Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 22, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | CELGENE CORP /DE/ | |
Entity Central Index Key | 0000816284 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 705,259,536 | |
Entity Emerging Growth Company | false | |
Entity Small Business | false |
CONSOLIDATED STATEMENTS OF INCO
CONSOLIDATED STATEMENTS OF INCOME - USD ($) shares in Millions, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenue: | ||
Total revenue | $ 4,025 | $ 3,538 |
Expenses: | ||
Cost of goods sold (excluding amortization of acquired intangible assets) | 140 | 135 |
Research and development | 1,216 | 2,203 |
Selling, general and administrative | 773 | 864 |
Amortization of acquired intangible assets | 109 | 87 |
Acquisition/integration related charges and restructuring, net | 77 | 31 |
Total costs and expenses | 2,315 | 3,320 |
Operating income | 1,710 | 218 |
Other income and (expense): | ||
Interest and investment income, net | 34 | 13 |
Interest (expense) | (192) | (166) |
Other income, net | 262 | 965 |
Income before income taxes | 1,814 | 1,030 |
Income tax provision | 269 | 184 |
Net income | $ 1,545 | $ 846 |
Net income per common share: | ||
Basic (in dollars per share) | $ 2.20 | $ 1.13 |
Diluted (in dollars per share) | $ 2.14 | $ 1.10 |
Weighted average shares: | ||
Basic (in shares) | 702.4 | 748.3 |
Diluted (in shares) | 720.5 | 768.3 |
Net product sales | ||
Revenue: | ||
Total revenue | $ 4,024 | $ 3,531 |
Other revenue | ||
Revenue: | ||
Total revenue | $ 1 | $ 7 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net income | $ 1,545 | $ 846 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | (10) | 16 |
Net unrealized gains (losses) related to cash flow hedges: | ||
Unrealized holding gains (losses) | 51 | (99) |
Tax benefit | 1 | |
Unrealized holding gains (losses), net of tax | 51 | (98) |
Reclassification adjustment for (gains) losses included in net income | (23) | 27 |
Tax (benefit) | 0 | 0 |
Reclassification adjustment for (gains) losses included in net income, net of tax | (23) | 27 |
Excluded component related to cash flow hedges: | ||
Amortization of excluded component (gains) | (1) | (8) |
Reclassification of realized excluded component losses to net income | 1 | 11 |
Net reclassification adjustment included in net income | 0 | 3 |
Net unrealized gains (losses) on debt securities available-for-sale: | ||
Unrealized holding (losses) | 0 | (9) |
Tax benefit | 0 | 2 |
Unrealized holding (losses), net of tax | 0 | (7) |
Reclassification adjustment for losses included in net income | 0 | 18 |
Tax (benefit) | 0 | (4) |
Reclassification adjustment for losses included in net income, net of tax | 0 | 14 |
Total other comprehensive income (loss) | 18 | (45) |
Comprehensive income | $ 1,563 | $ 801 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 5,433 | $ 4,234 |
Debt securities available-for-sale | 664 | 496 |
Equity investments with readily determinable fair values | 1,594 | 1,312 |
Accounts receivable, net of allowances of $43 and $38 as of March 31, 2019 and December 31, 2018, respectively | 2,327 | 2,066 |
Inventory | 442 | 458 |
Other current assets | 521 | 501 |
Total current assets | 10,981 | 9,067 |
Property, plant and equipment, net | 1,383 | 1,367 |
Intangible assets, net | 16,101 | 16,213 |
Goodwill | 8,003 | 8,003 |
Other non-current assets | 1,171 | 830 |
Total assets | 37,639 | 35,480 |
Current liabilities: | ||
Short-term borrowings and current portion of long-term debt | 500 | 501 |
Accounts payable | 340 | 418 |
Accrued expenses and other current liabilities | 2,975 | 2,987 |
Income taxes payable | 72 | 78 |
Current portion of deferred revenue | 68 | 73 |
Total current liabilities | 3,955 | 4,057 |
Deferred revenue, net of current portion | 76 | 73 |
Income taxes payable | 2,232 | 2,190 |
Deferred income tax liabilities | 2,714 | 2,753 |
Other non-current liabilities | 716 | 477 |
Long-term debt, net of discount | 19,781 | 19,769 |
Total liabilities | 29,474 | 29,319 |
Commitments and Contingencies (See Note 15) | ||
Stockholders’ Equity | ||
Preferred stock, $.01 par value per share, 5.0 million shares authorized; none outstanding as of March 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $.01 par value per share, 1,150.0 million shares authorized; issued 985.7 million and 981.5 million shares as of March 31, 2019 and December 31, 2018, respectively | 10 | 10 |
Common stock in treasury, at cost; 280.9 million and 281.3 million shares as of March 31, 2019 and December 31, 2018, respectively | (26,298) | (26,336) |
Additional paid-in capital | 15,381 | 14,978 |
Retained earnings | 19,104 | 17,559 |
Accumulated other comprehensive (loss) | (32) | (50) |
Total stockholders’ equity | 8,165 | 6,161 |
Total liabilities and stockholders’ equity | $ 37,639 | $ 35,480 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable | $ 43 | $ 38 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 1,150,000,000 | 1,150,000,000 |
Common stock, shares issued | 985,700,000 | 981,500,000 |
Common stock, treasury (in shares) | 280,900,000 | 281,300,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net income | $ 1,545 | $ 846 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation | 47 | 38 |
Amortization | 110 | 88 |
Deferred income taxes | (41) | (52) |
Change in value of contingent consideration and success payments | 30 | (30) |
Net loss on sales of debt securities available-for-sale | 0 | 18 |
Fair value adjustments on equity investments | (269) | (959) |
Share-based compensation expense | 257 | 208 |
Share-based employee benefit plan expense | 0 | 9 |
Derivative instruments | 8 | (22) |
Other, net | 2 | 2 |
Change in current assets and liabilities, excluding the effect of acquisitions and disposals: | ||
Accounts receivable | (271) | (47) |
Inventory | 16 | 6 |
Other operating assets | 50 | (171) |
Accounts payable and other operating liabilities | (28) | (219) |
Income tax payable | 35 | (10) |
Payment of contingent consideration | (13) | (22) |
Deferred revenue | (2) | (8) |
Net cash provided by (used in) operating activities | 1,476 | (325) |
Cash flows from investing activities: | ||
Proceeds from sales of debt securities available-for-sale | 261 | 3,203 |
Purchases of debt securities available-for-sale | (428) | (62) |
Capital expenditures | (69) | (88) |
Proceeds from sales of equity investment securities | 2 | 55 |
Purchases of equity investment securities | (61) | (118) |
Payments for acquisition of business, net of cash acquired | 0 | (8,648) |
Net cash (used in) investing activities | (295) | (5,658) |
Cash flows from financing activities: | ||
Payment for treasury shares | 0 | (2,700) |
Proceeds from short-term borrowing | 0 | 1,815 |
Principal repayments on short-term borrowing | 0 | (1,815) |
Proceeds from issuance of long-term debt | 0 | 4,452 |
Payment of contingent consideration | (58) | (40) |
Net proceeds from share-based compensation arrangements | 84 | 44 |
Net cash provided by financing activities | 26 | 1,756 |
Effect of currency rate changes on cash and cash equivalents | (8) | 33 |
Net increase (decrease) in cash and cash equivalents | 1,199 | (4,194) |
Cash and cash equivalents at beginning of period | 4,234 | 7,013 |
Cash and cash equivalents at end of period | 5,433 | 2,819 |
Supplemental schedule of non-cash investing and financing activity: | ||
Change in net unrealized loss on debt securities available-for-sale | 0 | 9 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 281 | 190 |
Income taxes paid | $ 275 | $ 387 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Millions | Total | Common Stock | Treasury Stock | Additional Paid-in Capital | Retained Earnings | Accumulated Other Comprehensive Income (Loss) |
Beginning balance at Dec. 31, 2017 | $ 6,921 | $ 10 | $ (20,243) | $ 13,806 | $ 13,061 | $ 287 |
Net income | 846 | 846 | ||||
Other comprehensive income | (45) | (45) | ||||
Exercise of stock options and conversion of restricted stock units | 51 | (9) | 60 | |||
Shares purchased under share repurchase program | (2,725) | (2,725) | ||||
Issuance of common stock for employee benefit plans | 34 | 31 | 3 | |||
Expense related to share-based compensation | 208 | 208 | ||||
Adoption of ASU 2014-09, ASU 2016-01, ASU 2018-03, ASU 2018-02, ASU 2016-16 (Note 1) | (118) | 452 | (570) | |||
Ending balance at Mar. 31, 2018 | 5,172 | 10 | (22,946) | 14,077 | 14,359 | (328) |
Beginning balance at Dec. 31, 2018 | 6,161 | 10 | (26,336) | 14,978 | 17,559 | (50) |
Net income | 1,545 | 1,545 | ||||
Other comprehensive income | 18 | 18 | ||||
Exercise of stock options and conversion of restricted stock units | 152 | 0 | (12) | 164 | ||
Issuance of common stock for employee benefit plans | 32 | 50 | (18) | |||
Expense related to share-based compensation | 257 | 257 | ||||
Ending balance at Mar. 31, 2019 | $ 8,165 | $ 10 | $ (26,298) | $ 15,381 | $ 19,104 | $ (32) |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation and New Accounting Standards | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business, Basis of Presentation and New Accounting Standards | Nature of Business, Basis of Presentation and New Accounting Standards Celgene Corporation, together with its subsidiaries (collectively “we,” “our,” “us,” “Celgene” or the “Company”), is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. Celgene Corporation was incorporated in the State of Delaware in 1986. Our primary commercial stage products include REVLIMID ® , POMALYST ® /IMNOVID ® , OTEZLA ® , ABRAXANE ® , and VIDAZA ® . In addition, we earn revenue from other product sales and licensing arrangements. Merger Agreement with Bristol-Myers Squibb Company On January 2, 2019, we entered into a definitive merger agreement with Bristol-Myers Squibb Company (Bristol-Myers Squibb) under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion , based on the closing price of Bristol-Myers Squibb shares of $52.43 on January 2, 2019 (Bristol-Myers Squibb - Celgene Merger). On April 12, 2019, the stockholders of each of Bristol-Myers Squibb and Celgene approved the Bristol-Myers Squibb - Celgene Merger. The transaction remains subject to the satisfaction of customary closing conditions and regulatory approvals. The Bristol-Myers Squibb - Celgene Merger is expected to close in the third quarter of 2019. The definitive merger agreement includes restrictions on the conduct of our business prior to the completion of the merger or termination of the merger agreement, generally requiring us to conduct our business in the ordinary course consistent with past practice. Without limiting the generality of the foregoing, we are subject to a variety of specified restrictions. Unless we obtain Bristol-Myers Squibb’s prior written consent (which consent may not be unreasonably withheld, conditioned or delayed) and except (i) as required or expressly contemplated by the merger agreement, (ii) as required by applicable law or (iii) as set forth in the confidential disclosure schedule delivered by Celgene to Bristol-Myers Squibb, we may not, among other things, incur additional indebtedness, issue additional shares of our common stock outside of our equity incentive plans, repurchase our common stock, pay dividends, acquire assets, securities or property (subject to certain exceptions, including without limitation, acquisitions up to a specified individual amount and an aggregate limitation), dispose of businesses or assets, enter into material contracts or make certain additional capital expenditures. Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene stockholders at closing is valued at $102.43 per Celgene share and one Contingent Value Right (Bristol-Myers Squibb CVR). The Bristol-Myers Squibb CVR will entitle its holder to receive a one-time potential payment of $9.00 in cash upon U.S. Food and Drug Administration (FDA) approval of all three of ozanimod (by December 31, 2020), liso-cel (JCAR017) (by December 31, 2020) and bb2121 (by March 31, 2021), in each case for a specified indication. When completed, Bristol-Myers Squibb stockholders are expected to own approximately 69% of the company, and Celgene stockholders are expected to own approximately 31% . The transaction is not subject to a financing condition. The cash portion will be funded through a combination of cash on hand and debt financing. Bristol-Myers Squibb has obtained fully committed debt financing from Morgan Stanley Senior Funding, Inc. and MUFG Bank, Ltd. On April 17, 2019, in connection with the Bristol-Myers Squibb - Celgene Merger, Bristol-Myers Squibb commenced an exchange offer for any and all outstanding notes issued by us (the “Celgene Notes”) for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb and cash. In conjunction with the exchange offer, Bristol-Myers Squibb is concurrently soliciting consents to adopt certain proposed amendments to each of the indentures governing the Celgene Notes to eliminate substantially all of the restrictive covenants in such indentures. The exchange offers and consent solicitations are conditioned upon, among other things, the closing of the Bristol-Myers Squibb - Celgene Merger. The exchange offers are expected to close on or about the closing date for the Bristol-Myers Squibb - Celgene Merger. In connection with the Bristol-Myers Squibb - Celgene Merger, we have incurred, and will continue to incur, merger-related and integration-related preparation costs. A significant portion of those costs are contingent on the merger closing, such as investment banking fees, legal fees, and other employee related costs. We incurred $47 million of such costs during the three-month period ended March 31, 2019 , which were recorded in Acquisition/integration related charges and restructuring, net within the Consolidated Statement of Income. We will incur approximately $171 million of professional fees due upon closing and approximately $205 million of employee-related costs, a portion of which is due upon closing with the remainder subject to satisfaction of a specified service period. Basis of Presentation The consolidated financial statements include the accounts of Celgene Corporation and its subsidiaries. Investments in limited partnerships and interests where we have an equity interest of 50% or less and do not otherwise have a controlling financial interest are accounted for by one of three methods: the equity method, as an investment without a readily determinable fair value or as an investment with a readily determinable fair value. We operate in a single segment engaged in the discovery, development, manufacturing, marketing, distribution and sale of innovative therapies for the treatment of cancer and inflammatory diseases. Consistent with our operational structure, our Chief Executive Officer (CEO), as the chief operating decision maker, manages and allocates resources at the global corporate level. Our global research and development organization is responsible for discovery of new product candidates and supports development and registration efforts for potential future products. Our global supply chain organization is responsible for the manufacturing and supply of products. Regional/therapeutic area commercial organizations market, distribute and sell our products. The business is also supported by global corporate staff functions. Managing and allocating resources at the global corporate level enables our CEO to assess both the overall level of resources available and how to best deploy these resources across functions, therapeutic areas, regional commercial organizations and research and development projects in line with our overarching long-term corporate-wide strategic goals, rather than on a product or franchise basis. Consistent with this decision-making process, our CEO uses consolidated, single-segment financial information for purposes of evaluating performance, allocating resources, setting incentive compensation targets, as well as forecasting future period financial results. The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect reported amounts and disclosures. Actual results could differ from those estimates. We are subject to certain risks and uncertainties related to, among other things, product development, regulatory approval, market acceptance, scope of patent and proprietary rights, competition, outcome of legal and governmental proceedings, credit risk, technological change and product liability. Interim results may not be indicative of the results that may be expected for the full year. In the opinion of management, these unaudited consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim unaudited consolidated financial statements. Certain prior year amounts have been reclassified to conform to the current year's presentation. Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2018 Annual Report on Form 10-K. Such significant accounting policies are applicable for periods prior to the adoption of the following new accounting standards. Effective January 1, 2019, we changed our approach to lease accounting in conjunction with our adoption of Accounting Standards Update No. 2016-02, "Leases" (ASU 2016-02) and subsequent amendments to ASU 2016-02, including Accounting Standards Update No. 2018-11 “Leases: Targeted Improvements” (ASU 2018-11 and, when taken together with ASU 2016-02, the “New Lease Accounting Standard”). As a result of the adoption of the New Lease Accounting Standard, we have updated our lease accounting policies as detailed below. There were no other changes to our significant accounting policies from those disclosed in our 2018 Annual Report on Form 10-K. See Note 16 for additional details related to our adoption of the New Lease Accounting Standard. Leases : In accordance with the guidance pursuant to the New Lease Accounting Standard, the determination of whether an arrangement is, or contains, a lease is based on the substance of the arrangement at inception date and includes considerations such as whether there is an identified asset, whether we have the right to obtain substantially all of the economic benefits from use of the identified asset and whether we have the right to direct the use of the identified asset. Leases are included in our Consolidated Balance Sheet as follows: Asset/Liability Operating Leases Finance Leases (1) Right of use (ROU) assets Other non-current assets Property, plant and equipment, net Current lease liabilities Accrued expenses and other current liabilities Short-term borrowings and current portion of long-term debt Non-current lease liabilities Other non-current liabilities Long-term debt, net of discount (1) As of March 31, 2019 , Celgene did not have any leases classified as finance leases. ROU assets represent our right to use an underlying asset for the expected lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and related lease liabilities are recognized at commencement date based on the present value of lease payments over the expected lease term, including contractually specified annual rent increases. When determinable, we use the rate implicit in the lease to determine the present value of lease payments. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Our leasing portfolio is comprised entirely of operating leases, which we account for at the asset level. Additionally, our lease agreements may include both lease and non-lease components, which we account for as a single lease component when the payments are fixed. Lease expense for operating lease payments is recognized on a straight-line basis over the expected lease term. We do not recognize ROU assets or related lease liabilities with a lease term of twelve months or less on our Consolidated Balance Sheet. Such lease payments are recorded in our Consolidated Statements of Income in the period in which the obligation for those payments was incurred. All of our leases are with unaffiliated parties . New accounting standards which have been adopted In February 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-02 and has subsequently issued a number of amendments to ASU 2016-02, including ASU 2018-11, which offers a transition option to entities adopting the New Lease Accounting Standard. Under the transition option, entities can elect to apply the new guidance using a modified retrospective approach at the beginning of the year in which New Lease Accounting Standard is adopted, rather than to the earliest comparative period presented in their financial statements. The New Lease Accounting Standard was effective for us as of January 1, 2019. The New Lease Accounting Standard provides accounting guidance for both lessee and lessor accounting models. Among other things, lessees will recognize on their balance sheet a ROU asset and a lease liability, based on the characterization of the lease as either an operating or finance lease. For income statement purposes, operating leases will result in the recognition of straight-line rent expense, while finance leases will result in a front-loaded expense pattern made up of both interest expense and amortization of the ROU asset. We have elected to adopt the New Lease Accounting Standard using the modified retrospective method and, therefore, have not recast comparative periods presented in our unaudited consolidated financial statements. We have elected the package of transition practical expedients for our existing leases and therefore we have not reassessed the following: lease classification for existing leases, whether any existing contracts contained leases, if any initial direct costs were incurred and whether existing land easements should be accounted for as leases. As permitted under the New Lease Accounting Standard, we have elected as accounting policy elections to not recognize ROU assets and related lease liabilities for leases with terms of twelve months or less and to not separate lease and non-lease components, and instead account for the non-lease components together with the lease components as a single lease component. The New Lease Accounting Standard had an impact on our Consolidated Balance Sheets as of January 1, 2019 and March 31, 2019, with the recognition of ROU assets in the amount of $293 million and $286 million , respectively, and the recognition of operating lease liabilities of $323 million and $313 million , respectively. However, the New Lease Accounting Standard did not have any significant impact on our Consolidated Statements of Income for any period. There was no material tax impact of adopting the New Lease Accounting Standard. Accounting Standards Adopted in 2018 On January 1, 2018, we adopted several new accounting standards, including the following which required cumulative effect adjustments to Retained earnings and Accumulated Other Comprehensive Income (AOCI): • ASU 2014-09 "Revenue from Contracts with Customers" (ASU 2014-09); • ASU 2016-01 "Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities" (ASU 2016-01); • ASU 2018-03 "Technical Corrections and Improvements to Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities" (ASU 2018-03); • ASU 2018-02 "Income Statement-Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income" (ASU 2018-02); and • ASU 2016-16 "Intra-Entity Transfers of Assets Other Than Inventory" (ASU 2016-16). Additional information related to the adoption of these accounting standards is disclosed in Note 1 of Notes to Consolidated Financial Statements contained in our 2018 Annual Report on Form 10-K. The following table presents a summary of cumulative effect adjustments to Retained earnings and AOCI due to the adoption of new accounting standards on January 1, 2018 as noted above: Retained Earnings Increase / (Decrease) AOCI (Decrease) / Increase ASU 2014-09 $ 4 $ — ASU 2016-01 687 (687 ) ASU 2018-03 44 — ASU 2018-02 (117 ) 117 ASU 2016-16 (166 ) — Net cumulative effect adjustments to Retained earnings and AOCI on January 1, 2018 due to the adoption of new accounting standards $ 452 $ (570 ) New accounting standards which have not yet been adopted In June 2016, the FASB issued Accounting Standards Update No. 2016-13, "Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments" (ASU 2016-13). ASU 2016-13 requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. ASU 2016-13 limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The new standard will be effective for us on January 1, 2020. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures. In November 2018, the FASB issued Accounting Standards Update No. 2018-18, “Collaboration Arrangements: Clarifying the Interaction between Topic 808 and Topic 606” (ASU 2018-18). The issuance of ASU 2014-09 raised questions about the interaction between the guidance on collaborative arrangements and revenue recognition. ASU 2018-18 addresses this uncertainty by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASU 2014-09 when the collaboration arrangement participant is a customer, (2) adding unit of account guidance to assess whether the collaboration arrangement or a part of the arrangement is with a customer and (3) precluding a company from presenting transactions with collaboration arrangement participants that are not directly related to sales to third parties together with revenue from contracts with customers. The new standard will be effective for us on January 1, 2020 with early adoption permitted. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The majority of our revenue is derived from product sales. Our primary commercial stage products include REVLIMID ® , POMALYST ® /IMNOVID ® , OTEZLA ® , ABRAXANE ® , and VIDAZA ® . In addition, we recognize revenue from other product sales and royalties based on licensees’ sales of our products or products using our technologies. We do not consider royalty revenue to be a material source of our consolidated revenue. As such, the following disclosure only relates to revenue associated with net product sales. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in the current revenue standard. