Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Jan. 31, 2019 | Jun. 29, 2018 | |
Entity Information [Line Items] | |||
Entity Registrant Name | REGENERON PHARMACEUTICALS INC | ||
Entity Central Index Key | 872,589 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Shell Company | false | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 35,741,000,000 | ||
Common Stock | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 107,365,835 | ||
Class A Stock | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 1,911,354 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 1,467.7 | $ 812.7 |
Marketable securities | 1,342.2 | 596.8 |
Accounts receivable - trade, net | 1,723.7 | 1,538.6 |
Accounts receivable from Sanofi | 226.4 | 193.7 |
Accounts receivable from Bayer | 293.1 | 242 |
Inventories | 1,151.2 | 726.1 |
Prepaid expenses and other current assets | 243.3 | 225.1 |
Total current assets | 6,447.6 | 4,335 |
Marketable securities | 1,755 | 1,486.5 |
Property, plant, and equipment, net | 2,575.8 | 2,358.6 |
Deferred tax assets | 828.7 | 506.3 |
Other noncurrent assets | 127.4 | 77.9 |
Total assets | 11,734.5 | 8,764.3 |
Current liabilities: | ||
Accounts payable | 218.2 | 178.2 |
Accrued expenses and other current liabilities | 772.1 | 637.2 |
Deferred revenue, current | 452.5 | 320.1 |
Total current liabilities | 1,442.8 | 1,135.5 |
Capital and facility lease obligations | 708.5 | 703.5 |
Deferred revenue, noncurrent | 464.2 | 629.2 |
Other noncurrent liabilities | 361.7 | 152 |
Total liabilities | 2,977.2 | 2,620.2 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred Stock, $.01 par value; 30,0000,000 shares authorized; issued and outstanding - none | 0 | 0 |
Additional paid-in capital | 3,911.6 | 3,512.9 |
Retained earnings | 5,254.3 | 2,946.7 |
Accumulated other comprehensive (loss) income | (12.3) | 0.6 |
Treasury Stock, at cost; 3,990,021 shares in 2018 and 3,763,868 shares in 2017 | (396.4) | (316.2) |
Total stockholders' equity | 8,757.3 | 6,144.1 |
Total liabilities and stockholders' equity | 11,734.5 | 8,764.3 |
Class A Stock | ||
Stockholders' equity: | ||
Common stock | 0 | 0 |
Total stockholders' equity | 0 | 0 |
Common Stock | ||
Stockholders' equity: | ||
Common stock | 0.1 | 0.1 |
Total stockholders' equity | 0.1 | 0.1 |
Sanofi | ||
Current liabilities: | ||
Deferred revenue, current | 246.7 | 177.7 |
Deferred revenue, noncurrent | 279.3 | 379.9 |
Other | ||
Current liabilities: | ||
Deferred revenue, current | 205.8 | 142.4 |
Deferred revenue, noncurrent | $ 184.9 | $ 249.3 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Liabilities and Equity [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 30,000,000 | 30,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Treasury stock, outstanding (in shares) | 3,990,021 | 3,763,868 |
Class A Stock | ||
Liabilities and Equity [Abstract] | ||
Common Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Common Stock, shares issued (in shares) | 1,911,354 | 1,911,354 |
Common Stock, shares outstanding (in shares) | 1,911,354 | 1,911,354 |
Common Stock | ||
Liabilities and Equity [Abstract] | ||
Common Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (in shares) | 320,000,000 | 320,000,000 |
Common Stock, shares issued (in shares) | 111,084,951 | 109,477,222 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - USD ($) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Revenues | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Expenses: | |||
Research and development | 2,186.1 | 2,075.1 | 2,052.3 |
Selling, general, and administrative | 1,556.2 | 1,320.4 | 1,177.7 |
Total expenses | 4,176.4 | 3,792.6 | 3,529.7 |
Income from operations | 2,534.4 | 2,079.6 | 1,330.7 |
Other income (expense): | |||
Other income (expense), net | 47.3 | 24 | 6.3 |
Interest expense | (28.2) | (25.1) | (7.2) |
Total other income (expense) | 19.1 | (1.1) | (0.9) |
Income before income taxes | 2,553.5 | 2,078.5 | 1,329.8 |
Income tax expense | (109.1) | (880) | (434.3) |
Net income | $ 2,444.4 | $ 1,198.5 | $ 895.5 |
Net income per share - basic (in dollars per share) | $ 22.65 | $ 11.27 | $ 8.55 |
Net income per share - diluted (in dollars per share) | $ 21.29 | $ 10.34 | $ 7.70 |
Weighted average shares outstanding - basic (in shares) | 107.9 | 106.3 | 104.7 |
Weighted average shares outstanding - diluted (in shares) | 114.8 | 115.9 | 116.3 |
Statements of Comprehensive Income | |||
Net income | $ 2,444.4 | $ 1,198.5 | $ 895.5 |
Other comprehensive income (loss), net of tax: | |||
Unrealized (loss) gain on marketable securities | (7) | 12.7 | (21.4) |
Unrealized gain on cash flow hedges | 0.7 | 0.8 | 0 |
Comprehensive income | 2,438.1 | 1,212 | 874.1 |
Product | |||
Revenues: | |||
Revenues | 4,106.2 | 3,718.5 | 3,338.4 |
Expenses: | |||
Cost of goods sold | 180 | 202.5 | 194.6 |
Collaboration and contract manufacturing | |||
Expenses: | |||
Cost of goods sold | 254.1 | 194.6 | 105.1 |
Sanofi | Product and service, other | |||
Revenues: | |||
Revenues | 1,111.1 | 877.2 | 658.7 |
Bayer | Product and service, other | |||
Revenues: | |||
Revenues | 1,076.7 | 938.1 | 744.3 |
Other | Product and service, other | |||
Revenues: | |||
Revenues | $ 416.8 | $ 338.4 | $ 119 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Millions, $ in Millions | Total | Additional Paid-in Capital | Retained Earnings | Accumulated Other Comprehensive Income (Loss) | Treasury Stock | Class A Stock | Common Stock | Restricted stock |
Beginning Balance (in shares) at Dec. 31, 2015 | 3.6 | 1.9 | 106.4 | |||||
Beginning Balance at Dec. 31, 2015 | $ 3,654.8 | $ 3,099.5 | $ 852.7 | $ 8.6 | $ (306.1) | $ 0 | $ 0.1 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of Common Stock in connection with exercise of stock options (in shares) | 1.7 | |||||||
Issuance of Common Stock in connection with exercise of stock options | 115.2 | 115.2 | $ 0 | |||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations (in shares) | (0.3) | |||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations | (143.2) | (143.2) | ||||||
Issuance of Common Stock in connection with conversion of convertible notes (in shares) | 0.1 | |||||||
Issuance of Common Stock in connection with conversion of convertible notes | 48 | 48 | ||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution (in shares) | 0 | |||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan | 16.6 | 16.6 | ||||||
Stock-based compensation charges | 574.9 | 574.9 | ||||||
Acquisition of Common Stock (in shares) | (0.2) | |||||||
Acquisition of Common Stock | 0 | 10.1 | $ (10.1) | |||||
Reduction of warrants | (643.3) | (643.3) | ||||||
Reduction of equity component of convertible notes | (47.8) | (47.8) | ||||||
Net income | 895.5 | 895.5 | ||||||
Other comprehensive loss, net of tax | (21.4) | (21.4) | ||||||
Ending Balance (in shares) at Dec. 31, 2016 | 3.8 | 1.9 | 107.9 | |||||
Ending Balance at Dec. 31, 2016 | 4,449.3 | 3,030 | 1,748.2 | (12.8) | $ (316.2) | $ 0 | $ 0.1 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of Common Stock in connection with exercise of stock options (in shares) | 2.3 | |||||||
Issuance of Common Stock in connection with exercise of stock options | 240.6 | 240.6 | $ 0 | |||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations (in shares) | (0.8) | |||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations | (301.7) | (301.7) | ||||||
Issuance of restricted stock under Long-Term Incentive Plan (in shares) | 0.1 | |||||||
Issuance of restricted stock under Long-Term Incentive Plan | 0 | |||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution (in shares) | 0 | |||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan | 19.4 | 19.4 | ||||||
Stock-based compensation charges | 524.6 | 524.6 | ||||||
Net income | 1,198.5 | 1,198.5 | ||||||
Other comprehensive loss, net of tax | 13.4 | 13.4 | ||||||
Ending Balance (in shares) at Dec. 31, 2017 | 3.8 | 1.9 | 109.5 | |||||
Ending Balance at Dec. 31, 2017 | 6,144.1 | 3,512.9 | 2,946.7 | 0.6 | $ (316.2) | $ 0 | $ 0.1 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of Common Stock in connection with exercise of stock options (in shares) | 1.7 | |||||||
Issuance of Common Stock in connection with exercise of stock options | 114.2 | 114.2 | $ 0 | |||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations (in shares) | (0.5) | |||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations | (187.2) | (187.2) | ||||||
Issuance of restricted stock under Long-Term Incentive Plan (in shares) | 0.3 | |||||||
Issuance of restricted stock under Long-Term Incentive Plan | 0 | |||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution (in shares) | 0.1 | |||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan | 26.9 | 26.9 | ||||||
Stock-based compensation charges | 444.8 | 444.8 | ||||||
Acquisition of Common Stock (in shares) | (0.2) | |||||||
Acquisition of Common Stock | (80.2) | $ (80.2) | ||||||
Change in accounting standards | Accounting Standards Update 2014-09 And 2016-01 | (143.4) | (136.8) | ||||||
Change in accounting standards | Accounting Standards Update 2016-01 | (6.6) | |||||||
Net income | 2,444.4 | 2,444.4 | ||||||
Other comprehensive loss, net of tax | (6.3) | (6.3) | ||||||
Ending Balance (in shares) at Dec. 31, 2018 | 4 | 1.9 | 111.1 | |||||
Ending Balance at Dec. 31, 2018 | $ 8,757.3 | $ 3,911.6 | $ 5,254.3 | $ (12.3) | $ (396.4) | $ 0 | $ 0.1 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net income | $ 2,444.4 | $ 1,198.5 | $ 895.5 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 148.2 | 145.5 | 104.7 |
Non-cash compensation expense | 427.4 | 507.3 | 559.9 |
Other non-cash items, net | 12.1 | 63.5 | 45.1 |
Deferred taxes | (140) | 318.8 | (360.1) |
Changes in assets and liabilities: | |||
Increase in Sanofi, Bayer, and trade accounts receivable | (268.9) | (362.7) | (143.8) |
Increase in inventories | (387.9) | (314.2) | (149.8) |
(Increase) decrease in prepaid expenses and other assets | (55.7) | (113.3) | 36.1 |
(Decrease) increase in deferred revenue | (194.5) | (113.1) | 244.3 |
Increase (decrease) in accounts payable, accrued expenses, and other liabilities | 210 | (23.2) | 254 |
Total adjustments | (249.3) | 108.6 | 590.4 |
Net cash provided by operating activities | 2,195.1 | 1,307.1 | 1,485.9 |
Cash flows from investing activities: | |||
Purchases of marketable and other securities | (1,845.5) | (1,277.2) | (809.4) |
Sales or maturities of marketable securities | 775.6 | 544.6 | 274.5 |
Capital expenditures | (383.1) | (272.6) | (511.9) |
Other | (10) | 0 | 0 |
Net cash used in investing activities | (1,463) | (1,005.2) | (1,046.8) |
Cash flows from financing activities: | |||
Proceeds in connection with capital and facility lease obligations | 0 | 57 | 5.1 |
Payments in connection with capital and facility lease obligations | 0 | (19.9) | (32.8) |
Repayments of convertible senior notes | 0 | 0 | (12.9) |
Payments in connection with reduction of outstanding warrants | 0 | 0 | (643.4) |
Proceeds from issuance of Common Stock | 114.5 | 240.2 | 126.7 |
Payments in connection with Common Stock tendered for employee tax obligations | (187.2) | (301.7) | (143.2) |
Repurchases of Common Stock | (4.4) | 0 | 0 |
Net cash used in financing activities | (77.1) | (24.4) | (700.5) |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 655 | 277.5 | (261.4) |
Cash, cash equivalents, and restricted cash at beginning of period | 825.2 | 547.7 | 809.1 |
Cash, cash equivalents, and restricted cash at end of period | 1,480.2 | 825.2 | 547.7 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest (net of amounts capitalized) | 22.3 | 18.7 | 5.5 |
Cash paid for income taxes | $ 205.6 | $ 754.8 | $ 481.4 |
Business Overview and Summary o
Business Overview and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Business Overview and Summary of Significant Accounting Policies | Business Overview and Summary of Significant Accounting Policies Organization and Business Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases. Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases, and rare diseases. The Company's products that have received marketing approval consist of EYLEA ® (aflibercept), Dupixent ® (dupilumab), Praluent ® (alirocumab), Kevzara ® (sarilumab), Libtayo ® (cemiplimab), ARCALYST ® (rilonacept), and ZALTRAP ® (ziv-aflibercept) . The Company is a party to collaboration agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3). The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for the treatment of serious diseases. The Company's business is subject to certain risks including, but not limited to, uncertainties relating to conducting pharmaceutical research, product development, obtaining regulatory approvals, market acceptance, competition, and obtaining and enforcing patents. Basis of Presentation The consolidated financial statements include the accounts of Regeneron and its wholly-owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation. Certain reclassifications have been made to prior period amounts to conform with the current period's presentation. We adopted Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers , as of January 1, 2018. The Company adopted the standard using the modified retrospective method, and thus recognized a cumulative-effect adjustment to reduce Retained earnings and increase Deferred revenue on January 1, 2018 by $143.4 million , net of tax. Prior period amounts have not been adjusted in connection with the adoption of this standard. The new standard did not have an impact on the recognition of revenue from product sales (see Note 2). However, the new standard has resulted in certain changes to the timing of revenue recognition related to our collaboration agreements (see Note 3). As a result of adopting ASC 606, non-refundable upfront payments, which were previously recognized ratably over the performance period, and substantive development milestones, which were previously recognized in the period when the milestone was achieved, will be recognized over the remaining performance period based on the Company's progress towards satisfying its identified performance obligation. The following tables summarize the impacts of adopting ASC 606 on the Company's consolidated financial statements as of and for the year ended December 31, 2018 compared with the guidance that was in effect before the change. December 31, 2018 Balance Sheet Data As Reported Adjustments Balance Without Adoption of ASC 606 Inventories $ 1,151.2 $ 17.5 $ 1,168.7 Deferred tax assets $ 828.7 $ 17.5 $ 846.2 Total assets $ 11,734.5 $ 35.0 $ 11,769.5 Accrued expenses and other current liabilities $ 772.1 $ (1.3 ) $ 770.8 Deferred revenue from Sanofi (current) $ 246.7 $ (93.0 ) $ 153.7 Deferred revenue - other (current) $ 205.8 $ (58.3 ) $ 147.5 Total current liabilities $ 1,442.8 $ (152.6 ) $ 1,290.2 Deferred revenue from Sanofi (noncurrent) $ 279.3 $ 163.2 $ 442.5 Deferred revenue - other (noncurrent) $ 184.9 $ 21.8 $ 206.7 Total liabilities $ 2,977.2 $ 32.4 $ 3,009.6 Retained earnings $ 5,254.3 $ 2.6 $ 5,256.9 Total stockholders' equity $ 8,757.3 $ 2.6 $ 8,759.9 Total liabilities and stockholders' equity $ 11,734.5 $ 35.0 $ 11,769.5 Year Ended December 31, 2018 Consolidated Statement of Operations Data As Reported Adjustments Balance Without Adoption of ASC 606 Sanofi collaboration revenue $ 1,111.1 $ (163.8 ) $ 947.3 Other revenue $ 416.8 $ (31.7 ) $ 385.1 Total revenues $ 6,710.8 $ (195.5 ) $ 6,515.3 Cost of collaboration and contract manufacturing $ 254.1 $ (17.5 ) $ 236.6 Income from operations $ 2,534.4 $ (178.0 ) $ 2,356.4 Income before income taxes $ 2,553.5 $ (178.0 ) $ 2,375.5 Income tax expense $ (109.1 ) $ 37.2 $ (71.9 ) Net income $ 2,444.4 $ (140.8 ) $ 2,303.6 The Company also adopted Accounting Standards Update ("ASU") 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, as of January 1, 2018 . The amendments require companies to measure equity investments at fair value with changes in fair value recognized in net income. Upon adoption, the Company recognized a cumulative-effect adjustment, related to unrealized gains on equity securities, to reduce Accumulated other comprehensive income and increase Retained earnings on January 1, 2018 by $6.6 million . See Note 4 and Note 5. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid debt instruments with a maturity of three months or less when purchased to be cash equivalents. The carrying amount reported in the Consolidated Balance Sheet for cash and cash equivalents approximates its fair value. Marketable Securities The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. We invest our cash primarily in debt securities of investment grade institutions. We consider our investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB"). These assets are carried at fair value and the unrealized gains and losses are included in Accumulated other comprehensive income (loss). Realized gains and losses on available-sale-sale debt securities are included in Other income (expense), net. We also have investments in equity securities that are carried at fair value with changes in fair value recognized within Other income (expense), net. We have elected to measure certain equity investments we hold that do not have readily determinable fair values at cost less impairment, if any, and adjust for observable price changes in orderly transactions for identical or similar investments of the same issuer. The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost are other-than-temporary. If a decline in the fair value of an available-for-sale debt security in the Company's investment portfolio is deemed to be other-than-temporary, the Company writes down the cost basis of the security to its current fair value and recognizes a loss as a charge against income. Accounts Receivable - Trade The Company's trade accounts receivable arise from product sales and represent amounts due from its distributors and specialty pharmacies (collectively, the Company's trade "customers"), which are all located in the United States. The Company monitors the financial performance and credit worthiness of its large customers so that it can properly assess and respond to changes in their credit profile. The Company provides reserves against trade receivables for estimated losses, if any, that may result from a customer's inability to pay. Amounts determined to be uncollectible are written-off against the reserve. Inventories Inventories are stated at the lower of cost or estimated realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes-down such inventories as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to write down such unmarketable inventory to its estimated realizable value. Property, Plant, and Equipment Property, plant, and equipment are stated at cost, net of accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the lease term. Costs of construction of certain long-lived assets include capitalized interest, which is amortized over the estimated useful life of the related asset. Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized in operations. The estimated useful lives of property, plant, and equipment are as follows: Building and improvements 10–50 years Laboratory and other equipment 3–10 years Furniture and fixtures 5 years The Company periodically assesses the recoverability of long-lived assets, such as property, plant, and equipment, and evaluates such assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Revenue Recognition a. Product Revenue Product revenue consists of U.S. sales of EYLEA, Libtayo, and ARCALYST. Revenue from product sales is recognized at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt by our distributors and specialty pharmacies. The Company's written contracts with its customers stipulate product is shipped freight on board destination (FOB destination). The Company sells its marketed products in the United States to several distributors and specialty pharmacies. Under these distribution models, the distributors and specialty pharmacies generally take physical delivery of product. For EYLEA and Libatyo, the distributors and specialty pharmacies generally sell the product directly to healthcare providers. The amount of revenue we recognize from product sales varies due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions. In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration that we will be entitled to. This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payer mix, and other relevant factors. The Company reviews its estimates of rebates, chargebacks, and other applicable provisions each period and records any necessary adjustments in the current period's net product sales. Government Rebates and Chargebacks: The Company estimates reductions to product sales for Medicaid and Veterans' Administration ("VA") programs, and for certain other qualifying federal and state government programs. Based upon the Company's contracts with government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, and estimated payer mix, the Company estimates and records an allowance for rebates and chargebacks. The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, and invoices received for claims from prior quarters that have not been paid. The Company's reserves related to discounted pricing to VA, Public Health Services ("PHS"), and other institutions (collectively "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., distributors and specialty pharmacies). The Company's customers charge the Company for the difference between what they pay for the products and the ultimate selling price to the qualified healthcare providers. The Company's reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Distribution-Related Fees: The Company has written contracts with its customers that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customers generally based on gross sales. Product Returns: Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date. The Company will accept returns for three months prior to and up to six months after the product expiration date. Product returned is generally not resalable given the nature of the Company's products and method of administration. The Company develops estimates for product returns based upon historical experience, shelf life of the product, and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customers of EYLEA and Libtayo to healthcare providers and ARCALYST to patients using product-specific data provided by its customers. If necessary, the Company's estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. Other Sales-Related Deductions : The Company estimates discounts and other sales-related deductions offered to customers, group purchasing organizations, and end-user customers, based on written contracts. The Company estimates and records other sales-related deductions generally based on gross sales. b. Collaboration Revenue We have entered into various agreements related to our activities to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms. The Company earns collaboration revenue in connection with collaboration agreements to utilize our technology platforms and develop and/or commercialize product candidates where we deem the collaborator to be our customer. As described above, during the first quarter of 2018, we adopted ASC 606. Under the terms of the new standard, revenue is measured as the amount of consideration we expect to be entitled to in exchange for transferring promised goods or providing services to a customer, and is recognized when (or as) we satisfy performance obligations under the terms of a contract. Depending on the terms of the arrangement, we may defer the recognition of all or a portion of the consideration received because the performance obligations are satisfied over time. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In agreements involving multiple goods or services promised to be transferred to a customer, we must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. The terms of these agreements typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, payments for development activities, as well as payments for commercialization activities, sales milestones, and sharing of profits or losses arising from the commercialization of products. At the inception of the contract, the transaction price reflects the amount of consideration we expect to be entitled to in exchange for transferring promised goods or services to our customer. In arrangements where we satisfy performance obligation(s) during the development phase over time, we recognize collaboration revenue over time typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion. We review our estimate of the transaction price and the total expected cost each period, and make revisions to such estimates as necessary. When we are entitled to reimbursement of all or a portion of the research and development expenses that we incur under a collaboration, we record those reimbursable amounts as collaboration revenue proportionately as we recognize our expenses. If the collaboration is a cost-sharing arrangement in which both we and our collaborator perform development work and share costs, we also recognize, as research and development expense in the period when our collaborator incurs development expenses, the portion of the collaborator's development expenses that we are obligated to reimburse. Our collaborators provide us with estimated development expenses for the most recent fiscal quarter. Under certain of the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company shares in any profits or losses arising from the commercialization of such products, and records its share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborator. Our collaborators provide us with estimates of our share of the profits or losses for such quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our share of the profit or loss is adjusted accordingly, as necessary In arrangements where the collaborator records product sales, the Company may be obligated to use commercially reasonable efforts to supply commercial product to its collaborators, and may be reimbursed for its manufacturing costs as commercial product is shipped to its collaborators; however, recognition of such cost reimbursements as collaboration revenue is deferred until the product is sold by the Company's collaborators to third-party customers. In addition, we may also be reimbursed for a portion of costs incurred for other commercial-related activities, which are recorded as collaboration revenue in the period in which such costs are incurred. Research and Development Expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to the Company's clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, preclinical development, and clinical trials, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services. Costs associated with research and development are expensed. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as contract research organizations ("CROs"), independent clinical investigators, and other third-party service providers to assist us with the execution of our clinical studies. For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators or CROs are expected to provide services. Clinical activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management. These start-up costs usually occur within a few months after the contract has been executed and are event-driven in nature. The remaining activities and related costs, such as patient monitoring and administration, generally occur ratably throughout the life of the individual contract or study. In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding down of the clinical trial and/or penalties. For clinical study sites, where payments are made periodically on a per-patient basis to the institutions performing the clinical study, we accrue expenses on an estimated cost-per-patient basis, based on subject enrollment and activity in each quarter. The amount of clinical study expense recognized in a quarter may vary from period to period based on the duration and progress of the study, the activities to be performed by the sites each quarter, the required level of patient enrollment, the rate at which patients actually enroll in and drop-out of the clinical study, and the number of sites involved in the study. Clinical trials that bear the greatest risk of change in estimates are typically those that have a significant number of sites, require a large number of patients, have complex patient screening requirements, and span multiple years. During the course of a trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates. Our estimates and assumptions for clinical expense recognition could differ significantly from our actual results, which could cause material increases or decreases in research and development expenses in future periods when the actual results become known. Stock-based Compensation The Company recognizes stock-based compensation expense for grants of stock option, restricted stock awards, and restricted stock units under the Company's Long-Term Incentive Plans to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award's requisite service period. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company's Common Stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions. Under this method, deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets will not be realized. Uncertain tax positions, for which management's assessment is that there is more than a 50% probability of sustaining the position upon challenge by a taxing authority based upon its technical merits, are subjected to certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. The Company adjusts the level of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. The Company recognizes interest and penalties related to income tax matters in income tax expense. Per Share Data Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Basic net income per share excludes restricted stock awards until vested. Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive. Common stock equivalents include: (i) outstanding stock options and restricted stock under the Company's Long-Term Incentive Plans, which are included under the "treasury stock method" when dilutive, (ii) if applicable, Common Stock to be issued upon the assumed conversion of the Company's convertible senior notes, which are included under the "if-converted method" when dilutive, and (iii) if applicable, Common Stock to be issued upon the exercise of outstanding warrants, which are included under the "treasury stock method" when dilutive. Concentration of Credit Risk Financial instruments which potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, certain financial instruments, and accounts receivable. In accordance with the Company's policies, the Company mandates asset diversification and monitors exposure with its counterparties. Concentrations of credit risk with respect to accounts receivable are significant. The Company has a concentration of credit risk associated with the receivables due from its collaborators Bayer, Sanofi, and Teva. The Company is also subject to credit risk with accounts receivable from its product sales, which are due from several distributors and specialty pharmacies (the Company's customers). As of December 31, 2018 and 2017, three individual customers accounted for 99% of the Company's net trade accounts receivable balances. The Company has contractual payment terms with each of its customers, and the Company monitors its customers' financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile. As of December 31, 2018 and 2017, there were no reserves against trade accounts receivable. In addition, during the years ended December 31, 2018, 2017, and 2016, the Company did no t recognize any charges for write-offs of trade accounts receivable. Recently Issued Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases . The new standard requires a lessee to recognize on its balance sheet (for both finance and operating leases) a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term. The amendments are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. We will adopt this new standard on January 1, 2019 (the "effective date") and use the effective date as our date of initial application. As such, we will not adjust prior period amounts. Furthermore, we expect to elect the practical expedients upon transition, which permit companies to not reassess lease identification, classification, and initial direct costs under the new standard for leases that commenced prior to the effective date. We have substantially completed the process of analyzing and extracting relevant data from the Company’s lease contracts. We are finalizing our evaluation of the impact that this guidance will have on our financial statements, including related disclosures, and expect to recognize additional right-of-use assets and corresponding lease liabilities related to operating leases of approximately $30 million as of January 1, 2019. We have also evaluated our facilities for which the Company has historically applied build-to-suit accounting, and do not expect a material impact on our financial statements upon adoption of the new standard. The ultimate impact that the new standard will have will depend on the total amount of the Company's lease commitments as of our first reporting period subsequent to the adoption date. We are also finalizing our implementation of a new lease accounting software system and updating our internal controls and processes. |
