Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 17, 2019 | |
Entity Information [Line Items] | ||
Entity Registrant Name | REGENERON PHARMACEUTICALS INC | |
Entity Central Index Key | 0000872589 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 107,727,418 | |
Class A Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 1,911,354 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 1,708.5 | $ 1,467.7 |
Marketable securities | 1,523.9 | 1,342.2 |
Accounts receivable - trade, net | 1,728.4 | 1,723.7 |
Accounts receivable from Sanofi | 287.6 | 226.4 |
Accounts receivable from Bayer | 289.2 | 293.1 |
Inventories | 1,208.8 | 1,151.2 |
Prepaid expenses and other current assets | 182.2 | 243.3 |
Total current assets | 6,928.6 | 6,447.6 |
Marketable securities | 2,339.8 | 1,755 |
Property, plant, and equipment, net | 2,612.8 | 2,575.8 |
Deferred tax assets | 829.3 | 828.7 |
Other noncurrent assets | 144.3 | 127.4 |
Total assets | 12,854.8 | 11,734.5 |
Current liabilities: | ||
Accounts payable | 239.6 | 218.2 |
Accrued expenses and other current liabilities | 741.1 | 772.1 |
Total current liabilities | 1,511.4 | 1,442.8 |
Finance lease liabilities | 709.9 | |
Finance lease liabilities | 708.5 | |
Other noncurrent liabilities | 376.3 | 361.7 |
Total liabilities | 3,410.1 | 2,977.2 |
Stockholders' equity: | ||
Preferred Stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none | 0 | 0 |
Additional paid-in capital | 4,160.9 | 3,911.6 |
Retained earnings | 5,725.1 | 5,254.3 |
Accumulated other comprehensive income (loss) | 2.8 | (12.3) |
Treasury Stock, at cost; 4,046,627 shares in 2019 and 3,990,021 shares in 2018 | (444.2) | (396.4) |
Total stockholders' equity | 9,444.7 | 8,757.3 |
Total liabilities and stockholders' equity | 12,854.8 | 11,734.5 |
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 | 334.1 | 246.7 |
Deferred revenue, noncurrent | 633.7 | 279.3 |
Other | ||
Current liabilities: | ||
Deferred revenue, current | 196.6 | 205.8 |
Deferred revenue, noncurrent | $ 178.8 | $ 184.9 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEET (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Stockholders' equity: | ||
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) | 4,046,627 | 3,990,021 |
Class A Stock | ||
Stockholders' equity: | ||
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 | ||
Stockholders' equity: | ||
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) | 111,718,248 | 111,084,951 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited) - USD ($) shares in Millions, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Revenues | $ 1,711.8 | $ 1,511.5 |
Expenses: | ||
Research and development | 641.8 | 498.6 |
Selling, general, and administrative | 410.8 | 330.8 |
Total expenses | 1,231.8 | 944.3 |
Income from operations | 480 | 567.2 |
Other income (expense): | ||
Other income (expense), net | 73.8 | 24.6 |
Interest expense | (7.7) | (6.4) |
Total other income (expense) | 66.1 | 18.2 |
Income before income taxes | 546.1 | 585.4 |
Income tax expense | (85) | (107.4) |
Net income | $ 461.1 | $ 478 |
Net income per share - basic (in dollars per share) | $ 4.23 | $ 4.44 |
Net income per share - diluted (in dollars per share) | $ 3.99 | $ 4.16 |
Weighted average shares outstanding - basic (in shares) | 108.9 | 107.6 |
Weighted average shares - diluted (in shares) | 115.5 | 114.9 |
Statements of Comprehensive Income | ||
Net income | $ 461.1 | $ 478 |
Other comprehensive income (loss), net of tax: | ||
Unrealized gain (loss) on debt securities | 16.1 | (11.1) |
Unrealized (loss) gain on cash flow hedges | (1) | 1.4 |
Comprehensive income | 476.2 | 468.3 |
Product | ||
Revenues: | ||
Revenues | 1,104.4 | 987.9 |
Expenses: | ||
Cost of goods sold | 70.9 | 69.2 |
Collaboration and contract manufacturing | ||
Expenses: | ||
Cost of goods sold | 108.3 | 45.7 |
Sanofi | Product and service, other | ||
Revenues: | ||
Revenues | 246.4 | 189.5 |
Bayer | Product and service, other | ||
Revenues: | ||
Revenues | 276.2 | 247.9 |
Other | Product and service, other | ||
Revenues: | ||
Revenues | $ 84.8 | $ 86.2 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - 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 |
Beginning Balance (in shares) at Dec. 31, 2017 | (3.8) | 1.9 | 109.5 | ||||
Beginning 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) | 0.1 | ||||||
Issuance of Common Stock in connection with exercise of stock options | 13.6 | 13.6 | $ 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 | (0.7) | (0.7) | $ 0 | ||||
Stock-based compensation charges | 85.8 | 85.8 | |||||
Net income | 478 | 478 | |||||
Other comprehensive loss, net of tax | (9.7) | (9.7) | |||||
Ending Balance (in shares) at Mar. 31, 2018 | (3.8) | 1.9 | 109.7 | ||||
Ending Balance at Mar. 31, 2018 | 6,567.6 | 3,611.6 | 3,287.8 | (15.7) | $ (316.2) | $ 0 | $ 0.1 |
Beginning Balance (in shares) at Dec. 31, 2018 | (4) | 1.9 | 111.1 | ||||
Beginning Balance at Dec. 31, 2018 | 8,757.3 | 3,911.6 | 5,254.3 | (12.3) | $ (396.4) | $ 0 | $ 0.1 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of Common Stock in connection with exercise of stock options (in shares) | 0.6 | ||||||
Issuance of Common Stock in connection with exercise of stock options | 140.9 | 140.9 | $ 0 | ||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations | (10.7) | (10.7) | |||||
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 | 10.5 | 4.3 | $ 6.2 | ||||
Repurchases of Common Stock from Sanofi (in shares) | (0.1) | ||||||
Repurchases of Common Stock from Sanofi | (54) | $ (54) | |||||
Stock-based compensation charges | 114.8 | 114.8 | |||||
Net income | 461.1 | 461.1 | |||||
Other comprehensive loss, net of tax | 15.1 | 15.1 | |||||
Ending Balance (in shares) at Mar. 31, 2019 | (4) | 1.9 | 111.7 | ||||
Ending Balance at Mar. 31, 2019 | $ 9,444.7 | $ 4,160.9 | $ 5,725.1 | $ 2.8 | $ (444.2) | $ 0 | $ 0.1 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net income | $ 461.1 | $ 478 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 51 | 36.4 |
Non-cash compensation expense | 107.9 | 82.4 |
Other non-cash items, net | (23.8) | (4.2) |
Deferred taxes | (10.7) | (6.4) |
Changes in assets and liabilities: | ||
(Increase) decrease in Sanofi, Bayer, and trade accounts receivable | (106.1) | 30.4 |
Increase in inventories | (58.6) | (88.8) |
Decrease in prepaid expenses and other assets | 69.3 | 68.8 |
Increase (decrease) in deferred revenue | 426.5 | (54.5) |
(Decrease) increase in accounts payable, accrued expenses, and other liabilities | (19.6) | 76.7 |
Total adjustments | 435.9 | 140.8 |
Net cash provided by operating activities | 897 | 618.8 |
Cash flows from investing activities: | ||
Purchases of marketable and other securities | (1,040.2) | (601.3) |
Sales or maturities of marketable securities | 338.4 | 255.3 |
Capital expenditures | (74.3) | (79.4) |
Net cash used in investing activities | (776.1) | (425.4) |
Cash flows from financing activities: | ||
Proceeds from issuance of Common Stock | 140.6 | 13.4 |
Payments in connection with Common Stock tendered for employee tax obligations | (10.7) | 0 |
Repurchases of Common Stock | (10) | 0 |
Net cash provided by financing activities | 119.9 | 13.4 |
Net increase in cash, cash equivalents, and restricted cash | 240.8 | 206.8 |
Cash, cash equivalents, and restricted cash at beginning of period | 1,480.2 | 825.2 |
Cash, cash equivalents, and restricted cash at end of period | $ 1,721 | $ 1,032 |
Interim Financial Statements
Interim Financial Statements | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Interim Financial Statements | Interim Financial Statements The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company's financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair presentation of the Company's condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, 2018 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 . Certain reclassifications have been made to prior period amounts to conform with the current period's presentation. We adopted Accounting Standards Codification ("ASC") 842, Leases , on January 1, 2019 (the "effective date") and used the effective date as our date of initial application. See Note 8. The new standard requires a lessee to recognize on its balance sheet (for both finance and operating leases) a liability for future lease payments and a right-of-use asset representing its right to use the underlying asset over the lease term. We elected the practical expedients upon transition, which permitted companies to not reassess lease identification, classification, and initial direct costs under the new standard for leases that commenced prior to the effective date. Upon adoption of the new standard, we recognized right-of-use assets of $33.2 million related to operating leases as of January 1, 2019. The impact of adopting the standard for the facilities that we had historically applied build-to-suit and capital lease accounting was not material to our Condensed Consolidated Financial Statements. Prior period amounts have not been adjusted in connection with the adoption of this standard. |
Product Sales
Product Sales | 3 Months Ended |
