Fair Value Measurements (Tables) |
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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:
(1) Represents the fair value of the current payment 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.
(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.
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Summary of fair and carrying value of debt instruments | The fair and carrying values of our debt instruments, which are Level 2 liabilities, are summarized as follows:
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Fair value of contingent consideration obligations | In connection with our acquisition of Convergence, we agreed to make additional payments based upon the achievement of certain milestone events. The following table provides a roll forward of the fair value of our contingent consideration obligations, which were classified as Level 3 measurements:
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- References No definition available.
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- Definition Tabular disclosure of the fair value measurement of liabilities using significant unobservable inputs (Level 3), a reconciliation of the beginning and ending balances, separately presenting changes attributable to the following: (1) total gains or losses for the period (realized and unrealized), segregating those gains or losses included in earnings (or changes in net assets), and gains or losses recognized in other comprehensive income (loss) and a description of where those gains or losses included in earnings (or changes in net assets) are reported in the statement of income (or activities); (2) purchases, sales, issues, and settlements (each type disclosed separately); and (3) transfers in and transfers out of Level 3 (for example, transfers due to changes in the observability of significant inputs) by class of liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of information pertaining to carrying amount and estimated fair value of short-term and long-term debt instruments or arrangements, including but not limited to, identification of terms, features, and collateral requirements. No definition available.
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- Definition Tabular disclosure of assets and liabilities, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amortization and Impairment of Acquired Intangible Assets No definition available.
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- Definition Collaboration profit (loss) sharing No definition available.
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- Definition Income (Loss) from Equity Method Investments, Net of Tax No definition available.
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- Definition The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Total costs of sales and operating expenses for the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- References No definition available.
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- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of Net Income (Loss) attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The net amount of other operating income and expenses, the components of which are not separately disclosed on the income statement, from items that are associated with the entity's normal revenue producing operations. No definition available.
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- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The costs incurred in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, excluding in-process research and development acquired in a business combination consummated during the period. Excludes software research and development, which has a separate concept. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Other Consolidated Financial Statement (Details Textual) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
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Litigation settlement agreement | $ 0.0 | $ 900.0 | $ 0.0 | $ 900.0 | |
Net gains recognized on the increase in fair value of equity securities | (105.8) | 76.5 | (29.3) | 267.4 | |
Net gains (losses) realized during the period on equity securities | (0.7) | 0.7 | 0.9 | 0.5 | |
Other long-term liabilities | 776.9 | 776.9 | $ 944.2 | ||
Accrued income taxes | 383.3 | 383.3 | $ 541.7 | ||
Ionis, Sangamo, Denali and Sage | |||||
Net gains recognized on the increase in fair value of equity securities | 117.7 | 75.3 | 78.0 | 277.1 | |
Net losses recognized on the decrease in fair value of equity securities | $ 10.9 | $ 47.4 | |||
Net gains recognized on the decrease in fair value of equity securities | $ 3.4 | $ 19.0 |
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- Definition Carrying amount as of the balance sheet date of the unpaid sum of the known and estimated amounts payable to satisfy all domestic and foreign income tax obligations due beyond one year or the operating cycle, whichever is longer. Alternate captions include income taxes payable, noncurrent. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of realized gain (loss) from sale of investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of unrealized gain on investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of unrealized gain (loss) on investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of litigation expense, including but not limited to legal, forensic, accounting, and investigative fees. No definition available.
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- Definition Amount of liabilities classified as other, due after one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition End date of current fiscal year in the format --MM-DD. No definition available.
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- Definition Fiscal period values are FY, Q1, Q2, and Q3. 1st, 2nd and 3rd quarter 10-Q or 10-QT statements have value Q1, Q2, and Q3 respectively, with 10-K, 10-KT or other fiscal year statements having FY. No definition available.
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- Definition For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD. No definition available.
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- Definition Code for the postal or zip code No definition available.
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- Definition Name of the state or province. No definition available.
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- Definition A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Local phone number for entity. No definition available.
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- Definition Title of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Name of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Trading symbol of an instrument as listed on an exchange. No definition available.
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- Definition Accounts Payable, To Collaborator No definition available.
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- Definition Accounts Receivable, From Collaborator No definition available.
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- Definition Collaborative Arrangement, Profit (Loss) Sharing No definition available.
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- Definition Percentage of future development costs related to Eisai No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of loss from reductions in inventory due to subsequent measurement adjustments, including, but not limited to, physical deterioration, obsolescence, or changes in price levels. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amortization and Impairment of Acquired Intangible Assets No definition available.
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- Definition Useful life of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
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- Definition Accumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in next fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in remainder of current fiscal year. No definition available.
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in fourth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in third fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of amortization for assets, excluding financial assets and goodwill, lacking physical substance with finite life expected to be recognized in second fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount before amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of assets, excluding financial assets and goodwill, lacking physical substance and having a projected indefinite period of benefit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount before accumulated amortization of intangible assets, excluding goodwill. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Sum of the carrying amounts of all intangible assets, excluding goodwill, as of the balance sheet date, net of accumulated amortization and impairment charges. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Restructuring, Business Transformation and Other Cost Saving Initiatives |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring, Business Transformation and Other Cost Saving Initiatives | 2023 Cost Saving Initiatives In 2023 we initiated additional cost saving measures as part of our Fit for Growth initiative to reduce operating costs, while improving efficiency and effectiveness. Total charges incurred from our 2023 cost saving initiatives are summarized as follows:
Other Costs: includes costs associated with items such as asset abandonment and write-offs, facility closure costs, pretax gains and losses resulting from the termination of certain leases, employee non-severance expense, consulting fees and other costs. 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, deprioritization of certain research and development programs, the consolidation of certain real estate locations and operating efficiencies across our selling, general and administrative and research and development functions. Charges related to our 2022 cost saving initiatives were substantially incurred during 2022 with remaining payments expected to be made through 2026. Total charges incurred from our 2022 cost saving initiatives are summarized as follows:
Charges and spending related to our 2023 and 2022 workforce reductions are summarized as follows:
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- Definition The entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Fair Value Measurements (Details 2) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2022 |
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Business Acquisition, Contingent Consideration [Line Items] | ||||
Contingent consideration impairment | $ 0.0 | $ 4.5 | $ 0.0 | $ 11.6 |
Fair Value, Measurements Recurring | ||||
Business Acquisition, Contingent Consideration [Line Items] | ||||
Fair value, beginning of period | 202.0 | 209.1 | ||
Fair value, end of period | $ 197.5 | $ 197.5 |
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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- Definition Amount of liability recognized arising from contingent consideration in a business combination. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of gain (loss) recognized in income from liability measured at fair value on recurring basis using unobservable input (level 3). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Financial Instruments |
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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:
The carrying values of our commercial paper, including accrued interest, overnight reverse repurchase agreements, money market funds, short-term certificates of deposit 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:
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:
The average maturity of our marketable debt securities classified as available-for-sale as of both June 30, 2023 and December 31, 2022, was approximately 8 months. 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:
Realized losses for the three and six months ended June 30, 2023, primarily relate to sales of U.S. treasuries and corporate bonds. Realized losses for the three and six months ended June 30, 2022, primarily relate to sales of corporate bonds, agency mortgage-backed securities and other asset-backed securities. Strategic Investments As of June 30, 2023 and December 31, 2022, our strategic investment portfolio was comprised of investments totaling $770.7 million and $846.0 million, respectively, which are included in investments and other assets in our condensed consolidated balance sheets. Our strategic investment portfolio includes investments in equity securities of certain biotechnology companies, which are reflected within our disclosures included in Note 7, Fair Value Measurements, to these condensed consolidated financial statements, venture capital funds where the underlying investments are in equity securities of certain biotechnology companies and non-marketable equity securities. The decrease in our strategic investment portfolio as of June 30, 2023, was primarily due to the sale of our remaining Ionis common stock during the second quarter of 2023. For additional information on our strategic investments in Denali, Sangamo and Sage common stock, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K.
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Fair Value Measurements (Details 1) - USD ($) $ in Millions |
6 Months Ended | |
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Jun. 30, 2023 |
Dec. 31, 2022 |
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Debt Instrument [Line Items] | ||
Notes Payable | $ 6,284.6 | $ 6,281.0 |
Debt Instrument, Fair Value Disclosure | 5,534.5 | 5,410.2 |
BIIB054 | ||
Debt Instrument [Line Items] | ||
Reduction in contingent consideration | 195.4 | |
4.050% Senior Notes due 2025 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | 1,693.2 | 1,699.9 |
Notes Payable | 1,745.7 | 1,744.7 |
2.250% Senior Notes due May 1, 2030 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | 1,083.8 | 1,033.2 |
Notes Payable | 1,100.4 | 1,100.3 |
5.200% Senior Notes due 2045 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | 1,248.0 | 1,219.0 |
Notes Payable | 1,493.4 | 1,492.9 |
3.250% Senior Notes, Due February 15, 2051 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | 486.7 | 469.1 |
Notes Payable | 471.0 | 469.3 |
3.150% Senior Notes due May 1, 2050 | ||
Debt Instrument [Line Items] | ||
Notes payable, fair value | 1,022.8 | 989.0 |
Notes Payable | $ 1,474.1 | $ 1,473.8 |
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- Definition Period remaining until the derivative contract matures, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
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- Definition The percentage of ownership of common stock or equity participation in the investee accounted for under the equity method of accounting. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Aggregate net gain (loss) on all derivative instruments recognized in earnings during the period, before tax effects. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in the cumulative translation adjustment from gain (loss), after tax, on foreign currency derivatives, that are designated as, and are effective as, economic hedges of a net investment in a foreign entity. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The net change in the difference between the fair value and the carrying value, or in the comparative fair values, of derivative instruments, including options, swaps, futures, and forward contracts, held at each balance sheet date, that was included in earnings for the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Financial Instruments Financial Instruments (Details Textual 2) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
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Other noncurrent assets | Strategic Investments | ||
Business Acquisition [Line Items] | ||
Strategic investment portfolio | $ 770.7 | $ 846.0 |
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Property, Plant and Equipment (Details) $ in Millions |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2023
USD ($)
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Jun. 30, 2022
USD ($)
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Jun. 30, 2023
USD ($)
ft²
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Dec. 31, 2022
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Property, Plant and Equipment [Line Items] | |||||
Accumulated depreciation | $ | $ 2,282.1 | $ 2,282.1 | $ 2,165.7 | ||
Depreciation | $ | 64.5 | $ 67.2 | $ 126.6 | $ 143.5 | |
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 | $ | $ 732.2 | $ 732.2 | $ 711.1 |
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Litigation (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2019 |
---|---|---|
Loss Contingency, Information about Litigation Matters [Abstract] | ||
Loss Contingency, Estimate of Possible Loss | $ 49.9 | $ 200.0 |
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Earnings per Share (Tables) |
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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:
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Summary of Significant Accounting Policies |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
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 innovative therapies for people living with serious and complex diseases worldwide. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA and co-developed two treatments to address a defining pathology of Alzheimer's disease. We are focused on advancing our pipeline in neurology, neuropsychiatry, specialized immunology and rare diseases. We support our drug discovery and development efforts through internal research and development programs and external collaborations. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; QALSODY for ALS, which was granted accelerated approval by the FDA during the second quarter of 2023; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We also collaborate with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted traditional approval by the FDA in July 2023. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma, which was granted accelerated approval by the FDA during the fourth quarter of 2022; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma, which was granted accelerated approval by the FDA during the second quarter of 2023; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group. In addition to continuing to invest in new potential innovation in MS and SMA we are advancing our mid-to-late stage programs including zuranolone for MDD and PPD, BIIB080 for Alzheimer's disease and both litifilimab and dapirolizumab pegol for certain forms of lupus. We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA. For additional information on our collaboration arrangements, please read Note 16, Collaborative and Other Relationships, to these unaudited condensed consolidated financial statements (condensed consolidated financial statements). For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our audited consolidated financial statements included in our 2022 Form 10-K. Basis of Presentation In the opinion of management, our condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair statement of our financial statements for interim periods in accordance with U.S. GAAP. The information included in this quarterly report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our 2022 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2022 Form 10-K and updated, as necessary, in this report. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period. We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Consolidation Our condensed consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries and certain variable interest entities where we are the primary beneficiary. For consolidated entities where we own or are exposed to less than 100.0% of the economics, we record net income (loss) attributable to noncontrolling interests, net of tax in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners. Use of Estimates The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expense and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and assumptions. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expense. Actual results may differ from these estimates. The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including sales, expense, reserves and allowances, the supply chain, manufacturing, clinical trials, research and development costs and employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including the economic impact on local, regional, national and international customers and markets. Additionally, the ongoing geopolitical tensions related to the conflict in Ukraine, and the related sanctions and other penalties imposed, are creating substantial uncertainty in the global economy. The extent and duration of the conflict, sanctions and resulting market disruptions are highly unpredictable. We have made estimates of the impact of the COVID-19 pandemic and the ongoing geopolitical conflict within our condensed consolidated financial statements and there may be changes to those estimates in future periods. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have had or may have a material impact on our condensed consolidated financial statements or disclosures. Fair Value Measurements In June 2022 the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for us on January 1, 2024. We elected to early adopt this standard on a prospective basis during the third quarter of 2022. Upon adoption, we recorded an immaterial amount in other (income) expense, net in our condensed consolidated statements of income, as a result of removing the impact of the remaining contractual sale restrictions from the fair value measurement of certain shares in Sage.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Investments in Variable Interest Entities (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
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Variable Interest Entity [Line Items] | ||||
(Gain) loss on equity method investments | $ 0.0 | $ 2.6 | ||
Percentage of future development costs related to Eisai | 45.00% | |||
Deferred tax assets, unrecognized tax benefit | $ 85.0 | |||
Investment in biotechnology companies that are determined to be unconsolidated variable interest entities | $ 25.2 | $ 27.8 | ||
Neurimmune | ||||
Variable Interest Entity [Line Items] | ||||
Collaboration agreement term | 12 years | |||
Research and development costs, percentage | 100.00% | |||
Eisai | ||||
Variable Interest Entity [Line Items] | ||||
Percentage of future development costs related to Eisai | 45.00% |
X | ||||||||||
- Definition Collaboration Agreement Term No definition available.
