Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Jul. 20, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
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 | 175,268,321 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 354,864 | $ 408,330 | |
Short-term investments | 372,912 | 381,347 | |
Accounts receivable, net | 238,338 | 215,280 | |
Inventory | 429,831 | 355,126 | |
Other current assets | 62,875 | 61,708 | |
Total current assets | 1,458,820 | 1,421,791 | |
Noncurrent assets: | |||
Long-term investments | 482,036 | 572,711 | |
Property, plant and equipment, net | 851,097 | 798,768 | |
Intangible assets, net | 538,565 | 553,780 | |
Goodwill | 197,039 | 197,039 | |
Deferred tax assets | 470,961 | 446,786 | |
Other assets | 21,447 | 32,815 | |
Total assets | 4,019,965 | 4,023,690 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 319,210 | 370,505 | |
Short-term convertible debt, net | 0 | 22,478 | |
Short-term contingent acquisition consideration payable | 55,093 | 46,327 | |
Total current liabilities | 374,303 | 439,310 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 676,205 | 660,761 | |
Long-term contingent acquisition consideration payable | 122,899 | 115,310 | |
Other long-term liabilities | 50,979 | 42,034 | |
Total liabilities | 1,224,386 | 1,257,415 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 175,248,847 and 172,647,588 shares issued and outstanding as of June 30, 2017 and December 31, 2016, respectively. | 175 | 173 | |
Additional paid-in capital | 4,397,980 | 4,288,113 | |
Company common stock held by Nonqualified Deferred Compensation Plan (NQDC) | (14,289) | (14,321) | |
Accumulated other comprehensive income (loss) | (14,658) | 12,816 | |
Accumulated deficit | (1,573,629) | (1,520,506) | |
Total stockholders’ equity | 2,795,579 | 2,766,275 | |
Total liabilities and stockholders’ equity | $ 4,019,965 | $ 4,023,690 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 | [1] |
Statement Of Financial Position [Abstract] | |||
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 500,000,000 | 500,000,000 | |
Common stock, shares issued | 175,248,847 | 172,647,588 | |
Common stock, shares outstanding | 175,248,847 | 172,647,588 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
REVENUES: | ||||
Net product revenues | $ 315,926 | $ 298,576 | $ 618,116 | $ 533,933 |
Royalty and other revenues | 1,522 | 1,555 | 3,077 | 2,934 |
Total revenues | 317,448 | 300,131 | 621,193 | 536,867 |
OPERATING EXPENSES: | ||||
Cost of sales | 56,305 | 51,617 | 106,311 | 94,735 |
Research and development | 143,039 | 167,039 | 288,042 | 325,832 |
Selling, general and administrative | 143,505 | 109,577 | 263,524 | 214,877 |
Intangible asset amortization and contingent consideration | 13,411 | (54,414) | 22,336 | (43,972) |
Impairment of intangible assets | 0 | 599,118 | 0 | 599,118 |
Total operating expenses | 356,260 | 872,937 | 680,213 | 1,190,590 |
LOSS FROM OPERATIONS | (38,812) | (572,806) | (59,020) | (653,723) |
Equity in the loss of BioMarin/Genzyme LLC | (220) | (135) | (743) | (270) |
Interest income | 2,983 | 1,357 | 6,055 | 2,928 |
Interest expense | (10,040) | (9,944) | (20,159) | (19,787) |
Other income (expense) | 543 | (1,417) | 4,015 | (1,219) |
LOSS BEFORE INCOME TAXES | (45,546) | (582,945) | (69,852) | (672,071) |
Benefit from income taxes | (8,713) | (163,931) | (16,729) | (170,006) |
NET LOSS | $ (36,833) | $ (419,014) | $ (53,123) | $ (502,065) |
NET LOSS PER SHARE, BASIC AND DILUTED | $ (0.21) | $ (2.58) | $ (0.31) | $ (3.10) |
Weighted average common shares outstanding, basic and diluted | 174,374 | 162,587 | 173,547 | 162,067 |
COMPREHENSIVE LOSS | $ (56,511) | $ (414,533) | $ (80,597) | $ (518,570) |
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, 2015 | $ 21,033 | ||||||
Net loss | $ (502,065) | ||||||
Ending Balance at Jun. 30, 2016 | 4,528 | ||||||
Beginning Balance at Mar. 31, 2016 | 47 | ||||||
Net loss | (419,014) | ||||||
Ending Balance at Jun. 30, 2016 | 4,528 | ||||||
Beginning Balance at Dec. 31, 2016 | 2,766,275 | [1] | $ 173 | $ 4,288,113 | $ (14,321) | 12,816 | $ (1,520,506) |
Beginning Balance (in shares) at Dec. 31, 2016 | 172,648 | ||||||
Net loss | (53,123) | (53,123) | |||||
Other comprehensive loss | (27,474) | (27,474) | |||||
Issuances under equity incentive plans, net of tax (in share) | 1,402 | ||||||
Issuances under equity incentive plans, net of tax | 7,331 | $ 1 | 7,330 | ||||
Issuances of common stock under the Employee Stock Purchase Plan (the ESPP) | 6,704 | 6,704 | |||||
Issuances of common stock under the Employee Stock Purchase Plan (the ESPP) (in shares) | 95 | ||||||
Conversion of convertible notes, net | 22,477 | $ 1 | 22,476 | ||||
Conversion of convertible notes, net (in shares) | 1,104 | ||||||
Common stock held by NQDC | 32 | 32 | |||||
Stock-based compensation | 73,357 | 73,357 | |||||
Ending Balance at Jun. 30, 2017 | 2,795,579 | $ 175 | 4,397,980 | (14,289) | (14,658) | (1,573,629) | |
Ending Balance (in shares) at Jun. 30, 2017 | 175,249 | ||||||
Beginning Balance at Mar. 31, 2017 | 5,020 | ||||||
Net loss | (36,833) | ||||||
Ending Balance at Jun. 30, 2017 | $ 2,795,579 | $ 175 | $ 4,397,980 | $ (14,289) | $ (14,658) | $ (1,573,629) | |
Ending Balance (in shares) at Jun. 30, 2017 | 175,249 | ||||||
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (53,123) | $ (502,065) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 38,497 | 47,383 | |
Non-cash interest expense | 15,601 | 14,762 | |
Accretion of discount on investments | 1,327 | 536 | |
Stock-based compensation | 70,775 | 64,075 | |
Gain on the sale of equity investments | (3,252) | 2,027 | |
Impairment of intangible assets | 0 | 599,118 | |
Deferred income taxes | (22,770) | (191,131) | |
Unrealized foreign exchange gain on forward contracts | (4,870) | (7,882) | |
Non-cash changes in the fair value of contingent acquisition consideration payable | 7,195 | (59,066) | |
Other | 3,806 | 705 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (16,834) | (50,250) | |
Inventory | (60,369) | (41,600) | |
Other current assets | (3,710) | 3,186 | |
Other assets | (1,109) | (1,439) | |
Accounts payable and accrued liabilities | (36,286) | (87,560) | |
Other long-term liabilities | 3,459 | (8,058) | |
Net cash used in operating activities | (61,663) | (217,259) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (116,847) | (70,710) | |
Maturities and sales of investments | 234,617 | 283,780 | |
Purchase of available-for-sale securities | (130,986) | (58,914) | |
Business acquisitions, net of cash acquired | 0 | (1,467) | |
Other | (1,560) | (150) | |
Net cash (used in) provided by investing activities | (14,776) | 152,539 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of stock options and the ESPP | 40,659 | 23,014 | |
Taxes paid related to net share settlement of equity awards | (26,624) | (52,824) | |
Payment of contingent acquisition consideration payable | (1,894) | 0 | |
Other | (28) | 0 | |
Net cash provided by (used in) financing activities | 12,113 | (29,810) | |
Effect of exchange rate changes on cash | 10,860 | 3,459 | |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (53,466) | (91,071) | |
Cash and cash equivalents: | |||
Beginning of period | 408,330 | [1] | 397,040 |
End of period | 354,864 | 305,969 | |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |||
Cash paid for interest, net of interest capitalized into fixed assets | 4,519 | 4,521 | |
Cash paid for income taxes | 16,341 | 93,969 | |
Stock-based compensation capitalized into inventory | 7,600 | 5,751 | |
Depreciation capitalized into inventory | 11,752 | 8,993 | |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON CASH INVESTING AND FINANCING ACTIVITIES: | |||
Decrease in accounts payable and accrued liabilities related to fixed assets | (29,300) | (17,130) | |
Conversion of convertible debt | 22,477 | 6,941 | |
Accrual for inventory purchases related to the acquisition of the Merck PKU Business | $ 0 | $ 1,322 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
NATURE OF OPERATIONS AND BUSINE
NATURE OF OPERATIONS AND BUSINESS RISKS | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
NATURE OF OPERATIONS AND BUSINESS RISKS | (1) NATURE OF OPERATIONS AND BUSINESS RISKS BioMarin Pharmaceutical Inc. (the Company) is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare 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 therapy portfolio consists of six approved products and multiple clinical and pre-clinical product candidates. 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 through proceeds from debt or equity offerings, commercial borrowing, or through collaborative agreements with corporate partners. If the Company elects to increase its spending on development programs significantly above current long-term plans or enters into potential licenses and other acquisitions of complementary technologies, products or companies, the Company may need additional capital. The Company is subject to a number of risks, including: the financial performance of its commercial products; the potential 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; significant competition from larger organizations; 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. Please see “Risk Factors” included in Part II, Item 1A of this Quarterly Report on Form 10-Q for a more detailed discussion of these risks. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | (2) BASIS OF PRESENTATION The accompanying Condensed Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and 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 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, 2016 included in the Company’s Annual Report on Form 10-K. U.S. GAAP 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 six months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2017 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, except for the transaction disclosed in Note 20. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2017 | |
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 six months ended June 30, 2017, 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, 2016. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 6 Months Ended |
Jun. 30, 2017 | |
New Accounting Pronouncements And Changes In Accounting Principles [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 six months ended June 30, 2017, 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, 2016, that the Company believes are of significance or potential significance to the Company. In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09 (ASU 2014-09) regarding Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers ’ As of June 30, 2017, the Company has not elected early adoption and has not concluded on an adoption method. The Company has formed a task force that is in the process of analyzing the Company ’ ’ In January 2016, the FASB issued ASU No. 2016-01 (ASU 2016-01), Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU No. 2016-02, Leases As of June 30, 2017, the Company has formed a task force that is in the process of analyzing the Company’s lease contracts and the potential impacts the standard may have on its Consolidated Financial Statements and related disclosures. After completing the analysis of the accounting for the Company’s lease contracts under the amendments, management will assess the required changes to the Company’s accounting policies, systems and internal control over financial reporting. Based on management’s preliminary analysis, the Company anticipates the amendments will have a material impact on the Company’s Consolidated Balance Sheets due to the requirement to recognize lease ROU assets and corresponding liabilities related to leases on the Company’s Consolidated Balance Sheets, but they are not anticipated to have a material impact on the Company’s other Consolidated Financial Statements. In May 2017 the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting |
ACQUISITIONS
ACQUISITIONS | 6 Months Ended |
Jun. 30, 2017 | |
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 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 years ended December 31, 2016 and 2015. Pursuant to the A&R Kuvan Agreement, the Company paid Merck Serono $374.5 million € € 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. At the time of the acquisition, pegvaliase was 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 submitted a marketing application in the U.S. in June 2017 and announced its plans to submit an application for registration in the European Union (EU). Kuvan has Orphan Drug exclusivity in the 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. Key assumptions include a discount rate and various probability factors. 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 as of June 30, 2017. Consolidated The following table presents the final 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. |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 6 Months Ended |
Jun. 30, 2017 | |
