares at a price above the fair value based on the trailing 10-day weighted-average close price prior to entering into the 2018 Ionis Agreement in April 2018 and the effect of certain holding period restrictions. We recorded an asset of $462.9 million in investments and other assets in our consolidated balance sheets reflecting the fair value of the Ionis common stock as of the purchase date and a charge of $162.1 million to research and development expense in our consolidated statements of income in the second quarter of 2018 reflecting the premium paid for the Ionis common stock. Our investment in Ionis common stock is remeasured each reporting period. Changes in the fair value of our investment in Ionis common stock, including the effect of the holding period restrictions, are reflected in other income (expense), net in our consolidated statements of income. For additional information on the fair value of our investment in Ionis common stock, please read Note 7, Fair Value Measurements , to these consolidated financial statements. We have the option to license therapies arising out of the 2018 Ionis 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. During the years ended December 31, 2021, 2020 and 2019, we incurred milestones of $22.5 million, $11.3 million and $30.0 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. Upon entering into this agreement, we made a $25.0 million upfront payment to Ionis and 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. BIIB115 In December 2021 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115, a preclinical investigational ASO in development for SMA. In connection with this option exercise, we made an opt-in payment of $60.0 million to Ionis, which was recorded as research and development expense in our consolidated statements of income. 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 BIIB067 (tofersen), an investigational treatment for ALS with superoxide dismutase 1 (SOD1) mutations. In connection with the option exercise, we made a payment of $35.0 million to Ionis, which was recorded as research and development expense in our consolidated statements of income. Future payments may include potential post-licensing milestone payments of up to $55.0 million and royalties in the low- to mid-teen percentages on potential annual worldwide net sales. We are solely responsible for the costs and expense related to the development, manufacturing and commercialization of tofersen following the option exercise. During the years ending December 31, 2021, 2020 and 2019, we incurred milestones of $10.0 million, $28.0 million and $20.0 million, respectively, related to the advancement of programs under this agreement, which were recorded as research and development expense in our consolidated statements of income. Eisai Co., Ltd. Lecanemab Collaboration We have a collaboration agreement with Eisai to jointly develop and commercialize lecanemab (BAN2401), an anti-amyloid antibody, and elenbecestat, the oral BACE (base amyloid cleaving enzyme) inhibitor, two Eisai product candidates for the potential treatment of Alzheimer's disease (the Lecanemab Collaboration). In September 2019 we and Eisai discontinued the global Phase 3 studies of elenbecestat in early Alzheimer's disease. Eisai serves as the global operational and regulatory lead for lecanemab and all costs, including research, development, sales and marketing expense, are shared equally between us and Eisai. If lecanemab receives marketing approval, we and Eisai will co-promote lecanemab and share profits equally. In addition, the Lecanemab Collaboration provides both parties with certain rights and obligations in the event of a change in control of either party. The Lecanemab 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). Eisai may exercise the Anti-Tau Option after completion of the Phase 1 clinical trial of such anti-tau monoclonal antibody. If Eisai exercises its Anti-Tau Option, we will receive an upfront payment from Eisai and will be entitled to additional development and commercial milestone payments. Eisai has not yet exercised its Anti-Tau Option. A summary of development and sales and marketing expense related to the Lecanemab Collaboration is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 323.0 $ 219.3 $ 348.7 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our consolidated statements of income 161.5 109.6 174.3 Total sales and marketing expense incurred by the Lecanemab Collaboration 27.2 9.8 32.4 Biogen's share of lecanemab and elenbecestat sales and marketing expense reflected in selling, general and administrative expense in our consolidated statements of income 13.6 4.9 16.2 ADUHELM Collaboration Agreement Under the ADUHELM Collaboration Agreement, we lead the ongoing development of ADUHELM, and we and Eisai will co-promote ADUHELM with a region-based profit split. Beginning January 1, 2019, Eisai is reimbursing us for 45.0% of development costs incurred by the collaboration for the advancement of ADUHELM (ADUHELM development expense). In March 2019, based on a pre-specified futility analysis, we discontinued the global Phase 3 trials, EMERGE and ENGAGE, designed to evaluate the efficacy and safety of ADUHELM in patients with early Alzheimer's disease. In the first quarter of 2019, as a result of the decision to discontinue the Phase 3 EMERGE and ENGAGE trials following the futility analysis, we accrued and subsequently paid approximately $45.0 million related to the termination of various clinical trials and research and development contracts net of the expected 45.0% Eisai reimbursement of development costs incurred under the ADUHELM Collaboration Agreement. In October 2019 we and Eisai announced that we planned to pursue regulatory approval for ADUHELM in the U.S. A new analysis of a larger dataset from these trials, conducted in scientific collaboration with the FDA, showed that the Phase 3 EMERGE trial met its pre-specified primary and secondary endpoints. In July 2020 we completed the submission of a BLA for the approval of ADUHELM to the FDA and made a $75.0 million milestone payment to Neurimmune. We recognized net profit-sharing income of $33.8 million to reflect Eisai's 45.0% share of the $75.0 million milestone payment. In June 2021 ADUHELM was granted accelerated approval by the FDA for the treatment of Alzheimer's disease and had its first commercial sale. As a result of the launch of ADUHELM in the U.S., we made a $100.0 million milestone payment to Neurimmune. For the year ended December 31, 2021, we recognized net profit-sharing income of $45.0 million to reflect Eisai's 45.0% share of the $100.0 million milestone payment. Upon commercialization, both companies will co-promote ADUHELM with a region-based profit split. We will receive a 55.0% share of the potential profits (losses) in the U.S., a 68.5% share of the potential profits (losses) in the E.U. and a 20.0% share of the potential profits (losses) in Japan and Asia, excluding China and South Korea. The two companies will share equally in the potential profits (losses) in rest of world markets. Sales and marketing expense are shared in proportion to the same region-based profit split that is utilized to co-promote ADUHELM. A summary of development expense, sales and marketing expense and milestone payments related to the ADUHELM Collaboration Agreement is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total ADUHELM development expense $ 183.7 $ 152.0 $ 179.4 Biogen's share of ADUHELM development expense reflected in research and development expense in our consolidated statements of income 101.1 83.6 98.7 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement 562.3 353.0 27.4 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit (loss) sharing in our consolidated statements of income 301.4 193.7 15.1 Total ADUHELM collaboration third-party milestones 100.0 75.0 — Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our consolidated statements of income 45.0 33.8 — Co-promotion Profits and Losses In the U.S. we recognize revenue on sales to third-parties as a component of product revenue, net in our consolidated statements of income. We also record the related cost of revenue and sales and marketing expense in our consolidated statements of income as these costs are incurred. Payments made to and received from Eisai for its 45.0% share of the co-promotion profits or losses in the U.S. are recognized in collaboration profit (loss) sharing in our consolidated statements of income. For the year ended December 31, 2021, we recognized net profit-sharing income of $233.2 million to reflect Eisai's 45.0% sharing of the net collaboration losses in the U.S. In addition, we and Eisai co-promote AVONEX, TYSABRI and TECFIDERA in Japan in certain settings and Eisai distributes AVONEX, TYSABRI, TECFIDERA and PLEGRIDY in India and other Asia-Pacific markets, excluding China. During the fourth quarter of 2021 we recorded approximately $164.0 million of charges associated with inventory and purchase commitments in excess of forecasted demand related to ADUHELM, which was recognized in cost of sales within our consolidated statements of income. In addition, we recognized the expected share of these charges from Eisai's 45.0% share in collaboration profit (loss) sharing within our consolidated statements of income. Amounts receivable from Eisai related to the agreements discussed above we re $285.4 million a nd $151.1 million as of December 31, 2021 and 2020, respectively. Amounts payable to Eisai related to the agreements discussed above we re $46.5 million a nd $111.9 million as of December 31, 2021 and 2020, respectively. 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 systemic lupus erythematosus 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. Upon marketing approval, we and UCB will co-promote dapirolizumab pegol and share profits equally. A summary of development expense related to the UCB collaboration agreement is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total UCB collaboration development expense $ 84.2 $ 58.3 $ 31.9 Biogen's share of UCB development expense reflected in research and development expense in our consolidated statements of income 42.1 29.2 16.0 Alkermes In November 2017 we entered into an exclusive license and collaboration agreement with Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc (Alkermes), for VUMERITY, a novel fumarate for the treatment of RMS. In October 2019 the FDA approved VUMERITY in the U.S. for the treatment of RMS. In November 2019 VUMERITY became commercially available in the U.S. During the fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in the E.U., Switzerland and the U.K. Under this agreement, we received an exclusive, worldwide license to develop and commercialize VUMERITY and we pay Alkermes royalties of 15.0% on worldwide net commercial sales of VUMERITY, which are recognized in cost of sales within our consolidated statements of income. Royalties payable on net commercial sales of VUMERITY are subject, under certain circumstances, to tiered minimum annual payment requirements for a period of five years following FDA approval. Royalty cost of sales related to sales of VUMERITY for the years ended December 31, 2021, 2020 and 2019, totaled $61.6 million, $12.9 million and $1.6 million, respectively. Alkermes is eligible to receive royalties in the high-single digits to sub-teen double digits of annual net commercial sales upon successful development and commercialization of new product candidates, other than VUMERITY, developed under the exclusive license from Alkermes. During the fourth quarter of 2019, following the FDA's approval of VUMERITY, we paid Alkermes $155.0 million in milestone payments, which were recorded in intangible assets in our consolidated balance sheets and will be amortized over the useful life of the product. For the years ended December 31, 2021, 2020 and 2019, we recorded $26.5 million, $32.4 million and $53.5 million, respectively, in research and development expense in our consolidated statements of income related to this collaboration. Alkermes currently supplies VUMERITY to us pursuant to a supply agreement. In October 2019 we entered into a new supply agreement and amended our license and collaboration agreement with Alkermes. We have elected to initiate a technology transfer and, following a transition period, to manufacture VUMERITY or have VUMERITY manufactured by a third-party we have engaged in exchange for paying an increased royalty rate to Alkermes on any portion of future worldwide net commercial sales of VUMERITY that is manufactured by us or our designee. Acorda Therapeutics, Inc. In June 2009 we entered into a collaboration and license agreement with Acorda Therapeutics, Inc. (Acorda) to develop and commercialize products containing fampridine, such as FAMPYRA, in markets outside the U.S. We are responsible for all regulatory activities and the future clinical development of related products in those markets. 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, which would be capitalized as intangible assets upon achievement of the milestones and amortized utilizing an economic consumption model. The next expected milestone of $15.0 million, due if ex-U.S. net sales reach $100.0 million over a period of four consecutive quarters, was recognized during the third quarter of 2020 and capitalized within intangible assets, net in our consolidated balance sheets. Royalty payments are recognized in cost of sales within our consolidated statements of income. In connection with the collaboration and license agreement, we also entered into a supply agreement with Acorda for the commercial supply of FAMPYRA. This agreement is a sublicense arrangement of an existing agreement between Acorda and Alkermes Inc., who acquired Elan Drug Technologies, the original party to the license with Acorda. For the years ending December 31, 2021, 2020 and 2019, total cost of sales related to royalties and commercial supply of FAMPYRA reflected in our consolidated statements of income were $46.6 million, $44.5 million and $42.0 million, respectively. Sage Therapeutics, Inc. In November 2020 we entered into a global collaboration and license agreement with Sage to jointly develop and commercialize BIIB125 (zuranolone) for the potential treatment of major depressive disorder and postpartum depression and BIIB124 (SAGE-324) for the potential treatment of essential tremor with potential in other neurological conditions such as epilepsy. 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 are subject to transfer restrictions. We recorded an asset in investments and other assets in our consolidated balance sheets to reflect the initial fair value of the Sage common stock acquired and a charge of approximately $209.0 million to research and development expense in our consolidated statements of income to reflect the premium paid for the Sage common stock. We also made an upfront payment of $875.0 million that was recorded as research and development expense in our consolidated statements of income. We may also pay Sage development and commercial milestone payments that could total up to approximately $1.6 billion if all the specified milestones set forth in this collaboration are achieved. 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. A summary of development and sales and marketing expense related to this collaboration is as follows: For the Years Ended December 31, (In millions) 2021 Total Sage collaboration development expense $ 167.7 Biogen's share of Sage development expense reflected in research and development expense in our consolidated statements of income 83.8 Total Sage sales and marketing expense incurred by the collaboration 36.4 Biogen's share of Sage sales and marketing expense reflected in selling, general and administrative expense in our consolidated statements of |
Investments in Variable Interes
Investments in Variable Interest Entities | 12 Months Ended |
Dec. 31, 2021 | |
Investments in Variable Interest Entities [Abstract] | |
Investments in Variable Interest Entities | 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 We have a collaboration and license agreement with Neurimmune for the development and commercialization of antibodies for the potential treatment of Alzheimer's disease, including ADUHELM (as amended, the Neurimmune Agreement). We are responsible for the development, manufacturing and commercialization of all collaboration products. The Neurimmune Agreement is effective for the longer of the duration of certain patents relating to a licensed product or 12 years from the first commercial sale of a licensed product. We consolidate the results of Neurimmune as we determined that we are the primary beneficiary of Neurimmune because we have the power through the collaboration to direct the activities that most significantly impact the entity’s economic performance and we are required to fund 100.0% of the research and development costs incurred in support of the collaboration. In October 2017 we amended the terms of the Neurimmune Agreement and made a $150.0 million payment to Neurimmune in exchange for a 15.0% reduction in the previously negotiated royalty rates payable on products developed under the Neurimmune Agreement, including royalties payable on potential commercial sales of ADUHELM. In May 2018 we made an additional $50.0 million payment to Neurimmune to further reduce the previously negotiated royalty rates payable on products developed under the Neurimmune Agreement, including royalties payable on commercial sales of ADUHELM, by an additional 5.0%. Our royalty rates payable on products developed under the Neurimmune Agreement, including royalty rates payable on commercial sales of ADUHELM, now range from the high single digits to sub-teens. As we consolidate the results of Neurimmune, we treated these payments as distributions and recognized them as charges to noncontrolling interests in the fourth quarter of 2017 and the second quarter of 2018, as applicable. Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $75.0 million upon the regulatory filing with the FDA for the approval of ADUHELM. During the second quarter of 2020 we paid Neurimmune $75.0 million upon the completed submission of the BLA for the approval of ADUHELM to the FDA, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income. In addition, during the second quarter of 2020 we recognized net profit-sharing income of $33.8 million to reflect Eisai's 45.0% share of the $75.0 million milestone payment, which was recognized in collaboration profit (loss) sharing in our consolidated statements of income. In June 2021 ADUHELM was granted accelerated approval by the FDA. Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $100.0 million related to the launch of ADUHELM in the U.S. During the second quarter of 2021 we made this $100.0 million payment, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income. In addition, during the second quarter of 2021 we recognized net profit-sharing income of $45.0 million to reflect Eisai's 45.0% share of the $100.0 million milestone payment, which was recognized in collaboration profit (loss) sharing in our consolidated statements of income. Additionally, if aducanumab receives regulatory approval in the jurisdictions where we have submitted filings, we may pay up to $100.0 million in additional milestones to Neurimmune, which includes $50.0 million if launched in three or more countries in the E.U. and $50.0 million if launched in Japan. Milestones payable to Neurimmune are shared expenses under the ADUHELM Collaboration Agreement. Research and development costs for which we reimburse Neurimmune are reflected in research and development expense in our consolidated statements of income. During the years ending December 31, 2021, 2020 and 2019, amounts reimbursed were immaterial. During the second quarter of 2021 we recorded a net deferred tax asset of approximately $490.0 million. The net deferred tax asset is comprised of approximately $945.0 million of gross deferred tax asset, reduced by approximately $455.0 million of unrecognized tax benefit. The deferred tax benefit relates to Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM and approval of the Swiss cantonal tax authorities. During the fourth quarter of 2021 we recorded a valuation allowance of approximately $390.0 million related to this deferred tax asset. There is 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. Under the ADUHELM Collaboration Agreement, Eisai had an option to share in the benefit and cost associated with the royalty reductions, as discussed above; however, Eisai did not elect to share in the benefit and cost with respect to either the October 2017 or May 2018 royalty reductions, which will impact the amount of profits (losses) on commercial sales of ADUHELM to be shared with Eisai. For additional information on our collaboration arrangements with Eisai, please read Note 18, 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, 2021 and 2020, the carrying value of our investments in certain biotechnology companies representing potential unconsolidated variable interest entities totaled $24.6 million and $12.8 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 previously contractually required amounts. |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2021 | |
Loss Contingency, Information about Litigation Matters [Abstract] | |
