Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 24, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
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 | 2022 | |
Document Fiscal Period Focus | Q3 | |
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, $0.0005 par value | |
Trading Symbol | BIIB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 144,001,404 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Income (Unaudited) - USD ($) shares in Thousands, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Total revenue | $ 2,508.5 | $ 2,778.9 | $ 7,629.4 | $ 8,247.9 |
Cost and expenses: | ||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | 469.5 | 511.8 | 1,707.4 | 1,449.6 |
Research and development | 549.2 | 702.4 | 1,629.5 | 1,801.7 |
Selling, general and administrative | 563.3 | 654.1 | 1,770.8 | 1,886.4 |
Amortization and impairment of acquired intangible assets | 56.5 | 111 | 190.9 | 813.2 |
Collaboration profit (loss) sharing | 45.3 | 21.2 | (42.6) | 74.5 |
(Gain) loss on fair value remeasurement of contingent consideration | (2.1) | (15.6) | (13.7) | (49.1) |
Acquired in-process research and development | 0 | 0 | 0 | 18 |
Restructuring charges | 15.4 | 0 | 124.1 | 0 |
Gain on sale of building | (503.7) | 0 | (503.7) | 0 |
Other (income) expense, net | (56) | 502.9 | (221.3) | 913.4 |
Total cost and expense | 1,137.4 | 2,487.8 | 4,641.4 | 6,907.7 |
Income before income tax expense and equity in loss of investee, net of tax | 1,371.1 | 291.1 | 2,988 | 1,340.2 |
Income tax (benefit) expense | 236.2 | (25.9) | 578.5 | (390.7) |
Equity in (income) loss of investee, net of tax | 0 | (1.1) | (2.6) | (17.2) |
Net income | 1,134.9 | 318.1 | 2,412.1 | 1,748.1 |
Net income (loss) attributable to noncontrolling interests, net of tax | 0.2 | (11.1) | (84.4) | 560.2 |
Net income attributable to Biogen Inc. | $ 1,134.7 | $ 329.2 | $ 2,496.5 | $ 1,187.9 |
Net income per share: | ||||
Basic earnings per share attributable to Biogen Inc. | $ 7.86 | $ 2.22 | $ 17.12 | $ 7.93 |
Diluted earnings per share attributable to Biogen Inc. | $ 7.84 | $ 2.22 | $ 17.07 | $ 7.90 |
Weighted-average shares used in calculating: | ||||
Basic earnings per share attributable to Biogen Inc. | 144,400 | 148,000 | 145,800 | 149,900 |
Diluted earnings per share attributable to Biogen Inc. | 144,800 | 148,600 | 146,200 | 150,300 |
Product, net | ||||
Total revenue | $ 1,962.1 | $ 2,205.7 | $ 6,083.3 | $ 6,653.4 |
Revenue from anti-CD20 therapeutic programs | ||||
Total revenue | 416.9 | 415.4 | 1,252.6 | 1,244.4 |
Other | ||||
Total revenue | $ 129.5 | $ 157.8 | $ 293.5 | $ 350.1 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Unaudited) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income attributable to Biogen Inc. | $ 1,134.7 | $ 329.2 | $ 2,496.5 | $ 1,187.9 |
Other comprehensive income: | ||||
Unrealized gains (losses) on securities available for sale, net of tax | (1) | 0.1 | (19) | (1.4) |
Unrealized gains (losses) on cash flow hedges, net of tax | 5.9 | 66.2 | 79 | 205 |
Gains (losses) on net investment hedges, net of tax | 0 | 15.1 | (25.5) | 35.2 |
Unrealized gains (losses) on pension benefit obligation, net of tax | 1.5 | 1.5 | 4.2 | 3.9 |
Currency translation adjustment | (59.6) | (47.7) | (95.6) | (80.3) |
Total other comprehensive income (loss), net of tax | (53.2) | 35.2 | (56.9) | 162.4 |
Comprehensive income (loss) attributable to Biogen Inc. | 1,081.5 | 364.4 | 2,439.6 | 1,350.3 |
Comprehensive income (loss) attributable to noncontrolling interests, net of tax | 0.2 | (11.1) | (84.4) | 560.8 |
Comprehensive income (loss) attributable to noncontrolling interests, net of tax | $ 1,081.7 | $ 353.3 | $ 2,355.2 | $ 1,911.1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 3,675.6 | $ 2,261.4 |
Marketable securities | 1,235.5 | 1,541.1 |
Accounts receivable, net | 1,568.8 | 1,549.4 |
Due from anti-CD20 therapeutic programs | 415.4 | 412.3 |
Inventory | 1,375 | 1,351.5 |
Other current assets | 1,495.5 | 740.8 |
Total current assets | 9,765.8 | 7,856.5 |
Marketable securities | 860.3 | 892 |
Property, plant and equipment, net | 3,266.4 | 3,416.4 |
Operating lease assets | 424.5 | 375.4 |
Intangible assets, net | 2,008.9 | 2,221.3 |
Goodwill | 5,741.2 | 5,761.1 |
Deferred tax asset | 1,174.5 | 1,415.1 |
Investments and other assets | 1,612.6 | 1,939.5 |
Total assets | 24,854.2 | 23,877.3 |
Current liabilities: | ||
Current portion of notes payable | 0 | 999.1 |
Taxes payable | 237.3 | 174.7 |
Accounts payable | 383.2 | 589.2 |
Accrued expense and other | 3,305.9 | 2,535.2 |
Total current liabilities | 3,926.4 | 4,298.2 |
Notes payable | 6,279.2 | 6,274 |
Deferred tax liability | 328.9 | 694.5 |
Long-term operating lease liabilities | 354.8 | 330.4 |
Other long-term liabilities | 1,198.1 | 1,320.5 |
Total liabilities | 12,087.4 | 12,917.6 |
Commitments, contingencies and guarantees | ||
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 | 68.2 |
Accumulated other comprehensive income (loss) | (163.6) | (106.7) |
Retained earnings | 15,916.1 | 13,911.7 |
Treasury stock, at cost | (2,977.1) | (2,977.1) |
Total Biogen Inc. shareholders’ equity | 12,775.5 | 10,896.2 |
Noncontrolling interests | (8.7) | 63.5 |
Total equity | 12,766.8 | 10,959.7 |
Total liabilities and equity | $ 24,854.2 | $ 23,877.3 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flow from operating activities: | ||
Net income | $ 2,412.1 | $ 1,748.1 |
Adjustments to reconcile net income to net cash flow from operating activities: | ||
Depreciation and amortization | 398.6 | 353 |
Impairment of intangible assets | 0 | 629.3 |
Excess and obsolescence charges related to inventory | 321.6 | 36.5 |
Acquired in-process research and development | 0 | 18 |
Share-based compensation | 186.9 | 179.8 |
Contingent consideration | (13.7) | (49.1) |
Deferred income taxes | (139.8) | (750.1) |
(Gain) loss on strategic investments | 160.3 | 710.5 |
(Gain) loss on equity method investments | (2.6) | (17.2) |
Gain on sale of equity interest in Samsung Bioepis | (1,505.4) | 0 |
Gain on sale of building | (503.7) | 0 |
Other | 147.8 | 164.5 |
Changes in operating assets and liabilities, net: | ||
Accounts receivable | (109.5) | 157.8 |
Due from anti-CD20 therapeutic programs | (3) | 13.5 |
Inventory | (338.3) | (322.6) |
Accrued expense and other current liabilities | 632.3 | (243.3) |
Income tax assets and liabilities | (100.2) | 260.5 |
Other changes in operating assets and liabilities, net | 15.9 | (87.6) |
Net cash flow provided by (used in) operating activities | 1,559.3 | 2,801.6 |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (153.9) | (206.5) |
Proceeds from sales and maturities of marketable securities | 3,104.7 | 2,028.1 |
Purchases of marketable securities | (2,805.9) | (2,372.6) |
Proceeds from sale of equity interest in Samsung Bioepis | (990.3) | 0 |
Proceeds from sale of building | 582.6 | 0 |
Proceeds from divestiture of Hillerød, Denmark manufacturing operations | 0 | 28.1 |
Acquired in-process research and development | 0 | (18) |
Acquisitions of intangible assets | (1.9) | (1.9) |
Proceeds from sales of strategic investments | 0 | 91.2 |
Other | 1.8 | 0.6 |
Net cash flow provided by (used in) investing activities | 1,717.7 | (451) |
Cash flows from financing activities: | ||
Purchases of treasury stock | (750) | (1,800) |
Payments related to issuance of stock for share-based compensation arrangements, net | (5.8) | (8.3) |
Repayment of borrowings and premiums paid | (1,002.2) | (170) |
Net (distribution) contribution to noncontrolling interest | 12.2 | (94.8) |
Other | 5.9 | (22.9) |
Net cash flow provided by (used in) financing activities | (1,739.9) | (2,096) |
Net increase (decrease) in cash and cash equivalents | 1,537.1 | 254.6 |
Effect of exchange rate changes on cash and cash equivalents | (122.9) | (44) |
Cash and cash equivalents, beginning of the period | 2,261.4 | 1,331.2 |
Cash and cash equivalents, end of the period | $ 3,675.6 | $ 1,541.8 |
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 | 2020 Share Repurchase Program | 2020 Share Repurchase Program Common stock | 2020 Share Repurchase Program Additional paid-in capital | 2020 Share Repurchase Program Retained earnings | 2020 Share Repurchase Program Treasury stock | 2020 Share Repurchase Program Parent |
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 | 1,748.1 | 1,187.9 | 1,187.9 | 560.2 | |||||||||||
Other comprehensive income (loss), net of tax | 163 | 162.4 | 162.4 | 0.6 | |||||||||||
Capital contribution from noncontrolling interest | 5.2 | 5.2 | |||||||||||||
Distribution to noncontrolling interest | (100) | (100) | |||||||||||||
Repurchase of common stock, at cost, shares | (6) | (6) | |||||||||||||
Repurchase of common stock, at cost | $ (1,800) | $ (1,800) | $ (1,800) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (6) | (6) | |||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | $ (231.9) | $ (1,568.1) | $ 1,800 | ||||||||||||
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 | 44.3 | 44.3 | 44.3 | ||||||||||||
Issuance of common stock under award plan, shares | 0.3 | ||||||||||||||
Issuance of common stock under stock award plan | (52.6) | (52.6) | (52.6) | ||||||||||||
Compensation related to share-based payments | 186.1 | 186.1 | 186.1 | ||||||||||||
Other | 1.5 | 1.5 | 1.5 | ||||||||||||
Ending balance at Sep. 30, 2021 | 10,881.7 | $ 0 | $ 0.1 | 0 | (136.6) | 13,543.5 | $ (2,977.1) | 10,429.9 | 451.8 | ||||||
Ending balance, shares at Sep. 30, 2021 | 0 | 170.7 | 23.8 | ||||||||||||
Beginning balance, shares at Jun. 30, 2021 | 0 | 172.9 | 23.8 | ||||||||||||
Beginning 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 | ||||||
Net income | 318.1 | 329.2 | 329.2 | (11.1) | |||||||||||
Other comprehensive income (loss), net of tax | 35.2 | 35.2 | 35.2 | 0 | |||||||||||
Repurchase of common stock, at cost, shares | (2.2) | (2.2) | |||||||||||||
Repurchase of common stock, at cost | $ (750) | $ (750) | (750) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (2.2) | (2.2) | |||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | (68.6) | (681.4) | $ 750 | ||||||||||||
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 | 11 | 11 | ||||||||||||
Issuance of common stock under award plan, shares | 0 | ||||||||||||||
Issuance of common stock under stock award plan | (5) | (5) | (5) | ||||||||||||
Compensation related to share-based payments | 57.6 | 57.6 | 57.6 | ||||||||||||
Ending balance at Sep. 30, 2021 | 10,881.7 | $ 0 | $ 0.1 | 0 | (136.6) | 13,543.5 | $ (2,977.1) | 10,429.9 | 451.8 | ||||||
Ending balance, shares at Sep. 30, 2021 | 0 | 170.7 | 23.8 | ||||||||||||
Beginning balance, shares at Dec. 31, 2021 | 0 | 170.8 | 23.8 | ||||||||||||
Beginning balance at Dec. 31, 2021 | 10,959.7 | $ 0 | $ 0.1 | 68.2 | (106.7) | 13,911.7 | $ (2,977.1) | 10,896.2 | 63.5 | ||||||
Net income | 2,412.1 | 2,496.5 | 2,496.5 | (84.4) | |||||||||||
Other comprehensive income (loss), net of tax | (56.9) | (56.9) | (56.9) | ||||||||||||
Capital contribution from noncontrolling interest | 12.2 | 12.2 | |||||||||||||
Repurchase of common stock, at cost, shares | (3.6) | ||||||||||||||
Repurchase of common stock, at cost | $ (750) | $ (750) | (750) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (3.6) | (3.6) | (3.6) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | $ (750) | (257.9) | (492.1) | $ 750 | |||||||||||
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 | 37.5 | 37.5 | 37.5 | ||||||||||||
Issuance of common stock under award plan, shares | 0.4 | ||||||||||||||
Issuance of common stock under stock award plan | (43.2) | (43.2) | (43.2) | ||||||||||||
Compensation related to share-based payments | 194.1 | 194.1 | 194.1 | ||||||||||||
Other | 1.3 | 1.3 | 1.3 | ||||||||||||
Ending balance at Sep. 30, 2022 | 12,766.8 | $ 0 | $ 0.1 | 0 | (163.6) | 15,916.1 | $ (2,977.1) | 12,775.5 | (8.7) | ||||||
Ending balance, shares at Sep. 30, 2022 | 0 | 167.8 | 23.8 | ||||||||||||
Beginning balance, shares at Jun. 30, 2022 | 0 | 169 | 23.8 | ||||||||||||
Beginning balance at Jun. 30, 2022 | 11,863.4 | $ 0 | $ 0.1 | 0 | (110.4) | 14,959.9 | $ (2,977.1) | 11,872.5 | (9.1) | ||||||
Net income | 1,134.9 | 1,134.7 | 1,134.7 | 0.2 | |||||||||||
Other comprehensive income (loss), net of tax | (53.2) | (53.2) | (53.2) | ||||||||||||
Capital contribution from noncontrolling interest | 0.2 | 0.2 | |||||||||||||
Repurchase of common stock, at cost, shares | (1.2) | ||||||||||||||
Repurchase of common stock, at cost | $ (250) | $ (250) | $ (250) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Programs, at cost, shares | (1.2) | (1.2) | (1.2) | ||||||||||||
Retirement of common stock pursuant to Share Repurchase Progams, at cost | 0 | $ (250) | $ (71.5) | $ (178.5) | $ 250 | ||||||||||
Issuance of common stock under stock option and stock purchase plans, shares | 0 | ||||||||||||||
Issuance of common stock under stock option and stock purchase plans | 8.6 | 8.6 | 8.6 | ||||||||||||
Issuance of common stock under award plan, shares | 0 | ||||||||||||||
Issuance of common stock under stock award plan | (2.8) | (2.8) | (2.8) | ||||||||||||
Compensation related to share-based payments | 65.7 | 65.7 | 65.7 | ||||||||||||
Other | 0 | 0 | 0 | ||||||||||||
Ending balance at Sep. 30, 2022 | $ 12,766.8 | $ 0 | $ 0.1 | $ 0 | $ (163.6) | $ 15,916.1 | $ (2,977.1) | $ 12,775.5 | $ (8.7) | ||||||
Ending balance, shares at Sep. 30, 2022 | 0 | 167.8 | 23.8 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
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. We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and developed the first and only approved treatment to address a defining pathology of Alzheimer's disease. We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology. Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group. For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships, to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 (2021 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 collaboration with Samsung Bioepis Co., Ltd. (Samsung Bioepis) 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, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, 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 2021 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2021 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 nine months ended September 30, 2022, 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, net of tax in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners. Use of Estimates The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates. The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, the supply chain, manufacturing, clinical trials, research and development costs and employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets. Additionally, the ongoing geopolitical tensions related to the conflict in Ukraine, and the related sanctions and other penalties imposed, are creating substantial uncertainty in the global economy. The extent and duration of the conflict, sanctions and resulting market disruptions are highly unpredictable. We have made estimates of the impact of the COVID-19 pandemic and the ongoing geopolitical conflict within our condensed consolidated financial statements and there may be changes to those estimates in future periods. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the 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 had or may have a material impact on our condensed consolidated financial statements or disclosures. Fair Value Measurements |
Restructuring, Business Transfo
Restructuring, Business Transformation and Other Cost Saving Initiatives | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring, Business Transformation and Other Cost Saving Initiatives | RESTRUCTURING 2022 Cost Saving Initiatives In December 2021 and May 2022 we announced our plans to implement a series of cost-reduction measures during 2022. These savings are being achieved through a number of initiatives, including reductions to our workforce, the substantial elimination of our commercial ADUHELM infrastructure, the consolidation of certain real estate locations and operating efficiencies across our selling, general and administrative and research and development functions. Under these initiatives, we expect to incur restructuring charges ranging from approximately $130.0 million to $150.0 million. These amounts are primarily related to severance and are expected to be substantially incurred and paid by the end of 2022. For the three and nine months ended September 30, 2022, we recognized approximately $15.4 million and $124.1 million, respectively, of net pre-tax restructuring charges related to our 2022 cost saving initiatives, of which approximately $21.6 million and $110.2 million, respectively, consisted of employee severance costs. These costs were recorded in restructuring charges in our condensed consolidated statements of income. Our restructuring reserve is included in accrued expense and other in our condensed consolidated balance sheets. In September 2022 we entered into an agreement to partially terminate a portion of our lease located at 300 Binney Street, Cambridge, MA (300 Binney Street), as well as to reduce the lease term for the majority of the remaining space. This resulted in a gain of approximately $5.3 million, which was recorded within restructuring charges in our condensed consolidated statements of income for the three and nine months ended September 30, 2022. For additional information on our 300 Binney Street lease modification, please read Note 11, Leases , to these condensed consolidated financial statements. Following an evaluation of our current capacity needs, in March 2022 we ceased using a patient services office space in Durham, North Carolina. Our decision to cease use of the facility resulted in the immediate expense of certain leasehold improvements and other assets at this facility. As a result, for the nine months ended September 30, 2022, we recognized approximately $10.4 million of accelerated depreciation expense, which was recorded in restructuring charges in our condensed consolidated statements of income. In May 2022 we entered into a lease assignment agreement whereby we assigned our remaining lease obligations to an external third party. As a result of the lease assignment, we derecognized the related operating lease obligation and right-of-use asset during the second quarter of 2022. For the nine months ended September 30, 2022, we recognized other restructuring costs of approximately $8.8 million, which were recorded in restructuring charges in our condensed consolidated statements of income. Other restructuring costs include items such as facility closure costs, employee non-severance expense, asset write-offs and other costs. The following table summarizes the charges and spending related to our 2022 workforce reductions for the three and nine months ended September 30, 2022: (In millions) Total Restructuring reserve as of December 31, 2021 $ — Expense 27.7 Payment (6.2) Restructuring reserve as of March 31, 2022 21.5 Expense 60.9 Payment (29.7) Foreign currency and other adjustments (0.5) Restructuring reserve as of June 30, 2022 52.2 Expense 21.6 Payment (32.3) Foreign currency and other adjustments (1.3) Restructuring reserve as of September 30, 2022 $ 40.2 |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Product Revenue Revenue by product is summarized as follows: For the Three Months Ended September 30, 2022 2021 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): TECFIDERA $ 92.5 $ 246.5 $ 339.0 $ 179.2 $ 319.4 $ 498.6 VUMERITY (1) 127.9 9.9 137.8 120.7 0.2 120.9 Total Fumarate 220.4 256.4 476.8 299.9 319.6 619.5 AVONEX 174.8 80.3 255.1 213.2 88.1 301.3 PLEGRIDY 39.7 41.2 80.9 39.2 47.0 86.2 Total Interferon 214.5 121.5 336.0 252.4 135.1 387.5 TYSABRI 273.0 232.5 505.5 281.1 241.7 522.8 FAMPYRA — 22.0 22.0 — 26.2 26.2 Subtotal: MS 707.9 632.4 1,340.3 833.4 722.6 1,556.0 Spinal Muscular Atrophy: SPINRAZA 140.2 290.9 431.1 139.8 304.3 444.1 Biosimilars: BENEPALI — 110.2 110.2 — 120.8 120.8 IMRALDI — 57.7 57.7 — 57.4 57.4 FLIXABI — 19.0 19.0 — 24.6 24.6 BYOOVIZ (2) 0.7 — 0.7 — — — Subtotal: Biosimilars 0.7 186.9 187.6 — 202.8 202.8 Other: FUMADERM — 1.5 1.5 — 2.5 2.5 ADUHELM 1.6 — 1.6 0.3 — 0.3 Total product revenue $ 850.4 $ 1,111.7 $ 1,962.1 $ 973.5 $ 1,232.2 $ 2,205.7 (1) VUMERITY became commercially available in the European Union (E.U.) during the fourth quarter of 2021. (2) BYOOVIZ launched in the United States (U.S.) in June 2022 and became commercially available during the third quarter of 2022. For the Nine Months Ended September 30, 2022 2021 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): TECFIDERA $ 330.3 $ 816.5 $ 1,146.8 $ 520.1 $ 945.3 $ 1,465.4 VUMERITY (1) 383.0 19.6 402.6 285.0 0.5 285.5 Total Fumarate 713.3 836.1 1,549.4 805.1 945.8 1,750.9 AVONEX 493.8 249.6 743.4 636.4 286.9 923.3 PLEGRIDY 114.2 138.2 252.4 115.2 149.9 265.1 Total Interferon 608.0 387.8 995.8 751.6 436.8 1,188.4 TYSABRI 849.4 693.1 1,542.5 854.2 696.2 1,550.4 FAMPYRA — 73.7 73.7 — 78.8 78.8 Subtotal: MS 2,170.7 1,990.7 4,161.4 2,410.9 2,157.6 4,568.5 Spinal Muscular Atrophy: SPINRAZA 443.3 891.4 1,334.7 437.8 1,026.6 1,464.4 Biosimilars: BENEPALI — 340.7 340.7 — 363.9 363.9 IMRALDI — 172.4 172.4 — 170.9 170.9 FLIXABI — 62.0 62.0 — 75.4 75.4 BYOOVIZ (2) 1.2 — 1.2 — — — Subtotal: Biosimilars 1.2 575.1 576.3 — 610.2 610.2 Other: FUMADERM — 6.4 6.4 — 8.3 8.3 ADUHELM 4.5 — 4.5 2.0 — 2.0 Total product revenue $ 2,619.7 $ 3,463.6 $ 6,083.3 $ 2,850.7 $ 3,802.7 $ 6,653.4 (1) VUMERITY became commercially available in the E.U. during the fourth quarter of 2021. (2) BYOOVIZ launched in the U.S. in June 2022 and became commercially available during the third quarter of 2022. We recognized revenue from two wholesalers accounting for 26.9% and 10.5% of gross product revenue for the three months ended September 30, 2022, and 26.8% and 10.7% of gross product revenue for the nine months ended September 30, 2022. We recognized revenue from two wholesalers accounting for 26.9% and 10.8% of gross product revenue for the three months ended September 30, 2021, and 29.1% and 10.0% of gross product revenue for the nine months ended September 30, 2021. An analysis of the change in reserves for discounts and allowances is summarized as follows: (In millions) Discounts Contractual Returns Total Balance, December 31, 2021 $ 137.7 $ 759.6 $ 38.0 $ 935.3 Current provisions relating to sales in current year 499.3 1,993.6 8.5 2,501.4 Adjustments relating to prior years (2.5) (18.4) (7.7) (28.6) Payments/credits relating to sales in current year (379.6) (1,442.0) — (1,821.6) Payments/credits relating to sales in prior years (124.5) (463.7) (14.4) (602.6) Balance, September 30, 2022 $ 130.4 $ 829.1 $ 24.4 $ 983.9 The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows: (In millions) As of September 30, 2022 As of December 31, 2021 Reduction of accounts receivable $ 129.4 $ 133.2 Component of accrued expense and other 854.5 802.1 Total revenue-related reserves $ 983.9 $ 935.3 Revenue from Anti-CD20 Therapeutic Programs Revenue from anti-CD20 therapeutic programs is summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Biogen’s share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 131.1 $ 145.8 $ 414.2 $ 498.7 OCREVUS and other revenue from anti-CD20 therapeutic programs 285.8 269.6 838.4 745.7 Total revenue from anti-CD20 therapeutic programs $ 416.9 $ 415.4 $ 1,252.6 $ 1,244.4 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 2021 Form 10-K. Other Revenue Other revenue is summarized as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 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 $ 6.5 $ 6.3 $ 20.9 $ 15.7 Other royalty and corporate revenue: Royalty 8.8 7.7 29.7 20.3 Other corporate 114.2 143.8 242.9 314.1 Total other revenue $ 129.5 $ 157.8 $ 293.5 $ 350.1 We receive royalties from net sales on products related to patents that we have out-licensed and we record other corporate revenue primarily from amounts earned under contract manufacturing agreements. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | The components of inventory are summarized as follows: (In millions) As of September 30, 2022 As of December 31, 2021 Raw materials $ 394.2 $ 349.6 Work in process (1) 771.0 814.0 Finished goods 209.8 187.9 Total inventory $ 1,375.0 $ 1,351.5 (1) Work in process inventory as of September 30, 2022, includes approximately $118.0 million related to lecanemab. In April 2022 the Centers for Medicare and Medicaid Services (CMS) released the final National Coverage Decision (NCD) for the class of anti-amyloid treatments in Alzheimer’s disease, including ADUHELM. The final NCD confirmed coverage with evidence development, in which patients with Medicare can only access treatment if they are part of an approved clinical trial. We expect that this decision will reduce future demand for ADUHELM to a minimal level. During the first quarter of 2022 we wrote-off approximately $275.0 million of inventory related to ADUHELM, as a result of this CMS decision, which was recognized in cost of sales within our condensed consolidated statements of income for the nine months ended September 30, 2022 . We have recognized approximately $136.0 million related to Eisai's 45.0% share of these charges in collaboration profit (loss) sharing within our condensed consolidated statements of income for the nine months ended September 30, 2022. During the fourth quarter of 2021 we wrote-off approximately $120.0 million of inventory in excess of forecasted demand related to ADUHELM, which was recognized in cost of sales within our condensed consolidated statements of income for the year ended December 31, 2021. We have recognized approximately $59.0 million related to Eisai's 45.0% share of these charges in collaboration profit (loss) sharing within our condensed consolidated statements of income for the year ended December 31, 2021. As of September 30, 2022, the carrying value of our ADUHELM inventory was de minimis. As of December 31, 2021, we had approximately $223.0 million of ADUHELM inventory. For additional information please read Note 18, Collaborative and Other Relationships , to these condensed consolidated financial statements. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 As of December 31, 2021 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,415.0 $ (5,579.4) $ 1,835.6 $ 7,413.1 $ (5,388.5) $ 2,024.6 In-process research and development Indefinite until commercialization 109.3 — 109.3 132.7 — 132.7 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,588.3 $ (5,579.4) $ 2,008.9 $ 7,609.8 $ (5,388.5) $ 2,221.3 Amortization and Impairments For the three and nine months ended September 30, 2022, amortization and impairment of acquired intangible assets totaled $56.5 million and $190.9 million, respectively, compared to $111.0 million and $813.2 million, respectively, in the prior year comparative periods. For the three and nine months ended September 30, 2022, we had no impairment charges. For the three and nine months ended September 30, 2021, amortization and impairment of acquired intangible assets reflects impairment charges of $15.0 million and $365.0 million, respectively, related to BIIB111 (timrepigene emparvovec) for the potential treatment of choroideremia and impairment charges of $28.4 million and $220.0 million, respectively, related to BIIB112 (cotoretigene toliparvovec) for the potential treatment of X-linked retinitis pigmentosa. For the nine months ended September 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). 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 In-process research and development (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 September 30, 2022, relates to the IPR&D programs we acquired in connection with our acquisition of Convergence Pharmaceuticals Holdings Ltd. (Convergence). Vixotrigine In the periods since we acquired vixotrigine, there have been numerous delays in the initiation of Phase 3 studies for the potential treatment of TGN and for the potential treatment of diabetic painful neuropathy (DPN), another form of neuropathic pain. We have engaged with the U.S. Food and Drug Administration (FDA) regarding the design of the Phase 3 studies of vixotrigine for the potential treatment of TGN and DPN and are now performing an additional clinical trial of vixotrigine, which is expected to be completed by the end of 2022. 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 fi rst quarter of 2021. As of September 30, 2022, the carrying value associated with the remaining vixotrigine IPR&D intangible asset for DPN was $109.3 million a nd the fair value of this asset was not significantly in excess of its carrying value. We will reassess the carrying value of this program upon conclusion of the ongoing clinical trial, or sooner if there is a reevaluation event, and may record an impairment charge related to this asset. BIIB111 and BIIB112 During the second quarter of 2021 we announced that our Phase 3 STAR study of BIIB111 and our Phase 2/3 XIRIUS study of BIIB112 did not meet their primary endpoints. In the third quarter of 2021 we suspended further development on these programs based on the decision by management as part of its strategic review process. For the three and nine months ended September 30, 2021, we recognized impairment charges of $15.0 million and $365.0 million, respectively, related to BIIB111, and impairment charges of $28.4 million and $220.0 million, respectively, related to BIIB112, reducing the remaining book values of these IPR&D intangible assets to zero. In addition, as a result of our decision to suspend further development of BIIB111 and BIIB112, we recorded charges of approximately $39.1 million during the third quarter of 2021 related to our manufacturing arrangements and other costs that we expect to incur as a result of suspending 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 September 30, 2022 2022 (remaining three months) $ 55.0 2023 215.0 2024 195.0 2025 190.0 2026 175.0 2027 165.0 Goodwill The following table provides a roll forward of the changes in our goodwill balance: (In millions) As of September 30, 2022 Goodwill, December 31, 2021 $ 5,761.1 Other (19.9) Goodwill, September 30, 2022 $ 5,741.2 As of September 30, 2022, we had no ac |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
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: Fair Value Measurements on a Recurring Basis As of September 30, 2022 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 3,191.8 $ — $ 3,191.8 $ — Marketable debt securities: Corporate debt securities 1,219.1 — 1,219.1 — Government securities 702.0 — 702.0 — Mortgage and other asset backed securities 174.7 — 174.7 — Marketable equity securities 896.0 896.0 — — Other current assets: Receivable from Samsung BioLogics (1) 790.8 — — 790.8 Other assets: Derivative contracts 195.9 — 195.9 — Plan assets for deferred compensation 32.2 — 32.2 — Receivable from Samsung BioLogics (1) 402.8 — — 402.8 Total $ 7,605.3 $ 896.0 $ 5,515.7 $ 1,193.6 Liabilities: Derivative contracts $ 22.8 $ — $ 22.8 $ — Contingent consideration obligations 195.4 — — 195.4 Total $ 218.2 $ — $ 22.8 $ 195.4 (1) Represents the fair value of the current and non-current payments due from Samsung BioLogics as a result of the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics during the second quarter of 2022, for which we elected the fair value option. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. Fair Value Measurements on a Recurring Basis As of December 31, 2021 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 1,632.2 $ — $ 1,632.2 $ — Marketable debt securities: Corporate debt securities 1,108.2 — 1,108.2 — Government securities 1,192.7 — 1,192.7 — Mortgage and other asset backed securities 132.2 — 132.2 — Marketable equity securities 1,048.5 181.7 866.8 — Derivative contracts 80.9 — 80.9 — Plan assets for deferred compensation 33.4 — 33.4 — Total $ 5,228.1 $ 181.7 $ 5,046.4 $ — Liabilities: Derivative contracts $ 10.8 $ — $ 10.8 $ — Contingent consideration obligations 209.1 — — 209.1 Total $ 219.9 $ — $ 10.8 $ 209.1 The fair value of Level 2 instruments classified as cash equivalents and marketable debt securities was determined through third-party pricing services. As of September 30, 2022, we elected to early adopt ASU 2022-03 on a prospective basis, which resulted in removing the impact of contractual sale restrictions from the fair value measurement of our remaining Sage common stock subject to certain holding period restrictions. As of September 30, 2022, our entire investment in the common stock of Sage was classified as a Level 1 measurement. Prior to the adoption of this standard, the fair value of Level 2 instruments classified as marketable equity securities represented a portion of our investment in the common stock of Sage and was valued using an option pricing valuation model. The initial holding period restriction for a portion of our investment in the common stock of Sage expired during the second quarter of 2022 with the remaining holding period restriction set to expire in the fourth quarter of 2022. Our investments in the common stock of Sangamo Therapeutics, Inc. (Sangamo) and Denali Therapeutics Inc. (Denali) had holding period restrictions that expired during 2022. As of September 30, 2022, the fair values of our investments in Sangamo and Denali common stock were classified as Level 1 measurements. Prior to the expiration of these holding period restrictions the investments were classified as Level 2 measurements. For additional information on our investments in Sangamo, Denali and Sage common stock, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in our 2021 Form 10-K. There have been no material impairments of our assets measured and carried at fair value as of September 30, 2022 and December 31, 2021. There have been no significant changes to our valuation techniques as of September 30, 2022 and December 31, 2021. 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 2021 Form 10-K. Level 3 Assets and Liabilities Held at Fair Value The following table presents quantitative information, as of the dates indicated, about the valuation techniques and significant unobservable inputs used in the valuation of our level 3 financial assets and liabilities measured at fair value on a recurring basis: Quantitative Information about Level 3 Fair Value Measurements Fair Value Weighted Average (In millions) September 30, 2022 December 31, 2021 Valuation Technique Significant Range September 30, 2022 December 31, 2021 Liabilities: Contingent consideration obligations $ 195.4 $ 209.1 Discounted cash flow Discount rate 4.50% 4.50 % 1.30 % Expected timing of achievement of development milestones 2023 to 2028 — — The weighted average discount rates were calculated based on the relative fair value of our contingent consideration obligations. In addition, we apply various probabilities of technological and regulatory success to the valuation models to estimate the fair values of our contingent consideration obligations, which ranged from 10.9% to certain probability as of September 30, 2022 and December 31, 2021. There were no transfers of assets or liabilities into or out of Level 3 as of September 30, 2022 and December 31, 2021. 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 are classified as Level 3 measurements: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Fair value, beginning of period $ 197.5 $ 226.3 $ 209.1 $ 259.8 Changes in fair value (2.1) (15.6) (13.7) (49.1) Fair value, end of period $ 195.4 $ 210.7 $ 195.4 $ 210.7 As of September 30, 2022 and December 31, 2021, approximately $195.4 million and $209.1 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 any remaining balances reflected as a component of accrued expense and other. Changes in the fair values of our contingent consideration obligations are recorded in (gain) loss on fair value remeasurement of contingent consideration in our condensed consolidated statements of income. For the three and nine months ended September 30, 2022, the changes in the fair value of our contingent consideration obligations were primarily due to increases in the discount rates used to revalue these obligations and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs. For the three and nine months ended September 30, 2021, the changes in the fair value of our contingent consideration obligations were primarily due to reductions in the probability of technical and regulatory success and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs. Financial Instruments Not Carried at Fair Value Other Financial Instruments Due to the short-term nature of certain financial instruments, the carrying value reflected in our condensed consolidated balance sheets for current accounts receivable, due from anti-CD20 therapeutic programs, other current assets, accounts payable and accrued expense and other, approximates fair value. Debt Instruments The fair and carrying values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of September 30, 2022 As of December 31, 2021 (In millions) Fair Carrying Fair Carrying 3.625% Senior Notes due September 15, 2022 (1) $ — $ — $ 1,020.0 $ 999.1 4.050% Senior Notes due September 15, 2025 1,697.8 1,744.3 1,895.2 1,742.9 2.250% Senior Notes due May 1, 2030 1,183.0 1,492.7 1,475.9 1,492.0 5.200% Senior Notes due September 15, 2045 997.2 1,100.2 1,463.0 1,099.9 3.150% Senior Notes due May 1, 2050 965.6 1,473.6 1,457.7 1,473.2 3.250% Senior Notes due February 15, 2051 452.8 468.4 692.9 466.0 Total $ 5,296.4 $ 6,279.2 $ 8,004.7 $ 7,273.1 (1) Our 3.625% Senior Notes due September 15, 2022, were redeemed in full in July 2022. For additional information, please read Note 12, 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. The changes in the fair values of our Senior Notes as of September 30, 2022, compared to December 31, 2021, are related to increases in U.S. treasury yields and wider credit spreads used to value our Senior Notes since December 31, 2021. For additional information related to our Senior Notes, please read Note 12, Indebtedness, to our consolidated financial statements included in our 2021 Form 10-K. |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 As of December 31, 2021 Commercial paper $ 3.2 $ 247.6 Overnight reverse repurchase agreements 115.5 200.0 Money market funds 3,070.6 901.6 Short-term debt securities 2.5 283.0 Total $ 3,191.8 $ 1,632.2 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 September 30, 2022 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 833.6 $ — $ (6.9) $ 826.7 Non-current 400.5 — (8.1) 392.4 Government securities: Current 412.1 0.1 (3.5) 408.7 Non-current 298.8 — (5.5) 293.3 Mortgage and other asset backed securities: Current 0.1 — — 0.1 Non-current 177.6 — (3.0) 174.6 Total marketable debt securities $ 2,122.7 $ 0.1 $ (27.0) $ 2,095.8 Marketable equity securities Marketable equity securities, non-current $ 1,133.8 $ — $ (237.8) $ 896.0 Total marketable equity securities $ 1,133.8 $ — $ (237.8) $ 896.0 As of December 31, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 723.6 $ 0.1 $ (0.3) $ 723.4 Non-current 385.4 0.2 (0.8) 384.8 Government securities: Current 817.0 — (0.4) 816.6 Non-current 377.0 0.1 (1.0) 376.1 Mortgage and other asset backed securities: Current 1.1 — — 1.1 Non-current 131.8 — (0.7) 131.1 Total marketable debt securities $ 2,435.9 $ 0.4 $ (3.2) $ 2,433.1 Marketable equity securities Marketable equity securities, current $ 33.9 $ 9.9 $ — $ 43.8 Marketable equity securities, non-current 1,133.1 151.0 (279.4) 1,004.7 Total marketable equity securities $ 1,167.0 $ 160.9 $ (279.4) $ 1,048.5 Summary of Contractual Maturities: Available-for-Sale Debt Securities The estimated fair value and amortized cost of our marketable debt securities classified as available-for-sale by contractual maturity are summarized as follows: As of September 30, 2022 As of December 31, 2021 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,235.5 $ 1,245.8 $ 1,541.1 $ 1,541.7 Due after one year through five years 848.3 864.0 868.2 870.2 Due after five years 12.0 12.9 23.8 24.0 Total marketable debt securities $ 2,095.8 $ 2,122.7 $ 2,433.1 $ 2,435.9 The average maturity of our marketable debt securities classified as available-for-sale as of September 30, 2022 and December 31, 2021, was approximately 9 months and 10 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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Proceeds from maturities and sales $ 1,643.2 $ 575.4 $ 3,104.7 $ 2,028.1 Realized gains — 0.1 — 0.4 Realized losses 7.9 0.5 9.3 1.7 Realized losses for the three and nine months ended September 30, 2022 and 2021, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed securities. Strategic Investments As of September 30, 2022, our strategic investment portfolio was comprised of investments totaling $948.5 million which are included in investments and other assets in our condensed consolidated balance sheets. As of December 31, 2021, our strategic investment portfolio totaled $1,110.3 million and was included in other current assets and 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 7, 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 decrease in our strategic investment portfolio as of September 30, 2022, was primarily due to a decrease in the fair value of our investments in Denali and Sangamo common stock. For additional information on our investments in Denali, Sage and Sangamo common stock, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in our 2021 Form 10-K. |
Derivative Instruments
Derivative Instruments | 9 Months Ended |
Sep. 30, 2022 | |
