Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Jul. 17, 2015 | |
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 | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 101,736,534 | |
Class A Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 1,951,868 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 390,554 | $ 648,719 |
Marketable securities | 213,694 | 251,761 |
Accounts receivable - trade, net | 1,071,665 | 739,379 |
Accounts Receivable from Sanofi | 197,693 | 111,510 |
Accounts receivable from Bayer HealthCare | 125,767 | 125,483 |
Inventories | 171,266 | 128,861 |
Deferred tax assets | 69,603 | 46,179 |
Prepaid expenses and other current assets | 43,099 | 79,046 |
Total current assets | 2,283,341 | 2,130,938 |
Marketable securities | 589,595 | 460,154 |
Property, plant, and equipment, at cost, net of accumulated depreciation and amortization | 1,326,112 | 974,309 |
Deferred tax assets | 323,784 | 269,237 |
Other assets | 4,138 | 3,034 |
Total assets | 4,526,970 | 3,837,672 |
Current liabilities: | ||
Accounts payable and accrued expenses | 529,505 | 483,489 |
Deferred revenue from Sanofi, current portion | 18,026 | 15,927 |
Deferred revenue - other, current portion | 51,720 | 58,098 |
Other Liabilities, Current | 2,291 | 97,146 |
Total current liabilities | 601,542 | 654,660 |
Deferred revenue from Sanofi | 46,095 | 62,819 |
Deferred Revenue - other | 76,748 | 72,430 |
Facility lease obligations | 357,687 | 310,938 |
Convertible senior notes | 30,360 | 146,773 |
Other long-term liabilities | 76,080 | 39,801 |
Total liabilities | 1,188,512 | 1,287,421 |
Stockholders' equity: | ||
Preferred Stock | 0 | 0 |
Additional paid-in capital | 3,118,969 | 2,450,782 |
Retained earnings | 487,308 | 216,644 |
Accumulated other comprehensive income | 19,153 | 52,251 |
Treasury stock | (287,079) | (169,530) |
Total stockholders' equity | 3,338,458 | 2,550,251 |
Total liabilities and stockholders' equity | 4,526,970 | 3,837,672 |
Class A Stock | ||
Stockholders' equity: | ||
Common stock | 2 | 2 |
Common Stock | ||
Stockholders' equity: | ||
Common stock | $ 105 | $ 102 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
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) | 3,416,788 | 2,017,732 |
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) | 1,951,868 | 1,973,368 |
Common Stock, shares outstanding (in shares) | 1,951,868 | 1,973,368 |
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 | |
Common Stock, shares issued (in shares) | 105,106,034 | 102,475,154 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - Scenario, Unspecified [Domain] - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenues: | ||||
Net product sales | $ 657,819 | $ 418,022 | $ 1,202,392 | $ 780,400 |
Sanofi collaboration revenue | 195,110 | 142,595 | 368,466 | 273,103 |
Bayer HealthCare collaboration revenue | 134,237 | 97,295 | 258,083 | 222,607 |
Technology licensing and other revenue | 11,451 | 7,788 | 39,288 | 15,330 |
Total revenues | 998,617 | 665,700 | 1,868,229 | 1,291,440 |
Expenses: | ||||
Research and development | 390,330 | 294,501 | 733,443 | 581,880 |
Selling, general, and administrative | 174,588 | 96,730 | 333,579 | 199,957 |
Cost of goods sold | 60,855 | 29,945 | 103,425 | 57,418 |
Cost of collaboration and contract manufacturing | 27,985 | 16,434 | 69,370 | 32,533 |
Total expenses | 653,758 | 437,610 | 1,239,817 | 871,788 |
Income from operations | 344,859 | 228,090 | 628,412 | 419,652 |
Other income (expense): | ||||
Investment and other income | 1,849 | 1,677 | 1,930 | 2,614 |
Interest expense | (2,748) | (10,177) | (8,917) | (21,790) |
Loss on extinguishment of debt | (15,964) | (10,787) | (16,906) | (10,787) |
Total other income (expense) | (16,863) | (19,287) | (23,893) | (29,963) |
Income before income taxes | 327,996 | 208,803 | 604,519 | 389,689 |
Income tax expense | (133,353) | (112,452) | (333,855) | (225,033) |
Net income | $ 194,643 | $ 96,351 | $ 270,664 | $ 164,656 |
Net income per share - basic | $ 1.89 | $ 0.96 | $ 2.64 | $ 1.65 |
Net income per share - diluted | $ 1.69 | $ 0.85 | $ 2.35 | $ 1.46 |
Weighted average shares outstanding - basic | 102,886 | 100,391 | 102,558 | 100,085 |
Weighted average shares outstanding - diluted | 115,259 | 113,032 | 114,962 | 113,121 |
Statements of Comprehensive Income | ||||
Net income | $ 194,643 | $ 96,351 | $ 270,664 | $ 164,656 |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on marketable securities, net of tax | (28,751) | 2,798 | (33,098) | 5,451 |
Comprehensive income | $ 165,892 | $ 99,149 | $ 237,566 | $ 170,107 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - Scenario, Unspecified [Domain] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Cash flows from operating activities: | ||
Net income | $ 270,664 | $ 164,656 |
Adjustments to reconcile net income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 31,325 | 24,546 |
Non-cash compensation expense | 198,016 | 140,613 |
Non-cash interest expense | 2,745 | 10,871 |
Losses on Extinguishment of Debt | 16,906 | 10,787 |
Other non-cash charges and expenses, net | 17,627 | 6,598 |
Deferred Taxes | (59,069) | (19,092) |
Changes in assets and liabilites | ||
Increase in Sanofi, Bayer HealthCare, and trade accounts receivable | (418,753) | 84,776 |
Increase in Inventories | (49,852) | (37,295) |
Decrease (increase) in prepaid expenses and other assets | 33,842 | (29,446) |
(Decrease) increase in deferred revenue | (16,685) | 16,105 |
Increase (decrease) in accounts payable, accrued expenses and other liabilities | 129,338 | 16,820 |
Total adjustments | (114,560) | 225,283 |
Net cash (used in) provided by operating activities | 156,104 | 389,939 |
Cash flows from investing activities: | ||
Purchases of marketable securities | (340,844) | (374,509) |
Sales or maturities of marketable securities | 193,769 | 155,850 |
Capital expenditures | (354,055) | (135,695) |
Net cash used in investing activities | (501,130) | (354,354) |
Cash flows from financing activities: | ||
Proceeds (payments) in connection with facility and capital lease obligations | 26,780 | (534) |
Repayments of convertible senior notes | (144,001) | (61,125) |
Payments in connection with deduction of outstanding warrants | (124,531) | (143,041) |
Proceeds from issuance of Common Stock | 115,825 | 63,057 |
Payments in connection with Common Stock tendered for employee tax obligations | (35,930) | (64,990) |
Excess tax benefit from stock-based compensation | 248,718 | 235,575 |
Net cash provided by financing activities | 86,861 | 28,942 |
Net decrease in cash and cash equivalents | (258,165) | 64,527 |
Cash and cash equivalents at beginning of period | 648,719 | 535,608 |
Cash and cash equivalents at end of period | $ 390,554 | $ 600,135 |
Interim Financial Statements (N
Interim Financial Statements (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Interim Financial Statements | Interim Financial Statements The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. ("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, 2014 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, 2014. The previously issued (i) Consolidated Balance Sheet as of December 31, 2014 contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, and (ii) Condensed Consolidated Statement of Operations and Comprehensive Income for the three and six months ended June 30, 2014 and Condensed Consolidated Statement of Cash Flows for the six months ended June 30, 2014 contained in the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2014, have each been revised in this Quarterly Report on Form 10-Q to reflect a correction in the Company's accounting for certain stock option awards. See Note 4. In addition, the previously issued Consolidated Balance Sheet as of December 31, 2014 has been revised in this Quarterly Report on Form 10-Q to reflect a correction related to the accounting for costs incurred in connection with commercial bulk drug product manufactured by the Company, but not billed, under the Company's collaboration agreements with Sanofi and Bayer HealthCare, and the related tax impacts. The correcting adjustments results in a reduction to both accounts receivable and deferred revenue by $41.0 million , and reduce both income tax assets, net and additional paid-in capital by $14.2 million . The previously issued Condensed Consolidated Statement of Cash Flows for the six months ended June 30, 2014 was also revised in this Quarterly Report on Form 10-Q to reflect an $8.6 million increase in cash flows from operating activities and a corresponding reduction in cash flows from financing activities related to the tax impact of these adjustments. These adjustments had no impact on the Company's previously issued Consolidated Statements of Operations and Comprehensive Income in any reporting period. The Company determined that the error is not material to any previously-issued financial statements. 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) | 6 Months Ended |
Jun. 30, 2015 | |
Revenues [Abstract] | |
Product Sales and Concentration Risk [Text Block] | Product Sales EYLEA ® net product sales in the United States totaled $654.6 million and $414.8 million for the three months ended June 30, 2015 and 2014, respectively, and $1,195.7 million and $773.8 million for the six months ended June 30, 2015 and 2014, respectively. In addition, ARCALYST ® net product sales totaled $3.2 million for each of the three-month periods ended June 30, 2015 and 2014, respectively, and $6.7 million and $6.6 million for the six months ended June 30, 2015 and 2014, respectively. The Company recorded 69% and 73% for the three months ended June 30, 2015 and 2014, respectively, and 69% and 76% for the six months ended June 30, 2015 and 2014, 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 six months ended June 30, 2015 and 2014. Rebates & Chargebacks Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2014 $ 3,083 $ 21,166 $ 532 $ 24,781 Provision related to current period sales 25,481 54,747 3,454 83,682 Credits/payments (23,090 ) (36,433 ) (3,482 ) (63,005 ) Balance as of June 30, 2015 $ 5,474 $ 39,480 $ 504 $ 45,458 Balance as of December 31, 2013 $ 4,400 $ 19,663 $ 538 $ 24,601 Provision related to current period sales 14,817 36,206 818 51,841 Credits/payments (15,077 ) (35,449 ) (834 ) (51,360 ) Balance as of June 30, 2014 $ 4,140 $ 20,420 $ 522 $ 25,082 |
Collaboration Agreements (Notes
Collaboration Agreements (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Collaboration Agreement [Abstract] | |
