Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 28, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | BMRN | |
Entity Registrant Name | BIOMARIN PHARMACEUTICAL INC | |
Entity Central Index Key | 1,048,477 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 171,987,437 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 707,349 | $ 397,040 | |
Short-term investments | 327,499 | 195,579 | |
Accounts receivable, net (allowance for doubtful accounts: $66 and $93, at September 30, 2016 and December 31, 2015, respectively) | 215,894 | 164,959 | |
Inventory | 347,420 | 271,683 | |
Other current assets | 68,409 | 60,378 | |
Total current assets | 1,666,571 | 1,089,639 | |
Noncurrent assets: | |||
Long-term investments | 362,956 | 425,652 | |
Property, plant and equipment, net | 729,836 | 704,207 | |
Intangible assets, net | 561,387 | 683,996 | |
Goodwill | 197,039 | 197,039 | |
Deferred tax assets | 288,006 | 220,191 | |
Other assets | 36,443 | 408,644 | |
Total assets | 3,842,238 | 3,729,368 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 306,129 | 392,511 | |
Short-term convertible debt, net | 22,460 | 0 | |
Short-term contingent acquisition consideration payable | 48,746 | 52,946 | |
Total current liabilities | 377,335 | 445,457 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 653,178 | 662,286 | |
Long-term contingent acquisition consideration payable | 122,644 | 32,663 | |
Deferred tax liabilities | 0 | 143,527 | |
Other long-term liabilities | 43,273 | 44,588 | |
Total liabilities | 1,196,430 | 1,328,521 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 250,000,000 shares authorized at September 30, 2016 and December 31, 2015: 171,697,649 and 161,526,044 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 173 | 162 | |
Additional paid-in capital | 4,231,514 | 3,414,837 | |
Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (14,969) | (13,616) | |
Accumulated other comprehensive income | 2,158 | 21,033 | |
Accumulated deficit | (1,573,068) | (1,021,569) | |
Total stockholders’ equity | 2,645,808 | 2,400,847 | |
Total liabilities and stockholders’ equity | $ 3,842,238 | $ 3,729,368 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | [1] |
Statement Of Financial Position [Abstract] | |||
Allowance for doubtful accounts | $ 66 | $ 93 | |
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 250,000,000 | 250,000,000 | |
Common stock, shares issued | 171,697,649 | 161,526,044 | |
Common stock, shares outstanding | 171,697,649 | 161,526,044 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
REVENUES: | ||||
Net product revenues | $ 278,262 | $ 207,767 | $ 812,195 | $ 658,102 |
Collaborative agreement revenues | 1 | 131 | 234 | 849 |
Royalty, license and other revenues | 1,633 | 1,006 | 4,334 | 3,008 |
Total revenues | 279,896 | 208,904 | 816,763 | 661,959 |
OPERATING EXPENSES: | ||||
Cost of sales | 50,738 | 34,904 | 145,473 | 103,965 |
Research and development | 160,831 | 158,713 | 486,663 | 458,688 |
Selling, general and administrative | 118,758 | 94,044 | 333,635 | 288,364 |
Intangible asset amortization and contingent consideration | 9,654 | 3,116 | (34,318) | 22,963 |
Impairment of intangible assets | 0 | 0 | 599,118 | 0 |
Total operating expenses | 339,981 | 290,777 | 1,530,571 | 873,980 |
LOSS FROM OPERATIONS | (60,085) | (81,873) | (713,808) | (212,021) |
Equity in the loss of BioMarin/Genzyme LLC | (104) | (186) | (374) | (539) |
Interest income | 1,633 | 1,344 | 4,561 | 3,050 |
Interest expense | (9,980) | (9,447) | (29,767) | (28,911) |
Debt conversion expense | 0 | 0 | 0 | (163) |
Other income (expense) | 1,723 | (281) | 504 | (9,105) |
LOSS BEFORE INCOME TAXES | (66,813) | (90,443) | (738,884) | (247,689) |
Provision for (benefit from) income taxes | (24,016) | 483 | (187,385) | (7,273) |
NET LOSS | $ (42,797) | $ (90,926) | $ (551,499) | $ (240,416) |
NET LOSS PER SHARE, BASIC | $ (0.26) | $ (0.57) | $ (3.36) | $ (1.51) |
NET LOSS PER SHARE, DILUTED | $ (0.26) | $ (0.60) | $ (3.37) | $ (1.51) |
Weighted average common shares outstanding, basic | 167,714 | 160,886 | 163,963 | 159,647 |
Weighted average common shares outstanding, diluted | 167,714 | 161,134 | 164,216 | 159,647 |
COMPREHENSIVE LOSS | $ (45,167) | $ (98,203) | $ (570,374) | $ (242,698) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Company Common Stock Held By The NQDC | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | |
Beginning Balance at Dec. 31, 2014 | $ 27,466 | ||||||
Net loss | $ (240,416) | ||||||
Ending Balance at Sep. 30, 2015 | 25,184 | ||||||
Beginning Balance at Jun. 30, 2015 | 32,461 | ||||||
Net loss | (90,926) | ||||||
Ending Balance at Sep. 30, 2015 | 25,184 | ||||||
Beginning Balance at Dec. 31, 2015 | 2,400,847 | [1] | $ 162 | $ 3,414,837 | $ (13,616) | 21,033 | $ (1,021,569) |
Beginning Balance (in shares) at Dec. 31, 2015 | 161,526 | ||||||
Net loss | (551,499) | (551,499) | |||||
Other comprehensive loss | (18,875) | (18,875) | |||||
Issuance of common stock, net of offering costs | 712,938 | $ 8 | 712,930 | ||||
Issuance of common stock, net of offering costs (in shares) | 7,500 | ||||||
Issuance of common stock under the 2006 Employee Stock Purchase Plan (the ESPP) | 6,048 | 6,048 | |||||
Issuance of common stock under the 2006 Employee Stock Purchase Plan (the ESPP) (in shares) | 110 | ||||||
Exercise of common stock options | 43,450 | $ 1 | 43,449 | ||||
Exercise of common stock options (in shares) | 1,345 | ||||||
Excess tax benefit from stock option exercises | 563 | 563 | |||||
Restricted stock units vested during the period, net (in shares) | 779 | ||||||
Restricted stock units vested during the period, net | (55,241) | $ 1 | (55,242) | ||||
Conversion of convertible notes, net (in shares) | 438 | ||||||
Conversion of convertible notes, net | 8,924 | $ 1 | 8,923 | ||||
Common stock held by the NQDC | (1,353) | (1,353) | |||||
Stock-based compensation | 100,006 | 100,006 | |||||
Ending Balance at Sep. 30, 2016 | 2,645,808 | $ 173 | 4,231,514 | (14,969) | 2,158 | (1,573,068) | |
Ending Balance (in shares) at Sep. 30, 2016 | 171,698 | ||||||
Beginning Balance at Jun. 30, 2016 | 4,528 | ||||||
Net loss | (42,797) | ||||||
Ending Balance at Sep. 30, 2016 | $ 2,645,808 | $ 173 | $ 4,231,514 | $ (14,969) | $ 2,158 | $ (1,573,068) | |
Ending Balance (in shares) at Sep. 30, 2016 | 171,698 | ||||||
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (551,499) | $ (240,416) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 76,805 | 34,301 | |
Non-cash interest expense | 22,276 | 21,243 | |
Accretion of discount on investments | 681 | 1,616 | |
Stock-based compensation | 97,220 | 80,959 | |
(Gain) loss on sale of equity investment | 2,020 | (3,022) | |
Impairment of assets | 599,118 | 12,802 | |
Deferred income taxes | (206,691) | 14,629 | |
Excess tax benefit from stock option exercises | (563) | (463) | |
Unrealized foreign exchange gain on forward contracts | (10,961) | (16,491) | |
Non-cash changes in the fair value of contingent acquisition consideration payable | (56,954) | 15,101 | |
Other | 1,044 | 1,059 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (52,023) | 146 | |
Inventory | (59,802) | (47,469) | |
Other current assets | (1,556) | (27,970) | |
Other assets | (5,002) | (1,391) | |
Accounts payable and accrued liabilities | (77,852) | 924 | |
Other long-term liabilities | (4,451) | 790 | |
Net cash used in operating activities | (228,190) | (153,652) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (96,806) | (123,844) | |
Funds held in escrow for the purchase of real property | (8,383) | (12,500) | |
Maturities and sales of investments | 302,801 | 261,786 | |
Purchase of available-for-sale securities | (370,393) | (842,873) | |
Purchase of promissory note | 0 | (3,326) | |
Business acquisitions, net of cash acquired | (1,467) | (538,392) | |
Other | (150) | 0 | |
Net cash used in investing activities | (174,398) | (1,259,149) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of stock options and the ESPP | 49,498 | 51,515 | |
Taxes paid related to net share settlement of equity awards | (55,241) | (21,968) | |
Proceeds from public offering of common stock, net | 712,938 | 888,257 | |
Excess tax benefit from stock option exercises | 563 | 463 | |
Other | 0 | (2,062) | |
Net cash provided by financing activities | 707,758 | 916,205 | |
Effect of exchange rate changes on cash | 5,139 | (2,544) | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 310,309 | (499,140) | |
Cash and cash equivalents: | |||
Beginning of period | 397,040 | [1] | 875,486 |
End of period | 707,349 | 376,346 | |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |||
Cash paid for interest, net of interest capitalized into fixed assets | 4,564 | 4,979 | |
Cash paid for income taxes | 95,163 | 15,377 | |
Stock-based compensation capitalized into inventory | 8,960 | 8,271 | |
Depreciation capitalized into inventory | 13,402 | 11,005 | |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON CASH INVESTING AND FINANCING ACTIVITIES: | |||
Decrease in accounts payable and accrued liabilities related to fixed assets | (13,988) | (11,386) | |
Conversion of convertible debt | 8,924 | 8,957 | |
Accrual for inventory purchases related to the acquisition of the Merck PKU Business | $ 1,322 | $ 0 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
NATURE OF OPERATIONS AND BUSINE
NATURE OF OPERATIONS AND BUSINESS RISKS | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
NATURE OF OPERATIONS AND BUSINESS RISKS | (1) NATURE OF OPERATIONS AND BUSINESS RISKS BioMarin Pharmaceutical Inc. (the Company), a Delaware corporation, develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company’s product portfolio consists of five approved products and multiple clinical and investigational product candidates. The Company’s approved products are Vimizim (elosulfase alfa), Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Aldurazyme (laronidase) and Firdapse (amifampridine phosphate). The Company expects to continue to finance future cash needs that exceed its operating activities primarily through its current cash, cash equivalents, short-term and long-term investments and, to the extent appropriate, through proceeds from equity or debt financings, loans and collaborative agreements with corporate partners. Until the Company consistently generates positive cash flows from its operations, the Company expects to raise the capital necessary to fund its current operations and long-term plans. Additional capital may also be necessary if the Company enters into potential licenses and other acquisitions of complementary technologies, products or companies. The Company is subject to a number of risks and uncertainties, including, without limitation: the financial performance of its approved products; the expected need for additional financings; the Company’s ability to successfully commercialize its approved products; the uncertainty of the Company’s research and development (R&D) efforts resulting in future successful commercial products; the Company’s ability to successfully obtain regulatory approval for new products; the Company’s ability to compete effectively; reliance on the proprietary technology of others; dependence on key personnel; uncertain patent protection; dependence on corporate partners and collaborators; and possible restrictions on reimbursement from governmental agencies and healthcare organizations, as well as other changes in the health care industry. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | (2) BASIS OF PRESENTATION The accompanying Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by the United States generally accepted accounting principles (U.S. GAAP) for complete financial statements, although the Company believes that the disclosures herein are adequate to ensure that the information presented is not misleading. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2015 included in the Company’s Annual Report on Form 10-K. The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. The results of operations for the three and nine months ended September 30, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016 or any other period. Management performed an evaluation of the Company’s activities through the date of filing of this Quarterly Report on Form 10-Q, and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | (3) SIGNIFICANT ACCOUNTING POLICIES There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2016, as compared to the significant accounting policies disclosed in Note 3 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Changes And Error Corrections [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | (4) RECENT ACCOUNTING PRONOUNCEMENTS Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 2016, as compared to the recent accounting pronouncements described in Note 4 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, that are of significance or potential significance to the Company. In March 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-09, Improvements to Employee Share-Based Payment Accounting (ASU 2016-09), which is intended to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 will be effective for the Company’s fiscal year beginning January 1, 2017 unless it elects early adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases (ASU 2016-02). The amended guidance requires balance sheet recognition of lease assets and liabilities by lessees for leases classified as operating leases, with an option to not recognize lease assets and lease liabilities for leases with a term of 12 months or less. The amendments also require new disclosures providing additional qualitative and quantitative information about the amounts recorded in the financial statements. Lessor accounting is largely unchanged. ASU 2016-02 will be effective for the Company’s fiscal year beginning January 1, 2019 unless it elects early adoption. The amendments require a modified retrospective approach with optional practical expedients. In May 2014, the FASB issued ASU No. 2014-09 (ASU 2014-09) regarding Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers . |
ACQUISITIONS
ACQUISITIONS | 9 Months Ended |
Sep. 30, 2016 | |
Business Combinations [Abstract] | |