Litigation | LITIGATION We are currently involved in various claims and legal proceedings, including the matters described below. For information as to our accounting policies relating to claims and legal proceedings, including use of estimates and contingencies, please read Note 1, Summary of Significant Accounting Policies , to 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. The claims and legal proceedings in which we are involved also include challenges to the scope, validity or enforceability of the patents relating to our products, pipeline or processes and challenges to the scope, validity or enforceability of the patents held by others. These include claims by third-parties that we infringe their patents. An adverse outcome in any of these proceedings could result in one or more of the following and have a material impact on our business or consolidated results of operations and financial position: (i) loss of patent protection; (ii) inability to continue to engage in certain activities; and (iii) payment of significant damages, royalties, penalties and/or license fees to third parties. Loss Contingencies ADUHELM Securities Litigation We and certain current and former officers are named as defendants in an action filed by a shareholder on November 13, 2020, and now pending in the U.S. District Court for the District of Massachusetts. The action alleges violations of federal securities laws under 15 U.S.C §78j(b) and §78t(a) and 17 C.F.R. §240.10b-5 and seeks a declaration of the action as a class action and monetary relief. An estimate of the possible loss or range of loss cannot be made at this time. No trial date has been set. We have filed a motion to dismiss, which is pending. IMRALDI Patent Litigation In September 2018 Fresenius Kabi Deutschland GmbH (Fresenius Kabi) commenced proceedings for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris (the French proceeding) and in November 2018 against Biogen GmbH in the Düsseldorf Regional Court (the German proceeding), alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen has commercialized in Europe, infringes national counterparts of European Patent No. 3 148 510 (the EP '510 Patent, expiring in May 2035). In May 2020 the European Patent Office (EPO) held the EP '510 Patent invalid. Fresenius Kabi' has appealed to the EPO's Technical Boards of Appeal, a hearing has been set for June 2022, and the German and French proceedings have been stayed pending the decision on appeal. In June 2020 Fresenius Kabi commenced proceedings in Denmark's Maritime and Commercial High Court alleging that IMRALDI infringes the Danish counterpart of European Patent No. 3 145 488 (the EP '488 Patent, expiring in May 2035) and a Danish utility model. In September 2021 the Court ruled that the patent and utility model are invalid and not infringed. Fresenius Kabi has appealed to the High Court of Eastern Denmark and the appeal is pending. The EPO has scheduled a hearing on the validity of the EP '488 Patent for October 2022. In July 2020 the Danish Patent Board of Appeal revoked the Danish utility models that Fresenius Kabi had asserted against Biogen and Fresenius Kabi has appealed to the Danish Maritime and Commercial High Court. No hearing has been scheduled. In July 2019 Gedeon Richter Nyrt commenced proceedings for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of the German counterpart of European Patent No. 3 212 667, which expires in October 2035. The case has been stayed pending proceedings in the EPO seeking to invalidate the patent. In November 2020 Gedeon Richter Nyrt commenced additional proceedings against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of a German utility model. In October 2021 Biogen filed cancellation proceedings in respect of the German utility model and the infringement proceedings have been stayed pending the outcome of the cancellation proceedings. An estimate of the possible loss or range of loss in the IMRALDI patent litigation described above cannot be made at this time. Qui Tam Litigation In July 2015 a qui tam action filed by Michael Bawduniak on behalf of the U.S. and certain states was unsealed by the U.S. District Court for the District of Massachusetts. The action alleges sales and promotional activities in violation of the federal False Claims Act and state law counterparts and seeks damages of $981.1 million plus statutory trebling of damages, civil penalties, attorneys' fees and costs. A trial is scheduled for the third quarter of 2022. The U.S. has not made an intervention decision. An estimate of the possible loss cannot be made at this time. Dispute with Former Convergence Shareholders In November and December 2019 Shareholder Representative Services LLC, on behalf of the former shareholders of Convergence, sent us correspondence asserting claims of $200.0 million for alleged breach of the contract under which we acquired Convergence. We dispute the claims. Samsung BioLogics Arbitration In December 2020 we requested arbitration in the International Chamber of Commerce Court of International Arbitration against Samsung BioLogics seeking interpretation of certain provisions of the parties Joint Venture Agreement. Samsung BioLogics counterclaimed for breach and seeks declaratory relief and unspecified damages. The arbitration hearing has concluded and a decision is pending. An estimate of the possible loss or range of loss cannot be made at this time. ERISA Class Action Litigation In September 2020 the U.S. District Court for the District of Massachusetts consolidated two cases filed against us in July and August 2020 by participants in the Biogen 401(k) Savings Plan alleging breach of fiduciary duty under ERISA. Plaintiffs seek a declaration of the action as a class action and monetary and other relief. No trial date has been set. An estimate of the possible loss or range of loss cannot be made at this time. Humana Patient Assistance Litigation In September 2021 Humana Inc. (Humana) filed suit against us in the U.S District Court for the District of Massachusetts alleging damages related to our providing MS patients with free medications and making charitable contributions to non-profit organizations that assist MS patients. Humana alleges violation of the federal RICO Act and state laws and seeks statutory treble damages, attorneys' fees and costs. No trial date has been set. An estimate of the possible loss or range of loss cannot be made at this time. Other Matters Government Investigations The U.S. House of Representatives Committees on Oversight and Reform and Energy and Commerce and the Office of Inspector General of the U.S. Department of Health and Human Services have announced investigations relating to ADUHELM. In addition, the Company has received a civil investigative demand from the Federal Trade Commission and an inquiry from the Securities and Exchange Commission seeking information relating to ADUHELM, including healthcare sites, ADUHELM’s approval and ADUHELM’s marketing. Hatch-Waxman Act Litigation relating to TECFIDERA Orange-Book Listed Patents In 2017 to 2020 we filed patent infringement proceedings relating to TECFIDERA Orange-Book listed patents pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act (the Delaware Actions), against Accord Healthcare Inc., Alkem Laboratories Ltd., Amneal Pharmaceuticals LLC, Cipla Limited, Graviti Pharmaceuticals Pvt. Ltd., Hetero USA, Inc., Lupin Atlantis Holdings SA, Macleods Pharmaceuticals, Ltd., MSN Laboratories Pvt. Ltd., Pharmathen S.A., Prinston Pharmaceutical Inc., Sandoz Inc., Shilpa Medicare Limited, Slayback Pharma LLC, Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., Sun Pharma Global FZE, Torrent Pharmaceuticals Ltd., TWi Pharmaceuticals, Inc., Windlas Healthcare Pvt. Ltd. and Zydus Pharmaceuticals (USA) Inc. (collectively, the Delaware Defendants) in the U.S. District Court for the District of Delaware (the Delaware Court) and against Mylan in the U.S. District Court for the Northern District of West Virginia (the West Virginia Court). In June 2020 the West Virginia Court entered judgment for Mylan that the asserted claims of the ‘514 Patent are invalid for lack of written description and in November 2021 the Federal Circuit affirmed. The Delaware Court entered judgment for the Delaware Defendants on the grounds that the judgment of the West Virginia Court applies to the Delaware Actions under principles of collateral estoppel. The appeals in the Delaware cases were stayed and we expect will remain so until the Federal Circuit's decision in the West Virginia case becomes final. Petition for Inter Partes Review In July 2018 Mylan Pharmaceuticals, Inc. (Mylan) filed a petition that was granted by the U.S. Patent Trial and Appeal Board (PTAB) for inter partes review of our U.S. Patent No. 8,399,514 (the '514 Patent). The '514 Patent includes claims covering treatment of MS with 480 mg of dimethyl fumarate per day as provided for in our TECFIDERA label. In February 2020 the PTAB issued a final written decision upholding the patentability of the ‘514 Patent and in November 2021 the Federal Circuit ruled that the decision was moot. European Patent Office Oppositions In January 2022 the Technical Boards of Appeal of the EPO affirmed the EPO's 2016 decision revoking our European Patent No. 2 137 537, which covers the treatment of MS with 480 mg of dimethyl fumarate as provided for in our TECFIDERA label. TYSABRI Patent Revocation Matters In November 2017 Swiss Pharma International AG, affiliated with the Polpharma Group, filed an action in the Commercial Court of Rome to invalidate the Italian counterpart of the European Patent No. 1 485 127 (the E.U. '127 Patent) which covers administration of natalizumab (TYSABRI) to treat MS and expires in February 2023. A hearing has been set for June 2022. In August 2020 Polpharma Biologics S.A., also affiliated with the Polpharma Group, brought an action in the Polish Patent Office to revoke our Polish Patent No. 215263, which corresponds to the E.U. '127 Patent and expires in February 2023. The action was suspended by the Polish Patent Office in April 2021 pending examination of our amended patent claims. In June 2021 Polpharma Biologics S.A., Sandoz B.V. and Sandoz AG filed an action in the District Court of the Hague, Netherlands to invalidate the Dutch counterpart of our European Patent 2 676 967 (the EU '967 Patent), which expires in 2027 and covers methods of treatment using natalizumab (TYSABRI) and pre-treatment testing of patients. A hearing has been set for September 2022. In July 2021 the EPO revoked the EU ‘967 Patent. We have appealed to the EPO’s Technical Boards of Appeal. A hearing date has not been set. In September 2021 Polpharma Biologics S.A., Sandoz AG, Sandoz Limited and Sandoz GmbH filed an action in the English High Court to revoke the UK counterpart of the EU ‘967 Patent and seeking a declaration that the patent would not be infringed by the marketing of Polpharma’s proposed natalizumab biosimilar. A hearing has been set for November 2022. Annulment Proceedings in General Court of the European Union relating to TECFIDERA Pharmaceutical Works Polpharma SA (Polpharma) and Mylan Ireland Ltd. (Mylan Ireland) each filed actions in the General Court of the European Union (Polpharma in October 2018 and Mylan Ireland in November 2020) to annul the European Medicines Agency's (EMA) decision not to validate their applications to market generic versions of TECFIDERA on the grounds that TECFIDERA benefits from regulatory data protection. On May 5, 2021, the European General Court annulled the EMA's non-validation decision with respect to Polpharma. We have appealed the decision to the European Court of Justice and the appeal is pending. The case brought by Mylan Ireland has been stayed. Product Liability and Other Legal Proceedings We are also involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial condition. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Royalty Payments TYSABRI In 2013 we acquired from Elan full ownership of all remaining rights to TYSABRI that we did not already own or control. Under the acquisition agreement, we are obligated to make contingent payments to Elan of 18.0% on annual worldwide net commercial sales up to $2.0 billion and 25.0% on annual worldwide net commercial sales that exceed $2.0 billion. Royalty payments to Elan and other third-parties are recognized as cost of sales in our consolidated statements of income. Elan was acquired by Perrigo Company plc (Perrigo) in December 2013 and Perrigo subsequently sold its rights to these payments to a third-party effective January 2017. SPINRAZA In 2016 we exercised our option to develop and commercialize SPINRAZA from Ionis. Under our agreement with Ionis, we make royalty payments to Ionis on annual worldwide net commercial sales of SPINRAZA using a tiered royalty rate between 11.0% and 15.0%, which are recorded as cost of sales in our consolidated statements of income. For additional information on our collaboration arrangements with Ionis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. VUMERITY In October 2019 the FDA approved VUMERITY for the treatment of RMS. During the fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in the E.U., Switzerland and the U.K. Under our agreement with Alkermes, we make royalty payments to Alkermes on worldwide net commercial sales of VUMERITY using a royalty rate of 15.0%, which are recorded as cost of sales in our consolidated statements of income. Royalties payable on net commercial sales of VUMERITY are subject, under certain circumstances, to tiered minimum annual payment requirements for a period of five years following FDA approval. For additional information on our collaboration arrangement with Alkermes, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Contingent Consideration related to Business Combinations In connection with our acquisition of Convergence, we agreed to make additional payments based upon the achievement of certain milestone events. As the acquisition of Convergence occurred after January 1, 2009, we recognized the contingent consideration liabilities associated with this transaction at their fair value on the acquisition date and revalue the remaining obligations each reporting period. We may pay up to approximately $400.0 million in remaining milestones related to this acquisition. Fumapharm AG In 2006 we acquired Fumapharm AG. As part of this acquisition we acquired the Fumapharm Products. We were required to make contingent payments to former shareholders of Fumapharm AG and holders of their rights based on the attainment of certain cumulative sales levels of Fumapharm Products and the level of total net sales of Fumapharm Products in the prior 12-month period, as defined in the acquisition agreement, until such time as the cumulative sales level reached $20.0 billion, at which time no further contingent payments were due. During the first quarter of 2019 we paid the final $300.0 million contingent payment as we achieved the $20.0 billion cumulative sales levels related to the Fumapharm Products in the fourth quarter of 2018. Contingent Development, Regulatory and Commercial Milestone Payments Based on our development plans as of December 31, 2021, we could trigger potential future milestone payments to third-parties of up to approximately $10.0 billion, including approximately $2.0 billion in development milestones, approximately $900.0 million in regulatory milestones and approximately $7.1 billion in commercial milestones, as part of our various collaborations, including licensing and development programs. 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, 2021, 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 $133.9 million in milestones in 2022 under our current agreements. Additionally, if aducanumab receives regulatory approval in the jurisdictions where we have submitted filings, we may pay up to $100.0 million in additional milestones to Neurimmune in 2022, which includes $50.0 million if launched in three or more countries in the E.U. and $50.0 million if launched in Japan. Milestones payable to Neurimmune are shared expenses under the ADUHELM Collaboration Agreement. During the second quarter of 2020 we paid Neurimmune $75.0 million upon the completed submission of the BLA for the approval of ADUHELM to the FDA, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income. In June 2021 ADUHELM was granted accelerated approval by the FDA. Under the terms of the Neurimmune Agreement, we were required to pay Neurimmune a milestone payment of $100.0 million related to the launch of ADUHELM in the U.S. During the second quarter of 2021 we made this $100.0 million payment, which was recognized as a charge to net income (loss) attributable to noncontrolling interests, net of tax in our consolidated statements of income. Other Funding Commitments As of December 31, 2021, 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 $27.3 million in our consolidated balance sheets for expenditures incurred by CROs as of December 31, 2021. We have approximately $676.1 million in cancellable future commitments based on existing CRO contracts as of December 31, 2021. As part of the sale of our Hillerød, Denmark manufacturing operations to FUJIFILM, we provided FUJIFILM with certain minimum batch production commitment guarantees. There is a risk that the minimum contractual batch production commitments will not be met. Based upon current estimates we do not expect to incur an adverse commitment obligation associated with such guarantees. We developed this estimate using a probability-weighted estimate of future manufacturing activity and may further adjust this estimate based upon changes in business conditions, which may result in the increase or reduction of this adverse commitment obligation in subsequent periods. For additional information on the divestiture of our Hillerød, Denmark manufacturing operations, please read Note 3, Divestitures , to these consolidated financial statements. 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, 2021, we have approximately $106.8 million of liabilities associated with uncertain tax positions. As of December 31, 2021 and 2020, we have accrued income tax liabilities of approximately $633.0 million and $697.0 million, respectively, under the Transition Toll Tax. Of the amounts accrued as of December 31, 2021, approximately $72.7 million is expected to be paid within one year. The Transition Toll Tax will be paid in installments over an eight--year period, which started in 2018, and will not accrue interest. For additional information on the Transition Toll Tax, please read Note 16, Income Taxes , to these consolidated financial statements. |
Guarantees
Guarantees | 12 Months Ended |
Dec. 31, 2021 | |
Guarantees [Abstract] | |
Guarantees | GUARANTEES As of December 31, 2021 and 2020, 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, 2021 and 2020. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 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) 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 $58.4 million, $44.3 million and $44.8 million for the years ended December 31, 2021, 2020 and 2019, respectively. Deferred Compensation Plan We maintain a non-qualified deferred compensation plan, known as the Supplemental Savings Plan (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, 2021 and 2020, totaled approximately $131.4 million and $120.0 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 2021, 2020 and 2019. 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, 2021 and 2020, the Swiss plan had an unfunded net pension obligation of $64.1 million and $75.7 million, respectively, and plan assets that totaled $200.1 million and $170.0 million, respectively. In 2021, 2020 and 2019 we recognized expense totaling $21.5 million, $15.5 million and $14.7 million, respectively, related to our Swiss plan, of which $3.5 million, $2.6 million and $1.2 million, respectively, was included in other income (expense), net in our consolidated statements of income. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Segment Information | SEGMENT INFORMATION 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. Our Chief Executive Officer (CEO), as the chief operating decision-maker, manages and allocates resources to the operations of our company on a total company basis. 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. The company is also supported by corporate staff functions. Managing and allocating resources on a total company basis enables our CEO to assess 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. Consistent with this decision-making process, our CEO uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Enterprise-wide disclosures about product revenue, other revenue and long-lived assets by geographic area are presented below. 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, 2021 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 3,805.7 $ 2,626.0 $ 1,162.4 $ 688.0 $ 564.8 $ 8,846.9 Revenue from anti-CD20 therapeutic programs 1,596.7 — — — 61.8 1,658.5 Other revenue from external customers 429.9 9.7 — 36.7 — 476.3 Long-lived assets 1,390.5 2,337.8 25.4 16.4 21.7 3,791.8 December 31, 2020 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 5,900.1 $ 2,495.3 $ 1,161.1 $ 596.7 $ 539.0 $ 10,692.2 Revenue from anti-CD20 therapeutic programs 1,897.4 0.1 — — 80.3 1,977.8 Other revenue from external customers 733.6 8.0 0.1 32.9 — 774.6 Long-lived assets 1,496.3 2,290.2 31.2 16.2 10.9 3,844.8 December 31, 2019 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 6,713.8 $ 2,668.4 $ 1,126.1 $ 320.3 $ 551.2 $ 11,379.8 Revenue from anti-CD20 therapeutic programs 2,211.9 0.2 — — 78.3 2,290.4 Other revenue from external customers 585.8 9.4 0.3 112.2 — 707.7 Long-lived assets 1,493.2 2,135.4 27.5 6.2 12.0 3,674.3 (1) Represents amounts related to Europe less those attributable to Germany. Other As of December 31, 2021, 2020 and 2019, approximately $2,237.0 million, $2,180.6 million and $2,028.8 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 large-scale biologics manufacturing facility in Solothurn, Switzerland, please read Note 10, Property, Plant and Equipment, to these consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Business Overview | Business Overview Biogen is a global biopharmaceutical company focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and are providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology. Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group. For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Our innovative drug development and commercialization activities are complemented by our biosimilar business that expands access to medicines and reduces the cost burden for healthcare systems. Through our agreements with Samsung Bioepis Co., Ltd. (Samsung Bioepis), our joint venture with Samsung BioLogics Co., Ltd. (Samsung BioLogics), we market and sell BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe. We have also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was approved in the U.S., the E.U. and the U.K. during the third quarter of 2021. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. |
Consolidation | Consolidation Our consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries and those of 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 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 | 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. 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. We have made estimates of the impact of the COVID-19 pandemic within our consolidated financial statements and there may be changes to those estimates in future periods. |
Revenue Recognition | 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 the FASB Accounting Standards Codification (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 distributors and specialty pharmacy providers. 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 and wholesaler incentives. 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. Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay) assistance, Veterans Administration (VA) and Public Health Service (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 chargebacks consist of amounts that we expect to issue 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 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 and GAZYVA and royalty revenue on the sale 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 and GAZYVA; and (ii) other revenue from anti-CD20 therapeutic programs, which primarily consist of our share of pre-tax co-promotion profits on RITUXAN in Canada and royalty revenue on sales of OCREVUS. Pre-tax co-promotion profits on RITUXAN and GAZYVA 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 and GAZYVA 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. For additional information on our relationship with Genentech, please read Note 18, Collaborative and Other Relationships, to these consolidated financial statements. Other Revenue Royalty Revenue We recognize royalty revenue related to sales by our licensees of products covered under patents that we own. Collaborative and Other Relationships We 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, we record our share of the revenue, cost of sales and operating expense on a net basis in collaborative and other relationships included in other revenue in our consolidated statements of income. Our development and commercialization arrangements with Genentech 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. 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 and Samsung Bioepis, please read Note 18, Collaborative and Other Relationships , to these consolidated financial statements. Other Corporate Revenue We record other corporate revenue primarily from amounts earned under contract manufacturing agreements. 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. |
Fair Value Measurements | 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. Our financial assets (which include our cash equivalents, marketable debt securities and certain of our marketable equity securities, derivative contracts and plan assets for deferred compensation) 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, 2021 and 2020. 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 | 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, 2021 and 2020, cash equivalents were comprised of money market funds, commercial paper, overnight reverse repurchase agreements and other debt securities with maturities less than 90 days from the date of purchase. |
Accounts Receivable | 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. In countries where we have experienced a pattern of payments extending beyond our contractual payment term and we expect to collect receivables greater than one year from the time of sale, we have assessed whether the customer has a significant financing component and discounted our receivables and reduced related revenue over the period of time that we estimate those amounts will be paid using the country’s market-based borrowing rate for such period. The related receivables are classified at the time of sale as non-current assets. We accrete interest income on these receivables, which is recorded as a component of other income (expense), net in our consolidated statements of income. 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. |
Concentration of Credit Risk | 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. |
Marketable Securities and Other Investments | 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 accumulated other comprehensive income (loss) 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. 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 changes in observable prices, 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 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 accumulated other comprehensive income (loss). 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 | Equity Method of AccountingIn 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 | 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. 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 a change in such judgment, 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 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 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 | 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 we will exercise that option. 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 in 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 |