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. We enter into foreign currency forward contracts and foreign currency options with financial institutions with the primary objective to mitigate the impact of foreign currency exchange rate fluctuations on our international revenue and operating expense. Foreign currency forward contracts and foreign currency options in effect as of September 30, 2022 and December 31, 2021, had durations of 1 to 15 months. 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 have been impacted by the hedged item. The notional amount 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 September 30, 2022 As of December 31, 2021 Euro $ 1,089.2 $ 1,828.0 British pound 43.5 166.2 Swiss franc 37.8 — Japanese yen 23.5 72.7 Canadian dollar 14.7 59.9 Total foreign currency forward contracts $ 1,208.7 $ 2,126.8 The pre-tax portion of the fair value of these foreign currency forward contracts that were included in accumulated other comprehensive income (loss) in total equity is summarized as follows: (In millions) As of September 30, 2022 As of December 31, 2021 Unrealized gains $ 146.5 $ 60.8 Unrealized (losses) (2.2) (7.0) Net unrealized gains (losses) $ 144.3 $ 53.8 We expect the net unrealized gains of approximately $144.3 million to be settled over the next 15 months, of which approximately $142.6 million of these net unrealized gains are expected to be settled over the next 12 months, with any amounts in accumulated other comprehensive income (loss) to be reported as an adjustment to revenue or operating expense. We consider the impact of our and our counterparties’ credit risk on the fair value of the contracts as well as the ability of each party to execute its contractual obligations. As of September 30, 2022 and December 31, 2021, 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 September 30, Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Revenue $ 77.7 $ (14.9) Revenue $ 6.6 $ (0.7) Operating expense (0.8) (0.3) Operating expense (0.1) — For the Nine Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Revenue $ 143.2 $ (68.7) Revenue $ (0.8) $ (4.5) Operating expense (3.5) (0.3) Operating expense (0.4) (0.4) 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 related to this transaction was exposed to the currency fluctuations in the South Korean won. In order to mitigate the currency fluctuations between the U.S. dollar and South Korean won, we entered into foreign currency forward contracts. These contracts were designated as net investment hedges. In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics and closed these foreign currency forward contracts. Upon completing this sale, the cumulative gains on our net investment hedges of $57.0 million were reclassified from accumulated other comprehensive income (loss) and reflected within the total pre-tax gain recognized from the sale, which was recorded in other (income) expense, net in our condensed consolidated statements of income. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. Prior to the sale of our 49.9% equity interest in Samsung Bioepis, we recognized changes in the spot exchange rate of these foreign currency forward contracts in accumulated other comprehensive income (loss). The pre-tax portion of the fair value of these foreign currency forward contracts that were included in accumulated other comprehensive income (loss) in total equity reflected net gains of $10.6 million as of December 31, 2021. We excluded fair value changes related to the forward rate from our hedging relationship and amortized 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 net losses of $3.6 million as of December 31, 2021. The following tables summarize the effect of our net investment hedges in our condensed consolidated financial statements: For the Three Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Location 2022 2021 Gains (losses) on net investment hedges (1) $ — $ 24.9 Gains (losses) on net investment hedges (1) $ — $ — Other (income) expense (1) $ — $ — For the Nine Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Location 2022 2021 Gains (losses) on net investment hedges (1) $ 20.4 $ 46.1 Gains (losses) on net investment hedges (1) $ (3.2) $ (1.1) Other (income) expense (1) $ (4.6) $ 0.1 (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, 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 $1,285.4 million and $1,268.0 million as of September 30, 2022 and December 31, 2021, respectively. Net losses of $36.5 million and $85.8 million related to these contracts were recorded as a component of other (income) expense, net for the three and nine months ended September 30, 2022, respectively, compared to net losses of $13.5 million and $26.1 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 September 30, 2022 As of December 31, 2021 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 158.2 $ 66.2 Investments and other assets 5.0 5.5 Liability derivative instruments Accrued expense and other 2.6 6.6 Net Investment Hedging Instruments: (1) Asset derivative instruments Other current assets 21.4 4.1 Other Derivative Instruments: Asset derivative instruments Other current assets 11.3 5.1 Liability derivative instruments Accrued expense and other 20.2 4.2 (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. Amount represents unsettled balance of our closed net investment hedges. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
Property, Plant and Equipment
Property, Plant and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
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 $2,098.0 million and $2,006.6 million as of September 30, 2022 and December 31, 2021, respectively. For the three and nine months ended September 30, 2022, depreciation expense totaled $64.2 million and $207.7 million, respectively, compared to $65.1 million and $168.7 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 space and 51,000 square feet of administrative space. As of September 30, 2022 and December 31, 2021, we had approximately $701.0 million and $677.0 million, respectively, capitalized as construction in progress related to this facility. In the second quarter of 2021, a portion of the facility received a Good Manufacturing Practice multi-product license from the Swiss Agency for Therapeutic Products, resulting in approximately $1.2 billion of fixed assets being placed in service during the second quarter of 2021. In April 2022 the FDA approved the Prior Approval Supplement for the Solothurn facility for ADUHELM. We estimate the second manufacturing suite at the Solothurn facility will be operational during the second half of 2023. 125 Broadway Building Sale In September 2022 we completed the sale of our building and land parcel located at 125 Broadway, Cambridge, MA (125 Broadway) for an aggregate sales price of approximately $603.0 million, which is inclusive of a $10.8 million tenant allowance. This sale resulted in a pre-tax gain on sale of approximately $503.7 million, net of transaction costs, which is reflected within gain on sale of building in our condensed consolidated statements of income for the three and nine months ended September 30, 2022. This transaction included approximately $79.2 million of property, plant and equipment, net, which comprised of approximately $72.6 million for buildings, approximately $1.6 million for land and approximately $5.0 million for machinery and equipment. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | LEASES 125 Broadway Building Sale and Leaseback Transaction in connection with the sale of our building at 125 Broadway, we simultaneously leased back the building for a term of approximately 5.5 years, which resulted in the recognition of approximately $168.2 million in new lease liabilities and right-of-use assets recorded within our condensed consolidated balance sheets as of September 30, 2022. The sale and immediate leaseback of this building qualified for sale and leaseback treatment and is classified as an operating lease. For additional information on the sale of our building, please read Note 10, Property, Plant and Equipment , to these condensed consolidated financial statements. 300 Binney Street Lease Modification In September 2022 we entered into an agreement to partially terminate a portion of our lease located at 300 Binney Street, Cambridge MA, as well as to reduce the lease term for the majority of the remaining space. The agreement was driven by our 2022 efforts to reduce costs by consolidating real estate locations. The transaction was treated as a lease modification as of the effective date and resulted in the derecognition of right of use assets of approximately $47.4 million and lease liabilities of approximately $52.7 million, which resulted in a gain of approximately $5.3 million, which was recorded within restructuring charges in our condensed consolidated statements of income for the three and nine months ended September 30, 2022. |
Indebtedness
Indebtedness | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Indebtedness | 3.625% Senior Notes due September 15, 2022 On September 15, 2015, we issued $1.0 billion aggregate principal amount of our 3.625% Senior Notes due September 15, 2022, at 99.920% of par. Our 3.625% Senior Notes were senior unsecured obligations. In July 2022 we redeemed our 3.625% Senior Notes prior to their maturity and recognized a net pre-tax charge of approximately $2.4 million upon the extinguishment of these Senior Notes, which primarily reflects the payment of an early call premium as well as the write-off of remaining unamortized original debt issuance costs and discount balances. These charges were recognized as interest expense in other (income) expense, net in our condensed consolidated statements of income for the three and nine months ended September 30, 2022. 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 nine months ended September 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 nine months ended September 30, 2021. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2022 | |
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 1.2 million and 3.6 million shares of our common stock at a cost of approximately $250.0 million and $750.0 million during the three and nine months ended September 30, 2022, respectively. During the three and nine months ended September 30, 2021, we repurchased and retired approximately 2.2 million and 6.0 million shares of our common stock at a cost of approximately $750.0 million and $1.8 billion, respectively. Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of September 30, 2022. 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 Hedges, Net of Tax (1) Unrealized gains (losses) on pension benefit obligation, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2021 $ (2.2) $ 53.8 $ 25.5 $ (44.8) $ (139.0) $ (106.7) Other comprehensive income (loss) before reclassifications (26.4) 204.5 12.6 4.2 (154.5) 40.4 Amounts reclassified from accumulated other comprehensive income (loss) 7.4 (125.5) (38.1) — 58.9 (97.3) Net current period other comprehensive income (loss) (19.0) 79.0 (25.5) 4.2 (95.6) (56.9) Balance, September 30, 2022 $ (21.2) $ 132.8 $ — $ (40.6) $ (234.6) $ (163.6) (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax Gains (Losses) on Net Investment Hedges, Net of Tax Unrealized gains (losses) on pension benefit obligation, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) Other comprehensive income (loss) before reclassifications (2.5) 143.0 35.3 3.9 (80.3) 99.4 Amounts reclassified from accumulated other comprehensive income (loss) 1.1 62.0 (0.1) — — 63.0 Net current period other comprehensive income (loss) (1.4) 205.0 35.2 3.9 (80.3) 162.4 Balance, September 30, 2021 $ — $ 26.0 $ 26.7 $ (62.4) $ (126.9) $ (136.6) 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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Gains (losses) on securities available for sale Other (income) expense $ (8.0) $ (0.4) $ (9.4) $ (1.3) Income tax benefit (expense) 1.7 0.1 2.0 0.3 Gains (losses) on cash flow hedges Revenue 77.7 (14.9) 143.2 (68.7) Operating expense (0.8) (0.3) (3.5) (0.3) Other (income) expense — — (0.2) 0.1 Income tax benefit (expense) (7.8) 1.5 (14.0) 6.8 Gains (losses) on net investment hedges (1) Other (income) expense — — 38.1 0.1 Currency Translation Adjustments Other (income) expense — — (58.9) — Total reclassifications, net of tax $ 62.8 $ (14.0) $ 97.3 $ (63.0) (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
Earnings per Share
Earnings per Share | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Numerator: Net income attributable to Biogen Inc. $ 1,134.7 $ 329.2 $ 2,496.5 $ 1,187.9 Denominator: Weighted average number of common shares outstanding 144.4 148.0 145.8 149.9 Effect of dilutive securities: Time-vested restricted stock units 0.3 0.4 0.3 0.2 Market stock units — 0.1 — 0.1 Performance stock units settled in stock 0.1 0.1 0.1 0.1 Dilutive potential common shares 0.4 0.6 0.4 0.4 Shares used in calculating diluted earnings per share 144.8 148.6 146.2 150.3 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 | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Research and development $ 24.5 $ 19.5 $ 72.6 $ 72.2 Selling, general and administrative 46.5 42.6 129.3 127.8 Subtotal 71.0 62.1 201.9 200.0 Capitalized share-based compensation costs (2.0) (1.9) (7.1) (6.3) Share-based compensation expense included in total cost and expense 69.0 60.2 194.8 193.7 Income tax effect (13.0) (10.9) (36.0) (35.8) Share-based compensation expense included in net income attributable to Biogen Inc. $ 56.0 $ 49.3 $ 158.8 $ 157.9 The following table summarizes share-based compensation expense associated with each of our share-based compensation programs: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Market stock units $ 4.0 $ 9.7 $ 11.4 $ 35.5 Time-vested restricted stock units 48.7 38.8 150.4 121.9 Performance stock units settled in stock 10.5 4.9 22.1 14.2 Performance stock units settled in cash 5.4 4.4 7.9 13.9 Employee stock purchase plan 2.4 4.3 10.1 14.5 Subtotal 71.0 62.1 201.9 200.0 Capitalized share-based compensation costs (2.0) (1.9) (7.1) (6.3) Share-based compensation expense included in total cost and expense $ 69.0 $ 60.2 $ 194.8 $ 193.7 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 | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Statutory rate 21.0 % 21.0 % 21.0 % 21.0 % State taxes 1.9 0.3 1.1 0.9 Taxes on foreign earnings (3.4) (20.2) (4.4) (11.5) Tax credits (1.4) (7.1) (1.5) (4.1) Purchased intangible assets 0.1 (6.2) 0.2 (1.4) GILTI 0.8 2.6 0.5 1.6 Sale of Samsung Bioepis (0.8) — (1.9) — Litigation settlement agreement (1.2) — 3.1 — Neurimmune tax impacts — (0.5) 2.8 (36.4) International reorganization — — (1.7) — Other 0.2 1.2 0.2 0.7 Effective tax rate 17.2 % (8.9) % 19.4 % (29.2) % Changes in Tax Rate For the three and nine months ended September 30, 2022, compared to the same periods in 2021, the increases in our effective tax rates include the tax impacts on the sale of one of our buildings and the favorable prior year tax effects of changes in the value of our equity investments, where we recorded unrealized losses, and the BIIB111 and BIIIB112 impairment charges. The tax effects of this change in value of our equity investments were recorded discretely as changes in value of equity investments cannot be forecasted. For the nine months ended September 30, 2022, compared to the same period in 2021, the increase in our effective tax rate also reflects the net effects of the Neurimmune SubOne AG (Neurimmune) matters, as discussed below, and the litigation settlement agreement. During the second quarter of 2021 we recorded a net deferred tax asset in Switzerland of approximately $490.0 million on Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, we recorded a valuation allowance of approximately $390.0 million. During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an additional valuation allowance of approximately $85.0 million to reduce the net value of this deferred tax asset to zero. These adjustments to our deferred tax assets and their valuation allowances are each recorded 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 the litigation settlement agreement, please read Note 20, Litigation , to these condensed consolidated financial statements. For additional information on our collaboration arrangement with Neurimmune, please read Note 19, Investments in Variable Interest Entities , to these condensed consolidated financial statements. 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. 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 $500.0 million, including approximately $455.0 million related to the unrecognized tax benefits related to Neurimmune's tax basis in ADUHELM, in the next 12 months as a result of various audit |
Other Consolidated Financial St
Other Consolidated Financial Statement Detail | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Gain on sale of equity interest in Samsung Bioepis (1) $ — $ — $ (1,505.4) $ — Litigation settlement agreement — — 900.0 — Interest income (23.9) (2.6) (39.4) (8.2) Interest expense 59.9 66.3 191.8 187.3 (Gains) losses on investments, net (101.8) 424.5 167.5 707.2 Foreign exchange (gains) losses, net 11.5 13.7 39.0 23.1 Other, net (1.7) 1.0 25.2 4.0 Total other (income) expense, net $ (56.0) $ 502.9 $ (221.3) $ 913.4 (1) Reflects the pre-tax gain, net of transaction costs, recognized from the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. (Gains) losses on investments, net, as reflected in the table above, relate to debt securities, equity securities of certain biotechnology companies, venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities. During the second quarter of 2022 we recorded a pre-tax charge of $900.0 million, plus estimated fees and expenses, related to a litigation settlement agreement to resolve a qui tam litigation relating to conduct prior to 2015. This charge is included within other (income) expense, net in our condensed consolidated statements of income for the nine months ended September 30, 2022. For additional information on the litigation settlement agreement, please read Note 20, Litigation , to these condensed consolidated financial statements. The following table summarizes our (gains) losses on investments, net that relate to our equity securities held during the following periods: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Net (gains) losses recognized on equity securities $ (109.8) $ 424.2 $ 158.1 $ 705.9 Less: Net (gains) losses realized on equity securities (0.5) (2.7) — (9.3) Net unrealized (gains) losses recognized on equity securities $ (109.3) $ 426.9 $ 158.1 $ 715.2 The net unrealized gains recognized during the three months ended September 30, 2022, primarily reflect an increase in the aggregate fair value of our investments in Sage, Ionis Pharmaceuticals, Inc. (Ionis), Sangamo and Denali common stock of approximately $112.5 million. The net unrealized losses recognized during the nine months ended September 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Denali and Sangamo common stock of approximately $198.0 million. Accrued Expense and Other Accrued expense and other consists of the following: (In millions) As of September 30, 2022 As of December 31, 2021 Litigation settlement agreement (1) $ 900.0 $ — Revenue-related reserves for discounts and allowances 854.5 802.1 Collaboration expense 260.1 324.7 Royalties and licensing fees 208.6 234.7 Employee compensation and benefits 313.5 345.1 Other 769.2 828.6 Total accrued expense and other $ 3,305.9 $ 2,535.2 (1) During the second quarter of 2022 we recorded a pre-tax charge of $900.0 million, plus estimated fees and expenses, related to a litigation settlement agreement to resolve a qui tam litigation relating to conduct prior to 2015. For additional information on the litigation settlement agreement, please read Note 20, Litigation , to these condensed consolidated financial statements. Other Long-term Liabilities Other long-term liabilities were $1,198.1 million and $1,320.5 million as of September 30, 2022 and December 31, 2021, respectively, and included accrued income taxes totaling $559.7 million and $664.5 million, respectively. |
Collaborative and Other Relatio
Collaborative and Other Relationships | 9 Months Ended |
Sep. 30, 2022 | |