Product Sales
Product Sales | 12 Months Ended |
Dec. 31, 2018 | |
Revenues [Abstract] | |
Product Sales | Product Sales Net product sales consist of the following: Year Ended December 31, Net Product Sales in the United States 2018 2017 2016 EYLEA $ 4,076.7 $ 3,701.9 $ 3,323.1 Libtayo 14.8 — — ARCALYST 14.7 16.6 15.3 $ 4,106.2 $ 3,718.5 $ 3,338.4 The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for each of the years ended December 31, 2018 , 2017 , and 2016 . Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Year Ended December 31, 2018 2017 2016 Besse Medical, a subsidiary of AmerisourceBergen Corporation 56 % 51 % 55 % McKesson Corporation 36 % 29 % 28 % Curascript SD Specialty Distribution, a subsidiary of Express Scripts ** 19 % 16 % ** Sales to Curascript SD Specialty Distribution represented less than 10% of total gross product revenue during the period. Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts, distribution-related fees, and other sales-related deductions. Accruals for chargebacks and discounts are recorded as a direct reduction to accounts receivable. Accruals for rebates, distribution-related fees, and other sales-related deductions are recorded within accrued liabilities. The following table summarizes the provisions, and credits/payments, for these sales-related deductions for the years ended December 31, 2018 , 2017 , and 2016 . Rebates, Chargebacks, and Discounts Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2015 $ 6.4 $ 48.4 $ 0.5 $ 55.3 Provisions 93.4 154.4 30.4 278.2 Credits/payments (87.1 ) (173.3 ) (27.3 ) (287.7 ) Balance as of December 31, 2016 12.7 29.5 3.6 45.8 Provisions 167.8 194.1 46.4 408.3 Credits/payments (150.6 ) (189.5 ) (28.7 ) (368.8 ) Balance as of December 31, 2017 29.9 34.1 21.3 85.3 Provisions 223.4 211.0 44.5 478.9 Credits/payments (212.2 ) (203.1 ) (57.5 ) (472.8 ) Balance as of December 31, 2018 $ 41.1 $ 42.0 $ 8.3 $ 91.4 |
Collaboration and License Agree
Collaboration and License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements We have entered into various agreements related to our activities to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms. Significant agreements of this kind are described below. a. Sanofi Sanofi owned a total of 23,654,384 shares of our Common Stock as of December 31, 2018, a portion of which was purchased in connection with the companies' antibody collaboration described below. See Note 13 for a description of the investor agreement between us and Sanofi. The collaboration revenue we earned from Sanofi is detailed below: Year Ended December 31, Sanofi Collaboration Revenue 2018 2017 2016 Antibody: Reimbursement of Regeneron research and development expenses $ 265.3 $ 508.4 $ 564.9 Reimbursement of Regeneron commercialization-related expenses 417.2 368.8 305.9 Regeneron's share of losses in connection with commercialization of antibodies (227.0 ) (442.6 ) (459.0 ) Other 103.5 119.1 28.4 Total Antibody 559.0 553.7 440.2 Immuno-oncology: Reimbursement of Regeneron research and development expenses 311.8 240.0 138.5 Reimbursement of Regeneron commercialization-related expenses 8.9 7.0 — Other 231.4 76.5 80.0 Total Immuno-oncology 552.1 323.5 218.5 $ 1,111.1 $ 877.2 $ 658.7 Antibodies In November 2007, the Company entered into a global, strategic collaboration with Sanofi to discover, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration") . The Antibody Collaboration was governed by the companies' Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and a License and Collaboration Agreement (each as amended). In connection with the execution of the Antibody Discovery Agreement in 2007, the Company received a non-refundable up-front payment of $85.0 million from Sanofi. In addition, under the Antibody Discovery Agreement, Sanofi funded the Company's research to identify and validate potential drug discovery targets and develop fully human monoclonal antibodies against these targets. Pursuant to the Antibody Discovery Agreement, as amended, Sanofi agreed to fund the Company's research activities up to $130.0 million in both 2016 and 2017. The Company's Antibody Discovery Agreement with Sanofi ended on December 31, 2017 without any extension and, therefore, funding from Sanofi under the Antibody Discovery Agreement ceased after 2017. The Company accelerated the recognition of deferred revenue from the $85.0 million up-front payment and other payments in connection with Sanofi's decision to end the Antibody Discovery Agreement between the Company and Sanofi on December 31, 2017. The Company has the right to develop or continue to develop product candidates discovered under the Antibody Discovery Agreement, with the exception of those that are being developed (and commercialized, as applicable) under the Antibody License and Collaboration Agreement (Dupixent, Praluent, Kevzara, and REGN3500), independently, or with other collaborators. Under the License and Collaboration Agreement, following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate ("Shared Phase 3 Trial Costs") are shared 80% by Sanofi and 20% by Regeneron. The Company recognized as research and development expense $47.7 million , $91.8 million , and $108.6 million in 2018, 2017, and 2016, respectively, its share of antibody development expenses that Sanofi incurred related to Praluent, Kevzara, and Dupixent. All other agreed-upon worldwide development expenses incurred by both companies are funded by Sanofi. If the Antibody Collaboration becomes profitable, we will be obligated to reimburse Sanofi for 50% of worldwide development expenses that were fully funded by Sanofi and 30% of Shared Phase 3 Trial Costs, in accordance with a defined formula based on the amounts of these expenses and the Company's share of collaboration profits from commercialization of collaboration products. However, the Company is only required to apply 10% of its share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs. The Company's contingent reimbursement obligation to Sanofi under the Antibody Collaboration was approximately $2.786 billion as of December 31, 2018. Effective January 7, 2018, the Company and Sanofi entered into a letter agreement (the "Letter Agreement") in connection with, among other matters, the allocation of additional funds to certain activities relating to dupilumab and REGN3500 (collectively, the "Dupilumab/REGN3500 Eligible Investments"). Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement. During 2018, Sanofi elected to sell, and we elected to purchase (in cash), 10,766 shares of the Company's Common Stock in connection with Sanofi's funding obligation for Dupilumab/REGN3500 Eligible Investments. Consequently, we recorded the cost of the shares received, or $4.4 million , as Treasury Stock during 2018. Regeneron is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the Antibody Collaboration until commercial supplies of that drug candidate are being manufactured. Sanofi leads commercialization activities for products developed under the License and Collaboration Agreement, subject to the Company's right to co-promote such products. The Company has exercised its option to co-promote Praluent, Kevzara, and Dupixent in the United States and thus far has not exercised any of its options to co-promote Praluent, Kevzara, and Dupixent outside the United States. The parties equally share profits and losses from sales within the United States. The parties share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/ 35% (Regeneron) and ending at 55% (Sanofi)/ 45% (Regeneron), and losses outside the United States at 55% (Sanofi)/ 45% (Regeneron). In addition to profit and loss sharing, the Company is entitled to receive up to $250.0 million in sales milestone payments, with milestone payments commencing after aggregate annual sales of antibodies (subject to this agreement) outside the United States exceed $1.0 billion on a rolling twelve -month basis. "Reimbursement of Regeneron commercialization-related expenses" in the table above represents reimbursement of internal and external costs in connection with commercializing Praluent, Kevzara, and Dupixent. During the same periods that the Company recorded reimbursements from Sanofi related to the Company's commercialization expenses, the Company also recorded its share of losses in connection with the companies commercializing Praluent, Kevzara, and Dupixent within Sanofi collaboration revenue. In March and September 2017, the U.S. Food and Drug Administration ("FDA") and the European Commission, respectively, approved Dupixent for the treatment of adult patients with moderate-to-severe atopic dermatitis. In October 2018, the FDA also approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In May and June 2017, the FDA and the European Commission, respectively, approved Kevzara for the treatment of adult patients with rheumatoid arthritis. With respect to each antibody product in development under the License and Collaboration Agreement, Sanofi or the Company may, by giving twelve months' notice, opt-out of further development and/or commercialization of the product, in which event the other party retains exclusive rights to continue the development and/or commercialization of the product. The License and Collaboration Agreement contains other termination provisions, including for material breach by the other party. Upon termination of the collaboration in its entirety, the Company's obligation to reimburse Sanofi for development costs out of any future profits from collaboration products will terminate. The Company's significant promised goods and services consist of providing research and development services, including the manufacturing of clinical supplies, and providing commercial-related services, including the manufacturing of commercial supplies. As we recognize Sanofi antibody collaboration revenue in an amount equal to the amount we have the right to invoice and such amount corresponds directly with the value to Sanofi of our performance to date, we do not disclose the value of the transaction price allocated to our remaining unsatisfied performance obligations. The amount of variable consideration related to our share of profits and losses, as well as sales milestones, is deemed to be constrained as of December 31, 2018, and therefore has not been included in the transaction price. The following table summarizes accounts receivable and deferred revenue information in connection with the Company's Antibody Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 138.2 $ 121.0 Deferred revenue $ 236.1 $ 117.7 Significant changes in deferred revenue balances are as follows: Year Ended December 31, 2018 Increase due to shipments of commercial supplies to Sanofi $ 251.6 Revenue recognized that was included in deferred revenue at the beginning of the period $ (133.2 ) Immuno-Oncology In July 2015, the Company and Sanofi entered into a collaboration to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). The IO Collaboration is governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement"). In connection with the execution of the original Immuno-oncology Discovery and Development Agreement in 2015 ("2015 IO Discovery Agreement"), which has been replaced by the Amended IO Discovery Agreement (as discussed below), Sanofi made a $265.0 million non-refundable up-front payment to the Company. Pursuant to the 2015 IO Discovery Agreement, the Company was to spend up to $1,090.0 million ("IO Discovery Budget") to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept, and Sanofi was to reimburse the Company for up to $825.0 million ("IO Discovery Funding") of these costs, subject to certain annual limits. The original term of the 2015 IO Discovery Agreement was to continue through the later of five years from the effective date of the IO Collaboration or the date the IO Discovery Budget was exhausted, subject to Sanofi’s option to extend it for up to an additional three years for the continued development (and funding) of selected ongoing programs. Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the 2015 IO Discovery Agreement to developing therapeutic bi-specific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof of concept. The Amended IO Discovery Agreement provided for Sanofi’s payment of $461.9 million to the Company as consideration for (x) the termination of the 2015 IO Discovery Agreement, (y) the prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program, and (z) the reimbursement of costs incurred by the Company under the 2015 IO Discovery Agreement during the fourth quarter of 2018. Under the terms of the Amended IO Discovery Agreement, the Company is required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $70.0 million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program through the earlier of clinical proof of concept or the expenditure of $50.0 million (the "MUC16xCD3 Program Costs Cap"); provided that under certain circumstances, Sanofi will have the option to increase the MUC16xCD3 Program Costs Cap to $70.0 million by making a payment to the Company in the amount of $20.0 million . Pursuant to the Amended IO Discovery Agreement, we are primarily responsible for antibody development, preclinical activities, toxicology studies, manufacture of clinical supplies, filing of Investigational New Drug Applications ("INDs"), and clinical development through proof-of-concept. We are obligated to reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the IO Discovery Agreement from our share of future profits, if any, from commercialized IO Collaboration products to the extent they are sufficient for this purpose. However, the Company is only required to apply 10% of its share of the profits from IO Collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs. The Company's contingent reimbursement obligation to Sanofi under the IO Collaboration was approximately $58 million as of December 31, 2018. With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when clinical proof-of-concept is established, the applicable Program Costs Cap is reached, or in certain other limited circumstances, Sanofi will have the option to license rights to the product candidate and other antibodies targeting the same targets for, with regard to BCMAxCD3, immuno-oncology indications, and with regard to MUC16xCD3, all indications, pursuant to the IO License and Collaboration Agreement, as amended. If Sanofi does not exercise its option to license rights to a product candidate, the Company will retain the exclusive right to develop and commercialize such product candidate and Sanofi will receive a royalty on sales. Pursuant to the Amended IO Discovery Agreement, the parties agreed that (i) if Sanofi exercises its option with respect to a BCMAxCD3 Program antibody, Sanofi will lead the development and commercialization of such BCMAxCD3 Program antibody; and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) the Company will lead the development of such MUC16xCD3 Program antibody and commercialization of such MUC16xCD3 Program antibody within the United States and (y) Sanofi will lead the commercialization of such MUC16xCD3 Program antibody outside of the United States. The Amended IO Discovery Agreement provides that Regeneron retains exclusive rights to all other immuno-oncology programs that were part of the 2015 IO Discovery Agreement, provided that Sanofi will receive a royalty on global sales of two product candidates currently in clinical development, REGN3767 and REGN4659. The Amended IO Discovery Agreement will terminate as of the earlier of (a) Sanofi having elected to exercise or not exercise its options with respect to the BCMAxCD3 Program and the MUC16xCD3 Program in accordance with the terms of the Amended IO Discovery Agreement and (b) December 31, 2022. In connection with the IO License and Collaboration Agreement, Sanofi made a $375.0 million non-refundable up-front payment to the Company. If Sanofi exercises its option to license rights to a BCMAxCD3 Program antibody or MUC16xCD3 Program antibody thereunder, it will co-develop these drug candidates with the Company through product approval. Sanofi will fund development costs up front for a BCMAxCD3 Program antibody and we will reimburse half of the total development costs for such antibody from our share of future IO Collaboration profits to the extent they are sufficient for this purpose, subject to the same 10% reimbursement provision described above. In addition, we and Sanofi will share equally, on an ongoing basis, the development costs for a MUC16xCD3 Program antibody. Under the terms of the IO License and Collaboration Agreement, the parties are co-developing Libtayo (cemiplimab), an antibody targeting the receptor known as programmed cell death protein 1 (PD-1). The parties share equally, on an ongoing basis, agreed-upon development expenses for Libtayo. Pursuant to the Letter Agreement, the Libtayo development budget was increased and the Company has agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development and Dupilumab/REGN3500 Eligible Investments by selling up to an aggregate of 1,400,000 shares of our Common Stock directly or indirectly owned by Sanofi through September 30, 2020. If Sanofi desires to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or Dupilumab/REGN3500 Eligible Investments, we may elect to purchase, in whole or in part, such shares from Sanofi. If we do not elect to purchase such shares, Sanofi may sell the applicable number of shares (subject to certain daily and quarterly limits) in one or more open-market transactions. During 2018, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 215,387 shares of the Company's Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs. Consequently, we recorded the cost of the shares received, or $75.8 million , as Treasury Stock during 2018. The Company has principal control over the development of Libtayo and leads commercialization activities in the United States, while Sanofi will lead commercialization activities outside of the United States and the parties will equally share profits from worldwide sales. On September 28, 2018, the FDA approved Libtayo for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), and Sanofi has exercised its option to co-promote Libtayo in the United States. The Company will be entitled to a milestone payment of $375.0 million in the event that global sales of certain licensed products targeting PD-1 (including Libtayo), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with any of such licensed products targeting PD-1, equal or exceed $2.0 billion in any consecutive twelve -month period. The amount of variable consideration related to such milestone is deemed to be constrained as of December 31, 2018, and therefore has not been included in the transaction price. In August 2018, we and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo. Under the agreement, we and Sanofi made an up-front payment of $20.0 million and are obligated to pay royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5% from January 1, 2024 through December 31, 2026. The up-front payment was shared, and the royalties are shared, equally by us and Sanofi. Each party will have the right to co-promote licensed products in countries where it is not the lead commercialization party. The parties will share equally in profits and losses in connection with the commercialization of collaboration products. The Company is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured. With respect to each product candidate that enters development under the IO License and Collaboration Agreement, Sanofi or the Company may, by giving twelve months' notice, opt-out of further development and/or commercialization of the product, in which event the other party will retain exclusive rights to continue the development and/or commercialization of such product. At the inception of the IO Collaboration, the Company's significant promised goods and services consisted of a license to certain rights and intellectual property and providing research and development services, including the manufacturing of clinical supplies. The Company concluded that the license was not distinct, primarily as a result of (i) Sanofi being unable to benefit on its own or together with other resources that are readily available as the license provides access to Regeneron's complex and specialized know-how and (ii) the research and development services, including manufacturing in support of such services, were expected to significantly modify the initial license. Therefore, the promised goods and services were considered a single performance obligation. Consequently, the $640.0 million in aggregate up-front payments made by Sanofi during 2015 in connection with the execution of the IO Collaboration has been recorded as deferred revenue and has been included in the transaction price at the inception of the contract. "Other" Sanofi immuno-oncology revenue in the Sanofi Collaboration Revenue table above primarily includes recognition of deferred revenue from the $640.0 million of up-front payments. As it relates to the IO Collaboration, "Reimbursement of Regeneron commercialization-related expenses" in the table above represents reimbursement of costs by Sanofi in connection with the commercialization of Libtayo outside of the United States. The following table summarizes accounts receivable and deferred revenue information in connection with the Company's IO Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 77.9 $ 59.3 Deferred revenue $ 289.9 $ 440.0 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 93.6 Net decrease as a result of cumulative catch-up adjustments arising from changes in the estimate of the stage of completion $ (135.0 ) Revenue recognized that was included in deferred revenue at the beginning of the period $ (108.7 ) During 2018, we reduced our estimate of the total research and development costs expected to complete the contract, including in connection with entering into the Amended IO Discovery Agreement (as described above). The $135.0 million cumulative catch-up adjustments in the table above includes a $192.7 million adjustment related to the modification of the IO Discovery Agreement. The aggregate amount of the transaction price under the IO Collaboration allocated to the Company's performance obligation that was unsatisfied (or partially unsatisfied) as of December 31, 2018 was $1,398.4 million . This amount is expected to be recognized as revenue over the remaining period the Company is obligated to satisfy its performance obligation in connection with performing development activities. b. Bayer EYLEA outside the United States Revenue earned in connection with our Bayer EYLEA collaboration is as follows (note that the table excludes amounts in connection with our Bayer Ang2 antibody and PDGFR-beta antibody collaboration agreements, which are described below): Year Ended December 31, Bayer EYLEA Collaboration Revenue 2018 2017 2016 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 992.3 $ 802.3 $ 649.2 Reimbursement of Regeneron EYLEA development expenses 11.2 13.3 9.0 Other 73.6 58.7 52.6 $ 1,077.1 $ 874.3 $ 710.8 In October 2006, the Company entered into a license and collaboration agreement with Bayer for the global development and commercialization outside the United States of EYLEA. All agreed-upon EYLEA development expenses incurred by the Company and Bayer, under a global development plan, are shared equally. The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product of EYLEA. Bayer has the right to terminate the license and collaboration agreement without cause with at least six months' or twelve months' advance notice depending on defined circumstances at the time of termination. In the event of termination of the agreement for any reason, the Company retains all rights to EYLEA. Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In Japan, the Company is entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales. Within the United States, the Company is responsible for commercialization of EYLEA and retains exclusive rights to all profits from such commercialization in the United States. The Company is obligated to reimburse Bayer out of its share of the collaboration profits (including the Company's percentage of sales of EYLEA in Japan) for 50% of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option. The Company's contingent reimbursement obligation to Bayer was approximately $265 million as of December 31, 2018. Ang2 antibody and PDGFR-beta antibody outside the United States In 2016, the Company entered into an agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to angiopoietin-2 (Ang2), REGN910-3, for the treatment of ocular diseases or disorders. In connection with the agreement, Bayer made a $50.0 million non-refundable up-front payment and paid a portion of our global development costs and development costs exclusively for the territory outside the United States. In the fourth quarter of 2017, the Company reported that results from two Phase 2 studies of REGN910-3 did not provide sufficient differentiation to warrant Phase 3 development. Therefore, during the fourth quarter of 2017, the Company recognized $37.4 million of revenue related to the acceleration of the recognition of the remaining amount of deferred revenue from the up-front payment (which was initially recorded as deferred revenue) received from Bayer as the Company deemed its performance obligation to be satisfied. On November 1, 2018, the Company and Bayer agreed to terminate this collaboration agreement. In 2014, the Company entered into a license and collaboration agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), REGN2176-3. Effective in the first quarter of 2017, the Company discontinued clinical development of REGN2176-3, and on July 31, 2017, the Company and Bayer agreed to terminate this collaboration agreement. In 2017 and 2016, the Company recognized a total of $63.8 million and $33.5 million , respectively, of revenue in connection with its Ang2 and PDGFR-beta collaboration agreements with Bayer. Revenue recognized thereunder was not material in 2018. c. Teva In September 2016, the Company and Teva entered into a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation. In connection with the execution of the Teva Collaboration Agreement, Teva made a $250.0 million non-refundable up-front payment. The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan. Within the United States, the Company will lead commercialization activities, and the parties will share equally in any profits and losses in connection with commercialization of fasinumab. In the territory outside the United States, Teva will lead commercialization activities and the Company will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances). Unless terminated earlier in accordance with its provisions, the Teva Collaboration Agreement will continue to be in effect until such time as neither party is developing or commercializing fasinumab. In 2017, the Company earned, and recognized as substantive milestones, development milestones of $25.0 million and $35.0 million , respectively, from Teva upon initiation of two Phase 3 trials. During 2018, the Company achieved a development milestone of $60.0 million . The Company is entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1,890.0 million in contingent payments upon achievement of specified annual net sales amounts; the amount of variable consideration related to such milestones is deemed to be constrained as of December 31, 2018, and therefore has not been included in the transaction price. At the inception of the Teva Collaboration Agreement, the Company's significant promised goods and services consisted of a license to certain rights and intellectual property and providing research and development services, including the manufacturing of clinical supplies. The Company concluded that the license was not distinct, primarily as a result of (i) Teva being unable to benefit from the license on its own or together with other resources that are readily available as the license providing access to Regeneron's complex and specialized know-how and (ii) the research and development services, including manufacturing in support of such services, were expected to significantly modify the initial license. Therefore, the promised goods and services were considered a single performance obligation. Consequently, the $250.0 million up-front payment and development milestones received or receivable from Teva, as described above, have been recorded as deferred revenue and have been included in the transaction price. The Company recognized $244.6 million , $221.5 million , and $37.9 million of revenue in 2018, 2017, and 2016, respectively, in connection with the Teva Collaboration Agreement. The following tables summarize accounts receivable and deferred revenue information in connection with the Teva Collaboration Agreement: As of December 31, 2018 2017 Accounts receivable (recorded within Prepaid expenses and other current assets) $ 28.8 $ 71.3 Deferred revenue $ 194.5 $ 197.4 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 48.2 Increase due to amounts invoiced, excluding amounts recognized as revenue during the period $ 30.7 Revenue recognized that was included in deferred revenue at the beginning of the period $ (83.8 ) The aggregate amount of the transaction price under the Teva Collaboration Agreement allocated to the Company's performance obligation that was unsatisfied (or partially unsatisfied) as of December 31, 2018 was $472.2 million . This amount is expected to be recognized as revenue over the remaining period the Company is obligated to satisfy its performance obligation in connection with performing development activities. d. Other In addition to the collaboration agreements discussed above, the Company has various other collaboration agreements that are not individually, or in the aggregate, significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts upon the achievement of various development and commercial milestones which in the aggregate could be significant. The Company may also incur, or get reimbursed for, significant research and development costs if the related product candidate(s) were to advance to late stage clinical trials. In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay, or it may receive, royalties on future sales. The payment or receipt of these amounts, however, is contingent upon the occurrence of various future events. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities as of December 31, 2018 and 2017 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 5) as well as equity securities of publicly traded companies (see Note 5). The following tables summarize the Company's investments in available-for-sale debt securities: Amortized Unrealized Fair As of December 31, 2018 Cost Basis Gains Losses Value Available-for-sale debt securities: Corporate bonds $ 2,734.8 $ 1.0 $ (17.4 ) $ 2,718.4 U.S. government and government agency obligations 110.4 — (1.0 ) 109.4 Sovereign bonds 7.6 — — 7.6 Commercial paper 113.8 — — 113.8 Certificates of deposit 60.0 — — 60.0 $ 3,026.6 $ 1.0 $ (18.4 ) $ 3,009.2 As of December 31, 2017 Available-for-sale debt securities: Corporate bonds $ 1,718.0 $ 2.2 $ (7.7 ) $ 1,712.5 U.S. government and government agency obligations 186.7 — (1.2 ) 185.5 Municipal and sovereign bonds 4.6 — — 4.6 Commercial paper 107.0 — — 107.0 Certificates of deposit 11.0 — — 11.0 $ 2,027.3 $ 2.2 $ (8.9 ) $ 2,020.6 The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities listed as of December 31, 2018 mature at various dates through November 2023. The fair values of available-for-sale debt security investments by contractual maturity consist of the following: As of December 31, 2018 2017 Maturities within one year $ 1,342.2 $ 593.8 Maturities after one year through five years 1,667.0 1,426.8 $ 3,009.2 $ 2,020.6 The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual securities have been in a continuous unrealized loss position. Less than 12 Months 12 Months or Greater Total As of December 31, 2018 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 1,482.6 $ (6.1 ) $ 801.6 $ (11.3 ) $ 2,284.2 $ (17.4 ) U.S. government and government agency obligations — — 99.1 (1.0 ) 99.1 (1.0 ) $ 1,482.6 $ (6.1 ) $ 900.7 $ (12.3 ) $ 2,383.3 $ (18.4 ) As of December 31, 2017 Corporate bonds $ 931.0 $ (4.9 ) $ 256.8 $ (2.8 ) $ 1,187.8 $ (7.7 ) U.S. government and government agency obligations 110.5 (0.4 ) 67.9 (0.8 ) 178.4 (1.2 ) $ 1,041.5 $ (5.3 ) $ 324.7 $ (3.6 ) $ 1,366.2 $ (8.9 ) There were no other-than-temporary impairment charges recorded with respect to the Company's investments during 2018 and 2017. During the year ended December 31, 2016, the Company recorded an other-than-temporary impairment charge of $9.8 million related to its investment in an equity security. Realized gains and losses on sales of marketable securities were not material for the years ended December 31, 2018, 2017, and 2016. With respect to marketable securities, for the years ended December 31, 2018, 2017, and 2016, amounts reclassified from Accumulated other comprehensive (loss) income into Other income (expense), net were related to realized gains and losses on sales and the 2016 impairment charge on the equity security described above. The Company adopted ASU 2016-01 (see Note 1) during the first quarter of 2018; as a result, there were $41.9 million of net unrealized losses on equity securities recognized in Other income (expense), net for the year ended December 31, 2018. During the years ended December 31, 2017 and 2016, we recorded net unrealized gains of $14.7 million and net unrealized losses of $22.6 million , respectively, on equity securities in Other comprehensive (loss) income. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company's assets that are measured at fair value on a recurring basis consist of the following: Fair Value Measurements at Reporting Date Using As of December 31, 2018 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale debt securities: Corporate bonds $ 2,718.4 — $ 2,718.4 U.S. government and government agency obligations 109.4 — 109.4 Sovereign bonds 7.6 — 7.6 Commercial paper 113.8 — 113.8 Certificates of deposit 60.0 — 60.0 Equity securities (unrestricted) 43.6 $ 43.6 — Equity securities (restricted) 44.4 — 44.4 $ 3,097.2 $ 43.6 $ 3,053.6 As of December 31, 2017 Available-for-sale debt securities: Corporate bonds $ 1,712.5 — $ 1,712.5 U.S. government and government agency obligations 185.5 — 185.5 Municipal and sovereign bonds 4.6 — 4.6 Commercial paper 107.0 — 107.0 Certificates of deposit 11.0 — 11.0 Equity securities (unrestricted) 62.7 $ 62.7 — $ 2,083.3 $ 62.7 $ 2,020.6 Marketable securities included in Level 2 are valued using quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable. The Company considers market liquidity in determining the fair value for these securities. The Company did no t record any charges for other-than-temporary impairment of its Level 2 marketable securities in 2018 , 2017 , and 2016 . The Company held certain restricted equity securities as of December 31, 2018, which are subject to transfer restrictions until 2020. The fair value of interest rate swap and interest rate cap contracts, which were recorded within Other noncurrent assets , was not material as of December 31, 2018 and 2017, respectively (see Note 6). The fair value of these contracts was determined based on Level 2 inputs, using significant inputs that are observable either directly or indirectly, including London Interbank Offered Rate ("LIBOR") and interest rate swap rates. As of December 31, 2018 and 2017, the Company had $ 45.5 million and $37.5 million , respectively, in equity investments that do not have a readily determinable fair value. These investments are recorded at cost within Other noncurrent assets. |
Derivative Instruments and Hedg
Derivative Instruments and Hedging Activities | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Instruments and Hedging Activities | Derivative Instruments and Hedging Activities The Company is exposed to market fluctuations in interest rates, including those in connection with its March 2017 lease of laboratory and office facilities in Tarrytown, New York (see Note 12). Commencing in the second quarter of 2017, the Company entered into interest rate swap and interest rate cap agreements to manage a portion of such interest rate risk; no new agreements of this nature were entered into during the year ended December 31, 2018. All of the Company's derivative instruments are utilized for risk management purposes, and are not used for trading or speculative purposes. The Company's derivative instruments are designated as cash flow hedges for accounting purposes. Since the specific terms of the derivative instruments match those of the item being hedged, the derivative instruments are deemed to be highly effective in offsetting the changes in cash flows of the hedged item. As such, changes in the fair value of these derivatives are recorded in accumulated other comprehensive income (loss) until the underlying transaction affects earnings, and are then reclassified to earnings in the same account as the hedged transaction. The Company would record any gain or loss related to the ineffectiveness directly to earnings. The Company assesses, both at inception and on an ongoing basis, whether derivatives used continue to be highly effective in offsetting changes in cash flows of the hedged items. The Company does not exclude any portion of the cash flow hedge contracts from the assessment of hedge effectiveness. If and when a derivative is no longer expected to be highly effective, hedge accounting would be discontinued. The following table summarizes the notional amounts of the Company's outstanding interest rate swap and cap agreements: As of December 31, 2018 2017 Interest rate swap contracts $ 75.0 $ 75.0 Interest rate cap contracts $ 75.0 $ 75.0 As it relates to cash flow hedges, for the years ended December 31, 2018 and 2017, amounts of gains and losses recognized in Other comprehensive income (loss), and amounts reclassified from Accumulated other comprehensive (loss) income into Interest expense were not material. As of December 31, 2018 , the amounts expected to be reclassified out of Accumulated other comprehensive (loss) income into Interest expense over the next 12 months are not expected to be material. There was no ineffective portion of the derivative instruments for the years ended December 31, 2018 and 2017, respectively. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: As of December 31, 2018 2017 Raw materials $ 226.8 $ 190.0 Work-in-process 571.1 302.0 Finished goods 24.4 21.8 Deferred costs 328.9 212.3 $ 1,151.2 $ 726.1 Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred (see Note 1). |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, Plant, and Equipment Property, plant, and equipment consists of the following: As of December 31, 2018 2017 Land $ 199.0 $ 192.8 Building and improvements 1,507.2 1,441.6 Leasehold improvements 97.0 102.6 Construction-in-progress 469.6 408.9 Laboratory and other equipment 773.7 599.1 Furniture, computer and office equipment, and other 258.0 179.9 3,304.5 2,924.9 Less, accumulated depreciation and amortization (728.7 ) (566.3 ) $ 2,575.8 $ 2,358.6 As of December 31, 2018 and 2017 , $1,813.8 million and $1,692.9 million , respectively, of the Company's net property, plant, and equipment was located in the United States and $762.0 million and $665.7 million , respectively, was located in Europe (primarily in Ireland). Depreciation and amortization expense (including as it relates to capital and facility leases) on property, plant, and equipment amounted to $144.1 million , $142.2 million , and $104.7 million for the years ended December 31, 2018 , 2017 , and 2016 , respectively. Property, plant, and equipment, at cost, as of December 31, 2018 and 2017 included $723.9 million and $724.1 million , respectively, of leased property under the Company's capital and facility leases at its Tarrytown, New York facility. See Note 12. Accumulated amortization related to these assets amounted to $61.7 million and $47.9 million as of December 31, 2018 and 2017 , respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: As of December 31, 2018 2017 Accrued payroll and related costs $ 261.8 $ 191.8 Accrued clinical trial expense 142.2 120.9 Accrued sales-related charges, deductions, and royalties 182.7 194.5 Income taxes payable 20.8 0.2 Other accrued expenses and liabilities 164.6 129.8 $ 772.1 $ 637.2 |
Deferred Revenue
Deferred Revenue | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Deferred Revenue | Deferred Revenue Deferred revenue consists of the following: As of December 31, 2018 2017 Current portion: Received or receivable from Sanofi (see Note 3a) $ 246.7 $ 177.7 Received or receivable from Bayer (see Note 3b) 44.4 39.0 Received or receivable from Teva (see Note 3c) 92.5 43.5 Other 68.9 59.9 $ 452.5 $ 320.1 Long-term portion: Received or receivable from Sanofi (see Note 3a) $ 279.3 $ 379.9 Received or receivable from Bayer (see Note 3b) 45.1 29.7 Received or receivable from Teva (see Note 3c) 102.0 153.9 Other 37.8 65.7 $ 464.2 $ 629.2 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Debt a. Convertible Debt In October 2011, the Company issued $400.0 million aggregate principal amount of 1.875% convertible senior notes (the "Notes") in a private placement, and the Notes matured on October 1, 2016. The Notes were convertible, subject to certain conditions, into cash, shares of the Company's Common Stock, or a combination of cash and shares of Common Stock, at the Company's option. The Notes initial conversion price was $84.02 per share. In connection with the offering of the Notes, the Company entered into convertible note hedge ("call option") and warrant transactions with multiple counterparties, including an affiliate of the initial purchaser of the Notes. The convertible note hedge covered, subject to customary anti-dilution adjustments, the number of shares of the Company's Common Stock that initially underlie the Notes, and were intended to reduce the potential dilutive impact of the conversion feature of the Notes. During 2016, the Company settled conversion obligations for $12.9 million principal amount of the Company's Notes. Consequently, in 2016, the Company paid $12.9 million in cash and issued 121,058 shares of Common Stock. In addition, the Company allocated $47.8 million of the settlement consideration provided to the Note holders to the reacquisition of the equity component of the Notes, and recognized such amount as a reduction of stockholders' equity. The loss on the debt extinguishment in connection with the Notes that were surrendered for conversion during 2016 was not material. As a result of these Note conversions, the Company also exercised a proportionate amount of its convertible note hedges during 2016, for which the Company received 121,048 shares of Common Stock, which was approximately equal to the number of shares the Company was required to issue to settle the non-cash portion of the related Note conversions. The Company recorded the cost of the shares received, or $10.2 million , as Treasury Stock during 2016. Total interest expense associated with the Notes, net of capitalized interest as applicable, was not material in 2016. Warrant Transactions During 2015 and 2016, the Company entered into amendment agreements with warrant holders whereby the parties agreed to reduce a portion of the number of warrants held by the warrant holders. The Company was able to settle, at its option, any payments due under the amendment agreement in cash or by delivering shares of Common Stock. As a result of the warrant holders closing out a portion of their hedge positions, the Company paid a total of $242.2 million in 2016 to reduce the number of warrants held by such warrant holders. In addition, during 2016, the Company and warrant holders entered into warrant termination agreements whereby the parties agreed to cancel the remaining warrants held by the warrant holders and to terminate the respective warrant agreements in consideration for payments by the Company of $401.2 million in the aggregate. The Company made the termination payments in 2016, and, as a result, no warrants remained outstanding as of December 31, 2016. b. Credit Facility In December 2018, we entered into an agreement with a syndicate of lenders (the "Credit Agreement") which provides for a $750.0 million senior unsecured five -year revolving credit facility (the "Credit Facility"), and contemporaneously terminated our then-existing credit agreement (the "Prior Credit Agreement"). The Credit Agreement was entered into on terms substantially similar to those of the Prior Credit Agreement. No borrowings were outstanding under the Prior Credit Agreement at the time of its termination. The Credit Agreement includes an option for us to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $250.0 million , subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions. Proceeds of the loans under the Credit Facility may be used to finance working capital needs, and for general corporate or other lawful purposes, of Regeneron and its subsidiaries. The Credit Agreement also provides a $50.0 million sublimit for letters of credit. The Credit Agreement includes an option for us to elect to extend the maturity date of the Credit Facility beyond December 2023, subject to the consent of the extending lenders and certain other conditions. Amounts borrowed under the Credit Facility may be prepaid, and the commitments under the Credit Facility may be terminated, at any time without premium or penalty. We had no borrowings outstanding under the Credit Facility as of December 31, 2018 . The Credit Agreement contains financial and operating covenants. The Company was in compliance with all covenants of the Credit Facility as of December 31, 2018. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies See Note 17 for disclosures related to legal contingencies. a. Leases The Company leases laboratory and office facilities in Tarrytown, New York (the "Tarrytown Leases"). Prior to December 30, 2016, certain of the premises under the Tarrytown Leases had been accounted for as operating leases, while for certain other buildings the Company leased, the Company was deemed, in substance, to be the owner of the landlord's buildings (collectively, the "Build-to-Suit Buildings") in accordance with the application of FASB authoritative guidance. In 2016, the Company entered into a Purchase Agreement with BMR-Landmark at Eastview LLC and BMR-Landmark at Eastview IV LLC (collectively, "BMR"), pursuant to which the Company agreed to purchase BMR's Tarrytown, New York facilities (the "Facility") for a purchase price of $720.0 million . The Company occupied a significant portion of the Facility, with the remaining rentable area under leases to third-party tenants. In accordance with the terms of the Purchase Agreement, the Company paid $57.0 million toward the purchase price to BMR in December 2016. In March 2017, the Company also entered into a Participation Agreement with Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively, the "Participants"). The Participation Agreement provided for lease financing in connection with the acquisition by BAL of the Facility and the Company's lease of the Facility from BAL. On March 3, 2017, the right to take title to the Facility under the Purchase Agreement was assigned by the Company to BAL, and the Participants advanced $720.0 million , which was used by BAL to finance the purchase price for the Facility and to reimburse the Company for the $57.0 million payment made to BMR in December 2016. The $57.0 million reimbursement was recorded by the Company in March 2017 as an increase to capital and facility lease obligations in amounts equal to those initially recorded as reductions upon making such payment to BMR in December 2016. In March 2017, the Company entered into a lease agreement (the "Lease") with BAL, pursuant to which the Company has leased the Facility from BAL for a five -year term. As a result of entering into the Lease, certain parts of the Facility became subleased from the Company by existing third-party tenants. The Lease requires the Company to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. The Company is also required to make monthly payments of basic rent during the term of the Lease in an amount equal to a variable rate per annum based on the one-month LIBOR, plus an applicable margin that varies with the Company’s debt rating and total leverage ratio. The Participation Agreement and the Lease include an option for the Company to elect to extend the maturity date of the Participation Agreement and the term of the Lease for an additional five -year period, subject to the consent of all the Participants and certain other conditions. The Company also has the option prior to the end of the term of the Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Participation Agreement, all accrued and unpaid interest and yield thereon, and all other outstanding amounts under the Participation Agreement, the Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL. The advances under the Participation Agreement mature, and all amounts outstanding thereunder will become due and payable in full at the end of the term of the Lease. As a result of entering into the Lease, the premises that were classified as a capital lease as of December 31, 2016 were reassessed. The Company has the option to purchase the Facility (under terms that made it reasonably assured to be exercised), and as a result, the Company is deemed to have continuing involvement in such premises. Accordingly, these premises continue to be classified as a capital lease, with the related property, plant, and equipment and capital lease liability remaining on the Company's Consolidated Balance Sheet. In addition, upon entering into the Lease, the Company began to lease space occupied by third-party tenants. The lease of such premises is also classified as a capital lease. The execution of the Lease did not impact the balance sheet classification for the Build-to-Suit Buildings. However, in 2017, the Company recorded a $30.1 million loss on extinguishment of debt associated with the Build-to-Suit Buildings. In the aggregate, the Company had $720.0 million of capital and facility lease obligations upon execution of the Lease for the Facility. The Participation Agreement and the Lease contain financial and operating covenants, which are substantially similar to the covenants set forth in the Company's credit facility (see Note 11). The Company was in compliance with all covenants of the Participation Agreement and the Lease as of December 31, 2018. Commitments under Operating Leases The estimated future minimum noncancelable lease commitments under existing operating leases, as of December 31, 2018, are as follows: Facilities Equipment Total 2019 $ 4.2 $ 6.2 $ 10.4 2020 3.6 0.2 3.8 2021 3.3 0.1 3.4 2022 2.2 — 2.2 2023 1.5 — 1.5 Thereafter 4.1 — 4.1 $ 18.9 $ 6.5 $ 25.4 Rent expense under operating leases was: Year Ended December 31, Facilities Equipment Total 2018 $ 3.7 $ 1.2 $ 4.9 2017 $ 3.1 $ 1.2 $ 4.3 2016 $ 15.9 $ 0.9 $ 16.8 Capital and Facility Lease Obligations In 2018, 2017, and 2016, the Company recognized $21.5 million , $19.5 million , and $5.4 million , respectively, of interest expense in connection with the Company's capital and facility lease obligations. As of December 31, 2018, the estimated future minimum noncancelable commitments under the Company's capital and facility lease obligations, excluding the purchase price the Company would be obligated to pay if the Company were to exercise its option to purchase the Facility (as described above), are as follows: Capital and Facility Lease Obligations 2019 $ 26.4 2020 28.4 2021 27.9 2022 7.0 2023 — Thereafter — $ 89.7 b. Research Collaboration and Licensing Agreements As part of the Company's research and development efforts, the Company enters into research collaboration and licensing agreements with other companies, universities, and other organizations. These agreements contain varying terms and provisions which include fees to be paid by the Company, services to be provided, and license rights to certain proprietary technology developed under the agreements. Some of these agreements may require the Company to pay additional amounts upon the achievement of various development and commercial milestones, contingent upon the occurrence of various future events. Additionally, we have in-license patent and/or technology agreements which contain provisions which require the Company to pay royalties, as defined, at rates that range from 0.5% to 11.5% , in the event the Company sells or licenses any proprietary products developed under the respective agreements. The Company also has contingent reimbursement obligations to its collaborators Sanofi and Bayer once the applicable collaboration becomes profitable. See Note 3 for a more detailed description of collaboration agreements. The Company and Genentech, a member of the Roche Group, entered into a Non-Exclusive License and Partial Settlement Agreement, as amended (the "Genentech Agreement"), that covered making, using, and selling EYLEA for the prevention of human eye diseases and disorders, and ended the litigation relating to those matters. Pursuant to the Genentech Agreement, the Company received a non-exclusive license to certain patents relating to VEGF receptor proteins, known as the Davis-Smyth patents, and other technology patents. The Genentech Agreement obligated the Company to make payments to Genentech based on worldwide sales of EYLEA through May 7, 2016, when the licenses granted to the Company thereunder became fully paid up and royalty free for the duration of the remaining term of the underlying patents. All payments to Genentech under the Genentech Agreement were made by the Company, and Bayer shared in all such payments based on the proportion of EYLEA sales outside the United States to worldwide EYLEA sales. For the years ended December 31, 2018, 2017, and 2016, the Company recorded royalty expense of $36.7 million , $30.8 million , and $125.3 million , respectively, based on product sales of commercial products under various licensing agreements (including, in 2016, the Genentech Agreement described above). |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity The Company's Restated Certificate of Incorporation, as amended, provides for the issuance of up to 40 million shares of Class A Stock, par value $0.001 per share, and 320 million shares of Common Stock, par value $0.001 per share. Shares of Class A Stock are convertible, at any time, at the option of the holder into shares of Common Stock on a share-for-share basis. Holders of Class A Stock have rights and privileges identical to Common Stockholders except that each share of Class A is entitled to ten votes per share, while each share of Common Stock is entitled to one vote per share. Class A Stock may only be transferred to specified Permitted Transferees, as defined. Under the Company's Restated Certificate of Incorporation, the Company's board of directors is authorized to issue up to 30 million shares of Preferred Stock, in series, with rights, privileges, and qualifications of each series determined by the board of directors. In December 2007, Sanofi purchased 12 million newly issued, unregistered shares of the Company's Common Stock. As a condition to the closing of this transaction, Sanofi entered into an investor agreement, as amended and restated, with the Company. Under the terms of the amended and restated investor agreement, Sanofi has