Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | Apr. 14, 2016 | |
Entity Information [Line Items] | ||
Entity Registrant Name | REGENERON PHARMACEUTICALS INC | |
Entity Central Index Key | 872,589 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 103,165,457 | |
Class A Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 1,913,136 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 604,214 | $ 809,102 |
Marketable securities | 244,965 | 236,121 |
Accounts receivable - trade, net | 1,450,572 | 1,152,489 |
Accounts Receivable from Sanofi | 173,782 | 153,152 |
Accounts receivable from Bayer | 240,867 | 162,152 |
Inventories | 303,294 | 238,578 |
Prepaid expenses and other current assets | 115,685 | 163,501 |
Total current assets | 3,133,379 | 2,915,095 |
Marketable securities | 555,210 | 632,162 |
Property, plant, and equipment, net | 1,666,391 | 1,594,120 |
Deferred tax assets | 543,689 | 461,945 |
Other assets | 5,791 | 5,810 |
Total assets | 5,904,460 | 5,609,132 |
Current liabilities: | ||
Accounts payable and accrued expenses | 733,276 | 644,112 |
Deferred revenue from Sanofi, current portion | 99,314 | 101,573 |
Deferred revenue - other, current portion | 73,626 | 51,914 |
Other current liabilities | 13,508 | 13,563 |
Total current liabilities | 919,724 | 811,162 |
Deferred revenue from Sanofi | 565,773 | 582,664 |
Deferred Revenue - other | 170,658 | 82,015 |
Facility lease obligations | 362,230 | 362,919 |
Other long-term liabilities | 120,993 | 115,535 |
Total liabilities | 2,139,378 | 1,954,295 |
Stockholders' equity: | ||
Preferred Stock | 0 | 0 |
Additional paid-in capital | 3,049,651 | 3,099,526 |
Retained earnings | 1,018,436 | 852,700 |
Accumulated other comprehensive income | 4,364 | 8,572 |
Treasury stock | (307,478) | (306,069) |
Total stockholders' equity | 3,765,082 | 3,654,837 |
Total liabilities and stockholders' equity | 5,904,460 | 5,609,132 |
Class A Stock | ||
Stockholders' equity: | ||
Common stock | 2 | 2 |
Common Stock | ||
Stockholders' equity: | ||
Common stock | $ 107 | $ 106 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
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, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Treasury Stock, shares outstanding (in shares) | 3,659,588 | 3,642,820 |
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) | 1,913,136 | 1,913,776 |
Common Stock, shares outstanding (in shares) | 1,913,136 | 1,913,776 |
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) | 106,739,966 | 106,378,001 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenues: | ||
Net product sales | $ 784,182 | $ 544,573 |
Sanofi collaboration revenue | 219,694 | 173,356 |
Bayer Collaboration Revenue | 179,592 | 123,846 |
Other revenue | 17,381 | 27,837 |
Total revenues | 1,200,849 | 869,612 |
Expenses: | ||
Research and development | 470,112 | 343,113 |
Selling, general, and administrative | 289,677 | 158,991 |
Cost of goods sold | 78,942 | 42,570 |
Cost of collaboration and contract manufacturing | 32,810 | 41,385 |
Total expenses | 871,541 | 586,059 |
Income from operations | 329,308 | 283,553 |
Other income (expense): | ||
Investment income | 2,249 | 180 |
Interest and other expense, net | 1,406 | 7,210 |
Nonoperating Income (Expense) | 843 | (7,030) |
Income before income taxes | 330,151 | 276,523 |
Income tax expense | (164,415) | (200,502) |
Net income | $ 165,736 | $ 76,021 |
Net income per share - basic | $ 1.59 | $ 0.74 |
Net income per share - diluted | $ 1.45 | $ 0.66 |
Weighted average shares outstanding - basic | 104,290 | 102,227 |
Weighted average shares outstanding - diluted | 114,228 | 114,519 |
Statements of Comprehensive Income | ||
Net income | $ 165,736 | $ 76,021 |
Other comprehensive income (loss): | ||
Unrealized loss on marketable securities, net of tax | (4,208) | (4,347) |
Comprehensive income | $ 161,528 | $ 71,674 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Cash flows from operating activities: | ||
Net income | $ 165,736 | $ 76,021 |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 22,977 | 16,027 |
Non-cash compensation expense | 142,250 | 103,759 |
Other non-cash charges and expenses, net | 3,957 | 8,808 |
Deferred taxes | (79,785) | (37,256) |
Changes in assets and liabilites | ||
Increase in Sanofi, Bayer, and trade accounts receivable | (397,428) | (329,746) |
Increase in Inventories | (62,263) | (5,434) |
Decrease in prepaid expenses and other assets | 39,260 | 43,434 |
Increase (decrease) in deferred revenue | 91,205 | (7,457) |
Increase in accounts payable, accrued expenses and other liabilities | 103,431 | 30,117 |
Total adjustments | (136,396) | (177,748) |
Net cash provided by (used in) operating activities | 29,340 | (101,727) |
Cash flows from investing activities: | ||
Purchases of marketable securities | 0 | (95,775) |
Sales or maturities of marketable securities | 60,409 | 80,456 |
Capital expenditures | (104,094) | (114,162) |
Net cash used in investing activities | (43,685) | (129,481) |
Cash flows from financing activities: | ||
(Payments) proceeds in connection with facility lease obligations | (598) | 6,738 |
Repayments of convertible senior notes | (1,739) | (16,686) |
Payments in connection with deduction of outstanding warrants | (242,117) | (124,531) |
Proceeds from issuance of Common Stock | 39,304 | 76,273 |
Payments in connection with Common Stock tendered for employee tax obligations | (1,042) | (21,192) |
Excess tax benefit from stock-based compensation | 15,649 | 169,794 |
Net cash (used in) provided by financing activities | (190,543) | 90,396 |
Net decrease in cash and cash equivalents | (204,888) | (140,812) |
Cash and cash equivalents at beginning of period | 809,102 | 648,719 |
Cash and cash equivalents at end of period | $ 604,214 | $ 507,907 |
Interim Financial Statements (N
Interim Financial Statements (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
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" or the "Company") 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 statement of the Company's financial position, results of operations, and cash flows for such periods. The results of operations for any interim periods are not necessarily indicative of the results for the full year. The December 31, 2015 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, 2015. Certain reclassifications have been made to prior period amounts to conform with the current period's presentation. |
Net Product Sales (Notes)
Net Product Sales (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Revenues [Abstract] | |
Product Sales and Concentration Risk [Text Block] | Product Sales EYLEA ® net product sales in the United States totaled $780.9 million and $541.1 million for the three months ended March 31, 2016 and 2015 , respectively. In addition, ARCALYST ® net product sales totaled $3.3 million and $3.5 million for the three months ended March 31, 2016 and 2015 , respectively. For the three months ended March 31, 2016 and 2015 , the Company recorded 60% and 69% , respectively, of its total gross product revenue from sales to Besse Medical, a subsidiary of AmerisourceBergen Corporation. Revenue from product sales is recorded net of applicable provisions for rebates and chargebacks under governmental programs, distribution-related fees, and other sales-related deductions. The following table summarizes the provisions, and credits/payments, for these sales-related deductions during the three months ended March 31, 2016 and 2015 . Rebates & Chargebacks Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2015 $ 6,419 $ 48,313 $ 517 $ 55,249 Provision related to current period sales 18,885 35,788 2,910 57,583 Credits/payments (17,457 ) (50,353 ) (2,557 ) (70,367 ) Balance as of March 31, 2016 $ 7,847 $ 33,748 $ 870 $ 42,465 Balance as of December 31, 2014 $ 3,083 $ 21,166 $ 532 $ 24,781 Provision related to current period sales 11,353 24,781 1,383 37,517 Credits/payments (9,779 ) (13,036 ) (1,411 ) (24,226 ) Balance as of March 31, 2015 $ 4,657 $ 32,911 $ 504 $ 38,072 |
Collaboration Agreements (Notes
Collaboration Agreements (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Collaboration Agreement [Abstract] | |
Collaboration Agreements | Collaboration Agreements a. Sanofi The collaboration revenue the Company earned from Sanofi is detailed below: Three Months Ended March 31, Sanofi Collaboration Revenue 2016 2015 Antibody: Reimbursement of Regeneron research and development expenses $ 193,602 $ 168,820 Reimbursement of Regeneron commercialization-related expenses 73,274 8,458 Regeneron's share of losses in connection with commercialization of antibodies (99,422 ) (22,405 ) Other 2,965 2,561 Total Antibody 170,419 157,434 Immuno-oncology: Reimbursement of Regeneron research and development expenses 29,275 — Other 20,000 — Total Immuno-oncology 49,275 — ZALTRAP ® : Reimbursement of Regeneron research and development expenses — 686 Other — 15,236 Total ZALTRAP — 15,922 $ 219,694 $ 173,356 Antibodies In November 2007, the Company entered into a global, strategic collaboration with Sanofi to discover, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration") . The Antibody Collaboration is governed by the companies' Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and a License and Collaboration Agreement (each as amended). Pursuant to the Antibody Discovery Agreement, Sanofi will fund up to $130.0 million of the Company's research activities in each of 2016 and 2017. Under the License and Collaboration Agreement, agreed-upon worldwide development expenses incurred by both companies are funded by Sanofi, except that 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. During the