ACQUISITIONS | (5) ACQUISITIONS The Merck PKU Business On October 1, 2015, the Company entered into a Termination and Transition Agreement with Ares Trading S.A. (Merck Serono), as amended and restated on December 23, 2015 (the A&R Kuvan Agreement), to terminate the Development, License and Commercialization Agreement, dated May 13, 2005, as amended (the License Agreement), between the Company and Merck Serono, including the license to Kuvan the Company had granted to Merck Serono under the License Agreement. Also on October 1, 2015, the Company and Merck Serono entered into a Termination Agreement (the Pegvaliase Agreement) to terminate the license to pegvaliase the Company had granted to Merck Serono under the License Agreement. On January 1, 2016, pursuant to the A&R Kuvan Agreement and the Pegvaliase Agreement, the Company completed the acquisition from Merck Serono and its affiliates of certain rights and other assets with respect to Kuvan and pegvaliase (the Merck PKU Business). As a result, the Company acquired all global rights to Kuvan and pegvaliase from Merck Serono, with the exception of Kuvan in Japan. Previously, the Company had exclusive rights to Kuvan in the United States (U.S.) and Canada and pegvaliase in the U.S. and Japan. In connection with the acquisition of the , the Company recognized transaction costs of $0.6 million, of which $0.3 million was recognized in each of the year ended December 31, 2015 and in the nine month period ended . Pursuant to the A&R Kuvan Agreement, the Company paid Merck Serono $374.5 million € € The Company and Merck Serono have no further rights or obligations under the License Agreement with respect to pegvaliase. The License Agreement will continue in effect, but in no event later than December 31, 2016, in order to complete the transfer of certain assets related to Kuvan, the majority of which occurred in January 2016. Accordingly, as of September 30, 2016, the Company continues to rely on Merck Serono to provide critical transition services for the sales and distribution of Kuvan in approximately eight remaining countries until marketing authorizations can be transferred in such countries. Prior to the consummation of the transactions described above, the Company sold Kuvan to Merck Serono at a price near its manufacturing costs, and Merck Serono resold the product to end users outside the U.S., Canada and Japan. The royalty earned by the Company from Kuvan product sold by Merck Serono was included as a component of Net Product Revenues in the period earned. Kuvan is a commercialized product for the treatment of patients with phenylketonuria (PKU) and/or for primary BH4 deficiency in certain countries. Pegvaliase is currently in pivotal studies as a potential therapeutic option for adult patients with PKU. In March 2016, the Company announced that its pivotal Phase 3 PRISM-2 study of pegvaliase met the primary endpoint of change in blood Phe compared with placebo (p<0.0001); and the Company also announced its plans to submit a marketing application in the U.S. Kuvan has Orphan Drug exclusivity in the European Union (EU) until 2020, and pegvaliase has Orphan Drug designation in the U.S. and the EU. The acquisition date fair value of the contingent acquisition consideration payments, Kuvan global marketing rights, with the exception of Japan, and pegvaliase in-process research and development (IPR&D) acquired was estimated by applying a probability-based income approach utilizing an appropriate discount rate. This estimation was based on significant inputs that are not observable in the market, referred to as level 3 inputs. The range of outcomes and assumptions used to develop these estimates has been updated to estimate the fair value of the contingent acquisition consideration payable at September 30, 2016. The following table presents the preliminary allocation of the purchase consideration for the Merck PKU Business Cash payments $ 374,545 Estimated fair value of contingent acquisition consideration payable 138,974 Total consideration $ 513,519 Kuvan intangible assets $ 172,961 Pegvaliase IPR&D 326,359 Inventory 14,199 Total identifiable assets acquired $ 513,519 The amount allocated to the Kuvan intangible assets is considered to be finite-lived and will be amortized on a straight-line basis over its estimated useful life through 2024. The amount allocated to acquired pegvaliase IPR&D is considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate the reduction in the fair value of the IPR&D assets below their respective carrying amounts. When development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point. See Note 8 to these Condensed Consolidated Financial Statements for further discussion of the indefinite-lived intangible assets. Pro Forma Financial Information The following unaudited pro forma financial information presents the combined results of operations of the Company and the Merck PKU Business as if the acquisition occurred on January 1, 2015. This unaudited pro forma financial information is presented for informational purposes only and is not necessarily indicative of the results of future operations that would have been achieved had the acquisitions taken place at the beginning of 2015. Three Months Ended September 30, Nine Months Ended September 30, 2015 2015 Total revenues $ 225,697 $ 713,930 Net loss $ (84,395 ) $ (220,465 ) Net loss per share, basic $ (0.52 ) $ (1.38 ) Net loss per share, diluted $ (0.55 ) $ (1.38 ) Weighted average common shares outstanding, basic 160,886 159,647 Weighted average common shares outstanding, diluted 161,134 159,647 |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
NET LOSS PER COMMON SHARE | (6) NET LOSS PER COMMON SHARE Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the Company’s ESPP, unvested restricted stock units (RSUs), common stock held by the NQDC and contingent issuances of common stock related to convertible debt. The following table sets forth the computation of basic and diluted earnings per common share (in thousands of common shares): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Numerator: Net loss, basic $ (42,797 ) $ (90,926 ) $ (551,499 ) $ (240,416 ) Gain on common stock held by the NQDC — (4,980 ) (1,753 ) — Net loss, diluted $ (42,797 ) $ (95,906 ) $ (553,252 ) $ (240,416 ) Denominator: Weighted-average common shares outstanding, basic 167,714 160,886 163,963 159,647 Effect of dilutive securities: Common shares held by the NQDC — 248 253 — Weighted-average common shares outstanding, diluted 167,714 161,134 164,216 159,647 Net loss per common share, basic $ (0.26 ) $ (0.57 ) $ (3.36 ) $ (1.51 ) Net loss per common share, diluted $ (0.26 ) $ (0.60 ) $ (3.37 ) $ (1.51 ) In addition to the equity instruments included in the table above, the table below presents the shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method (in thousands of shares): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Options to purchase common stock 9,610 10,503 9,610 10,503 Common stock issuable under the 2017 Notes 1,105 1,553 1,105 1,553 Common stock issuable under the 2018 and 2020 Notes 7,966 7,966 7,966 7,966 Unvested restricted stock units 2,728 1,757 2,728 1,633 Common stock potentially issuable for ESPP purchases 130 229 114 220 Common stock held by the NQDC 253 — — 248 Total number of potentially issuable shares 21,792 22,008 21,523 22,123 The effect of the Company’s 0.7% senior subordinated convertible notes due in 2018 (the 2018 Notes) and the Company’s 1.50% senior subordinated convertible notes due in 2020 (the 2020 Notes, and together with the 2018 Notes, the Notes) were excluded from the diluted net loss per common share because they were antidilutive. The Company’s closing stock price on September 30, 2016 and 2015 did not exceed the conversion price of $94.15 per share for the Notes. |
INVESTMENTS
INVESTMENTS | 9 Months Ended |
Sep. 30, 2016 | |
Investments Schedule [Abstract] | |
INVESTMENTS | (7) INVESTMENTS All investments were classified as available-for-sale at September 30, 2016 and December 31, 2015. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale securities by major security type at September 30, 2016 and December 31, 2015 are summarized in the tables below: Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at September 30, 2016 Certificates of deposit $ 2,800 $ — $ — $ 2,800 Corporate debt securities 420,259 873 (165 ) 420,967 Commercial paper 16,692 — — 16,692 U.S. government agency securities 249,674 190 (2 ) 249,862 Greek government-issued bonds 52 82 — 134 Total $ 689,477 $ 1,145 $ (167 ) $ 690,455 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at December 31, 2015 Certificates of deposit $ 63,919 $ 1 $ — $ 63,920 Corporate debt securities 358,625 20 (732 ) 357,913 Commercial paper 12,733 — — 12,733 U.S. government agency securities 186,882 — (344 ) 186,538 Greek government-issued bonds 48 79 — 127 Total $ 622,207 $ 100 $ (1,076 ) $ 621,231 As of December 31, 2015, the Company had two investments in marketable equity securities measured using quoted prices in their respective active markets that are collectively considered strategic investments. In the second quarter of 2016, the remaining shares of one strategic investment were sold for a realized loss of $2.0 million. As of September 30, 2016, the fair value of the Company’s marketable equity securities was $7.3 million, which included an unrealized gain of $4.3 million. As of December 31, 2015, the fair value of the Company’s marketable equity securities was $18.1 million, which included an unrealized gain of $12.7 million. The Company’s investments are recorded in Other Assets in the Company’s Condensed Consolidated Balance Sheets. The fair values of available-for-sale securities by contractual maturity were as follows: September 30, December 31, 2016 2015 Maturing in one year or less $ 327,499 $ 195,579 Maturing after one year through five years 362,956 425,652 Total $ 690,455 $ 621,231 Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is other-than-temporary and, if it is other-than-temporary, an impairment loss is recognized in earnings equal to the difference between the investment’s amortized cost and fair value at such date. As of September 30, 2016, some of the Company’s investments were in an unrealized loss position. However, the Company has the ability and intent to hold all investments that have been in a continuous loss position until maturity or recovery, thus no other-than-temporary impairment is deemed to have occurred. See Note 13 to these Condensed Consolidated Financial Statements for additional discussion regarding the fair value of the Company’s available-for-sale securities. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 9 Months Ended |
Sep. 30, 2016 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | (8) INTANGIBLE ASSETS Intangible assets consisted of the following: September 30, December 31, 2016 2015 Intangible assets: Finite-lived intangible assets $ 305,122 $ 129,572 Indefinite-lived intangible assets 332,199 607,548 Gross intangible assets: 637,321 737,120 Less: Accumulated amortization (75,934 ) (53,124 ) Net carrying value $ 561,387 $ 683,996 Indefinite-Lived Intangible Assets Intangible assets related to IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate a reduction in the fair value of the IPR&D assets below their respective carrying amounts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time. During the second quarter of 2016, the Company withdrew its Marketing Authorization Application (MAA) for Kyndrisa from the European Medicines Agency (EMA) and announced it would discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053 (other exons), for the treatment of distinct forms of Duchenne muscular dystrophy. Based on the then current status of the European development efforts, the Company recognized an impairment charge of $574.1 million in the second quarter of 2016 related to the Kyndrisa and other exon See Note 8 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for additional information related to the Company’s intangible assets. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2016 | |
Property Plant And Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | (9) PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, net consisted of the following: September 30, December 31, 2016 2015 Building and improvements $ 505,894 $ 442,100 Manufacturing and laboratory equipment 229,818 145,313 Computer hardware and software 123,557 113,442 Leasehold improvements 44,802 44,247 Furniture and equipment 26,359 22,817 Land improvements 4,881 4,881 Land 45,727 45,727 Construction-in-progress 76,992 164,283 1,058,030 982,810 Less: Accumulated depreciation (328,194 ) (278,603 ) Total property, plant and equipment, net $ 729,836 $ 704,207 Construction in-process primarily includes costs related to the Company’s significant in-process projects at its facilities in Marin County, California, and its manufacturing facility in Shanbally, Cork, Ireland. Depreciation expense for the three and nine months ended September 30, 2016 was $23.2 million and $56.1 million, respectively, of which $4.4 million and $13.4 million, respectively, was capitalized into inventory. Depreciation expense for the three and nine months ended September 30, 2015 was $12.7 million and $36.4 million, respectively, of which $3.7 million and $11.0 million, respectively, was capitalized into inventory. Capitalized interest related to the Company’s property, plant and equipment purchases for each of the three and nine months ended September 30, 2016 and 2015 was insignificant. |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 9 Months Ended |
Sep. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | (10) SUPPLEMENTAL BALANCE SHEET INFORMATION Inventory consisted of the following: September 30, December 31, 2016 2015 Raw materials $ 46,951 $ 46,115 Work-in-process 189,596 150,289 Finished goods 110,873 75,279 Total inventory $ 347,420 $ 271,683 In the first quarter of 2016, process qualification production activities commenced in the Company’s Shanbally facility related to Vimizim production. As of September 30, 2016, the value of the qualification campaign was $29.8 million, which was capitalized as inventory because the product is expected to be sold commercially. While the Company believes it is unlikely that the manufacturing process will not be approved for Vimizim production, should that occur, the value of the inventory would be expensed at that time. Inventory as of September 30, 2016, included $31.3 million of pre-launch Brineura (formerly referred to as cerliponase alfa) inventory for production that commenced in the second quarter of 2016. Brineura is an investigational therapy to treat children with CLN2 disease, or late infantile neuronal ceroid lipofuscinosis, a lysosomal storage disorder primarily affecting the brain. The Company must receive marketing approval from the applicable regulators before the Brineura inventory can be sold commercially. Although regulatory approval cannot be assured, the Company expects to receive regulatory approval and realize the costs of the inventory through future sales. The Company believes that all material uncertainties related to the ultimate regulatory approval of Brineura for commercial sale have been significantly reduced based on positive data from Phase I/II clinical trial results and the filings of Biologics License Application (BLA) with the Food and Drug Administration (FDA) and the MAA with the EMA during the second quarter of 2016. In its evaluation, the Company also considered its historical experience with developing and commercially producing similar products for rare genetic disorders. Other Assets consisted of the following: September 30, December 31, 2016 2015 Deposit for business acquisition $ — $ 371,756 Deposits 19,748 8,606 Strategic investments 7,267 18,056 Long-term forward foreign currency exchange contract assets 750 3,533 Other 8,678 6,693 Total other assets $ 36,443 $ 408,644 Included in Deposits is an $8.4 million escrow deposit to purchase land in Shanbally, Ireland. Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, 2016 2015 Accounts payable and accrued operating expenses $ 148,773 $ 179,294 Accrued compensation expense 85,219 95,345 Accrued rebates payable 34,184 32,553 Accrued royalties payable 14,183 10,412 Value added taxes payable 7,961 6,377 Accrued income taxes — 59,572 Other 15,809 8,958 Total accounts payable and accrued liabilities $ 306,129 $ 392,511 Accounts payable and accrued operating expenses as of September 30, 2016, included approximately $4.9 million of employee termination benefits accrued as a result of the termination of the Kyndrisa and other exon development programs. This plan was approved and communicated to the impacted employees in the third quarter of 2016. Cash payments to employees will be made through the first quarter of 2017. |
CONVERTIBLE DEBT
CONVERTIBLE DEBT | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE DEBT | (11) CONVERTIBLE DEBT The following table summarizes information regarding the Company’s convertible debt: September 30, 2016 December 31, 2015 Convertible Notes due in 2017 $ 22,506 $ 31,430 Unamortized deferred offering costs (46 ) (110 ) Convertible Notes due in 2017, net 22,460 31,320 Convertible Notes due in 2018 374,980 374,980 Unamortized discount (31,219 ) (41,904 ) Unamortized deferred offering costs (3,968 ) (5,415 ) Convertible Notes due in 2018, net 339,793 327,661 Convertible Notes due in 2020 374,993 374,993 Unamortized discount (56,364 ) (65,478 ) Unamortized deferred offering costs (5,244 ) (6,210 ) Convertible Notes due in 2020, net 313,385 303,305 Total convertible debt, net $ 675,638 $ 662,286 Fair value of fixed rate convertible debt Convertible Notes due in 2017 (1) $ 101,789 $ 162,016 Convertible Notes due in 2018 (1) 448,247 482,584 Convertible Notes due in 2020 (1) 469,487 502,701 Total $ 1,019,523 $ 1,147,301 (1) The fair value of the Company’s fixed rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Coupon interest $ 2,466 $ 2,283 $ 7,491 $ 7,667 Amortization of issuance costs 826 823 2,476 2,471 Accretion of debt discount 6,688 6,341 19,800 18,773 Total interest expense on convertible debt $ 9,980 $ 9,447 $ 29,767 $ 28,911 During the three and nine months ended September 30, 2016, certain existing holders of the Company’s senior subordinated notes due in 2017 (the 2017 Notes) elected to convert $2.0 million and $8.9 million, respectively, in aggregate principal amount of the 2017 Notes into 97,348 and 438,315 shares of the Company’s common stock, respectively. During the nine months ended September 30, 2015, the Company entered into three separate agreements with certain existing holders of its 2017 Notes pursuant to which such holders converted $8.1 million in aggregate principal amount of the 2017 Notes into 399,469 shares of the Company’s common stock. In addition to issuing the requisite number of shares of the Company’s common stock, the Company also made varying cash payments to the holders totaling $0.2 million in the aggregate, of which $0.2 million was recognized in total as debt conversion expense on the Company’s Condensed Consolidated Statement of Comprehensive Loss for the nine months ended September 30, 2015. See Note 14 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for additional information related to the Company’s convertible debt. |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 9 Months Ended |