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X | ||||||||||
- Definition Investment in biotechnology companies that are determined to be unconsolidated variable interest entities. No definition available.
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X | ||||||||||
- Definition Percentage of future development costs related to Eisai No definition available.
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X | ||||||||||
- Definition Research and Development Costs, Percentage No definition available.
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X | ||||||||||
- Definition Amount of deferred tax assets for which it is more likely than not that a tax benefit will not be realized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of income (loss) for proportionate share of equity method investee's income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Details
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- Details
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Revenues - Other Revenues (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 2,456.0 | $ 2,589.1 | $ 4,919.0 | $ 5,120.9 |
Contract manufacturing revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 183.1 | 81.2 | 490.0 | 128.7 |
Royalty and other revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 14.4 | 16.7 | 26.6 | 35.3 |
Contract manufacturing, royalty and other revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 197.5 | $ 97.9 | $ 516.6 | $ 164.0 |
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition Amount of other expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses associated with a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of expenses for special or contractual termination benefits provided to current employees involuntarily terminated under a benefit arrangement associated exit or disposal activities pursuant to an authorized plan. Excludes expenses related to one-time termination benefits, a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Details
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- Details
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- Details
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- Details
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Financial Instruments (Details 2) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Summary of Contractual Maturities: Available-for-Sale Securities | ||
Due in one year or less, amortized cost | $ 3,468.2 | $ 1,483.3 |
Due in one year or less, estimated fair value | 3,460.5 | 1,473.5 |
Due after one year through five years, amortized cost | 1,202.9 | 703.7 |
Due after one year through five years, estimated fair value | 1,192.9 | 694.4 |
Due after five years, amortized cost | 15.7 | 12.1 |
Due after five years, estimated fair value | 15.1 | 11.3 |
Marketable debt securities | 4,668.5 | 2,179.2 |
Amortized Cost | $ 4,686.8 | $ 2,199.1 |
X | ||||||||||
- Definition This item represents debt securities, at cost, net of adjustments made for accretion, amortization, other-than-temporary impairments, and hedging, if any, which are expected to mature after five years from the balance sheet date and which are categorized neither as held-to-maturity nor trading securities. No definition available.
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X | ||||||||||
- Definition This item represents the fair value of debt securities, which are expected to mature after five years from the balance sheet date and which are categorized neither as held-to-maturity nor trading securities. No definition available.
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X | ||||||||||
- Definition Amortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), with single maturity date and allocated without single maturity date, maturing in second through fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Fair value of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), with single maturity date and allocated without single maturity date, maturing in second through fifth fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), with single maturity date and allocated without single maturity date, maturing in next fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Fair value of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), with single maturity date and allocated without single maturity date, maturing in next fiscal year following current fiscal year. Excludes interim and annual periods when interim periods are reported from current statement of financial position date (rolling approach). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Intangible Assets and Goodwill (Tables) |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets | Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows:
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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:
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Summary of roll forward of the changes in goodwill | The following table provides a roll forward of the changes in our goodwill balance:
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- Definition Intangible assets excluding goodwill. No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of goodwill by reportable segment and in total which includes a rollforward schedule. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Tabular disclosure of the amount of amortization expense expected to be recorded in succeeding fiscal years for finite-lived intangible assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Financial Instruments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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:
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Marketable debt and equity securities | The following tables summarize our marketable debt and equity securities, classified as available-for-sale:
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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:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
|
X | ||||||||||
- Definition Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Tabular disclosure of maturities of an entity's investments as well as any other information pertinent to the investments. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of realized gains and losses on investments reported in the statement of income. No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of the components of cash and cash equivalents. No definition available.
|
Collaborative and Other Relationships - Summary of Activity Related To Denali Therapeutics (Details) - Research and development - Denali Therapeutics - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Expense incurred by the collaboration | $ 22.1 | $ 23.2 | $ 38.7 | $ 38.1 |
Expense reflected within statements of income | $ 13.2 | $ 13.2 | $ 23.2 | $ 22.1 |
X | ||||||||||
- Definition Expense incurred by the collaboration No definition available.
|
X | ||||||||||
- Definition Expense reflected within statements of income No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition Noncontrolling Interest, Capital Contribution No definition available.
|
X | ||||||||||
- Definition Amount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount after tax and reclassification adjustments of other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of treasury shares or units reissued. Excludes reissuance of shares or units in treasury for award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Value of stock issued as a result of the exercise of stock options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Value of treasury shares or units reissued. Excludes reissuance of shares or units in treasury for award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of shares that have been repurchased and retired during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of equity (deficit) attributable to parent and noncontrolling interest. Excludes temporary equity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition This element represents movements included in the statement of changes in stockholders' equity which are not separately disclosed or provided for elsewhere in the taxonomy. No definition available.
|
X | ||||||||||
- Definition Number of previously issued common shares repurchased by the issuing entity and held in treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of decrease of par value, additional paid in capital (APIC) and retained earnings of common and preferred stock retired from treasury when treasury stock is accounted for under the cost method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of shares that have been repurchased during the period and are being held in treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Equity impact of the cost of common and preferred stock that were repurchased during the period. Recorded using the cost method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Intangible Assets and Goodwill |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
Amortization and Impairments For the three and six months ended June 30, 2023, amortization and impairment of acquired intangible assets totaled $52.9 million and $103.1 million, respectively, compared to $67.5 million and $134.4 million, respectively, in the prior year comparative periods. The decreases were primarily due to lower rates of amortization for acquired intangible assets. For the three and six months ended June 30, 2023 and 2022, we had no impairment charges. Completed Technology Completed technology primarily relates to our other marketed products and programs acquired through asset acquisitions, licenses and business combinations. 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:
Goodwill The following table provides a roll forward of the changes in our goodwill balance:
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The entire disclosure for goodwill and intangible assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Inventory (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Components of inventory | The components of inventory are summarized as follows:
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Tabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Share based compensation expense included in costs and expenses. No definition available.
|
X | ||||||||||
- Definition Summary of share-based compensation expense associated with different programs. No definition available.
|
X | ||||||||||
- Definition Amount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount, after tax, of expense for award under share-based payment arrangement. No definition available.
|
X | ||||||||||
- Definition The expenses and losses recorded for each transaction with the acquiree that was recognized separately from the acquisition of assets and assumptions of liabilities in the business combination. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cost capitalized for award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
|
X | ||||||||||
- Definition Adjustments to product revenue reserves relating to sales in prior years. No definition available.
|
X | ||||||||||
- Definition Current provisions to product revenue reserves relating to sales in current year. No definition available.
|
X | ||||||||||
- Definition Payments/ returns applied against product revenue reserves relating to current year. No definition available.
|
X | ||||||||||
- Definition Payments/ returns applied against product revenue reserves relating to prior year. No definition available.
|
X | ||||||||||
- References Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of valuation and qualifying accounts and reserves. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition Total expense incurred by collaboration. No definition available.
|
X | ||||||||||
- Definition Expense incurred by the collaboration No definition available.
|
X | ||||||||||
- Definition Expense reflected within statements of income No definition available.
|
X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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Fair Value Measurements (Details Textual) - USD ($) |
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2023 |
|
Fair Value Disclosures [Abstract] | ||
Asset impairment charges | $ 0 | $ 0 |
X | ||||||||||
- Definition Amount of write-down of assets recognized in the income statement. Includes, but is not limited to, losses from tangible assets, intangible assets and goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
Derivative Instruments |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 June 30, 2023 and December 31, 2022, had durations of 1 to 18 months and 1 to 12 months, respectively. These contracts have been designated as cash flow hedges and unrealized gains and losses on the portion of these foreign currency forward contracts and foreign currency options that are included in the effectiveness test are reported in AOCI. Realized gains and losses of such contracts and options 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 AOCI 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 and foreign currency options that were entered into to hedge forecasted revenue and operating expense is summarized as follows:
The pre-tax portion of the fair value of these foreign currency forward contracts and foreign currency options that were included in AOCI in total equity is summarized as follows:
We expect the net unrealized losses of approximately $21.9 million to be settled over the next 18 months, of which approximately $23.7 million of these net unrealized losses are expected to be settled over the next 12 months, with any amounts in AOCI to be reported as an adjustment to revenue or operating expense. We consider the impact of our and our counterparties’ credit risk on the fair value of the contracts as well as the ability of each party to execute its contractual obligations. As of June 30, 2023 and December 31, 2022, credit risk did not materially change the fair value of our foreign currency forward contracts and forward currency options. The following tables summarize the effect of foreign currency forward contracts and forward currency options designated as hedging instruments in our condensed consolidated statements of income:
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%. 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 AOCI 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. The following tables summarize the effect of our net investment hedges in our condensed consolidated financial statements:
(1) Beginning in the second quarter of 2022 we no longer held 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 16, Collaborative and Other Relationships, to these condensed consolidated financial statements. Foreign Currency Forward Contracts - Other Derivative Instruments We also enter into other foreign currency forward contracts, usually with durations of one month or less, to mitigate the foreign currency risk related to certain balance sheet positions. We have not elected hedge accounting for these transactions. The aggregate notional amount of these outstanding foreign currency forward contracts was $1,233.5 million and $1,238.8 million as of June 30, 2023 and December 31, 2022, respectively. Net losses of $7.2 million and $5.4 million related to these contracts were recorded as a component of other (income) expense, net for the three and six months ended June 30, 2023, respectively, compared to net losses of $37.1 million and $49.3 million, respectively, in the prior year comparative periods. Summary of Derivative Instruments While certain of our derivative instruments are subject to netting arrangements with our counterparties, we do not offset derivative assets and liabilities in our condensed consolidated balance sheets. The amounts in the table below would not be substantially different if the derivative assets and liabilities were offset. The following table summarizes the fair value and presentation in our condensed consolidated balance sheets of our outstanding derivative instruments, including those designated as hedging instruments:
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- References No definition available.