Mar. 31, 2019 | |
Revenues [Abstract] | |
Product Sales | Product Sales Net product sales consist of the following: Three Months Ended Net Product Sales in the United States 2019 2018 EYLEA ® $ 1,074.1 $ 984.0 Libtayo ® 26.8 — ARCALYST ® 3.5 3.9 $ 1,104.4 $ 987.9 The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for each of the three months ended March 31, 2019 and 2018 . Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Three Months Ended 2019 2018 Besse Medical, a subsidiary of AmerisourceBergen Corporation 59 % 55 % McKesson Corporation 31 % 40 % The following table summarizes the provisions, and credits/payments, for these sales-related deductions during the three months ended March 31, 2019 and 2018 . Rebates, Chargebacks, and Discounts Distribution- Other Sales- Total Balance as of December 31, 2018 $ 41.1 $ 42.0 $ 8.3 $ 91.4 Provisions 78.6 52.8 16.1 147.5 Credits/payments (60.8 ) (47.9 ) (0.4 ) (109.1 ) Balance as of March 31, 2019 $ 58.9 $ 46.9 $ 24.0 $ 129.8 Balance as of December 31, 2017 $ 29.9 $ 34.1 $ 21.3 $ 85.3 Provisions 48.5 51.7 11.2 111.4 Credits/payments (30.7 ) (42.0 ) (14.7 ) (87.4 ) Balance as of March 31, 2018 $ 47.7 $ 43.8 $ 17.8 $ 109.3 |
Collaboration Agreements
Collaboration Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Collaboration Agreements | Collaboration Agreements a. Sanofi The collaboration revenue we earned from Sanofi is detailed below: Three Months Ended Sanofi Collaboration Revenue 2019 2018 Antibody: Reimbursement of Regeneron research and development expenses $ 74.5 $ 60.4 Reimbursement of Regeneron commercialization-related expenses 116.6 85.4 Regeneron's share of losses in connection with commercialization of antibodies (27.8 ) (74.8 ) Other 12.9 17.3 Total Antibody 176.2 88.3 Immuno-oncology: Reimbursement of Regeneron research and development expenses 46.4 73.8 Reimbursement of Regeneron commercialization-related expenses 2.3 1.2 Other 21.5 26.2 Total Immuno-oncology 70.2 101.2 $ 246.4 $ 189.5 Antibody The Company is party to a global, strategic collaboration with Sanofi to discover, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration") . Under the companies' 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 expenses $9.3 million and $13.9 million during the three months ended March 31, 2019 and 2018, respectively, its share of antibody development expenses that Sanofi incurred related to Praluent ® (alirocumab), Kevzara ® (sarilumab), and Dupixent ® (dupilumab). All other agreed-upon worldwide development expenses incurred by both companies are funded by Sanofi. 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 the first quarter of 2019, Sanofi elected to sell, and we elected to purchase (in cash), 24,143 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 $10.0 million , as Treasury Stock during the first quarter of 2019. Sanofi leads commercialization activities for products developed under the Antibody Collaboration, subject to the Company's right to co-promote such products. 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 only if and after aggregate annual sales outside the United States exceed $1.0 billion on a rolling twelve -month basis. 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 March 31, 2019 , 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: March 31, December 31, 2019 2018 Accounts receivable $ 264.4 $ 138.2 Deferred revenue $ 302.0 $ 236.1 Significant changes in deferred revenue balances are as follows: Three Months Ended Increase due to shipments of commercial supplies to Sanofi $ 86.0 Revenue recognized that was included in deferred revenue at the beginning of the period $ (20.1 ) 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. Immuno-Oncology In 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"). Effective December 31, 2018, the Company and Sanofi entered into an 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 bispecific 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. 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. 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 the Libtayo development and Dupilumab/REGN3500 Eligible Investments by selling up to an aggregate of 1,400,000 shares (of which 1,042,732 currently remains available) 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 the first quarter of 2019, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 106,972 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 $44.0 million as Treasury Stock during the first quarter of 2019. Refer to the " Antibody " section above for a description of share transactions related to Dupilumab/REGN3500 Eligible Investments. 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 and losses from worldwide sales. 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: March 31, December 31, 2019 2018 Accounts receivable $ 18.6 $ 77.9 Deferred revenue $ 665.8 $ 289.9 Significant changes in deferred revenue balances are as follows: Three Months Ended Increase as a result of payment received from Sanofi $ 415.9 Revenue recognized that was included in deferred revenue at the beginning of the period $ (26.2 ) Revenue recognized that was added to deferred revenue during the period $ (13.8 ) 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 March 31, 2019 was $1,324.7 million . This amount is expected to be recognized as revenue over the remaining period in which the Company is obligated to satisfy its performance obligation in connection with performing development activities. b. Bayer 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 were previously terminated): Three Months Ended Bayer EYLEA Collaboration Revenue 2019 2018 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 249.3 $ 232.1 Reimbursement of Regeneron EYLEA development expenses 2.6 3.5 Other 24.3 11.8 $ 276.2 $ 247.4 The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA outside the United States. 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 product sales. In addition, the Company and Bayer share the funding of agreed-upon EYLEA development costs. 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 Teva Collaboration Agreement, Teva made a $250.0 million non-refundable up-front payment in September 2016. The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan. The Company is also responsible for the manufacture and supply of fasinumab globally. The Company recognized $53.7 million and $58.6 million of revenue for the three months ended March 31, 2019 and 2018 , respectively, in connection with the Teva Collaboration Agreement. The following table summarizes accounts receivable and deferred revenue information in connection with the Teva Collaboration Agreement: March 31, December 31, 2019 2018 Accounts receivable (recorded within Prepaid expenses and other current assets) $ 32.2 $ 28.8 Deferred revenue $ 173.3 $ 194.5 Significant changes in deferred revenue balances are as follows: Three Months Ended Revenue recognized that was included in deferred revenue at the beginning of the period $ (21.2 ) 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 March 31, 2019 was $418.2 million . This amount is expected to be recognized as revenue over the remaining period in which the Company is obligated to satisfy its performance obligation in connection with performing development activities. d. Alnylam In April 2019, the Company and Alnylam Pharmaceuticals, Inc. entered into a global, strategic collaboration to discover, develop, and commercialize RNA interference (RNAi) therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver. The collaboration is governed by a Master Collaboration Agreement (the "Master Agreement") (including the form of a License Agreement and a Co-Commercialization Collaboration Agreement). Under the terms of the Master Agreement, we are obligated to make an up-front payment of $400.0 million to Alnylam. For each program, we will provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to $200.0 million in clinical proof-of-principle milestones for eye or CNS programs. Under the collaboration, the parties plan to perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a License Agreement or a Co-Commercialization Collaboration Agreement structure. The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term"). In addition, we have an option to extend the Research Term for an additional five -year period for a research extension fee ranging from $200.0 million to $400.0 million ; the actual amount of the fee will be determined based on the acceptance of one or more INDs (or their equivalent in certain other countries) for programs in the eye and CNS. In connection with the collaboration, we and Alnylam also entered into a Stock Purchase Agreement. Pursuant to the terms of the Stock Purchase Agreement, we have agreed to purchase shares of Alnylam common stock for aggregate cash consideration of approximately $400.0 million . |
Net Income Per Share
Net Income Per Share | 3 Months Ended |
Mar. 31, 2019 | |