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 table below presents potential shares of common stock that were excluded from the computation of basic and diluted earnings per common share as they were anti-dilutive using the if-converted or treasury stock method (in thousands): Three and Six Months Ended June 30, 2017 2016 Options to purchase common stock 8,440 10,445 Common stock issuable under the 2017 Notes — 1,203 Common stock issuable under the 2018 and 2020 Notes 7,966 7,966 Unvested restricted stock units 3,041 2,829 Common stock potentially issuable for ESPP purchases 387 356 Common stock held by the NQDC 224 253 Total number of potentially issuable shares 20,058 23,052 The effect of the Company’s 0.75% 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 using the if-converted method. The Company’s closing stock price on June 30, 2017 and 2016 did not exceed the conversion price of $94.15 per share for the Notes. |
AVAILABLE-FOR-SALE SECURITIES
AVAILABLE-FOR-SALE SECURITIES | 6 Months Ended |
Jun. 30, 2017 | |
Investments Schedule [Abstract] | |
AVAILABLE-FOR-SALE SECURITIES | (7) AVAILABLE-FOR-SALE SECURITIES All investments were classified as available-for-sale at June 30, 2017 and December 31, 2016. 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 June 30, 2017 and December 31, 2016 are summarized in the tables below: Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at June 30, 2017 Corporate debt securities $ 615,435 $ 426 $ (1,411 ) $ 614,450 Commercial paper 8,976 — — 8,976 U.S. government agency securities 233,898 4 (840 ) 233,062 Greek government-issued bonds 48 122 (1 ) 169 Total $ 858,357 $ 552 $ (2,252 ) $ 856,657 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at December 31, 2016 Certificates of deposit $ 2,800 $ — $ — $ 2,800 Corporate debt securities 641,670 329 (2,282 ) 639,717 Commercial paper 16,075 — — 16,075 U.S. government agency securities 310,635 37 (747 ) 309,925 Greek government-issued bonds 48 86 — 134 Total $ 971,228 $ 452 $ (3,029 ) $ 968,651 As of December 31, 2016, the Company had one investment in marketable equity securities, measured using quoted prices in its active market, which was considered a strategic investment. In the first quarter of 2017, the strategic investment was sold for a realized gain of $3.3 million. As of December 31, 2016, the fair value of the Company’s marketable equity securities was $4.1 million, which included an unrealized gain of $2.3 million, and was recorded in Other Assets in the Company’s Condensed Consolidated Balance Sheet. The fair values of available-for-sale securities by contractual maturity were as follows: June 30, December 31, 2017 2016 Maturing in one year or less $ 374,621 $ 395,940 Maturing after one year through five years 482,036 572,711 Total $ 856,657 $ 968,651 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 June 30, 2017, some of the Company’s investments were in an unrealized loss position, which the Company considers temporary in nature. 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 | 6 Months Ended |
Jun. 30, 2017 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | (8) INTANGIBLE ASSETS Intangible assets consisted of the following: June 30, December 31, 2017 2016 Intangible assets: Finite-lived intangible assets $ 303,297 $ 305,122 Indefinite-lived intangible assets 332,199 332,199 Gross intangible assets: 635,496 637,321 Less: Accumulated amortization (96,931 ) (83,541 ) Net carrying value $ 538,565 $ 553,780 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 recorded impairment charges of $574.1 million based on the status of development efforts. These impairments reduced the remaining book value of certain IPR&D assets to zero due to the termination of the Kyndrisa and other exon programs. During the three and six months ended June 30, 2016, the Company also recognized an impairment charge of $25.0 million related to the reveglucosidase alfa IPR&D assets due to the decision to terminate that development program. When a triggering event occurs, management evaluates both IPR&D assets and goodwill for possible impairments. Although management concluded these IPR&D assets were impaired as of June 30, 2016, management determined that goodwill was not impaired as of June 30, 2016. Because the Company’s single reporting unit is the consolidated entity, management compares the total carrying value of the single reporting unit, including goodwill, to the fair value of the reporting unit, as evidenced by the Company’s market capitalization. As of June 30, 2016, the Company’s capitalization exceeded the carrying value of its single reporting unit supporting management’s conclusion that goodwill was not impaired. See Note 7 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 for additional information related to the Company’s intangible assets. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 6 Months Ended |
Jun. 30, 2017 | |
Property Plant And Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | (9) PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, net consisted of the following: June 30, December 31, 2017 2016 Building and improvements $ 555,868 $ 510,805 Manufacturing and laboratory equipment 261,616 242,899 Computer hardware and software 137,041 129,506 Leasehold improvements 43,614 44,184 Furniture and equipment 28,370 27,229 Land improvements 4,881 4,881 Land 56,050 55,412 Construction-in-progress 135,159 126,446 1,222,599 1,141,362 Less: Accumulated depreciation (371,502 ) (342,594 ) Total property, plant and equipment, net $ 851,097 $ 798,768 The construction-in-process balance primarily includes costs related to the Company’s significant in-process projects at its facilities in Marin County, California, and in Shanbally, Cork, Ireland. Depreciation expense for the three and six months ended June 30, 2017 was $17.9 million and $35.4 million, respectively, of which $6.2 million and $11.8 million, respectively, was capitalized into inventory. Depreciation expense for the three and six months ended June 30, 2016 was $17.2 million and $32.9 million, respectively, of which $4.8 million and $9.0 million, respectively, was capitalized into inventory. Capitalized interest related to the Company’s property, plant and equipment purchases for each of the three and six months ended June 30, 2017 and 2016 was insignificant. |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 6 Months Ended |
Jun. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | (10) SUPPLEMENTAL BALANCE SHEET INFORMATION Inventory consisted of the following: June 30, December 31, 2017 2016 Raw materials $ 46,602 $ 51,250 Work-in-process 253,658 167,788 Finished goods 129,571 136,088 Total inventory $ 429,831 $ 355,126 In the third quarter of 2016, process qualification production activities commenced in the Company’s Shanbally facility related to the Brineura manufacturing process. As of June 30, 2017, the value of the Shanbally qualification campaign was $22.7 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 Brineura, should that occur, the value of the inventory would be expensed at that time. Accounts Payable and Accrued Liabilities consisted of the following: June 30, December 31, 2017 2016 Accounts payable and accrued operating expenses $ 158,229 $ 191,353 Accrued compensation expense 80,604 109,038 Accrued rebates payable 37,973 34,737 Accrued royalties payable 15,541 15,151 Value added taxes payable 8,609 7,848 Other 18,254 12,378 Total accounts payable and accrued liabilities $ 319,210 $ 370,505 |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
DEBT | (11) DEBT Convertible Notes The following table summarizes information regarding the Company’s convertible debt: June 30, December 31, 2017 2016 Convertible Notes due in 2017 $ — $ 22,503 Unamortized deferred offering costs — (25 ) Convertible Notes due in 2017, net — 22,478 Convertible Notes due in 2018 374,980 374,980 Unamortized discount (20,122 ) (27,566 ) Unamortized deferred offering costs (2,515 ) (3,484 ) Convertible Notes due in 2018, net 352,343 343,930 Convertible Notes due in 2020 374,993 374,993 Unamortized discount (46,854 ) (53,239 ) Unamortized deferred offering costs (4,277 ) (4,923 ) Convertible Notes due in 2020, net 323,862 316,831 Total convertible debt, net $ 676,205 $ 683,239 Fair value of fixed rate convertible debt Convertible Notes due in 2017 (1) $ — $ 90,977 Convertible Notes due in 2018 (1) 416,337 423,202 Convertible Notes due in 2020 (1) 446,725 442,754 Total $ 863,062 $ 956,933 (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 June 30, Six Months Ended June 30, 2017 2016 2017 2016 Coupon interest $ 2,194 $ 2,520 $ 4,558 $ 5,026 Amortization of issuance costs 886 825 1,772 1,649 Accretion of debt discount 6,960 6,599 13,829 13,112 Total interest expense on convertible debt $ 10,040 $ 9,944 $ 20,159 $ 19,787 In April 2017, the remaining $22.5 million of the Company’s senior subordinated notes due in 2017 (the 2017 Notes) matured and were converted into 1,103,704 shares of the Company’s common stock. During three and six months ended June 30, 2016, certain existing holders of the Company’s senior subordinated notes due in 2017 elected to convert $6.9 million in aggregate principal amount of the 2017 Notes into 340,967 shares of the Company’s common stock. See Note 13 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 for additional information related to the Company’s convertible debt. Revolving Credit Facility In November 2016, the Company entered into a credit agreement (Credit Agreement) with Bank of America, N.A., as the administrative agent, swing line lender and letter of credit issuer. The Credit Agreement provides for up to $100.0 million in revolving loans (Revolving Credit Facility), a $10.0 million letter of credit subfacility and a $15.0 million swing line loan subfacility. The maturity date of the Revolving Credit Facility will occur on November 29, 2018. Interest on any outstanding balance of the Revolving Credit Facility is payable quarterly and draws may be voluntary prepaid at any time without penalty. In connection with entering into the Credit Agreement, $0.6 million in financing costs were incurred and will be amortized as Interest Expense over the term of the Credit Agreement. As of June 30, 2017 and December 31, 2016, there were no outstanding amounts due under the Revolving Credit Facility. In connection with the Revolving Credit Facility, the Company and certain of its subsidiaries are required to comply with covenants, including, among other things, restrictions on the Company’s and such subsidiaries’ ability to incur additional indebtedness, dispose of its assets, incur liens, make investments, and pay dividends or other distributions, in each case subject to specified exceptions. The Credit Agreement also contains customary indemnification obligations and customary events of default. If the Company’s Global Liquidity, which is defined as the sum of the market value of unrestricted cash, marketable securities and other assets to the extent constituting “cash and cash equivalents,” “short-term investments” or “long-term investments” as reflected in the Company’s Condensed Consolidated Balance Sheet, in each case, held by the Company or certain of the Company’s subsidiaries at such time, regardless of where such assets are domiciled, falls below $225.0 million at the end of any month or at the time of any borrowing or issuance of a letter of credit under the Revolving Credit Facility, then the Company’s obligations under the Credit Agreement will also be secured by the assets held by the Company in the custody account, which was established in the first quarter of 2017. As of June 30, 2017, the Company and certain of its subsidiaries that serve as guarantors were in compliance with all covenants. |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros – Purchase 72 114.3 Jul. 2017 - Jun. 2020 Euros – Sell 300 379.6 Jul. 2017 - Jun. 2020 Canadian Dollars – Sell 12 11.9 Jul. 2017 - Dec. 2017 Colombian Pesos – Sell 6 31,152.0 Jul. 2017 - Dec. 2017 Brazilian Reais – Sell 2 33.0 Oct. 2017 Total 392 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 June 2020. Over the next twelve months, the Company expects to reclassify unrealized losses of $9.2 million from accumulated other comprehensive income (loss) to earnings as the forecasted revenue and operating expense transactions occur. 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 June 30, 2017 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros – Purchase 2 92.2 July 2017 British Pounds – Sell 1 11.3 July 2017 Total 3 The fair value carrying amounts of the Company’s derivative instruments were as follows: Asset Derivatives Liability Derivatives June 30, 2017 June 30, 2017 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 1,743 Accounts payable and accrued liabilities $ 9,434 Forward foreign currency exchange contracts Other assets 2,558 Other long- term liabilities 6,506 Total 4,301 15,940 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 507 Accounts payable and accrued liabilities 58 Total 507 58 Total value of derivative contracts $ 4,808 $ 15,998 Asset Derivatives Liability Derivatives December 31, 2016 December 31, 2016 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 13,048 Accounts payable and accrued liabilities $ 5,176 Forward foreign currency exchange contracts Other assets 8,194 Other long- term liabilities 2,342 Total 21,242 7,518 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 964 Accounts payable and accrued liabilities 25 Total 964 25 Total value of derivative contracts $ 22,206 $ 7,543 The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three and six months ended June 30, 2017 and 2016 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in accumulated other comprehensive income (loss) (1) $ (19,165 ) $ 4,608 $ (23,364 ) $ (3,873 ) Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings (2) 695 (197 ) 3,211 3,130 Net gain (loss) recognized in net loss (3) 826 (603 ) 1,706 5,267 Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ 5,373 $ 1,012 $ 5,631 $ (3,272 ) (1) Net change in the fair value of the effective portion classified as accumulated other comprehensive income (loss). (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. 