Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 21, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 0-19311 | |
Entity Registrant Name | BIOGEN INC. | |
Entity Central Index Key | 0000875045 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
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, $0.0005 par value | |
Trading Symbol | BIIB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 149,033,443 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income (Unaudited) - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Total revenue | $ 2,775 | $ 3,681.6 | $ 5,469 | $ 7,215.9 |
Cost and expenses: | ||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | 459.7 | 411.1 | 937.8 | 865.5 |
Research and development | 585.1 | 647.6 | 1,099.3 | 1,123.9 |
Selling, general and administrative | 637.3 | 555.1 | 1,232.3 | 1,125.2 |
Amortization and impairment of acquired intangible assets | 604.1 | 61.5 | 702.2 | 133 |
Collaboration profit sharing | (15.2) | 21.8 | 53.3 | 93.5 |
(Gain) loss on fair value remeasurement of contingent consideration | 0.3 | 10 | (33.5) | 5.5 |
Acquired in-process research and development | 18 | 0 | 18 | 75 |
Total cost and expense | 2,289.3 | 1,707.1 | 4,009.4 | 3,421.6 |
Income from operations | 485.7 | 1,974.5 | 1,459.6 | 3,794.3 |
Other income (expense), net | 96.4 | 63 | (410.5) | (57.5) |
Income before income tax expense and equity in loss of investee, net of tax | 582.1 | 2,037.5 | 1,049.1 | 3,736.8 |
Income tax (benefit) expense | (409.1) | 446.1 | (364.9) | 738.2 |
Equity in (income) loss of investee, net of tax | (34.3) | (15.1) | (16.1) | (0.4) |
Net income | 1,025.5 | 1,606.5 | 1,430.1 | 2,999 |
Net income (loss) attributable to noncontrolling interests, net of tax | 577 | 64.4 | 571.4 | 57.8 |
Net income attributable to Biogen Inc. | $ 448.5 | $ 1,542.1 | $ 858.7 | $ 2,941.2 |
Net income per share: | ||||
Basic earnings per share attributable to Biogen Inc. | $ 3 | $ 9.60 | $ 5.70 | $ 17.65 |
Diluted earnings per share attributable to Biogen Inc. | $ 2.99 | $ 9.59 | $ 5.68 | $ 17.61 |
Weighted-average shares used in calculating: | ||||
Basic earnings per share attributable to Biogen Inc. | 149.7 | 160.6 | 150.8 | 166.7 |
Diluted earnings per share attributable to Biogen Inc. | 150.1 | 160.9 | 151.2 | 167 |
Product, net | ||||
Total revenue | $ 2,236 | $ 2,795.7 | $ 4,447.7 | $ 5,700.3 |
Revenue from anti-CD20 therapeutic programs | ||||
Total revenue | 440 | 478.3 | 829 | 998.7 |
Other | ||||
Total revenue | $ 99 | $ 407.6 | $ 192.3 | $ 516.9 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Unaudited) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income attributable to Biogen Inc. | $ 448.5 | $ 1,542.1 | $ 858.7 | $ 2,941.2 |
Other comprehensive income: | ||||
Unrealized gains (losses) on securities available for sale, net of tax | (0.5) | 8.7 | (1.3) | 0.9 |
Unrealized gains (losses) on cash flow hedges, net of tax | (11) | (51.2) | 138.6 | (17.4) |
Gains (losses) on net investment hedges | (2.3) | (6.2) | 20.1 | 16.8 |
Unrealized gains (losses) on pension benefit obligation, net of tax | 0.4 | 0.1 | 2.4 | 0.9 |
Currency translation adjustment | 15.9 | 16.9 | (32.6) | (47) |
Total other comprehensive income (loss), net of tax | 2.5 | (31.7) | 127.2 | (45.8) |
Comprehensive income attributable to Biogen Inc. | 451 | 1,510.4 | 985.9 | 2,895.4 |
Comprehensive income (loss) attributable to noncontrolling interests, net of tax | 576.9 | 65.5 | 572 | 59.6 |
Comprehensive income (loss) attributable to noncontrolling interests, net of tax | $ 1,027.9 | $ 1,575.9 | $ 1,557.9 | $ 2,955 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 1,742 | $ 1,331.2 |
Marketable securities | 1,308.8 | 1,278.9 |
Accounts receivable, net | 1,688 | 1,913.8 |
Due from anti-CD20 therapeutic programs | 422.2 | 413.5 |
Inventory | 1,254.8 | 1,068.6 |
Other current assets | 767.9 | 881.1 |
Total current assets | 7,183.7 | 6,887.1 |
Marketable securities | 915.1 | 772.1 |
Property, plant and equipment, net | 3,442.2 | 3,411.5 |
Operating lease assets | 402.5 | 433.3 |
Intangible assets, net | 2,385 | 3,084.3 |
Goodwill | 5,763.9 | 5,762.1 |
Deferred tax asset | 1,849.9 | 1,369.5 |
Investments and other assets | 2,528.1 | 2,899 |
Total assets | 24,470.4 | 24,618.9 |
Current liabilities: | ||
Taxes payable | 230.9 | 142 |
Accounts payable | 375.3 | 454.9 |
Accrued expense and other | 2,741 | 3,145.3 |
Total current liabilities | 3,347.2 | 3,742.2 |
Notes payable | 7,269.2 | 7,426.2 |
Deferred tax liability | 918.9 | 1,032.8 |
Long-term operating lease liabilities | 363.9 | 402 |
Other long-term liabilities | 1,356.4 | 1,329.6 |
Total liabilities | 13,255.6 | 13,932.8 |
Commitments and contingencies | ||
Biogen Idec 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 | 0 | 0 |
Accumulated other comprehensive loss | (171.8) | (299) |
Retained earnings | 13,900.7 | 13,976.3 |
Treasury stock, at cost | (2,977.1) | (2,977.1) |
Total Biogen Inc. shareholders’ equity | 10,751.9 | 10,700.3 |
Noncontrolling interests | 462.9 | (14.2) |
Total equity | 11,214.8 | 10,686.1 |
Total liabilities and equity | $ 24,470.4 | $ 24,618.9 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Common stock, par value | $ 0.0005 | $ 0.0005 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flow from operating activities: | ||
Net income | $ 1,430.1 | $ 2,999 |
Adjustments to reconcile net income to net cash flow from operating activities: | ||
Depreciation and amortization | 219.8 | 232.8 |
Impairment of intangible assets | 585.9 | 0 |
Acquired in-process research and development | 18 | 75 |
Share-based compensation | 124.1 | 115.8 |
Gain on interest rate swap | 0 | (3.3) |
Contingent consideration | (33.5) | 5.5 |
Deferred income taxes | (622.8) | 180.2 |
(Gain) loss on strategic investments | 283.6 | (39.7) |
Loss on equity method investment | (16.1) | 1.6 |
Other | 112.4 | 83.7 |
Changes in operating assets and liabilities, net: | ||
Accounts receivable | 211.5 | (268.8) |
Due from anti-CD20 therapeutic programs | (8.7) | 149.1 |
Inventory | (193.8) | (188.2) |
Accrued expense and other current liabilities | (188.4) | (441.4) |
Income tax assets and liabilities | 171.5 | 504.6 |
Other changes in operating assets and liabilities, net | (97.3) | 9.9 |
Net cash flow provided by operating activities | 1,996.3 | 3,415.8 |
Cash flows from investing activities: | ||
Proceeds from sales and maturities of marketable securities | 1,452.7 | 3,879.9 |
Purchases of marketable securities | (1,626.9) | (3,753.9) |
Proceeds from divestiture of Hillerød, Denmark manufacturing operations | 28.1 | 0 |
Purchases of property, plant and equipment | (164.5) | (254.7) |
Acquired in-process research and development | 0 | (75) |
Acquisitions of intangible assets | 0 | (37) |
Proceeds from sales of strategic investments | 91.2 | 0.5 |
Other | 2 | (7.8) |
Net cash flow used in investing activities | (217.4) | (389.8) |
Cash flows from financing activities: | ||
Purchases of treasury stock | (1,050) | (5,029.1) |
Payments related to issuance of stock for share-based compensation arrangements, net | (14.2) | (19.2) |
Repayment of borrowings and premiums paid on debt exchange | (170) | 0 |
Proceeds from borrowings | 0 | 2,967.3 |
Repayment of borrowings | 0 | (1,500) |
Cash proceeds from settlement of swap | 0 | 3.3 |
Net distribution to noncontrolling interest | (94.8) | 0 |
Other | (20.5) | 19 |
Net cash flow used in financing activities | (1,349.5) | (3,558.7) |
Net increase (decrease) in cash and cash equivalents | 429.4 | (532.7) |
Effect of exchange rate changes on cash and cash equivalents | 18.6 | (3.9) |
Cash and cash equivalents, beginning of the period | 1,331.2 | 2,913.7 |
Cash and cash equivalents, end of the period | 1,742 | 2,384.9 |
Sangamo | ||
Cash flows from investing activities: | ||
Purchase of Sangamo Therapeutics, Inc. stock | $ 0 | $ (141.8) |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Equity Statement - USD ($) shares in Millions, $ in Millions | Total | Preferred stock | Common stock | Additional paid-in capital | Accumulated Other Comprehensive Income | Retained earnings | Treasury stock | Parent | Noncontrolling interest | 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 ProgramParent | 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 ProgramParent | 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 ProgramParent |
Beginning balance, shares at Dec. 31, 2019 | 0 | (198) | (23.8) | ||||||||||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ 13,339.1 | $ 0 | $ 0.1 | $ 0 | $ (135.2) | $ 16,455.4 | $ (2,977.1) | $ 13,343.2 | $ (4.1) | ||||||||||||||||||
Net income | 2,999 | 2,941.2 | 2,941.2 | 57.8 | |||||||||||||||||||||||
Other comprehensive income (loss), net of tax | (44) | (45.8) | (45.8) | 1.8 | |||||||||||||||||||||||
Distribution to noncontrolling interest | (75) | (75) | |||||||||||||||||||||||||
Repurchase of common stock, at cost, shares | (12.2) | (4.1) | |||||||||||||||||||||||||
Repurchase of common stock, at cost | $ (3,750) | $ (3,750) | $ (3,750) | $ (1,279.1) | $ (1,279.1) | $ (1,279.1) | |||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (12.2) | (12.2) | (4.1) | (4.1) | |||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | 0 | $ 0 | $ (76.2) | $ (3,673.8) | $ 3,750 | 0 | $ (71) | $ (1,208.1) | $ 1,279.1 | ||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans, shares | 0.1 | ||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 29.1 | $ 0 | 29.1 | 29.1 | |||||||||||||||||||||||
Issuance of common stock under award plan, shares | 0.3 | ||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (48) | $ 0 | 0 | (48) | (48) | ||||||||||||||||||||||
Compensation related to share-based payments | 118.8 | 118.8 | 0 | 118.8 | |||||||||||||||||||||||
Stockholders' Equity, Other | 0.7 | 0.7 | 0.7 | ||||||||||||||||||||||||
Ending balance at Jun. 30, 2020 | 11,289.2 | $ 0 | $ 0.1 | 0 | (181) | 14,466.7 | $ (2,977.1) | 11,308.7 | (19.5) | ||||||||||||||||||
Ending balance, shares at Jun. 30, 2020 | 0 | (182.1) | (23.8) | ||||||||||||||||||||||||
Beginning balance, shares at Mar. 31, 2020 | 0 | (191.1) | (23.8) | ||||||||||||||||||||||||
Beginning balance at Mar. 31, 2020 | 12,536.9 | $ 0 | $ 0.1 | 0.1 | (149.3) | 15,673.1 | $ (2,977.1) | 12,546.9 | (10) | ||||||||||||||||||
Net income | 1,606.5 | 1,542.1 | 1,542.1 | 64.4 | |||||||||||||||||||||||
Other comprehensive income (loss), net of tax | (30.6) | (31.7) | (31.7) | 1.1 | |||||||||||||||||||||||
Repurchase of common stock, at cost, shares | (9) | (4.1) | (12.2) | ||||||||||||||||||||||||
Repurchase of common stock, at cost | (2,808.9) | $ (2,808.9) | (2,808.9) | ||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (9) | (9) | |||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | $ 0 | $ 0 | $ (60.7) | $ (2,748.2) | $ 2,808.9 | $ 0 | |||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans, shares | 0 | ||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 11.1 | $ 0 | 11.1 | 11.1 | |||||||||||||||||||||||
Issuance of common stock under award plan, shares | 0 | ||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (0.3) | $ 0 | 0 | (0.3) | (0.3) | ||||||||||||||||||||||
Compensation related to share-based payments | 49.5 | 49.5 | 0 | 49.5 | |||||||||||||||||||||||
Ending balance at Jun. 30, 2020 | 11,289.2 | $ 0 | $ 0.1 | 0 | (181) | 14,466.7 | $ (2,977.1) | 11,308.7 | (19.5) | ||||||||||||||||||
Ending balance, shares at Jun. 30, 2020 | 0 | (182.1) | (23.8) | ||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2020 | 0 | (176.2) | (23.8) | ||||||||||||||||||||||||
Beginning balance at Dec. 31, 2020 | 10,686.1 | $ 0 | $ 0.1 | 0 | (299) | 13,976.3 | $ (2,977.1) | 10,700.3 | (14.2) | ||||||||||||||||||
Net income | 1,430.1 | 858.7 | 858.7 | 571.4 | |||||||||||||||||||||||
Other comprehensive income (loss), net of tax | 127.8 | 127.2 | 127.2 | 0.6 | |||||||||||||||||||||||
Capital contribution by noncontrolling interest | 5.1 | 5.1 | |||||||||||||||||||||||||
Distribution to noncontrolling interest | (100) | (100) | |||||||||||||||||||||||||
Repurchase of common stock, at cost, shares | (3.8) | ||||||||||||||||||||||||||
Repurchase of common stock, at cost | $ (1,050) | $ (1,050) | $ (1,050) | ||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (3.8) | (3.8) | |||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | $ 0 | $ (163.3) | $ (886.7) | $ 1,050 | |||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans, shares | 0.2 | ||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 33.4 | $ 0 | 33.4 | 33.4 | |||||||||||||||||||||||
Issuance of common stock under award plan, shares | 0.3 | ||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (47.6) | $ 0 | 0 | (47.6) | (47.6) | ||||||||||||||||||||||
Compensation related to share-based payments | 128.4 | 128.4 | 128.4 | ||||||||||||||||||||||||
Stockholders' Equity, Other | 1.5 | 1.5 | 0 | 1.5 | |||||||||||||||||||||||
Ending balance at Jun. 30, 2021 | 11,214.8 | $ 0 | $ 0.1 | 0 | (171.8) | 13,900.7 | $ (2,977.1) | 10,751.9 | 462.9 | ||||||||||||||||||
Ending balance, shares at Jun. 30, 2021 | 0 | (172.9) | (23.8) | ||||||||||||||||||||||||
Beginning balance, shares at Mar. 31, 2021 | 0 | (174.4) | (23.8) | ||||||||||||||||||||||||
Beginning balance at Mar. 31, 2021 | 10,663.2 | $ 0 | $ 0.1 | 0 | (174.3) | 13,833.5 | $ (2,977.1) | 10,682.2 | (19) | ||||||||||||||||||
Net income | 1,025.5 | 448.5 | 448.5 | 577 | |||||||||||||||||||||||
Other comprehensive income (loss), net of tax | 2.4 | 2.5 | 2.5 | (0.1) | |||||||||||||||||||||||
Capital contribution by noncontrolling interest | 5 | 0 | 5 | ||||||||||||||||||||||||
Distribution to noncontrolling interest | (100) | (100) | |||||||||||||||||||||||||
Repurchase of common stock, at cost, shares | 0 | (9) | (1.6) | ||||||||||||||||||||||||
Repurchase of common stock, at cost | $ (450) | $ (450) | $ (450) | ||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (1.6) | (1.6) | |||||||||||||||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | $ 0 | $ 0 | $ (69.5) | $ (380.5) | $ 450 | $ 0 | |||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans, shares | 0.1 | ||||||||||||||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 13.7 | $ 0 | 13.7 | 13.7 | |||||||||||||||||||||||
Issuance of common stock under award plan, shares | 0 | ||||||||||||||||||||||||||
Issuance of common stock under stock award plan | (0.8) | $ 0 | 0 | (0.8) | (0.8) | ||||||||||||||||||||||
Compensation related to share-based payments | 55.8 | 55.8 | 55.8 | ||||||||||||||||||||||||
Stockholders' Equity, Other | 0 | 0 | 0 | 0 | |||||||||||||||||||||||
Ending balance at Jun. 30, 2021 | $ 11,214.8 | $ 0 | $ 0.1 | $ 0 | $ (171.8) | $ 13,900.7 | $ (2,977.1) | $ 10,751.9 | $ 462.9 | ||||||||||||||||||
Ending balance, shares at Jun. 30, 2021 | 0 | (172.9) | (23.8) |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
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. Our core growth areas include multiple sclerosis (MS) and neuroimmunology; Alzheimer’s disease and dementia; neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS); movement disorders, including Parkinson's disease; ophthalmology; and neuropsychiatry. We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging growth areas of immunology; acute neurology; and neuropathic pain. In addition, we commercialize biosimilars of advanced biologics. 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 and relapsing MS; and other potential anti-CD20 therapies 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 our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020 (2020 Form 10-K). 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. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to these unaudited condensed consolidated financial statements (condensed consolidated financial statements). Basis of Presentation In the opinion of management, our condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair statement of our financial statements for interim periods in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The information included in this quarterly report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our 2020 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2020 Form 10-K and updated, as necessary, in this report. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three and six months ended June 30, 2021, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period. We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Consolidation Our condensed 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 in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. These considerations impact the way we account for our existing collaborative relationships and other arrangements. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners. Use of Estimates The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates. The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, 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 condensed consolidated financial statements and there may be changes to those estimates in future periods. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (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 condensed 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 condensed consolidated financial statements and related disclosures. |
Acquisitions
Acquisitions | 6 Months Ended |
Jun. 30, 2021 | |
Business Combinations [Abstract] | |