three demand rights to require the Company to use all reasonable efforts to conduct a registered underwritten public offering with respect to shares of the Company's Common Stock held by Sanofi from time to time. Under the amended and restated investor agreement, Sanofi has also agreed not to dispose of any shares of the Company's Common Stock beneficially owned by Sanofi from time to time until December 20, 2020 (subject to the limited waiver described below). These restrictions on dispositions are subject to earlier termination upon the occurrence of certain events, such as the consummation of a change-of-control transaction involving the Company or the Company's dissolution or liquidation, and certain restrictions have been imposed on the manner of sales thereafter. As described in Note 3, effective January 7, 2018, the Company and Sanofi entered into a Letter Agreement, which, among other things, has amended certain provisions of the amended and restated investor agreement. Pursuant to the Letter Agreement, the Company has granted Sanofi a limited waiver of the lock-up obligations under the investor agreement to allow Sanofi to sell up to an aggregate of 1,400,000 shares (of which 1,173,847 shares remain available to be sold as of December 31, 2018) of the Company's Common Stock held by Sanofi for the quarterly periods through September 30, 2020. Further, pursuant to the amended and restated investor agreement, Sanofi is bound by certain "standstill" provisions, which contractually prohibit Sanofi from seeking to directly or indirectly exert control of the Company or acquiring more than 30% of the outstanding shares of the Company's Class A Stock and Common Stock (taken together). This prohibition will remain in place until the earliest of (i) the later of the fifth anniversaries of the expiration or earlier termination of the Company's License and Collaboration Agreement with Sanofi and the Company's ZALTRAP Agreement with Sanofi, each as amended, and (ii) other specified events. Sanofi has also agreed to vote as recommended by the Company's board of directors, except that it may elect to vote proportionally with the votes cast by all of the Company's other shareholders with respect to certain change-of-control transactions, and to vote in its sole discretion with respect to liquidation or dissolution, stock issuances equal to or exceeding 20% of the outstanding shares or voting rights of the Company's Class A Stock and Common Stock (taken together), and new equity compensation plans or amendments if not materially consistent with the Company's historical equity compensation practices. The rights and restrictions under the investor agreement are subject to termination upon the occurrence of certain events. In addition, upon Sanofi reaching 20% ownership of the Company's outstanding shares of Class A Stock and Common Stock (taken together) during 2014, the Company was required to appoint an individual agreed upon by the Company and Sanofi to the Company's board of directors. This individual is required to be independent of the Company, and not to be a current or former officer, director, employee, or paid consultant of Sanofi. Subject to certain exceptions, the Company is required to use its reasonable efforts (including recommending that its shareholders vote in favor) to cause the election of this designee at the Company's annual shareholder meetings for so long as (other than during the term of the Letter Agreement) Sanofi maintains a specified equity interest in the Company. In connection with the Company's license and collaboration agreements with Bayer for the joint development and commercialization outside the United States of antibody product candidates to PDGFR-beta and Ang2 (see Note 3b), Bayer is bound by certain "standstill" provisions, which contractually prohibit Bayer from seeking to influence the control of the Company or acquiring more than 20% of the Company's outstanding shares of Class A Stock and Common Stock (taken together). With respect to each of these agreements, this prohibition will remain in place until the earliest of (i) the fifth anniversary of the expiration or earlier termination of the agreement (which, in the case of the PDGFR-beta license and collaboration agreement, occurred on July 31, 2017, and, in the case of the Ang2 agreement, occurred on November 1, 2018) or (ii) other specified events. Further, pursuant to the 2016 Teva Collaboration Agreement, Teva and its affiliates are bound by certain "standstill" provisions, which contractually prohibit them from seeking to directly or indirectly exert control of the Company or acquiring more than 5% of the Company's Class A Stock and Common Stock (taken together). This prohibition will remain in place until the earliest of (i) the fifth anniversary of the expiration or earlier termination of the agreement or (ii) other specified events. |
Long-Term Incentive Plans
Long-Term Incentive Plans | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Long-Term Incentive Plans | Long-Term Incentive Plans The Company has used long-term incentive plans for the purpose of granting equity awards to employees of the Company, including officers, and nonemployees, including consultants and nonemployee members of the Company's board of directors (collectively, "Participants"). The Participants may receive awards as determined by a committee of independent members of the Company's board of directors or, to the extent authorized by such committee with respect to certain Participants, a duly authorized employee (collectively, the "Committee"). The incentive plan currently used by the Company is the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (the "Amended and Restated 2014 Incentive Plan"). It was adopted in 2017 and the Company registered an additional 12,000,000 shares of Common Stock for issuance thereunder. As of the shareholder approval date, the Amended and Restated 2014 Incentive Plan provided for the issuance of up to 18,559,431 shares of Common Stock in respect of awards. In addition, upon expiration, forfeiture, surrender, exchange, cancellation, or termination of any award previously granted under the Amended and Restated 2014 Incentive Plan, the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (the "Original 2014 Incentive Plan"), or the Second Amended and Restated 2000 Long-Term Incentive Plan (the predecessor to the Original 2014 Incentive Plan), any shares subject to such award are added to the pool of shares available for grant under the Amended and Restated 2014 Incentive Plan. The awards that may be made under the Amended and Restated 2014 Incentive Plan include: (a) incentive stock options and nonqualified stock options, (b) shares of restricted stock, (c) shares of phantom stock (also referred to as restricted stock units), and (d) other awards. Stock option awards grant Participants the right to purchase shares of Common Stock at prices determined by the Committee, with exercise prices that are equal to or greater than the average of the high and low market prices of the Company's Common Stock on the date of grant (the "Market Price"). Options vest over a period of time determined by the Committee, generally on a pro rata basis over a three - to four -year period. The Committee also determines the expiration date of each option. The maximum term of options that have been awarded under the 2000 Incentive Plan, the Original 2014 Incentive Plan, and the Amended and Restated 2014 Incentive Plan (collectively, the "Incentive Plans") is ten years. Restricted stock awards grant Participants shares of restricted Common Stock or allow Participants to purchase such shares at a price determined by the Committee. Such shares are nontransferable for a period determined by the Committee ("vesting period"). Should employment terminate, as specified in the Incentive Plans, except as determined by the Committee in its discretion and subject to the applicable Incentive Plan documents, the ownership of any unvested restricted stock will be transferred to the Company. Phantom stock awards provide the Participant the right to receive, within 30 days of the date on which the share vests, an amount, in cash and/or shares of Common Stock as determined by the Committee, equal to the sum of the fair market value of a share of Common Stock on the date such share of phantom stock vests and the aggregate amount of cash dividends paid with respect to a share of Common Stock during the period from the grant date of the share of phantom stock to the date on which the share vests. The Incentive Plans contain provisions that allow for the Committee to provide for the immediate vesting of awards upon a change in control of the Company, as defined in the Incentive Plans. As of December 31, 2018 , there were 12,115,845 shares available for future grants under the Amended and Restated 2014 Incentive Plan. No additional awards may be made under the 2000 Incentive Plan or the Original 2014 Incentive Plan. a. Stock Options Transactions involving stock option awards during 2018 under the Company's Incentive Plans are summarized in the table below. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Intrinsic Value Outstanding as of December 31, 2017 26,205,373 $ 295.98 2018: Granted 4,665,320 $ 378.51 Forfeited (668,550 ) $ 422.56 Expired (205,030 ) $ 467.40 Exercised (1,717,417 ) $ 66.87 Outstanding as of December 31, 2018 28,279,696 $ 319.28 6.43 $ 2,290.5 Vested and expected to vest as of December 31, 2018 27,192,461 $ 316.51 6.32 $ 2,289.1 Exercisable as of December 31, 2018 17,893,976 $ 275.10 4.98 $ 2,276.2 The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock. The total intrinsic value of stock options exercised during 2018 , 2017 , and 2016 was $510.6 million , $735.6 million , and $550.4 million , respectively. The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option. The table below summarizes the weighted-average exercise prices and weighted-average grant-date fair values of options issued during the years ended December 31, 2018 , 2017 , and 2016 . The fair value of each option granted under the Company's Incentive Plans during these periods was estimated on the date of grant using the Black-Scholes option-pricing model. Number of Options Granted Weighted-Average Exercise Price Weighted-Average Fair Value 2018: Exercise price equal to Market Price 4,665,320 $ 378.51 $ 114.39 2017: Exercise price equal to Market Price 4,235,015 $ 383.56 $ 118.70 2016: Exercise price equal to Market Price 4,201,978 $ 386.44 $ 126.68 For the years ended December 31, 2018 , 2017 , and 2016 , the Company recognized $421.8 million , $492.8 million , and $546.0 million , respectively, of non-cash stock-based compensation expense related to stock option awards (net of amounts capitalized to inventory of $17.1 million , $16.8 million , and $14.6 million , respectively). As of December 31, 2018 , there was $702.6 million of stock-based compensation cost related to outstanding stock options, net of estimated forfeitures, which had not yet been recognized. The Company expects to recognize this compensation cost over a weighted-average period of 1.9 years. Fair Value Assumptions: The following table summarizes the weighted average values of the assumptions used in computing the fair value of option grants during 2018 , 2017 , and 2016 . 2018 2017 2016 Expected volatility 29 % 31 % 34 % Expected lives from grant date 4.9 years 5.1 years 5.1 years Expected dividend yield 0 % 0 % 0 % Risk-free interest rate 2.69 % 2.16 % 1.84 % Expected volatility has been estimated based on actual movements in the Company's stock price over the most recent historical periods equivalent to the options' expected lives. Expected lives are principally based on the Company's historical exercise experience with previously issued employee and board of directors' option grants. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. The risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the options' expected lives. b. Restricted Stock Awards and Restricted Stock Units A summary of the Company's activity related to restricted stock awards and restricted stock units (collectively, "restricted stock") during 2018 is summarized below: Number of Shares/Units Weighted-Average Grant Date Fair Value Balance as of December 31, 2017 106,260 $ 404.72 2018: Granted 380,980 $ 381.21 Vested (6,090 ) $ 276.46 Forfeited/Cancelled (8,520 ) $ 478.19 Balance as of December 31, 2018 472,630 $ 386.10 The Company recognized non-cash stock-based compensation expense from restricted stock of $5.6 million , $14.5 million , and $13.9 million in 2018 , 2017 , and 2016 , respectively (net of amounts capitalized to inventory, which were not material for each of the three years). As of December 31, 2018 , there was $124.4 million of stock-based compensation cost related to unvested restricted stock which had not yet been recognized. The Company expects to recognize this compensation cost over a weighted-average period of 4.6 years. |
Employee Savings Plan
Employee Savings Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Savings Plan | Employee Savings Plans The Company maintains the Regeneron Pharmaceuticals, Inc. 401(k) Savings Plan, as amended and restated (the "Savings Plan"). The terms of the Savings Plan allow U.S. employees (as defined by the Savings Plan) to contribute to the Savings Plan a percentage of their compensation. In addition, the Company may make discretionary contributions ("Contribution"), as defined, to the accounts of participants under the Savings Plan. The Company recognized $27.0 million , $19.6 million , and $17.7 million of Contribution expense in 2018 , 2017 , and 2016 , respectively. The Company also maintains the Regeneron Ireland Pension Plan (the "Ireland Plan"), a defined contribution occupational pension plan which covers all eligible Ireland-based employees (as defined by the Ireland Plan). Contributions to the Ireland Plan are comprised of two components: (i) a minimum mandatory employee and employer contribution rate, and (ii) a matching feature, whereby the Company will match employee contributions up to a certain percentage. Employees can make additional voluntary contributions to the Ireland Plan. Expenses recognized by the Company related to contributions to the Ireland Plan were not material during 2018 , 2017 , and 2016 . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company is subject to U.S. federal, state, and foreign income taxes. Components of income before income taxes consist of the following: Year Ended December 31, 2018 2017 2016 United States $ 2,151.7 $ 1,964.7 $ 1,650.9 Foreign 401.8 113.8 (321.1 ) $ 2,553.5 $ 2,078.5 $ 1,329.8 Components of income tax expense consist of the following: Year Ended December 31, 2018 2017 2016 Current: Federal $ 223.7 $ 560.3 $ 787.0 State 4.8 (4.1 ) 8.8 Foreign 20.6 4.8 (1.4 ) Total current tax expense 249.1 561.0 794.4 Deferred: Federal 687.6 317.1 (377.4 ) State (1.9 ) (1.3 ) 13.4 Foreign (825.7 ) 3.2 3.9 Total deferred tax (benefit) expense (140.0 ) 319.0 (360.1 ) $ 109.1 $ 880.0 $ 434.3 On December 22, 2017, the bill known as the "Tax Cuts and Jobs Act" (the "Act") was signed into law. The Act, which became effective with respect to most of its provisions as of January 1, 2018, significantly revised U.S. corporate income tax laws by, among other things, reducing the U.S. federal corporate income tax rate from 35% to 21% , changing the taxation of foreign earnings (including taxation of certain global intangible low-taxed income ("GILTI")), allowing for a foreign-derived intangible income deduction and immediate expensing for qualified assets, repealing the deduction for domestic manufacturing, and imposing further limitations on the deductibility of executive compensation. As a result of the Act being signed into law, the Company recognized a provisional charge of $326.2 million in the fourth quarter of 2017 related to the re-measurement of its U.S. net deferred tax assets at the lower enacted corporate tax rate. The provisional charge recorded in the fourth quarter of 2017 was an estimate, and the measurement of deferred tax assets was subject to further analysis, such as developing interpretations and clarifications of the provisions of the Act. During 2018, we recorded an income tax benefit of $68.0 million as an adjustment to the provisional amount recorded as of December 31, 2017, which was partly attributable to our election to record deferred tax assets and liabilities for expected amounts of GILTI inclusions. Our assessment of the re-measurement of U.S. net deferred tax assets at the lower enacted corporate tax rate is now complete. A reconciliation of the U.S. statutory income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2018 2017 2016 U.S. federal statutory tax rate 21.0 % 35.0 % 35.0 % Impact of change in U.S. corporate tax rate (the Act) (2.7 ) 15.7 — Sale of non-inventory related assets between foreign subsidiaries (6.3 ) — — Stock-based compensation (2.5 ) (9.0 ) (10.9 ) Taxation of non-U.S. operations (1.9 ) 0.7 8.8 Income tax credits (2.6 ) (1.3 ) (1.2 ) Non-deductible Branded Prescription Drug Fee 0.6 1.7 1.9 Foreign-derived intangible income deduction (1.0 ) — — Domestic production activities deduction — (2.6 ) (2.8 ) State and local income taxes 0.1 0.1 1.3 Other permanent differences (0.4 ) 2.0 0.6 Effective income tax rate 4.3 % 42.3 % 32.7 % In 2018 , the difference between the U.S. federal statutory rate of 21% and the Company's effective tax rate of 4.3% was primarily attributable to the impact of the Company's sale of non-inventory related assets between foreign subsidiaries (including the associated impact of global intangible low-taxed income), as well as the federal tax credit for research activities, stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, and the tax benefit associated with tax planning in connection with the Act. In 2017 , the difference between the U.S. federal statutory rate of 35% and the Company's effective tax rate of 42.3% was primarily attributable to the negative impact of the charge related to the re-measurement of the Company's U.S. net deferred tax assets upon the enactment of the Act (see above), partly offset by the tax benefit associated with stock-based compensation. In 2016 , the difference between the U.S. federal statutory rate of 35% and the Company's effective tax rate of 32.7% was primarily attributable to the tax benefit associated with stock-based compensation, partly offset by the negative impact of losses incurred in foreign jurisdictions with rates lower than the U.S. federal statutory rate. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets and liabilities are as follows: As of December 31, 2018 2017 Deferred tax assets: Deferred compensation $ 458.2 $ 391.0 Fixed assets and intangible assets 107.8 — Deferred revenue 20.2 102.4 Accrued expenses 53.3 38.3 Other 33.3 26.5 672.8 558.2 Valuation allowance — (4.2 ) Total deferred tax assets 672.8 554.0 Deferred tax liabilities: Fixed assets and intangible assets — (44.6 ) Other (2.7 ) (3.1 ) Total deferred tax liabilities (2.7 ) (47.7 ) Net deferred tax assets $ 670.1 $ 506.3 The Company's 2013 through 2017 federal income tax returns remain open to examination by the IRS. The Company's 2013 and 2015 federal income tax returns are currently under audit by the IRS. In general, the Company's state income tax returns from 2015 to 2017 remain open to examination. The United States and many states generally have statutes of limitation ranging from 3 to 5 years; however, those statutes could be extended due to the Company's net operating loss and tax credit carryforward positions in a number of the Company's tax jurisdictions. In general, tax authorities have the ability to review income tax returns for loss periods in which the statute of limitation has previously expired to adjust the net operating loss carryforward or tax credits generated in those years. The following table summarizes the gross amounts of unrecognized tax benefits. The amount of unrecognized tax benefits that, if settled, would impact the effective tax rate is $189.5 million , $146.2 million , and $107.2 million as of December 31, 2018 , 2017 , and 2016 , respectively. 2018 2017 2016 Balance as of January 1 $ 146.2 $ 117.2 $ 116.6 Gross increases related to current year tax positions 51.4 49.0 45.6 Gross increases (decreases) related to prior year tax positions 5.6 (5.6 ) (42.3 ) Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation (13.7 ) (14.4 ) (2.7 ) Balance as of December 31 $ 189.5 $ 146.2 $ 117.2 In 2018 , 2017 and 2016 , the increases in unrecognized tax benefits primarily related to the Company's calculation of certain tax credits and other items related to the Company's international operations. In 2018, there was a decrease in unrecognized tax benefits related to a settlement of the audit of the 2012 U.S. federal tax return and a lapse in the 2014 federal statute of limitations. In 2017 and 2016 , there was a decrease in unrecognized tax benefits related to a settlement of a disputed state tax matter. In 2018 , 2017 , and 2016 , accrued interest related to unrecognized tax benefits recorded by the Company was not material. The Company does not believe that it is reasonably possible that the resolution of tax exposures within the next twelve months will have a material impact on its unrecognized tax benefits as of December 31, 2018. |
Legal Matters
Legal Matters | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Matters | Legal Matters From time to time, the Company is a party to legal proceedings in the course of the Company's business. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. Unless otherwise noted below, the Company is unable to predict the outcome, or estimate a range of possible loss or possible gain, of the respective proceedings. If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted. Proceedings Relating to '287 Patent, '163 Patent, and '018 Patent The Company is a party to patent infringement litigation initiated by the Company involving its European Patent No. 1,360,287 (the "'287 Patent"), its European Patent No. 2,264,163 (the "'163 Patent"), and its U.S. Patent No. 8,502,018 (the "'018 Patent"). Each of these patents concerns genetically engineered mice capable of producing chimeric antibodies that are part human and part mouse. Chimeric antibody sequences can be used to produce high-affinity fully human monoclonal antibodies. In these proceedings, the Company claims infringement of several claims of the '287 Patent, the '163 Patent, and the '018 Patent (as applicable), and seeks, among other types of relief, an injunction and an account of profits in connection with the defendants' infringing acts, which may include, among other things, the making, use, keeping, sale, or offer for sale of genetically engineered mice (or certain cells from which they are derived) that infringe one or more claims of the '287 Patent, the '163 Patent, and the '018 Patent (as applicable). On September 25, 2013, the Company commenced patent infringement litigation against Kymab Ltd in the English High Court of Justice, Chancery Division, Patents Court, in London, asserting the '287 Patent and '163 Patent. A trial to adjudicate the claims of infringement and counterclaims of invalidity of the '287 Patent and the '163 Patent was held from November 16, 2015 through December 8, 2015. On February 1, 2016, the court issued a final judgment, finding that the asserted claims of the '287 and '163 Patents are novel, not obvious, and infringed by Kymab's genetically engineered mice. However, the court invalidated the '287 and '163 Patents on the ground of insufficiency. The hearing for the Company's appeal and Kymab's cross-appeal was held on October 17–20, 2017. On March 28, 2018, the Court of Appeal (Civil Division of England and Wales) reversed the English High Court's decision and held that the '287 Patent and '163 Patent are both valid and infringed by Kymab. On June 5, 2018, the Court of Appeal issued a final order, which enjoins Kymab from infringing the '287 Patent and '163 Patent (subject to certain exceptions) and requires Kymab to destroy or deliver to a third party all products and antibodies and cells engineered to produce antibodies which infringe the '287 Patent and '163 Patent (subject to certain exceptions). On November 29, 2018, the Supreme Court of the United Kingdom granted Kymab's application for permission to appeal the order made by the Court of Appeal. The provisions of the final order of the Court of Appeal are stayed pending final determination of Kymab's appeal to the Supreme Court of the United Kingdom. The Company has also been awarded a portion of the legal fees incurred by it in connection with the proceedings in the English High Court of Justice and the Court of Appeal described above. On March 11, 2014, the Company commenced '287 Patent infringement litigation and '018 Patent infringement litigation against Merus N.V., a company based in Utrecht, The Netherlands, in the District Court of The Hague and the United States District Court for the Southern District of New York, respectively. On November 21, 2014, the United States District Court for the Southern District of New York issued its Opinion and Order on Claim Construction in the '018 Patent infringement litigation, in which it held the '018 Patent invalid and not infringed. On November 2, 2015, the United States District Court for the Southern District of New York issued an opinion and order finding that the '018 Patent was procured by inequitable conduct, thus rendering it unenforceable. On July 27, 2017, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") affirmed the District Court's decision regarding inequitable conduct without deciding the issues of validity and infringement; and, on December 26, 2017, the Federal Circuit denied the Company's petition for panel rehearing and rehearing en banc . On October 1, 2018, the United States Supreme Court denied the Company's petition for a writ of certiorari. On December 20, 2018, the Company settled the '018 Patent infringement litigation as well as the '287 Patent infringement litigation in the Netherlands and all administrative proceedings between Merus and the Company pertaining to certain antibody generation platforms of each company (including the proceedings relating to Merus discussed in the paragraph below). As part of the settlement, both parties have signed a global patent cross-license agreement, Merus agreed to dismiss its action for legal fees, and the Company purchased 600,000 common shares of Merus for an aggregate purchase price of $15.0 million . On July 8 and July 13, 2016, notices of opposition against the '163 Patent were filed in the European Patent Office (the "EPO") by Merus N.V. and Kymab and Novo Nordisk A/S, respectively. The notices assert, as applicable, lack of novelty, lack of inventive step, and insufficiency. The Company's response to the oppositions was filed on December 30, 2016. Following an oral hearing before the Opposition Division of the EPO on February 5–7, 2018, the Opposition Division upheld the '163 Patent without amendments. Kymab, Merus, and Novo Nordisk each filed a notice of appeal of the Opposition Division's decision on February 9, 2018, May 25, 2018, and June 26, 2018, respectively. Proceedings Relating to Praluent (alirocumab) Injection As described in greater detail below, the Company is currently a party to patent infringement actions initiated by Amgen Inc. against the Company and Sanofi (and/or the Company's and Sanofi's respective affiliated entities) in a number of jurisdictions relating to Praluent, which the Company is jointly developing and commercializing with Sanofi. In the United States, Amgen has asserted a number of U.S. patents, which were subsequently narrowed to U.S. Patent Nos. 8,829,165 (the "'165 Patent") and 8,859,741 (the "'741 Patent"), and seeks a permanent injunction to prevent the Company and the Sanofi defendants from commercial manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) (collectively, "Commercializing") Praluent. Amgen also seeks a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees. A jury trial in this litigation was held in the United States District Court for the District of Delaware (the "District Court") from March 8 to March 16, 2016. During the course of the trial, the District Court ruled as a matter of law in favor of Amgen that the asserted patent claims were not obvious, and in favor of the Company and the Sanofi defendants that there was no willful infringement of the asserted patent claims by the Company or the Sanofi defendants. On March 16, 2016, the jury returned a verdict in favor of Amgen, finding that the asserted claims of the '165 and '741 Patents were not invalid based on either a lack of written description or a lack of enablement. On January 3, 2017, the District Court issued a final opinion and judgment, denying the Company and the Sanofi defendants' motions for new trial and judgment as a matter of law. The District Court also denied as moot Amgen's motion to strike the Company and the Sanofi defendants' request to obtain a judgment as a matter of law, which allowed the Federal Circuit to address the Company and the Sanofi defendants' patent invalidity arguments on appeal. On January 12, 2017, the Company and the Sanofi defendants filed a notice of appeal with the Federal Circuit. On April 19, 2017, the District Court granted Amgen's motion to amend the judgment on an accounting of supplemental damages and enhancement of such damages if deemed appropriate, but deferred the order until after the Federal Circuit issued a decision on the appeal. Oral argument on the appeal was held on June 6, 2017. On October 5, 2017, the Federal Circuit reversed in part the District Court's