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 lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. All costs, including research, development, sales and marketing expense, are shared equally between us and Eisai. If lecanemab receives marketing approval, we and Eisai will co-promote lecanemab and share profits or losses equally. In March 2022 we extended our supply agreement related to lecanemab from five years to ten years for the manufacture of lecanemab drug substance and drug product. In May 2022 Eisai completed the submission of a Biologics License Application (BLA) to the FDA for the accelerated approval of lecanemab. In July 2022 the FDA accepted the BLA and granted Priority Review with a Prescription Drug User Fee Act action date of January 6, 2023. The Lecanemab Collaboration also provided Eisai with an option to jointly develop and commercialize ADUHELM (aducanumab) (ADUHELM Option). In October 2017 Eisai exercised its ADUHELM Option and we entered into a new collaboration agreement for the joint development and commercialization of ADUHELM (the ADUHELM Collaboration Agreement). A summary of development and sales and marketing expense related to the Lecanemab Collaboration is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 109.3 $ 118.4 $ 264.9 $ 236.1 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our condensed consolidated statements of income 54.7 59.2 132.5 118.0 Total sales and marketing expense incurred by the Lecanemab Collaboration 29.0 5.6 68.3 15.6 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 14.5 2.8 34.2 7.8 For additional information on our Lecanemab Collaboration, please read Note 18, Collaborative and Other Relationships , to our consolidated financial statements included in our 2021 Form 10-K. ADUHELM Collaboration Agreement Under our initial ADUHELM Collaboration Agreement, we would lead the ongoing development of ADUHELM, and we and Eisai would co-promote ADUHELM with a region-based profit split. Beginning January 1, 2019, Eisai was reimbursing us for 45.0% of development costs incurred by the collaboration for the advancement of ADUHELM (ADUHELM development expense). 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 nine months ended September 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, which was recorded in collaboration profit (loss) sharing in our condensed consolidated statements of income. In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. Effective March 2022, we have sole decision making and commercialization rights worldwide on ADUHELM and beginning January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM, rather than sharing global profits and losses. Eisai's share of development, commercialization and manufacturing expense is limited to $335.0 million for the period from January 1, 2022 to December 31, 2022. As of September 30, 2022, Eisai's portion of these expenses was approximately $300.0 million. Once this limit is achieved, we will be responsible for all ADUHELM related development costs. After the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM’s economics beyond these royalties. 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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total ADUHELM development expense $ 34.6 $ 43.7 $ 116.0 $ 132.8 Biogen's share of ADUHELM development expense reflected in research and development expense in our condensed consolidated statements of income 19.0 24.0 63.8 73.0 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement (8.0) 154.3 127.8 391.7 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit (loss) sharing in our condensed consolidated statements of income (3.9) 83.3 68.1 211.2 Total ADUHELM collaboration third party milestones — — — 100.0 Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our condensed consolidated statements of income — — — 45.0 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 (loss) sharing in our condensed consolidated statements of income. For the three and nine months ended September 30, 2022, we recognized a net reduction to our operating expense of $3.4 million and $214.0 million , respectively, to reflect Eisai's 45.0% share of net collaboration losses in the U.S. , compared to $50.6 million and $90.7 million, respectively, in the prior year comparative periods. In addition, we and Eisai co-promote AVONEX, TYSABRI and TECFIDERA in Japan in certain settings and Eisai distributes AVONEX, TYSABRI, TECFIDERA and PLEGRIDY in India and other Asia-Pacific markets, excluding China. During the first quarter of 2022 we recorded approximately $275.0 million of gross charges associated with inventory and purchase commitments in excess of forecasted demand related to ADUHELM. F or the nine months ended September 30, 2022, we have also recorded approximately $76.0 million of aggregate gross idle capacity charges related to ADUHELM. We have recognized approximately $177.0 million related to Eisai's 45.0% share of inventory and idle capacity charges in collaboration profit (loss) sharing within our condensed consolidated statements of income for the nine months ended September 30, 2022. Amounts receivable from Eisai related to the agreements discussed above were $110.6 million and $285.4 million as of September 30, 2022 and December 31, 2021 , respectively. Amounts payable to Eisai related to the agreements discussed above were $81.7 million and $46.5 million as of September 30, 2022 and December 31, 2021, respectively . For additional information on the ADUHELM Collaboration Agreement, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K. 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. If marketing approval is obtained, 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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total UCB collaboration development expense $ 18.3 $ 16.5 $ 51.5 $ 49.5 Biogen's share of UCB development expense reflected in research and development expense in our condensed consolidated statements of income 9.1 8.2 25.7 24.8 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. Under this collaboration, both companies will share equal responsibility and costs for development as well as profits and losses for commercialization in the U.S. Outside of the U.S., we are responsible for development and commercialization, excluding Japan, Taiwan and South Korea, with respect to zuranolone and may pay Sage potential tiered royalties in the high teens to low twenties. A summary of development and sales and marketing expense related to this collaboration is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total Sage collaboration development expense $ 40.9 $ 40.8 $ 130.4 $ 134.9 Biogen's share of Sage development expense reflected in research and development expense in our condensed consolidated statements of income 20.5 20.4 65.2 67.3 Total Sage sales and marketing expense incurred by the collaboration 28.5 7.4 69.9 23.2 Biogen's share of Sage sales and marketing expense reflected in selling, general and administrative expense in our condensed consolidated statements of income 14.2 3.7 34.9 11.6 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. Under this collaboration, both companies share responsibility and costs for global development based on specified percentages as well as profits and losses for commercialization in the U.S. and China. Outside the U.S. and China we are responsible for commercialization and may pay Denali potential tiered royalties. 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 ATV-enabled therapeutics for indications within specific neurodegenerative diseases, should Denali decide to seek a collaboration for such programs. In October 2022 we and Denali announced the initiation of the Phase 3 LIGHTHOUSE study for BIIB122 (DNL151), a small molecule inhibitor of LRRK2 for the potential treatment of Parkinson's disease. A summary of development expense related to this collaboration is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total Denali collaboration development expense $ 19.9 $ 8.5 $ 58.0 $ 27.2 Biogen's share of Denali development expense reflected in research and development expense in our condensed consolidated statements of income 11.4 5.1 33.5 16.3 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 to modulate the expression of key genes involved in neurological diseases. Under this collaboration, we may pay Sangamo tiered royalties on potential net sales of any products developed under this collaboration in the high single digit to sub-teen percentages. A summary of development expense related to this collaboration is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total Sangamo collaboration development expense $ 5.5 $ 6.2 $ 16.4 $ 16.4 Biogen's share of Sangamo development expense reflected in research and development expense in our condensed consolidated statements of income 3.1 1.9 10.2 9.5 InnoCare Pharma Limited In July 2021 we entered into a collaboration and license 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 collaboration, we 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 retains ex clusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). In connection with the closing of this transaction in August 2021 we made an upfront payment of $125.0 million that was recorded as research and development expense in our condensed consolidated statements of income. We may also pay InnoCare up to approximately $812.5 million in potential development milestones and potential commercial payments should this collaboration achieve certain development, commercial milestones and sales thresholds. In addition, we may pay InnoCare tiered royalties on potential net sales of any products developed under this collaboration in the low to high 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 nine months ended September 30, 2022, we recorded $14.0 million and $51.5 million, respectively, as research and development expense in our condensed consolidated statements of income related to other research and discovery related arrangements, compared to $7.7 million and $84.9 million, respectively, 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 April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction. As part of the transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones. Our policy for contingent payments of this nature is to recognize them in the period that they become realizable, which is generally the same period in which they are earned. Prior to this sale, we recognized our share of the results of operations related to our investment in Samsung Bioepis under the equity method of accounting one quarter in arrears when the results of the entity became available, which was reflected as equity in (income) loss of investee, net of tax in our condensed consolidated statements of income. Upon investment, the equity method of accounting required us to identify and allocate differences between the fair value of our investment and the carrying value of our interest in the underlying net assets of the investee. These basis differences were being amortized over their economic life until the completion of the sale in April 2022, as discussed above. The total basis difference was approximately $675.0 million and related to inventory, developed technology, IPR&D and deferred tax balances. The basis differences related to inventory were amortized, net of tax, over their estimated useful lives of 1.5 years, and the basis differences related to developed technology and IPR&D for marketed products were being amortized, net of tax, over their estimated useful lives of 15 years. For the nine months ended September 30, 2022, we recognized net income on our investment of $2.6 million, reflecting our share of Samsung Bioepis' operating profits, net of tax totaling $17.0 million, offset by amortization of basis differences totaling $14.4 million. This amount reflects our share of results prior to the sale of Samsung Bioepis as the results are recognized one quarter in arrears. Following the sale of Samsung Bioepis we no longer recognize gains or losses associated with Samsung Bioepis' results of operations and amortization related to basis differences. For the three and nine months ended September 30, 2021, we recognized net income on our investment of $1.1 million and $17.2 million, respectively, reflecting our share of Samsung Bioepis' operating profits, net of tax to taling $8.9 million and $39.5 million, respectively, offset by amortization of basis differences totaling $7.8 million and $22.3 million, respectively. As of December 31, 2021, the carrying value of our investment in Samsung Bioepis totaled 713.3 billion South Korean won ($599.9 million), which is classified as a component of investments and other assets in our condensed consolidated balance sheets. In connection with the sale of Samsung Bioepis, the carrying value of our investment was reduced to zero. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. 2019 Development and Commercialization Agreement In December 2019 we completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two potential ophthalmology biosimilar products, BYOOVIZ (ranibizumab-nuna), a 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 at a pre-specified gross margin of approximately 45.0%. 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 our condensed consolidated statements of income in 2019 and $37.0 million was recorded as intangible assets, net in our condensed consolidated balance sheets in 2019. During the third quarter of 2021 we accrued $15.0 million in milestone payments related to the approval of BYOOVIZ in the U.S., the E.U. and the United Kingdom (U.K.), that were capitalized within intangible assets, net in our condensed consolidated balance sheets. We may also pay Samsung Bioepis up to approximately $180.0 million in additional development, regulatory and sales-based milestones. We also acquired an option to extend the term of our 2013 c ommercial 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 (loss) sharing in our condensed consolidated statements of income. For the three and nine months ended September 30, 2022, we recognized net profit-sharing expense of $48.7 million and $171.4 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits, compared to a net profit-sharing expense of $71.8 million and $210.2 million, respectively, in the prior year comparative periods. 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 is reflected in revenue from collaborative and other relationships as a component of other revenue in our condensed consolidated statements of income. Amounts receivable from Samsung Bioepis related to the agreements discussed above were $1.8 million and $4.1 million as of September 30, 2022 and December 31, 2021, respectively. Amounts payable to Samsung Bioepis related to the agreements discussed abo ve were $53.8 million and $148.7 million as of September 30, 2022 and December 31, 2021, 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 | 9 Months Ended |
Sep. 30, 2022 | |
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 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 (loss) sharing in our condensed consolidated statements of income. During the second quarter of 2021 we recorded a net deferred tax asset in Switzerland of approximately $490.0 million on Neurimmune's tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, we recorded a valuation allowance of approximately $390.0 million related to this deferred tax asset. During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an additional valuation allowance of approximately $85.0 million to reduce the net value of this deferred tax asset to zero. These adjustments to our deferred tax assets and their valuation allowances are each recorded 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. For additional information on our collaboration arrangements with Eisai, please read Note 18, 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 September 30, 2022 and December 31, 2021, the carrying value of our investments in certain biotechnology companies representing potential unconsolidated variable interest entities totaled $25.3 million and $24.6 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 previous 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 2021 Form 10-K. |
Litigation
Litigation | 9 Months Ended |
Sep. 30, 2022 | |
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 2021 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 actions filed by shareholders in November 2020 (the November 2020 Securities Action) and February 2022 (the February 2022 Securities Action) and pending in the U.S. District Court for the District of Massachusetts. The actions allege violations of federal securities laws under 15 U.S.C §78j(b) and §78t(a) and 17 C.F.R. §240.10b-5 and seek declarations of the actions as class actions and monetary relief. In September 2022, the court dismissed the November 2020 Securities Action, and the plaintiff has appealed to the U.S. Court of Appeals for the First Circuit. Our motion to dismiss the February 2022 Securities Action is pending. An estimate of the possible loss or range of loss cannot be made at this time. Derivative Action We and members of the Board of Directors are named as defendants in derivative actions filed by shareholders on February 9 and July 21, 2022, in the U.S. District Court for the District of Massachusetts. The actions allege violations of federal securities laws under 15 U.S.C. §78n(a) and 17 C.F.R. §240 14.a-9, breaches of fiduciary duties and waste of corporate assets, and seek declaratory and injunctive relief, monetary relief payable to Biogen, and attorneys’ fees and costs payable to the plaintiffs. The court has stayed both cases. An estimate of the possible loss or range of loss cannot be made at this time. 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 and proceedings against Biogen GmbH in the Düsseldorf Regional Court, alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes national counterparts of European Patent No. 3 148 510 (the EP '510 Patent). In June 2022 Fresenius Kabi amended both actions to assert claims under European Patent 3 145 488 (the EP ‘488 Patent), which expires in May 2035. No hearing has been set in either action. In June 2020 Fresenius Kabi commenced preliminary injunction proceedings in Denmark's Maritime and Commercial High Court alleging that IMRALDI infringes the Danish counterpart of the EP '488 Patent and a corresponding Danish utility model, DK 2020 00038 Y3. In September 2021 the Court refused Fresenius Kabi's request for a preliminary injunction, finding that the patent and utility model are invalid and not infringed. Fresenius Kabi has appealed to the High Court of Eastern Denmark, and a hearing is scheduled for January 2023. In June 2022 the Technical Boards of Appeal (TBA) of the European Patent Office (EPO) affirmed the revocation of the EP '510 Patent, which resolves all pending infringement claims under the EP '510 Patent. The EPO has scheduled a hearing on the validity of the EP '488 Patent for October 26, 2022. In July 2019 Gedeon Richter Nyrt commenced proceedings for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court, alleging infringement of the German counterpart of European Patent No. 3 212 667 (EP '667 Patent), which expires in October 2035. The case has been stayed pending proceedings in the EPO to invalidate the EP '667 Patent. In July 2021 the Opposition Division of the EPO revoked the EP '667 Patent. Gedeon Richter Nyrt have appealed that decision to the TBA of the EPO. No hearing has been set in that appeal. In November 2020 Gedeon Richter Nyrt commenced proceedings against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of a German utility model corresponding to EP '667. The proceeding has been stayed pending the outcome of proceedings that Biogen has filed in the German Patent and Trademark Office to cancel the utility model. No hearing has been set in the cancellation proceedings. An estimate of the possible loss or range of loss in the IMRALDI patent litigation described above cannot be made at this time. Qui Tam Litigation In September 2022, without admitting any liability, we agreed to pay $900.0 million to settle previously disclosed litigation unsealed in July 2015 and filed by Michael Bawduniak on behalf of the U.S. and certain states in the U.S. District Court for the District of Massachusetts alleging violations of the federal False Claims Act and state law counterparts. In October 2022 the court dismissed the case with prejudice. 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. ERISA Class Action Litigation In September 2020 the U.S. District Court for the District of Massachusetts consolidated two cases filed against us in July and August 2020 by participants in the Biogen 401(k) Savings Plan, alleging breach of fiduciary duty under ERISA. Plaintiffs seek a declaration of the action as a class action and monetary and other relief. An estimate of the possible loss or range of loss cannot be made at this time. Humana Patient Assistance Litigation In September 2021 Humana Inc. (Humana) filed suit against us in the U.S. District Court for the District of Massachusetts, alleging damages related to our providing MS patients with free medications and making charitable contributions to non-profit organizations that assist MS patients. Humana alleges violation of the federal RICO Act and state laws and seeks statutory treble damages, attorneys' fees and costs. We filed a motion to dismiss, which is pending. An estimate of the possible loss cannot be made at this time. Other Matters Government Investigations The U.S. House of Representatives Committees on Oversight and Reform and Energy and Commerce and the Office of Inspector General of the U.S. Department of Health and Human Services have announced investigations relating to ADUHELM. The Company also received a civil investigative demand from the Federal Trade Commission (FTC) and a subpoena from the Securities and Exchange Commission seeking information relating to ADUHELM, including healthcare sites, ADUHELM’s approval and ADUHELM’s marketing. In July 2022 the FTC informed us that it had closed its investigation. TECFIDERA Patent Matters In October 2022 the U.S. Supreme Court denied our petition for writ of certiorari for review of the previously disclosed decision of the U.S. Court of Appeals for the Federal Circuit holding that the asserted claims of our U.S. Patent No. 8,399,514 (the '514 Patent) are invalid. Thereafter, we moved to dismiss our appeals from the judgments in the previously disclosed Delaware Actions, and we and Mylan Pharmaceuticals, Inc. (Mylan) agreed that the judgment in our favor in the previously reported inter partes review filed by Mylan in 2018 should be vacated. TYSABRI Patent Matters In September 2022 we filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc. and Polpharma Biologics S.A. under the Biologics Price Competition and Innovation Act, 42 U.S.C. §262, seeking a declaratory judgment of patent infringement, following our receipt of Sandoz inc.'s notice of intent to commercially market a biosimilar version of TYSABRI (natalizumab). No trial date has been set. In November 2017 Swiss Pharma International AG, affiliated with the Polpharma Group, filed an action in the Commercial Court of Rome to invalidate the Italian counterpart of the European Patent No. 1 485 127 (the EP '127 Patent), which covers administration of natalizumab to treat MS and expires in February 2023. A hearing has been set for November 2022. In August 2020 Polpharma Biologics S.A. brought an action in the Polish Patent Office to revoke our Polish Patent No. 215263, which corresponds to the EP '127 Patent and expires in February 2023. The action was suspended by the Polish Patent Office in April 2021 pending examination of our amended patent claims. In June 2021 Polpharma Biologics S.A., Sandoz B.V. and Sandoz AG filed an action in the District Court of the Hague, Netherlands to invalidate the Dutch counterpart of our European Patent 2 676 967 (the EP '967 Patent), which expires in 2027 and covers methods of treatment using natalizumab (TYSABRI) and pre-treatment testing of patients. A hearing has not been scheduled. In July 2021 the EPO revoked the EP ‘967 Patent. A hearing on our appeal to the TBA of the EPO is set for December 2022. In September 2021 Polpharma Biologics S.A., Sandoz AG, Sandoz Limited and Sandoz GmbH filed an action in the English High Court to revoke the U.K. counterpart of the EP ‘967 Patent and seeking a declaration that the patent would not be infringed by the marketing of Polpharma’s proposed natalizumab biosimilar. A hearing has been set for February 2023. Annulment Proceedings in the General Court of the European Union relating to TECFIDERA Pharmaceutical Works Polpharma SA (Polpharma) and Mylan Ireland Ltd. (Mylan Ireland) each filed actions in the General Court of the European Union (Polpharma in October 2018 and Mylan Ireland in November 2020) to annul the European Medicines Agency's (EMA) decision not to validate their applications to market generic versions of TECFIDERA on the grounds that TECFIDERA benefits from regulatory data protection. On May 5, 2021, the European General Court annulled the EMA's non-validation decision with respect to Polpharma. We have appealed the decision to the European Court of Justice and the appeal is pending. The case brought by Mylan Ireland has been stayed. Product Liability and Other Legal Proceedings We are also involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial condition. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS |