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. At contract inception, we assess the goods promised in our contracts with customers and identify a performance obligation for each promise to transfer to the customer a good that is distinct. When identifying our performance obligations, we consider all goods promised in the contract regardless of whether explicitly stated in the customer contract or implied by customary business practices. Generally, our contracts with customers require us to transfer an individual distinct product, which would represent a single performance obligation. In limited situations, our contracts with customers will require us to transfer two or more distinct products, which would represent multiple performance obligations for each distinct product. For contracts with multiple performance obligations, we allocate the contract’s transaction price to each performance obligation on a relative standalone selling price basis. In determining our standalone selling prices for our products, we utilize observable prices for our goods sold separately in similar circumstances and to customers in the same geographical region or market. Our performance obligations with respect to our product sales are satisfied at a point in time, which transfer control upon delivery of product to our customers. We consider control to have transferred upon delivery because the customer has legal title to the asset, we have transferred physical possession of the asset, the customer has significant risks and rewards of ownership of the asset, and in most instances we have a present right to payment at that time. The aggregate dollar value of unfulfilled orders as of March 31, 2019 was not material. Distribution REVLIMID ® and POMALYST ® are distributed in the United States primarily through contracted pharmacies under the REVLIMID Risk Evaluation and Mitigation Strategy (REMS) and POMALYST REMS ® programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of REVLIMID ® and POMALYST ® . Internationally, REVLIMID ® and IMNOVID ® are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the product’s safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies. OTEZLA ® , ABRAXANE ® and VIDAZA ® are distributed through the more traditional pharmaceutical industry supply chain and are not subject to the same risk-management distribution programs as REVLIMID ® and POMALYST ® /IMNOVID ® . Significant Payment Terms Our contracts with our customers state the terms of the sale including the description, quantity, and price for each product purchased, as well as the payment and shipping terms. Our contractual payment terms vary by jurisdiction. In the United States, our contractual payment terms are typically due in no more than 30 days. Sales made outside the United States typically have payment terms that are greater than 60 days, thereby extending collection periods beyond those in the United States. The period between when we transfer control of the promised goods to a customer and when we receive payment from such customer is expected to be one year or less. Any exceptions to this are either not material or we collect interest from the customer for the time period between the invoice due date and the payment date. As such, we do not adjust the invoice amount for the effects of a significant financing component as the impact is not material to our consolidated financial statements. Contract Balances When the timing of our delivery of product is different from the timing of payments made by the customers, we recognize either a contract asset (performance precedes the contractual due date) or a contract liability (customer payment precedes performance). There were no significant changes in our contract asset or liability balances during the three- month periods ended March 31, 2019 and March 31, 2018 other than from transactions in the ordinary course of operating activities as described above. Contract Assets In limited situations, certain customer contractual payment terms require us to bill in arrears; thus, we satisfy some or all of our performance obligations before we are contractually entitled to bill the customer. In these situations, billing occurs subsequent to revenue recognition, which results in a contract asset. We reflect these contract assets as a component of Other current assets on the Consolidated Balance Sheet. For example, certain of our contractual arrangements do not permit us to bill until the product is sold through to the end-customer. As of March 31, 2019 and December 31, 2018 , such contract assets were $36 million . Contract Liabilities In other limited situations, certain customer contractual payment terms allow us to bill in advance; thus, we receive customer cash payment before satisfying some or all of its performance obligations. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. We reflect these contract liabilities as Deferred revenue on our Consolidated Balance Sheet. For example, certain of our contractual arrangements provide the customer with free product after the customer has purchased a contractual minimum amount of product. We concluded the free product represents a future performance obligation in the form of a contractual material right. As such, we defer a portion of the transaction price as a contract liability upon each sale of product until the contractual minimum volume is achieved. As we satisfy our remaining performance obligations, we release a portion of the deferred revenue balance. As of March 31, 2019 and December 31, 2018, such contract liabilities were $138 million and $137 million , respectively. Revenue recognized for the three- month period ended March 31, 2019 that was reflected in the deferred revenue balance as of December 31, 2018 was $12 million . Revenue recognized for the three- month period ended March 31, 2018 that was reflected in the deferred revenue balance at the beginning of 2018 was $16 million . Gross-to-Net Sales Adjustments We record gross-to-net sales accruals for government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances, and sales discounts. Provisions for discounts, early payments, rebates, sales returns, distributor service fees and chargebacks under terms customary in the industry are provided for in the same period the related sales are recorded. We record estimated reductions to revenue for volume-based discounts and rebates at the time of the initial sale based upon the sales terms, historical experience and trend analysis. We estimate these accruals using an expected value approach based primarily upon our historical rebate and discount payments made and the provisions included in current customer contracts and government regulations. Government Rebates, including Medicaid and Medicare Rebates Government rebate accruals are based on estimated payments due to governmental agencies for purchases made by third parties under various governmental programs. In the U.S., we participate in state government Medicaid programs and other Federal and state government programs, which require rebates to participating government entities. U.S. Medicaid rebate accruals are generally based on historical payment data and estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. The Medicaid rebate percentage was increased and extended to Medicaid Managed Care Organizations in March 2010. The accrual of the rebates associated with Medicaid Managed Care Organizations is calculated based on estimated historical patient data related to Medicaid Managed Care Organizations. We also analyze actual billings received from the states to further support the accrual rates. Effective in 2019, manufacturers of pharmaceutical products are responsible for 70% of the patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap, an increase of 20 percentage points from 2018. In order to estimate the cost to us of this coverage gap responsibility, we analyze data for eligible Medicare Part D patients against data for eligible Medicare Part D patients treated with our products, as well as the historical invoices. This expense is recognized throughout the year as costs are incurred. In certain international markets, government-sponsored programs require rebates to be paid based on program specific rules and, accordingly, the rebate accruals are determined primarily on estimated eligible sales. Chargebacks, Distributor Service Fees, Other Rebates and Administrative Fees Chargeback accruals are based on the differentials between product acquisition prices paid by wholesalers and lower government contract pricing paid by eligible customers covered under federally qualified programs. Distributor service fee accruals are based on contractual fees to be paid to the wholesale distributor for services provided. TRICARE is a health care program of the U.S. Department of Defense Military Health System that provides civilian health benefits for military personnel, military retirees and their dependents. TRICARE rebate accruals are included in chargeback accruals and are based on estimated Department of Defense eligible sales multiplied by the TRICARE rebate formula. Rebates or administrative fees are offered to certain wholesale customers, group purchasing organizations and end-user customers, consistent with pharmaceutical industry practices. Settlement of rebates and administrative fees may generally occur from one to 15 months from the date of sale. We record a provision for rebates at the time of sale based on contracted rates and historical redemption rates. Assumptions used to establish the provision include level of wholesaler inventories, contract sales volumes and average contract pricing. We regularly review the information related to these estimates and adjust the provision accordingly. Returns, Refunds and Warranties We base our sales returns allowance on estimated on-hand retail/hospital inventories, measured end-customer demand as reported by third-party sources, actual returns history and other factors, such as the trend experience for lots where product is still being returned or inventory centralization and rationalization initiatives conducted by major pharmacy chains, as applicable. If the historical data we use to calculate these estimates do not properly reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues in that period could be materially affected. Under this methodology, we track actual returns by individual production lots. Returns on closed lots, that is, lots no longer eligible for return credits, are analyzed to determine historical returns experience. Returns on open lots, that is, lots still eligible for return credits, are monitored and compared with historical return trend rates. Any changes from the historical trend rates are considered in determining the current sales return allowance. We do not provide warranties on our products to our customers unless the product is defective as manufactured or damaged in transit within a reasonable period of time after receipt of the product by the customer. Sales Discounts Sales discounts are based on payment terms extended to customers, which are generally offered as an incentive for prompt payment. We record our best estimate of sales discounts to which customers are likely to be entitled based on both historical information and current trends. The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows: Three-Month Periods Ended March 31, 2019 2018 Gross Product Sales $ 5,028 $ 4,247 Gross-to-Net Adjustments: Government Rebates (383 ) (291 ) Chargebacks and Distributor Services Fees (543 ) (367 ) Sales Discounts (68 ) (56 ) Sales Returns and Allowances (10 ) (2 ) Total Gross-to-Net Adjustments (1,004 ) (716 ) Net Product Sales $ 4,024 $ 3,531 Total revenues from external customers by our franchises (Hematology / Oncology and Inflammation & Immunology), product and geography for the three- month periods ended March 31, 2019 and 2018 were as follows: Three-Month Periods Ended March 31, 2019 2018 Hematology / Oncology: REVLIMID ® U.S. $ 1,686 $ 1,487 International 891 747 Worldwide 2,577 2,234 POMALYST ® /IMNOVID ® U.S. 390 300 International 167 153 Worldwide 557 453 ABRAXANE ® U.S. 196 159 International 90 103 Worldwide 286 262 VIDAZA ® U.S. 3 2 International 148 155 Worldwide 151 157 All Other U.S. 45 55 International 19 17 Worldwide 64 72 Total Hematology / Oncology: U.S. 2,320 2,003 International 1,315 1,175 Worldwide 3,635 3,178 Inflammation & Immunology: OTEZLA ® U.S. 301 276 International 88 77 Worldwide 389 353 Total net product sales U.S. 2,621 2,279 International 1,403 1,252 Worldwide 4,024 3,531 Other revenue 1 7 Total revenue $ 4,025 $ 3,538 |
Acquisitions and Divestitures
Acquisitions and Divestitures | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisitions and Divestitures | Acquisitions and Divestitures Acquisitions in Fiscal 2018: Impact Biomedicines, Inc. (Impact): On February 12, 2018, we acquired all of the outstanding shares of Impact, a privately held biotechnology company which was developing fedratinib, a highly selective JAK2 kinase inhibitor, for myelofibrosis. The consideration included an initial payment of approximately $1.1 billion . In addition, the sellers of Impact are eligible to receive contingent consideration based upon regulatory approvals of up to $1.4 billion and contingent consideration of up to $4.5 billion based upon the achievement of sales in any four consecutive calendar quarters between $1.0 billion and $5.0 billion . The acquisition of Impact was concentrated in one single identifiable asset and thus, for accounting purposes, we have concluded that the acquired assets do not meet the accounting definition of a business. The initial payment was allocated primarily to fedratinib, resulting in a $1.1 billion research and development asset acquisition expense and the balance of approximately $7 million was allocated to the remaining net assets acquired. Juno Therapeutics, Inc. (Juno): On March 6, 2018, we acquired all of the outstanding shares of Juno (Juno Acquisition), resulting in Juno becoming our wholly-owned subsidiary. Juno is developing CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a broad, novel portfolio evaluating multiple targets and cancer indications. The acquisition added a novel scientific platform and scalable manufacturing capabilities including JCAR017 and JCARH125, both directed CAR T therapeutics currently in programs for relapsed and/or refractory diffuse large B-cell lymphoma and relapsed and/or refractory multiple myeloma, respectively. Total consideration for the acquisition was approximately $10.4 billion , consisting of $9.1 billion for common stock outstanding, $966 million for the fair value of our investment in Juno and $367 million for the portion of equity compensation attributable to the pre-combination service period. In addition, the fair value of the awards attributed to post-combination service period was $666 million , which will be recognized as compensation expense over the requisite service period in our post-combination financial statements. We recognized $28 million and $250 million of post combination share-based compensation for the three- month periods ended March 31, 2019 and 2018, respectively. The acquisition has been accounted for as a business combination using the acquisition method of accounting which requires that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date and requires the fair value of acquired in-process research and development (IPR&D) to be classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. The total consideration for the acquisition of Juno was $10.4 billion , which consisted of the following: Total Consideration Cash paid for outstanding common stock at $87.00 per share $ 9,101 Celgene investment in Juno at $87.00 per share (1) 966 Cash for equity compensation attributable to pre-combination service (2) 367 Total consideration $ 10,434 (1) The Company recognized a gain of $458 million during the first quarter of 2018, as a result of remeasuring to fair value the equity interest in Juno held by us before the business combination, which was recorded in Other income, net within the Consolidated Statement of Income. (2) All equity compensation attributable to pre-combination service was paid during the first quarter of 2018. The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed on March 6, 2018 based upon their respective fair values summarized below. The determination of fair value was finalized in the fourth quarter of 2018. Amounts Recognized as of the acquisition date of March 6, 2018 Working capital (1) $ 452 IPR&D 6,980 Technology platform intangible asset 1,260 Property, plant and equipment, net 144 Other non-current assets 32 Deferred tax liabilities, net (1,530 ) Other non-current liabilities (41 ) Total identifiable net assets 7,297 Goodwill 3,137 Total net assets acquired $ 10,434 (1) Includes cash and cash equivalents, debt securities available-for-sale, accounts receivable, net of allowances, other current assets, accounts payable, accrued expenses and other current liabilities (including accrued litigation). See Note 17 for litigation matters related to Juno. The fair value assigned to acquired IPR&D was based on the present value of expected after-tax cash flows attributable to JCAR017, which is in a pivotal phase II trial and JCARH125. The present value of expected after-tax cash flows attributable to JCAR017 and JCARH125 assigned to IPR&D was determined by estimating the after-tax costs to complete development of JCAR017 and JCARH125 into commercially viable products, estimating future revenue and ongoing expenses to produce, support and sell JCAR017 and JCARH125, on an after-tax basis, and discounting the resulting net cash flows to present value. The revenue and costs projections used were reduced based on the probability that products at similar stages of development will become commercially viable products. The rate utilized to discount the net cash flows to their present value reflects the risk associated with the intangible asset and is benchmarked to the cost of equity. Acquired IPR&D will be accounted for as indefinite-lived intangible assets until regulatory approvals for JCAR017 and JCARH125 in a major market or discontinuation of development. The fair value of the technology platform intangible asset is equal to the present value of the expected after-tax cash flows attributable to the intangible asset, which was calculated based on the multi-period excess earnings method of the income approach. The multi-period excess earnings method of the income approach included estimating probability adjusted annual after-tax net cash flows through the cycle of development and commercialization of potential products generated by the technology platform then discounting the resulting probability adjusted net post-tax cash flows using a discount rate commensurate with the risk of our overall business operations to arrive at the net present value. The excess of purchase price over the fair value amounts assigned to identifiable assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is primarily attributable to the broadening of our product portfolio and research capabilities in the hematology and oncology therapeutic area, the assembled workforce and the deferred tax consequences of the IPR&D asset recorded for financial statement purposes. We do not expect any portion of this goodwill to be deductible for tax purposes. The goodwill attributable to the acquisition has been recorded as a non-current asset in our Consolidated Balance Sheets and is not amortized, but is subject to review for impairment annually. Juno's actual operating results represent a partial quarter in fiscal 2018, from the acquisition date of March 6, 2018 through the end of the quarter on March 31, 2018. There were no revenues reported for such period. However, a net loss of $304 million was included in such period, including share-based compensation charges of $250 million and $22 million of acquisition related charges. Pro Forma Financial Information for the Juno Acquisition: The following table provides unaudited pro forma financial information for the three-month period ended March 31, 2018 as if the Juno Acquisition had occurred on January 1, 2017. Three-Month Period Ended March 31, 2018 Total revenue $ 3,548 Net income 609 Net income per common share: basic $ 0.81 Net income per common share: diluted $ 0.79 The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of Celgene and Juno. The supplemental pro forma financial information reflects primarily the following pro forma adjustments: • Elimination of research related cost sharing transactions between Celgene and Juno; • The pro forma financial information assumes that the acquisition related transaction fees and costs, including post combination share-based compensation related to the acquisition, were removed from the three-month period ended March 31, 2018 and were assumed to have been incurred during the first quarter of 2017; • The pro forma financial information assumes that the gain recognized as a result of remeasuring to fair value the equity interest we held in Juno prior to the business combination was removed from the three-month period ended March 31, 2018 and was assumed to have been recognized during the first quarter of 2017; • Additional interest expense and amortization of debt issuance costs for a portion of the $4.5 billion of debt that was issued in February 2018 to partially finance the acquisition; • Additional amortization expense on the acquired technology platform asset; and • Statutory tax rates were applied, as appropriate, to each pro forma adjustment based on the jurisdiction in which the adjustment occurred. The unaudited pro forma results do not reflect any operating efficiencies or potential cost savings that may result from the combined operations of Celgene and Juno. Accordingly, these unaudited pro forma results are presented for illustrative purposes and are not intended to represent or be indicative of the actual results of operations of the combined company that would have been achieved had the acquisition occurred at the beginning of the periods presented, nor are they intended to represent or be indicative of future results of operations. |
Earnings Per Share
Earnings Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | Earnings Per Share Three-Month Periods Ended March 31, (Amounts in millions, except per share) 2019 2018 Net income $ 1,545 $ 846 Weighted-average shares: Basic 702.4 748.3 Effect of dilutive securities: Options, restricted stock units, performance stock units and other 18.1 20.0 Diluted 720.5 768.3 Net income per share: Basic $ 2.20 $ 1.13 Diluted $ 2.14 $ 1.10 The total number of potential shares of common stock excluded from the diluted earnings per share computation because their inclusion would have been anti-dilutive was 41.7 million and 35.7 million shares for the three-month periods ended March 31, 2019 and 2018 , respectively. Share Repurchase Program: As of March 31, 2019, we had remaining availability under our authorized common stock share repurchase program of $2.8 billion . We did no t repurchase any shares of our common stock during the three-month period ended March 31, 2019. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive (Loss) Income | 3 Months Ended |
Mar. 31, 2019 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract] | |
Accumulated Other Comprehensive (Loss) Income | Accumulated Other Comprehensive (Loss) Income The components of other comprehensive (loss) income consist of changes in pension liability, changes in net unrealized gains (losses) on debt securities available-for-sale, changes in net unrealized gains (losses) related to cash flow hedges, the amortization of the excluded component related to cash flow hedges and changes in foreign currency translation adjustments. The accumulated balances related to each component of other comprehensive (loss) income, net of tax, are summarized as follows: Pension Liability Adjustment Net Unrealized Gains (Losses) On Debt Securities Available-for-Sale (1) Net Unrealized Gains (Losses) Related to Cash Flow Hedges Amortization of Excluded Component Related to Cash Flow Hedges Foreign Currency Translation Adjustments Accumulated Other Comprehensive (Loss) Income Balance as of December 31, 2018 $ (28 ) $ 3 $ 42 $ (7 ) $ (60 ) $ (50 ) Other comprehensive income (loss) before reclassifications, net of tax — — 51 (1 ) (10 ) 40 Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax — — (23 ) 1 — (22 ) Net current-period other comprehensive income (loss), net of tax — — 28 — (10 ) 18 Balance as of March 31, 2019 $ (28 ) $ 3 $ 70 $ (7 ) $ (70 ) $ (32 ) Balance as of December 31, 2017 $ (22 ) $ 562 $ (206 ) $ (15 ) $ (32 ) $ 287 Cumulative effect adjustment for the adoption of ASU 2016-01 and ASU 2018-02 — (566 ) (4 ) — — (570 ) Other comprehensive (loss) income before reclassifications, net of tax — (7 ) (98 ) (8 ) 16 (97 ) Reclassified losses from accumulated other comprehensive income (loss), net of tax — 14 27 11 — 52 Net current-period other comprehensive income (loss), net of tax — 7 (71 ) 3 16 (45 ) Balance as of March 31, 2018 $ (22 ) $ 3 $ (281 ) $ (12 ) $ (16 ) $ (328 ) (1) Balances as of December 31, 2017 are prior to the adoption of ASU 2016-01 and, as such, include equity securities with readily determinable fair values. Upon adoption of ASU 2016-01, we recorded a cumulative effect adjustment for our net unrealized gains related to our equity securities with readily determinable fair values as of January 1, 2018. Therefore, the unrealized gains (losses) position as of March 31, 2018 solely relate to debt securities available-for-sale. Gains (Losses) Reclassified Out of Accumulated Other Comprehensive (Loss) Income Accumulated Other Comprehensive (Loss) Income Components Classification in the Consolidated Statements of Income Three-Month Periods Ended March 31, 2019 2018 (Losses) gains related to cash-flow hedges: Foreign exchange contracts Net product sales $ 24 $ (26 ) Treasury rate lock agreements Interest (expense) (1 ) (1 ) Excluded component related to cash-flow hedges: Foreign exchange contracts Net product sales — (3 ) (Losses) gains on debt securities available-for-sale: Realized gain (loss) on sales of debt securities available-for-sale Interest and investment income, net (1) — (18 ) Income tax provision - (expense) benefit (1) — 4 Total reclassification, net of tax $ 23 $ (44 ) (1) We use a specific identification approach to release the realized gain (loss) on sales of debt securities available-for-sale and income tax effects into Accumulated other comprehensive (loss). |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurement | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments and Fair Value Measurement | Financial Instruments and Fair Value Measurement The tables below present information about assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 and the valuation techniques we utilized to determine such fair value. • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Our level 1 assets consist of equity investments with readily determinable fair values. Our level 1 liability relates to our publicly traded Abraxis contingent value rights (Abraxis CVRs). See Note 19 of Notes to Consolidated Financial Statements included in our 2018 Annual Report on Form 10-K for a description of the Abraxis CVRs. • Level 2 inputs utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for identical or similar assets in markets that are not very active. From time to time, our level 2 assets consist primarily of U.S. Treasury securities, U.S. government-sponsored agency securities, U.S. government-sponsored agency mortgage-backed securities (MBS), global corporate debt securities, asset backed securities, ultra short income fund investments, time deposits and repurchase agreements with original maturities of greater than three months. We also have derivative instruments including foreign currency forward contracts, purchased currency options, zero-cost collar currency contracts and interest rate swap contracts, which may be in an asset or liability position. • Level 3 inputs utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market activity. We do not have any level 3 assets. Our level 3 liabilities consist of contingent consideration related to undeveloped product rights and technology platforms resulting from the acquisitions of Gloucester Pharmaceuticals, Inc. (Gloucester), Nogra Pharma Limited (Nogra), Avila Therapeutics, Inc. (Avila) and Quanticel Pharmaceuticals, Inc. (Quanticel). In addition, in connection the Juno Acquisition, we assumed Juno's contingent consideration and success payment liabilities. Our contingent consideration obligations are recorded at their estimated fair values and we revalue these obligations each reporting period until the related contingencies are resolved. The fair value measurements are estimated using probability-weighted discounted cash flow approaches that are based on significant unobservable inputs related to product candidates acquired in business combinations and are reviewed quarterly. These inputs include, as applicable, estimated probabilities and timing of achieving specified development and regulatory milestones, estimated annual sales and the discount rate used to calculate the present value of estimated future payments. Significant