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 in-process research and development (IPR&D) in our |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Product Revenue Revenue by product is summarized as follows: For the Three Months Ended June 30, 2021 2020 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate* $ 269.1 $ 309.4 $ 578.5 $ 921.7 $ 268.6 $ 1,190.3 Interferon** 257.4 143.0 400.4 345.6 135.8 481.4 TYSABRI 299.8 224.4 524.2 244.1 187.9 432.0 FAMPYRA — 26.1 26.1 — 23.0 23.0 Subtotal: MS product revenue 826.3 702.9 1,529.2 1,511.4 615.3 2,126.7 Spinal Muscular Atrophy: SPINRAZA 149.3 350.4 499.7 210.3 284.3 494.6 Alzheimer's disease: ADUHELM*** 1.6 — 1.6 — — — Biosimilars: BENEPALI — 121.5 121.5 — 106.2 106.2 IMRALDI — 55.6 55.6 — 44.8 44.8 FLIXABI — 25.3 25.3 — 20.6 20.6 Subtotal: Biosimilar product revenue — 202.4 202.4 — 171.6 171.6 Other: FUMADERM — 3.1 3.1 — 2.8 2.8 Total product revenue $ 977.2 $ 1,258.8 $ 2,236.0 $ 1,721.7 $ 1,074.0 $ 2,795.7 *Fumarate includes TECFIDERA and VUMERITY. **Interferon includes AVONEX and PLEGRIDY. *** In June 2021 the U.S. Food and Drug Administration (FDA) granted accelerated approval of ADUHELM, which became commercially available in the United States (U.S.) during the second quarter of 2021. For additional information, please read Note 16, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these condensed consolidated financial statements. For the Six Months Ended June 30, 2021 2020 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate* $ 505.1 $ 626.3 $ 1,131.4 $ 1,699.2 $ 591.9 $ 2,291.1 Interferon** 499.2 301.7 800.9 638.2 309.2 947.4 TYSABRI 573.1 454.4 1,027.5 521.8 432.6 954.4 FAMPYRA — 52.7 52.7 — 51.3 51.3 Subtotal: MS product revenue 1,577.4 1,435.1 3,012.5 2,859.2 1,385.0 4,244.2 Spinal Muscular Atrophy: SPINRAZA 298.0 722.2 1,020.2 445.7 613.9 1,059.6 Alzheimer's disease: ADUHELM*** 1.6 — 1.6 — — — Biosimilars: BENEPALI — 243.2 243.2 — 239.7 239.7 IMRALDI — 113.5 113.5 — 106.4 106.4 FLIXABI — 50.8 50.8 — 44.3 44.3 Subtotal: Biosimilar product revenue — 407.5 407.5 — 390.4 390.4 Other: FUMADERM — 5.9 5.9 — 6.1 6.1 Total product revenue $ 1,877.0 $ 2,570.7 $ 4,447.7 $ 3,304.9 $ 2,395.4 $ 5,700.3 *Fumarate includes TECFIDERA and VUMERITY. **Interferon includes AVONEX and PLEGRIDY. *** 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 16, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these condensed consolidated financial statements. We recognized revenue from two wholesalers accounting for 30.2% and 9.9% of gross product revenue for the three months ended June 30, 2021, and 30.1% and 9.6% of gross product revenue for the six months ended June 30, 2021. We recognized revenue from two wholesalers accounting for 31.7% and 17.9% of gross product revenue for the three months ended June 30, 2020, and 30.8% and 16.2% of gross product revenue for the six months ended June 30, 2020. An analysis of the change in reserves for discounts and allowances is summarized as follows: (In millions) Discounts Contractual Returns Total Balance, December 31, 2020 $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 Current provisions relating to sales in current year 375.6 1,577.0 7.4 1,960.0 Adjustments relating to prior years 1.1 (51.5) 1.6 (48.8) Payments/credits relating to sales in current year (275.5) (906.9) — (1,182.4) Payments/credits relating to sales in prior years (119.2) (676.4) (6.9) (802.5) Balance, June 30, 2021 $ 123.4 $ 1,035.2 $ 43.7 $ 1,202.3 The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows: (In millions) As of June 30, 2021 As of December 31, 2020 Reduction of accounts receivable $ 160.2 $ 195.4 Component of accrued expense and other 1,042.1 1,080.6 Total revenue-related reserves $ 1,202.3 $ 1,276.0 Revenue from Anti-CD20 Therapeutic Programs Revenue from anti-CD20 therapeutic programs are summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Biogen’s share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 178.8 $ 257.5 $ 352.9 $ 598.8 Other revenue from anti-CD20 therapeutic programs 261.2 220.8 476.1 399.9 Total revenue from anti-CD20 therapeutic programs $ 440.0 $ 478.3 $ 829.0 $ 998.7 For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2020 Form 10-K. Other Revenue Other revenue is summarized as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 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 $ 5.5 $ 4.5 $ 9.4 $ 8.2 Other revenue from collaborative and other relationships — 0.5 — 0.7 Other royalty and corporate revenue: Royalty 6.4 7.1 12.6 18.5 Other corporate 87.1 395.5 170.3 489.5 Total other revenue $ 99.0 $ 407.6 $ 192.3 $ 516.9 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | The components of inventory are summarized as follows: (In millions) As of June 30, 2021 As of December 31, 2020 Raw materials $ 328.0 $ 314.9 Work in process 723.0 544.5 Finished goods 203.8 209.2 Total inventory $ 1,254.8 $ 1,068.6 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Intangible Assets Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: As of June 30, 2021 As of December 31, 2020 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,394.3 $ (5,252.7) $ 2,141.6 $ 7,394.3 $ (5,136.5) $ 2,257.8 In-process research and development Indefinite until commercialization 179.4 — 179.4 762.5 — 762.5 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,637.7 $ (5,252.7) $ 2,385.0 $ 8,220.8 $ (5,136.5) $ 3,084.3 For the three and six months ended June 30, 2021, amortization and impairment of acquired intangible assets totaled $604.1 million and $702.2 million, respectively, compared to $61.5 million and $133.0 million, respectively, in the prior year comparative periods. For the three and six months ended June 30, 2021, amortization and impairment of acquired intangible assets reflects a $350.0 million impairment charge related to BIIB111 (timrepigene emparvovec) for the potential treatment of choroideremia and a $191.6 million impairment charge related to BIIB112 (cotoretigene toliparvovec) for the potential treatment of X-linked retinitis pigmentosa. For the six months ended June 30, 2021, amortization and impairment of acquired intangible assets also reflects a $44.3 million impairment charge related to vixotrigine (BIIB074) for the potential treatment of trigeminal neuralgia (TGN). For the three and six months ended June 30, 2020, we had no impairment charges. 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 June 30, 2021, relates to the various IPR&D programs we acquired in connection with our acquisitions of Nightstar Therapeutics plc (NST) and Convergence Pharmaceuticals Holdings Ltd. (Convergence). For additional information on our acquisition of NST, please read Note 2, Acquisitions , to our consolidated financial statements included in our 2020 Form 10-K. 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 diabetic painful neuropathy (DPN), another form of neuropathic pain. We have engaged with the FDA regarding the design of the Phase 3 studies of vixotrigine for the potential treatment of TGN and DPN and now plan to perform an additional clinical trial of vixotrigine before initiating a Phase 3 study of DPN. The performance of this additional clinical trial has 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 June 30, 2021, the carrying value associated with our remaining vixotrigine IPR&D assets was $136.0 million, all of which is related to DPN. 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 did not meet its primary or key secondary endpoints. We reassessed the fair value of the program based on the results of this study and recognized an impairment charge of $350.0 million during the second quarter of 2021, which resulted in a reduction of the IPR&D asset from $365.0 million to $15.0 million. During the second quarter of 2021 we announced that our Phase 2/3 XIRIUS study of BIIB112 did not meet its primary endpoint; however, positive trends were observed across several clinically relevant prespecified secondary endpoints. We reassessed the fair value of the program based on the results of this study and recognized an impairment charge of $191.6 million during the second quarter of 2021, which resulted in a reduction of the IPR&D asset from $220.0 million to $28.4 million . We are evaluating the results of our Phase 3 STAR study of BIIB111 and our Phase 2/3 XIRIUS study of BIIB112, including evaluation of any future development activities we may perform. Our estimates of the current fair values of the BIIB111 and BIIB112 programs were derived by using a discounted, probability-weighted calculation of future estimated cash flows associated with the programs under multiple scenarios, including the possibility that we will cease further development of BIIB111 and/or BIIB112, which could result in further impairment of these assets. The key assumptions in our estimates are the amount and timing of revenue, probability of technical and regulatory success, discount rate and clinical data associated with the programs. In addition, we have entered into third-party manufacturing agreements related to the BIIB111 and BIIB112 programs and we may incur a financial penalty if these agreements are terminated. Should we decide to terminate either or both of these programs and/or manufacturing agreements, we will likely incur impairment charges related to the remaining book value of the applicable program as well as charges up to, in the aggregate, approximately $30.0 million related to our inventory arrangements and other costs associated with discontinuing these programs. 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 June 30, 2021 2021 (remaining six months) $ 110.0 2022 215.0 2023 215.0 2024 225.0 2025 220.0 2026 200.0 Goodwill The following table provides a roll forward of the changes in our goodwill balance: (In millions) As of June 30, 2021 Goodwill, December 31, 2020 $ 5,762.1 Other 1.8 Goodwill, June 30, 2021 $ 5,763.9 As of June 30, 2021, we had no ac |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
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 June 30, 2021 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 1,180.2 $ — $ 1,180.2 $ — Marketable debt securities: Corporate debt securities 1,382.5 — 1,382.5 — Government securities 688.6 — 688.6 — Mortgage and other asset backed securities 152.8 — 152.8 — Marketable equity securities 1,593.5 273.3 1,320.2 — Derivative contracts 20.8 — 20.8 — Plan assets for deferred compensation 33.7 — 33.7 — Total $ 5,052.1 $ 273.3 $ 4,778.8 $ — Liabilities: Derivative contracts $ 72.4 $ — $ 72.4 $ — Contingent consideration obligations 226.3 — — 226.3 Total $ 298.7 $ — $ 72.4 $ 226.3 As of December 31, 2020 (In millions) Total Quoted Prices Significant Other 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 three and six months ended June 30, 2021. In addition, there have been no changes in valuation techniques during the three and six months ended June 30, 2021. 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 June 30, 2021. For additional information on our investments in Sangamo, Denali and Sage common stock, please read Note 7, Financial Instruments, to these condensed 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 Note 1, Summary of Significant Accounting Policies - Fair Value Measurements, to our consolidated financial statements included in our 2020 Form 10-K. The following tables summarize the significant unobservable inputs in the fair value measurement of our contingent consideration obligations as of June 30, 2021 and December 31, 2020: As of June 30, 2021 (In millions) Fair Value Valuation Technique Unobservable Input(s) Range Weighted Average Liabilities: Contingent consideration obligation $ 226.3 Discounted cash flow Discount rate 0.68% 0.68% Expected timing of achievement of development milestones 2022 to 2027 — As of December 31, 2020 (In millions) Fair Value Valuation Technique Unobservable Input(s) 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 21.7% to certain probability, to the valuation models to estimate the fair values of our contingent consideration obligations. Nonrecurring Fair Value Measurements In addition to assets and liabilities that are recorded at fair value on a recurring basis, we record assets and liabilities at fair value on a nonrecurring basis as required by U.S. GAAP. Generally, assets are recorded at fair value on a nonrecurring basis as a result of impairment charges. The gains or losses on assets measured at fair value on a nonrecurring basis, are summarized as follows: As of June 30, 2021 (In millions) Beginning Book Value Impairment Ending Book Value BIIB111 intangible asset $ 365.0 $ (350.0) $ 15.0 BIIB112 intangible asset 220.0 (191.6) 28.4 For the three and six months ended June 30, 2021, we recorded a partial impairment charge of $350.0 million related to BIIB111 and $191.6 million related to BIIB112. For additional information, please read Note 5, Intangible Assets and Goodwill , to these condensed consolidated financial statements. Debt Instruments The fair and carrying values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of June 30, 2021 As of December 31, 2020 (In millions) Fair Carrying Fair Carrying 3.625% Senior Notes due September 15, 2022 $ 1,037.8 $ 998.5 $ 1,054.1 $ 997.9 4.050% Senior Notes due September 15, 2025 1,945.3 1,742.0 2,003.1 1,741.2 2.250% Senior Notes due May 1, 2030 1,503.3 1,491.6 1,557.2 1,491.1 5.200% Senior Notes due September 15, 2045 (1) 1,483.1 1,099.7 2,365.1 1,723.4 3.150% Senior Notes due May 1, 2050 1,471.1 1,472.9 1,536.4 1,472.6 3.250% Senior Notes due February 15, 2051 (1) 700.1 464.5 — — Total $ 8,140.7 $ 7,269.2 $ 8,515.9 $ 7,426.2 (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 10, Indebtedness , to these condensed 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 issued on April 30, 2020 and September 15, 2015, please read Note 12, Indebtedness, to our consolidated financial statements included in our 2020 Form 10-K. Contingent Consideration Obligations In connection with our acquisitions of Convergence and Biogen International Neuroscience GmbH, 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: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Fair value, beginning of period $ 226.0 $ 341.6 $ 259.8 $ 346.1 Changes in fair value 0.3 10.0 (33.5) 5.5 Fair value, end of period $ 226.3 $ 351.6 $ 226.3 $ 351.6 As of June 30, 2021 and December 31, 2020, approximately $226.3 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 condensed consolidated balance sheets with the remaining balance reflected as a component of accrued expense and other. For the three and six months ended June 30, 2021, changes in the fair value of our contingent consideration obligations were primarily due to delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs. For the three and six months ended June 30, 2020, changes in the fair value of our contingent consideration obligations were primarily due to changes in the interest rates used to revalue our contingent consideration liabilities, changes in the probability and the expected timing of the achievement of certain remaining developmental milestones and the passage of time. |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
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 condensed consolidated balance sheets: (In millions) As of June 30, 2021 As of December 31, 2020 Commercial paper $ 130.0 $ 61.1 Overnight reverse repurchase agreements 297.8 37.4 Money market funds 725.9 505.1 Short-term debt securities 26.5 23.3 Total $ 1,180.2 $ 626.9 The carrying values of our commercial paper, including accrued interest, overnight reverse repurchase agreements, money market funds and 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 condensed consolidated statements of income. The following tables summarize our marketable debt and equity securities, classified as available for sale: As of June 30, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 1,072.2 $ 0.3 $ (0.4) $ 1,072.1 Non-current 309.9 0.6 (0.1) 310.4 Government securities: Current 236.5 0.1 — 236.6 Non-current 452.1 0.2 (0.3) 452.0 Mortgage and other asset backed securities: Current 0.2 — — 0.2 Non-current 152.7 0.2 (0.3) 152.6 Total marketable debt securities $ 2,223.6 $ 1.4 $ (1.1) $ 2,223.9 Marketable equity securities Marketable equity securities, non-current $ 1,168.9 $ 607.6 $ (183.0) $ 1,593.5 Total marketable equity securities $ 1,168.9 $ 607.6 $ (183.0) $ 1,593.5 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 June 30, 2021 As of December 31, 2020 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,308.8 $ 1,308.9 $ 1,278.9 $ 1,278.6 Due after one year through five years 870.9 870.5 722.6 721.3 Due after five years 44.2 44.2 49.5 49.2 Total marketable debt securities $ 2,223.9 $ 2,223.6 $ 2,051.0 $ 2,049.1 The average maturity of our marketable debt securities available-for-sale as of June 30, 2021 and December 31, 2020, was approximately 13 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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Proceeds from maturities and sales $ 633.5 $ 1,490.6 $ 1,452.7 $ 3,879.9 Realized gains 0.1 6.1 0.3 11.8 Realized losses (0.5) (5.2) (1.2) (24.3) Strategic Investments As of June 30, 2021 and December 31, 2020, our strategic investment portfolio was comprised of investments totaling $1,647.8 million and $2,024.6 million, respectively, which are included in investments and other assets in our condensed 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 6, Fair Value Measurements, to these condensed consolidated financial statements, venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities. The increase in our strategic investment portfolio for the three months ended June 30, 2021, was primarily due to an increase in the fair value of our investment in Denali, partially offset by decreases in the fair values of our investments in Ionis Pharmaceuticals, Inc. (Ionis), Sage and Sangamo common stock. The decrease in our strategic investment portfolio for the six months ended June 30, 2021, was primarily due to decreases in the fair values of our investments in Ionis, Sage, Denali 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 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 16, Collaborative and Other Relationships , to these condensed 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 approximately $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 arrangement with Denali, please read Note 16, Collaborative and Other Relationships, to these condensed 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 June 30, 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 arrangement with Sangamo, please read Note 16, Collaborative and Other Relationships, to these condensed consolidated financial statements. |
Derivative Instruments
Derivative Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
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 June 30, 2021 and December 31, 2020, had durations of 1 to 18 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 tables 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 condensed 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) As of June 30, 2021 As of December 31, 2020 Euro $ 2,269.2 $ 2,979.1 British pound 128.6 250.6 Swiss franc 109.9 — Japanese yen 62.5 — Canadian dollar 53.3 — Total foreign currency forward contracts $ 2,623.5 $ 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 as of June 30, 2021, reflected aggregate net unrealized losses of $53.7 million, composed of gross unrealized losses of approximately $67.0 million and gross unrealized gains of approximately $13.3 million, compared to aggregate net unrealized losses of $212.5 million as of December 31, 2020. We expect the net unrealized losses of $53.7 million to be settled over the next 18 months, of which $58.2 million of unrealized losses 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 June 30, 2021 and December 31, 2020, credit risk did not materially change the fair value of our foreign currency forward contracts. The following tables summarize the effect of foreign currency forward contracts designated as hedging instruments in our condensed consolidated statements of income: For the Three Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Revenue $ (30.7) $ 23.7 Revenue $ (0.8) $ (1.6) Operating expense 0.4 — Operating expense (0.3) (0.2) For the Six Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Revenue $ (53.8) $ 50.7 Revenue $ (3.8) $ 7.7 Operating expense — (0.1) Operating expense (0.4) (1.1) 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 condensed consolidated statements of income during the second quarter of 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 the 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 June 30, 2021, had a remaining duration of four 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 $0.1 million and net losses of $21.2 million as of June 30, 2021 and December 31, 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 condensed 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 gains of $0.1 million and $0.2 million as of June 30, 2021 and December 31, 2020, respectively. The following tables summarize the effect of our net investment hedge in our condensed consolidated financial statements: For the Three Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Location 2021 2020 Gains (losses) on net investment hedge $ (2.5) $ (8.8) Gains (losses) on net investment hedge $ 0.3 $ 3.5 Other income (expense) $ — $ 0.8 For the Six Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Location 2021 2020 Gains (losses) on net investment hedge $ 21.3 $ 15.4 Gains (losses) on net investment hedge $ (1.1) $ 3.2 Other income (expense) $ 0.1 $ 1.7 For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to these condensed 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 $1,205.1 million and $1,158.0 million as of June 30, 2021 and December 31, 2020, respectively. Net gains of $4.8 million and net losses of $12.6 million related to these contracts were recorded as a component of other income (expense), net for the three and six months ended June 30, 2021, respectively, compared to net gains of $8.3 million and $5.9 million, respectively, in the prior year comparative periods. 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 condensed 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 condensed consolidated balance sheets of our outstanding derivative instruments, including those designated as hedging instruments: (In millions) Balance Sheet Location As of June 30, 2021 As of December 31, 2020 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 9.7 $ — Investments and other assets 7.4 — Liability derivative instruments Accrued expense and other 55.2 157.1 Other long-term liabilities — 35.7 Net Investment Hedging Instruments: Asset derivative instruments Other current assets 0.4 — Liability derivative instruments Accrued expense and other — 19.7 Other Derivative Instruments: Asset derivative instruments Other current assets 3.3 20.5 Liability derivative instruments Accrued expense and other 17.2 4.7 |