Dispositions
Dispositions | 9 Months Ended |
Sep. 30, 2022 | |
Divestitures [Abstract] | |
Dispositions | DISPOSITIONS Sale of Joint Venture Equity Interest in Samsung Bioepis In April 2022 we completed the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics Co., Ltd (Samsung BioLogics). Under the terms of this transaction, we received approximately $1.0 billion in cash at closing and expect to receive approximately $1.3 billion in cash to be deferred over two payments of approximately $812.5 million due at the first anniversary and approximately $437.5 million due at the second anniversary of the closing of this transaction. Prior to the sale, the carrying value of our investment in Samsung Bioepis totaled $581.6 million. For the nine months ended September 30, 2022, we recognized a pre-tax gain of approximately $1.5 billion related to this transaction, which was recorded in other (income) expense, net in our condensed consolidated statements of income. This pre-tax gain included reclassifications from accumulated other comprehensive income (loss) to net income of approximately $58.9 million in cumulative translation losses, partially offset by approximately $57.0 million in gains resulting from the termination of our net investment hedge. We have concluded that the divestment of Samsung Bioepis does not meet the criteria to be reported as discontinued operations in our condensed consolidated financial statements, as our decision to divest this business does not represent a strategic shift that will have a major effect on our operations and financial results. We elected the fair value option and measured the payments due to us from Samsung BioLogics at fair value. As of September 30, 2022, the estimated fair values of the first and second payments using risk-adjusted discount rates of 4.9% and 5.3%, respectively, were approximately $790.8 million and $402.8 million , respectively. These payments have been classified as level 3 measurements and are reflected in other current assets and investments and other assets, respectively, in our condensed consolidated balance sheets. For the three and nine months ended September 30, 2022, we recognized a gain of approximately $2.7 million and a loss of approximately $4.0 million to reflect the changes in fair value related to our first and second payments, respectively. These changes were recorded in other (income) expense, net in our condensed consolidated statements of income. As part of this transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones. Our policy for contingent payments of this nature is to recognize them in the period that they become realizable, which is generally the same period in which they are earned. If any payments due to us remain outstanding after the second anniversary of the closing of this transaction, we may elect to receive shares of Samsung BioLogics common stock at a 5.0% discount in lieu of a cash payment for the remaining amount due. Currently, we believe that the likelihood of Samsung BioLogics failing to make timely payments to us for the amounts due is remote. Additionally, for the nine months ended September 30, 2022, we recorded a discrete tax expense of approximately $258.3 million related to this transaction, which is reflected in income tax (benefit) expense in our condensed consolidated statements of income. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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. We have a leading portfolio of medicines to treat multiple sclerosis (MS), have introduced the first approved treatment for spinal muscular atrophy (SMA) and developed the first and only approved treatment to address a defining pathology of Alzheimer's disease. We also commercialize biosimilars of advanced biologics and focus on advancing our pipeline in neuroscience and specialized immunology. Lastly, we are focused on accelerating our efforts in digital health to support our commercial and pipeline programs while also creating opportunities for potential digital therapeutics. We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS); and other potential anti-CD20 therapies, including mosunetuzumab, pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group. For additional information on our collaboration arrangements with Genentech, please read Note 18, Collaborative and Other Relationships, to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 (2021 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 collaboration with Samsung Bioepis Co., Ltd. (Samsung Bioepis) 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, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 18, 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 2021 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2021 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 nine months ended September 30, 2022, 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, net of tax in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners. |
Use of estimates | The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates. The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, the supply chain, manufacturing, clinical trials, research and development costs and employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets. Additionally, the ongoing geopolitical tensions related to the conflict in Ukraine, and the related sanctions and other penalties imposed, are creating substantial uncertainty in the global economy. The extent and duration of the conflict, sanctions and resulting market disruptions are highly unpredictable. We have made estimates of the impact of the COVID-19 pandemic and the ongoing geopolitical conflict within our condensed consolidated financial statements and there may be changes to those estimates in future periods. |
New accounting pronouncements | From time to time, new accounting pronouncements are issued by the 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 had or may have a material impact on our condensed consolidated financial statements or disclosures. Fair Value Measurements |
Restructuring, Business Trans_2
Restructuring, Business Transformation and Other Cost Saving Initiatives (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Reserve by Type of Cost | The following table summarizes the charges and spending related to our 2022 workforce reductions for the three and nine months ended September 30, 2022: (In millions) Total Restructuring reserve as of December 31, 2021 $ — Expense 27.7 Payment (6.2) Restructuring reserve as of March 31, 2022 21.5 Expense 60.9 Payment (29.7) Foreign currency and other adjustments (0.5) Restructuring reserve as of June 30, 2022 52.2 Expense 21.6 Payment (32.3) Foreign currency and other adjustments (1.3) Restructuring reserve as of September 30, 2022 $ 40.2 |
Revenues (Tables)
Revenues (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenues by product | Revenue by product is summarized as follows: For the Three Months Ended September 30, 2022 2021 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): TECFIDERA $ 92.5 $ 246.5 $ 339.0 $ 179.2 $ 319.4 $ 498.6 VUMERITY (1) 127.9 9.9 137.8 120.7 0.2 120.9 Total Fumarate 220.4 256.4 476.8 299.9 319.6 619.5 AVONEX 174.8 80.3 255.1 213.2 88.1 301.3 PLEGRIDY 39.7 41.2 80.9 39.2 47.0 86.2 Total Interferon 214.5 121.5 336.0 252.4 135.1 387.5 TYSABRI 273.0 232.5 505.5 281.1 241.7 522.8 FAMPYRA — 22.0 22.0 — 26.2 26.2 Subtotal: MS 707.9 632.4 1,340.3 833.4 722.6 1,556.0 Spinal Muscular Atrophy: SPINRAZA 140.2 290.9 431.1 139.8 304.3 444.1 Biosimilars: BENEPALI — 110.2 110.2 — 120.8 120.8 IMRALDI — 57.7 57.7 — 57.4 57.4 FLIXABI — 19.0 19.0 — 24.6 24.6 BYOOVIZ (2) 0.7 — 0.7 — — — Subtotal: Biosimilars 0.7 186.9 187.6 — 202.8 202.8 Other: FUMADERM — 1.5 1.5 — 2.5 2.5 ADUHELM 1.6 — 1.6 0.3 — 0.3 Total product revenue $ 850.4 $ 1,111.7 $ 1,962.1 $ 973.5 $ 1,232.2 $ 2,205.7 (1) VUMERITY became commercially available in the European Union (E.U.) during the fourth quarter of 2021. (2) BYOOVIZ launched in the United States (U.S.) in June 2022 and became commercially available during the third quarter of 2022. For the Nine Months Ended September 30, 2022 2021 (In millions) United Rest of Total United Rest of Total Multiple Sclerosis (MS): TECFIDERA $ 330.3 $ 816.5 $ 1,146.8 $ 520.1 $ 945.3 $ 1,465.4 VUMERITY (1) 383.0 19.6 402.6 285.0 0.5 285.5 Total Fumarate 713.3 836.1 1,549.4 805.1 945.8 1,750.9 AVONEX 493.8 249.6 743.4 636.4 286.9 923.3 PLEGRIDY 114.2 138.2 252.4 115.2 149.9 265.1 Total Interferon 608.0 387.8 995.8 751.6 436.8 1,188.4 TYSABRI 849.4 693.1 1,542.5 854.2 696.2 1,550.4 FAMPYRA — 73.7 73.7 — 78.8 78.8 Subtotal: MS 2,170.7 1,990.7 4,161.4 2,410.9 2,157.6 4,568.5 Spinal Muscular Atrophy: SPINRAZA 443.3 891.4 1,334.7 437.8 1,026.6 1,464.4 Biosimilars: BENEPALI — 340.7 340.7 — 363.9 363.9 IMRALDI — 172.4 172.4 — 170.9 170.9 FLIXABI — 62.0 62.0 — 75.4 75.4 BYOOVIZ (2) 1.2 — 1.2 — — — Subtotal: Biosimilars 1.2 575.1 576.3 — 610.2 610.2 Other: FUMADERM — 6.4 6.4 — 8.3 8.3 ADUHELM 4.5 — 4.5 2.0 — 2.0 Total product revenue $ 2,619.7 $ 3,463.6 $ 6,083.3 $ 2,850.7 $ 3,802.7 $ 6,653.4 (1) VUMERITY became commercially available in the E.U. during the fourth quarter of 2021. (2) BYOOVIZ launched in the U.S. in June 2022 and became commercially available during the third quarter of 2022. |
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, 2021 $ 137.7 $ 759.6 $ 38.0 $ 935.3 Current provisions relating to sales in current year 499.3 1,993.6 8.5 2,501.4 Adjustments relating to prior years (2.5) (18.4) (7.7) (28.6) Payments/credits relating to sales in current year (379.6) (1,442.0) — (1,821.6) Payments/credits relating to sales in prior years (124.5) (463.7) (14.4) (602.6) Balance, September 30, 2022 $ 130.4 $ 829.1 $ 24.4 $ 983.9 |
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 September 30, 2022 As of December 31, 2021 Reduction of accounts receivable $ 129.4 $ 133.2 Component of accrued expense and other 854.5 802.1 Total revenue-related reserves $ 983.9 $ 935.3 |
Revenues from anti-CD20 therapeutic programs | Revenue from anti-CD20 therapeutic programs is summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Biogen’s share of pre-tax profits in the U.S. for RITUXAN and GAZYVA $ 131.1 $ 145.8 $ 414.2 $ 498.7 OCREVUS and other revenue from anti-CD20 therapeutic programs 285.8 269.6 838.4 745.7 Total revenue from anti-CD20 therapeutic programs $ 416.9 $ 415.4 $ 1,252.6 $ 1,244.4 |
Other revenues | Other revenue is summarized as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 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 $ 6.5 $ 6.3 $ 20.9 $ 15.7 Other royalty and corporate revenue: Royalty 8.8 7.7 29.7 20.3 Other corporate 114.2 143.8 242.9 314.1 Total other revenue $ 129.5 $ 157.8 $ 293.5 $ 350.1 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Components of inventory | The components of inventory are summarized as follows: (In millions) As of September 30, 2022 As of December 31, 2021 Raw materials $ 394.2 $ 349.6 Work in process (1) 771.0 814.0 Finished goods 209.8 187.9 Total inventory $ 1,375.0 $ 1,351.5 (1) Work in process inventory as of September 30, 2022, includes approximately $118.0 million related to lecanemab. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible assets | Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: As of September 30, 2022 As of December 31, 2021 (In millions) Estimated Life Cost Accumulated Net Cost Accumulated Net Completed technology 4-28 years $ 7,415.0 $ (5,579.4) $ 1,835.6 $ 7,413.1 $ (5,388.5) $ 2,024.6 In-process research and development Indefinite until commercialization 109.3 — 109.3 132.7 — 132.7 Trademarks and trade names Indefinite 64.0 — 64.0 64.0 — 64.0 Total intangible assets $ 7,588.3 $ (5,579.4) $ 2,008.9 $ 7,609.8 $ (5,388.5) $ 2,221.3 |
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 September 30, 2022 2022 (remaining three months) $ 55.0 2023 215.0 2024 195.0 2025 190.0 2026 175.0 2027 165.0 |
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 September 30, 2022 Goodwill, December 31, 2021 $ 5,761.1 Other (19.9) Goodwill, September 30, 2022 $ 5,741.2 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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: Fair Value Measurements on a Recurring Basis As of September 30, 2022 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 3,191.8 $ — $ 3,191.8 $ — Marketable debt securities: Corporate debt securities 1,219.1 — 1,219.1 — Government securities 702.0 — 702.0 — Mortgage and other asset backed securities 174.7 — 174.7 — Marketable equity securities 896.0 896.0 — — Other current assets: Receivable from Samsung BioLogics (1) 790.8 — — 790.8 Other assets: Derivative contracts 195.9 — 195.9 — Plan assets for deferred compensation 32.2 — 32.2 — Receivable from Samsung BioLogics (1) 402.8 — — 402.8 Total $ 7,605.3 $ 896.0 $ 5,515.7 $ 1,193.6 Liabilities: Derivative contracts $ 22.8 $ — $ 22.8 $ — Contingent consideration obligations 195.4 — — 195.4 Total $ 218.2 $ — $ 22.8 $ 195.4 (1) Represents the fair value of the current and non-current payments due from Samsung BioLogics as a result of the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics during the second quarter of 2022, for which we elected the fair value option. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. Fair Value Measurements on a Recurring Basis As of December 31, 2021 (In millions) Total Quoted Prices Significant Other Significant Assets: Cash equivalents $ 1,632.2 $ — $ 1,632.2 $ — Marketable debt securities: Corporate debt securities 1,108.2 — 1,108.2 — Government securities 1,192.7 — 1,192.7 — Mortgage and other asset backed securities 132.2 — 132.2 — Marketable equity securities 1,048.5 181.7 866.8 — Derivative contracts 80.9 — 80.9 — Plan assets for deferred compensation 33.4 — 33.4 — Total $ 5,228.1 $ 181.7 $ 5,046.4 $ — Liabilities: Derivative contracts $ 10.8 $ — $ 10.8 $ — Contingent consideration obligations 209.1 — — 209.1 Total $ 219.9 $ — $ 10.8 $ 209.1 |
Summary of fair and carrying value of debt instruments | The following table presents quantitative information, as of the dates indicated, about the valuation techniques and significant unobservable inputs used in the valuation of our level 3 financial assets and liabilities measured at fair value on a recurring basis: Quantitative Information about Level 3 Fair Value Measurements Fair Value Weighted Average (In millions) September 30, 2022 December 31, 2021 Valuation Technique Significant Range September 30, 2022 December 31, 2021 Liabilities: Contingent consideration obligations $ 195.4 $ 209.1 Discounted cash flow Discount rate 4.50% 4.50 % 1.30 % Expected timing of achievement of development milestones 2023 to 2028 — — The fair and carrying values of our debt instruments, which are Level 2 liabilities, are summarized as follows: As of September 30, 2022 As of December 31, 2021 (In millions) Fair Carrying Fair Carrying 3.625% Senior Notes due September 15, 2022 (1) $ — $ — $ 1,020.0 $ 999.1 4.050% Senior Notes due September 15, 2025 1,697.8 1,744.3 1,895.2 1,742.9 2.250% Senior Notes due May 1, 2030 1,183.0 1,492.7 1,475.9 1,492.0 5.200% Senior Notes due September 15, 2045 997.2 1,100.2 1,463.0 1,099.9 3.150% Senior Notes due May 1, 2050 965.6 1,473.6 1,457.7 1,473.2 3.250% Senior Notes due February 15, 2051 452.8 468.4 692.9 466.0 Total $ 5,296.4 $ 6,279.2 $ 8,004.7 $ 7,273.1 (1) Our 3.625% Senior Notes due September 15, 2022, were redeemed in full in July 2022. For additional information, please read Note 12, Indebtedness , to these condensed consolidated financial statements. |
Fair value of 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 are classified as Level 3 measurements: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Fair value, beginning of period $ 197.5 $ 226.3 $ 209.1 $ 259.8 Changes in fair value (2.1) (15.6) (13.7) (49.1) Fair value, end of period $ 195.4 $ 210.7 $ 195.4 $ 210.7 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 As of December 31, 2021 Commercial paper $ 3.2 $ 247.6 Overnight reverse repurchase agreements 115.5 200.0 Money market funds 3,070.6 901.6 Short-term debt securities 2.5 283.0 Total $ 3,191.8 $ 1,632.2 |
Marketable debt and equity securities | The following tables summarize our marketable debt and equity securities, classified as available-for-sale: As of September 30, 2022 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 833.6 $ — $ (6.9) $ 826.7 Non-current 400.5 — (8.1) 392.4 Government securities: Current 412.1 0.1 (3.5) 408.7 Non-current 298.8 — (5.5) 293.3 Mortgage and other asset backed securities: Current 0.1 — — 0.1 Non-current 177.6 — (3.0) 174.6 Total marketable debt securities $ 2,122.7 $ 0.1 $ (27.0) $ 2,095.8 Marketable equity securities Marketable equity securities, non-current $ 1,133.8 $ — $ (237.8) $ 896.0 Total marketable equity securities $ 1,133.8 $ — $ (237.8) $ 896.0 As of December 31, 2021 (In millions) Amortized Gross Gross Fair Marketable debt securities Corporate debt securities: Current $ 723.6 $ 0.1 $ (0.3) $ 723.4 Non-current 385.4 0.2 (0.8) 384.8 Government securities: Current 817.0 — (0.4) 816.6 Non-current 377.0 0.1 (1.0) 376.1 Mortgage and other asset backed securities: Current 1.1 — — 1.1 Non-current 131.8 — (0.7) 131.1 Total marketable debt securities $ 2,435.9 $ 0.4 $ (3.2) $ 2,433.1 Marketable equity securities Marketable equity securities, current $ 33.9 $ 9.9 $ — $ 43.8 Marketable equity securities, non-current 1,133.1 151.0 (279.4) 1,004.7 Total marketable equity securities $ 1,167.0 $ 160.9 $ (279.4) $ 1,048.5 |
Summary of contractual maturities: available-for-sale securities | The estimated fair value and amortized cost of our marketable debt securities classified as available-for-sale by contractual maturity are summarized as follows: As of September 30, 2022 As of December 31, 2021 (In millions) Estimated Amortized Estimated Amortized Due in one year or less $ 1,235.5 $ 1,245.8 $ 1,541.1 $ 1,541.7 Due after one year through five years 848.3 864.0 868.2 870.2 Due after five years 12.0 12.9 23.8 24.0 Total marketable debt securities $ 2,095.8 $ 2,122.7 $ 2,433.1 $ 2,435.9 |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Proceeds from maturities and sales $ 1,643.2 $ 575.4 $ 3,104.7 $ 2,028.1 Realized gains — 0.1 — 0.4 Realized losses 7.9 0.5 9.3 1.7 |
Derivative Instruments (Tables)
Derivative Instruments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Foreign currency forward contracts that were entered into to hedge forecasted revenue | The notional amount 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 September 30, 2022 As of December 31, 2021 Euro $ 1,089.2 $ 1,828.0 British pound 43.5 166.2 Swiss franc 37.8 — Japanese yen 23.5 72.7 Canadian dollar 14.7 59.9 Total foreign currency forward contracts $ 1,208.7 $ 2,126.8 |
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 September 30, Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Revenue $ 77.7 $ (14.9) Revenue $ 6.6 $ (0.7) Operating expense (0.8) (0.3) Operating expense (0.1) — For the Nine Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Revenue $ 143.2 $ (68.7) Revenue $ (0.8) $ (4.5) Operating expense (3.5) (0.3) Operating expense (0.4) (0.4) |
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 hedges in our condensed consolidated financial statements: For the Three Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Location 2022 2021 Gains (losses) on net investment hedges (1) $ — $ 24.9 Gains (losses) on net investment hedges (1) $ — $ — Other (income) expense (1) $ — $ — For the Nine Months Ended September 30, Net Gains/(Losses) Net Gains/(Losses) Net Gains/(Losses) Location 2022 2021 Location 2022 2021 Location 2022 2021 Gains (losses) on net investment hedges (1) $ 20.4 $ 46.1 Gains (losses) on net investment hedges (1) $ (3.2) $ (1.1) Other (income) expense (1) $ (4.6) $ 0.1 (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