changes which increase or decrease the probabilities of achieving the related development and regulatory events, shorten or lengthen the time required to achieve such events, or increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of these obligations. The fair value of our contingent consideration as of March 31, 2019 and December 31, 2018 was calculated using the following significant unobservable inputs: Inputs Ranges (weighted average) utilized as of: March 31, 2019 December 31, 2018 Discount rate 3.6% to 4.8% (4.3%) 3.6% to 4.8% (4.3%) Probability of payment 0% to 68% (5%) 0% to 68% (5%) Projected year of payment for development and regulatory milestones 2020 to 2029 (2024) 2020 to 2029 (2024) Projected year of payment for sales-based milestones and other amounts calculated as a percentage of annual sales N/A N/A The maximum remaining potential payments related to the contingent consideration from the acquisitions of Gloucester, Avila, Quanticel and those assumed in the Juno Acquisition are estimated to be $120 million , $475 million , $214 million and $283 million , respectively, and $1.8 billion plus other amounts calculated as a percentage of annual sales pursuant to the license agreement with Nogra. Success payment obligations assumed through the Juno Acquisition are also recorded at their estimated fair values and are revalued quarterly. Changes in the fair value of contingent consideration and success payment obligations are recognized in Acquisition/integration related charges and restructuring, net in the Consolidated Statements of Income. The following tables present the Company's hierarchy for its assets and liabilities measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 : Fair Value Measurements as of March 31, 2019 Balance as of March 31, 2019 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Debt securities available-for-sale $ 664 $ — $ 664 $ — Equity investments with readily determinable fair values 1,594 1,594 — — Forward currency contracts 83 — 83 — Zero-cost collar currency contracts 17 — 17 — Interest rate swaps 2 — 2 — Total assets $ 2,360 $ 1,594 $ 766 $ — Liabilities: Contingent value rights $ (48 ) $ (48 ) $ — $ — Other acquisition related contingent consideration and success payments (162 ) — — (162 ) Total liabilities $ (210 ) $ (48 ) $ — $ (162 ) Fair Value Measurements as of December 31, 2018 Balance as of December 31, 2018 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Debt securities available-for-sale $ 496 $ — $ 496 $ — Equity investments with readily determinable fair values 1,312 1,312 — — Forward currency contracts 78 — 78 — Total assets $ 1,886 $ 1,312 $ 574 $ — Liabilities: Contingent value rights $ (19 ) $ (19 ) $ — $ — Interest rate swaps (10 ) — (10 ) — Zero-cost collar currency contracts (1 ) — (1 ) — Other acquisition related contingent consideration and success payments (163 ) — — (163 ) Total liabilities $ (193 ) $ (19 ) $ (11 ) $ (163 ) We measure equity investments without a readily determinable fair value at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer or at net asset value, as a practical expedient, if available. We record upward adjustments, downward adjustments and impairments of equity investments without readily determinable fair values within Other income, net on the Consolidated Statements of Income. The following table represents a roll-forward of equity investments without readily determinable fair values: Three-Month Period Ended March 31, 2019 Balance as of December 31, 2018 $ 545 Purchases 25 Upward adjustments 15 Downward adjustments and impairments (1 ) Balance as of March 31, 2019 $ 584 Three-Month Period Ended March 31, 2018 Balance as of December 31, 2017 $ 513 Cumulative effect adjustment for the adoption of ASU 2018-03 59 Purchases 16 Upward adjustments 21 Sales (3 ) Downward adjustments and impairments (1 ) Transfer to readily determinable fair value (10 ) Balance as of March 31, 2018 $ 595 For equity investments without a readily determinable fair value held as of March 31, 2019 , cumulative upward adjustments and downward adjustments and impairments since the adoption of ASU 2016-01 for the period January 1, 2018 through March 31, 2019 were $81 million and $135 million , respectively. For equity investments with and without readily determinable fair values held as of March 31, 2019 and 2018 , we recorded a net unrealized gain of $268 million and $449 million within Other income, net on the Consolidated Statements of Income for the three- month periods ended March 31, 2019 and 2018 , respectively. There were no security transfers between levels 1, 2 and 3 during the three-month periods ended March 31, 2019 and 2018 . The following tables represent a roll-forward of the fair value of level 3 instruments: Three-Month Period Ended March 31, 2019 Liabilities: Balance as of December 31, 2018 $ (163 ) Net change in fair value — Balance as of March 31, 2019 $ (163 ) Three-Month Period Ended March 31, 2018 Liabilities: Balance as of December 31, 2017 $ (80 ) Amounts acquired from Juno (122 ) Net change in fair value 1 Balance as of March 31, 2018 $ (201 ) |
Derivative Instruments and Hedg
Derivative Instruments and Hedging Activities | 3 Months Ended |
Mar. 31, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Instruments and Hedging Activities | Derivative Instruments and Hedging Activities Our revenue and earnings, cash flows and fair values of assets and liabilities can be impacted by fluctuations in foreign exchange rates and interest rates. We actively manage the impact of foreign exchange rate and interest rate movements through operational means and through the use of various financial instruments, including derivative instruments such as foreign currency option contracts, foreign currency forward contracts, treasury rate lock agreements and interest rate swap contracts. In instances where these financial instruments are accounted for as cash flow hedges or fair value hedges we may from time to time terminate the hedging relationship. If a hedging relationship is terminated, we generally either settle the instrument or enter into an offsetting instrument. Foreign Currency Risk Management We maintain a foreign exchange exposure management program to mitigate the impact of volatility in foreign exchange rates on future foreign currency cash flows, translation of foreign earnings and changes in the fair value of assets and liabilities denominated in foreign currencies. Through our revenue hedging program, we endeavor to reduce the impact of possible unfavorable changes in foreign exchange rates on our future U.S. Dollar cash flows that are derived from foreign currency denominated sales. To achieve this objective, we hedge a portion of our forecasted foreign currency denominated sales that are expected to occur in the foreseeable future, typically within the next three years , with a maximum of five years . We manage our anticipated transaction exposure principally with foreign currency forward contracts, a combination of foreign currency zero-cost collars, and occasionally purchased foreign currency put options. Foreign Currency Forward Contracts: We use foreign currency forward contracts to hedge specific forecasted transactions denominated in foreign currencies, manage exchange rate volatility in the translation of foreign earnings, and reduce exposures to foreign currency fluctuations of certain assets and liabilities denominated in foreign currencies. We manage a portfolio of foreign currency forward contracts to protect against changes in anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates, primarily associated with non-functional currency denominated revenues and expenses of foreign subsidiaries. The foreign currency forward hedging contracts outstanding as of March 31, 2019 and December 31, 2018 had settlement dates within 27 months and 30 months , respectively. The spot rate components of these foreign currency forward contracts are designated as cash flow hedges and any unrealized gains or losses are reported in Other Comprehensive Income (OCI) and reclassified to the Consolidated Statements of Income in the same periods during which the underlying hedged transactions affect earnings. If a hedging relationship is terminated with respect to a foreign currency forward contract, accumulated gains or losses associated with the contract remain in OCI until the hedged forecasted transaction occurs and are reclassified to operations in the same periods during which the underlying hedged transactions affect earnings. We recognize in earnings the initial value of the forward point components on a straight-line basis over the life of the derivative instrument within the same line item in the Consolidated Statements of Income that is used to present the earnings effect of the hedged item. Foreign currency forward contracts entered into to hedge forecasted revenue and expenses were as follows as of March 31, 2019 and December 31, 2018 : Notional Amount Foreign Currency March 31, 2019 December 31, 2018 Australian Dollar $ 31 $ 46 British Pound 49 82 Canadian Dollar 112 158 Euro 887 1,381 Japanese Yen 320 424 Total $ 1,399 $ 2,091 We consider the impact of our own and the counterparties’ credit risk on the fair value of the contracts as well as the ability of each party to execute its obligations under the contract on an ongoing basis. As of March 31, 2019 , credit risk did not materially change the fair value of our foreign currency forward contracts. We also manage a portfolio of foreign currency contracts to reduce exposures to foreign currency fluctuations of certain recognized assets and liabilities denominated in foreign currencies and, from time to time, we enter into foreign currency contracts to manage exposure related to translation of foreign earnings. These foreign currency forward contracts have not been designated as hedges and, accordingly, any changes in their fair value are recognized on the Consolidated Statements of Income in Other income, net in the current period. The aggregate notional amount of the foreign currency forward non-designated hedging contracts outstanding as of March 31, 2019 and December 31, 2018 were $398 million and $347 million , respectively. Foreign Currency Option Contracts: From time to time, we may hedge a portion of our future foreign currency exposure by utilizing a strategy that involves both a purchased local currency put option and a written local currency call option that are accounted for as hedges of future sales denominated in that local currency. Specifically, we sell (or write) a local currency call option and purchase a local currency put option with the same expiration dates and local currency notional amounts but with different strike prices. The premium collected from the sale of the call option is equal to the premium paid for the purchased put option, resulting in no net premium being paid. This combination of transactions is generally referred to as a “zero-cost collar.” The expiration dates and notional amounts correspond to the amount and timing of forecasted foreign currency sales. The foreign currency zero-cost collar contracts outstanding as of March 31, 2019 and December 31, 2018 had settlement dates within 21 months and 24 months , respectively. If the U.S. Dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value reduces to zero and we benefit from the increase in the U.S. Dollar equivalent value of our anticipated foreign currency cash flows; however, this benefit would be capped at the strike level of the written call, which forms the upper end of the collar. Outstanding foreign currency zero-cost collar contracts entered into to hedge forecasted revenue were as follows as of March 31, 2019 and December 31, 2018 : Notional Amount (1) March 31, 2019 December 31, 2018 Foreign currency zero-cost collar contracts designated as hedging activity: Purchased Put $ 1,893 $ 1,933 Written Call 2,171 2,216 (1) U.S. Dollar notional amounts are calculated as the hedged local currency amount multiplied by the strike value of the foreign currency option. The local currency notional amounts of our purchased put and written call that are designated as hedging activities are equal to each other. We previously entered into foreign currency purchased put option contracts to hedge forecasted revenue which were not part of a collar strategy. Such purchased put option contracts had a notional value of nil as of March 31, 2019 and December 31, 2018 . We de-designated all of our purchased put option contracts prior to March 31, 2019 . Interest Rate Risk Management Forward Starting Interest Rate Swaps and Treasury Rate Locks: In anticipation of issuing fixed-rate debt, we may use forward starting interest rate swaps (forward starting swaps) or treasury rate lock agreements (treasury rate locks) that are designated as cash flow hedges to hedge against changes in interest rates that could impact expected future issuances of debt. To the extent these hedges of cash flows related to anticipated debt are effective, any realized or unrealized gains or losses on the forward starting swaps or treasury rate locks are reported in OCI and are recognized in income over the life of the anticipated fixed-rate notes. As of March 31, 2019 and December 31, 2018 , we did not have any outstanding forward starting swaps or treasury rate locks. Interest Rate Swap Contracts: From time to time we hedge the fair value of certain debt obligations through the use of interest rate swap contracts. The interest rate swap contracts are designated hedges of the fair value changes in the notes attributable to changes in benchmark interest rates. Gains or losses resulting from changes in fair value of the underlying debt attributable to the hedged benchmark interest rate risk are recorded on the Consolidated Statements of Income within Interest (expense) with an associated offset to the carrying value of the notes recorded on the Consolidated Balance Sheets. Since the specific terms and notional amount of the swap are intended to match those of the debt being hedged all changes in fair value of the swap are recorded on the Consolidated Statements of Income within Interest (expense) with an associated offset to the derivative asset or liability on the Consolidated Balance Sheets. Consequently, there is no net impact recorded in income. Any net interest payments made or received on interest rate swap contracts are recognized as interest expense on the Consolidated Statements of Income. If a hedging relationship is terminated for an interest rate swap contract, accumulated gains or losses associated with the contract are measured and recorded as a reduction or increase of current and future interest expense associated with the previously hedged debt obligations. The following table summarizes the notional amounts of our outstanding interest rate swap contracts as of March 31, 2019 and December 31, 2018 : Notional Amount March 31, 2019 December 31, 2018 Interest rate swap contracts entered into as fair value hedges of the following fixed-rate senior notes: 3.875% senior notes due 2025 $ 200 $ 200 3.450% senior notes due 2027 450 450 3.900% senior notes due 2028 — 200 Total $ 650 $ 850 We have entered into swap contracts that were designated as hedges of certain of our fixed rate notes in 2019 and 2018 , and also terminated the hedging relationship by settling certain of those swap contracts during 2019 and 2018 . In 2019 , we settled $200 million notional amount of certain swap contracts. The settlement of swap contracts resulted in the receipt of net proceeds of $5 million during the three-month period ended March 31, 2019 , which are accounted for as a reduction of current and future interest expense associated with these notes. During 2018 , we settled $250 million notional amount of certain swap contracts. The settlement of swap contracts resulted in the receipt of net proceeds of $2 million during the year ended December 31, 2018 , which were accounted for as a reduction of current and future interest expense associated with these notes. See Note 11 for additional details related to reductions of current and future interest expense. The following tables summarize the fair value and presentation in the Consolidated Balance Sheets for derivative instruments as of March 31, 2019 and December 31, 2018 : March 31, 2019 Balance Sheet Location Fair Value Instrument Asset Derivatives Liability Derivatives Derivatives designated as hedging instruments: Foreign exchange contracts (1) Other current assets $ 58 $ 7 Other non-current assets 49 10 Interest rate swap agreements Other current assets 6 — Other non-current assets 2 — Other non-current liabilities 2 8 Derivatives not designated as hedging instruments: Foreign exchange contracts (1) Other current assets 21 1 Accrued expenses and other current liabilities 1 11 Interest rate swap agreements Other non-current assets 3 3 Total $ 142 $ 40 (1) Derivative instruments in this category are subject to master netting arrangements and are presented on a net basis in the Consolidated Balance Sheet in accordance with ASC 210-20. December 31, 2018 Fair Value Instrument Balance Sheet Location Asset Derivatives Liability Derivatives Derivatives designated as hedging instruments: Foreign exchange contracts (1) Other current assets $ 63 $ 18 Other non-current assets 45 16 Other non-current liabilities 12 15 Interest rate swap agreements Other current assets 7 — Other non-current assets 1 — Other non-current liabilities 1 19 Derivatives not designated as hedging instruments: Foreign exchange contracts (1) Other current assets 21 5 Accrued expenses and other current liabilities 2 12 Interest rate swap agreements Other current assets 2 3 Other non-current assets 5 4 Total $ 159 $ 92 (1) Derivative instruments in this category are subject to master netting arrangements and are presented on a net basis in the Consolidated Balance Sheets in accordance with ASC 210-20. As of March 31, 2019 and December 31, 2018 , the following amounts were recorded on the Consolidated Balance Sheets related to cumulative basis adjustments for fair value hedges: Carrying Amount of the Hedged Liability Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liability Consolidated Balance Sheet Classification in Which the Hedged Item Is Included March 31, 2019 (1) December 31, 2018 (1) March 31, 2019 (2) December 31, 2018 (2) Current portion of long-term debt, net of discount $ 500 $ 501 $ 1 $ 2 Long-term debt, net of discount 8,237 8,227 98 90 (1) The current portion of long-term debt, net of discount, includes $500 million and $501 million of carrying value with discontinued hedging relationships as of March 31, 2019 and December 31, 2018 , respectively. The Long-term debt, net of discount includes approximately $4.8 billion and $3.3 billion of carrying value with discontinued hedging relationships as of March 31, 2019 and December 31, 2018 , respectively. (2) The current portion of long-term debt, net of discount, includes $1 million and $2 million of discontinued hedging relationships at March 31, 2019 and December 31, 2018 , respectively. The Long-term debt, net of discount includes $102 million and $107 million of hedging adjustment on discontinued hedging relationships on long-term debt as of March 31, 2019 and December 31, 2018 , respectively. The following tables summarize the effect of derivative instruments designated as cash flow hedging instruments in AOCI for the three-month periods ended March 31, 2019 and 2018 : Three-Month Period Ended March 31, 2019 Instrument Amount of (1) Classification of Amount of Classification of Gain/(Loss) Recognized in Income Related to Amount Excluded from Effectiveness Testing Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing Foreign exchange contracts $ 51 Net product sales $ 24 Net product sales $ — Treasury rate lock agreements — Interest (expense) (1 ) N/A — (1) Net gains of $53 million are expected to be reclassified from AOCI into income in the next 12 months. Three-Month Period Ended March 31, 2018 Instrument Amount of Classification of Amount of Classification of Gain/(Loss) Recognized in Income Related to Amount Excluded from Effectiveness Testing Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing Foreign exchange contracts $ (95 ) Net product sales $ (26 ) Net product sales $ (2 ) Treasury rate lock agreements (4 ) Interest (expense) (1 ) N/A — The following table summarizes the effect of derivative instruments which were designated as fair value hedging instruments on the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Amount of Gain/(Loss) Recognized in Income on Derivative Three-Month Periods Ended March 31, Instrument Classification of Gain/(Loss) Recognized in Income on Derivative 2019 (1) 2018 (1) Interest rate swap agreements Interest (expense) $ 20 $ (5 ) (1) The amounts include a benefit of $8 million and $8 million for the three-month periods ending March 31, 2019 and 2018, respectively, relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships. The following table summarizes the effect of derivative instruments not designated as hedging instruments on the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Classification of Gain/(Loss) Recognized in Income on Derivative Three-Month Periods Ended March 31, Instrument Classification of Gain/(Loss) Recognized in Income on Derivative 2019 2018 Foreign exchange contracts Other income, net $ 9 $ (13 ) The impact of gains and losses on foreign exchange contracts not designated as hedging instruments related to changes in the fair value of assets and liabilities denominated in foreign currencies are generally offset by net foreign exchange gains and losses, which are also included on the Consolidated Statements of Income in Other income, net for all periods presented. When we enter into foreign exchange contracts not designated as hedging instruments to mitigate the impact of exchange rate volatility in the translation of foreign earnings, gains and losses will generally be offset by fluctuations in the U.S. Dollar translated amounts of each Consolidated Statements of Income account in current and/or future periods. Classification and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships Three-Month Period Ended March 31, 2019 Net product sales Interest (expense) Other income, net Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded $ 4,024 $ (192 ) $ 262 The effects of fair value and cash flow hedging: (Loss) gain on fair value hedging relationships Interest rate swap agreements: Hedged items — (12 ) — Derivatives designated as hedging instruments (1) — 20 — Gain (loss) on cash flow hedging relationships Foreign exchange contracts: Amount of gain reclassified from AOCI into income 24 — — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value 1 — — Reclassification adjustment for excluded component (loss) (1 ) — — Treasury rate lock agreements: Amount of (loss) reclassified from AOCI into income — (1 ) — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value — — — (1) The amounts include a benefit of $8 million relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships for the three-month period ending March 31, 2019 . Classification and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships Three-Month Period Ended March 31, 2018 Net product sales Interest (expense) Other income, net Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded $ 3,531 $ (166 ) $ 965 The effects of fair value and cash flow hedging: Gain (loss) on fair value hedging relationships Interest rate swap agreements: Hedged items — 14 — Derivatives designated as hedging instruments (1) — (5 ) — (Loss) gain on cash flow hedging relationships Foreign exchange contracts: Amount of (loss) reclassified from AOCI into income (26 ) — — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value 8 — — Reclassification adjustment for excluded component (loss) (11 ) Treasury rate lock agreements: Amount of (loss) reclassified from AOCI into income — (1 ) — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value — — — (1) The amounts include a benefit of $8 million relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships for the three-month period ending March 31, 2018 . |
Cash, Cash Equivalents and Debt
Cash, Cash Equivalents and Debt Securities Available-for-Sale | 3 Months Ended |