Property, Plant and Equipment P
Property, Plant and Equipment Property, Plant and Equipment | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Accumulated depreciation on property, plant and equipment was $1,880.3 million and $1,782.3 million as of June 30, 2021 and December 31, 2020, respectively. For the three and six months ended June 30, 2021, depreciation expense totaled $54.7 million and $103.5 million, respectively, compared to $51.3 million and $99.7 million, respectively, in the prior year comparative periods. 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 related to a large-scale biologics manufacturing facility, 290,000 square feet of warehouse, utilities and support |
Indebtedness (Notes)
Indebtedness (Notes) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Indebtedness | Indebtedness 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 condensed consolidated statements of income for the six months ended June 30, 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 condensed consolidated statements of income for the six months ended June 30, 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. 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 condensed consolidated balance sheet. For additional information on our 2020 Senior Notes, please read Note 12, Indebtedness , to our consolidated financial statements included in our 2020 Form 10-K. 2.90% Senior Notes due September 15, 2020 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 our 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 during the second quarter of 2020. This charge, which was recognized in interest expense in other income (expense), net in our condensed consolidated statements of income and 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 swap contracts, please read Note 8, Derivative Instruments, to these condensed consolidated financial statements. |
Equity
Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Equity | 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 1.6 million and 3.8 million shares of our common stock at a cost of approximately $450.0 million and $1.1 billion during the three and six months ended June 30, 2021, respectively. Approximately $3.6 billion remained available under our 2020 Share Repurchase Program as of June 30, 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 9.0 million and 12.2 million shares of our common stock at a cost of approximately $2.8 billion and $3.7 billion during the three and six months ended June 30, 2020, respectively. 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 shares of our common stock at a cost of approximately $1.3 billion during the six months ended June 30, 2020. Accumulated Other Comprehensive Income (Loss) The following tables summarize the changes in accumulated other comprehensive income (loss), net of tax by component: (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 (2.0) 90.2 20.2 2.4 (32.6) 78.2 Amounts reclassified from accumulated other comprehensive income (loss) 0.7 48.4 (0.1) — — 49.0 Net current period other comprehensive income (loss) (1.3) 138.6 20.1 2.4 (32.6) 127.2 Balance, June 30, 2021 $ 0.1 $ (40.4) $ 11.6 $ (63.9) $ (79.2) $ (171.8) (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 (9.0) 33.2 18.6 0.9 (47.0) (3.3) Amounts reclassified from accumulated other comprehensive income (loss) 9.9 (50.6) (1.8) — — (42.5) Net current period other comprehensive income (loss) 0.9 (17.4) 16.8 0.9 (47.0) (45.8) Balance, June 30, 2020 $ 5.1 $ (9.6) $ 41.9 $ (31.9) $ (186.5) $ (181.0) The following table summarizes the amounts reclassified from accumulated other comprehensive income (loss): (In millions) Income Statement Location Amounts Reclassified from Accumulated Other Comprehensive Income (Loss) For the Three Months Ended June 30, For the Six Months Ended June 30, 2021 2020 2021 2020 Gains (losses) on securities available for sale Other income (expense) $ (0.4) $ 3.9 $ (0.9) $ (12.5) Income tax benefit (expense) 0.1 (0.8) 0.2 2.6 Gains (losses) on cash flow hedges Revenue (30.7) 23.7 (53.8) 50.7 Operating expense 0.4 — — (0.1) Other income (expense) (0.1) 0.1 0.1 0.2 Income tax benefit (expense) 3.0 (0.1) 5.3 (0.2) Gains (losses) on net investment hedge Other income (expense) 0.1 0.9 0.1 1.8 Total reclassifications, net of tax $ (27.6) $ 27.7 $ (49.0) $ 42.5 |
Earnings per Share
Earnings per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Earnings per Share | Basic and diluted shares outstanding used in our earnings per share calculation are calculated as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Numerator: Net income attributable to Biogen Inc. $ 448.5 $ 1,542.1 $ 858.7 $ 2,941.2 Denominator: Weighted average number of common shares outstanding 149.7 160.6 150.8 166.7 Effect of dilutive securities: Time-vested restricted stock units 0.2 0.1 0.2 0.1 Market stock units 0.1 0.1 0.1 0.1 Performance stock units settled in stock 0.1 0.1 0.1 0.1 Dilutive potential common shares 0.4 0.3 0.4 0.3 Shares used in calculating diluted earnings per share 150.1 160.9 151.2 167.0 Amounts excluded from the calculation of net income per diluted share because their effects were anti-dilutive were insignificant. |
Share-based Payments
Share-based Payments | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Payments | Share-based Compensation Expense The following table summarizes share-based compensation expense included in our condensed consolidated statements of income: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Research and development $ 19.1 $ 15.2 $ 52.7 $ 48.5 Selling, general and administrative 40.3 30.3 85.2 73.4 Subtotal 59.4 45.5 137.9 121.9 Capitalized share-based compensation costs (1.7) (1.5) (4.3) (3.0) Share-based compensation expense included in total cost and expense 57.7 44.0 133.6 118.9 Income tax effect (10.9) (7.0) (24.9) (20.3) Share-based compensation expense included in net income attributable to Biogen Inc. $ 46.8 $ 37.0 $ 108.7 $ 98.6 The following table summarizes share-based compensation expense associated with each of our share-based compensation programs: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Market stock units $ 9.3 $ 7.4 $ 25.8 $ 26.5 Time-vested restricted stock units 40.4 34.5 83.2 72.0 Cash settled performance units — (0.1) — (1.7) Performance units — — — (0.1) Performance stock units settled in stock 3.0 2.1 9.3 12.4 Performance stock units settled in cash 3.4 (4.0) 9.4 4.9 Employee stock purchase plan 3.3 5.6 10.2 7.9 Subtotal 59.4 45.5 137.9 121.9 Capitalized share-based compensation costs (1.7) (1.5) (4.3) (3.0) Share-based compensation expense included in total cost and expense $ 57.7 $ 44.0 $ 133.6 $ 118.9 We estimate the fair value of our obligations associated with our performance stock units settled in cash at the end of each reporting period through expected settlement. Cumulative adjustments to these obligations are recognized each quarter to reflect changes in the stock price and estimated outcome of the performance-related conditions. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | TECFIDERA In June 2020 and September 2020 judgments were entered in favor of the defendants in the 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, in West Virginia and Delaware. We have appealed the judgments in both actions. For additional information, please read Note 18, Litigation, to these condensed 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 have a substantial negative impact on our TECFIDERA revenue for as long as there is generic competition. 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 value of certain deferred tax assets by approximately $1.7 billion and reduced the value of deferred tax liabilities associated with global intangible low-taxed income (GILTI) and tax credits by approximately $1.6 billion. We continue to assess the realizability of these deferred tax assets and have recorded an increase in these deferred tax assets by approximately $92.6 million and an increase in these deferred tax liabilities by approximately $88.7 million for the three and six months ended June 30, 2021. Tax Rate A reconciliation between the U.S. federal statutory tax rate and our effective tax rate is summarized as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, 2021 2020 2021 2020 Statutory rate 21.0 % 21.0 % 21.0 % 21.0 % State taxes 1.3 0.4 1.1 0.5 Taxes on foreign earnings (7.7) (3.4) (9.1) (3.7) Tax credits (2.9) (1.0) (3.3) (1.0) Purchased intangible assets (0.8) 0.2 (0.1) 0.2 TECFIDERA impairment — 2.7 — 1.5 GILTI 1.5 1.5 1.3 1.1 Neurimmune tax impacts (83.1) (0.2) (46.3) (0.2) Other 0.4 0.7 0.6 0.4 Effective tax rate (70.3) % 21.9 % (34.8) % 19.8 % Changes in Tax Rate For the three and six months ended June 30, 2021, compared to the same periods in 2020, the decreases in our effective tax rate were primarily due to a current year deferred tax benefit in Switzerland resulting from the accelerated approval of ADUHELM by the FDA in the U.S. We recorded a net deferred tax asset of approximately $500.0 million. The net deferred tax asset is comprised of approximately $875.0 million of gross deferred tax asset, reduced by approximately $375.0 million of unrecognized tax benefit discussed below. The deferred tax benefit relates to Neurimmune SubOne AG's (Neurimmune) 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 condensed 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 17, Investments in Variable Interest Entities , to these condensed consolidated financial statements. In addition, the decreases in our effective tax rate, excluding the impact of the Neurimmune deferred tax asset discussed above, were primarily due to the change in the territorial mix of our profitability, which included the effect of generic competition for TECFIDERA in the U.S. market. Our 2020 effective tax rate 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., as discussed above. For the six months ended June 30, 2021, our 2021 effective tax rate reflects a decrease related to the non-cash tax effects of changes in the value of our equity investments, where we recorded a reduction of value in 2021. The tax effects of this change in value of our equity investments were recorded discretely, as the changes in value of equity investments cannot be forecasted. Accounting for Uncertainty in Income Taxes 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. As of June 30, 2021, we increased our gross unrecognized tax benefits by approximately $375.0 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 discussed above, and not as a separate liability on our condensed consolidated balance sheet. 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 $20.0 million 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 | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Other Consolidated Financial Statement Detail | Other Income (Expense), Net Components of other income (expense), net, are summarized as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Interest income $ 2.7 $ 7.6 $ 5.6 $ 32.0 Interest expense (56.4) (66.0) (121.1) (110.3) Gain (loss) on investments, net 153.9 106.8 (282.7) 29.5 Foreign exchange gains (losses), net (0.8) 10.4 (9.4) (8.5) Other, net (3.0) 4.2 (2.9) (0.2) Total other income (expense), net $ 96.4 $ 63.0 $ (410.5) $ (57.5) 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. For the three months ended June 30, 2021, net unrealized gains and realized gains on our holdings in equity securities were approximately $153.9 million and $0.4 million, respectively, compared to net unrealized gains and realized gains (losses) of $102.9 million and zero, respectively, in the prior year comparative period. The net unrealized gains recognized during the three months ended June 30, 2021, primarily reflect an increase in the fair value of Denali common stock of approximately $263.0 million, partially offset by decreases in the fair value of Ionis, Sangamo and Sage common stock of approximately $105.8 million. For the six months ended June 30, 2021, net unrealized losses and realized gains on our holdings in equity securities were approximately $288.4 million and $6.6 million, respectively, compared to net unrealized gains and realized gains (losses) of $42.0 million and zero, respectively, in the prior year comparative period. The net unrealized losses recognized during the six months ended June 30, 2021, primarily reflect decreases in the fair value of Ionis, Sangamo, Denali and Sage common stock of approximately $284.8 million. The following table summarizes our gain (loss) on investments, net that relates to our equity securities held as of June 30, 2021 and 2020: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Net gains (losses) recognized during the period on equity securities $ 154.3 $ 102.9 $ (281.8) $ 42.0 Less: Net gains (losses) realized during the period on equity securities 0.4 — 6.6 — Unrealized gains (losses) recognized during the period on equity securities $ 153.9 $ 102.9 $ (288.4) $ 42.0 Accrued Expense and Other Accrued expense and other consists of the following: (In millions) As of June 30, 2021 As of December 31, 2020 Revenue-related reserves for discounts and allowances $ 1,042.1 $ 1,080.6 Collaboration expense 383.4 389.9 Employee compensation and benefits 242.5 333.8 Royalties and licensing fees 240.3 218.5 Derivative liabilities 72.4 181.5 Current portion of contingent consideration obligations — 149.6 Other 760.3 791.4 Total accrued expense and other $ 2,741.0 $ 3,145.3 Other Long-term Liabilities Other long-term liabilities were $1,356.4 million and $1,329.6 million as of June 30, 2021 and December 31, 2020, respectively, and included accrued income taxes totaling $652.7 million and $709.9 million, respectively. |
Collaborative and Other Relatio
Collaborative and Other Relationships | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative and Other Relationships | Eisai Co., Ltd. Lecanemab Collaboration We have a collaboration agreement with Eisai Co., Ltd. (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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 62.2 $ 33.9 $ 117.7 $ 77.5 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our condensed consolidated statements of income 31.1 17.0 58.8 38.7 Total sales and marketing expense incurred by the Lecanemab Collaboration 4.3 1.4 10.0 6.3 Biogen's share of lecanemab and elenbecestat sales and marketing expense reflected in selling, general and administrative expense in our condensed consolidated statements of income 2.1 0.7 5.0 3.2 For additional information on our Lecanemab Collaboration, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in our 2020 Form 10-K. 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 Biologics License Application (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 three and six months ended June 30, 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. 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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total ADUHELM development expense $ 42.1 $ 35.9 $ 89.1 $ 55.0 Biogen's share of ADUHELM development expense reflected in research and development expense in our condensed consolidated statements of income 23.2 19.7 49.0 30.3 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement 125.6 45.2 237.4 67.9 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit sharing in our condensed consolidated statements of income 67.6 25.2 127.9 37.5 Total ADUHELM collaboration third party milestones 100.0 75.0 100.0 75.0 Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit sharing in our condensed consolidated statements of income 45.0 33.8 45.0 33.8 C o-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 condensed consolidated statements of income. We also record the related cost of revenue and sales and marketing expense in our condensed 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 sharing in our condensed consolidated statements of income. For the three and six months ended June 30, 2021, we recognized net profit-sharing income of $40.1 million to reflect Eisai's 45.0% sharing of the net collaboration losses in the U.S. For additional information on the ADUHELM Collaboration Agreement, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2020 Form 10-K. 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. 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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total UCB collaboration development expense $ 16.1 $ 6.5 $ 33.0 $ 25.5 Biogen's share of UCB development expense reflected in research and development expense in our condensed consolidated statements of income 8.1 3.2 16.5 12.7 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 condensed 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 condensed 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. 