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- Definition The entire disclosure for derivative instruments and hedging activities including, but not limited to, risk management strategies, non-hedging derivative instruments, assets, liabilities, revenue and expenses, and methodologies and assumptions used in determining the amounts. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Intangible Assets and Goodwill (Details 1) |
6 Months Ended |
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Jun. 30, 2023
USD ($)
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Summary of roll forward of the changes in goodwill | |
Goodwill, beginning of period | $ 5,749,000,000 |
Other | 4,700,000 |
Goodwill, end of period | 5,753,700,000 |
Accumulated impairment losses related to goodwill | $ 0 |
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- Definition Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of accumulated impairment loss for an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of increase (decrease), classified as other, of an asset representing the future economic benefits from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
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Collaborative and Other Relationships |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative and Other Relationships |
Genentech, Inc. (Roche Group) We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO (mosunetuzumab), for the treatment of relapsed or refractory follicular lymphoma, which was granted accelerated approval in the U.S. during the fourth quarter of 2022; COLUMVI (glofitamab), a bispecific antibody for the treatment of non-Hodgkin's lymphoma, which was granted accelerated approval by the FDA during the second quarter of 2023; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group. For purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN. RITUXAN Genentech and its affiliates are responsible for the worldwide manufacture of RITUXAN as well as all development and commercialization activities as follows: •U.S.: We have co-exclusively licensed our rights to develop, commercialize and market RITUXAN in the U.S. •Canada: We have co-exclusively licensed our rights to develop, commercialize and market RITUXAN in Canada. GAZYVA The Roche Group and its sub-licensees maintain sole responsibility for the development, manufacture and commercialization of GAZYVA in the U.S. The level of gross sales of GAZYVA in the U.S. has impacted our percentage of the co-promotion profits for RITUXAN and LUNSUMIO, as summarized in the table below. OCREVUS Pursuant to the terms of our collaboration arrangements with Genentech, we receive a tiered royalty on U.S. net sales from 13.5% and increasing up to 24.0% if annual net sales exceed $900.0 million. There will be a 50.0% reduction to these royalties if a biosimilar to OCREVUS is approved in the U.S. In addition, we receive a gross 3.0% royalty on net sales of OCREVUS outside the U.S., with the royalty period lasting 11 years from the first commercial sale of OCREVUS on a country-by-country basis. The commercialization of OCREVUS does not impact the percentage of the co-promotion profits we receive for RITUXAN, LUNSUMIO or GAZYVA. Genentech is solely responsible for development and commercialization of OCREVUS and funding future costs. Genentech cannot develop OCREVUS in CLL, non-Hodgkin's lymphoma or rheumatoid arthritis. OCREVUS royalty revenue is based on our estimates from third-party and market research data of OCREVUS sales occurring during the corresponding period. Differences between actual and estimated royalty revenue will be adjusted for in the period in which they become known, which is generally expected to be the following quarter. LUNSUMIO (mosunetuzumab) In January 2022 we exercised our option with Genentech to participate in the joint development and commercialization of LUNSUMIO. Under our collaboration with Genentech, we were responsible for 30.0% of development costs for LUNSUMIO prior to FDA approval and will be entitled to a tiered share of co-promotion operating profits and losses in the U.S., as summarized in the table below. In addition, we receive low single-digit royalties on sales of LUNSUMIO outside the U.S. In December 2022 LUNSUMIO was granted accelerated approval by the FDA for the treatment of relapsed or refractory follicular lymphoma. Prior to regulatory approval, we record our share of the expense incurred by the collaboration for the development of anti-CD20 products in research and development expense and pre-commercialization costs within selling, general and administrative expense in our condensed consolidated statements of income. After an anti-CD20 product is approved, we record our share of the development and sales and marketing expense related to that product as a reduction of our share of pre-tax profits in revenue from anti-CD20 therapeutic programs. COLUMVI (glofitamab) In December 2022 we entered into an agreement with Genentech related to the commercialization and sharing of economics for COLUMVI, a bispecific antibody for the treatment of B-cell non-Hodgkin's lymphoma, which was subsequently granted accelerated approval by the FDA in June 2023. Under the terms of this agreement, we will have no payment obligations. Genentech will have sole decision-making rights on the commercialization of COLUMVI within the U.S. and we will receive tiered royalties in the mid-single digit range on net sales of COLUMVI in the U.S. The commercialization of COLUMVI does not impact the percentage of the co-promotion profits we receive for RITUXAN, LUNSUMIO or GAZYVA. Profit-sharing Formulas RITUXAN and LUNSUMIO Profit Share Our current pretax co-promotion profit-sharing formula for RITUXAN and LUNSUMIO in the U.S. provides for a 30.0% share on the first $50.0 million of combined co-promotion operating profits earned each calendar year. As a result of the FDA approval of LUNSUMIO our share of the combined annual co-promotion profits for RITUXAN and LUNSUMIO in excess of $50.0 million varies upon the following events, as summarized in the table below:
First Threshold Date means the earlier of (i) the first day of the calendar quarter following the date U.S. gross sales of GAZYVA within any consecutive 12-month period have reached $500.0 million or (ii) the first date in any calendar year in which U.S. gross sales of LUNSUMIO have reached $150.0 million. Second Threshold Date means the later of (i) the first date the gross sales in any calendar year in which U.S. gross sales of LUNSUMIO reach $350.0 million or (ii) January 1 of the calendar year following the calendar year in which the First Threshold Date occurs. In March 2023 the First Threshold Date was achieved. As a result, beginning in April 2023 the pre-tax profit share for RITUXAN and LUNSUMIO was 35.0%. GAZYVA Profit Share Our current pretax profit-sharing formula for GAZYVA provides for a 35.0% share on the first $50.0 million of operating profits earned each calendar year. Our share of annual co-promotion profits in excess of $50.0 million varies upon the following events, as summarized in the table below:
Second GAZYVA Threshold Date means the first day of the calendar quarter following the date U.S. gross sales of GAZYVA within any consecutive 12-month period have reached $500.0 million. The second GAZYVA threshold date can be achieved regardless of whether GAZYVA has been approved in a non-CLL indication. In March 2023 the Second GAZYVA Threshold Date was achieved. As a result, beginning in April 2023 the pre-tax profit share for GAZYVA was 35.0%. Eisai Co., Ltd. During the first quarter of 2023 we accrued a $31.0 million payable to Eisai related to the termination of an agreement whereby Eisai co-promoted or distributed our MS products in certain Asia-Pacific markets and settings. This termination fee is included in selling, general and administrative expense in our condensed consolidated statements of income for the six months ended June 30, 2023. LEQEMBI (lecanemab) Collaboration We have a collaboration agreement with Eisai to jointly develop and commercialize LEQEMBI (lecanemab), an anti-amyloid antibody for the treatment of Alzheimer's disease (the LEQEMBI Collaboration). Eisai serves as the lead of LEQEMBI 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. We and Eisai co-promote LEQEMBI and share profits and losses equally. We currently manufacture LEQEMBI drug substance and drug product and in March 2022 we extended our supply agreement with Eisai related to LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance. In July 2023 the FDA granted traditional approval of LEQEMBI. Prior to receiving traditional approval, LEQEMBI had been granted accelerated approval by the FDA in January 2023, at which time it became commercially available in the U.S. Upon commercialization, we began recognizing commercial profits and losses related to the LEQEMBI Collaboration Agreement on a net basis. As we are not the principal on sales transactions related to LEQEMBI, our 50.0% share of profits are recorded on a net basis in revenue from LEQEMBI Collaboration, which is a separate component of revenue within our condensed consolidated statements of income. For the three and six months ended June 30, 2023, we recognized reductions to revenue of approximately $20.7 million and $39.6 million, respectively, reflecting our net profit-share of the LEQEMBI Collaboration results in the U.S. This amount is included in revenue from LEQEMBI Collaboration within our condensed consolidated statements of income. During the first quarter of 2023, upon commercialization of LEQEMBI, we began recognizing our portion of the profit share in revenue from LEQEMBI Collaboration within our condensed consolidated income statements. Our share of LEQEMBI development expense will continue to be recorded within research and development expense and, until commercial approval on a region by region basis, non-U.S. selling and marketing expense will continue to be recorded in selling, general and administrative expense within our condensed consolidated statements of income. A summary of development and sales and marketing expense related to the LEQEMBI Collaboration is as follows:
(1) Beginning in the first quarter of 2023 reimbursement to Eisai for our portion of the profit share is recognized in revenue from LEQEMBI Collaboration within our condensed consolidated statements of income. ADUHELM Collaboration Agreement The LEQEMBI 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). 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 in 2019, Eisai was reimbursing us for 45.0% of development and sales and marketing expense incurred by the collaboration for the advancement of ADUHELM. In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. As of the amendment date, we have sole decision making and commercialization rights worldwide on ADUHELM, and beginning January 1, 2023, Eisai receives only a tiered royalty based on net sales of ADUHELM, and no longer participates in sharing ADUHELM's global profits and losses. Eisai's share of development, commercialization and manufacturing expense was limited to $335.0 million for the period from January 1, 2022 to December 31, 2022, which was achieved as of December 31, 2022. Once this limit was achieved, we became responsible for all ADUHELM related costs. A summary of development expense and sales and marketing expense related to our initial ADUHELM Collaboration Agreement is as follows:
ADUHELM Co-promotion Profits and Losses Under our initial ADUHELM Collaboration Agreement, we recognized revenue on sales of ADUHELM in the U.S. to third parties as a component of product revenue in our condensed consolidated statements of income. We also recorded the related cost of revenue and sales and marketing expense in our condensed consolidated statements of income as these costs were incurred. Payments made to and received from Eisai for its 45.0% share of the co-promotion profits or losses in the U.S. were recognized in collaboration profit sharing/(loss reimbursement) in our condensed consolidated statements of income. For the three and six months ended June 30, 2022, we recognized net reductions to our operating expense of approximately $28.9 million and $210.6 million, respectively, to reflect Eisai's 45.0% share of net collaboration losses in the U.S. During the first quarter of 2022, as a result of the final NCD, we recorded approximately $275.0 million of charges associated with the write-off of inventory and purchase commitments in excess of forecasted demand related to ADUHELM, as well as approximately $45.0 million of gross idle capacity charges, which were recognized in cost of sales within our condensed consolidated statements of income for the six months ended June 30, 2022. We recognized approximately $160.0 million related to Eisai's 45.0% share of these charges in collaboration profit sharing/(loss reimbursement) within our condensed consolidated statements of income for the six months ended June 30, 2022. Amounts receivable from Eisai related to the agreements discussed above were approximately $23.5 million and $88.0 million as of June 30, 2023 and December 31, 2022, respectively. Amounts payable to Eisai related to the agreements discussed above were $99.3 million and $81.2 million as of June 30, 2023 and December 31, 2022, respectively. For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K. UCB We have a collaboration agreement with UCB, effective November 2003, to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for the potential treatment of SLE 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, both companies will co-promote dapirolizumab pegol and share profits and losses equally. A summary of development expense related to the UCB collaboration agreement is as follows:
Sage Therapeutics, Inc. In November 2020 we entered into a global collaboration and license agreement with Sage to jointly develop and commercialize zuranolone for the potential treatment of MDD and PPD 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. We may pay Sage milestones totaling $225.0 million upon the first commercial sale of zuranolone in the U.S. A summary of development and sales and marketing expense related to the Sage collaboration is as follows:
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 LRRK2 for Parkinson's disease and also entered into a separate agreement to obtain an exclusive option to license two preclinical programs from Denali's Transport Vehicle platform, including its ATV-enabled anti-amyloid beta program and a second program utilizing its Transport Vehicle technology. In April 2023 we exercised our option with Denali to license the ATV-enabled anti-amyloid beta program. In connection with this exercise, we assumed responsibility for all development and commercial activities and associated expenses related to this program. In addition, we made a one-time option exercise payment to Denali and, should certain milestones be achieved, may pay Denali additional development and commercial milestone payments and royalties based on future net sales. Under the LRRK2 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. A summary of development expense related to the Denali collaboration is as follows:
Other Research and Discovery Arrangements These arrangements may include the potential for future milestone payments based on the achievement of certain clinical and commercial development payable over a period of several years. Other For the three and six months ended June 30, 2023, we recorded $2.6 million and $2.8 million, respectively, as research and development expense in our condensed consolidated statements of income related to other research and discovery related arrangements, compared to $18.0 million and $37.5 million, respectively, in the prior year comparative periods. Samsung Bioepis Co., Ltd. 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 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 commercial agreement for BENEPALI, IMRALDI and FLIXABI by an additional five years, subject to payment of an option exercise fee of $60.0 million, and obtained an option to acquire exclusive rights to commercialize these products in China. 2013 Commercial Agreement We reflect revenue on sales of BENEPALI, IMRALDI and FLIXABI to third parties in product revenue, net in our condensed consolidated statements of income and record the related cost of revenue and sales and marketing expense in our condensed consolidated statements of income to their respective line items when these costs are incurred. We share 50.0% of the profit or loss related to our commercial agreement with Samsung Bioepis, which is recognized in collaboration profit sharing/(loss reimbursement) in our condensed consolidated statements of income. For the three and six months ended June 30, 2023, we recognized net profit-sharing expense of $56.9 million and $114.0 million, respectively, to reflect Samsung Bioepis' 50.0% sharing of the net collaboration profits, compared to a net profit-sharing expense of $58.3 million and $122.7 million, respectively, in the prior year comparative periods. Other Services Simultaneous with the formation of Samsung Bioepis, we also entered into a license agreement with Samsung Bioepis. Under the license agreement, we granted Samsung Bioepis an exclusive license to use, develop, manufacture and commercialize biosimilar products created by Samsung Bioepis using Biogen product-specific technology. In exchange, we receive single digit royalties on biosimilar products developed and commercialized by Samsung Bioepis. Royalty revenue under the license agreement is recognized as a component of contract manufacturing, royalty and other revenue in our condensed consolidated statements of income. Amounts receivable from Samsung Bioepis related to the agreements discussed above were $7.0 million and $2.0 million as of June 30, 2023 and December 31, 2022, respectively. Amounts payable to Samsung Bioepis related to the agreements discussed above were $162.8 million and $40.5 million as of June 30, 2023 and December 31, 2022, respectively. For additional information on our collaboration arrangements with Samsung Bioepis and our other significant collaboration arrangements, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K.