decision, remanded for a new trial on the issues of written description and enablement, and, as discussed below, vacated the District Court's permanent injunction. In addition, it affirmed the District Court's ruling that Amgen's patents were not obvious. The Federal Circuit further concluded the Company and the Sanofi defendants were not entitled to judgment as a matter of law on the issues of written description and enablement on this record. On February 23, 2018, the Federal Circuit denied Amgen's petition for rehearing en banc , and on March 2, 2018 the Federal Circuit issued a mandate to transfer jurisdiction of the case back to the District Court. On July 23, 2018, Amgen filed a petition for a writ of certiorari with the United States Supreme Court. On January 7, 2019, the United States Supreme Court denied Amgen's petition for a writ of certiorari. On January 3, 2019, the District Court held oral argument on the Company and the Sanofi defendants' motion for judgment on the pleadings regarding Amgen's willful infringement claim. On January 18, 2019, the District Court entered an order (i) denying the Company and the Sanofi defendants' motion for summary judgment on validity, (ii) denying Amgen's motion for partial summary judgment on estoppel, and (iii) granting the Company and the Sanofi defendants' cross-motion for summary judgment on estoppel. A new jury trial is currently scheduled to begin on February 19, 2019. On January 5, 2017, the District Court granted a permanent injunction prohibiting Regeneron and the Sanofi defendants from Commercializing Praluent in the United States but subsequently delayed its imposition until February 21, 2017. The Federal Circuit stayed the injunction pending appeal on February 8, 2017 and vacated it on October 5, 2017. On July 25, 2016, Amgen filed a lawsuit against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi-Synthelabo Limited, Aventis Pharma Limited, Sanofi Winthrop Industrie S.A., and Sanofi-Aventis Deutschland GmbH in the English High Court of Justice, Chancery Division, Patents Court, in London, seeking a declaration of infringement of Amgen's European Patent No. 2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, by Praluent. The lawsuit also seeks a permanent injunction, damages, an accounting of profits, and costs and interest. On February 8, 2017, the court temporarily stayed this litigation on terms mutually agreed by the parties. Also on July 25, 2016, Amgen filed a lawsuit for infringement of the '124 Patent against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A., and Sanofi-Aventis Deutschland GmbH in the Regional Court of Düsseldorf, Germany (the "Düsseldorf Regional Court"), seeking a permanent injunction, an accounting of marketing activities, a recall of Praluent and its removal from distribution channels, and damages. On November 14, 2017, the Düsseldorf Regional Court issued a decision staying the infringement proceedings until a decision of the Opposition Division of the EPO concerning the pending opposition filed by the Company, Sanofi, and several other opponents against the '124 Patent (as discussed below). Following Amgen's request to reopen the proceedings in light of the issuance of the Preliminary Opinion (as defined below), the Düsseldorf Regional Court held an oral hearing on September 11, 2018 and ruled on December 10, 2018 that the infringement proceedings would be reopened, with the next oral hearing in the Düsseldorf Regional Court scheduled for April 30, 2019. On July 12, 2018, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., and Sanofi Winthrop Industrie S.A. filed an action in the Federal Patents Court (the "FPC") in Munich, Germany, seeking a compulsory license from Amgen based on the '124 Patent for the continued commercializing of Praluent in Germany. This compulsory license action included a request for a provisional compulsory license. The FPC held an oral hearing on September 6, 2018 in the provisional compulsory license proceedings and denied Sanofi's request for the provisional compulsory license. On January 16, 2019, the Sanofi parties appealed the FPC's decision in the provisional compulsory license proceedings. The compulsory license proceedings are continuing. On September 26, 2016, Amgen filed a lawsuit for infringement of the '124 Patent in the Tribunal de grande instance in Paris, France against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie, and Sanofi Chimie (subsequently added as a defendant). Amgen is seeking the prohibition of allegedly infringing activities with a €10,000 penalty per drug unit of Praluent produced in violation of the court order sought by Amgen; an appointment of an expert for the assessment of damages; disclosure of technical (including supply-chain) and accounting information to the expert and the court; provisional damages of €10.0 million (which would be awarded on an interim basis pending final determination); reimbursement of costs; publication of the ruling in three newspapers; and provisional enforcement of the decision to be issued, which would ensure enforcement of the decision (including any provisional damages) pending appeal. Amgen is not seeking a preliminary injunction in this proceeding at this time. On April 10, 2017, the Company and the Sanofi parties filed briefs seeking invalidation of certain of the claims of the '124 Patent, and Amgen filed a response on July 28, 2017. Oral hearing on this infringement lawsuit (originally scheduled for February 12, 2019) has yet to be scheduled. The '124 Patent is also subject to opposition proceedings in the EPO seeking to invalidate certain of its claims, which were initiated by Sanofi on February 24, 2016 and, separately, by the Company, Sanofi, and several other opponents on November 24, 2016. On December 13, 2017, the Opposition Division of the EPO issued a preliminary, non-binding opinion (the "Preliminary Opinion") regarding the validity of the '124 Patent, indicating that it currently considers the claims of a new request filed by Amgen in response to the opposition to satisfy the requirements for patentability. An oral hearing on the oppositions against the '124 Patent was held on November 28–30, 2018, at which the Opposition Division upheld the validity of the '124 Patent's claims in amended form. The Company and Sanofi filed notices of appeal to the Technical Board of Appeal of the EPO on November 30, 2018. The Company has recorded an accrual for loss contingencies associated with the '124 Patent proceedings discussed above. The ultimate resolution of these proceedings is not expected to have a material impact on the Company’s financial statements. On May 19, 2017, Amgen filed a lawsuit for infringement of Amgen's Japanese Patent Nos. 5,906,333 (the "'333 Patent") and 5,705,288 (the "'288 Patent") in the Tokyo District Court Civil Division (the "Tokyo District Court") against Sanofi K.K. Amgen's complaint alleges that manufacturing, selling or otherwise transferring, and offering to sell or otherwise transfer Praluent (alirocumab) in Japan (as well as importing Praluent (alirocumab) into Japan) infringe the '333 and '288 Patents. The complaint further seeks a permanent injunction, disposal of product, and court costs. The Company has not been named as a defendant in this litigation. On January 17, 2019, the Tokyo District Court upheld the validity of the '333 Patent and '288 Patent and ordered a permanent injunction against Sanofi K.K. to stop manufacturing, selling or otherwise transferring, and offering to sell or otherwise transfer Praluent (alirocumab) in Japan (as well as importing Praluent (alirocumab) into Japan) and to dispose of all product. However, the Tokyo District Court stayed the enforcement of such injunction pending appeal to the Intellectual Property High Court of Japan (the "IPHC"). On January 30, 2019, Sanofi K.K. appealed the Tokyo District Court's decision in the infringement proceedings to the IPHC. Proceedings Relating to Dupixent (dupilumab) Injection On March 20, 2017, the Company, Sanofi-Aventis U.S. LLC, and Genzyme Corporation filed a lawsuit against Amgen and Immunex Corporation, a wholly owned subsidiary of Amgen, in the United States District Court for the District of Massachusetts seeking a declaratory judgment that the Company's and the other plaintiffs' Commercializing of Dupixent does not directly or indirectly infringe U.S. Patent No. 8,679,487 (the "'487 Patent") owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor. On May 1, 2017, the Company and the other plaintiffs filed a notice of voluntary dismissal of this action without prejudice. On March 23, 2017, the Company, Sanofi-Aventis U.S. LLC, and Genzyme Corporation initiated an inter partes review ("IPR") in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of the '487 Patent. On July 28 and 31, 2017, the same parties filed two additional IPR petitions in the USPTO seeking declarations of invalidity of the '487 Patent based on different grounds (the "Additional IPR Petitions"). On October 4, 2017, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a decision on the first IPR petition and declined to institute an IPR proceeding to review the validity of the '487 Patent. On February 15, 2018, the PTAB issued two decisions instituting the Company's and Sanofi's Additional IPR Petitions on all claims of the '487 Patent for which review had been requested. Oral hearings on the Additional IPR Petitions before the PTAB were held on November 14, 2018. On April 5, 2017, Immunex Corporation filed a lawsuit against the Company, Sanofi, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Aventisub LLC in the United States District Court for the Central District of California seeking a judgment of patent infringement of the '487 Patent and a declaratory judgment of infringement of the '487 Patent, in each case by the Company's and the other defendants' Commercializing of Dupixent; monetary damages (together with interest); an order of willful infringement of the '487 Patent, which would allow the court in its discretion to award damages up to three times the amount assessed; costs and expenses of the lawsuit; and attorneys' fees. Immunex is not seeking an injunction in this proceeding at this time. On June 21, 2017, the court denied a motion to dismiss Immunex's complaint previously filed by the Company and the Sanofi parties. On June 28, 2017, the Company and the Sanofi parties filed an answer to Immunex's complaint and counterclaims against Immunex and Amgen (which was amended on October 31, 2017 to, among other things, add an inequitable conduct allegation), and Immunex and Amgen filed an answer to the counterclaims on July 28, 2017. A combined hearing on the construction of certain disputed claim terms of the '487 Patent and the Company and the Sanofi parties' motion for summary judgment on the issue of indefiniteness of the '487 Patent claims was held on July 12, 2018. On August 24, 2018, the court issued an order denying this motion and construed the disputed claim terms as proposed by Amgen. A jury trial has been scheduled to start on November 5, 2019. On September 30, 2016, Sanofi initiated a revocation proceeding in the United Kingdom to invalidate the U.K. counterpart of European Patent No. 2,292,665 (the "'665 Patent"), another patent owned by Immunex relating to antibodies that bind the human interleukin-4 receptor. At the joint request of the parties to the revocation proceeding, the U.K. Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the currently pending EPO opposition proceedings initiated by the Company and Sanofi in relation to the '665 Patent. The oral hearing before the EPO on the oppositions occurred on November 20, 2017, at which the claims of the '665 Patent were found invalid and the patent was revoked. A final written decision of revocation of the '665 Patent was issued by the EPO on January 4, 2018. Immunex filed a notice of appeal of the EPO's decision on January 31, 2018. On September 20, 2017 and September 21, 2017, respectively, the Company and Sanofi initiated opposition proceedings in the EPO against Immunex's European Patent No. 2,990,420 (the "'420 Patent"), a divisional patent of the '665 Patent ( i.e. , a patent that shares the same priority date, disclosure, and patent term of the parent '665 Patent but contains claims to a different invention). An oral hearing before the EPO on the '420 Patent opposition proceedings has been scheduled for February 14–15, 2019. The original patent term of the Immunex patents is set to expire in 2021. Proceedings Relating to EYLEA (aflibercept) Injection and ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion On March 19, 2018, Novartis Vaccines and Diagnostics, Inc., Novartis Pharma AG, and Grifols Worldwide Operations Limited (collectively, the "Novartis Parties") filed a lawsuit against the Company in the United States District Court for the Southern District of New York, seeking a judgment of patent infringement of U.S. Patent No. 5,688,688 (the "'688 Patent") by the Company's manufacture of aflibercept (the active ingredient used in both EYLEA and ZALTRAP); monetary damages (together with interest) for a limited period prior to the '688 Patent expiration; an order of willful infringement of the '688 Patent (dismissed on October 24, 2018); costs and expenses of the lawsuit; and attorneys' fees. The '688 Patent expired on November 18, 2014. The Novartis Parties are not seeking an injunction in these proceedings. Proceedings Relating to Shareholder Derivative Claims On December 30, 2015, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then current and certain former non-employee members of the Company's board of directors, the Chairman of the board of directors, the Company's Chief Executive Officer, and the Company's Chief Scientific Officer as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and were unjustly enriched when they approved and/or received allegedly excessive compensation in 2013 and 2014. The complaint seeks damages in favor of the Company for the alleged breaches of fiduciary duties and unjust enrichment; changes to Regeneron's corporate governance and internal procedures; invalidation of the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan with respect to the individual defendants' compensation and a shareholder vote regarding the individual defendants' equity compensation; equitable relief, including an equitable accounting with disgorgement; and award of the costs of the action, including attorneys' fees. On June 28, 2017, the court dismissed the plaintiff's claims with respect to certain compensation awarded in 2013 but denied the defendants' motion to dismiss the other claims set forth in the complaint. On November 8, 2017, another alleged shareholder filed a second shareholder derivative complaint in the New York Supreme Court, naming the then current and certain former non-employee members of the Company's board of directors, the Chairman of the board of directors, the Company's Chief Executive Officer, the Company's Chief Scientific Officer, and Regeneron as defendants. The complaint asserts that the individual defendants breached their fiduciary duties and were unjustly enriched when they approved and/or received allegedly excessive compensation in 2014, 2015, and 2016. The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties and unjust enrichment; changes to Regeneron's corporate governance and internal procedures; invalidation of Regeneron's 2014 Long-Term Incentive Plan with respect to the individual defendants' compensation and the imposition of meaningful limits on the amount of equity payable to the individual defendants; a shareholder vote regarding the individual defendants' equity compensation; equitable relief, including an equitable accounting with disgorgement; and award of the costs of the action, including attorneys' fees. On December 4, 2017, the plaintiff in the second action moved to consolidate both actions, to be appointed lead plaintiff, and to have its counsel be appointed lead counsel in the proposed consolidated action. The court heard oral argument on March 7, 2018 and denied the motion. The parties in both the first derivative action and the second derivative action agreed to a schedule for document discovery and the filing of defendants' appeal of the court's June 28, 2017 decision, as well as a stay of all non-document discovery pending a decision on defendants' appeal. On March 19, 2018, the defendants appealed the court's June 28, 2017 decision to the Appellate Division of the Supreme Court, First Department. On April 19, 2018, the Appellate Division granted the second plaintiff's motion to intervene in this appeal. On October 9, 2018, the parties to both derivative actions filed with the court a stipulation of compromise and settlement of both derivative actions. The stipulation requires Regeneron to, among other things, impose specified limitations on certain director compensation for the five years starting in December 2018, implement certain corporate governance measures, and pay the agreed-upon amount of attorneys' fees and expenses. Following a hearing o n December 3, 2018, the court entered final judgments in both the first derivative action and the second derivative action, approving the settlement. Pursuant to the Company's By-Laws and the New York Business Corporation Law, expenses in connection with the foregoing were advanced by the Company for the individual defendants. On or about December 15, 2015, the Company received a shareholder litigation demand upon the Company's board of directors made by a purported Regeneron shareholder. On or about November 3, 2017, the Company received a second shareholder litigation demand upon the Company's board of directors made by another purported Regeneron shareholder, which was substantially similar to the December 15, 2015 shareholder litigation demand. The demands asserted that the then current and certain former non-employee members of the board of directors and the Chairman of the board of directors excessively compensated themselves in 2013 and 2014. The demands requested that the board of directors investigate and bring legal action against these directors for breach of fiduciary duty, unjust enrichment, and corporate waste, and implement internal controls and systems designed to prohibit and prevent similar actions in the future. On December 20, 2017, the parties to the shareholder derivative action filed on December 30, 2015 entered into a stipulation with the second demanding shareholder. The stipulation provides that the purported shareholder will intervene as a plaintiff in the action, and that the purported shareholder's litigation demand will be withdrawn and deemed null and void. The stipulation was approved by the court on January 18, 2018. The first shareholder litigation demand has also since been withdrawn. Department of Justice Investigation In January 2017, the Company received a subpoena from the U.S. Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients; documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST, and ZALTRAP); and certain other related documents and communications. The Company is cooperating with this investigation. |
Net Income Per Share
Net Income Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | Net Income Per Share The Company's basic net income per share amounts have been computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Diluted net income per share includes the potential dilutive effect of other securities as if such securities were converted or exercised during the period, when the effect is dilutive. The calculations of basic and diluted net income per share are as follows: Year Ended December 31, 2018 2017 2016 Net income - basic $ 2,444.4 $ 1,198.5 $ 895.5 Effect of dilutive securities: Convertible senior notes - interest expense and amortization of discount and note issuance costs — — 0.4 Net income - diluted $ 2,444.4 $ 1,198.5 $ 895.9 (Shares in millions) Weighted average shares - basic 107.9 106.3 104.7 Effect of dilutive securities: Stock options 6.9 9.1 10.2 Restricted stock — 0.5 0.5 Warrants — — 0.9 Dilutive potential shares 6.9 9.6 11.6 Weighted average shares - diluted 114.8 115.9 116.3 Net income per share - basic $ 22.65 $ 11.27 $ 8.55 Net income per share - diluted $ 21.29 $ 10.34 $ 7.70 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive, include the following: Year Ended December 31, (Shares in millions) 2018 2017 2016 Stock options 14.9 9.2 8.0 |
Statement of Cash Flows
Statement of Cash Flows | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Information [Abstract] | |
Statement of Cash Flows | Statement of Cash Flows The Company adopted ASU 2016-18, Statement of Cash Flows - Restricted Cash , during the first quarter of 2018, and the standard has been retrospectively applied to all periods presented. The following provides a reconciliation of cash, cash equivalents, and restricted cash to the total of the same such amounts shown in the Consolidated Statement of Cash Flows: December 31, December 31, December 31, 2018 2017 2016 Cash and cash equivalents $ 1,467.7 $ 812.7 $ 535.2 Restricted cash included in Other noncurrent assets 12.5 12.5 12.5 Total cash, cash equivalents, and restricted cash shown in the Consolidated Statement of Cash Flows $ 1,480.2 $ 825.2 $ 547.7 Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements. Supplemental disclosure of non-cash investing and financing activities Included in accounts payable, accrued expenses, and other liabilities as of December 31, 2018 , 2017 , and 2016 were $54.5 million , $41.8 million , and $28.2 million , respectively, of accrued capital expenditures. As described in Note 3, during 2018, we purchased (by issuing a credit towards the amount owed by Sanofi) 215,387 shares of our Common Stock from Sanofi to satisfy Sanofi's funding obligation related to Libtayo development costs, and recorded the cost of the shares received, or $75.8 million , as Treasury Stock. The Company recognized additional capital and facility lease obligations of $201.2 million and $154.9 million during 2017 and 2016 , respectively, in connection with the Company's Tarrytown Leases (see Note 12). No additional capital and facility lease obligations were recognized during 2018. |
Unaudited Quarterly Results
Unaudited Quarterly Results | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Results | Unaudited Quarterly Results Summarized quarterly financial data (unaudited) for the years ended December 31, 2018 and 2017 are set forth in the following tables. First Quarter Ended March 31, 2018 (1) Second Quarter Ended June 30, 2018 Third Quarter Ended September 30, 2018 Fourth Quarter Ended December 31, 2018 (2)(3) Revenues $ 1,511.5 $ 1,608.0 $ 1,663.5 $ 1,927.8 Net income $ 478.0 $ 551.4 $ 594.7 $ 820.4 Net income per share - basic $ 4.44 $ 5.12 $ 5.50 $ 7.58 Net income per share - diluted $ 4.16 $ 4.82 $ 5.17 $ 7.15 First Quarter Ended Second Quarter Ended Third Quarter Ended Fourth Quarter Ended (4) Revenues $ 1,319.0 $ 1,470.1 $ 1,500.7 $ 1,582.4 Net income $ 248.9 $ 387.7 $ 388.3 $ 173.5 Net income per share - basic $ 2.36 $ 3.66 $ 3.64 $ 1.62 Net income per share - diluted $ 2.16 $ 3.34 $ 3.32 $ 1.50 (1) In the first quarter of 2018, the Company adopted ASC 606 and ASU 2016-01. Prior period amounts have not been adjusted in connection with the adoption of these accounting standards. See Note 1. (2) Includes impact of a cumulative catch-up adjustment recorded to revenue upon modification of the Amended IO Discovery Agreement. See Note 3. (3) Includes tax impact of the sale of non-inventory related assets between foreign subsidiaries completed during the fourth quarter of 2018. See Note 16. (4) As a result of the Act being signed into law on December 22, 2017, the Company recognized a charge of $326.2 million in the fourth quarter of 2017 related to the re-measurement of its U.S. net deferred tax assets at the lower enacted corporate tax rate. See Note 16. |
Business Overview and Summary_2
Business Overview and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of Regeneron and its wholly-owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation. Certain reclassifications have been made to prior period amounts to conform with the current period's presentation. We adopted Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers , as of January 1, 2018. The Company adopted the standard using the modified retrospective method, and thus recognized a cumulative-effect adjustment to reduce Retained earnings and increase Deferred revenue on January 1, 2018 by $143.4 million , net of tax. Prior period amounts have not been adjusted in connection with the adoption of this standard. The new standard did not have an impact on the recognition of revenue from product sales (see Note 2). However, the new standard has resulted in certain changes to the timing of revenue recognition related to our collaboration agreements (see Note 3). As a result of adopting ASC 606, non-refundable upfront payments, which were previously recognized ratably over the performance period, and substantive development milestones, which were previously recognized in the period when the milestone was achieved, will be recognized over the remaining performance period based on the Company's progress towards satisfying its identified performance obligation. The Company also adopted Accounting Standards Update ("ASU") 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, as of January 1, 2018 . The amendments require companies to measure equity investments at fair value with changes in fair value recognized in net income. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid debt instruments with a maturity of three months or less when purchased to be cash equivalents. The carrying amount reported in the Consolidated Balance Sheet for cash and cash equivalents approximates its fair value. |
Marketable Securities | Marketable Securities The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. We invest our cash primarily in debt securities of investment grade institutions. We consider our investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB"). These assets are carried at fair value and the unrealized gains and losses are included in Accumulated other comprehensive income (loss). Realized gains and losses on available-sale-sale debt securities are included in Other income (expense), net. We also have investments in equity securities that are carried at fair value with changes in fair value recognized within Other income (expense), net. We have elected to measure certain equity investments we hold that do not have readily determinable fair values at cost less impairment, if any, and adjust for observable price changes in orderly transactions for identical or similar investments of the same issuer. The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost are other-than-temporary. If a decline in the fair value of an available-for-sale debt security in the Company's investment portfolio is deemed to be other-than-temporary, the Company writes down the cost basis of the security to its current fair value and recognizes a loss as a charge against income. |
Accounts Receivable - Trade | Accounts Receivable - Trade The Company's trade accounts receivable arise from product sales and represent amounts due from its distributors and specialty pharmacies (collectively, the Company's trade "customers"), which are all located in the United States. The Company monitors the financial performance and credit worthiness of its large customers so that it can properly assess and respond to changes in their credit profile. The Company provides reserves against trade receivables for estimated losses, if any, that may result from a customer's inability to pay. Amounts determined to be uncollectible are written-off against the reserve. |
Inventories | Inventories Inventories are stated at the lower of cost or estimated realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes-down such inventories as appropriate. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to write down such unmarketable inventory to its estimated realizable value. |
Property, Plant and Equipment | Property, Plant, and Equipment Property, plant, and equipment are stated at cost, net of accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the lease term. Costs of construction of certain long-lived assets include capitalized interest, which is amortized over the estimated useful life of the related asset. Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized in operations. The estimated useful lives of property, plant, and equipment are as follows: Building and improvements 10–50 years Laboratory and other equipment 3–10 years Furniture and fixtures 5 years The Company periodically assesses the recoverability of long-lived assets, such as property, plant, and equipment, and evaluates such assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. |