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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total Sage collaboration development expense $ 54.0 $ — $ 93.8 $ — Biogen's share of Sage development expense reflected in research and development expense in our condensed consolidated statements of income 27.0 — 46.9 — Total Sage sales and marketing expense incurred by the collaboration 10.5 — 15.8 — Biogen's share of Sage sales and marketing expense reflected in selling, general and administrative expense in our condensed consolidated statements of income 5.2 — 7.9 — Denali Therapeutics Inc. In August 2020 we entered into a collaboration and license agreement with Denali to co-develop and co-commercialize Denali's small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson's disease. In addition to the LRRK2 program, we also have an exclusive option to license two preclinical programs from Denali’s Transport Vehicle platform, including its Antibody Transport Vehicle (ATV): ATV enabled anti-amyloid beta program and a second program utilizing its Transport Vehicle technology. Further, we have the right of first negotiation on two additional Transport Vehicle-enabled therapeutics, should Denali decide to seek a collaboration for such programs. As part of this collaboration we purchased approximately $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. We recorded an asset in investments and other assets in our condensed consolidated balance sheets to reflect the initial fair value of the Denali common stock acquired and a charge of approximately $41.3 million to research and development expense in our condensed consolidated statements of income to reflect the premium paid for the Denali common stock. We also made an upfront payment of $560.0 million that was recorded as research and development expense. We may also pay Denali development and commercial milestone payments that could total up to approximately $1.1 billion if the milestones related to the LRRK2 program are achieved. Under this collaboration, both companies share responsibility and costs for global development based on specified percentages and we are responsible for commercialization and may pay Denali potential tiered royalties. A summary of development expense related to this collaboration is as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total Denali collaboration development expense $ 10.4 $ — $ 18.7 $ — Biogen's share of Denali development expense reflected in research and development expense in our condensed consolidated statements of income 6.2 — 11.2 — Sangamo Therapeutics, Inc. In February 2020 we entered into a collaboration and license agreement with Sangamo to develop and commercialize ST-501 for tauopathies, including Alzheimer's disease; ST-502 for synucleinopathies, including Parkinson’s disease; a third neuromuscular disease target; and up to nine additional neurological disease targets to be identified and selected within a five-year period. The companies are leveraging Sangamo’s proprietary zinc finger protein technology delivered via adeno-associated virus with the aim to modulate the expression of key genes involved in neurological diseases. In connection with the closing of this transaction in April 2020 we purchased $225.0 million of Sangamo common stock, or approximately 24 million shares at approximately $9.21 per share, of which approximately 12 million shares remain subject to transfer restrictions as of June 30, 2021 . We recorded an asset in investments and other assets in our condensed consolidated balance sheets to reflect the initial fair value of the Sangamo common stock acquired and a charge of approximately $83.0 million to research and development expense in our condensed consolidated statements of income to reflect the premium paid for the Sangamo common stock. We also made an upfront payment of $125.0 million that was recorded as research and development expense. We may also pay Sangamo research, development, regulatory and commercial milestone payments that could total up to approximately $2.4 billion if we select all of the targets allowed under this collaboration and all the specified milestones set forth in this collaboration are achieved. Of this amount, up to $80.0 million relates to the selection of targets, $1.9 billion relates to the achievement of specified research, clinical development, regulatory and first commercial sale milestones and $380.0 million relates to the achievement of specified sales-based milestones if annual worldwide net sales of licensed products reach specified levels. In addition, we may pay Sangamo tiered royalties on potential net commercial sales of any products developed under this collaboration in the high single digit to double digit sub-teen percentages. Other Research and Discovery Arrangements These arrangements may include the potential for future milestone payments based on the achievement of certain clinical and commercial development payable over a period of several years. Other For the three and six months ended June 30, 2021 , we record ed $77.2 million as research and development expense in our condensed consolidated statements of income related to other research and discovery related arrangements, compared to $9.6 million in the prior year comparative periods . Samsung Bioepis Co., Ltd. Joint Venture Agreement In February 2012 we entered into a joint venture agreement with Samsung BioLogics establishing an entity, Samsung Bioepis, to develop, manufacture and market biosimilar products. 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. As of June 30, 2021, our ownership percentage remained at approximately 49.9%. We recognize our share of the results of operations related to our investment in Samsung Bioepis under the equity method of accounting one quarter in arrears when the results of the entity become available, which is reflected as equity in (income) loss of investee, net of tax in our condensed consolidated statements of income. During 2015, as our share of losses exceeded the carrying value of our initial investment, we suspended recognizing additional losses. In the first quarter of 2019 we restarted recognizing our share of Samsung Bioepis' income (losses), and we began recognizing amortization on certain basis differences resulting from our November 2018 investment. Upon investment, the equity method of accounting requires us to identify and allocate differences between the fair value of our investment and the carrying value of our interest in the underlying net assets of the investee. These basis differences are amortized over their economic life. The total basis difference was approximately $675.0 million and relates to inventory, developed technology, IPR&D and deferred tax balances. The basis differences related to inventory were amortized, net of tax, over their estimated useful lives of 1.5 years, and the basis differences related to developed technology and IPR&D for marketed products will be amortized, net of tax, over their estimated useful lives of 15 years. Certain officers and affiliates of our joint venture partner, Samsung BioLogics, are currently subject to ongoing criminal proceedings that we continue to monitor. While these proceedings could impact the operations of Samsung Bioepis and its business, we have assessed the value of our investment in Samsung Bioepis and continue to believe that the fair value of the investment is in excess of its net book value. For the three and six months ended June 30, 2021, we recognized net income on our investment of $34.3 million and $16.1 million, respectively, reflecting our share of Samsung Bioepis' operating results and amortization of basis differences, net of tax, compared to net income on our investment of $15.1 million and $0.4 million, respectively, in the prior year comparative periods. Net income on our investment for the three and six months ended June 30, 2021, reflects a $31.2 million benefit related to the release of a valuation allowance on deferred tax assets associated with Samsung Bioepis. The valuation allowance was released in the current period based on a consideration of the positive and negative evidence, including the historic earnings of Samsung Bioepis. As of June 30, 2021 and December 31, 2020, the carrying value of our investment in Samsung Bioepis totaled 691.6 billion South Korean won ($612.8 million) and 673.8 billion South Korean won ($620.2 million), respectively, which is classified as a component of investments and other assets in our condensed consolidated balance sheets. 2019 Development and Commercialization Agreement In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, SB11, a proposed ranibizumab biosimilar referencing LUCENTIS, and SB15, a proposed aflibercept biosimilar referencing EYLEA, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia. Samsung Bioepis will be responsible for development and will supply both products to us. In connection with this transaction, we made an upfront payment of $100.0 million to Samsung Bioepis in January 2020, of which $63.0 million was recorded as research and development expense in 2019 and $37.0 million was recorded as an intangible asset in 2019. Additionally, during the third quarter of 2020, we paid Samsung Bioepis a $15.0 million development milestone, which was included in research and development expense in our condensed consolidated statements of income. We may pay Samsung Bioepis up to $195.0 million in additional development, regulatory and sales-based milestones. We also acquired an option to extend the term of our 2013 commercial agreement for BENEPALI, IMRALDI and FLIXABI by an additional five years, subject to payment of an option exercise fee of $60.0 million, and obtained an option to acquire exclusive rights to commercialize these products in China. 2013 Commercial Agreement We reflect revenue on sales of BENEPALI, IMRALDI and FLIXABI to third parties in product revenue, net in our condensed consolidated statements of income and record the related cost of revenue and sales and marketing expense in our condensed consolidated statements of income to their respective line items when these costs are incurred. We share 50.0% of the profit or loss related to our commercial agreement with Samsung Bioepis, which is recognized in collaboration profit sharing in our condensed consolidated statements of income. For the three and six months ended June 30, 2021, we recognized net profit-sharing expense of $69.9 million and $138.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits, compared to a net profit-sharing expense of $55.4 million and $127.2 million, respectively, in the prior year comparative periods. As discussed above, we have an option to extend this agreement by an additional five years, subject to the payment of an option exercise fee of $60.0 million. Other Services Simultaneous with the formation of Samsung Bioepis, we also entered into a technical development services agreement, a manufacturing agreement and a license agreement with Samsung Bioepis. Revenue related to these services are reflected in revenue from collaborative and other relationships as a component of other revenue in our condensed consolidated statements of income. Amounts payable to Samsung Bioepis related to the agreements discussed above were $158.7 million and $99.0 million as of June 30, 2021 and December 31, 2020, respectively. For additional information on our collaboration arrangements with Samsung Bioepis and our other significant collaboration arrangements, please read Note 18, Collaborative and Other Relationships, |
Investments in Variable Interes
Investments in Variable Interest Entities | 6 Months Ended |
Jun. 30, 2021 | |
Investments in Variable Interest Entities [Abstract] | |
Investments in Variable Interest Entities | Consolidated Variable Interest Entities Our condensed 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 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 condensed 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 sharing in our condensed 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 condensed 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 sharing in our condensed 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 European Union (E.U.) and $50.0 million if launched in Japan. Milestones payable to Neurimmune are shared expenses under the ADUHELM Collaboration Agreement with Eisai. Research and development costs for which we reimburse Neurimmune are reflected in research and development expense in our condensed consolidated statements of income. During the three and six months ended June 30, 2021 and 2020, amounts reimbursed were immaterial. During the three and six months ended June 30, 2021, we recorded a net deferred tax asset of approximately $500.0 million. The net deferred tax asset is comprised of approximately $875.0 million of gross deferred tax asset, reduced by approximately $375.0 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, with an equal and offsetting amount assigned to net income (loss) attributable to noncontrolling interests, net of tax in our condensed 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 condensed 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 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 16, Collaborative and Other Relationships, to these condensed 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 June 30, 2021 and December 31, 2020, the carrying value of our investments in certain biotechnology companies representing potential unconsolidated variable interest entities totaled $15.2 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 condensed consolidated statements of income as they are incurred. We have provided no financing to these variable interest entities other than previously contractually required amounts. For additional information on our investments in Neurimmune and other variable interest entities, please read Note 19, Investments in Variable Interest Entities, to our consolidated financial statements included in our 2020 Form 10-K. |
Litigation
Litigation | 6 Months Ended |
Jun. 30, 2021 | |
Loss Contingency, Information about Litigation Matters [Abstract] | |
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 our consolidated financial statements included in our 2020 Form 10-K. 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, in the U.S. District Court for the Central District of California and transferred to the U.S. District Court for the District of Massachusetts in March 2021. 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 an award of damages, interest and attorneys' fees. 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 the action, 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, alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis UK Limited that Biogen has commercialized in Europe, infringes the French counterpart of European Patent No. 3 148 510 (the '510 Patent), which was issued in June 2018 and expires in May 2035. No hearing has been scheduled. In October 2018 Fresenius Kabi commenced preliminary injunction proceedings against Biogen (Denmark) Manufacturing ApS and Biogen Denmark A/S in Denmark's Maritime and Commercial High Court alleging infringement of Danish Utility Models. The request for preliminary injunction was denied in June 2019 and the decision was affirmed on appeal in February 2021. In July 2020 the Danish Patent Board of Appeal revoked the Danish Utility Models that were the subject of Fresenius Kabi’s October 2018 request for a preliminary injunction and Fresenius Kabi has appealed those revocations to Denmark’s Maritime and Commercial High Court. No hearing has been scheduled in that appeal. In June 2020 Fresenius Kabi commenced preliminary injunction proceedings against Biogen (Denmark) Manufacturing ApS and Biogen (Denmark) A/S in Denmark’s Maritime and Commercial High Court alleging infringement of another Danish Utility Model. A hearing was held in May and June 2021. In November 2018 Fresenius Kabi commenced infringement proceedings for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court relating to the German counterpart of the ‘510 Patent. The case has been stayed pending proceedings at the European Patent Office (EPO). In July 2019 Gedeon Richter PLC commenced proceedings against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of the German counterpart of European Patent No. 3 212 667, which was issued in September 2018 and expires in October 2035, and seeking damages and injunctive relief. A hearing has been set for November 2021. 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 single and treble damages, civil penalties, interest, attorneys’ fees and costs. No trial date has been set. The U.S. has not made an intervention decision. An estimate of the possible loss or range of 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 in the Joint Venture Agreement executed on December 6, 2011, as amended, by and between Biogen and Samsung BioLogics (the Joint Venture Agreement). Samsung BioLogics has asserted counterclaims, including breach of the Joint Venture Agreement, and seeks declaratory relief and unspecified damages. An estimate of the possible loss or range of loss cannot be made at this time. We expect a hearing in the fourth quarter of 2021. Other Matters 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 April 2020 Mylan filed an appeal in the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit), which is pending. 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). On June 22, 2020, the West Virginia Court entered judgment for Mylan that the asserted claims of the ‘514 Patent are invalid for lack of written description. We appealed the judgment to the Federal Circuit and the appeal is pending. 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. We have appealed the judgments and the appeal is pending. Hatch-Waxman Act Litigation relating to VUMERITY Orange-Book Listed Patents In March 2021 Biogen and Alkermes Pharma Ireland Limited filed patent infringement proceedings relating to VUMERITY Orange-Book listed patents (U.S. Patent Nos. 8,699,281, 9,090,558 and 10,080,733) pursuant to the Hatch-Waxman Act in the Delaware Court against Teva Pharmaceuticals Development, Inc. A trial date has not yet been set. European Patent Office Oppositions In 2016 the EPO revoked 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. We have appealed to the Technical Boards of Appeal of the EPO and a hearing date has been set for January 2022. In March 2018 the EPO revoked Forward Pharma A/S' (Forward Pharma) European Patent No. 2 801 355, which expires in October 2025. Forward Pharma has filed an appeal to the Technical Boards of Appeal of the EPO and a hearing has been set for September 2021. TYSABRI Patent Revocation Matters In November 2017 Bioeq GMBH, affiliated with the Polpharma Group, brought an action in the Polish Patent Office seeking to revoke Polish Patent No. 215263 (the Polish '263 Patent), which corresponds to our European Patent No. 1 485 127 (the E.U. '127 Patent) and covers administration of natalizumab (TYSABRI) to treat MS. The Polish '263 Patent expires in February 2023. The Polish Patent Office dismissed the action in February 2021. In August 2020 a related entity, Polpharma Biologics S.A., also brought an action seeking to revoke the Polish ‘263 Patent in the Polish Patent Office. The action was suspended by the Polish Patent Office in April 2021. Swiss Pharma International AG, also affiliated with the Polpharma Group, filed actions in the District Court of the Hague, Netherlands (January 2016), the German Patents Court (March 2016) and the Commercial Court of Rome (November 2017) seeking to invalidate the Dutch, German and Italian counterparts, respectively, of the E.U. '127 Patent, which also cover administration of natalizumab (TYSABRI) to treat MS and expire in February 2023. The Dutch and German counterparts were ruled invalid. The decision in the Dutch action was affirmed on appeal and the German appeal has been withdrawn. A hearing in the Italian action will be held in June 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 applications in the General Court of the European Union (Polpharma in October 2018 and Mylan Ireland in November 2020) seeking to annul decisions of the European Medicines Agency (EMA) refusing to validate Polpharma’s and Mylan Ireland’s respective applications to market a generic version of TECFIDERA. The EMA’s refusals were on the grounds that TECFIDERA benefits from regulatory data protection. Biogen and the European Commission were granted leave to intervene in support of the EMA in the case brought by Polpharma. On May 5, 2021, the European General Court annulled the EMA's non-validation decision with respect to a generic application related to TECFIDERA in the E.U. This generic application is now before the EMA, which is reassessing TECFIDERA's regulatory data protection by performing a scientific assessment pursuant to the European General Court's decision. The result of the scientific assessment of the EMA is expected in the fourth quarter of 2021. We have appealed the European General Court's 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. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In July 2021 we entered into a license and collaboration agreement with InnoCare Pharma Limited (InnoCare) for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor for the potential treatment of MS. Orelabrutinib is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS. Under the terms of the proposed collaboration, we will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125.0 million upfront payment and is eligible to receive up to approximately $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