Sep. 30, 2016 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | (12) DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The Company uses forward foreign currency exchange contracts to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company’s forecasted revenues and operating expenses being denominated in currencies other than the U.S. dollar, primarily the Euro. The Company designates certain of these forward foreign currency exchange contracts as hedging instruments and enters into some forward foreign currency exchange contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward foreign currency exchange contracts protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues, operating expenses and asset or liability positions designated in currencies other than the U.S. dollar. The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates, and take into consideration the current creditworthiness of the counterparties or the Company, as applicable. Information regarding the specific instruments used by the Company to hedge its exposure to foreign currency exchange rate fluctuations is provided below. See Note 13 to these Condensed Consolidated Financial Statements for additional discussion regarding the fair value of forward foreign currency exchange contracts. The Company enters into forward foreign currency exchange contracts in order to protect against the fluctuations in revenue and operating expenses associated with foreign currency-denominated cash flows. The Company has formally designated these forward foreign currency exchange contracts as cash flow hedges and expects them to be highly effective in offsetting fluctuations in operating expenses denominated in Euros and revenues denominated in currencies other than the U.S. dollar related to changes in foreign currency exchange rates. The following table summarizes the Company’s designated forward foreign currency exchange contracts outstanding as of September 30, 2016 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros - Purchase 84 92.5 Oct. 2016 - Sep. 2019 Euros - Sell 280 316.5 Oct. 2016 - Sep. 2019 Canadian Dollars - Sell 6 3.1 Oct. 2016 - Dec. 2016 Colombian Pesos - Sell 3 9,798.0 Oct. 2016 - Dec. 2016 British Pounds - Sell 1 0.6 October 2016 Total 374 The Company also enters into forward foreign currency exchange contracts that are not designated as hedges for accounting purposes. The changes in fair value of these forward foreign currency exchange contracts are included as a part of selling, general and administrative (SG&A) expense in the Company’s Condensed Consolidated Statements of Comprehensive Loss. The following table summarizes the Company’s non-designated forward foreign currency exchange contracts outstanding as of September 30, 2016 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros - Purchase 1 99.4 October 2016 British Pounds - Sell 1 6.9 October 2016 Total 2 The maximum length of time over which the Company is hedging its exposure to the reduction in value of forecasted foreign currency revenues through forward foreign currency exchange contracts is through September 2019. Over the next twelve months, the Company expects to reclassify $0.5 million from accumulated other comprehensive income to earnings as the forecasted revenue and operating expense transactions occur. The fair value carrying amounts of the Company’s derivative instruments were as follows: Asset Derivatives Liability Derivatives September 30, 2016 September 30, 2016 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 4,785 Accounts payable and accrued liabilities $ 3,290 Forward foreign currency exchange contracts Other assets 750 Other long- term liabilities 1,979 Total 5,535 5,269 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 25 Accounts payable and accrued liabilities 65 Forward foreign currency exchange contracts Other assets — Other long- term liabilities — Total 25 65 Total value of derivative contracts $ 5,560 $ 5,334 Asset Derivatives Liability Derivatives December 31, 2015 December 31, 2015 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 10,478 Accounts payable and accrued liabilities $ 1,986 Forward foreign currency exchange contracts Other assets 3,533 Other long- term liabilities 3,057 Total 14,011 5,043 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets — Accounts payable and accrued liabilities 22 Total — 22 Total value of derivative contracts $ 14,011 $ 5,065 The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2016 and 2015 was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in Other Comprehensive Income (OCI) (1) $ (1,984 ) $ 3,126 $ (5,857 ) $ 14,191 Net gain reclassified from accumulated OCI into earnings (2) 1,486 5,187 4,616 15,084 Net gain (loss) recognized in net loss (3) 9 (264 ) 5,276 (404 ) Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ 826 $ (514 ) $ (2,446 ) $ 6,052 (1) Net change in the fair value of the effective portion classified as OCI. (2) Effective portion classified as Net Product Revenues and SG&A expense. (3) Ineffective portion and amount excluded from effectiveness testing classified as SG&A expense. (4) Classified as SG&A expense. At September 30, 2016 and December 31, 2015, accumulated other comprehensive income associated with forward foreign currency exchange contracts qualifying for hedge accounting treatment was a gain of $1.2 million and $13.6 million, respectively. The Company is exposed to counterparty credit risk on all of its derivative financial instruments. The Company has established and maintains strict counterparty credit guidelines and enters into hedges only with financial institutions that are investment grade or better to minimize the Company ’ |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | (13) FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value on a recurring basis, including available-for-sale fixed income securities and foreign currency derivatives. The tables below present the fair value of these financial assets and liabilities determined using the following input levels. Fair Value Measurements at September 30, 2016 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Overnight deposits $ 246,568 $ — $ — $ 246,568 Money market instruments — 460,781 — 460,781 Total cash and cash equivalents 246,568 460,781 — 707,349 Available-for-sale securities: Short-term: Certificates of deposit — 2,800 — 2,800 Corporate debt securities — 139,073 — 139,073 Commercial paper — 16,692 — 16,692 U.S. government agency securities — 168,934 — 168,934 Long-term: Corporate debt securities — 281,894 — 281,894 U.S. government agency securities — 80,928 — 80,928 Greek government-issued bonds — 134 — 134 Total available-for-sale securities — 690,455 — 690,455 Other current assets: Nonqualified Deferred Compensation Plan assets — 309 — 309 Forward foreign currency exchange contract (1) — 4,810 — 4,810 Restricted investments (2) — 4,052 — 4,052 Total other current assets — 9,171 — 9,171 Other assets: Nonqualified Deferred Compensation Plan assets — 8,562 — 8,562 Forward foreign currency exchange contract (1) — 750 — 750 Strategic investment (3) 7,267 — — 7,267 Total other assets 7,267 9,312 — 16,579 Total assets $ 253,835 $ 1,169,719 $ — $ 1,423,554 Liabilities: Current liabilities: Nonqualified Deferred Compensation Plan liability $ 4,008 $ 309 $ — $ 4,317 Forward foreign currency exchange contract (1) — 3,355 — 3,355 Contingent acquisition consideration payable — — 48,746 48,746 Total current liabilities 4,008 3,664 48,746 56,418 Other long-term liabilities: Nonqualified Deferred Compensation Plan liability $ 19,394 $ 8,562 — 27,956 Forward foreign currency exchange contract (1) — 1,979 — 1,979 Contingent acquisition consideration payable — — 122,644 122,644 Total other long-term liabilities 19,394 10,541 122,644 152,579 Total liabilities $ 23,402 $ 14,205 $ 171,390 $ 208,997 Fair Value Measurements at December 31, 2015 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Overnight deposits $ 290,731 $ — $ — $ 290,731 Money market instruments — 106,309 — 106,309 Total cash and cash equivalents 290,731 106,309 — 397,040 Available-for-sale securities: Short-term: Certificates of deposit — 56,951 — 56,951 Corporate debt securities — 42,673 — 42,673 Commercial paper — 12,733 — 12,733 U.S. government agency securities — 83,222 — 83,222 Long-term: Certificates of deposit — 6,969 — 6,969 Corporate debt securities — 315,240 — 315,240 U.S. government agency securities — 103,316 — 103,316 Greek government-issued bonds — 127 — 127 Total available-for-sale securities — 621,231 — 621,231 Other current assets: Nonqualified Deferred Compensation Plan assets — 440 — 440 Forward foreign currency exchange contract (1) — 10,478 — 10,478 Restricted investments (2) — 7,348 — 7,348 Total other current assets — 18,266 — 18,266 Other assets: Nonqualified Deferred Compensation Plan assets — 6,362 — 6,362 Forward foreign currency exchange contract (1) — 3,533 — 3,533 Strategic investment (3) 18,056 — — 18,056 Total other assets 18,056 9,895 — 27,951 Total assets $ 308,787 $ 755,701 $ — $ 1,064,488 Liabilities: Current liabilities: Nonqualified Deferred Compensation Plan liability $ 1,151 $ 440 $ — $ 1,591 Forward foreign currency exchange contract (1) — 2,008 — 2,008 Contingent acquisition consideration payable — — 52,946 52,946 Total current liabilities 1,151 2,448 52,946 56,545 Other long-term liabilities: Nonqualified Deferred Compensation Plan liability 24,341 6,362 — 30,703 Forward foreign currency exchange contract (1) — 3,057 — 3,057 Contingent acquisition consideration payable — — 32,663 32,663 Total other long-term liabilities 24,341 9,419 32,663 66,423 Total liabilities $ 25,492 $ 11,867 $ 85,609 $ 122,968 (1) See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. (2) The restricted investments at September 30, 2016 and December 31, 2015 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. (3) The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investments. There were no transfers between levels during the three and nine months ended September 30, 2016. The Company’s Level 2 securities are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs. The Company validates the prices provided by its third-party pricing services by understanding the models used, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming those securities traded in active markets. See Note 7 to these Condensed Consolidated Financial Statements for further information regarding the Company’s financial instruments. Liabilities measured at fair value using Level 3 inputs consisted of contingent acquisition consideration payable and asset retirement obligations. The Company ’ ’ ’ Contingent acquisition consideration payable at December 31, 2015 $ 85,609 Addition of contingent acquisition consideration payable related to the purchase of the Merck PKU Business 138,974 Changes in the fair value of contingent acquisition consideration payable for continuing development programs 7,032 Reduction of fair value related to termination of Kyndrisa development program (43,652 ) Reduction of fair value related to termination of reveglucosidase alfa development program (20,334 ) Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 3,761 Contingent acquisition consideration payable at September 30, 2016 $ 171,390 Under certain of the Company ’ Asset retirement obligations at December 31, 2015 $ 4,704 Accretion expense 79 Reversals (250 ) Asset retirement obligations at September 30, 2016 $ 4,533 The Company acquired intangible assets as a result of various business acquisitions. The estimated fair value of these long-lived assets was measured using Level 3 inputs as of the acquisition date. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
STOCK-BASED COMPENSATION | (14) STOCK-BASED COMPENSATION The Company’s stock-based compensation plans include the Amended and Restated 2006 Share Incentive Plan (the Share Incentive Plan) and the ESPP. The Company previously had a 2014 Inducement Plan and a 2012 Inducement Plan, which expired in June 2015 and May 2013, respectively. The Company’s stock-based compensation plans are administered by the Compensation Committee of the Company’s Board of Directors (the Board), which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the awards. See Note 18 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for additional information related to these stock-based compensation plans. Determining the Fair Value of Stock Options and Stock Purchase Rights The fair value of each option award is estimated on the date of grant using the Black-Scholes valuation model and the assumptions noted in the tables below. The expected life of options is based on observed historical exercise patterns. Groups of employees that have similar historical exercise patterns were considered separately for valuation purposes, and as of September 30, 2016 the Company has identified two groups with distinctly different exercise patterns. The two groups identified are executive and non-executive employees. The executive employee group has a history of holding options for longer periods than non-executive employees. The expected volatility of stock options is based upon the weighted average of the historical volatility of the Company s common stock. The risk-free interest rate is based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term equal to the expected term of the option. The dividend yield reflects that the Company has not paid any cash dividends since inception and does not intend to pay any cash dividends in the foreseeable future Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Expected volatility 38 – 40% 41 – 44% 36 – 44% 39 – 45% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected life 5.0 – 6.7 years 6.9 – 8.0 years 5.0 – 8.1 years 6.4 – 8.0 years Risk-free interest rate 1.1 – 1.4% 1.9 – 2.2% 1.1 – 2.1% 1.5 – 2.2% During the nine The Company did not issue any new stock purchase rights under the ESPP during the three months ended September 30, 2016. Restricted Stock Unit Awards with Service-Based Vesting Conditions RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. During the nine Restricted Stock Unit Awards with Performance and Market-Based Vesting Conditions During 2012 and 2011, p ursuant to the approval of the Board, the Company granted 860,000 RSU awards with performance and market-based vesting conditions (the 2011/2012 Base RSUs) under the Share Incentive Plan and the 2012 Inducement Plan to certain executive officers. The 2011/2012 Base RSUs had a weighted-average grant date fair value of $34.66 and vested on February 29, 2016, based upon the achievement of the Vimizim approval and the 2015 revenue goal. The Company determined the number of Base RSUs that were earned on the vesting date (the Earned RSUs) and to determine the total number of RSUs to be awarded the Earned RSUs were multiplied by the Total Shareholder Return multiplier of 124% resulting in the issuance of 799,800 shares on February 29, 2016. Restricted Stock Unit Awards with Performance Conditions On March 15, 2016, pursuant to Board approval, the Company granted 130,310 RSU awards with performance-vesting conditions (the 2016 Base RSUs) under the Share Incentive Plan to certain executive officers. The vesting of the 2016 Base RSUs under this specific grant is contingent upon the achievement of a 2016 revenue target and a three-year service period. The number of RSUs to be awarded from the 2016 Base RSUs upon achievement of the performance condition shall be calculated by multiplying the 2016 Base RSUs by a revenue multiplier (determined based on the Company’s performance against the revenue target), which could range between 80% and 120%. Stock-based compensation for these awards will be recognized over the service period beginning in the period the Company determines it is probable that the revenue target will be achieved. The cost of the 2016 Base RSUs was determined to be $83.43 per RSU, based on the fair value of the common stock underlying the 2016 Base RSUs on the grant date. The Company evaluated the 2016 revenue target in the context of its current 2016 revenue forecast and related confidence level in the forecast, and determined that attainment of the revenue target was probable for accounting purposes in the first quarter of 2016. As a result, the Company recognized $1.0 million and $2.1 million of compensation expense related to these awards during the three and nine months ended September 30, 2016, respectively. On March 3, 2015, pursuant to Board approval, the Company granted 58,300 RSU awards with performance-vesting conditions (the 2015 Base RSUs) and a three-year service period, under the Share Incentive Plan, to certain executive officers . ’ Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Loss for all stock-based compensation arrangements was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Cost of sales $ 2,092 $ 1,386 $ 5,943 $ 4,484 R&D 14,165 12,578 42,929 34,972 SG&A 16,645 14,794 48,348 41,503 Total stock-based compensation expense $ 32,902 $ 28,758 $ 97,220 $ 80,959 Stock-based compensation expense of $9.0 million and $8.3 million was capitalized into inventory for the nine months ended September 30, 2016 and 2015, respectively. Capitalized stock-based compensation is recognized as Cost of Sales when the related product is sold. |