three months ended March 31, 2016 and 2015 , the Company recognized as additional research and development expense $21.7 million and $25.0 million , respectively, of antibody development expenses that the Company was obligated to reimburse to Sanofi related to Praluent ® , sarilumab, and, commencing in the first quarter of 2016, dupilumab. Reimbursement of Regeneron commercialization-related expenses represents reimbursement of internal and external costs in connection with preparing to commercialize or commercializing, as applicable, Praluent, sarilumab, and, effective in the first quarter of 2016, dupilumab. During the three months ended March 31, 2015, the Company and Sanofi shared pre-launch commercialization expenses, including those incurred by Sanofi, related to Praluent and sarilumab in accordance with the companies’ License and Collaboration Agreement. In addition, effective in the first quarter of 2016, the Company and Sanofi also began sharing pre-launch commercialization expenses related to dupilumab. As such, the Company recorded its share of losses in connection with preparing to commercialize Praluent, sarilumab, and dupilumab within Sanofi collaboration revenue. In July 2015, the U.S. Food and Drug Administration (FDA) approved Praluent in the United States and in September 2015, the European Commission granted marketing authorization of Praluent. Therefore, commencing in the third quarter of 2015, the Company also recorded within Sanofi collaboration revenue its share of the Antibody Collaboration's losses in connection with commercialization of Praluent. Immuno-Oncology In July 2015, the Company and Sanofi entered into a collaboration to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). The IO Collaboration is governed by an Immuno-oncology Discovery and Development Agreement ("IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement"). Pursuant to the IO Discovery Agreement, Sanofi will reimburse the Company for up to $150.0 million in 2016 to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept. Under the terms of the IO License and Collaboration Agreement, the parties are co-developing the Company's antibody product candidate targeting the receptor known as programmed cell death protein 1, or PD-1 ("REGN2810"). The parties share equally, on an ongoing basis, development expenses for REGN2810. The $640.0 million in aggregate up-front payments made by Sanofi during 2015 in connection with the execution of the IO Collaboration has been recorded by the Company as deferred revenue, and is being recognized ratably as revenue over the related performance period. ZALTRAP In February 2015, the Company and Sanofi entered into an amended and restated ZALTRAP agreement ("Amended ZALTRAP Agreement"). Under the terms of the Amended ZALTRAP Agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP for cancer indications worldwide. Sanofi bears the cost of all development and commercialization activities and reimburses Regeneron for its costs for any such activities. Sanofi pays the Company a percentage of aggregate net sales of ZALTRAP during each calendar year. As a result of entering into the Amended ZALTRAP Agreement, in the first quarter of 2015, the Company recognized $14.9 million of collaboration revenue, which was previously recorded as deferred revenue under the ZALTRAP Collaboration Agreement, related to (i) amounts that were previously reimbursed by Sanofi for manufacturing commercial supplies of ZALTRAP since the risk of inventory loss no longer existed, and (ii) the unamortized portion of up-front payments from Sanofi as the Company had no further performance obligations. In addition, during the first quarter of 2015, the Company recorded $19.8 million , in other revenue, primarily related to manufacturing ZALTRAP commercial supplies for Sanofi, and a percentage of net sales of ZALTRAP from July 1, 2014 (the effective date of the Amended ZALTRAP Agreement) through March 31, 2015. During the first quarter of 2016, the Company recorded $5.3 million , in other revenue, primarily related to a percentage of net sales of ZALTRAP and manufacturing ZALTRAP commercial supplies for Sanofi. b. Bayer The collaboration revenue the Company earned from Bayer is detailed below: Three Months Ended March 31, Bayer Collaboration Revenue 2016 2015 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 145,835 $ 89,426 Sales milestones — 15,000 Cost-sharing of Regeneron EYLEA development expenses 2,743 2,657 Other 26,492 12,912 Total EYLEA 175,070 119,995 PDGFR-beta antibody: Cost-sharing of rinucumab/aflibercept (REGN2176-3) development expenses 1,896 1,254 Other 2,626 2,597 Total PDGFR-beta 4,522 3,851 $ 179,592 $ 123,846 EYLEA outside the United States Under the terms of the license and collaboration agreement with Bayer for the global development and commercialization outside the United States of EYLEA, Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In Japan, the Company is entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales. In addition, all agreed-upon EYLEA development costs incurred by the Company and Bayer are shared equally. In the first quarter of 2015, the Company earned a $15.0 million sales milestone from Bayer upon total aggregate net sales of specific commercial supplies of EYLEA outside the United States exceeding $200 million over a twelve -month period, which was the final milestone payment under the agreement. PDGFR-beta antibody outside the United States In 2014, the Company entered into an agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), including in combination with aflibercept, for the treatment of ocular diseases or disorders. In connection with the agreement, Bayer is obligated to pay 25% of global development costs and 50% of development costs exclusively for the territory outside the United States. Ang2 antibody outside the United States On March 23, 2016, the Company entered into an agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to angiopoietin-2 (Ang2), including in combination with aflibercept, for the treatment of ocular diseases or disorders. In connection with the agreement, Bayer was obligated to make a $50.0 million non-refundable up-front payment to the Company (which was receivable as of March 31, 2016) and is obligated to pay 25% of global development costs and 50% of development costs exclusively for the territory outside the United States. The Company is also entitled to receive up to an aggregate of $80.0 million in development milestone payments from Bayer. Bayer will share profits and losses from sales outside the United States equally with the Company, and is responsible for certain royalties payable to Sanofi on sales of the product outside of the United States. Within the United States, the Company has exclusive commercialization rights and will retain all of the profits from sales. At the inception of the agreement, the Company's significant deliverables consisted of (i) a license to certain rights and intellectual property, (ii) providing research and development services, and (iii) manufacturing clinical supplies. The Company concluded that the license did not have standalone value, as such right was not sold separately by the Company, nor could Bayer receive any benefit from the license without the fulfillment of other ongoing obligations by the Company, including the clinical supply arrangement. Therefore, the deliverables were considered a single unit of accounting. Consequently, the $50.0 million up-front payment was initially recorded as deferred revenue, and will be recognized ratably as revenue over the related performance period. Unless terminated earlier in accordance with its provisions, the agreement will continue to be in effect until such time as neither party or its respective affiliates or sublicensees is developing or commercializing an Ang2 antibody in the specified field outside of the United States and such discontinuation is acknowledged as permanent by both the Company and Bayer. c. Mitsubishi Tanabe Pharma In September 2015, the Company and Mitsubishi Tanabe Pharma Corporation ("MTPC") entered into a collaboration agreement providing MTPC with development and commercial rights to fasinumab, the Company's nerve growth factor antibody in late-stage clinical development, in certain Asian countries. In connection with the agreement, MTPC made a $10.0 million non-refundable up-front payment. In the first quarter of 2016, MTPC made additional payments of $45.0 million and $15.0 million to the Company, which were recorded as deferred revenue and will be recognized ratably as revenue over the same performance period as the up-front payment. d. Intellia Therapeutics In April 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc., a privately held company, to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development. The Company will collaborate with Intellia to conduct research for the discovery, development, and commercialization of new therapies ("Product Collaboration"), in addition to the research and technology development of the CRISPR/Cas platform ("Technology Collaboration"). In connection with the execution of the agreement, the Company made a $75.0 million up-front payment in April 2016, and has also agreed to purchase up to $50.0 million of Intellia shares contingent upon Intellia consummating its next equity financing. The Company is responsible for costs of developing and commercializing CRISPR/Cas products under the Product Collaboration agreement and is also obligated to pay potential development and sales milestones, and royalties on any future sales of such products resulting from the development and commercialization of CRISPR/Cas products. In addition, under the Technology Collaboration agreement, the Company is responsible for funding certain research and technology development costs. Under the terms of the Product Collaboration agreement, the parties agreed to a target selection process, whereby the Company may obtain exclusive rights in up to 10 targets to be chosen by the Company during the collaboration term, subject to various adjustments and limitations set forth in the agreement. Additionally, the Company may replace a limited number of targets with substitute targets upon the payment of a replacement fee, in which case rights to the replaced target(s) will revert to Intellia. The Technology Collaboration term and the period for selecting targets for inclusion under the Product Collaboration both end in 2022, provided that the Company may make a one -time payment to extend the term for an additional two -year period. The Product Collaboration agreement will continue until the date when no royalty or other payment obligations are due, unless earlier terminated in accordance with the terms of the agreement. Certain targets that either the Company or Intellia select pursuant to the target selection process may be subject to a co-development and co-commercialization arrangement at the Company's option or Intellia's option, as applicable. |