Collaboration Agreements | Collaboration Agreements a. Sanofi Sanofi collaboration revenue, as detailed below, consisted primarily of reimbursement for research and development expenses that the Company incurred, partly offset by sharing of pre-launch commercialization expenses, in connection with the companies' Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and License and Collaboration Agreement (each as amended), collectively referred to as the "Antibody Collaboration". Three Months Ended June 30, Sanofi Collaboration Revenue 2015 2014 Antibody: Reimbursement of Regeneron research and development expenses $ 211,516 $ 137,893 Reimbursement of Regeneron commercialization-related expenses 27,347 4,307 Regeneron's share of losses in connection with commercialization of antibodies (46,313 ) (4,295 ) Other 2,560 2,560 Total Antibody 195,110 140,465 ZALTRAP: Regeneron's share of losses in connection with commercialization of ZALTRAP — (692 ) Reimbursement of Regeneron research and development expenses — 1,338 Other — 1,484 Total ZALTRAP — 2,130 $ 195,110 $ 142,595 Six Months Ended June 30, Sanofi Collaboration Revenue 2015 2014 Antibody: Reimbursement of Regeneron research and development expenses $ 380,336 $ 264,715 Reimbursement of Regeneron commercialization-related expenses 35,805 5,375 Regeneron's share of losses in connection with commercialization of antibodies (68,718 ) (4,295 ) Other 5,121 5,121 Total Antibody 352,544 270,916 ZALTRAP: Regeneron's share of losses in connection with commercialization of ZALTRAP — (3,904 ) Reimbursement of Regeneron research and development expenses 686 2,430 Other 15,236 3,661 Total ZALTRAP 15,922 2,187 $ 368,466 $ 273,103 Antibodies Under the Company's November 2007 Antibody Collaboration with Sanofi, as amended, agreed upon worldwide research and development expenses incurred by both companies during the term of the agreement 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 June 30, 2015 and 2014, the Company recognized as additional research and development expense $22.5 million and $29.1 million , respectively, and during the six months ended June 30, 2015 and 2014, the Company recognized as additional research and development expense $47.5 million and $52.9 million , respectively, of antibody development expenses that the Company was obligated to reimburse to Sanofi related to Praluent ® and sarilumab. Effective in the second and fourth quarters of 2014, the Company and Sanofi began sharing pre-launch commercialization expenses related to Praluent and sarilumab, respectively, in accordance with the companies’ License and Collaboration Agreement. In July 2015, the U.S. Food and Drug Administration ("FDA") approved Praluent for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein ("LDL") cholesterol. In May 2013, the Company acquired from Sanofi full exclusive rights to antibodies targeting the platelet derived growth factor (PDGF) family of receptors and ligands in ophthalmology. With respect to PDGF antibodies, the Company made two $5.0 million development milestone payments to Sanofi in the first quarter of 2014 and a $10.0 million development milestone payment to Sanofi in the second quarter of 2015, each of which was recorded as research and development expense. The Company is also obligated to pay up to $20.0 million in additional potential development milestones as well as royalties on any future sales of PDGF antibodies. In July 2015, in connection with the Company’s new immuno-oncology collaboration with Sanofi, as described below, the Company’s Antibody Discovery Agreement and License and Collaboration Agreement with Sanofi were each amended. In connection with these amendments, Sanofi's funding of the Company’s antibody discovery activities under the existing Antibody Collaboration will be reduced from $160.0 million to $145.0 million in 2015, and from $160.0 million to $130.0 million in both 2016 and 2017, or an aggregate reduction of $75.0 million over this three -year period. In addition, the Company's discovery activities to identify and validate potential drug discovery targets in the field of immuno-oncology and develop fully human monoclonal antibodies against these targets will now be funded by Sanofi under the terms of the companies’ new immuno-oncology collaboration. ZALTRAP ® In September 2003, the Company entered into a collaboration agreement ("ZALTRAP Collaboration Agreement") with Aventis Pharmaceuticals Inc. (predecessor to Sanofi U.S.) to jointly develop and commercialize ZALTRAP. Under the terms of the ZALTRAP Collaboration Agreement, as amended, Regeneron and Sanofi shared co-promotion rights and profits and losses on sales of ZALTRAP outside of Japan, and the Company was entitled to receive a percentage of sales of ZALTRAP in Japan. Sanofi commenced sales of ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, in combination with 5-fluorouracil, leucovorin, irinotecan ("FOLFIRI"), for patients with metastatic colorectal cancer ("mCRC") that is resistant to or has progressed following an oxaliplatin-containing regimen, in the United States in the third quarter of 2012 and in certain European and other countries in the first quarter of 2013. In February 2015, the Company and Sanofi entered into an amended and restated ZALTRAP agreement ("Amended ZALTRAP Agreement"), with an effective date of July 1, 2014. 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, which percentage shall be from 15% to 30% , depending on the aggregate net sales of ZALTRAP in such calendar year. The Company will also be paid for all quantities of ZALTRAP manufactured by it, pursuant to a supply agreement, through the earlier of 2021 or the date Sanofi receives regulatory approval to manufacture ZALTRAP at one of its facilities, or a facility of a third party. In addition, Regeneron no longer has a contingent contractual obligation to reimburse Sanofi for 50% of the development expenses that Sanofi previously funded for the development of ZALTRAP under the ZALTRAP Collaboration Agreement. Unless terminated earlier in accordance with its provisions, the Amended ZALTRAP Agreement will continue to be in effect until such time as neither Sanofi nor its affiliates or sublicensees is developing or commercializing ZALTRAP. 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 three and six months ended June 30, 2015, the Company recorded $3.2 million and $23.0 million , respectively, in technology licensing and other revenue, primarily related to (i) revenues earned from Sanofi based on a percentage of net sales of ZALTRAP and (ii) revenues earned from Sanofi for manufacturing ZALTRAP commercial supplies. Immuno-Oncology In July 2015, the Company and Sanofi entered into a global strategic 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"). In connection with the IO Discovery Agreement, Sanofi will make a $265.0 million non-refundable upfront payment to the Company. Pursuant to the IO Discovery Agreement, the Company will spend up to $1,090.0 million to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept. Sanofi will reimburse the Company for up to $825.0 million ("IO Discovery Funding") of these costs, subject to certain annual limits, which consists of (i) $750.0 million in new funding and (ii) $75.0 million of funding that would have otherwise been available to Regeneron under the existing Antibody Discovery Agreement, as described above. The term of the IO Discovery Agreement will continue through the later of five years from the effective date of the IO Collaboration or the date the IO Discovery Funding is exhausted, subject to Sanofi’s option to extend it for up to an additional three years for the continued development (and funding) of selected ongoing programs. Pursuant to the IO Discovery Agreement, the Company will be primarily responsible for the design and conduct of all research activities, including target identification and validation, antibody development, preclinical activities, toxicology studies, manufacture of preclinical and clinical supplies, filing of Investigational New Drug ("IND") Applications, and clinical development through proof-of-concept. The Company will reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the IO Discovery Agreement from Regeneron's share of future profits to the extent they are sufficient for this purpose. However, the Company is not required to apply more than 10% of its share of the profits from IO Collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs. With regard to product candidates for which proof-of-concept is established, Sanofi will have the option to license rights to the candidate pursuant to the IO License and Collaboration Agreement (as further described below). If Sanofi does not exercise its option to license rights to a product candidate, the Company will retain the exclusive right to develop and commercialize such product candidate and Sanofi will be entitled to receive a royalty on sales. In connection with the IO License and Collaboration Agreement, Sanofi will make a $375.0 million non-refundable upfront payment to the Company. If Sanofi exercises its option to license rights to a product candidate thereunder, it will co-develop the drug candidate with the Company through product approval. Principal control of development of each product candidate that enters development under the IO License and Collaboration Agreement will alternate between the Company and Sanofi on a candidate-by-candidate basis. Sanofi will fund drug candidate development costs up front for the candidates for which it is the principal controlling party and the Company will reimburse half of the total development costs for all such candidates from its share of future profits to the extent they are sufficient for this purpose, subject to the same 10% reimbursement limitation described above. In addition, Sanofi and the Company will share equally, on an ongoing basis, the development costs for the drug candidates for which the Company is the principal controlling party. The party having principal control over the development of a product candidate will also lead the commercialization activities for such product candidate in the United States. For all products commercialized under the IO License and Collaboration Agreement, Sanofi will lead commercialization activities outside of the United States. Each party will have the right to co-promote licensed products in countries where it is not the lead commercialization party. The parties will share equally in any profits from worldwide sales of collaboration products. Regeneron is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured. Under the terms of the IO License and Collaboration Agreement, the parties will also co-develop the Company’s antibody product candidate targeting the receptor known as Programmed Cell Death protein 1, or PD-1 ("REGN2810"). The parties will share equally, on an ongoing basis, development expenses for REGN2810 up to a total of $650.0 million . The Company will have principal control over the development of REGN2810 and will lead commercialization activities in the United States, subject to Sanofi’s right to co-promote, while Sanofi will lead commercialization activities outside of the United States and the parties will equally share profits from worldwide sales. The Company will be entitled to a milestone payment of $375.0 million in the event that sales of all licensed products targeting PD-1 (including REGN2810), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with a licensed product targeting PD-1, equal or exceed $2.0 billion in any consecutive twelve -month period. With respect to each product candidate that enters development under the IO License and Collaboration Agreement, Sanofi or the Company may, by giving twelve months’ notice, opt-out of further development and/or commercialization of the product, in which event the other party will retain exclusive rights to continue the development and/or commercialization of such product. b. Bayer HealthCare LLC The Company and Bayer HealthCare globally collaborate on the development