COMPREHENSIVE LOSS
COMPREHENSIVE LOSS | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
COMPREHENSIVE LOSS | (15) COMPREHENSIVE LOSS The following table summarizes amounts reclassified out of Accumulated Other Comprehensive Income (AOCI) and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, Nine Months Ended September 30, Consolidated Statement of Details about AOCI Components 2016 2015 2016 2015 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ 1,436 $ 4,411 $ 4,036 $ 13,660 Net product revenues Forward foreign currency exchange contracts 50 776 4,874 1,424 SG&A Gain (loss) on sale of available-for-sale securities 7 14 (2,020 ) 3,036 Other income (expense) Less: Income tax effect of the above 2 5 (735 ) 1,098 Provision for (Benefit from) income taxes $ 1,491 $ 5,196 $ 7,625 $ 17,022 Net loss The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income and reclassifications out of AOCI for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 Other comprehensive income (loss) before reclassifications (1,984 ) 1,738 (1 ) (247 ) Less net gain reclassified from AOCI 1,486 7 — 1,493 Tax effect — (630 ) — (630 ) Net current-period other comprehensive income (loss) (3,470 ) 1,101 (1 ) (2,370 ) AOCI balance at September 30, 2016 $ (1,165 ) $ 3,332 $ (9 ) $ 2,158 Nine Months Ended September 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2015 $ 13,602 $ 7,441 $ (10 ) $ 21,033 Other comprehensive income (loss) before reclassifications (5,857 ) (8,477 ) 1 (14,333 ) Less net gain (loss) reclassified from AOCI 8,910 (2,020 ) — 6,890 Tax effect — 2,348 — 2,348 Net current-period other comprehensive income (loss) (14,767 ) (4,109 ) 1 (18,875 ) AOCI balance at September 30, 2016 $ (1,165 ) $ 3,332 $ (9 ) $ 2,158 Three Months Ended September 30, 2015 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at June 30, 2015 $ 17,074 $ 15,336 $ 51 $ 32,461 Other comprehensive income (loss) before reclassifications 3,126 (8,159 ) 1 (5,032 ) Less gain reclassified from AOCI 5,187 14 — 5,201 Tax effect — 2,956 — 2,956 Net current-period other comprehensive loss (2,061 ) (5,217 ) 1 (7,277 ) AOCI balance at September 30, 2015 $ 15,013 $ 10,119 $ 52 $ 25,184 Nine Months Ended September 30, 2015 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2014 $ 15,906 $ 11,511 $ 49 $ 27,466 Other comprehensive income before reclassifications 14,191 865 3 15,059 Less gain reclassified from AOCI 15,084 3,036 — 18,120 Tax effect — 779 — 779 Net current-period other comprehensive income (loss) (893 ) (1,392 ) 3 (2,282 ) AOCI balance at September 30, 2015 $ 15,013 $ 10,119 $ 52 $ 25,184 |
REVENUE AND CREDIT CONCENTRATIO
REVENUE AND CREDIT CONCENTRATIONS | 9 Months Ended |
Sep. 30, 2016 | |
Risks And Uncertainties [Abstract] | |
REVENUE AND CREDIT CONCENTRATIONS | (16) REVENUE AND CREDIT CONCENTRATIONS Net Product Revenue— The Company considers there to be revenue concentration risks for regions where net product revenue exceeds 10% of consolidated net product revenue. The concentration of the Company’s net product revenue within the regions below may have a material adverse effect on the Company’s revenue and results of operations if sales in the respective regions experience difficulties. The table below summarizes consolidated net product revenue concentrations based on patient location for Vimizim, Naglazyme, Kuvan and Firdapse which are sold directly by the Company and global sales of Aldurazyme which is marketed by Genzyme Corporation (Genzyme). Genzyme is the Company’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Net product revenues from Genzyme consisted of royalties on worldwide net Aldurazyme sales and incremental product transfer revenues. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net product revenues marketed by the Company United States 38 % 44 % 38 % 38 % Europe 23 % 21 % 23 % 19 % Latin America 14 % 12 % 13 % 19 % Rest of world 16 % 13 % 19 % 15 % Total net product revenue marketed by the Company 91 % 90 % 93 % 91 % Aldurazyme net product revenues marketed by Genzyme 9 % 10 % 7 % 9 % Total net product revenues 100 % 100 % 100 % 100 % The following table illustrates the percentage of the Company’s consolidated net product revenues attributed to the Company’s largest customers for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Customer A 19 % 15 % 19 % 14 % Customer B 13 % 9 % 13 % 11 % Customer C 6 % 6 % 6 % 13 % Customer D 10 % 13 % 10 % 5 % Total 48 % 43 % 48 % 43 % On a consolidated basis, the Company’s two largest customers accounted for 22% and 19% of the September 30, 2016 accounts receivable balance, respectively, compared to December 31, 2015, when the two largest customers accounted for 37% and 18% of the accounts receivable balance, respectively. Genzyme is the Company’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third-parties. As of September 30, 2016, and December 31, 2015, the accounts receivable balance for Genzyme included $22.6 million and $36.1 million, respectively, of unbilled accounts receivable related to net incremental Aldurazyme product transfers to Genzyme. The Company does not require collateral from its customers, but does perform periodic credit evaluations of its customers’ financial condition and requires immediate payment in certain circumstances. The Company is subject to credit risk from accounts receivable related to product sales. The majority of the Company ’ ’ ’ As of September 30, 2016, the Company’s accounts receivable in certain European countries, specifically Italy, Spain, Portugal, Greece and Russia, totaled approximately $26.4 million, of which $2.6 million were greater than 90 days past due. The Company also sells its products in other countries that face economic crises and local currency devaluation. Although the Company has historically collected receivables from customers in those countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for the Company ’ |
SEGMENT INFORMATION
SEGMENT INFORMATION | 9 Months Ended |
Sep. 30, 2016 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | (17) SEGMENT INFORMATION The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative biopharmaceuticals for serious diseases and medical conditions. All products are included in one segment because the majority of the Company ’ Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net product revenues by product: Vimizim $ 80,903 65,106 $ 260,310 $ 169,608 Naglazyme 77,728 54,131 221,575 243,386 Kuvan 90,899 64,219 257,806 174,501 Aldurazyme 23,751 20,509 58,819 58,991 Firdapse 4,981 3,802 13,685 11,616 Total net product revenues $ 278,262 $ 207,767 $ 812,195 $ 658,102 The following table summarizes total revenues from external customers and collaborative partners by geographic region. Net product revenues by geographic region are based on patient location for Vimizim, Naglazyme, Kuvan and Firdapse and Genzyme ’ ’ Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Total revenues by geographic region: United States $ 130,356 $ 112,254 $ 365,674 310,209 Europe 62,821 42,816 187,328 124,252 Latin America 38,789 25,588 106,803 127,147 Rest of world 47,930 28,246 156,958 100,351 Total revenues $ 279,896 $ 208,904 $ 816,763 $ 661,959 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | (18) COMMITMENTS AND CONTINGENCIES Contingencies From time to time the Company is involved in legal actions arising in the normal course of its business. The most significant of these actions are described below. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters could adversely affect the Company, its results of operations, financial condition and cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable. Paragraph IV Notices The Company received a paragraph IV notice letter, dated January 22, 2015, from Par Pharmaceutical, Inc. (Par), notifying it that Par had filed an abbreviated new drug application (ANDA) seeking approval of a proposed generic version of Kuvan (sapropterin dihydrochloride) 100 mg oral tablets prior to the expiration of the Company’s patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). Together with Merck & Cie, on March 6, 2015, the Company filed a lawsuit against Par in the U.S. District Court for the District of New Jersey alleging infringement of its patents relating to Kuvan tablets and seeking an injunction to prevent Par from introducing a generic version of Kuvan tablets that would infringe its patents prior to their expiration. The filing of that lawsuit triggered the automatic 30-month stay on the approval of Par’s ANDA in accordance with the Hatch-Waxman Act, which expires in July 2017. In response, Par alleged, inter alia, that the asserted patents are not infringed and/or are invalid. The Company also received a paragraph IV notice letter, dated January 14, 2016, from Par, notifying the Company that Par has filed a separate ANDA seeking approval of a proposed generic version of Kuvan 100 mg oral powder prior to the expiration of the Company’s patents listed in the FDA's Orange Book. On February 22, 2016, the Company filed a lawsuit against Par in the U.S. District Court for the District of New Jersey alleging infringement of its patents relating to Kuvan powder and seeking an injunction to prevent Par from introducing a generic version of Kuvan powder that would infringe its patents prior to their expiration. The filing of that lawsuit triggered the automatic 30-month stay on the approval of Par’s ANDA in accordance with the Hatch-Waxman Act, which expires in July 2018. In response, Par alleged, inter alia The two cases against Par have been consolidated in the District of New Jersey. The court held a claim construction hearing on May 5, 2016 but has not yet issued its ruling. Fact discovery closed in September 2016 and trial is scheduled for June 2017. SEC Subpoena In August 2016, the Company received a subpoena from the staff of the SEC requesting that the Company produce documents in connection with a non-public, fact-finding inquiry related to its former drisapersen program. The letter enclosing the subpoena states that the investigation and the subpoena do not mean that the Company or anyone else has broken the law, or that the SEC has a negative opinion of any person, entity or security. The Company intends to cooperate fully with the SEC in this matter. The Company is not able to predict whether any proceeding may be instituted in connection with the subpoena, or the outcome of any proceeding that may be instituted. Contingent Payments As of September 30, 2016, the Company is subject to contingent payments totaling approximately $754.4 million upon achievement of certain development and regulatory activities and commercial sales and licensing milestones if they occur before certain dates in the future. Of this amount, $207.6 million (or €185 million based on the exchange rate of 1.12 USD per Euro in effect on September 30, 2016) relates to the Merck PKU Business acquisition and $58.2 million relates to programs that are no longer being developed. As of September 30, 2016, the Company has recorded $171.4 million of contingent acquisition consideration payable on its Condensed Consolidated Balances Sheets in Short-term and Long-term Contingent Acquisition Consideration Payable, of which $48.7 million is expected to be paid in the next twelve months. Other Commitments In the normal course of business, the Company enters into various firm purchase commitments primarily related to active pharmaceutical ingredients September 30, 2016 |
BENEFIT FROM INCOME TAXES
BENEFIT FROM INCOME TAXES | 9 Months Ended |
Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
BENEFIT FROM INCOME TAXES | The Company has historically computed its interim period benefit from income taxes by applying its forecasted effective tax rate to year-to-date earnings. However, due to a significant amount of U.S. permanent differences relative to the amount of U.S. forecasted income used in computing the effective tax rate, the effective tax rate can be highly sensitive to minor fluctuations in U.S forecasted income. As such, the Company has computed the U.S component of the consolidated benefit from income taxes for the three and nine months ended September 30, 2016 using an actual year-to-date tax calculation. Foreign tax expense was computed using a forecasted annual effective tax rate for the three and nine months ended September 30, 2016. The consolidated benefit from income taxes for the three and nine ended September 30, 2015 was computed using a forecasted annual effective tax rate. |
ACQUISITIONS (Tables)
ACQUISITIONS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Business Combinations [Abstract] | |
Summary of Estimated Fair Values of Assets Acquired and Liabilities Assumed | The following table presents the preliminary allocation of the purchase consideration for the Merck PKU Business Cash payments $ 374,545 Estimated fair value of contingent acquisition consideration payable 138,974 Total consideration $ 513,519 Kuvan intangible assets $ 172,961 Pegvaliase IPR&D 326,359 Inventory 14,199 Total identifiable assets acquired $ 513,519 |
Summary of Pro Forma Financial Information | The following unaudited pro forma financial information presents the combined results of operations of the Company and the Merck PKU Business as if the acquisition occurred on January 1, 2015. This unaudited pro forma financial information is presented for informational purposes only and is not necessarily indicative of the results of future operations that would have been achieved had the acquisitions taken place at the beginning of 2015. Three Months Ended September 30, Nine Months Ended September 30, 2015 2015 Total revenues $ 225,697 $ 713,930 Net loss $ (84,395 ) $ (220,465 ) Net loss per share, basic $ (0.52 ) $ (1.38 ) Net loss per share, diluted $ (0.55 ) $ (1.38 ) Weighted average common shares outstanding, basic 160,886 159,647 Weighted average common shares outstanding, diluted 161,134 159,647 |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings per Common Share | The following table sets forth the computation of basic and diluted earnings per common share (in thousands of common shares): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Numerator: Net loss, basic $ (42,797 ) $ (90,926 ) $ (551,499 ) $ (240,416 ) Gain on common stock held by the NQDC — (4,980 ) (1,753 ) — Net loss, diluted $ (42,797 ) $ (95,906 ) $ (553,252 ) $ (240,416 ) Denominator: Weighted-average common shares outstanding, basic 167,714 160,886 163,963 159,647 Effect of dilutive securities: Common shares held by the NQDC — 248 253 — Weighted-average common shares outstanding, diluted 167,714 161,134 164,216 159,647 Net loss per common share, basic $ (0.26 ) $ (0.57 ) $ (3.36 ) $ (1.51 ) Net loss per common share, diluted $ (0.26 ) $ (0.60 ) $ (3.37 ) $ (1.51 ) |