Intangible Assets | Intangible Assets Our intangible assets consist of completed technology (comprised of acquired and in-licensed rights and patents, developed technology, out-licensed patents), in-process research and development (IPR&D) acquired after January 1, 2009, 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 acquired and in-licensed rights and patents, developed technology and out-licensed patents 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. Acquired and in-licensed rights and patents primarily relate to our acquisition of all remaining rights to TYSABRI from Elan Pharma International Ltd. (Elan), an affiliate of Elan Corporation, plc. Acquired and in-licensed rights and patents also include other amounts related to our other marketed products and programs acquired through business combinations. Developed technology primarily relates to our AVONEX product, which was recorded in connection with the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation in 2003. We amortize the intangible assets related to our TYSABRI, AVONEX, SPINRAZA, VUMERITY and TECFIDERA (rest of world) products using the economic consumption method based on revenue generated from the products underlying the related intangible assets. An analysis of the anticipated lifetime revenue of our TYSABRI, AVONEX, SPINRAZA, VUMERITY and TECFIDERA (rest of world) products is performed annually during our long-range planning cycle and whenever events or changes in circumstances would significantly affect the anticipated lifetime revenue of our TYSABRI, AVONEX, SPINRAZA, VUMERITY and TECFIDERA (rest of world) products. Intangible assets related to trademarks, trade names and IPR&D prior to commercialization 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 (IPR&D) | Acquired In-process Research and Development (IPR&D) 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 their 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 in 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 |
Goodwill | 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. Goodwill 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. |
Impairment of Long-Lived Assets | 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. |
Contingent Consideration | 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. |
Derivative Instruments and Hedging Activities | 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 accumulated other comprehensive income (loss), 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 We are exposed to the impact of foreign exchange fluctuations on our investment in the equity of Samsung Bioepis, which is denominated in a currency other than the U.S. dollar, and could adversely impact the U.S. dollar value of this investment. Using derivative instruments, we have hedged our net investment position to mitigate the effects of foreign exchange fluctuations. We recognize these designated net investment hedges as either assets or liabilities, at fair value, in our consolidated balance sheets. We hedge the changes in the spot exchange rate in accumulated other comprehensive income (loss) 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. For additional information on our derivative instruments and hedging activities, please read Note 9, Derivative Instruments , to these consolidated financial statements. |
Translation of Foreign Currencies | 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 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 accumulated other comprehensive income (loss), 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 | Royalty Cost of SalesWe 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 | 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 market stock units (MSUs), performance-vested restricted stock units that settle in cash (CSPUs), time-vested restricted stock units (RSUs), performance-vested restricted stock units that can be settled in cash or shares of our common stock (PUs) at the sole discretion of the Compensation and Management Development Committee of our Board of Directors, performance-vested stock units that settle in stock or cash (PSUs) and shares issued under our employee stock purchase plan (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 MSUs 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 our MSUs. 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 CSPUs, PUs and 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 CSPUs, PUs and 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 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 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 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 contract research organizations (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 18, Collaborative and Other Relationships, to these consolidated financial statements. Because an initial indication has been approved for both RITUXAN and GAZYVA, expense incurred by Genentech in the ongoing development of RITUXAN and GAZYVA 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. For collaborations with commercialized products, if we are the principal, we record revenue and the corresponding operating costs in their respective line items in our consolidated statements of income. If we are not the principal, we record operating costs as a reduction of revenue. |
Selling, General and Administrative Expense | 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. |
Income Taxes | 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 global intangible low-taxed income (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. |
Contingencies | 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 | 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. |
New Accounting Pronouncements | 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. Income Taxes In December 2019 the FASB issued Accounting Standards Update No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard removes certain exceptions to the general principles in Topic 740 and simplifies certain other aspects of the accounting for income taxes. This standard became effective for us on January 1, 2021, and did not have a material impact on our consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Property, plant and equipment estimated useful lives | 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 |
Revenues (Tables)
Revenues (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue by product | Revenue by product are summarized as follows: For the Years Ended December 31, 2021 2020 2019 (In millions) United Rest of Total United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate (1) $ 1,089.5 $ 1,272.8 $ 2,362.3 $ 2,742.0 $ 1,163.4 $ 3,905.4 $ 3,312.0 $ 1,126.2 $ 4,438.2 Interferon (2) 983.1 583.0 1,566.1 1,273.5 604.0 1,877.5 1,426.6 675.2 2,101.8 TYSABRI 1,142.2 920.9 2,063.1 1,096.8 849.3 1,946.1 1,041.8 850.4 1,892.2 FAMPYRA — 105.2 105.2 — 103.1 103.1 — 97.1 97.1 Subtotal: MS 3,214.8 2,881.9 6,096.7 5,112.3 2,719.8 7,832.1 5,780.4 2,748.9 8,529.3 Spinal Muscular Atrophy: SPINRAZA 587.9 1,317.2 1,905.1 787.8 1,264.3 2,052.1 933.4 1,163.6 2,097.0 Alzheimer's disease: ADUHELM (3) 3.0 — 3.0 — — — — — — Biosimilars: BENEPALI — 498.3 498.3 — 481.6 481.6 — 486.2 486.2 IMRALDI — 233.4 233.4 — 216.3 216.3 — 184.0 184.0 FLIXABI — 99.4 99.4 — 97.9 97.9 — 68.1 68.1 Subtotal: Biosimilars — 831.1 831.1 — 795.8 795.8 — 738.3 738.3 Other: FUMADERM — 11.0 11.0 — 12.2 12.2 — 15.2 15.2 Total product revenue $ 3,805.7 $ 5,041.2 $ 8,846.9 $ 5,900.1 $ 4,792.1 $ 10,692.2 $ 6,713.8 $ 4,666.0 $ 11,379.8 (1) Fumarate includes TECFIDERA and VUMERITY. VUMERITY became commercially available in the E.U. during the fourth quarter of 2021. (2) Interferon includes AVONEX and PLEGRIDY. (3) In June 2021 the FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S. during the second quarter of 2021. For additional information, please read Note 18, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these consolidated financial statements. |
Analysis of change in reserves | An analysis of the change in reserves for discounts and allowances is summarized as follows: December 31, 2021 (In millions) Discounts Contractual Returns Total Beginning balance $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 Current provisions relating to sales in current year 736.7 2,948.7 15.2 3,700.6 Adjustments relating to prior years (4.0) (96.1) (3.3) (103.4) Payments/credits relating to sales in current year (599.3) (2,283.1) (0.4) (2,882.8) Payments/credits relating to sales in prior years (137.1) (902.9) (15.1) (1,055.1) Ending balance $ 137.7 $ 759.6 $ 38.0 $ 935.3 December 31, 2020 (In millions) Discounts Contractual Returns Total Beginning balance $ 131.1 $ 1,027.3 $ 40.5 $ 1,198.9 Current provisions relating to sales in current year 774.7 3,308.8 19.0 4,102.5 Adjustments relating to prior years (1.0) (54.0) 1.3 (53.7) Payments/credits relating to sales in current year (635.1) (2,426.1) — (3,061.2) Payments/credits relating to sales in prior years (128.3) (763.0) (19.2) (910.5) Ending balance $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 December 31, 2019 (In millions) Discounts Contractual Returns Total Beginning balance $ 127.8 $ 888.8 $ 34.7 $ 1,051.3 Current provisions relating to sales in current year 666.2 3,011.5 20.9 3,698.6 Adjustments relating to prior years 0.3 (54.1) 5.5 (48.3) Payments/credits relating to sales in current year (535.5) (2,242.9) (0.2) (2,778.6) Payments/credits relating to sales in prior years (127.7) (576.0) (20.4) (724.1) Ending balance $ 131.1 $ 1,027.3 $ 40.5 $ 1,198.9 |
Total reserves included in consolidated balance sheet | The total reserves above, which are included in our consolidated balance sheets, are summarized as follows: As of December 31, (In millions) 2021 2020 Reduction of accounts receivable $ 133.2 $ 195.4 Component of accrued expense and other 802.1 1,080.6 Total revenue-related reserves $ 935.3 $ 1,276.0 |
Revenues 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) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 Revenue from anti-CD20 therapeutic programs is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 |
Other revenues | Other revenue is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Revenue from collaborative and other relationships: Revenue earned under our technical development agreement, manufacturing services agreements and royalty revenue on biosimilar products with Samsung Bioepis $ 20.7 $ 20.9 $ 106.2 Other revenue from collaborative and other relationships — 0.7 — Other royalty and corporate revenue: Royalty 27.9 33.9 17.0 Other corporate 427.7 719.1 584.5 Total other revenue $ 476.3 $ 774.6 $ 707.7 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Components of inventory | The components of inventory are summarized as follows: As of December 31, (In millions) 2021 2020 Raw materials $ 349.6 $ 314.9 Work in process 814.0 544.5 Finished goods 187.9 209.2 Total inventory $ 1,351.5 $ 1,068.6 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible assets | Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: As of December 31, 2021 As of December 31, 2020 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,413.1 $ (5,388.5) $ 2,024.6 $ 7,394.3 $ (5,136.5) $ 2,257.8 In-process research and development Indefinite until commercialization 132.7 — 132.7 762.5 — 762.5 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,609.8 $ (5,388.5) $ 2,221.3 $ 8,220.8 $ (5,136.5) $ 3,084.3 |
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, 2021 2022 $ 255.0 2023 210.0 2024 195.0 2025 195.0 2026 180.0 |
Summary of roll forward of the changes in goodwill | The following table provides a roll forward of the changes in our goodwill balance: As of December 31, (In millions) 2021 2020 Goodwill, beginning of year $ 5,762.1 $ 5,757.8 Other (1.0) 4.3 Goodwill, end of year $ 5,761.1 $ 5,762.1 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities recorded at fair value | 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: As of December 31, 2021 (In millions) Total Quoted Prices in Significant Other Significant Assets: Cash equivalents $ 1,632.2 $ — $ 1,632.2 $ — Marketable debt securities: Corporate debt securities 1,108.2 — 1,108.2 — Government securities 1,192.7 — 1,192.7 — Mortgage and other asset backed securities 132.2 — 132.2 — Marketable equity securities 1,048.5 181.7 866.8 — Derivative contracts 80.9 — 80.9 — Plan assets for deferred compensation 33.4 — 33.4 — Total $ 5,228.1 $ 181.7 $ 5,046.4 $ — Liabilities: Derivative contracts $ 10.8 $ — $ 10.8 $ — Contingent consideration obligations 209.1 — — 209.1 Total $ 219.9 $ — $ 10.8 $ 209.1 As of December 31, 2020 (In millions) Total Quoted Prices Significant Significant Assets: Cash equivalents $ 626.9 $ — $ 626.9 $ — Marketable debt securities: Corporate debt securities 1,301.5 — 1,301.5 — Government securities 627.1 — 627.1 — Mortgage and other asset backed securities 122.4 — 122.4 — Marketable equity securities 1,974.3 271.1 1,703.2 — Derivative contracts 20.5 — 20.5 — Plan assets for deferred compensation 28.2 — 28.2 — Total $ 4,700.9 $ 271.1 $ 4,429.8 $ — Liabilities: Derivative contracts $ 217.2 $ — $ 217.2 $ — Contingent consideration obligations 259.8 — — 259.8 Total $ 477.0 $ — $ 217.2 $ 259.8 |
Summary of significant unobservable inputs | The following tables summarize the significant unobservable inputs in the fair value measurement of our contingent consideration obligations as of December 31, 2021 and 2020: As of December 31, 2021 (In millions) Fair Value Valuation Technique Unobservable Input Range Weighted Average Liabilities: Contingent consideration obligation $209.1 Discounted cash flow Discount rate 1.30% 1.30% Expected timing of achievement of development milestones 2023 to 2027 — As of December 31, 2020 (In millions) Fair Value Valuation Technique Unobservable Input Range Weighted Average Liabilities: Contingent consideration obligation $259.8 Discounted cash flow Discount rate 0.60% 0.60% Expected timing of achievement of development milestones 2021 to 2025 — |
Summary of fair and carrying value of debt instruments | The fair values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of December 31, (In millions) 2021 2020 3.625% Senior Notes due September 15, 2022 $ 1,020.0 $ 1,054.1 4.050% Senior Notes due September 15, 2025 1,895.2 2,003.1 2.250% Senior Notes due May 1, 2030 1,475.9 1,557.2 5.200% Senior Notes due September 15, 2045 (1) 1,463.0 2,365.1 3.150% Senior Notes due May 1, 2050 1,457.7 1,536.4 3.250% Senior Notes due February 15, 2051 (1) 692.9 — Total $ 8,004.7 $ 8,515.9 (1) In February 2021 we completed a private offer to exchange (Exchange Offer) our tendered 5.200% Senior Notes due September 15, 2045 (2045 Senior Notes), whereby approximately $624.6 million of our 2045 Senior Notes were exchanged for approximately $700.7 million of a new series of 3.250% Senior Notes due February 15, 2051 (2051 Senior Notes). For additional information on our Exchange Offer, please read Note 12, Indebtedness , to these consolidated financial statements. |
Fair value of contingent consideration obligations | The following table provides a roll forward of the fair values of our contingent consideration obligations, which includes Level 3 measurements: As of December 31, (In millions) 2021 2020 Fair value, beginning of year $ 259.8 $ 346.1 Changes in fair value (50.7) (86.3) Fair value, end of year $ 209.1 $ 259.8 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, All Other Investments [Abstract] | |
Summary of financial assets with maturities of less than 90 days included within cash and cash equivalents | 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) 2021 2020 Commercial paper $ 247.6 $ 61.1 Overnight reverse repurchase agreements 200.0 37.4 Money market funds 901.6 505.1 Short-term debt securities 283.0 23.3 Total $ 1,632.2 $ 626.9 |
Marketable debt and equity securities | The following tables summarize our marketable debt and equity securities, classified as available for sale: As of December 31, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities: Corporate debt securities: Current $ 723.6 $ 0.1 $ (0.3) $ 723.4 Non-current 385.4 0.2 (0.8) 384.8 Government securities: Current 817.0 — (0.4) 816.6 Non-current 377.0 0.1 (1.0) 376.1 Mortgage and other asset backed securities: Current 1.1 — — 1.1 Non-current 131.8 — (0.7) 131.1 Total marketable debt securities $ 2,435.9 $ 0.4 $ (3.2) $ 2,433.1 Marketable equity securities: Marketable equity securities, current $ 33.9 $ 9.9 $ — $ 43.8 Marketable equity securities, non-current 1,133.1 151.0 (279.4) 1,004.7 Total marketable equity securities $ 1,167.0 $ 160.9 $ (279.4) $ 1,048.5 As of December 31, 2020 (In millions) Amortized Gross Gross Fair Marketable debt securities: Corporate debt securities: Current $ 897.8 $ 0.4 $ (0.2) $ 898.0 Non-current 402.5 1.1 (0.1) 403.5 Government securities: Current 380.6 0.1 — 380.7 Non-current 245.9 0.5 — 246.4 Mortgage and other asset backed securities: Current 0.2 — — 0.2 Non-current 122.1 0.2 (0.1) 122.2 Total marketable debt securities $ 2,049.1 $ 2.3 $ (0.4) $ 2,051.0 Marketable equity securities: Marketable equity securities, current $ 70.6 $ 15.9 $ — $ 86.5 Marketable equity securities, non-current 1,168.9 733.8 (14.9) 1,887.8 Total marketable equity securities $ 1,239.5 $ 749.7 $ (14.9) $ 1,974.3 |
Summary of contractual maturities: available-for-sale securities | The estimated fair value and amortized cost of our marketable debt securities available-for-sale by contractual maturity are summarized as follows: As of December 31, 2021 As of December 31, 2020 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,541.1 $ 1,541.7 $ 1,278.9 $ 1,278.6 Due after one year through five years 868.2 870.2 722.6 721.3 Due after five years 23.8 24.0 49.5 49.2 Total marketable debt securities $ 2,433.1 $ 2,435.9 $ 2,051.0 $ 2,049.1 |
Proceeds from marketable securities, excluding strategic investments | 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) 2021 2020 2019 Proceeds from maturities and sales $ 3,405.4 $ 7,299.4 $ 6,007.0 Realized gains 0.2 17.7 6.0 Realized losses 4.0 26.0 1.5 |
Derivative Instruments (Tables)
Derivative Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Foreign currency forward contracts that were entered into to hedge forecasted revenue | The notional value of foreign currency forward contracts that were entered into to hedge forecasted revenue and operating expense is summarized as follows: Notional Amount (In millions) 2021 2020 Euro $ 1,828.0 $ 2,979.1 British pound 166.2 250.6 Japanese yen 72.7 — Canadian dollar 59.9 — Total foreign currency forward contracts $ 2,126.8 $ 3,229.7 |
Summary of unrealized gain (loss) on derivative instruments that are included in AOCI | The pre-tax portion of the fair value of these foreign currency forward contracts that were included in accumulated other comprehensive income (loss) in total equity is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Unrealized gains $ 60.8 $ — $ 6.9 Unrealized (losses) (7.0) (212.5) (6.4) Net unrealized gains (losses) $ 53.8 $ (212.5) $ 0.5 |
Summary of the effect of derivatives designated as cash flow hedging instruments on our consolidated statements of income | The following table summarizes the effect of foreign currency forward contracts 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) Location 2021 2020 2019 Location 2021 2020 2019 Revenue $ (60.0) $ 18.3 $ 118.6 Revenue $ (8.4) $ (9.9) $ 2.9 Operating expense (0.8) 3.3 (3.3) Operating expense — — 0.2 |
Summary of the effect of derivatives designated as net investment hedging instruments on our consolidated statement of income | The following table summarizes the effect of our net investment hedges in our consolidated financial statements: For the Years Ended December 31, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 2019 Location 2021 2020 2019 Location 2021 2020 2019 Gains (losses) on net investment hedge $ 46.0 $ (35.1) $ 25.3 Gains (losses) on net investment hedge $ (3.2) $ 4.5 $ 3.3 Other income (expense) $ (0.6) $ 2.9 $ 7.0 |
Summary of the fair value for our outstanding derivatives | 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 2021 2020 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 66.2 $ — Investments and other assets 5.5 — Liability derivative instruments Accrued expense and other 6.6 157.1 Other long-term liabilities — 35.7 Net Investment Hedging Instruments: Asset derivative instruments Other current assets 4.1 — Liability derivative instruments Accrued expense and other — 19.7 Other Derivative Instruments: Asset derivative instruments Other current assets 5.1 20.5 Liability derivative instruments Accrued expense and other 4.2 4.7 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Components of property, plant and equipment, net | Components of property, plant and equipment, net are summarized as follows: As of December 31, (In millions) 2021 2020 Land $ 207.5 $ 119.8 Buildings 1,699.7 1,025.3 Leasehold improvements 121.0 104.6 Machinery and equipment 1,585.5 1,027.8 Computer software and hardware 971.6 903.0 Furniture and fixtures 67.4 62.5 Construction in progress 770.3 1,950.8 Total cost 5,423.0 5,193.8 Less: accumulated depreciation (2,006.6) (1,782.3) Total property, plant and equipment, net $ 3,416.4 $ 3,411.5 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of operating leases | 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 2021 2020 Assets: Operating lease assets Operating lease assets $ 375.4 $ 433.3 Liabilities Current operating lease liabilities Accrued expense and other $ 89.1 $ 83.2 Non-current operating lease liabilities Long-term operating lease liabilities 330.4 402.0 Total operating lease liabilities $ 419.5 $ 485.2 |
Operating lease costs | 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 2021 2020 Operating lease cost Research and development $ 3.4 $ 5.2 Selling, general and administrative 95.9 93.1 Variable lease cost Research and development 0.8 1.1 Selling, general and administrative 25.7 21.1 Sublease income Selling, general and administrative (23.9) (24.2) Other (income) expense, net (4.0) (3.9) Net lease cost $ 97.9 $ 92.4 |
Operating lease liability maturity | The minimum lease payments for the next five years and thereafter is expected to be as follows: (In millions) As of December 31, 2021 2022 $ 99.6 2023 89.7 2024 79.7 2025 57.2 2026 44.8 Thereafter 84.0 Total lease payments $ 455.0 Less: interest 35.5 Present value of operating lease liabilities $ 419.5 |
Operating lease weighted average remaining term and discount rate | The weighted average remaining lease term and weighted average discount rate of our operating leases are as follows: As of December 31, 2021 2020 Weighted average remaining lease term in years 5.43 6.30 Weighted average discount rate 2.9 % 2.9 % |
Operating lease supplemental cash flow disclosure | 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) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities $ 105.8 $ 100.2 Operating lease assets obtained in exchange for lease obligations 18.1 59.0 |
Indebtedness (Tables)
Indebtedness (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of indebtedness | Our indebtedness is summarized as follows: As of December 31, (In millions) 2021 2020 Current portion: 3.625% Senior Notes due September 15, 2022 $ 999.1 $ — Current portion of notes payable $ 999.1 $ — Non-current portion: 3.625% Senior Notes due September 15, 2022 $ — $ 997.9 4.050% Senior Notes due September 15, 2025 1,742.9 1,741.2 2.250% Senior Notes due May 1, 2030 1,492.0 1,491.1 5.200% Senior Notes due September 15, 2045 (1) 1,099.9 1,723.4 3.150% Senior Notes due May 1, 2050 1,473.2 1,472.6 3.250% Senior Notes due February 15, 2051 (1) 466.0 — Non-current portion of notes payable $ 6,274.0 $ 7,426.2 (1) In February 2021 we completed our Exchange Offer of our tendered 2045 Senior Notes, whereby approximately $624.6 million of our 2045 Senior Notes were exchanged for approximately $700.7 million of our 2051 Senior Notes. |
Total debt maturities | The total gross payments due under our debt arrangements are as follows: (In millions) As of December 31, 2021 2022 $ 1,000.0 2023 — 2024 — 2025 1,750.0 2026 — 2027 and thereafter 4,817.3 Total $ 7,567.3 |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of common stock | The following table describes the number of shares authorized, issued and outstanding of our common stock as of December 31, 2021, 2020 and 2019: As of December 31, 2021 As of December 31, 2020 As of December 31, 2019 (In millions) Authorized Issued Outstanding Authorized Issued Outstanding Authorized Issued Outstanding Common stock 1,000.0 170.8 147.0 1,000.0 176.2 152.4 1,000.0 198.0 174.2 |