Mar. 31, 2019 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Cash, Cash Equivalents and Debt Securities Available-for-Sale | Cash, Cash Equivalents and Debt Securities Available-for-Sale Time deposits, repurchase agreements, and commercial paper instruments with original maturities less than three months and money market funds are included in Cash and cash equivalents. As of March 31, 2019 , the carrying value of our time deposits and repurchase agreements was $2.0 billion and money market funds was $2.1 billion , all of which are included in Cash and cash equivalents. As of December 31, 2018 , the carrying value of our time deposits and repurchase agreements was $276 million , and money market funds was $2.9 billion , all of which were included in Cash and cash equivalents. The carrying values approximated fair value as of March 31, 2019 and December 31, 2018 . The amortized cost, gross unrealized holding gains, gross unrealized holding losses and estimated fair value of debt securities available-for-sale by major security type and class of security as of March 31, 2019 and December 31, 2018 were as follows: March 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Ultra short income fund $ 526 $ — $ — $ 526 Time deposits (1) and Repurchase agreements (1) 138 — — 138 Total debt securities available-for-sale $ 664 $ — $ — $ 664 (1) Have original maturities of greater than three months. December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Ultra short income fund $ 450 $ — $ — $ 450 Time deposits (1) and Repurchase agreements (1) 46 — — 46 Total debt securities available-for-sale $ 496 $ — $ — $ 496 (1) Have original maturities of greater than three months. Ultra short income fund includes investments in certificates of deposit, repurchase agreements, commercial paper and corporate notes. Time deposits and repurchase agreements in the tables above have original maturities greater than three months. Our repurchase agreements are collateralized by U.S. government securities, cash, bonds, commercial paper and bank certificates of deposit. As of March 31, 2019 , all of our time deposits and repurchase agreements had original maturities less than one year. Duration periods of debt securities available-for-sale as of March 31, 2019 were as follows: Amortized Cost Fair Value Duration of one year or less $ 664 $ 664 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventories as of March 31, 2019 and December 31, 2018 are summarized by major category as follows: March 31, 2019 December 31, 2018 Raw materials $ 235 $ 252 Work in process 87 79 Finished goods 120 127 Total inventory $ 442 $ 458 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Intangible Assets and Goodwill Intangible Assets: Our finite-lived intangible assets primarily consist of developed product rights and technology obtained from the acquisitions of Abraxis BioScience, Inc. (Abraxis) and Juno. The remaining weighted-average amortization period for finite-lived intangible assets not fully amortized is approximately 8.8 years . Our indefinite lived intangible assets consist of acquired IPR&D product rights from the acquisitions of Receptos Inc. (Receptos), Gloucester and Juno. The gross carrying amount and accumulated amortization of intangible assets as of March 31, 2019 and December 31, 2018 are summarized as follows: March 31, 2019 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,414 $ (2,349 ) $ 1,065 Technology 1,743 (573 ) 1,170 Licenses 66 (36 ) 30 Other 43 (38 ) 5 5,266 (2,996 ) 2,270 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,097 $ (2,996 ) $ 16,101 December 31, 2018 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,406 $ (2,261 ) $ 1,145 Technology 1,743 (552 ) 1,191 Licenses 66 (35 ) 31 Other 54 (39 ) 15 5,269 (2,887 ) 2,382 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,100 $ (2,887 ) $ 16,213 Amortization expense related to intangible assets was $110 million and $88 million for the three-month periods ended March 31, 2019 and 2018 , respectively. Assuming no changes in the gross carrying amount of finite-lived intangible assets, the future annual amortization expense related to intangible assets is expected to be approximately $441 million in 2019, $440 million in 2020, $437 million in 2021, $178 million in 2022 and $92 million in 2023. Goodwill: There was no change in the carrying value of the Company's goodwill from December 31, 2018 to March 31, 2019 . |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Debt Short-Term Borrowings and Current Portion of Long-Term Debt: We had no outstanding short-term borrowings as of March 31, 2019 and December 31, 2018. The carrying value of the current portion of long-term debt as of March 31, 2019 and December 31, 2018 includes: March 31, 2019 December 31, 2018 2.250% senior notes due 2019 $ 500 $ 501 Long-Term Debt: Our outstanding senior notes with maturity dates in excess of one year after March 31, 2019 have an aggregate principal amount of $19.850 billion with varying maturity dates and interest rates. The carrying values of the long-term portion of these senior notes as of March 31, 2019 and December 31, 2018 includes: March 31, 2019 December 31, 2018 2.875% senior notes due 2020 $ 1,497 $ 1,497 3.950% senior notes due 2020 508 509 2.250% senior notes due 2021 498 498 2.875% senior notes due 2021 499 498 3.250% senior notes due 2022 1,032 1,034 3.550% senior notes due 2022 996 996 2.750% senior notes due 2023 747 747 3.250% senior notes due 2023 994 994 4.000% senior notes due 2023 729 730 3.625% senior notes due 2024 1,000 1,000 3.875% senior notes due 2025 2,482 2,478 3.450% senior notes due 2027 997 986 3.900% senior notes due 2028 1,490 1,490 5.700% senior notes due 2040 247 247 5.250% senior notes due 2043 393 393 4.625% senior notes due 2044 987 987 5.000% senior notes due 2045 1,975 1,975 4.350% senior notes due 2047 1,234 1,234 4.550% senior notes due 2048 1,476 1,476 Total long-term debt $ 19,781 $ 19,769 As of March 31, 2019 and December 31, 2018 , the fair value of our outstanding Senior Notes was approximately $20.7 billion and $19.3 billion , respectively, and represented a level 2 measurement within the fair value measurement hierarchy. Debt Issuance: In February 2018, we issued $500 million principal amount of 2.875% senior notes due 2021 (2021 Notes), $1.000 billion principal amount of 3.250% senior notes due 2023 (2023 Notes), $1.500 billion principal amount of 3.900% senior notes due 2028 (2028 Notes) and $1.500 billion principal amount of 4.550% senior notes due 2048 (2048 Notes). The 2021 Notes, 2023 Notes, 2028 Notes and 2048 Notes were issued at 99.954% , 99.758% , 99.656% and 99.400% of par, respectively, and the discount is being amortized as additional interest expense over the period from issuance through maturity. Offering costs of approximately $32 million were recorded as a direct deduction from the carrying amount of the 2021 Notes, 2023 Notes, 2028 Notes and 2048 Notes on our Consolidated Balance Sheets. The offering costs are being amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity. Interest on the 2021 Notes is payable semi-annually in arrears on February 19 and August 19 of each year, beginning August 19, 2018 and the principal is due in full at the maturity date. Interest on the 2023 Notes, 2028 Notes and 2048 Notes is payable semi-annually in arrears on February 20 and August 20 of each year, beginning August 20, 2018 and the principal is due in full at the maturity date. The 2021 Notes, 2023 Notes, 2028 Notes and 2048 Notes may be redeemed at our option, in whole or in part, at any time at a redemption price equaling accrued and unpaid interest plus the greater of 100% of the principal amount of the Notes to be redeemed or the sum of the present values of the remaining schedule payments of interest and principal discounted to the date of redemption on a semi-annual basis plus 10 basis points for the 2021 Notes, 15 basis points for the 2023 Notes, 20 basis points for the 2028 Notes and 25 basis points for the 2048 Notes. If we experience a change of control accompanied by a downgrade of the debt to below investment grade, we will be required to offer to repurchase the 2021 Notes, 2023 Notes, 2028 Notes and 2048 Notes at a purchase price equal to 101% of the principal amount plus accrued and unpaid interest. We are subject to covenants which limit our ability to pledge properties as security under borrowing arrangements and limit our ability to perform sale and leaseback transactions involving our property. From time to time, we have used treasury rate locks and forward starting interest rate swap contracts to hedge against changes in interest rates in anticipation of issuing fixed-rate notes. As of March 31, 2019 , and December 31, 2018 a balance of $29 million and $31 million , respectively, in net losses remained in AOCI related to the settlement of these derivative instruments and will be recognized as interest expense over the life of the notes. As of March 31, 2019 , we were party to pay-floating, receive-fixed interest rate swap contracts designated as fair value hedges of fixed-rate notes as described in Note 7. Our swap contracts outstanding as of March 31, 2019 effectively convert the hedged portion of our fixed-rate notes to floating rates. From time to time, we terminate the hedging relationship on certain of our swap contracts by settling the contracts or by entering into offsetting contracts. Any net proceeds received or paid in these settlements are accounted for as a reduction or increase of current and future interest expense associated with the previously hedged notes. As of March 31, 2019 and December 31, 2018 , we had balances of $103 million and $109 million , respectively, of unamortized gains recorded as a component of our debt as a result of past swap contract settlements. See Note 7 for additional details related to interest rate swap contract activity. Commercial Paper: As of March 31, 2019 and December 31, 2018 , we had available capacity to issue up to $2.0 billion of commercial paper. As of March 31, 2019 and December 31, 2018 , there were no borrowings under the program. Senior Unsecured Credit Facility: We maintain a senior unsecured revolving credit facility (Credit Facility) that provides revolving credit in the aggregate amount of $2.0 billion . Amounts may be borrowed in U.S. Dollars for general corporate purposes. The Credit Facility currently serves as backup liquidity for our commercial paper borrowings and expires on April 25, 2023. As of March 31, 2019 and December 31, 2018 , there were no outstanding borrowings against the Credit Facility. The Credit Facility contains affirmative and negative covenants, including certain customary financial covenants. We were in compliance with all financial covenants as of March 31, 2019 . |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | Share-Based Compensation We have stockholder-approved stock incentive plans, the Celgene Corporation 2017 Stock Incentive Plan and the 2014 Equity Incentive Plan (formerly known as the Juno Therapeutics, Inc. 2014 Equity Incentive Plan) (collectively, the Plans) that provide for the granting of options, restricted stock units (RSUs), performance stock units (PSUs) and other share-based and performance- based awards to our employees, officers and non-employee directors. The Management Compensation and Development Committee of the Board of Directors (Compensation Committee) may determine the type, amount and terms, including vesting, of any awards made under the Plans. Share-based compensation expense recognized reflects an estimate of the number of awards expected to vest after taking into consideration an estimate of award forfeitures based on actual experience and is recognized on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting. The following table summarizes the components of share-based compensation expense in the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Three-Month Periods Ended March 31, 2019 2018 Cost of goods sold (excluding amortization of acquired intangible assets) $ 12 $ 9 Research and development (1) 126 199 Selling, general and administrative (2) 119 193 Total share-based compensation expense 257 401 Tax benefit related to share-based compensation expense (3) 49 37 Reduction in net income $ 208 $ 364 (1) The three- month periods ended March 31, 2019 and 2018 include Juno related share-based compensation expense related to the post-combination servi ce period of $17 million and $133 million , respectively. (2) The three- month periods ended March 31, 2019 and 2018 include Juno related share-based compensation expense related to the post-combination service per iod of $11 million and $117 million , respectively. (3) The tax benefit related to share-based compensation expense above excludes excess tax benefits of $16 million and $11 million from share-based compensation awards that vested or were exercised during the three-month periods ended March 31, 2019 and 2018 , respectively. The following table summarizes the activity for stock options, RSUs and PSUs for the three-month period ended March 31, 2019 (in millions unless otherwise noted): Stock Options RSUs PSUs (in thousands) Outstanding as of December 31, 2018 71.1 11.7 660 Changes during the Year: Granted — 8.2 200 Exercised / Released (3.8 ) (0.4 ) (73 ) Forfeited (0.9 ) (0.3 ) (40 ) Outstanding as of March 31, 2019 66.4 19.2 747 Total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized as of March 31, 2019 were as follows: Stock Options RSUs PSUs Unrecognized compensation cost $ 386 $ 1,079 $ 35 Expected weighted-average period in years of compensation cost to be recognized 2.1 1.9 1.5 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We regularly evaluate the likelihood of the realization of our deferred tax assets and reduce the carrying amount of those deferred tax assets by a valuation allowance to the extent we believe a portion will not be realized. We consider many factors when assessing the likelihood of future realization of our deferred tax assets, including recent cumulative earnings experience by taxing jurisdiction, expectations of future taxable income, the carryforward periods available to us for tax reporting purposes and other relevant factors. Significant judgment is required in making this assessment. Our tax returns are under routine examination in many taxing jurisdictions. The scope of these examinations includes, but is not limited to, the review of our taxable presence in a jurisdiction, our deduction of certain items, our claims for research and development credits, our compliance with transfer pricing rules and regulations and the inclusion or exclusion of amounts from our tax returns as filed. Our U.S. federal income tax returns have been audited by the Internal Revenue Service (IRS) through the year ended December 31, 2008. Tax returns for the years ended December 31, 2009, 2010 and 2011 are currently under examination by the IRS. We are also subject to audits by various state and foreign taxing authorities, including most U.S. states and countries where we have operations. We regularly re-evaluate our tax positions and the associated interest and penalties, if applicable, resulting from audits of federal, state and foreign income tax filings, as well as changes in tax law (including regulations, administrative pronouncements, judicial precedents, etc.) that would reduce the technical merits of the position to below more likely than not. We believe that our accruals for tax liabilities are adequate for all open years. Many factors are considered in making these evaluations, including past history, recent interpretations of tax law and the specifics of each matter. Because tax regulations are subject to interpretation and tax litigation is inherently uncertain, these evaluations can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. We apply a variety of methodologies in making these estimates and assumptions, which include studies performed by independent economists, advice from industry and subject matter experts, evaluation of public actions taken by the IRS and other taxing authorities, as well as our industry experience. These evaluations are based on estimates and assumptions that have been deemed reasonable by management. However, if management’s estimates are not representative of actual outcomes, our results of operations could be materially impacted. Unrecognized tax benefits, generally represented by liabilities on the Consolidated Balance Sheets and all subject to tax examinations, arise when the estimated benefit recorded in the financial statements differs from the amounts taken or expected to be taken in a tax return because of the uncertainties described above. These unrecognized tax benefits relate primarily to issues common among multinational corporations. Virtually all of these unrecognized tax benefits, if recognized, would impact the effective income tax rate. We account for interest and potential penalties related to uncertain tax positions as part of our provision for income taxes. For the three-month period ended March 31, 2019 gross unrecognized tax benefits increased by $24 million , including interest, primarily due to current year tax positions. The liability for unrecognized tax benefits is expected to increase in the next 12 months relating to operations occurring in that period. Any settlements of examinations with taxing authorities or statute of limitations expirations would likely result in a decrease in our liability for unrecognized tax benefits and a corresponding increase in taxes paid or payable and/or a decrease in income tax expense. It is reasonably possible that the amount of the liability for unrecognized tax benefits could change by a significant amount during the next twelve-month period as a result of settlements or statute of limitations expirations. Finalizing examinations with the relevant taxing authorities can include formal administrative and legal proceedings and, as a result, it is difficult to estimate the timing and range of possible change related to the Company’s unrecognized tax benefits. An estimate of the range of possible change cannot be made until issues are further developed or examinations close. Our estimates of tax benefits and potential tax benefits may not be representative of actual outcomes and variation from such estimates could materially affect our consolidated financial statements in the period of settlement or when the statutes of limitations expire. |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Collaboration Agreements [Abstract] | |
Collaboration Agreements | Collaboration Arrangements We enter into collaborative arrangements for the research and development, license, manufacture and/or commercialization of products and/or product candidates. In addition, we also acquire product candidates and research and development technology rights and establish research and development collaborations with third parties to enhance our strategic position within our industry by strengthening and diversifying our research and development capabilities, product pipeline and marketed product base. These arrangements may include non-refundable, upfront payments, payments by us for options to acquire rights to products and product candidates and other rights, as well as contingent obligations by us for potential development, regulatory and commercial performance milestone payments, cost sharing arrangements, royalty payments, profit sharing and equity investments (including equity investments in the event of an initial public offering of equity by our partners). Upfront and milestone payments made to third parties in connection with research and development collaborations are expensed as incurred up to the point of regulatory approval. Milestone payments made to third parties upon regulatory approval are capitalized and amortized over the remaining useful life of the related product. Upfront payments are recorded when incurred, and milestone payments are recorded when the specific milestone has been achieved. The activities under these collaboration agreements are performed with no guarantee of either technological or commercial success. Although we do not consider any individual alliance to be material, certain of the more notable alliances are described in Note 18 of Notes to Consolidated Financial Statements included in our 2018 Annual Report on Form 10-K. During the three-month period ended March 31, 2019 , there were no new notable collaborations nor any significant activity related to those collaborations which we have described in detail in our 2018 Annual Report on Form 10-K. Amounts related to collaborations that are not specifically presented are included in the aggregate as Other Collaboration Arrangements. Other Collaboration Arrangements in 2019: A financial summary of certain period activity and the period-end balances related to our other collaboration arrangements is presented below (1) : Three-Month Periods Ended March 31, Research and Development Expense Upfront Fees Milestones Extension/Termination of Arrangements Amortization of Prepaid Research and Development Equity Investments Made During Period 2019 $ 216 $ 11 $ — $ 2 $ 52 2018 245 — — 2 101 Balances as of: Intangible Asset Balance Equity Investment Balance Percentage of Outstanding Equity March 31, 2019 $ 11 $ 1,581 N/A December 31, 2018 13 1,280 N/A (1) In addition to the expenses noted in the table above, we may also incur expenses for collaboration agreement related activities that are managed or funded by us. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Collaboration Arrangements and Acquired Research and Development Assets: We have entered into certain research and development collaboration arrangements with third parties that include our funding of certain development, manufacturing and commercialization efforts and the potential for making future milestone and royalty payments upon the achievement of pre-established developmental, regulatory and/or commercial targets. In addition, we have also made certain acquisitions that included potential future development, regulatory and commercial milestones. Our obligation to fund these efforts and make milestone payments is contingent upon our continued involvement in the programs and/or the lack of any adverse events which could cause the discontinuance of the programs. Due to the nature of these arrangements, the future potential payments are inherently uncertain, and accordingly no amounts have been recorded for the potential future achievement of these targets in our accompanying Consolidated Balance Sheets as of March 31, 2019 and December 31, 2018 . See Note 3 and Note 14 for additional details related to our acquisitions and collaboration arrangements, respectively. Contingencies: We believe we maintain insurance coverage adequate for our current needs. Our operations are subject to environmental laws and regulations which, among other things, impose limitations on the discharge of pollutants into the air and water and establish standards for the treatment, storage and disposal of solid and hazardous wastes. We review the effects of such laws and regulations on our operations and modify our operations as appropriate. We believe we are in substantial compliance with all applicable environmental laws and regulations. We have ongoing customs, duties and value-added-tax examinations in various countries that have yet to be settled. Based on our knowledge of the claims and facts and circumstances to date, none of these matters, individually or in the aggregate, are deemed to be material to our financial condition. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases We routinely enter into leases for the use of office and research facilities, which comprise the majority of our total lease obligation, as well as leases for the use of automobiles and certain equipment in various locations globally. Our leasing portfolio is comprised entirely of operating leases. A brief description of these leasing activities follows. Our leases for the use of office and research facilities generally have minimum annual rents, which may be subject to specified annual rent increases or annual changes in the Consumer Price Index (CPI). While contractually specified minimum rent and annual rent increases are included in the measurement of the ROU asset and related lease liability, changes in CPI are treated as variable lease payments, and as such, are recognized in our Consolidated Statements of Income in the period in which the obligation for those payments is incurred. Additionally, under these lease arrangements, we may be required to pay directly, or reimburse the lessors, for real estate taxes, insurance, utilities, maintenance and other operating costs. Such amounts are generally variable and therefore not included in the measurement of the ROU asset and related lease liability but are instead recognized as variable lease expense in our Consolidated Statements of Income when they are incurred. Our leases for the use of office and research facilities have remaining lease terms ranging from less than 1 year up to 10 years , some of which include options to extend the leases for subsequent periods ranging from 1 year to 9 years , and some of which include options to terminate the leases for a fee. Our lease terms include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Certain of our leases have options to extend the term at a future negotiated market rate. Such renewal periods are not included in the lease term as the future market rate is unknown at lease commencement. We also lease automobiles for use by our sales force and other certain employees, primarily under several Master Lease Agreements (MLAs). Under these MLAs, we may be required to make additional lease payments for exceeding a specified mileage, as well as for other operating costs such as maintenance and repair services. These costs are generally variable in nature and therefore are not included in the measurement of the ROU asset and related lease liability. Instead, such costs are recognized as variable lease expense in our Consolidated Statements of Income when they are incurred. Depending upon the country location of the automobile, each leased automobile has a term between 3 years and 4 years and are generally not renewed beyond that term. With regards to our leases for the use of office and other equipment, these leases have remaining lease terms ranging from less than 1 year up to 8 years , some of which include options to extend and some of which include options to terminate the leases for an insignificant fee. For our equipment leases, we may be required to make additional lease payments based on exceeding a specified usage, such as pages copied/printed, as well as other operating costs such as maintenance and repair services. These costs are generally variable in nature and therefore are not included in the measurement of the ROU asset and related lease liability. Instead, such costs are recognized as variable lease expense in our Consolidated Statements of Income when they are incurred. Our leased equipment is an insignificant component of our ROU assets and lease liabilities. The components of lease expense were as follows: Three-Month Period Ended March 31, 2019 Operating lease cost $ 23 Short-term lease cost — Variable lease cost 8 Sublease income — Total lease cost $ 31 Supplemental cash flow information related to leases was as follows: Three-Month Period Ended March 31, 2019 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 27 Supplemental noncash information related to leases was as follows: Three-Month Period Ended March 31, 2019 ROU assets obtained in exchange for new operating liabilities $ 18 Supplemental balance sheet information related to leases was as follows: March 31, 2019 Operating Leases Other non-current assets $ 286 Accrued expenses and other current liabilities 79 Other non-current liabilities 234 Weighted-average remaining lease term - operating leases 4.47 Weighted-average discount rate - operating leases 3.98 % Maturities of lease liabilities as of March 31, 2019 were as follows: Operating Leases 2019 (excluding the three-month period ended March 31, 2019) $ 72 2020 85 2021 64 2022 54 2023 40 2024 17 Thereafter 11 Total undiscounted lease payments $ 343 Less: imputed interest (30 ) Total discounted lease payments $ 313 Future minimum lease payments under non-cancelable operating leases as of December 31, 2018 were: Operating Leases 2019 $ 92 2020 89 2021 70 2022 59 2023 45 Thereafter 68 Total minimum lease payments $ 423 As of March 31, 2019 , we have $286 million of aggregate ROU assets and $313 million of related lease liabilities. Additionally, we have an operating lease which has not yet commenced with total undiscounted lease obligations of $66 million . The agreement was entered into during the fourth quarter of 2018 to lease a portion of a building which will be used primarily for office and research facilities. The lessor is currently building this space and we do not have access to the building until construction is complete. The lease is expected to commence in early- to mid-2020 when construction of the asset is completed. |
Legal Proceedings