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 September 30, 2022 As of December 31, 2021 Cash Flow Hedging Instruments: Asset derivative instruments Other current assets $ 158.2 $ 66.2 Investments and other assets 5.0 5.5 Liability derivative instruments Accrued expense and other 2.6 6.6 Net Investment Hedging Instruments: (1) Asset derivative instruments Other current assets 21.4 4.1 Other Derivative Instruments: Asset derivative instruments Other current assets 11.3 5.1 Liability derivative instruments Accrued expense and other 20.2 4.2 (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. Amount represents unsettled balance of our closed net investment hedges. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
Derivative Instruments, Unrealized Gain (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 is summarized as follows: (In millions) As of September 30, 2022 As of December 31, 2021 Unrealized gains $ 146.5 $ 60.8 Unrealized (losses) (2.2) (7.0) Net unrealized gains (losses) $ 144.3 $ 53.8 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 Hedges, Net of Tax (1) Unrealized gains (losses) on pension benefit obligation, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2021 $ (2.2) $ 53.8 $ 25.5 $ (44.8) $ (139.0) $ (106.7) Other comprehensive income (loss) before reclassifications (26.4) 204.5 12.6 4.2 (154.5) 40.4 Amounts reclassified from accumulated other comprehensive income (loss) 7.4 (125.5) (38.1) — 58.9 (97.3) Net current period other comprehensive income (loss) (19.0) 79.0 (25.5) 4.2 (95.6) (56.9) Balance, September 30, 2022 $ (21.2) $ 132.8 $ — $ (40.6) $ (234.6) $ (163.6) (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. (In millions) Unrealized Gains (Losses) on Securities Available for Sale, Net of Tax Unrealized Gains (Losses) on Cash Flow Hedges, Net of Tax Gains (Losses) on Net Investment Hedges, Net of Tax Unrealized gains (losses) on pension benefit obligation, Net of Tax Currency Translation Adjustments Total Balance, December 31, 2020 $ 1.4 $ (179.0) $ (8.5) $ (66.3) $ (46.6) $ (299.0) Other comprehensive income (loss) before reclassifications (2.5) 143.0 35.3 3.9 (80.3) 99.4 Amounts reclassified from accumulated other comprehensive income (loss) 1.1 62.0 (0.1) — — 63.0 Net current period other comprehensive income (loss) (1.4) 205.0 35.2 3.9 (80.3) 162.4 Balance, September 30, 2021 $ — $ 26.0 $ 26.7 $ (62.4) $ (126.9) $ (136.6) |
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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Gains (losses) on securities available for sale Other (income) expense $ (8.0) $ (0.4) $ (9.4) $ (1.3) Income tax benefit (expense) 1.7 0.1 2.0 0.3 Gains (losses) on cash flow hedges Revenue 77.7 (14.9) 143.2 (68.7) Operating expense (0.8) (0.3) (3.5) (0.3) Other (income) expense — — (0.2) 0.1 Income tax benefit (expense) (7.8) 1.5 (14.0) 6.8 Gains (losses) on net investment hedges (1) Other (income) expense — — 38.1 0.1 Currency Translation Adjustments Other (income) expense — — (58.9) — Total reclassifications, net of tax $ 62.8 $ (14.0) $ 97.3 $ (63.0) (1) Beginning in the second quarter of 2022 we no longer hold net investment hedges as they were closed with the sale of our 49.9% equity interest in Samsung Bioepis in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
Earnings per Share (Tables)
Earnings per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Numerator: Net income attributable to Biogen Inc. $ 1,134.7 $ 329.2 $ 2,496.5 $ 1,187.9 Denominator: Weighted average number of common shares outstanding 144.4 148.0 145.8 149.9 Effect of dilutive securities: Time-vested restricted stock units 0.3 0.4 0.3 0.2 Market stock units — 0.1 — 0.1 Performance stock units settled in stock 0.1 0.1 0.1 0.1 Dilutive potential common shares 0.4 0.6 0.4 0.4 Shares used in calculating diluted earnings per share 144.8 148.6 146.2 150.3 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Research and development $ 24.5 $ 19.5 $ 72.6 $ 72.2 Selling, general and administrative 46.5 42.6 129.3 127.8 Subtotal 71.0 62.1 201.9 200.0 Capitalized share-based compensation costs (2.0) (1.9) (7.1) (6.3) Share-based compensation expense included in total cost and expense 69.0 60.2 194.8 193.7 Income tax effect (13.0) (10.9) (36.0) (35.8) Share-based compensation expense included in net income attributable to Biogen Inc. $ 56.0 $ 49.3 $ 158.8 $ 157.9 |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Market stock units $ 4.0 $ 9.7 $ 11.4 $ 35.5 Time-vested restricted stock units 48.7 38.8 150.4 121.9 Performance stock units settled in stock 10.5 4.9 22.1 14.2 Performance stock units settled in cash 5.4 4.4 7.9 13.9 Employee stock purchase plan 2.4 4.3 10.1 14.5 Subtotal 71.0 62.1 201.9 200.0 Capitalized share-based compensation costs (2.0) (1.9) (7.1) (6.3) Share-based compensation expense included in total cost and expense $ 69.0 $ 60.2 $ 194.8 $ 193.7 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Statutory rate 21.0 % 21.0 % 21.0 % 21.0 % State taxes 1.9 0.3 1.1 0.9 Taxes on foreign earnings (3.4) (20.2) (4.4) (11.5) Tax credits (1.4) (7.1) (1.5) (4.1) Purchased intangible assets 0.1 (6.2) 0.2 (1.4) GILTI 0.8 2.6 0.5 1.6 Sale of Samsung Bioepis (0.8) — (1.9) — Litigation settlement agreement (1.2) — 3.1 — Neurimmune tax impacts — (0.5) 2.8 (36.4) International reorganization — — (1.7) — Other 0.2 1.2 0.2 0.7 Effective tax rate 17.2 % (8.9) % 19.4 % (29.2) % |
Other Consolidated Financial _2
Other Consolidated Financial Statement Detail (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Gain on sale of equity interest in Samsung Bioepis (1) $ — $ — $ (1,505.4) $ — Litigation settlement agreement — — 900.0 — Interest income (23.9) (2.6) (39.4) (8.2) Interest expense 59.9 66.3 191.8 187.3 (Gains) losses on investments, net (101.8) 424.5 167.5 707.2 Foreign exchange (gains) losses, net 11.5 13.7 39.0 23.1 Other, net (1.7) 1.0 25.2 4.0 Total other (income) expense, net $ (56.0) $ 502.9 $ (221.3) $ 913.4 (1) Reflects the pre-tax gain, net of transaction costs, recognized from the sale of our 49.9% equity interest in Samsung Bioepis to Samsung BioLogics in April 2022. For additional information on the sale of our equity interest in Samsung Bioepis, please read Note 2, Dispositions, to these condensed consolidated financial statements. |
Gain (loss) on investments in equity securities | The following table summarizes our (gains) losses on investments, net that relate to our equity securities held during the following periods: For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Net (gains) losses recognized on equity securities $ (109.8) $ 424.2 $ 158.1 $ 705.9 Less: Net (gains) losses realized on equity securities (0.5) (2.7) — (9.3) Net unrealized (gains) losses recognized on equity securities $ (109.3) $ 426.9 $ 158.1 $ 715.2 The net unrealized gains recognized during the three months ended September 30, 2022, primarily reflect an increase in the aggregate fair value of our investments in Sage, Ionis Pharmaceuticals, Inc. (Ionis), Sangamo and Denali common stock of approximately $112.5 million. The net unrealized losses recognized during the nine months ended September 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Denali and Sangamo common stock of approximately $198.0 million. |
Accrued expenses and other | Accrued expense and other consists of the following: (In millions) As of September 30, 2022 As of December 31, 2021 Litigation settlement agreement (1) $ 900.0 $ — Revenue-related reserves for discounts and allowances 854.5 802.1 Collaboration expense 260.1 324.7 Royalties and licensing fees 208.6 234.7 Employee compensation and benefits 313.5 345.1 Other 769.2 828.6 Total accrued expense and other $ 3,305.9 $ 2,535.2 (1) During the second quarter of 2022 we recorded a pre-tax charge of $900.0 million, plus estimated fees and expenses, related to a litigation settlement agreement to resolve a qui tam litigation relating to conduct prior to 2015. For additional information on the litigation settlement agreement, please read Note 20, Litigation , to these condensed consolidated financial statements. |
Collaborative and Other Relat_2
Collaborative and Other Relationships (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Activity Related to BAN2401 and Elenbecestat Collaboration | For the Three Months Ended September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total development expense incurred by the collaboration related to the advancement of lecanemab and elenbecestat $ 109.3 $ 118.4 $ 264.9 $ 236.1 Biogen's share of lecanemab and elenbecestat development expense reflected in research and development expense in our condensed consolidated statements of income 54.7 59.2 132.5 118.0 Total sales and marketing expense incurred by the Lecanemab Collaboration 29.0 5.6 68.3 15.6 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 14.5 2.8 34.2 7.8 |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total ADUHELM development expense $ 34.6 $ 43.7 $ 116.0 $ 132.8 Biogen's share of ADUHELM development expense reflected in research and development expense in our condensed consolidated statements of income 19.0 24.0 63.8 73.0 Total ADUHELM sales and marketing expense incurred by the ADUHELM Collaboration Agreement (8.0) 154.3 127.8 391.7 Biogen's share of ADUHELM sales and marketing expense reflected in selling, general and administrative expense and collaboration profit (loss) sharing in our condensed consolidated statements of income (3.9) 83.3 68.1 211.2 Total ADUHELM collaboration third party milestones — — — 100.0 Biogen's share of reimbursement from Eisai of ADUHELM milestone payments reflected in collaboration profit (loss) sharing in our condensed consolidated statements of income — — — 45.0 |
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 September 30, For the Nine Months Ended September 30, (In millions) 2022 2021 2022 2021 Total Denali collaboration development expense $ 19.9 $ 8.5 $ 58.0 $ 27.2 Biogen's share of Denali development expense reflected in research and development expense in our condensed consolidated statements of income 11.4 5.1 33.5 16.3 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2022 segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Interest in subsidiary (less than given percentage) | 100% |
Restructuring, Business Trans_3
Restructuring, Business Transformation and Other Cost Saving Initiatives - Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charges | $ 15.4 | $ 0 | $ 124.1 | $ 0 | ||
Employee related costs | $ 21.6 | 110.2 | ||||
Gain due to lease termination | $ 5.3 | |||||
Accelerated depreciation expense | 10.4 | |||||
Other restructuring costs | $ 8.8 | |||||
Minimum | Forecast | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charges | $ 130 | |||||
Maximum | Forecast | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charges | $ 150 |
Restructuring, Business Trans_4
Restructuring, Business Transformation and Other Cost Saving Initiatives - Restructuring Reserve Roll Forward (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Restructuring Cost and Reserve [Line Items] | ||||||
Expense | $ 15.4 | $ 0 | $ 124.1 | $ 0 | ||
Foreign currency and other adjustments | (1.3) | $ (0.5) | ||||
Workforce Reduction | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring reserve, beginning | 52.2 | 21.5 | $ 0 | 0 | ||
Expense | 21.6 | 60.9 | 27.7 | |||
Payment | (32.3) | (29.7) | (6.2) | |||
Restructuring reserve, ending | $ 40.2 | $ 52.2 | $ 21.5 | $ 40.2 |
Revenues - Revenues by product
Revenues - Revenues by product (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ 2,508.5 | $ 2,778.9 | $ 7,629.4 | $ 8,247.9 |
MS Product Revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1,340.3 | 1,556 | 4,161.4 | 4,568.5 |
MS Product Revenues | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 707.9 | 833.4 | 2,170.7 | 2,410.9 |
MS Product Revenues | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 632.4 | 722.6 | 1,990.7 | 2,157.6 |
Fumarate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 476.8 | 619.5 | 1,549.4 | 1,750.9 |
Fumarate | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 220.4 | 299.9 | 713.3 | 805.1 |
Fumarate | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 256.4 | 319.6 | 836.1 | 945.8 |
TECFIDERA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 339 | 498.6 | 1,146.8 | 1,465.4 |
TECFIDERA | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 92.5 | 179.2 | 330.3 | 520.1 |
TECFIDERA | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 246.5 | 319.4 | 816.5 | 945.3 |
VUMERITY | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 137.8 | 120.9 | 402.6 | 285.5 |
VUMERITY | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 127.9 | 120.7 | 383 | 285 |
VUMERITY | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 9.9 | 0.2 | 19.6 | 0.5 |
Interferon | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 336 | 387.5 | 995.8 | 1,188.4 |
Interferon | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 214.5 | 252.4 | 608 | 751.6 |
Interferon | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 121.5 | 135.1 | 387.8 | 436.8 |
AVONEX | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 255.1 | 301.3 | 743.4 | 923.3 |
AVONEX | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 174.8 | 213.2 | 493.8 | 636.4 |
AVONEX | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 80.3 | 88.1 | 249.6 | 286.9 |
PLEGRIDY | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 80.9 | 86.2 | 252.4 | 265.1 |
PLEGRIDY | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 39.7 | 39.2 | 114.2 | 115.2 |
PLEGRIDY | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 41.2 | 47 | 138.2 | 149.9 |
TYSABRI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 505.5 | 522.8 | 1,542.5 | 1,550.4 |
TYSABRI | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 273 | 281.1 | 849.4 | 854.2 |
TYSABRI | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 232.5 | 241.7 | 693.1 | 696.2 |
FAMPYRA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 22 | 26.2 | 73.7 | 78.8 |
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 | 22 | 26.2 | 73.7 | 78.8 |
SPINRAZA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 431.1 | 444.1 | 1,334.7 | 1,464.4 |
SPINRAZA | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 140.2 | 139.8 | 443.3 | 437.8 |
SPINRAZA | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 290.9 | 304.3 | 891.4 | 1,026.6 |
Biosimilars | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 187.6 | 202.8 | 576.3 | 610.2 |
Biosimilars | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0.7 | 0 | 1.2 | 0 |
Biosimilars | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 186.9 | 202.8 | 575.1 | 610.2 |
BENEPALI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 110.2 | 120.8 | 340.7 | 363.9 |
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 | 110.2 | 120.8 | 340.7 | 363.9 |
IMRALDI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 57.7 | 57.4 | 172.4 | 170.9 |
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 | 57.7 | 57.4 | 172.4 | 170.9 |
FLIXABI | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 19 | 24.6 | 62 | 75.4 |
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 | 19 | 24.6 | 62 | 75.4 |
BYOOVIZ | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0.7 | 0 | 1.2 | 0 |
BYOOVIZ | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0.7 | 0 | 1.2 | 0 |
BYOOVIZ | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
FUMADERM | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1.5 | 2.5 | 6.4 | 8.3 |
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 | 1.5 | 2.5 | 6.4 | 8.3 |
ADUHELM | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1.6 | 0.3 | 4.5 | 2 |
ADUHELM | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1.6 | 0.3 | 4.5 | 2 |
ADUHELM | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 0 | 0 | 0 | 0 |
Product, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 1,962.1 | 2,205.7 | 6,083.3 | 6,653.4 |
Product, net | U.S. | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | 850.4 | 973.5 | 2,619.7 | 2,850.7 |
Product, net | Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ 1,111.7 | $ 1,232.2 | $ 3,463.6 | $ 3,802.7 |
Revenues Reserves for Discounts
Revenues Reserves for Discounts and Allowances (Details 1) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | $ 935.3 |
Current Provisions Relating To Sales In Current Year | 2,501.4 |
Adjustments Relating To Prior Years | (28.6) |
Payments/Returns Relating To Sales in Current Year | (1,821.6) |
Payments/Returns Relating To Sales in Prior Year | (602.6) |
Ending Balance | 983.9 |
Discounts | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 137.7 |
Current Provisions Relating To Sales In Current Year | 499.3 |
Adjustments Relating To Prior Years | (2.5) |
Payments/Returns Relating To Sales in Current Year | (379.6) |
Payments/Returns Relating To Sales in Prior Year | (124.5) |
Ending Balance | 130.4 |
Contractual adjustments | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 759.6 |
Current Provisions Relating To Sales In Current Year | 1,993.6 |
Adjustments Relating To Prior Years | (18.4) |
Payments/Returns Relating To Sales in Current Year | (1,442) |
Payments/Returns Relating To Sales in Prior Year | (463.7) |
Ending Balance | 829.1 |
Returns | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning Balance | 38 |
Current Provisions Relating To Sales In Current Year | 8.5 |
Adjustments Relating To Prior Years | (7.7) |
Payments/Returns Relating To Sales in Current Year | 0 |
Payments/Returns Relating To Sales in Prior Year | (14.4) |
Ending Balance | $ 24.4 |
Revenues- Reserves for Discount
Revenues- Reserves for Discounts and Allowances (Details 2) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Total Reserves | $ 983.9 | $ 935.3 |
Reduction of accounts receivable | ||
Total Reserves | 129.4 | 133.2 |
Component of accrued expenses and other | ||
Total Reserves | $ 854.5 | $ 802.1 |
Revenues - Revenues from Anti-C
Revenues - Revenues from Anti-CD20 Therapeutic Programs (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 2,508.5 | $ 2,778.9 | $ 7,629.4 | $ 8,247.9 |
Genentech | ||||
Disaggregation of Revenue [Line Items] | ||||
Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA | 131.1 | 145.8 | 414.2 | 498.7 |
Other revenues from anti-CD20 therapeutic programs | 285.8 | 269.6 | 838.4 | 745.7 |
Revenue from anti-CD20 therapeutic programs | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 416.9 | $ 415.4 | $ 1,252.6 | $ 1,244.4 |
Revenues - Other Revenues (Deta
Revenues - Other Revenues (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 2,508.5 | $ 2,778.9 | $ 7,629.4 | $ 8,247.9 |
Royalty | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 8.8 | 7.7 | 29.7 | 20.3 |
Other corporate revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 114.2 | 143.8 | 242.9 | 314.1 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 129.5 | 157.8 | 293.5 | 350.1 |
Collaborative arrangement | ZINBRYTA | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 6.5 | $ 6.3 | $ 20.9 | $ 15.7 |
Revenues - Narrative (Details)
Revenues - Narrative (Details) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) wholesaler | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) wholesaler | Sep. 30, 2021 USD ($) | |
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 2,508.5 | $ 2,778.9 | $ 7,629.4 | $ 8,247.9 |
Number of wholesalers | wholesaler | 2 | 2 | ||
Distributor One | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 26.90% | 26.90% | 26.80% | 29.10% |
Distributor Two | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 10.50% | 10.80% | 10.70% | 10% |
Other corporate revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 114.2 | $ 143.8 | $ 242.9 | $ 314.1 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Other Revenues | $ 129.5 | $ 157.8 | $ 293.5 | $ 350.1 |
Inventory - Components of Inven
Inventory - Components of Inventory (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory [Line Items] | ||
Raw materials | $ 394.2 | $ 349.6 |
Work in process | 771 | 814 |
Finished goods | 209.8 | 187.9 |
Total inventory | 1,375 | $ 1,351.5 |
Lecanemab | ||
Inventory [Line Items] | ||
Work in process | $ 118 |
Inventory - Narrative (Details)
Inventory - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Inventory [Line Items] | |||||||
Excess and obsolescence charges related to inventory | $ 321.6 | $ 36.5 | |||||
(Gain) loss on equity method investments | $ 2.6 | 17.2 | |||||
Percentage of future development costs related to Eisai | 45% | ||||||
Eisai | |||||||
Inventory [Line Items] | |||||||
(Gain) loss on equity method investments | $ 3.4 | $ 50.6 | $ 214 | $ 90.7 | |||
Percentage of future development costs related to Eisai | 45% | ||||||
ADUHELM | |||||||
Inventory [Line Items] | |||||||
Excess and obsolescence charges related to inventory | $ 275 | $ 120 | |||||
Inventory | $ 223 | ||||||
ADUHELM | Eisai | |||||||
Inventory [Line Items] | |||||||
(Gain) loss on equity method investments | $ 59 | $ 45 | $ 45 | 177 | |||
ADUHELM | Eisai | Centers for Medicare and Medicaid Service | |||||||
Inventory [Line Items] | |||||||
(Gain) loss on equity method investments | $ 136 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Intangible assets | |||||
Total intangible assets, gross | $ 7,588.3 | $ 7,588.3 | $ 7,609.8 | ||