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. Our core growth areas include multiple sclerosis (MS) and neuroimmunology; Alzheimer’s disease and dementia; neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS); movement disorders, including Parkinson's disease; ophthalmology; and neuropsychiatry. We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging growth areas of immunology; acute neurology; and neuropathic pain. In addition, we commercialize biosimilars of advanced biologics. 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 and relapsing MS; and other potential anti-CD20 therapies 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 our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020 (2020 Form 10-K). 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. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, |
Basis of presentation | In the opinion of management, our condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair statement of our financial statements for interim periods in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The information included in this quarterly report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our 2020 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2020 Form 10-K and updated, as necessary, in this report. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three and six months ended June 30, 2021, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period. We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. |
Consolidation | Our condensed 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 in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. These considerations impact the way we account for our existing collaborative relationships and other arrangements. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners. |
Use of estimates | The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates.The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, 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 condensed consolidated financial statements and there may be changes to those estimates in future periods. |
New accounting pronouncements | From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (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 condensed 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 condensed consolidated financial statements and related disclosures. |
Revenues (Tables)
Revenues (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenues by product | Revenue by product is summarized as follows: For the Three Months Ended June 30, 2021 2020 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate* $ 269.1 $ 309.4 $ 578.5 $ 921.7 $ 268.6 $ 1,190.3 Interferon** 257.4 143.0 400.4 345.6 135.8 481.4 TYSABRI 299.8 224.4 524.2 244.1 187.9 432.0 FAMPYRA — 26.1 26.1 — 23.0 23.0 Subtotal: MS product revenue 826.3 702.9 1,529.2 1,511.4 615.3 2,126.7 Spinal Muscular Atrophy: SPINRAZA 149.3 350.4 499.7 210.3 284.3 494.6 Alzheimer's disease: ADUHELM*** 1.6 — 1.6 — — — Biosimilars: BENEPALI — 121.5 121.5 — 106.2 106.2 IMRALDI — 55.6 55.6 — 44.8 44.8 FLIXABI — 25.3 25.3 — 20.6 20.6 Subtotal: Biosimilar product revenue — 202.4 202.4 — 171.6 171.6 Other: FUMADERM — 3.1 3.1 — 2.8 2.8 Total product revenue $ 977.2 $ 1,258.8 $ 2,236.0 $ 1,721.7 $ 1,074.0 $ 2,795.7 *Fumarate includes TECFIDERA and VUMERITY. **Interferon includes AVONEX and PLEGRIDY. *** In June 2021 the U.S. Food and Drug Administration (FDA) granted accelerated approval of ADUHELM, which became commercially available in the United States (U.S.) during the second quarter of 2021. For additional information, please read Note 16, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these condensed consolidated financial statements. For the Six Months Ended June 30, 2021 2020 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): Fumarate* $ 505.1 $ 626.3 $ 1,131.4 $ 1,699.2 $ 591.9 $ 2,291.1 Interferon** 499.2 301.7 800.9 638.2 309.2 947.4 TYSABRI 573.1 454.4 1,027.5 521.8 432.6 954.4 FAMPYRA — 52.7 52.7 — 51.3 51.3 Subtotal: MS product revenue 1,577.4 1,435.1 3,012.5 2,859.2 1,385.0 4,244.2 Spinal Muscular Atrophy: SPINRAZA 298.0 722.2 1,020.2 445.7 613.9 1,059.6 Alzheimer's disease: ADUHELM*** 1.6 — 1.6 — — — Biosimilars: BENEPALI — 243.2 243.2 — 239.7 239.7 IMRALDI — 113.5 113.5 — 106.4 106.4 FLIXABI — 50.8 50.8 — 44.3 44.3 Subtotal: Biosimilar product revenue — 407.5 407.5 — 390.4 390.4 Other: FUMADERM — 5.9 5.9 — 6.1 6.1 Total product revenue $ 1,877.0 $ 2,570.7 $ 4,447.7 $ 3,304.9 $ 2,395.4 $ 5,700.3 *Fumarate includes TECFIDERA and VUMERITY. **Interferon includes AVONEX and PLEGRIDY. *** 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 16, Collaborative and Other Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to these condensed consolidated financial statements. |
Analysis of change In reserves | An analysis of the change in reserves for discounts and allowances is summarized as follows: (In millions) Discounts Contractual Returns Total Balance, December 31, 2020 $ 141.4 $ 1,093.0 $ 41.6 $ 1,276.0 Current provisions relating to sales in current year 375.6 1,577.0 7.4 1,960.0 Adjustments relating to prior years 1.1 (51.5) 1.6 (48.8) Payments/credits relating to sales in current year (275.5) (906.9) — (1,182.4) Payments/credits relating to sales in prior years (119.2) (676.4) (6.9) (802.5) Balance, June 30, 2021 $ 123.4 $ 1,035.2 $ 43.7 $ 1,202.3 |
Total reserves included in consolidated balance sheets | The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows: (In millions) As of June 30, 2021 As of December 31, 2020 Reduction of accounts receivable $ 160.2 $ 195.4 Component of accrued expense and other 1,042.1 1,080.6 Total revenue-related reserves $ 1,202.3 $ 1,276.0 |
Revenues from anti-CD20 therapeutic programs | Revenue from anti-CD20 therapeutic programs are summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Biogen’s share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 178.8 $ 257.5 $ 352.9 $ 598.8 Other revenue from anti-CD20 therapeutic programs 261.2 220.8 476.1 399.9 Total revenue from anti-CD20 therapeutic programs $ 440.0 $ 478.3 $ 829.0 $ 998.7 |
Other revenues | Other revenue is summarized as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 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 $ 5.5 $ 4.5 $ 9.4 $ 8.2 Other revenue from collaborative and other relationships — 0.5 — 0.7 Other royalty and corporate revenue: Royalty 6.4 7.1 12.6 18.5 Other corporate 87.1 395.5 170.3 489.5 Total other revenue $ 99.0 $ 407.6 $ 192.3 $ 516.9 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Components of inventory | The components of inventory are summarized as follows: (In millions) As of June 30, 2021 As of December 31, 2020 Raw materials $ 328.0 $ 314.9 Work in process 723.0 544.5 Finished goods 203.8 209.2 Total inventory $ 1,254.8 $ 1,068.6 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 6 Months Ended |
Jun. 30, 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 June 30, 2021 As of December 31, 2020 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,394.3 $ (5,252.7) $ 2,141.6 $ 7,394.3 $ (5,136.5) $ 2,257.8 In-process research and development Indefinite until commercialization 179.4 — 179.4 762.5 — 762.5 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,637.7 $ (5,252.7) $ 2,385.0 $ 8,220.8 $ (5,136.5) $ 3,084.3 |
Estimated future amortization for acquired 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 June 30, 2021 2021 (remaining six months) $ 110.0 2022 215.0 2023 215.0 2024 225.0 2025 220.0 2026 200.0 |
Summary of roll forward of the changes in goodwill | The following table provides a roll forward of the changes in our goodwill balance: (In millions) As of June 30, 2021 Goodwill, December 31, 2020 $ 5,762.1 Other 1.8 Goodwill, June 30, 2021 $ 5,763.9 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 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 June 30, 2021 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 1,180.2 $ — $ 1,180.2 $ — Marketable debt securities: Corporate debt securities 1,382.5 — 1,382.5 — Government securities 688.6 — 688.6 — Mortgage and other asset backed securities 152.8 — 152.8 — Marketable equity securities 1,593.5 273.3 1,320.2 — Derivative contracts 20.8 — 20.8 — Plan assets for deferred compensation 33.7 — 33.7 — Total $ 5,052.1 $ 273.3 $ 4,778.8 $ — Liabilities: Derivative contracts $ 72.4 $ — $ 72.4 $ — Contingent consideration obligations 226.3 — — 226.3 Total $ 298.7 $ — $ 72.4 $ 226.3 As of December 31, 2020 (In millions) Total Quoted Prices Significant Other 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 |
Fair value measurements, nonrecurring | The gains or losses on assets measured at fair value on a nonrecurring basis, are summarized as follows: As of June 30, 2021 (In millions) Beginning Book Value Impairment Ending Book Value BIIB111 intangible asset $ 365.0 $ (350.0) $ 15.0 BIIB112 intangible asset 220.0 (191.6) 28.4 |
Summary of fair and carrying value of debt instruments | The fair and carrying values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of June 30, 2021 As of December 31, 2020 (In millions) Fair Carrying Fair Carrying 3.625% Senior Notes due September 15, 2022 $ 1,037.8 $ 998.5 $ 1,054.1 $ 997.9 4.050% Senior Notes due September 15, 2025 1,945.3 1,742.0 2,003.1 1,741.2 2.250% Senior Notes due May 1, 2030 1,503.3 1,491.6 1,557.2 1,491.1 5.200% Senior Notes due September 15, 2045 (1) 1,483.1 1,099.7 2,365.1 1,723.4 3.150% Senior Notes due May 1, 2050 1,471.1 1,472.9 1,536.4 1,472.6 3.250% Senior Notes due February 15, 2051 (1) 700.1 464.5 — — Total $ 8,140.7 $ 7,269.2 $ 8,515.9 $ 7,426.2 (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 10, Indebtedness , to these condensed 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: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Fair value, beginning of period $ 226.0 $ 341.6 $ 259.8 $ 346.1 Changes in fair value 0.3 10.0 (33.5) 5.5 Fair value, end of period $ 226.3 $ 351.6 $ 226.3 $ 351.6 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [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 condensed consolidated balance sheets: (In millions) As of June 30, 2021 As of December 31, 2020 Commercial paper $ 130.0 $ 61.1 Overnight reverse repurchase agreements 297.8 37.4 Money market funds 725.9 505.1 Short-term debt securities 26.5 23.3 Total $ 1,180.2 $ 626.9 |
Marketable debt and equity securities | The following tables summarize our marketable debt and equity securities, classified as available for sale: As of June 30, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 1,072.2 $ 0.3 $ (0.4) $ 1,072.1 Non-current 309.9 0.6 (0.1) 310.4 Government securities: Current 236.5 0.1 — 236.6 Non-current 452.1 0.2 (0.3) 452.0 Mortgage and other asset backed securities: Current 0.2 — — 0.2 Non-current 152.7 0.2 (0.3) 152.6 Total marketable debt securities $ 2,223.6 $ 1.4 $ (1.1) $ 2,223.9 Marketable equity securities Marketable equity securities, non-current $ 1,168.9 $ 607.6 $ (183.0) $ 1,593.5 Total marketable equity securities $ 1,168.9 $ 607.6 $ (183.0) $ 1,593.5 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 June 30, 2021 As of December 31, 2020 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,308.8 $ 1,308.9 $ 1,278.9 $ 1,278.6 Due after one year through five years 870.9 870.5 722.6 721.3 Due after five years 44.2 44.2 49.5 49.2 Total marketable debt securities $ 2,223.9 $ 2,223.6 $ 2,051.0 $ 2,049.1 |
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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Proceeds from maturities and sales $ 633.5 $ 1,490.6 $ 1,452.7 $ 3,879.9 Realized gains 0.1 6.1 0.3 11.8 Realized losses (0.5) (5.2) (1.2) (24.3) |
Derivative Instruments (Tables)
Derivative Instruments (Tables) | 6 Months Ended |
Jun. 30, 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) As of June 30, 2021 As of December 31, 2020 Euro $ 2,269.2 $ 2,979.1 British pound 128.6 250.6 Swiss franc 109.9 — Japanese yen 62.5 — Canadian dollar 53.3 — Total foreign currency forward contracts $ 2,623.5 $ 3,229.7 |
Summary of the effect of cash flow derivatives designated as hedging instruments on the condensed consolidated statements of income | The following tables summarize the effect of foreign currency forward contracts designated as hedging instruments in our condensed consolidated statements of income: For the Three Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Revenue $ (30.7) $ 23.7 Revenue $ (0.8) $ (1.6) Operating expense 0.4 — Operating expense (0.3) (0.2) For the Six Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Revenue $ (53.8) $ 50.7 Revenue $ (3.8) $ 7.7 Operating expense — (0.1) Operating expense (0.4) (1.1) |
Summary of the effect of derivatives designated as net investment hedging instruments on our consolidated statement of income | The following tables summarize the effect of our net investment hedge in our condensed consolidated financial statements: For the Three Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Location 2021 2020 Gains (losses) on net investment hedge $ (2.5) $ (8.8) Gains (losses) on net investment hedge $ 0.3 $ 3.5 Other income (expense) $ — $ 0.8 For the Six Months Ended June 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2021 2020 Location 2021 2020 Location 2021 2020 Gains (losses) on net investment hedge $ 21.3 $ 15.4 Gains (losses) on net investment hedge $ (1.1) $ 3.2 Other income (expense) $ 0.1 $ 1.7 |
Summary of fair value and presentation of derivatives | The following table summarizes the fair value and presentation in our condensed consolidated balance sheets of our outstanding derivative instruments, including those designated as hedging instruments: (In millions) Balance Sheet Location As of June 30, 2021 As of December 31, 2020 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 9.7 $ — Investments and other assets 7.4 — Liability derivative instruments Accrued expense and other 55.2 157.1 Other long-term liabilities — 35.7 Net Investment Hedging Instruments: Asset derivative instruments Other current assets 0.4 — Liability derivative instruments Accrued expense and other — 19.7 Other Derivative Instruments: Asset derivative instruments Other current assets 3.3 20.5 Liability derivative instruments Accrued expense and other 17.2 4.7 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Schedule of Accumulated Other Comprehensive Income (Loss) | The following tables summarize the changes in accumulated other comprehensive income (loss), net of tax by component: (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 (2.0) 90.2 20.2 2.4 (32.6) 78.2 Amounts reclassified from accumulated other comprehensive income (loss) 0.7 48.4 (0.1) — — 49.0 Net current period other comprehensive income (loss) (1.3) 138.6 20.1 2.4 (32.6) 127.2 Balance, June 30, 2021 $ 0.1 $ (40.4) $ 11.6 $ (63.9) $ (79.2) $ (171.8) (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 (9.0) 33.2 18.6 0.9 (47.0) (3.3) Amounts reclassified from accumulated other comprehensive income (loss) 9.9 (50.6) (1.8) — — (42.5) Net current period other comprehensive income (loss) 0.9 (17.4) 16.8 0.9 (47.0) (45.8) Balance, June 30, 2020 $ 5.1 $ (9.6) $ 41.9 $ (31.9) $ (186.5) $ (181.0) |
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 Accumulated Other Comprehensive Income (Loss) For the Three Months Ended June 30, For the Six Months Ended June 30, 2021 2020 2021 2020 Gains (losses) on securities available for sale Other income (expense) $ (0.4) $ 3.9 $ (0.9) $ (12.5) Income tax benefit (expense) 0.1 (0.8) 0.2 2.6 Gains (losses) on cash flow hedges Revenue (30.7) 23.7 (53.8) 50.7 Operating expense 0.4 — — (0.1) Other income (expense) (0.1) 0.1 0.1 0.2 Income tax benefit (expense) 3.0 (0.1) 5.3 (0.2) Gains (losses) on net investment hedge Other income (expense) 0.1 0.9 0.1 1.8 Total reclassifications, net of tax $ (27.6) $ 27.7 $ (49.0) $ 42.5 |
Earnings per Share (Tables)
Earnings per Share (Tables) | 6 Months Ended |
Jun. 30, 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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Numerator: Net income attributable to Biogen Inc. $ 448.5 $ 1,542.1 $ 858.7 $ 2,941.2 Denominator: Weighted average number of common shares outstanding 149.7 160.6 150.8 166.7 Effect of dilutive securities: Time-vested restricted stock units 0.2 0.1 0.2 0.1 Market stock units 0.1 0.1 0.1 0.1 Performance stock units settled in stock 0.1 0.1 0.1 0.1 Dilutive potential common shares 0.4 0.3 0.4 0.3 Shares used in calculating diluted earnings per share 150.1 160.9 151.2 167.0 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-based compensation expense included in condensed consolidated statements of income | The following table summarizes share-based compensation expense included in our condensed consolidated statements of income: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Research and development $ 19.1 $ 15.2 $ 52.7 $ 48.5 Selling, general and administrative 40.3 30.3 85.2 73.4 Subtotal 59.4 45.5 137.9 121.9 Capitalized share-based compensation costs (1.7) (1.5) (4.3) (3.0) Share-based compensation expense included in total cost and expense 57.7 44.0 133.6 118.9 Income tax effect (10.9) (7.0) (24.9) (20.3) Share-based compensation expense included in net income attributable to Biogen Inc. $ 46.8 $ 37.0 $ 108.7 $ 98.6 |
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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Market stock units $ 9.3 $ 7.4 $ 25.8 $ 26.5 Time-vested restricted stock units 40.4 34.5 83.2 72.0 Cash settled performance units — (0.1) — (1.7) Performance units — — — (0.1) Performance stock units settled in stock 3.0 2.1 9.3 12.4 Performance stock units settled in cash 3.4 (4.0) 9.4 4.9 Employee stock purchase plan 3.3 5.6 10.2 7.9 Subtotal 59.4 45.5 137.9 121.9 Capitalized share-based compensation costs (1.7) (1.5) (4.3) (3.0) Share-based compensation expense included in total cost and expense $ 57.7 $ 44.0 $ 133.6 $ 118.9 |
Income Taxes (Tables)
Income Taxes (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
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 Three Months Ended June 30, For the Six Months Ended June 30, 2021 2020 2021 2020 Statutory rate 21.0 % 21.0 % 21.0 % 21.0 % State taxes 1.3 0.4 1.1 0.5 Taxes on foreign earnings (7.7) (3.4) (9.1) (3.7) Tax credits (2.9) (1.0) (3.3) (1.0) Purchased intangible assets (0.8) 0.2 (0.1) 0.2 TECFIDERA impairment — 2.7 — 1.5 GILTI 1.5 1.5 1.3 1.1 Neurimmune tax impacts (83.1) (0.2) (46.3) (0.2) Other 0.4 0.7 0.6 0.4 Effective tax rate (70.3) % 21.9 % (34.8) % 19.8 % |
Other Consolidated Financial _2
Other Consolidated Financial Statement Detail (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Other income (expense), net | Components of other income (expense), net, are summarized as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Interest income $ 2.7 $ 7.6 $ 5.6 $ 32.0 Interest expense (56.4) (66.0) (121.1) (110.3) Gain (loss) on investments, net 153.9 106.8 (282.7) 29.5 Foreign exchange gains (losses), net (0.8) 10.4 (9.4) (8.5) Other, net (3.0) 4.2 (2.9) (0.2) Total other income (expense), net $ 96.4 $ 63.0 $ (410.5) $ (57.5) |
Gain (loss) on investments in equity securities | The following table summarizes our gain (loss) on investments, net that relates to our equity securities held as of June 30, 2021 and 2020: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Net gains (losses) recognized during the period on equity securities $ 154.3 $ 102.9 $ (281.8) $ 42.0 Less: Net gains (losses) realized during the period on equity securities 0.4 — 6.6 — Unrealized gains (losses) recognized during the period on equity securities $ 153.9 $ 102.9 $ (288.4) $ 42.0 |
Accrued expenses and other | Accrued expense and other consists of the following: (In millions) As of June 30, 2021 As of December 31, 2020 Revenue-related reserves for discounts and allowances $ 1,042.1 $ 1,080.6 Collaboration expense 383.4 389.9 Employee compensation and benefits 242.5 333.8 Royalties and licensing fees 240.3 218.5 Derivative liabilities 72.4 181.5 Current portion of contingent consideration obligations — 149.6 Other 760.3 791.4 Total accrued expense and other $ 2,741.0 $ 3,145.3 |