Legal Proceedings | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | Legal Proceedings Like many companies in our industry, we have, from time to time, received inquiries and subpoenas and other types of information requests from government authorities and others and we have been subject to claims and other actions related to our business activities. While the ultimate outcome of investigations, inquiries, information requests and legal proceedings is difficult to predict, adverse resolutions or settlements of those matters may result in, among other things, modification of our business practices, product recalls, costs and significant payments, which may have a material adverse effect on our results of operations, cash flows or financial condition. Pending patent proceedings include challenges to the scope, validity and/or enforceability of our patents relating to certain of our products, uses of products or processes. Further, as certain of our products mature or they near the end of their regulatory exclusivity periods, it is more likely that we will receive challenges to our patents, and in some jurisdictions we have received such challenges. We are also subject, from time to time, to claims of third parties that we infringe their patents covering products or processes. Although we believe we have substantial defenses to these challenges and claims, there can be no assurance as to the outcome of these matters and an adverse decision in these proceedings could result in one or more of the following: (i) a loss of patent protection, which could lead to a significant reduction of sales that could materially affect our future results of operations, cash flows or financial condition; (ii) our inability to continue to engage in certain activities; and (iii) significant liabilities, including payment of damages, royalties and/or license fees to any such third party. We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously. Among the principal matters pending are the following: Patent-Related Proceedings: REVLIMID ® : In 2012, our European patent EP 1 667 682 (the ’682 patent) relating to certain polymorphic forms of lenalidomide expiring in 2024 was opposed in a proceeding before the European Patent Office (EPO) by Generics (UK) Ltd. and Teva Pharmaceutical Industries Ltd. On July 21, 2015, the EPO determined that the ’682 patent was not valid. We appealed the EPO ruling to the EPO Board of Appeal, thereby staying any revocation of the patent until the appeal is finally adjudicated. No appeal hearing date has been set. We believe that our patent portfolio for lenalidomide in the major markets in Europe, including the composition of matter patent including its supplementary protection certificate, which expires in 2022, is strong. In the event that we do not prevail on the appeal relating to the ’682 patent, we still expect that we will have protection in the major markets in the EU for lenalidomide until at least 2022. In June 2017, Accord Healthcare Ltd. (Accord) commenced lawsuits against us in the United Kingdom (UK) seeking to revoke our UK patents protecting REVLIMID ® . In June 2018, we entered into a settlement agreement with Accord resolving the lawsuits. In February 2019, Synthon B.V. (Synthon) commenced a lawsuit against us in the Netherlands seeking to revoke our Netherlands patent protecting REVLIMID ® . The trial is anticipated to take place on November 8, 2019. We received a Notice of Allegation dated June 13, 2017 from Dr. Reddy’s Laboratories Ltd. (DRL) notifying us of the filing of DRL’s Abbreviated New Drug Submission (ANDS) with Canada’s Minister of Health, with respect to Canadian Letters Patent Nos. 2,261,762; 2,476,983; 2,477,301; 2,537,092; 2,687,924; 2,687,927; 2,688,694; 2,688,695; 2,688,708; 2,688,709; 2,741,412 and 2,741,575. DRL is seeking to manufacture and market a generic version of 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in Canada. We commenced a proceeding in the Federal Court of Canada on July 27, 2017, seeking an order prohibiting the Minister of Health from granting marketing approval to DRL until expiry of these patents. We received a further Notice of Allegation dated September 20, 2017 from DRL relating to the same submission, but also referencing 2.5 mg REVLIMID ® (lenalidomide) capsules. DRL’s Notice of Allegation contains invalidity allegations relating to Canadian Letters Patent Nos. 2,537,092; 2,687,924; 2,687,927; 2,688,694; 2,688,695; 2,688,708; 2,688,709; 2,741,412 and 2,741,575. We commenced a proceeding in the Federal Court of Canada on November 2, 2017, seeking an order prohibiting the Minister of Health from granting marketing approval to DRL until expiry of these patents. The parties entered into a confidential settlement agreement and these proceedings were discontinued in April 2019. We received two Notices of Allegation on July 3, 2018 and July 6, 2018 from Natco Pharma (Canada) Inc. (Natco Canada) notifying us of the filing of Natco Canada’s two separate ANDSs with Canada’s Minister of Health, with respect to Canadian Letters Patent Nos. 2,476,983; 2,477,301; 2,537,092; 2,687,924; 2,687,927; 2,688,694; 2,688,695; 2,688,708; 2,688,709; 2,741,412 and 2,741,575. Natco Canada is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in Canada. We commenced infringement actions in the Federal Court of Canada on August 16, 2018, asserting all the patents, and seeking a declaration of infringement and a permanent injunction. The trial is scheduled to start on March 30, 2020. We received four Notices of Allegation on October 4, 2018 from Apotex Inc. (Apotex) notifying us of the filing of Apotex’s ANDS with Canada’s Minister of Health, with respect to Canadian Letters Patent Nos. 2,476,983; 2,477,301; 2,537,092; 2,687,924; 2,687,927; 2,688,694; 2,688,695; 2,688,708; 2,688,709; 2,741,412 and 2,741,575. Apotex is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in Canada. We commenced infringement actions in the Federal Court of Canada on November 15, 2018, asserting all the patents, and seeking a declaration of infringement and a permanent injunction. The trial is scheduled to start on May 4, 2020. We received a Notice Letter dated September 9, 2016 from DRL notifying us of its Abbreviated New Drug Application (ANDA) which contains Paragraph IV certifications against U.S. Patent Nos. 7,465,800; 7,855,217; 7,968,569; 8,530,498; 8,648,095; 9,101,621 and 9,101,622 that are listed in the U.S. Food and Drug Administration (FDA) list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book (Orange Book), for REVLIMID ® . DRL is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against DRL in the U.S. District Court for the District of New Jersey on October 20, 2016. As a result of the filing of our action, the FDA cannot grant final approval of DRL’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) March 12, 2019. On November 18, 2016, DRL filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. On December 27, 2016, we filed our answer to DRL’s counterclaims. Fact discovery is closed. Expert discovery is ongoing. The court has not yet entered a schedule for trial. We received an additional Notice Letter from DRL dated June 8, 2017 notifying us of additional Paragraph IV certifications against U.S. Patent Nos. 7,189,740; 8,404,717 and 9,056,120 that are listed in the Orange Book for REVLIMID ® . In response to that Notice Letter, we timely filed an infringement action against DRL in the U.S. District Court for the District of New Jersey on July 20, 2017. As a result of the filing of our action, the FDA cannot grant final approval of DRL’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) December 9, 2019. On October 18, 2017, DRL filed an amended answer and counterclaims asserting that each of the patents is invalid and/or not infringed. We filed our answer to DRL’s counterclaims on November 15, 2017. Fact discovery is set to close on May 31, 2019. The court has not yet entered a schedule for expert discovery or trial. We received another Notice Letter from DRL dated February 26, 2018 notifying us of additional Paragraph IV certifications against U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531 that are listed in the Orange Book for REVLIMID ® . In response to the Notice Letter, we timely filed an infringement action against DRL in the U.S. District Court for the District of New Jersey on April 12, 2018. As a result of the filing of our action, the FDA cannot grant final approval of DRL’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) August 27, 2020. DRL filed an amended answer and counterclaims on May 31, 2018 asserting that each of the patents is invalid and/or not infringed. We filed our answer to DRL’s counterclaims on June 28, 2018. The case is stayed until July 1, 2019, subject to renewal by agreement of the parties and the court’s approval of same. The court has not yet entered a schedule for expert discovery or trial. We received a Notice Letter dated February 27, 2017 from Zydus Pharmaceuticals (USA) Inc. (Zydus) notifying us of Zydus’s ANDA, which contains Paragraph IV certifications against U.S. Patent Nos. 7,465,800; 7,855,217; 7,968,569; 8,530,498; 8,648,095; 9,101,621 and 9,101,622 that are listed in the Orange Book for REVLIMID ® . Zydus is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against Zydus in the U.S. District Court for the District of New Jersey on April 12, 2017. As a result of the filing of our action, the FDA cannot grant final approval of Zydus’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) August 28, 2019. On August 7, 2017, Zydus filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. On September 11, 2017, we filed our answer to Zydus’s counterclaims. Fact discovery is set to close on May 31, 2019. The court has yet to enter a schedule for expert discovery and trial. On April 27, 2018, we filed another infringement action against Zydus in the U.S. District Court for the District of New Jersey. The patents-in-suit are U.S. Patent Nos. 7,977,357; 8,193,219 and 8,431,598, which are patents that are not listed in the Orange Book. Zydus filed its answer on July 9, 2018 asserting that each of the patents is invalid and/or not infringed. Fact discovery is set to close on May 31, 2019. The court has yet to enter a schedule for expert discovery and trial. We received a Notice Letter dated June 30, 2017 from Cipla Ltd., India (Cipla) notifying us of Cipla’s ANDA which contains Paragraph IV certifications against U.S. Patent Nos. 7,465,800; 7,855,217; 7,968,569; 8,530,498; 8,648,095; 9,101,621 and 9,101,622 that are listed in the Orange Book for REVLIMID ® . Cipla is seeking to manufacture and market a generic version of 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, on August 15, 2017, we timely filed an infringement action against Cipla in the U.S. District Court for the District of New Jersey. As a result of the filing of our action, the FDA cannot grant final approval of Cipla’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) January 5, 2020. On October 13, 2017, Cipla filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. We filed our answer to Cipla’s counterclaims on November 17, 2017. Fact discovery is set to close on May 31, 2019. The court has yet to enter a schedule for expert discovery and trial. On May 8, 2018, we filed another infringement action against Cipla in the U.S. District Court for the District of New Jersey. The patents-in-suit are U.S. Patent Nos. 7,977,357; 8,193,219 and 8,431,598, which are patents that are not listed in the Orange Book. Cipla filed its answer and counterclaims on July 16, 2018 asserting that each of the patents is invalid and/or not infringed. We filed our answer to Cipla’s counterclaims on August 20, 2018. Fact discovery is set to close on May 31, 2019. The court has yet to enter a schedule for expert discovery and trial. We received a Notice Letter dated July 24, 2017 from Lotus Pharmaceutical Co., Inc. (Lotus) notifying us of Lotus’s ANDA which contains Paragraph IV certifications against U.S. Patent Nos. 5,635,517; 6,315,720; 6,561,977; 6,755,784; 7,189,740; 7,465,800; 7,855,217; 7,968,569; 8,315,886; 8,404,717; 8,530,498; 8,626,531; 8,648,095; 9,056,120; 9,101,621 and 9,101,622 that are listed in the Orange Book for REVLIMID ® . Lotus is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against Lotus in the U.S. District Court for the District of New Jersey on September 6, 2017. On July 10, 2018, we filed another infringement action against Lotus in the U.S. District Court for the District of New Jersey. The patents-in-suit are U.S. Patent Nos. 7,977,357; 8,193,219 and 8,431,598, which are patents that are not listed in the Orange Book. On March 29, 2019, we settled all outstanding claims in the litigation with Lotus. Pursuant to the settlement, we agreed to provide Lotus with a license to our patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022 volume-limited license date that we previously provided to Natco. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Lotus cannot exceed certain agreed-upon percentages. Although the agreed-upon percentages are confidential, they increase gradually each period to no more than a single-digit percentage in the final volume-limited period. In addition, we agreed to provide Lotus with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026. Lotus’ ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an ANDA. We received a Notice Letter dated November 28, 2017 from Apotex Inc. (Apotex) notifying us of Apotex’s ANDA, which contains Paragraph IV certifications against U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 7,465,800; 7,468,363; 7,855,217; 8,315,886; 8,626,531 and 8,741,929 that are listed in the Orange Book for REVLIMID ® . Apotex is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against Apotex in the U.S. District Court for the District of New Jersey on January 11, 2018. As a result of the filing of our action, the FDA cannot grant final approval of Apotex’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) May 29, 2020. On April 2, 2018, Apotex responded to the complaint by filing a motion to dismiss the case for failure to join a necessary party. We filed our response on May 21, 2018. Apotex filed its reply brief on June 11, 2018. On August 15, 2018, the parties submitted a proposed stipulation resolving the motion to dismiss. The court ordered the stipulation and the motion was terminated as moot. Apotex filed its answer on August 30, 2018. Fact discovery is set to close on January 17, 2020. The court has yet to enter a schedule for expert discovery and trial. We received an additional Notice Letter from Apotex dated January 14, 2019 notifying us of additional Paragraph IV certifications against U.S. Patent Nos. 7,189,740; 8,404,717; and 9,056,120 that are listed in the Orange Book for REVLIMID ® . In response to that Notice Letter, we timely filed an infringement action against Apotex in the U.S. District Court for the District of New Jersey on February 26, 2019. As a result of the filing of our action, the FDA cannot grant final approval of Apotex’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) July 15, 2021. Apotex filed its answer on April 2, 2019. The court has not yet entered a schedule for fact discovery, expert discovery, or trial. We received a Notice Letter dated May 30, 2018 from Sun Pharmaceutical Industries Limited (Sun) notifying us of Sun’s ANDA, which contains Paragraph IV certifications against U.S. Patent Nos. 7,465,800; 7,855,217 and 7,968,569 that are listed in the Orange Book for REVLIMID ® . Sun is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against Sun in the U.S. District Court for the District of New Jersey on July 13, 2018. As a result of the filing of our action, the FDA cannot grant final approval of Sun’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, or (ii) November 30, 2020. On August 14, 2018, Sun filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. We filed our answer to Sun’s counterclaims on September 18, 2018. Fact discovery is set to close on January 17, 2020. The court has yet to enter a schedule for expert discovery and trial. We received a Notice Letter dated November 9, 2018 from Hetero USA Inc. (Hetero) notifying us of Hetero’s ANDA, which contains Paragraph IV certifications against U.S. Patent Nos. 7,465,800; 7,855,217; 7,468,363; and 8,741,929 that are listed in the Orange Book for REVLIMID ® . Hetero is seeking to manufacture and market a generic version of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID ® (lenalidomide) capsules in the United States. In response to the Notice Letter, we timely filed an infringement action against Hetero in the U.S. District Court for the District of New Jersey on December 20, 2018. As a result of the filing of our action, the FDA cannot grant final approval of Hetero’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, or (ii) May 12, 2021. On March 11, 2019, Hetero filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. We filed our answer to Hetero’s counterclaims on April 15, 2019. The court has yet to enter a schedule for fact discovery, expert discovery, or trial. POMALYST ® : We received a Notice Letter dated March 30, 2017 from Teva Pharmaceuticals USA, Inc. (Teva) (the Teva Notice Letter) notifying us of Teva’s ANDA submitted to the FDA, which contains Paragraph IV certifications against U.S. Patent Nos. 6,316,471; 8,198,262; 8,673,939; 8,735,428 and 8,828,427 that are listed in the Orange Book for POMALYST ® . Teva is seeking to manufacture and market a generic version of 1 mg, 2 mg, 3 mg, and 4 mg POMALYST ® (pomalidomide) capsules in the United States. We later received similar Notice Letters (together with the Teva Notice Letter, the Pomalidomide Notice Letters) from other generic drug manufacturers—Apotex; Hetero USA, Inc. (Hetero); Aurobindo Pharma Ltd. (Aurobindo); Mylan Pharmaceuticals Inc. (Mylan); and Breckenridge Pharmaceutical, Inc. (Breckenridge)—relating to these and other POMALYST ® patents listed in the Orange Book. In May 2018, we received a similar Notice Letter from Synthon Pharmaceuticals Inc. (the Synthon Notice Letter). In response to the Pomalidomide Notice Letters, we timely filed infringement actions in the U.S. District Court for the District of New Jersey against Teva on May 4, 2017 and against Apotex, Hetero, Aurobindo, Mylan, and Breckenridge on May 11, 2017. As a result of the filing of our actions, the FDA cannot grant final approval of these ANDAs until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) August 8, 2020. On July 13, 2017, Apotex and Hetero each filed answers and counterclaims asserting that each of the patents is invalid and/or not infringed, and further seeking declaratory judgments of noninfringement and invalidity for additional patents listed in the Orange Book for POMALYST ® , namely U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531. On August 17, 2017, we filed replies to Apotex’s and Hetero’s counterclaims, as well as counter-counterclaims against Apotex and Hetero asserting infringement of U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531. Apotex and Hetero filed replies to our counter-counterclaims on September 6 and September 8, 2017, respectively. On July 31, 2017, Breckenridge filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. We filed our answer to Breckenridge’s counterclaims on September 5, 2017. On December 6, 2017, Breckenridge filed an amended pleading to include counterclaims seeking declaratory judgments of noninfringement and invalidity for additional patents listed in the Orange Book for POMALYST ® , namely U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531. We replied to Breckenridge’s amended counterclaims and asserted counter-counterclaims on January 3, 2018. Breckenridge filed its answer to our counter-counterclaims on January 24, 2018. On August 7, 2017, Teva filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed. On September 11, 2017, we filed our answer to Teva’s counterclaims. On August 9, 2017, Mylan filed a motion to dismiss the complaint, and on March 2, 2018, the court denied Mylan’s motion to dismiss without prejudice and granted our request for venue-related discovery. On September 15, 2017, Aurobindo filed an answer and counterclaims asserting that each of the patents is invalid and/or not infringed, and further seeking declaratory judgments of noninfringement and invalidity for additional patents listed in the Orange Book for POMALYST ® , namely U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531. We filed our answer to Aurobindo’s counterclaims and counter-counterclaims concerning U.S. Patent Nos. 6,315,720; 6,561,977; 6,755,784; 8,315,886 and 8,626,531 on October 20, 2017. Aurobindo filed its answer to our counter-counterclaims on November 24, 2017. In response to the Synthon Notice Letter, we timely filed an infringement action against Synthon in the U.S. District Court for the District of New Jersey on June 19, 2018. As a result of the filing of our actions, the FDA cannot grant final approval of Synthon’s ANDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, and (ii) November 7, 2020. On July 16, 2018, Synthon filed an answer and counterclaims asserting that each of the patents asserted in the complaint is invalid and/or not infringed. On August 20, 2018, we filed our answer to Synthon’s counterclaims. We received a notice letter dated October 5, 2018 from Synthon notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an amended complaint against Synthon on November 20, 2018. On December 4, 2018, Synthon filed an answer and counterclaims asserting that each of the patents in the amended complaint is invalid and/or not infringed. On January 2, 2019, we filed our answer to Synthon’s counterclaims. Fact discovery is scheduled to close on January 10, 2020 and expert discovery is scheduled to close on August 7, 2020. Trial has not been scheduled. We received a Notice Letter dated August 7, 2018 from Hetero notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Hetero in the U.S. District Court for the District of New Jersey on September 20, 2018 (“the Hetero ’467 Action”). On November 30, 2018, Hetero filed its Answer, Affirmative Defenses, and Counterclaims. We filed our answer to Hetero’s counterclaims on January 4, 2019. We received a Notice Letter dated August 13, 2018 from Teva notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Teva in the U.S. District Court for the District of New Jersey on September 27, 2018 (“the Teva ’467 Action”). On November 14, 2018, Teva filed its Answer, Affirmative Defenses, and Counterclaims. We filed our answer to Teva’s counterclaims on December 18, 2018. We received a Notice Letter dated August 22, 2018 from Breckenridge notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Breckenridge in the U.S. District Court for the District of New Jersey on October 5, 2018 (“the Breckenridge ’467 Action”). On November 7, 2018, Breckenridge filed its Answer, Affirmative Defenses, and Counterclaims. We filed our answer to Breckenridge’s counterclaims on December 12, 2018. We received a Notice Letter dated September 28, 2018 from Mylan notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Mylan in the U.S. District Court for the District of New Jersey on November 9, 2018 (“the Mylan ’467 Action”). On January 22, 2019, Mylan filed its Answer. We received a Notice Letter dated October 9, 2018 from Apotex notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Apotex in the U.S. District Court for the District of New Jersey on November 21, 2018 (“the Apotex ’467 Action”). On December 12, 2018, Apotex filed its Answer, Affirmative Defenses, and Counterclaims. We filed our answer to Apotex’s counterclaims on January 16, 2019. We received a Notice Letter dated November 30, 2018 from Aurobindo notifying us of an additional Paragraph IV certification against U.S. Patent No. 9,993,467 that is listed in the Orange Book for POMALYST ® . In response to the Notice Letter, we timely filed an infringement action against Aurobindo in the U.S. District Court for the District of New Jersey on January 4, 2019 (“the Aurobindo ’467 Action”). On January 18, 2019, Aurobindo filed its Answer, Affirmative Defenses, and Counterclaims. We filed our answer to Aurobindo's counterclaims on February 22, 2019. On January 31, 2019, the above-referenced POMALYST ® actions filed in May 2017 against (i) Teva and (ii) Apotex, Hetero, Aurobindo, Mylan, and Breckenridge were consolidated with the Hetero ’467 Action, the Teva ’467 Action, the Breckenridge ’467 Action, the Mylan ’467 Action, the Apotex ’467 Action, and the Aurobindo ’467 Action. In the consolidated case, fact discovery is set to close on August 30, 2019, and expert discovery is set to close on March 13, 2020. The court has yet to enter a schedule for trial. On February 14, 2019, we filed additional infringement actions in the U.S. District Court for the District of New Jersey against each of Apotex, Aurobindo, Breckenridge, Hetero, and Mylan. On March 19, 2019, we filed an additional infringement action in the U.S. District Court for the District of New Jersey against Teva. The patents-in-suit in each of these six actions are 10,093,647, 10,093,648, and 10,093,649, which patents are not listed in the Orange Book. ABRAXANE ® : On March 21, 2019, following a referral by the UK High Court of Justice in the context of our request for a Supplemental Protection Certificate (SPC) to the ABRAXANE ® patent UK No. 0 961 612 (the ’612 patent), the Court of Justice for the EU held, in substance, that no SPC was available to the extent ABRAXANE ® was assessed as a novel formulation of paclitaxel. On the basis of this decision, no SPC will be available in the UK. Applications are still pending in other jurisdictions, including in Germany. The ’612 patent expired in Europe in September 2017. However, if granted, the SPCs will expire in 2022. Data exclusivity in Europe expired in January 2019. We received a Notice Letter dated November 5, 2018 from HBT Labs, Inc. (HBT) notifying us of HBT’s 505(b)(2) NDA which contains Paragraph IV certifications against U.S. Patent Nos. 7,758,891; 7,820,788; 7,923,536; 8,034,375; 8,138,229; 8,268,348; 8,314,156; 8,853,260; 9,101,543; 9,393,318; 9,511,046 and 9,597,409 that are listed in the Orange Book for ABRAXANE ® . HBT is seeking to manufacture and market Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial in the United States. In response to the Notice letter, we timely filed infringement actions against HBT in the U.S. District Court for the District of New Jersey on December 17, 2018, and in the U.S. District Court for the District of Delaware on December 19, 2018. As a result of these filings, the FDA cannot grant final approval of HBT’s 505(b)(2) NDA until at least the earlier of (i) a final decision that each of the patents is invalid, unenforceable, and/or not infringed, or (ii) May 6, 2021. On February 5, 2019, we filed a notice of voluntary dismissal without prejudice in the United States District Court for the District of New Jersey. The court ordered the notice of voluntary dismissal on February 7, 2019. On February 11, 2019, HBT filed a motion to dismiss and transfer in the United States District Court for the District of Delaware. We filed our opposition on March 4, 2019, and HBT filed its reply on March 11, 2019. On March 14, 2019, we filed a request for oral argument, which is currently pending before the court. The motion remains pending. OTEZLA ® : We received Notice Letters from each of the following company groups (individual or joint) between May 14, 2018 and June 1, 2018: Alkem Laboratories Ltd. (Alkem); Amneal Pharmaceuticals LLC (Amneal); Annora Pharma Private Ltd. (Annora) and Hetero USA Inc. (Hetero); Aurobindo Pharma Ltd. and Aurobindo Pharma U.S.A. Inc. (Aurobindo); Cipla Ltd. (Cipla); Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (DRL); Emcure Pharmaceuticals Ltd. (Emcure) and Heritage Pharmaceuticals Inc. (Heritage); Glenmark Pharmaceuticals Ltd. (Glenmark); Macleods Pharmaceuticals Ltd. (Macleods); Mankind Pharma Ltd. (Mankind); MSN Laboratories Private Ltd. (MSN); Pharmascience Inc. (Pharmascience); Prinston Pharmaceutical Inc. (Prinston); Sandoz Inc. (Sandoz); Shilpa Medicare Ltd. (Shilpa); Teva Pharmaceuticals USA, Inc. (Teva) and Actavis LLC (Actavis); Torrent Pharmaceuticals Ltd. (Torrent); Unichem Laboratories, Ltd. (Uni |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation and New Accounting Standards (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