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: Three Months Ended 2019 2018 Net income - basic and diluted $ 461.1 $ 478.0 (Shares in millions) Weighted average shares - basic 108.9 107.6 Effect of dilutive securities: Stock options 6.5 7.3 Restricted stock 0.1 — Dilutive potential shares 6.6 7.3 Weighted average shares - diluted 115.5 114.9 Net income per share - basic $ 4.23 $ 4.44 Net income per share - diluted $ 3.99 $ 4.16 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended (Shares in millions) 2019 2018 Stock options 12.3 14.9 Restricted stock — 0.1 |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities as of March 31, 2019 and December 31, 2018 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6). The following tables summarize the Company's investments in available-for-sale debt securities: Amortized Unrealized Fair As of March 31, 2019 Cost Basis Gains Losses Value Available-for-sale debt securities: Corporate bonds $ 3,352.4 $ 9.3 $ (6.3 ) $ 3,355.4 U.S. government and government agency obligations 129.7 0.1 (0.6 ) 129.2 Sovereign bonds 26.8 0.2 — 27.0 Commercial paper 152.0 — — 152.0 Certificates of deposit 69.3 0.1 — 69.4 $ 3,730.2 $ 9.7 $ (6.9 ) $ 3,733.0 As of December 31, 2018 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 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 March 31, 2019 mature at various dates through February 2024. The fair values of available-for-sale debt security investments by contractual maturity consist of the following: March 31, 2019 December 31, 2018 Maturities within one year $ 1,523.9 $ 1,342.2 Maturities after one year through five years 2,209.1 1,667.0 $ 3,733.0 $ 3,009.2 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 March 31, 2019 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 313.3 $ (0.3 ) $ 941.0 $ (6.0 ) $ 1,254.3 $ (6.3 ) U.S. government and government agency obligations 204.0 — 92.4 (0.6 ) 296.4 (0.6 ) $ 517.3 $ (0.3 ) $ 1,033.4 $ (6.6 ) $ 1,550.7 $ (6.9 ) As of December 31, 2018 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 ) There were no realized losses on sales of marketable securities, and realized gains were not material, for the three months ended March 31, 2019 and 2018. With respect to marketable securities, for the three months ended March 31, 2019 and 2018 , amounts reclassified from Accumulated other comprehensive (loss) income into Other income (expense), net were related to realized gains on sales of debt securities. During the three months ended March 31, 2019 and 2018, we recorded $42.8 million and $9.4 million , respectively, of net unrealized gains on equity securities in Other income (expense), net. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 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 $ 3,355.4 — $ 3,355.4 U.S. government and government agency obligations 129.2 — 129.2 Sovereign bonds 27.0 — 27.0 Commercial paper 152.0 — 152.0 Certificates of deposit 69.4 — 69.4 Equity securities (unrestricted) 56.9 $ 56.9 — Equity securities (restricted) 73.8 66.0 7.8 $ 3,863.7 $ 122.9 $ 3,740.8 As of December 31, 2018 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 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 during the three months ended March 31, 2019 and 2018 . The Company held certain restricted equity securities as of March 31, 2019 which are subject to transfer restrictions until 2020. As of March 31, 2019 and December 31, 2018 , the Company had $45.5 million in equity investments that do not have a readily determinable fair value. These investments are recorded at cost within Other noncurrent assets. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: March 31, December 31, 2019 2018 Raw materials $ 232.4 $ 226.8 Work-in-process 581.3 571.1 Finished goods 30.8 24.4 Deferred costs 364.3 328.9 $ 1,208.8 $ 1,151.2 Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases We conduct certain of our research, development, and administrative activities at leased facilities. We also lease certain warehouses and vehicles. As described in Note 1, during the first quarter of 2019, we adopted ASC 842, Leases . We determine if an arrangement is a lease considering whether there is an identified asset and the contract conveys the right to control its use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Our lease terms may include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We account for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs). Right-of-use assets and lease liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option we are reasonably certain to exercise. For leases where an implicit rate is not readily determinable, we use our incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term. Operating leases Amounts recognized in the financial statements associated with operating leases were not material as of, and for the three months ended, March 31, 2019 and 2018. Operating lease right-of-use assets are included within other noncurrent assets and lease liabilities are included in other current and other noncurrent liabilities on our Condensed Consolidated Balance Sheet. Finance leases In March 2017, we entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively, the "Participants"). In March 2017, we also entered into a Lease and Remedies Agreement with BAL, pursuant to which we have leased laboratory and office facilities in Tarrytown, New York (the "Facility") for a five -year term. The Participation Agreement, the Lease and Remedies Agreement, and certain other related agreements were amended and restated in May 2019, among other things, to revise certain covenants, representations and warranties, and events of default to be substantially similar to those set forth in the agreement governing the Company's revolving credit facility (as so amended and restated, the "Participation Agreement" and the "Lease," respectively). The Lease requires us to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. We are 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 our debt rating and total leverage ratio. The Participation Agreement and the Lease include an option for us 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. We also have 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. Prior to January 1, 2019, for certain of the premises under the Lease we were deemed, in substance, to be the owner of the buildings (collectively, the "Build-to-Suit Buildings"). Upon the adoption of ASC 842, the classification of the Build-to-Suit Buildings, for which the construction period had been completed, was reassessed and, consequently, they were derecognized and recognized as a finance lease. These premises, along with the other premises under the Lease, are classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably assured to be exercised. The agreements governing the Lease financing contain financial and operating covenants, which are substantially similar to the covenants set forth in the Company's revolving credit facility. The Company was in compliance with all such covenants as of March 31, 2019. Amounts recognized in the Condensed Consolidated Balance Sheet related to the Facility are included in the table below. We had no leases accounted for as finance leases, other than the Facility, as of March 31, 2019. March 31, Classification 2019 Finance lease assets Property, plant, and equipment, net (a) $ 670.9 Finance lease liabilities Finance lease liabilities (noncurrent) $ 709.9 (a) Finance lease assets are recorded net of accumulated amortization of $65.3 million as of March 31, 2019. As of December 31, 2018, property, plant, and equipment, at cost, included $723.9 million of leased property under the Company's capital and facility leases related to the Facility. Accumulated amortization related to these assets amounted to $61.7 million as of December 31, 2018. Finance lease costs consist of the following: Three Months Ended March 31, 2019 Amortization of right-of-use assets $ 3.5 Interest on lease liabilities 7.2 $ 10.7 Other information related to finance leases consist of the following: March 31, 2019 Remaining lease term (in years) 2.93 Discount rate 3.69 % Supplemental information Maturities of lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases 2019 $ 6.2 $ 19.5 2020 8.4 26.9 2021 5.1 26.6 2022 3.0 726.5 2023 2.6 — 2024 2.9 — Thereafter 4.3 — Total undiscounted lease payments 32.5 799.5 Imputed interest (3.1 ) (82.2 ) Debt financing costs — (7.4 ) Total lease liabilities $ 29.4 $ 709.9 As of December 31, 2018, the estimated future minimum noncancelable lease commitments, excluding the purchase price we would be obligated to pay if we were to exercise our option to purchase the Facility, were as follows: Operating Leases Capital and Facility Lease Obligations 2019 $ 10.4 $ 26.4 2020 3.8 28.4 2021 3.4 27.9 2022 2.2 7.0 2023 1.5 — Thereafter 4.1 — $ 25.4 $ 89.7 |