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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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Financial Instruments (Details Textual) |
6 Months Ended |
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Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Average maturity of marketable securities, months | 8 months |
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- Definition Average remaining time to maturity of marketable debt securities, available-for-sale securities. No definition available.
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Revenues - Revenues from Anti-CD20 Therapeutic Programs (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 2,456.0 | $ 2,589.1 | $ 4,919.0 | $ 5,120.9 |
Genentech | ||||
Disaggregation of Revenue [Line Items] | ||||
Biogen's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA | 103.6 | 139.9 | 216.1 | 283.1 |
Other revenues from anti-CD20 therapeutic programs | 4.3 | 4.6 | 7.7 | 8.5 |
Revenue from anti-CD20 therapeutic programs | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | 433.4 | 436.3 | 832.9 | 835.7 |
Royalty Attributed To OCREVUS | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues from anti-CD20 therapeutic programs | $ 325.5 | $ 291.8 | $ 609.1 | $ 544.1 |
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- Definition Other revenues from anti-CD20 therapeutic programs consists of revenue on sales of RITUXAN outside the U.S., which consist of our share of pre-tax co-promotion profits in Canada and royalty revenue on sales of Ocrevus. No definition available.
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- Definition Amount of excess of issue price over par or stated value of stock and from other transaction involving stock or stockholder. Includes, but is not limited to, additional paid-in capital (APIC) for common and preferred stock. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale), classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Sum of the carrying amounts of all intangible assets, excluding goodwill, as of the balance sheet date, net of accumulated amortization and impairment charges. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all liabilities that are recognized. Liabilities are probable future sacrifices of economic benefits arising from present obligations of an entity to transfer assets or provide services to other entities in the future. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of equity (deficit) attributable to noncontrolling interest. Excludes temporary equity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of accumulated undistributed earnings (deficit). Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of equity (deficit) attributable to parent and noncontrolling interest. Excludes temporary equity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Carrying value as of the balance sheet date of obligations incurred and payable for statutory income, sales, use, payroll, excise, real, property and other taxes. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Collaborative and Other Relationships - Summary of Activity Related to Sage Therapeutics (Details) - Sage Therapeutics - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | |||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2023 |
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Forecast | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Potential future milestone payments commitment to third party | $ 225.0 | ||||
Research and development | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Expense incurred by the collaboration | $ 52.1 | $ 50.8 | $ 86.9 | $ 89.5 | |
Expense reflected within statements of income | 26.1 | 25.3 | 43.5 | 44.7 | |
Selling, general and administrative | |||||
Collaborative arrangements and non-collaborative arrangement transactions | |||||
Expense incurred by the collaboration | 60.1 | 23.0 | 98.3 | 41.4 | |
Expense reflected within statements of income | $ 30.0 | $ 11.5 | $ 49.1 | $ 20.7 |
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- Definition Potential future milestone payments commitment to third party approximately. No definition available.
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Dispositions |
6 Months Ended |
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Jun. 30, 2023 | |
Divestitures [Abstract] | |
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 in exchange for total consideration of approximately $2.3 billion. Under the terms of this transaction, we received approximately $1.0 billion in cash at closing, with approximately $1.3 billion in cash to be deferred over two payments. The first payment of $812.5 million was received in April 2023 and the second payment of $437.5 million is due at the second anniversary of the closing of this transaction. Prior to the sale, the carrying value of our investment in Samsung Bioepis totaled $581.6 million. During the second quarter of 2022 we recognized a pre-tax gain of approximately $1.5 billion related to this transaction, which was recorded in other (income) expense, net in our condensed consolidated statements of income for the three and six months ended June 30, 2022. This pre-tax gain included reclassifications from AOCI to net income of approximately $58.9 million in cumulative translation losses, partially offset by approximately $57.0 million in gains resulting from the termination of our net investment hedge. We elected the fair value option and measured the payments due to us from Samsung BioLogics at fair value. As of June 30, 2023, the estimated fair value of the remaining second payment using a risk-adjusted discount rate of 6.6% was approximately $415.2 million. This payment has been classified as a Level 3 measurement and is reflected in other current assets within our condensed consolidated balance sheets as of June 30, 2023. For the three and six months ended June 30, 2023, we recognized gains of approximately $2.6 million and $13.7 million, respectively, to reflect the changes in fair value related to the first payment due to us, which was received in April 2023. Additionally, for the three and six months ended June 30, 2023, we recognized gains of approximately $3.6 million and $9.8 million, respectively, to reflect the changes in fair value related to the second payment due to us. These changes were recorded in other (income) expense, net in our condensed consolidated statements of income. As part of this transaction, we are also eligible to receive up to an additional $50.0 million upon the achievement of certain commercial milestones. Our policy for contingent payments of this nature is to recognize the payments in the period the payments become realizable, which is generally the same period in which the payments are earned. For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K.
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- Definition Divestitures [Abstract] No definition available.
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Income Taxes (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of the reconciliation using percentage or dollar amounts of the reported amount of income tax expense attributable to continuing operations for the year to the amount of income tax expense that would result from applying domestic federal statutory tax rates to pretax income from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Revenues |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenues | Product Revenue Revenue by product is summarized as follows:
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023. (2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023.
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023. (2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023. We recognized revenue from two wholesalers accounting for 27.0% and 9.3% of gross product revenue for the three months ended June 30, 2023, and 27.2% and 8.4% of gross product revenue for the six months ended June 30, 2023. We recognized revenue from two wholesalers accounting for 27.4% and 11.2% of gross product revenue for the three months ended June 30, 2022, and 26.8% and 10.8% of gross product revenue for the six months ended June 30, 2022. An analysis of the change in reserves for discounts and allowances is summarized as follows:
The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:
Revenue from LEQEMBI Collaboration In July 2023 the FDA granted traditional approval of LEQEMBI. Prior to receiving traditional approval, LEQEMBI had been granted accelerated approval by the FDA in January 2023, at which time it became commercially available in the U.S. Upon commercialization of LEQEMBI, we began recognizing our portion of the profit share on a net basis as a separate component of total revenue within revenue from LEQEMBI collaboration in our condensed consolidated income statements, as we are not the principal. For the three and six months ended June 30, 2023, we recognized reductions to revenue of approximately $20.7 million and $39.6 million, respectively, reflecting our net profit-share of the LEQEMBI Collaboration results in the U.S. For additional information on our collaboration arrangements with Eisai, please read Note 16, Collaborative and Other Relationships, to these condensed consolidated financial statements. Revenue from Anti-CD20 Therapeutic Programs Revenue from anti-CD20 therapeutic programs is summarized in the table below. For the purposes of this footnote, we refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
(1) LUNSUMIO became commercially available in the U.S. during the first quarter of 2023. For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K. Contract Manufacturing, Royalty and Other Revenue Contract manufacturing, royalty and other revenue is summarized in the table below.
Contract Manufacturing Revenue Contract manufacturing revenue primarily reflects amounts earned under contract manufacturing agreements with our strategic customers. During the first quarter of 2023 we began recognizing contract manufacturing revenue for LEQEMBI, upon accelerated approval of LEQEMBI in the U.S. Prior to accelerated approval, contract manufacturing amounts related to LEQEMBI were recognized in research and development within our condensed consolidated income statements. Royalty and Other Revenue Royalty and other revenue primarily reflects the royalties we receive from net sales on products related to patents that we have out-licensed, as well as royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis. For additional information on our license arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to these condensed consolidated financial statements.
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- References No definition available.
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- Definition The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Restructuring, Business Transformation and Other Cost Saving Initiatives (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restructuring Reserve by Type of Cost | Charges and spending related to our 2023 and 2022 workforce reductions are summarized as follows:
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Restructuring and Related Costs | Total charges incurred from our 2023 cost saving initiatives are summarized as follows:
Total charges incurred from our 2022 cost saving initiatives are summarized as follows:
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- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of costs incurred for restructuring including, but not limited to, exit and disposal activities, remediation, implementation, integration, asset impairment, and charges against earnings from the write-down of assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of an entity's restructuring reserve that occurred during the period associated with the exit from or disposal of business activities or restructurings for each major type of cost. This element may also include a description of any reversal and other adjustment made during the period to the amount of an accrued liability for restructuring activities. This element may be used to encapsulate the roll forward presentations of an entity's restructuring reserve by type of cost and in total, and explanation of changes that occurred in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Other Assets, Current, Fair Value Disclosure, No definition available.
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- Definition Fair values as of the balance sheet date of all assets of deferred compensation plans. No definition available.
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- Definition Fair value portion of probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of liability recognized arising from contingent consideration in a business combination. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Fair value portion of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. No definition available.
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- Definition Fair value, after the effects of master netting arrangements, of a financial asset or other contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes assets not subject to a master netting arrangement and not elected to be offset. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The percentage of ownership of common stock or equity participation in the investee accounted for under the equity method of accounting. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Fair value portion of asset contracts related to the exchange of different currencies, including, but not limited to, foreign currency options, forward contracts, and swaps. No definition available.