Revenue Recognition | Revenue Recognition a. Product Revenue Product revenue consists of U.S. sales of EYLEA, Libtayo, and ARCALYST. Revenue from product sales is recognized at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt by our distributors and specialty pharmacies. The Company's written contracts with its customers stipulate product is shipped freight on board destination (FOB destination). The Company sells its marketed products in the United States to several distributors and specialty pharmacies. Under these distribution models, the distributors and specialty pharmacies generally take physical delivery of product. For EYLEA and Libatyo, the distributors and specialty pharmacies generally sell the product directly to healthcare providers. The amount of revenue we recognize from product sales varies due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions. In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration that we will be entitled to. This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payer mix, and other relevant factors. The Company reviews its estimates of rebates, chargebacks, and other applicable provisions each period and records any necessary adjustments in the current period's net product sales. Government Rebates and Chargebacks: The Company estimates reductions to product sales for Medicaid and Veterans' Administration ("VA") programs, and for certain other qualifying federal and state government programs. Based upon the Company's contracts with government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, and estimated payer mix, the Company estimates and records an allowance for rebates and chargebacks. The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, and invoices received for claims from prior quarters that have not been paid. The Company's reserves related to discounted pricing to VA, Public Health Services ("PHS"), and other institutions (collectively "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., distributors and specialty pharmacies). The Company's customers charge the Company for the difference between what they pay for the products and the ultimate selling price to the qualified healthcare providers. The Company's reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Distribution-Related Fees: The Company has written contracts with its customers that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customers generally based on gross sales. Product Returns: Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date. The Company will accept returns for three months prior to and up to six months after the product expiration date. Product returned is generally not resalable given the nature of the Company's products and method of administration. The Company develops estimates for product returns based upon historical experience, shelf life of the product, and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customers of EYLEA and Libtayo to healthcare providers and ARCALYST to patients using product-specific data provided by its customers. If necessary, the Company's estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. Other Sales-Related Deductions : The Company estimates discounts and other sales-related deductions offered to customers, group purchasing organizations, and end-user customers, based on written contracts. The Company estimates and records other sales-related deductions generally based on gross sales. b. Collaboration Revenue We have entered into various agreements related to our activities to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms. The Company earns collaboration revenue in connection with collaboration agreements to utilize our technology platforms and develop and/or commercialize product candidates where we deem the collaborator to be our customer. As described above, during the first quarter of 2018, we adopted ASC 606. Under the terms of the new standard, revenue is measured as the amount of consideration we expect to be entitled to in exchange for transferring promised goods or providing services to a customer, and is recognized when (or as) we satisfy performance obligations under the terms of a contract. Depending on the terms of the arrangement, we may defer the recognition of all or a portion of the consideration received because the performance obligations are satisfied over time. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In agreements involving multiple goods or services promised to be transferred to a customer, we must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. The terms of these agreements typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, payments for development activities, as well as payments for commercialization activities, sales milestones, and sharing of profits or losses arising from the commercialization of products. At the inception of the contract, the transaction price reflects the amount of consideration we expect to be entitled to in exchange for transferring promised goods or services to our customer. In arrangements where we satisfy performance obligation(s) during the development phase over time, we recognize collaboration revenue over time typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion. We review our estimate of the transaction price and the total expected cost each period, and make revisions to such estimates as necessary. When we are entitled to reimbursement of all or a portion of the research and development expenses that we incur under a collaboration, we record those reimbursable amounts as collaboration revenue proportionately as we recognize our expenses. If the collaboration is a cost-sharing arrangement in which both we and our collaborator perform development work and share costs, we also recognize, as research and development expense in the period when our collaborator incurs development expenses, the portion of the collaborator's development expenses that we are obligated to reimburse. Our collaborators provide us with estimated development expenses for the most recent fiscal quarter. Under certain of the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company shares in any profits or losses arising from the commercialization of such products, and records its share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborator. Our collaborators provide us with estimates of our share of the profits or losses for such quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our share of the profit or loss is adjusted accordingly, as necessary In arrangements where the collaborator records product sales, the Company may be obligated to use commercially reasonable efforts to supply commercial product to its collaborators, and may be reimbursed for its manufacturing costs as commercial product is shipped to its collaborators; however, recognition of such cost reimbursements as collaboration revenue is deferred until the product is sold by the Company's collaborators to third-party customers. In addition, we may also be reimbursed for a portion of costs incurred for other commercial-related activities, which are recorded as collaboration revenue in the period in which such costs are incurred. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to the Company's clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, preclinical development, and clinical trials, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services. Costs associated with research and development are expensed. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as contract research organizations ("CROs"), independent clinical investigators, and other third-party service providers to assist us with the execution of our clinical studies. For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators or CROs are expected to provide services. Clinical activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management. These start-up costs usually occur within a few months after the contract has been executed and are event-driven in nature. The remaining activities and related costs, such as patient monitoring and administration, generally occur ratably throughout the life of the individual contract or study. In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding down of the clinical trial and/or penalties. For clinical study sites, where payments are made periodically on a per-patient basis to the institutions performing the clinical study, we accrue expenses on an estimated cost-per-patient basis, based on subject enrollment and activity in each quarter. The amount of clinical study expense recognized in a quarter may vary from period to period based on the duration and progress of the study, the activities to be performed by the sites each quarter, the required level of patient enrollment, the rate at which patients actually enroll in and drop-out of the clinical study, and the number of sites involved in the study. Clinical trials that bear the greatest risk of change in estimates are typically those that have a significant number of sites, require a large number of patients, have complex patient screening requirements, and span multiple years. During the course of a trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates. Our estimates and assumptions for clinical expense recognition could differ significantly from our actual results, which could cause material increases or decreases in research and development expenses in future periods when the actual results become known. |
Stock-based Compensation | Stock-based Compensation The Company recognizes stock-based compensation expense for grants of stock option, restricted stock awards, and restricted stock units under the Company's Long-Term Incentive Plans to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award's requisite service period. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company's Common Stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. |
Income Taxes | Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions. Under this method, deferred tax assets and liabilities are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets will not be realized. Uncertain tax positions, for which management's assessment is that there is more than a 50% probability of sustaining the position upon challenge by a taxing authority based upon its technical merits, are subjected to certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. The Company adjusts the level of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. The Company recognizes interest and penalties related to income tax matters in income tax expense. |
Per Share Data | Per Share Data Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Basic net income per share excludes restricted stock awards until vested. Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive. Common stock equivalents include: (i) outstanding stock options and restricted stock under the Company's Long-Term Incentive Plans, which are included under the "treasury stock method" when dilutive, (ii) if applicable, Common Stock to be issued upon the assumed conversion of the Company's convertible senior notes, which are included under the "if-converted method" when dilutive, and (iii) if applicable, Common Stock to be issued upon the exercise of outstanding warrants, which are included under the "treasury stock method" when dilutive. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, certain financial instruments, and accounts receivable. In accordance with the Company's policies, the Company mandates asset diversification and monitors exposure with its counterparties. Concentrations of credit risk with respect to accounts receivable are significant. The Company has a concentration of credit risk associated with the receivables due from its collaborators Bayer, Sanofi, and Teva. The Company is also subject to credit risk with accounts receivable from its product sales, which are due from several distributors and specialty pharmacies (the Company's customers). As of December 31, 2018 and 2017, three individual customers accounted for 99% of the Company's net trade accounts receivable balances. The Company has contractual payment terms with each of its customers, and the Company monitors its customers' financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases . The new standard requires a lessee to recognize on its balance sheet (for both finance and operating leases) a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term. The amendments are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. We will adopt this new standard on January 1, 2019 (the "effective date") and use the effective date as our date of initial application. As such, we will not adjust prior period amounts. Furthermore, we expect to elect the practical expedients upon transition, which permit companies to not reassess lease identification, classification, and initial direct costs under the new standard for leases that commenced prior to the effective date. We have substantially completed the process of analyzing and extracting relevant data from the Company’s lease contracts. We are finalizing our evaluation of the impact that this guidance will have on our financial statements, including related disclosures, and expect to recognize additional right-of-use assets and corresponding lease liabilities related to operating leases of approximately $30 million as of January 1, 2019. We have also evaluated our facilities for which the Company has historically applied build-to-suit accounting, and do not expect a material impact on our financial statements upon adoption of the new standard. The ultimate impact that the new standard will have will depend on the total amount of the Company's lease commitments as of our first reporting period subsequent to the adoption date. We are also finalizing our implementation of a new lease accounting software system and updating our internal controls and processes. |
Legal Costs | Costs associated with the Company's involvement in legal proceedings are expensed as incurred. |
Business Overview and Summary_3
Business Overview and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The following tables summarize the impacts of adopting ASC 606 on the Company's consolidated financial statements as of and for the year ended December 31, 2018 compared with the guidance that was in effect before the change. December 31, 2018 Balance Sheet Data As Reported Adjustments Balance Without Adoption of ASC 606 Inventories $ 1,151.2 $ 17.5 $ 1,168.7 Deferred tax assets $ 828.7 $ 17.5 $ 846.2 Total assets $ 11,734.5 $ 35.0 $ 11,769.5 Accrued expenses and other current liabilities $ 772.1 $ (1.3 ) $ 770.8 Deferred revenue from Sanofi (current) $ 246.7 $ (93.0 ) $ 153.7 Deferred revenue - other (current) $ 205.8 $ (58.3 ) $ 147.5 Total current liabilities $ 1,442.8 $ (152.6 ) $ 1,290.2 Deferred revenue from Sanofi (noncurrent) $ 279.3 $ 163.2 $ 442.5 Deferred revenue - other (noncurrent) $ 184.9 $ 21.8 $ 206.7 Total liabilities $ 2,977.2 $ 32.4 $ 3,009.6 Retained earnings $ 5,254.3 $ 2.6 $ 5,256.9 Total stockholders' equity $ 8,757.3 $ 2.6 $ 8,759.9 Total liabilities and stockholders' equity $ 11,734.5 $ 35.0 $ 11,769.5 Year Ended December 31, 2018 Consolidated Statement of Operations Data As Reported Adjustments Balance Without Adoption of ASC 606 Sanofi collaboration revenue $ 1,111.1 $ (163.8 ) $ 947.3 Other revenue $ 416.8 $ (31.7 ) $ 385.1 Total revenues $ 6,710.8 $ (195.5 ) $ 6,515.3 Cost of collaboration and contract manufacturing $ 254.1 $ (17.5 ) $ 236.6 Income from operations $ 2,534.4 $ (178.0 ) $ 2,356.4 Income before income taxes $ 2,553.5 $ (178.0 ) $ 2,375.5 Income tax expense $ (109.1 ) $ 37.2 $ (71.9 ) Net income $ 2,444.4 $ (140.8 ) $ 2,303.6 |
Schedule of Estimated Useful Lives of Property, Plant, and Equipment | The estimated useful lives of property, plant, and equipment are as follows: Building and improvements 10–50 years Laboratory and other equipment 3–10 years Furniture and fixtures 5 years |
Product Sales (Tables)
Product Sales (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenues [Abstract] | |
Schedule of Product Sales | Net product sales consist of the following: Year Ended December 31, Net Product Sales in the United States 2018 2017 2016 EYLEA $ 4,076.7 $ 3,701.9 $ 3,323.1 Libtayo 14.8 — — ARCALYST 14.7 16.6 15.3 $ 4,106.2 $ 3,718.5 $ 3,338.4 The collaboration revenue we earned from Sanofi is detailed below: Year Ended December 31, Sanofi Collaboration Revenue 2018 2017 2016 Antibody: Reimbursement of Regeneron research and development expenses $ 265.3 $ 508.4 $ 564.9 Reimbursement of Regeneron commercialization-related expenses 417.2 368.8 305.9 Regeneron's share of losses in connection with commercialization of antibodies (227.0 ) (442.6 ) (459.0 ) Other 103.5 119.1 28.4 Total Antibody 559.0 553.7 440.2 Immuno-oncology: Reimbursement of Regeneron research and development expenses 311.8 240.0 138.5 Reimbursement of Regeneron commercialization-related expenses 8.9 7.0 — Other 231.4 76.5 80.0 Total Immuno-oncology 552.1 323.5 218.5 $ 1,111.1 $ 877.2 $ 658.7 Revenue earned in connection with our Bayer EYLEA collaboration is as follows (note that the table excludes amounts in connection with our Bayer Ang2 antibody and PDGFR-beta antibody collaboration agreements, which are described below): Year Ended December 31, Bayer EYLEA Collaboration Revenue 2018 2017 2016 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 992.3 $ 802.3 $ 649.2 Reimbursement of Regeneron EYLEA development expenses 11.2 13.3 9.0 Other 73.6 58.7 52.6 $ 1,077.1 $ 874.3 $ 710.8 |
Schedules of Concentration of Risk, by Risk Factor | The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for each of the years ended December 31, 2018 , 2017 , and 2016 . Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Year Ended December 31, 2018 2017 2016 Besse Medical, a subsidiary of AmerisourceBergen Corporation 56 % 51 % 55 % McKesson Corporation 36 % 29 % 28 % Curascript SD Specialty Distribution, a subsidiary of Express Scripts ** 19 % 16 % ** Sales to Curascript SD Specialty Distribution represented less than 10% of total gross product revenue during the period. |
Sales Related Deductions Activity | The following table summarizes the provisions, and credits/payments, for these sales-related deductions for the years ended December 31, 2018 , 2017 , and 2016 . Rebates, Chargebacks, and Discounts Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2015 $ 6.4 $ 48.4 $ 0.5 $ 55.3 Provisions 93.4 154.4 30.4 278.2 Credits/payments (87.1 ) (173.3 ) (27.3 ) (287.7 ) Balance as of December 31, 2016 12.7 29.5 3.6 45.8 Provisions 167.8 194.1 46.4 408.3 Credits/payments (150.6 ) (189.5 ) (28.7 ) (368.8 ) Balance as of December 31, 2017 29.9 34.1 21.3 85.3 Provisions 223.4 211.0 44.5 478.9 Credits/payments (212.2 ) (203.1 ) (57.5 ) (472.8 ) Balance as of December 31, 2018 $ 41.1 $ 42.0 $ 8.3 $ 91.4 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of collaboration revenue | Net product sales consist of the following: Year Ended December 31, Net Product Sales in the United States 2018 2017 2016 EYLEA $ 4,076.7 $ 3,701.9 $ 3,323.1 Libtayo 14.8 — — ARCALYST 14.7 16.6 15.3 $ 4,106.2 $ 3,718.5 $ 3,338.4 The collaboration revenue we earned from Sanofi is detailed below: Year Ended December 31, Sanofi Collaboration Revenue 2018 2017 2016 Antibody: Reimbursement of Regeneron research and development expenses $ 265.3 $ 508.4 $ 564.9 Reimbursement of Regeneron commercialization-related expenses 417.2 368.8 305.9 Regeneron's share of losses in connection with commercialization of antibodies (227.0 ) (442.6 ) (459.0 ) Other 103.5 119.1 28.4 Total Antibody 559.0 553.7 440.2 Immuno-oncology: Reimbursement of Regeneron research and development expenses 311.8 240.0 138.5 Reimbursement of Regeneron commercialization-related expenses 8.9 7.0 — Other 231.4 76.5 80.0 Total Immuno-oncology 552.1 323.5 218.5 $ 1,111.1 $ 877.2 $ 658.7 Revenue earned in connection with our Bayer EYLEA collaboration is as follows (note that the table excludes amounts in connection with our Bayer Ang2 antibody and PDGFR-beta antibody collaboration agreements, which are described below): Year Ended December 31, Bayer EYLEA Collaboration Revenue 2018 2017 2016 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 992.3 $ 802.3 $ 649.2 Reimbursement of Regeneron EYLEA development expenses 11.2 13.3 9.0 Other 73.6 58.7 52.6 $ 1,077.1 $ 874.3 $ 710.8 |
Schedule of accounts receivable and deferred revenue information | The following table summarizes accounts receivable and deferred revenue information in connection with the Company's IO Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 77.9 $ 59.3 Deferred revenue $ 289.9 $ 440.0 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 93.6 Net decrease as a result of cumulative catch-up adjustments arising from changes in the estimate of the stage of completion $ (135.0 ) Revenue recognized that was included in deferred revenue at the beginning of the period $ (108.7 ) The following tables summarize accounts receivable and deferred revenue information in connection with the Teva Collaboration Agreement: As of December 31, 2018 2017 Accounts receivable (recorded within Prepaid expenses and other current assets) $ 28.8 $ 71.3 Deferred revenue $ 194.5 $ 197.4 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 48.2 Increase due to amounts invoiced, excluding amounts recognized as revenue during the period $ 30.7 Revenue recognized that was included in deferred revenue at the beginning of the period $ (83.8 ) The following table summarizes accounts receivable and deferred revenue information in connection with the Company's Antibody Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 138.2 $ 121.0 Deferred revenue $ 236.1 $ 117.7 Significant changes in deferred revenue balances are as follows: Year Ended December 31, 2018 Increase due to shipments of commercial supplies to Sanofi $ 251.6 Revenue recognized that was included in deferred revenue at the beginning of the period $ (133.2 ) Deferred revenue consists of the following: As of December 31, 2018 2017 Current portion: Received or receivable from Sanofi (see Note 3a) $ 246.7 $ 177.7 Received or receivable from Bayer (see Note 3b) 44.4 39.0 Received or receivable from Teva (see Note 3c) 92.5 43.5 Other 68.9 59.9 $ 452.5 $ 320.1 Long-term portion: Received or receivable from Sanofi (see Note 3a) $ 279.3 $ 379.9 Received or receivable from Bayer (see Note 3b) 45.1 29.7 Received or receivable from Teva (see Note 3c) 102.0 153.9 Other 37.8 65.7 $ 464.2 $ 629.2 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Debt Securities | The following tables summarize the Company's investments in available-for-sale debt securities: Amortized Unrealized Fair As of December 31, 2018 Cost Basis Gains Losses Value Available-for-sale debt securities: Corporate bonds $ 2,734.8 $ 1.0 $ (17.4 ) $ 2,718.4 U.S. government and government agency obligations 110.4 — (1.0 ) 109.4 Sovereign bonds 7.6 — — 7.6 Commercial paper 113.8 — — 113.8 Certificates of deposit 60.0 — — 60.0 $ 3,026.6 $ 1.0 $ (18.4 ) $ 3,009.2 As of December 31, 2017 Available-for-sale debt securities: Corporate bonds $ 1,718.0 $ 2.2 $ (7.7 ) $ 1,712.5 U.S. government and government agency obligations 186.7 — (1.2 ) 185.5 Municipal and sovereign bonds 4.6 — — 4.6 Commercial paper 107.0 — — 107.0 Certificates of deposit 11.0 — — 11.0 $ 2,027.3 $ 2.2 $ (8.9 ) $ 2,020.6 |
Marketable Securities, Based on Contractual Maturity Dates | The fair values of available-for-sale debt security investments by contractual maturity consist of the following: As of December 31, 2018 2017 Maturities within one year $ 1,342.2 $ 593.8 Maturities after one year through five years 1,667.0 1,426.8 $ 3,009.2 $ 2,020.6 |
Fair Value and Unrealized Losses of Marketable Securities | The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual securities have been in a continuous unrealized loss position. Less than 12 Months 12 Months or Greater Total As of December 31, 2018 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 1,482.6 $ (6.1 ) $ 801.6 $ (11.3 ) $ 2,284.2 $ (17.4 ) U.S. government and government agency obligations — — 99.1 (1.0 ) 99.1 (1.0 ) $ 1,482.6 $ (6.1 ) $ 900.7 $ (12.3 ) $ 2,383.3 $ (18.4 ) As of December 31, 2017 Corporate bonds $ 931.0 $ (4.9 ) $ 256.8 $ (2.8 ) $ 1,187.8 $ (7.7 ) U.S. government and government agency obligations 110.5 (0.4 ) 67.9 (0.8 ) 178.4 (1.2 ) $ 1,041.5 $ (5.3 ) $ 324.7 $ (3.6 ) $ 1,366.2 $ (8.9 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets measured at fair value on a recurring basis | The Company's assets that are measured at fair value on a recurring basis consist of the following: Fair Value Measurements at Reporting Date Using As of December 31, 2018 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale debt securities: Corporate bonds $ 2,718.4 — $ 2,718.4 U.S. government and government agency obligations 109.4 — 109.4 Sovereign bonds 7.6 — 7.6 Commercial paper 113.8 — 113.8 Certificates of deposit 60.0 — 60.0 Equity securities (unrestricted) 43.6 $ 43.6 — Equity securities (restricted) 44.4 — 44.4 $ 3,097.2 $ 43.6 $ 3,053.6 As of December 31, 2017 Available-for-sale debt securities: Corporate bonds $ 1,712.5 — $ 1,712.5 U.S. government and government agency obligations 185.5 — 185.5 Municipal and sovereign bonds 4.6 — 4.6 Commercial paper 107.0 — 107.0 Certificates of deposit 11.0 — 11.0 Equity securities (unrestricted) 62.7 $ 62.7 — $ 2,083.3 $ 62.7 $ 2,020.6 |
Derivative Instruments and He_2
Derivative Instruments and Hedging Activities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Notional Amounts of Outstanding Derivative Positions | The following table summarizes the notional amounts of the Company's outstanding interest rate swap and cap agreements: As of December 31, 2018 2017 Interest rate swap contracts $ 75.0 $ 75.0 Interest rate cap contracts $ 75.0 $ 75.0 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventories consist of the following: As of December 31, 2018 2017 Raw materials $ 226.8 $ 190.0 Work-in-process 571.1 302.0 Finished goods 24.4 21.8 Deferred costs 328.9 212.3 $ 1,151.2 $ 726.1 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant, and equipment consists of the following: As of December 31, 2018 2017 Land $ 199.0 $ 192.8 Building and improvements 1,507.2 1,441.6 Leasehold improvements 97.0 102.6 Construction-in-progress 469.6 408.9 Laboratory and other equipment 773.7 599.1 Furniture, computer and office equipment, and other 258.0 179.9 3,304.5 2,924.9 Less, accumulated depreciation and amortization (728.7 ) (566.3 ) $ 2,575.8 $ 2,358.6 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consist of the following: As of December 31, 2018 2017 Accrued payroll and related costs $ 261.8 $ 191.8 Accrued clinical trial expense 142.2 120.9 Accrued sales-related charges, deductions, and royalties 182.7 194.5 Income taxes payable 20.8 0.2 Other accrued expenses and liabilities 164.6 129.8 $ 772.1 $ 637.2 |
Deferred Revenue (Tables)
Deferred Revenue (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of deferred revenue | The following table summarizes accounts receivable and deferred revenue information in connection with the Company's IO Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 77.9 $ 59.3 Deferred revenue $ 289.9 $ 440.0 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 93.6 Net decrease as a result of cumulative catch-up adjustments arising from changes in the estimate of the stage of completion $ (135.0 ) Revenue recognized that was included in deferred revenue at the beginning of the period $ (108.7 ) The following tables summarize accounts receivable and deferred revenue information in connection with the Teva Collaboration Agreement: As of December 31, 2018 2017 Accounts receivable (recorded within Prepaid expenses and other current assets) $ 28.8 $ 71.3 Deferred revenue $ 194.5 $ 197.4 Significant changes in deferred revenue balances are as follows: Year Ended Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 $ 48.2 Increase due to amounts invoiced, excluding amounts recognized as revenue during the period $ 30.7 Revenue recognized that was included in deferred revenue at the beginning of the period $ (83.8 ) The following table summarizes accounts receivable and deferred revenue information in connection with the Company's Antibody Collaboration with Sanofi: As of December 31, 2018 2017 Accounts receivable $ 138.2 $ 121.0 Deferred revenue $ 236.1 $ 117.7 Significant changes in deferred revenue balances are as follows: Year Ended December 31, 2018 Increase due to shipments of commercial supplies to Sanofi $ 251.6 Revenue recognized that was included in deferred revenue at the beginning of the period $ (133.2 ) Deferred revenue consists of the following: As of December 31, 2018 2017 Current portion: Received or receivable from Sanofi (see Note 3a) $ 246.7 $ 177.7 Received or receivable from Bayer (see Note 3b) 44.4 39.0 Received or receivable from Teva (see Note 3c) 92.5 43.5 Other 68.9 59.9 $ 452.5 $ 320.1 Long-term portion: Received or receivable from Sanofi (see Note 3a) $ 279.3 $ 379.9 Received or receivable from Bayer (see Note 3b) 45.1 29.7 Received or receivable from Teva (see Note 3c) 102.0 153.9 Other 37.8 65.7 $ 464.2 $ 629.2 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of commitments under operating leases | The estimated future minimum noncancelable lease commitments under existing operating leases, as of December 31, 2018, are as follows: Facilities Equipment Total 2019 $ 4.2 $ 6.2 $ 10.4 2020 3.6 0.2 3.8 2021 3.3 0.1 3.4 2022 2.2 — 2.2 2023 1.5 — 1.5 Thereafter 4.1 — 4.1 $ 18.9 $ 6.5 $ 25.4 |
Schedule of rent expense under operating leases | Rent expense under operating leases was: Year Ended December 31, Facilities Equipment Total 2018 $ 3.7 $ 1.2 $ 4.9 2017 $ 3.1 $ 1.2 $ 4.3 2016 $ 15.9 $ 0.9 $ 16.8 |
Schedule of commitments under facility lease obligation | As of December 31, 2018, the estimated future minimum noncancelable commitments under the Company's capital and facility lease obligations, excluding the purchase price the Company would be obligated to pay if the Company were to exercise its option to purchase the Facility (as described above), are as follows: Capital and Facility Lease Obligations 2019 $ 26.4 2020 28.4 2021 27.9 2022 7.0 2023 — Thereafter — $ 89.7 |
Long-Term Incentive Plans (Tabl