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’s exposure to potential defaults. The Company does not require collateral to be pledged under these agreements. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 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: Money market instruments $ — $ 44,566 $ — $ 44,566 Corporate debt securities — 1,709 — 1,709 Total cash and cash equivalents — 46,275 — 46,275 Available-for-sale securities: Short-term: Corporate debt securities — 252,696 — 252,696 Commercial paper — 8,976 — 8,976 U.S. government agency securities — 111,240 — 111,240 Long-term: Corporate debt securities — 360,045 — 360,045 U.S. government agency securities — 121,822 — 121,822 Greek government-issued bonds — 169 — 169 Total available-for-sale securities — 854,948 — 854,948 Other current assets: NQDC Plan assets — 661 — 661 Forward foreign currency exchange contract (1) — 2,250 — 2,250 Restricted investments (2) — 9,327 — 9,327 Total other current assets — 12,238 — 12,238 Other assets: NQDC Plan assets — 11,347 — 11,347 Forward foreign currency exchange contract (1) — 2,558 — 2,558 Total other assets — 13,905 — 13,905 Total assets $ — $ 927,366 $ — $ 927,366 Liabilities: Current liabilities: NQDC Plan liability $ 2,326 $ 661 $ — $ 2,987 Forward foreign currency exchange contract (1) — 9,492 — 9,492 Contingent acquisition consideration payable — — 55,093 55,093 Total current liabilities 2,326 10,153 55,093 67,572 Other long-term liabilities: NQDC Plan liability $ 17,844 $ 11,347 — 29,191 Forward foreign currency exchange contract (1) — 6,506 — 6,506 Contingent acquisition consideration payable — — 122,899 122,899 Total other long-term liabilities 17,844 17,853 122,899 158,596 Total liabilities $ 20,170 $ 28,006 $ 177,992 $ 226,168 Fair Value Measurements at December 31, 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: Money market instruments $ — $ 235,571 $ — $ 235,571 Corporate debt securities — 8,593 — 8,593 U.S. government agency securities — 6,000 — 6,000 Total cash and cash equivalents — 250,164 — 250,164 Available-for-sale securities: Short-term: Certificates of deposit — 2,800 — 2,800 Corporate debt securities — 193,974 — 193,974 Commercial paper — 16,075 — 16,075 U.S. government agency securities — 168,498 — 168,498 Long-term: Corporate debt securities — 437,150 — 437,150 U.S. government agency securities — 135,427 — 135,427 Greek government-issued bonds — 134 — 134 Total available-for-sale securities — 954,058 — 954,058 Other current assets: NQDC Plan assets — 163 — 163 Forward foreign currency exchange contract (1) — 14,012 — 14,012 Restricted investments (2) — 3,754 — 3,754 Total other current assets — 17,929 — 17,929 Other assets: NQDC Plan assets — 9,121 — 9,121 Forward foreign currency exchange contract (1) — 8,194 — 8,194 Strategic investment (3) 4,064 — — 4,064 Total other assets 4,064 17,315 — 21,379 Total assets $ 4,064 $ 1,239,466 $ — $ 1,243,530 Liabilities: Current liabilities: NQDC Plan liability $ 2,073 $ 163 $ — $ 2,236 Forward foreign currency exchange contract (1) — 5,201 — 5,201 Contingent acquisition consideration payable — — 46,327 46,327 Total current liabilities 2,073 5,364 46,327 53,764 Other long-term liabilities: NQDC Plan liability 17,303 9,121 — 26,424 Forward foreign currency exchange contract (1) — 2,342 — 2,342 Contingent acquisition consideration payable — — 115,310 115,310 Total other long-term liabilities 17,303 11,463 115,310 144,076 Total liabilities $ 19,376 $ 16,827 $ 161,637 $ 197,840 (1) See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. (2) The restricted investments at June 30, 2017 and December 31, 2016 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. (3) The Company had investments in marketable equity securities measured using quoted prices in an active market that were considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investment. There were no transfers between levels during the three and six months ended June 30, 2017. 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 6 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’s contingent acquisition consideration payable is estimated using a probability-based income approach utilizing an appropriate discount rate. Key assumptions used by management to estimate the fair value of contingent acquisition consideration payable include estimated probabilities, the estimated timing of when a milestone may be attained and assumed discount periods and rates. Subsequent changes in the fair value of the contingent acquisition consideration payable, resulting from management’s revision of key assumptions, will be recorded in Intangible Asset Amortization and Contingent Consideration in the Company’s Condensed Consolidated Statements of Comprehensive Loss. The probability-based income approach used by management to estimate the fair value of the contingent acquisition consideration is most sensitive to changes in the estimated probabilities. Contingent acquisition consideration payable at December 31, 2016 $ 161,637 Changes in the fair value of contingent acquisition consideration payable for continuing development programs 7,195 Milestone payments to former Huxley Pharmaceuticals, Inc. shareholders (3,500 ) Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 12,660 Contingent acquisition consideration payable at June 30, 2017 $ 177,992 Under certain of the Company’s lease agreements, the Company is contractually obligated to return leased space to its original condition upon termination of the lease agreement. The Company records an asset retirement obligation liability and a corresponding capital asset in an amount equal to the estimated fair value of the obligation, when estimable. In subsequent periods, for each such lease, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciates each capitalized asset retirement obligation asset, both over the term of the associated lease agreement. As of June 30, 2017, the balance of the asset retirement obligation liability was $4.1 million. 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 | 6 Months Ended |
Jun. 30, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
STOCK-BASED COMPENSATION | (14) STOCK-BASED COMPENSATION The Company’s stock-based compensation plans include the 2017 Equity Incentive Plan (the 2017 Equity Incentive Plan) and the ESPP. The 2017 Equity Incentive Plan, which was approved by the Company’s stockholders on June 6, 2017 and became effective that same date, and is the successor to and continuation of the Company’s Amended and Restated 2006 Share Incentive Plan (the 2006 Share Incentive Plan), provides for awards of RSUs and stock options as well as other forms of equity compensation. No additional awards will be granted under the 2006 Share Incentive Plan; however, there are vested and unvested awards outstanding under the 2006 Share Incentive Plan. Stock option awards granted to employees generally vest over a four-year period on a cliff basis one year after the grant date and then monthly thereafter. The contractual term of the outstanding options is generally ten years. RSUs granted to employees generally vest annually on a straight-line basis over a four-year period after the grant date. RSUs granted to directors generally vest in full one year after the grant date. Shares formerly reserved for future issuance under the 2006 Share Incentive Plan were transferred to the 2017 Equity Incentive Plan, from which future shares shall be issued. The Company’s stock-based compensation plans are administered by the Company’s Board of Directors, or designated Committee thereof, 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. 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 are considered separately for valuation purposes. 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 and the implied volatility of traded options on the Company’s common stock for fiscal periods in which there is sufficient trading volume in options on 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. Effective January 1, 2016, forfeitures were accounted for as they occurred. The assumptions used to estimate the per share fair value of stock options granted under the 2017 Equity Incentive Plan and the 2006 Share Incentive Plan were as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Expected volatility 38 – 40% 37 - 40% 38 – 40% 36 – 44% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected life 5.0 – 6.6 years 5.1 - 6.8 years 5.0 – 6.6 years 5.1 – 8.1 years Risk-free interest rate 1.8 – 1.9% 1.1 - 1.5% 1.8 – 2.2% 1.1 – 2.1% During the six The assumptions used to estimate the per share fair value of stock purchase rights granted under the ESPP were as follows: Six Months Ended June 30, 2017 2016 Expected volatility 31 - 42% 42 - 50% Dividend yield 0.0% 0.0% Expected life 6-24 months 6-24 months Risk-free interest rate 1.0 - 1.3% 0.4 - 0.8% 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, based on the market price of the Company’s common stock on that date, ratably over the period during which the vesting restrictions lapse. During the six Restricted Stock Unit Awards with Performance Conditions On March 22, 2017, pursuant to Board approval, the Company granted 133,250 RSUs with performance-vesting conditions (the 2017 Base RSUs) under the 2006 Share Incentive Plan to certain executive officers. The award of the RSUs under this specific grant is contingent upon the achievement of a 2017 revenue target and the awarded RSUs, if any, vest ratably over a three-year service period. The number of RSUs to be awarded upon achievement of the performance condition may range between 50% and 200% of the 2017 Base RSUs, dependent on the percentage of 2017 “managed revenues” (defined as the Company’s net product revenues, excluding net revenues attributable to Aldurazyme) achieved against the target managed revenues with a threshold achievement level of 75% of target and a ceiling achievement level of 125% of target. 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 2017 Base RSUs was determined to be $87.42 per RSU, based on the fair value of the common stock underlying the 2017 Base RSUs on the grant date based on the market price of the Company’s common stock on that date. The Company evaluated the 2017 revenue target in the context of its current 2017 revenue forecast and related confidence level in the forecast, and determined that attainment of the revenue target was probable for accounting purposes commencing with the first quarter of 2017. As a result, the Company recognized $1.5 million and $1.6 million of compensation expense related to these awards during the three and six months ended June 30, 2017. On March 15, 2016, pursuant to Board approval, the Company granted 130,310 RSUs with performance-vesting conditions (the 2016 Base RSUs) and a three-year service period, under the 2006 Share Incentive Plan, to certain executive officers. Based on the Company ’ On March 3, 2015, pursuant to Board approval, the Company granted 58,300 RSUs with performance-vesting conditions (the 2015 Base RSUs) and a three-year service period, under the 2006 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 June 30, Six Months Ended June 30, 2017 2016 2017 2016 Cost of sales $ 2,510 $ 2,289 $ 4,796 $ 3,851 R&D 14,647 14,814 26,141 28,521 SG&A 22,944 16,795 39,838 31,703 Total stock-based compensation expense $ 40,101 $ 33,898 $ 70,775 $ 64,075 The Company adopted ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting Stock-based compensation expense of $4.4 million and $7.6 million was capitalized into inventory for the three and six months ended June 30, 2017 and Stock-based compensation expense of $3.3 million and $5.8 million was capitalized into inventory for the three and six months ended June 30, 2016, respectively. Capitalized stock-based compensation is recognized as Cost of Sales when the related product is sold. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | (15) ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) The following table summarizes amounts reclassified out of Accumulated Other Comprehensive Income (Loss) (AOCI) and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2017 and 2016. Three Months Ended June 30, Six Months Ended June 30, Consolidated Statement of Details about AOCI Components 2017 2016 2017 2016 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ 1,119 $ (589 ) $ 4,661 $ 2,600 Net product revenues Forward foreign currency exchange contracts (424 ) 392 (1,450 ) 4,824 SG&A Total gain (loss) on cash flow hedges 695 (197 ) 3,211 7,424 Gain (loss) on sale of available-for-sale securities — (2,027 ) 3,252 (2,027 ) Other income Income tax effect of the above — 737 (1,181 ) 737 Benefit from income taxes $ 695 $ (1,487 ) $ 5,282 $ 6,134 Net loss The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI for the three and six months ended June 30, 2017 and 2016. Three Months Ended June 30, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at March 31, 2017 $ 6,291 $ (1,258 ) $ (13 ) $ 5,020 Other comprehensive income (loss) before reclassifications (19,165 ) 267 4 (18,894 ) Less net gain reclassified from AOCI 695 — — 695 Tax effect — (89 ) — (89 ) Net current-period other comprehensive loss (19,860 ) 178 4 (19,678 ) AOCI balance at June 30, 2017 $ (13,569 ) $ (1,080 ) $ (9 ) $ (14,658 ) Three Months Ended June 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at March 31, 2016 $ (2,500 ) $ 2,554 $ (7 ) $ 47 Other comprehensive income (loss) before reclassifications 4,608 (2,536 ) (1 ) 2,071 Less loss reclassified from AOCI (197 ) (2,027 ) — (2,224 ) Tax effect — 186 — 186 Net current-period other comprehensive income (loss) 4,805 (323 ) (1 ) 4,481 AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 Six Months Ended June 30, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (23,364 ) 1,834 3 (21,527 ) Less net gain reclassified from AOCI 3,211 3,252 — 6,463 Tax effect — 516 — 516 Net current-period other comprehensive income (loss) (26,575 ) (902 ) 3 (27,474 ) AOCI balance at June 30, 2017 $ (13,569 ) $ (1,080 ) $ (9 ) $ (14,658 ) Six Months Ended June 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 (3,873 ) (10,215 ) 2 (14,086 ) Less gain (loss) reclassified from AOCI 7,424 (2,027 ) — 5,397 Tax effect — 2,978 — 2,978 Net current-period other comprehensive income (loss) (11,297 ) (5,210 ) 2 (16,505 ) AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 |