Schedule of Accumulated Other Comprehensive Income (Loss) | The following tables summarize the changes in accumulated other comprehensive income (loss), net of tax by component: December 31, 2021 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) Other comprehensive income (loss) before reclassifications (6.6) 178.2 33.4 21.5 (92.4) 134.1 Amounts reclassified from accumulated other comprehensive income (loss) 3.0 54.6 0.6 — — 58.2 Net current period other comprehensive income (loss) (3.6) 232.8 34.0 21.5 (92.4) 192.3 Balance, December 31, 2021 $ (2.2) $ 53.8 $ 25.5 $ (44.8) $ (139.0) $ (106.7) December 31, 2020 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2019 $ 4.2 $ 7.8 $ 25.1 $ (32.8) $ (139.5) $ (135.2) Other comprehensive income (loss) before reclassifications (9.3) (165.0) (30.7) (33.5) 92.9 (145.6) Amounts reclassified from accumulated other comprehensive income (loss) 6.5 (21.8) (2.9) — — (18.2) Net current period other comprehensive income (loss) (2.8) (186.8) (33.6) (33.5) 92.9 (163.8) Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) December 31, 2019 (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 Hedge, Net of Tax Unfunded Status of Postretirement Benefit Plans, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2018 $ (4.0) $ 34.7 $ 3.5 $ (31.3) $ (243.3) $ (240.4) Other comprehensive income (loss) before reclassifications 11.8 88.1 28.6 (1.5) 103.8 230.8 Amounts reclassified from accumulated other comprehensive income (loss) (3.6) (115.0) (7.0) — — (125.6) Net current period other comprehensive income (loss) 8.2 (26.9) 21.6 (1.5) 103.8 105.2 Balance, December 31, 2019 $ 4.2 $ 7.8 $ 25.1 $ (32.8) $ (139.5) $ (135.2) |
Reclassification out of Accumulated Other Comprehensive Income | The following table summarizes the amounts reclassified from accumulated other comprehensive income (loss): (In millions) Income Statement Location Amounts Reclassified from For the Years Ended December 31, 2021 2020 2019 Gains (losses) on securities available for sale Other income (expense) $ (3.8) $ (8.2) $ 4.5 Income tax benefit (expense) 0.8 1.7 (0.9) Gains (losses) on cash flow hedges Revenue (60.0) 18.3 118.6 Operating expense (0.8) 3.3 (3.3) Other income (expense) 0.2 0.3 0.3 Income tax benefit (expense) 6.0 (0.1) (0.6) Gains (losses) on net investment hedge Other income (expense) (0.6) 2.9 7.0 Total reclassifications, net of tax $ (58.2) $ 18.2 $ 125.6 |
Earnings per Share (Tables)
Earnings per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Basic and diluted 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) 2021 2020 2019 Numerator: Net income attributable to Biogen Inc. $ 1,556.1 $ 4,000.6 $ 5,888.5 Denominator: Weighted average number of common shares outstanding 149.1 160.9 187.1 Effect of dilutive securities: Time-vested restricted stock units 0.3 0.2 0.2 Market stock units 0.1 0.1 0.1 Performance stock units settled in stock 0.1 0.1 — Dilutive potential common shares 0.5 0.4 0.3 Shares used in calculating diluted earnings per share 149.6 161.3 187.4 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-based compensation expense included in consolidated statements of income | The following table summarizes share-based compensation expense included in our consolidated statements of income: For the Years Ended December 31, (In millions) 2021 2020 2019 Research and development $ 89.3 $ 80.0 $ 77.1 Selling, general and administrative 169.5 131.3 148.3 Subtotal 258.8 211.3 225.4 Capitalized share-based compensation costs (8.0) (6.2) (8.9) Share-based compensation expense included in total cost and expense 250.8 205.1 216.5 Income tax effect (46.7) (33.5) (35.7) Share-based compensation expense included in net income attributable to Biogen Inc. $ 204.1 $ 171.6 $ 180.8 |
Summary of share-based compensation expense associated with each of our share-based compensating programs | 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) 2021 2020 2019 Market stock units $ 45.6 $ 40.5 $ 30.4 Time-vested restricted stock units 159.8 142.6 134.0 Cash settled performance units — (1.7) 0.7 Performance units — (0.1) 1.6 Performance stock units settled in stock 23.9 7.9 15.5 Performance stock units settled in cash 12.2 8.6 5.5 Employee stock purchase plan 17.3 13.5 11.5 NST stock options — — 26.2 Subtotal 258.8 211.3 225.4 Capitalized share-based compensation costs (8.0) (6.2) (8.9) Share-based compensation expense included in total cost and expense $ 250.8 $ 205.1 $ 216.5 |
Tax benefit and cash received from stock option exercises | The following table summarizes the amount of tax benefit realized for stock options and cash received from the exercise of stock options: For the Years Ended December 31, (In millions) 2020 2019 Tax benefit realized for stock options $ 2.9 $ 2.5 Cash received from the exercise of stock options 0.7 0.4 |
Market stock units activity | The following table summarizes our MSU activity: December 31, 2021 Shares Weighted Average Unvested at December 31, 2020 201,000 $ 388.98 Granted (1) 151,000 358.77 Vested (80,000) 382.95 Forfeited (15,000) 383.72 Unvested at December 31, 2021 257,000 $ 372.08 (1) MSUs granted during 2021 include awards granted in conjunction with our annual awards made in February 2021 and MSUs 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. MSUs granted in 2021 also reflect an adjustment based upon the final performance multiplier in relation to shares granted in 2020, 2019 and 2018. |
Assumptions used in valuation of market based stock units | The assumptions used in our valuation are summarized as follows: For the Years Ended December 31, 2021 2020 2019 Expected dividend yield —% —% —% Range of expected stock price volatility 54.8% - 61.6% 37.8% - 44.1% 31.2% - 33.6% Range of risk-free interest rates 0.06% - 0.21% 1.41% - 1.48% 2.46% - 2.53% 30 calendar day average stock price on grant date $262.23 - $360.31 $257.83 - $325.40 $228.59 - $331.18 Weighted-average per share grant date fair value $358.77 $398.61 $378.08 |
Performance stock units settled in stock activity | The following table summarizes our PSUs that settle in stock activity: Shares Weighted Unvested at December 31, 2020 155,000 $ 304.19 Granted (1) 110,000 276.61 Vested (56,000) 316.66 Forfeited (13,000) 287.55 Unvested at December 31, 2021 196,000 $ 289.94 |
Performance stock units settled in cash activity | The following table summarizes our PSUs that settle in cash activity: Shares Unvested at December 31, 2020 120,000 Granted (1) 60,000 Vested (37,000) Forfeited (9,000) Unvested at December 31, 2021 134,000 (1) PSUs settled in cash granted in 2021 include awards granted in conjunction with our annual awards made in February 2021 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. |
Time-vested restricted stock units activity | The following table summarizes our RSU activity: Shares Weighted Average Unvested at December 31, 2020 1,018,000 $ 314.46 Granted (1) 826,000 276.90 Vested (466,000) 313.99 Forfeited (176,000) 294.34 Unvested at December 31, 2021 1,202,000 $ 291.54 (1) RSUs granted in 2021 primarily represent RSUs granted in conjunction with our annual awards made in February 2021 and awards made in conjunction with the hiring of new employees. RSUs granted in 2021 also include approximately 10,000 RSUs granted to our Board of Directors. |
Shares issued under employee stock purchase plan | The following table summarizes our ESPP activity: For the Years Ended December 31, (In millions, except share amounts) 2021 2020 2019 Shares issued under the 2015 ESPP 248,000 212,000 204,000 Cash received under the 2015 ESPP $ 54.4 $ 48.6 $ 40.4 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income before income tax provision and the income tax expense | Income before income tax expense and the income tax expense consist of the following: For the Years Ended December 31, (In millions) 2021 2020 2019 Income before income taxes (benefit): Domestic $ 448.3 $ 3,290.0 $ 4,725.3 Foreign 1,296.9 1,757.5 2,400.6 Total $ 1,745.2 $ 5,047.5 $ 7,125.9 Income tax expense (benefit): Current: Federal $ 319.1 $ 647.0 $ 947.4 State 23.1 41.2 59.1 Foreign 137.1 155.1 84.4 Total 479.3 843.3 1,090.9 Deferred: Federal $ (242.5) $ (1,749.9) $ 1,143.9 State (11.9) (6.8) (2.3) Foreign (172.4) 1,905.7 (1,074.5) Total (426.8) 149.0 67.1 Total income tax expense $ 52.5 $ 992.3 $ 1,158.0 |
Components of deferred tax assets and liabilities | Significant components of our deferred tax assets and liabilities are summarized as follows: As of December 31, (In millions) 2021 2020 Deferred tax assets: Tax credits $ 121.0 $ 113.4 Inventory, other reserves and accruals 199.4 165.9 Intangibles, net 1,477.5 1,546.0 Neurimmune's tax basis in ADUHELM 475.8 — Net operating loss 1,973.0 2,080.3 Share-based compensation 31.7 23.3 Other 208.8 103.1 Valuation allowance (1,961.3) (1,753.9) Total deferred tax assets $ 2,525.9 $ 2,278.1 Deferred tax liabilities: Purchased intangible assets $ (256.6) $ (396.2) GILTI (1,037.6) (1,143.7) Tax credits (260.2) (174.6) Depreciation, amortization and other (250.9) (227.0) Total deferred tax liabilities $ (1,805.3) $ (1,941.5) |
Reconciliation between the U.S. federal statutory tax rate and effective 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, 2021 2020 2019 Statutory rate 21.0 % 21.0 % 21.0 % State taxes 0.8 0.7 0.8 Taxes on foreign earnings (10.5) (3.3) (4.5) Tax credits (3.8) (1.2) (1.1) Purchased intangible assets (1.6) 0.7 0.4 Divestiture of Denmark manufacturing operations — (0.4) 1.0 Internal reorganization of certain intellectual property rights — — (2.1) TECFIDERA impairment — 1.8 — GILTI 1.3 1.3 1.5 Swiss tax reform — — (0.8) Neurimmune tax impacts (5.3) (0.1) — Other 1.1 (0.8) 0.1 Effective tax rate 3.0 % 19.7 % 16.3 % |
Reconciliation of beginning and ending amount of unrecognized tax benefits | A reconciliation of the beginning and ending amount of our unrecognized tax benefits is summarized as follows: (In millions) 2021 2020 2019 Beginning balance $ 75.7 $ 129.9 $ 114.2 Additions based on tax positions related to the current period 4.2 1.5 5.3 Additions for tax positions of prior periods 509.9 51.7 17.2 Reductions for tax positions of prior periods (18.8) (63.6) (10.3) Statute expirations (3.2) (7.9) (0.1) Settlement refund (payment) (4.4) (35.9) 3.6 Ending balance $ 563.4 $ 75.7 $ 129.9 |
Other Consolidated Financial _2
Other Consolidated Financial Statement Detail (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Supplemental cash flow information | Supplemental disclosure of cash flow information for the years ended December 31, 2021, 2020 and 2019, is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Cash paid during the year for: Interest $ 280.8 $ 272.7 $ 244.2 Income taxes 247.9 906.7 1,064.5 |
Other income (expense), net | Components of other income (expense), net, are summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Interest income $ 11.0 $ 42.0 $ 120.0 Interest expense (253.6) (222.5) (187.4) Gain (loss) on investments, net (824.9) 685.7 204.7 Foreign exchange gains (losses), net (22.4) (10.7) (7.0) Other, net (5.6) 2.9 (47.0) Total other income (expense), net $ (1,095.5) $ 497.4 $ 83.3 |
Gain (loss) on investments | The following table summarizes our gain (loss) on investments, net that relates to our equity securities held as of December 31, 2021, 2020 and 2019: For the Years Ended December 31, (In millions) 2021 2020 2019 Net gains (losses) recognized during the period on equity securities $ (821.1) $ 693.9 $ 200.1 Less: Net gains (losses) realized during the period and on equity securities 10.3 12.1 50.0 Unrealized gains (losses) recognized during the period on equity securities $ (831.4) $ 681.8 $ 150.1 |
Accrued expense and other | Accrued expense and other consists of the following: As of December 31, (In millions) 2021 2020 Revenue-related reserves for discounts and allowances $ 802.1 $ 1,080.6 Collaboration expense 324.7 389.9 Employee compensation and benefits 345.1 333.8 Royalties and licensing fees 234.7 218.5 Derivative liabilities 10.8 181.5 Current portion of contingent consideration obligations — 149.6 Other 817.8 791.4 Total accrued expense and other $ 2,535.2 $ 3,145.3 |
Collaborative and Other Relat_2
Collaborative and Other Relationships (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Co-promotion profit sharing formula | Our share of annual co-promotion profits in excess of $50.0 million varies, as summarized in the table below, upon the following events: After First GAZYVA Threshold Date until Second GAZYVA Threshold Date 37.5 % After Second GAZYVA Threshold Date 35.0 % |
Pretax profit sharing formula | Our share of annual profits in excess of $50.0 million varies, as summarized in the table below, upon the following events: After First GAZYVA Threshold Date until Second GAZYVA Threshold Date 37.5 % After Second GAZYVA Threshold Date 35.0 % |
Revenues 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) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 Revenue from anti-CD20 therapeutic programs is summarized as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 647.7 $ 1,080.2 $ 1,542.4 Other revenue from anti-CD20 therapeutic programs 1,010.8 897.6 748.0 Total revenue from anti-CD20 therapeutic programs $ 1,658.5 $ 1,977.8 $ 2,290.4 |
Summary of activity related to BAN2401 and Elenbecestat collaboration | A summary of development and sales and marketing expense related to the Lecanemab Collaboration is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 323.0 $ 219.3 $ 348.7 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our consolidated statements of income 161.5 109.6 174.3 Total sales and marketing expense incurred by the Lecanemab Collaboration 27.2 9.8 32.4 Biogen's share of lecanemab and elenbecestat sales and marketing expense reflected in selling, general and administrative expense in our consolidated statements of income 13.6 4.9 16.2 |
Summary of activity related to Aducanumab collaboration | A summary of development expense, sales and marketing expense and milestone payments related to the ADUHELM Collaboration Agreement is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total ADUHELM development expense $ 183.7 $ 152.0 $ 179.4 Biogen's share of ADUHELM development expense reflected in research and development expense in our consolidated statements of income 101.1 83.6 98.7 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement 562.3 353.0 27.4 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit (loss) sharing in our consolidated statements of income 301.4 193.7 15.1 Total ADUHELM collaboration third-party milestones 100.0 75.0 — Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our consolidated statements of income 45.0 33.8 — |
Summary of activity related to the UCB collaboration | A summary of development expense related to the UCB collaboration agreement is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total UCB collaboration development expense $ 84.2 $ 58.3 $ 31.9 Biogen's share of UCB development expense reflected in research and development expense in our consolidated statements of income 42.1 29.2 16.0 |
Summary of Activity Related to Sage Therapuetics | A summary of development and sales and marketing expense related to this collaboration is as follows: For the Years Ended December 31, (In millions) 2021 Total Sage collaboration development expense $ 167.7 Biogen's share of Sage development expense reflected in research and development expense in our consolidated statements of income 83.8 Total Sage sales and marketing expense incurred by the collaboration 36.4 Biogen's share of Sage sales and marketing expense reflected in selling, general and administrative expense in our consolidated statements of income 18.2 |
Summary of Activity Related to Denali Therapeutics Collaboration | A summary of development expense related to this collaboration is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total Denali collaboration development expense $ 42.5 $ 14.6 $ — Biogen's share of Denali development expense reflected in research and development expense in our consolidated statements of income 25.5 8.8 — |
Summary of Activity Related to Sangamo Therapeutics | A summary of development expense related to this collaboration is as follows: For the Years Ended December 31, (In millions) 2021 2020 2019 Total Sangamo collaboration development expense $ 22.7 $ 10.1 $ — Biogen's share of Sangamo development expense reflected in research and development expense in our consolidated statements of income 14.6 6.4 — |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Geographic information | The following tables contain certain financial information by geographic area: December 31, 2021 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 3,805.7 $ 2,626.0 $ 1,162.4 $ 688.0 $ 564.8 $ 8,846.9 Revenue from anti-CD20 therapeutic programs 1,596.7 — — — 61.8 1,658.5 Other revenue from external customers 429.9 9.7 — 36.7 — 476.3 Long-lived assets 1,390.5 2,337.8 25.4 16.4 21.7 3,791.8 December 31, 2020 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 5,900.1 $ 2,495.3 $ 1,161.1 $ 596.7 $ 539.0 $ 10,692.2 Revenue from anti-CD20 therapeutic programs 1,897.4 0.1 — — 80.3 1,977.8 Other revenue from external customers 733.6 8.0 0.1 32.9 — 774.6 Long-lived assets 1,496.3 2,290.2 31.2 16.2 10.9 3,844.8 December 31, 2019 (In millions) U.S. Europe (1) Germany Asia Other Total Product revenue from external customers $ 6,713.8 $ 2,668.4 $ 1,126.1 $ 320.3 $ 551.2 $ 11,379.8 Revenue from anti-CD20 therapeutic programs 2,211.9 0.2 — — 78.3 2,290.4 Other revenue from external customers 585.8 9.4 0.3 112.2 — 707.7 Long-lived assets 1,493.2 2,135.4 27.5 6.2 12.0 3,674.3 (1) Represents amounts related to Europe less those attributable to Germany. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Interest in subsidiary (less than given percentage) | 100.00% | ||
Number of operating segments | segment | 1 | ||
Advertising costs | $ | $ 98.7 | $ 111.8 | $ 79.2 |
Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Payment terms of accounts receivable arising from product sales | 30 days | ||
Minimum | Computer Software and Hardware | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life | 3 years | ||
Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Payment terms of accounts receivable arising from product sales | 90 days | ||
Maximum | Computer Software and Hardware | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Property, Plant and Equipment Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Minimum | Buildings | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 15 years |
Minimum | Furniture and Fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Minimum | Machinery and Equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Minimum | Computer Software and Hardware | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Maximum | Buildings | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 40 years |
Maximum | Furniture and Fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Maximum | Machinery and Equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 20 years |
Maximum | Computer Software and Hardware | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Acquisitions (Details)
Acquisitions (Details) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2020USD ($) | Jun. 30, 2019USD ($)product$ / shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Business Acquisition [Line Items] | |||||
Acquired in-process research and development | $ 18,000,000 | $ 75,000,000 | $ 0 | ||
BIIB118 | |||||
Business Acquisition [Line Items] | |||||
Acquired in-process research and development | $ 75,000,000 | ||||
Estimated additional payments upon achievement of development and commercial milestones | $ 635,000,000 | ||||
Nightstar | |||||
Business Acquisition [Line Items] | |||||
Clinical assets acquired | product | 2 | ||||
Price per share | $ / shares | $ 25.50 | ||||
Total transaction value | $ 847,600,000 | ||||
Payments for pre-combination equity compensation | $ 4,600,000 | ||||
Fair value, in-process research and development, discount rate | 12.50% | ||||
Deferred tax liabilities, goodwill | 60,900,000 | ||||
Nightstar | BIIB111 | |||||
Business Acquisition [Line Items] | |||||
Intangible assets | $ 480,000,000 | ||||
Intangible assets (excluding goodwill) | 0 | ||||
Nightstar | BIIB112 | |||||
Business Acquisition [Line Items] | |||||
Intangible assets | 220,000,000 | ||||
Intangible assets (excluding goodwill) | $ 0 | ||||
Nightstar | Post-acquisition equity compensation | |||||
Business Acquisition [Line Items] | |||||
Fair-value post-combination equity compensation | 26,200,000 | ||||
Nightstar | Post-acquisition equity compensation | Selling, general and administrative | |||||
Business Acquisition [Line Items] | |||||
Fair-value post-combination equity compensation | 18,400,000 | ||||
Nightstar | Post-acquisition equity compensation | Research and development | |||||
Business Acquisition [Line Items] | |||||
Fair-value post-combination equity compensation | $ 7,800,000 |
Divestitures (Details)
Divestitures (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Aug. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
(Gain) loss on divestiture of Hillerød, Denmark manufacturing operations | $ 0 | $ 92.5 | $ (55.3) | |
Denmark Manufacturing Operations | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Consideration received for sale of Denmark manufacturing operations | $ 881.9 | |||
Loss on divestiture of Hillerød, Denmark manufacturing operations, net of tax | 124.2 | |||
(Gain) loss on divestiture of Hillerød, Denmark manufacturing operations | 30.5 | (55.3) | ||
Expected costs to sell disposal group | 11.2 | |||
Future minimum batch production for Denmark manufacturing operations | 74 | |||
Tax expense on disposal group | $ 68.9 | |||
Purchase commitment, reduction | $ 62 |
Revenues - Revenues by Product
Revenues - Revenues by Product (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Total product revenue | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Fumarate | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 2,362.3 | 3,905.4 | 4,438.2 |
Interferon | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,566.1 | 1,877.5 | 2,101.8 |
TYSABRI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 2,063.1 | 1,946.1 | 1,892.2 |
FAMPYRA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 105.2 | 103.1 | 97.1 |
Subtotal: MS | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 6,096.7 | 7,832.1 | 8,529.3 |
SPINRAZA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,905.1 | 2,052.1 | 2,097 |
ADUHELM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 3 | 0 | 0 |
BENEPALI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 498.3 | 481.6 | 486.2 |
IMRALDI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 233.4 | 216.3 | 184 |
FLIXABI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 99.4 | 97.9 | 68.1 |
Subtotal: Biosimilars | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 831.1 | 795.8 | 738.3 |
FUMADERM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 11 | 12.2 | 15.2 |
Total product revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 8,846.9 | 10,692.2 | 11,379.8 |
United States | Fumarate | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,089.5 | 2,742 | 3,312 |
United States | Interferon | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 983.1 | 1,273.5 | 1,426.6 |
United States | TYSABRI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,142.2 | 1,096.8 | 1,041.8 |
United States | FAMPYRA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | Subtotal: MS | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 3,214.8 | 5,112.3 | 5,780.4 |
United States | SPINRAZA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 587.9 | 787.8 | 933.4 |
United States | ADUHELM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 3 | 0 | 0 |
United States | BENEPALI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | IMRALDI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | FLIXABI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | Subtotal: Biosimilars | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | FUMADERM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
United States | Total product revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 3,805.7 | 5,900.1 | 6,713.8 |
Rest of World | Fumarate | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,272.8 | 1,163.4 | 1,126.2 |
Rest of World | Interferon | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 583 | 604 | 675.2 |
Rest of World | TYSABRI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 920.9 | 849.3 | 850.4 |
Rest of World | FAMPYRA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 105.2 | 103.1 | 97.1 |
Rest of World | Subtotal: MS | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 2,881.9 | 2,719.8 | 2,748.9 |
Rest of World | SPINRAZA | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 1,317.2 | 1,264.3 | 1,163.6 |
Rest of World | ADUHELM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 0 | 0 | 0 |
Rest of World | BENEPALI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 498.3 | 481.6 | 486.2 |
Rest of World | IMRALDI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 233.4 | 216.3 | 184 |
Rest of World | FLIXABI | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 99.4 | 97.9 | 68.1 |
Rest of World | Subtotal: Biosimilars | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 831.1 | 795.8 | 738.3 |
Rest of World | FUMADERM | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 11 | 12.2 | 15.2 |
Rest of World | Total product revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | $ 5,041.2 | $ 4,792.1 | $ 4,666 |
Revenues - Narrative (Details)
Revenues - Narrative (Details) $ in Millions | 12 Months Ended | |||
Dec. 31, 2021USD ($)wholesaler | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2020USD ($) | |