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- Definition Fair value portion of liability contracts related to the exchange of different currencies, including, but not limited to, foreign currency options, forward (delivery or nondelivery) contracts, and swaps entered into. No definition available.
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- Definition Fair value portion of investment securities, including, but not limited to, marketable securities, derivative financial instruments, and investments accounted for under the equity method. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Fair value of financial and nonfinancial obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Fair value portion of other assets. No definition available.
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Equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity | Share Repurchases In October 2020 our Board of Directors authorized our 2020 Share Repurchase Program, which is a program to repurchase up to $5.0 billion of our common stock. 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 2.4 million shares of our common stock at a cost of approximately $500.0 million during the three and six months ended June 30, 2022. There were no share repurchases of our common stock during the three and six months ended June 30, 2023. Approximately $2.1 billion remained available under our 2020 Share Repurchase Program as of June 30, 2023. Accumulated Other Comprehensive Income (Loss) The following tables summarize the changes in AOCI, net of tax by component:
(1) Beginning in the second quarter of 2022 we no longer held 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. The following table summarizes the amounts reclassified from AOCI:
(1) Beginning in the second quarter of 2022 we no longer held 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.
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- Definition The entire disclosure for equity. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Fair Value Measurements |
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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:
(1) Represents the fair value of the current payment 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.
(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. The fair value of Level 2 instruments classified as cash equivalents and marketable debt securities was determined through third-party pricing services. During the third quarter of 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 December 31, 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. Our investments in the common stock of Sangamo and Denali had holding period restrictions that expired during 2022. As of December 31, 2022, the fair values of our investments in Sangamo and Denali common stock were classified as Level 1 measurements. Although the contractual holding period restrictions on our investments in Denali, Sage and Sangamo have expired, our ability to liquidate these investments may be limited by the size of our interest, the volume of market related activity, our concentrated level of ownership and potential restrictions resulting from our status as a collaborator. Therefore, we may realize significantly less than the current value of such investments. For additional information on our investments in Denali, Sangamo and Sage common stock, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in our 2022 Form 10-K. There have been no material impairments of our assets measured and carried at fair value as of June 30, 2023 and December 31, 2022. In addition, there have been no changes to our valuation techniques as of June 30, 2023 and December 31, 2022. 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 2022 Form 10-K. Level 3 Assets and Liabilities Held at Fair Value There were no transfers of assets or liabilities into or out of Level 3 as of June 30, 2023 and December 31, 2022. Contingent Consideration Obligations In connection with our acquisition of Convergence, we agreed to make additional payments based upon the achievement of certain milestone events. The following table provides a roll forward of the fair value of our contingent consideration obligations, which were classified as Level 3 measurements:
Changes in the fair value of our contingent consideration obligations are recorded in (gain) loss on fair value remeasurement of contingent consideration in our condensed consolidated statements of income. During the fourth quarter of 2022 we discontinued further development efforts related to vixotrigine for the potential treatment of TGN and DPN, resulting in a reduction of our contingent consideration obligations of approximately $195.4 million, reducing the fair value of vixotrigine to zero. For the three and six months ended June 30, 2022, the changes in 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. 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:
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 June 30, 2023, compared to December 31, 2022, are primarily related to decreases in U.S. treasury yields and credit spreads used to value our Senior Notes since December 31, 2022. For additional information related to our Senior Notes, please read Note 13, Indebtedness, to our consolidated financial statements included in our 2022 Form 10-K.
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- Definition The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income (loss) and other comprehensive income (loss), attributable to noncontrolling interests. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, after tax and adjustment, of unrealized gain (loss) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale) and unrealized gain (loss) on investment in debt security measured at amortized cost (held-to-maturity) from transfer to available-for-sale. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, after tax and reclassification, of gain (loss) from derivative instrument designated and qualifying as cash flow hedge included in assessment of hedge effectiveness. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax and reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax of other comprehensive income (loss) attributable to parent entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount, after tax and reclassification adjustment, of (increase) decrease in accumulated other comprehensive income for defined benefit plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of increase (decrease) in the cumulative translation adjustment from gain (loss), after tax, on foreign currency derivatives, that are designated as, and are effective as, economic hedges of a net investment in a foreign entity. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Investments in Variable Interest Entities |
6 Months Ended |
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Jun. 30, 2023 | |
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. Our royalty rates payable on products developed under the Neurimmune Agreement, including royalty rates payable on commercial sales of ADUHELM, range from the high single digits to sub-teens. During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $85.0 million to reduce the net value of a previously recorded deferred tax asset to zero. This adjustment to our net deferred tax asset is 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. Unconsolidated Variable Interest Entities We have relationships with various variable interest entities that we do not consolidate as we lack the power to direct the activities that significantly impact the economic success of these entities. These relationships include investments in certain biotechnology companies and research collaboration agreements. As of June 30, 2023 and December 31, 2022, the carrying value of our investments in certain biotechnology companies representing potential unconsolidated variable interest entities totaled $25.2 million and $27.8 million, respectively. Our maximum exposure to loss related to these variable interest entities is limited to the carrying value of our investments. We have also entered into research collaboration agreements with certain variable interest entities where we are required to fund certain development activities. These development activities are included in research and development expense in our condensed consolidated statements of income as they are incurred. We have provided no financing to these variable interest entities other than previous contractually required amounts. For additional information on our investments in Neurimmune and other variable interest entities, please read Note 20, Investments in Variable Interest Entities, to our consolidated financial statements included in our 2022 Form 10-K.
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- Definition Investments In Variable Interest Entities. No definition available.
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- Definition The entire disclosure for a variable interest entity (VIE), including but not limited to, judgments and assumptions in determining whether to consolidate and in identifying the primary beneficiary, gain (loss) recognized on the initial consolidation of the VIE, terms of arrangements, amounts and classification of the VIE's assets and liabilities, and the entity's maximum exposure to loss. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Income Taxes (Details Textual) $ in Millions |
Jun. 30, 2023
USD ($)
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Income Tax Contingency [Line Items] | |
Deferred tax assets, unrecognized tax benefit | $ 85.0 |
Decrease in unrecognized tax benefits is reasonably possible | 470.0 |
ADUHELM | |
Income Tax Contingency [Line Items] | |
Decrease in unrecognized tax benefits is reasonably possible | $ 460.0 |
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- Definition Amount of decrease reasonably possible in the next twelve months for the unrecognized tax benefit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of deferred tax assets for which it is more likely than not that a tax benefit will not be realized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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- Details
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Earnings per Share (Details) - USD ($) shares in Thousands, $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Numerator: | ||||
Net income attributable to Biogen Inc. | $ 591.6 | $ 1,058.0 | $ 979.5 | $ 1,361.8 |
Weighted-average shares used in calculating: | ||||
Weighted average number of common shares outstanding | 144,700 | 145,900 | 144,600 | 146,500 |
Effect of dilutive securities: | ||||
Dilutive potential common shares | 800 | 300 | 800 | 300 |
Shares used in calculating diluted earnings per share | 145,500 | 146,200 | 145,400 | 146,800 |
Time-vested restricted stock units | ||||
Effect of dilutive securities: | ||||
Stock units | 700 | 200 | 700 | 200 |
Performance stock units settled in stock | ||||
Effect of dilutive securities: | ||||
Stock units | 100 | 100 | 100 | 100 |
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- References No definition available.
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- Definition Additional shares included in the calculation of diluted EPS as a result of the potentially dilutive effect of share based payment arrangements using the treasury stock method. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition The sum of dilutive potential common shares or units used in the calculation of the diluted per-share or per-unit computation. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Additional milestone payment. No definition available.
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- Definition Other Assets, Current, Fair Value Disclosure, No definition available.
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- Definition Other Assets, Measurement Input No definition available.
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- Definition Payables To Divestiture Of Interest In Joint Venture No definition available.
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- Definition The percentage of ownership of common stock or equity participation in the investee accounted for under the equity method of accounting. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of the entity's equity method investment which has been sold. No definition available.
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- Definition This item represents the carrying amount on the entity's balance sheet of its investment in common stock of an equity method investee. This is not an indicator of the fair value of the investment, rather it is the initial cost adjusted for the entity's share of earnings and losses of the investee, adjusted for any distributions (dividends) and other than temporary impairment (OTTI) losses recognized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of gain (loss) on sale or disposal of assets, including but not limited to property plant and equipment, intangible assets and equity in securities of subsidiaries or equity method investee. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The net realized gain (loss) on investments sold during the period, not including gains (losses) on securities separately or otherwise categorized as trading, available-for-sale, or held-to-maturity, which, for cash flow reporting, is a component of proceeds from investing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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- Definition Amount before tax, after reclassification adjustments of gain (loss) on foreign currency translation adjustments, foreign currency transactions designated and effective as economic hedges of a net investment in a foreign entity and intra-entity foreign currency transactions that are of a long-term-investment nature. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount, before tax, of reclassification from accumulated other comprehensive income (AOCI) for gain (loss) from derivative designated and qualifying as net investment hedge. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The cash inflow from the sale of an investment interest in a joint venture that the reporting entity has not previously accounted for using consolidation or the equity method of accounting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Inventory |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | The components of inventory are summarized as follows:
During the first quarter of 2022 we wrote-off approximately $275.0 million of inventory related to ADUHELM, as a result of the final NCD, which was recognized in cost of sales within our condensed consolidated statements of income for the six months ended June 30, 2022. We recognized approximately $136.0 million related to Eisai's 45.0% share of these charges in collaboration profit sharing/(loss reimbursement) within our condensed consolidated statements of income for the six months ended June 30, 2022. As of June 30, 2023 and December 31, 2022, the carrying value of our ADUHELM inventory was immaterial.
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- Definition The entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Share-based Payments |
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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:
The following table summarizes share-based compensation expense associated with each of our share-based compensation programs:
(1) During the fourth quarter of 2022 we granted stock options. For additional information, please read Note 16, Share-Based Payments, to our consolidated financial statements included in our 2022 Form 10-K. 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.
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- Definition The entire disclosure for share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- References No definition available.
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Summary of Significant Accounting Policies Summary of Significant Accounting Policies (Policies) |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Overview | Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases worldwide. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA and co-developed two treatments to address a defining pathology of Alzheimer's disease. We are focused on advancing our pipeline in neurology, neuropsychiatry, specialized immunology and rare diseases. We support our drug discovery and development efforts through internal research and development programs and external collaborations. Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; QALSODY for ALS, which was granted accelerated approval by the FDA during the second quarter of 2023; ADUHELM for the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe plaque psoriasis. We also collaborate with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease, which was granted traditional approval by the FDA in July 2023. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma, which was granted accelerated approval by the FDA during the fourth quarter of 2022; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma, which was granted accelerated approval by the FDA during the second quarter of 2023; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group. In addition to continuing to invest in new potential innovation in MS and SMA we are advancing our mid-to-late stage programs including zuranolone for MDD and PPD, BIIB080 for Alzheimer's disease and both litifilimab and dapirolizumab pegol for certain forms of lupus. We also commercialize biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. We continue to develop potential biosimilar products including BIIB800, a proposed tocilizumab biosimilar referencing ACTEMRA, and SB15, a proposed aflibercept biosimilar referencing EYLEA. For additional information on our collaboration arrangements, please read Note 16, Collaborative and Other Relationships, to these unaudited condensed consolidated financial statements (condensed consolidated financial statements). For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our audited consolidated financial statements included in our 2022 Form 10-K.