Schedule Of Anti-Dilutive Common Stock Excluded From Computation of Diluted Net Loss Per Share | In addition to the equity instruments included in the table above, the table below presents the shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method (in thousands of shares): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Options to purchase common stock 9,610 10,503 9,610 10,503 Common stock issuable under the 2017 Notes 1,105 1,553 1,105 1,553 Common stock issuable under the 2018 and 2020 Notes 7,966 7,966 7,966 7,966 Unvested restricted stock units 2,728 1,757 2,728 1,633 Common stock potentially issuable for ESPP purchases 130 229 114 220 Common stock held by the NQDC 253 — — 248 Total number of potentially issuable shares 21,792 22,008 21,523 22,123 |
INVESTMENTS (Tables)
INVESTMENTS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Investments Schedule [Abstract] | |
Amortized Cost, Gross Unrealized Holding Gain or Loss, and Fair Value of Available For Sale Security by Major Security type | The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale securities by major security type at September 30, 2016 and December 31, 2015 are summarized in the tables below: Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at September 30, 2016 Certificates of deposit $ 2,800 $ — $ — $ 2,800 Corporate debt securities 420,259 873 (165 ) 420,967 Commercial paper 16,692 — — 16,692 U.S. government agency securities 249,674 190 (2 ) 249,862 Greek government-issued bonds 52 82 — 134 Total $ 689,477 $ 1,145 $ (167 ) $ 690,455 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at December 31, 2015 Certificates of deposit $ 63,919 $ 1 $ — $ 63,920 Corporate debt securities 358,625 20 (732 ) 357,913 Commercial paper 12,733 — — 12,733 U.S. government agency securities 186,882 — (344 ) 186,538 Greek government-issued bonds 48 79 — 127 Total $ 622,207 $ 100 $ (1,076 ) $ 621,231 |
Fair Values of Available-For-Sale Securities by Contractual Maturity | The fair values of available-for-sale securities by contractual maturity were as follows: September 30, December 31, 2016 2015 Maturing in one year or less $ 327,499 $ 195,579 Maturing after one year through five years 362,956 425,652 Total $ 690,455 $ 621,231 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: September 30, December 31, 2016 2015 Intangible assets: Finite-lived intangible assets $ 305,122 $ 129,572 Indefinite-lived intangible assets 332,199 607,548 Gross intangible assets: 637,321 737,120 Less: Accumulated amortization (75,934 ) (53,124 ) Net carrying value $ 561,387 $ 683,996 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property Plant and Equipment Net | Property, plant and equipment, net consisted of the following: September 30, December 31, 2016 2015 Building and improvements $ 505,894 $ 442,100 Manufacturing and laboratory equipment 229,818 145,313 Computer hardware and software 123,557 113,442 Leasehold improvements 44,802 44,247 Furniture and equipment 26,359 22,817 Land improvements 4,881 4,881 Land 45,727 45,727 Construction-in-progress 76,992 164,283 1,058,030 982,810 Less: Accumulated depreciation (328,194 ) (278,603 ) Total property, plant and equipment, net $ 729,836 $ 704,207 |
SUPPLEMENTAL BALANCE SHEET IN31
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule Of Inventory | Inventory consisted of the following: September 30, December 31, 2016 2015 Raw materials $ 46,951 $ 46,115 Work-in-process 189,596 150,289 Finished goods 110,873 75,279 Total inventory $ 347,420 $ 271,683 |
Schedule of Other Assets | Other Assets consisted of the following: September 30, December 31, 2016 2015 Deposit for business acquisition $ — $ 371,756 Deposits 19,748 8,606 Strategic investments 7,267 18,056 Long-term forward foreign currency exchange contract assets 750 3,533 Other 8,678 6,693 Total other assets $ 36,443 $ 408,644 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, 2016 2015 Accounts payable and accrued operating expenses $ 148,773 $ 179,294 Accrued compensation expense 85,219 95,345 Accrued rebates payable 34,184 32,553 Accrued royalties payable 14,183 10,412 Value added taxes payable 7,961 6,377 Accrued income taxes — 59,572 Other 15,809 8,958 Total accounts payable and accrued liabilities $ 306,129 $ 392,511 |
CONVERTIBLE DEBT (Tables)
CONVERTIBLE DEBT (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Summary of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: September 30, 2016 December 31, 2015 Convertible Notes due in 2017 $ 22,506 $ 31,430 Unamortized deferred offering costs (46 ) (110 ) Convertible Notes due in 2017, net 22,460 31,320 Convertible Notes due in 2018 374,980 374,980 Unamortized discount (31,219 ) (41,904 ) Unamortized deferred offering costs (3,968 ) (5,415 ) Convertible Notes due in 2018, net 339,793 327,661 Convertible Notes due in 2020 374,993 374,993 Unamortized discount (56,364 ) (65,478 ) Unamortized deferred offering costs (5,244 ) (6,210 ) Convertible Notes due in 2020, net 313,385 303,305 Total convertible debt, net $ 675,638 $ 662,286 Fair value of fixed rate convertible debt Convertible Notes due in 2017 (1) $ 101,789 $ 162,016 Convertible Notes due in 2018 (1) 448,247 482,584 Convertible Notes due in 2020 (1) 469,487 502,701 Total $ 1,019,523 $ 1,147,301 (1) The fair value of the Company’s fixed rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. |
Summary of Convertible Debt Interest Expense | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Coupon interest $ 2,466 $ 2,283 $ 7,491 $ 7,667 Amortization of issuance costs 826 823 2,476 2,471 Accretion of debt discount 6,688 6,341 19,800 18,773 Total interest expense on convertible debt $ 9,980 $ 9,447 $ 29,767 $ 28,911 |
DERIVATIVE INSTRUMENTS AND HE33
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Derivative [Line Items] | |
Fair Value Carrying Amount of Derivative Instruments | The fair value carrying amounts of the Company’s derivative instruments were as follows: Asset Derivatives Liability Derivatives September 30, 2016 September 30, 2016 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 4,785 Accounts payable and accrued liabilities $ 3,290 Forward foreign currency exchange contracts Other assets 750 Other long- term liabilities 1,979 Total 5,535 5,269 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 25 Accounts payable and accrued liabilities 65 Forward foreign currency exchange contracts Other assets — Other long- term liabilities — Total 25 65 Total value of derivative contracts $ 5,560 $ 5,334 Asset Derivatives Liability Derivatives December 31, 2015 December 31, 2015 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 10,478 Accounts payable and accrued liabilities $ 1,986 Forward foreign currency exchange contracts Other assets 3,533 Other long- term liabilities 3,057 Total 14,011 5,043 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets — Accounts payable and accrued liabilities 22 Total — 22 Total value of derivative contracts $ 14,011 $ 5,065 |
Effect of Derivative Instruments | The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2016 and 2015 was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in Other Comprehensive Income (OCI) (1) $ (1,984 ) $ 3,126 $ (5,857 ) $ 14,191 Net gain reclassified from accumulated OCI into earnings (2) 1,486 5,187 4,616 15,084 Net gain (loss) recognized in net loss (3) 9 (264 ) 5,276 (404 ) Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ 826 $ (514 ) $ (2,446 ) $ 6,052 (1) Net change in the fair value of the effective portion classified as OCI. (2) Effective portion classified as Net Product Revenues and SG&A expense. (3) Ineffective portion and amount excluded from effectiveness testing classified as SG&A expense. (4) Classified as SG&A expense. |
Derivatives Designated As Hedging Instruments | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company’s designated forward foreign currency exchange contracts outstanding as of September 30, 2016 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros - Purchase 84 92.5 Oct. 2016 - Sep. 2019 Euros - Sell 280 316.5 Oct. 2016 - Sep. 2019 Canadian Dollars - Sell 6 3.1 Oct. 2016 - Dec. 2016 Colombian Pesos - Sell 3 9,798.0 Oct. 2016 - Dec. 2016 British Pounds - Sell 1 0.6 October 2016 Total 374 |
Not Designated as Hedging Instrument | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company’s non-designated forward foreign currency exchange contracts outstanding as of September 30, 2016 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros - Purchase 1 99.4 October 2016 British Pounds - Sell 1 6.9 October 2016 Total 2 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The tables below present the fair value of these financial assets and liabilities determined using the following input levels. Fair Value Measurements at September 30, 2016 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Overnight deposits $ 246,568 $ — $ — $ 246,568 Money market instruments — 460,781 — 460,781 Total cash and cash equivalents 246,568 460,781 — 707,349 Available-for-sale securities: Short-term: Certificates of deposit — 2,800 — 2,800 Corporate debt securities — 139,073 — 139,073 Commercial paper — 16,692 — 16,692 U.S. government agency securities — 168,934 — 168,934 Long-term: Corporate debt securities — 281,894 — 281,894 U.S. government agency securities — 80,928 — 80,928 Greek government-issued bonds — 134 — 134 Total available-for-sale securities — 690,455 — 690,455 Other current assets: Nonqualified Deferred Compensation Plan assets — 309 — 309 Forward foreign currency exchange contract (1) — 4,810 — 4,810 Restricted investments (2) — 4,052 — 4,052 Total other current assets — 9,171 — 9,171 Other assets: Nonqualified Deferred Compensation Plan assets — 8,562 — 8,562 Forward foreign currency exchange contract (1) — 750 — 750 Strategic investment (3) 7,267 — — 7,267 Total other assets 7,267 9,312 — 16,579 Total assets $ 253,835 $ 1,169,719 $ — $ 1,423,554 Liabilities: Current liabilities: Nonqualified Deferred Compensation Plan liability $ 4,008 $ 309 $ — $ 4,317 Forward foreign currency exchange contract (1) — 3,355 — 3,355 Contingent acquisition consideration payable — — 48,746 48,746 Total current liabilities 4,008 3,664 48,746 56,418 Other long-term liabilities: Nonqualified Deferred Compensation Plan liability $ 19,394 $ 8,562 — 27,956 Forward foreign currency exchange contract (1) — 1,979 — 1,979 Contingent acquisition consideration payable — — 122,644 122,644 Total other long-term liabilities 19,394 10,541 122,644 152,579 Total liabilities $ 23,402 $ 14,205 $ 171,390 $ 208,997 Fair Value Measurements at December 31, 2015 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Overnight deposits $ 290,731 $ — $ — $ 290,731 Money market instruments — 106,309 — 106,309 Total cash and cash equivalents 290,731 106,309 — 397,040 Available-for-sale securities: Short-term: Certificates of deposit — 56,951 — 56,951 Corporate debt securities — 42,673 — 42,673 Commercial paper — 12,733 — 12,733 U.S. government agency securities — 83,222 — 83,222 Long-term: Certificates of deposit — 6,969 — 6,969 Corporate debt securities — 315,240 — 315,240 U.S. government agency securities — 103,316 — 103,316 Greek government-issued bonds — 127 — 127 Total available-for-sale securities — 621,231 — 621,231 Other current assets: Nonqualified Deferred Compensation Plan assets — 440 — 440 Forward foreign currency exchange contract (1) — 10,478 — 10,478 Restricted investments (2) — 7,348 — 7,348 Total other current assets — 18,266 — 18,266 Other assets: Nonqualified Deferred Compensation Plan assets — 6,362 — 6,362 Forward foreign currency exchange contract (1) — 3,533 — 3,533 Strategic investment (3) 18,056 — — 18,056 Total other assets 18,056 9,895 — 27,951 Total assets $ 308,787 $ 755,701 $ — $ 1,064,488 Liabilities: Current liabilities: Nonqualified Deferred Compensation Plan liability $ 1,151 $ 440 $ — $ 1,591 Forward foreign currency exchange contract (1) — 2,008 — 2,008 Contingent acquisition consideration payable — — 52,946 52,946 Total current liabilities 1,151 2,448 52,946 56,545 Other long-term liabilities: Nonqualified Deferred Compensation Plan liability 24,341 6,362 — 30,703 Forward foreign currency exchange contract (1) — 3,057 — 3,057 Contingent acquisition consideration payable — — 32,663 32,663 Total other long-term liabilities 24,341 9,419 32,663 66,423 Total liabilities $ 25,492 $ 11,867 $ 85,609 $ 122,968 (1) See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. (2) The restricted investments at September 30, 2016 and December 31, 2015 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. (3) The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investments. |
Liabilities Measured at Fair Value Using Level 3 Inputs | Contingent acquisition consideration payable at December 31, 2015 $ 85,609 Addition of contingent acquisition consideration payable related to the purchase of the Merck PKU Business 138,974 Changes in the fair value of contingent acquisition consideration payable for continuing development programs 7,032 Reduction of fair value related to termination of Kyndrisa development program (43,652 ) Reduction of fair value related to termination of reveglucosidase alfa development program (20,334 ) Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 3,761 Contingent acquisition consideration payable at September 30, 2016 $ 171,390 |
Asset Retirement Obligation Liability and Corresponding Capital Asset | Asset retirement obligations at December 31, 2015 $ 4,704 Accretion expense 79 Reversals (250 ) Asset retirement obligations at September 30, 2016 $ 4,533 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Valuation Assumptions | The assumptions used to estimate the per share fair value of stock options granted under the 2012 Inducement Plan, the 2014 Inducement Plan and the Share Incentive Plan were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Expected volatility 38 – 40% 41 – 44% 36 – 44% 39 – 45% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected life 5.0 – 6.7 years 6.9 – 8.0 years 5.0 – 8.1 years 6.4 – 8.0 years Risk-free interest rate 1.1 – 1.4% 1.9 – 2.2% 1.1 – 2.1% 1.5 – 2.2% |
Stock-Based Compensation Expense | Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Loss for all stock-based compensation arrangements was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Cost of sales $ 2,092 $ 1,386 $ 5,943 $ 4,484 R&D 14,165 12,578 42,929 34,972 SG&A 16,645 14,794 48,348 41,503 Total stock-based compensation expense $ 32,902 $ 28,758 $ 97,220 $ 80,959 |
COMPREHENSIVE LOSS (Tables)
COMPREHENSIVE LOSS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Amounts Reclassified out of Accumulated Other Comprehensive Income | The following table summarizes amounts reclassified out of Accumulated Other Comprehensive Income (AOCI) and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, Nine Months Ended September 30, Consolidated Statement of Details about AOCI Components 2016 2015 2016 2015 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ 1,436 $ 4,411 $ 4,036 $ 13,660 Net product revenues Forward foreign currency exchange contracts 50 776 4,874 1,424 SG&A Gain (loss) on sale of available-for-sale securities 7 14 (2,020 ) 3,036 Other income (expense) Less: Income tax effect of the above 2 5 (735 ) 1,098 Provision for (Benefit from) income taxes $ 1,491 $ 5,196 $ 7,625 $ 17,022 Net loss |