Net Income Per Share (Notes)
Net Income Per Share (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
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 2016 2015 Net income - basic $ 165,736 $ 76,021 Effect of dilutive securities: Convertible senior notes - interest expense related to contractual coupon interest rate and amortization of discount and note issuance costs 56 — Net income - diluted $ 165,792 $ 76,021 (Shares in thousands) Weighted average shares - basic 104,290 102,227 Effect of dilutive securities: Stock options 8,147 9,313 Restricted stock 469 467 Convertible senior notes 44 — Warrants 1,278 2,512 Dilutive potential shares 9,938 12,292 Weighted average shares - diluted 114,228 114,519 Net income per share - basic $ 1.59 $ 0.74 Net income per share - diluted $ 1.45 $ 0.66 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended March 31, (Shares in thousands) 2016 2015 Stock options 7,539 3,673 Restricted stock 19 — Convertible senior notes — 1,929 |
Marketable Securities (Notes)
Marketable Securities (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities as of March 31, 2016 and December 31, 2015 consist of both debt securities of investment grade issuers as well as equity securities. The following tables summarize the Company's investments in marketable securities: Amortized Unrealized Fair As of March 31, 2016 Cost Basis Gains Losses Value Corporate bonds $ 710,989 $ 1,920 $ (879 ) $ 712,030 U.S. government and government agency obligations 50,383 194 (2 ) 50,575 Municipal bonds 16,113 45 (3 ) 16,155 Equity securities 17,005 10,057 (5,647 ) 21,415 $ 794,490 $ 12,216 $ (6,531 ) $ 800,175 As of December 31, 2015 Corporate bonds $ 770,092 $ 156 $ (2,565 ) $ 767,683 U.S. government and government agency obligations 51,402 — (193 ) 51,209 Municipal bonds 17,930 5 (11 ) 17,924 Equity securities 17,005 14,461 — 31,466 $ 856,429 $ 14,622 $ (2,769 ) $ 868,282 The Company classifies its debt security investments based on their contractual maturity dates. The debt securities listed as of March 31, 2016 mature at various dates through August 2020. The fair values of debt security investments by contractual maturity consist of the following: March 31, 2016 December 31, 2015 Maturities within one year $ 244,965 $ 236,121 Maturities after one year through five years 533,795 600,695 $ 778,760 $ 836,816 The following table shows the fair value of the Company's marketable 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, 2016 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 132,085 $ (190 ) $ 135,211 $ (689 ) $ 267,296 $ (879 ) U.S. government and government agency obligations 7,822 (3 ) — — 7,822 (3 ) Municipal bonds 2,571 (2 ) — — 2,571 (2 ) Equity securities 9,353 (5,647 ) — — 9,353 (5,647 ) $ 151,831 $ (5,842 ) $ 135,211 $ (689 ) $ 287,042 $ (6,531 ) As of December 31, 2015 Corporate bonds $ 668,199 $ (2,473 ) $ 23,749 $ (92 ) $ 691,948 $ (2,565 ) U.S. government and government agency obligations 51,215 (193 ) — — 51,215 (193 ) Municipal bonds 11,917 (11 ) — — 11,917 (11 ) $ 731,331 $ (2,677 ) $ 23,749 $ (92 ) $ 755,080 $ (2,769 ) There were no realized gains and losses on sales of marketable securities for the three months ended March 31, 2016 , and such amounts were not material for the three months ended March 31, 2015 . Changes in the Company's accumulated other comprehensive income (loss) for the three months ended March 31, 2016 and 2015 related to unrealized gains and losses on available-for-sale marketable securities. For the three months ended March 31, 2015 , amounts reclassified from accumulated other comprehensive income (loss) into investment income in the Company's Statements of Operations were related to realized gains and losses on sales of marketable securities; there were no such amounts reclassified during the three months ended March 31, 2016. |
Fair Value Measurements (Notes)
Fair Value Measurements (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
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, 2016 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale marketable securities: Corporate bonds $ 712,030 — $ 712,030 U.S. government and government agency obligations 50,575 — 50,575 Municipal bonds 16,155 — 16,155 Equity securities 21,415 $ 21,415 — $ 800,175 $ 21,415 $ 778,760 As of December 31, 2015 Available-for-sale marketable securities: Corporate bonds $ 767,683 — $ 767,683 U.S. government and government agency obligations 51,209 — 51,209 Municipal bonds 17,924 — 17,924 Equity securities 31,466 $ 31,466 — $ 868,282 $ 31,466 $ 836,816 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, 2016 and 2015 . There were no purchases, sales, or maturities of Level 3 marketable securities and no unrealized gains or losses related to Level 3 marketable securities for the three months ended March 31, 2016 and 2015 . During the three months ended March 31, 2015, transfers of marketable securities from Level 2 to Level 1 were $91.4 million in connection with the lapse of the transfer restrictions on the Company's investment in Avalanche Biotechnologies, Inc. common shares in January 2015. The Company's policy for recognition of transfers between levels of the fair value hierarchy is to recognize any transfer at the beginning of the fiscal quarter in which the determination to transfer was made. There were no other transfers of marketable securities between Levels 1, 2, or 3 classifications during the three months ended March 31, 2016 and 2015. As of March 31, 2016 and December 31, 2015 , the Company had $10.6 million and $11.2 million , respectively, in aggregate principal amount of 1.875% convertible senior notes (the "Notes") outstanding that will mature on October 1, 2016 unless earlier converted or repurchased (see Note 9). The fair value of the outstanding Notes was estimated to be $49.6 million and $72.8 million as of March 31, 2016 and December 31, 2015 , respectively, and was determined based on Level 2 inputs, such as market and observable sources. |
Inventory (Notes)
Inventory (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventories Inventories consist of the following: March 31, December 31, 2016 2015 Raw materials $ 85,180 $ 59,151 Work-in-process 157,921 132,068 Finished goods 14,231 11,197 Deferred costs 45,962 36,162 $ 303,294 $ 238,578 Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred. For the three months ended March 31, 2016 and 2015 , cost of goods sold included inventory write-downs and reserves totaling $4.3 million and $1.7 million , respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following: March 31, December 31, 2016 2015 Accounts payable $ 120,595 $ 140,962 Accrued payroll and related costs 92,668 133,223 Accrued clinical trial expense 82,533 88,297 Accrued sales-related charges, deductions, and royalties 190,763 195,986 Income taxes payable 144,078 — Other accrued expenses and liabilities 102,639 85,644 $ 733,276 $ 644,112 |
Debt (Notes)