and commercialization of EYLEA outside of the United States. In addition, in January 2014, the Company entered into a license and collaboration agreement with Bayer HealthCare governing the joint development and commercialization outside the United States of an antibody product candidate to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta). The collaboration revenue the Company earned from Bayer HealthCare is detailed below: Three Months Ended June 30, Bayer HealthCare Collaboration Revenue 2015 2014 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 106,631 $ 66,781 Sales milestones — 15,000 Cost-sharing of Regeneron EYLEA development expenses 2,464 1,494 Other 16,618 10,813 Total EYLEA 125,713 94,088 PDGFR-beta antibody: Cost-sharing of REGN2176-3 development expenses 5,926 626 Other 2,598 2,581 Total PDGFR-beta 8,524 3,207 $ 134,237 $ 97,295 Six Months Ended June 30, Bayer HealthCare Collaboration Revenue 2015 2014 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 196,057 $ 127,940 Sales milestones 15,000 45,000 Cost-sharing of Regeneron EYLEA development expenses 5,121 21,841 Other 29,530 21,745 Total EYLEA 245,708 216,526 PDGFR-beta antibody: Cost-sharing of REGN2176-3 development expenses 7,180 1,139 Other 5,195 4,942 Total PDGFR-beta 12,375 6,081 $ 258,083 $ 222,607 EYLEA outside the United States In the first quarter of 2015, the Company earned a $15.0 million sales milestone from Bayer HealthCare upon total aggregate net sales of specific commercial supplies of EYLEA outside the United States exceeding $200 million over a twelve -month period. In the first half of 2014, the Company earned three $15.0 million sales milestones from Bayer HealthCare upon total aggregate net sales of EYLEA outside the United States exceeding $500 million , $600 million , and $700 million , respectively, over a twelve -month period. In January 2014, Bayer HealthCare decided to participate in the global development and commercialization of EYLEA outside the United States for the treatment of macular edema following branch retinal vein occlusion ("BRVO"). In connection with this decision, Bayer HealthCare reimbursed Regeneron $15.7 million for a defined share of the EYLEA global development costs that the Company had incurred prior to February 2014 for the BRVO indication, which was recognized as Bayer HealthCare collaboration revenue in the first quarter of 2014 and is included with "Cost-sharing of Regeneron EYLEA development expenses" in the table above. In addition, all future agreed upon global EYLEA development expenses incurred in connection with BRVO are being shared equally, and any profits or losses on sales of EYLEA outside of the United States for the treatment of macular edema following BRVO are also shared (for countries other than Japan). The Company is entitled to receive a tiered percentage of EYLEA net sales in Japan. PDGFR-beta antibody outside the United States In January 2014, the Company entered into an agreement with Bayer HealthCare governing the joint development and commercialization outside the United States of an antibody product candidate to PDGFR-beta, including in combination with EYLEA, for the treatment of ocular diseases or disorders. In connection with the agreement, Bayer HealthCare made a $25.5 million non-refundable upfront payment to the Company in January 2014, and is obligated to pay 25% of global development costs and 50% of development costs exclusively for the territory outside the United States under the initial development plan. The $25.5 million upfront payment was initially recorded as deferred revenue, and will be recognized as revenue over the related performance period. Bayer HealthCare is also obligated to reimburse the Company for 50% of development milestone payments to Sanofi related to the Company's acquisition of rights to antibodies targeting the PDGF family of receptors in May 2013, as described above. In that regard, Bayer HealthCare made two $2.5 million development milestone payments to the Company in the first quarter of 2014 (both of which, for the purpose of revenue recognition, were not considered substantive) and a $5.0 million development milestone payment to the Company in the second quarter of 2015 (which was recognized as a substantive milestone). |
Stock-based Compensation (Notes
Stock-based Compensation (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Stock-based Compensation The Company recognizes stock-based compensation expense for grants of stock option awards and restricted stock under the Company's applicable Long-Term Incentive Plan based on the grant-date fair value of those awards. The Company recognized stock-based compensation expense of $94.3 million and $64.8 million for the three months ended June 30, 2015 and 2014, respectively, and $198.0 million and $140.6 million for the six months ended June 30, 2015 and 2014, respectively. Revisions of Previously-Issued Financial Statements During the first quarter of 2015, the Company determined that for certain stock option awards granted to an employee in prior periods, the incorrect requisite service period was utilized in determining the period over which the related compensation expense should have been recorded. Such awards were made as part of the Company's annual employee option grants in December of each applicable year. As a result, compensation expense for the three months and years ended December 31, 2014 and 2013 was understated, and compensation expense for the three months ended March 31, 2014 and 2013, June 30, 2014 and 2013, and September 30, 2014 and 2013 was overstated. These revisions consisted entirely of non-cash adjustments, and therefore had no impact on the Company's previously reported total cash flows from operating activities and total cash flows in its Statements of Cash Flows. The Company evaluated the impact of these items on prior periods, assessing materiality quantitatively and qualitatively, and concluded that the errors were not considered to be material to any previously-issued quarterly or annual financial statements. However, the Company concluded that it would revise the applicable prior period amounts in this filing to reflect the impact of these corrections because the cumulative amount of such corrections is expected to be material to the year ending December 31, 2015. The Company's prior-period financial statements will reflect these revisions for the applicable periods presented in future filings. The table below presents the impact of these revisions, including the related tax effect, on the Company's previously-filed financial statements. December 31, 2014 As Previously Reported Adjustments As Revised Balance Sheet Data: Deferred tax assets (noncurrent) $ 266,869 $ 22,152 $ 289,021 Total assets 3,871,827 22,152 3,893,979 Additional paid-in capital 2,404,118 60,890 2,465,008 Retained earnings 255,382 (38,738 ) 216,644 Total stockholders' equity 2,542,325 22,152 2,564,477 Total liabilities and stockholders' equity 3,871,827 22,152 3,893,979 Three Months Ended June 30, 2014 Six Months Ended June 30, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Consolidated Statement of Operations Data: Selling, general, and administrative $ 102,414 $ (5,684 ) $ 96,730 $ 211,264 $ (11,307 ) $ 199,957 Total operating expenses 443,294 (5,684 ) 437,610 883,095 (11,307 ) 871,788 Income from operations 222,406 5,684 228,090 408,345 11,307 419,652 Income before income taxes 203,119 5,684 208,803 378,382 11,307 389,689 Income tax expense 110,384 2,068 112,452 220,204 4,829 225,033 Net income 92,735 3,616 96,351 158,178 6,478 164,656 Net income per share - basic $ 0.92 $ 0.04 $ 0.96 $ 1.58 $ 0.07 $ 1.65 Net income per share - diluted $ 0.82 $ 0.03 $ 0.85 $ 1.40 $ 0.06 $ 1.46 Six Months Ended June 30, 2014 As Previously Reported Adjustments As Revised Consolidated Statement of Cash Flows Data: Cash flows from operating activities Net income $ 158,178 $ 6,478 $ 164,656 Non-cash compensation expense 151,920 (11,307 ) 140,613 Deferred taxes (32,543 ) 4,829 (27,714 ) The tables below present the impact of these revisions, including the related tax effects, on additional previously-filed interim and year-end Consolidated Statements of Operations for the three and nine months ended September 30, 2014, and for the three months and year ended December 31, 2014. Three Months Ended September 30, 2014 Nine Months Ended September 30, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Selling, general, and administrative $ 149,748 $ (5,745 ) $ 144,003 $ 361,012 $ (17,052 ) $ 343,960 Total operating expenses 543,069 (5,745 ) 537,324 1,426,164 (17,052 ) 1,409,112 Income from operations 182,719 5,745 188,464 591,064 17,052 608,116 Income before income taxes 176,078 5,745 181,823 554,460 17,052 571,512 Income tax expense 96,358 2,090 98,448 316,562 6,919 323,481 Net income 79,720 3,655 83,375 237,898 10,133 248,031 Net income per share - basic $ 0.79 $ 0.04 $ 0.83 $ 2.37 $ 0.10 $ 2.47 Net income per share - diluted $ 0.70 $ 0.03 $ 0.73 $ 2.10 $ 0.09 $ 2.19 Three Months Ended December 31, 2014 Year Ended December 31, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Selling, general, and administrative $ 143,743 $ 31,564 $ 175,307 $ 504,755 $ 14,512 $ 519,267 Total operating expenses 554,962 31,564 586,526 1,981,126 14,512 1,995,638 Income from operations 247,367 (31,564 ) 215,803 838,431 (14,512 ) 823,919 Income before income taxes 221,287 (31,564 ) 189,723 775,747 (14,512 ) 761,235 Income tax expense 111,111 (11,483 ) 99,628 427,673 (4,564 ) 423,109 Net income 110,176 (20,081 ) 90,095 348,074 (9,948 ) 338,126 Net income per share - basic $ 1.09 $ (0.20 ) $ 0.89 $ 3.46 $ (0.10 ) $ 3.36 Net income per share - diluted $ 0.96 $ (0.18 ) $ 0.78 $ 3.07 $ (0.09 ) $ 2.98 |
Net Income Per Share (Notes)
Net Income Per Share (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 2014 Net income - basic and diluted $ 194,643 $ 96,351 (Shares in thousands) Weighted average shares - basic 102,886 100,391 Effect of dilutive securities: Stock options 9,438 9,359 Restricted stock 474 405 Warrants 2,461 2,877 Dilutive potential shares 12,373 12,641 Weighted average shares - diluted 115,259 113,032 Net income per share - basic $ 1.89 $ 0.96 Net income per share - diluted $ 1.69 $ 0.85 Six Months Ended June 30, 2015 2014 Net income - basic and diluted $ 270,664 $ 164,656 (Shares in thousands) Weighted average shares - basic 102,558 100,085 Effect of dilutive securities: Stock options 9,441 9,615 Restricted stock 471 403 Warrants 2,492 3,018 Dilutive potential shares 12,404 13,036 Weighted average shares - diluted 114,962 113,121 Net income per share - basic $ 2.64 $ 1.65 Net income per share - diluted $ 2.35 $ 1.46 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended June 30, (Shares in thousands) 2015 2014 Stock options 3,366 3,765 Convertible senior notes 1,539 4,662 Six Months Ended June 30, (Shares in thousands) 2015 2014 Stock options 3,370 3,714 Convertible senior notes 1,733 4,711 |
Marketable Securities (Notes)