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income and Reclassifications | The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income and reclassifications out of AOCI for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 Other comprehensive income (loss) before reclassifications (1,984 ) 1,738 (1 ) (247 ) Less net gain reclassified from AOCI 1,486 7 — 1,493 Tax effect — (630 ) — (630 ) Net current-period other comprehensive income (loss) (3,470 ) 1,101 (1 ) (2,370 ) AOCI balance at September 30, 2016 $ (1,165 ) $ 3,332 $ (9 ) $ 2,158 Nine Months Ended September 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2015 $ 13,602 $ 7,441 $ (10 ) $ 21,033 Other comprehensive income (loss) before reclassifications (5,857 ) (8,477 ) 1 (14,333 ) Less net gain (loss) reclassified from AOCI 8,910 (2,020 ) — 6,890 Tax effect — 2,348 — 2,348 Net current-period other comprehensive income (loss) (14,767 ) (4,109 ) 1 (18,875 ) AOCI balance at September 30, 2016 $ (1,165 ) $ 3,332 $ (9 ) $ 2,158 Three Months Ended September 30, 2015 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at June 30, 2015 $ 17,074 $ 15,336 $ 51 $ 32,461 Other comprehensive income (loss) before reclassifications 3,126 (8,159 ) 1 (5,032 ) Less gain reclassified from AOCI 5,187 14 — 5,201 Tax effect — 2,956 — 2,956 Net current-period other comprehensive loss (2,061 ) (5,217 ) 1 (7,277 ) AOCI balance at September 30, 2015 $ 15,013 $ 10,119 $ 52 $ 25,184 Nine Months Ended September 30, 2015 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2014 $ 15,906 $ 11,511 $ 49 $ 27,466 Other comprehensive income before reclassifications 14,191 865 3 15,059 Less gain reclassified from AOCI 15,084 3,036 — 18,120 Tax effect — 779 — 779 Net current-period other comprehensive income (loss) (893 ) (1,392 ) 3 (2,282 ) AOCI balance at September 30, 2015 $ 15,013 $ 10,119 $ 52 $ 25,184 |
REVENUE AND CREDIT CONCENTRAT37
REVENUE AND CREDIT CONCENTRATIONS (Tables) - Net Product Revenue | 9 Months Ended |
Sep. 30, 2016 | |
Geographic Concentration Risk | |
Concentration Risk [Line Items] | |
Schedules of Consolidated Net Product Revenue Concentration | The table below summarizes consolidated net product revenue concentrations based on patient location for Vimizim, Naglazyme, Kuvan and Firdapse which are sold directly by the Company and global sales of Aldurazyme which is marketed by Genzyme Corporation (Genzyme). Genzyme is the Company’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Net product revenues from Genzyme consisted of royalties on worldwide net Aldurazyme sales and incremental product transfer revenues. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net product revenues marketed by the Company United States 38 % 44 % 38 % 38 % Europe 23 % 21 % 23 % 19 % Latin America 14 % 12 % 13 % 19 % Rest of world 16 % 13 % 19 % 15 % Total net product revenue marketed by the Company 91 % 90 % 93 % 91 % Aldurazyme net product revenues marketed by Genzyme 9 % 10 % 7 % 9 % Total net product revenues 100 % 100 % 100 % 100 % |
Customer Concentration Risk | |
Concentration Risk [Line Items] | |
Schedules of Consolidated Net Product Revenue Concentration | The following table illustrates the percentage of the Company’s consolidated net product revenues attributed to the Company’s largest customers for the three and nine months ended September 30, 2016 and 2015. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Customer A 19 % 15 % 19 % 14 % Customer B 13 % 9 % 13 % 11 % Customer C 6 % 6 % 6 % 13 % Customer D 10 % 13 % 10 % 5 % Total 48 % 43 % 48 % 43 % |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Segment Reporting [Abstract] | |
Segment Information by Product Revenue | The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative biopharmaceuticals for serious diseases and medical conditions. All products are included in one segment because the majority of the Company ’ Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net product revenues by product: Vimizim $ 80,903 65,106 $ 260,310 $ 169,608 Naglazyme 77,728 54,131 221,575 243,386 Kuvan 90,899 64,219 257,806 174,501 Aldurazyme 23,751 20,509 58,819 58,991 Firdapse 4,981 3,802 13,685 11,616 Total net product revenues $ 278,262 $ 207,767 $ 812,195 $ 658,102 |
Summary of Total Revenues from External Customers and Collaborative Partners by Geographic Region | The following table summarizes total revenues from external customers and collaborative partners by geographic region. Net product revenues by geographic region are based on patient location for Vimizim, Naglazyme, Kuvan and Firdapse and Genzyme ’ ’ Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Total revenues by geographic region: United States $ 130,356 $ 112,254 $ 365,674 310,209 Europe 62,821 42,816 187,328 124,252 Latin America 38,789 25,588 106,803 127,147 Rest of world 47,930 28,246 156,958 100,351 Total revenues $ 279,896 $ 208,904 $ 816,763 $ 661,959 |
Nature of Operations and Busi39
Nature of Operations and Business Risks - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2016Product | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of approved products | 5 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) $ in Thousands, € in Millions | Jan. 02, 2016USD ($) | Sep. 30, 2016USD ($)Country | Jan. 01, 2016USD ($) | Jan. 01, 2016EUR (€) | Dec. 31, 2015USD ($) |
Merck PKU Business | |||||
Business Acquisition [Line Items] | |||||
Business combination transaction costs | $ 300 | $ 600 | $ 300 | ||
Business acquisition, cash paid | $ 374,545 | ||||
Transfer of marketing authorizations in remaining countries | Country | 8 | ||||
Estimated useful life | through 2,024 | ||||
Intangible assets amortization method | straight-line basis | ||||
Merck Serono | |||||
Business Acquisition [Line Items] | |||||
Business acquisition, cash paid | $ 374,500 | ||||
Merck Serono | A&R Kuvan Agreement | |||||
Business Acquisition [Line Items] | |||||
Maximum potential additional consideration milestone payments | € | € 60 | ||||
Merck Serono | Pegvaliase Agreement | |||||
Business Acquisition [Line Items] | |||||
Maximum potential additional consideration milestone payments | € | € 125 |
Acquisitions - Summary of Estim
Acquisitions - Summary of Estimated Fair Values of Assets Acquired and Liabilities Assumed (Detail) - Merck PKU Business - USD ($) $ in Thousands | Jan. 02, 2016 | Jan. 01, 2016 |
Business Acquisition [Line Items] | ||
Cash payments | $ 374,545 | |
Estimated fair value of contingent acquisition consideration payable | $ 138,974 | |
Total consideration | $ 513,519 | |
Kuvan intangible assets | 172,961 | |
Pegvaliase IPR&D | 326,359 | |
Inventory | 14,199 | |
Total identifiable assets acquired | $ 513,519 |
Acquisitions - Summary of Pro F
Acquisitions - Summary of Pro Forma Financial Information (Detail) - Merck PKU Business - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2015 | Sep. 30, 2015 | |
Business Acquisition [Line Items] | ||
Total revenues | $ 225,697 | $ 713,930 |
Net loss | $ (84,395) | $ (220,465) |
Net loss per share, basic | $ (0.52) | $ (1.38) |
Net loss per share, diluted | $ (0.55) | $ (1.38) |
Weighted average common shares outstanding, basic | 160,886 | 159,647 |
Weighted average common shares outstanding, diluted | 161,134 | 159,647 |
Computation of Basic and Dilute
Computation of Basic and Diluted Earnings per Common Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Earnings Per Share [Abstract] | ||||
Net loss, basic | $ (42,797) | $ (90,926) | $ (551,499) | $ (240,416) |
Gain on common stock held by the NQDC | 0 | (4,980) | (1,753) | 0 |
Net loss, diluted | $ (42,797) | $ (95,906) | $ (553,252) | $ (240,416) |
Weighted-average common shares outstanding, basic | 167,714 | 160,886 | 163,963 | 159,647 |
Common shares held by the NQDC | 0 | 248 | 253 | 0 |
Weighted-average common shares outstanding, diluted | 167,714 | 161,134 | 164,216 | 159,647 |
Net loss per common share, basic | $ (0.26) | $ (0.57) | $ (3.36) | $ (1.51) |
Net loss per common share, diluted | $ (0.26) | $ (0.60) | $ (3.37) | $ (1.51) |
Anti-Dilutive Common Stock Excl
Anti-Dilutive Common Stock Excluded From Computation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 21,792 | 22,008 | 21,523 | 22,123 |
Stock Option | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 9,610 | 10,503 | 9,610 | 10,503 |
Common stock issuable under the 2017 Notes | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 1,105 | 1,553 | 1,105 | 1,553 |
Common stock issuable under the 2018 and 2020 Notes | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 7,966 | 7,966 | 7,966 | 7,966 |
Unvested restricted stock units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 2,728 | 1,757 | 2,728 | 1,633 |
Common stock potentially issuable for ESPP purchases | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 130 | 229 | 114 | 220 |
Common stock held by the NQDC | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 253 | 0 | 0 | 248 |
Net Loss Per Common Share - Add
Net Loss Per Common Share - Additional Information (Detail) - $ / shares | Sep. 30, 2016 | Sep. 30, 2015 |
Convertible Notes due 2018 | ||
Earnings Per Share [Line Items] | ||
Debt instrument, interest rate, stated percentage, per annum | 0.70% | |
Convertible Notes due 2020 | ||
Earnings Per Share [Line Items] | ||
Debt instrument, interest rate, stated percentage, per annum | 1.50% | |
The Notes | ||
Earnings Per Share [Line Items] | ||
Debt instrument, convertible, conversion price, per share | $ 94.15 | $ 94.15 |
Amortized Cost Gross Unrealized
Amortized Cost Gross Unrealized Holding Gain or Loss and Fair Value of Available for Sale Security by Major Security Type (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 689,477 | $ 622,207 |
Gross Unrealized Holding Gains | 1,145 | 100 |
Gross Unrealized Holding Losses | (167) | (1,076) |
Aggregate Fair Value | 690,455 | 621,231 |
Certificates of Deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 2,800 | 63,919 |
Gross Unrealized Holding Gains | 0 | 1 |
Gross Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | 2,800 | 63,920 |
Corporate Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 420,259 | 358,625 |
Gross Unrealized Holding Gains | 873 | 20 |
Gross Unrealized Holding Losses | (165) | (732) |
Aggregate Fair Value | 420,967 | 357,913 |
Commercial Paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 16,692 | 12,733 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | 16,692 | 12,733 |
U.S. Government Agency Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 249,674 | 186,882 |
Gross Unrealized Holding Gains | 190 | 0 |
Gross Unrealized Holding Losses | (2) | (344) |
Aggregate Fair Value | 249,862 | 186,538 |
Greek Government-Issued Bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 52 | 48 |
Gross Unrealized Holding Gains | 82 | 79 |
Gross Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | $ 134 | $ 127 |
Investments - Additional Inform
Investments - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Jun. 30, 2016USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2015USD ($)Investment | |
Investments Debt And Equity Securities [Abstract] | |||
Number of investments in marketable equity securities | Investment | 2 | ||
Marketable equity securities, realized loss | $ (2,000,000) | ||
Fair value of marketable equity securities | $ 7,300,000 | $ 18,100,000 | |
Marketable equity securities, unrealized gain (loss) | 4,300,000 | $ 12,700,000 | |
Other- than- temporary impairment | $ 0 |
Fair Values of Available-For-Sa
Fair Values of Available-For-Sale Securities by Contractual Maturity (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Investments Debt And Equity Securities [Abstract] | ||
Maturing in one year or less | $ 327,499 | $ 195,579 |
Maturing after one year through five years | 362,956 | 425,652 |
Total | $ 690,455 | $ 621,231 |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Intangible assets: | |||
Finite-lived intangible assets | $ 305,122 | $ 129,572 | |
Indefinite-lived intangible assets | 332,199 | 607,548 | |
Gross intangible assets: | 637,321 | 737,120 | |
Less: Accumulated amortization | (75,934) | (53,124) | |
Net carrying value | $ 561,387 | $ 683,996 | [1] |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2016 | Jun. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Goodwill And Intangible Assets [Line Items] | ||||||
Impairment charge | $ 0 | $ 0 | $ 599,118,000 | $ 0 | ||
Indefinite-lived intangible assets | $ 332,199,000 | $ 332,199,000 | $ 607,548,000 | |||
IPR&D of Kyndrisa and Other Exon | ||||||
Goodwill And Intangible Assets [Line Items] | ||||||
Impairment charge | $ 574,100,000 | |||||
Indefinite-lived intangible assets | 0 | |||||
IPR&D of Reveglucosidase Alfa | ||||||
Goodwill And Intangible Assets [Line Items] | ||||||
Impairment charge | $ 25,000,000 |
Property Plant and Equipment (D
Property Plant and Equipment (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 1,058,030 | $ 982,810 | |
Less: Accumulated depreciation | (328,194) | (278,603) | |
Total property, plant and equipment, net | 729,836 | 704,207 | [1] |
Building and Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 505,894 | 442,100 | |
Manufacturing and Laboratory Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 229,818 | 145,313 | |
Computer Hardware and Software | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 123,557 | 113,442 | |
Leasehold Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 44,802 | 44,247 | |
Furniture and Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 26,359 | 22,817 | |
Land Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 4,881 | 4,881 | |
Land | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 45,727 | 45,727 | |
Construction-in-Progress | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 76,992 | $ 164,283 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Property Plant and Equipment -
Property Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation expense | $ 23,200 | $ 12,700 | $ 56,100 | $ 36,400 |
Depreciation capitalized into inventory | $ 4,400 | $ 3,700 | $ 13,402 | $ 11,005 |
Schedule of Inventory (Detail)
Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 46,951 | $ 46,115 | |
Work-in-process | 189,596 | 150,289 | |
Finished goods | 110,873 | 75,279 | |
Total inventory | $ 347,420 | $ 271,683 | [1] |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Supplemental Balance Sheet In54
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | [1] |
Inventory [Line Items] | |||
Inventory | $ 347,420 | $ 271,683 | |
Accounts Payable and Accrued Liabilities | Kyndrisa and Other Exon | |||
Inventory [Line Items] | |||
Accrued employee termination benefits | 4,900 | ||
Shanbally, Ireland | |||
Inventory [Line Items] | |||
Escrow deposit to purchase land | 8,400 | ||
Vimizim PreQual Inventory | |||
Inventory [Line Items] | |||
Inventory | 29,800 | ||
Brineura Inventory | |||
Inventory [Line Items] | |||
Inventory | $ 31,300 | ||
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Schedule of Other Assets (Detai
Schedule of Other Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Condensed Financial Information Of Parent Company Only Disclosure [Abstract] | |||
Deposit for business acquisition | $ 0 | $ 371,756 | |
Deposits | 19,748 | 8,606 | |
Strategic investments | 7,267 | 18,056 | |
Long-term forward foreign currency exchange contract assets | 750 | 3,533 | |
Other | 8,678 | 6,693 | |
Total other assets | $ 36,443 | $ 408,644 | [1] |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Condensed Financial Information Of Parent Company Only Disclosure [Abstract] | |||
Accounts payable and accrued operating expenses | $ 148,773 | $ 179,294 | |
Accrued compensation expense | 85,219 | 95,345 | |
Accrued rebates payable | 34,184 | 32,553 | |
Accrued royalties payable | 14,183 | 10,412 | |
Value added taxes payable | 7,961 | 6,377 | |
Accrued income taxes | 0 | 59,572 | |
Other | 15,809 | 8,958 | |
Total accounts payable and accrued liabilities | $ 306,129 | $ 392,511 | [1] |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Summary of Convertible Debt (De
Summary of Convertible Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | ||
Debt Instrument [Line Items] | ||||
Convertible Notes, net of unamortized deferred offering costs | $ 22,460 | $ 0 | [1] | |
Convertible Notes, net of unamortized discount and deferred offering costs | 653,178 | 662,286 | [1] | |
Total convertible debt, net | 675,638 | 662,286 | ||