Debt (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | Debt a. Convertible Debt In the first quarter of 2016, the Company settled conversion obligations for $1.7 million principal amount of the Company's Notes that was previously surrendered for conversion. Consequently, in the first quarter of 2016, the Company paid $1.7 million in cash and issued 16,774 shares of Common Stock. In addition, the Company allocated $6.7 million of the settlement consideration provided to the Note holders to the reacquisition of the equity component of the Notes, and recognized such amount as a reduction of stockholder's equity. The loss on the debt extinguishment in connection with the Notes that were surrendered for conversion during the first quarter of 2016 was not material. As a result of these Note conversions, in the first quarter of 2016, the Company also exercised a proportionate amount of its convertible note hedges, for which the Company received 16,768 shares of Common Stock, which was approximately equal to the number of shares the Company was required to issue to settle the non-cash portion of the related Note conversions. The Company recorded the cost of the shares received, or $1.4 million , as Treasury Stock during the first quarter of 2016. As of March 31, 2016 , an aggregate principal amount of $10.6 million of Notes remained outstanding. In addition to the Note conversions described above, the Company received notifications in April 2016 that an additional $10.4 million aggregate principal amount of the Notes was surrendered for conversion, and settlement is anticipated during the second quarter of 2016. The Company has elected to settle the related conversion obligations through a combination of cash and shares (total payment will be based on the average of the volume-weighted-average prices of the Common Stock during the 40 trading-day cash settlement averaging period specified in the indenture governing the Notes). In connection with these Note conversions, the Company exercised a proportionate amount of its convertible note hedges, for which the Company expects to receive shares of Common Stock approximately equal to the number of shares the Company will be required to issue to settle the non-cash portion of the related Note conversions. In the first quarter of 2015, the Company settled conversion obligations for $16.7 million principal amount of the Company's Notes. Upon settlement of the Notes, the Company paid $16.7 million in cash and issued 146,253 shares of Common Stock. In addition, in the first quarter of 2015, the Company allocated $62.6 million of the settlement consideration provided to the Note holders to the reacquisition of the equity component of the Notes, and recognized such amount as a reduction of stockholder's equity. The related loss on the debt extinguishment in the first quarter of 2015 was not material. In connection with the Note conversions in the first quarter of 2015, the Company also exercised a proportionate amount of its convertible note hedges, for which the Company received 146,248 shares of Common Stock, which was approximately equal to the number of shares the Company was required to issue to settle the non-cash portion of the related Note conversions. The Company recorded the cost of the shares received, or $12.3 million , as Treasury Stock during the first quarter of 2015. Warrant Transactions In November 2015, the Company entered into an amendment agreement with a warrant holder whereby the parties agreed to reduce a portion of the number of warrants held by the warrant holder. The reduction in the number of warrants was determined based on the number of warrants with respect to which the warrant holder closed out its hedge position, provided that the warrant holder did not effect any purchases at a price per share exceeding $535.00 per share, during the period starting on November 16, 2015 and ending no later than February 9, 2016. The Company may settle, at its option, any payments due under the amendment agreement in cash or by delivering shares of Common Stock. As a result of the warrant holder closing out a portion of its hedge position in the first quarter of 2016, the Company paid a total of $135.2 million to reduce the number of warrants held by such warrant holder by 360,406 (which was the remaining maximum number of warrants to be reduced subject to the amendment agreement). In February 2016, the Company entered into an amendment agreement with a warrant holder whereby the parties agreed to reduce a portion of the number of warrants held by the warrant holder by up to a maximum of 975,142 . The reduction in the number of warrants is determined based on the number of warrants with respect to which the warrant holder has closed out its hedge position, provided that the warrant holder does not effect any purchases at a price per share exceeding $375.00 per share, during the period starting on February 22, 2016 and ending no later than May 5, 2016. The Company may settle, at its option, any payments due under the amendment agreement in cash or by delivering shares of Common Stock. As a result of the warrant holder closing out a portion of its hedge position during the first quarter of 2016, the Company paid a total of $106.9 million to reduce the number of warrants held by such warrant holder by 403,665 . As of March 31, 2016, an aggregate of 1,345,027 warrants (subject to adjustment from time to time as provided in the applicable warrant agreements) remained outstanding. In November 2014, the Company entered into an amendment agreement with a warrant holder whereby the parties agreed to reduce a portion of the number of warrants held by the warrant holder. The reduction in the number of warrants was determined based on the number of warrants with respect to which the warrant holder had closed out its hedge position, provided that the warrant holder did not effect any purchases at a price per share exceeding $397.75 per share, during the period starting on November 26, 2014 and ending no later than February 12, 2015. The Company was obligated to settle any payments due under the amendment agreement in February 2015. Given that the amendment agreement contained a conditional obligation that required settlement in cash, and the Company's obligation was indexed to the Company's share price, the Company reclassified the estimated fair value of the warrants subject to the agreement from additional paid-in capital to a liability in November 2014, with such liability subsequently measured at fair value with changes in fair value recognized in earnings. In February 2015, the Company paid a total of $124.0 million to reduce the number of warrants held by such warrant holder by 416,480 . Upon expiration of the November 2014 amended agreement, in the first quarter of 2015 the remaining warrants were re-measured at fair value, and $23.3 million was reclassified back to additional paid-in capital, consistent with the original classification of the warrants under the 2011 issuance. Total losses related to changes in fair value of the warrants during the first quarter of 2015 were not material. b. Credit Facility In March 2015, the Company entered into an agreement with a syndicate of lenders which provides for a $750.0 million senior unsecured five -year revolving credit facility. As of March 31, 2016, the Company had no borrowings outstanding under the credit facility and was in compliance with all credit facility covenants. |
Income Taxes (Notes)
Income Taxes (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company is subject to U.S. federal, state, and foreign income taxes. The Company recorded an income tax provision in its Statement of Operations of $164.4 million and $200.5 million for the three months ended March 31, 2016 and 2015 , respectively. The Company's effective tax rate was 49.8% and 72.5% for the three months ended March 31, 2016 and 2015 , respectively. The Company's effective tax rate for the three months ended March 31, 2016 was negatively impacted, compared to the U.S. federal statutory rate, by losses incurred in foreign jurisdictions with rates lower than the U.S. federal statutory rate and the non-tax deductible Branded Prescription Drug Fee, partly offset by the positive impact of the domestic manufacturing deduction and the federal tax credit for increased research activities. The Company's effective tax rate for the three months ended March 31, 2015 was negatively impacted, compared to the U.S. federal statutory rate, by losses incurred in foreign jurisdictions with rates lower than the U.S. federal statutory rate, the non-deductible Branded Prescription Drug Fee, and expiration, at the end of 2014, of the federal tax credit for increased research activities. The Company also recorded an income tax benefit in its Statement of Comprehensive Income of $2.0 million and $2.5 million for the three months ended March 31, 2016 and 2015, respectively, in connection with unrealized gains (losses) on available-for-sale marketable securities. |
Statement of Cash Flows (Notes)
Statement of Cash Flows (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
Cash Flow, Noncash Investing and Financing Activities Disclosure [Abstract] | |
Statement of Cash Flows | Statement of Cash Flows Supplemental disclosure of non-cash investing and financing activities Included in accounts payable and accrued expenses as of March 31, 2016 and December 31, 2015 were $44.6 million and $50.7 million , respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses as of March 31, 2015 and December 31, 2014 were $84.1 million and $56.2 million , respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses as of December 31, 2014 was $7.5 million for the Company's conversion settlement obligation related to the Company's Notes which were surrendered for conversion but not settled as of December 31, 2014. The amount of such liability was not material as of March 31, 2016, December 31, 2015, and March 31, 2015. Included in accounts payable and accrued expenses as of December 31, 2014 was $59.8 million related to the Company's payment obligation for a reduction in the number of warrants based on a warrant holder closing out a portion of its hedge position. Additionally, included within other current liabilities as of December 31, 2014 was $87.5 million in connection with the estimated fair value of the remaining warrant liability. There were no such liabilities recorded in connection with warrants as of March 31, 2016 , December 31, 2015, and March 31, 2015 . The Company recognized an additional facility lease obligation of $10.8 million during the three months ended March 31, 2015 , in connection with capitalizing, on the Company's books, the landlord's costs of constructing new facilities that the Company has leased. No such amount was recognized during the three months ended March 31, 2016. |
Legal Matters (Notes)
Legal Matters (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