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Basis of presentation | In the opinion of management, our condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair statement of our financial statements for interim periods in accordance with U.S. GAAP. The information included in this quarterly report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our 2022 Form 10-K. Our accounting policies are described in the Notes to Consolidated Financial Statements in our 2022 Form 10-K and updated, as necessary, in this report. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period. We operate as one operating segment, focused on discovering, developing and delivering worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. |
Consolidation | Our condensed consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries and certain variable interest entities where we are the primary beneficiary. For consolidated entities where we own or are exposed to less than 100.0% of the economics, we record net income (loss) attributable to noncontrolling interests, net of tax in our condensed consolidated statements of income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. Intercompany balances and transactions are eliminated in consolidation. In determining whether we are the primary beneficiary of a variable interest entity, we apply a qualitative approach that determines whether we have both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We continuously assess whether we are the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in us consolidating or deconsolidating one or more of our collaborators or partners.
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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 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.
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New accounting pronouncements | From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed below, we do not believe that the adoption of recently issued standards have had or may have a material impact on our condensed consolidated financial statements or disclosures. Fair Value Measurements In June 2022 the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for us on January 1, 2024. We elected to early adopt this standard on a prospective basis during the third quarter of 2022. Upon adoption, we recorded an immaterial amount in other (income) expense, net in our condensed consolidated statements of income, as a result of removing the impact of the remaining contractual sale restrictions from the fair value measurement of certain shares in Sage.
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- Definition Disclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). No definition available.
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- Definition Disclosure of accounting policy regarding (1) the principles it follows in consolidating or combining the separate financial statements, including the principles followed in determining the inclusion or exclusion of subsidiaries or other entities in the consolidated or combined financial statements and (2) its treatment of interests (for example, common stock, a partnership interest or other means of exerting influence) in other entities, for example consolidation or use of the equity or cost methods of accounting. The accounting policy may also address the accounting treatment for intercompany accounts and transactions, noncontrolling interest, and the income statement treatment in consolidation for issuances of stock by a subsidiary. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact. No definition available.
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- Definition Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Other Consolidated Financial Statement Detail |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
(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. The (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 settlement 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 three and six months ended June 30, 2022. The following table summarizes our (gains) losses on investments, net that relate to our equity securities held during the following periods:
The net unrealized gains recognized during the three months ended June 30, 2023, primarily reflect an increase in the aggregate fair value of our investments in Denali and Sage common stock of approximately $117.7 million, partially offset by a decrease in the fair value of Sangamo common stock of approximately $10.9 million. The net unrealized losses recognized during the three months ended June 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Sangamo, Denali and Ionis common stock of approximately $75.3 million, partially offset by an increase in the fair value of Sage common stock of approximately $3.4 million. The net unrealized gains recognized during the six months ended June 30, 2023, primarily reflect an increase in the aggregate fair value of our investments in Denali and Sage common stock of approximately $78.0 million, partially offset by a decrease in the fair value of Sangamo and Ionis common stock of approximately $47.4 million. The net unrealized losses recognized during the six months ended June 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Denali, Sangamo and Sage common stock of approximately $277.1 million, partially offset by an increase in the fair value of Ionis common stock of approximately $19.0 million. Accrued Expense and Other Accrued expense and other consists of the following:
Other Long-term Liabilities Other long-term liabilities were $776.9 million and $944.2 million as of June 30, 2023 and December 31, 2022, respectively, and included accrued income taxes totaling $383.3 million and $541.7 million, respectively.
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- Definition The entire disclosures of supplemental information, including descriptions and amounts, related to the balance sheet, income statement, and/or cash flow statement. No definition available.
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- References No definition available.
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Collaborative and Other Relationships (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Co-promotion profit sharing formula | As a result of the FDA approval of LUNSUMIO our share of the combined annual co-promotion profits for RITUXAN and LUNSUMIO in excess of $50.0 million varies upon the following events, as summarized in the table below:
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Pretax profit sharing formula | Our share of annual co-promotion profits in excess of $50.0 million varies upon the following events, as summarized in the table below:
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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.
(1) LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
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Summary of activity related to Aducanumab collaboration | A summary of development expense and sales and marketing expense related to our initial ADUHELM Collaboration Agreement is as follows:
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Summary of activity related to the UCB collaboration | A summary of development expense related to the UCB collaboration agreement is as follows:
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Summary of Activity Related to Denali Therapeutics Collaboration | A summary of development expense related to the Denali collaboration is as follows:
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Summary of Activity Related to BAN2401 and Elenbecestat Collaboration |
(1) Beginning in the first quarter of 2023 reimbursement to Eisai for our portion of the profit share is recognized in revenue from LEQEMBI Collaboration within our condensed consolidated statements of income.
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Summary of Activity Related to Sage Therapeutics | A summary of development and sales and marketing expense related to the Sage collaboration is as follows:
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- Definition Pretax Profit Sharing Formula [Table Text Block] No definition available.
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- Definition Revenues from anti-CD20 therapeutic programs No definition available.
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- Definition Summary of Activity Related to Denali Therapeutics Collaboration No definition available.
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- Definition Summary of Activity Related to Sage Therapeutics No definition available.
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- Definition Summary of Activity Related to the UCB Collaboration No definition available.
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- Definition [Table Text Block] for Summary of Activity Related to Aducanumab Collaboration [Table] No definition available.
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- Definition [Table Text Block] for Summary of Activity Related to E2609 and BAN2401 Collaboration [Table] No definition available.
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- References No definition available.
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Derivative Instruments (Tables) |
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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 and foreign currency options that were entered into to hedge forecasted revenue and operating expense is summarized as follows:
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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 and forward currency options designated as hedging instruments in our condensed consolidated statements of income:
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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:
(1) Beginning in the second quarter of 2022 we no longer held 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.
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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:
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Derivative Instruments, Unrealized Gain (Loss) | The pre-tax portion of the fair value of these foreign currency forward contracts and foreign currency options that were included in AOCI in total equity is summarized as follows:
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- Definition Derivative Instruments, Unrealized Gain (Loss) No definition available.
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- References No definition available.
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- Definition Tabular disclosure of the location and amount of derivative instruments and nonderivative instruments designated as hedging instruments reported before netting adjustments, and the amount of gain (loss) on derivative instruments and nonderivative instruments designated and qualified as hedging instruments. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Tabular disclosure of the location and fair value amounts of derivative instruments (and nonderivative instruments that are designated and qualify as hedging instruments) reported in the statement of financial position. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of the effective portion of gains and losses on derivative instruments (and nonderivative instruments) designated and qualifying in net investment hedges recorded in accumulated other comprehensive income (loss) during the term of the hedging relationship and reclassified into earnings during the current period. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Tabular disclosure of the notional amounts of outstanding derivative positions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Other Consolidated Financial Statement Detail (Tables) |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other income (expense), net | Components of other (income) expense, net, are summarized as follows:
(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.
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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:
The net unrealized gains recognized during the three months ended June 30, 2023, primarily reflect an increase in the aggregate fair value of our investments in Denali and Sage common stock of approximately $117.7 million, partially offset by a decrease in the fair value of Sangamo common stock of approximately $10.9 million. The net unrealized losses recognized during the three months ended June 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Sangamo, Denali and Ionis common stock of approximately $75.3 million, partially offset by an increase in the fair value of Sage common stock of approximately $3.4 million. The net unrealized gains recognized during the six months ended June 30, 2023, primarily reflect an increase in the aggregate fair value of our investments in Denali and Sage common stock of approximately $78.0 million, partially offset by a decrease in the fair value of Sangamo and Ionis common stock of approximately $47.4 million. The net unrealized losses recognized during the six months ended June 30, 2022, primarily reflect a decrease in the aggregate fair value of our investments in Denali, Sangamo and Sage common stock of approximately $277.1 million, partially offset by an increase in the fair value of Ionis common stock of approximately $19.0 million.
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Accrued expenses and other | Accrued expense and other consists of the following:
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- Definition Tabular disclosure of realized and unrealized gain (loss) on investment in security. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- References No definition available.
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- Definition Tabular disclosure of the components of accrued liabilities. No definition available.
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- Definition Tabular disclosure of the components of non-operating income or non-operating expense that may include amounts earned from dividends, interest on securities, gains (losses) on securities sold, equity earnings of unconsolidated affiliates, net gain (loss) on sales of business, interest expense and other miscellaneous income or expense items. No definition available.
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- Definition Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Earnings per Share |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per Share | Basic and diluted shares outstanding used in our earnings per share calculation are calculated as follows:
Amounts excluded from the calculation of net income per diluted share because their effects were anti-dilutive were insignificant.
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- References No definition available.
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- Definition The entire disclosure for earnings per share. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, after tax, of accumulated increase (decrease) in equity from transaction and other event and circumstance from nonowner source. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax, before reclassification adjustments of other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax and reclassification adjustments of other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax of other comprehensive income (loss) attributable to parent entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after tax of reclassification adjustments of other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Equity Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax No definition available.
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- Definition Equity Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, Before Tax No definition available.
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- Definition Amount, before tax, of unrealized gain in accumulated other comprehensive income (AOCI) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount, before tax, of unrealized loss in accumulated other comprehensive income (AOCI) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI), classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Cost of investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI). Excludes equity method investment and investment in equity security without readily determinable fair value. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Collaborative and Other Relationships - Other Arrangements (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Collaborative arrangements and non-collaborative arrangement transactions | ||||
Research and development | $ 584.2 | $ 528.6 | $ 1,154.8 | $ 1,080.3 |
Other research and discovery | ||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Research and development | $ 2.6 | $ 18.0 | $ 2.8 | $ 37.5 |
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The costs incurred in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, excluding in-process research and development acquired in a business combination consummated during the period. Excludes software research and development, which has a separate concept. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Revenues - Narrative (Details) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023
USD ($)
wholesaler
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Jun. 30, 2022
USD ($)
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Jun. 30, 2023
USD ($)
wholesaler
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Jun. 30, 2022
USD ($)
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Disaggregation of Revenue [Line Items] | ||||
Number of wholesalers | wholesaler | 2 | 2 | ||
Product revenues | $ 2,456.0 | $ 2,589.1 | $ 4,919.0 | $ 5,120.9 |
Distributor One | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 27.00% | 27.40% | 27.20% | 26.80% |
Distributor Two | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage of revenues from major distributors | 9.30% | 11.20% | 8.40% | 10.80% |
Contract manufacturing, royalty and other revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ 197.5 | $ 97.9 | $ 516.6 | $ 164.0 |
LEQEMBI Collaboration | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenues | $ (20.7) | $ 0.0 | $ (39.6) | $ 0.0 |
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- Definition Entity wide percentage of revenue from major distributors. No definition available.
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- Definition Number of Wholesalers No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Collaborative and Other Relationships - OCREVUS (Details) - USD ($) $ in Millions |
1 Months Ended | 6 Months Ended |
---|---|---|
Mar. 31, 2017 |
Jun. 30, 2023 |
|
OCREVUS | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Royalty operating profit threshold for highest royalty rate percentage | $ 900.0 | |
Reduction in royalty rate | 50.00% | |
Collaboration agreement term | 11 years | |
OCREVUS | Foreign Tax Authority | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Royalty percentage to be received | 3.00% | |
OCREVUS | Minimum | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Royalty percentage to be received | 13.50% | |
OCREVUS | Maximum | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Royalty percentage to be received | 24.00% | |
Mosunetuzumab | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Percentage of future development costs | 30.00% |
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- Definition Future royalties percentage to be received on sale of product. No definition available.
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- Definition Percentage Of Future Development Costs No definition available.
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- Definition Period Of Collaboration Agreement No definition available.
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- Definition Reduction in royalty rate No definition available.
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- Definition Royalty operating profit threshold for highest royalty rate percentage No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Financial Instruments (Details 3) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from maturities and sales | $ 1,275.5 | $ 917.9 | $ 1,682.2 | $ 1,461.5 |
Realized gains | 0.3 | 0.0 | 0.4 | 0.0 |
Realized losses | $ 1.4 | $ 0.8 | $ 2.1 | $ 1.4 |
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- Definition Amount of realized gain on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of realized loss on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
|
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- Definition Amount of cash inflow from sale, maturity, prepayment and call of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Accumulated Other Comprehensive Income (Loss) (Tables) |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accumulated Other Comprehensive Income (Loss) | The following tables summarize the changes in AOCI, net of tax by component:
(1) Beginning in the second quarter of 2022 we no longer held 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.