Long-Term Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of transactions involving stock option awards | Transactions involving stock option awards during 2018 under the Company's Incentive Plans are summarized in the table below. Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Intrinsic Value Outstanding as of December 31, 2017 26,205,373 $ 295.98 2018: Granted 4,665,320 $ 378.51 Forfeited (668,550 ) $ 422.56 Expired (205,030 ) $ 467.40 Exercised (1,717,417 ) $ 66.87 Outstanding as of December 31, 2018 28,279,696 $ 319.28 6.43 $ 2,290.5 Vested and expected to vest as of December 31, 2018 27,192,461 $ 316.51 6.32 $ 2,289.1 Exercisable as of December 31, 2018 17,893,976 $ 275.10 4.98 $ 2,276.2 |
Schedule of weighted-average exercise prices and weighted-average grant-date fair values of options issued | The fair value of each option granted under the Company's Incentive Plans during these periods was estimated on the date of grant using the Black-Scholes option-pricing model. Number of Options Granted Weighted-Average Exercise Price Weighted-Average Fair Value 2018: Exercise price equal to Market Price 4,665,320 $ 378.51 $ 114.39 2017: Exercise price equal to Market Price 4,235,015 $ 383.56 $ 118.70 2016: Exercise price equal to Market Price 4,201,978 $ 386.44 $ 126.68 |
Schedule of weighted-average values of assumptions used in computing fair value of option grants | The following table summarizes the weighted average values of the assumptions used in computing the fair value of option grants during 2018 , 2017 , and 2016 . 2018 2017 2016 Expected volatility 29 % 31 % 34 % Expected lives from grant date 4.9 years 5.1 years 5.1 years Expected dividend yield 0 % 0 % 0 % Risk-free interest rate 2.69 % 2.16 % 1.84 % |
Schedule of activity related to restricted stock awards | A summary of the Company's activity related to restricted stock awards and restricted stock units (collectively, "restricted stock") during 2018 is summarized below: Number of Shares/Units Weighted-Average Grant Date Fair Value Balance as of December 31, 2017 106,260 $ 404.72 2018: Granted 380,980 $ 381.21 Vested (6,090 ) $ 276.46 Forfeited/Cancelled (8,520 ) $ 478.19 Balance as of December 31, 2018 472,630 $ 386.10 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of income before income tax | Components of income before income taxes consist of the following: Year Ended December 31, 2018 2017 2016 United States $ 2,151.7 $ 1,964.7 $ 1,650.9 Foreign 401.8 113.8 (321.1 ) $ 2,553.5 $ 2,078.5 $ 1,329.8 |
Schedule of components of income tax expense | Components of income tax expense consist of the following: Year Ended December 31, 2018 2017 2016 Current: Federal $ 223.7 $ 560.3 $ 787.0 State 4.8 (4.1 ) 8.8 Foreign 20.6 4.8 (1.4 ) Total current tax expense 249.1 561.0 794.4 Deferred: Federal 687.6 317.1 (377.4 ) State (1.9 ) (1.3 ) 13.4 Foreign (825.7 ) 3.2 3.9 Total deferred tax (benefit) expense (140.0 ) 319.0 (360.1 ) $ 109.1 $ 880.0 $ 434.3 |
Schedule of effective income tax rate reconciliation | A reconciliation of the U.S. statutory income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2018 2017 2016 U.S. federal statutory tax rate 21.0 % 35.0 % 35.0 % Impact of change in U.S. corporate tax rate (the Act) (2.7 ) 15.7 — Sale of non-inventory related assets between foreign subsidiaries (6.3 ) — — Stock-based compensation (2.5 ) (9.0 ) (10.9 ) Taxation of non-U.S. operations (1.9 ) 0.7 8.8 Income tax credits (2.6 ) (1.3 ) (1.2 ) Non-deductible Branded Prescription Drug Fee 0.6 1.7 1.9 Foreign-derived intangible income deduction (1.0 ) — — Domestic production activities deduction — (2.6 ) (2.8 ) State and local income taxes 0.1 0.1 1.3 Other permanent differences (0.4 ) 2.0 0.6 Effective income tax rate 4.3 % 42.3 % 32.7 % |
Schedule of deferred tax assets and liabilities | Significant components of the Company's deferred tax assets and liabilities are as follows: As of December 31, 2018 2017 Deferred tax assets: Deferred compensation $ 458.2 $ 391.0 Fixed assets and intangible assets 107.8 — Deferred revenue 20.2 102.4 Accrued expenses 53.3 38.3 Other 33.3 26.5 672.8 558.2 Valuation allowance — (4.2 ) Total deferred tax assets 672.8 554.0 Deferred tax liabilities: Fixed assets and intangible assets — (44.6 ) Other (2.7 ) (3.1 ) Total deferred tax liabilities (2.7 ) (47.7 ) Net deferred tax assets $ 670.1 $ 506.3 |
Schedule of unrecognized tax benefits | The following table summarizes the gross amounts of unrecognized tax benefits. The amount of unrecognized tax benefits that, if settled, would impact the effective tax rate is $189.5 million , $146.2 million , and $107.2 million as of December 31, 2018 , 2017 , and 2016 , respectively. 2018 2017 2016 Balance as of January 1 $ 146.2 $ 117.2 $ 116.6 Gross increases related to current year tax positions 51.4 49.0 45.6 Gross increases (decreases) related to prior year tax positions 5.6 (5.6 ) (42.3 ) Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation (13.7 ) (14.4 ) (2.7 ) Balance as of December 31 $ 189.5 $ 146.2 $ 117.2 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Income (Loss) Per Share | The calculations of basic and diluted net income per share are as follows: Year Ended December 31, 2018 2017 2016 Net income - basic $ 2,444.4 $ 1,198.5 $ 895.5 Effect of dilutive securities: Convertible senior notes - interest expense and amortization of discount and note issuance costs — — 0.4 Net income - diluted $ 2,444.4 $ 1,198.5 $ 895.9 (Shares in millions) Weighted average shares - basic 107.9 106.3 104.7 Effect of dilutive securities: Stock options 6.9 9.1 10.2 Restricted stock — 0.5 0.5 Warrants — — 0.9 Dilutive potential shares 6.9 9.6 11.6 Weighted average shares - diluted 114.8 115.9 116.3 Net income per share - basic $ 22.65 $ 11.27 $ 8.55 Net income per share - diluted $ 21.29 $ 10.34 $ 7.70 |
Antidilutive Securities | Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive, include the following: Year Ended December 31, (Shares in millions) 2018 2017 2016 Stock options 14.9 9.2 8.0 |
Statement of Cash Flows (Tables
Statement of Cash Flows (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Information [Abstract] | |
Schedule of restrictions on cash and cash equivalents | The following provides a reconciliation of cash, cash equivalents, and restricted cash to the total of the same such amounts shown in the Consolidated Statement of Cash Flows: December 31, December 31, December 31, 2018 2017 2016 Cash and cash equivalents $ 1,467.7 $ 812.7 $ 535.2 Restricted cash included in Other noncurrent assets 12.5 12.5 12.5 Total cash, cash equivalents, and restricted cash shown in the Consolidated Statement of Cash Flows $ 1,480.2 $ 825.2 $ 547.7 |
Unaudited Quarterly Results (Ta
Unaudited Quarterly Results (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Summarized quarterly financial data (unaudited) for the years ended December 31, 2018 and 2017 are set forth in the following tables. First Quarter Ended March 31, 2018 (1) Second Quarter Ended June 30, 2018 Third Quarter Ended September 30, 2018 Fourth Quarter Ended December 31, 2018 (2)(3) Revenues $ 1,511.5 $ 1,608.0 $ 1,663.5 $ 1,927.8 Net income $ 478.0 $ 551.4 $ 594.7 $ 820.4 Net income per share - basic $ 4.44 $ 5.12 $ 5.50 $ 7.58 Net income per share - diluted $ 4.16 $ 4.82 $ 5.17 $ 7.15 First Quarter Ended Second Quarter Ended Third Quarter Ended Fourth Quarter Ended (4) Revenues $ 1,319.0 $ 1,470.1 $ 1,500.7 $ 1,582.4 Net income $ 248.9 $ 387.7 $ 388.3 $ 173.5 Net income per share - basic $ 2.36 $ 3.66 $ 3.64 $ 1.62 Net income per share - diluted $ 2.16 $ 3.34 $ 3.32 $ 1.50 (1) In the first quarter of 2018, the Company adopted ASC 606 and ASU 2016-01. Prior period amounts have not been adjusted in connection with the adoption of these accounting standards. See Note 1. (2) Includes impact of a cumulative catch-up adjustment recorded to revenue upon modification of the Amended IO Discovery Agreement. See Note 3. (3) Includes tax impact of the sale of non-inventory related assets between foreign subsidiaries completed during the fourth quarter of 2018. See Note 16. (4) As a result of the Act being signed into law on December 22, 2017, the Company recognized a charge of $326.2 million in the fourth quarter of 2017 related to the re-measurement of its U.S. net deferred tax assets at the lower enacted corporate tax rate. See Note 16. |
Business Overview and Summary_4
Business Overview and Summary of Significant Accounting Policies - Narrative (Details) | Jan. 01, 2018USD ($) | Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2019USD ($) |
Accounting Policies [Abstract] | |||||
Number of business segments | segment | 1 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Allowance for doubtful accounts receivable, current | $ 0 | $ 0 | |||
Provision for doubtful accounts | $ 0 | $ 0 | $ 0 | ||
Accounting Standards Update 2014-09 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Deferred revenue | $ 143,400,000 | ||||
Equity Securities | Unrestricted | Accounting Standards Update 2016-01 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Reclassification from accumulated other comprehensive income, current period, before tax | 6,600,000 | ||||
Pro Forma | Accounting Standards Update 2016-02 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Right-of-use asset | $ 30,000,000 | ||||
Lease liabilities | $ 30,000,000 | ||||
Three individual customers | Customer concentration risk | Gross Sales Revenue | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Concentration risk, percentage | 99.00% | 99.00% | |||
Retained Earnings | Accounting Standards Update 2014-09 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Cumulative effect on retained earnings, net of tax | (143,400,000) | ||||
Retained Earnings | Equity Securities | Unrestricted | Accounting Standards Update 2016-01 | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Cumulative effect on retained earnings, net of tax | $ 6,600,000 |
Business Overview and Summary_5
Business Overview and Summary of Significant Accounting Policies - Schedule of Balance Sheet Data (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Inventories | $ 1,151.2 | $ 726.1 | ||
Deferred tax assets | 828.7 | 506.3 | ||
Total assets | 11,734.5 | 8,764.3 | ||
Accrued expenses and other current liabilities | 772.1 | 637.2 | ||
Deferred revenue, current | 452.5 | 320.1 | ||
Total current liabilities | 1,442.8 | 1,135.5 | ||
Deferred revenue, noncurrent | 464.2 | 629.2 | ||
Total liabilities | 2,977.2 | 2,620.2 | ||
Retained earnings | 5,254.3 | 2,946.7 | ||
Total stockholders' equity | 8,757.3 | 6,144.1 | $ 4,449.3 | $ 3,654.8 |
Total liabilities and stockholders' equity | 11,734.5 | 8,764.3 | ||
Balance Without Adoption of ASC 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Inventories | 1,168.7 | |||
Deferred tax assets | 846.2 | |||
Total assets | 11,769.5 | |||
Accrued expenses and other current liabilities | 770.8 | |||
Total current liabilities | 1,290.2 | |||
Total liabilities | 3,009.6 | |||
Retained earnings | 5,256.9 | |||
Total stockholders' equity | 8,759.9 | |||
Total liabilities and stockholders' equity | 11,769.5 | |||
Adjustments | Accounting Standards Update 2014-09 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Inventories | 17.5 | |||
Deferred tax assets | 17.5 | |||
Total assets | 35 | |||
Accrued expenses and other current liabilities | (1.3) | |||
Total current liabilities | (152.6) | |||
Total liabilities | 32.4 | |||
Retained earnings | 2.6 | |||
Total stockholders' equity | 2.6 | |||
Total liabilities and stockholders' equity | 35 | |||
Sanofi | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | 246.7 | 177.7 | ||
Deferred revenue, noncurrent | 279.3 | 379.9 | ||
Sanofi | Balance Without Adoption of ASC 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | 153.7 | |||
Deferred revenue, noncurrent | 442.5 | |||
Sanofi | Adjustments | Accounting Standards Update 2014-09 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | (93) | |||
Deferred revenue, noncurrent | 163.2 | |||
Other | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | 205.8 | 142.4 | ||
Deferred revenue, noncurrent | 184.9 | $ 249.3 | ||
Other | Balance Without Adoption of ASC 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | 147.5 | |||
Deferred revenue, noncurrent | 206.7 | |||
Other | Adjustments | Accounting Standards Update 2014-09 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue, current | (58.3) | |||
Deferred revenue, noncurrent | $ 21.8 |
Business Overview and Summary_6
Business Overview and Summary of Significant Accounting Policies - Schedule of Statements of Operations Data (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Income from operations | 2,534.4 | 2,079.6 | 1,330.7 | ||||||||
Income before income taxes | 2,553.5 | 2,078.5 | 1,329.8 | ||||||||
Income tax expense | (109.1) | (880) | (434.3) | ||||||||
Net income | $ 820.4 | $ 594.7 | $ 551.4 | $ 478 | $ 173.5 | $ 388.3 | $ 387.7 | $ 248.9 | 2,444.4 | 1,198.5 | 895.5 |
Collaboration and contract manufacturing | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Cost of collaboration and contract manufacturing | 254.1 | 194.6 | 105.1 | ||||||||
Balance Without Adoption of ASC 606 | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | 6,515.3 | ||||||||||
Income from operations | 2,356.4 | ||||||||||
Income before income taxes | 2,375.5 | ||||||||||
Income tax expense | (71.9) | ||||||||||
Net income | 2,303.6 | ||||||||||
Balance Without Adoption of ASC 606 | Collaboration and contract manufacturing | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Cost of collaboration and contract manufacturing | 236.6 | ||||||||||
Accounting Standards Update 2014-09 | Adjustments | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | (195.5) | ||||||||||
Income from operations | (178) | ||||||||||
Income before income taxes | (178) | ||||||||||
Income tax expense | 37.2 | ||||||||||
Net income | (140.8) | ||||||||||
Accounting Standards Update 2014-09 | Adjustments | Collaboration and contract manufacturing | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Cost of collaboration and contract manufacturing | (17.5) | ||||||||||
Sanofi | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | 1,111.1 | 877.2 | 658.7 | ||||||||
Sanofi | Balance Without Adoption of ASC 606 | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | 947.3 | ||||||||||
Sanofi | Accounting Standards Update 2014-09 | Adjustments | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | (163.8) | ||||||||||
Other | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | 416.8 | $ 338.4 | $ 119 | ||||||||
Other | Balance Without Adoption of ASC 606 | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | 385.1 | ||||||||||
Other | Accounting Standards Update 2014-09 | Adjustments | Product and service, other | |||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||
Revenues | $ (31.7) |
Business Overview and Summary_7
Business Overview and Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Building and improvements | Minimum | |
Estimated useful life | 10 years |
Building and improvements | Maximum | |
Estimated useful life | 50 years |
Laboratory and other equipment | Minimum | |
Estimated useful life | 3 years |
Laboratory and other equipment | Maximum | |
Estimated useful life | 10 years |
Furniture and fixtures | Maximum | |
Estimated useful life | 5 years |
Product Sales - Schedule of Net
Product Sales - Schedule of Net Product Sales (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Product | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 4,106.2 | 3,718.5 | 3,338.4 | ||||||||
United States | EYLEA | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 4,076.7 | 3,701.9 | 3,323.1 | ||||||||
United States | Libtayo | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 14.8 | 0 | 0 | ||||||||
United States | ARCALYST | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 14.7 | 16.6 | 15.3 | ||||||||
United States | Product | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 4,106.2 | $ 3,718.5 | $ 3,338.4 |
Product Sales - Schedule of Con
Product Sales - Schedule of Concentration of Risk, by Risk Factor (Details) - Gross Sales Revenue - Customer concentration risk | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Besse Medical, a subsidiary of AmerisourceBergen Corporation | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 56.00% | 51.00% | 55.00% |
McKesson Corporation | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 36.00% | 29.00% | 28.00% |
Curascript SD Specialty Distribution, a subsidiary of Express Scripts | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 19.00% | 16.00% |
Product Sales - Schedule of Sal
Product Sales - Schedule of Sales Related Deductions Activity (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning Balance | $ 85.3 | $ 45.8 | $ 55.3 |
Provisions | 478.9 | 408.3 | 278.2 |
Credits/payments | (472.8) | (368.8) | (287.7) |
Ending Balance | 91.4 | 85.3 | 45.8 |
Rebates, Chargebacks, and Discounts | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning Balance | 29.9 | 12.7 | 6.4 |
Provisions | 223.4 | 167.8 | 93.4 |
Credits/payments | (212.2) | (150.6) | (87.1) |
Ending Balance | 41.1 | 29.9 | 12.7 |
Distribution- Related Fees | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning Balance | 34.1 | 29.5 | 48.4 |
Provisions | 211 | 194.1 | 154.4 |
Credits/payments | (203.1) | (189.5) | (173.3) |
Ending Balance | 42 | 34.1 | 29.5 |
Other Sales- Related Deductions | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning Balance | 21.3 | 3.6 | 0.5 |
Provisions | 44.5 | 46.4 | 30.4 |
Credits/payments | (57.5) | (28.7) | (27.3) |
Ending Balance | $ 8.3 | $ 21.3 | $ 3.6 |
Collaboration and License Agr_3
Collaboration and License Agreements - Schedule of Collaboration Revenue Earned From Sanofi (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Product and service, other | Sanofi Collaboration Agreement, Antibody | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 559 | 553.7 | 440.2 | ||||||||
Product and service, other | Sanofi Collaboration Agreement, Immuno-oncology | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 552.1 | 323.5 | 218.5 | ||||||||
Product and service, other | Sanofi | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 1,111.1 | 877.2 | 658.7 | ||||||||
Reimbursement of Regeneron research and development expenses | Sanofi Collaboration Agreement, Antibody | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 265.3 | 508.4 | 564.9 | ||||||||
Reimbursement of Regeneron research and development expenses | Sanofi Collaboration Agreement, Immuno-oncology | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 311.8 | 240 | 138.5 | ||||||||
Reimbursement of Regeneron commercialization-related expenses | Sanofi Collaboration Agreement, Antibody | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 417.2 | 368.8 | 305.9 | ||||||||
Reimbursement of Regeneron commercialization-related expenses | Sanofi Collaboration Agreement, Immuno-oncology | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 8.9 | 7 | 0 | ||||||||
Regeneron's share of losses in connection with commercialization of antibodies | Sanofi Collaboration Agreement, Antibody | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | (227) | (442.6) | (459) | ||||||||
Other | Sanofi Collaboration Agreement, Antibody | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 103.5 | 119.1 | 28.4 | ||||||||
Other | Sanofi Collaboration Agreement, Immuno-oncology | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 231.4 | $ 76.5 | $ 80 |
Collaboration and License Agr_4
Collaboration and License Agreements - Sanofi, Antibodies Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2007 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | ||||
Research and development | $ 2,186.1 | $ 2,075.1 | $ 2,052.3 | |
Cost of Treasury stock shares received | $ 80.2 | 0 | ||
Sanofi | ||||
Disaggregation of Revenue [Line Items] | ||||
Common Stock, shares issued (in shares) | 23,654,384 | |||
Sanofi Collaboration Agreement, Antibody | ||||
Disaggregation of Revenue [Line Items] | ||||
Proceeds from collaborators | $ 85 | |||
Annual funding maximum of research activities per amended agreement | 130 | 130 | ||
Percentage of Trial Costs borne by collaborating party | 80.00% | |||
Percentage of Trial Costs borne by entity | 20.00% | |||
Percentage of repayment of development balance out of profits | 50.00% | |||
Percentage of trial costs to be reimbursed due to profitability of agreement | 30.00% | |||
Excess share of profit not required to to be applied to reimburse development cost | 10.00% | |||
Contingent reimbursement obligation | $ 2,786 | |||
Treasury stock, shares acquired (in shares) | 10,766 | |||
Cost of Treasury stock shares received | $ 4.4 | |||
Starting share of profits outside the United States, based on sales, for collaborating party | 65.00% | |||
Starting share of profits outside the United States, based on sales, for Company | 35.00% | |||
Ending share of profits outside the United States, based on sales, for collaborating party | 55.00% | |||
Ending share of profits outside the United States, based on sales, for Company | 45.00% | |||
Share of losses outside the United States, for collaborating party | 55.00% | |||
Share of losses outside the United States, for Company | 45.00% | |||
Maximum amount of sales milestone payments if total sales achieve specific levels | $ 250 | |||
Levels of twelve month sales at which sales milestone payments would be received | $ 1,000 | |||
Period for achieving sales target for milestone payment, rolling basis | 12 months | |||
Period of notice to opt out of further development and or commercialization | 12 months | |||
Praluent, Kevzara, and Dupixent | Sanofi Collaboration Agreement, Antibody | ||||
Disaggregation of Revenue [Line Items] | ||||
Research and development | $ 47.7 | $ 91.8 | $ 108.6 |
Collaboration and License Agr_5
Collaboration and License Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, Antibody Collaboration (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | $ 226.4 | $ 193.7 |
Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | 138.2 | 121 |
Deferred revenue | $ 236.1 | $ 117.7 |
Collaboration and License Agr_6
Collaboration and License Agreements - Schedule of Significant Changes in Deferred Revenue Balances, Antibody Collaboration (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||
(Decrease) increase in deferred revenue | $ (194.5) | $ (113.1) | $ 244.3 |
Sanofi Collaboration Agreement, Antibody | |||
Disaggregation of Revenue [Line Items] | |||
(Decrease) increase in deferred revenue | 251.6 | ||
Revenue recognized that was included in deferred revenue at the beginning of the period | $ (133.2) |
Collaboration and License Agr_7
Collaboration and License Agreements - Sanofi, Immuno-Oncology Narrative (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Aug. 31, 2018 | Jul. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2015 | Jan. 07, 2018 |
Disaggregation of Revenue [Line Items] | ||||||||
Maximum shares the collaborator could sell (in shares) | 1,173,847 | 1,173,847 | 1,173,847 | 1,400,000 | ||||
Cost of Treasury stock shares received | $ 80.2 | $ 0 | ||||||
Sanofi Collaboration Agreement, Immuno-oncology | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Excess share of profit not required to to be applied to reimburse development cost | 10.00% | |||||||
Contingent reimbursement obligation | $ 58 | $ 58 | $ 58 | |||||
Maximum shares the collaborator could sell (in shares) | 1,400,000 | 1,400,000 | 1,400,000 | |||||
Treasury stock, shares acquired (in shares) | 215,387 | |||||||
Cost of Treasury stock shares received | $ 75.8 | |||||||
Maximum amount of sales milestone payments if total sales achieve specific levels | $ 375 | |||||||
Upfront payment made | $ 20 | |||||||
Remaining performance obligation | $ 1,398.4 | $ 1,398.4 | 1,398.4 | |||||
Sanofi Collaboration Agreement, Immuno-oncology | IO Discovery Agreement | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Up-front payment received | 265 | |||||||
Potential future R&D expenses | 1,090 | |||||||
Funding maximum of research activities per agreement | $ 825 | |||||||
License agreement term | 5 years | |||||||
Additional years to extend the agreement | 3 years | |||||||
Sanofi Collaboration Agreement, Immuno-oncology | Amended IO Discovery Agreement | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Aggregate payment received with regards to amendment | 461.9 | |||||||
Cumulative catch-up adjustment to revenue, modification of contract | (192.7) | 135 | ||||||
Sanofi Collaboration Agreement, Immuno-oncology | BCMAxCD3 Program | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Expenditure costs cap | 70 | |||||||
Sanofi Collaboration Agreement, Immuno-oncology | MUC16xCD3 Program | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Expenditure costs cap | 50 | |||||||
Potential maximum expenditure | 70 | $ 70 | $ 70 | |||||
Optional payment to increase development cost funding | $ 20 | |||||||
Sanofi Collaboration Agreement, Immuno-oncology | IO Agreement | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Up-front payment received | $ 640 | |||||||
Sanofi Collaboration Agreement, Immuno-oncology | IO License and Collaboration Agreement | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Up-front payment received | $ 375 | |||||||
Excess share of profit not required to to be applied to reimburse development cost | 10.00% | |||||||
Period of notice to opt out of further development and or commercialization | 12 months | |||||||
Sanofi Collaboration Agreement, Immuno-oncology | IO License and Collaboration Agreement | PD-1 | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Levels of twelve month sales at which sales milestone payments would be received | $ 2,000 | |||||||
Period for achieving sales target for milestone payment, rolling basis | 12 months | |||||||
Through December 31, 2023 | Sanofi Collaboration Agreement, Immuno-oncology | Libtayo | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Percentage of royalties to be paid | 8.00% | |||||||
January 1, 2024 Through December 31, 2026 | Sanofi Collaboration Agreement, Immuno-oncology | Libtayo | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Percentage of royalties to be paid | 2.50% |
Collaboration and License Agr_8
Collaboration and License Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, IO Collaboration (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | $ 226.4 | $ 193.7 |
Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | 77.9 | 59.3 |
Deferred revenue | $ 289.9 | $ 440 |
Collaboration and License Agr_9
Collaboration and License Agreements - Schedule of Significant Changes in Deferred Revenue Balances, IO Collaboration (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 | $ (194.5) | $ (113.1) | $ 244.3 |
Sanofi Collaboration Agreement, Immuno-oncology | |||
Disaggregation of Revenue [Line Items] | |||
Revenue recognized that was included in deferred revenue at the beginning of the period | (108.7) | ||
Accounting Standards Update 2014-09 | Sanofi Collaboration Agreement, Immuno-oncology | |||
Disaggregation of Revenue [Line Items] | |||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 | $ 93.6 |
Collaboration and License Ag_10
Collaboration and License Agreements - Schedule of Collaboration Revenue Earned From Bayer (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Bayer | Product and service, other | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 1,076.7 | 938.1 | 744.3 | ||||||||
Outside United States | Bayer | Product and service, other | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 1,077.1 | 874.3 | 710.8 | ||||||||
Outside United States | Bayer | Net profit in connection with commercialization | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 992.3 | 802.3 | 649.2 | ||||||||
Outside United States | Bayer | Reimbursement of Regeneron research and development expenses | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 11.2 | 13.3 | 9 | ||||||||
Outside United States | Bayer | Other | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 73.6 | $ 58.7 | $ 52.6 |
Collaboration and License Ag_11
Collaboration and License Agreements - Bayer Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Bayer | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Minimum advance notice required to terminate collaboration agreement | 6 months | ||||||||||
Maximum advance notice required to terminate collaboration agreement | 12 months | ||||||||||
Percentage of repayment of development balance out of profits | 50.00% | ||||||||||
Contingent reimbursement obligation | $ 265 | $ 265 | |||||||||
Ang2 antibody | Bayer | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Up-front payment received | $ 37.4 | 50 | |||||||||
Ang2 antibody and PDGFR-beta antibody | Bayer | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 63.8 | $ 33.5 | |||||||||
Minimum | Bayer | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue based on percentage of annual sales in Japan | 33.50% | ||||||||||
Maximum | Bayer | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue based on percentage of annual sales in Japan | 40.00% |
Collaboration and License Ag_12
Collaboration and License Agreements - Teva Narrative (Details) - USD ($) $ in Millions | Sep. 30, 2016 | Sep. 30, 2016 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Disaggregation of Revenue [Line Items] | |||||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 | ||
Teva | |||||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||||
Up-front payment received | $ 250 | $ 250 | |||||||||||
Revenue recognition, milestone method, revenue recognized | $ 35 | $ 25 | 60 | ||||||||||
Aggregate future development milestone payments the Company is eligible to receive | 340 | ||||||||||||
Collaborative arrangement, additional eligible aggregate payments | 1,890 | ||||||||||||
Revenues | 244.6 | $ 221.5 | $ 37.9 | ||||||||||
Remaining performance obligation | $ 472.2 | $ 472.2 |
Collaboration and License Ag_13
Collaboration and License Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, Teva Collaboration (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable (recorded within Prepaid expenses and other current assets) | $ 243.3 | $ 225.1 |