REVENUE AND CREDIT CONCENTRATIO
REVENUE AND CREDIT CONCENTRATIONS | 6 Months Ended |
Jun. 30, 2017 | |
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 Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim which are sold directly by the Company and global sales of Aldurazyme which is marketed by Genzyme. Genzyme is the Company ’ Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 United States 38 % 36 % 38 % 37 % Europe 21 % 22 % 21 % 23 % Latin America 18 % 17 % 15 % 13 % Rest of world 17 % 19 % 20 % 20 % Total net product revenue marketed by the Company 94 % 94 % 94 % 93 % Aldurazyme net product revenues marketed by Genzyme 6 % 6 % 6 % 7 % 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 six months ended June 30, 2017 and 2016. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Customer A 17 % 19 % 17 % 19 % Customer B 14 % 12 % 13 % 13 % Customer C 10 % 9 % 10 % 10 % Customer D 10 % 10 % 7 % 6 % Total 51 % 50 % 47 % 48 % On a consolidated basis, the Company’s two largest customer accounts receivable balances accounted for 21% and 19% of the June 30, 2017 total accounts receivable balance, respectively, compared to December 31, 2016, when the two largest customer accounts receivable balances accounted for 26% and 20% of the total accounts receivable balance, respectively. As of June 30, 2017, and December 31, 2016, the accounts receivable balance for Genzyme included $20.0 million and $30.7 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 sells its products in countries, including Southern European countries, Russia, Chile and Brazil, which 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’s products. The Company has not historically experienced a significant level of uncollected receivables and has received continued payments from its more aged accounts in these countries. The Company believes that the allowances for doubtful accounts related to these countries, if any, is adequate based on its analysis of the specific business circumstances and expectations of collection for each of the underlying accounts in these countries. |
SEGMENT INFORMATION
SEGMENT INFORMATION | 6 Months Ended |
Jun. 30, 2017 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | (17) SEGMENT INFORMATION The Company operates in one business segment, which focuses on the development and commercialization of innovative therapies for people with serious and life threatening rare diseases and medical conditions. All products are included in one segment because all of the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Net product revenues by product: Aldurazyme $ 19,985 $ 18,623 $ 39,340 $ 35,068 Brineura 254 — 254 — Firdapse 4,855 4,465 8,965 8,704 Kuvan 101,944 90,215 194,290 166,907 Naglazyme 85,751 78,444 166,309 143,847 Vimizim 103,137 106,829 208,958 179,407 Total net product revenues $ 315,926 $ 298,576 $ 618,116 $ 533,933 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 the Company’s commercial products, except for Aldurazyme, which is based on the location of Genzyme’s headquarters. Although Genzyme sells Aldurazyme worldwide, the revenues earned by the Company based on Genzyme’s net sales are included in the U.S. region, as the transactions are with Genzyme whose headquarters are located in the U.S. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Total revenues by geographic region: United States $ 141,612 $ 126,172 $ 274,097 $ 235,318 Europe 64,931 64,798 130,950 124,508 Latin America 58,205 49,635 95,468 68,015 Rest of world 52,700 59,526 120,678 109,026 Total revenues $ 317,448 $ 300,131 $ 621,193 $ 536,867 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2017 | |
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 October 3, 2014, from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, DRL), notifying us that DRL 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 November 17, 2014, the Company filed a lawsuit against DRL in the U.S. District Court for the District of New Jersey alleging infringement of the Company’s patents relating to Kuvan tablets and seeking an injunction to prevent DRL from introducing a generic version of Kuvan tablets that would infringe the Company’s patents prior to their expiration. In September 2015, the Company and Merck & Cie entered into a settlement agreement with DRL (the DRL Tablet Settlement Agreement) that resolved the patent litigation with DRL in the U.S. related to Kuvan 100 mg oral tablets. Under the terms of the DRL Tablet Settlement Agreement, the Company granted DRL a non-exclusive license to its Kuvan-related patents to allow DRL to market a generic version of sapropterin dihydrochloride 100 mg oral tablets in the U.S. for the indications approved for Kuvan beginning on October 1, 2020, or earlier under certain circumstances. Additionally, the Company received a paragraph IV notice letter, dated January 22, 2015, from Par Pharmaceutical, Inc. (Par), notifying it that Par had filed an ANDA seeking approval of a proposed generic version of Kuvan 100 mg oral tablets prior to the expiration of the Company’s patents listed in the FDA’s 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 it that Par had 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, that the asserted patents are not infringed and/or are invalid. In April 2017, the Company and Merck & Cie entered into a settlement agreement with Par (the Par Settlement Agreement) that resolved both cases against Par. Under the Par Settlement Agreement, the Company granted Par a non-exclusive license to its Kuvan-related patents to allow Par to market a generic version of sapropterin dihydrochloride in 100 mg oral tablets and oral powder in 100 mg and 500 mg packet formulations in the U.S. for the indications approved for Kuvan beginning on: April 1, 2021 if Par is not entitled to the statutory 180-day first filer exclusivity period; October 1, 2020 if Par is entitled to the statutory 180-day first filer exclusivity period; or earlier under certain circumstances. The Company also received a paragraph IV notice letter, dated December 23, 2016, from DRL, notifying it that DRL had 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 6, 2017, the Company filed a lawsuit against DRL 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 DRL from introducing a generic version of Kuvan powder that would infringe the Company’s patents prior to their expiration. The filing of that lawsuit triggered the automatic 30-month stay on the approval of DRL’s ANDA in accordance with the Hatch-Waxman Act, which expires in June 2019 or earlier if the court enters judgment finding that each of the then-asserted patents is invalid or not infringed, or such shorter or longer period as the court may order. DRL filed its answer to the complaint on April 10, 2017, alleging, inter alia, that the patents are not infringed and/or are invalid. Neither the DRL Tablet Settlement Agreement nor the Par Settlement Agreement affects this currently pending litigation against DRL relating to Kuvan 100 mg oral powder. 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 June 30, 2017, the Company is subject to contingent payments totaling approximately $585.5 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, $210.9 million (or €185 million based on the exchange rate of 1.14 USD per Euro in effect on June 30, 2017) relates to the Merck PKU Business acquisition and $52.2 million relates to programs that are no longer being developed. As of June 30, 2017, the Company has recorded a total of $178.0 million of short-term and long-term contingent acquisition consideration payable on its Condensed Consolidated Balances Sheet, of which $55.1 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 June 30, 2017 |
BENEFIT FROM INCOME TAXES
BENEFIT FROM INCOME TAXES | 6 Months Ended |
Jun. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
BENEFIT FROM INCOME TAXES | (19) 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 six months ended June 30, 2017 and 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 six months ended June 30, 2017 and 2016. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | (20) SUBSEQUENT EVENT On July 17, 2017, the Company executed license and settlement agreements (the Agreements) with Sarepta Therapeutics (Sarepta) that provide Sarepta with global exclusive rights to the Company’s Duchenne muscular dystrophy (DMD) patent estate for EXONDYS 51 and all future exon-skipping products. The Agreements resolved the ongoing worldwide patent proceedings related to the use of EXONDYS 51 and all future exon-skipping products for the treatment of DMD. Under the Agreements, Sarepta made a one-time $35.0 million payment to the Company and certain additional regulatory and commercial milestone payments for exons 51, 45, 53 and possibly on future exon-skipping products to the Company. Sarepta will also pay royalties to the Company based on 5% of net sales through the end of 2023 in the U.S. and 8% of net sales through September 30, 2024 in the EU and in other countries where certain of the Company’s patents exist. The Company retained the right to convert the license to a co-exclusive right in the event it decides to proceed with an exon-skipping therapy for DMD. |
ACQUISITIONS (Tables)
ACQUISITIONS (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Business Combinations [Abstract] | |
Summary of Estimated Fair Values of Assets Acquired and Liabilities Assumed | The following table presents the final 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 |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Earnings Per Share [Abstract] | |
Schedule Of Anti-Dilutive Common Stock Excluded From Computation of Basic and Diluted Net Loss Per Share | The table below presents potential shares of common stock that were excluded from the computation of basic and diluted earnings per common share as they were anti-dilutive using the if-converted or treasury stock method (in thousands): Three and Six Months Ended June 30, 2017 2016 Options to purchase common stock 8,440 10,445 Common stock issuable under the 2017 Notes — 1,203 Common stock issuable under the 2018 and 2020 Notes 7,966 7,966 Unvested restricted stock units 3,041 2,829 Common stock potentially issuable for ESPP purchases 387 356 Common stock held by the NQDC 224 253 Total number of potentially issuable shares 20,058 23,052 |
AVAILABLE-FOR-SALE SECURITIES (
AVAILABLE-FOR-SALE SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 and December 31, 2016 are summarized in the tables below: Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at June 30, 2017 Corporate debt securities $ 615,435 $ 426 $ (1,411 ) $ 614,450 Commercial paper 8,976 — — 8,976 U.S. government agency securities 233,898 4 (840 ) 233,062 Greek government-issued bonds 48 122 (1 ) 169 Total $ 858,357 $ 552 $ (2,252 ) $ 856,657 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Aggregate Fair Value at December 31, 2016 Certificates of deposit $ 2,800 $ — $ — $ 2,800 Corporate debt securities 641,670 329 (2,282 ) 639,717 Commercial paper 16,075 — — 16,075 U.S. government agency securities 310,635 37 (747 ) 309,925 Greek government-issued bonds 48 86 — 134 Total $ 971,228 $ 452 $ (3,029 ) $ 968,651 |