Marketable Securities (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities as of June 30, 2015 and December 31, 2014 consist of both debt securities issued by investment grade institutions as well as equity securities. The Company also held restricted marketable securities as of December 31, 2014, consisting of the Company's investment in Avalanche Biotechnologies, Inc. common shares, which were subject to customary transfer restrictions until January 2015 under a lock-up agreement with the underwriters of Avalanche's initial public offering. The following tables summarize the Company's investments in marketable securities: Amortized Unrealized Fair As of June 30, 2015 Cost Basis Gains Losses Value Unrestricted Corporate bonds $ 661,084 $ 256 $ (951 ) $ 660,389 U.S. government and government agency obligations 56,998 31 (24 ) 57,005 Municipal bonds 39,764 17 (10 ) 39,771 Equity securities 17,005 29,119 — 46,124 $ 774,851 $ 29,423 $ (985 ) $ 803,289 As of December 31, 2014 Unrestricted Corporate bonds $ 548,832 $ 136 $ (1,462 ) $ 547,506 U.S. government and government agency obligations 28,596 3 (46 ) 28,553 Municipal bonds 37,044 37 (43 ) 37,038 Equity securities 2,005 5,374 — 7,379 616,477 5,550 (1,551 ) 620,476 Restricted Equity securities 15,000 76,439 — 91,439 $ 631,477 $ 81,989 $ (1,551 ) $ 711,915 The Company classifies its debt security investments based on their contractual maturity dates. The debt securities listed as of June 30, 2015 mature at various dates through August 2024. The fair values of debt security investments by contractual maturity consist of the following: June 30, 2015 December 31, 2014 Maturities within one year $ 213,694 $ 251,761 Maturities after one year through five years 542,369 360,208 Maturities after five years through ten years 1,102 1,128 $ 757,165 $ 613,097 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 June 30, 2015 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 413,794 $ (920 ) $ 7,602 $ (31 ) $ 421,396 $ (951 ) U.S. government and government agency obligations 20,397 (24 ) — — 20,397 (24 ) Municipal bonds 12,675 (10 ) — — — 12,675 (10 ) $ 446,866 $ (954 ) $ 7,602 $ (31 ) $ 454,468 $ (985 ) As of December 31, 2014 Corporate bonds $ 390,613 $ (1,462 ) — — $ 390,613 $ (1,462 ) U.S. government and government agency obligations 25,549 (46 ) — — 25,549 (46 ) Municipal bonds 10,779 (43 ) — — 10,779 (43 ) $ 426,941 $ (1,551 ) — — $ 426,941 $ (1,551 ) For the three and six months ended June 30, 2015 and 2014, total realized gains and losses on sales of marketable securities were not material. Changes in the Company's accumulated other comprehensive income (loss) for the three and six months ended June 30, 2015 and 2014 related to unrealized gains and losses on available-for-sale marketable securities. For the three and six months ended June 30, 2015 and 2014, 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. |
Fair Value Measurements (Notes)
Fair Value Measurements (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale marketable securities: Unrestricted Corporate bonds $ 660,389 — $ 660,389 U.S. government and government agency obligations 57,005 — 57,005 Municipal bonds 39,771 — 39,771 Equity securities 46,124 $ 46,124 — $ 803,289 $ 46,124 $ 757,165 As of December 31, 2014 Available-for-sale marketable securities: Unrestricted Corporate bonds $ 547,506 — $ 547,506 U.S. government and government agency obligations 28,553 — 28,553 Municipal bonds 37,038 — 37,038 Equity securities 7,379 $ 7,379 — 620,476 7,379 613,097 Restricted Equity securities 91,439 — 91,439 $ 711,915 $ 7,379 $ 704,536 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 and six months ended June 30, 2015 and 2014 . 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 and six months ended June 30, 2015 and 2014 . During the six months ended June 30, 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 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 six months ended June 30, 2015, and there were no transfers of marketable securities between Levels 1, 2, or 3 classifications during the six months ended June 30, 2014. As of June 30, 2015 and December 31, 2014 , the Company had $33.3 million and $169.4 million , respectively, in aggregate principal amount of 1.875% convertible senior notes (the "Notes") that will mature on October 1, 2016 unless earlier converted or repurchased. As described in Note 10, a portion of the Notes was surrendered for conversion during the first half of 2015. The fair value of the outstanding Notes was estimated to be $201.6 million and $819.8 million as of June 30, 2015 and December 31, 2014 , respectively, and was determined based on Level 2 inputs, such as market and observable sources. Additionally, as described in Note 10, pursuant to a November 2014 amendment agreement with a warrant holder, a portion of the Company's warrants were classified as a liability and measured at fair value as of December 31, 2014. The fair value of this liability was estimated to be $87.5 million as of December 31, 2014 , and was determined based on Level 2 inputs, such as market and observable sources. During the first quarter of 2015, upon expiration of the November 2014 amendment agreement, the remaining warrants were re-measured at fair value and reclassified back to additional paid-in capital. |
Inventory (Notes)
Inventory (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventories Inventories consist of the following: June 30, December 31, 2015 2014 Raw materials $ 20,999 $ 10,923 Work-in-process 111,564 73,519 Finished goods 9,495 10,768 Deferred costs 29,208 33,651 $ 171,266 $ 128,861 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 June 30, 2015 and 2014, cost of goods sold included inventory write-downs and reserves totaling $6.4 million and $0.8 million , respectively. For the six months ended June 30, 2015 and 2014, cost of goods sold included inventory write-downs and reserves totaling $8.1 million and $1.9 million , respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following: June 30, December 31, 2015 2014 Accounts payable $ 130,016 $ 99,508 Accrued payroll and related costs 83,105 92,778 Accrued clinical trial expense 48,084 41,555 Accrued sales-related charges, deductions, and royalties 196,095 133,085 Other accrued expenses and liabilities 72,205 116,563 $ 529,505 $ 483,489 |
Debt (Notes)
Debt (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | Debt a. Convertible Debt In the first half of 2015, the Company settled conversion obligations for $144.0 million principal amount of the Company's Notes that was previously surrendered for conversion. As of June 30, 2015, an aggregate principal amount of $33.3 million of the original $400.0 million aggregate principal amount of Notes remained outstanding. In accordance with the terms of the Notes, the Company elected to settle these conversion obligations through a combination of cash, in an amount equal to the principal amount of the converted Notes, and shares of the Company's Common Stock in respect of any amounts due in excess thereof. Consequently, in the first half of 2015, the Company paid $144.0 million in cash and issued 1,399,069 shares of Common Stock. In addition, in the first half of 2015, the Company allocated $694.7 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 stockholders' equity, and recognized a $16.9 million loss on the debt extinguishment. In connection with the initial offering of the Notes in October 2011, the Company entered into convertible note hedge and warrant transactions with multiple counterparties, which were recorded to additional paid-in capital. As a result of the Note conversions described above, in the first half of 2015, the Company also exercised a proportionate amount of its convertible note hedges, for which the Company received 1,399,056 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 $117.5 million , as Treasury Stock during the first half of 2015. In the first half of 2014, the Company settled conversion obligations for $61.1 million principal amount of the Notes surrendered for conversion. Upon settlement of the Notes during the second quarter of 2014, the Company paid $61.1 million in cash and issued 521,876 shares of Common Stock. In addition, during the second quarter of 2014, the Company allocated $156.7 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 stockholders' equity, and recognized a $10.8 million loss on the debt extinguishment. In connection with the Note conversions in the first half of 2014, the Company also exercised a proportionate amount of its convertible note hedges, for which the Company received 521,876 shares of Common Stock, which was equivalent 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 $43.8 million , as Treasury Stock during the first half of 2014. 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 by up to a maximum of 493,229 . 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 493,229 warrants 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. As a result of the warrant holder closing out a portion of its hedge position prior to December 31, 2014, the Company recorded a $59.8 million accrued liability as of December 31, 2014 in connection with the warrant holder reducing the number of warrants it held. During the first quarter of 2015, the warrant holder closed out additional portions of its hedge position, and, as a result, 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, 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. During the first half of 2014, the Company entered into agreements to reduce the number of warrants held by warrant holders. Pursuant to the agreements, the Company paid an aggregate amount of $143.0 million to the warrant holders to reduce the maximum number of shares of Common Stock issuable upon exercise of the warrants by 727,516 in the aggregate. b. Credit Facility In March 2015, the Company entered into an agreement with a syndicate of lenders (the "Credit Agreement") which provides for a $750.0 million senior unsecured five -year revolving credit facility (the "Credit Facility"). The Credit Agreement includes an option for the Company to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $250.0 million subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions. Proceeds of the loans under the Credit Facility may be used to finance working capital needs, and for general corporate or other lawful purposes, of Regeneron and its subsidiaries. The Credit Agreement also provides a $100.0 million sublimit for letters of credit. The Credit Agreement includes an option for the Company to elect to extend the maturity date of the Credit Facility beyond March 2020, subject to the consent of the extending lenders and certain other conditions. Amounts borrowed under the Credit Facility may be prepaid, and the commitments under the Credit Facility may be terminated, at any time without premium or penalty. Any loans under the Credit Facility have a variable interest rate based on either the London Interbank Offered Rate ("LIBOR") or an alternate base rate, plus an applicable margin that varies with the Company's debt rating and total leverage ratio. The Company had no borrowings outstanding under the Credit Facility as of June 30, 2015. The Credit Agreement contains financial and operating covenants. Financial covenants include a maximum total leverage ratio and a minimum interest expense coverage ratio. The Company was in compliance with all covenants of the Credit Facility as of June 30, 2015. |
Income Taxes (Notes)
Income Taxes (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