Convertible Notes, fair value | 1,019,523 | 1,147,301 | ||
Convertible Notes due 2017 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 22,506 | 31,430 | ||
Convertible debt, Unamortized deferred offering costs | (46) | (110) | ||
Convertible Notes, net of unamortized deferred offering costs | 22,460 | 31,320 | ||
Convertible Notes, fair value | [2] | 101,789 | 162,016 | |
Convertible Notes due 2018 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 374,980 | 374,980 | ||
Convertible debt, unamortized discount | (31,219) | (41,904) | ||
Convertible debt, Unamortized deferred offering costs | (3,968) | (5,415) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 339,793 | 327,661 | ||
Convertible Notes, fair value | [2] | 448,247 | 482,584 | |
Convertible Notes due 2020 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 374,993 | 374,993 | ||
Convertible debt, unamortized discount | (56,364) | (65,478) | ||
Convertible debt, Unamortized deferred offering costs | (5,244) | (6,210) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 313,385 | 303,305 | ||
Convertible Notes, fair value | [2] | $ 469,487 | $ 502,701 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. | |||
[2] | The fair value of the Company’s fixed rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. |
Summary of Interest Expense on
Summary of Interest Expense on Convertible Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Schedule Of Interest Expenses [Line Items] | ||||
Total interest expense on convertible debt | $ 9,980 | $ 9,447 | $ 29,767 | $ 28,911 |
Convertible Senior Notes | ||||
Schedule Of Interest Expenses [Line Items] | ||||
Coupon interest | 2,466 | 2,283 | 7,491 | 7,667 |
Amortization of issuance costs | 826 | 823 | 2,476 | 2,471 |
Accretion of debt discount | 6,688 | 6,341 | 19,800 | 18,773 |
Total interest expense on convertible debt | $ 9,980 | $ 9,447 | $ 29,767 | $ 28,911 |
Convertible Debt - Additional I
Convertible Debt - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($)Agreementshares | |
Debt Conversion [Line Items] | ||||
Convertible cash premium paid to holder for agreeing to convert | $ 0 | $ 0 | $ 0 | $ 163 |
Convertible Notes due 2017 | ||||
Debt Conversion [Line Items] | ||||
Number of agreements | Agreement | 3 | |||
Convertible Notes due 2017 | 2015 Induced Conversion | ||||
Debt Conversion [Line Items] | ||||
Convertible notes aggregate principal | $ 2,000 | $ 8,900 | $ 8,100 | |
Notes converted, number of shares | shares | 97,348 | 438,315 | 399,469 | |
Convertible cash premium paid to holder for agreeing to convert | $ 200 | |||
Convertible Notes due 2017 | Convertible Senior Notes | 2015 Induced Conversion | ||||
Debt Conversion [Line Items] | ||||
Convertible cash premium paid to holder for agreeing to convert | $ 200 |
Summary of Designated Forward F
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 9 Months Ended | |||
Sep. 30, 2016EUR (€)Derivative | Sep. 30, 2016CADDerivative | Sep. 30, 2016COPDerivative | Sep. 30, 2016GBP (£)Derivative | |
Maximum | ||||
Derivative [Line Items] | ||||
Maturity | Sep. 30, 2019 | |||
Derivatives Designated As Hedging Instruments | ||||
Derivative [Line Items] | ||||
Number of Contracts | 374 | 374 | 374 | 374 |
Derivatives Designated As Hedging Instruments | Euros | Purchase | ||||
Derivative [Line Items] | ||||
Number of Contracts | 84 | 84 | 84 | 84 |
Aggregate Notional Amount in Foreign Currency | € | € 92,500,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 280 | 280 | 280 | 280 |
Aggregate Notional Amount in Foreign Currency | € | € 316,500,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Oct. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Oct. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Sep. 30, 2019 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Sep. 30, 2019 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 6 | 6 | 6 | 6 |
Aggregate Notional Amount in Foreign Currency | CAD | CAD 3,100,000 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Oct. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 3 | 3 | 3 | 3 |
Aggregate Notional Amount in Foreign Currency | COP | COP 9,798,000,000 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Oct. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2016 | |||
Derivatives Designated As Hedging Instruments | British Pounds | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 1 | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | £ | £ 600,000 | |||
Maturity | Oct. 31, 2016 |
Summary of Non-Designated Forwa
Summary of Non-Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 9 Months Ended | |
Sep. 30, 2016EUR (€)Derivative | Sep. 30, 2016GBP (£)Derivative | |
Maximum | ||
Derivative [Line Items] | ||
Maturity | Sep. 30, 2019 | |
Not Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Number of Contracts | 2 | 2 |
Not Designated as Hedging Instrument | Euros | Purchase | ||
Derivative [Line Items] | ||
Number of Contracts | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | € | € 99,400,000 | |
Maturity | Oct. 31, 2016 | |
Not Designated as Hedging Instrument | British Pounds | Sell | ||
Derivative [Line Items] | ||
Number of Contracts | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | £ | £ 6,900,000 | |
Maturity | Oct. 31, 2016 |
Derivative Instruments and He62
Derivative Instruments and Hedging Strategies - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Derivative [Line Items] | ||
Gain (Loss) from foreign currency exchange contracts in accumulated other comprehensive income | $ 1.2 | $ 13.6 |
Foreign Currency Derivatives | ||
Derivative [Line Items] | ||
Amount reclassified from accumulated other comprehensive income to earnings as related to forecasted revenue and operating expense transactions | $ 0.5 | |
Maximum length of time over which hedging its exposure to the reduction in value of forecasted foreign currency cash flows through foreign currency forward contracts | 12 months | |
Foreign Currency Derivatives | Maximum | ||
Derivative [Line Items] | ||
Maturity period of foreign currency derivatives | Sep. 30, 2019 |
Derivative Instruments and He63
Derivative Instruments and Hedging Strategies (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Derivative [Line Items] | ||
Derivative Asset, Fair Value | $ 5,560 | $ 14,011 |
Derivative Liability, Fair Value | 5,334 | 5,065 |
Derivatives Designated As Hedging Instruments | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 5,535 | 14,011 |
Derivative Liability, Fair Value | 5,269 | 5,043 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 4,785 | 10,478 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 750 | 3,533 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | 3,290 | 1,986 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Long-Term Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | 1,979 | 3,057 |
Not Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 25 | 0 |
Derivative Liability, Fair Value | 65 | 22 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 25 | 0 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 0 | |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | 65 | $ 22 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Long-Term Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | $ 0 |
Effect of Derivative Instrument
Effect of Derivative Instruments (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||||||
Net gain (loss) recognized in Other Comprehensive Income (OCI) | $ 1,200 | $ 13,600 | ||||
Forward Foreign Currency Exchange Contracts | Derivatives Designated As Hedging Instruments | ||||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||||
Net gain (loss) recognized in Other Comprehensive Income (OCI) | [1] | $ (1,984) | $ 3,126 | (5,857) | $ 14,191 | |
Net gain reclassified from accumulated OCI into earnings | [2] | 1,486 | 5,187 | 4,616 | 15,084 | |
Net gain (loss) recognized in net loss | [3] | 9 | (264) | 5,276 | (404) | |
Forward Foreign Currency Exchange Contracts | Not Designated as Hedging Instrument | ||||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||||
Net gain (loss) recognized in net loss | [4] | $ 826 | $ (514) | $ (2,446) | $ 6,052 | |
[1] | Net change in the fair value of the effective portion classified as OCI. | |||||
[2] | Effective portion classified as Net Product Revenues and SG&A expense. | |||||
[3] | Ineffective portion and amount excluded from effectiveness testing classified as SG&A expense. | |||||
[4] | Classified as SG&A expense. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities | $ 690,455 | $ 621,231 | |
Fair Value, Measurements, Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 707,349 | 397,040 | |
Fair value of Available-for-sale securities | 690,455 | 621,231 | |
Fair value of other current assets | 9,171 | 18,266 | |
Fair value of other non-current assets | 16,579 | 27,951 | |
Fair value of financial assets, Total | 1,423,554 | 1,064,488 | |
Fair value of other current liabilities | 56,418 | 56,545 | |
Fair value of other non-current liabilities | 152,579 | 66,423 | |
Fair value of financial liabilities, Total | 208,997 | 122,968 | |
Fair Value, Measurements, Recurring | Overnight Deposits | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 246,568 | 290,731 | |
Fair Value, Measurements, Recurring | Money Market Instruments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 460,781 | 106,309 | |
Fair Value, Measurements, Recurring | Nonqualified Deferred Compensation Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 4,317 | 1,591 | |
Fair value of other non-current liabilities | 27,956 | 30,703 | |
Fair Value, Measurements, Recurring | Forward Foreign Currency Exchange Contract, Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | [1] | 3,355 | 2,008 |
Fair value of other non-current liabilities | [1] | 1,979 | 3,057 |
Fair Value, Measurements, Recurring | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 48,746 | 52,946 | |
Fair value of other non-current liabilities | 122,644 | 32,663 | |
Fair Value, Measurements, Recurring | Certificates of Deposit | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 2,800 | 56,951 | |
Fair value of Available-for-sale securities, non-current | 6,969 | ||
Fair Value, Measurements, Recurring | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 139,073 | 42,673 | |
Fair value of Available-for-sale securities, non-current | 281,894 | 315,240 | |
Fair Value, Measurements, Recurring | Commercial Paper | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 16,692 | 12,733 | |
Fair Value, Measurements, Recurring | U.S. Government Agency Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 168,934 | 83,222 | |
Fair value of Available-for-sale securities, non-current | 80,928 | 103,316 | |
Fair Value, Measurements, Recurring | Greek Government-Issued Bonds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, non-current | 134 | 127 | |
Fair Value, Measurements, Recurring | Nonqualified Deferred Compensation Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 309 | 440 | |
Fair value of other non-current assets | 8,562 | 6,362 | |
Fair Value, Measurements, Recurring | Forward Foreign Current Exchange Contract Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 4,810 | 10,478 |
Fair value of other non-current assets | [1] | 750 | 3,533 |
Fair Value, Measurements, Recurring | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [2] | 4,052 | 7,348 |
Fair Value, Measurements, Recurring | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | 7,267 | 18,056 |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 246,568 | 290,731 | |
Fair value of Available-for-sale securities | 0 | 0 | |
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 7,267 | 18,056 | |
Fair value of financial assets, Total | 253,835 | 308,787 | |
Fair value of other current liabilities | 4,008 | 1,151 | |
Fair value of other non-current liabilities | 19,394 | 24,341 | |
Fair value of financial liabilities, Total | 23,402 | 25,492 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Overnight Deposits | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 246,568 | 290,731 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Money Market Instruments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Nonqualified Deferred Compensation Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 4,008 | 1,151 | |
Fair value of other non-current liabilities | 19,394 | 24,341 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Forward Foreign Currency Exchange Contract, Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | [1] | 0 | 0 |
Fair value of other non-current liabilities | [1] | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 0 | 0 | |
Fair value of other non-current liabilities | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Certificates of Deposit | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | ||
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Commercial Paper | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | U.S. Government Agency Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Greek Government-Issued Bonds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Nonqualified Deferred Compensation Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Forward Foreign Current Exchange Contract Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 0 | 0 |
Fair value of other non-current assets | [1] | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [2] | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted Price In Active Markets For Identical Assets (Level 1) | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | 7,267 | 18,056 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 460,781 | 106,309 | |
Fair value of Available-for-sale securities | 690,455 | 621,231 | |
Fair value of other current assets | 9,171 | 18,266 | |
Fair value of other non-current assets | 9,312 | 9,895 | |
Fair value of financial assets, Total | 1,169,719 | 755,701 | |
Fair value of other current liabilities | 3,664 | 2,448 | |
Fair value of other non-current liabilities | 10,541 | 9,419 | |
Fair value of financial liabilities, Total | 14,205 | 11,867 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Overnight Deposits | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Money Market Instruments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 460,781 | 106,309 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Nonqualified Deferred Compensation Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 309 | 440 | |
Fair value of other non-current liabilities | 8,562 | 6,362 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Forward Foreign Currency Exchange Contract, Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | [1] | 3,355 | 2,008 |
Fair value of other non-current liabilities | [1] | 1,979 | 3,057 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 0 | 0 | |
Fair value of other non-current liabilities | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Certificates of Deposit | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 2,800 | 56,951 | |
Fair value of Available-for-sale securities, non-current | 6,969 | ||
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 139,073 | 42,673 | |
Fair value of Available-for-sale securities, non-current | 281,894 | 315,240 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Commercial Paper | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 16,692 | 12,733 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | U.S. Government Agency Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 168,934 | 83,222 | |
Fair value of Available-for-sale securities, non-current | 80,928 | 103,316 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Greek Government-Issued Bonds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, non-current | 134 | 127 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Nonqualified Deferred Compensation Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 309 | 440 | |
Fair value of other non-current assets | 8,562 | 6,362 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Forward Foreign Current Exchange Contract Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 4,810 | 10,478 |
Fair value of other non-current assets | [1] | 750 | 3,533 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [2] | 4,052 | 7,348 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 0 | 0 | |