Accumulated Amortization | (5,579.4) | (5,579.4) | (5,388.5) | ||
Intangible assets, net | 2,008.9 | 2,008.9 | 2,221.3 | ||
Amortization and impairment of acquired intangible assets | 56.5 | $ 111 | 190.9 | $ 813.2 | |
Expected future amortization expense, 2019 (remaining three months) | 55 | 55 | |||
Expected future amortization expense, 2020 | 215 | 215 | |||
Expected future amortization expense, 2021 | 195 | 195 | |||
Expected future amortization expense, 2022 | 190 | 190 | |||
Expected future amortization expense, 2023 | 175 | 175 | |||
Expected future amortization expense, 2024 | 165 | 165 | |||
Completed technology | |||||
Intangible assets | |||||
Cost | 7,415 | 7,415 | 7,413.1 | ||
Net | 1,835.6 | 1,835.6 | 2,024.6 | ||
Accumulated Amortization | (5,579.4) | $ (5,579.4) | (5,388.5) | ||
Completed technology | Minimum | |||||
Intangible assets | |||||
Useful life | 4 years | ||||
Completed technology | Maximum | |||||
Intangible assets | |||||
Useful life | 28 years | ||||
In-process research and development | |||||
Intangible assets | |||||
Cost and Net | 109.3 | $ 109.3 | 132.7 | ||
Accumulated Amortization | 0 | 0 | 0 | ||
Indefinite-lived Intangible Assets (Excluding Goodwill) | 109.3 | 109.3 | 132.7 | ||
Trademarks and Trade Names | |||||
Intangible assets | |||||
Cost and Net | 64 | 64 | 64 | ||
Accumulated Amortization | 0 | 0 | 0 | ||
Indefinite-lived Intangible Assets (Excluding Goodwill) | 64 | 64 | $ 64 | ||
BIIB111 | |||||
Intangible assets | |||||
Amortization and impairment of acquired intangible assets | 15 | 365 | |||
BIIB112 | |||||
Intangible assets | |||||
Amortization and impairment of acquired intangible assets | 28.4 | 220 | |||
Vixotrigine | |||||
Intangible assets | |||||
Amortization and impairment of acquired intangible assets | $ 44.3 | ||||
TGN | In-process research and development | |||||
Intangible assets | |||||
Cost and Net | 109.3 | 109.3 | |||
Indefinite-lived Intangible Assets (Excluding Goodwill) | $ 109.3 | $ 109.3 | |||
BIIB111 and BIIB112 | |||||
Intangible assets | |||||
Amortization and impairment of acquired intangible assets | $ 39.1 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Details 1) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Summary of roll forward of the changes in goodwill | |
Goodwill, beginning of period | $ 5,761,100,000 |
Other | (19,900,000) |
Goodwill, end of period | 5,741,200,000 |
Accumulated impairment losses related to goodwill | $ 0 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Assets: | ||||||
Marketable debt securities | $ 2,095.8 | $ 2,433.1 | ||||
Samsung Bioepis | ||||||
Liabilities: | ||||||
Equity, ownership interest | 49.90% | |||||
Fair Value, Measurements Recurring | ||||||
Assets: | ||||||
Cash equivalents | $ 3,191.8 | 1,632.2 | ||||
Marketable equity securities | 896 | 1,048.5 | ||||
Derivative contracts | 195.9 | 80.9 | ||||
Plan assets for deferred compensation | 32.2 | 33.4 | ||||
Total | 7,605.3 | 5,228.1 | ||||
Liabilities: | ||||||
Derivative contracts | 22.8 | 10.8 | ||||
Contingent consideration obligations | 195.4 | $ 197.5 | 209.1 | $ 210.7 | $ 226.3 | $ 259.8 |
Total | 218.2 | 219.9 | ||||
Fair Value, Measurements Recurring | Samsung Bioepis | ||||||
Assets: | ||||||
Other current assets, receivable | 790.8 | |||||
Other assets, receivable | 402.8 | |||||
Fair Value, Measurements Recurring | Corporate debt securities | ||||||
Assets: | ||||||
Marketable debt securities | 1,219.1 | 1,108.2 | ||||
Fair Value, Measurements Recurring | Government securities | ||||||
Assets: | ||||||
Marketable debt securities | 702 | 1,192.7 | ||||
Fair Value, Measurements Recurring | Mortgage and other asset backed securities | ||||||
Assets: | ||||||
Marketable debt securities | 174.7 | 132.2 | ||||
Quoted Prices in Active Markets (Level 1) | Fair Value, Measurements Recurring | ||||||
Assets: | ||||||
Cash equivalents | 0 | 0 | ||||
Marketable equity securities | 896 | 181.7 | ||||
Derivative contracts | 0 | 0 | ||||
Plan assets for deferred compensation | 0 | 0 | ||||
Total | 896 | 181.7 | ||||
Liabilities: | ||||||
Derivative contracts | 0 | 0 | ||||
Contingent consideration obligations | 0 | 0 | ||||
Total | 0 | 0 | ||||
Quoted Prices in Active Markets (Level 1) | Fair Value, Measurements Recurring | Samsung Bioepis | ||||||
Assets: | ||||||
Other current assets, receivable | 0 | |||||
Other assets, receivable | 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 | 3,191.8 | 1,632.2 | ||||
Marketable equity securities | 0 | 866.8 | ||||
Derivative contracts | 195.9 | 80.9 | ||||
Plan assets for deferred compensation | 32.2 | 33.4 | ||||
Total | 5,515.7 | 5,046.4 | ||||
Liabilities: | ||||||
Derivative contracts | 22.8 | 10.8 | ||||
Contingent consideration obligations | 0 | 0 | ||||
Total | 22.8 | 10.8 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements Recurring | Samsung Bioepis | ||||||
Assets: | ||||||
Other current assets, receivable | 0 | |||||
Other assets, receivable | 0 | |||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements Recurring | Corporate debt securities | ||||||
Assets: | ||||||
Marketable debt securities | 1,219.1 | 1,108.2 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements Recurring | Government securities | ||||||
Assets: | ||||||
Marketable debt securities | 702 | 1,192.7 | ||||
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements Recurring | Mortgage and other asset backed securities | ||||||
Assets: | ||||||
Marketable debt securities | 174.7 | 132.2 | ||||
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 | 1,193.6 | 0 | ||||
Liabilities: | ||||||
Derivative contracts | 0 | 0 | ||||
Contingent consideration obligations | 195.4 | 209.1 | ||||
Total | 195.4 | 209.1 | ||||
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements Recurring | Samsung Bioepis | ||||||
Assets: | ||||||
Other current assets, receivable | 790.8 | |||||
Other assets, receivable | 402.8 | |||||
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 | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |||
Asset impairment charges | $ 0 | $ 0 | |
Contingent consideration obligations | $ 195,400,000 | $ 195,400,000 | $ 209,100,000 |
Technological and Regulatory Success, Probability | 10.90% |
Fair Value Measurements Fair Va
Fair Value Measurements Fair Value Measurements - Contingent Consideration (Details) - Discount rate | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.0450 | |
December 31, 2021 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Discount rate | 0.0450 | 0.0130 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 1) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Notes payable, carrying value | $ 6,279.2 | $ 7,273.1 |
Debt instruments, fair value | $ 5,296.4 | 8,004.7 |
Senior notes interest rate | 3.625% | |
3.625% Senior Notes due 2022 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 0 | 1,020 |
Notes payable, carrying value | $ 0 | 999.1 |
Senior notes interest rate | 3.625% | |
4.050% Senior Notes due 2025 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 1,697.8 | 1,895.2 |
Notes payable, carrying value | $ 1,744.3 | 1,742.9 |
Senior notes interest rate | 4.05% | |
2.250% Senior Notes due May 1, 2030 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 997.2 | 1,475.9 |
Notes payable, carrying value | $ 1,100.2 | 1,492 |
Senior notes interest rate | 2.25% | |
5.200% Senior Notes due 2045 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 1,183 | 1,463 |
Notes payable, carrying value | $ 1,492.7 | 1,099.9 |
Senior notes interest rate | 5.20% | |
3.150% Senior Notes due May 1, 2050 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 965.6 | 1,457.7 |
Notes payable, carrying value | $ 1,473.6 | 1,473.2 |
Senior notes interest rate | 3.15% | |
3.250% Senior Notes, Due February 15, 2051 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | $ 452.8 | 692.9 |
Notes payable, carrying value | $ 468.4 | $ 466 |
Senior notes interest rate | 3.25% |
Fair Value Measurements (Deta_4
Fair Value Measurements (Details 2) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Business Acquisition, Contingent Consideration [Line Items] | ||||
Contingent consideration impairment | $ 2.1 | $ 15.6 | $ 13.7 | $ 49.1 |
Fair Value, Measurements Recurring | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Fair value, beginning of period | 197.5 | 226.3 | 209.1 | 259.8 |
Fair value, end of period | $ 195.4 | $ 210.7 | $ 195.4 | $ 210.7 |
Financial Instruments (Details)
Financial Instruments (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | $ 3,191.8 | $ 1,632.2 |
Commercial paper | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 3.2 | 247.6 |
Overnight reverse repurchase agreements | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 115.5 | 200 |
Money market funds | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | 3,070.6 | 901.6 |
Short-term debt securities | ||
Summary of financial assets with original maturities of less than 90 days included within cash and cash equivalents | ||
Cash equivalents | $ 2.5 | $ 283 |
Financial Instruments (Details
Financial Instruments (Details 1) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Marketable debt securities | ||
Amortized Cost | $ 2,122.7 | $ 2,435.9 |
Gross unrealized gains | 0.1 | 0.4 |
Gross unrealized losses | (27) | (3.2) |
Fair value | 2,095.8 | 2,433.1 |
Marketable equity securities | ||
Amortized Cost | 1,133.8 | 1,167 |
Gross Unrealized Gains | 0 | 160.9 |
Gross Unrealized Losses | (237.8) | (279.4) |
Fair Value | 896 | 1,048.5 |
Corporate debt securities Current | ||
Marketable debt securities | ||
Amortized Cost | 833.6 | 723.6 |
Gross unrealized gains | 0 | 0.1 |
Gross unrealized losses | (6.9) | (0.3) |
Fair value | 826.7 | 723.4 |
Corporate debt securities Non-current | ||
Marketable debt securities | ||
Amortized Cost | 400.5 | 385.4 |
Gross unrealized gains | 0 | 0.2 |
Gross unrealized losses | (8.1) | (0.8) |
Fair value | 392.4 | 384.8 |
Government securities Current | ||
Marketable debt securities | ||
Amortized Cost | 412.1 | 817 |
Gross unrealized gains | 0.1 | 0 |
Gross unrealized losses | (3.5) | (0.4) |
Fair value | 408.7 | 816.6 |
Government securities Non-current | ||
Marketable debt securities | ||
Amortized Cost | 298.8 | 377 |
Gross unrealized gains | 0 | 0.1 |
Gross unrealized losses | (5.5) | (1) |
Fair value | 293.3 | 376.1 |
Mortgage and other asset backed securities Current | ||
Marketable debt securities | ||
Amortized Cost | 0.1 | 1.1 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair value | 0.1 | 1.1 |
Mortgage and other asset backed securities Non-current | ||
Marketable debt securities | ||
Amortized Cost | 177.6 | 131.8 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | (3) | (0.7) |
Fair value | 174.6 | 131.1 |
Equity Securities, Current | ||
Marketable equity securities | ||
Amortized Cost | 33.9 | |
Gross Unrealized Gains | 9.9 | |
Gross Unrealized Losses | 0 | |
Fair Value | 43.8 | |
Equity Securities, Non-Current | ||
Marketable equity securities | ||
Amortized Cost | 1,133.8 | 1,133.1 |
Gross Unrealized Gains | 0 | 151 |
Gross Unrealized Losses | (237.8) | (279.4) |
Fair Value | $ 896 | $ 1,004.7 |
Financial Instruments (Detail_2
Financial Instruments (Details 2) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Summary of Contractual Maturities: Available-for-Sale Securities | ||
Due in one year or less, amortized cost | $ 1,235.5 | $ 1,541.1 |
Due in one year or less, estimated fair value | 1,245.8 | 1,541.7 |
Due after one year through five years, amortized cost | 848.3 | 868.2 |
Due after one year through five years, estimated fair value | 864 | 870.2 |
Due after five years, amortized cost | 12 | 23.8 |
Due after five years, estimated fair value | 12.9 | 24 |
Estimated Fair Value | 2,095.8 | 2,433.1 |
Amortized Cost | $ 2,122.7 | $ 2,435.9 |
Financial Instruments (Detail_3
Financial Instruments (Details 3) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from maturities and sales | $ 1,643.2 | $ 575.4 | $ 3,104.7 | $ 2,028.1 |
Realized gains | 0 | 0.1 | 0 | 0.4 |
Realized losses | $ 7.9 | $ 0.5 | $ 9.3 | $ 1.7 |
Financial Instruments (Detail_4
Financial Instruments (Details Textual) | 3 Months Ended | 9 Months Ended |
Mar. 31, 2022 | Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Average maturity of marketable securities, months | 10 months | 9 months |
Financial Instruments Financial
Financial Instruments Financial Instruments (Details Textual 2) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Other noncurrent assets | Strategic Investments | ||
Business Acquisition [Line Items] | ||
Strategic investment portfolio | $ 948.5 | $ 1,110.3 |
Derivative Instruments (Details
Derivative Instruments (Details) $ in Millions, ₩ in Billions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Nov. 30, 2018 USD ($) | Nov. 30, 2018 KRW (₩) | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | May 31, 2018 | |
Derivatives [Line Items] | |||||||||
Gain (loss) on foreign currency derivative instruments not designated as hedging instruments | $ 36.5 | $ (13.5) | $ 85.8 | $ (26.1) | |||||
Gains (losses) on net investment hedges, net of tax | 0 | 15.1 | $ (25.5) | 35.2 | |||||
Minimum | |||||||||
Derivatives [Line Items] | |||||||||
Range of durations of foreign currency forward contracts | 1 month | ||||||||
Maximum | |||||||||
Derivatives [Line Items] | |||||||||
Range of durations of foreign currency forward contracts | 15 months | 15 months | |||||||
Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 1,285.4 | $ 1,285.4 | $ 1,268 | ||||||
Other current assets | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 158.2 | 158.2 | 66.2 | ||||||
Other current assets | Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 11.3 | 11.3 | 5.1 | ||||||
Other noncurrent assets | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 5 | 5 | 5.5 | ||||||
Accrued expenses and other | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 2.6 | 2.6 | 6.6 | ||||||
Accrued expenses and other | Not designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative liability, fair value | 20.2 | 20.2 | 4.2 | ||||||
Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 1,208.7 | 1,208.7 | 2,126.8 | ||||||
Foreign Exchange Forward | |||||||||
Derivatives [Line Items] | |||||||||
Unrealized Gain on Derivatives | 146.5 | 60.8 | |||||||
Unrealized Loss on Derivatives | (2.2) | (7) | |||||||
Unrealized Gain (Loss) on Derivatives | 144.3 | 53.8 | |||||||
Net Investment Hedging | |||||||||
Derivatives [Line Items] | |||||||||
Unrealized gain (loss) on net investment hedges in AOCI | $ 10.6 | ||||||||
Derivative qualifying as net investment hedge, excluded component | 3.6 | ||||||||
Gains (losses) on net investment hedges, net of tax | 0 | 24.9 | 20.4 | 46.1 | |||||
Gains (losses) on net investment hedge, excluded component | 0 | 0 | (3.2) | (1.1) | |||||
Net Investment Hedging | Foreign exchange contract | Other current assets | |||||||||
Derivatives [Line Items] | |||||||||
Derivative asset, fair value | 21.4 | 21.4 | 4.1 | ||||||
Revenue | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Other Comprehensive Income (Loss), Cash Flow Hedge, Gain (Loss), Reclassification, before Tax | 77.7 | (14.9) | 143.2 | (68.7) | |||||
Revenue | Cash flows, revenue | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Gain on interest rate swap | 6.6 | (0.7) | (0.8) | (4.5) | |||||
Operating expense | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Other Comprehensive Income (Loss), Cash Flow Hedge, Gain (Loss), Reclassification, before Tax | (0.8) | (0.3) | (3.5) | (0.3) | |||||
Operating expense | Cash flows, operating expenses | Foreign exchange contract | |||||||||
Derivatives [Line Items] | |||||||||
Gain on interest rate swap | (0.1) | 0 | (0.4) | (0.4) | |||||
Other income (expense) | Net Investment Hedging | |||||||||
Derivatives [Line Items] | |||||||||
Gain (loss) recognized in net income, excluded component | 0 | $ 0 | (4.6) | $ 0.1 | |||||
Euro | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 1,089.2 | 1,089.2 | 1,828 | ||||||
British pound | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 23.5 | 23.5 | 72.7 | ||||||
Swiss franc | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 43.5 | 43.5 | 166.2 | ||||||
Japan, Yen | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | 14.7 | 14.7 | 59.9 | ||||||
Canadian dollar | Foreign exchange contract | Designated as hedging instrument | |||||||||
Derivatives [Line Items] | |||||||||
Derivative, Notional Amount | $ 37.8 | $ 37.8 | $ 0 | ||||||
Samsung Bioepis | |||||||||
Derivatives [Line Items] | |||||||||
Equity, ownership interest | 49.90% | 49.90% | |||||||
Percentage of stake in entity | 5% | ||||||||
Payments to acquire additional investment in equity method investment | $ 676.6 | ₩ 759.5 | |||||||
Short-term derivative | |||||||||
Derivatives [Line Items] | |||||||||
Range of durations of foreign currency forward contracts | 12 months | ||||||||
Gain/Loss on fair value of foreign currency forward contracts | $ 142.6 | $ 142.6 |
Property, Plant and Equipment (
Property, Plant and Equipment (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Property, Plant and Equipment [Line Items] | ||||||
Accumulated depreciation | $ 2,098 | $ 2,098 | $ 2,098 | $ 2,006.6 | ||
Depreciation | 64.2 | $ 65.1 | 207.7 | $ 168.7 | ||
Sales price | 582.6 | 0 | ||||
Gain on sale of building | 503.7 | $ 0 | 503.7 | $ 0 | ||
Property, plant and equipment, net | 3,266.4 | 3,266.4 | 3,266.4 | 3,416.4 | ||
125 Broadway Building | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Sales price | 603 | |||||
Tenant allowance | 10.8 | |||||
Gain on sale of building | 503.7 | |||||
Property, plant and equipment, net | 79.2 | 79.2 | 79.2 | |||
Building | 125 Broadway Building | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property, plant and equipment, net | 72.6 | 72.6 | 72.6 | |||
Land | 125 Broadway Building | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property, plant and equipment, net | 1.6 | 1.6 | 1.6 | |||
Machinery and Equipment | 125 Broadway Building | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property, plant and equipment, net | 5 | 5 | $ 5 | |||
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 | 701 | 701 | $ 701 | $ 677 | ||
Fixed assets placed into service | $ 1,200 | $ 1,200 | $ 1,200 |
Leases (Details Textual)
Leases (Details Textual) - USD ($) $ in Millions | 1 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Operating Leased Assets [Line Items] | ||
Operating lease assets | $ 424.5 | $ 375.4 |
Right-of-use assets derecognized | 47.4 | |
Lease liabilities derecognized | 52.7 | |
Gain due to lease termination | $ 5.3 | |
125 Broadway Building | ||
Operating Leased Assets [Line Items] | ||
Lease term | 5 years 6 months | |
Operating lease assets | $ 168.2 | |
Operating lease liabilities | $ 168.2 |
Indebtedness (Details)
Indebtedness (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jul. 31, 2022 | Feb. 28, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 15, 2022 | Sep. 15, 2015 | |
Debt Instrument [Line Items] | ||||||||
Face amount | $ 1,000 | |||||||
Redemption rate | 99.92% | |||||||
Senior notes interest rate | 3.625% | 3.625% | ||||||
Extinguishment of Debt, Amount | $ 2.4 | |||||||
Repayments of Senior Debt | $ 151.8 | |||||||
Interest Expense | $ 59.9 | $ 66.3 | $ 191.8 | $ 187.3 | ||||
5.200% Senior Notes due 2045 | ||||||||
Debt Instrument [Line Items] | ||||||||
Senior notes interest rate | 5.20% | 5.20% | ||||||
Repayments of Senior Debt | 12.1 | |||||||
Debt Instrument, Redemption, Amount | 8.9 | |||||||
Long Term Debt, Exchanged, Amount | 624.6 | |||||||
Gain (Loss) on Extinguishment of Debt | $ 3.2 | |||||||
Repayments of borrowings and premiums paid on debt exchange | 13.8 | |||||||
Interest Expense | $ 6.1 | |||||||
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 | $ 700.7 |
Share Repurchases (Details)
Share Repurchases (Details) - USD ($) shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Oct. 31, 2020 | |
Class of Stock [Line Items] | ||||
Payments for repurchase of common stock | $ 750,000,000 | $ 1,800,000,000 | ||
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 | 2.2 | 6 | ||
Payments for repurchase of common stock | $ 750,000,000 | $ 1,800,000,000 | ||
Amount remaining under 2019 Share Repurchase Program | $ 2,100,000,000 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | $ (106.7) | $ (299) | ||
Balance, January 1, 2018 | $ (163.6) | $ (136.6) | (163.6) | (136.6) |
Other comprehensive income (loss), before reclassifications, net of tax | 40.4 | 99.4 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | (97.3) | 63 | ||
Other comprehensive income (loss), net of tax | (53.2) | 35.2 | (56.9) | 163 |
Accumulated other comprehensive income (loss), net of tax ending balance | (163.6) | (136.6) | (163.6) | (136.6) |
Other comprehensive income (loss), net of tax | (53.2) | 35.2 | (56.9) | 162.4 |
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 | (2.2) | 1.4 | ||
Balance, January 1, 2018 | (21.2) | 0 | (21.2) | 0 |
Other comprehensive income (loss), before reclassifications, net of tax | (26.4) | (2.5) | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 7.4 | 1.1 | ||
Other comprehensive income (loss), net of tax | (19) | (1.4) | ||
Accumulated other comprehensive income (loss), net of tax ending balance | (21.2) | 0 | (21.2) | 0 |
Unrealized gains (losses) on cash flow hedges | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | 53.8 | (179) | ||
Balance, January 1, 2018 | 132.8 | 26 | 132.8 | 26 |