Fair Values of Available-For-Sale Securities by Contractual Maturity | The fair values of available-for-sale securities by contractual maturity were as follows: June 30, December 31, 2017 2016 Maturing in one year or less $ 374,621 $ 395,940 Maturing after one year through five years 482,036 572,711 Total $ 856,657 $ 968,651 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: June 30, December 31, 2017 2016 Intangible assets: Finite-lived intangible assets $ 303,297 $ 305,122 Indefinite-lived intangible assets 332,199 332,199 Gross intangible assets: 635,496 637,321 Less: Accumulated amortization (96,931 ) (83,541 ) Net carrying value $ 538,565 $ 553,780 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property Plant and Equipment Net | Property, plant and equipment, net consisted of the following: June 30, December 31, 2017 2016 Building and improvements $ 555,868 $ 510,805 Manufacturing and laboratory equipment 261,616 242,899 Computer hardware and software 137,041 129,506 Leasehold improvements 43,614 44,184 Furniture and equipment 28,370 27,229 Land improvements 4,881 4,881 Land 56,050 55,412 Construction-in-progress 135,159 126,446 1,222,599 1,141,362 Less: Accumulated depreciation (371,502 ) (342,594 ) Total property, plant and equipment, net $ 851,097 $ 798,768 |
SUPPLEMENTAL BALANCE SHEET IN32
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: June 30, December 31, 2017 2016 Raw materials $ 46,602 $ 51,250 Work-in-process 253,658 167,788 Finished goods 129,571 136,088 Total inventory $ 429,831 $ 355,126 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: June 30, December 31, 2017 2016 Accounts payable and accrued operating expenses $ 158,229 $ 191,353 Accrued compensation expense 80,604 109,038 Accrued rebates payable 37,973 34,737 Accrued royalties payable 15,541 15,151 Value added taxes payable 8,609 7,848 Other 18,254 12,378 Total accounts payable and accrued liabilities $ 319,210 $ 370,505 |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Summary of Convertible Debt | Convertible Notes The following table summarizes information regarding the Company’s convertible debt: June 30, December 31, 2017 2016 Convertible Notes due in 2017 $ — $ 22,503 Unamortized deferred offering costs — (25 ) Convertible Notes due in 2017, net — 22,478 Convertible Notes due in 2018 374,980 374,980 Unamortized discount (20,122 ) (27,566 ) Unamortized deferred offering costs (2,515 ) (3,484 ) Convertible Notes due in 2018, net 352,343 343,930 Convertible Notes due in 2020 374,993 374,993 Unamortized discount (46,854 ) (53,239 ) Unamortized deferred offering costs (4,277 ) (4,923 ) Convertible Notes due in 2020, net 323,862 316,831 Total convertible debt, net $ 676,205 $ 683,239 Fair value of fixed rate convertible debt Convertible Notes due in 2017 (1) $ — $ 90,977 Convertible Notes due in 2018 (1) 416,337 423,202 Convertible Notes due in 2020 (1) 446,725 442,754 Total $ 863,062 $ 956,933 (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 Interest Expense on Debt | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Coupon interest $ 2,194 $ 2,520 $ 4,558 $ 5,026 Amortization of issuance costs 886 825 1,772 1,649 Accretion of debt discount 6,960 6,599 13,829 13,112 Total interest expense on convertible debt $ 10,040 $ 9,944 $ 20,159 $ 19,787 |
DERIVATIVE INSTRUMENTS AND HE34
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 June 30, 2017 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 1,743 Accounts payable and accrued liabilities $ 9,434 Forward foreign currency exchange contracts Other assets 2,558 Other long- term liabilities 6,506 Total 4,301 15,940 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 507 Accounts payable and accrued liabilities 58 Total 507 58 Total value of derivative contracts $ 4,808 $ 15,998 Asset Derivatives Liability Derivatives December 31, 2016 December 31, 2016 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Forward foreign currency exchange contracts Other current assets $ 13,048 Accounts payable and accrued liabilities $ 5,176 Forward foreign currency exchange contracts Other assets 8,194 Other long- term liabilities 2,342 Total 21,242 7,518 Derivatives not designated as hedging instruments: Forward foreign currency exchange contracts Other current assets 964 Accounts payable and accrued liabilities 25 Total 964 25 Total value of derivative contracts $ 22,206 $ 7,543 |
Effect of Derivative Instruments | The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three and six months ended June 30, 2017 and 2016 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in accumulated other comprehensive income (loss) (1) $ (19,165 ) $ 4,608 $ (23,364 ) $ (3,873 ) Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings (2) 695 (197 ) 3,211 3,130 Net gain (loss) recognized in net loss (3) 826 (603 ) 1,706 5,267 Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ 5,373 $ 1,012 $ 5,631 $ (3,272 ) (1) Net change in the fair value of the effective portion classified as accumulated other comprehensive income (loss). (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 June 30, 2017 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros – Purchase 72 114.3 Jul. 2017 - Jun. 2020 Euros – Sell 300 379.6 Jul. 2017 - Jun. 2020 Canadian Dollars – Sell 12 11.9 Jul. 2017 - Dec. 2017 Colombian Pesos – Sell 6 31,152.0 Jul. 2017 - Dec. 2017 Brazilian Reais – Sell 2 33.0 Oct. 2017 Total 392 |
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 June 30, 2017 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Euros – Purchase 2 92.2 July 2017 British Pounds – Sell 1 11.3 July 2017 Total 3 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 June 30, 2017 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: Money market instruments $ — $ 44,566 $ — $ 44,566 Corporate debt securities — 1,709 — 1,709 Total cash and cash equivalents — 46,275 — 46,275 Available-for-sale securities: Short-term: Corporate debt securities — 252,696 — 252,696 Commercial paper — 8,976 — 8,976 U.S. government agency securities — 111,240 — 111,240 Long-term: Corporate debt securities — 360,045 — 360,045 U.S. government agency securities — 121,822 — 121,822 Greek government-issued bonds — 169 — 169 Total available-for-sale securities — 854,948 — 854,948 Other current assets: NQDC Plan assets — 661 — 661 Forward foreign currency exchange contract (1) — 2,250 — 2,250 Restricted investments (2) — 9,327 — 9,327 Total other current assets — 12,238 — 12,238 Other assets: NQDC Plan assets — 11,347 — 11,347 Forward foreign currency exchange contract (1) — 2,558 — 2,558 Total other assets — 13,905 — 13,905 Total assets $ — $ 927,366 $ — $ 927,366 Liabilities: Current liabilities: NQDC Plan liability $ 2,326 $ 661 $ — $ 2,987 Forward foreign currency exchange contract (1) — 9,492 — 9,492 Contingent acquisition consideration payable — — 55,093 55,093 Total current liabilities 2,326 10,153 55,093 67,572 Other long-term liabilities: NQDC Plan liability $ 17,844 $ 11,347 — 29,191 Forward foreign currency exchange contract (1) — 6,506 — 6,506 Contingent acquisition consideration payable — — 122,899 122,899 Total other long-term liabilities 17,844 17,853 122,899 158,596 Total liabilities $ 20,170 $ 28,006 $ 177,992 $ 226,168 Fair Value Measurements at December 31, 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: Money market instruments $ — $ 235,571 $ — $ 235,571 Corporate debt securities — 8,593 — 8,593 U.S. government agency securities — 6,000 — 6,000 Total cash and cash equivalents — 250,164 — 250,164 Available-for-sale securities: Short-term: Certificates of deposit — 2,800 — 2,800 Corporate debt securities — 193,974 — 193,974 Commercial paper — 16,075 — 16,075 U.S. government agency securities — 168,498 — 168,498 Long-term: Corporate debt securities — 437,150 — 437,150 U.S. government agency securities — 135,427 — 135,427 Greek government-issued bonds — 134 — 134 Total available-for-sale securities — 954,058 — 954,058 Other current assets: NQDC Plan assets — 163 — 163 Forward foreign currency exchange contract (1) — 14,012 — 14,012 Restricted investments (2) — 3,754 — 3,754 Total other current assets — 17,929 — 17,929 Other assets: NQDC Plan assets — 9,121 — 9,121 Forward foreign currency exchange contract (1) — 8,194 — 8,194 Strategic investment (3) 4,064 — — 4,064 Total other assets 4,064 17,315 — 21,379 Total assets $ 4,064 $ 1,239,466 $ — $ 1,243,530 Liabilities: Current liabilities: NQDC Plan liability $ 2,073 $ 163 $ — $ 2,236 Forward foreign currency exchange contract (1) — 5,201 — 5,201 Contingent acquisition consideration payable — — 46,327 46,327 Total current liabilities 2,073 5,364 46,327 53,764 Other long-term liabilities: NQDC Plan liability 17,303 9,121 — 26,424 Forward foreign currency exchange contract (1) — 2,342 — 2,342 Contingent acquisition consideration payable — — 115,310 115,310 Total other long-term liabilities 17,303 11,463 115,310 144,076 Total liabilities $ 19,376 $ 16,827 $ 161,637 $ 197,840 (1) See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. (2) The restricted investments at June 30, 2017 and December 31, 2016 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. (3) The Company had investments in marketable equity securities measured using quoted prices in an active market that were considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investment. |
Liabilities Measured at Fair Value Using Level 3 Inputs | Contingent acquisition consideration payable at December 31, 2016 $ 161,637 Changes in the fair value of contingent acquisition consideration payable for continuing development programs 7,195 Milestone payments to former Huxley Pharmaceuticals, Inc. shareholders (3,500 ) Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 12,660 Contingent acquisition consideration payable at June 30, 2017 $ 177,992 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 2017 Equity Incentive Plan and the 2006 Share Incentive Plan were as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Expected volatility 38 – 40% 37 - 40% 38 – 40% 36 – 44% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected life 5.0 – 6.6 years 5.1 - 6.8 years 5.0 – 6.6 years 5.1 – 8.1 years Risk-free interest rate 1.8 – 1.9% 1.1 - 1.5% 1.8 – 2.2% 1.1 – 2.1% |
Employee Stock Purchase Plan Valuation Assumptions | The assumptions used to estimate the per share fair value of stock purchase rights granted under the ESPP were as follows: Six Months Ended June 30, 2017 2016 Expected volatility 31 - 42% 42 - 50% Dividend yield 0.0% 0.0% Expected life 6-24 months 6-24 months Risk-free interest rate 1.0 - 1.3% 0.4 - 0.8% |
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 June 30, Six Months Ended June 30, 2017 2016 2017 2016 Cost of sales $ 2,510 $ 2,289 $ 4,796 $ 3,851 R&D 14,647 14,814 26,141 28,521 SG&A 22,944 16,795 39,838 31,703 Total stock-based compensation expense $ 40,101 $ 33,898 $ 70,775 $ 64,075 |
ACCUMULATED OTHER COMPREHENSI37
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Amounts Reclassified out of Accumulated Other Comprehensive Income (Loss) | The following table summarizes amounts reclassified out of Accumulated Other Comprehensive Income (Loss) (AOCI) and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2017 and 2016. Three Months Ended June 30, Six Months Ended June 30, Consolidated Statement of Details about AOCI Components 2017 2016 2017 2016 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ 1,119 $ (589 ) $ 4,661 $ 2,600 Net product revenues Forward foreign currency exchange contracts (424 ) 392 (1,450 ) 4,824 SG&A Total gain (loss) on cash flow hedges 695 (197 ) 3,211 7,424 Gain (loss) on sale of available-for-sale securities — (2,027 ) 3,252 (2,027 ) Other income Income tax effect of the above — 737 (1,181 ) 737 Benefit from income taxes $ 695 $ (1,487 ) $ 5,282 $ 6,134 Net loss |
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI | The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI for the three and six months ended June 30, 2017 and 2016. Three Months Ended June 30, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at March 31, 2017 $ 6,291 $ (1,258 ) $ (13 ) $ 5,020 Other comprehensive income (loss) before reclassifications (19,165 ) 267 4 (18,894 ) Less net gain reclassified from AOCI 695 — — 695 Tax effect — (89 ) — (89 ) Net current-period other comprehensive loss (19,860 ) 178 4 (19,678 ) AOCI balance at June 30, 2017 $ (13,569 ) $ (1,080 ) $ (9 ) $ (14,658 ) Three Months Ended June 30, 2016 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at March 31, 2016 $ (2,500 ) $ 2,554 $ (7 ) $ 47 Other comprehensive income (loss) before reclassifications 4,608 (2,536 ) (1 ) 2,071 Less loss reclassified from AOCI (197 ) (2,027 ) — (2,224 ) Tax effect — 186 — 186 Net current-period other comprehensive income (loss) 4,805 (323 ) (1 ) 4,481 AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 Six Months Ended June 30, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Securities Foreign Currency Items Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (23,364 ) 1,834 3 (21,527 ) Less net gain reclassified from AOCI 3,211 3,252 — 6,463 Tax effect — 516 — 516 Net current-period other comprehensive income (loss) (26,575 ) (902 ) 3 (27,474 ) AOCI balance at June 30, 2017 $ (13,569 ) $ (1,080 ) $ (9 ) $ (14,658 ) Six Months Ended June 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 (3,873 ) (10,215 ) 2 (14,086 ) Less gain (loss) reclassified from AOCI 7,424 (2,027 ) — 5,397 Tax effect — 2,978 — 2,978 Net current-period other comprehensive income (loss) (11,297 ) (5,210 ) 2 (16,505 ) AOCI balance at June 30, 2016 $ 2,305 $ 2,231 $ (8 ) $ 4,528 |
REVENUE AND CREDIT CONCENTRAT38
REVENUE AND CREDIT CONCENTRATIONS (Tables) - Net Product Revenue | 6 Months Ended |