Leases | Leases We conduct certain of our research, development, and administrative activities at leased facilities. We also lease certain warehouses and vehicles. As described in Note 1, during the first quarter of 2019, we adopted ASC 842, Leases . We determine if an arrangement is a lease considering whether there is an identified asset and the contract conveys the right to control its use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Our lease terms may include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We account for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs). Right-of-use assets and lease liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option we are reasonably certain to exercise. For leases where an implicit rate is not readily determinable, we use our incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term. Operating leases Amounts recognized in the financial statements associated with operating leases were not material as of, and for the three months ended, March 31, 2019 and 2018. Operating lease right-of-use assets are included within other noncurrent assets and lease liabilities are included in other current and other noncurrent liabilities on our Condensed Consolidated Balance Sheet. Finance leases In March 2017, we entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively, the "Participants"). In March 2017, we also entered into a Lease and Remedies Agreement with BAL, pursuant to which we have leased laboratory and office facilities in Tarrytown, New York (the "Facility") for a five -year term. The Participation Agreement, the Lease and Remedies Agreement, and certain other related agreements were amended and restated in May 2019, among other things, to revise certain covenants, representations and warranties, and events of default to be substantially similar to those set forth in the agreement governing the Company's revolving credit facility (as so amended and restated, the "Participation Agreement" and the "Lease," respectively). The Lease requires us to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. We are 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 our debt rating and total leverage ratio. The Participation Agreement and the Lease include an option for us 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. We also have 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. Prior to January 1, 2019, for certain of the premises under the Lease we were deemed, in substance, to be the owner of the buildings (collectively, the "Build-to-Suit Buildings"). Upon the adoption of ASC 842, the classification of the Build-to-Suit Buildings, for which the construction period had been completed, was reassessed and, consequently, they were derecognized and recognized as a finance lease. These premises, along with the other premises under the Lease, are classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably assured to be exercised. The agreements governing the Lease financing contain financial and operating covenants, which are substantially similar to the covenants set forth in the Company's revolving credit facility. The Company was in compliance with all such covenants as of March 31, 2019. Amounts recognized in the Condensed Consolidated Balance Sheet related to the Facility are included in the table below. We had no leases accounted for as finance leases, other than the Facility, as of March 31, 2019. March 31, Classification 2019 Finance lease assets Property, plant, and equipment, net (a) $ 670.9 Finance lease liabilities Finance lease liabilities (noncurrent) $ 709.9 (a) Finance lease assets are recorded net of accumulated amortization of $65.3 million as of March 31, 2019. As of December 31, 2018, property, plant, and equipment, at cost, included $723.9 million of leased property under the Company's capital and facility leases related to the Facility. Accumulated amortization related to these assets amounted to $61.7 million as of December 31, 2018. Finance lease costs consist of the following: Three Months Ended March 31, 2019 Amortization of right-of-use assets $ 3.5 Interest on lease liabilities 7.2 $ 10.7 Other information related to finance leases consist of the following: March 31, 2019 Remaining lease term (in years) 2.93 Discount rate 3.69 % Supplemental information Maturities of lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases 2019 $ 6.2 $ 19.5 2020 8.4 26.9 2021 5.1 26.6 2022 3.0 726.5 2023 2.6 — 2024 2.9 — Thereafter 4.3 — Total undiscounted lease payments 32.5 799.5 Imputed interest (3.1 ) (82.2 ) Debt financing costs — (7.4 ) Total lease liabilities $ 29.4 $ 709.9 As of December 31, 2018, the estimated future minimum noncancelable lease commitments, excluding the purchase price we would be obligated to pay if we were to exercise our option to purchase the Facility, were as follows: Operating Leases Capital and Facility Lease Obligations 2019 $ 10.4 $ 26.4 2020 3.8 28.4 2021 3.4 27.9 2022 2.2 7.0 2023 1.5 — Thereafter 4.1 — $ 25.4 $ 89.7 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company is subject to U.S. federal, state, and foreign income taxes. The Company's effective tax rate was 15.6% and 18.3% for the three months ended March 31, 2019 and 2018 , respectively. The Company's effective tax rate for the three months ended March 31, 2019 was positively impacted, compared to the U.S. federal statutory rate, primarily by the federal tax credit for research activities, stock-based compensation, the foreign-derived intangible income deduction, and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. The Company's effective tax rate for the three months ended March 31, 2018 was positively impacted, compared to the U.S. federal statutory rate, primarily by the foreign-derived intangible income deduction and the federal tax credit for research activities. |
Statement of Cash Flows
Statement of Cash Flows | 3 Months Ended |
Mar. 31, 2019 | |
Supplemental Cash Flow Information [Abstract] | |
Statement of Cash Flows | Statement of Cash Flows The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet to the total of the same such amounts shown in the Condensed Consolidated Statement of Cash Flows: March 31, March 31, 2019 2018 Cash and cash equivalents $ 1,708.5 $ 1,019.5 Restricted cash included in Other noncurrent assets 12.5 12.5 Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows $ 1,721.0 $ 1,032.0 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 March 31, 2019 and December 31, 2018 were $54.4 million and $54.5 million , respectively, of accrued capital expenditures. Included in accounts payable, accrued expenses, and other liabilities as of March 31, 2018 and December 31, 2017 were $40.2 million and $41.8 million , respectively, of accrued capital expenditures. As described in Note 3, during the three months ended March 31, 2019 , we purchased (by issuing a credit towards the amount owed by Sanofi) 106,972 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 $44.0 million , as Treasury Stock. |
Legal Matters
Legal Matters | 3 Months Ended |
Mar. 31, 2019 | |
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 and '163 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") and its European Patent No. 2,264,163 (the "'163 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 and the '163 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 and the '163 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. Following a trial to adjudicate the claims of infringement and counterclaims of invalidity of the '287 Patent and the '163 Patent, the court issued a final judgment on February 1, 2016, 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. On appeal, 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 and subsequently 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). Thereafter, the Supreme Court of the United Kingdom granted Kymab's application for permission to appeal the order made by the Court of Appeal and scheduled an oral hearing for February 11–12, 2020. 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 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. 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. On January 7, 2019, Merus withdrew its appeal of the '163 Patent in the EPO in connection with the previously announced global settlement. 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 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. The first jury trial in this litigation (the "First Trial") 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 First 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 in the First Trial, 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 October 5, 2017, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") reversed in part the District Court's decision and remanded for a new trial on the issues of written description and enablement. In addition, it affirmed the District Court's ruling that Amgen's patents were not obvious. On January 3, 2019, the District Court held oral argument in the remanded proceedings 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. On February 8, 2019, the District Court granted the Company and the Sanofi defendants' motion for judgment on the pleadings, thereby dismissing Amgen's claim of willful infringement. The second jury trial in this litigation (the "Second Trial") was held before the District Court in February 2019 to determine the validity of Amgen's asserted patent claims. On February 25, 2019, the jury returned a verdict in the Second Trial generally in favor of Amgen, finding that two claims of the '165 Patent and one claim of the '741 Patent were not invalid. The jury also found that two claims of the '165 Patent were invalid for lack of adequate written description while rejecting the lack of enablement challenges to those two claims. On February 25, 2019, the District Court notified the parties that a remedies trial, if necessary, would be held following the resolution of any appeals from the jury verdict in the Second Trial on the validity of Amgen's asserted patents. The District Court's final judgment is expected to be issued following resolution of the parties' post-trial motions (including Amgen's motion for a permanent injunction discussed below). The Company and the Sanofi defendants plan to appeal any aspect of the final judgment that is adverse to the Company and the Sanofi defendants. On March 18, 2019, Amgen filed a motion for a permanent injunction to prohibit the Company and the Sanofi defendants from Commercializing Praluent in the United States (a "Permanent Injunction"), and an oral hearing on this motion has been scheduled for June 2019. Previously, the Federal Circuit stayed and then vacated a Permanent Injunction granted by the District Court in connection with the First Trial. 