New accounting standards which have been adopted and not yet adopted | New accounting standards which have been adopted In February 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-02 and has subsequently issued a number of amendments to ASU 2016-02, including ASU 2018-11, which offers a transition option to entities adopting the New Lease Accounting Standard. Under the transition option, entities can elect to apply the new guidance using a modified retrospective approach at the beginning of the year in which New Lease Accounting Standard is adopted, rather than to the earliest comparative period presented in their financial statements. The New Lease Accounting Standard was effective for us as of January 1, 2019. The New Lease Accounting Standard provides accounting guidance for both lessee and lessor accounting models. Among other things, lessees will recognize on their balance sheet a ROU asset and a lease liability, based on the characterization of the lease as either an operating or finance lease. For income statement purposes, operating leases will result in the recognition of straight-line rent expense, while finance leases will result in a front-loaded expense pattern made up of both interest expense and amortization of the ROU asset. We have elected to adopt the New Lease Accounting Standard using the modified retrospective method and, therefore, have not recast comparative periods presented in our unaudited consolidated financial statements. We have elected the package of transition practical expedients for our existing leases and therefore we have not reassessed the following: lease classification for existing leases, whether any existing contracts contained leases, if any initial direct costs were incurred and whether existing land easements should be accounted for as leases. As permitted under the New Lease Accounting Standard, we have elected as accounting policy elections to not recognize ROU assets and related lease liabilities for leases with terms of twelve months or less and to not separate lease and non-lease components, and instead account for the non-lease components together with the lease components as a single lease component. The New Lease Accounting Standard had an impact on our Consolidated Balance Sheets as of January 1, 2019 and March 31, 2019, with the recognition of ROU assets in the amount of $293 million and $286 million , respectively, and the recognition of operating lease liabilities of $323 million and $313 million , respectively. However, the New Lease Accounting Standard did not have any significant impact on our Consolidated Statements of Income for any period. There was no material tax impact of adopting the New Lease Accounting Standard. Accounting Standards Adopted in 2018 On January 1, 2018, we adopted several new accounting standards, including the following which required cumulative effect adjustments to Retained earnings and Accumulated Other Comprehensive Income (AOCI): • ASU 2014-09 "Revenue from Contracts with Customers" (ASU 2014-09); • ASU 2016-01 "Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities" (ASU 2016-01); • ASU 2018-03 "Technical Corrections and Improvements to Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities" (ASU 2018-03); • ASU 2018-02 "Income Statement-Reporting Comprehensive Income: Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income" (ASU 2018-02); and • ASU 2016-16 "Intra-Entity Transfers of Assets Other Than Inventory" (ASU 2016-16). Additional information related to the adoption of these accounting standards is disclosed in Note 1 of Notes to Consolidated Financial Statements contained in our 2018 Annual Report on Form 10-K. The following table presents a summary of cumulative effect adjustments to Retained earnings and AOCI due to the adoption of new accounting standards on January 1, 2018 as noted above: Retained Earnings Increase / (Decrease) AOCI (Decrease) / Increase ASU 2014-09 $ 4 $ — ASU 2016-01 687 (687 ) ASU 2018-03 44 — ASU 2018-02 (117 ) 117 ASU 2016-16 (166 ) — Net cumulative effect adjustments to Retained earnings and AOCI on January 1, 2018 due to the adoption of new accounting standards $ 452 $ (570 ) New accounting standards which have not yet been adopted In June 2016, the FASB issued Accounting Standards Update No. 2016-13, "Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments" (ASU 2016-13). ASU 2016-13 requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. ASU 2016-13 limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The new standard will be effective for us on January 1, 2020. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures. In November 2018, the FASB issued Accounting Standards Update No. 2018-18, “Collaboration Arrangements: Clarifying the Interaction between Topic 808 and Topic 606” (ASU 2018-18). The issuance of ASU 2014-09 raised questions about the interaction between the guidance on collaborative arrangements and revenue recognition. ASU 2018-18 addresses this uncertainty by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASU 2014-09 when the collaboration arrangement participant is a customer, (2) adding unit of account guidance to assess whether the collaboration arrangement or a part of the arrangement is with a customer and (3) precluding a company from presenting transactions with collaboration arrangement participants that are not directly related to sales to third parties together with revenue from contracts with customers. The new standard will be effective for us on January 1, 2020 with early adoption permitted. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures. |
Nature of Business, Basis of _3
Nature of Business, Basis of Presentation and New Accounting Standards (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The following table presents a summary of cumulative effect adjustments to Retained earnings and AOCI due to the adoption of new accounting standards on January 1, 2018 as noted above: Retained Earnings Increase / (Decrease) AOCI (Decrease) / Increase ASU 2014-09 $ 4 $ — ASU 2016-01 687 (687 ) ASU 2018-03 44 — ASU 2018-02 (117 ) 117 ASU 2016-16 (166 ) — Net cumulative effect adjustments to Retained earnings and AOCI on January 1, 2018 due to the adoption of new accounting standards $ 452 $ (570 ) |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Reconciliation of Gross Product to Net Product Sales | The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows: Three-Month Periods Ended March 31, 2019 2018 Gross Product Sales $ 5,028 $ 4,247 Gross-to-Net Adjustments: Government Rebates (383 ) (291 ) Chargebacks and Distributor Services Fees (543 ) (367 ) Sales Discounts (68 ) (56 ) Sales Returns and Allowances (10 ) (2 ) Total Gross-to-Net Adjustments (1,004 ) (716 ) Net Product Sales $ 4,024 $ 3,531 |
Disaggregation of Revenue | Total revenues from external customers by our franchises (Hematology / Oncology and Inflammation & Immunology), product and geography for the three- month periods ended March 31, 2019 and 2018 were as follows: Three-Month Periods Ended March 31, 2019 2018 Hematology / Oncology: REVLIMID ® U.S. $ 1,686 $ 1,487 International 891 747 Worldwide 2,577 2,234 POMALYST ® /IMNOVID ® U.S. 390 300 International 167 153 Worldwide 557 453 ABRAXANE ® U.S. 196 159 International 90 103 Worldwide 286 262 VIDAZA ® U.S. 3 2 International 148 155 Worldwide 151 157 All Other U.S. 45 55 International 19 17 Worldwide 64 72 Total Hematology / Oncology: U.S. 2,320 2,003 International 1,315 1,175 Worldwide 3,635 3,178 Inflammation & Immunology: OTEZLA ® U.S. 301 276 International 88 77 Worldwide 389 353 Total net product sales U.S. 2,621 2,279 International 1,403 1,252 Worldwide 4,024 3,531 Other revenue 1 7 Total revenue $ 4,025 $ 3,538 |
Acquisitions and Divestitures (
Acquisitions and Divestitures (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Schedule of Business Acquisitions, by Acquisition | The total consideration for the acquisition of Juno was $10.4 billion , which consisted of the following: Total Consideration Cash paid for outstanding common stock at $87.00 per share $ 9,101 Celgene investment in Juno at $87.00 per share (1) 966 Cash for equity compensation attributable to pre-combination service (2) 367 Total consideration $ 10,434 (1) The Company recognized a gain of $458 million during the first quarter of 2018, as a result of remeasuring to fair value the equity interest in Juno held by us before the business combination, which was recorded in Other income, net within the Consolidated Statement of Income. (2) All equity compensation attributable to pre-combination service was paid during the first quarter of 2018. |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed | The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed on March 6, 2018 based upon their respective fair values summarized below. The determination of fair value was finalized in the fourth quarter of 2018. Amounts Recognized as of the acquisition date of March 6, 2018 Working capital (1) $ 452 IPR&D 6,980 Technology platform intangible asset 1,260 Property, plant and equipment, net 144 Other non-current assets 32 Deferred tax liabilities, net (1,530 ) Other non-current liabilities (41 ) Total identifiable net assets 7,297 Goodwill 3,137 Total net assets acquired $ 10,434 (1) Includes cash and cash equivalents, debt securities available-for-sale, accounts receivable, net of allowances, other current assets, accounts payable, accrued expenses and other current liabilities (including accrued litigation). See Note 17 for litigation matters related to Juno. |
Business Acquisition, Pro Forma Information | The following table provides unaudited pro forma financial information for the three-month period ended March 31, 2018 as if the Juno Acquisition had occurred on January 1, 2017. Three-Month Period Ended March 31, 2018 Total revenue $ 3,548 Net income 609 Net income per common share: basic $ 0.81 Net income per common share: diluted $ 0.79 |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of earnings per share | Three-Month Periods Ended March 31, (Amounts in millions, except per share) 2019 2018 Net income $ 1,545 $ 846 Weighted-average shares: Basic 702.4 748.3 Effect of dilutive securities: Options, restricted stock units, performance stock units and other 18.1 20.0 Diluted 720.5 768.3 Net income per share: Basic $ 2.20 $ 1.13 Diluted $ 2.14 $ 1.10 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive (Loss) Income (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract] | |
Summary of other comprehensive income (loss) | The accumulated balances related to each component of other comprehensive (loss) income, net of tax, are summarized as follows: Pension Liability Adjustment Net Unrealized Gains (Losses) On Debt Securities Available-for-Sale (1) Net Unrealized Gains (Losses) Related to Cash Flow Hedges Amortization of Excluded Component Related to Cash Flow Hedges Foreign Currency Translation Adjustments Accumulated Other Comprehensive (Loss) Income Balance as of December 31, 2018 $ (28 ) $ 3 $ 42 $ (7 ) $ (60 ) $ (50 ) Other comprehensive income (loss) before reclassifications, net of tax — — 51 (1 ) (10 ) 40 Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax — — (23 ) 1 — (22 ) Net current-period other comprehensive income (loss), net of tax — — 28 — (10 ) 18 Balance as of March 31, 2019 $ (28 ) $ 3 $ 70 $ (7 ) $ (70 ) $ (32 ) Balance as of December 31, 2017 $ (22 ) $ 562 $ (206 ) $ (15 ) $ (32 ) $ 287 Cumulative effect adjustment for the adoption of ASU 2016-01 and ASU 2018-02 — (566 ) (4 ) — — (570 ) Other comprehensive (loss) income before reclassifications, net of tax — (7 ) (98 ) (8 ) 16 (97 ) Reclassified losses from accumulated other comprehensive income (loss), net of tax — 14 27 11 — 52 Net current-period other comprehensive income (loss), net of tax — 7 (71 ) 3 16 (45 ) Balance as of March 31, 2018 $ (22 ) $ 3 $ (281 ) $ (12 ) $ (16 ) $ (328 ) (1) Balances as of December 31, 2017 are prior to the adoption of ASU 2016-01 and, as such, include equity securities with readily determinable fair values. Upon adoption of ASU 2016-01, we recorded a cumulative effect adjustment for our net unrealized gains related to our equity securities with readily determinable fair values as of January 1, 2018. Therefore, the unrealized gains (losses) position as of March 31, 2018 solely relate to debt securities available-for-sale. |
Schedule of gains (losses) reclassified out of accumulated other comprehensive income | Gains (Losses) Reclassified Out of Accumulated Other Comprehensive (Loss) Income Accumulated Other Comprehensive (Loss) Income Components Classification in the Consolidated Statements of Income Three-Month Periods Ended March 31, 2019 2018 (Losses) gains related to cash-flow hedges: Foreign exchange contracts Net product sales $ 24 $ (26 ) Treasury rate lock agreements Interest (expense) (1 ) (1 ) Excluded component related to cash-flow hedges: Foreign exchange contracts Net product sales — (3 ) (Losses) gains on debt securities available-for-sale: Realized gain (loss) on sales of debt securities available-for-sale Interest and investment income, net (1) — (18 ) Income tax provision - (expense) benefit (1) — 4 Total reclassification, net of tax $ 23 $ (44 ) (1) We use a specific identification approach to release the realized gain (loss) on sales of debt securities available-for-sale and income tax effects into Accumulated other comprehensive (loss). |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Significant Unobservable Inputs Calculation | The fair value of our contingent consideration as of March 31, 2019 and December 31, 2018 was calculated using the following significant unobservable inputs: Inputs Ranges (weighted average) utilized as of: March 31, 2019 December 31, 2018 Discount rate 3.6% to 4.8% (4.3%) 3.6% to 4.8% (4.3%) Probability of payment 0% to 68% (5%) 0% to 68% (5%) Projected year of payment for development and regulatory milestones 2020 to 2029 (2024) 2020 to 2029 (2024) Projected year of payment for sales-based milestones and other amounts calculated as a percentage of annual sales N/A N/A |
Assets and liabilities measured at fair value on recurring basis | The following tables present the Company's hierarchy for its assets and liabilities measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 : Fair Value Measurements as of March 31, 2019 Balance as of March 31, 2019 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Debt securities available-for-sale $ 664 $ — $ 664 $ — Equity investments with readily determinable fair values 1,594 1,594 — — Forward currency contracts 83 — 83 — Zero-cost collar currency contracts 17 — 17 — Interest rate swaps 2 — 2 — Total assets $ 2,360 $ 1,594 $ 766 $ — Liabilities: Contingent value rights $ (48 ) $ (48 ) $ — $ — Other acquisition related contingent consideration and success payments (162 ) — — (162 ) Total liabilities $ (210 ) $ (48 ) $ — $ (162 ) Fair Value Measurements as of December 31, 2018 Balance as of December 31, 2018 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Debt securities available-for-sale $ 496 $ — $ 496 $ — Equity investments with readily determinable fair values 1,312 1,312 — — Forward currency contracts 78 — 78 — Total assets $ 1,886 $ 1,312 $ 574 $ — Liabilities: Contingent value rights $ (19 ) $ (19 ) $ — $ — Interest rate swaps (10 ) — (10 ) — Zero-cost collar currency contracts (1 ) — (1 ) — Other acquisition related contingent consideration and success payments (163 ) — — (163 ) Total liabilities $ (193 ) $ (19 ) $ (11 ) $ (163 ) |
Schedule of Remeasurement of Equity Investments | The following table represents a roll-forward of equity investments without readily determinable fair values: Three-Month Period Ended March 31, 2019 Balance as of December 31, 2018 $ 545 Purchases 25 Upward adjustments 15 Downward adjustments and impairments (1 ) Balance as of March 31, 2019 $ 584 Three-Month Period Ended March 31, 2018 Balance as of December 31, 2017 $ 513 Cumulative effect adjustment for the adoption of ASU 2018-03 59 Purchases 16 Upward adjustments 21 Sales (3 ) Downward adjustments and impairments (1 ) Transfer to readily determinable fair value (10 ) Balance as of March 31, 2018 $ 595 |
Roll-forward of fair value of Level 3 instruments (significant unobservable inputs), liabilities | The following tables represent a roll-forward of the fair value of level 3 instruments: Three-Month Period Ended March 31, 2019 Liabilities: Balance as of December 31, 2018 $ (163 ) Net change in fair value — Balance as of March 31, 2019 $ (163 ) Three-Month Period Ended March 31, 2018 Liabilities: Balance as of December 31, 2017 $ (80 ) Amounts acquired from Juno (122 ) Net change in fair value 1 Balance as of March 31, 2018 $ (201 ) |
Derivative Instruments and He_2
Derivative Instruments and Hedging Activities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of notional amount of derivative contracts | Foreign currency forward contracts entered into to hedge forecasted revenue and expenses were as follows as of March 31, 2019 and December 31, 2018 : Notional Amount Foreign Currency March 31, 2019 December 31, 2018 Australian Dollar $ 31 $ 46 British Pound 49 82 Canadian Dollar 112 158 Euro 887 1,381 Japanese Yen 320 424 Total $ 1,399 $ 2,091 The following table summarizes the notional amounts of our outstanding interest rate swap contracts as of March 31, 2019 and December 31, 2018 : Notional Amount March 31, 2019 December 31, 2018 Interest rate swap contracts entered into as fair value hedges of the following fixed-rate senior notes: 3.875% senior notes due 2025 $ 200 $ 200 3.450% senior notes due 2027 450 450 3.900% senior notes due 2028 — 200 Total $ 650 $ 850 |
Schedule of foreign exchange contracts, statement of financial position | Outstanding foreign currency zero-cost collar contracts entered into to hedge forecasted revenue were as follows as of March 31, 2019 and December 31, 2018 : Notional Amount (1) March 31, 2019 December 31, 2018 Foreign currency zero-cost collar contracts designated as hedging activity: Purchased Put $ 1,893 $ 1,933 Written Call 2,171 2,216 (1) U.S. Dollar notional amounts are calculated as the hedged local currency amount multiplied by the strike value of the foreign currency option. The local currency notional amounts of our purchased put and written call that are designated as hedging activities are equal to each other. |
Schedule of derivative instruments in statement of financial position | The following tables summarize the fair value and presentation in the Consolidated Balance Sheets for derivative instruments as of March 31, 2019 and December 31, 2018 : March 31, 2019 Balance Sheet Location Fair Value Instrument Asset Derivatives Liability Derivatives Derivatives designated as hedging instruments: Foreign exchange contracts (1) Other current assets $ 58 $ 7 Other non-current assets 49 10 Interest rate swap agreements Other current assets 6 — Other non-current assets 2 — Other non-current liabilities 2 8 Derivatives not designated as hedging instruments: Foreign exchange contracts (1) Other current assets 21 1 Accrued expenses and other current liabilities 1 11 Interest rate swap agreements Other non-current assets 3 3 Total $ 142 $ 40 (1) Derivative instruments in this category are subject to master netting arrangements and are presented on a net basis in the Consolidated Balance Sheet in accordance with ASC 210-20. December 31, 2018 Fair Value Instrument Balance Sheet Location Asset Derivatives Liability Derivatives Derivatives designated as hedging instruments: Foreign exchange contracts (1) Other current assets $ 63 $ 18 Other non-current assets 45 16 Other non-current liabilities 12 15 Interest rate swap agreements Other current assets 7 — Other non-current assets 1 — Other non-current liabilities 1 19 Derivatives not designated as hedging instruments: Foreign exchange contracts (1) Other current assets 21 5 Accrued expenses and other current liabilities 2 12 Interest rate swap agreements Other current assets 2 3 Other non-current assets 5 4 Total $ 159 $ 92 (1) Derivative instruments in this category are subject to master netting arrangements and are presented on a net basis in the Consolidated Balance Sheets in accordance with ASC 210-20. |
Cumulative basis adjustments for fair value hedges | As of March 31, 2019 and December 31, 2018 , the following amounts were recorded on the Consolidated Balance Sheets related to cumulative basis adjustments for fair value hedges: Carrying Amount of the Hedged Liability Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liability Consolidated Balance Sheet Classification in Which the Hedged Item Is Included March 31, 2019 (1) December 31, 2018 (1) March 31, 2019 (2) December 31, 2018 (2) Current portion of long-term debt, net of discount $ 500 $ 501 $ 1 $ 2 Long-term debt, net of discount 8,237 8,227 98 90 (1) The current portion of long-term debt, net of discount, includes $500 million and $501 million of carrying value with discontinued hedging relationships as of March 31, 2019 and December 31, 2018 , respectively. The Long-term debt, net of discount includes approximately $4.8 billion and $3.3 billion of carrying value with discontinued hedging relationships as of March 31, 2019 and December 31, 2018 , respectively. (2) The current portion of long-term debt, net of discount, includes $1 million and $2 million of discontinued hedging relationships at March 31, 2019 and December 31, 2018 , respectively. The Long-term debt, net of discount includes $102 million and $107 million of hedging adjustment on discontinued hedging relationships on long-term debt as of March 31, 2019 and December 31, 2018 , respectively. |
Schedule of effect of derivative instruments designated as hedging instruments on Consolidated Statements of Income | Classification and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships Three-Month Period Ended March 31, 2019 Net product sales Interest (expense) Other income, net Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded $ 4,024 $ (192 ) $ 262 The effects of fair value and cash flow hedging: (Loss) gain on fair value hedging relationships Interest rate swap agreements: Hedged items — (12 ) — Derivatives designated as hedging instruments (1) — 20 — Gain (loss) on cash flow hedging relationships Foreign exchange contracts: Amount of gain reclassified from AOCI into income 24 — — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value 1 — — Reclassification adjustment for excluded component (loss) (1 ) — — Treasury rate lock agreements: Amount of (loss) reclassified from AOCI into income — (1 ) — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value — — — (1) The amounts include a benefit of $8 million relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships for the three-month period ending March 31, 2019 . Classification and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships Three-Month Period Ended March 31, 2018 Net product sales Interest (expense) Other income, net Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded $ 3,531 $ (166 ) $ 965 The effects of fair value and cash flow hedging: Gain (loss) on fair value hedging relationships Interest rate swap agreements: Hedged items — 14 — Derivatives designated as hedging instruments (1) — (5 ) — (Loss) gain on cash flow hedging relationships Foreign exchange contracts: Amount of (loss) reclassified from AOCI into income (26 ) — — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value 8 — — Reclassification adjustment for excluded component (loss) (11 ) Treasury rate lock agreements: Amount of (loss) reclassified from AOCI into income — (1 ) — Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value — — — (1) The amounts include a benefit of $8 million relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships for the three-month period ending March 31, 2018 . The following tables summarize the effect of derivative instruments designated as cash flow hedging instruments in AOCI for the three-month periods ended March 31, 2019 and 2018 : Three-Month Period Ended March 31, 2019 Instrument Amount of (1) Classification of Amount of Classification of Gain/(Loss) Recognized in Income Related to Amount Excluded from Effectiveness Testing Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing Foreign exchange contracts $ 51 Net product sales $ 24 Net product sales $ — Treasury rate lock agreements — Interest (expense) (1 ) N/A — (1) Net gains of $53 million are expected to be reclassified from AOCI into income in the next 12 months. Three-Month Period Ended March 31, 2018 Instrument Amount of Classification of Amount of Classification of Gain/(Loss) Recognized in Income Related to Amount Excluded from Effectiveness Testing Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing Foreign exchange contracts $ (95 ) Net product sales $ (26 ) Net product sales $ (2 ) Treasury rate lock agreements (4 ) Interest (expense) (1 ) N/A — The following table summarizes the effect of derivative instruments which were designated as fair value hedging instruments on the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Amount of Gain/(Loss) Recognized in Income on Derivative Three-Month Periods Ended March 31, Instrument Classification of Gain/(Loss) Recognized in Income on Derivative 2019 (1) 2018 (1) Interest rate swap agreements Interest (expense) $ 20 $ (5 ) (1) The amounts include a benefit of $8 million and $8 million for the three-month periods ending March 31, 2019 and 2018, respectively, relating to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged liability for discontinued hedging relationships. The following table summarizes the effect of derivative instruments not designated as hedging instruments on the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Classification of Gain/(Loss) Recognized in Income on Derivative Three-Month Periods Ended March 31, Instrument Classification of Gain/(Loss) Recognized in Income on Derivative 2019 2018 Foreign exchange contracts Other income, net $ 9 $ (13 ) |
Cash, Cash Equivalents and De_2
Cash, Cash Equivalents and Debt Securities Available-for-Sale (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Schedule of available-for-sale securities by major security type and class | The amortized cost, gross unrealized holding gains, gross unrealized holding losses and estimated fair value of debt securities available-for-sale by major security type and class of security as of March 31, 2019 and December 31, 2018 were as follows: March 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Ultra short income fund $ 526 $ — $ — $ 526 Time deposits (1) and Repurchase agreements (1) 138 — — 138 Total debt securities available-for-sale $ 664 $ — $ — $ 664 (1) Have original maturities of greater than three months. December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Ultra short income fund $ 450 $ — $ — $ 450 Time deposits (1) and Repurchase agreements (1) 46 — — 46 Total debt securities available-for-sale $ 496 $ — $ — $ 496 (1) Have original maturities of greater than three months. |
Schedule of duration periods of available-for-sale debt securities | Duration periods of debt securities available-for-sale as of March 31, 2019 were as follows: Amortized Cost Fair Value Duration of one year or less $ 664 $ 664 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Summary of inventories by major category | Inventories as of March 31, 2019 and December 31, 2018 are summarized by major category as follows: March 31, 2019 December 31, 2018 Raw materials $ 235 $ 252 Work in process 87 79 Finished goods 120 127 Total inventory $ 442 $ 458 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of finite-live intangible assets | The gross carrying amount and accumulated amortization of intangible assets as of March 31, 2019 and December 31, 2018 are summarized as follows: March 31, 2019 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,414 $ (2,349 ) $ 1,065 Technology 1,743 (573 ) 1,170 Licenses 66 (36 ) 30 Other 43 (38 ) 5 5,266 (2,996 ) 2,270 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,097 $ (2,996 ) $ 16,101 December 31, 2018 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,406 $ (2,261 ) $ 1,145 Technology 1,743 (552 ) 1,191 Licenses 66 (35 ) 31 Other 54 (39 ) 15 5,269 (2,887 ) 2,382 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,100 $ (2,887 ) $ 16,213 |