Jun. 30, 2017 | |
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 Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim which are sold directly by the Company and global sales of Aldurazyme which is marketed by Genzyme. Genzyme is the Company ’ Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 United States 38 % 36 % 38 % 37 % Europe 21 % 22 % 21 % 23 % Latin America 18 % 17 % 15 % 13 % Rest of world 17 % 19 % 20 % 20 % Total net product revenue marketed by the Company 94 % 94 % 94 % 93 % Aldurazyme net product revenues marketed by Genzyme 6 % 6 % 6 % 7 % 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 six months ended June 30, 2017 and 2016. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Customer A 17 % 19 % 17 % 19 % Customer B 14 % 12 % 13 % 13 % Customer C 10 % 9 % 10 % 10 % Customer D 10 % 10 % 7 % 6 % Total 51 % 50 % 47 % 48 % |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Segment Reporting [Abstract] | |
Segment Information by Product Revenue | The Company operates in one business segment, which focuses on the development and commercialization of innovative therapies for people with serious and life threatening rare diseases and medical conditions. All products are included in one segment because all of the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Net product revenues by product: Aldurazyme $ 19,985 $ 18,623 $ 39,340 $ 35,068 Brineura 254 — 254 — Firdapse 4,855 4,465 8,965 8,704 Kuvan 101,944 90,215 194,290 166,907 Naglazyme 85,751 78,444 166,309 143,847 Vimizim 103,137 106,829 208,958 179,407 Total net product revenues $ 315,926 $ 298,576 $ 618,116 $ 533,933 |
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 the Company’s commercial products, except for Aldurazyme, which is based on the location of Genzyme’s headquarters. Although Genzyme sells Aldurazyme worldwide, the revenues earned by the Company based on Genzyme’s net sales are included in the U.S. region, as the transactions are with Genzyme whose headquarters are located in the U.S. Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Total revenues by geographic region: United States $ 141,612 $ 126,172 $ 274,097 $ 235,318 Europe 64,931 64,798 130,950 124,508 Latin America 58,205 49,635 95,468 68,015 Rest of world 52,700 59,526 120,678 109,026 Total revenues $ 317,448 $ 300,131 $ 621,193 $ 536,867 |
Nature of Operations and Busi40
Nature of Operations and Business Risks - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2017Product | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of approved products | 6 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - Merck Serono $ in Thousands, € in Millions | Jan. 02, 2016USD ($) | Jun. 30, 2017 | Dec. 31, 2016USD ($) | Dec. 31, 2016EUR (€) | Jan. 01, 2016USD ($) | Dec. 31, 2015USD ($) |
Business Acquisition [Line Items] | ||||||
Business combination transaction costs | $ | $ 300 | $ 600 | $ 300 | |||
Business acquisition, cash paid | $ | $ 374,545 | $ 374,500 | ||||
Estimated useful life | through 2,024 | |||||
Intangible assets amortization method | straight-line basis | |||||
A&R Kuvan Agreement | ||||||
Business Acquisition [Line Items] | ||||||
Maximum potential additional consideration milestone payments | € | € 60 | |||||
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 Serono - USD ($) $ in Thousands | Jan. 02, 2016 | Dec. 31, 2016 | Jan. 01, 2016 |
Business Acquisition [Line Items] | |||
Cash payments | $ 374,545 | $ 374,500 | |
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 |
Anti-Dilutive Common Stock Excl
Anti-Dilutive Common Stock Excluded From Computation of Basic and Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
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 | 20,058 | 23,052 | 20,058 | 23,052 |
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 | 8,440 | 10,445 | 8,440 | 10,445 |
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 | 0 | 1,203 | 0 | 1,203 |
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 | 3,041 | 2,829 | 3,041 | 2,829 |
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 | 387 | 356 | 387 | 356 |
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 | 224 | 253 | 224 | 253 |
Net Loss Per Common Share - Add
Net Loss Per Common Share - Additional Information (Detail) - $ / shares | Jun. 30, 2017 | Jun. 30, 2016 |
Convertible Notes due 2018 | ||
Earnings Per Share [Line Items] | ||
Debt instrument, interest rate, stated percentage, per annum | 0.75% | |
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 | Jun. 30, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 858,357 | $ 971,228 |
Gross Unrealized Holding Gains | 552 | 452 |
Gross Unrealized Holding Losses | (2,252) | (3,029) |
Aggregate Fair Value | 856,657 | 968,651 |
Certificates of Deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 2,800 | |
Gross Unrealized Holding Gains | 0 | |
Gross Unrealized Holding Losses | 0 | |
Aggregate Fair Value | 2,800 | |
Corporate Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 615,435 | 641,670 |
Gross Unrealized Holding Gains | 426 | 329 |
Gross Unrealized Holding Losses | (1,411) | (2,282) |
Aggregate Fair Value | 614,450 | 639,717 |
Commercial Paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,976 | 16,075 |
Gross Unrealized Holding Gains | 0 | 0 |
Gross Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | 8,976 | 16,075 |
U.S. Government Agency Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 233,898 | 310,635 |
Gross Unrealized Holding Gains | 4 | 37 |
Gross Unrealized Holding Losses | (840) | (747) |
Aggregate Fair Value | 233,062 | 309,925 |
Greek Government-Issued Bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 48 | 48 |
Gross Unrealized Holding Gains | 122 | 86 |
Gross Unrealized Holding Losses | (1) | 0 |
Aggregate Fair Value | $ 169 | $ 134 |
Available-For-Sale Securities -
Available-For-Sale Securities - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Mar. 31, 2017USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2016USD ($)Investment | |
Investments Debt And Equity Securities [Abstract] | |||
Number of investments in marketable equity securities | Investment | 1 | ||
Marketable equity securities, realized gain | $ 3,300,000 | ||
Fair value of marketable equity securities | $ 4,100,000 | ||
Marketable equity securities, unrealized gain (loss) | $ 2,300,000 | ||
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 | Jun. 30, 2017 | Dec. 31, 2016 |
Investments Debt And Equity Securities [Abstract] | ||
Maturing in one year or less | $ 374,621 | $ 395,940 |
Maturing after one year through five years | 482,036 | 572,711 |
Total | $ 856,657 | $ 968,651 |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | |
Intangible assets: | |||
Finite-lived intangible assets | $ 303,297 | $ 305,122 | |
Indefinite-lived intangible assets | 332,199 | 332,199 | |
Gross intangible assets: | 635,496 | 637,321 | |
Less: Accumulated amortization | (96,931) | (83,541) | |
Net carrying value | $ 538,565 | $ 553,780 | [1] |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Goodwill And Intangible Assets [Line Items] | |||||
Impairment charge | $ 0 | $ 599,118,000 | $ 0 | $ 599,118,000 | |
Indefinite-lived intangible assets | $ 332,199,000 | $ 332,199,000 | $ 332,199,000 | ||
IPR&D of Kyndrisa and Other Exon | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Impairment charge | 574,100,000 | ||||
Indefinite-lived intangible assets | 0 | 0 | |||
IPR&D of Reveglucosidase Alfa | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Impairment charge | $ 25,000,000 | $ 25,000,000 |
Property Plant and Equipment (D
Property Plant and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 1,222,599 | $ 1,141,362 | |
Less: Accumulated depreciation | (371,502) | (342,594) | |
Total property, plant and equipment, net | 851,097 | 798,768 | [1] |
Building and Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 555,868 | 510,805 | |
Manufacturing and Laboratory Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 261,616 | 242,899 | |
Computer Hardware and Software | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 137,041 | 129,506 | |
Leasehold Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 43,614 | 44,184 | |
Furniture and Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 28,370 | 27,229 | |
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 | 56,050 | 55,412 | |
Construction-in-Progress | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 135,159 | $ 126,446 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Property Plant and Equipment -
Property Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation expense | $ 17,900 | $ 17,200 | $ 35,400 | $ 32,900 |
Depreciation capitalized into inventory | $ 6,200 | $ 4,800 | $ 11,752 | $ 8,993 |
Schedule of Inventory (Detail)
Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 46,602 | $ 51,250 | |
Work-in-process | 253,658 | 167,788 | |
Finished goods | 129,571 | 136,088 | |
Total inventory | $ 429,831 | $ 355,126 | [1] |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Supplemental Balance Sheet In53
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | [1] |
Inventory [Line Items] | |||
Inventory | $ 429,831 | $ 355,126 | |
Brineura Inventory | |||
Inventory [Line Items] | |||
Inventory | $ 22,700 | ||
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | |
Condensed Financial Information Of Parent Company Only Disclosure [Abstract] | |||
Accounts payable and accrued operating expenses | $ 158,229 | $ 191,353 | |
Accrued compensation expense | 80,604 | 109,038 | |
Accrued rebates payable | 37,973 | 34,737 | |
Accrued royalties payable | 15,541 | 15,151 | |
Value added taxes payable | 8,609 | 7,848 | |
Other | 18,254 | 12,378 | |
Total accounts payable and accrued liabilities | $ 319,210 | $ 370,505 | [1] |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Summary of Convertible Debt (De
Summary of Convertible Debt (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | ||
Debt Instrument [Line Items] | ||||
Convertible Notes, net of unamortized deferred offering costs | $ 0 | $ 22,478 | [1] | |
Convertible Notes, net of unamortized discount and deferred offering costs | 676,205 | 660,761 | [1] | |
Total convertible debt, net | 676,205 | 683,239 | ||
Convertible Notes, fair value | 863,062 | 956,933 | ||
Convertible Notes due 2017 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 0 | 22,503 | ||
Convertible debt, Unamortized deferred offering costs | 0 | (25) | ||
Convertible Notes, net of unamortized deferred offering costs | 0 | 22,478 | ||
Convertible Notes, fair value | [2] | 0 | 90,977 | |
Convertible Notes due 2018 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 374,980 | 374,980 | ||
Convertible debt, unamortized discount | (20,122) | (27,566) | ||
Convertible debt, Unamortized deferred offering costs | (2,515) | (3,484) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 352,343 | 343,930 | ||
Convertible Notes, fair value | [2] | 416,337 | 423,202 | |
Convertible Notes due 2020 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 374,993 | 374,993 | ||
Convertible debt, unamortized discount | (46,854) | (53,239) | ||
Convertible debt, Unamortized deferred offering costs | (4,277) | (4,923) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 323,862 | 316,831 | ||
Convertible Notes, fair value | [2] | $ 446,725 | $ 442,754 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. | |||
[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 | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Schedule Of Interest Expenses [Line Items] | ||||
Total interest expense on convertible debt | $ 10,040 | $ 9,944 | $ 20,159 | $ 19,787 |
Convertible Senior Notes | ||||
Schedule Of Interest Expenses [Line Items] | ||||
Coupon interest | 2,194 | 2,520 | 4,558 | 5,026 |
Amortization of issuance costs | 886 | 825 | 1,772 | 1,649 |
Accretion of debt discount | 6,960 | 6,599 | 13,829 | 13,112 |
Total interest expense on convertible debt | $ 10,040 | $ 9,944 | $ 20,159 | $ 19,787 |
Debt - Additional Information (
Debt - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Apr. 30, 2017USD ($)shares | Nov. 30, 2016USD ($) | Jun. 30, 2016USD ($)shares | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($)shares | Dec. 31, 2016USD ($) | |
Revolving Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 100,000,000 | |||||
Maturity date of convertible debt | Nov. 29, 2018 | |||||
Frequency of interest payment | quarterly | |||||
Amortization of issuance costs | 600,000 | |||||
Outstanding amount | $ 0 | $ 0 | ||||
Debt instrument liquidity covenant assets, maximum | $ 225,000,000 | |||||
Letter of credit subfacility | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | 10,000,000 | |||||
Swing line loan subfacility | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 15,000,000 | |||||
Convertible Notes due 2017 | ||||||
Debt Instrument [Line Items] | ||||||
Convertible notes aggregate principal | $ 22,500,000 | $ 6,900,000 | $ 6,900,000 | |||
Notes converted, number of shares | shares | 1,103,704 | 340,967 | 340,967 |
Summary of Designated Forward F
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 6 Months Ended | |||
Jun. 30, 2017EUR (€)Derivative | Jun. 30, 2017CADDerivative | Jun. 30, 2017COPDerivative | Jun. 30, 2017BRLDerivative | |
Maximum | ||||
Derivative [Line Items] | ||||
Maturity | Jun. 30, 2020 | |||