Other comprehensive income (loss), before reclassifications, net of tax | 204.5 | 143 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | (125.5) | 62 | ||
Other comprehensive income (loss), net of tax | 79 | 205 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | 132.8 | 26 | 132.8 | 26 |
Gains (losses) on net investment hedge | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | 25.5 | (8.5) | ||
Balance, January 1, 2018 | 0 | 26.7 | 0 | 26.7 |
Other comprehensive income (loss), before reclassifications, net of tax | 12.6 | 35.3 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | (38.1) | (0.1) | ||
Other comprehensive income (loss), net of tax | (25.5) | 35.2 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | 0 | 26.7 | 0 | 26.7 |
Unfunded status of postretirement benefit plans | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (44.8) | (66.3) | ||
Balance, January 1, 2018 | (40.6) | (62.4) | (40.6) | (62.4) |
Other comprehensive income (loss), before reclassifications, net of tax | 4.2 | 3.9 | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 0 | 0 | ||
Other comprehensive income (loss), net of tax | 4.2 | 3.9 | ||
Accumulated other comprehensive income (loss), net of tax ending balance | (40.6) | (62.4) | (40.6) | (62.4) |
Currency translation adjustments | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Accumulated other comprehensive income (loss), net of tax beginning balance | (139) | (46.6) | ||
Balance, January 1, 2018 | (234.6) | (126.9) | (234.6) | (126.9) |
Other comprehensive income (loss), before reclassifications, net of tax | (154.5) | (80.3) | ||
Amounts reclassified from accumulated other comprehensive income, net of tax | 58.9 | 0 | ||
Other comprehensive income (loss), net of tax | (95.6) | (80.3) | ||
Accumulated other comprehensive income (loss), net of tax ending balance | $ (234.6) | $ (126.9) | $ (234.6) | $ (126.9) |
Reclassification out of Accumul
Reclassification out of Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | ||||
Other (income) expense | $ 56 | $ (502.9) | $ 221.3 | $ (913.4) |
Income Tax Expense (Benefit) | 236.2 | (25.9) | 578.5 | (390.7) |
Product revenues | 2,508.5 | 2,778.9 | 7,629.4 | 8,247.9 |
Net income attributable to Biogen Inc. | $ 1,134.7 | 329.2 | $ 2,496.5 | 1,187.9 |
Samsung Bioepis | ||||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | ||||
Equity, ownership interest | 49.90% | 49.90% | ||
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. | $ 62.8 | (14) | $ 97.3 | (63) |
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] | ||||
Other (income) expense | (8) | (0.4) | (9.4) | (1.3) |
Income Tax Expense (Benefit) | 1.7 | 0.1 | 2 | 0.3 |
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] | ||||
Other (income) expense | 0 | 0 | (0.2) | 0.1 |
Income Tax Expense (Benefit) | (7.8) | 1.5 | (14) | 6.8 |
Product revenues | 77.7 | (14.9) | 143.2 | (68.7) |
Operating Expenses | (0.8) | (0.3) | (3.5) | (0.3) |
Gains (losses) on net investment hedge | Reclassification out of Accumulated Other Comprehensive Income | ||||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | ||||
Other (income) expense | 0 | 0 | 38.1 | 0.1 |
Currency Translation Adjustments | Reclassification out of Accumulated Other Comprehensive Income | ||||
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | ||||
Other (income) expense | $ 0 | $ 0 | $ (58.9) | $ 0 |
Earnings per Share (Details)
Earnings per Share (Details) - USD ($) shares in Thousands, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||
Net income attributable to Biogen Inc. | $ 1,134.7 | $ 329.2 | $ 2,496.5 | $ 1,187.9 |
Weighted-average shares used in calculating: | ||||
Weighted average number of common shares outstanding | 144,400 | 148,000 | 145,800 | 149,900 |
Effect of dilutive securities: | ||||
Dilutive potential common shares | 400 | 600 | 400 | 400 |
Shares used in calculating diluted earnings per share | 144,800 | 148,600 | 146,200 | 150,300 |
Time-vested restricted stock units | ||||
Effect of dilutive securities: | ||||
Stock units | 300 | 400 | 300 | 200 |
Market stock units | ||||
Effect of dilutive securities: | ||||
Stock units | 0 | 100 | 0 | 100 |
Performance stock units settled in stock | ||||
Effect of dilutive securities: | ||||
Stock units | 100 | 100 | 100 | 100 |
Share-Based Payments (Details)
Share-Based Payments (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | $ (65.7) | $ (57.6) | $ (194.1) | $ (186.1) |
Subtotal | 71 | 62.1 | 201.9 | 200 |
Capitalized share-based compensation costs | (2) | (1.9) | (7.1) | (6.3) |
Share-based compensation expense included in total costs and expenses | 69 | 60.2 | 194.8 | 193.7 |
Income tax effect | (13) | (10.9) | (36) | (35.8) |
Research and development | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | 24.5 | 19.5 | 72.6 | 72.2 |
Selling, general and administrative | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | 46.5 | 42.6 | 129.3 | 127.8 |
Total share-based compensation expense, net of tax | ||||
Share-based Compensation Expense included in consolidated statements of income | ||||
Share-based compensation expense | $ 56 | $ 49.3 | $ 158.8 | $ 157.9 |
Share-Based Payments (Details 1
Share-Based Payments (Details 1) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | $ (65.7) | $ (57.6) | $ (194.1) | $ (186.1) |
Subtotal | 71 | 62.1 | 201.9 | 200 |
Capitalized share-based compensation costs | (2) | (1.9) | (7.1) | (6.3) |
Share-based compensation expense included in total costs and expenses | 69 | 60.2 | 194.8 | 193.7 |
Market stock units | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 4 | 9.7 | 11.4 | 35.5 |
Time-vested restricted stock units | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 48.7 | 38.8 | 150.4 | 121.9 |
Performance stock units settled in stock | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 10.5 | 4.9 | 22.1 | 14.2 |
Performance stock units settled in cash | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | 5.4 | 4.4 | 7.9 | 13.9 |
Employee stock purchase plan | ||||
Summary of share based compensation expense associated with different programs [Abstract] | ||||
Share-based compensation expense | $ 2.4 | $ 4.3 | $ 10.1 | $ 14.5 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) $ in Millions, ₩ in Billions | Dec. 31, 2022 USD ($) | Sep. 30, 2022 KRW (₩) | Sep. 30, 2022 USD ($) | Dec. 31, 2021 KRW (₩) | Dec. 31, 2021 USD ($) |
Income Tax Contingency [Line Items] | |||||
Deferred tax assets, unrecognized tax benefit | $ 85 | $ 390 | |||
Deferred tax assets, net | 490 | ||||
Samsung Bioepis | |||||
Income Tax Contingency [Line Items] | |||||
Investment in Samsung Bioepis | ₩ 0 | ₩ 713.3 | $ 599.9 | ||
Forecast | |||||
Income Tax Contingency [Line Items] | |||||
Decrease in unrecognized tax benefits is reasonably possible | $ 500 | ||||
Forecast | ADUHELM | |||||
Income Tax Contingency [Line Items] | |||||
Decrease in unrecognized tax benefits is reasonably possible | $ 455 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Reconciliation between the U.S. federal statutory tax rate and effective tax rate | ||||
Statutory rate | 21% | 21% | 21% | 21% |
State taxes | 1.90% | 0.30% | 1.10% | 0.90% |
Taxes on foreign earnings | (3.40%) | (20.20%) | (4.40%) | (11.50%) |
Credits and net operating loss utilization | (1.40%) | (7.10%) | (1.50%) | (4.10%) |
Purchased intangible assets | 0.10% | (6.20%) | 0.20% | (1.40%) |
GILTI | 0.80% | 2.60% | 0.50% | 1.60% |
Sale of Samsung Bioepis | (0.80%) | 0% | (1.90%) | 0% |
Litigation settlement agreement | (1.20%) | 0% | 3.10% | 0% |
Neurimmune tax impacts | 0 | (0.005) | 0.028 | (0.364) |
International reorganization | 0% | 0% | (1.70%) | 0% |
Other | 0.20% | 1.20% | 0.20% | 0.70% |
Effective tax rate | 17.20% | (8.90%) | 19.40% | (29.20%) |
Other Consolidated Financial _3
Other Consolidated Financial Statement Detail (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Other Income (Expense), Net | ||||||
Gain on sale of equity interest in Samsung Bioepis(1) | $ 0 | $ 0 | $ (1,505.4) | $ 0 | ||
Litigation settlement agreement | 0 | $ 900 | 0 | 900 | 0 | |
Interest income | (23.9) | (2.6) | (39.4) | (8.2) | ||
Interest expense | 59.9 | 66.3 | 191.8 | 187.3 | ||
(Gains) losses on investments, net | (101.8) | 424.5 | 167.5 | 707.2 | ||
Foreign exchange (gains) losses, net | 11.5 | 13.7 | 39 | 23.1 | ||
Other, net | (1.7) | 1 | 25.2 | 4 | ||
Other (income) expense | (56) | 502.9 | (221.3) | 913.4 | ||
Equity Securities, FV-NI, Gain (Loss), Alternative [Abstract] | ||||||
Net (gains) losses recognized on equity securities | (109.8) | 424.2 | 158.1 | 705.9 | ||
Less: Net (gains) losses realized on equity securities | (0.5) | (2.7) | 0 | (9.3) | ||
Net unrealized (gains) losses recognized on equity securities | (109.3) | $ 426.9 | 158.1 | $ 715.2 | ||
Accrued Expenses and Other | ||||||
Litigation settlement agreement(1) | 900 | 900 | $ 0 | |||
Revenue-related reserves for discounts and allowances | 983.9 | 983.9 | 935.3 | |||
Collaboration expense | 313.5 | 313.5 | 345.1 | |||
Royalties and licensing fees | 208.6 | 208.6 | 234.7 | |||
Collaboration expense | 260.1 | 260.1 | 324.7 | |||
Other | 769.2 | 769.2 | 828.6 | |||
Total accrued expense and other | 3,305.9 | 3,305.9 | 2,535.2 | |||
Ionis, Sangamo, Denali and Sage | ||||||
Equity Securities, FV-NI, Gain (Loss), Alternative [Abstract] | ||||||
Net unrealized (gains) losses recognized on equity securities | 112.5 | 198 | ||||
Component of accrued expenses and other | ||||||
Accrued Expenses and Other | ||||||
Revenue-related reserves for discounts and allowances | $ 854.5 | $ 854.5 | $ 802.1 |
Other Consolidated Financial _4
Other Consolidated Financial Statement (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Net gains recognized on the increase in fair value of equity securities | $ (109.3) | $ 426.9 | $ 158.1 | $ 715.2 | |
Net gains (losses) realized during the period on equity securities | (0.5) | $ (2.7) | 0 | $ (9.3) | |
Other long-term liabilities | 1,198.1 | 1,198.1 | $ 1,320.5 | ||
Accrued income taxes | 559.7 | 559.7 | $ 664.5 | ||
Ionis, Sangamo, Denali and Sage | |||||
Net gains recognized on the increase in fair value of equity securities | $ 112.5 | $ 198 |
Collaborative and Other Relat_3
Collaborative and Other Relationships - Collaborations (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||||||||
Apr. 30, 2022 USD ($) | Aug. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2019 product | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Sep. 30, 2021 USD ($) | Mar. 31, 2020 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Percentage of future development costs related to Eisai | 45% | ||||||||||||
Research and Development Expense (Excluding Acquired in Process Cost) | $ 549.2 | $ 702.4 | $ 1,629.5 | $ 1,801.7 | |||||||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | 469.5 | 511.8 | 1,707.4 | 1,449.6 | |||||||||
(Gain) loss on equity method investments | 2.6 | 17.2 | |||||||||||
Samsung Bioepis | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
(Gain) loss on equity method investments | 8.9 | 17 | 39.5 | ||||||||||
Loss recorded on Samsung Bioepis joint venture | 1.1 | 2.6 | 17.2 | ||||||||||
Amortization | $ 7.8 | 14.4 | 22.3 | ||||||||||
ADUHELM | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development expense | 300 | ||||||||||||
Cost of sales, excluding amortization and impairment of acquired intangible assets | $ 275 | ||||||||||||
ADUHELM | Maximum | Forecast | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development expense | $ 335 | ||||||||||||
Eisai | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Percentage of future development costs related to Eisai | 45% | ||||||||||||
(Gain) loss on equity method investments | 3.4 | $ 50.6 | 214 | 90.7 | |||||||||
Due from Related Parties | 110.6 | $ 285.4 | 110.6 | ||||||||||
Due to Related Parties | 81.7 | 46.5 | 81.7 | ||||||||||
Eisai | BAN2401 and Elenbecestat | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense Incurred By Collaboration | 109.3 | 118.4 | 264.9 | 236.1 | |||||||||
Expense reflected within statements of income | 54.7 | 59.2 | 132.5 | 118 | |||||||||
Eisai | ADUHELM | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense reflected within statements of income | 0 | 0 | 0 | 45 | |||||||||
Additional milestone payment | $ 100 | 0 | 0 | 0 | 100 | ||||||||
(Gain) loss on equity method investments | $ 59 | 45 | 45 | $ 177 | |||||||||
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 | ||||||||||||
Additional milestone payment | $ 50 | ||||||||||||
Due from Related Parties | 1.8 | 4.1 | $ 1.8 | ||||||||||
Due to Related Parties | 53.8 | $ 148.7 | $ 53.8 | ||||||||||
Contingent Commercialized Rights, Number Of Products | product | 2 | ||||||||||||
Sangamo Therapeutics, Inc. Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
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) | 14 | 7.7 | $ 51.5 | 84.9 | |||||||||
InnoCare Pharma Limited (InnoCare) Agreement | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Upfront and milestone payments made to collaborative partner | $ 125 | ||||||||||||
Contingent additional milestone payment | $ 812.5 | ||||||||||||
Research and development | Eisai | ADUHELM | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 34.6 | 43.7 | 116 | 132.8 | |||||||||
Expense reflected within statements of income | 19 | 24 | 63.8 | 73 | |||||||||
Research and development | Denali Therapeutics | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 19.9 | 8.5 | 58 | 27.2 | |||||||||
Expense reflected within statements of income | 11.4 | 5.1 | 33.5 | 16.3 | |||||||||
Research and development | Samsung Bioepis | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 5.5 | 6.2 | $ 16.4 | 16.4 | |||||||||
Expense reflected within statements of income | 3.1 | 1.9 | $ 9.5 | 10.2 | |||||||||
Research and development | Sage Therapeutics Inc. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 40.9 | 40.8 | 130.4 | 134.9 | |||||||||
Expense reflected within statements of income | 20.5 | 20.4 | 65.2 | 67.3 | |||||||||
Research and development | UCB Pharma S.A. [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 18.3 | 16.5 | 51.5 | 49.5 | |||||||||
Expense reflected within statements of income | 9.1 | 8.2 | 25.7 | 24.8 | |||||||||
Selling, general and administrative | Eisai | BAN2401 and Elenbecestat | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 29 | 5.6 | 68.3 | 15.6 | |||||||||
Expense reflected within statements of income | 14.5 | 2.8 | 34.2 | 7.8 | |||||||||
Selling, general and administrative | Eisai | ADUHELM | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | (8) | 154.3 | 127.8 | 391.7 | |||||||||
Expense reflected within statements of income | (3.9) | 83.3 | 68.1 | 211.2 | |||||||||
Selling, general and administrative | Sage Therapeutics Inc. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Expense incurred by the collaboration | 28.5 | 7.4 | 69.9 | 23.2 | |||||||||
Expense reflected within statements of income | $ 14.2 | $ 3.7 | $ 34.9 | $ 11.6 |
Collaborative and Other Relat_4
Collaborative and Other Relationships - Equity Method Investments (Details) ₩ in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||
Apr. 30, 2022 USD ($) | Dec. 31, 2019 | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Sep. 30, 2021 USD ($) | Mar. 31, 2020 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 KRW (₩) | Jun. 30, 2022 KRW (₩) | Jan. 31, 2022 USD ($) | Dec. 31, 2021 KRW (₩) | Jan. 31, 2020 USD ($) | Nov. 07, 2018 USD ($) | |
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Income (loss) from equity method investments | $ 2.6 | $ 17.2 | |||||||||||||
Collaboration profit (loss) sharing | $ 45.3 | $ 21.2 | (42.6) | 74.5 | |||||||||||
ADUHELM | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Research and development expense | $ 300 | ||||||||||||||
Samsung Bioepis | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Percentage of stake in entity maximum | 49.90% | 49.90% | 49.90% | ||||||||||||
Amortization of basis differences | $ 675 | ||||||||||||||
Loss recorded on Samsung Bioepis joint venture | 1.1 | $ 2.6 | 17.2 | ||||||||||||
Income (loss) from equity method investments | 8.9 | 17 | 39.5 | ||||||||||||
Investment in Samsung Bioepis | $ 599.9 | ₩ 0 | ₩ 713,300 | ||||||||||||
Collaboration profit (loss) sharing | $ 48.7 | 71.8 | 171.4 | 210.2 | |||||||||||
Eisai | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Income (loss) from equity method investments | 3.4 | 50.6 | 214 | $ 90.7 | |||||||||||
Due to Related Parties | 81.7 | 46.5 | 81.7 | ||||||||||||
Eisai | ADUHELM | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Income (loss) from equity method investments | $ 59 | 45 | $ 45 | $ 177 | |||||||||||
Samsung Bioepis | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Proceeds from divestiture of interest in joint venture | $ 1,000 | ||||||||||||||
Investment in Samsung Bioepis | ₩ | ₩ 581.6 | ||||||||||||||
Payables to divestiture of interest in joint venture | $ 1,300 | ||||||||||||||
Equity Method Investments, Expected Profit Share | 45% | 50% | |||||||||||||
Upfront and milestone payments made to collaborative partner | $ 100 | ||||||||||||||
Research and development expense | $ 63 | ||||||||||||||
Prepaid research and development expenses | $ 37 | ||||||||||||||
Accrued milestone payments | 15 | ||||||||||||||
Estimated additional payments upon achievement of development and commercial milestones | $ 180 | ||||||||||||||
Contract Option Exercise Fee | 60 | ||||||||||||||
Due to Related Parties | $ 53.8 | $ 148.7 | $ 53.8 | ||||||||||||
Samsung Bioepis | Payment Due At First Anniversary | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Payables to divestiture of interest in joint venture | 812.5 | ||||||||||||||
Samsung Bioepis | Payment Due At Second Anniversary | |||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||
Payables to divestiture of interest in joint venture | $ 437.5 | ||||||||||||||
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 | 9 Months Ended | ||||
Jun. 30, 2021 | Sep. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Variable Interest Entity [Line Items] | |||||||
(Gain) loss on equity method investments | $ 2.6 | $ 17.2 | |||||
Percentage of future development costs related to Eisai | 45% | ||||||
Deferred tax assets, net | $ 490 | ||||||
Deferred tax assets, unrecognized tax benefit | $ 85 | 390 | $ 85 | ||||
Investment in biotechnology companies that are determined to be unconsolidated variable interest entities | 25.3 | 24.6 | $ 25.3 | ||||
Neurimmune | |||||||
Variable Interest Entity [Line Items] | |||||||
Collaboration agreement term | 12 years | ||||||
Research and development costs, percentage | 100% | ||||||
Eisai | |||||||
Variable Interest Entity [Line Items] | |||||||
(Gain) loss on equity method investments | 3.4 | $ 50.6 | $ 214 | 90.7 | |||
Percentage of future development costs related to Eisai | 45% | ||||||
Eisai | ADUHELM | |||||||
Variable Interest Entity [Line Items] | |||||||
(Gain) loss on equity method investments | $ 59 | 45 | $ 45 | 177 | |||
Additional milestone payment | $ 100 | $ 0 | $ 0 | $ 0 | $ 100 | ||
Eisai | Regulatory Milestones | Neurimmune | ADUHELM | |||||||
Variable Interest Entity [Line Items] | |||||||
Potential future milestone payments commitment to third party | $ 100 |
Litigation (Details)
Litigation (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2020 | |
Loss Contingency, Information about Litigation Matters [Abstract] | ||||||
Litigation agreement in principle | $ 0 | $ 900 | $ 0 | $ 900 | $ 0 | |
Loss Contingency, Estimate of Possible Loss | $ 200 |
Dispositions (Details Textual)
Dispositions (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Apr. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jan. 31, 2022 USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Gain on sale of equity interest in Samsung Bioepis | $ (1,505.4) | $ 0 | |||
Samsung Bioepis | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Equity, ownership interest | 49.90% | 49.90% | |||
Samsung Bioepis | Fair Value, Recurring | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Other current assets, receivable | $ 790.8 | $ 790.8 | |||
Other assets, receivable | $ 402.8 | $ 402.8 | |||
Samsung Bioepis | Payment Due At First Anniversary | Discount rate | Fair Value, Recurring | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Risk-adjusted discount rates | 0.049 | 0.049 | |||
Samsung Bioepis | Payment Due At Second Anniversary | Discount rate | Fair Value, Recurring | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Risk-adjusted discount rates | 0.053 | 0.053 | |||
Samsung Bioepis | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Proceeds from divestiture of interest in joint venture | $ 1,000 | ||||
Payables to divestiture of interest in joint venture | $ 1,300 | ||||
Gain on sale of equity interest in Samsung Bioepis | $ 1,500 | ||||
Cumulative translation loss | 58.9 | ||||
Gain on derivative used in net investment hedge | 57 | ||||
Gain (loss) on sale | $ 2.7 | (4) | |||
Additional milestone payment | $ 50 | ||||
Contingent discount on common shares | 5% | ||||
Discrete income tax expense (benefit) | $ 258.3 | $ 258.3 | |||
Samsung Bioepis | Payment Due At First Anniversary | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Payables to divestiture of interest in joint venture | 812.5 | ||||
Samsung Bioepis | Payment Due At Second Anniversary | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Payables to divestiture of interest in joint venture | $ 437.5 |