Disaggregation of Revenue [Line Items] | ||||
Number of wholesalers | wholesaler | 2 | |||
Percentage of total revenues | 15.10% | 14.70% | 15.90% | |
Revenues | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 | |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 476.3 | 774.6 | 707.7 | |
Other corporate | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 427.7 | 719.1 | 584.5 | |
Remaining performance obligation, amount | 153.8 | $ 500 | ||
Bioverativ | Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 18.2 | 48.6 | $ 383.2 | |
Contract Manufacturing Customer | Other corporate | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 346.2 | |||
Distributor One | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenue from major distributors | 28.80% | 30.50% | 30.00% | |
Percentage receivables of wholesale distributor accounted in consolidated receivables | 21.90% | 21.10% | ||
Distributor Two | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenue from major distributors | 10.10% | 15.30% | 17.20% | |
Percentage receivables of wholesale distributor accounted in consolidated receivables | 10.20% | 8.50% |
Revenues - Reserves for Discoun
Revenues - Reserves for Discounts and Allowances (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning balance | $ 1,276 | $ 1,198.9 | $ 1,051.3 |
Current provisions relating to sales in current year | 3,700.6 | 4,102.5 | 3,698.6 |
Adjustments relating to prior years | (103.4) | (53.7) | (48.3) |
Payments/credits relating to sales in current year | (2,882.8) | (3,061.2) | (2,778.6) |
Payments/credits relating to sales in prior years | (1,055.1) | (910.5) | (724.1) |
Ending balance | 935.3 | 1,276 | 1,198.9 |
Discounts | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning balance | 141.4 | 131.1 | 127.8 |
Current provisions relating to sales in current year | 736.7 | 774.7 | 666.2 |
Adjustments relating to prior years | (4) | (1) | 0.3 |
Payments/credits relating to sales in current year | (599.3) | (635.1) | (535.5) |
Payments/credits relating to sales in prior years | (137.1) | (128.3) | (127.7) |
Ending balance | 137.7 | 141.4 | 131.1 |
Contractual Adjustments | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning balance | 1,093 | 1,027.3 | 888.8 |
Current provisions relating to sales in current year | 2,948.7 | 3,308.8 | 3,011.5 |
Adjustments relating to prior years | (96.1) | (54) | (54.1) |
Payments/credits relating to sales in current year | (2,283.1) | (2,426.1) | (2,242.9) |
Payments/credits relating to sales in prior years | (902.9) | (763) | (576) |
Ending balance | 759.6 | 1,093 | 1,027.3 |
Returns | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning balance | 41.6 | 40.5 | 34.7 |
Current provisions relating to sales in current year | 15.2 | 19 | 20.9 |
Adjustments relating to prior years | (3.3) | 1.3 | 5.5 |
Payments/credits relating to sales in current year | (0.4) | 0 | (0.2) |
Payments/credits relating to sales in prior years | (15.1) | (19.2) | (20.4) |
Ending balance | $ 38 | $ 41.6 | $ 40.5 |
Revenues - Total Reserves for D
Revenues - Total Reserves for Discounts and Allowances (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Revenue-related reserves for discounts and allowances | $ 935.3 | $ 1,276 | $ 1,198.9 | $ 1,051.3 |
Reduction of accounts receivable | ||||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Revenue-related reserves for discounts and allowances | 133.2 | 195.4 | ||
Component of accrued expense and other | ||||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Revenue-related reserves for discounts and allowances | $ 802.1 | $ 1,080.6 |
Revenues - Revenues from Anti-C
Revenues - Revenues from Anti-CD20 Therapeutic Programs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Total revenue from anti-CD20 therapeutic programs | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Revenue from anti-CD20 therapeutic programs | |||
Disaggregation of Revenue [Line Items] | |||
Total revenue from anti-CD20 therapeutic programs | 1,658.5 | 1,977.8 | 2,290.4 |
Genentech | |||
Disaggregation of Revenue [Line Items] | |||
Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA | 647.7 | 1,080.2 | 1,542.4 |
Other revenue from anti-CD20 therapeutic programs | $ 1,010.8 | $ 897.6 | $ 748 |
Revenues - Other Revenues (Deta
Revenues - Other Revenues (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Total product revenue | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Royalty | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 27.9 | 33.9 | 17 |
Other corporate | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 427.7 | 719.1 | 584.5 |
Total other revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 476.3 | 774.6 | 707.7 |
Collaborative Arrangement | Samsung Bioepis | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | 20.7 | 20.9 | 106.2 |
Collaborative Arrangement | Other Relationships | |||
Disaggregation of Revenue [Line Items] | |||
Total product revenue | $ 0 | $ 0.7 | $ 0 |
Inventory - Components of Inven
Inventory - Components of Inventory (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 349.6 | $ 314.9 |
Work in process | 814 | 544.5 |
Finished goods | 187.9 | 209.2 |
Total inventory | $ 1,351.5 | $ 1,068.6 |
Inventory - Narrative (Details)
Inventory - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | ||||
Write-downs on excess, obsolete, unmarketable or other inventory | $ 167.6 | $ 26.6 | $ 52.2 | |
Inventory | $ 1,351.5 | 1,351.5 | $ 1,068.6 | |
ADUHELM | ||||
Inventory [Line Items] | ||||
Write-downs on excess, obsolete, unmarketable or other inventory | 120 | |||
Inventory | $ 223 | $ 223 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill - Summary of Intangible Assets (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 7,413.1 | $ 7,394.3 |
Total intangible assets | 7,609.8 | 8,220.8 |
Accumulated Amortization | (5,388.5) | (5,136.5) |
Net | 2,024.6 | 2,257.8 |
Total intangible assets | $ 2,221.3 | 3,084.3 |
Minimum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated life (in years) | 4 years | |
Maximum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated life (in years) | 28 years | |
In-process research and development | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost and net | $ 132.7 | 762.5 |
Trademarks and trade names | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost and net | $ 64 | $ 64 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||
Sep. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill [Line Items] | |||||||
Amortization and impairment of acquired intangible assets | $ 881,300,000 | $ 464,800,000 | $ 489,900,000 | ||||
Amortization of acquired intangible assets | 252,000,000 | 255,100,000 | 274,000,000 | ||||
Accumulated impairment losses related to goodwill | 0 | ||||||
In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | $ 215,900,000 | ||||||
Intangible assets (excluding goodwill) | $ 762,500,000 | 132,700,000 | 762,500,000 | ||||
Intangible asset, fair value | 0 | $ 0 | 0 | ||||
BIIB111 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 365,000,000 | 115,000,000 | |||||
BIIB111 | In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Intangible asset, fair value | $ 0 | 0 | |||||
BIIB112 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 220,000,000 | ||||||
BIIB112 | In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Intangible asset, fair value | 0 | 0 | |||||
BIIB054 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 75,400,000 | ||||||
In Process Research and Development Other | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 19,300,000 | ||||||
BG00011 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | $ 215,900,000 | ||||||
TGN | In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | $ 44,300,000 | ||||||
DPN | In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Intangible assets (excluding goodwill) | 132,700,000 | ||||||
BIIB111 and BIIB112 | |||||||
Goodwill [Line Items] | |||||||
Manufacturing and other costs | 39,100,000 | ||||||
Nightstar | BIIB111 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | $ 365,000,000 | ||||||
Intangible assets (excluding goodwill) | 0 | ||||||
Nightstar | BIIB111 | In-process research and development | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 115,000,000 | ||||||
Nightstar | BIIB112 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 220,000,000 | ||||||
Intangible assets (excluding goodwill) | $ 0 | ||||||
Nightstar | BIIB054 | |||||||
Goodwill [Line Items] | |||||||
Impairment of intangible assets | 75,400,000 | ||||||
Intangible asset, fair value | $ 0 | $ 0 |
Intangible Assets and Goodwil_4
Intangible Assets and Goodwill - Estimated Future Amortization of Intangible Assets (Details) $ in Millions | Dec. 31, 2021USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2022 | $ 255 |
2023 | 210 |
2024 | 195 |
2025 | 195 |
2026 | $ 180 |
Intangible Assets and Goodwil_5
Intangible Assets and Goodwill - Changes in Goodwill (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill [Roll Forward] | ||
Goodwill, beginning of year | $ 5,762.1 | $ 5,757.8 |
Other | (1) | 4.3 |
Goodwill, end of year | $ 5,761.1 | $ 5,762.1 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Recorded at Fair Value (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | |||
Marketable debt securities | $ 2,433.1 | $ 2,051 | |
Fair value, measurements, recurring | |||
Assets: | |||
Cash equivalents | 1,632.2 | 626.9 | |
Marketable equity securities | 1,048.5 | 1,974.3 | |
Derivative contracts | 80.9 | 20.5 | |
Plan assets for deferred compensation | 33.4 | 28.2 | |
Total | 5,228.1 | 4,700.9 | |
Liabilities: | |||
Derivative contracts | 10.8 | 217.2 | |
Contingent consideration obligations | 209.1 | 259.8 | $ 346.1 |
Total | 219.9 | 477 | |
Fair value, measurements, recurring | Corporate debt securities | |||
Assets: | |||
Marketable debt securities | 1,108.2 | 1,301.5 | |
Fair value, measurements, recurring | Government securities | |||
Assets: | |||
Marketable debt securities | 1,192.7 | 627.1 | |
Fair value, measurements, recurring | Mortgage and other asset backed securities | |||
Assets: | |||
Marketable debt securities | 132.2 | 122.4 | |
Quoted Prices in Active Markets (Level 1) | Fair value, measurements, recurring | |||
Assets: | |||
Cash equivalents | 0 | 0 | |
Marketable equity securities | 181.7 | 271.1 | |
Derivative contracts | 0 | 0 | |
Plan assets for deferred compensation | 0 | 0 | |
Total | 181.7 | 271.1 | |
Liabilities: | |||
Derivative contracts | 0 | 0 | |
Contingent consideration obligations | 0 | 0 | |
Total | 0 | 0 | |
Quoted Prices in Active Markets (Level 1) | Fair value, measurements, recurring | Corporate debt securities | |||
Assets: | |||
Marketable debt securities | 0 | 0 | |
Quoted Prices in Active Markets (Level 1) | Fair value, measurements, recurring | Government securities | |||
Assets: | |||
Marketable debt securities | 0 | 0 | |
Quoted Prices in Active Markets (Level 1) | Fair value, measurements, recurring | Mortgage and other asset backed securities | |||
Assets: | |||
Marketable debt securities | 0 | 0 | |
Significant Other Observable Inputs (Level 2) | Fair value, measurements, recurring | |||
Assets: | |||
Cash equivalents | 1,632.2 | 626.9 | |
Marketable equity securities | 866.8 | 1,703.2 | |
Derivative contracts | 80.9 | 20.5 | |
Plan assets for deferred compensation | 33.4 | 28.2 | |
Total | 5,046.4 | 4,429.8 | |
Liabilities: | |||
Derivative contracts | 10.8 | 217.2 | |
Contingent consideration obligations | 0 | 0 | |
Total | 10.8 | 217.2 | |
Significant Other Observable Inputs (Level 2) | Fair value, measurements, recurring | Corporate debt securities | |||
Assets: | |||
Marketable debt securities | 1,108.2 | 1,301.5 | |
Significant Other Observable Inputs (Level 2) | Fair value, measurements, recurring | Government securities | |||
Assets: | |||
Marketable debt securities | 1,192.7 | 627.1 | |
Significant Other Observable Inputs (Level 2) | Fair value, measurements, recurring | Mortgage and other asset backed securities | |||
Assets: | |||
Marketable debt securities | 132.2 | 122.4 | |
Significant Unobservable Inputs (Level 3) | Fair value, measurements, recurring | |||
Assets: | |||
Cash equivalents | 0 | 0 | |
Marketable equity securities | 0 | 0 | |
Derivative contracts | 0 | 0 | |
Plan assets for deferred compensation | 0 | 0 | |
Total | 0 | 0 | |
Liabilities: | |||
Derivative contracts | 0 | 0 | |
Contingent consideration obligations | 209.1 | 259.8 | |
Total | 209.1 | 259.8 | |
Significant Unobservable Inputs (Level 3) | Fair value, measurements, recurring | Corporate debt securities | |||
Assets: | |||
Marketable debt securities | 0 | 0 | |
Significant Unobservable Inputs (Level 3) | Fair value, measurements, recurring | Government securities | |||
Assets: | |||
Marketable debt securities | 0 | 0 | |
Significant Unobservable Inputs (Level 3) | Fair value, measurements, recurring | Mortgage and other asset backed securities | |||
Assets: | |||
Marketable debt securities | $ 0 | $ 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Significant Unobservable Inputs (Details) $ in Millions | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Discount rate | Fair Value, Inputs, Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Unobservable Input | 13,000 | 6,000 | |
Weighted Average | Discount rate | Fair Value, Inputs, Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Unobservable Input | 0.0130 | 0.0060 | |
Fair Value, Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value | $ 209.1 | $ 259.8 | $ 346.1 |
Fair Value, Recurring | Fair Value, Inputs, Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value | $ 209.1 | $ 259.8 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Feb. 28, 2015 | Dec. 31, 2010 | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2019 | |
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Technological and regulatory success, probability | 10.90% | |||||||
In-process research and development | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | $ 215,900,000 | |||||||
Intangible asset, fair value | $ 0 | 0 | $ 0 | |||||
Convergence Pharmaceuticals | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Additions | $ 274,500,000 | |||||||
Contingent consideration obligations | 259,800,000 | $ 209,100,000 | 259,800,000 | |||||
Maximum contingent consideration in the form of development and approval milestones | $ 400,000,000 | |||||||
Convergence Pharmaceuticals | Discount rate | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Fair value measurement and measurement inputs, recurring and nonrecurring | 1.30% | |||||||
Biogen Idec International Neuroscience GmbH | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Additions | $ 81,200,000 | 0 | ||||||
Contingent consideration obligations | 101,500,000 | 101,500,000 | ||||||
Biogen Idec International Neuroscience GmbH | In-process research and development | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Acquired intangible asset | 110,900,000 | |||||||
Stromedix, Inc. | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Intangible assets | $ 219,200,000 | |||||||
Other long-term liabilities | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Contingent consideration obligations | 110,300,000 | $ 209,100,000 | 110,300,000 | |||||
BIIB111 | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 365,000,000 | 115,000,000 | ||||||
BIIB111 | In-process research and development | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Intangible asset, fair value | $ 0 | 0 | ||||||
BIIB111 | Nightstar | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 365,000,000 | |||||||
Intangible assets | $ 480,000,000 | |||||||
BIIB112 | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 220,000,000 | |||||||
BIIB112 | In-process research and development | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Intangible asset, fair value | $ 0 | 0 | ||||||
BIIB112 | Nightstar | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | $ 220,000,000 | |||||||
Intangible assets | $ 220,000,000 | |||||||
BIIB054 | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 75,400,000 | |||||||
Reduction in contingent consideration | 51,000,000 | |||||||
BIIB054 | Biogen Idec International Neuroscience GmbH | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 75,400,000 | |||||||
BIIB054 | Nightstar | ||||||||
Business Acquisition, Contingent Consideration [Line Items] | ||||||||
Impairment of intangible assets | 75,400,000 | |||||||
Intangible asset, fair value | $ 0 | $ 0 |
Fair Value Measurements - Sum_3
Fair Value Measurements - Summary of Fair and Carrying Value of Debt Instruments (Details) - Senior Notes - USD ($) $ in Millions | 1 Months Ended | |||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | |
Debt Instrument | ||||
Notes payable, fair value | $ 8,004.7 | $ 8,515.9 | ||
3.625% Senior Notes due September 15, 2022 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 1,020 | 1,054.1 | ||
Interest rate on senior notes | 3.625% | |||
4.050% Senior Notes due September 15, 2025 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 1,895.2 | 2,003.1 | ||
Interest rate on senior notes | 4.05% | |||
2.250% Senior Notes due May 1, 2030 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 1,475.9 | 1,557.2 | ||
Interest rate on senior notes | 2.25% | 2.25% | ||
5.200% Senior Notes due September 15, 2045 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 1,463 | 2,365.1 | ||
Interest rate on senior notes | 5.20% | |||
Long term debt, exchanged amount | $ 624.6 | |||
3.150% Senior Notes due May 1, 2050 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 1,457.7 | 1,536.4 | ||
Interest rate on senior notes | 3.15% | 3.15% | ||
3.250% Senior Notes due February 15, 2051 | ||||
Debt Instrument | ||||
Notes payable, fair value | $ 692.9 | $ 0 | ||
Interest rate on senior notes | 3.25% | |||
Long term debt, exchanged amount | $ 700.7 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Contingent Consideration Obligations (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Changes in fair value | $ (50.7) | $ (86.3) | $ (63.7) |
Fair value, measurements, recurring | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Fair value, beginning of year | 259.8 | 346.1 | |
Changes in fair value | (50.7) | (86.3) | |
Fair value, end of year | $ 209.1 | $ 259.8 | $ 346.1 |
Financial Instruments - Summary
Financial Instruments - Summary of Financial Assets with Maturities (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, total | $ 1,632.2 | $ 626.9 |
Commercial paper | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, total | 247.6 | 61.1 |
Overnight reverse repurchase agreements | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, total | 200 | 37.4 |
Money market funds | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, total | 901.6 | 505.1 |
Short-term debt securities | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents, total | $ 283 | $ 23.3 |
Financial Instruments - Summa_2
Financial Instruments - Summary of Marketable Securities (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable debt securities: | ||
Amortized Cost | $ 2,435.9 | $ 2,049.1 |
Gross Unrealized Gains | 0.4 | 2.3 |
Gross Unrealized Losses | (3.2) | (0.4) |
Fair Value | 2,433.1 | 2,051 |
Marketable equity securities: | ||
Amortized Cost | 1,167 | 1,239.5 |
Gross Unrealized Gains | 160.9 | 749.7 |
Gross Unrealized Losses | (279.4) | (14.9) |
Fair Value | 1,048.5 | 1,974.3 |
Corporate debt securities Current | ||
Marketable debt securities: | ||
Amortized Cost | 723.6 | 897.8 |
Gross Unrealized Gains | 0.1 | 0.4 |
Gross Unrealized Losses | (0.3) | (0.2) |
Fair Value | 723.4 | 898 |
Corporate debt securities Non-current | ||
Marketable debt securities: | ||
Amortized Cost | 385.4 | 402.5 |
Gross Unrealized Gains | 0.2 | 1.1 |
Gross Unrealized Losses | (0.8) | (0.1) |
Fair Value | 384.8 | 403.5 |
Government securities Current | ||
Marketable debt securities: | ||
Amortized Cost | 817 | 380.6 |
Gross Unrealized Gains | 0 | 0.1 |
Gross Unrealized Losses | (0.4) | 0 |
Fair Value | 816.6 | 380.7 |
Government securities Non-current | ||
Marketable debt securities: | ||
Amortized Cost | 377 | 245.9 |
Gross Unrealized Gains | 0.1 | 0.5 |
Gross Unrealized Losses | (1) | 0 |
Fair Value | 376.1 | 246.4 |
Mortgage and other asset backed securities Current | ||
Marketable debt securities: | ||
Amortized Cost | 1.1 | 0.2 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 1.1 | 0.2 |
Mortgage and other asset backed securities Non-current | ||
Marketable debt securities: | ||
Amortized Cost | 131.8 | 122.1 |
Gross Unrealized Gains | 0 | 0.2 |
Gross Unrealized Losses | (0.7) | (0.1) |
Fair Value | 131.1 | 122.2 |
Marketable equity securities, current | ||
Marketable equity securities: | ||
Amortized Cost | 33.9 | 70.6 |
Gross Unrealized Gains | 9.9 | 15.9 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 43.8 | 86.5 |
Marketable equity securities, non-current | ||
Marketable equity securities: | ||
Amortized Cost | 1,133.1 | 1,168.9 |
Gross Unrealized Gains | 151 | 733.8 |
Gross Unrealized Losses | (279.4) | (14.9) |
Fair Value | $ 1,004.7 | $ 1,887.8 |
Financial Instruments - Summa_3
Financial Instruments - Summary of Contractual Maturities (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Estimated Fair Value | ||
Due in one year or less | $ 1,541.1 | $ 1,278.9 |
Due after one year through five years | 868.2 | 722.6 |
Due after five years | 23.8 | 49.5 |
Total marketable debt securities | 2,433.1 | 2,051 |
Amortized Cost | ||
Due in one year or less | 1,541.7 | 1,278.6 |
Due after one year through five years | 870.2 | 721.3 |
Due after five years | 24 | 49.2 |
Amortized Cost | $ 2,435.9 | $ 2,049.1 |
Financial Instruments - Proceed
Financial Instruments - Proceeds from Marketable Debt Securities (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Investments, All Other Investments [Abstract] | |||
Proceeds from maturities and sales | $ 3,405.4 | $ 7,299.4 | $ 6,007 |
Realized gains | 0.2 | 17.7 | 6 |
Realized losses | $ 4 | $ 26 | $ 1.5 |
Financial Instruments - Narrati
Financial Instruments - Narrative (Details) $ / shares in Units, shares in Millions, $ in Millions, ₩ in Billions | 1 Months Ended | 12 Months Ended | |||||||||||
Dec. 31, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($)$ / sharesshares | Nov. 30, 2018USD ($) | Nov. 30, 2018KRW (₩) | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Dec. 31, 2021KRW (₩)shares | Dec. 31, 2020KRW (₩) | Jun. 30, 2018 | May 31, 2018 | Feb. 29, 2012USD ($) | Feb. 29, 2012KRW (₩) | |
Business Acquisition [Line Items] | |||||||||||||
Average maturity of marketable securities, months | 10 months | 11 months | |||||||||||
Sage Therapeutics | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Global licensing collaboration, shares purchased, amount | $ | $ 650 | ||||||||||||
Global licensing collaboration, shares purchased (in shares) | shares | 6.2 | ||||||||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ / shares | $ 104.14 | ||||||||||||
Denali Therapeutics | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Global licensing collaboration, shares purchased, amount | $ | $ 465 | ||||||||||||
Global licensing collaboration, shares purchased (in shares) | shares | 13 | ||||||||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ / shares | $ 34.94 | ||||||||||||
Sangamo Therapeutics, Inc. Agreement | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Global licensing collaboration, shares purchased, amount | $ | $ 225 | ||||||||||||
Global licensing collaboration, shares purchased (in shares) | shares | 24 | ||||||||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ / shares | $ 9.21 | ||||||||||||
Investment in common stock, shares purchased (in shares) | shares | 12 | 12 | |||||||||||
Samsung Bioepis | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Ownership percentage before additional purchase transaction | 5.00% | ||||||||||||
Ownership percentage | 49.90% | 49.90% | 49.90% | 15.00% | 15.00% | ||||||||
Payments to increase investment in Samsung Bioepis | $ 676.6 | ₩ 759.5 | |||||||||||
Investment in Samsung Bioepis | $ 620.2 | $ 599.9 | $ 620.2 | ₩ 713.3 | ₩ 673.8 | $ 45 | ₩ 49.5 | ||||||
Sage Therapeutics | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Dividend yield percentage | 0.00% | ||||||||||||
Denali Therapeutics | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Dividend yield percentage | 0.00% | ||||||||||||
Sangamo Therapeutics | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Dividend yield percentage | 0.00% | ||||||||||||
Strategic Investments | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Strategic investment portfolio | $ | $ 2,024.6 | $ 1,110.3 | $ 2,024.6 |
Derivative Instruments - Narrat
Derivative Instruments - Narrative (Details) $ in Millions, ₩ in Billions | 1 Months Ended | 12 Months Ended | ||||||
Nov. 30, 2018KRW (₩) | Nov. 30, 2018USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2018 | May 31, 2018 | Feb. 29, 2012 | |
Derivatives, Fair Value [Line Items] | ||||||||
Range of durations of foreign currency forward contracts | 15 months | |||||||
Net gains (losses) of other income (expense) related to foreign currency forward contracts | $ (43.3) | $ 30.1 | $ (5.9) | |||||