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. An oral hearing in the Düsseldorf Regional Court was held on April 30, 2019, at which the Düsseldorf Regional Court deferred ruling on Amgen's request for a permanent injunction until June 6, 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 to the Federal Court of Justice of Germany and the oral hearing on the appeal has been scheduled for June 4, 2019. 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 S.A., 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 February 14, 2019, the PTAB issued final written decisions on the Additional IPR Petitions, invalidating all 17 claims of the '487 Patent as obvious based on one of the Additional IPR Petitions while declining to hold the challenged claims of the '487 Patent invalid based on the other. 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. On February 28, 2019, the court granted a joint stipulation by the parties to stay the litigation pending resolution of any appeal of the PTAB's final written decisions on the Additional IPR Petitions discussed above. 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). The oral hearing before the EPO on the oppositions occurred on February 14–15, 2019, at which the '420 Patent was revoked in its entirety. 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. On March 20, 2019, the court issued its Opinion and Order on Claim Construction (the "Claim Construction Order") in the '688 Patent infringement litigation. Pursuant to the Claim Construction Order, on April 1, 2019, the court approved a joint stipulation and entered a partial judgment of noninfringement of the '688 Patent of nine asserted claims. As a result, only one claim for infringement of the '688 Patent remains pending. 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. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In June 2016, the FASB issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded instead of reducing the amortized cost of the investment. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. We are evaluating the impact that the new standard will have on our financial statements. |
Recently Issued Accounting St_2
Recently Issued Accounting Standards (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Leases | Leases with an initial term of 12 months or less are not recorded on the balance sheet. Our lease terms may include options to extend or terminate a lease when it is reasonably certain that we will exercise that option. We account for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs). |
Legal Matters | Costs associated with the Company's involvement in legal proceedings are expensed as incurred. |
New Accounting Pronouncements | Recently Issued Accounting Standards In June 2016, the FASB issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded instead of reducing the amortized cost of the investment. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. We are evaluating the impact that the new standard will have on our financial statements. |
Product Sales (Tables)
Product Sales (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenues [Abstract] | |
Schedule of product sales | Net product sales consist of the following: Three Months Ended Net Product Sales in the United States 2019 2018 EYLEA ® $ 1,074.1 $ 984.0 Libtayo ® 26.8 — ARCALYST ® 3.5 3.9 $ 1,104.4 $ 987.9 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 were previously terminated): Three Months Ended Bayer EYLEA Collaboration Revenue 2019 2018 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 249.3 $ 232.1 Reimbursement of Regeneron EYLEA development expenses 2.6 3.5 Other 24.3 11.8 $ 276.2 $ 247.4 The collaboration revenue we earned from Sanofi is detailed below: Three Months Ended Sanofi Collaboration Revenue 2019 2018 Antibody: Reimbursement of Regeneron research and development expenses $ 74.5 $ 60.4 Reimbursement of Regeneron commercialization-related expenses 116.6 85.4 Regeneron's share of losses in connection with commercialization of antibodies (27.8 ) (74.8 ) Other 12.9 17.3 Total Antibody 176.2 88.3 Immuno-oncology: Reimbursement of Regeneron research and development expenses 46.4 73.8 Reimbursement of Regeneron commercialization-related expenses 2.3 1.2 Other 21.5 26.2 Total Immuno-oncology 70.2 101.2 $ 246.4 $ 189.5 |
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 three months ended March 31, 2019 and 2018 . Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Three Months Ended 2019 2018 Besse Medical, a subsidiary of AmerisourceBergen Corporation 59 % 55 % McKesson Corporation 31 % 40 % |
Sales Related Deductions Activity | The following table summarizes the provisions, and credits/payments, for these sales-related deductions during the three months ended March 31, 2019 and 2018 . Rebates, Chargebacks, and Discounts Distribution- Other Sales- Total Balance as of December 31, 2018 $ 41.1 $ 42.0 $ 8.3 $ 91.4 Provisions 78.6 52.8 16.1 147.5 Credits/payments (60.8 ) (47.9 ) (0.4 ) (109.1 ) Balance as of March 31, 2019 $ 58.9 $ 46.9 $ 24.0 $ 129.8 Balance as of December 31, 2017 $ 29.9 $ 34.1 $ 21.3 $ 85.3 Provisions 48.5 51.7 11.2 111.4 Credits/payments (30.7 ) (42.0 ) (14.7 ) (87.4 ) Balance as of March 31, 2018 $ 47.7 $ 43.8 $ 17.8 $ 109.3 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of collaboration revenue | Net product sales consist of the following: Three Months Ended Net Product Sales in the United States 2019 2018 EYLEA ® $ 1,074.1 $ 984.0 Libtayo ® 26.8 — ARCALYST ® 3.5 3.9 $ 1,104.4 $ 987.9 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 were previously terminated): Three Months Ended Bayer EYLEA Collaboration Revenue 2019 2018 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 249.3 $ 232.1 Reimbursement of Regeneron EYLEA development expenses 2.6 3.5 Other 24.3 11.8 $ 276.2 $ 247.4 The collaboration revenue we earned from Sanofi is detailed below: Three Months Ended Sanofi Collaboration Revenue 2019 2018 Antibody: Reimbursement of Regeneron research and development expenses $ 74.5 $ 60.4 Reimbursement of Regeneron commercialization-related expenses 116.6 85.4 Regeneron's share of losses in connection with commercialization of antibodies (27.8 ) (74.8 ) Other 12.9 17.3 Total Antibody 176.2 88.3 Immuno-oncology: Reimbursement of Regeneron research and development expenses 46.4 73.8 Reimbursement of Regeneron commercialization-related expenses 2.3 1.2 Other 21.5 26.2 Total Immuno-oncology 70.2 101.2 $ 246.4 $ 189.5 |
Schedule of accounts receivable and deferred revenue information | The following table summarizes accounts receivable and deferred revenue information in connection with the Teva Collaboration Agreement: March 31, December 31, 2019 2018 Accounts receivable (recorded within Prepaid expenses and other current assets) $ 32.2 $ 28.8 Deferred revenue $ 173.3 $ 194.5 Significant changes in deferred revenue balances are as follows: Three Months Ended Revenue recognized that was included in deferred revenue at the beginning of the period $ (21.2 ) The following table summarizes accounts receivable and deferred revenue information in connection with the Company's IO Collaboration with Sanofi: March 31, December 31, 2019 2018 Accounts receivable $ 18.6 $ 77.9 Deferred revenue $ 665.8 $ 289.9 Significant changes in deferred revenue balances are as follows: Three Months Ended Increase as a result of payment received from Sanofi $ 415.9 Revenue recognized that was included in deferred revenue at the beginning of the period $ (26.2 ) Revenue recognized that was added to deferred revenue during the period $ (13.8 ) The following table summarizes accounts receivable and deferred revenue information in connection with the Company's Antibody Collaboration with Sanofi: March 31, December 31, 2019 2018 Accounts receivable $ 264.4 $ 138.2 Deferred revenue $ 302.0 $ 236.1 Significant changes in deferred revenue balances are as follows: Three Months Ended Increase due to shipments of commercial supplies to Sanofi $ 86.0 Revenue recognized that was included in deferred revenue at the beginning of the period $ (20.1 ) |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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: Three Months Ended 2019 2018 Net income - basic and diluted $ 461.1 $ 478.0 (Shares in millions) Weighted average shares - basic 108.9 107.6 Effect of dilutive securities: Stock options 6.5 7.3 Restricted stock 0.1 — Dilutive potential shares 6.6 7.3 Weighted average shares - diluted 115.5 114.9 Net income per share - basic $ 4.23 $ 4.44 Net income per share - diluted $ 3.99 $ 4.16 |