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Reclassification out of Accumulated Other Comprehensive Income | The following table summarizes the amounts reclassified from AOCI:
(1) Beginning in the second quarter of 2022 we no longer held 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.
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- References No definition available.
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- Definition Tabular disclosure of information about items reclassified out of accumulated other comprehensive income (loss). No definition available.
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- Definition Tabular disclosure of the components of accumulated other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Share Repurchases (Details) - USD ($) shares in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Oct. 31, 2020 |
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Class of Stock [Line Items] | ||||
Repurchase of common stock, at cost (in shares) | 2,400 | 2,400 | ||
Treasury stock, value, acquired, cost method | $ 500,000,000 | $ 500,000,000 | ||
2020 Share Repurchase Program | ||||
Class of Stock [Line Items] | ||||
Stock Repurchase Program, Authorized Amount | $ 5,000,000,000 | |||
Amount remaining under 2019 Share Repurchase Program | $ 2,100,000,000 | |||
Treasury stock, value, acquired, cost method | $ 500,000,000.0 | $ 500,000,000.0 |
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Amount of stock repurchase plan authorized. No definition available.
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- Definition Amount remaining of a stock repurchase plan authorized. No definition available.
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- Definition Number of shares that have been repurchased during the period and are being held in treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Equity impact of the cost of common and preferred stock that were repurchased during the period. Recorded using the cost method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Collaborative and Other Relationships - Eisai (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Collaborative arrangements and non-collaborative arrangement transactions | ||||
Product revenues | $ 2,456.0 | $ 2,589.1 | $ 4,919.0 | $ 5,120.9 |
LEQEMBI Collaboration | ||||
Collaborative arrangements and non-collaborative arrangement transactions | ||||
Product revenues | (20.7) | $ 0.0 | (39.6) | $ 0.0 |
Payable Due To Termination Agreement | $ 31.0 | $ 31.0 |
X | ||||||||||
- Definition Accrued Payment To Termination Agreement No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Litigation |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
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 2022 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. If an estimate of the possible loss or range of loss can be made at this time, it is included in the potential loss contingency description below. 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 In March 2023 the United States District Court for the District of Massachusetts (the District Court) dismissed the previously disclosed shareholder action related to ADUHELM that had been filed in February 2022 against us and certain current and former officers. In May 2023 the plaintiff filed a motion to alter the judgment and amend the complaint, which is pending. The second previously disclosed shareholder action related to ADUHELM, filed in November 2022 and dismissed by the District Court in September 2021, remains on appeal to the U.S. Court of Appeals for the First Circuit. Both actions alleged violations of federal securities laws under 15 U.S.C §78j(b) and §78t(a) and 17 C.F.R. §240.10b-5. Derivative Action We and members of the Board of Directors are named as defendants in derivative actions filed by shareholders in February and July 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, and 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 District Court has stayed both cases. IMRALDI Patent Litigation In June 2022 Fresenius Kabi Deutschland GmbH (Fresenius Kabi) filed a claim for damages and injunctive relief against Biogen France SAS in the Tribunal de Grande Instance de Paris, alleging that IMRALDI, the adalimumab biosimilar product of Samsung Bioepis that Biogen commercializes in Europe, infringes the French counterpart of European Patent 3 145 488 (the EP ‘488 Patent), which expires in May 2035. In August 2022 Fresenius Kabi filed a claim for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court, alleging infringement of the German counterpart of the EP '488 Patent. A hearing in the Düsseldorf Regional Court has been set for December 2023. No hearing has been set in the French action. In July 2019 Gedeon Richter Nyrt (Gedeon Richter) filed a claim 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 (the EP '667 Patent, expiring in October 2035), and in November 2020 Gedeon Richter filed a claim for damages and injunctive relief against Biogen GmbH in the Düsseldorf Regional Court alleging infringement of a German utility model corresponding to the EP '667 Patent (expiring in October 2025). In July 2023 we and Gedeon Richter entered an agreement resolving the claims. Litigation with Former Convergence Shareholders In 2015 Biogen acquired Convergence, a U.K. company. In 2019 Shareholder Representative Services LLC, on behalf of the former shareholders of Convergence, asserted claims of $200.0 million for alleged breaches of the contract pursuant to which we acquired Convergence. In June 2023 Shareholder Representative Services LLC and 24 former shareholders filed suit against us in the High Court of Justice of England and Wales on one of the previously asserted claims, seeking payment of $49.9 million, interest and costs. No trial date has been set. 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 and seeking a declaration of the action as a class action and monetary and other relief. In June 2023 the parties reached a settlement in principle, subject to approval of the settlement by the court. Humana Patient Assistance Litigation In March 2023 the District Court for the District of Massachusetts dismissed the previously disclosed action filed against us by Humana in September 2020. Humana had alleged damages related to our providing MS patients with free medications and making charitable contributions to non-profit organizations that assist MS patients and had alleged violations of the federal RICO Act and state laws. In April 2023 Humana filed a motion to alter the judgment and amend the complaint, which is pending. Distributor Matter In December 2022 we terminated our distribution agreement with the distributor of products for Biogen in various countries in the Middle East and northern Africa. The former distributor has asserted breach of contract. No suit has been filed. Genentech Litigation In February 2023 Genentech, Inc. filed suit against us in the U.S. District Court for the Northern District of California, alleging that it is owed royalties on sales of TYSABRI that occurred after the expiration of a patent licensed by Genentech to Biogen, together with interest and costs. No trial date has been set. Other Matters Government Investigation The Company has received subpoenas from the Securities and Exchange Commission seeking information relating to ADUHELM, including healthcare sites and ADUHELM’s approval. TYSABRI Biosimilar Patent Matter In September 2022, following Sandoz Inc.'s announcement that the FDA had accepted its biologics license application for a proposed biosimilar referring to TYSABRI, we filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc., other Sandoz entities 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. No trial has been set. Annulment Proceedings in the General Court of the European Union relating to TECFIDERA In November 2020 Mylan Ireland filed an action in the General Court of the European Union (the General Court) to annul the EMA's decision not to validate its applications to market generic versions of TECFIDERA on the grounds that TECFIDERA benefits from regulatory data protection. No trial date has been set. Hatch-Waxman Act Litigation relating to VUMERITY Orange-Book Listed Patents In July 2023 Biogen and Alkermes Pharma Ireland Limited filed patent infringement proceedings relating to VUMERITY Orange-Book listed patents (U.S. Patent Nos. 8,669,281, 9,090,558 and 10,080,733) pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) in the U.S. District Court for the District of Delaware against Zydus Worldwide DMCC. No trial date has been set. 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.
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- Definition The entire disclosure for legal proceedings, legal contingencies, litigation, regulatory and environmental matters and other contingencies. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Inventory - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Mar. 31, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Inventory [Line Items] | |||||
Excess and obsolescence charges related to inventory | $ 36.8 | $ 305.6 | |||
(Gain) loss on equity method investments | $ 0.0 | $ 2.6 | |||
Percentage of future development costs related to Eisai | 45.00% | ||||
Inventory | $ 1,399.3 | $ 1,365.5 | |||
Eisai | |||||
Inventory [Line Items] | |||||
Percentage of future development costs related to Eisai | 45.00% | ||||
ADUHELM | |||||
Inventory [Line Items] | |||||
Excess and obsolescence charges related to inventory | $ 275.0 | $ 275.0 | |||
ADUHELM | Eisai | Centers for Medicare and Medicaid Service | |||||
Inventory [Line Items] | |||||
(Gain) loss on equity method investments | $ 136.0 |
X | ||||||||||
- Definition Inventory, Net Current and Noncurrent No definition available.
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X | ||||||||||
- Definition Percentage of future development costs related to Eisai No definition available.
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- Definition Amount of income (loss) for proportionate share of equity method investee's income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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- Definition Amount of loss from reductions in inventory due to subsequent measurement adjustments, including, but not limited to, physical deterioration, obsolescence, or changes in price levels. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- References No definition available.
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Income Taxes (Details) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Reconciliation between the U.S. federal statutory tax rate and effective tax rate | ||||
Statutory rate | 21.00% | 21.00% | 21.00% | 21.00% |
State taxes | 1.20% | 0.60% | 1.20% | 0.40% |
Taxes on foreign earnings | (4.70%) | (3.80%) | (5.00%) | (5.30%) |
Credits and net operating loss utilization | (2.00%) | (1.40%) | (3.70%) | (1.60%) |
Purchased intangible assets | 0.30% | 0.10% | 0.30% | 0.20% |
GILTI | 0.20% | 0.20% | 0.30% | 0.20% |
Sale of Samsung Bioepis | 0.00% | (3.70%) | 0.00% | (2.90%) |
Litigation settlement agreement | 0.00% | 8.50% | 0.00% | 6.70% |
Neurimmune tax impacts | 0 | 0 | 0 | 0.052 |
International reorganization | 0.00% | (4.00%) | 0.00% | (3.10%) |
Other | 0.20% | (0.40%) | 0.30% | 0.40% |
Effective tax rate | 16.20% | 17.10% | 14.40% | 21.20% |
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- Definition Effective Tax Rate Reconciliation, GILTI tax No definition available.
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- Definition Effective Tax Rate Reconciliation, International Reorganization No definition available.
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- Definition Effective Tax Rate Reconciliation, Litigation Agreement No definition available.
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- Definition Effective Tax Rate Reconciliation, NuerImmune Tax Impacts No definition available.
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- Definition Effective Tax Rate Reconciliation, Sale Of Samsung Bioepis No definition available.
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- Definition Percentage of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations applicable to statutory income tax expense (benefit) outside of the country of domicile. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to depreciation and amortization. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to other adjustments. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations applicable to state and local income tax expense (benefit), net of federal tax expense (benefit). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to tax credits. Including, but not limited to, research credit, foreign tax credit, investment tax credit, and other tax credits. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The percentage of ownership of common stock or equity participation in the investee accounted for under the equity method of accounting. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
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- Definition The net amount of other operating income and expenses, the components of which are not separately disclosed on the income statement, from items that are associated with the entity's normal revenue producing operations. No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Amount of cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage. Excludes amount for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of increase (decrease) in cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; excluding effect from exchange rate change. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of deferred income tax expense (benefit) pertaining to income (loss) from continuing operations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) from effect of exchange rate changes on cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; held in foreign currencies. Excludes amounts for disposal group and discontinued operations. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of gain (loss) recognized in income from liability measured at fair value on recurring basis using unobservable input (level 3). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of gain (loss) on sale or disposal of equity in securities of subsidiaries or equity method investee. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Amount of income (loss) for proportionate share of equity method investee's income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The increase (decrease) during the reporting period in amount due within one year (or one business cycle) from customers for the credit sale of goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The increase (decrease) during the period in the amount due for taxes based on the reporting entity's earnings or attributable to the entity's income earning process (business presence) within a given jurisdiction. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The increase (decrease) during the reporting period in the aggregate amount of expenses incurred but not yet paid. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of increase (decrease) of investment in equity security measured at fair value with change in fair value recognized in net income (FV-NI). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition The increase (decrease) during the reporting period in the aggregate value of all inventory held by the reporting entity, associated with underlying transactions that are classified as operating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of increase (decrease) in operating assets after deduction of operating liabilities classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of loss from reductions in inventory due to subsequent measurement adjustments, including, but not limited to, physical deterioration, obsolescence, or changes in price levels. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Amount of income (expense) included in net income that results in no cash inflow (outflow), classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of cash (inflow) outflow from investing activities classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition The cash outflow to reacquire common stock during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of cash outflow to satisfy grantee's tax withholding obligation for award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of cash outflow to acquire investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition The cash outflow to acquire asset without physical form usually arising from contractual or other legal rights, excluding goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cash inflow (outflow) from financing activities classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Amount of cash inflow (outflow) from (to) a noncontrolling interest. Excludes dividends paid to the noncontrolling interest. No definition available.