Collaborative and Other Relat_2
Collaborative and Other Relationships (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Activity Related to BAN2401 and Elenbecestat Collaboration | For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 62.2 $ 33.9 $ 117.7 $ 77.5 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our condensed consolidated statements of income 31.1 17.0 58.8 38.7 Total sales and marketing expense incurred by the Lecanemab Collaboration 4.3 1.4 10.0 6.3 Biogen's share of lecanemab and elenbecestat sales and marketing expense reflected in selling, general and administrative expense in our condensed consolidated statements of income 2.1 0.7 5.0 3.2 |
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 Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total ADUHELM development expense $ 42.1 $ 35.9 $ 89.1 $ 55.0 Biogen's share of ADUHELM development expense reflected in research and development expense in our condensed consolidated statements of income 23.2 19.7 49.0 30.3 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement 125.6 45.2 237.4 67.9 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit sharing in our condensed consolidated statements of income 67.6 25.2 127.9 37.5 Total ADUHELM collaboration third party milestones 100.0 75.0 100.0 75.0 Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit sharing in our condensed consolidated statements of income 45.0 33.8 45.0 33.8 |
Summary of Activity Related to Denali Therapeutics Collaboration | A summary of development expense related to this collaboration is as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, (In millions) 2021 2020 2021 2020 Total Denali collaboration development expense $ 10.4 $ — $ 18.7 $ — Biogen's share of Denali development expense reflected in research and development expense in our condensed consolidated statements of income 6.2 — 11.2 — |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 6 Months Ended |
Jun. 30, 2021segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Interest in subsidiary (less than given percentage) | 100.00% |
Business Acquisition (Details T
Business Acquisition (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Business Acquisition [Line Items] | |||||
Acquired in-process research and development | $ 18 | $ 0 | $ 18 | $ 75 | |
BIIB118 | |||||
Business Acquisition [Line Items] | |||||
Acquired in-process research and development | $ 75 | ||||
Estimated additional payments upon achievement of development and commercial milestones | $ 635 |
Revenues by Product (Details)
Revenues by Product (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ 2,775 | $ 3,681.6 | $ 5,469 | $ 7,215.9 |
Fumarate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 578.5 | 1,190.3 | 1,131.4 | 2,291.1 |
Fumarate | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 269.1 | 921.7 | 505.1 | 1,699.2 |
Fumarate | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 309.4 | 268.6 | 626.3 | 591.9 |
Interferon | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 400.4 | 481.4 | 800.9 | 947.4 |
Interferon | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 257.4 | 345.6 | 499.2 | 638.2 |
Interferon | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 143 | 135.8 | 301.7 | 309.2 |
TYSABRI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 524.2 | 432 | 1,027.5 | 954.4 |
TYSABRI | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 299.8 | 244.1 | 573.1 | 521.8 |
TYSABRI | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 224.4 | 187.9 | 454.4 | 432.6 |
FAMPYRA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 26.1 | 23 | 52.7 | 51.3 |
FAMPYRA | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
FAMPYRA | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 26.1 | 23 | 52.7 | 51.3 |
MS Product Revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1,529.2 | 2,126.7 | 3,012.5 | 4,244.2 |
MS Product Revenues | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 826.3 | 1,511.4 | 1,577.4 | 2,859.2 |
MS Product Revenues | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 702.9 | 615.3 | 1,435.1 | 1,385 |
SPINRAZA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 499.7 | 494.6 | 1,020.2 | 1,059.6 |
SPINRAZA | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 149.3 | 210.3 | 298 | 445.7 |
SPINRAZA | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 350.4 | 284.3 | 722.2 | 613.9 |
ADUHELM | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1.6 | 0 | 1.6 | 0 |
ADUHELM | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1.6 | 0 | 1.6 | 0 |
ADUHELM | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
BENEPALI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 121.5 | 106.2 | 243.2 | 239.7 |
BENEPALI | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
BENEPALI | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 121.5 | 106.2 | 243.2 | 239.7 |
IMRALDI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 55.6 | 44.8 | 113.5 | 106.4 |
IMRALDI | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
IMRALDI | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 55.6 | 44.8 | 113.5 | 106.4 |
FLIXABI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 25.3 | 20.6 | 50.8 | 44.3 |
FLIXABI | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
FLIXABI | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 25.3 | 20.6 | 50.8 | 44.3 |
Biosimilars | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 202.4 | 171.6 | 407.5 | 390.4 |
Biosimilars | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
Biosimilars | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 202.4 | 171.6 | 407.5 | 390.4 |
FUMADERM | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 3.1 | 2.8 | 5.9 | 6.1 |
FUMADERM | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
FUMADERM | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 3.1 | 2.8 | 5.9 | 6.1 |
Product, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 2,236 | 2,795.7 | 4,447.7 | 5,700.3 |
Product, net | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 977.2 | 1,721.7 | 1,877 | 3,304.9 |
Product, net | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ 1,258.8 | $ 1,074 | $ 2,570.7 | $ 2,395.4 |
Reserves for Discounts and Allo
Reserves for Discounts and Allowances (Details 1) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($) | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | $ 1,276 |
Current Provisions Relating To Sales In Current Year | 1,960 |
Adjustments Relating To Prior Years | (48.8) |
Payments/Returns Relating To Sales in Current Year | (1,182.4) |
Payments/Returns Relating To Sales in Prior Year | (802.5) |
Ending Balance | 1,202.3 |
Discounts | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 141.4 |
Current Provisions Relating To Sales In Current Year | 375.6 |
Adjustments Relating To Prior Years | 1.1 |
Payments/Returns Relating To Sales in Current Year | (275.5) |
Payments/Returns Relating To Sales in Prior Year | (119.2) |
Ending Balance | 123.4 |
Contractual adjustments | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 1,093 |
Current Provisions Relating To Sales In Current Year | 1,577 |
Adjustments Relating To Prior Years | (51.5) |
Payments/Returns Relating To Sales in Current Year | (906.9) |
Payments/Returns Relating To Sales in Prior Year | (676.4) |
Ending Balance | 1,035.2 |
Returns | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 41.6 |
Current Provisions Relating To Sales In Current Year | 7.4 |
Adjustments Relating To Prior Years | 1.6 |
Payments/Returns Relating To Sales in Current Year | 0 |
Payments/Returns Relating To Sales in Prior Year | (6.9) |
Ending Balance | $ 43.7 |
Reserves for Discounts and Al_2
Reserves for Discounts and Allowances (Details 2) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Total Reserves | $ 1,202.3 | $ 1,276 |
Reduction of accounts receivable | ||
Total Reserves | 160.2 | 195.4 |
Component of accrued expenses and other | ||
Total Reserves | $ 1,042.1 | $ 1,080.6 |
Revenues from Anti-CD20 Therape
Revenues from Anti-CD20 Therapeutic Programs (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 2,775 | $ 3,681.6 | $ 5,469 | $ 7,215.9 |
Genentech | ||||
Disaggregation of Revenue [Line Items] | ||||
Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA | 178.8 | 257.5 | 352.9 | 598.8 |
Other revenues from anti-CD20 therapeutic programs | 261.2 | 220.8 | 476.1 | 399.9 |
Revenue from anti-CD20 therapeutic programs | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 440 | $ 478.3 | $ 829 | $ 998.7 |
Other Revenues (Details)
Other Revenues (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 2,775 | $ 3,681.6 | $ 5,469 | $ 7,215.9 |
Royalty | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 6.4 | 7.1 | 12.6 | 18.5 |
Other corporate revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 87.1 | 395.5 | 170.3 | 489.5 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 99 | 407.6 | 192.3 | 516.9 |
Collaborative arrangement | Samsung Bioepis | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 0 | 0.5 | 0 | 0.7 |
Collaborative arrangement | ZINBRYTA | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 5.5 | $ 4.5 | $ 9.4 | $ 8.2 |
Revenues (Details Textual)
Revenues (Details Textual) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($)wholesaler | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)wholesaler | Jun. 30, 2020USD ($) | |
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 2,775 | $ 3,681.6 | $ 5,469 | $ 7,215.9 |
Number of wholesalers | wholesaler | 2 | 2 | ||
Distributor One | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 30.20% | 31.70% | 30.10% | 30.80% |
Distributor Two | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 9.90% | 17.90% | 9.60% | 16.20% |
Other corporate revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 87.1 | $ 395.5 | $ 170.3 | $ 489.5 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 99 | $ 407.6 | $ 192.3 | $ 516.9 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Components of inventories | ||
Raw materials | $ 328 | $ 314.9 |
Work in process | 723 | 544.5 |
Finished goods | 203.8 | 209.2 |
Total inventory | $ 1,254.8 | $ 1,068.6 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2021 | |
Intangible assets | |||||||
Contingent consideration impairment | $ (300,000) | $ (10,000,000) | $ 33,500,000 | $ (5,500,000) | |||
Total intangible assets, gross | 7,637,700,000 | $ 8,220,800,000 | 7,637,700,000 | ||||
Accumulated Amortization | (5,252,700,000) | (5,136,500,000) | (5,252,700,000) | ||||
Intangible assets, net | 2,385,000,000 | 3,084,300,000 | 2,385,000,000 | ||||
Amortization and impairment of acquired intangible assets | 604,100,000 | 61,500,000 | 702,200,000 | 133,000,000 | |||
Expected future amortization expense, 2019 (remaining three months) | 110,000,000 | 110,000,000 | |||||
Expected future amortization expense, 2020 | 215,000,000 | 215,000,000 | |||||
Expected future amortization expense, 2021 | 215,000,000 | 215,000,000 | |||||
Expected future amortization expense, 2022 | 225,000,000 | 225,000,000 | |||||
Expected future amortization expense, 2023 | 220,000,000 | 220,000,000 | |||||
Expected future amortization expense, 2024 | 200,000,000 | 200,000,000 | |||||
Impairment of intangible assets | 585,900,000 | 0 | |||||
Impairment of Intangible Assets (Excluding Goodwill) | 0 | 0 | $ 0 | ||||
Out-licensed patents | |||||||
Intangible assets | |||||||
Cost | 7,394,300,000 | 7,394,300,000 | 7,394,300,000 | ||||
Net | 2,141,600,000 | 2,257,800,000 | 2,141,600,000 | ||||
Accumulated Amortization | (5,252,700,000) | (5,136,500,000) | $ (5,252,700,000) | ||||
Out-licensed patents | Minimum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 13 years | ||||||
Out-licensed patents | Maximum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 23 years | ||||||
Developed technology | Minimum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 15 years | ||||||
Developed technology | Maximum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 28 years | ||||||
Acquired and in-licensed rights and patents | Minimum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 4 years | ||||||
Acquired and in-licensed rights and patents | Maximum | |||||||
Intangible assets | |||||||
Estimated life, (in years) | 18 years | ||||||
In Process Research and Development | |||||||
Intangible assets | |||||||
Indefinite lived intangible assets useful life | Indefinite until commercialization | ||||||
Cost and Net | 179,400,000 | 762,500,000 | $ 179,400,000 | ||||
Accumulated Amortization | 0 | 0 | $ 0 | ||||
Trademarks and Trade Names | |||||||
Intangible assets | |||||||
Indefinite lived intangible assets useful life | Indefinite | ||||||
Cost and Net | 64,000,000 | 64,000,000 | $ 64,000,000 | ||||
Accumulated Amortization | 0 | 0 | 0 | ||||
Vixotrigine | |||||||
Intangible assets | |||||||
Amortization and impairment of acquired intangible assets | 44,300,000 | $ 0 | |||||
TGN [Member] | In Process Research and Development | |||||||
Intangible assets | |||||||
Cost and Net | 136,000,000 | 136,000,000 | |||||
BIIB111 | In Process Research and Development | |||||||
Intangible assets | |||||||
Cost and Net | 15,000,000 | 15,000,000 | $ 365,000,000 | ||||
BIIB111 | Nightstar | |||||||
Intangible assets | |||||||
Impairment of intangible assets | 350,000,000 | $ 115,000,000 | 350,000,000 | ||||
BIIB112 | In Process Research and Development | |||||||
Intangible assets | |||||||
Cost and Net | 28,400,000 | 28,400,000 | $ 220,000,000 | ||||
BIIB112 | Nightstar | |||||||
Intangible assets | |||||||
Impairment of intangible assets | $ 191,600,000 | $ 191,600,000 | |||||
BIIB111 and BIIB112 | Nightstar | Forecast | |||||||
Intangible assets | |||||||
Impairment of intangible assets | $ 30,000,000 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Details 1) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Summary of roll forward of the changes in goodwill | ||||
Goodwill, beginning of period | $ 5,762.1 | |||
Other | 1.8 | |||
Goodwill, end of period | $ 5,763.9 | 5,763.9 | ||
Accumulated impairment losses related to goodwill | 0 | 0 | ||
Amortization and impairment of acquired intangible assets | $ 604.1 | $ 61.5 | 702.2 | $ 133 |
Impairment of intangible assets | $ 585.9 | $ 0 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Assets: | ||||||
Marketable debt securities | $ 2,223.9 | $ 2,051 | ||||
Fair Value, Measurements, Recurring | ||||||
Assets: | ||||||
Cash equivalents | 1,180.2 | 626.9 | ||||
Marketable equity securities | 1,593.5 | 1,974.3 | ||||
Derivative contracts | 20.8 | 20.5 | ||||
Plan assets for deferred compensation | 33.7 | 28.2 | ||||
Total | 5,052.1 | 4,700.9 | ||||
Liabilities: | ||||||
Derivative contracts | 72.4 | 217.2 | ||||
Contingent consideration obligations | 226.3 | $ 226 | 259.8 | $ 351.6 | $ 341.6 | $ 346.1 |
Total | 298.7 | 477 | ||||
Fair Value, Measurements, Recurring | Corporate debt securities | ||||||
Assets: | ||||||
Marketable debt securities | 1,382.5 | 1,301.5 | ||||
Fair Value, Measurements, Recurring | Government securities | ||||||
Assets: | ||||||
Marketable debt securities | 688.6 | 627.1 | ||||
Fair Value, Measurements, Recurring | Mortgage and other asset backed securities | ||||||
Assets: | ||||||
Marketable debt securities | 152.8 | 122.4 | ||||
Quoted Prices in Active Markets (Level 1) | Fair Value, Measurements, Recurring | ||||||
Assets: | ||||||
Cash equivalents | 0 | 0 | ||||
Marketable equity securities | 273.3 | 271.1 | ||||
Derivative contracts | 0 | 0 | ||||
Plan assets for deferred compensation | 0 | 0 | ||||
Total | 273.3 | 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 | 1,180.2 | 626.9 | ||||
Marketable equity securities | 1,320.2 | 1,703.2 | ||||
Derivative contracts | 20.8 | 20.5 | ||||
Plan assets for deferred compensation | 33.7 | 28.2 | ||||
Total | 4,778.8 | 4,429.8 | ||||
Liabilities: | ||||||
Derivative contracts | 72.4 | 217.2 | ||||
Contingent consideration obligations | 0 | 0 | ||||
Total | 72.4 | 217.2 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Corporate debt securities | ||||||
Assets: | ||||||
Marketable debt securities | 1,382.5 | 1,301.5 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Government securities | ||||||
Assets: | ||||||
Marketable debt securities | 688.6 | 627.1 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Mortgage and other asset backed securities | ||||||
Assets: | ||||||
Marketable debt securities | 152.8 | 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 | 226.3 | 259.8 | ||||
Total | 226.3 | 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 (Deta_2
Fair Value Measurements (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | |
Business Acquisition, Contingent Consideration [Line Items] | |||
Asset impairment charges | $ 0 | $ 0 | |
Contingent consideration obligations | $ 226,300,000 | $ 226,300,000 | $ 110,300,000 |
Technological and Regulatory Success, Probability | 21.70% | ||
2.900% Senior Notes due 2020 | |||
Business Acquisition, Contingent Consideration [Line Items] | |||
Senior notes interest rate | 2.90% | 2.90% | |
3.625% Senior Notes due 2022 | |||
Business Acquisition, Contingent Consideration [Line Items] | |||
Senior notes interest rate | 3.625% | 3.625% | |
4.050% Senior Notes due 2025 | |||
Business Acquisition, Contingent Consideration [Line Items] | |||
Senior notes interest rate | 4.05% | 4.05% | |
5.200% Senior Notes due 2045 | |||
Business Acquisition, Contingent Consideration [Line Items] | |||
Senior notes interest rate | 5.20% | 5.20% |
Fair Value Measurements Fair Va
Fair Value Measurements Fair Value Measurements - Contingent Consideration (Details) - Discount rate | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.68 | 0.0060 |
Minimum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.0083 | |
Maximum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.0118 | |
Weighted Average | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.0068 | 0.0060 |
Fair Value Measurements - Nonre
Fair Value Measurements - Nonrecurring Assets (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Fair Value, Assets Measured on Nonrecurring Basis, Reconciliation, Calculation [Roll Forward] | ||||
Impairment of intangible assets | $ (585.9) | $ 0 | ||
BIIB111 | Nightstar | ||||
Fair Value, Assets Measured on Nonrecurring Basis, Reconciliation, Calculation [Roll Forward] | ||||
Impairment of intangible assets | $ (350) | $ (115) | (350) | |
BIIB111 | Fair Value, Nonrecurring | ||||
Fair Value, Assets Measured on Nonrecurring Basis, Reconciliation, Calculation [Roll Forward] | ||||
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 365 | |||
Impairment of intangible assets | (350) | |||
Ending Book Value | 15 | 365 | 15 | |
BIIB112 | Nightstar | ||||
Fair Value, Assets Measured on Nonrecurring Basis, Reconciliation, Calculation [Roll Forward] | ||||
Impairment of intangible assets | (191.6) | (191.6) | ||
BIIB112 | Fair Value, Nonrecurring | ||||
Fair Value, Assets Measured on Nonrecurring Basis, Reconciliation, Calculation [Roll Forward] | ||||
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 220 | |||
Impairment of intangible assets | (191.6) | |||
Ending Book Value | $ 28.4 | $ 220 | $ 28.4 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 1) - USD ($) $ in Millions | 1 Months Ended | ||
Feb. 28, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Notes payable, carrying value | $ 7,269.2 | $ 7,426.2 | |
Debt instruments, fair value | $ 8,140.7 | 8,515.9 | |
2.900% Senior Notes due 2020 | |||
Debt Instrument [Line Items] | |||
Senior notes interest rate | 2.90% | ||