Net investment hedge | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Forward contracts duration | 10 months | |||||||
Derivative qualifying as hedge gain (loss), excluded component, after tax | $ (3.6) | 0.2 | ||||||
Samsung Bioepis | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Ownership percentage before additional purchase transaction | 5.00% | |||||||
Ownership percentage | 49.90% | 49.90% | 15.00% | |||||
Payments to increase investment in Samsung Bioepis | ₩ 759.5 | $ 676.6 | ||||||
Designated as Hedging Instrument | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Derivative, notional amount | $ 2,126.8 | 3,229.7 | ||||||
Not designated as hedging instrument | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Derivative, notional amount | 1,268 | 1,158 | ||||||
Foreign Exchange Forward | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Unrealized gain (loss) on derivative instruments | 53.8 | (212.5) | $ 0.5 | |||||
Foreign Exchange Forward | Net investment hedge | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Unrealized gain (loss) on derivative instruments | 10.6 | (21.2) | ||||||
Interest rate swap | Interest Expense | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Gain (loss) on derivative instruments, net, pretax | $ 3.3 | |||||||
Interest rate swap | Designated as Hedging Instrument | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Derivative, notional amount | $ 675 | |||||||
Short-term derivative | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Range of durations of foreign currency forward contracts | 12 months | |||||||
Unrealized gain (loss) on derivative instruments | $ 48.2 | |||||||
Minimum | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Range of durations of foreign currency forward contracts | 1 month | 1 month | ||||||
Maximum | ||||||||
Derivatives, Fair Value [Line Items] | ||||||||
Range of durations of foreign currency forward contracts | 15 months | 24 months |
Derivative Instruments - Foreig
Derivative Instruments - Foreign Currency Forward Contracts Entered into Hedge Forecasted Revenues (Details) - Designated as Hedging Instrument - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Derivatives, Fair Value [Line Items] | ||
Total foreign currency forward contracts | $ 2,126.8 | $ 3,229.7 |
Euro | ||
Derivatives, Fair Value [Line Items] | ||
Total foreign currency forward contracts | 1,828 | 2,979.1 |
British pound | ||
Derivatives, Fair Value [Line Items] | ||
Total foreign currency forward contracts | 166.2 | 250.6 |
Japanese yen | ||
Derivatives, Fair Value [Line Items] | ||
Total foreign currency forward contracts | 72.7 | 0 |
Canadian dollar | ||
Derivatives, Fair Value [Line Items] | ||
Total foreign currency forward contracts | $ 59.9 | $ 0 |
Derivative Instruments - Summar
Derivative Instruments - Summary of Unrealized Gain (Loss) on Derivative Instruments Included in AOCI (Details) - Foreign Exchange Forward - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Derivative Instruments, Gain (Loss) [Line Items] | |||
Unrealized gains | $ 60.8 | $ 0 | $ 6.9 |
Unrealized (losses) | (7) | (212.5) | (6.4) |
Net unrealized gains (losses) | $ 53.8 | $ (212.5) | $ 0.5 |
Derivative Instruments - Summ_2
Derivative Instruments - Summary of the Effect of Derivatives Designated as Cash Flow Hedging Instruments (Details) - Foreign exchange contract - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Reclassified from AOCI into Operating Income (in millions) | $ (60) | $ 18.3 | $ 118.6 |
Operating expense | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Reclassified from AOCI into Operating Income (in millions) | (0.8) | 3.3 | (3.3) |
Cash flows, revenue | Revenue | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Recognized in Net Income (Amounts Excluded from Effectiveness Testing) (in millions) | (8.4) | (9.9) | 2.9 |
Cash flows, operating expenses | Operating expense | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Recognized in Net Income (Amounts Excluded from Effectiveness Testing) (in millions) | $ 0 | $ 0 | $ 0.2 |
Derivative Instruments - Summ_3
Derivative Instruments - Summary of the Effect of Derivatives Designated as Net Investment Hedging Instruments (Details) - Net investment hedge - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Recognized in Other Comprehensive Income (Effective Portion) (in millions) | $ 46 | $ (35.1) | $ 25.3 |
Net Gains/(Losses) Recognized in Other Comprehensive Income (Amounts Excluded from Effectiveness Testing) (in millions) | (3.2) | 4.5 | 3.3 |
Other (income) expense, net | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net Gains/(Losses) Recognized in Net Income (Amounts Excluded from Effectiveness Testing) (in millions) | $ (0.6) | $ 2.9 | $ 7 |
Derivative Instruments - Summ_4
Derivative Instruments - Summary of the Fair Value for our Outstanding Derivatives (Details) - Foreign exchange contract - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Other current assets | Not designated as hedging instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Asset derivative instruments | $ 5.1 | $ 20.5 |
Other current assets | Cash flow hedge | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Asset derivative instruments | 66.2 | 0 |
Other current assets | Net investment hedge | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Asset derivative instruments | 4.1 | 0 |
Investments and other assets | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Asset derivative instruments | 5.5 | 0 |
Accrued expense and other | Not designated as hedging instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Liability derivative instruments | 4.2 | 4.7 |
Accrued expense and other | Cash flow hedge | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Liability derivative instruments | 6.6 | 157.1 |
Accrued expense and other | Net investment hedge | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Liability derivative instruments | 0 | 19.7 |
Other long-term liabilities | Cash flow hedge | Designated as Hedging Instrument | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Liability derivative instruments | $ 0 | $ 35.7 |
Property, Plant and Equipment -
Property, Plant and Equipment - Components of property, plant, and equipment, net (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Abstract] | ||
Land | $ 207.5 | $ 119.8 |
Buildings | 1,699.7 | 1,025.3 |
Leasehold improvements | 121 | 104.6 |
Machinery and equipment | 1,585.5 | 1,027.8 |
Computer software and hardware | 971.6 | 903 |
Furniture and fixtures | 67.4 | 62.5 |
Construction in progress | 770.3 | 1,950.8 |
Total cost | 5,423 | 5,193.8 |
Less: accumulated depreciation | (2,006.6) | (1,782.3) |
Total property, plant and equipment, net | $ 3,416.4 | $ 3,411.5 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Narrative (Details) ft² in Thousands, $ in Millions | 12 Months Ended | |||
Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2021USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation expense | $ 235.3 | $ 201.9 | $ 190.6 | |
Interest costs capitalized | 36.3 | 65.2 | $ 68.8 | |
Construction in progress | 770.3 | 1,950.8 | ||
Property, plant and equipment, gross | 5,423 | 5,193.8 | ||
Solothurn, Switzerland | ||||
Property, Plant and Equipment [Line Items] | ||||
Construction in progress | $ 677 | $ 1,800 | ||
Property, plant and equipment, gross | $ 1,200 | |||
Biologics Manufacturing | Solothurn, Switzerland | ||||
Property, Plant and Equipment [Line Items] | ||||
Number of square feet | ft² | 393 | |||
Warehouse, Utilities and Support Space | Solothurn, Switzerland | ||||
Property, Plant and Equipment [Line Items] | ||||
Number of square feet | ft² | 290 | |||
Administrative Space | Solothurn, Switzerland | ||||
Property, Plant and Equipment [Line Items] | ||||
Number of square feet | ft² | 51 |
Leases - Narrative (Details)
Leases - Narrative (Details) | Dec. 31, 2021 |
Minimum | |
Operating Leased Assets [Line Items] | |
Operating lease, contract term | 1 year |
Operating lease, renewal term | 1 year |
Minimum | Sublease | |
Operating Leased Assets [Line Items] | |
Operating lease, contract term | 3 years |
Maximum | |
Operating Leased Assets [Line Items] | |
Operating lease, contract term | 9 years |
Operating lease, renewal term | 6 years |
Maximum | Sublease | |
Operating Leased Assets [Line Items] | |
Operating lease, contract term | 7 years |
Leases - Schedule of Operating
Leases - Schedule of Operating Leases (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Operating lease assets | $ 375.4 | $ 433.3 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities, Current | Other Liabilities, Current |
Long-term operating lease liabilities | $ 330.4 | $ 402 |
Present value of operating lease liabilities | 419.5 | 485.2 |
Operating lease assets | ||
Operating lease assets | 375.4 | 433.3 |
Accrued expense and other | ||
Operating lease liability, current | 89.1 | 83.2 |
Long-term operating lease liabilities | ||
Long-term operating lease liabilities | $ 330.4 | $ 402 |
Leases - Operating Lease Costs
Leases - Operating Lease Costs (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Net lease cost | $ 97.9 | $ 92.4 |
Research and development | ||
Operating lease cost | 3.4 | 5.2 |
Variable lease cost | 0.8 | 1.1 |
Selling, general and administrative | ||
Operating lease cost | 95.9 | 93.1 |
Variable lease cost | 25.7 | 21.1 |
Sublease income | (23.9) | (24.2) |
Other (income) expense, net | ||
Sublease income | $ (4) | $ (3.9) |
Leases - Operating Lease Liabil
Leases - Operating Lease Liability Maturity (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 99.6 | |
2023 | 89.7 | |
2024 | 79.7 | |
2025 | 57.2 | |
2026 | 44.8 | |
Thereafter | 84 | |
Total lease payments | 455 | |
Less: interest | 35.5 | |
Present value of operating lease liabilities | $ 419.5 | $ 485.2 |
Leases - Operating Lease Weight
Leases - Operating Lease Weighted Average Remaining Term and Discount Rate (Details) | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Weighted average remaining lease term in years | 5 years 5 months 4 days | 6 years 3 months 18 days |
Weighted average discount rate | 2.90% | 2.90% |
Leases - Operating Lease Supple
Leases - Operating Lease Supplemental Cash Flow Disclosure (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 105.8 | $ 100.2 |
Operating lease assets obtained in exchange for lease obligations | $ 18.1 | $ 59 |
Indebtedness - Summary of Indeb
Indebtedness - Summary of Indebtedness (Details) - USD ($) $ in Millions | 1 Months Ended | |||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | |
Non-current portion: | ||||
Non-current portion of notes payable | $ 7,567.3 | |||
Senior Notes | ||||
Current portion: | ||||
Current portion of notes payable | 999.1 | $ 0 | ||
Non-current portion: | ||||
Non-current portion of notes payable | 6,274 | 7,426.2 | ||
3.625% Senior Notes due September 15, 2022 | Senior Notes | ||||
Current portion: | ||||
Current portion of notes payable | 999.1 | 0 | ||
Non-current portion: | ||||
Non-current portion of notes payable | $ 0 | 997.9 | ||
Interest rate on senior notes | 3.625% | |||
4.050% Senior Notes due September 15, 2025 | Senior Notes | ||||
Non-current portion: | ||||
Non-current portion of notes payable | $ 1,742.9 | 1,741.2 | ||
Interest rate on senior notes | 4.05% | |||
2.250% Senior Notes due May 1, 2030 | Senior Notes | ||||
Non-current portion: | ||||
Non-current portion of notes payable | $ 1,492 | 1,491.1 | ||
Interest rate on senior notes | 2.25% | 2.25% | ||
5.200% Senior Notes due September 15, 2045 | Senior Notes | ||||
Non-current portion: | ||||
Non-current portion of notes payable | $ 1,099.9 | 1,723.4 | ||
Interest rate on senior notes | 5.20% | |||
Long term debt, exchanged amount | $ 624.6 | |||
3.150% Senior Notes due May 1, 2050 | Senior Notes | ||||
Non-current portion: | ||||
Non-current portion of notes payable | $ 1,473.2 | 1,472.6 | ||
Interest rate on senior notes | 3.15% | 3.15% | ||
3.250% Senior Notes due February 15, 2051 | Senior Notes | ||||
Non-current portion: | ||||
Non-current portion of notes payable | $ 466 | $ 0 | ||
Interest rate on senior notes | 3.25% | |||
Long term debt, exchanged amount | $ 700.7 |
Indebtedness - Exchange Offer (
Indebtedness - Exchange Offer (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument | ||||
Aggregate cash payments | $ 0 | $ 1,500,000,000 | $ 0 | |
Interest expense | 253,600,000 | $ 222,500,000 | $ 187,400,000 | |
5.200% Senior Notes due September 15, 2045 | Senior Notes | ||||
Debt Instrument | ||||
Aggregate principal amount, debt converted | $ 8,900,000 | |||
Aggregate cash payments | 12,100,000 | |||
Loss on extinguishment of debt | 3,200,000 | |||
Cash payments on debt extinguishment, including accrued interest | 13,800,000 | |||
Interest expense | 6,100,000 | |||
5.200% Senior Notes due September 15, 2045 | Senior Notes | ||||
Debt Instrument | ||||
Aggregate principal amount, debt converted | 624,600,000 | |||
Aggregate principal amount | $ 1,120,000,000 | |||
Aggregate cash payments | 151,800,000 | |||
3.250% Senior Notes due February 15, 2051 | Senior Notes | ||||
Debt Instrument | ||||
Aggregate principal amount | $ 700,700,000 |
Indebtedness - Additional Infor
Indebtedness - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
May 31, 2020 | Jan. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | Sep. 15, 2015 | |
Revolving Credit Facility | ||||||
Debt Instrument | ||||||
Senior unsecured revolving credit facility maximum borrowing capacity | $ 1,000,000,000 | |||||
Debt instrument, term | 5 years | |||||
Outstanding borrowings | $ 0 | |||||
Interest Expense | Interest rate swap | ||||||
Debt Instrument | ||||||
Gain (loss) on derivative instruments, net, pretax | $ 3,300,000 | |||||
2015 Senior Notes | ||||||
Debt Instrument | ||||||
Redemptions percentage of 2015 notes | 100.00% | |||||
Redemption percentage for change in control provision | 101.00% | |||||
Senior Notes | Interest Expense | Interest rate swap | ||||||
Debt Instrument | ||||||
Gain (loss) on derivative instruments, net, pretax | 3,300,000 | |||||
Senior Notes | 2020 Senior Notes | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 3,000,000,000 | |||||
Redemptions percentage of 2015 notes | 100.00% | |||||
Redemption percentage for change in control provision | 101.00% | |||||
Costs associated with the senior notes offerings | $ 24,400,000 | |||||
Senior Notes | 2.250% Senior Notes due May 1, 2030 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,500,000,000 | |||||
Interest rate on senior notes | 2.25% | 2.25% | ||||
Redemption percentage par value of senior notes | 99.973% | |||||
Senior Notes | 3.150% Senior Notes due May 1, 2050 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,500,000,000 | |||||
Interest rate on senior notes | 3.15% | 3.15% | ||||
Redemption percentage par value of senior notes | 99.174% | |||||
Senior Notes | 2015 Senior Notes | ||||||
Debt Instrument | ||||||
Costs associated with the senior notes offerings | $ 47,500,000 | |||||
Senior Notes | 3.625% Senior Notes due September 15, 2022 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,000,000,000 | |||||
Interest rate on senior notes | 3.625% | |||||
Redemption percentage par value of senior notes | 99.92% | |||||
Senior Notes | 4.050% Senior Notes due September 15, 2025 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,750,000,000 | |||||
Interest rate on senior notes | 4.05% | |||||
Redemption percentage par value of senior notes | 99.764% | |||||
Senior Notes | 5.200% Senior Notes due September 15, 2045 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,120,000,000 | |||||
Interest rate on senior notes | 5.20% | |||||
Redemption percentage par value of senior notes | 99.294% | |||||
Senior Notes | 2.900% Senior Notes due September 15, 2020 | ||||||
Debt Instrument | ||||||
Senior notes aggregate principal amount | $ 1,500,000,000 | |||||
Interest rate on senior notes | 2.90% | |||||
Redemption percentage par value of senior notes | 99.792% | |||||
Pre-tax charge | $ 12,700,000 | |||||
Senior Notes | 2.900% Senior Notes due September 15, 2020 | Interest Expense | ||||||
Debt Instrument | ||||||
Pre-tax charge | $ 9,400,000 |
Indebtedness - Total Debt Matur
Indebtedness - Total Debt Maturities (Details) $ in Millions | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 1,000 |
2023 | 0 |
2024 | 0 |
2025 | 1,750 |
2026 | 0 |
2027 and thereafter | 4,817.3 |
Total | $ 7,567.3 |
Equity - Narrative (Details)
Equity - Narrative (Details) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2020 | Mar. 31, 2019 | Aug. 31, 2018 | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 8,000,000 | |||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||
Payments for repurchase of common stock | $ 1,800,000,000 | $ 6,679,100,000 | $ 5,868,300,000 | |||
2020 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Authorized amount of share repurchases | $ 5,000,000,000 | |||||
Repurchase of common stock, at cost (in shares) | 6,000,000 | 1,600,000 | ||||
Payments for repurchase of common stock | $ 1,800,000,000 | $ 400,000,000 | ||||
Remaining authorized amount of share repurchases | $ 2,800,000,000 | |||||
December 2019 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Authorized amount of share repurchases | $ 5,000,000,000 | |||||
Repurchase of common stock, at cost (in shares) | 16,700,000 | |||||
Payments for repurchase of common stock | $ 5,000,000,000 | |||||
March 2019 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Authorized amount of share repurchases | $ 5,000,000,000 | |||||
Repurchase of common stock, at cost (in shares) | 4,100,000 | 14,700,000 | ||||
Payments for repurchase of common stock | $ 1,300,000,000 | $ 3,700,000,000 | ||||
2018 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Authorized amount of share repurchases | $ 3,500,000,000 | |||||
Repurchase of common stock, at cost (in shares) | 8,900,000 | |||||
Payments for repurchase of common stock | $ 2,100,000,000 | |||||
Series A | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 1,750,000 | |||||
Series X junior participating | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 1,000,000 | |||||
Undesignated | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 5,250,000 |
Equity - Summary of Common Stoc
Equity - Summary of Common Stock (Details) - shares shares in Millions | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Equity [Abstract] | |||
Common stock authorized (in shares) | 1,000 | 1,000 | 1,000 |
Common stock issued (in shares) | 170.8 | 176.2 | 198 |
Common stock outstanding (in shares) | 147 | 152.4 | 174.2 |
Equity - Accumulated Other Comp
Equity - Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | $ (299) | ||
Other comprehensive income (loss) before reclassifications | 134.1 | $ (145.6) | $ 230.8 |
Amounts reclassified from accumulated other comprehensive income (loss) | 58.2 | (18.2) | (125.6) |
Total other comprehensive income (loss), net of tax | 192.3 | (163.8) | 105.2 |
AOCI, ending balance | (106.7) | (299) | |
Accumulated other comprehensive loss | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | (299) | (135.2) | (240.4) |
AOCI, ending balance | (106.7) | (299) | (135.2) |
Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | 1.4 | 4.2 | (4) |
Other comprehensive income (loss) before reclassifications | (6.6) | (9.3) | 11.8 |
Amounts reclassified from accumulated other comprehensive income (loss) | 3 | 6.5 | (3.6) |
Total other comprehensive income (loss), net of tax | (3.6) | (2.8) | 8.2 |
AOCI, ending balance | (2.2) | 1.4 | 4.2 |
Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | (179) | 7.8 | 34.7 |
Other comprehensive income (loss) before reclassifications | 178.2 | (165) | 88.1 |
Amounts reclassified from accumulated other comprehensive income (loss) | 54.6 | (21.8) | (115) |
Total other comprehensive income (loss), net of tax | 232.8 | (186.8) | (26.9) |
AOCI, ending balance | 53.8 | (179) | 7.8 |
Gains (Losses) on Net Investment Hedge, Net of Tax | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | (8.5) | 25.1 | 3.5 |
Other comprehensive income (loss) before reclassifications | 33.4 | (30.7) | 28.6 |
Amounts reclassified from accumulated other comprehensive income (loss) | 0.6 | (2.9) | (7) |
Total other comprehensive income (loss), net of tax | 34 | (33.6) | 21.6 |
AOCI, ending balance | 25.5 | (8.5) | 25.1 |
Unfunded Status of Postretirement Benefit Plans, Net of Tax | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | (66.3) | (32.8) | (31.3) |
Other comprehensive income (loss) before reclassifications | 21.5 | (33.5) | (1.5) |
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | 0 | 0 |
Total other comprehensive income (loss), net of tax | 21.5 | (33.5) | (1.5) |
AOCI, ending balance | (44.8) | (66.3) | (32.8) |
Currency Translation Adjustments | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
AOCI, beginning balance | (46.6) | (139.5) | (243.3) |
Other comprehensive income (loss) before reclassifications | (92.4) | 92.9 | 103.8 |
Amounts reclassified from accumulated other comprehensive income (loss) | 0 | 0 | 0 |
Total other comprehensive income (loss), net of tax | (92.4) | 92.9 | 103.8 |
AOCI, ending balance | $ (139) | $ (46.6) | $ (139.5) |
Equity - Reclassification out o
Equity - Reclassification out of Accumulated Other Comprehensive Income (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |||
Other income (expense) | $ 1,095.5 | $ (497.4) | $ (83.3) |
Income tax benefit (expense) | 52.5 | 992.3 | 1,158 |
Revenues | (10,981.7) | (13,444.6) | (14,377.9) |
Net income attributable to Biogen Inc. | (1,556.1) | (4,000.6) | (5,888.5) |
Reclassification out of Accumulated Other Comprehensive Income | |||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |||
Net income attributable to Biogen Inc. | (58.2) | 18.2 | 125.6 |
Gains (losses) on securities available for sale | Reclassification out of Accumulated Other Comprehensive Income | |||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |||
Other income (expense) | (3.8) | (8.2) | 4.5 |
Income tax benefit (expense) | 0.8 | 1.7 | (0.9) |
Gains (losses) on cash flow hedges | Reclassification out of Accumulated Other Comprehensive Income | |||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |||
Other income (expense) | 0.2 | 0.3 | 0.3 |
Income tax benefit (expense) | 6 | (0.1) | (0.6) |
Revenues | (60) | 18.3 | 118.6 |
Operating expense | (0.8) | 3.3 | (3.3) |
Gains (losses) on net investment hedge | Reclassification out of Accumulated Other Comprehensive Income | |||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |||
Other income (expense) | $ (0.6) | $ 2.9 | $ 7 |
Earnings per Share - Basic and
Earnings per Share - Basic and Diluted Earnings Per Share (Details) - USD ($) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net income attributable to Biogen Inc. | $ 1,556.1 | $ 4,000.6 | $ 5,888.5 |
Denominator: | |||
Weighted average number of common shares outstanding (in shares) | 149.1 | 160.9 | 187.1 |
Effect of dilutive securities: | |||
Dilutive potential common shares (in shares) | 0.5 | 0.4 | 0.3 |
Shares used in calculating diluted earnings per share (in shares) | 149.6 | 161.3 | 187.4 |
Time-vested restricted stock units | |||
Effect of dilutive securities: | |||
Dilutive securities (in shares) | 0.3 | 0.2 | 0.2 |
Market stock units | |||
Effect of dilutive securities: | |||
Dilutive securities (in shares) | 0.1 | 0.1 | 0.1 |
Performance stock units settled in stock | |||
Effect of dilutive securities: | |||
Dilutive securities (in shares) | 0.1 | 0.1 | 0 |
Earnings per Share - Narrative
Earnings per Share - Narrative (Details) - shares shares in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||
Repurchase of common stock (in shares) | 6 | 22.4 | 23.6 |
Share-Based Payments - Share-ba
Share-Based Payments - Share-based Compensation Expense Included in Consolidation Statements of Income (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ (246.6) | $ (204.5) | $ (191.2) |
Subtotal | 258.8 | 211.3 | 225.4 |
Capitalized share-based compensation costs | (8) | (6.2) | (8.9) |
Share-based compensation expense included in total cost and expense | 250.8 | 205.1 | 216.5 |
Income tax effect | (46.7) | (33.5) | (35.7) |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 89.3 | 80 | 77.1 |
Selling, general and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 169.5 | 131.3 | 148.3 |
Share-based compensation expense included in net income attributable to Biogen Inc. | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 204.1 | $ 171.6 | $ 180.8 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Share-based Compensation Expense Associated with Each Share-based Compensating Programs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ (246.6) | $ (204.5) | $ (191.2) |
Subtotal | 258.8 | 211.3 | 225.4 |
Capitalized share-based compensation costs | (8) | (6.2) | (8.9) |
Share-based compensation expense included in total cost and expense | 250.8 | 205.1 | 216.5 |
Market stock units | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 45.6 | 40.5 | 30.4 |