Antidilutive Securities | Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended (Shares in millions) 2019 2018 Stock options 12.3 14.9 Restricted stock — 0.1 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 Cost Basis Gains Losses Value Available-for-sale debt securities: Corporate bonds $ 3,352.4 $ 9.3 $ (6.3 ) $ 3,355.4 U.S. government and government agency obligations 129.7 0.1 (0.6 ) 129.2 Sovereign bonds 26.8 0.2 — 27.0 Commercial paper 152.0 — — 152.0 Certificates of deposit 69.3 0.1 — 69.4 $ 3,730.2 $ 9.7 $ (6.9 ) $ 3,733.0 As of December 31, 2018 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 |
Marketable Securities, Based on Contractual Maturity Dates | The fair values of available-for-sale debt security investments by contractual maturity consist of the following: March 31, 2019 December 31, 2018 Maturities within one year $ 1,523.9 $ 1,342.2 Maturities after one year through five years 2,209.1 1,667.0 $ 3,733.0 $ 3,009.2 |
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 March 31, 2019 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 313.3 $ (0.3 ) $ 941.0 $ (6.0 ) $ 1,254.3 $ (6.3 ) U.S. government and government agency obligations 204.0 — 92.4 (0.6 ) 296.4 (0.6 ) $ 517.3 $ (0.3 ) $ 1,033.4 $ (6.6 ) $ 1,550.7 $ (6.9 ) As of December 31, 2018 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 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 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 $ 3,355.4 — $ 3,355.4 U.S. government and government agency obligations 129.2 — 129.2 Sovereign bonds 27.0 — 27.0 Commercial paper 152.0 — 152.0 Certificates of deposit 69.4 — 69.4 Equity securities (unrestricted) 56.9 $ 56.9 — Equity securities (restricted) 73.8 66.0 7.8 $ 3,863.7 $ 122.9 $ 3,740.8 As of December 31, 2018 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 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories consist of the following: March 31, December 31, 2019 2018 Raw materials $ 232.4 $ 226.8 Work-in-process 581.3 571.1 Finished goods 30.8 24.4 Deferred costs 364.3 328.9 $ 1,208.8 $ 1,151.2 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of amounts recognized in the Condensed Consolidated Balance Sheet | Amounts recognized in the Condensed Consolidated Balance Sheet related to the Facility are included in the table below. We had no leases accounted for as finance leases, other than the Facility, as of March 31, 2019. March 31, Classification 2019 Finance lease assets Property, plant, and equipment, net (a) $ 670.9 Finance lease liabilities Finance lease liabilities (noncurrent) $ 709.9 (a) Finance lease assets are recorded net of accumulated amortization of $65.3 million as of March 31, 2019. |
Schedule of lease cost and other information | Finance lease costs consist of the following: Three Months Ended March 31, 2019 Amortization of right-of-use assets $ 3.5 Interest on lease liabilities 7.2 $ 10.7 Other information related to finance leases consist of the following: March 31, 2019 Remaining lease term (in years) 2.93 Discount rate 3.69 % |
Schedule of maturities of lease liabilities | Maturities of lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases 2019 $ 6.2 $ 19.5 2020 8.4 26.9 2021 5.1 26.6 2022 3.0 726.5 2023 2.6 — 2024 2.9 — Thereafter 4.3 — Total undiscounted lease payments 32.5 799.5 Imputed interest (3.1 ) (82.2 ) Debt financing costs — (7.4 ) Total lease liabilities $ 29.4 $ 709.9 |
Schedule of maturities of lease liabilities | Maturities of lease liabilities as of March 31, 2019 are as follows: Operating Leases Finance Leases 2019 $ 6.2 $ 19.5 2020 8.4 26.9 2021 5.1 26.6 2022 3.0 726.5 2023 2.6 — 2024 2.9 — Thereafter 4.3 — Total undiscounted lease payments 32.5 799.5 Imputed interest (3.1 ) (82.2 ) Debt financing costs — (7.4 ) Total lease liabilities $ 29.4 $ 709.9 |
Schedule of future minimum noncancelable lease commitments | As of December 31, 2018, the estimated future minimum noncancelable lease commitments, excluding the purchase price we would be obligated to pay if we were to exercise our option to purchase the Facility, were as follows: Operating Leases Capital and Facility Lease Obligations 2019 $ 10.4 $ 26.4 2020 3.8 28.4 2021 3.4 27.9 2022 2.2 7.0 2023 1.5 — Thereafter 4.1 — $ 25.4 $ 89.7 |
Schedule of future minimum noncancelable lease commitments | As of December 31, 2018, the estimated future minimum noncancelable lease commitments, excluding the purchase price we would be obligated to pay if we were to exercise our option to purchase the Facility, were as follows: Operating Leases Capital and Facility Lease Obligations 2019 $ 10.4 $ 26.4 2020 3.8 28.4 2021 3.4 27.9 2022 2.2 7.0 2023 1.5 — Thereafter 4.1 — $ 25.4 $ 89.7 |
Statement of Cash Flows (Tables
Statement of Cash Flows (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Supplemental Cash Flow Information [Abstract] | |
Restrictions on Cash and Cash Equivalents | The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet to the total of the same such amounts shown in the Condensed Consolidated Statement of Cash Flows: March 31, March 31, 2019 2018 Cash and cash equivalents $ 1,708.5 $ 1,019.5 Restricted cash included in Other noncurrent assets 12.5 12.5 Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows $ 1,721.0 $ 1,032.0 |
Interim Financial Statements -
Interim Financial Statements - Narrative (Details) $ in Millions | Jan. 01, 2019USD ($) |
Accounting Standards Update 2016-02 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Right-of-use assets | $ 33.2 |
Product Sales - Schedule of Net
Product Sales - Schedule of Net Product Sales (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 1,711.8 | $ 1,511.5 |
Product | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,104.4 | 987.9 |
UNITED STATES | EYLEA | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,074.1 | 984 |
UNITED STATES | Libtayo | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 26.8 | 0 |
UNITED STATES | ARCALYST | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 3.5 | 3.9 |
UNITED STATES | Product | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 1,104.4 | $ 987.9 |
Product Sales - Schedule of Con
Product Sales - Schedule of Concentration of Risk, by Risk Factor (Details) - Gross Sales Revenue - Customer concentration risk | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Besse Medical, a subsidiary of AmerisourceBergen Corporation | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 59.00% | 55.00% |
McKesson Corporation | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 31.00% | 40.00% |
Product Sales - Schedule of Sal
Product Sales - Schedule of Sales Related Deductions Activity (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | $ 91.4 | $ 85.3 |
Provisions | 147.5 | 111.4 |
Credits/payments | (109.1) | (87.4) |
Ending Balance | 129.8 | 109.3 |
Rebates, Chargebacks, and Discounts | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 41.1 | 29.9 |
Provisions | 78.6 | 48.5 |
Credits/payments | (60.8) | (30.7) |
Ending Balance | 58.9 | 47.7 |
Distribution- Related Fees | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 42 | 34.1 |
Provisions | 52.8 | 51.7 |
Credits/payments | (47.9) | (42) |
Ending Balance | 46.9 | 43.8 |
Other Sales- Related Deductions | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning Balance | 8.3 | 21.3 |
Provisions | 16.1 | 11.2 |
Credits/payments | (0.4) | (14.7) |
Ending Balance | $ 24 | $ 17.8 |
Collaboration Agreements - Sche
Collaboration Agreements - Schedule of Collaboration Revenue Earned From Sanofi (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 1,711.8 | $ 1,511.5 |
Product and service, other | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 176.2 | 88.3 |
Product and service, other | Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 70.2 | 101.2 |
Product and service, other | Sanofi | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 246.4 | 189.5 |
Reimbursement of Regeneron research and development expenses | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 74.5 | 60.4 |
Reimbursement of Regeneron research and development expenses | Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 46.4 | 73.8 |
Reimbursement of Regeneron commercialization-related expenses | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 116.6 | 85.4 |
Reimbursement of Regeneron commercialization-related expenses | Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 2.3 | 1.2 |