Teva | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable (recorded within Prepaid expenses and other current assets) | 28.8 | 71.3 |
Deferred revenue | $ 194.5 | $ 197.4 |
Collaboration and License Ag_14
Collaboration and License Agreements - Schedule of Significant Changes in Deferred Revenue Balances, Teva Collaboration (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 | $ (194.5) | $ (113.1) | $ 244.3 |
Teva | Accounting Standards Update 2014-09 | |||
Disaggregation of Revenue [Line Items] | |||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606 | 48.2 | ||
Increase due to amounts invoiced, excluding amounts recognized as revenue during the period | 30.7 | ||
Revenue recognized that was included in deferred revenue at the beginning of the period | $ (83.8) |
Marketable Securities - Schedul
Marketable Securities - Schedule of Investments in Available For Sale Debt Securities (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | $ 3,026.6 | $ 2,027.3 |
Unrealized Gains | 1 | 2.2 |
Unrealized Losses | (18.4) | (8.9) |
Fair Value | 3,009.2 | 2,020.6 |
Corporate bonds | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 2,734.8 | 1,718 |
Unrealized Gains | 1 | 2.2 |
Unrealized Losses | (17.4) | (7.7) |
Fair Value | 2,718.4 | 1,712.5 |
U.S. government and government agency obligations | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 110.4 | 186.7 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (1) | (1.2) |
Fair Value | 109.4 | 185.5 |
Sovereign bonds | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 7.6 | |
Unrealized Gains | 0 | |
Unrealized Losses | 0 | |
Fair Value | 7.6 | |
Municipal and sovereign bonds | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 4.6 | |
Unrealized Gains | 0 | |
Unrealized Losses | 0 | |
Fair Value | 4.6 | |
Commercial paper | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 113.8 | 107 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | 113.8 | 107 |
Certificates of deposit | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 60 | 11 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | $ 60 | $ 11 |
Marketable Securities - Sched_2
Marketable Securities - Schedule of Debt Securities Based on Contractual Maturity Dates (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturities within one year | $ 1,342.2 | $ 593.8 |
Maturities after one year through five years | 1,667 | 1,426.8 |
Total | $ 3,009.2 | $ 2,020.6 |
Marketable Securities - Sched_3
Marketable Securities - Schedule of Fair Value and Unrealized Losses of Debt Securities (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | $ 1,482.6 | $ 1,041.5 |
Unrealized Loss - Less than 12 months | (6.1) | (5.3) |
Fair Value - 12 Months or Greater | 900.7 | 324.7 |
Unrealized Loss - 12 Months or Greater | (12.3) | (3.6) |
Fair Value - Total | 2,383.3 | 1,366.2 |
Unrealized Loss - Total | (18.4) | (8.9) |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | 1,482.6 | 931 |
Unrealized Loss - Less than 12 months | (6.1) | (4.9) |
Fair Value - 12 Months or Greater | 801.6 | 256.8 |
Unrealized Loss - 12 Months or Greater | (11.3) | (2.8) |
Fair Value - Total | 2,284.2 | 1,187.8 |
Unrealized Loss - Total | (17.4) | (7.7) |
U.S. government and government agency obligations | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | 0 | 110.5 |
Unrealized Loss - Less than 12 months | 0 | (0.4) |
Fair Value - 12 Months or Greater | 99.1 | 67.9 |
Unrealized Loss - 12 Months or Greater | (1) | (0.8) |
Fair Value - Total | 99.1 | 178.4 |
Unrealized Loss - Total | $ (1) | $ (1.2) |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Gain (Loss) on Securities [Line Items] | |||
Net unrealized gain (loss) on securities | $ (41,900,000) | $ 14,700,000 | $ (22,600,000) |
Equity Securities | |||
Gain (Loss) on Securities [Line Items] | |||
Other-than-temporary Impairment charges | $ 0 | $ 0 | $ 9,800,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Available-for-sale debt securities: | ||
Available-for-sale debt securities | $ 3,009.2 | $ 2,020.6 |
Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Total marketable securities | 43.6 | 62.7 |
Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Total marketable securities | 3,053.6 | 2,020.6 |
Unrestricted | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Equity securities | 43.6 | 62.7 |
Unrestricted | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Equity securities | 0 | 0 |
Restricted | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Equity securities | 0 | |
Restricted | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Equity securities | 44.4 | |
Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Total marketable securities | 3,097.2 | 2,083.3 |
Estimate of Fair Value Measurement | Unrestricted | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Equity securities | 43.6 | 62.7 |
Estimate of Fair Value Measurement | Restricted | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Equity securities | 44.4 | |
Corporate bonds | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | 0 |
Corporate bonds | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 2,718.4 | 1,712.5 |
Corporate bonds | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 2,718.4 | 1,712.5 |
Corporate bonds | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 2,718.4 | 1,712.5 |
U.S. government and government agency obligations | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | 0 |
U.S. government and government agency obligations | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 109.4 | 185.5 |
U.S. government and government agency obligations | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 109.4 | 185.5 |
U.S. government and government agency obligations | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 109.4 | 185.5 |
Sovereign bonds | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | |
Sovereign bonds | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 7.6 | |
Sovereign bonds | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 7.6 | |
Sovereign bonds | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 7.6 | |
Municipal and sovereign bonds | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | |
Municipal and sovereign bonds | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 4.6 | |
Municipal and sovereign bonds | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 4.6 | |
Municipal and sovereign bonds | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 4.6 | |
Commercial paper | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | 0 |
Commercial paper | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 113.8 | 107 |
Commercial paper | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 113.8 | 107 |
Commercial paper | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 113.8 | 107 |
Certificates of deposit | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 0 | 0 |
Certificates of deposit | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 60 | 11 |
Certificates of deposit | Unrestricted | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | 60 | 11 |
Certificates of deposit | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Available-for-sale debt securities: | ||
Available-for-sale debt securities | $ 60 | $ 11 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Securities owned not readily marketable | $ 45,500,000 | $ 37,500,000 | |
Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Other-than-temporary Impairment charges | $ 0 | $ 0 | $ 0 |
Derivative Instruments and He_3
Derivative Instruments and Hedging Activities - Schedule of Notional Amounts of Outstanding Derivative Positions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Derivative [Line Items] | ||
Gain (loss) related to ineffective portion of the derivative instruments | $ 0 | $ 0 |
Interest rate swap contracts | ||
Derivative [Line Items] | ||
Derivative, notional amount | 75,000,000 | 75,000,000 |
Interest rate cap contracts | ||
Derivative [Line Items] | ||
Derivative, notional amount | $ 75,000,000 | $ 75,000,000 |
Inventories - Schedule of inven
Inventories - Schedule of inventories (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 226.8 | $ 190 |
Work-in-process | 571.1 | 302 |
Finished goods | 24.4 | 21.8 |
Deferred costs | 328.9 | 212.3 |
Total Inventories | $ 1,151.2 | $ 726.1 |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Schedule of property, plant, and equipment (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | $ 3,304.5 | $ 2,924.9 |
Less, accumulated depreciation and amortization | (728.7) | (566.3) |
Property, plant, and equipment, net | 2,575.8 | 2,358.6 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 199 | 192.8 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 1,507.2 | 1,441.6 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 97 | 102.6 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 469.6 | 408.9 |
Laboratory and other equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 773.7 | 599.1 |
Furniture, computer and office equipment, and other | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | $ 258 | $ 179.9 |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant, and equipment, net | $ 2,575.8 | $ 2,358.6 | |
Depreciation and amortization expense | 144.1 | 142.2 | $ 104.7 |
Capital and facility leases, at cost | 723.9 | 724.1 | |
Accumulated amortization of capital and facility leases | 61.7 | 47.9 | |
United States | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant, and equipment, net | 1,813.8 | 1,692.9 | |
Europe | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant, and equipment, net | $ 762 | $ 665.7 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of accrued expenses and other current liabilities (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accrued payroll and related costs | $ 261.8 | $ 191.8 |
Accrued clinical trial expense | 142.2 | 120.9 |
Accrued sales-related charges, deductions, and royalties | 182.7 | 194.5 |
Income taxes payable | 20.8 | 0.2 |
Other accrued expenses and liabilities | 164.6 | 129.8 |
Accrued expenses and other current liabilities | $ 772.1 | $ 637.2 |
Deferred Revenue - Schedule of
Deferred Revenue - Schedule of deferred revenue (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Current portion: | ||
Deferred revenue, current | $ 452.5 | $ 320.1 |
Long-term portion: | ||
Deferred revenue, noncurrent | 464.2 | 629.2 |
Sanofi | ||
Current portion: | ||
Deferred revenue, current | 246.7 | 177.7 |
Long-term portion: | ||
Deferred revenue, noncurrent | 279.3 | 379.9 |
Bayer | ||
Current portion: | ||
Deferred revenue, current | 44.4 | 39 |
Long-term portion: | ||
Deferred revenue, noncurrent | 45.1 | 29.7 |
Teva | ||
Current portion: | ||
Deferred revenue, current | 92.5 | 43.5 |
Long-term portion: | ||
Deferred revenue, noncurrent | 102 | 153.9 |
Other | ||
Current portion: | ||
Deferred revenue, current | 68.9 | 59.9 |
Long-term portion: | ||
Deferred revenue, noncurrent | $ 37.8 | $ 65.7 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Oct. 31, 2011 | |
Debt Instrument [Line Items] | |||||
Repayments of convertible senior notes | $ 0 | $ 0 | $ 12,900,000 | ||
Reduction of equity component of convertible notes | 47,800,000 | ||||
Cost of Treasury stock shares received | 80,200,000 | 0 | |||
Payments in connection with reduction of outstanding warrants | 0 | $ 0 | 643,400,000 | ||
Warrants outstanding | 0 | ||||
Borrowings outstanding | $ 0 | $ 0 | |||
November 2016 Agreement [Member] [Member] | |||||
Debt Instrument [Line Items] | |||||
Payments in connection with reduction of outstanding warrants | 401,200,000 | ||||
Warrant | |||||
Debt Instrument [Line Items] | |||||
Payments in connection with reduction of outstanding warrants | 242,200,000 | ||||
Convertible senior notes | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 400,000,000 | ||||
Interest rate, stated percentage | 1.875% | ||||
Initial conversion price (in dollars per share) | $ 84.02 | ||||
Repayments of convertible senior notes | $ 12,900,000 | ||||
Stock issued, new shares (in shares) | 121,058 | ||||
Reduction of equity component of convertible notes | $ (47,800,000) | ||||
Treasury Stock | |||||
Debt Instrument [Line Items] | |||||
Treasury stock, shares acquired (in shares) | 200,000 | 200,000 | |||
Cost of Treasury stock shares received | $ 80,200,000 | $ 10,100,000 | |||
Treasury Stock | Convertible senior notes | |||||
Debt Instrument [Line Items] | |||||
Treasury stock, shares acquired (in shares) | 121,048 | ||||
Cost of Treasury stock shares received | $ 10,200,000 | ||||
Senior unsecured revolving credit facility | Line of credit | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 750,000,000 | 750,000,000 | |||
Debt term | 5 years | ||||
Increase Limit | $ 250,000,000 | 250,000,000 | |||
Letters of credit | Line of credit | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 50,000,000 | $ 50,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Leases Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 03, 2017 | Dec. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | ||||||
Facility purchase price | $ 720 | |||||
Payment towards purchase price of Tarrytown facility | $ 57 | |||||
Aggregate funding advanced by the participants | $ 720 | |||||
Reimbursement received by the Company | $ 57 | |||||
Initial term of lease | 5 years | |||||
Potential extended term of lease | 5 years | |||||
Loss on extinguishment of debt | 30.1 | |||||
Tarrytown facility capital and facility lease obligations | 720 | |||||
Interest expense in connection with capital and facility leases | $ 21.5 | $ 19.5 | $ 5.4 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of commitments under operating leases (Details) $ in Millions | Dec. 31, 2018USD ($) |
Operating Leased Assets [Line Items] | |
2,019 | $ 10.4 |
2,020 | 3.8 |
2,021 | 3.4 |
2,022 | 2.2 |
2,023 | 1.5 |
Thereafter | 4.1 |
Total | 25.4 |
Facilities | |
Operating Leased Assets [Line Items] | |
2,019 | 4.2 |
2,020 | 3.6 |
2,021 | 3.3 |
2,022 | 2.2 |
2,023 | 1.5 |
Thereafter | 4.1 |
Total | 18.9 |
Equipment | |
Operating Leased Assets [Line Items] | |
2,019 | 6.2 |
2,020 | 0.2 |
2,021 | 0.1 |
2,022 | 0 |
2,023 | 0 |
Thereafter | 0 |
Total | $ 6.5 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of rent expense under operating leases (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Leased Assets [Line Items] | |||
Rent expense under operating leases | $ 4.9 | $ 4.3 | $ 16.8 |
Facilities | |||
Operating Leased Assets [Line Items] | |||
Rent expense under operating leases | 3.7 | 3.1 | 15.9 |
Equipment | |||
Operating Leased Assets [Line Items] | |||
Rent expense under operating leases | $ 1.2 | $ 1.2 | $ 0.9 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of commitments under capital and facility lease obligations (Details) $ in Millions | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 26.4 |
2,020 | 28.4 |
2,021 | 27.9 |
2,022 | 7 |
2,023 | 0 |
Thereafter | 0 |
Total | $ 89.7 |
Commitments and Contingencies_5
Commitments and Contingencies - Research Collaboration and Licensing Agreements Narrative (Details) - Agreements with Royalty Provisions - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Research Collaboration and Licensing Arrangements [Line Items] | |||
Royalty rate minimum | 0.50% | ||
Royalty rate maximum | 11.50% | ||
Royalty expense | $ 36.7 | $ 30.8 | $ 125.3 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2007shares | Dec. 31, 2018votedemand_right$ / sharesshares | Jan. 07, 2018shares | Dec. 31, 2017$ / sharesshares | |
Class of Stock [Line Items] | ||||
Preferred stock, shares authorized (in shares) | 30,000,000 | 30,000,000 | ||
Number of demand rights to require the Company to conduct registered underwritten public offering | demand_right | 3 | |||
Maximum shares the collaborator could sell (in shares) | 1,173,847 | 1,400,000 | ||
Class A Stock | ||||
Class of Stock [Line Items] | ||||
Common Stock, shares authorized (in shares) | 40,000,000 | 40,000,000 | ||
Common Stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Number of votes per share | vote | 10 | |||
Common Stock | ||||
Class of Stock [Line Items] | ||||
Common Stock, shares authorized (in shares) | 320,000,000 | 320,000,000 | ||
Common Stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Number of votes per share | vote | 1 | |||
Sanofi | ||||
Class of Stock [Line Items] | ||||
Number of shares of Common Stock purchased | 12,000,000 | |||
Maximum percentage of outstanding shares that may be acquired, under 'standstill' provisions | 30.00% | |||
Percentage of outstanding shares or voting rights under amended investor agreement | 20.00% | |||
Percentage of outstanding shares that the Company is required to appoint an individual agreed upon by the Company and the Collaborator to the Company's board of directors | 20.00% | |||
Bayer | ||||
Class of Stock [Line Items] | ||||
Maximum percentage of outstanding shares that may be acquired, under 'standstill' provisions | 20.00% | |||
Teva | ||||
Class of Stock [Line Items] | ||||
Maximum percentage of outstanding shares that may be acquired, under 'standstill' provisions | 5.00% |
Long-Term Incentive Plans - Nar
Long-Term Incentive Plans - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum term of awards | 10 years | ||
Total intrinsic value - of stock options exercised | $ 510.6 | $ 735.6 | $ 550.4 |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock options | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 3 years | ||
Stock options | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Award vesting period | 4 years | ||
Non-performance based stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $ 421.8 | $ 492.8 | $ 546 |
Capitalized to inventory | 17.1 | 16.8 | 14.6 |
Unrecognized stock-based compensation cost, net of estimated forfeitures | $ 702.6 | ||
Weighted average period for recognition of total unrecognized compensation expense (in years) | 1 year 11 months | ||
Phantom stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Period within vesting date that awards may be received | 30 days | ||
Restricted stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $ 5.6 | $ 14.5 | $ 13.9 |
Unrecognized stock-based compensation cost, net of estimated forfeitures | $ 124.4 | ||
Weighted average period for recognition of total unrecognized compensation expense (in years) | 4 years 7 months | ||
Long-Term Incentive Plan 2000 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for future grants (in shares) | 0 | ||
Amended & Restated Long-Term Incentive Plan 2014 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares authorized for issuance (in shares) | 18,559,431 | ||
Additional shares registered (in shares) | 12,000,000 | ||
Long-Term Incentive Plan 2014 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for future grants (in shares) | 12,115,845 |
Long-Term Incentive Plans - Sum
Long-Term Incentive Plans - Summary of transactions involving stock option awards (Details) - Stock options - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Shares | |||
Outstanding at beginning of period (in shares) | 26,205,373,000 | ||
Granted (in shares) | 4,665,320,000 | 4,235,015,000 | 4,201,978,000 |
Forfeited (in shares) | (668,550,000) | ||
Expired (in shares) | (205,030,000) | ||
Exercised (in shares) | (1,717,417,000) | ||
Outstanding at end of period (in shares) | 28,279,696,000 | 26,205,373,000 | |
Vested and expected to vest (in shares) | 27,192,461,000 | ||
Exercisable (in shares) | 17,893,976,000 | ||
Weighted-Average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 295.98 | ||
Granted (in dollars per share) | 378.51 | $ 383.56 | $ 386.44 |
Forfeited (in dollars per share) | 422.56 | ||
Expired (in dollars per share) | 467.40 | ||
Exercised (in dollars per share) | 66.87 | ||
Outstanding at end of period (in dollars per share) | 319.28 | $ 295.98 | |
Vested and expected to vest (in dollars per share) | 316.51 | ||
Exercisable (in dollars per share) | $ 275.10 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted average remaining contractual term (in years) - outstanding | 6 years 5 months 5 days | ||
Weighted average remaining contractual term - vested and expected to vest | 6 years 3 months 25 days | ||
Weighted average remaining contractual term - exercisable | 4 years 11 months 23 days | ||
Instrinsic value - outstanding | $ 2,290.5 | ||
Intrinsic value - vested and expected to vest | 2,289.1 | ||
Intrinsic value - exercisable | $ 2,276.2 |
Long-Term Incentive Plans - S_2
Long-Term Incentive Plans - Summary of weighted-average exercise prices and weighted-average grant-date fair values of options issued (Details) - Stock options - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Options Granted (in shares) | 4,665,320,000 | 4,235,015,000 | 4,201,978,000 |
Weighted-Average Exercise Price (in dollars per share) | $ 378.51 | $ 383.56 | $ 386.44 |
Weighted-Average Fair Value (in dollars per share) | $ 114.39 | $ 118.70 | $ 126.68 |
Long-Term Incentive Plans - S_3
Long-Term Incentive Plans - Summary of weighted-average values of assumptions used in computing fair value of option grants (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 29.00% | 31.00% | 34.00% |
Expected lives from grant date | 4 years 10 months 24 days | 5 years 1 month 1 day | 5 years 1 month 1 day |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate | 2.69% | 2.16% | 1.84% |
Long-Term Incentive Plans - S_4
Long-Term Incentive Plans - Summary of activity related to restricted stock awards (Details) - Restricted stock | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Shares/Units | |
Beginning balance (in shares) | shares | 106,260 |
Granted (in shares) | shares | 380,980 |
Vested (in shares) | shares | (6,090) |
Forfeited/Cancelled (in shares) | shares | (8,520) |
Ending balance (in shares) | shares | 472,630 |
Weighted-Average Grant Date Fair Value | |
Beginning balance (in dollars of shares) | $ / shares | $ 404.72 |
Granted (in dollars of shares) | $ / shares | 381.21 |
Vested (in dollars of shares) | $ / shares | 276.46 |
Forfeited/Cancelled (in dollars of shares) | $ / shares | 478.19 |
Ending balance (in dollars of shares) | $ / shares | $ 386.10 |
Employee Savings Plan - Narrati
Employee Savings Plan - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | |||
Employer contribution expense to 401(k) Savings Plan | $ 27 | $ 19.6 | $ 17.7 |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income before income tax (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Income before income taxes | $ 2,553.5 | $ 2,078.5 | $ 1,329.8 |
United States | |||
Operating Loss Carryforwards [Line Items] | |||
Income before income taxes | 2,151.7 | 1,964.7 | 1,650.9 |
Foreign | |||
Operating Loss Carryforwards [Line Items] | |||
Income before income taxes | $ 401.8 | $ 113.8 | $ (321.1) |
Income Taxes - Schedule of comp
Income Taxes - Schedule of components of income tax expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current: | |||
Federal | $ 223.7 | $ 560.3 | $ 787 |
State | 4.8 | (4.1) | 8.8 |
Foreign | 20.6 | 4.8 | (1.4) |
Total current tax expense | 249.1 | 561 | 794.4 |
Deferred: | |||
Federal | 687.6 | 317.1 | (377.4) |
State | (1.9) | (1.3) | 13.4 |
Foreign | (825.7) | 3.2 | 3.9 |
Total deferred tax (benefit) expense | (140) | 319 | (360.1) |
Total income tax expense (benefit) | $ 109.1 | $ 880 | $ 434.3 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||||
U.S. federal statutory tax rate | 21.00% | 35.00% | 35.00% | |
Remeasurement of Deferred Tax Assets due to US Tax Reform | $ 326.2 | |||
Recognition of provisional charge | 326.2 | |||
Adjustment to provisional amount recorded | $ 68 | |||
Effective income tax rate | 4.30% | 42.30% | 32.70% | |
Unrecognized tax benefits that would impact effective tax rate | $ 146.2 | $ 189.5 | $ 146.2 | $ 107.2 |
Income Taxes - Schedule of effe
Income Taxes - Schedule of effective income tax rate reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal statutory tax rate | 21.00% | 35.00% | 35.00% |
Impact of change in U.S. corporate tax rate (the Act) | (2.70%) | 15.70% | 0.00% |
Sale of non-inventory related assets between foreign subsidiaries | (6.30%) | 0.00% | 0.00% |
Stock-based compensation | (2.50%) | (9.00%) | (10.90%) |
Taxation of non-U.S. operations | (1.90%) | 0.70% | 8.80% |
Income tax credits | (2.60%) | (1.30%) | (1.20%) |
Non-deductible Branded Prescription Drug Fee | 0.60% | 1.70% | 1.90% |
Foreign-derived intangible income deduction | (1.00%) | (0.00%) | (0.00%) |
Domestic production activities deduction | (0.00%) | (2.60%) | (2.80%) |
State and local income taxes | 0.10% | 0.10% | 1.30% |
Other permanent differences | (0.40%) | 2.00% | 0.60% |
Effective income tax rate | 4.30% | 42.30% | 32.70% |
Income Taxes - Schedule of defe
Income Taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Deferred compensation | $ 458.2 | $ 391 |
Fixed assets and intangible assets | 107.8 | 0 |
Deferred revenue | 20.2 | 102.4 |
Accrued expenses | 53.3 | 38.3 |
Other | 33.3 | 26.5 |
Deferred tax assets, gross | 672.8 | 558.2 |
Valuation allowance | 0 | (4.2) |
Total deferred tax assets | 672.8 | 554 |
Deferred tax liabilities: | ||
Fixed assets and intangible assets | 0 | (44.6) |
Other | (2.7) | (3.1) |
Total deferred tax liabilities | (2.7) | (47.7) |
Net deferred tax assets | $ 670.1 | $ 506.3 |
Income Taxes - Schedule of unre
Income Taxes - Schedule of unrecognized tax benefits (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance as of January 1 | $ 146.2 | $ 117.2 | $ 116.6 |
Gross increases related to current year tax positions | 51.4 | 49 | 45.6 |
Gross increases (decreases) related to prior year tax positions | 5.6 | (5.6) | (42.3) |
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation | (13.7) | (14.4) | (2.7) |
Balance as of December 31 | $ 189.5 | $ 146.2 | $ 117.2 |
Legal Matters - Narrative (Deta
Legal Matters - Narrative (Details) € in Thousands, $ in Millions | Dec. 20, 2018USD ($)shares | Sep. 26, 2016EUR (€) |
Regeneron v.s. Merus N.V. | Settled litigation | ||
Loss Contingencies [Line Items] | ||
Common stock purchased (in shares) | shares | 600,000 | |
Purchase price of common stock | $ | $ 15 | |
Amgen v.s. Regeneron | Pending litigation | ||
Loss Contingencies [Line Items] | ||
Loss Contingency, damages sought, per unit produced | € 10 | |
Loss contingency, damages sought | € 10,000 |
Net Income Per Share - Schedule
Net Income Per Share - Schedule of Basic and Diluted Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||
Net income - basic | $ 820.4 | $ 594.7 | $ 551.4 | $ 478 | $ 173.5 | $ 388.3 | $ 387.7 | $ 248.9 | $ 2,444.4 | $ 1,198.5 | $ 895.5 |
Convertible senior notes - interest expense and amortization of discount and note issuance costs | 0 | 0 | 0.4 | ||||||||
Net income - diluted | $ 2,444.4 | $ 1,198.5 | $ 895.9 | ||||||||
Weighted average shares outstanding - basic (in shares) | 107.9 | 106.3 | 104.7 | ||||||||
Effect of dilutive securities: | |||||||||||
Warrants (in shares) | 0 | 0 | 0.9 | ||||||||
Dilutive potential shares (in shares) | 6.9 | 9.6 | 11.6 | ||||||||
Weighted average shares - diluted (in shares) | 114.8 | 115.9 | 116.3 | ||||||||
Net income per share - basic (in dollars per share) | $ 7.58 | $ 5.50 | $ 5.12 | $ 4.44 | $ 1.62 | $ 3.64 | $ 3.66 | $ 2.36 | $ 22.65 | $ 11.27 | $ 8.55 |
Net income per share - diluted (in dollars per share) | $ 7.15 | $ 5.17 | $ 4.82 | $ 4.16 | $ 1.50 | $ 3.32 | $ 3.34 | $ 2.16 | $ 21.29 | $ 10.34 | $ 7.70 |
Stock options | |||||||||||
Effect of dilutive securities: | |||||||||||
Effect of dilutive securities (in shares) | 6.9 | 9.1 | 10.2 | ||||||||
Restricted stock | |||||||||||
Effect of dilutive securities: | |||||||||||
Effect of dilutive securities (in shares) | 0 | 0.5 | 0.5 |
Net Income Per Share - Schedu_2
Net Income Per Share - Schedule of Antidilutive Securities Excluded From Computation (Details) - shares shares in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of shares (in shares) | 14.9 | 9.2 | 8 |
Statement of Cash Flows - Sched
Statement of Cash Flows - Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Supplemental Cash Flow Information [Abstract] | ||||
Cash and cash equivalents | $ 1,467.7 | $ 812.7 | $ 535.2 | |
Restricted cash included in Other noncurrent assets | 12.5 | 12.5 | 12.5 | |
Total cash, cash equivalents, and restricted cash shown in the Consolidated Statement of Cash Flows | $ 1,480.2 | $ 825.2 | $ 547.7 | $ 809.1 |
Statement of Cash Flows - Narra
Statement of Cash Flows - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Condensed Cash Flow Statements, Captions [Line Items] | |||
Accrued capital expenditures | $ 54.5 | $ 41.8 | $ 28.2 |
Cost of Treasury stock shares received | $ 80.2 | 0 | |
Capital lease obligations incurred | $ 201.2 | $ 154.9 | |
Sanofi Collaboration Agreement, Immuno-oncology | |||
Condensed Cash Flow Statements, Captions [Line Items] | |||
Treasury stock, shares acquired (in shares) | 215,387 | ||
Cost of Treasury stock shares received | $ 75.8 |
Unaudited Quarterly Results - S
Unaudited Quarterly Results - Schedule of unaudited quarterly results (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 1,927.8 | $ 1,663.5 | $ 1,608 | $ 1,511.5 | $ 1,582.4 | $ 1,500.7 | $ 1,470.1 | $ 1,319 | $ 6,710.8 | $ 5,872.2 | $ 4,860.4 |
Net income | $ 820.4 | $ 594.7 | $ 551.4 | $ 478 | $ 173.5 | $ 388.3 | $ 387.7 | $ 248.9 | $ 2,444.4 | $ 1,198.5 | $ 895.5 |
Net income per share - basic (in dollars per share) | $ 7.58 | $ 5.50 | $ 5.12 | $ 4.44 | $ 1.62 | $ 3.64 | $ 3.66 | $ 2.36 | $ 22.65 | $ 11.27 | $ 8.55 |
Net income per share - diluted (in USD per shares) | $ 7.15 | $ 5.17 | $ 4.82 | $ 4.16 | $ 1.50 | $ 3.32 | $ 3.34 | $ 2.16 | $ 21.29 | $ 10.34 | $ 7.70 |
Remeasurement of Deferred Tax Assets due to US Tax Reform | $ 326.2 |