3.625% Senior Notes due 2022 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 1,037.8 | 1,054.1 | |
Notes payable, carrying value | $ 998.5 | 997.9 | |
Senior notes interest rate | 3.625% | ||
4.050% Senior Notes due 2025 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 1,945.3 | 2,003.1 | |
Notes payable, carrying value | $ 1,742 | 1,741.2 | |
Senior notes interest rate | 4.05% | ||
2.250% Senior Notes due May 1, 2030 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 1,483.1 | 1,557.2 | |
Notes payable, carrying value | $ 1,099.7 | 1,491.1 | |
Senior notes interest rate | 2.25% | ||
5.200% Senior Notes due 2045 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 1,503.3 | 2,365.1 | |
Notes payable, carrying value | $ 1,491.6 | 1,723.4 | |
Senior notes interest rate | 5.20% | ||
Long Term Debt, Exchanged, Amount | $ 624.6 | ||
3.150% Senior Notes due May 1, 2050 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 1,471.1 | 1,536.4 | |
Notes payable, carrying value | $ 1,472.9 | 1,472.6 | |
Senior notes interest rate | 3.15% | ||
3.250% Senior Notes, Due February 15, 2051 | |||
Debt Instrument [Line Items] | |||
Notes payable, fair value | $ 700.1 | 0 | |
Notes payable, carrying value | $ 464.5 | $ 0 | |
Senior notes interest rate | 3.25% | ||
Long Term Debt, Exchanged, Amount | $ 700.7 |
Fair Value Measurements (Deta_4
Fair Value Measurements (Details 2) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Business Acquisition, Contingent Consideration [Line Items] | ||||
Contingent consideration impairment | $ (0.3) | $ (10) | $ 33.5 | $ (5.5) |
Fair Value, Measurements, Recurring | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Fair value, beginning of period | 226 | 341.6 | 259.8 | 346.1 |
Fair value, end of period | $ 226.3 | $ 351.6 | $ 226.3 | $ 351.6 |
Financial Instruments (Details)
Financial Instruments (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | $ 1,180.2 | $ 626.9 |
Commercial paper | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 130 | 61.1 |
Overnight reverse repurchase agreements | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 297.8 | 37.4 |
Money market funds | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 725.9 | 505.1 |
Short-term debt securities | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | $ 26.5 | $ 23.3 |
Financial Instruments (Details
Financial Instruments (Details 1) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 2,223.6 | $ 2,049.1 |
Gross unrealized gains | 1.4 | 2.3 |
Gross unrealized losses | (1.1) | (0.4) |
Fair value | 2,223.9 | 2,051 |
Marketable equity securities, fair value | 2,223.9 | 2,051 |
Equity Securities, FV-NI, Cost | 1,239.5 | |
Equity Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | 749.7 | |
Equity Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, Before Tax | (14.9) | |
Equity Securities, FV-NI | 1,974.3 | |
Corporate debt securities Current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 1,072.2 | 897.8 |
Gross unrealized gains | 0.3 | 0.4 |
Gross unrealized losses | (0.4) | (0.2) |
Fair value | 1,072.1 | 898 |
Corporate debt securities Non-current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 309.9 | 402.5 |
Gross unrealized gains | 0.6 | 1.1 |
Gross unrealized losses | (0.1) | (0.1) |
Fair value | 310.4 | 403.5 |
Government securities Current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 236.5 | 380.6 |
Gross unrealized gains | 0.1 | 0.1 |
Gross unrealized losses | 0 | 0 |
Fair value | 236.6 | 380.7 |
Government securities Non-current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 452.1 | 245.9 |
Gross unrealized gains | 0.2 | 0.5 |
Gross unrealized losses | (0.3) | 0 |
Fair value | 452 | 246.4 |
Mortgage and other asset backed securities Current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 0.2 | 0.2 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair value | 0.2 | 0.2 |
Mortgage and other asset backed securities Non-current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 152.7 | 122.1 |
Gross unrealized gains | 0.2 | 0.2 |
Gross unrealized losses | (0.3) | (0.1) |
Fair value | 152.6 | 122.2 |
Equity Securities, Current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Equity Securities, FV-NI, Cost | 1,168.9 | 70.6 |
Equity Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | 607.6 | 15.9 |
Equity Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, Before Tax | (183) | 0 |
Equity Securities, FV-NI | 1,593.5 | 86.5 |
Equity Securities, Non-Current | ||
Debt Securities, Available-for-sale [Line Items] | ||
Equity Securities, FV-NI, Cost | 1,168.9 | 1,168.9 |
Equity Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | 607.6 | 733.8 |
Equity Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, Before Tax | (183) | (14.9) |
Equity Securities, FV-NI | $ 1,593.5 | $ 1,887.8 |
Financial Instruments (Detail_2
Financial Instruments (Details 2) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Summary of Contractual Maturities: Available-for-Sale Securities | ||
Due in one year or less, amortized cost | $ 1,308.8 | $ 1,278.9 |
Due in one year or less, estimated fair value | 1,308.9 | 1,278.6 |
Due after one year through five years, amortized cost | 870.9 | 722.6 |
Due after one year through five years, estimated fair value | 870.5 | 721.3 |
Due after five years, amortized cost | 44.2 | 49.5 |
Due after five years, estimated fair value | 44.2 | 49.2 |
Amortized cost | 2,223.6 | 2,049.1 |
Available-for-sale Securities | $ 2,223.9 | $ 2,051 |
Financial Instruments (Detail_3
Financial Instruments (Details 3) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from maturities and sales | $ 633.5 | $ 1,490.6 | $ 1,452.7 | $ 3,879.9 |
Realized gains | 0.1 | 6.1 | 0.3 | 11.8 |
Realized losses | $ (0.5) | $ (5.2) | $ (1.2) | $ (24.3) |
Financial Instruments (Detail_4
Financial Instruments (Details Textual) | 6 Months Ended | 9 Months Ended |
Jun. 30, 2021 | Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||
Average maturity of marketable securities, months | 13 months | 11 months |
Financial Instruments Financial
Financial Instruments Financial Instruments (Details Textual 2) - USD ($) $ / shares in Units, shares in Millions, number in Millions, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Nov. 30, 2020 | Apr. 30, 2020 | Feb. 29, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | |
Sage Therapeutics Inc. | |||||
Business Acquisition [Line Items] | |||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 650 | ||||
Global licensing collaboration agreement, shares, purchased (in shares) | 6.2 | ||||
Global licensing collaboration agreement, purchase price per share (in usd per share) | $ 104.14 | ||||
Dividend yield percentage | 0.00% | ||||
Sangamo Therapeutics, Inc. Agreement | |||||
Business Acquisition [Line Items] | |||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 225 | ||||
Global licensing collaboration agreement, shares, purchased (in shares) | 24 | ||||
Global licensing collaboration agreement, shares purchased per share (in usd per share) | $ 9.21 | ||||
Denali Therapeutics | |||||
Business Acquisition [Line Items] | |||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 465 | ||||
Global licensing collaboration agreement, shares purchased per share (in usd per share) | $ 34.94 | ||||
Strategic Investments | |||||
Business Acquisition [Line Items] | |||||
Strategic investment portfolio | $ 1,647.8 | ||||
Other noncurrent assets | Strategic Investments | |||||
Business Acquisition [Line Items] | |||||
Strategic investment portfolio | $ 2,024.6 | ||||
Denali Therapeutics | |||||
Business Acquisition [Line Items] | |||||
Investment in common stock, shares purchased | 13 | ||||
Dividend yield percentage | 0.00% | ||||
Sangamo | |||||
Business Acquisition [Line Items] | |||||
Investment in common stock, shares purchased | 12 | ||||
Dividend yield percentage | 0.00% |
Derivative Instruments (Details
Derivative Instruments (Details) $ in Millions, ₩ in Billions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Nov. 30, 2018USD ($) | Nov. 30, 2018KRW (₩) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Sep. 30, 2020 | Dec. 31, 2020USD ($) | |
Derivatives [Line Items] | |||||||||
Gain/Loss on fair value of foreign currency forward contracts | $ 53.7 | $ 53.7 | $ (212.5) | ||||||
Gain on interest rate swap | 0 | $ 3.3 | |||||||
Net gains (losses) of other income (expense) related to foreign currency forward contracts | (4.8) | $ (8.3) | (12.6) | 5.9 | |||||
Unrealized Gross Losses on Foreign Currency Derivatives, Net, before Tax | 67 | 67 | |||||||
Unrealized Gross Gains on Foreign Currency Derivatives, Net, before Tax | 13.3 | 13.3 | |||||||
Gains (losses) on net investment hedges | (2.3) | (6.2) | 20.1 | 16.8 | |||||
Ionis, Sangamo, Denali and Sage | |||||||||
Derivatives [Line Items] | |||||||||
Net losses recognized on the decrease in fair value of equity securities | 105.8 | $ 284.8 | |||||||
Minimum | |||||||||
Derivatives [Line Items] | |||||||||
Range of durations of foreign currency forward contracts | 1 month | 1 month | |||||||
Maximum | |||||||||
Derivatives [Line Items] | |||||||||
Range of durations of foreign currency forward contracts | 18 months | 24 months | |||||||
Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 1,205.1 | $ 1,205.1 | 1,158 | ||||||
Other current assets | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 9.7 | 9.7 | 0 | ||||||
Other current assets | Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 3.3 | 3.3 | 20.5 | ||||||
Other noncurrent assets | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 7.4 | 7.4 | 0 | ||||||
Accrued expenses and other | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 55.2 | 55.2 | 157.1 | ||||||
Accrued expenses and other | Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 17.2 | 17.2 | 4.7 | ||||||
Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 2,623.5 | 2,623.5 | 3,229.7 | ||||||
Interest rate swap | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 675 | 675 | |||||||
Cash Flow Hedging [Member] | Foreign exchange contract | Other long-term liabilities | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 0 | $ 0 | 35.7 | ||||||
Net Investment Hedging | |||||||||
Derivatives [Line Items] | |||||||||
Remaining duration of Net Investment Hedges | 4 months | ||||||||
Unrealized gain (loss) on net investment hedges in AOCI | $ 0.1 | 21.2 | |||||||
Derivative qualifying as net investment hedge, excluded component | 0.1 | 0.1 | 0.2 | ||||||
Gains (losses) on net investment hedges | (2.5) | (8.8) | 21.3 | 15.4 | |||||
Gains (losses) on net investment hedge, excluded component | 0.3 | 3.5 | (1.1) | 3.2 | |||||
Net Investment Hedging | Foreign exchange contract | Other current assets | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 0.4 | 0.4 | 0 | ||||||
Net Investment Hedging | Foreign exchange contract | Accrued expenses and other | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 0 | 0 | 19.7 | ||||||
Interest Expense | Interest rate swap | |||||||||
Derivatives [Line Items] | |||||||||
Gain on interest rate swap | 3.3 | ||||||||
Revenue | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Other Comprehensive Income (Loss), Cash Flow Hedge, Gain (Loss), Reclassification, before Tax | (30.7) | 23.7 | (53.8) | 50.7 | |||||
Revenue | Cash flows, revenue | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Gain on interest rate swap | (0.8) | (1.6) | (3.8) | 7.7 | |||||
Operating expense | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Other Comprehensive Income (Loss), Cash Flow Hedge, Gain (Loss), Reclassification, before Tax | 0.4 | 0 | 0 | (0.1) | |||||
Operating expense | Cash flows, operating expenses | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Gain on interest rate swap | (0.3) | (0.2) | (0.4) | (1.1) | |||||
Other income (expense) | Net Investment Hedging | |||||||||
Derivatives [Line Items] | |||||||||
Gain (loss) recognized in net income, excluded component | 0 | $ 0.8 | 0.1 | $ 1.7 | |||||
Euro | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 2,269.2 | 2,269.2 | 2,979.1 | ||||||
British pound | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 62.5 | 62.5 | 0 | ||||||
Swiss franc | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 128.6 | 128.6 | 250.6 | ||||||
Japan, Yen | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 53.3 | 53.3 | 0 | ||||||
Canadian dollar | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | $ 109.9 | $ 109.9 | $ 0 | ||||||
2.900% Senior Notes due 2020 | |||||||||
Derivatives [Line Items] | |||||||||
Senior notes interest rate | 2.90% | 2.90% | |||||||
Samsung Bioepis | |||||||||
Derivatives [Line Items] | |||||||||
Percentage of stake in entity | 5.00% | 5.00% | |||||||
Equity Method Investment, Ownership Percentage | 49.90% | 49.90% | |||||||
Payments to acquire additional investment in equity method investment | $ 676.6 | ₩ 759.5 | $ 676.6 | ||||||
Short-term derivative | |||||||||
Derivatives [Line Items] | |||||||||
Gain/Loss on fair value of foreign currency forward contracts | $ 58.2 | $ 58.2 | |||||||
Range of durations of foreign currency forward contracts | 12 months |
Property, Plant and Equipment (
Property, Plant and Equipment (Details) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)ft² | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Property, Plant and Equipment [Line Items] | |||||
Accumulated depreciation | $ 1,880.3 | $ 1,880.3 | $ 1,782.3 | ||
Depreciation | 54.7 | $ 51.3 | $ 103.5 | $ 99.7 | |
Biologics Manufacturing | |||||
Property, Plant and Equipment [Line Items] | |||||
Number of square feet | ft² | 393,000 | ||||
Warehouse, Utilities and Support Space | |||||
Property, Plant and Equipment [Line Items] | |||||
Number of square feet | ft² | 290,000 | ||||
Administrative Space | |||||
Property, Plant and Equipment [Line Items] | |||||
Number of square feet | ft² | 51,000 | ||||
Solothurn, Switzerland | |||||
Property, Plant and Equipment [Line Items] | |||||
Construction in progress | 618.4 | $ 618.4 | $ 1,800 | ||
Fixed assets placed into service | $ 1,300 | $ 1,300 |
Indebtedness (Details)
Indebtedness (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Feb. 28, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Apr. 30, 2020 | Sep. 15, 2015 | |
Debt Instrument [Line Items] | |||||||
Payments of financing costs | $ 24,400,000 | ||||||
Derivative, gain on derivative | 0 | $ 3,300,000 | |||||
Repayments of Senior Debt | $ 151,800,000 | ||||||
Repayments of borrowings and premiums paid on debt exchange | 170,000,000 | 0 | |||||
Interest Expense | $ 56,400,000 | $ 66,000,000 | $ 121,100,000 | $ 110,300,000 | |||
2.250% Senior Notes due May 1, 2030 | |||||||
Debt Instrument [Line Items] | |||||||
Senior notes interest rate | 2.25% | 2.25% | |||||
3.150% Senior Notes due May 1, 2050 | |||||||
Debt Instrument [Line Items] | |||||||
Senior notes interest rate | 3.15% | 3.15% | |||||
5.200% Senior Notes due 2045 | |||||||
Debt Instrument [Line Items] | |||||||
Senior notes interest rate | 5.20% | 5.20% | |||||
Repayments of Senior Debt | 12,100,000 | ||||||
Debt Instrument, Redemption, Amount | 8,900,000 | ||||||
Long Term Debt, Exchanged, Amount | 624,600,000 | ||||||
Gain (Loss) on Extinguishment of Debt | $ 3,200,000 | ||||||
Repayments of borrowings and premiums paid on debt exchange | 13,800,000 | ||||||
Interest Expense | $ 6,100,000 | ||||||
3.250% Senior Notes, Due February 15, 2051 | |||||||
Debt Instrument [Line Items] | |||||||
Senior notes interest rate | 3.25% | 3.25% | |||||
Long Term Debt, Exchanged, Amount | $ 700,700,000 | ||||||
Senior Notes | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | $ 3,000,000,000 | ||||||
Senior Notes | 2.250% Senior Notes due May 1, 2030 | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | $ 1,500,000,000 | ||||||
Senior notes interest rate | 2.25% | ||||||
Percentage par value of senior notes | 99.973% | ||||||
Senior Notes | 3.150% Senior Notes due May 1, 2050 | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | $ 1,500,000,000 | ||||||
Senior notes interest rate | 3.15% | ||||||
Percentage par value of senior notes | 99.174% | ||||||
Senior Notes | 2.90% Senior Notes Due Sept 15, 2020 | |||||||
Debt Instrument [Line Items] | |||||||
Face amount | $ 1,500,000,000 | ||||||
Senior notes interest rate | 2.90% | ||||||
Percentage par value of senior notes | 99.792% | ||||||
Payment of early call premium and write off of remaining unamortized debt issuance costs | $ 12,700,000 | ||||||
Interest Expense | Senior Notes | 2.90% Senior Notes Due Sept 15, 2020 | |||||||
Debt Instrument [Line Items] | |||||||
Pre-tax charge, payment of early call premium and write off of remaining unamortized debt issuance costs, net of derivative gain | 9,400,000 | ||||||
Interest Expense | Interest rate swap | |||||||
Debt Instrument [Line Items] | |||||||
Derivative, gain on derivative | $ 3,300,000 |
Share Repurchases (Details)
Share Repurchases (Details) - USD ($) shares in Millions | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Oct. 31, 2020 | |
Class of Stock [Line Items] | ||||||
Payments for repurchase of common stock | $ 1,050,000,000 | $ 5,029,100,000 | ||||
December 2019 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Stock Repurchase Program, Authorized Amount | $ 5,000,000,000 | |||||
Repurchase of common stock, at cost, shares | 9 | 12.2 | ||||
Payments for repurchase of common stock | $ 2,800,000,000 | $ 3,700,000,000 | ||||
2020 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Stock Repurchase Program, Authorized Amount | $ 5,000,000,000 | $ 5,000,000,000 | ||||
Repurchase of common stock, at cost, shares | 4.1 | |||||
Payments for repurchase of common stock | $ 1,300,000,000 | |||||
October 2020 Share Repurchase Program | ||||||
Class of Stock [Line Items] | ||||||
Stock Repurchase Program, Authorized Amount | $ 5,000,000,000 | |||||
Repurchase of common stock, at cost, shares | 1.6 | 3.8 | ||||
Payments for repurchase of common stock | $ 450,000,000 | $ 1,100,000,000 | ||||
Amount remaining under 2019 Share Repurchase Program | $ 3,600,000,000 | $ 3,600,000,000 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | $ (299) | $ (135.2) | ||
Balance, January 1, 2018 | $ (171.8) | $ (181) | (171.8) | (181) |
Other comprehensive income (loss), before reclassifications, net of tax | 78.2 | (3.3) | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 49 | (42.5) | ||
Other comprehensive income (loss), net of tax | 2.4 | (30.6) | 127.8 | (44) |
Accumulated other comprehensive income (loss), net of tax ending balance | (171.8) | (181) | (171.8) | (181) |
Other comprehensive income (loss), net of tax | 2.5 | (31.7) | 127.2 | (45.8) |
Unrealized gains (losses) on securities available for sale | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | 1.4 | 4.2 | ||
Balance, January 1, 2018 | 0.1 | 5.1 | 0.1 | 5.1 |
Other comprehensive income (loss), before reclassifications, net of tax | (2) | (9) | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 0.7 | 9.9 | ||
Other comprehensive income (loss), net of tax | (1.3) | 0.9 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | 0.1 | 5.1 | 0.1 | 5.1 |
Unrealized gains (losses) on cash flow hedges | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (179) | 7.8 | ||
Balance, January 1, 2018 | (40.4) | (9.6) | (40.4) | (9.6) |
Other comprehensive income (loss), before reclassifications, net of tax | 90.2 | 33.2 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 48.4 | (50.6) | ||
Other comprehensive income (loss), net of tax | 138.6 | (17.4) | ||
Accumulated other comprehensive income (loss), net of tax ending balance | (40.4) | (9.6) | (40.4) | (9.6) |
Gains (losses) on net investment hedge | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (8.5) | 25.1 | ||
Balance, January 1, 2018 | 11.6 | 41.9 | 11.6 | 41.9 |