Schedule of indefinite-live intangible assets | The gross carrying amount and accumulated amortization of intangible assets as of March 31, 2019 and December 31, 2018 are summarized as follows: March 31, 2019 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,414 $ (2,349 ) $ 1,065 Technology 1,743 (573 ) 1,170 Licenses 66 (36 ) 30 Other 43 (38 ) 5 5,266 (2,996 ) 2,270 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,097 $ (2,996 ) $ 16,101 December 31, 2018 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Amortizable intangible assets: Acquired developed product rights $ 3,406 $ (2,261 ) $ 1,145 Technology 1,743 (552 ) 1,191 Licenses 66 (35 ) 31 Other 54 (39 ) 15 5,269 (2,887 ) 2,382 Non-amortizable intangible assets: Acquired IPR&D product rights 13,831 — 13,831 Total intangible assets $ 19,100 $ (2,887 ) $ 16,213 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Short-term Debt | The carrying value of the current portion of long-term debt as of March 31, 2019 and December 31, 2018 includes: March 31, 2019 December 31, 2018 2.250% senior notes due 2019 $ 500 $ 501 |
Carrying values of the senior notes | The carrying values of the long-term portion of these senior notes as of March 31, 2019 and December 31, 2018 includes: March 31, 2019 December 31, 2018 2.875% senior notes due 2020 $ 1,497 $ 1,497 3.950% senior notes due 2020 508 509 2.250% senior notes due 2021 498 498 2.875% senior notes due 2021 499 498 3.250% senior notes due 2022 1,032 1,034 3.550% senior notes due 2022 996 996 2.750% senior notes due 2023 747 747 3.250% senior notes due 2023 994 994 4.000% senior notes due 2023 729 730 3.625% senior notes due 2024 1,000 1,000 3.875% senior notes due 2025 2,482 2,478 3.450% senior notes due 2027 997 986 3.900% senior notes due 2028 1,490 1,490 5.700% senior notes due 2040 247 247 5.250% senior notes due 2043 393 393 4.625% senior notes due 2044 987 987 5.000% senior notes due 2045 1,975 1,975 4.350% senior notes due 2047 1,234 1,234 4.550% senior notes due 2048 1,476 1,476 Total long-term debt $ 19,781 $ 19,769 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Components of share-based compensation expense | The following table summarizes the components of share-based compensation expense in the Consolidated Statements of Income for the three-month periods ended March 31, 2019 and 2018 : Three-Month Periods Ended March 31, 2019 2018 Cost of goods sold (excluding amortization of acquired intangible assets) $ 12 $ 9 Research and development (1) 126 199 Selling, general and administrative (2) 119 193 Total share-based compensation expense 257 401 Tax benefit related to share-based compensation expense (3) 49 37 Reduction in net income $ 208 $ 364 (1) The three- month periods ended March 31, 2019 and 2018 include Juno related share-based compensation expense related to the post-combination servi ce period of $17 million and $133 million , respectively. (2) The three- month periods ended March 31, 2019 and 2018 include Juno related share-based compensation expense related to the post-combination service per iod of $11 million and $117 million , respectively. |
Summary of activity for stock options, RSUs and PSUs | The following table summarizes the activity for stock options, RSUs and PSUs for the three-month period ended March 31, 2019 (in millions unless otherwise noted): Stock Options RSUs PSUs (in thousands) Outstanding as of December 31, 2018 71.1 11.7 660 Changes during the Year: Granted — 8.2 200 Exercised / Released (3.8 ) (0.4 ) (73 ) Forfeited (0.9 ) (0.3 ) (40 ) Outstanding as of March 31, 2019 66.4 19.2 747 |
Schedule of unvested awards compensation cost not yet recognized and weighted-average periods for recognition | Total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized as of March 31, 2019 were as follows: Stock Options RSUs PSUs Unrecognized compensation cost $ 386 $ 1,079 $ 35 Expected weighted-average period in years of compensation cost to be recognized 2.1 1.9 1.5 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Collaboration Agreements [Abstract] | |
Schedule of Collaboration Agreements | A financial summary of certain period activity and the period-end balances related to our other collaboration arrangements is presented below (1) : Three-Month Periods Ended March 31, Research and Development Expense Upfront Fees Milestones Extension/Termination of Arrangements Amortization of Prepaid Research and Development Equity Investments Made During Period 2019 $ 216 $ 11 $ — $ 2 $ 52 2018 245 — — 2 101 Balances as of: Intangible Asset Balance Equity Investment Balance Percentage of Outstanding Equity March 31, 2019 $ 11 $ 1,581 N/A December 31, 2018 13 1,280 N/A (1) In addition to the expenses noted in the table above, we may also incur expenses for collaboration agreement related activities that are managed or funded by us. |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Lease, Cost | The components of lease expense were as follows: Three-Month Period Ended March 31, 2019 Operating lease cost $ 23 Short-term lease cost — Variable lease cost 8 Sublease income — Total lease cost $ 31 |
Schedule Of Supplemental Cash Flow Information Related To Leases | Supplemental cash flow information related to leases was as follows: Three-Month Period Ended March 31, 2019 Cash paid for amounts included in measurement of lease liabilities: Operating cash flows from operating leases $ 27 Supplemental noncash information related to leases was as follows: Three-Month Period Ended March 31, 2019 ROU assets obtained in exchange for new operating liabilities $ 18 |
Schedule Of Supplemental Balance Sheet Information Related To Leases | Supplemental balance sheet information related to leases was as follows: March 31, 2019 Operating Leases Other non-current assets $ 286 Accrued expenses and other current liabilities 79 Other non-current liabilities 234 Weighted-average remaining lease term - operating leases 4.47 Weighted-average discount rate - operating leases 3.98 % |
Lessee, Operating Lease, Liability, Maturity | Maturities of lease liabilities as of March 31, 2019 were as follows: Operating Leases 2019 (excluding the three-month period ended March 31, 2019) $ 72 2020 85 2021 64 2022 54 2023 40 2024 17 Thereafter 11 Total undiscounted lease payments $ 343 Less: imputed interest (30 ) Total discounted lease payments $ 313 Future minimum lease payments under non-cancelable operating leases as of December 31, 2018 were: Operating Leases 2019 $ 92 2020 89 2021 70 2022 59 2023 45 Thereafter 68 Total minimum lease payments $ 423 |
Nature of Business, Basis of _4
Nature of Business, Basis of Presentation and New Accounting Standards (Narrative) (Details) | Jan. 03, 2019USD ($)right$ / shares | Mar. 31, 2019USD ($) | Apr. 17, 2019USD ($) | Jan. 02, 2019$ / shares | Jan. 01, 2019USD ($) |
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from transaction | $ 74,000,000,000 | ||||
Sale of stock, price per share (usd per share) | $ / shares | $ 102.43 | ||||
Contingent value rights | right | 1 | ||||
Contingent payment | $ / shares | $ 9 | ||||
Cost incurred to date | $ 47,000,000 | ||||
Maximum equity ownership percentage, investments | 50.00% | ||||
Right-of-use asset | $ 286,000,000 | $ 293,000,000 | |||
Operating lease liability | 313,000,000 | $ 323,000,000 | |||
Bristol-Myers Squibb Company | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Share price (usd per share) | $ / shares | $ 52.43 | ||||
Ownership after merger | 69.00% | ||||
Celgene | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Ownership after merger | 31.00% | ||||
Professional Fees | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Expected cost | 171,000,000 | ||||
Employee Related Costs | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Expected cost | $ 205,000,000 | ||||
Subsequent Event [Member] | Bristol-Myers Squibb Company | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Purchase of notes offer from Bristol-Myers | $ 19,850,000,000 |
Nature of Business, Basis of _5
Nature of Business, Basis of Presentation and New Accounting Standards (Cumulative Effect Adjustments) (Details) $ in Millions | Jan. 01, 2018USD ($) |
Retained Earnings Increase / (Decrease) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | $ 452 |
Retained Earnings Increase / (Decrease) | ASU 2014-09 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 4 |
Retained Earnings Increase / (Decrease) | ASU 2016-01 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 687 |
Retained Earnings Increase / (Decrease) | ASU 2018-03 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 44 |
Retained Earnings Increase / (Decrease) | ASU 2018-02 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | (117) |
Retained Earnings Increase / (Decrease) | ASU 2016-16 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | (166) |
AOCI Increase / (Decrease) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | (570) |
AOCI Increase / (Decrease) | ASU 2014-09 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 0 |
AOCI Increase / (Decrease) | ASU 2016-01 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | (687) |
AOCI Increase / (Decrease) | ASU 2018-03 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 0 |
AOCI Increase / (Decrease) | ASU 2018-02 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | 117 |
AOCI Increase / (Decrease) | ASU 2016-16 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Cumulative effect adjustment | $ 0 |
Revenue (Narrative) (Details)
Revenue (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |||
Contract with customer asset | $ 36 | ||
Contract with customer, liability | $ 138 | $ 137 | |
Contract with customer liability revenue recognized | $ 12 | $ 16 |
Revenue (Gross Product Sales to
Revenue (Gross Product Sales to Net Product Sales Reconciliation) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,025 | $ 3,538 |
Gross to Net Sales Adjustments | (1,004) | (716) |
Government Rebates | ||
Disaggregation of Revenue [Line Items] | ||
Gross to Net Sales Adjustments | (383) | (291) |
Chargebacks and Distributor Services Fees | ||
Disaggregation of Revenue [Line Items] | ||
Gross to Net Sales Adjustments | (543) | (367) |
Sales Discounts | ||
Disaggregation of Revenue [Line Items] | ||
Gross to Net Sales Adjustments | (68) | (56) |
Sales Returns and Allowances | ||
Disaggregation of Revenue [Line Items] | ||
Gross to Net Sales Adjustments | (10) | (2) |
Gross Product Sales | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 5,028 | 4,247 |
Net product sales | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,024 | $ 3,531 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,025 | $ 3,538 |
Hematology / Oncology: | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 3,635 | 3,178 |
Hematology / Oncology: | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,320 | 2,003 |
Hematology / Oncology: | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 1,315 | 1,175 |
Hematology / Oncology: | Revlimid | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,577 | 2,234 |
Hematology / Oncology: | Revlimid | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 1,686 | 1,487 |
Hematology / Oncology: | Revlimid | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 891 | 747 |
Hematology / Oncology: | Pomalyst/Imnovid | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 557 | 453 |
Hematology / Oncology: | Pomalyst/Imnovid | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 390 | 300 |
Hematology / Oncology: | Pomalyst/Imnovid | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 167 | 153 |
Hematology / Oncology: | Abraxane | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 286 | 262 |
Hematology / Oncology: | Abraxane | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 196 | 159 |
Hematology / Oncology: | Abraxane | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 90 | 103 |
Hematology / Oncology: | Vidaza | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 151 | 157 |
Hematology / Oncology: | Vidaza | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 3 | 2 |
Hematology / Oncology: | Vidaza | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 148 | 155 |
Hematology / Oncology: | All Other Hematology and Oncology | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 64 | 72 |
Hematology / Oncology: | All Other Hematology and Oncology | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 45 | 55 |
Hematology / Oncology: | All Other Hematology and Oncology | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 19 | 17 |
Inflammation & Immunology: | Otezla | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 389 | 353 |
Inflammation & Immunology: | Otezla | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 301 | 276 |
Inflammation & Immunology: | Otezla | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 88 | 77 |
Net product sales | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 4,024 | 3,531 |
Net product sales | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,621 | 2,279 |
Net product sales | International | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 1,403 | 1,252 |
Other revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 1 | $ 7 |
Acquisitions and Divestitures_2
Acquisitions and Divestitures (Impact Biomedicines) (Details) - Impact Biomedicines Inc $ in Millions | Feb. 12, 2018USD ($) |
Business Acquisition [Line Items] | |
Payments to acquire assets | $ 1,100 |
Contingent regulatory milestones eligibility | 1,400 |
Potential milestone payment | 4,500 |
Net assets acquired | 7 |
Minimum | |
Business Acquisition [Line Items] | |
Revenues | 1,000 |
Maximum | |
Business Acquisition [Line Items] | |
Revenues | $ 5,000 |
Acquisitions and Divestitures_3
Acquisitions and Divestitures (Juno Therapeutics - Narrative) (Details) - USD ($) $ in Millions | Mar. 06, 2018 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 |
Business Acquisition [Line Items] | ||||
Allocated compensation expense | $ 257 | $ 401 | ||
Acquisition/integration related charges and restructuring, net | 77 | 31 | ||
Juno | ||||
Business Acquisition [Line Items] | ||||
Consideration transferred | $ 10,434 | |||
Cash paid for outstanding common stock | 9,101 | |||
Celgene investment in Juno, fair value | 966 | |||
Equity compensation attributable to the pre-combination service period | $ 367 | |||
Cash for the portion of equity compensation attributable to the post-combination service period | 666 | |||
Post combination share-based compensation | $ 28 | $ 250 | ||
Loss since acquisition date | $ 304 | |||
Allocated compensation expense | 250 | |||
Acquisition/integration related charges and restructuring, net | $ 22 |
Acquisitions and Divestitures_4
Acquisitions and Divestitures (Juno) (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 06, 2018 | Mar. 31, 2018 | Mar. 31, 2019 | Dec. 31, 2018 |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Net [Abstract] | ||||
Goodwill | $ 8,003 | $ 8,003 | ||
Juno | ||||
Business Combination, Consideration Transferred | ||||
Cash paid for outstanding common stock | $ 9,101 | |||
Celgene investment in Juno at $87.00 per share | 966 | |||
Cash for equity compensation attributable to pre-combination service | 367 | |||
Total consideration | $ 10,434 | |||
Gain recognized based on fair market value of equity interest | $ 458 | |||
Investment owned, price per share (usd per share) | $ 87 | |||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Net [Abstract] | ||||
Working capital | $ 452 | |||
In-process research and development (IPR&D) | 6,980 | |||
Technology platform intangible asset | 1,260 | |||
Property, plant and equipment | 144 | |||
Other non-current assets | 32 | |||
Deferred tax liabilities, net | (1,530) | |||
Other non-current liabilities | (41) | |||
Total identifiable net assets | 7,297 | |||
Goodwill | 3,137 | |||
Total net assets acquired | $ 10,434 |
Acquisitions and Divestitures_5
Acquisitions and Divestitures (Juno- Pro Forma) (Details) - Juno - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Feb. 28, 2018 | |
Business Acquisition [Line Items] | ||
Total revenue | $ 3,548 | |
Net income | $ 609 | |
Net income per common share: basic (in dollars per share) | $ 0.81 | |
Net income per common share: diluted (in dollars per share) | $ 0.79 | |
Debt issuance costs | $ 4,500 |
Earnings Per Share (Schedule of
Earnings Per Share (Schedule of Earnings Per Share) (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Net income | $ 1,545 | $ 846 |
Weighted-average shares: | ||
Basic (in shares) | 702.4 | 748.3 |
Effect of dilutive securities: | ||
Options, restricted stock units, performance-based restricted stock units and other (in shares) | 18.1 | 20 |
Diluted (in shares) | 720.5 | 768.3 |
Net income per share: | ||
Basic (in dollars per share) | $ 2.20 | $ 1.13 |
Diluted (in dollars per share) | $ 2.14 | $ 1.10 |
Earnings Per Share (Narrative)
Earnings Per Share (Narrative) (Details) - USD ($) $ in Billions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 41,700,000 | 35,700,000 |
Aggregate authorized amount | $ 2.8 | |
Shares repurchased under share repurchase program (in shares) | 0 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive (Loss) Income (Components of AOCI) (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | |
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | $ (50) | $ 287 | |
Other comprehensive income (loss) before reclassifications, net of tax | 40 | (97) | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | (22) | 52 | |
Total other comprehensive income (loss) | 18 | (45) | |
Balance at the end of the period | (32) | (328) | |
Pension Liability Adjustment | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | (28) | (22) | |
Other comprehensive income (loss) before reclassifications, net of tax | 0 | 0 | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | 0 | 0 | |
Total other comprehensive income (loss) | 0 | 0 | |
Balance at the end of the period | (28) | (22) | |
Net Unrealized Gains (Losses) On Debt Securities Available-for-Sale(1) | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | 3 | 562 | |
Other comprehensive income (loss) before reclassifications, net of tax | 0 | (7) | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | 0 | 14 | |
Total other comprehensive income (loss) | 0 | 7 | |
Balance at the end of the period | 3 | 3 | |
Net Unrealized Gains (Losses) Related to Cash Flow Hedges | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | 42 | (206) | |
Other comprehensive income (loss) before reclassifications, net of tax | 51 | (98) | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | (23) | 27 | |
Total other comprehensive income (loss) | 28 | (71) | |
Balance at the end of the period | 70 | (281) | |
Amortization of Excluded Component Related to Cash Flow Hedges | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | (7) | (15) | |
Other comprehensive income (loss) before reclassifications, net of tax | (1) | (8) | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | 1 | 11 | |
Total other comprehensive income (loss) | 0 | 3 | |
Balance at the end of the period | (7) | (12) | |
Foreign Currency Translation Adjustments | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Balance at the beginning of the period | (60) | (32) | |
Other comprehensive income (loss) before reclassifications, net of tax | (10) | 16 | |
Reclassified (gains) losses from accumulated other comprehensive income (loss), net of tax | 0 | 0 | |
Total other comprehensive income (loss) | (10) | 16 | |
Balance at the end of the period | $ (70) | $ (16) | |
Accounting Standards Update 2016-01 and 2018-02 | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | $ (570) | ||
Accounting Standards Update 2016-01 and 2018-02 | Pension Liability Adjustment | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | 0 | ||
Accounting Standards Update 2016-01 and 2018-02 | Net Unrealized Gains (Losses) On Debt Securities Available-for-Sale(1) | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | (566) | ||
Accounting Standards Update 2016-01 and 2018-02 | Net Unrealized Gains (Losses) Related to Cash Flow Hedges | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | (4) | ||
Accounting Standards Update 2016-01 and 2018-02 | Amortization of Excluded Component Related to Cash Flow Hedges | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | 0 | ||
Accounting Standards Update 2016-01 and 2018-02 | Foreign Currency Translation Adjustments | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Cumulative effect adjustment | $ 0 |
Accumulated Other Comprehensi_4
Accumulated Other Comprehensive (Loss) Income (Reclassification of AOCI) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Other Comprehensive Income (Loss) | ||
Total revenue | $ 4,025 | $ 3,538 |
Interest (expense) | (192) | (166) |
Interest and investment income, net | 34 | 13 |
Income tax provision - (expense) benefit(1) | 269 | 184 |
Total reclassification, net of tax | 22 | (52) |
(Losses) gains related to cash-flow hedges: | ||
Other Comprehensive Income (Loss) | ||
Total reclassification, net of tax | 23 | (27) |
Gains (Losses) Reclassified Out of Accumulated Other Comprehensive Income | ||
Other Comprehensive Income (Loss) | ||
Total reclassification, net of tax | 23 | (44) |
Gains (Losses) Reclassified Out of Accumulated Other Comprehensive Income | (Losses) gains related to cash-flow hedges: | Foreign exchange contracts | ||
Other Comprehensive Income (Loss) | ||
Total revenue | 24 | (26) |
Gains (Losses) Reclassified Out of Accumulated Other Comprehensive Income | (Losses) gains related to cash-flow hedges: | Treasury rate lock agreements | ||
Other Comprehensive Income (Loss) | ||
Interest (expense) | 1 | 1 |
Gains (Losses) Reclassified Out of Accumulated Other Comprehensive Income | Excluded component related to cash-flow hedges: | Foreign exchange contracts | ||
Other Comprehensive Income (Loss) | ||
Total revenue | 0 | (3) |
Gains (Losses) Reclassified Out of Accumulated Other Comprehensive Income | (Losses) gains on available-for-sale debt securities: | ||
Other Comprehensive Income (Loss) | ||
Interest and investment income, net | 0 | (18) |
Income tax provision - (expense) benefit(1) | $ 0 | $ 4 |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurement (Assumption Calculations) (Details) - Significant Unobservable Inputs (Level 3) - Income Approach Valuation Technique - Obligations | Mar. 31, 2019 | Dec. 31, 2018 |
Discount rate | Minimum | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0.036 | 0.036 |
Discount rate | Maximum | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0.048 | 0.048 |
Discount rate | Weighted Average | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0.043 | 0.043 |
Probability of payment | Minimum | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0 | 0 |
Probability of payment | Maximum | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0.68 | 0.68 |
Probability of payment | Weighted Average | ||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] (Deprecated 2018-01-31) | ||
Debt instrument, measurement input | 0.05 | 0.05 |
Financial Instruments and Fai_4
Financial Instruments and Fair Value Measurement (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Business Acquisition [Line Items] | ||
Unrealized gain (loss) on investments | $ (268) | $ 449 |
Maximum | Gloucester Pharmaceuticals, Inc. | ||
Business Acquisition [Line Items] | ||
Potential milestone payment | 120 | |
Maximum | Avila | ||
Business Acquisition [Line Items] | ||
Potential milestone payment | 475 | |
Maximum | Quanticel | ||
Business Acquisition [Line Items] | ||
Potential milestone payment | 214 | |
Maximum | Juno | ||
Business Acquisition [Line Items] | ||
Potential milestone payment | 283 | |
Maximum | Nogra Pharma Limited | ||
Business Acquisition [Line Items] | ||
Potential milestone payment | 1,800 | |
ASU 2016-01 | ||
Business Acquisition [Line Items] | ||
Upward adjustments | 81 | |
Downward adjustments and impairments | $ 135 |
Financial Instruments and Fai_5
Financial Instruments and Fair Value Measurement (Measurement Inputs) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Debt securities available-for-sale | $ 664 | $ 496 |
Equity investments with readily determinable fair values | 1,594 | 1,312 |
Total assets | 2,360 | 1,886 |
Liabilities: | ||
Contingent value rights | (48) | (19) |
Interest rate swaps | (10) | |
Zero-cost collar currency contracts | (1) | |
Other acquisition related contingent consideration and success payments | (162) | (163) |
Total liabilities | (210) | (193) |
Forward currency contracts | ||
Assets: | ||
Forward currency contracts | 83 | 78 |
Zero-cost collar currency contracts | ||
Assets: | ||
Forward currency contracts | 17 | |
Interest rate swaps | ||
Assets: | ||
Forward currency contracts | 2 | |
Quoted Price in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Debt securities available-for-sale | 0 | 0 |
Equity investments with readily determinable fair values | 1,594 | 1,312 |
Total assets | 1,594 | 1,312 |
Liabilities: | ||
Contingent value rights | (48) | (19) |
Interest rate swaps | 0 | |
Zero-cost collar currency contracts | 0 | |
Other acquisition related contingent consideration and success payments | 0 | 0 |
Total liabilities | (48) | (19) |
Quoted Price in Active Markets for Identical Assets (Level 1) | Forward currency contracts | ||
Assets: | ||
Forward currency contracts | 0 | 0 |
Quoted Price in Active Markets for Identical Assets (Level 1) | Zero-cost collar currency contracts | ||
Assets: | ||
Forward currency contracts | 0 | |
Quoted Price in Active Markets for Identical Assets (Level 1) | Interest rate swaps | ||
Assets: | ||
Forward currency contracts | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Debt securities available-for-sale | 664 | 496 |
Equity investments with readily determinable fair values | 0 | 0 |
Total assets | 766 | 574 |
Liabilities: | ||
Contingent value rights | 0 | 0 |
Interest rate swaps | (10) | |
Zero-cost collar currency contracts | (1) | |
Other acquisition related contingent consideration and success payments | 0 | 0 |
Total liabilities | 0 | (11) |
Significant Other Observable Inputs (Level 2) | Forward currency contracts | ||
Assets: | ||
Forward currency contracts | 83 | 78 |
Significant Other Observable Inputs (Level 2) | Zero-cost collar currency contracts | ||
Assets: | ||
Forward currency contracts | 17 | |
Significant Other Observable Inputs (Level 2) | Interest rate swaps | ||
Assets: | ||
Forward currency contracts | 2 | |
Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Debt securities available-for-sale | 0 | 0 |
Equity investments with readily determinable fair values | 0 | 0 |
Total assets | 0 | 0 |
Liabilities: | ||
Contingent value rights | 0 | 0 |
Interest rate swaps | 0 | |
Zero-cost collar currency contracts | 0 | |
Other acquisition related contingent consideration and success payments | (162) | (163) |
Total liabilities | (162) | (163) |
Significant Unobservable Inputs (Level 3) | Forward currency contracts | ||
Assets: | ||
Forward currency contracts | 0 | $ 0 |
Significant Unobservable Inputs (Level 3) | Zero-cost collar currency contracts | ||
Assets: | ||
Forward currency contracts | 0 | |
Significant Unobservable Inputs (Level 3) | Interest rate swaps | ||
Assets: | ||
Forward currency contracts | $ 0 |
Financial Instruments and Fai_6
Financial Instruments and Fair Value Measurement (Schedule of Remeasurement of Equity Investments) (Details) - Investments - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 545 | $ 513 |
Cumulative effect adjustment for the adoption of ASU 2018-03 | 59 | |
Purchases | 25 | 16 |
Upward adjustments | 15 | 21 |
Sales | (3) | |
Downward adjustments and impairments | (1) | |
Downward adjustments and impairments | (1) | (10) |
Ending balance | $ 584 | $ 595 |
Financial Instruments and Fai_7