Regeneron's share of losses in connection with commercialization of antibodies | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | (27.8) | (74.8) |
Other | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 12.9 | 17.3 |
Other | Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 21.5 | $ 26.2 |
Collaboration Agreements - Sano
Collaboration Agreements - Sanofi, Antibody Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Research and development | $ 641.8 | $ 498.6 |
Cost of Treasury stock shares received | $ 54 | |
Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Percentage of Trial Costs borne by collaborating party | 80.00% | |
Percentage of Trial Costs borne by entity | 20.00% | |
Treasury stock, shares acquired | 24,143 | |
Cost of Treasury stock shares received | $ 10 | |
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 | |
Praluent, Kevzara, and Dupixent | Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Research and development | $ 9.3 | $ 13.9 |
Collaboration Agreements - Sc_2
Collaboration Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, Antibody Collaboration (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | $ 287.6 | $ 226.4 |
Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | 264.4 | 138.2 |
Deferred revenue | $ 302 | $ 236.1 |
Collaboration Agreements - Sc_3
Collaboration Agreements - Schedule of Significant Changes in Deferred Revenue Balances, Antibody Collaboration (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Increase (decrease) in deferred revenue | $ 426.5 | $ (54.5) |
Sanofi Collaboration Agreement, Antibody | ||
Disaggregation of Revenue [Line Items] | ||
Increase (decrease) in deferred revenue | 86 | |
Revenue recognized that was included in deferred revenue at the beginning of the period | $ (20.1) |
Collaboration Agreements - Sa_2
Collaboration Agreements - Sanofi, Immuno-Oncology Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Cost of Treasury stock shares received | $ 54 | |
Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Maximum shares the collaborator could sell (in shares) | 1,042,732 | 1,400,000 |
Cost of Treasury stock shares received | $ 44 | |
Revenue, performance obligation amount | $ 1,324.7 | |
Sanofi Collaboration Agreement, Immuno-oncology | Libtayo | ||
Disaggregation of Revenue [Line Items] | ||
Treasury stock, shares acquired | 106,972 | |
Sanofi Collaboration Agreement, Immuno-oncology | Amended IO Discovery Agreement | ||
Disaggregation of Revenue [Line Items] | ||
Aggregate payment received with regards to amendment | $ 461.9 |
Collaboration Agreements - Sc_4
Collaboration Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, IO Collaboration (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | $ 287.6 | $ 226.4 |
Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable | 18.6 | 77.9 |
Deferred revenue | $ 665.8 | $ 289.9 |
Collaboration Agreements - Sc_5
Collaboration Agreements - Schedule of Significant Changes in Deferred Revenue Balances, IO Collaboration (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Increase as a result of payment received from Sanofi | $ 426.5 | $ (54.5) |
Sanofi Collaboration Agreement, Immuno-oncology | ||
Disaggregation of Revenue [Line Items] | ||
Increase as a result of payment received from Sanofi | 415.9 | |
Revenue recognized that was included in deferred revenue at the beginning of the period | (26.2) | |
Revenue recognized that was added to deferred revenue during the period | $ (13.8) |
Collaboration Agreements - Sc_6
Collaboration Agreements - Schedule of Collaboration Revenue Earned From Bayer (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 1,711.8 | $ 1,511.5 |
Bayer | Product and service, other | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 276.2 | 247.9 |
Outside United States | Bayer | Product and service, other | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 276.2 | 247.4 |
Outside United States | Bayer | Net profit in connection with commercialization | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 249.3 | 232.1 |
Outside United States | Bayer | Reimbursement of Regeneron research and development expenses | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 2.6 | 3.5 |
Outside United States | Bayer | Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 24.3 | $ 11.8 |
Collaboration Agreements - Baye
Collaboration Agreements - Bayer Narrative (Details) - Bayer | 3 Months Ended |
Mar. 31, 2019 | |
Minimum | |
Disaggregation of Revenue [Line Items] | |
Revenue based on percentage of annual sales in Japan | 33.50% |
Maximum | |
Disaggregation of Revenue [Line Items] | |
Revenue based on percentage of annual sales in Japan | 40.00% |
Collaboration Agreements - Teva
Collaboration Agreements - Teva Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Sep. 30, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | |||
Revenues | $ 1,711.8 | $ 1,511.5 | |
Teva | |||
Disaggregation of Revenue [Line Items] | |||
Up-front payment received | $ 250 | ||
Revenues | 53.7 | $ 58.6 | |
Revenue, performance obligation amount | $ 418.2 |
Collaboration Agreements - Sc_7
Collaboration Agreements - Schedule of Accounts Receivable and Deferred Revenue Information, Teva Collaboration (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Disaggregation of Revenue [Line Items] | ||
Accounts receivable (recorded within Prepaid expenses and other current assets) | $ 182.2 | $ 243.3 |
Teva | ||
Disaggregation of Revenue [Line Items] | ||
Accounts receivable (recorded within Prepaid expenses and other current assets) | 32.2 | 28.8 |
Deferred revenue | $ 173.3 | $ 194.5 |
Collaboration Agreements - Sc_8
Collaboration Agreements - Schedule of Significant Changes in Deferred Revenue Balances, Teva Collaboration (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Teva | |
Disaggregation of Revenue [Line Items] | |
Revenue recognized that was included in deferred revenue at the beginning of the period | $ (21.2) |
Collaboration Agreements - Alny
Collaboration Agreements - Alnylam Narrative (Details) - Subsequent Event $ in Millions | 1 Months Ended |
Apr. 30, 2019USD ($) | |
Alnylam | |
Research Collaboration and Licensing Arrangements [Line Items] | |
Upfront payment made | $ 400 |
Additional payment eligible to be made | $ 200 |
Initial research term | 5 years |
Potential extension of research term | 5 years |
Alnylam Stock Purchase Agreement | |
Research Collaboration and Licensing Arrangements [Line Items] | |
Cash consideration | $ 400 |
Minimum | Alnylam | |
Research Collaboration and Licensing Arrangements [Line Items] | |
Extension of research term fee | $ 200 |
Maximum | Alnylam | |
Research Collaboration and Licensing Arrangements [Line Items] | |
Initial research term | 7 years |
Extension of research term fee | $ 400 |
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 | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Net income - basic and diluted | $ 461.1 | $ 478 |
Weighted average shares outstanding - basic (in shares) | 108.9 | 107.6 |
Effect of dilutive securities: | ||
Dilutive potential shares (in shares) | 6.6 | 7.3 |
Weighted average shares - diluted (in shares) | 115.5 | 114.9 |
Net income per share - basic (in dollars per share) | $ 4.23 | $ 4.44 |
Net income per share - diluted (in dollars per share) | $ 3.99 | $ 4.16 |
Stock options | ||
Effect of dilutive securities: | ||
Effect of dilutive securities (in shares) | 6.5 | 7.3 |
Restricted stock | ||
Effect of dilutive securities: | ||
Effect of dilutive securities (in shares) | 0.1 | 0 |
Net Income Per Share - Schedu_2
Net Income Per Share - Schedule of Antidilutive Securities Excluded From Computation (Details) - shares shares in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of shares (in shares) | 12.3 | 14.9 |
Restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of shares (in shares) | 0 | 0.1 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Investments in Available For Sale Debt Securities (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | $ 3,730.2 | $ 3,026.6 |
Unrealized Gains | 9.7 | 1 |
Unrealized Losses | (6.9) | (18.4) |
Available-for-sale debt securities: | 3,733 | 3,009.2 |
Corporate bonds | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 3,352.4 | 2,734.8 |
Unrealized Gains | 9.3 | 1 |
Unrealized Losses | (6.3) | (17.4) |
Available-for-sale debt securities: | 3,355.4 | 2,718.4 |
U.S. government and government agency obligations | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 129.7 | 110.4 |
Unrealized Gains | 0.1 | 0 |
Unrealized Losses | (0.6) | (1) |
Available-for-sale debt securities: | 129.2 | 109.4 |
Sovereign bonds | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 26.8 | 7.6 |
Unrealized Gains | 0.2 | 0 |
Unrealized Losses | 0 | 0 |
Available-for-sale debt securities: | 27 | 7.6 |
Commercial paper | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 152 | 113.8 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Available-for-sale debt securities: | 152 | 113.8 |
Certificates of deposit | Unrestricted | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 69.3 | 60 |
Unrealized Gains | 0.1 | 0 |
Unrealized Losses | 0 | 0 |
Available-for-sale debt securities: | $ 69.4 | $ 60 |
Marketable Securities - Sched_2