Other comprehensive income (loss), before reclassifications, net of tax | 20.2 | 18.6 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | (0.1) | (1.8) | ||
Other comprehensive income (loss), net of tax | 20.1 | 16.8 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | 11.6 | 41.9 | 11.6 | 41.9 |
Unfunded status of postretirement benefit plans | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (66.3) | (32.8) | ||
Balance, January 1, 2018 | (63.9) | (31.9) | (63.9) | (31.9) |
Other comprehensive income (loss), before reclassifications, net of tax | 2.4 | 0.9 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 0 | 0 | ||
Other comprehensive income (loss), net of tax | 2.4 | 0.9 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | (63.9) | (31.9) | (63.9) | (31.9) |
Currency translation adjustments | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (46.6) | (139.5) | ||
Balance, January 1, 2018 | (79.2) | (186.5) | (79.2) | (186.5) |
Other comprehensive income (loss), before reclassifications, net of tax | (32.6) | (47) | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 0 | 0 | ||
Other comprehensive income (loss), net of tax | (32.6) | (47) | ||
Accumulated other comprehensive income (loss), net of tax ending balance | $ (79.2) | $ (186.5) | $ (79.2) | $ (186.5) |
Reclassification out of Accumul
Reclassification out of Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | ||||
Nonoperating Income (Expense) | $ 96.4 | $ 63 | $ (410.5) | $ (57.5) |
Income Tax Expense (Benefit) | (409.1) | 446.1 | (364.9) | 738.2 |
Product revenues | 2,775 | 3,681.6 | 5,469 | 7,215.9 |
Net income attributable to Biogen Inc. | 448.5 | 1,542.1 | 858.7 | 2,941.2 |
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. | (27.6) | 27.7 | (49) | 42.5 |
Unrealized 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] | ||||
Nonoperating Income (Expense) | (0.4) | 3.9 | (0.9) | (12.5) |
Income Tax Expense (Benefit) | 0.1 | (0.8) | 0.2 | 2.6 |
Unrealized 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] | ||||
Nonoperating Income (Expense) | (0.1) | 0.1 | 0.1 | 0.2 |
Income Tax Expense (Benefit) | 3 | (0.1) | 5.3 | (0.2) |
Product revenues | 30.7 | 23.7 | 53.8 | 50.7 |
Operating Expenses | 0.4 | 0 | 0 | (0.1) |
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] | ||||
Nonoperating Income (Expense) | $ 0.1 | $ 0.9 | $ 0.1 | $ 1.8 |
Earnings per Share (Details)
Earnings per Share (Details) - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Numerator: | ||||
Net income attributable to Biogen Inc. | $ 448.5 | $ 1,542.1 | $ 858.7 | $ 2,941.2 |
Weighted-average shares used in calculating: | ||||
Weighted average number of common shares outstanding | 149.7 | 160.6 | 150.8 | 166.7 |
Effect of dilutive securities: | ||||
Dilutive potential common shares | 0.4 | 0.3 | 0.4 | 0.3 |
Shares used in calculating diluted earnings per share | 150.1 | 160.9 | 151.2 | 167 |
Time-vested restricted stock units | ||||
Effect of dilutive securities: | ||||
Stock units | 0.2 | 0.1 | 0.2 | 0.1 |
Market stock units | ||||
Effect of dilutive securities: | ||||
Stock units | 0.1 | 0.1 | 0.1 | 0.1 |
Performance stock units settled in stock | ||||
Effect of dilutive securities: | ||||
Stock units | 0.1 | 0.1 | 0.1 | 0.1 |
Share-Based Payments (Details)
Share-Based Payments (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | $ (55.8) | $ (49.5) | $ (128.4) | $ (118.8) |
Subtotal | 59.4 | 45.5 | 137.9 | 121.9 |
Capitalized share-based compensation costs | (1.7) | (1.5) | (4.3) | (3) |
Share-based compensation expense included in total costs and expenses | 57.7 | 44 | 133.6 | 118.9 |
Income tax effect | (10.9) | (7) | (24.9) | (20.3) |
Research and development | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | 19.1 | 15.2 | 52.7 | 48.5 |
Selling, general and administrative | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | 40.3 | 30.3 | 85.2 | 73.4 |
Total share-based compensation expense, net of tax | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | $ 46.8 | $ 37 | $ 108.7 | $ 98.6 |
Share-Based Payments (Details 1
Share-Based Payments (Details 1) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | $ (55.8) | $ (49.5) | $ (128.4) | $ (118.8) |
Subtotal | 59.4 | 45.5 | 137.9 | 121.9 |
Capitalized share-based compensation costs | (1.7) | (1.5) | (4.3) | (3) |
Share-based compensation expense included in total costs and expenses | 57.7 | 44 | 133.6 | 118.9 |
Market stock units | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 9.3 | 7.4 | 25.8 | 26.5 |
Time-vested restricted stock units | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 40.4 | 34.5 | 83.2 | 72 |
Cash settled performance shares | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 0 | (0.1) | 0 | (1.7) |
Performance units | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 0 | 0 | 0 | (0.1) |
Performance stock units settled in stock | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 3 | 2.1 | 9.3 | 12.4 |
Performance stock units settled in cash | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 3.4 | (4) | 9.4 | 4.9 |
Employee stock purchase plan | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | $ 3.3 | $ 5.6 | $ 10.2 | $ 7.9 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Income Tax Contingency [Line Items] | |||||
Deferred tax assets, net | $ 500 | $ 500 | |||
Deferred tax assets, gross | 875 | 875 | |||
Deferred tax assets, unrecognized tax benefit | 375 | 375 | |||
Decrease in unrecognized tax benefits is reasonably possible | $ 20 | ||||
TECFIDERA | |||||
Income Tax Contingency [Line Items] | |||||
Deferred tax assets, decrease in value | 1,700 | 1,700 | |||
Deferred tax liabilities, decrease in value | 1,600 | 1,600 | |||
Deferred tax asset, increase (decrease) in value | $ 92.6 | $ 92.6 | |||
Deferred tax liabilities, increase (decrease) in value | $ 88.7 | $ 88.7 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Reconciliation between the U.S. federal statutory tax rate and effective tax rate | ||||
Statutory rate | 21.00% | 21.00% | 21.00% | 21.00% |
State taxes | 1.30% | 0.40% | 1.10% | 0.50% |
Taxes on foreign earnings | (7.70%) | (3.40%) | (9.10%) | (3.70%) |
Credits and net operating loss utilization | (2.90%) | (1.00%) | (3.30%) | (1.00%) |
Purchased intangible assets | (0.80%) | 0.20% | (0.10%) | 0.20% |
TECFIDERA impairment | 0.00% | 2.70% | 0.00% | 1.50% |
GILTI | 1.50% | 1.50% | 1.30% | 1.10% |
Neurimmune tax impacts | (0.831) | (0.002) | (0.463) | (0.002) |
Other | 0.40% | 0.70% | 0.60% | 0.40% |
Effective tax rate | (70.30%) | 21.90% | (34.80%) | 19.80% |
Other Consolidated Financial _3
Other Consolidated Financial Statement Detail (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Other Income (Expense), Net | |||||
Interest income | $ 2.7 | $ 7.6 | $ 5.6 | $ 32 | |
Interest expense | (56.4) | (66) | (121.1) | (110.3) | |
Gain (loss) on investments, net | 153.9 | 106.8 | (282.7) | 29.5 | |
Foreign exchange gains (losses), net | (0.8) | 10.4 | (9.4) | (8.5) | |
Other, net | (3) | 4.2 | (2.9) | (0.2) | |
Total other income (expense), net | 96.4 | 63 | (410.5) | (57.5) | |
Equity Securities, FV-NI, Gain (Loss), Alternative [Abstract] | |||||
Net gains (losses) recognized during the period on equity securities | 154.3 | 102.9 | (281.8) | 42 | |
Less: Net gains (losses) realized during the period on equity securities | 0.4 | 0 | 6.6 | 0 | |
Unrealized gains (losses) recognized during the period on equity securities | 153.9 | $ 102.9 | (288.4) | $ 42 | |
Accrued Expenses and Other | |||||
Revenue-related reserves for discounts and allowances | 1,202.3 | 1,202.3 | $ 1,276 | ||
Collaboration expense | 242.5 | 242.5 | 333.8 | ||
Royalties and licensing fees | 240.3 | 240.3 | 218.5 | ||
Collaboration expense | 383.4 | 383.4 | 389.9 | ||
Current portion of contingent consideration obligations | 0 | 0 | 149.6 | ||
Derivative liabilities | 72.4 | 72.4 | 181.5 | ||
Other | 760.3 | 760.3 | 791.4 | ||
Total accrued expense and other | 2,741 | 2,741 | 3,145.3 | ||
Ionis, Sangamo, Denali and Sage | |||||
Equity Securities, FV-NI, Gain (Loss), Alternative [Abstract] | |||||
Unrealized gains (losses) recognized during the period on equity securities | 263 | ||||
Component of accrued expenses and other | |||||
Accrued Expenses and Other | |||||
Revenue-related reserves for discounts and allowances | $ 1,042.1 | $ 1,042.1 | $ 1,080.6 |
Other Consolidated Financial _4
Other Consolidated Financial Statement (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Net gains recognized on the increase in fair value of equity securities | $ 153.9 | $ 102.9 | $ (288.4) | $ 42 | |
Net gains (losses) realized during the period on equity securities | 0.4 | $ 0 | 6.6 | $ 0 | |
Other long-term liabilities | 1,356.4 | 1,356.4 | $ 1,329.6 | ||
Accrued income taxes | 652.7 | 652.7 | $ 709.9 | ||
Ionis, Sangamo, Denali and Sage | |||||
Net gains recognized on the increase in fair value of equity securities | 263 | ||||
Net losses recognized on the decrease in fair value of equity securities | $ 105.8 | $ 284.8 |
Collaborative and Other Relat_3
Collaborative and Other Relationships - Collaborations (Details) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2021USD ($) | Nov. 30, 2020USD ($)$ / sharesshares | Feb. 29, 2020USD ($)$ / sharesshares | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Jun. 30, 2021USD ($)product$ / shares | Jun. 30, 2020USD ($) | Jan. 31, 2020USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Research and Development Expense (Excluding Acquired in Process Cost) | $ 585.1 | $ 647.6 | $ 1,099.3 | $ 1,123.9 | |||||
Eisai | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Number of product candidates | product | 2 | ||||||||
Percentage of future development costs related to Eisai | 45.00% | 45.00% | |||||||
Loss on research and development contracts terminated with Eisai | $ 45 | ||||||||
Additional milestone payment | $ 75 | ||||||||
Eisai | BAN2401 and Elenbecestat | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense Incurred By Collaboration | $ 62.2 | 33.9 | $ 117.7 | 77.5 | |||||
Expense reflected within statements of income | 31.1 | 17 | 58.8 | 38.7 | |||||
Eisai | ADUHELM | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense reflected within statements of income | 45 | 33.8 | 45 | 33.8 | |||||
Additional milestone payment | $ 100 | 100 | 75 | 100 | 75 | ||||
Denali Therapeutics | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 465 | ||||||||
Global licensing collaboration agreement, shares purchased per share (in usd per share) | $ / shares | $ 34.94 | ||||||||
Upfront and milestone payments made to collaborative partner | $ 560 | ||||||||
Global Licensing Collaboration Agreement, Research, Development, Regulatory and Commercial Milestone Payments | 1,100 | ||||||||
Research and development expense | $ 41.3 | ||||||||
Samsung Bioepis | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Upfront and milestone payments made to collaborative partner | 100 | ||||||||
Collaboration agreement term | 5 years | ||||||||
Research and development expense | $ 63 | ||||||||
Prepaid research and development expenses | $ 37 | ||||||||
Additional milestone payment | 15 | ||||||||
Sage Therapeutics Inc. | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 650 | ||||||||
Global licensing collaboration agreement, shares, purchased (in shares) | shares | 6.2 | ||||||||
Upfront and milestone payments made to collaborative partner | $ 875 | ||||||||
Global Licensing Collaboration Agreement, Research, Development, Regulatory and Commercial Milestone Payments | 1,600 | ||||||||
Research and development expense | $ 209 | ||||||||
Global licensing collaboration agreement, purchase price per share (in usd per share) | $ / shares | $ 104.14 | ||||||||
Sangamo Therapeutics, Inc. Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Global licensing collaboration agreement, amount, shares purchased (in shares) | $ 225 | ||||||||
Global licensing collaboration agreement, shares, purchased (in shares) | shares | 24 | ||||||||
Global licensing collaboration agreement, shares purchased per share (in usd per share) | $ / shares | $ 9.21 | ||||||||
Upfront and milestone payments made to collaborative partner | $ 125 | ||||||||
Global Licensing Collaboration Agreement, Research, Development, Regulatory and Commercial Milestone Payments | 2,400 | ||||||||
Global Licensing Collaboration Agreement, Payment, Selection of Targets | 80 | ||||||||
Global Licensing Collaboration Agreement, Payment, Achievement of First Commercial Sale Milestones | 1,900 | ||||||||
Global Licensing Collaboration Agreement, Payment, Achievement of Specific Sales Based Milestones | 380 | ||||||||
Research and development expense | $ 83 | ||||||||
Term of collaboration agreement | 5 years | ||||||||
Other research and discovery | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Research and Development Expense (Excluding Acquired in Process Cost) | 77.2 | 9.6 | $ 77.2 | 9.6 | |||||
Research and development | Eisai | ADUHELM | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 42.1 | 35.9 | 89.1 | 55 | |||||
Expense reflected within statements of income | 23.2 | 19.7 | 49 | 30.3 | |||||
Research and development | Denali Therapeutics | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 10.4 | 0 | 18.7 | 0 | |||||
Expense reflected within statements of income | 6.2 | 0 | 11.2 | 0 | |||||
Research and development | Sage Therapeutics Inc. | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 54 | 0 | 93.8 | 0 | |||||
Expense reflected within statements of income | 27 | 0 | 46.9 | 0 | |||||
Research and development | UCB Pharma S.A. [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 16.1 | 6.5 | 33 | 25.5 | |||||
Expense reflected within statements of income | 8.1 | 3.2 | 16.5 | 12.7 | |||||
Selling, general and administrative | Eisai | BAN2401 and Elenbecestat | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 4.3 | 1.4 | 10 | 6.3 | |||||
Expense reflected within statements of income | 2.1 | 0.7 | 5 | 3.2 | |||||
Selling, general and administrative | Eisai | ADUHELM | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 125.6 | 45.2 | 237.4 | 67.9 | |||||
Expense reflected within statements of income | 67.6 | 25.2 | 127.9 | 37.5 | |||||
Selling, general and administrative | Sage Therapeutics Inc. | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Expense incurred by the collaboration | 10.5 | 0 | 15.8 | 0 | |||||
Expense reflected within statements of income | $ 5.2 | $ 0 | $ 7.9 | $ 0 |
Collaborative and Other Relat_4
Collaborative and Other Relationships - Equity Method Investments (Details) $ in Millions, ₩ in Billions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||
Jun. 30, 2021USD ($) | Nov. 30, 2018USD ($) | Nov. 30, 2018KRW (₩) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021KRW (₩) | Dec. 31, 2020USD ($) | Dec. 31, 2020KRW (₩) | Jan. 31, 2020USD ($) | Nov. 07, 2018USD ($) | |
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Loss on equity method investment | $ (16.1) | $ 1.6 | ||||||||||||
Income tax (benefit) expense | $ (409.1) | $ 446.1 | (364.9) | 738.2 | ||||||||||
Collaboration profit sharing | (15.2) | 21.8 | 53.3 | 93.5 | ||||||||||
Total revenue | 2,775 | 3,681.6 | 5,469 | 7,215.9 | ||||||||||
ADUHELM | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Total revenue | $ 1.6 | $ 0 | $ 1.6 | $ 0 | ||||||||||
Samsung Bioepis | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Percentage of stake in entity | 5.00% | 5.00% | ||||||||||||
Percentage of stake in entity maximum | 49.90% | 49.90% | 49.90% | 49.90% | ||||||||||
Payments to acquire additional investment in equity method investment | $ 676.6 | ₩ 759.5 | $ 676.6 | |||||||||||
Amortization of basis differences | $ 675 | |||||||||||||
Loss recorded on Samsung Bioepis joint venture | $ 34.3 | $ 15.1 | $ 16.1 | $ 0.4 | ||||||||||
Investment in Samsung Bioepis | $ 612.8 | 612.8 | 612.8 | ₩ 691.6 | $ 620.2 | ₩ 673.8 | ||||||||
Income tax (benefit) expense | 31.2 | $ 31.2 | ||||||||||||
Biogen share of co-promotion profits or losses | 50.00% | |||||||||||||
Collaboration profit sharing | 69.9 | 55.4 | $ 138.4 | 127.2 | ||||||||||
Eisai | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Loss on research and development contracts terminated with Eisai | $ 45 | |||||||||||||
Loss on equity method investment | (40.1) | (33.8) | ||||||||||||
Additional milestone payment | 75 | |||||||||||||
Eisai | ADUHELM | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Loss on equity method investment | (45) | (45) | ||||||||||||
Additional milestone payment | 100 | 100 | $ 75 | 100 | $ 75 | |||||||||
Samsung Bioepis | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Upfront and milestone payments made to collaborative partner | 100 | |||||||||||||
Research and development expense | 63 | |||||||||||||
Prepaid research and development expenses | $ 37 | |||||||||||||
Estimated additional payments upon achievement of development and commercial milestones | 195 | |||||||||||||
Additional milestone payment | 15 | |||||||||||||
Contract Option Exercise Fee | $ 60 | |||||||||||||
Due to Related Parties | $ 158.7 | $ 158.7 | $ 158.7 | $ 99 | ||||||||||
Inventory | Samsung Bioepis | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Equity method investment basis difference amortization period | 1 year 6 months | |||||||||||||
Developed technology | Samsung Bioepis | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
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 | 6 Months Ended | |||||
Jun. 30, 2021 | May 31, 2018 | Oct. 31, 2017 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Variable Interest Entity [Line Items] | ||||||||
Payments to Noncontrolling Interests | $ 94.8 | $ 0 | ||||||
Loss on equity method investment | 16.1 | (1.6) | ||||||
Deferred tax assets, net | $ 500 | $ 500 | 500 | |||||
Deferred tax assets, gross | 875 | 875 | 875 | |||||
Deferred tax assets, unrecognized tax benefit | 375 | 375 | 375 | |||||
Investment in biotechnology companies that are determined to be unconsolidated variable interest entities | 15.2 | 15.2 | $ 15.2 | $ 12.8 | ||||
Neurimmune | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Collaboration agreement term | 12 years | |||||||
Research and development costs, percentage | 100.00% | |||||||
Payments to Noncontrolling Interests | $ 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 | Neurimmune | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party | $ 75 | |||||||
Eisai | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Loss on equity method investment | $ 40.1 | $ 33.8 | ||||||
Percentage of future development costs related to Eisai | 45.00% | 45.00% | ||||||
Additional milestone payment | $ 75 | |||||||
Eisai | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Loss on equity method investment | $ 45 | $ 45 | ||||||
Additional milestone payment | 100 | 100 | $ 75 | 100 | $ 75 | |||
Eisai | Regulatory Milestones | Neurimmune | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party | 100 | 100 | 100 | |||||
Eisai | Regulatory Milestones | JAPAN | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party | 50 | 50 | 50 | |||||
Eisai | Regulatory Milestones | Europe | ADUHELM | ||||||||
Variable Interest Entity [Line Items] | ||||||||
Potential future milestone payments commitment to third party | $ 50 | $ 50 | $ 50 |
Litigation (Details)
Litigation (Details) $ in Millions | Dec. 31, 2020USD ($) |
Loss Contingency, Information about Litigation Matters [Abstract] | |
Loss Contingency, Estimate of Possible Loss | $ 200 |
Subsequent Events (Details)
Subsequent Events (Details) - InnoCare Pharma Limited (InnoCare) Agreement - Subsequent Event - Forecast $ in Millions | 6 Months Ended |
Dec. 31, 2021USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Upfront and milestone payments made to collaborative partner | $ 125 |
Potential future milestone payments commitment to third party | $ 812.5 |