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X | ||||||||||
- Definition The cash inflow associated with the aggregate amount received by the entity through sale or maturity of marketable securities (held-to-maturity or available-for-sale) during the period. No definition available.
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X | ||||||||||
- Definition The cash inflow associated with the sale of equity method investments, which are investments in joint ventures and entities in which the entity has an equity ownership interest normally of 20 to 50 percent and exercises significant influence. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of cash inflow from the sale of investments classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Details
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- Details
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Property, Plant and Equipment |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
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 $2,282.1 million and $2,165.7 million as of June 30, 2023 and December 31, 2022, respectively. For the three and six months ended June 30, 2023, depreciation expense totaled $64.5 million and $126.6 million, respectively, compared to $67.2 million and $143.5 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 June 30, 2023 and December 31, 2022, we had approximately $732.2 million and $711.1 million, respectively, capitalized as construction in progress related to this facility. In the second quarter of 2021 a portion of the facility (the first manufacturing suite) received a GMP multi-product license from the SWISSMEDIC and was placed into service. Solothurn has been approved for the manufacture of ADUHELM and LEQEMBI by the FDA. We estimate the second manufacturing suite will be operational by the end of 2023.
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- References No definition available.
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X | ||||||||||
- Definition The entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Inventory - Components of Inventory (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 452.8 | $ 413.2 |
Work in process | 751.7 | 751.9 |
Finished goods | 194.8 | 200.4 |
Inventory | 1,399.3 | 1,365.5 |
Inventory, current | 1,333.5 | 1,344.4 |
Inventory, noncurrent | $ 65.8 | $ 21.1 |
X | ||||||||||
- Definition Inventory, Net Current and Noncurrent No definition available.
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X | ||||||||||
- References No definition available.
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- Definition Carrying amount, net of valuation reserves and adjustments, as of the balance sheet date of merchandise or goods held by the company that are readily available for sale. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Amount after valuation and LIFO reserves of inventory expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Inventories not expected to be converted to cash, sold or exchanged within the normal operating cycle. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Definition Carrying amount, net of valuation reserves and adjustments, as of the balance sheet date of unprocessed items to be consumed in the manufacturing or production process. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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X | ||||||||||
- Definition Carrying amount, net of reserves and adjustments, as of the balance sheet date of merchandise or goods which are partially completed. This inventory is generally comprised of raw materials, labor and factory overhead costs, which require further materials, labor and overhead to be converted into finished goods, and which generally require the use of estimates to determine percentage complete and pricing. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Income Taxes |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | Inflation Reduction Act In August 2022 the IRA was signed into law in the U.S. The IRA introduced new tax provisions, including a 15.0% corporate alternative minimum tax and a 1.0% excise tax on stock repurchases. The provisions of the IRA are effective for periods after December 31, 2022. The IRA did not result in any material adjustments to our income tax provision or other income tax balances as of June 30, 2023 and December 31, 2022. We expect additional guidance and regulations to be issued in future periods and will continue to assess its potential impact on our business and results of operations as further information becomes available. Tax Rate A reconciliation between the U.S. federal statutory tax rate and our effective tax rate is summarized as follows:
Changes in Tax Rate For the three and six months ended June 30, 2023, compared to the same periods in 2022, the decreases in our effective tax rates were primarily due to the combined net unfavorable tax rate impacts during the second quarter of 2022 related to a litigation settlement agreement, the sale of our equity interest in Samsung Bioepis, the non-cash tax effects of changes in the value of our equity investments and an international reorganization to align with global tax developments. The decrease in our effective tax rate for the six months ended June 30, 2023, also reflects the resolution of an uncertain tax matter during the first quarter of 2023 related to tax credits as well as the impact of the Neurimmune valuation allowance recorded in the first quarter of 2022, as discussed below. Neurimmune Deferred Tax Asset During the first quarter of 2022, upon issuance of the final NCD related to ADUHELM, we recorded an increase in a valuation allowance of approximately $85.0 million to reduce the net value of a previously recorded deferred tax asset to zero. This adjustment to our net deferred tax asset is 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 our collaboration arrangement with Neurimmune, please read Note 17, 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 2019 or state, local or non-U.S. income tax examinations for years before 2013. 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 $470.0 million, including approximately $460.0 million related to the unrecognized tax benefits related to Neurimmune's tax basis in ADUHELM, as discussed above, in the next 12 months as a result of various audit closures, settlements and expiration of the statute of limitations. Any changes to our gross unrecognized tax benefits related to Neurimmune's tax basis in ADUHELM would result in a zero net impact to net income attributable to Biogen, Inc., as we have recorded a full valuation allowance against the relevant deferred tax assets.
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- References No definition available.
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X | ||||||||||
- Definition The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Collaborative and Other Relationships - Summary of Activity Related to ADUHELM Collaboration (Details) - Eisai - ADUHELM - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2022 |
Jun. 30, 2022 |
|
Research and development | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Expense incurred by the collaboration | $ 37.2 | $ 81.4 |
Expense reflected within statements of income | 20.5 | 44.8 |
Selling, general and administrative | ||
Collaborative arrangements and non-collaborative arrangement transactions | ||
Expense incurred by the collaboration | 40.8 | 135.8 |
Expense reflected within statements of income | $ 21.1 | $ 72.0 |
X | ||||||||||
- Definition Expense incurred by the collaboration No definition available.
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X | ||||||||||
- Definition Expense reflected within statements of income No definition available.
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Details
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Revenues- Reserves for Discounts and Allowances (Details 2) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Total Reserves | $ 1,114.5 | $ 1,035.0 |
Reduction of accounts receivable | ||
Total Reserves | 149.8 | 143.4 |
Component of accrued expenses and other | ||
Total Reserves | $ 964.7 | $ 891.6 |
X | ||||||||||
- Definition Amount of valuation and qualifying accounts and reserves. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Details
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- Details
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Summary of Significant Accounting Policies (Details) |
6 Months Ended |
---|---|
Jun. 30, 2023
segment
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Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Interest in subsidiary (less than given percentage) | 100.00% |
X | ||||||||||
- Definition Interest in subsidiary. No definition available.
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X | ||||||||||
- References No definition available.
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- Definition Number of segments reported by the entity. A reportable segment is a component of an entity for which there is an accounting requirement to report separate financial information on that component in the entity's financial statements. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Restructuring, Business Transformation and Other Cost Saving Initiatives - Restructuring Reserve Roll Forward (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Restructuring Cost and Reserve [Line Items] | ||||||
Expense | $ 34.4 | $ 70.6 | $ 44.0 | $ 108.7 | ||
2023 Cost Saving Initiatives | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Expense | 46.3 | 53.4 | ||||
Severance Costs | 2022 Cost Saving Initiative | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Expense | 0.0 | 60.9 | 0.0 | 88.6 | ||
Severance Costs | 2023 and 2022 Cost Saving Initiatives | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring reserve, beginning | 28.0 | $ 35.9 | 21.5 | $ 0.0 | 35.9 | 0.0 |
Expense | 17.8 | 7.1 | 60.9 | 27.7 | ||
Payment | (13.4) | (15.6) | (29.7) | (6.2) | ||
Foreign currency and other adjustments | (0.1) | 0.6 | (0.5) | 0.0 | ||
Restructuring reserve, ending | $ 32.3 | $ 28.0 | $ 52.2 | $ 21.5 | $ 32.3 | $ 52.2 |
X | ||||||||||
- Definition Amount of cash payments made as the result of exit or disposal activities. Excludes payments associated with a discontinued operation or an asset retirement obligation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses related to a discontinued operation or an asset retirement obligation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Carrying amount (including both current and noncurrent portions of the accrual) as of the balance sheet date pertaining to a specified type of cost associated with exit from or disposal of business activities or restructuring pursuant to a duly authorized plan. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Amount of foreign currency translation gain (loss) which decreases (increases) the restructuring reserve. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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X | ||||||||||
- Details
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- Details
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- Details
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- Details
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Share-Based Payments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
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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:
(1) During the fourth quarter of 2022 we granted stock options. For additional information, please read Note 16, Share-Based Payments, to our consolidated financial statements included in our 2022 Form 10-K.
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- References No definition available.
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- Definition Tabular disclosure of cost recognized for award under share-based payment arrangement by plan. Includes, but is not limited to, related tax benefit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Tabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Revenues (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenues by product | Revenue by product is summarized as follows:
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023. (2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023.
(1) BYOOVIZ became commercially available in the U.S. during the third quarter of 2022 and commercially available in international markets in 2023. (2) Other includes FUMADERM, ADUHELM and QALSODY, which became commercially available in the U.S. during the second quarter of 2023.
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Analysis of change In reserves | An analysis of the change in reserves for discounts and allowances is summarized as follows:
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Total reserves included in consolidated balance sheets | The total reserves above, which are included in our condensed consolidated balance sheets, are summarized as follows:
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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.
(1) LUNSUMIO became commercially available in the U.S. during the first quarter of 2023.
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Other revenues |
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- Definition Analysis of amount of and change in product revenue reserves. No definition available.
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- Definition Other revenues [Table Text Block] No definition available.
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- Definition Revenues from anti-CD20 therapeutic programs No definition available.
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- Definition Summary of total product revenue reserves included in consolidated balance sheets. No definition available.
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- Definition Tabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- References No definition available.
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Collaborative and Other Relationships - Summary of Activity Related to the UCB Collaboration (Details) - Research and development - UCB Pharma S.A. - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Collaborative arrangements and non-collaborative arrangement transactions | ||||
Expense incurred by the collaboration | $ 14.3 | $ 15.6 | $ 32.6 | $ 33.2 |
Expense reflected within statements of income | $ 7.1 | $ 7.8 | $ 16.3 | $ 16.6 |
X | ||||||||||
- Definition Expense incurred by the collaboration No definition available.
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- Definition Expense reflected within statements of income No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Collaborative and Other Relationships - Profit Sharing (Details) $ in Millions |
6 Months Ended |
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Jun. 30, 2023
USD ($)
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RITUXAN | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Percentage of co promotion operating profits first fifty million | 30.00% |
Until Second GAZYVA Threshold Date | 37.50% |
After Second GAZYVA Threshold Date | 35.00% |
Percentage Of Co Promotion Operating Profits Greater Than First Fifty Million Option Two Sub Option Four | 30.00% |
GAZYVA | |
Collaborative arrangements and non-collaborative arrangement transactions | |
Co-promotion operating profit threshold for Rituxan in US and Canada to determine share of co promotion operating profit prior to amendment | $ 50.0 |
Until Second GAZYVA Threshold Date | 37.50% |
After Second GAZYVA Threshold Date | 35.00% |
Limit of gross sale of GAZYVA to be achieved in preceding 12 months under option one | $ 500.0 |
Limit of gross sale of GAZYVA to be achieved in any 12 months under option one | 150.0 |
Sales trigger gross sales threshold | $ 350.0 |
X | ||||||||||
- Definition Co promotion operating profit threshold to determine share of co promotion operating profit prior to amendment. No definition available.
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- Definition Percentage of co promotion operating profits first fifty million. No definition available.
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- Definition Percentage Of Co Promotion Operating Profits Greater Than First Fifty Million Option Two Sub Option Four No definition available.
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- Definition Percentage of co promotion operating profits greater than first fifty million option two sub option three. No definition available.
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- Definition Percentage of co promotion operating profits greater than first fifty million option two sub option two. No definition available.
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- Definition Sales trigger gross sales threshold. No definition available.
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- Definition Threshold of gross sales of to be achieved in preceding twelve consecutive months under option one. No definition available.
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- Definition Threshold of gross sales to be achieved in any twelve consecutive months under option one. No definition available.
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- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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