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 $133.4 million and $112.5 million for the three months ended June 30, 2015 and 2014, respectively, and $333.9 million and $225.0 million for the six months ended June 30, 2015 and 2014, respectively. The Company's effective tax rate was 40.7% and 53.9% for the three months ended June 30, 2015 and 2014, respectively, and 55.2% and 57.7% for the six months ended June 30, 2015 and 2014, respectively. The Company's effective tax rate for the three and six months ended June 30, 2015 was negatively impacted, compared to the U.S. federal statutory rate, by (i) losses incurred in foreign jurisdictions with rates lower than the U.S. federal statutory rate, (ii) the non-deductible Branded Prescription Drug Fee, and (iii) expiration, at the end of 2014, of the federal tax credit for increased research activities. The Company's effective tax rate for the three and six months ended June 30, 2014 was negatively impacted by losses incurred in foreign jurisdictions with rates lower than the federal statutory rate and expiration at the end of 2013 of the federal tax credit for increased research activities. In addition, the Company's effective tax rate for the six months ended June 30, 2014 was negatively impacted by New York State tax legislation enacted in the first quarter of 2014. This tax legislation reduced the New York State income tax rate to zero percent for "qualified manufacturers", including Regeneron, effective in 2014; however, it also resulted in the Company reducing its related deferred tax assets as a discrete item in the first quarter of 2014. As a result, this tax legislation caused a net increase in the Company's effective tax rate by 3.9% for the six months ended June 30, 2014. The Company also recorded an income tax benefit in its Statement of Comprehensive Income of $16.3 million and $18.9 million for the three and six months ended June 30, 2015, in connection with unrealized losses on available-for-sale marketable securities. For both the three and six months ended June 30, 2014, the Company recorded an income tax provision in its Statement of Comprehensive Income of $1.4 million in connection with unrealized gains on available-for-sale marketable securities. |
Statement of Cash Flows (Notes)
Statement of Cash Flows (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 and December 31, 2014 were $67.9 million and $56.2 million , respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses as of June 30, 2014 and December 31, 2013 were $35.1 million and $16.1 million , respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses as of June 30, 2015 and December 31, 2014 was $2.0 million and $7.5 million , respectively, for the Company's conversion settlement obligation related to the Company's Notes which were surrendered for conversion but not settled as of the end of the respective period. No such amounts were payable as of June 30, 2014 and December 31, 2013. 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. See Note 10. There were no such liabilities recorded in connection with warrants as of June 30, 2015, June 30, 2014, and December 31, 2013. The Company recognized a facility lease obligation of $20.1 million and $50.6 million during the six months ended June 30, 2015 and 2014, respectively, in connection with capitalizing, on the Company's books, the landlord's costs of constructing new facilities that the Company has leased. |
Legal Matters (Notes)
Legal Matters (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
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 and ' 018 Patent The Company is a party to patent infringement litigation involving its European Patent No. 1,360,287 (the "'287 Patent") and its U.S. Patent No. 8,502,018 (the "'018 Patent"), both of which concern 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 "'287 Patent Infringement Litigation" and "'018 Patent Infringement Litigation," respectively), the Company claims infringement of several claims of the '287 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 and the '018 Patent (as applicable). At this time, the Company is not able to predict the outcome of, or an estimate of gain, if any, related to, these proceedings. Proceedings Relating to PCSK9 Antibody (Praluent) 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, the antibody to PCSK9 for LDL cholesterol reduction 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, and 8,859,741 in the first complaint, U.S. Patent Nos. 8,871,913 and 8,871,914 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. In its April 21, 2015 Scheduling Order, the court set a trial date of March 7, 2016. This matter has not yet progressed sufficiently through discovery and/or development of important factual information and legal issues to enable the Company to estimate a range of possible loss, if any. 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 (Los Angeles 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 jointly owned by Genentech, Inc. ("Genentech") and City of Hope relating to the production of recombinant antibodies in 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 seeking a declaration of invalidity of U.S. Patent No. 6,331,415 jointly owned by Genentech and City of Hope relating to the production of recombinant antibodies in host cells. At this time, the Company is not able to predict the outcome of these proceedings. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards (Notes) | 6 Months Ended |
Jun. 30, 2015 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Description of New Accounting Pronouncements Not yet Adopted [Text Block] | Recently Issued Accounting Standards In May 2014, the FASB issued a new standard related to revenue recognition, 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) | 6 Months Ended |
Jun. 30, 2015 | |
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) | 6 Months Ended |
Jun. 30, 2015 | |
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) | 6 Months Ended |
Jun. 30, 2015 | |
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) | 6 Months Ended |
Jun. 30, 2015 | |
Revenues [Abstract] | |
Sales Related Deductions Activity | The following table summarizes the provisions, and credits/payments, for these sales-related deductions during the six months ended June 30, 2015 and 2014. Rebates & Chargebacks Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2014 $ 3,083 $ 21,166 $ 532 $ 24,781 Provision related to current period sales 25,481 54,747 3,454 83,682 Credits/payments (23,090 ) (36,433 ) (3,482 ) (63,005 ) Balance as of June 30, 2015 $ 5,474 $ 39,480 $ 504 $ 45,458 Balance as of December 31, 2013 $ 4,400 $ 19,663 $ 538 $ 24,601 Provision related to current period sales 14,817 36,206 818 51,841 Credits/payments (15,077 ) (35,449 ) (834 ) (51,360 ) Balance as of June 30, 2014 $ 4,140 $ 20,420 $ 522 $ 25,082 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Collaboration Agreement [Abstract] | |
Collaboration revenue with related party | Sanofi collaboration revenue, as detailed below, consisted primarily of reimbursement for research and development expenses that the Company incurred, partly offset by sharing of pre-launch commercialization expenses, in connection with the companies' Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and License and Collaboration Agreement (each as amended), collectively referred to as the "Antibody Collaboration". Three Months Ended June 30, Sanofi Collaboration Revenue 2015 2014 Antibody: Reimbursement of Regeneron research and development expenses $ 211,516 $ 137,893 Reimbursement of Regeneron commercialization-related expenses 27,347 4,307 Regeneron's share of losses in connection with commercialization of antibodies (46,313 ) (4,295 ) Other 2,560 2,560 Total Antibody 195,110 140,465 ZALTRAP: Regeneron's share of losses in connection with commercialization of ZALTRAP — (692 ) Reimbursement of Regeneron research and development expenses — 1,338 Other — 1,484 Total ZALTRAP — 2,130 $ 195,110 $ 142,595 Six Months Ended June 30, Sanofi Collaboration Revenue 2015 2014 Antibody: Reimbursement of Regeneron research and development expenses $ 380,336 $ 264,715 Reimbursement of Regeneron commercialization-related expenses 35,805 5,375 Regeneron's share of losses in connection with commercialization of antibodies (68,718 ) (4,295 ) Other 5,121 5,121 Total Antibody 352,544 270,916 ZALTRAP: Regeneron's share of losses in connection with commercialization of ZALTRAP — (3,904 ) Reimbursement of Regeneron research and development expenses 686 2,430 Other 15,236 3,661 Total ZALTRAP 15,922 2,187 $ 368,466 $ 273,103 |
Collaboration revenue | The collaboration revenue the Company earned from Bayer HealthCare is detailed below: Three Months Ended June 30, Bayer HealthCare Collaboration Revenue 2015 2014 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 106,631 $ 66,781 Sales milestones — 15,000 Cost-sharing of Regeneron EYLEA development expenses 2,464 1,494 Other 16,618 10,813 Total EYLEA 125,713 94,088 PDGFR-beta antibody: Cost-sharing of REGN2176-3 development expenses 5,926 626 Other 2,598 2,581 Total PDGFR-beta 8,524 3,207 $ 134,237 $ 97,295 Six Months Ended June 30, Bayer HealthCare Collaboration Revenue 2015 2014 EYLEA: Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 196,057 $ 127,940 Sales milestones 15,000 45,000 Cost-sharing of Regeneron EYLEA development expenses 5,121 21,841 Other 29,530 21,745 Total EYLEA 245,708 216,526 PDGFR-beta antibody: Cost-sharing of REGN2176-3 development expenses 7,180 1,139 Other 5,195 4,942 Total PDGFR-beta 12,375 6,081 $ 258,083 $ 222,607 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Error Corrections and Prior Period Adjustments [Table Text Block] | The table below presents the impact of these revisions, including the related tax effect, on the Company's previously-filed financial statements. December 31, 2014 As Previously Reported Adjustments As Revised Balance Sheet Data: Deferred tax assets (noncurrent) $ 266,869 $ 22,152 $ 289,021 Total assets 3,871,827 22,152 3,893,979 Additional paid-in capital 2,404,118 60,890 2,465,008 Retained earnings 255,382 (38,738 ) 216,644 Total stockholders' equity 2,542,325 22,152 2,564,477 Total liabilities and stockholders' equity 3,871,827 22,152 3,893,979 Three Months Ended June 30, 2014 Six Months Ended June 30, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Consolidated Statement of Operations Data: Selling, general, and administrative $ 102,414 $ (5,684 ) $ 96,730 $ 211,264 $ (11,307 ) $ 199,957 Total operating expenses 443,294 (5,684 ) 437,610 883,095 (11,307 ) 871,788 Income from operations 222,406 5,684 228,090 408,345 11,307 419,652 Income before income taxes 203,119 5,684 208,803 378,382 11,307 389,689 Income tax expense 110,384 2,068 112,452 220,204 4,829 225,033 Net income 92,735 3,616 96,351 158,178 6,478 164,656 Net income per share - basic $ 0.92 $ 0.04 $ 0.96 $ 1.58 $ 0.07 $ 1.65 Net income per share - diluted $ 0.82 $ 0.03 $ 0.85 $ 1.40 $ 0.06 $ 1.46 Six Months Ended June 30, 2014 As Previously Reported Adjustments As Revised Consolidated Statement of Cash Flows Data: Cash flows from operating activities Net income $ 158,178 $ 6,478 $ 164,656 Non-cash compensation expense 151,920 (11,307 ) 140,613 Deferred taxes (32,543 ) 4,829 (27,714 ) The tables below present the impact of these revisions, including the related tax effects, on additional previously-filed interim and year-end Consolidated Statements of Operations for the three and nine months ended September 30, 2014, and for the three months and year ended December 31, 2014. Three Months Ended September 30, 2014 Nine Months Ended September 30, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Selling, general, and administrative $ 149,748 $ (5,745 ) $ 144,003 $ 361,012 $ (17,052 ) $ 343,960 Total operating expenses 543,069 (5,745 ) 537,324 1,426,164 (17,052 ) 1,409,112 Income from operations 182,719 5,745 188,464 591,064 17,052 608,116 Income before income taxes 176,078 5,745 181,823 554,460 17,052 571,512 Income tax expense 96,358 2,090 98,448 316,562 6,919 323,481 Net income 79,720 3,655 83,375 237,898 10,133 248,031 Net income per share - basic $ 0.79 $ 0.04 $ 0.83 $ 2.37 $ 0.10 $ 2.47 Net income per share - diluted $ 0.70 $ 0.03 $ 0.73 $ 2.10 $ 0.09 $ 2.19 Three Months Ended December 31, 2014 Year Ended December 31, 2014 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised Selling, general, and administrative $ 143,743 $ 31,564 $ 175,307 $ 504,755 $ 14,512 $ 519,267 Total operating expenses 554,962 31,564 586,526 1,981,126 14,512 1,995,638 Income from operations 247,367 (31,564 ) 215,803 838,431 (14,512 ) 823,919 Income before income taxes 221,287 (31,564 ) 189,723 775,747 (14,512 ) 761,235 Income tax expense 111,111 (11,483 ) 99,628 427,673 (4,564 ) 423,109 Net income 110,176 (20,081 ) 90,095 348,074 (9,948 ) 338,126 Net income per share - basic $ 1.09 $ (0.20 ) $ 0.89 $ 3.46 $ (0.10 ) $ 3.36 Net income per share - diluted $ 0.96 $ (0.18 ) $ 0.78 $ 3.07 $ (0.09 ) $ 2.98 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 2014 Net income - basic and diluted $ 194,643 $ 96,351 (Shares in thousands) Weighted average shares - basic 102,886 100,391 Effect of dilutive securities: Stock options 9,438 9,359 Restricted stock 474 405 Warrants 2,461 2,877 Dilutive potential shares 12,373 12,641 Weighted average shares - diluted 115,259 113,032 Net income per share - basic $ 1.89 $ 0.96 Net income per share - diluted $ 1.69 $ 0.85 Six Months Ended June 30, 2015 2014 Net income - basic and diluted $ 270,664 $ 164,656 (Shares in thousands) Weighted average shares - basic 102,558 100,085 Effect of dilutive securities: Stock options 9,441 9,615 Restricted stock 471 403 Warrants 2,492 3,018 Dilutive potential shares 12,404 13,036 Weighted average shares - diluted 114,962 113,121 Net income per share - basic $ 2.64 $ 1.65 Net income per share - diluted $ 2.35 $ 1.46 |
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 June 30, (Shares in thousands) 2015 2014 Stock options 3,366 3,765 Convertible senior notes 1,539 4,662 Six Months Ended June 30, (Shares in thousands) 2015 2014 Stock options 3,370 3,714 Convertible senior notes 1,733 4,711 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 Cost Basis Gains Losses Value Unrestricted Corporate bonds $ 661,084 $ 256 $ (951 ) $ 660,389 U.S. government and government agency obligations 56,998 31 (24 ) 57,005 Municipal bonds 39,764 17 (10 ) 39,771 Equity securities 17,005 29,119 — 46,124 $ 774,851 $ 29,423 $ (985 ) $ 803,289 As of December 31, 2014 Unrestricted Corporate bonds $ 548,832 $ 136 $ (1,462 ) $ 547,506 U.S. government and government agency obligations 28,596 3 (46 ) 28,553 Municipal bonds 37,044 37 (43 ) 37,038 Equity securities 2,005 5,374 — 7,379 616,477 5,550 (1,551 ) 620,476 Restricted Equity securities 15,000 76,439 — 91,439 $ 631,477 $ 81,989 $ (1,551 ) $ 711,915 |
Marketable Securities, Based on Contractual Maturity Dates | The fair values of debt security investments by contractual maturity consist of the following: June 30, 2015 December 31, 2014 Maturities within one year $ 213,694 $ 251,761 Maturities after one year through five years 542,369 360,208 Maturities after five years through ten years 1,102 1,128 $ 757,165 $ 613,097 |
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 June 30, 2015 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 413,794 $ (920 ) $ 7,602 $ (31 ) $ 421,396 $ (951 ) U.S. government and government agency obligations 20,397 (24 ) — — 20,397 (24 ) Municipal bonds 12,675 (10 ) — — — 12,675 (10 ) $ 446,866 $ (954 ) $ 7,602 $ (31 ) $ 454,468 $ (985 ) As of December 31, 2014 Corporate bonds $ 390,613 $ (1,462 ) — — $ 390,613 $ (1,462 ) U.S. government and government agency obligations 25,549 (46 ) — — 25,549 (46 ) Municipal bonds 10,779 (43 ) — — 10,779 (43 ) $ 426,941 $ (1,551 ) — — $ 426,941 $ (1,551 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 Fair Value Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Available-for-sale marketable securities: Unrestricted Corporate bonds $ 660,389 — $ 660,389 U.S. government and government agency obligations 57,005 — 57,005 Municipal bonds 39,771 — 39,771 Equity securities 46,124 $ 46,124 — $ 803,289 $ 46,124 $ 757,165 As of December 31, 2014 Available-for-sale marketable securities: Unrestricted Corporate bonds $ 547,506 — $ 547,506 U.S. government and government agency obligations 28,553 — 28,553 Municipal bonds 37,038 — 37,038 Equity securities 7,379 $ 7,379 — 620,476 7,379 613,097 Restricted Equity securities 91,439 — 91,439 $ 711,915 $ 7,379 $ 704,536 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories consist of the following: June 30, December 31, 2015 2014 Raw materials $ 20,999 $ 10,923 Work-in-process 111,564 73,519 Finished goods 9,495 10,768 Deferred costs 29,208 33,651 $ 171,266 $ 128,861 |
Accounts Payable and Accrued 30
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued expenses consist of the following: June 30, December 31, 2015 2014 Accounts payable $ 130,016 $ 99,508 Accrued payroll and related costs 83,105 92,778 Accrued clinical trial expense 48,084 41,555 Accrued sales-related charges, deductions, and royalties 196,095 133,085 Other accrued expenses and liabilities 72,205 116,563 $ 529,505 $ 483,489 |
Interim Financial Statements (D
Interim Financial Statements (Details) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2014 | Dec. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Reduction in accounts receivable | $ 41 | |
Reduction in deferred revenue | 41 | |
Reduction in income tax assets, net | 14.2 | |
Reduction in APIC | $ 14.2 | |
Increase in total cash from operating | $ 8.6 | |
Decrease in total cash from financing | $ 8.6 |
Net Product Sales (Details)
Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenue Disclosure [Line Items] | ||||||
Net product sales | $ 657,819 | $ 418,022 | $ 1,202,392 | $ 780,400 | ||
Activity of Sales Related Deductions [Roll Forward] | ||||||
Balance | 45,458 | 25,082 | 45,458 | 25,082 | $ 24,781 | $ 24,601 |
Provision related to current period sales | 83,682 | 51,841 | ||||
Credits/payments | (63,005) | (51,360) | ||||
Rebates and Chargebacks | ||||||
Activity of Sales Related Deductions [Roll Forward] | ||||||
Balance | 5,474 | 4,140 | 5,474 | 4,140 | 3,083 | 4,400 |
Provision related to current period sales | 25,481 | 14,817 | ||||
Credits/payments | (23,090) | (15,077) | ||||
Distribution Related Fees | ||||||
Activity of Sales Related Deductions [Roll Forward] | ||||||
Balance | 39,480 | 20,420 | 39,480 | 20,420 | 21,166 | 19,663 |
Provision related to current period sales | 54,747 | 36,206 | ||||
Credits/payments | (36,433) | (35,449) | ||||
Other Sales Related Deductions | ||||||
Activity of Sales Related Deductions [Roll Forward] | ||||||
Balance | $ 504 | $ 522 | 504 | 522 | $ 532 | $ 538 |
Provision related to current period sales | 3,454 | 818 | ||||
Credits/payments | $ (3,482) | $ (834) | ||||
Customer concentration risk | Gross Sales Revenue | ||||||
Risks and Uncertainties [Abstract] | ||||||
Concentration risk, percentage | 69.00% | 73.00% | 69.00% | 76.00% | ||
EYLEA | ||||||
Revenue Disclosure [Line Items] | ||||||
Net product sales | $ 654,600 | $ 414,800 | $ 1,195,700 | $ 773,800 | ||
ARCALYST | ||||||
Revenue Disclosure [Line Items] | ||||||
Net product sales | $ 3,200 | $ 3,200 | $ 6,700 | $ 6,600 |
Collaboration Agreements (Sanof
Collaboration Agreements (Sanofi) (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jul. 31, 2015USD ($) | Nov. 30, 2009USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Jun. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Collaboration Agreement [Line Items] | |||||||||||
Licenses Revenue | $ 11,451 | $ 7,788 | $ 39,288 | $ 15,330 | |||||||
Period for Achieving Sales Target for Milestone Payment, Rolling Basis | 12 months | 12 months | |||||||||
Revenue from Related Parties | 195,110 | 142,595 | 368,466 | $ 273,103 | |||||||
Research and development | 390,330 | 294,501 | $ 733,443 | 581,880 | |||||||
ZALTRAP Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Percentage of repayment of development balance out of profits | 50.00% | ||||||||||
Deferred Revenue, Revenue Recognized | $ 14,900 | ||||||||||
Licenses Revenue | 3,200 | $ 23,000 | |||||||||
Net profit (loss) from commercialization of products under collaboration agreement | 0 | (692) | 0 | (3,904) | |||||||
Reimbursement of Regeneron research and development expenses | 0 | 1,338 | 686 | 2,430 | |||||||
Contracts Revenue | 0 | 1,484 | 15,236 | 3,661 | |||||||
Revenue from Related Parties | 0 | 2,130 | 15,922 | 2,187 | |||||||
Antibody Collaboration | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Net profit (loss) from commercialization of products under collaboration agreement | (46,313) | (4,295) | (68,718) | (4,295) | |||||||
Recognition of Deferred Revenue | 2,560 | 2,560 | 5,121 | 5,121 | |||||||
Annual funding maximum of research activities per amended agreement | $ 160,000 | $ 130,000 | $ 130,000 | $ 145,000 | |||||||
Reduction of Funding for Research Activities Per Agreement | $ 75,000 | ||||||||||
Reimbursement of Regeneron research and development expenses | 211,516 | 137,893 | 380,336 | 264,715 | |||||||
Contracts Revenue | 27,347 | 4,307 | 35,805 | 5,375 | |||||||
Revenue from Related Parties | $ 195,110 | 140,465 | $ 352,544 | 270,916 | |||||||
Percentage of Trial Costs borne by collaborating party | 80.00% | ||||||||||
Percentage of Trial Costs borne by entity | 20.00% | ||||||||||
Research and development | $ 47,500 | 52,900 | |||||||||
Minimum IO Discovery Agreement Term | 3 years | ||||||||||
PDGF | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Number of Payments the Company made | 1 | 2 | |||||||||
Other Research and Development Expense | $ 10,000 | $ 5,000 | |||||||||
Milestone payment | $ 20,000 | ||||||||||
IO Discovery Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Amount of non refundable payment will receive for collaboration agreement | $ 265,000 | ||||||||||
Potential future R&D expenses | 1,090,000 | ||||||||||
Funding Maximum of Research Activities Per Agreement | $ 825,000 | ||||||||||
Minimum IO Discovery Agreement Term | 5 years | ||||||||||
Additional years to extend the agreement | 3 years | ||||||||||
Excess Share of profit not required to to be applied to reimburse development cost | 10.00% | ||||||||||
IO License and Collaboration Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Amount of non refundable payment will receive for collaboration agreement | $ 375,000 | ||||||||||