Derivatives Designated As Hedging Instruments | ||||
Derivative [Line Items] | ||||
Number of Contracts | 392 | 392 | 392 | 392 |
Derivatives Designated As Hedging Instruments | Euros | Purchase | ||||
Derivative [Line Items] | ||||
Number of Contracts | 72 | 72 | 72 | 72 |
Aggregate Notional Amount in Foreign Currency | € | € 114,300,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 300 | 300 | 300 | 300 |
Aggregate Notional Amount in Foreign Currency | € | € 379,600,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Jul. 1, 2017 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Jul. 1, 2017 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Jun. 30, 2020 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Jun. 30, 2020 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 12 | 12 | 12 | 12 |
Aggregate Notional Amount in Foreign Currency | CAD | CAD 11,900,000 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Jul. 1, 2017 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2017 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 6 | 6 | 6 | 6 |
Aggregate Notional Amount in Foreign Currency | COP | COP 31,152,000,000 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Jul. 1, 2017 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2017 | |||
Derivatives Designated As Hedging Instruments | Brazilian Reais | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 2 | 2 | 2 | 2 |
Aggregate Notional Amount in Foreign Currency | BRL | BRL 33,000,000 | |||
Maturity | Oct. 31, 2017 |
Derivative Instruments and He59
Derivative Instruments and Hedging Strategies - Additional Information (Detail) - Foreign Currency Derivatives $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Derivative [Line Items] | |
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 |
Reclassified unrealized losses from accumulated other comprehensive income (loss) to earnings as related to forecasted revenue and operating expense transactions | $ (9.2) |
Maximum | |
Derivative [Line Items] | |
Maturity period of foreign currency derivatives | Jun. 30, 2020 |
Summary of Non-Designated Forwa
Summary of Non-Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 6 Months Ended | |
Jun. 30, 2017EUR (€)Derivative | Jun. 30, 2017GBP (£)Derivative | |
Maximum | ||
Derivative [Line Items] | ||
Maturity | Jun. 30, 2020 | |
Not Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Number of Contracts | 3 | 3 |
Not Designated as Hedging Instrument | Euros | Purchase | ||
Derivative [Line Items] | ||
Number of Contracts | 2 | 2 |
Aggregate Notional Amount in Foreign Currency | € | € 92,200,000 | |
Maturity | Jul. 1, 2017 | |
Not Designated as Hedging Instrument | United Kingdom, Pounds | Sell | ||
Derivative [Line Items] | ||
Number of Contracts | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | £ | £ 11,300,000 | |
Maturity | Jul. 1, 2017 |
Fair Value Carrying Amount of D
Fair Value Carrying Amount of Derivative Instruments (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Derivative [Line Items] | ||
Derivative Asset, Fair Value | $ 4,808 | $ 22,206 |
Derivative Liability, Fair Value | 15,998 | 7,543 |
Derivatives Designated As Hedging Instruments | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 4,301 | 21,242 |
Derivative Liability, Fair Value | 15,940 | 7,518 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 1,743 | 13,048 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 2,558 | 8,194 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | 9,434 | 5,176 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Long-Term Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | 6,506 | 2,342 |
Not Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 507 | 964 |
Derivative Liability, Fair Value | 58 | 25 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative Asset, Fair Value | 507 | 964 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative Liability, Fair Value | $ 58 | $ 25 |
Effect of Derivative Instrument
Effect of Derivative Instruments (Detail) - Forward Foreign Currency Exchange Contracts - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | ||
Derivatives Designated As Hedging Instruments | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Net gain (loss) recognized in accumulated other comprehensive income (loss) | [1] | $ (19,165) | $ 4,608 | $ (23,364) | $ (3,873) |
Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings | [2] | 695 | (197) | 3,211 | 3,130 |
Net gain (loss) recognized in net loss | [3] | 826 | (603) | 1,706 | 5,267 |
Not Designated as Hedging Instrument | |||||
Derivative Instruments, Gain (Loss) [Line Items] | |||||
Net gain (loss) recognized in net loss | [4] | $ 5,373 | $ 1,012 | $ 5,631 | $ (3,272) |
[1] | Net change in the fair value of the effective portion classified as accumulated other comprehensive income (loss). | ||||
[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 | Jun. 30, 2017 | Dec. 31, 2016 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Available-for-sale securities | $ 856,657 | $ 968,651 | |
Fair Value, Measurements, Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 46,275 | 250,164 | |
Fair value of Available-for-sale securities | 854,948 | 954,058 | |
Fair value of other current assets | 12,238 | 17,929 | |
Fair value of other non-current assets | 13,905 | 21,379 | |
Fair value of financial assets, Total | 927,366 | 1,243,530 | |
Fair value of other current liabilities | 67,572 | 53,764 | |
Fair value of other non-current liabilities | 158,596 | 144,076 | |
Fair value of financial liabilities, Total | 226,168 | 197,840 | |
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 | 44,566 | 235,571 | |
Fair Value, Measurements, Recurring | NQDC Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 2,987 | 2,236 | |
Fair value of other non-current liabilities | 29,191 | 26,424 | |
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] | 9,492 | 5,201 |
Fair value of other non-current liabilities | [1] | 6,506 | 2,342 |
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 | 55,093 | 46,327 | |
Fair value of other non-current liabilities | 122,899 | 115,310 | |
Fair Value, Measurements, Recurring | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 1,709 | 8,593 | |
Fair value of Available-for-sale securities, current | 252,696 | 193,974 | |
Fair value of Available-for-sale securities, non-current | 360,045 | 437,150 | |
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 | 8,976 | 16,075 | |
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 Cash and cash equivalents | 6,000 | ||
Fair value of Available-for-sale securities, current | 111,240 | 168,498 | |
Fair value of Available-for-sale securities, non-current | 121,822 | 135,427 | |
Fair Value, Measurements, Recurring | NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 661 | 163 | |
Fair value of other non-current assets | 11,347 | 9,121 | |
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] | 2,250 | 14,012 |
Fair value of other non-current assets | [1] | 2,558 | 8,194 |
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] | 9,327 | 3,754 |
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 | ||
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 | 169 | 134 | |
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] | 4,064 | |
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 | 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 | 4,064 | |
Fair value of financial assets, Total | 0 | 4,064 | |
Fair value of other current liabilities | 2,326 | 2,073 | |
Fair value of other non-current liabilities | 17,844 | 17,303 | |
Fair value of financial liabilities, Total | 20,170 | 19,376 | |
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) | NQDC Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 2,326 | 2,073 | |
Fair value of other non-current liabilities | 17,844 | 17,303 | |
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) | Corporate Debt Securities | |||
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, 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 Cash and cash equivalents | 0 | ||
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) | NQDC 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) | 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 | ||
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) | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | 4,064 | |
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 | 46,275 | 250,164 | |
Fair value of Available-for-sale securities | 854,948 | 954,058 | |
Fair value of other current assets | 12,238 | 17,929 | |
Fair value of other non-current assets | 13,905 | 17,315 | |
Fair value of financial assets, Total | 927,366 | 1,239,466 | |
Fair value of other current liabilities | 10,153 | 5,364 | |
Fair value of other non-current liabilities | 17,853 | 11,463 | |
Fair value of financial liabilities, Total | 28,006 | 16,827 | |
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 | 44,566 | 235,571 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | NQDC Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 661 | 163 | |
Fair value of other non-current liabilities | 11,347 | 9,121 | |
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] | 9,492 | 5,201 |
Fair value of other non-current liabilities | [1] | 6,506 | 2,342 |
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) | Corporate Debt Securities | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of Cash and cash equivalents | 1,709 | 8,593 | |
Fair value of Available-for-sale securities, current | 252,696 | 193,974 | |
Fair value of Available-for-sale securities, non-current | 360,045 | 437,150 | |
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 | 8,976 | 16,075 | |
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 Cash and cash equivalents | 6,000 | ||
Fair value of Available-for-sale securities, current | 111,240 | 168,498 | |
Fair value of Available-for-sale securities, non-current | 121,822 | 135,427 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 661 | 163 | |
Fair value of other non-current assets | 11,347 | 9,121 | |
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] | 2,250 | 14,012 |
Fair value of other non-current assets | [1] | 2,558 | 8,194 |
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] | 9,327 | 3,754 |
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 | ||
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 | 169 | 134 | |
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 | |
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 | 55,093 | 46,327 | |
Fair value of other non-current liabilities | 122,899 | 115,310 | |
Fair value of financial liabilities, Total | 177,992 | 161,637 | |
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) | NQDC 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 | 55,093 | 46,327 | |
Fair value of other non-current liabilities | 122,899 | 115,310 | |
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 Cash and cash equivalents | 0 | 0 | |
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 Cash and cash equivalents | 0 | ||
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) | NQDC 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) | 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 | ||
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) | Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [3] | $ 0 | |
[1] | See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the derivative instruments. | ||
[2] | The restricted investments at June 30, 2017 and December 31, 2016 secure the Company’s irrevocable standby letter of credit obtained in connection with certain commercial agreements. | ||
[3] | The Company had investments in marketable equity securities measured using quoted prices in an active market that were considered strategic investments. See Note 7 to these Condensed Consolidated Financial Statements for additional discussion regarding the Company’s strategic investment. |
Liabilities Measured at Fair Va
Liabilities Measured at Fair Value Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Contingent acquisition consideration payable, Beginning balance | $ 161,637 |
Changes in the fair value of contingent acquisition consideration payable for continuing development programs | 7,195 |
Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable | 12,660 |
Contingent acquisition consideration payable, Ending balance | 177,992 |
Huxley Pharmaceuticals, Inc. | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Milestone payments to former shareholders | $ (3,500) |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) $ in Millions | Jun. 30, 2017USD ($) |
Fair Value Disclosures [Abstract] | |
Asset retirement obligations | $ 4.1 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | Mar. 22, 2017shares | Mar. 15, 2016shares | Mar. 03, 2015shares | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)$ / sharesshares | Jun. 30, 2016USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares, granted | 733,330 | ||||||
Weighted-average fair value per share granted | $ / shares | $ 36.02 | ||||||
Recognized compensation costs | $ | $ 40,101 | $ 33,898 | $ 70,775 | $ 64,075 | |||
Stock-based compensation expense capitalized to inventory | $ | 4,400 | 3,300 | $ 7,600 | 5,800 | |||