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. Proceedings Relating to '287 Patent, '163 Patent, and '018 Patent The Company is a party to patent infringement litigation initiated by the Company involving its European Patent No. 1,360,287 (the "'287 Patent"), its European Patent No. 2,264,163 (the "'163 Patent"), and its U.S. Patent No. 8,502,018 (the "'018 Patent"). Each of these patents concerns genetically altered mice capable of producing chimeric antibodies that are part human and part mouse. Chimeric antibody sequences can be used to produce high-affinity fully human monoclonal antibodies. In these proceedings, the Company claims infringement of several claims of the '287 Patent, the '163 Patent, and the '018 Patent (as applicable), and seeks, among other types of relief, an injunction and an account of profits in connection with the defendants' infringing acts, which may include, among other things, the making, use, keeping, sale, or offer for sale of genetically engineered mice (or certain cells from which they are derived) that infringe one or more claims of the '287 Patent, the '163 Patent, and the '018 Patent (as applicable). At this time, the Company is not able to predict the outcome of, or an estimate of gain or a range of possible loss, if any, related to, these proceedings. Proceedings Relating to Praluent (alirocumab) Injection On October 17, 2014 and October 28, 2014, Amgen Inc. filed complaints against Regeneron, Sanofi, Aventisub LLC (subsequently removed and replaced with Sanofi-Aventis U.S. LLC), and Aventis Pharmaceuticals, Inc. in the United States District Court for the District of Delaware seeking an injunction to prohibit Regeneron and the other defendants from manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) Praluent, which Regeneron is jointly developing with Sanofi. On November 11, 2014 and November 17, 2014 Amgen filed complaints against Regeneron, Sanofi, Sanofi-Aventis U.S. LLC, and Aventis Pharmaceuticals, Inc. in the same court seeking the same relief. Amgen asserts U.S. Patent Nos. 8,563,698, 8,829,165 (the "'165 Patent"), and 8,859,741 (the "'741 Patent") in the first complaint, U.S. Patent Nos. 8,871,913 and 8,871,914 (the "'914 Patent") in the second complaint, U.S. Patent No. 8,883,983 in the third complaint, and U.S. Patent No. 8,889,834 in the fourth complaint. 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. On December 15, 2014, all of the four proceedings were consolidated into a single case. On September 15, 2015, Amgen filed a motion for leave to file a supplemental and second amended complaint, which was granted on January 29, 2016. As amended, the complaint alleges, among other things, willful infringement of the asserted patents, which would allow the court to increase damages up to three times the amount assessed if the court finds willful infringement. On October 20, 2015, the District Court issued its claim construction order, in which it defined the meaning of certain disputed claim terms; none of the court's rulings were dispositive of the issues in the case. On November 3, 2015, pursuant to court order, the patents asserted by Amgen were narrowed to the '165, '741, and '914 Patents. On March 4, 2016, Amgen further narrowed the asserted patents to the '165 and '741 Patents. A jury trial in this litigation was held from March 8 to March 16, 2016. During the course of the trial, the court ruled as a matter of law in favor of Amgen that the asserted patent claims were not obvious, and in favor of Regeneron and Sanofi that there was no willful infringement of the asserted patent claims by Regeneron or Sanofi. On March 16, 2016, the jury returned a verdict in favor of Amgen, finding that the asserted claims of the '165 and '741 Patents were not invalid based on either a lack of written description or a lack of enablement. The court’s final opinion and judgment are expected to be issued following submission of post-trial briefs, which are expected to be submitted in the second quarter of 2016. The Company and Sanofi plan to appeal any judgment that is adverse to the Company and Sanofi. On March 23 and March 24, 2016, the court held a permanent injunction hearing to determine whether Regeneron and Sanofi should be prohibited from commercializing Praluent. The court deferred a decision on the permanent injunction until after post-trial briefs are submitted. At this time, the Company is not able to estimate a range of possible loss, if any, related to these proceedings. Proceedings Relating to Patents Owned by Genentech and City of Hope On July 27, 2015, the Company and Sanofi-Aventis U.S. LLC filed a complaint in the United States District Court for the Central District of California (Western Division) seeking a declaratory judgment of invalidity, as well as non-infringement by the manufacture, use, sale, offer of sale, or importation of Praluent (alirocumab), of U.S. Patent No. 7,923,221 (the "'221 Patent") jointly owned by Genentech, Inc. ("Genentech") and City of Hope relating to the production of recombinant antibodies by host cells. On the same day, the Company and Sanofi-Aventis U.S. LLC initiated an inter partes review in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of certain claims of U.S. Patent No. 6,331,415 jointly owned by Genentech and City of Hope relating to the production of recombinant antibodies by host cells. On February 5, 2016, the USPTO instituted an inter partes review of the validity of most of the patent claims for which review had been requested. On September 17, 2015, Genentech and City of Hope answered the complaint previously filed by the Company and Sanofi in the District Court and counterclaimed, alleging that the Company and Sanofi infringe the '221 Patent and seeking, among other types of relief, damages and a permanent injunction. On November 2, 2015, the court set a tentative trial date beginning on September 27, 2016. At this time, the Company is not able to predict the outcome of, or an estimate of gain or range of possible loss, if any, related to these proceedings. Proceedings Relating to Shareholder Derivative Claims On December 30, 2015, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former non-employee members of the Company's board of directors, the Chairman of the board of directors, the Company's Chief Executive Officer, and the Company's Chief Scientific Officer as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and were unjustly enriched when they approved and/or received allegedly excessive compensation in 2013 and 2014. The complaint seeks damages in favor of the Company for the alleged breaches of fiduciary duties and unjust enrichment; changes to Regeneron's corporate governance and internal procedures; invalidation of the 2014 Incentive Plan with respect to the individual defendants' compensation and a shareholder vote regarding the individual defendants' equity compensation; equitable relief, including an equitable accounting with disgorgement; and award of the costs of the action, including attorneys' fees. On March 2, 2016, the defendants filed a motion to dismiss the shareholder derivative complaint. On or about December 15, 2015, the Company received a shareholder litigation demand upon the Company's board of directors made by a purported Regeneron shareholder. The demand asserts that the current and certain former non-employee members of the board of directors and the Chairman of the board of directors excessively compensated themselves in 2013 and 2014. The demand requests that the board of directors investigate and bring legal action against these directors for breach of fiduciary duty, unjust enrichment, and corporate waste, and implement internal controls and systems designed to prohibit and prevent similar actions in the future. The Company's board of directors, working with outside counsel, investigated the allegations in the demand and the shareholder derivative complaint, and has determined to defer its decision on the demand until the court rules on the pending motion to dismiss the shareholder derivative complaint, as discussed above. At this time, the Company is not able to estimate a range of possible loss, if any, relating to these matters. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards (Notes) | 3 Months Ended |