Time-vested restricted stock units | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 159.8 | 142.6 | 134 |
Cash settled performance units | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 0 | (1.7) | 0.7 |
Performance units | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 0 | (0.1) | 1.6 |
Performance stock units settled in stock | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 23.9 | 7.9 | 15.5 |
Performance stock units settled in cash | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 12.2 | 8.6 | 5.5 |
Employee stock purchase plan | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 17.3 | 13.5 | 11.5 |
Nightstar | Share-based Payment Arrangement, Option | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
NST stock options | $ 0 | $ 0 | $ 26.2 |
Share-Based Payments - Narrativ
Share-Based Payments - Narrative (Details) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2015shares | Dec. 31, 2021USD ($)Incrementplan$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($)$ / shares | Dec. 31, 2013Increment | Jun. 30, 2017shares | |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Unrecognized compensation cost related to unvested share-based compensation | $ 235.5 | |||||
Weighted-average period to recognize the cost of unvested awards | 1 year 10 months 24 days | |||||
Number of share-based compensation plans pursuant to which awards are currently being made | plan | 3 | |||||
Total intrinsic value of options exercised | $ 2.9 | $ 4.2 | ||||
Shares issued under ESPP (in shares) | shares | 6.2 | |||||
Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Share based payment arrangement, term | 10 years | |||||
Stock Options | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting period | 1 year | |||||
Stock Options | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting period | 4 years | |||||
Market Stock Units (MSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Number of equal annual increments | Increment | 3 | 4 | ||||
Percentage of earnings of the target number of units granted based on actual stock performance | 0.00% | 0.00% | ||||
Percentage of earnings of the target number of units granted based on actual stock performance | 200.00% | 150.00% | ||||
Number of days for calculation of average closing stock price | 30 days | |||||
Total fair value of vested awards | $ 22.5 | $ 26.9 | $ 32.5 | |||
Granted (in dollars per share) | $ / shares | $ 358.77 | $ 398.61 | $ 378.08 | |||
Cash Settled Performance Units (CSPUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Number of equal annual increments | Increment | 3 | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 0.00% | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 200.00% | |||||
Number of days for calculation of average closing stock price | 30 days | |||||
Cash settlement of awards upon vesting | $ 3.8 | $ 10.6 | ||||
Performance Units (PUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Number of equal annual increments | Increment | 3 | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 0.00% | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 200.00% | |||||
Number of days for calculation of average closing stock price | 30 days | |||||
Cash settlement of awards upon vesting | 3.4 | 10.4 | ||||
PSUs Settled in Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting period | 3 years | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 0.00% | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 200.00% | |||||
Granted (in dollars per share) | $ / shares | $ 276.61 | |||||
PSUs Settled in Cash | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting period | 3 years | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 0.00% | |||||
Percentage of earnings of the target number of units granted based on actual stock performance | 200.00% | |||||
Number of days for calculation of average closing stock price | 30 days | |||||
Time-Vested Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting period | 3 years | |||||
Total fair value of vested awards | $ 132.2 | $ 140.5 | $ 131.5 | |||
Granted (in dollars per share) | $ / shares | $ 276.90 | $ 318.87 | $ 304.44 | |||
Time-Vested Restricted Stock Units (RSUs) | Share-based Payment Arrangement, Tranche One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting percentage | 33.33% | |||||
Time-Vested Restricted Stock Units (RSUs) | Share-based Payment Arrangement, Tranche Two | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting percentage | 33.33% | |||||
Time-Vested Restricted Stock Units (RSUs) | Share-based Payment Arrangement, Tranche Three | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Vesting percentage | 33.33% | |||||
Directors Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Total number of shares of common stock for issuance (in shares) | shares | 1.6 | |||||
Ratio of total number of shares reserved under the plan | 1.5 | |||||
2017 Omnibus Equity Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Ratio of total number of shares reserved under the plan | 1.5 | |||||
Omnibus Plan number of shares authorized (in shares) | shares | 8 |
Share-Based Payments - Tax Bene
Share-Based Payments - Tax Benefit and Cash Received from Stock Option Exercises (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Tax benefit realized for stock options | $ 2.9 | $ 2.5 |
Cash received from the exercise of stock options | $ 0.7 | $ 0.4 |
Share-Based Payments - Market S
Share-Based Payments - Market Stock Units Activity (Details) - Market stock units - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Shares | |||
Beginning balance, unvested (in shares) | 201 | ||
Granted (in shares) | 151 | ||
Vested (in shares) | (80) | ||
Forfeited (in shares) | (15) | ||
Ending balance, unvested shares (in shares) | 257 | 201 | |
Weighted Average Grant Date Fair Value | |||
Beginning balance, unvested (in dollars per share) | $ 388.98 | ||
Granted (in dollars per share) | 358.77 | $ 398.61 | $ 378.08 |
Vested (in dollars per share) | 382.95 | ||
Forfeited (in dollars per share) | 383.72 | ||
Ending balance, unvested (in dollars per share) | $ 372.08 | $ 388.98 |
Share-Based Payments - Assumpti
Share-Based Payments - Assumptions Used in Valuation of Market Based Stock Units (Details) - Market stock units - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Minimum range of risk-free interest rates | 0.06% | 1.41% | 2.46% |
Maximum range of risk-free interest rates | 0.21% | 1.48% | 2.53% |
Average stock price on grant date minimum | $ 262.23 | $ 257.83 | $ 228.59 |
Average stock price on grant date maximum | 360.31 | 325.40 | 331.18 |
Granted (in dollars per share) | $ 358.77 | $ 398.61 | $ 378.08 |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Range of expected stock price volatility | 54.80% | 37.80% | 31.20% |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Range of expected stock price volatility | 61.60% | 44.10% | 33.60% |
Share-Based Payments - Performa
Share-Based Payments - Performance Stock Units Settled in Stock Activity (Details) - Performance stock units settled in stock shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Shares | |
Beginning balance, unvested (in shares) | shares | 155,000 |
Granted (in shares) | shares | 110,000 |
Vested (in shares) | shares | (56,000) |
Forfeited (in shares) | shares | (13,000) |
Ending balance, unvested shares (in shares) | shares | 196,000 |
Weighted Average Grant Date Fair Value | |
Beginning balance, unvested (in dollars per share) | $ / shares | $ 304.19 |
Granted (in dollars per share) | $ / shares | 276.61 |
Vested (in dollars per share) | $ / shares | 316.66 |
Forfeited (in dollars per share) | $ / shares | 287.55 |
Ending balance, unvested (in dollars per share) | $ / shares | $ 289.94 |
Share-Based Payments - Perfor_2
Share-Based Payments - Performance Stock Units Settled in Cash Activity (Details) - Performance stock units settled in cash shares in Thousands | 12 Months Ended |
Dec. 31, 2021shares | |
Shares | |
Beginning balance, unvested (in shares) | 120,000 |
Granted (in shares) | 60,000 |
Vested (in shares) | (37,000) |
Forfeited (in shares) | (9,000) |
Ending balance, unvested shares (in shares) | 134,000 |
Share-Based Payments - Time-Ves
Share-Based Payments - Time-Vested Restricted Stock Units Activity (Details) - RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Shares | |||
Beginning balance, unvested (in shares) | 1,018,000 | ||
Granted (in shares) | 826,000 | ||
Vested (in shares) | (466,000) | ||
Forfeited (in shares) | (176,000) | ||
Ending balance, unvested shares (in shares) | 1,202,000 | 1,018,000 | |
Weighted Average Grant Date Fair Value | |||
Beginning balance, unvested (in dollars per share) | $ 314.46 | ||
Granted (in dollars per share) | 276.90 | $ 318.87 | $ 304.44 |
Vested (in dollars per share) | 313.99 | ||
Forfeited (in dollars per share) | 294.34 | ||
Ending balance, unvested (in dollars per share) | $ 291.54 | $ 314.46 | |
Number of shares granted (in shares) | 826,000 | ||
Director | |||
Shares | |||
Granted (in shares) | 10,000 | ||
Weighted Average Grant Date Fair Value | |||
Number of shares granted (in shares) | 10,000 |
Share-Based Payments - Shares I
Share-Based Payments - Shares Issued Under Employee Stock Purchase Plan (Details) - USD ($) shares in Thousands, $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2015 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | ||||
Shares issued under the 2015 ESPP (in shares) | 6,200 | |||
2015 ESPP | ||||
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | ||||
Shares issued under the 2015 ESPP (in shares) | 248 | 212 | 204 | |
Cash received under the 2015 ESPP | $ 54.4 | $ 48.6 | $ 40.4 |
Income Taxes - Income Before In
Income Taxes - Income Before Income Tax Provision and the Income Tax Expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income before income taxes (benefit): | |||
Domestic | $ 448.3 | $ 3,290 | $ 4,725.3 |
Foreign | 1,296.9 | 1,757.5 | 2,400.6 |
Income before income tax expense and equity in loss of investee, net of tax | 1,745.2 | 5,047.5 | 7,125.9 |
Current: | |||
Federal | 319.1 | 647 | 947.4 |
State | 23.1 | 41.2 | 59.1 |
Foreign | 137.1 | 155.1 | 84.4 |
Total | 479.3 | 843.3 | 1,090.9 |
Deferred: | |||
Federal | (242.5) | (1,749.9) | 1,143.9 |
State | (11.9) | (6.8) | (2.3) |
Foreign | (172.4) | 1,905.7 | (1,074.5) |
Total | (426.8) | 149 | 67.1 |
Total income tax expense | $ 52.5 | $ 992.3 | $ 1,158 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Millions, ₩ in Billions | 3 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2021KRW (₩) | Dec. 31, 2021USD ($) | Dec. 31, 2020KRW (₩) | Dec. 31, 2020USD ($) | Dec. 31, 2017 | Feb. 29, 2012KRW (₩) | Feb. 29, 2012USD ($) | |
Tax Credit Carryforward [Line Items] | |||||||||||
Income taxes paid | $ 72.7 | ||||||||||
Deferred tax liabilities, temporary differences, purchase accounting, foreign subsidiaries | $ 1,500 | ||||||||||
Total deferred charges and prepaid taxes | 39.6 | $ 142.2 | |||||||||
Deferred tax asset, net | $ 490 | ||||||||||
Deferred tax asset, gross | 945 | ||||||||||
Increase in unrecognized tax benefit | $ 455 | ||||||||||
Valuation allowance | 1,961.3 | 1,753.9 | |||||||||
Unrecognized tax benefit | $ 122.7 | 87.5 | 68.8 | ||||||||
Net interest expense | 2.7 | $ 1 | $ 4.7 | ||||||||
Unrecognized tax benefits, interest on income taxes accrued | 24.8 | 21.2 | |||||||||
Decrease in unrecognized tax benefits is reasonably possible | 475 | ||||||||||
Samsung Bioepis | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Investment in Samsung Bioepis | ₩ 713.3 | 599.9 | ₩ 673.8 | 620.2 | ₩ 49.5 | $ 45 | |||||
2017 Tax Act | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Transition toll tax liabilities | 633 | 697 | |||||||||
Foreign Tax Authority | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Increase in unrecognized tax benefit | 455 | ||||||||||
General Business | Domestic Country | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Operating loss carryforwards | 0.6 | ||||||||||
Tax credit carryforward, amount | 4.8 | ||||||||||
Operating loss carryforward, subject to expiration | 16,700 | ||||||||||
General Business | Foreign Tax Authority | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Operating loss carryforward, subject to expiration | 16,200 | ||||||||||
Research | State and Local Jurisdiction | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Tax credit carryforward, amount | 147.6 | ||||||||||
Earnings in the form of cash and cash equivalents | 2017 Tax Act | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Transition toll tax repatriation tax rate | 15.50% | ||||||||||
Other Foreign Earnings | 2017 Tax Act | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Transition toll tax repatriation tax rate | 8.00% | ||||||||||
Minimum | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Residual U.S. tax liability on reversal of deferred tax liabilities on foreign subsidiaries purchase accounting | 300 | ||||||||||
Maximum | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Residual U.S. tax liability on reversal of deferred tax liabilities on foreign subsidiaries purchase accounting | 400 | ||||||||||
TECFIDERA | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Deferred tax assets, value, reduction in value | 1,700 | ||||||||||
Deferred tax liabilities, value, reduction in value | $ 1,600 | ||||||||||
Income tax expense, reduction in deferred tax assets and liabilities, net | $ 90.3 | ||||||||||
Deferred tax assets, increase in value | 108.5 | ||||||||||
Deferred tax liability, increase in value | $ 103.9 | ||||||||||
ADUHELM | |||||||||||
Tax Credit Carryforward [Line Items] | |||||||||||
Valuation allowance | $ 390 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Tax credits | $ 121 | $ 113.4 |
Inventory, other reserves and accruals | 199.4 | 165.9 |
Intangibles, net | 1,477.5 | 1,546 |
Neurimmune's tax basis in ADUHELM | 475.8 | 0 |
Net operating loss | 1,973 | 2,080.3 |
Share-based compensation | 31.7 | 23.3 |
Other | 208.8 | 103.1 |
Valuation allowance | (1,961.3) | (1,753.9) |
Total deferred tax assets | 2,525.9 | 2,278.1 |
Deferred tax liabilities: | ||
Purchased intangible assets | (256.6) | (396.2) |
GILTI | (1,037.6) | (1,143.7) |
Tax credits | (260.2) | (174.6) |
Depreciation, amortization and other | (250.9) | (227) |
Total deferred tax liabilities | $ (1,805.3) | $ (1,941.5) |
Income Taxes - Tax Rate (Detail
Income Taxes - Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Statutory rate | 21.00% | 21.00% | 21.00% |
State taxes | 0.80% | 0.70% | 0.80% |
Taxes on foreign earnings | (10.50%) | (3.30%) | (4.50%) |
Tax credits | (3.80%) | (1.20%) | (1.10%) |
Purchased intangible assets | (1.60%) | 0.70% | 0.40% |
Divestiture of Denmark manufacturing operations | 0.00% | (0.40%) | 1.00% |
Internal reorganization of certain intellectual property rights | 0.00% | 0.00% | (2.10%) |
TECFIDERA impairment | 0.00% | 1.80% | 0.00% |
GILTI | 1.30% | 1.30% | 1.50% |
Swiss tax reform | 0.00% | 0.00% | (0.80%) |
Neurimmune tax impacts | (5.30%) | (0.10%) | 0.00% |
Other | 1.10% | (0.80%) | 0.10% |
Effective tax rate | 3.00% | 19.70% | 16.30% |
Income Taxes - Accounting for U
Income Taxes - Accounting for Uncertainty in Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning balance | $ 75.7 | $ 129.9 | $ 114.2 |
Additions based on tax positions related to the current period | 4.2 | 1.5 | 5.3 |
Additions for tax positions of prior periods | 509.9 | 51.7 | 17.2 |
Reductions for tax positions of prior periods | (18.8) | (63.6) | (10.3) |
Statute expirations | (3.2) | (7.9) | (0.1) |
Settlement payment | (4.4) | (35.9) | |
Settlement refund | 3.6 | ||
Ending balance | $ 563.4 | $ 75.7 | $ 129.9 |
Other Consolidated Financial _3
Other Consolidated Financial Statement Detail - Supplemental Cash Flow Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Interest | $ 280.8 | $ 272.7 | $ 244.2 |
Income taxes | $ 247.9 | $ 906.7 | $ 1,064.5 |
Other Consolidated Financial _4
Other Consolidated Financial Statement Detail - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Business Acquisition [Line Items] | ||||
Unrealized gains (losses) recognized during the period on equity securities | $ (831,400,000) | $ 681,800,000 | $ 150,100,000 | |
Other long-term liabilities | 1,320,500,000 | 1,329,600,000 | ||
Accrued income taxes | 664,500,000 | $ 709,900,000 | ||
Denali, Ionis, Sage, and Sangamo | ||||
Business Acquisition [Line Items] | ||||
Unrealized gains (losses) recognized during the period on equity securities | (819,600,000) | |||
Fumarate | Fumapharm AG | Twenty billion | ||||
Business Acquisition [Line Items] | ||||
Increase to goodwill | $ 300,000,000 | |||
Cumulative sales level | $ 20,000,000,000 | |||
Fumarate | Fumapharm AG | Each additional one billion up to twenty billion | ||||
Business Acquisition [Line Items] | ||||
Cumulative sales level | $ 20,000,000,000 | $ 20,000,000,000 |
Other Consolidated Financial _5
Other Consolidated Financial Statement Detail - Other Income (Expense), Net (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Interest income | $ 11 | $ 42 | $ 120 |
Interest expense | (253.6) | (222.5) | (187.4) |
Gain (loss) on investments, net | (824.9) | 685.7 | 204.7 |
Foreign exchange gains (losses), net | (22.4) | (10.7) | (7) |
Other, net | (5.6) | 2.9 | (47) |
Total other income (expense), net | $ (1,095.5) | $ 497.4 | $ 83.3 |
Other Consolidated Financial _6
Other Consolidated Financial Statement Detail - Gain (Loss) on Investments (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net gains (losses) recognized during the period on equity securities | $ (821.1) | $ 693.9 | $ 200.1 |
Less: Net gains (losses) realized during the period and on equity securities | (10.3) | (12.1) | (50) |
Unrealized gains (losses) recognized during the period on equity securities | $ (831.4) | $ 681.8 | $ 150.1 |
Other Consolidated Financial _7
Other Consolidated Financial Statement Detail - Accrued Expense and Other (Details) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Revenue-related reserves for discounts and allowances | $ 935.3 | $ 1,276 | $ 1,198.9 | $ 1,051.3 |
Total accrued expense and other | 2,535.2 | 3,145.3 | ||
Component of accrued expense and other | ||||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||||
Revenue-related reserves for discounts and allowances | 802.1 | 1,080.6 | ||
Collaboration expense | 324.7 | 389.9 | ||
Employee compensation and benefits | 345.1 | 333.8 | ||
Royalties and licensing fees | 234.7 | 218.5 | ||
Derivative liabilities | 10.8 | 181.5 | ||
Current portion of contingent consideration obligations | 0 | 149.6 | ||
Other | 817.8 | 791.4 | ||
Total accrued expense and other | $ 2,535.2 | $ 3,145.3 |
Collaborative and Other Relat_3
Collaborative and Other Relationships - OCREVUS (Details) - OCREVUS $ in Millions | 1 Months Ended |
Mar. 31, 2017USD ($) | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Royalty operating profit threshold for highest royalty rate percentage | $ 900 |
Reduction in royalty rate | 50.00% |
Collaboration agreement term | 11 years |
Foreign Tax Authority | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Royalty percentage to be received | 3.00% |
Minimum | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Royalty percentage to be received | 13.50% |
Maximum | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Royalty percentage to be received | 24.00% |
Collaborative and Other Relat_4
Collaborative and Other Relationships - Mosunetuzumab (Details) - Mosunetuzumab - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Dec. 31, 2021 | Dec. 31, 2021 | |
Collaborative arrangements and non-collaborative arrangement transactions | ||
Option exercise fee | $ 30 | |
Development of product candidate expense | $ 20 | |
Percentage of future development costs | 30.00% | |
Minimum | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Future percentage of co-promotion operating profits | 30.00% | |
Maximum | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Future percentage of co-promotion operating profits | 37.50% |
Collaborative and Other Relat_5
Collaborative and Other Relationships - Co-promotion Profit Sharing Formula (Details) - RITUXAN | Dec. 31, 2021 |
Collaborative arrangements and non-collaborative arrangement transactions | |
After First GAZYVA Threshold Date until Second GAZYVA Threshold Date | 37.50% |
After Second GAZYVA Threshold Date | 35.00% |
Collaborative and Other Relat_6
Collaborative and Other Relationships - Profit Sharing (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
RITUXAN | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Percentage of co promotion operating profits first fifty million | 30.00% | ||
After First GAZYVA Threshold Date until Second GAZYVA Threshold Date | 37.50% | ||
GAZYVA | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Percentage of co promotion operating profits first fifty million | 35.00% | ||
Co-promotion operating profit threshold for Rituxan in US and Canada to determine share of co promotion operating profit prior to amendment | $ 50 | ||
Limit of gross sale of GAZYVA to be achieved in preceding 12 months under option one | 150 | ||
Limit of gross sale of GAZYVA to be achieved in any 12 months under option one | 150 | ||
Sales trigger gross sales threshold | $ 500 | ||
After First GAZYVA Threshold Date until Second GAZYVA Threshold Date | 37.50% | 37.50% | 37.50% |
New Anti Cd20 | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Future percentage of co-promotion operating profits | 37.50% | 37.50% | 37.50% |
New Anti Cd20 | Minimum | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Future percentage of co-promotion operating profits | 30.00% | ||
New Anti Cd20 | Maximum | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Future percentage of co-promotion operating profits | 37.50% | ||
Mosunetuzumab | Minimum | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Future percentage of co-promotion operating profits | 30.00% | ||
Mosunetuzumab | Maximum | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Future percentage of co-promotion operating profits | 37.50% |
Collaborative and Other Relat_7
Collaborative and Other Relationships - Pretax Profit Sharing Formula (Details) - GAZYVA | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Collaborative arrangements and non-collaborative arrangement transactions | |||
After First GAZYVA Threshold Date until Second GAZYVA Threshold Date | 37.50% | 37.50% | 37.50% |
After Second GAZYVA Threshold Date | 35.00% |
Collaborative and Other Relat_8
Collaborative and Other Relationships - Revenues from Anti-CD20 Therapeutic Programs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||
Total revenue from anti-CD20 therapeutic programs | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Revenue from anti-CD20 therapeutic programs | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Total revenue from anti-CD20 therapeutic programs | 1,658.5 | 1,977.8 | 2,290.4 |
Genentech | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA | 647.7 | 1,080.2 | 1,542.4 |
Other revenue from anti-CD20 therapeutic programs | $ 1,010.8 | $ 897.6 | $ 748 |
Collaborative and Other Relat_9
Collaborative and Other Relationships - Ionis (Details) - USD ($) shares in Millions, $ in Millions | 1 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2016 | Jan. 31, 2022 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | $ 2,109.7 | $ 1,805.2 | $ 1,955.4 | ||||||||
Research and development | 2,501.2 | 3,990.9 | 2,280.6 | ||||||||
Ionis Pharmaceuticals | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
License fee | $ 70 | $ 70 | |||||||||
Expected license fee and regulatory milestone payments | $ 130 | $ 130 | |||||||||
Research and development expense asset acquired | $ 45 | ||||||||||
Additional milestone payment | $ 155 | ||||||||||
Term of collaboration agreement | 10 years | 6 years | |||||||||
Total payment to enter collaboration agreement | $ 1,000 | ||||||||||
Upfront payment for collaboration agreement | 375 | ||||||||||
Purchase of common stock | $ 625 | ||||||||||
Investment in common stock, shares purchased (in shares) | 11.5 | ||||||||||
Prepaid research and discovery services | $ 50.9 | ||||||||||
Research and development | 324.1 | 22.5 | 11.3 | 30 | |||||||
Investment in common stock, value | 462.9 | ||||||||||
Premium on purchase of common stock | 162.1 | ||||||||||
Estimated additional payments upon achievement of development and commercial milestones | $ 260 | ||||||||||
Upfront and milestone payments made to collaborative partner | 25 | ||||||||||
Expected additional milestone payments when certain sales threshold is met | $ 800 | ||||||||||
Ionis Pharmaceuticals | SPINRAZA | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | 267.1 | 286.6 | 293 | ||||||||
Ionis Pharmaceuticals | BIIB115 | Subsequent Event | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Upfront payment for collaboration agreement | $ 60 | ||||||||||
Ionis Pharmaceuticals | SOD1 | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Research and development | $ 10 | $ 28 | $ 20 | ||||||||
Estimated additional payments upon achievement of development and commercial milestones | $ 55 | ||||||||||
Upfront and milestone payments made to collaborative partner | $ 35 | ||||||||||
