Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 12, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | BMRN | ||
Entity Registrant Name | BIOMARIN PHARMACEUTICAL INC | ||
Entity Central Index Key | 1,048,477 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 178,372,202 | ||
Entity Public Float | $ 8.8 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Current assets: | |||
Cash and cash equivalents | $ 493,982 | $ 598,028 | |
Short-term investments | [1] | 590,326 | 797,940 |
Accounts receivable, net | 342,633 | 261,365 | |
Inventory | 530,871 | 475,775 | |
Other current assets | 98,403 | 74,036 | |
Total current assets | 2,056,215 | 2,207,144 | |
Noncurrent assets: | |||
Long-term investments | [2] | 235,864 | 385,785 |
Property, plant and equipment, net | 948,682 | 896,700 | |
Intangible assets, net | 491,808 | 517,510 | |
Goodwill | 197,039 | 197,039 | |
Deferred tax assets | 460,952 | 399,095 | |
Other assets | 36,568 | 29,852 | |
Total assets | 4,427,128 | 4,633,125 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 437,290 | 401,921 | |
Short-term convertible debt, net | 0 | 360,949 | |
Short-term contingent consideration | 85,951 | 53,648 | |
Total current liabilities | 523,241 | 816,518 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 830,417 | 813,521 | |
Long-term contingent consideration | 46,883 | 135,318 | |
Other long-term liabilities | 58,647 | 59,105 | |
Total liabilities | 1,459,188 | 1,824,462 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 178,252,954 and 175,843,749 shares issued and outstanding, respectively. | 178 | 176 | |
Additional paid-in capital | 4,669,926 | 4,483,220 | |
Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (13,301) | (14,224) | |
Accumulated other comprehensive income (loss) | 5,271 | (22,961) | |
Accumulated deficit | (1,694,134) | (1,637,548) | |
Total stockholders’ equity | 2,967,940 | 2,808,663 | |
Total liabilities and stockholders’ equity | $ 4,427,128 | $ 4,633,125 | |
[1] | The Company’s short-term marketable securities mature in one year or less. | ||
[2] | The Company’s long-term marketable securities mature between one and five years. |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 178,252,954 | 175,843,749 |
Common stock, shares outstanding | 178,252,954 | 175,843,749 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
REVENUES: | |||
Total revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 |
OPERATING EXPENSES: | |||
Cost of sales | 315,264 | 241,786 | 209,620 |
Research and development | 696,328 | 610,753 | 661,905 |
Selling, general and administrative | 604,353 | 554,336 | 476,593 |
Intangible asset amortization and contingent consideration | 48,791 | 46,471 | (26,953) |
Impairment of intangible assets | 0 | 0 | 599,118 |
Gain on sale of intangible assets | (50,000) | (125,000) | 0 |
Total operating expenses | 1,614,736 | 1,328,346 | 1,920,283 |
LOSS FROM OPERATIONS | (123,524) | (14,700) | (803,429) |
Equity in the loss of BioMarin/Genzyme LLC | (553) | (1,291) | (538) |
Interest income | 22,831 | 14,853 | 7,487 |
Interest expense | (43,664) | (42,707) | (39,499) |
Other income, net | 2,205 | 7,970 | 4,929 |
LOSS BEFORE INCOME TAXES | (142,705) | (35,875) | (831,050) |
Provision for (benefit from) income taxes | (65,494) | 81,167 | (200,840) |
NET LOSS | $ (77,211) | $ (117,042) | $ (630,210) |
NET LOSS PER SHARE, BASIC | $ (0.44) | $ (0.67) | $ (3.80) |
NET LOSS PER SHARE, DILUTED | $ (0.44) | $ (0.67) | $ (3.81) |
Weighted average common shares outstanding, basic | 177,061 | 174,427 | 165,985 |
Weighted average common shares outstanding, diluted | 177,268 | 174,427 | 166,219 |
Net Product Revenues | |||
REVENUES: | |||
Total revenues | $ 1,470,356 | $ 1,270,445 | $ 1,110,381 |
Royalty and Other Revenues | |||
REVENUES: | |||
Total revenues | $ 20,856 | $ 43,201 | $ 6,473 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
NET LOSS | $ (77,211) | $ (117,042) | $ (630,210) |
Available-for-sale debt securities: | |||
Unrealized holding gain (loss) arising during the period, net of tax impact of $(413), $272 and $4,412, respectively. | 1,391 | (483) | (7,692) |
Less: reclassifications to net loss, net of tax impact of $0, $(1,191) and $42, respectively. | 0 | 2,061 | (73) |