Restricted Stock With Service Based Vesting Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares, granted | 1,230,410 | ||||||
Weighted-average fair value per RSU granted | $ / shares | $ 87.78 | ||||||
2017 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 | $ 87.42 | ||||||
Granted restricted stock units | 133,250 | ||||||
Award vesting service period | 3 years | ||||||
Percentage of threshold achievement | 75.00% | ||||||
Percentage of ceiling achievement | 125.00% | ||||||
Recognized compensation costs | $ | 1,500 | $ 1,600 | |||||
2017 Base Restricted Stock Unit Awards with Performance Conditions | Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Performance percentage | 50.00% | ||||||
2017 Base Restricted Stock Unit Awards with Performance Conditions | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Performance percentage | 200.00% | ||||||
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 | $ | 1,200 | 900 | $ 2,300 | 1,100 | |||
Revenue multiplier | 1.03 | ||||||
Number of units that could vest if performance condition is achieved and a revenue multiplier is applied | 134,219 | ||||||
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 | ||||||
Award vesting service period | 3 years | ||||||
Recognized compensation costs | $ | $ 600 | $ 400 | $ 1,200 | $ 1,200 | |||
Revenue multiplier | 1.11 | ||||||
Number of units that could vest if performance condition is achieved and a revenue multiplier is applied | 64,713 | ||||||
Share Incentive Plan | Stock Option | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period, years | 4 years | ||||||
Initial time period vesting requirements | 1 year | ||||||
Outstanding options expiration term, years | 10 years | ||||||
Share Incentive Plan | Restricted Stock With Service Based Vesting Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period, years | 4 years | ||||||
Share Incentive Plan | Restricted Stock With Service Based Vesting Conditions | Board of Directors Chairman | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period, years | 1 year |
Assumptions Used to Estimate Pe
Assumptions Used to Estimate Per Share Fair Value of Stock Options Granted (Detail) - Stock Option | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility, minimum | 38.00% | 37.00% | 38.00% | 36.00% |
Expected volatility, maximum | 40.00% | 40.00% | 40.00% | 44.00% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.80% | 1.10% | 1.80% | 1.10% |
Risk-free interest rate, maximum | 1.90% | 1.50% | 2.20% | 2.10% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected life | 5 years | 5 years 1 month 6 days | 5 years | 5 years 1 month 6 days |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected life | 6 years 7 months 6 days | 6 years 9 months 18 days | 6 years 7 months 6 days | 8 years 1 month 6 days |
Assumptions Used to Estimate 68
Assumptions Used to Estimate Per Share Fair Value of Stock Purchase Rights Granted (Detail) - Employee Stock Purchase Plan | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 31.00% | 42.00% |
Expected volatility, maximum | 42.00% | 50.00% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.00% | 0.40% |
Risk-free interest rate, maximum | 1.30% | 0.80% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 6 months | 6 months |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 24 months | 24 months |
Compensation Expense (Detail)
Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 40,101 | $ 33,898 | $ 70,775 | $ 64,075 |
Cost of Sales | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 2,510 | 2,289 | 4,796 | 3,851 |
R&D | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 14,647 | 14,814 | 26,141 | 28,521 |
SG&A | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 22,944 | $ 16,795 | $ 39,838 | $ 31,703 |
Amounts Reclassified out of Acc
Amounts Reclassified out of Accumulated Other Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Net product revenues | $ 315,926 | $ 298,576 | $ 618,116 | $ 533,933 |
SG&A | 143,505 | 109,577 | 263,524 | 214,877 |
LOSS FROM OPERATIONS | (38,812) | (572,806) | (59,020) | (653,723) |
Other income | 543 | (1,417) | 4,015 | (1,219) |
Provision for (benefit from) income taxes | (8,713) | (163,931) | (16,729) | (170,006) |
NET LOSS | (36,833) | (419,014) | (53,123) | (502,065) |
Reclassified out of Accumulated Other Comprehensive Income | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Provision for (benefit from) income taxes | 0 | 737 | (1,181) | 737 |
NET LOSS | 695 | (1,487) | 5,282 | 6,134 |
Reclassified out of Accumulated Other Comprehensive Income | Gains (losses) on Cash Flow Hedges | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
LOSS FROM OPERATIONS | 695 | (197) | 3,211 | 7,424 |
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 | 1,119 | (589) | 4,661 | 2,600 |
SG&A | (424) | 392 | (1,450) | 4,824 |
Reclassified out of Accumulated Other Comprehensive Income | Gain on Sale of Available-For-Sale Securities | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Other income | $ 0 | $ (2,027) | $ 3,252 | $ (2,027) |
Summary of Changes in Accumulat
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | ||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | [1] | $ 2,766,275 | |||
Other comprehensive income (loss) before reclassifications | $ (18,894) | $ 2,071 | (21,527) | $ (14,086) | |
Less net gain (loss) reclassified from AOCI | 695 | (2,224) | 6,463 | 5,397 | |
Tax effect | (89) | 186 | 516 | 2,978 | |
Net current-period other comprehensive income (loss) | (19,678) | 4,481 | (27,474) | (16,505) | |
Ending Balance | 2,795,579 | 2,795,579 | |||
Unrealized Gains (Losses) on Cash Flow Hedges | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | 6,291 | (2,500) | 13,006 | 13,602 | |
Other comprehensive income (loss) before reclassifications | (19,165) | 4,608 | (23,364) | (3,873) | |
Less net gain (loss) reclassified from AOCI | 695 | (197) | 3,211 | 7,424 | |
Tax effect | 0 | 0 | 0 | 0 | |
Net current-period other comprehensive income (loss) | (19,860) | 4,805 | (26,575) | (11,297) | |
Ending Balance | (13,569) | 2,305 | (13,569) | 2,305 | |
Unrealized Gains (Losses) on Available-for-Sale Securities | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | (1,258) | 2,554 | (178) | 7,441 | |
Other comprehensive income (loss) before reclassifications | 267 | (2,536) | 1,834 | (10,215) | |
Less net gain (loss) reclassified from AOCI | 0 | (2,027) | 3,252 | (2,027) | |
Tax effect | (89) | 186 | 516 | 2,978 | |
Net current-period other comprehensive income (loss) | 178 | (323) | (902) | (5,210) | |
Ending Balance | (1,080) | 2,231 | (1,080) | 2,231 | |
Foreign Currency Items | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | (13) | (7) | (12) | (10) | |
Other comprehensive income (loss) before reclassifications | 4 | (1) | 3 | 2 | |
Less net gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | |
Tax effect | 0 | 0 | 0 | 0 | |
Net current-period other comprehensive income (loss) | 4 | (1) | 3 | 2 | |
Ending Balance | (9) | (8) | (9) | (8) | |
Accumulated Other Comprehensive Income (Loss) | |||||
Accumulated Other Comprehensive Income Loss [Line Items] | |||||
Beginning Balance | 5,020 | 47 | 12,816 | 21,033 | |
Other comprehensive income (loss) before reclassifications | 0 | 0 | 0 | 0 | |
Less net gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | |
Tax effect | 0 | 0 | 0 | 0 | |
Net current-period other comprehensive income (loss) | 0 | 0 | 0 | 0 | |
Ending Balance | $ (14,658) | $ 4,528 | $ (14,658) | $ 4,528 | |
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Revenue and Credit Concentrat72
Revenue and Credit Concentrations - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2017USD ($) | Jun. 30, 2016 | Jun. 30, 2017USD ($)Customer | Jun. 30, 2016 | Dec. 31, 2016USD ($)Customer | ||
Concentration Risk [Line Items] | ||||||
Accounts receivable, net | $ 238,338 | $ 238,338 | $ 215,280 | [1] | ||
Largest Customers | ||||||
Concentration Risk [Line Items] | ||||||
Accounts receivable, net | $ 20,000 | $ 20,000 | $ 30,700 | |||
Accounts Receivable | Largest Customers | ||||||
Concentration Risk [Line Items] | ||||||
Number of customers accounted for largest balance in accounts receivable | Customer | 2 | 2 | ||||
Geographic Concentration Risk | Net Product Revenue | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 94.00% | 94.00% | 94.00% | 93.00% | ||
Geographic Concentration Risk | Net Product Revenue | Minimum | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 10.00% | |||||
Credit Concentration Risk | Net Product Revenue | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 100.00% | 100.00% | 100.00% | 100.00% | ||
Credit Concentration Risk | Accounts Receivable | Larger Customer One | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 21.00% | 26.00% | ||||
Credit Concentration Risk | Accounts Receivable | Larger Customer Two | ||||||
Concentration Risk [Line Items] | ||||||
Concentration risk, percentage | 19.00% | 20.00% | ||||
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Consolidated Net Product Revenu
Consolidated Net Product Revenue Concentrations Based on Patient Location (Detail) - Net Product Revenue | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Geographic Concentration Risk | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 94.00% | 94.00% | 94.00% | 93.00% |
Geographic Concentration Risk | United States | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 38.00% | 36.00% | 38.00% | 37.00% |
Geographic Concentration Risk | Europe | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 21.00% | 22.00% | 21.00% | 23.00% |
Geographic Concentration Risk | Latin America | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 18.00% | 17.00% | 15.00% | 13.00% |
Geographic Concentration Risk | Rest of World | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 17.00% | 19.00% | 20.00% | 20.00% |
Customer Concentration Risk | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 51.00% | 50.00% | 47.00% | 48.00% |
Customer Concentration Risk | Genzyme | Aldurazyme | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 6.00% | 6.00% | 6.00% | 7.00% |
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 | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 51.00% | 50.00% | 47.00% | 48.00% |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 17.00% | 19.00% | 17.00% | 19.00% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 14.00% | 12.00% | 13.00% | 13.00% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10.00% | 9.00% | 10.00% | 10.00% |
Customer D | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10.00% | 10.00% | 7.00% | 6.00% |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2017Segment | |
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 | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenue from External Customer [Line Items] | ||||
Net product revenues | $ 315,926 | $ 298,576 | $ 618,116 | $ 533,933 |
Vimizim | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 103,137 | 106,829 | 208,958 | 179,407 |
Brineura | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 254 | 0 | 254 | 0 |
Naglazyme | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 85,751 | 78,444 | 166,309 | 143,847 |
Kuvan | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 101,944 | 90,215 | 194,290 | 166,907 |
Aldurazyme | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | 19,985 | 18,623 | 39,340 | 35,068 |
Firdapse | ||||
Revenue from External Customer [Line Items] | ||||
Net product revenues | $ 4,855 | $ 4,465 | $ 8,965 | $ 8,704 |
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 | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 317,448 | $ 300,131 | $ 621,193 | $ 536,867 |
United States | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 141,612 | 126,172 | 274,097 | 235,318 |
Europe | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 64,931 | 64,798 | 130,950 | 124,508 |
Latin America | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 58,205 | 49,635 | 95,468 | 68,015 |
Rest of World | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 52,700 | $ 59,526 | $ 120,678 | $ 109,026 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands, € in Millions | 6 Months Ended | |||
Jun. 30, 2017USD ($)$ / € | Jun. 30, 2017EUR (€) | Dec. 31, 2016USD ($) | [1] | |
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 585,500 | |||
Contingent consideration payable | 178,000 | |||
Short-term contingent acquisition consideration payable | 55,093 | $ 46,327 | ||
Purchase commitment for the next five years | 73,800 | |||
Merck Serono | ||||
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 210,900 | € 185 | ||
Currency exchange translation rate | $ / € | 1.14 | |||
Completed Programs | ||||
Commitments and Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 52,200 | |||
[1] | December 31, 2016 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, 2016, filed with the Securities and Exchange Commission (the SEC) on February 27, 2017. |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Sarepta Therapeutics - Subsequent Event $ in Millions | Jul. 17, 2017USD ($) |
Subsequent Event [Line Items] | |
Litigation Settlement, Amount | $ 35 |
United States | |
Subsequent Event [Line Items] | |
Royalties receivable percentage of net sales | 5.00% |
EU and Other Countries | |
Subsequent Event [Line Items] | |
Royalties receivable percentage of net sales | 8.00% |