Financial Instruments and Fair Value Measurement (Level 3 Fair Value Roll-Forward) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at beginning of period | $ (163) | $ (80) |
Amounts acquired from Juno, including measurement period adjustments | (122) | |
Net change in fair value | 0 | 1 |
Balance at end of period | $ (163) | $ (201) |
Derivative Instruments and He_3
Derivative Instruments and Hedging Activities (Narrative) (Details) - Foreign currency forward contracts | 3 Months Ended |
Mar. 31, 2019 | |
Minimum | |
Derivative [Line Items] | |
Derivative, remaining maturity | 3 years |
Maximum | |
Derivative [Line Items] | |
Derivative, remaining maturity | 5 years |
Derivative Instruments and He_4
Derivative Instruments and Hedging Activities (Foreign Currency Forward Contracts) (Details) - Foreign currency forward contracts - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2018 | |
Derivatives not designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | $ 398 | $ 347 | |
Cash flow hedges | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | 1,399 | 2,091 | |
Cash flow hedges | Australian Dollar | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | 31 | 46 | |
Cash flow hedges | British Pound | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | 49 | 82 | |
Cash flow hedges | Canadian Dollar | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | 112 | 158 | |
Cash flow hedges | Euro | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | 887 | 1,381 | |
Cash flow hedges | Japanese Yen | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Notional Amount | $ 320 | $ 424 | |
Minimum | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Derivative, remaining maturity | 3 years | ||
Minimum | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Derivative, remaining maturity | 27 months | ||
Maximum | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Derivative, remaining maturity | 5 years | ||
Maximum | Derivatives designated as hedging instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Derivative, remaining maturity | 30 months |
Derivative Instruments and He_5
Derivative Instruments and Hedging Activities (Foreign Currency Option Contracts) (Details) - Foreign exchange option contracts - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2018 | |
Purchased Put | |||
Derivative [Line Items] | |||
Notional Amount | $ 0 | ||
Derivatives designated as hedging instruments | Purchased Put | |||
Derivative [Line Items] | |||
Notional Amount | $ 1,893 | 1,933 | |
Derivatives designated as hedging instruments | Written Call | |||
Derivative [Line Items] | |||
Notional Amount | $ 2,171 | $ 2,216 | |
Minimum | Derivatives designated as hedging instruments | |||
Derivative [Line Items] | |||
Derivative, remaining maturity | 21 months | ||
Maximum | Derivatives designated as hedging instruments | |||
Derivative [Line Items] | |||
Derivative, remaining maturity | 24 months |
Derivative Instruments and He_6
Derivative Instruments and Hedging Activities (Interest Rate Swap Contracts) (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2018 | |
Interest rate swaps | |||
Derivative [Line Items] | |||
Terminated swap contracts, notional amount | $ 250 | ||
Cash received on hedge | $ 5 | 2 | |
3.875% senior notes due 2025 | |||
Derivative [Line Items] | |||
Interest rate | 3.875% | ||
3.900% senior notes due 2028 | |||
Derivative [Line Items] | |||
Interest rate | 3.90% | 3.90% | |
Senior notes | 3.875% senior notes due 2025 | Interest rate swaps | |||
Derivative [Line Items] | |||
Interest rate | 3.875% | ||
Senior notes | 3.450% senior notes due 2027 | Interest rate swaps | |||
Derivative [Line Items] | |||
Interest rate | 3.45% | ||
Senior notes | 3.900% senior notes due 2028 | Interest rate swaps | |||
Derivative [Line Items] | |||
Interest rate | 3.90% | ||
Senior notes | Derivatives designated as hedging instruments | |||
Derivative [Line Items] | |||
Terminated swap contracts, notional amount | $ 200 | ||
Fair value hedges | Senior notes | Derivatives designated as hedging instruments | Interest rate swaps | |||
Derivative [Line Items] | |||
Notional Amount | 650 | 850 | |
Fair value hedges | Senior notes | Derivatives designated as hedging instruments | 3.875% senior notes due 2025 | Interest rate swaps | |||
Derivative [Line Items] | |||
Notional Amount | 200 | 200 | |
Fair value hedges | Senior notes | Derivatives designated as hedging instruments | 3.450% senior notes due 2027 | Interest rate swaps | |||
Derivative [Line Items] | |||
Notional Amount | 450 | 450 | |
Fair value hedges | Senior notes | Derivatives designated as hedging instruments | 3.900% senior notes due 2028 | Interest rate swaps | |||
Derivative [Line Items] | |||
Notional Amount | $ 0 | $ 200 |
Derivative Instruments and He_7
Derivative Instruments and Hedging Activities (Fair Value and Presentation in the Balance Sheet) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | $ 142 | $ 159 |
Derivative liability, fair value, gross asset | 40 | 92 |
Foreign exchange contracts | Derivatives designated as hedging instruments: | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 58 | 63 |
Derivative liability, fair value, gross asset | 7 | 18 |
Foreign exchange contracts | Derivatives designated as hedging instruments: | Other non-current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 49 | 45 |
Derivative liability, fair value, gross asset | 10 | 16 |
Foreign exchange contracts | Derivatives designated as hedging instruments: | Other non-current liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross liability | 0 | 12 |
Derivative liability, fair value, gross liability | 0 | 15 |
Interest rate swaps | Derivatives designated as hedging instruments: | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 6 | 7 |
Derivative liability, fair value, gross asset | 0 | 0 |
Interest rate swaps | Derivatives designated as hedging instruments: | Other non-current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 2 | 1 |
Derivative liability, fair value, gross asset | 0 | 0 |
Interest rate swaps | Derivatives designated as hedging instruments: | Other non-current liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross liability | 2 | 1 |
Derivative liability, fair value, gross liability | 8 | 19 |
Interest rate swaps | Derivatives not designated as hedging instruments: | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 2 | |
Derivative liability, fair value, gross asset | 3 | |
Interest rate swaps | Derivatives not designated as hedging instruments: | Other non-current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 3 | 5 |
Derivative liability, fair value, gross asset | 3 | 4 |
Foreign exchange contracts | Derivatives not designated as hedging instruments: | Other current assets | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross asset | 21 | 21 |
Derivative liability, fair value, gross asset | 1 | 5 |
Foreign exchange contracts | Derivatives not designated as hedging instruments: | Accrued expenses and other current liabilities | ||
Derivatives, Fair Value [Line Items] | ||
Derivative asset, fair value, gross liability | 1 | 2 |
Derivative liability, fair value, gross liability | $ 11 | $ 12 |
Derivative Instruments and He_8
Derivative Instruments and Hedging Activities (Cumulative Basis Adjustments For Fair Value Hedges) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Derivative [Line Items] | ||
Long-term debt, net of discount | $ 19,781 | $ 19,769 |
Carrying Amount of the Hedged Liability | ||
Derivative [Line Items] | ||
Current portion of long-term debt, net of discount | 500 | 501 |
Long-term debt, net of discount | 8,237 | 8,227 |
Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liability | ||
Derivative [Line Items] | ||
Current portion of long-term debt, net of discount | 1 | 2 |
Long-term debt, net of discount | 98 | 90 |
Hedging Adjustment Discontinued Hedging Relationship ASU 2017-12 | Carrying Amount of the Hedged Liability | ||
Derivative [Line Items] | ||
Long-term debt, net of discount | 4,800 | 3,300 |
Hedging Adjustment Discontinued Hedging Relationship ASU 2017-12 | Cumulative Amount of Fair Value Hedging Adjustment Included in the Carrying Amount of the Hedged Liability | ||
Derivative [Line Items] | ||
Current portion of long-term debt, net of discount | 1 | 2 |
Long-term debt, net of discount | $ 102 | $ 107 |
Derivative Instruments and He_9
Derivative Instruments and Hedging Activities (Schedule of Impacts on Income) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing | $ (23) | $ 27 |
Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Foreign currency cash flow hedge gain (loss) to be reclassified during next 12 months | 53 | |
Foreign exchange contracts | Other income, net | Derivatives not designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in OCI on Derivative | 9 | (13) |
Cash flow hedges | Foreign exchange contracts | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in OCI on Derivative | 51 | (95) |
Cash flow hedges | Foreign exchange contracts | Net product sales | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Reclassified from Accumulated OCI into Income | 24 | (26) |
Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing | 0 | (2) |
Cash flow hedges | Treasury rate lock agreements | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in OCI on Derivative | 0 | (4) |
Cash flow hedges | Treasury rate lock agreements | Interest (expense) | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Reclassified from Accumulated OCI into Income | (1) | (1) |
Fair value hedges | Interest rate swap agreements | Interest (expense) | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing | 20 | (5) |
Accounting Standards Update 2017-12 | Fair value hedges | Interest rate swap agreements | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing | 8 | 8 |
Accounting Standards Update 2017-12 | Fair value hedges | Interest rate swap agreements | Interest (expense) | Derivatives designated as hedging instruments | ||
Derivative [Line Items] | ||
Amount of Gain/(Loss) Recognized in Income on Derivative Related to Amount Excluded from Effectiveness Testing | $ 8 | $ 8 |
Derivative Instruments and H_10
Derivative Instruments and Hedging Activities (Location and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships) (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | $ (8) | $ 22 |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | (23) | 27 |
Net product sales | Treasury rate lock agreements | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | 0 | 0 |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 0 | 0 |
Interest (expense) | ||
Derivative [Line Items] | ||
Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded | (192) | (166) |
Interest (expense) | Treasury rate lock agreements | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | (1) | (1) |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 0 | 0 |
Other income, net | ||
Derivative [Line Items] | ||
Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded | 262 | 965 |
Other income, net | Treasury rate lock agreements | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | 0 | 0 |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 0 | 0 |
Effects of Fair Value and Cash Flow Hedging | Net product sales | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | 0 | 0 |
Effects of Fair Value and Cash Flow Hedging | Interest (expense) | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | (12) | 14 |
Effects of Fair Value and Cash Flow Hedging | Other income, net | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | 0 | 0 |
Cash flow hedges | Net product sales | Foreign exchange contracts | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | 24 | (26) |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 1 | 8 |
Reclassification adjustment for excluded component (loss) | (1) | (11) |
Cash flow hedges | Interest (expense) | Foreign exchange contracts | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | 0 | 0 |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 0 | 0 |
Cash flow hedges | Other income, net | Foreign exchange contracts | ||
Derivative [Line Items] | ||
Amount of gain reclassified from AOCI into income | 0 | 0 |
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 0 | 0 |
Derivatives designated as hedging instruments | Effects of Fair Value and Cash Flow Hedging | Net product sales | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | 0 | 0 |
Derivatives designated as hedging instruments | Effects of Fair Value and Cash Flow Hedging | Interest (expense) | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | 20 | (5) |
Derivatives designated as hedging instruments | Effects of Fair Value and Cash Flow Hedging | Other income, net | Interest rate swap agreements | ||
Derivative [Line Items] | ||
(Loss) gain on fair value hedging relationships | 0 | 0 |
Accounting Standards Update 2017-12 | Derivatives designated as hedging instruments | Fair value hedges | Interest rate swap agreements | ||
Derivative [Line Items] | ||
Amount excluded from effectiveness testing recognized using a systematic and rational amortization approach / changes in fair value | 8 | 8 |
Net product sales | Net product sales | ||
Derivative [Line Items] | ||
Total amounts of income and expense line items presented in the Consolidated Statements of Income in which the effects of fair value or cash flow hedges are recorded | $ 4,024 | $ 3,531 |
Cash, Cash Equivalents and De_3
Cash, Cash Equivalents and Debt Securities Available-for-Sale (Narrative) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | ||
Time deposits and repurchase agreements | $ 2,000 | $ 276 |
Money market funds, at carrying value | $ 2,100 | $ 2,900 |
Cash, Cash Equivalents and De_4
Cash, Cash Equivalents and Debt Securities Available-for-Sale (Schedule of Available-for-Sale Reconciliation) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 664 | $ 496 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | 0 | 0 |
Estimated Fair Value | 664 | 496 |
Ultra short income fund | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 526 | 450 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | 0 | 0 |
Estimated Fair Value | 526 | 450 |
Time deposits and Repurchase agreements | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 138 | 46 |
Gross Unrealized Gain | 0 | 0 |
Gross Unrealized Loss | 0 | 0 |
Estimated Fair Value | $ 138 | $ 46 |
Cash, Cash Equivalents and De_5
Cash, Cash Equivalents and Debt Securities Available-for-Sale (Duration Periods) (Details) $ in Millions | Mar. 31, 2019USD ($) |
Amortized Cost | |
Duration of one year or less | $ 664 |
Fair Value | |
Duration of one year or less | $ 664 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 235 | $ 252 |
Work in process | 87 | 79 |
Finished goods | 120 | 127 |
Total inventory | $ 442 | $ 458 |
Intangible Assets and Goodwil_2
Intangible Assets and Goodwill (Summary of Intangible Assets) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Intangible Assets By Category | ||
Gross Carrying Value | $ 5,266 | $ 5,269 |
Accumulated Amortization | (2,996) | (2,887) |
Intangible Assets, Net | 2,270 | 2,382 |
Total intangible assets | ||
Gross Carrying Value | 19,097 | 19,100 |
Intangible Assets, Net | 16,101 | 16,213 |
Acquired developed product rights | ||
Intangible Assets By Category | ||
Gross Carrying Value | 3,414 | 3,406 |
Accumulated Amortization | (2,349) | (2,261) |
Intangible Assets, Net | 1,065 | 1,145 |
Technology | ||
Intangible Assets By Category | ||
Gross Carrying Value | 1,743 | 1,743 |
Accumulated Amortization | (573) | (552) |
Intangible Assets, Net | 1,170 | 1,191 |
Licenses | ||
Intangible Assets By Category | ||
Gross Carrying Value | 66 | 66 |
Accumulated Amortization | (36) | (35) |
Intangible Assets, Net | 30 | 31 |
Other | ||
Intangible Assets By Category | ||
Gross Carrying Value | 43 | 54 |
Accumulated Amortization | (38) | (39) |
Intangible Assets, Net | 5 | 15 |
Acquired IPR&D product rights | ||
Non-amortizable intangible assets: | ||
Carrying value | $ 13,831 | $ 13,831 |
Intangible Assets and Goodwil_3
Intangible Assets and Goodwill (Narrative) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Intangible asset, useful life | 8 years 10 months | |
Amortization of acquired intangible assets | $ 110,000,000 | $ 88,000,000 |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | ||
Future annual amortization, 2019 | 441,000,000 | |
Future annual amortization, 2020 | 440,000,000 | |
Future annual amortization, 2021 | 437,000,000 | |
Future annual amortization, 2022 | 178,000,000 | |
Future annual amortization, 2023 | 92,000,000 | |
Goodwill, period increase (decrease) | $ 0 |
Debt (Short-Term Borrowings and
Debt (Short-Term Borrowings and Current Portion of Long-Term Debt) (Details) - 2.250% senior notes due 2019 - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Short-term Debt [Line Items] | ||
Current portion of long-term debt, net of discount | $ 500 | $ 501 |
Interest rate | 2.25% |
Debt (Senior Notes Carrying Val
Debt (Senior Notes Carrying Values) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2018 |
Carrying values of the entity's senior notes | |||
Long-term debt | $ 19,781 | $ 19,769 | |
2.875% senior notes due 2020 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,497 | 1,497 | |
Interest rate | 2.875% | ||
3.950% senior notes due 2020 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 508 | 509 | |
Interest rate | 3.95% | ||
2.250% senior notes due 2021 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 498 | 498 | |
Interest rate | 2.25% | ||
2.875% senior notes due 2021 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 499 | 498 | $ 500 |
Interest rate | 2.875% | 2.875% | |
3.250% senior notes due 2022 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,032 | 1,034 | |
Interest rate | 3.25% | ||
3.550% senior notes due 2022 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 996 | 996 | |
Interest rate | 3.55% | ||
2.750% senior notes due 2023 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 747 | 747 | |
Interest rate | 2.75% | ||
3.250% senior notes due 2023 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 994 | 994 | $ 1,000 |
Interest rate | 3.25% | 3.25% | |
4.000% senior notes due 2023 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 729 | 730 | |
Interest rate | 4.00% | ||
3.625% senior notes due 2024 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,000 | 1,000 | |
Interest rate | 3.625% | ||
3.875% senior notes due 2025 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 2,482 | 2,478 | |
Interest rate | 3.875% | ||
3.450% senior notes due 2027 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 997 | 986 | |
Interest rate | 3.45% | ||
3.900% senior notes due 2028 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,490 | 1,490 | $ 1,500 |
Interest rate | 3.90% | 3.90% | |
5.700% senior notes due 2040 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 247 | 247 | |
Interest rate | 5.70% | ||
5.250% senior notes due 2043 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 393 | 393 | |
Interest rate | 5.25% | ||
4.625% senior notes due 2044 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 987 | 987 | |
Interest rate | 4.625% | ||
5.000% senior notes due 2045 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,975 | 1,975 | |
Interest rate | 5.00% | ||
4.350% senior notes due 2047 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,234 | 1,234 | |
Interest rate | 4.35% | ||
4.550% senior notes due 2048 | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 1,476 | $ 1,476 | $ 1,500 |
Interest rate | 4.55% | 4.55% | |
Senior notes | |||
Carrying values of the entity's senior notes | |||
Long-term debt | $ 19,850 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) | 1 Months Ended | |||
Feb. 28, 2018 | Mar. 31, 2019 | Dec. 31, 2018 | Apr. 30, 2016 | |
Debt Instrument [Line Items] | ||||
Long-term debt | $ 19,781,000,000 | $ 19,769,000,000 | ||
Treasury rate lock agreements | ||||
Debt Instrument [Line Items] | ||||
Losses recorded to AOCI | 29,000,000 | 31,000,000 | ||
Interest rate swaps | Derivatives designated as hedging instruments | ||||
Debt Instrument [Line Items] | ||||
Gains recorded as reduction of debt | 103,000,000 | 109,000,000 | ||
Commercial paper | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | 2,000,000,000 | 2,000,000,000 | $ 2,000,000,000 | |
Long-term line of credit | 0 | 0 | ||
Senior unsecured credit facility | ||||
Debt Instrument [Line Items] | ||||
Long-term line of credit | 0 | 0 | ||
Level 2 | ||||
Debt Instrument [Line Items] | ||||
Senior notes, fair value | 20,700,000,000 | 19,300,000,000 | ||
2.875% senior notes due 2021 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt | $ 500,000,000 | $ 499,000,000 | 498,000,000 | |
Interest rate | 2.875% | 2.875% | ||
Offering price as a percent of par | 99.954% | |||
Basis spread | 1000.00% | |||
3.250% senior notes due 2023 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt | $ 1,000,000,000 | $ 994,000,000 | 994,000,000 | |
Interest rate | 3.25% | 3.25% | ||
Offering price as a percent of par | 99.758% | |||
Basis spread | 1500.00% | |||
3.900% senior notes due 2028 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt | $ 1,500,000,000 | $ 1,490,000,000 | 1,490,000,000 | |
Interest rate | 3.90% | 3.90% | ||
Offering price as a percent of par | 99.656% | |||
Basis spread | 2000.00% | |||
4.550% senior notes due 2048 | ||||
Debt Instrument [Line Items] | ||||
Long-term debt | $ 1,500,000,000 | $ 1,476,000,000 | $ 1,476,000,000 | |
Interest rate | 4.55% | 4.55% | ||
Offering price as a percent of par | 99.40% | |||
Basis spread | 2500.00% | |||
2021 2023 2028 2048 Notes | ||||
Debt Instrument [Line Items] | ||||
Debt issuance costs | $ 32,000,000 | |||
Redemption price | 100.00% | |||
Redemption price, downgrade of debt | 101.00% |
Share-Based Compensation (Compo
Share-Based Compensation (Components of Share-Based Compensation Expense) (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 257 | $ 401 | |
Tax benefit related to share-based compensation expense (3) | 49 | 37 | |
Reduction in net income | 208 | 364 | |
Proceeds and excess tax benefit from share-based compensation | 16 | 11 | |
Cost of goods sold (excluding amortization of acquired intangible assets) | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 12 | 9 | |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 126 | 199 | |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 119 | 193 | |
Juno | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 250 | ||
Juno | Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Post combination allocated expenses | 17 | 133 | |
Juno | Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Post combination allocated expenses | $ 11 | $ 117 |
Share-Based Compensation (Summa
Share-Based Compensation (Summary of Stock Options, RSUs and PSUs) (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2019shares | |
Stock Options | |
Stock option activity | |
Outstanding as of December 31, 2018 | 71,100 |
Granted | 0 |
Exercised / Released | (3,800) |
Forfeited | (900) |
Outstanding as of March 31, 2019 | 66,400 |
RSUs | |
Restricted and Performance-Based Restricted Stock Units | |
Outstanding as of December 31, 2018 | 11,700 |
Granted | 8,200 |
Exercised / Released | (400) |
Forfeited | (300) |
Outstanding as of March 31, 2019 | 19,200 |
PSUs | |
Restricted and Performance-Based Restricted Stock Units | |
Outstanding as of December 31, 2018 | 660 |
Granted | 200 |
Exercised / Released | (73) |
Forfeited | (40) |
Outstanding as of March 31, 2019 | 747 |
Share-Based Compensation (Unves
Share-Based Compensation (Unvested Awards and Weighted-Average Periods) (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 386 |
Expected weighted-average period in years of compensation cost to be recognized | 2 years 1 month 6 days |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 1,079 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 10 months 24 days |
PSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 35 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 6 months |
Income Taxes (Details)
Income Taxes (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Income Tax Disclosure [Abstract] | |
Gross unrecognized tax benefits, increase | $ 24 |
Collaboration Agreements (Sched
Collaboration Agreements (Schedule of Collaboration Agreements) (Details) - Other Collaboration Arrangements - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Upfront Fees | $ 216 | $ 245 |
Milestones | 11 | 0 |
Extension/Termination of Arrangements | 0 | 0 |
Amortization of Prepaid Research and Development | 2 | 2 |
Equity Investments Made During Period | $ 52 | $ 101 |
Collaboration Agreements (Perio
Collaboration Agreements (Period End Balances) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Intangible Asset Balance | $ 16,101 | $ 16,213 |
Other Collaboration Arrangements | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Intangible Asset Balance | 11 | 13 |
Equity Investment Balance | $ 1,581 | $ 1,280 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Jan. 01, 2019 |
Lessee, Lease, Description [Line Items] | ||
Right-of-use asset | $ 286 | $ 293 |
Operating lease liability | $ 313 | $ 323 |
Minimum | Office and Research Facilities | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 1 year | |
Renewal term | 1 year | |
Minimum | Automobiles | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 3 years | |
Minimum | Office and Other Equipment | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 1 year | |
Maximum | Office and Research Facilities | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 10 years | |
Renewal term | 9 years | |
Maximum | Automobiles | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 4 years | |
Maximum | Office and Other Equipment | ||
Lessee, Lease, Description [Line Items] | ||
Term of contract | 8 years |
Leases (Components of Lease Exp
Leases (Components of Lease Expense) (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 23 |
Short-term lease cost | 0 |
Variable lease cost | 8 |
Sublease income | 0 |
Total lease cost | $ 31 |
Leases (Supplemental Cash Flow
Leases (Supplemental Cash Flow Information Related to Leases) (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cash paid for amounts included in measurement of lease liabilities: | |
Operating cash flows from operating leases | $ 27 |
ROU assets obtained in exchange for new operating liabilities | $ 18 |
Leases (Supplemental Balance Sh
Leases (Supplemental Balance Sheet Information Related to Leases) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
Other non-current assets | $ 286 | $ 293 |
Accrued expenses and other current liabilities | 79 | |
Other non-current liabilities | $ 234 | |
Weighted-average remaining lease term - operating leases | 4 years 5 months 19 days | |
Operating Lease, Weighted Average Discount Rate, Percent | 3.98% |
Leases (Maturities of Operating
Leases (Maturities of Operating Leases) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
2019 | $ 72 | |
2020 | 85 | |
2021 | 64 | |
2022 | 54 | |
2023 | 40 | |
2024 | 17 | |
Thereafter | 11 | |
Total undiscounted lease payments | 343 | |
Less: imputed interest | (30) | |
Total discounted lease payments | 313 | $ 323 |
Operating lease not yet commenced | $ 66 |
Leases (Maturities Prior to Ado
Leases (Maturities Prior to Adoption of ASC 842) (Details) $ in Millions | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 92 |
2020 | 89 |
2021 | 70 |
2022 | 59 |
2023 | 45 |
Thereafter | 68 |
Total minimum lease payments | $ 423 |
Legal Proceedings (Narrative) (
Legal Proceedings (Narrative) (Details) | Jun. 14, 2017plaintiff |
Commitments and Contingencies Disclosure [Abstract] | |
Number of plaintiffs | 3 |