Net change in unrealized holding gain (loss), net of tax | 1,391 | (2,544) | (7,619) |
Cash flow hedges: | |||
Unrealized holding gain (loss) arising during the period, net of tax impact of $0. | 25,386 | (38,351) | 9,677 |
Less: reclassifications to net loss, net of tax impact of $0. | (2,047) | (5,113) | 10,273 |
Net change in unrealized holding gain (loss), net of tax | 27,433 | (33,238) | (596) |
Other | (6) | 5 | (2) |
OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX | 28,818 | (35,777) | (8,217) |
COMPREHENSIVE LOSS | $ (48,393) | $ (152,819) | $ (638,427) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Unrealized holding gain (loss) arising during the period, tax | $ (413) | $ 272 | $ 4,412 |
Reclassifications to net loss, tax | 0 | (1,191) | 42 |
Unrealized holding gain (loss) arising during the period, tax | 0 | 0 | 0 |
Reclassifications to net loss, tax | $ 0 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Company Stock Held By NQDC | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | |
Beginning Balance at Dec. 31, 2015 | $ 2,400,847 | $ 162 | $ 3,414,837 | $ (13,616) | $ 21,033 | $ (1,021,569) | |
Beginning Balance (in shares) at Dec. 31, 2015 | 161,526 | ||||||
Net loss | (630,210) | (630,210) | |||||
Cumulative-effect adjustment of new share-based compensation guidance | 131,273 | 131,273 | |||||
Other comprehensive income (loss), net of tax | (8,217) | (8,217) | |||||
Issuance of common stock, net of offering costs | 712,938 | $ 8 | 712,930 | ||||
Issuance of common stock, net of offering costs (in shares) | 7,500 | ||||||
Issuances under equity incentive plans, net of tax | 14,758 | $ 3 | 14,755 | ||||
Issuances under equity incentive plans, net of tax (in share) | 3,184 | ||||||
Conversion of convertible notes, net | 8,928 | 8,928 | |||||
Conversion of convertible notes, net (in shares) | 438 | ||||||
Company stock held by NQDC | (705) | (705) | |||||
Stock-based compensation | 136,663 | 136,663 | |||||
Ending Balance at Dec. 31, 2016 | 2,766,275 | $ 173 | 4,288,113 | (14,321) | 12,816 | (1,520,506) | |
Ending Balance (in shares) at Dec. 31, 2016 | 172,648 | ||||||
Net loss | (117,042) | (117,042) | |||||
Other comprehensive income (loss), net of tax | (35,777) | (35,777) | |||||
Issuances under equity incentive plans, net of tax | 27,352 | $ 2 | 27,350 | ||||
Issuances under equity incentive plans, net of tax (in share) | 2,092 | ||||||
Conversion of convertible notes, net | 22,477 | $ 1 | 22,476 | ||||
Conversion of convertible notes, net (in shares) | 1,104 | ||||||
Company stock held by NQDC | 97 | 97 | |||||
Stock-based compensation | 145,281 | 145,281 | |||||
Ending Balance at Dec. 31, 2017 | 2,808,663 | $ 176 | 4,483,220 | (14,224) | (22,961) | (1,637,548) | |
Ending Balance (in shares) at Dec. 31, 2017 | 175,844 | ||||||
Impact of change inaccounting principle | ASC 606 | 20,039 | 20,039 | |||||
Impact of change inaccounting principle | ASU 2018-02 | (586) | [1] | (586) | 586 | |||
Adjusted balance at January 1, 2018 at Dec. 31, 2017 | 2,828,702 | $ 176 | 4,483,220 | (14,224) | (23,547) | (1,616,923) | |
Net loss | (77,211) | (77,211) | |||||
Other comprehensive income (loss), net of tax | 28,818 | 28,818 | |||||
Issuances under equity incentive plans, net of tax | 31,585 | $ 2 | 31,583 | ||||
Issuances under equity incentive plans, net of tax (in share) | 2,314 | ||||||
Conversion of convertible notes, net | (16) | (16) | |||||
Conversion of convertible notes, net (in shares) | 95 | ||||||
Company stock held by NQDC | 923 | 923 | |||||
Stock-based compensation | 155,139 | 155,139 | |||||
Ending Balance at Dec. 31, 2018 | $ 2,967,940 | $ 178 | $ 4,669,926 | $ (13,301) | $ 5,271 | $ (1,694,134) | |
Ending Balance (in shares) at Dec. 31, 2018 | 178,253 | ||||||
[1] | As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from AOCI to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion. |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (77,211,000) | $ (117,042,000) | $ (630,210,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 95,671,000 | 87,861,000 | 96,912,000 |
Non-cash interest expense | 31,186,000 | 32,300,000 | 29,930,000 |
Accretion of discount on investments | 358,000 | 3,077,000 | 1,300,000 |