Mar. 31, 2016 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Description of New Accounting Pronouncements Not yet Adopted [Text Block] | Recently Issued Accounting Standards In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update 2016-09, Compensation - Stock Compensation . The amendments require an entity to recognize all excess tax benefits and tax deficiencies in connection with stock-based compensation as income tax expense or benefit in the income statement. The amendments also require recognition of excess tax benefits regardless of whether the benefit reduces taxes payable in the current period, and excess tax benefits will be classified as an operating activity in the statement of cash flows. The tax effects of exercised or vested awards will be treated as discrete items in the reporting period in which they occur. The amendments are effective for annual periods, and interims periods within those annual periods, beginning after December 15, 2016. Early adoption is permitted. The Company is evaluating the impact that this guidance will have on the Company's financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases . The new standard requires a lessee to recognize in its balance sheet (for both finance and operating leases) a liability to make lease payments ("lease liability") and a right-of-use asset representing its right to use the underlying asset for the lease term. The amendments are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted. The Company is evaluating the impact that this guidance will have on the Company's financial statements. In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities . The amendments require equity investments (except those accounted for under the equity method of accounting or those that result in consolidation of the investee) to be measured at fair value with changes in fair value recognized in net income. The amendments are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. Other than an amendment relating to presenting in comprehensive income the portion of the total change in the fair value of a liability resulting from a change in instrument-specific credit risk (if the entity has elected to measure the liability at fair value), early adoption is not permitted. The implementation of the amendments is expected to increase the volatility of an entity's net income; however, the Company is not currently able to estimate the impact of adopting these amendments, as the significance of the impact will depend on the Company's equity investment balance upon adoption. In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers , which will replace existing revenue recognition guidance. The new standard requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. To achieve that core principle, an entity must identify the contract(s) with a customer, identify the performance obligations in the contract, determine the transaction price, allocate the transaction price to the performance obligations in the contract, and recognize revenue when (or as) the entity satisfies the performance obligation. In July 2015, the FASB decided to delay the effective date of the new standard by one year; as a result, the new standard will be effective for annual and interim reporting periods beginning after December 15, 2017. Early adoption will be permitted, but no earlier than 2017 for calendar year-end entities. The standard allows for two transition methods - retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption. The Company has not yet determined its method of transition and is evaluating the impact that this guidance will have on the Company's financial statements. |
Net Product Sales (Policies)
Net Product Sales (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Revenues [Abstract] | |
Revenue Recognition, Revenue Reductions [Policy Text Block] | Revenue from product sales is recorded net of applicable provisions for rebates and chargebacks under governmental programs, distribution-related fees, and other sales-related deductions. |
Fair Value Measurements (Polici
Fair Value Measurements (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Transfer, Policy [Policy Text Block] | The Company's policy for recognition of transfers between levels of the fair value hierarchy is to recognize any transfer at the beginning of the fiscal quarter in which the determination to transfer was made. |
Legal Matters (Policies)
Legal Matters (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Costs, Policy [Policy Text Block] | Costs associated with the Company's involvement in legal proceedings are expensed as incurred. |
Net Product Sales (Tables)
Net Product Sales (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Revenues [Abstract] | |
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, 2016 and 2015 . Rebates & Chargebacks Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2015 $ 6,419 $ 48,313 $ 517 $ 55,249 Provision related to current period sales 18,885 35,788 2,910 57,583 Credits/payments (17,457 ) (50,353 ) (2,557 ) (70,367 ) Balance as of March 31, 2016 $ 7,847 $ 33,748 $ 870 $ 42,465 Balance as of December 31, 2014 $ 3,083 $ 21,166 $ 532 $ 24,781 Provision related to current period sales 11,353 24,781 1,383 37,517 Credits/payments (9,779 ) (13,036 ) (1,411 ) (24,226 ) Balance as of March 31, 2015 $ 4,657 $ 32,911 $ 504 $ 38,072 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Collaboration Agreement [Abstract] | |
Collaboration revenue with related party | The collaboration revenue the Company earned from Sanofi is detailed below: Three Months Ended March 31, Sanofi Collaboration Revenue 2016 2015 Antibody: Reimbursement of Regeneron research and development expenses $ 193,602 $ 168,820 Reimbursement of Regeneron commercialization-related expenses 73,274 8,458 Regeneron's share of losses in connection with commercialization of antibodies (99,422 ) (22,405 ) Other 2,965 2,561 Total Antibody 170,419 157,434 Immuno-oncology: Reimbursement of Regeneron research and development expenses 29,275 — Other 20,000 — Total Immuno-oncology 49,275 — ZALTRAP ® : Reimbursement of Regeneron research and development expenses — 686 Other — 15,236 Total ZALTRAP — 15,922 $ 219,694 $ 173,356 |
Collaboration revenue | The collaboration revenue the Company earned from Bayer is detailed below: Three Months Ended March 31, Bayer Collaboration Revenue 2016 2015 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 145,835 $ 89,426 Sales milestones — 15,000 Cost-sharing of Regeneron EYLEA development expenses 2,743 2,657 Other 26,492 12,912 Total EYLEA 175,070 119,995 PDGFR-beta antibody: Cost-sharing of rinucumab/aflibercept (REGN2176-3) development expenses 1,896 1,254 Other 2,626 2,597 Total PDGFR-beta 4,522 3,851 $ 179,592 $ 123,846 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
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 2016 2015 Net income - basic $ 165,736 $ 76,021 Effect of dilutive securities: Convertible senior notes - interest expense related to contractual coupon interest rate and amortization of discount and note issuance costs 56 — Net income - diluted $ 165,792 $ 76,021 (Shares in thousands) Weighted average shares - basic 104,290 102,227 Effect of dilutive securities: Stock options 8,147 9,313 Restricted stock 469 467 Convertible senior notes 44 — Warrants 1,278 2,512 Dilutive potential shares 9,938 12,292 Weighted average shares - diluted 114,228 114,519 Net income per share - basic $ 1.59 $ 0.74 Net income per share - diluted $ 1.45 $ 0.66 |
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 March 31, (Shares in thousands) 2016 2015 Stock options 7,539 3,673 Restricted stock 19 — Convertible senior notes — 1,929 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Securities | The following tables summarize the Company's investments in marketable securities: Amortized Unrealized Fair As of March 31, 2016 Cost Basis Gains Losses Value Corporate bonds $ 710,989 $ 1,920 $ (879 ) $ 712,030 U.S. government and government agency obligations 50,383 194 (2 ) 50,575 Municipal bonds 16,113 45 (3 ) 16,155 Equity securities 17,005 10,057 (5,647 ) 21,415 $ 794,490 $ 12,216 $ (6,531 ) $ 800,175 As of December 31, 2015 Corporate bonds $ 770,092 $ 156 $ (2,565 ) $ 767,683 U.S. government and government agency obligations 51,402 — (193 ) 51,209 Municipal bonds 17,930 5 (11 ) 17,924 Equity securities 17,005 14,461 — 31,466 $ 856,429 $ 14,622 $ (2,769 ) $ 868,282 |
Marketable Securities, Based on Contractual Maturity Dates | The fair values of debt security investments by contractual maturity consist of the following: March 31, 2016 December 31, 2015 Maturities within one year $ 244,965 $ 236,121 Maturities after one year through five years 533,795 600,695 $ 778,760 $ 836,816 |
Fair Value and Unrealized Losses of Marketable Securities | The following table shows the fair value of the Company's marketable 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, 2016 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 132,085 $ (190 ) $ 135,211 $ (689 ) $ 267,296 $ (879 ) U.S. government and government agency obligations 7,822 (3 ) — — 7,822 (3 ) Municipal bonds 2,571 (2 ) — — 2,571 (2 ) Equity securities 9,353 (5,647 ) — — 9,353 (5,647 ) $ 151,831 $ (5,842 ) $ 135,211 $ (689 ) $ 287,042 $ (6,531 ) As of December 31, 2015 Corporate bonds $ 668,199 $ (2,473 ) $ 23,749 $ (92 ) $ 691,948 $ (2,565 ) U.S. government and government agency obligations 51,215 (193 ) — — 51,215 (193 ) Municipal bonds 11,917 (11 ) — — 11,917 (11 ) $ 731,331 $ (2,677 ) $ 23,749 $ (92 ) $ 755,080 $ (2,769 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
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, 2016 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale marketable securities: Corporate bonds $ 712,030 — $ 712,030 U.S. government and government agency obligations 50,575 — 50,575 Municipal bonds 16,155 — 16,155 Equity securities 21,415 $ 21,415 — $ 800,175 $ 21,415 $ 778,760 As of December 31, 2015 Available-for-sale marketable securities: Corporate bonds $ 767,683 — $ 767,683 U.S. government and government agency obligations 51,209 — 51,209 Municipal bonds 17,924 — 17,924 Equity securities 31,466 $ 31,466 — $ 868,282 $ 31,466 $ 836,816 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories consist of the following: March 31, December 31, 2016 2015 Raw materials $ 85,180 $ 59,151 Work-in-process 157,921 132,068 Finished goods 14,231 11,197 Deferred costs 45,962 36,162 $ 303,294 $ 238,578 |
Accounts Payable and Accrued 28
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued expenses consist of the following: March 31, December 31, 2016 2015 Accounts payable $ 120,595 $ 140,962 Accrued payroll and related costs 92,668 133,223 Accrued clinical trial expense 82,533 88,297 Accrued sales-related charges, deductions, and royalties 190,763 195,986 Income taxes payable 144,078 — Other accrued expenses and liabilities 102,639 85,644 $ 733,276 $ 644,112 |
Net Product Sales (Details)
Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue Disclosure [Line Items] | ||||