Marketable Securities - Schedule of Debt Securities Based on Contractual Maturity Dates (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturities within one year | $ 1,523.9 | $ 1,342.2 |
Maturities after one year through five years | 2,209.1 | 1,667 |
Total | $ 3,733 | $ 3,009.2 |
Marketable Securities - Sched_3
Marketable Securities - Schedule of Fair Value and Unrealized Losses of Debt Securities (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | $ 517.3 | $ 1,482.6 |
Unrealized Loss - Less than 12 months | (0.3) | (6.1) |
Fair Value - 12 Months or Greater | 1,033.4 | 900.7 |
Unrealized Loss - 12 Months or Greater | (6.6) | (12.3) |
Fair Value - Total | 1,550.7 | 2,383.3 |
Unrealized Loss - Total | (6.9) | (18.4) |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | 313.3 | 1,482.6 |
Unrealized Loss - Less than 12 months | (0.3) | (6.1) |
Fair Value - 12 Months or Greater | 941 | 801.6 |
Unrealized Loss - 12 Months or Greater | (6) | (11.3) |
Fair Value - Total | 1,254.3 | 2,284.2 |
Unrealized Loss - Total | (6.3) | (17.4) |
U.S. government and government agency obligations | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value - Less than 12 Months | 204 | 0 |
Unrealized Loss - Less than 12 months | 0 | 0 |
Fair Value - 12 Months or Greater | 92.4 | 99.1 |
Unrealized Loss - 12 Months or Greater | (0.6) | (1) |
Fair Value - Total | 296.4 | 99.1 |
Unrealized Loss - Total | $ (0.6) | $ (1) |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | ||
Net unrealized gain on securities | $ 42.8 | $ 9.4 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | $ 3,733 | $ 3,009.2 |
Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 122.9 | 43.6 |
Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 3,740.8 | 3,053.6 |
Unrestricted | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 56.9 | 43.6 |
Unrestricted | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 0 | 0 |
Restricted | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 66 | 0 |
Restricted | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 7.8 | 44.4 |
Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total marketable securities | 3,863.7 | 3,097.2 |
Estimate of Fair Value Measurement | Unrestricted | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 56.9 | 43.6 |
Estimate of Fair Value Measurement | Restricted | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 73.8 | 44.4 |
Corporate bonds | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 0 | 0 |
Corporate bonds | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 3,355.4 | 2,718.4 |
Corporate bonds | Unrestricted | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 3,355.4 | 2,718.4 |
Corporate bonds | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 3,355.4 | 2,718.4 |
U.S. government and government agency obligations | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
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) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 129.2 | 109.4 |
U.S. government and government agency obligations | Unrestricted | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 129.2 | 109.4 |
U.S. government and government agency obligations | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 129.2 | 109.4 |
Sovereign bonds | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 0 | 0 |
Sovereign bonds | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 27 | 7.6 |
Sovereign bonds | Unrestricted | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 27 | 7.6 |
Sovereign bonds | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 27 | 7.6 |
Commercial paper | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 0 | 0 |
Commercial paper | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 152 | 113.8 |
Commercial paper | Unrestricted | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 152 | 113.8 |
Commercial paper | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 152 | 113.8 |
Certificates of deposit | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 0 | 0 |
Certificates of deposit | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 69.4 | 60 |
Certificates of deposit | Unrestricted | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | 69.4 | 60 |
Certificates of deposit | Estimate of Fair Value Measurement | Measured on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale debt securities: | $ 69.4 | $ 60 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Securities owned not readily marketable | $ 45,500,000 | $ 45,500,000 | |
Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Other than temporary impairment losses, investments | $ 0 | $ 0 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 232.4 | $ 226.8 |
Work-in-process | 581.3 | 571.1 |
Finished goods | 30.8 | 24.4 |
Deferred costs | 364.3 | 328.9 |
Total Inventories | $ 1,208.8 | $ 1,151.2 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Mar. 31, 2017 |
Leases [Abstract] | ||
Finance lease, term of contract | 5 years | |
Finance lease, extension option | 5 years | |
Property, plant, and equipment, at cost | $ 723.9 | |
Accumulated amortization | $ 61.7 |
Leases - Amounts recognized in
Leases - Amounts recognized in Condensed Consolidated Balance Sheet (Details) $ in Millions | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
Finance lease assets | $ 670.9 |
Finance lease liabilities | 709.9 |
Accumulated amortization | $ 65.3 |
Leases - Finance lease costs (D
Leases - Finance lease costs (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Amortization of right-of-use assets | $ 3.5 |
Interest on lease liabilities | 7.2 |
Finance lease costs | $ 10.7 |
Leases - Other information rela
Leases - Other information related to finance leases (Details) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Remaining lease term (in years) | 2 years 11 months 5 days |
Discount rate | 3.69% |
Leases - Maturities on leases (
Leases - Maturities on leases (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Operating Leases | ||
2019 | $ 6.2 | |
2020 | 8.4 | |
2021 | 5.1 | |
2022 | 3 | |
2023 | 2.6 | |
2024 | 2.9 | |
Thereafter | 4.3 | |
Total undiscounted lease payments | 32.5 | |
Imputed interest | (3.1) | |
Debt financing costs | 0 | |
Total lease liabilities | 29.4 | |
Finance Leases | ||
2019 | 19.5 | |
2020 | 26.9 | |
2021 | 26.6 | |
2022 | 726.5 | |
2023 | 0 | |
2024 | 0 | |
Thereafter | 0 | |
Total undiscounted lease payments | 799.5 | |
Imputed interest | (82.2) | |
Debt financing costs | (7.4) | |
Finance lease liabilities | $ 709.9 | |
Operating Leases | ||
2019 | $ 10.4 | |
2020 | 3.8 | |
2021 | 3.4 | |
2022 | 2.2 | |
2023 | 1.5 | |
Thereafter | 4.1 | |
Operating Leases | 25.4 | |
Capital and Facility Lease Obligations | ||
2019 | 26.4 | |
2020 | 28.4 | |
2021 | 27.9 | |
2022 | 7 | |
2023 | 0 | |
Thereafter | 0 | |
Capital and Facility Lease Obligations | $ 89.7 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Effective income tax rate | 15.60% | 18.30% |
Statement of Cash Flows - Sched
Statement of Cash Flows - Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Supplemental Cash Flow Information [Abstract] | ||||
Cash and cash equivalents | $ 1,708.5 | $ 1,467.7 | $ 1,019.5 | |
Restricted cash included in Other noncurrent assets | 12.5 | 12.5 | ||
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows | $ 1,721 | $ 1,480.2 | $ 1,032 | $ 825.2 |
Statement of Cash Flows - Narra
Statement of Cash Flows - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | |
Condensed Cash Flow Statements, Captions [Line Items] | ||||
Accrued capital expenditures | $ 54.4 | $ 54.5 | $ 40.2 | $ 41.8 |
Cost of Treasury stock shares received | 54 | |||
Sanofi Collaboration Agreement, Immuno-oncology | ||||
Condensed Cash Flow Statements, Captions [Line Items] | ||||
Cost of Treasury stock shares received | $ 44 |
Legal Matters - Narrative (Deta
Legal Matters - Narrative (Details) - Pending Litigation € in Thousands | Sep. 26, 2016EUR (€) | Apr. 01, 2019claim | Feb. 25, 2019claim |
Amgen v.s. Regeneron | |||
Loss Contingencies [Line Items] | |||
Loss contingency, damages sought, per unit produced | € | € 10 | ||
Loss contingency, damages sought | € | € 10,000 | ||
'165 Patent | Amgen v.s. Regeneron | |||
Loss Contingencies [Line Items] | |||
Pending claims | 2 | ||
Invalid claims | 2 | ||
'741 Patent | Amgen v.s. Regeneron | |||
Loss Contingencies [Line Items] | |||
Pending claims | 1 | ||
Subsequent Event | '688 Patent | |||
Loss Contingencies [Line Items] | |||
Pending claims | 1 | ||
Asserted claims | 9 |
Uncategorized Items - regn-2019
Label | Element | Value |
Accounting Standards Update 2016-01 [Member] | AOCI Attributable to Parent [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (6,600,000) |
Accounting Standards Update 2016-02 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 9,700,000 |
Accounting Standards Update 2016-02 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 9,700,000 |
Accounting Standards Update 2014-09 And 2016-01 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | (143,500,000) |
Accounting Standards Update 2014-09 And 2016-01 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (136,900,000) |