Ionis Pharmaceuticals | Minimum | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Estimated additional payments upon achievement of development and commercial milestones | 125 | ||||||||||
Ionis Pharmaceuticals | Minimum | SPINRAZA | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Percentage of royalties as per collaboration | 11.00% | 11.00% | |||||||||
Ionis Pharmaceuticals | Maximum | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Estimated additional payments upon achievement of development and commercial milestones | $ 270 | ||||||||||
Ionis Pharmaceuticals | Maximum | SPINRAZA | |||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||
Percentage of royalties as per collaboration | 15.00% | 15.00% |
Collaborative and Other Rela_10
Collaborative and Other Relationships - Eisai (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2019USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2021USD ($)product | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Collaborative arrangements and non-collaborative arrangement transactions | ||||||
Income (loss) from equity method investments | $ 34.9 | $ 3.3 | $ (77.4) | |||
Eisai | ||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||
Number of product candidates | product | 2 | |||||
Loss on contract termination | $ 45 | |||||
Percentage of future development costs | 45.00% | |||||
Income (loss) from equity method investments | $ 33.8 | $ 33.8 | $ 45 | 33.8 | 0 | |
Additional milestone payment | $ 75 | $ 100 | $ 75 | $ 0 | ||
Eisai | United States | ||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||
Biogen share of co-promotion profits or losses | 55.00% | |||||
Eisai | European Union | ||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||
Biogen share of co-promotion profits or losses | 68.50% | |||||
Eisai | JAPAN | ||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||
Biogen share of co-promotion profits or losses | 20.00% |
Collaborative and Other Rela_11
Collaborative and Other Relationships - Summary of Activity Related to BAN2401 and Elenbecestat Collaboration (Details) - Eisai - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||
Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat | $ 323 | $ 219.3 | $ 348.7 |
Expense reflected within statements of income | 161.5 | 109.6 | 174.3 |
Selling, general and administrative | E2609 and BAN2401 | |||
Collaborative arrangements and non-collaborative arrangement transactions | |||
Expense reflected within statements of income | 13.6 | 4.9 | 16.2 |
Expense incurred by the collaboration | $ 27.2 | $ 9.8 | $ 32.4 |
Collaborative and Other Rela_12
Collaborative and Other Relationships - ADUHELM Collaboration Agreement (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2021 | Mar. 31, 2019 | Dec. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Income (loss) from equity method investments | $ 34.9 | $ 3.3 | $ (77.4) | ||||||
Royalty cost of sales | $ 2,109.7 | 1,805.2 | 1,955.4 | ||||||
ADUHELM | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Royalty cost of sales | $ 164 | ||||||||
Eisai | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Percentage of future development costs | 45.00% | ||||||||
Loss on contract termination | $ 45 | ||||||||
Additional milestone payment | $ 75 | $ 100 | 75 | 0 | |||||
Income (loss) from equity method investments | $ 33.8 | $ 33.8 | 45 | 33.8 | $ 0 | ||||
Due from related parties | 285.4 | 285.4 | 151.1 | ||||||
Due to related parties | $ 46.5 | 46.5 | $ 111.9 | ||||||
Eisai | Collaboration profit sharing | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Income (loss) from equity method investments | $ 233.2 | ||||||||
Eisai | United States | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Biogen share of co-promotion profits or losses | 55.00% | ||||||||
Eisai | European Union | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Biogen share of co-promotion profits or losses | 68.50% | ||||||||
Eisai | JAPAN | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Biogen share of co-promotion profits or losses | 20.00% | ||||||||
Eisai | ADUHELM | |||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||
Additional milestone payment | $ 100 | ||||||||
Income (loss) from equity method investments | $ 45 | $ 45 |
Collaborative and Other Rela_13
Collaborative and Other Relationships - Summary of Activity Related to Aducanumab Collaboration (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our consolidated statements of income | $ 34.9 | $ 3.3 | $ (77.4) | ||
Eisai | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Expense reflected within statements of income | 161.5 | 109.6 | 174.3 | ||
Total ADUHELM collaboration third-party milestones | $ 75 | 100 | 75 | 0 | |
Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our consolidated statements of income | $ 33.8 | $ 33.8 | 45 | 33.8 | 0 |
Aducanumab | Research and development | Eisai | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Expense incurred by the collaboration | 183.7 | 152 | 179.4 | ||
Expense reflected within statements of income | 101.1 | 83.6 | 98.7 | ||
Aducanumab | Selling, general and administrative | Eisai | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Expense incurred by the collaboration | 562.3 | 353 | 27.4 | ||
Expense reflected within statements of income | $ 301.4 | $ 193.7 | $ 15.1 |
Collaborative and Other Rela_14
Collaborative and Other Relationships - Summary of Activity Related to the UCB Collaboration (Details) - Research and development - UCB Pharma S.A. - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||
Expense incurred by the collaboration | $ 84.2 | $ 58.3 | $ 31.9 |
Expense reflected within statements of income | $ 42.1 | $ 29.2 | $ 16 |
Collaborative and Other Rela_15
Collaborative and Other Relationships - Alkermes (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Inventory and purchase commitment charges | $ 2,109.7 | $ 1,805.2 | $ 1,955.4 | |
Potential future milestone payments commitment to third party approximately | 10,000 | |||
Research and development | 2,501.2 | 3,990.9 | 2,280.6 | |
Alkermes | ||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Potential future milestone payments commitment to third party approximately | 155 | |||
Research and development | $ 26.5 | 32.4 | 53.5 | |
VUMERITY | Alkermes | ||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Percentage of royalties as per collaboration | 15.00% | 15.00% | ||
Royalties payable period, post FDA approval | 5 years | |||
Inventory and purchase commitment charges | $ 61.6 | $ 12.9 | $ 1.6 |
Collaborative and Other Rela_16
Collaborative and Other Relationships - Acorda (Details) - Acorda - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Expected additional milestone payments when certain sales threshold is met | $ 15 | |||
Foreign sales required to trigger milestone | $ 100 | |||
Expense reflected within statements of income | $ 46.6 | $ 44.5 | $ 42 |
Collaborative and Other Rela_17
Collaborative and Other Relationships - Other Arrangements (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Aug. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Apr. 30, 2020 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Research and development | $ 2,501.2 | $ 3,990.9 | $ 2,280.6 | |||||
Sage Therapeutics | ||||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Global licensing collaboration, shares purchased, amount | $ 650 | |||||||
Global licensing collaboration, shares purchased (in shares) | 6.2 | |||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ 104.14 | |||||||
Research and development expense asset acquired | $ 209 | |||||||
Upfront and milestone payments made to collaborative partner | 875 | |||||||
Global licensing collaboration, development and commercial milestone payments | $ 1,600 | |||||||
Denali Therapeutics | ||||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Global licensing collaboration, shares purchased, amount | $ 465 | |||||||
Global licensing collaboration, shares purchased (in shares) | 13 | |||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ 34.94 | |||||||
Research and development expense asset acquired | $ 41.3 | |||||||
Upfront and milestone payments made to collaborative partner | 560 | |||||||
Global licensing collaboration, development and commercial milestone payments | $ 1,100 | |||||||
Sangamo Therapeutics, Inc. Agreement | ||||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Global licensing collaboration, shares purchased, amount | $ 225 | |||||||
Global licensing collaboration, shares purchased (in shares) | 24 | |||||||
Global licensing collaboration, purchase price per share (in dollars per share) | $ 9.21 | |||||||
Research and development expense asset acquired | $ 83 | |||||||
Upfront and milestone payments made to collaborative partner | 125 | |||||||
Global licensing collaboration, development and commercial milestone payments | $ 2,400 | |||||||
Term of collaboration agreement | 5 years | |||||||
Investment in common stock, shares purchased (in shares) | 12 | |||||||
Global licensing collaboration, payment, selection of targets | $ 80 | |||||||
Global licensing collaboration, payment, first milestone | 1,900 | |||||||
Global licensing collaboration, payment, sales based milestone | $ 380 | |||||||
Other research and discovery | ||||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Research and development | $ 89.1 | $ 92.1 | $ 80.8 | |||||
InnoCare Pharma Limited (InnoCare) Agreement | ||||||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||||||
Upfront and milestone payments made to collaborative partner | $ 125 | |||||||
Contingent milestone payments made to collaborative partner | $ 812.5 |
Collaborative and Other Rela_18
Collaborative and Other Relationships - Summary of Activity Related to Sage Therapeutics (Details) - Sage Therapeutics $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Research and development | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Expense incurred by the collaboration | $ 167.7 |
Expense reflected within statements of income | 83.8 |
Selling, general and administrative | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Expense incurred by the collaboration | 36.4 |
Expense reflected within statements of income | $ 18.2 |
Collaborative and Other Rela_19
Collaborative and Other Relationships - Summary of Activity Related To Denali Therapeutics (Details) - Research and development - Denali Therapeutics - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||
Expense incurred by the collaboration | $ 42.5 | $ 14.6 | $ 0 |
Expense reflected within statements of income | $ 25.5 | $ 8.8 | $ 0 |
Collaborative and Other Rela_20
Collaborative and Other Relationships - Summary of Activity Related to Sangamo Therapeutics (Details) - Research and development - Sangamo Therapeutics, Inc. Agreement - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative arrangements and non-collaborative arrangement transactions | |||
Expense incurred by the collaboration | $ 22.7 | $ 10.1 | $ 0 |
Expense reflected within statements of income | $ 14.6 | $ 6.4 | $ 0 |
Collaborative and Other Rela_21
Collaborative and Other Relationships - Samsung Bioepis (Details) $ in Millions, ₩ in Billions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||||||
Jan. 31, 2022USD ($) | Jan. 31, 2020USD ($) | Nov. 30, 2018USD ($) | Nov. 30, 2018KRW (₩) | Aug. 31, 2017USD ($) | May 31, 2016USD ($) | Jan. 31, 2016USD ($) | Dec. 31, 2013USD ($) | Feb. 29, 2012USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)product | Dec. 31, 2021KRW (₩) | Dec. 31, 2020KRW (₩) | Jun. 30, 2018 | May 31, 2018 | Feb. 29, 2012KRW (₩) | |
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Income (loss) from equity method investments | $ 34.9 | $ 3.3 | $ (77.4) | ||||||||||||||||
Income tax benefit (expense) | 52.5 | 992.3 | $ 1,158 | ||||||||||||||||
Number of ophthalmolgy biosimilar products | product | 2 | ||||||||||||||||||
Research and development | 2,501.2 | 3,990.9 | $ 2,280.6 | ||||||||||||||||
Collaboration profit (loss) sharing | 7.2 | 232.9 | 241.6 | ||||||||||||||||
Revenue | 10,981.7 | 13,444.6 | 14,377.9 | ||||||||||||||||
Samsung Bioepis | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Upfront and milestone payments made to collaborative partner | $ 100 | ||||||||||||||||||
Research and development expense asset acquired | 63 | ||||||||||||||||||
Prepaid research and discovery services | 37 | ||||||||||||||||||
Accrued milestone payment | $ 15 | ||||||||||||||||||
Estimated additional payments upon achievement of development and commercial milestones | $ 180 | ||||||||||||||||||
Term of collaboration agreement | 10 years | 5 years | |||||||||||||||||
Option exercise fee | $ 60 | ||||||||||||||||||
Research and development | $ 46 | ||||||||||||||||||
Expected profit share percentage | 50.00% | ||||||||||||||||||
Collaboration profit (loss) sharing | $ 285.4 | 266.5 | 241.6 | ||||||||||||||||
Revenue | 20.7 | 20.9 | $ 106.2 | ||||||||||||||||
Due from related parties | 4.1 | 5.1 | |||||||||||||||||
Due to related parties | 148.7 | 99 | |||||||||||||||||
Samsung Bioepis | Subsequent Event | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Proceeds from divestiture of interest in joint venture | $ 1,000 | ||||||||||||||||||
Due from joint venture | 1,300 | ||||||||||||||||||
Estimated additional payments upon achievement of development and commercial milestones | 50 | ||||||||||||||||||
Samsung Bioepis | Payment Due At First Anniversary | Subsequent Event | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Due from joint venture | 812.5 | ||||||||||||||||||
Samsung Bioepis | Payment Due At Second Anniversary | Subsequent Event | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Due from joint venture | $ 437.5 | ||||||||||||||||||
Samsung Bioepis | Development Milestones | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Additional milestone payment | $ 15 | ||||||||||||||||||
Samsung Bioepis | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Contributions by third party | $ 250 | ₩ 280.5 | |||||||||||||||||
Joint venture ownership percentage | 85.00% | ||||||||||||||||||
Investment in Samsung Bioepis | $ 45 | $ 599.9 | 620.2 | ₩ 713.3 | ₩ 673.8 | ₩ 49.5 | |||||||||||||
Ownership percentage | 15.00% | 49.90% | 49.90% | 49.90% | 15.00% | ||||||||||||||
Ownership percentage before additional purchase transaction | 5.00% | ||||||||||||||||||
Payments to increase investment in Samsung Bioepis | $ 676.6 | ₩ 759.5 | |||||||||||||||||
Total basis difference | $ 675 | ||||||||||||||||||
Net profits on investment | $ 34.9 | 5.3 | |||||||||||||||||
Income (loss) from equity method investments | 64.6 | 45.3 | |||||||||||||||||
Amortization | 29.7 | $ 40 | |||||||||||||||||
Income tax benefit (expense) | $ 31.2 | ||||||||||||||||||
Additional milestone payment | $ 25 | ||||||||||||||||||
Net change in acquired and in-licensed rights and patents | $ 75 | $ 75 | $ 75 | ||||||||||||||||
Samsung Bioepis | Inventories | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Equity method investment basis difference amortization period | 1 year 6 months | ||||||||||||||||||
Samsung Bioepis | Completed technology | |||||||||||||||||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||||||||||||||||
Equity method investment basis difference amortization period | 15 years |
Investments in Variable Inter_2
Investments in Variable Interest Entities (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
May 31, 2018 | Oct. 31, 2017 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | $ 10,000 | |||||||
Income (loss) from equity method investments | 34.9 | $ 3.3 | $ (77.4) | |||||
Deferred tax asset, net | $ 490 | |||||||
Deferred tax asset, gross | 945 | |||||||
Increase in unrecognized tax benefit | 455 | |||||||
Valuation allowance | 1,961.3 | 1,753.9 | ||||||
Investment in biotechnology companies that are determined to be unconsolidated variable interest entities | 24.6 | 12.8 | ||||||
ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Valuation allowance | $ 390 | |||||||
Neurimmune | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Term of collaboration agreement | 12 years | |||||||
Research and development costs, percentage | 100.00% | |||||||
Payment to Neurimmune | $ 50 | $ 150 | ||||||
Reduction in royalty rate payable on commercial sales | 15.00% | |||||||
Additional reduction in royalty rate payable on commercial sales | 5.00% | |||||||
Regulatory Milestones | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | $ 900 | |||||||
Regulatory Milestones | Neurimmune | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | $ 75 | |||||||
Eisai | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Income (loss) from equity method investments | $ 33.8 | $ 33.8 | $ 45 | $ 33.8 | $ 0 | |||
Percentage of future development costs | 45.00% | |||||||
Eisai | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Income (loss) from equity method investments | 45 | $ 45 | ||||||
Eisai | Twelve months | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | 100 | |||||||
Eisai | Regulatory Milestones | European Union | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | 50 | |||||||
Eisai | Regulatory Milestones | JAPAN | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | $ 50 | |||||||
Eisai | Regulatory Milestones | Neurimmune | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party approximately | $ 100 |
Litigation (Details)
Litigation (Details) - USD ($) $ in Millions | 2 Months Ended | |
Dec. 31, 2019 | Jul. 15, 2021 | |
Loss Contingency, Information about Litigation Matters [Abstract] | ||
Loss contingency | $ 981.1 | |
Claims asserted | $ 200 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Oct. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2016 | Dec. 31, 2022 | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2013 | |
Business Acquisition [Line Items] | |||||||||||
Contingent payment | $ 300,000,000 | ||||||||||
Potential future milestone payments commitment, approximately | $ 10,000,000,000 | ||||||||||
Accrued expenses | 27,300,000 | ||||||||||
Cancellable future commitments | 676,100,000 | ||||||||||
Liabilities associated with uncertain tax positions | 106,800,000 | ||||||||||
Income taxes paid | 72,700,000 | ||||||||||
2017 Tax Act | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Transition toll tax liabilities | 633,000,000 | $ 697,000,000 | |||||||||
Development Milestones | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | 2,000,000,000 | ||||||||||
Regulatory Milestones | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | 900,000,000 | ||||||||||
Regulatory Milestones | Neurimmune | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 75,000,000 | ||||||||||
Commercial Milestones | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 7,100,000,000 | ||||||||||
Ionis Pharmaceuticals | Minimum | SPINRAZA | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Percentage of royalties as per collaboration | 11.00% | 11.00% | |||||||||
Ionis Pharmaceuticals | Maximum | SPINRAZA | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Percentage of royalties as per collaboration | 15.00% | 15.00% | |||||||||
Alkermes | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 155,000,000 | ||||||||||
Alkermes | VUMERITY | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Percentage of royalties as per collaboration | 15.00% | 15.00% | |||||||||
Royalties payable period, post FDA approval | 5 years | ||||||||||
Aducanumab | Forecast | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 133,900,000 | ||||||||||
Eisai | ADUHELM | Twelve months | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 100,000,000 | ||||||||||
Eisai | ADUHELM | Regulatory Milestones | Neurimmune | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | $ 100,000,000 | ||||||||||
Eisai | ADUHELM | Regulatory Milestones | European Union | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | 50,000,000 | ||||||||||
Eisai | ADUHELM | Regulatory Milestones | JAPAN | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Potential future milestone payments commitment, approximately | 50,000,000 | ||||||||||
TYSABRI | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Future contingent payment for annual worldwide net sales up to threshold, percentage | 18.00% | ||||||||||
Future contingent payment threshold | $ 2,000,000,000 | ||||||||||
Future contingent payment for annual worldwide net sales that exceeding threshold, percentage | 25.00% | ||||||||||
Fumapharm AG | Fumarate | Twenty billion | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Cumulative sales level | $ 20,000,000,000 | ||||||||||
Fumapharm AG | Fumarate | Each additional one billion up to twenty billion | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Cumulative sales level | 20,000,000,000 | $ 20,000,000,000 | |||||||||
Convergence Pharmaceuticals | |||||||||||
Business Acquisition [Line Items] | |||||||||||
Maximum contingent consideration in the form of development and approval milestones | $ 400,000,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Switzerland | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Percentage of minimum investment return | 1.00% | 1.00% | 1.00% |
Unfunded net pension | $ 64.1 | $ 75.7 | |
Employee benefit plan obligations | 200.1 | 170 | |
Pension cost (reversal) | 21.5 | 15.5 | $ 14.7 |
Switzerland | Other (income) expense, net | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Pension cost (reversal) | 3.5 | 2.6 | 1.2 |
Germany | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Employee benefit plan obligations | 68.4 | 75.5 | |
Periodic pension cost | 7.6 | 6.2 | 5.1 |
Germany | Other (income) expense, net | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Periodic pension cost | $ 2.1 | 2 | 1.4 |
Domestic Plan | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Minimum qualifying age for employee benefit plan | 21 years | ||
Expenses related to savings plan | $ 58.4 | 44.3 | $ 44.8 |
Deferred Compensation Plan | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Deferred compensation liability | $ 131.4 | $ 120 |
Segment Information - Narrative
Segment Information - Narrative (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Revenue from External Customer [Line Items] | |||
Number of reportable segment | segment | 1 | ||
Other long-lived assets | $ 3,791.8 | $ 3,844.8 | $ 3,674.3 |
Solothurn, Switzerland | |||
Revenue from External Customer [Line Items] | |||
Other long-lived assets | $ 2,237 | $ 2,180.6 | $ 2,028.8 |
Segment Information - Geographi
Segment Information - Geographic Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue, Major Customer [Line Items] | |||
Revenue | $ 10,981.7 | $ 13,444.6 | $ 14,377.9 |
Long-lived assets | 3,791.8 | 3,844.8 | 3,674.3 |
U.S. | |||
Revenue, Major Customer [Line Items] | |||
Long-lived assets | 1,390.5 | 1,496.3 | 1,493.2 |
Europe | |||
Revenue, Major Customer [Line Items] | |||
Long-lived assets | 2,337.8 | 2,290.2 | 2,135.4 |
Germany | |||
Revenue, Major Customer [Line Items] | |||
Long-lived assets | 25.4 | 31.2 | 27.5 |
Asia | |||
Revenue, Major Customer [Line Items] | |||
Long-lived assets | 16.4 | 16.2 | 6.2 |
Other | |||
Revenue, Major Customer [Line Items] | |||
Long-lived assets | 21.7 | 10.9 | 12 |
Product, net | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 8,846.9 | 10,692.2 | 11,379.8 |
Product, net | U.S. | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 3,805.7 | 5,900.1 | 6,713.8 |
Product, net | Europe | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 2,626 | 2,495.3 | 2,668.4 |
Product, net | Germany | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 1,162.4 | 1,161.1 | 1,126.1 |
Product, net | Asia | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 688 | 596.7 | 320.3 |
Product, net | Other | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 564.8 | 539 | 551.2 |
Revenue from anti-CD20 therapeutic programs | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 1,658.5 | 1,977.8 | 2,290.4 |
Revenue from anti-CD20 therapeutic programs | U.S. | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 1,596.7 | 1,897.4 | 2,211.9 |
Revenue from anti-CD20 therapeutic programs | Europe | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 0 | 0.1 | 0.2 |
Revenue from anti-CD20 therapeutic programs | Germany | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 0 | 0 | 0 |
Revenue from anti-CD20 therapeutic programs | Asia | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 0 | 0 | 0 |
Revenue from anti-CD20 therapeutic programs | Other | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 61.8 | 80.3 | 78.3 |
Other | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 476.3 | 774.6 | 707.7 |
Other | U.S. | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 429.9 | 733.6 | 585.8 |
Other | Europe | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 9.7 | 8 | 9.4 |
Other | Germany | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 0 | 0.1 | 0.3 |
Other | Asia | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 36.7 | 32.9 | 112.2 |
Other | Other | |||
Revenue, Major Customer [Line Items] | |||
Revenue | $ 0 | $ 0 | $ 0 |