Excess Share of profit not required to to be applied to reimburse development cost | 10.00% | ||||||||||
Period of Notice to Opt Out of Further Development and or Commercialization | 12 months | ||||||||||
IO License and Collaboration Agreement | PD-1 | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Maximum amount of sales milestone payments if total sales achieve specific levels | $ 375,000 | ||||||||||
Levels of twelve month sales at which sales milestone payments would be received | $ 2,000,000 | ||||||||||
Period for Achieving Sales Target for Milestone Payment, Rolling Basis | 12 months | ||||||||||
Maximum amount of shared development costs | $ 650,000 | ||||||||||
Minimum [Member] | ZALTRAP Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Percentage of net sales paid by the related party | 15.00% | ||||||||||
Maximum [Member] | ZALTRAP Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Percentage of net sales paid by the related party | 30.00% | ||||||||||
New Funding | IO Discovery Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Funding Maximum of Research Activities Per Agreement | 750,000 | ||||||||||
Previous Funding under Antibody Discovery Agreement | IO Discovery Agreement | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Funding Maximum of Research Activities Per Agreement | $ 75,000 | ||||||||||
sales achievement - $600 million | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 15,000 | ||||||||||
sales achievement - $500 million | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 15,000 | ||||||||||
sales achievement - $700 million | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 | ||||||||||
PDGF | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Number of development milestone payments the Company received | 1 | 2 | |||||||||
Percentage of repayment of development balance out of profits | 50.00% | ||||||||||
Amount of non refundable payment received for collaboration agreement | $ 25,500 | ||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 5,000 | ||||||||||
Praluent and sarilumab [Member] | Antibody Collaboration | |||||||||||
Collaboration Agreement [Line Items] | |||||||||||
Research and development | $ 22,500 | $ 29,100 |
Collaboration Agreements (Bayer
Collaboration Agreements (Bayer HealthCare LLC) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2014 | Mar. 31, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Collaboration Agreement [Line Items] | ||||||
Other Collaboration Revenue | $ 134,237 | $ 97,295 | $ 258,083 | $ 222,607 | ||
EYLEA | ||||||
Collaboration Agreement [Line Items] | ||||||
Net profit (loss) from commercialization of products under collaboration agreement | 106,631 | 66,781 | 196,057 | 127,940 | ||
Revenue Recognition, Milestone Method, Revenue Recognized | 0 | 15,000 | 15,000 | 45,000 | ||
Reimbursement of Regeneron research and development expenses | 2,464 | 1,494 | 5,121 | 21,841 | ||
Contracts Revenue | 16,618 | 10,813 | 29,530 | 21,745 | ||
Other Collaboration Revenue | 125,713 | 94,088 | 245,708 | 216,526 | ||
PDGFR-beta | ||||||
Collaboration Agreement [Line Items] | ||||||
Reimbursement of Regeneron research and development expenses | 5,926 | 626 | 7,180 | 1,139 | ||
Contracts Revenue | 2,598 | 2,581 | 5,195 | 4,942 | ||
Other Collaboration Revenue | $ 8,524 | $ 3,207 | $ 12,375 | $ 6,081 | ||
BRVO | ||||||
Collaboration Agreement [Line Items] | ||||||
Reimbursement of Regeneron research and development expenses | $ 15,700 | |||||
sales achievement - $200 million | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 |
Collaboration Agreements (EYLEA
Collaboration Agreements (EYLEA) (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Jun. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | |
Collaboration Agreement [Line Items] | ||||||
Number of sales milestone payments the Company received | 1 | 3 | ||||
Levels of twelve month sales at which sales milestone payments were received - 500 million | $ 500,000 | |||||
Levels of twelve month sales at which sales milestone payments were received - 600 million | 600,000 | |||||
Levels of twelve month sales at which sales milestone payments were received - 700 million | $ 700,000 | |||||
Period for Achieving Sales Target for Milestone Payment, Rolling Basis | 12 months | 12 months | ||||
sales achievement - $500 million | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 | |||||
sales achievement - $600 million | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 15,000 | |||||
sales achievement - $700 million | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 15,000 | |||||
sales achievement - $200 million | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 | |||||
Collaboration Agreement with Bayer HealthCare LLC [Member] | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 0 | $ 15,000 | $ 15,000 | 45,000 | ||
Levels of twelve month sales at which sales milestone payments were received - 200 million | $ 200,000 | |||||
Reimbursement of Regeneron research and development expenses | 2,464 | $ 1,494 | $ 5,121 | $ 21,841 | ||
PDGF | ||||||
Collaboration Agreement [Line Items] | ||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 5,000 | |||||
BRVO | ||||||
Collaboration Agreement [Line Items] | ||||||
Reimbursement of Regeneron research and development expenses | $ 15,700 |
Collaboration Agreements (PDGFR
Collaboration Agreements (PDGFR-beta Antibody) (Details) $ in Millions | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2015USD ($) | Mar. 31, 2014USD ($) | Jun. 30, 2015 | |
PDGF | |||
Collaboration Agreement [Line Items] | |||
Amount of non refundable payment received for collaboration agreement | $ 25.5 | ||
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% | ||
Percentage of development milestone payments to be reimbursed | 50.00% | ||
Number of development milestone payments the Company received | 1 | 2 | |
Deferred Revenue, Additions | $ 2.5 | ||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 5 | ||
PDGFR-beta outside the US [Member] | |||
Collaboration Agreement [Line Items] | |||
Proceeds from Collaborators | $ 25.5 |
Stock-based Compensation (Detai
Stock-based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Deferred tax assets (noncurrent) | $ 323,784 | $ 269,237 | $ 323,784 | $ 269,237 | ||||
Total assets | 4,526,970 | 3,837,672 | 4,526,970 | 3,837,672 | ||||
Additional paid-in-capital | 3,118,969 | 2,450,782 | 3,118,969 | 2,450,782 | ||||
Retained earnings | 487,308 | 216,644 | 487,308 | 216,644 | ||||
Total stockholders' equity | 3,338,458 | 2,550,251 | 3,338,458 | 2,550,251 | ||||
Total liabilities and stockholders' equity | 4,526,970 | 3,837,672 | 4,526,970 | 3,837,672 | ||||
Selling, general, and administrative | 174,588 | 175,307 | $ 144,003 | $ 96,730 | 333,579 | $ 199,957 | $ 343,960 | 519,267 |
Total operating expenses | 653,758 | 586,526 | 537,324 | 437,610 | 1,239,817 | 871,788 | 1,409,112 | 1,995,638 |
Income from operations | 344,859 | 215,803 | 188,464 | 228,090 | 628,412 | 419,652 | 608,116 | 823,919 |
Income before income taxes | 327,996 | 189,723 | 181,823 | 208,803 | 604,519 | 389,689 | 571,512 | 761,235 |
Income tax expense | 133,353 | 99,628 | 98,448 | 112,452 | 333,855 | 225,033 | 323,481 | 423,109 |
Net Income (Loss) Attributable to Parent | $ 194,643 | $ 90,095 | $ 83,375 | $ 96,351 | $ 270,664 | $ 164,656 | $ 248,031 | $ 338,126 |
Net income per share - basic | $ 1.89 | $ 0.89 | $ 0.83 | $ 0.96 | $ 2.64 | $ 1.65 | $ 2.47 | $ 3.36 |
Net income per share - diluted | $ 1.69 | $ 0.78 | $ 0.73 | $ 0.85 | $ 2.35 | $ 1.46 | $ 2.19 | $ 2.98 |
Non-cash compensation expense | $ 94,257 | $ 64,828 | $ 198,016 | $ 140,613 | ||||
Deferred taxes | (27,714) | |||||||
Adjustments to Reconcile Net Income (Loss) to Cash Provided by (Used in) Operating Activities | $ (114,560) | 225,283 | ||||||
Previously Reported | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Deferred tax assets (noncurrent) | $ 266,869 | $ 266,869 | ||||||
Total assets | 3,871,827 | 3,871,827 | ||||||
Additional paid-in-capital | 2,404,118 | 2,404,118 | ||||||
Retained earnings | 255,382 | 255,382 | ||||||
Total stockholders' equity | 2,542,325 | 2,542,325 | ||||||
Total liabilities and stockholders' equity | 3,871,827 | 3,871,827 | ||||||
Selling, general, and administrative | 143,743 | $ 149,748 | 102,414 | 211,264 | $ 361,012 | 504,755 | ||
Total operating expenses | 554,962 | 543,069 | 443,294 | 883,095 | 1,426,164 | 1,981,126 | ||
Income from operations | 247,367 | 182,719 | 222,406 | 408,345 | 591,064 | 838,431 | ||
Income before income taxes | 221,287 | 176,078 | 203,119 | 378,382 | 554,460 | 775,747 | ||
Income tax expense | 111,111 | 96,358 | 110,384 | 220,204 | 316,562 | 427,673 | ||
Net Income (Loss) Attributable to Parent | $ 110,176 | $ 79,720 | $ 92,735 | $ 158,178 | $ 237,898 | $ 348,074 | ||
Net income per share - basic | $ 1.09 | $ 0.79 | $ 0.92 | $ 1.58 | $ 2.37 | $ 3.46 | ||
Net income per share - diluted | $ 0.96 | $ 0.70 | $ 0.82 | $ 1.40 | $ 2.10 | $ 3.07 | ||
Non-cash compensation expense | $ 151,920 | |||||||
Deferred taxes | (32,543) | |||||||
Revision Adjustment | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Deferred tax assets (noncurrent) | $ 22,152 | $ 22,152 | ||||||
Total assets | 22,152 | 22,152 | ||||||
Additional paid-in-capital | 60,890 | 60,890 | ||||||
Retained earnings | (38,738) | (38,738) | ||||||
Total stockholders' equity | 22,152 | 22,152 | ||||||
Total liabilities and stockholders' equity | 22,152 | 22,152 | ||||||
Selling, general, and administrative | 31,564 | $ (5,745) | $ (5,684) | (11,307) | $ (17,052) | 14,512 | ||
Total operating expenses | 31,564 | (5,745) | (5,684) | (11,307) | (17,052) | 14,512 | ||
Income from operations | (31,564) | 5,745 | 5,684 | 11,307 | 17,052 | (14,512) | ||
Income before income taxes | (31,564) | 5,745 | 5,684 | 11,307 | 17,052 | (14,512) | ||
Income tax expense | (11,483) | 2,090 | 2,068 | 4,829 | 6,919 | (4,564) | ||
Net Income (Loss) Attributable to Parent | $ (20,081) | $ 3,655 | $ 3,616 | $ 6,478 | $ 10,133 | $ (9,948) | ||
Net income per share - basic | $ (0.20) | $ 0.04 | $ 0.04 | $ 0.07 | $ 0.10 | $ (0.10) | ||
Net income per share - diluted | $ (0.18) | $ 0.03 | $ 0.03 | $ 0.06 | $ 0.09 | $ (0.09) | ||
Non-cash compensation expense | $ (11,307) | |||||||
Deferred taxes | $ 4,829 | |||||||
Revised | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Deferred tax assets (noncurrent) | $ 289,021 | $ 289,021 | ||||||
Total assets | 3,893,979 | 3,893,979 | ||||||
Additional paid-in-capital | 2,465,008 | 2,465,008 | ||||||
Retained earnings | 216,644 | 216,644 | ||||||
Total stockholders' equity | 2,564,477 | 2,564,477 | ||||||
Total liabilities and stockholders' equity | $ 3,893,979 | $ 3,893,979 |
Net Income Per Share (Details)
Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2014 | |
Earnings Per Share [Abstract] | ||||||||
Net income | $ 194,643 | $ 90,095 | $ 83,375 | $ 96,351 | $ 270,664 | $ 164,656 | $ 248,031 | $ 338,126 |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||||||||
Weighted average shares outstanding - basic | 102,886 | 100,391 | 102,558 | 100,085 | ||||
Effect of dilutive securities (in shares): | ||||||||
Stock options | 9,438 | 9,359 | 9,441 | 9,615 | ||||
Restricted stock | 474 | 405 | 471 | 403 | ||||
Warrants | 2,461 | 2,877 | 2,492 | 3,018 | ||||
Dilutive potential shares | 12,373 | 12,641 | 12,404 | 13,036 | ||||