Net product sales | $ 784,182 | $ 544,573 | ||
Activity of Sales Related Deductions [Roll Forward] | ||||
Balance | 42,465 | 38,072 | $ 55,249 | $ 24,781 |
Provision related to current period sales | 57,583 | 37,517 | ||
Credits/payments | (70,367) | (24,226) | ||
Rebates and Chargebacks | ||||
Activity of Sales Related Deductions [Roll Forward] | ||||
Balance | 7,847 | 4,657 | 6,419 | 3,083 |
Provision related to current period sales | 18,885 | 11,353 | ||
Credits/payments | (17,457) | (9,779) | ||
Distribution Related Fees | ||||
Activity of Sales Related Deductions [Roll Forward] | ||||
Balance | 33,748 | 32,911 | 48,313 | 21,166 |
Provision related to current period sales | 35,788 | 24,781 | ||
Credits/payments | (50,353) | (13,036) | ||
Other Sales Related Deductions | ||||
Activity of Sales Related Deductions [Roll Forward] | ||||
Balance | 870 | 504 | $ 517 | $ 532 |
Provision related to current period sales | 2,910 | 1,383 | ||
Credits/payments | $ (2,557) | $ (1,411) | ||
Customer concentration risk | Gross Sales Revenue | ||||
Risks and Uncertainties [Abstract] | ||||
Concentration risk, percentage | 60.00% | 69.00% | ||
EYLEA | ||||
Revenue Disclosure [Line Items] | ||||
Net product sales | $ 780,900 | $ 541,100 | ||
ARCALYST | ||||
Revenue Disclosure [Line Items] | ||||
Net product sales | $ 3,300 | $ 3,500 |
Collaboration Agreements (Sanof
Collaboration Agreements (Sanofi) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2016 | Sep. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | |
Collaboration Agreement [Line Items] | |||||
Period for Achieving Sales Target for Milestone Payment, Rolling Basis | 12 months | ||||
Revenue from Related Parties | $ 219,694 | $ 173,356 | |||
Research and development | 470,112 | 343,113 | |||
ZALTRAP Agreement | |||||
Collaboration Agreement [Line Items] | |||||
Deferred Revenue, Revenue Recognized | 14,900 | ||||
Other Income | 5,300 | 19,800 | |||
Reimbursement of Regeneron research and development expenses | 0 | 686 | |||
Contracts Revenue | 0 | 15,236 | |||
Revenue from Related Parties | 0 | 15,922 | |||
Antibody Collaboration | |||||
Collaboration Agreement [Line Items] | |||||
Net profit (loss) from commercialization of products under collaboration agreement | (99,422) | (22,405) | |||
Recognition of Deferred Revenue | 2,965 | 2,561 | |||
Reimbursement of Regeneron research and development expenses | 193,602 | 168,820 | |||
Contracts Revenue | 73,274 | 8,458 | |||
Revenue from Related Parties | $ 170,419 | 157,434 | |||
Percentage of Trial Costs borne by collaborating party | 80.00% | ||||
Percentage of Trial Costs borne by entity | 20.00% | ||||
IO Discovery Agreement | |||||
Collaboration Agreement [Line Items] | |||||
Annual Funding Maximum of Research Activities Per Agreement | $ 150,000 | ||||
IO Agreement | |||||
Collaboration Agreement [Line Items] | |||||
Deferred Revenue, Additions | $ 640,000 | ||||
Immuno-oncology Agreement | |||||
Collaboration Agreement [Line Items] | |||||
Recognition of Deferred Revenue | $ 20,000 | 0 | |||
Reimbursement of Regeneron research and development expenses | 29,275 | 0 | |||
Revenue from Related Parties | $ 49,275 | 0 | |||
PDGF | |||||
Collaboration Agreement [Line Items] | |||||
Percentage of repayment of development balance out of profits | 50.00% | ||||
Praluent, sarilumab, and dupilumab | Antibody Collaboration | |||||
Collaboration Agreement [Line Items] | |||||
Research and development | $ 21,700 | $ 25,000 | |||
Scenario, Forecast [Member] | Antibody Collaboration | |||||
Collaboration Agreement [Line Items] | |||||
Annual funding maximum of research activities per amended agreement | $ 130,000 | $ 130,000 |
Collaboration Agreements (Bayer
Collaboration Agreements (Bayer) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Collaboration Agreement [Line Items] | ||
Other Collaboration Revenue | $ 179,592 | $ 123,846 |
EYLEA | ||
Collaboration Agreement [Line Items] | ||
Net profit (loss) from commercialization of products under collaboration agreement | 145,835 | 89,426 |
Revenue Recognition, Milestone Method, Revenue Recognized | 0 | 15,000 |
Reimbursement of Regeneron research and development expenses | 2,743 | 2,657 |
Contracts Revenue | 26,492 | 12,912 |
Other Collaboration Revenue | 175,070 | 119,995 |
PDGFR-beta | ||
Collaboration Agreement [Line Items] | ||
Reimbursement of Regeneron research and development expenses | 1,896 | 1,254 |
Contracts Revenue | 2,626 | 2,597 |
Other Collaboration Revenue | $ 4,522 | 3,851 |
sales achievement - $200 million | ||
Collaboration Agreement [Line Items] | ||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 |
Collaboration Agreements (EYLEA
Collaboration Agreements (EYLEA) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Collaboration Agreement [Line Items] | ||
Period for Achieving Sales Target for Milestone Payment, Rolling Basis | 12 months | |
sales achievement - $200 million | ||
Collaboration Agreement [Line Items] | ||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 | |
Collaboration Agreement with Bayer | ||
Collaboration Agreement [Line Items] | ||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 0 | 15,000 |
Levels of twelve month sales at which sales milestone payments were received - 200 million | $ 200,000 | |
Minimum [Member] | Collaboration Agreement with Bayer | ||
Collaboration Agreement [Line Items] | ||
Revenue based on percentage of annual sales in Japan | 33.50% | |
Maximum [Member] | Collaboration Agreement with Bayer | ||
Collaboration Agreement [Line Items] | ||
Revenue based on percentage of annual sales in Japan | 40.00% |
Collaboration Agreements (PDGFR
Collaboration Agreements (PDGFR-beta Antibody) (Details) - PDGF | 3 Months Ended |
Mar. 31, 2016 | |
Collaboration Agreement [Line Items] | |
Percentage of global development cost to be paid by the collaboration partner under the collaboration | 25.00% |
Percentage of development cost for the territory outside the United States to be paid for under the collaboration | 50.00% |
Collaboration Agreements (Ang2
Collaboration Agreements (Ang2 Antibody) (Details) - Ang2 Antibody [Member] - USD ($) $ in Millions | Mar. 31, 2016 | Mar. 31, 2016 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Deferred Revenue, Additions | $ 50 | |
Percentage of global development cost to be paid by the collaboration partner under the collaboration | 25.00% | |
Percentage of development cost for the territory outside the United States to be paid for under the collaboration | 50.00% | |
Future development milestone payment the Company is eligible to receive | $ 80 |
Collaboration Agreements (Mitsu
Collaboration Agreements (Mitsubishi Tanabe Pharma) (Details) - Mitsubishi Tanabe Pharma Corporation (MTPC) - Collaborative Arrangement - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Sep. 30, 2015 | Mar. 31, 2016 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred Revenue, Additions | $ 10 | |
First Payment [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred Revenue, Additions | $ 45 | |
Second Payment [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Deferred Revenue, Additions | $ 15 |
Collaboration Agreements (Intel
Collaboration Agreements (Intella Therapeutics) (Details) - Subsequent Event [Member] $ in Millions | 1 Months Ended |
Apr. 30, 2016USD ($)target | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Collaboration Agreement, Share Purchase Obligation | $ 50 |
Intella Therapeutics [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Up-front payment made in connection with research and development arrangement | $ 75 |
Collaboration Agreement, Number of Targets Company May Have Rights To | target | 10 |
Number of Payments the Company made | 1 |
Collaboration Agreement, Extension Period | 2 years |
Net Income Per Share (Details)
Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Earnings Per Share [Abstract] | ||
Net income | $ 165,736 | $ 76,021 |
Interest on Convertible Debt, Net of Tax | 56 | 0 |
Net Income (Loss) Available to Common Stockholders, Diluted | $ 165,792 | $ 76,021 |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Weighted average shares outstanding - basic | 104,290 | 102,227 |
Effect of dilutive securities (in shares): | ||
Stock options | 8,147 | 9,313 |
Restricted stock | 469 | 467 |
Incremental Common Shares Attributable to Dilutive Effect of Conversion of Debt Securities | 44 | 0 |
Warrants | 1,278 | 2,512 |
Dilutive potential shares | 9,938 | 12,292 |
Weighted average shares - diluted (in shares) | 114,228 | 114,519 |
Earnings Per Share, Basic and Diluted [Abstract] | ||
Net income per share - basic | $ 1.59 | $ 0.74 |
Net income per share - diluted (in dollars per share) | $ 1.45 | $ 0.66 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of shares | 7,539 | 3,673 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of shares | 19 | 0 |
Convertible senior notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of shares | 0 | 1,929 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Dec. 31, 2015 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Realized Gain (Loss) on Marketable Securities and Cost Method Investments, Excluding Other than Temporary Impairments, and Other Investments | $ 0 | |
Amortized Cost Basis | 794,490,000 | $ 856,429,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 12,216,000 | 14,622,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (6,531,000) | (2,769,000) |
Available-for-sale Securities | 800,175,000 | 868,282,000 |
Available-for-sale Securities, Debt Maturities, Fair Value [Abstract] | ||
Maturities within one year | 244,965,000 | 236,121,000 |
Maturities after one year through five years | 533,795,000 | 600,695,000 |