Fair value of Available-for-sale securities | 0 | 0 | |
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
Fair value of financial assets, Total | 0 | 0 | |
Fair value of other current liabilities | 48,746 | 52,946 | |
Fair value of other non-current liabilities | 122,644 | 32,663 | |
Fair value of financial liabilities, Total | 171,390 | 85,609 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Overnight Deposits | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Money Market Instruments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Nonqualified Deferred Compensation Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 0 | 0 | |
Fair value of other non-current liabilities | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Forward Foreign Currency Exchange Contract, Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | [1] | 0 | 0 |
Fair value of other non-current liabilities | [1] | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 48,746 | 52,946 | |
Fair value of other non-current liabilities | 122,644 | 32,663 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Certificates of Deposit | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | ||
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Commercial Paper | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | U.S. Government Agency Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, current | 0 | 0 | |
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Greek Government-Issued Bonds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities, non-current | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Nonqualified Deferred Compensation Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Forward Foreign Current Exchange Contract Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 0 | 0 |
Fair value of other non-current assets | [1] | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [2] | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | $ 0 | $ 0 |
[1] | See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. | ||
[2] | The restricted investments at September 30, 2016 and December 31, 2015 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. | ||
[3] | The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investments. |
Liabilities Measured at Fair Va
Liabilities Measured at Fair Value Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Contingent acquisition consideration payable, Beginning balance | $ 85,609 |
Addition of contingent acquisition consideration payable related to the purchase of the Merck PKU Business | 138,974 |
Changes in the fair value of contingent acquisition consideration payable for continuing development programs | 7,032 |
Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable | 3,761 |
Contingent acquisition consideration payable, Ending balance | 171,390 |
Kyndrisa | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Reduction of fair value related to termination of development program | (43,652) |
Reveglucosidase Alfa | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Reduction of fair value related to termination of development program | $ (20,334) |
Asset Retirement Obligation Lia
Asset Retirement Obligation Liability and Corresponding Capital Asset (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Asset Retirement Obligation Disclosure [Abstract] | |
Asset retirement obligation, Beginning balance | $ 4,704 |
Accretion expense | 79 |
Reversals | (250) |
Asset retirement obligations, Ending balance | $ 4,533 |
Assumptions Used to Estimate Pe
Assumptions Used to Estimate Per Share Fair Value of Stock Options Granted (Detail) - Stock Option | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility, minimum | 38.00% | 41.00% | 36.00% | 39.00% |
Expected volatility, maximum | 40.00% | 44.00% | 44.00% | 45.00% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.10% | 1.90% | 1.10% | 1.50% |
Risk-free interest rate, maximum | 1.40% | 2.20% | 2.10% | 2.20% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected life | 5 years | 6 years 10 months 24 days | 5 years | 6 years 4 months 24 days |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected life | 6 years 8 months 12 days | 8 years | 8 years 1 month 6 days | 8 years |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | Mar. 15, 2016shares | Mar. 03, 2015shares | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)$ / sharesshares | Sep. 30, 2015USD ($)$ / shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares, granted | 783,580 | |||||
Weighted-average fair value per share granted | $ / shares | $ 41.15 | |||||
Recognized compensation costs | $ | $ 32,902 | $ 28,758 | $ 97,220 | $ 80,959 | ||
Stock-based compensation expense capitalized to inventory | $ | $ 9,000 | $ 8,300 | ||||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares, granted | 1,223,654 | |||||
Weighted-average fair value per RSU granted | $ / shares | $ 83.81 | |||||
Restricted Stock With Performance and Market Based Vesting Conditions | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average fair value per RSU granted | $ / shares | $ 34.66 | |||||
Granted restricted stock units | 860,000 | 860,000 | ||||
Total shareholder return, percentage of multiplier range | 124.00% | |||||
Restricted stock units, earned | 799,800 | 799,800 | ||||
2016 Base Restricted Stock Unit Awards with Performance Conditions | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average fair value per RSU granted | $ / shares | $ 83.43 | |||||
Granted restricted stock units | 130,310 | |||||
Award vesting service period | 3 years | |||||
Recognized compensation costs | $ | $ 1,000 | $ 2,100 | ||||
2016 Base Restricted Stock Unit Awards with Performance Conditions | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Revenue multiplier | 0.80 | |||||
2016 Base Restricted Stock Unit Awards with Performance Conditions | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Revenue multiplier | 1.20 | |||||
2015 Base Restricted Stock Unit Awards with Performance Conditions | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average fair value per RSU granted | $ / shares | $ 108.36 | |||||
Granted restricted stock units | 58,300 | |||||
Revenue multiplier | 1.11 | |||||
Award vesting service period | 3 years | |||||
Recognized compensation costs | $ | $ 600 | $ 500 | $ 1,800 | $ 1,300 | ||
Number of units that could vest if performance condition is achieved and a revenue multiplier is applied | 64,713 |
Compensation Expense (Detail)
Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 32,902 | $ 28,758 | $ 97,220 | $ 80,959 |
Cost of Sales | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 2,092 | 1,386 | 5,943 | 4,484 |
Research and Development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 14,165 | 12,578 | 42,929 | 34,972 |
Selling, General and Administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 16,645 | $ 14,794 | $ 48,348 | $ 41,503 |
Amounts Reclassified out of Acc
Amounts Reclassified out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Net product revenues | $ 278,262 | $ 207,767 | $ 812,195 | $ 658,102 |
SG&A | 118,758 | 94,044 | 333,635 | 288,364 |
Other income (expense) | 1,723 | (281) | 504 | (9,105) |
Provision for (benefit from) income taxes | (24,016) | 483 | (187,385) | (7,273) |
NET LOSS | (42,797) | (90,926) | (551,499) | (240,416) |
Reclassified out of Accumulated Other Comprehensive Income | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Provision for (benefit from) income taxes | 2 | 5 | (735) | 1,098 |
NET LOSS | 1,491 | 5,196 | 7,625 | 17,022 |
Reclassified out of Accumulated Other Comprehensive Income | Gains (losses) on Cash Flow Hedges | Forward Foreign Currency Exchange Contracts | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Net product revenues | 1,436 | 4,411 | 4,036 | 13,660 |
SG&A | 50 | 776 | 4,874 | 1,424 |
Reclassified out of Accumulated Other Comprehensive Income | Gain (loss) on Sale of Available-For-Sale Securities | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Other income (expense) | $ 7 | $ 14 | $ (2,020) | $ 3,036 |
Summary of Changes in Accumulat
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income and Reclassifications (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | ||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | [1] | $ 2,400,847 | |||
Other comprehensive income (loss) before reclassifications | $ (247) | $ (5,032) | (14,333) | $ 15,059 | |
Less net gain (loss) reclassified from AOCI | 1,493 | 5,201 | 6,890 | 18,120 | |
Tax effect | (630) | 2,956 | 2,348 | 779 | |
Net current-period other comprehensive income (loss) | (2,370) | (7,277) | (18,875) | (2,282) | |
Ending Balance | 2,645,808 | 2,645,808 | |||
Unrealized Gains (Losses) on Cash Flow Hedges | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | 2,305 | 17,074 | 13,602 | 15,906 | |
Other comprehensive income (loss) before reclassifications | (1,984) | 3,126 | (5,857) | 14,191 | |
Less net gain (loss) reclassified from AOCI | 1,486 | 5,187 | 8,910 | 15,084 | |
Tax effect | 0 | 0 | 0 | 0 | |
Net current-period other comprehensive income (loss) | (3,470) | (2,061) | (14,767) | (893) | |
Ending Balance | (1,165) | 15,013 | (1,165) | 15,013 | |
Unrealized Gains (Losses) on Available-for-Sale Securities | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | 2,231 | 15,336 | 7,441 | 11,511 | |
Other comprehensive income (loss) before reclassifications | 1,738 | (8,159) | (8,477) | 865 | |
Less net gain (loss) reclassified from AOCI | 7 | 14 | (2,020) | 3,036 | |
Tax effect | (630) | 2,956 | 2,348 | 779 | |
Net current-period other comprehensive income (loss) | 1,101 | (5,217) | (4,109) | (1,392) | |
Ending Balance | 3,332 | 10,119 | 3,332 | 10,119 | |
Foreign Currency Items | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | (8) | 51 | (10) | 49 | |
Other comprehensive income (loss) before reclassifications | (1) | 1 | 1 | 3 | |
Less net gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | |
Tax effect | 0 | 0 | 0 | 0 | |
Net current-period other comprehensive income (loss) | (1) | 1 | 1 | 3 | |
Ending Balance | (9) | 52 | (9) | 52 | |
Accumulated Other Comprehensive Income (Loss) | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | 4,528 | 32,461 | 21,033 | 27,466 | |
Ending Balance | $ 2,158 | $ 25,184 | $ 2,158 | $ 25,184 | |
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Consolidated Net Product Revenu
Consolidated Net Product Revenue Concentrations Based on Patient Location (Detail) - Net Product Revenue | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Geographic Concentration Risk | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 91.00% | 90.00% | 93.00% | 91.00% |
Geographic Concentration Risk | United States | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 38.00% | 44.00% | 38.00% | 38.00% |
Geographic Concentration Risk | Europe | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 23.00% | 21.00% | 23.00% | 19.00% |
Geographic Concentration Risk | Latin America | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 14.00% | 12.00% | 13.00% | 19.00% |
Geographic Concentration Risk | Rest of World | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 16.00% | 13.00% | 19.00% | 15.00% |
Customer Concentration Risk | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 48.00% | 43.00% | 48.00% | 43.00% |
Customer Concentration Risk | Genzyme | Product Four | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 9.00% | 10.00% | 7.00% | 9.00% |
Credit Concentration Risk | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Consolidated Net Product Reve74
Consolidated Net Product Revenue Concentrations Attributed to Largest Customers (Detail) - Customer Concentration Risk - Net Product Revenue | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 48.00% | 43.00% | 48.00% | 43.00% |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 19.00% | 15.00% | 19.00% | 14.00% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 13.00% | 9.00% | 13.00% | 11.00% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 6.00% | 6.00% | 6.00% | 13.00% |
Customer D | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10.00% | 13.00% | 10.00% | 5.00% |
Revenue and Credit Concentrat75
Revenue and Credit Concentrations - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2016USD ($) | Sep. 30, 2015 | Sep. 30, 2016USD ($)Customer | Sep. 30, 2015 | Dec. 31, 2015USD ($)Customer | ||
Concentration Risk [Line Items] | ||||||
Accounts receivable, net | $ 215,894 | $ 215,894 | $ 164,959 | [1] | ||
Southern European Countries | ||||||
Concentration Risk [Line Items] | ||||||
Total amount past due | 26,400 | 26,400 | ||||
Southern European Countries | Greater than 90 days | ||||||
Concentration Risk [Line Items] | ||||||
Total amount past due | 2,600 | $ 2,600 | ||||
Largest Customers | ||||||
Concentration Risk [Line Items] | ||||||
Number of customers accounted for largest balance in accounts receivable | Customer | 2 | 2 | ||||
Accounts receivable, net | $ 22,600 | $ 22,600 | $ 36,100 | |||
Credit Concentration Risk | Accounts Receivable | Larger Customer One | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 22.00% | 37.00% | ||||
Credit Concentration Risk | Accounts Receivable | Larger Customer Two | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 19.00% | 18.00% | ||||
Credit Concentration Risk | Net Product Revenue | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 100.00% | 100.00% | 100.00% | 100.00% | ||
Geographic Concentration Risk | Accounts Receivable | Southern European Countries | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 12.00% | 12.00% | ||||
Geographic Concentration Risk | Net Product Revenue | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 91.00% | 90.00% | 93.00% | 91.00% | ||
Geographic Concentration Risk | Net Product Revenue | Southern European Countries | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 8.00% | 7.00% | ||||
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2016Segment | |
Segment Reporting [Abstract] | |
Number of operating business segment | 1 |
Segment Information by Product
Segment Information by Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue from External Customer [Line Items] | ||||
Net product revenues | $ 278,262 | $ 207,767 | $ 812,195 | $ 658,102 |
Vimizim | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 80,903 | 65,106 | 260,310 | 169,608 |
Naglazyme | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 77,728 | 54,131 | 221,575 | 243,386 |
Kuvan | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 90,899 | 64,219 | 257,806 | 174,501 |
Aldurazyme | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 23,751 | 20,509 | 58,819 | 58,991 |
Firdapse | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | $ 4,981 | $ 3,802 | $ 13,685 | $ 11,616 |
Summary of Total Revenues from
Summary of Total Revenues from External Customers and Collaborative Partners by Geographic Region (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 279,896 | $ 208,904 | $ 816,763 | $ 661,959 |
United States | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 130,356 | 112,254 | 365,674 | 310,209 |
Europe | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 62,821 | 42,816 | 187,328 | 124,252 |
Latin America | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 38,789 | 25,588 | 106,803 | 127,147 |
Rest of World | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 47,930 | $ 28,246 | $ 156,958 | $ 100,351 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | 9 Months Ended | |||
Sep. 30, 2016USD ($)$ / € | Sep. 30, 2016EUR (€) | Dec. 31, 2015USD ($) | [1] | |
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 754,400 | |||
Contingent consideration payable | 171,400 | |||
Short-term contingent acquisition consideration payable | 48,746 | $ 52,946 | ||
Purchase commitment for the next five years | 50,900 | |||
Merck PKU Business | ||||
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 207,600 | € 185 | ||
Currency exchange translation rate | $ / € | 1.12 | |||
Completed Programs | ||||
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 58,200 | |||
[1] | December 31, 2015 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (the SEC) on February 29, 2016. |