Weighted average shares - diluted (in shares) | 115,259 | 113,032 | 114,962 | 113,121 | ||||
Earnings Per Share, Basic and Diluted [Abstract] | ||||||||
Net income per share - basic | $ 1.89 | $ 0.89 | $ 0.83 | $ 0.96 | $ 2.64 | $ 1.65 | $ 2.47 | $ 3.36 |
Net income per share - diluted (in dollars per share) | $ 1.69 | $ 0.78 | $ 0.73 | $ 0.85 | $ 2.35 | $ 1.46 | $ 2.19 | $ 2.98 |
Stock options | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Weighted average number of shares | 3,366 | 3,765 | 3,370 | 3,714 | ||||
Convertible senior notes | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Weighted average number of shares | 1,539 | 4,662 | 1,733 | 4,711 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | $ 631,477 | |
Unrealized Gains | 81,989 | |
Unrealized (Losses) | (1,551) | |
Total fair value of available-for-sale marketable securities | 711,915 | |
Available-for-sale Securities, Debt Maturities, Fair Value [Abstract] | ||
Maturities within one year | $ 213,694 | 251,761 |
Maturities after one year through five years | 542,369 | 360,208 |
Maturities after five years through ten years | 1,102 | 1,128 |
Total | 757,165 | 613,097 |
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 446,866 | 426,941 |
Fair Value - 12 Months or Greater | 7,602 | 0 |
Fair Value - Total | 454,468 | 426,941 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (954) | (1,551) |
Unrealized Loss - 12 Months or Greater | (31) | 0 |
Unrealized Loss - Total | (985) | (1,551) |
U.S. government and government agency obligations | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 20,397 | 25,549 |
Fair Value - 12 Months or Greater | 0 | 0 |
Fair Value - Total | 20,397 | 25,549 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (24) | (46) |
Unrealized Loss - 12 Months or Greater | 0 | 0 |
Unrealized Loss - Total | (24) | (46) |
Corporate bonds | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 413,794 | 390,613 |
Fair Value - 12 Months or Greater | 7,602 | 0 |
Fair Value - Total | 421,396 | 390,613 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (920) | (1,462) |
Unrealized Loss - 12 Months or Greater | (31) | 0 |
Unrealized Loss - Total | (951) | (1,462) |
Municipal bonds | ||
Continuous Unrealized Loss Position, Fair Value [Abstract] | ||
Fair Value - Less than 12 Months | 12,675 | 10,779 |
Fair Value - 12 Months or Greater | 0 | 0 |
Fair Value - Total | 12,675 | 10,779 |
Continuous Unrealized Loss Position, Aggregate Losses [Abstract] | ||
Unrealized Loss - Less than 12 months | (10) | (43) |
Unrealized Loss - 12 Months or Greater | 0 | 0 |
Unrealized Loss - Total | (10) | (43) |
Unrestricted [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 774,851 | 616,477 |
Unrealized Gains | 29,423 | 5,550 |
Unrealized (Losses) | (985) | (1,551) |
Total fair value of available-for-sale marketable securities | 803,289 | 620,476 |
Unrestricted [Member] | U.S. government and government agency obligations | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 56,998 | 28,596 |
Unrealized Gains | 31 | 3 |
Unrealized (Losses) | (24) | (46) |
Total fair value of available-for-sale marketable securities | 57,005 | 28,553 |
Unrestricted [Member] | Corporate bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 661,084 | 548,832 |
Unrealized Gains | 256 | 136 |
Unrealized (Losses) | (951) | (1,462) |
Total fair value of available-for-sale marketable securities | 660,389 | 547,506 |
Unrestricted [Member] | Municipal bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 39,764 | 37,044 |
Unrealized Gains | 17 | 37 |
Unrealized (Losses) | (10) | (43) |
Total fair value of available-for-sale marketable securities | 39,771 | 37,038 |
Unrestricted [Member] | Equity Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 17,005 | 2,005 |
Unrealized Gains | 29,119 | 5,374 |
Unrealized (Losses) | 0 | 0 |
Total fair value of available-for-sale marketable securities | $ 46,124 | 7,379 |
Restricted [Member] | Equity Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost Basis | 15,000 | |
Unrealized Gains | 76,439 | |
Unrealized (Losses) | 0 | |
Total fair value of available-for-sale marketable securities | $ 91,439 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Jan. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | $ 0 | $ 0 | $ 0 | $ 0 | $ 91,400,000 | ||
Available-for-sale marketable securities: | |||||||
Total fair value of available-for-sale marketable securities | $ 711,915,000 | ||||||
Convertible senior notes | |||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||
Convertible Debt, Noncurrent | $ 33,300,000 | $ 33,300,000 | $ 169,400,000 | ||||
Convertible Debt [Abstract] | |||||||
Interest rate, stated percentage | 1.875% | 1.875% | 1.875% | ||||
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 | $ 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 | 0 | 0 | |||
Measured on a recurring basis | |||||||
Available-for-sale marketable securities: | |||||||
Total fair value of available-for-sale marketable securities | 803,289,000 | 803,289,000 | $ 711,915,000 | ||||
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 | 46,124,000 | 46,124,000 | 7,379,000 | ||||
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 | 757,165,000 | 757,165,000 | 704,536,000 | ||||
Convertible Debt [Abstract] | |||||||
Fair value of the outstanding notes | 201,600,000 | 201,600,000 | 819,800,000 | ||||
Restricted [Member] | Measured on a recurring basis | |||||||
Available-for-sale marketable securities: | |||||||
Equity securities | 91,439,000 | ||||||
Restricted [Member] | Measured on a recurring basis | Significant Other Observable Inputs (Level 2) | |||||||
Available-for-sale marketable securities: | |||||||
Equity securities | 91,439,000 | ||||||
Unrestricted [Member] | |||||||
Available-for-sale marketable securities: | |||||||
Total fair value of available-for-sale marketable securities | 803,289,000 | 803,289,000 | 620,476,000 | ||||
Unrestricted [Member] | Measured on a recurring basis | |||||||
Available-for-sale marketable securities: | |||||||
U.S. government and government agency obligations | 57,005,000 | 57,005,000 | 28,553,000 | ||||
Corporate bonds | 660,389,000 | 660,389,000 | 547,506,000 | ||||
Municipal bonds | 39,771,000 | 39,771,000 | 37,038,000 | ||||
Equity securities | 46,124,000 | 46,124,000 | 7,379,000 | ||||
Total fair value of available-for-sale marketable securities | 620,476,000 | ||||||
Unrestricted [Member] | Measured on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | |||||||
Available-for-sale marketable securities: | |||||||
Equity securities | 46,124,000 | 46,124,000 | 7,379,000 | ||||
Total fair value of available-for-sale marketable securities | 7,379,000 | ||||||
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 | 57,005,000 | 57,005,000 | 28,553,000 | ||||
Municipal bonds | 39,771,000 | 39,771,000 | 37,038,000 | ||||
Equity securities | 660,389,000 | 660,389,000 | 547,506,000 | ||||
Total fair value of available-for-sale marketable securities | 613,097,000 | ||||||
Warrant Transactions [Member] | |||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||
Other Liabilities, Fair Value Disclosure | $ 0 | $ 0 | $ 0 | $ 0 | $ 87,500,000 | $ 0 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Inventory Disclosure [Abstract] | |||||
Inventory Write-down | $ 6,400 | $ 800 | $ 8,100 | $ 1,900 | |
Raw materials | 20,999 | 20,999 | $ 10,923 | ||
Work in process | 111,564 | 111,564 | 73,519 | ||
Finished goods | 9,495 | 9,495 | 10,768 | ||
Deferred costs | 29,208 | 29,208 | 33,651 | ||
Total Inventories | $ 171,266 | $ 171,266 | $ 128,861 |
Accounts Payable and Accrued 42
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Accounts Payable and Accrued Liabilities, Current [Abstract] | ||
Accounts payable | $ 130,016 | $ 99,508 |
Accrued payroll and related costs | 83,105 | 92,778 |
Accrued clinical trial expense | 48,084 | 41,555 |
Accrued sales-related charges, deductions and royalties | 196,095 | 133,085 |
Other accrued expenses and liabilities | 72,205 | 116,563 |
Accounts payable and accrued expenses | $ 529,505 | $ 483,489 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Feb. 28, 2015 | Nov. 30, 2014 | Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Oct. 31, 2011 | |
Debt Conversion | $ 144,000,000 | $ 61,100,000 | |||||||
Debt Instrument, Face Amount | $ 33,300,000 | 33,300,000 | $ 400,000,000 | ||||||
Repayments of convertible senior notes | $ (144,001,000) | $ (61,125,000) | |||||||
Stock issued during period conversion of convertible notes | 1,399,069 | 521,876 | |||||||
Gains (Losses) on Extinguishment of Debt | $ 15,964,000 | $ 10,787,000 | $ 16,906,000 | $ 10,787,000 | |||||
Loss on extinguishment of debt | $ 16,900,000 | ||||||||
Treasury Stock, Shares | 3,416,788 | 3,416,788 | 2,017,732 | ||||||
Treasury Stock, Value | $ 287,079,000 | $ 287,079,000 | $ 169,530,000 | ||||||
Maximum reduction of warrants held by warrant holder | 493,229 | ||||||||
Limit price per share for warrant holders to close out hedge position | $ 397.75 | ||||||||
Payments in connection with deduction of outstanding warrants | $ (124,000,000) | (124,531,000) | $ (143,041,000) | ||||||
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, Increase (Decrease), Net | $ 250,000,000 | ||||||||
Line of Credit Facility, Maximum Month-end Outstanding Amount | 100,000,000 | ||||||||
Line of Credit Facility, Fair Value of Amount Outstanding | $ 0 | $ 0 | |||||||
Convertible senior notes | |||||||||
Treasury Stock, Shares | 1,399,056 | 521,876 | 1,399,056 | 521,876 | |||||
Treasury Stock, Value | $ 117,500,000 | $ 43,800,000 | $ 117,500,000 | $ 43,800,000 | |||||
Additional Paid-in Capital [Member] | |||||||||
Adjustments to Additional Paid in Capital, Equity Component of Convertible Debt, Subsequent Adjustments | $ 694,700,000 | $ 156,700,000 | |||||||
Adjustments to Additional Paid in Capital, Warrant Issued | $ 23,300,000 | ||||||||
Warrant Transactions [Member] | |||||||||
Accounts Payable, Other | $ 59,800,000 | ||||||||
Reduction of number of warrants | 416,480 | 727,516 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2014 | |
Operating Loss Carryforwards [Line Items] | ||||||||
Total income tax expense (benefit) | $ 133,353,000 | $ 99,628,000 | $ 98,448,000 | $ 112,452,000 | $ 333,855,000 | $ 225,033,000 | $ 323,481,000 | $ 423,109,000 |
Effective income tax rate | 40.70% | 53.90% | 55.20% | 57.70% | ||||
Effective Income Tax Rate Reconciliation, State and Local Income Taxes, Percent | 0.00% | |||||||
Effective Income Tax Rate Reconciliation, Change in Tax Rates, Percent | 3.90% | |||||||
Available-for-sale Securities, Income Tax Expense on Change in Unrealized Holding Gain (Loss) | $ (16,300,000) | $ 1,400,000 | $ (18,902,000) | $ 1,400,000 |
Statement of Cash Flows (Detail
Statement of Cash Flows (Details) - USD ($) | 6 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | |
Accrued capital expenditures | $ 67,900,000 | $ 35,100,000 | $ 56,200,000 | $ 16,100,000 |
Convertible Notes Payable, Current | 2,000,000 | 7,500,000 | ||
Notes Payable | 0 | 0 | ||
Facility lease obligation recognized during the period | 20,100,000 | 50,600,000 | ||
Warrant Transactions [Member] | ||||
Accounts Payable, Other | 59,800,000 | |||
Other Liabilities, Fair Value Disclosure | $ 0 | $ 0 | $ 87,500,000 | $ 0 |