Total | 778,760,000 | 836,816,000 |
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 151,831,000 | 731,331,000 |
Fair Value - 12 Months or Greater | 135,211,000 | 23,749,000 |
Fair Value - Total | 287,042,000 | 755,080,000 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (5,842,000) | (2,677,000) |
Unrealized Loss - 12 Months or Greater | (689,000) | (92,000) |
Unrealized Loss - Total | (6,531,000) | (2,769,000) |
Realized Gain (Loss) on Marketable Securities, Cost Method Investments, and Other Investments | 0 | |
Corporate Bond Securities [Member] | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 132,085,000 | 668,199,000 |
Fair Value - 12 Months or Greater | 135,211,000 | 23,749,000 |
Fair Value - Total | 267,296,000 | 691,948,000 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (190,000) | (2,473,000) |
Unrealized Loss - 12 Months or Greater | (689,000) | (92,000) |
Unrealized Loss - Total | (879,000) | (2,565,000) |
U.S. government and government agency obligations | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 7,822,000 | 51,215,000 |
Fair Value - 12 Months or Greater | 0 | 0 |
Fair Value - Total | 7,822,000 | 51,215,000 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (3,000) | (193,000) |
Unrealized Loss - 12 Months or Greater | 0 | 0 |
Unrealized Loss - Total | (3,000) | (193,000) |
Municipal bonds | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 2,571,000 | 11,917,000 |
Fair Value - 12 Months or Greater | 0 | 0 |
Fair Value - Total | 2,571,000 | 11,917,000 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (2,000) | (11,000) |
Unrealized Loss - 12 Months or Greater | 0 | 0 |
Unrealized Loss - Total | (2,000) | (11,000) |
Equity Securities | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 9,353,000 | |
Fair Value - 12 Months or Greater | 0 | |
Fair Value - Total | 9,353,000 | |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (5,647,000) | |
Unrealized Loss - 12 Months or Greater | 0 | |
Unrealized Loss - Total | (5,647,000) | |
Unrestricted [Member] | Corporate Bond Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 710,989,000 | 770,092,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 1,920,000 | 156,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (879,000) | (2,565,000) |
Available-for-sale Securities | 712,030,000 | 767,683,000 |
Unrestricted [Member] | U.S. government and government agency obligations | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 50,383,000 | 51,402,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 194,000 | 0 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (2,000) | (193,000) |
Available-for-sale Securities | 50,575,000 | 51,209,000 |
Unrestricted [Member] | Municipal bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 16,113,000 | 17,930,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 45,000 | 5,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (3,000) | (11,000) |
Available-for-sale Securities | 16,155,000 | 17,924,000 |
Unrestricted [Member] | Equity Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 17,005,000 | 17,005,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Gain, before Tax | 10,057,000 | 14,461,000 |
Available-for-sale Securities, Accumulated Gross Unrealized Loss, before Tax | (5,647,000) | 0 |
Available-for-sale Securities | $ 21,415,000 | $ 31,466,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 | $ 0 | |
Available-for-sale marketable securities: | |||
Total fair value of available-for-sale marketable securities | 800,175,000 | $ 868,282,000 | |
Convertible Debt [Abstract] | |||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 91,400,000 | ||
Convertible senior notes | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Convertible Debt | $ 10,600,000 | $ 11,200,000 | |
Convertible Debt [Abstract] | |||
Interest rate, stated percentage | 1.875% | 1.875% | |
Fair value of the outstanding notes | $ 49,600,000 | $ 72,800,000 | |
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 | |
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Marketable Securities, Unrealized Gain (Loss) | 0 | $ 0 | |
Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | |||
Available-for-sale marketable securities: | |||
Total fair value of available-for-sale marketable securities | 21,415,000 | 31,466,000 | |
Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | |||
Available-for-sale marketable securities: | |||
Total fair value of available-for-sale marketable securities | 778,760,000 | 836,816,000 | |
Unrestricted [Member] | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | |||
Available-for-sale marketable securities: | |||
Equity securities | 21,415,000 | 31,466,000 | |
Unrestricted [Member] | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | |||
Available-for-sale marketable securities: | |||
U.S. government and government agency obligations | 50,575,000 | 51,209,000 | |
Corporate bonds | 712,030,000 | 767,683,000 | |
Municipal bonds | 16,155,000 | 17,924,000 | |
Estimate of Fair Value Measurement [Member] | Measured on a recurring basis | |||
Available-for-sale marketable securities: | |||
Total fair value of available-for-sale marketable securities | 800,175,000 | 868,282,000 | |
Estimate of Fair Value Measurement [Member] | Unrestricted [Member] | Measured on a recurring basis | |||
Available-for-sale marketable securities: | |||
U.S. government and government agency obligations | 50,575,000 | 51,209,000 | |
Corporate bonds | 712,030,000 | 767,683,000 | |
Municipal bonds | 16,155,000 | 17,924,000 | |
Equity securities | $ 21,415,000 | $ 31,466,000 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |||
Inventory Write-down | $ 4,300 | $ 1,700 | |
Raw materials | 85,180 | $ 59,151 | |
Work in process | 157,921 | 132,068 | |
Finished goods | 14,231 | 11,197 | |
Deferred costs | 45,962 | 36,162 | |
Total Inventories | $ 303,294 | $ 238,578 |
Accounts Payable and Accrued 41
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accounts payable | $ 120,595 | $ 140,962 |
Accrued payroll and related costs | 92,668 | 133,223 |
Accrued clinical trial expense | 82,533 | 88,297 |
Accrued sales-related charges, deductions and royalties | 190,763 | 195,986 |
Taxes Payable, Current | 144,078 | 0 |
Other accrued expenses and liabilities | 102,639 | 85,644 |
Accounts payable and accrued expenses | $ 733,276 | $ 644,112 |
Debt (Details)
Debt (Details) | 1 Months Ended | 3 Months Ended | ||||
Apr. 30, 2016USD ($) | Feb. 28, 2015USD ($) | Nov. 30, 2014$ / shares | Mar. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2015USD ($)shares | Dec. 31, 2015USD ($)shares | |
Debt Conversion | $ 1,700,000 | $ 16,700,000 | ||||
Repayments of convertible senior notes | $ (1,739,000) | $ (16,686,000) | ||||
Stock Issued During Period, Shares, New Issues | shares | 16,774 | 146,253 | ||||
Treasury Stock, Shares | shares | 3,659,588 | 3,642,820 | ||||
Treasury Stock, Value | $ 307,478,000 | $ 306,069,000 | ||||
Limit price per share for warrant holders to close out hedge position | $ / shares | $ 397.75 | |||||
Payments in connection with deduction of outstanding warrants | $ (124,000,000) | (242,117,000) | $ (124,531,000) | |||
Credit Facility [Domain] | ||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 750,000,000 | |||||
Line of Credit Facility, Expiration Period | 5 years | |||||
Line of Credit Facility, Fair Value of Amount Outstanding | $ 0 | |||||
Convertible senior notes | ||||||
Treasury Stock, Shares | shares | 16,768 | 146,248 | ||||
Treasury Stock, Value | $ 1,400,000 | $ 12,300,000 | ||||
Convertible Debt | 10,600,000 | $ 11,200,000 | ||||
Additional Paid-in Capital [Member] | ||||||
Adjustments to Additional Paid in Capital, Equity Component of Convertible Debt, Subsequent Adjustments | $ 6,700,000 | 62,600,000 | ||||
Adjustments to Additional Paid in Capital, Warrant Issued | $ 23,300,000 | |||||
Scenario, Forecast [Member] | ||||||
Debt Conversion Not Yet Settled | $ 10,400,000 | |||||
Warrant Transactions [Member] | ||||||
Reduction of number of warrants | shares | 416,480 | |||||
Warrant outstanding balance | shares | 1,345,027 | |||||
November 2015 Warrant Agreement | ||||||
Limit price per share for warrant holders to close out hedge position | $ / shares | $ 535 | |||||
Payments in connection with deduction of outstanding warrants | $ 135,200,000 | |||||
Reduction of number of warrants | shares | 360,406 | |||||
February 2016 Warrant Agreement | ||||||
Maximum reduction of warrants held by warrant holder | shares | 975,142 | |||||
Limit price per share for warrant holders to close out hedge position | $ / shares | $ 375 | |||||
Payments in connection with deduction of outstanding warrants | $ 106,900,000 | |||||
Reduction of number of warrants | shares | 403,665 | |||||
Subsequent Event [Member] | Convertible senior notes | ||||||
Trading days to calculate settlement | 40 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating Loss Carryforwards [Line Items] | ||
Total income tax expense (benefit) | $ 164,415,000 | $ 200,502,000 |
Effective income tax rate | 49.80% | 72.50% |
Available-for-sale Securities, Income Tax Expense on Change in Unrealized Holding Gain (Loss) | $ 2,000,000 | $ 2,500,000 |
Statement of Cash Flows (Detail
Statement of Cash Flows (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Accrued capital expenditures | $ 44,600,000 | $ 84,100,000 | $ 50,700,000 | $ 56,200,000 |
Accounts Payable, Other | 7,500,000 | |||
Facility lease obligation recognized during the period | 0 | 10,800,000 | ||
Warrant Transactions [Member] | ||||
Accounts Payable, Other | 0 | 0 | 0 | 59,800,000 |
Other Liabilities, Fair Value Disclosure | $ 0 | $ 0 | $ 0 | $ 87,500,000 |