Stock-based compensation expense | 148,819,000 | 140,263,000 | 134,641,000 |
Gain on sale of intangible assets | (50,000,000) | (125,000,000) | 0 |
(Gain) loss on sale of equity investment | 0 | (3,252,000) | 108,000 |
Impairment of assets | 0 | 0 | 599,118,000 |
Deferred income taxes | (68,378,000) | 44,464,000 | (228,054,000) |
Unrealized foreign exchange loss (gain) | (17,766,000) | 6,258,000 | (14,481,000) |
Non-cash changes in the fair value of contingent consideration\ | 9,296,000 | 10,342,000 | (57,161,000) |
Other | (2,347,000) | 5,935,000 | 336,000 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (54,274,000) | (25,256,000) | (51,483,000) |
Inventory | (23,747,000) | (96,890,000) | (64,512,000) |
Other current assets | (17,767,000) | (20,687,000) | 19,316,000 |
Other assets | (935,000) | (2,439,000) | (4,979,000) |
Accounts payable and accrued liabilities | 38,389,000 | 45,517,000 | (53,205,000) |
Other long-term liabilities | 8,914,000 | 5,792,000 | (5,413,000) |
Net cash provided by (used in) operating activities | 20,208,000 | (8,757,000) | (227,837,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (144,620,000) | (199,219,000) | (148,380,000) |
Maturities and sales of investments | 993,734,000 | 425,960,000 | 367,569,000 |
Purchase of available-for-sale debt securities | (634,753,000) | (655,447,000) | (699,749,000) |
Proceeds from sale of intangible asset | 50,000,000 | 125,000,000 | 0 |
Business acquisitions, net of cash acquired | 0 | 0 | (2,789,000) |
Other | (10,000) | (1,753,000) | (698,000) |
Net cash provided by (used in) investing activities | 264,351,000 | (305,459,000) | (484,047,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 67,488,000 | 60,859,000 | 74,227,000 |
Taxes paid related to net share settlement of equity awards | (35,919,000) | (33,507,000) | (59,469,000) |
Proceeds from public offering of common stock, net | 0 | 0 | 712,938,000 |
Proceeds from convertible senior subordinated note offering, net | 0 | 481,713,000 | 0 |
Repayments of convertible debt | (374,953,000) | (26,000) | 0 |
Payment of contingent consideration | (44,623,000) | (1,894,000) | 0 |
Other | 0 | 0 | (588,000) |
Net cash (used in) provided by financing activities | (388,007,000) | 507,145,000 | 727,108,000 |
Effect of exchange rate changes on cash | (598,000) | (3,231,000) | (3,934,000) |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (104,046,000) | 189,698,000 | 11,290,000 |
Cash and cash equivalents: | |||
Beginning of period | 598,028,000 | 408,330,000 | 397,040,000 |
End of period | 493,982,000 | 598,028,000 | 408,330,000 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |||
Cash paid for interest, net of interest capitalized into fixed assets | 11,623,000 | 8,544,000 | 8,643,000 |
Cash paid for income taxes | 16,676,000 | 23,895,000 | 95,857,000 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Increase (decrease) in accounts payable and accrued liabilities related to fixed assets | (1,206,000) | (25,786,000) | 20,158,000 |
Conversion of convertible debt, net | $ 0 | $ 22,477,000 | $ 8,928,000 |
NATURE OF OPERATIONS AND BUSINE
NATURE OF OPERATIONS AND BUSINESS RISKS | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
NATURE OF OPERATIONS AND BUSINESS RISKS | (1) NATURE OF OPERATIONS AND BUSINESS RISKS BioMarin Pharmaceutical Inc. (the Company or BioMarin) 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 several commercial 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 and 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 financing; the Company’s ability to successfully commercialize its approved products; the uncertainty of the Company’s research and development 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 healthcare industry. Please see “Risk Factors” included in Part I, Item 1A of this Annual Report on Form 10-K for a more detailed discussion of these risks. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | (2) BASIS OF PRESENTATION Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange Commission (the SEC) for Annual Reports on Form 10-K and include the accounts of BioMarin and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Certain amounts in these notes to the Company’s Consolidated Financial Statements have been reclassified to conform to the current period presentation. Management performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and has concluded that there are no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing this Annual Report on Form 10-K that would require recognition or disclosure in the Consolidated Financial Statements. Effective January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting period. 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (3) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents and Investments The Company treats liquid investments with maturities of three months or less as cash equivalents. Cash and cash equivalents primarily consist of cash on deposit with banks, investments in money market funds and debt securities with original maturities of three months or less when purchased. The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such designations at each balance sheet date. The Company classifies its debt and equity securities with original maturities greater than three months when purchased as either short-term or long-term investments based on each instrument’s underlying contractual maturity date and its availability for use in current operations. Available-for-sale debt securities, which primarily consist of corporate securities, commercial paper, and U.S. federal government agency securities, are recorded at fair market value with unrealized gains and losses included in Accumulated Other Comprehensive Income (Loss) (AOCI) on the Company’s Consolidated Balance Sheets, with the exception of unrealized losses believed to be other-than-temporary, which, if any, are reported in Other Income, Net in the current period. 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. Inventory The Company values inventory at the lower of cost and net realizable value and determines the cost of inventory using the average-cost method. The Company analyzes its inventory levels quarterly and adjusts inventory to its net realizable value, if required, for obsolete, or has a cost basis in excess of its expected net realizable value or for quantities in excess of expected requirements. These adjustments are recognized as Cost of Sales in the Consolidated Statements of Operations. When future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment, the Company capitalizes pre-launch inventory costs prior to regulatory approval. A number of factors are taken into consideration, including the current status in the regulatory approval process, pivotal clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, commercialization and marketplace trends. Property, Plant and Equipment Property, plant and equipment are stated at historical cost net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Depreciation of property, plant and equipment are included in Cost of Sales, Research and Development (R&D) and Selling, General and Administrative (SG&A), as appropriate, in the Consolidated Statements of Operations. Property and equipment purchased for specific R&D projects with no alternative uses are expensed as incurred and recorded to R&D expense in the Consolidated Statements of Operations. Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 5 years Office furniture and equipment 5 years Vehicles 5 years Land improvements 10 years Land Not applicable Construction-in-progress Not applicable Leases Certain of the Company’s operating lease agreements include scheduled rent escalations over the lease term. Scheduled increases in rent expense are recognized on a straight-line basis over the lease term. The difference between rent expense and rent paid is recorded as deferred rent and included in Other Liabilities in the Consolidated Balance Sheets. The free rent periods are recognized as a reduction of rent expense over the lease term on a straight-line basis. Rent expense is recorded to Cost of Sales, R&D expense and/or SG&A expense, as appropriate, in the Consolidated Statements of Operations. See Note 4 to these Consolidated Financial Statements for further discussion on the Company’s planned adoption of Accounting Standards Codification (ASC) Topic 842, Leases Goodwill and Intangible Assets The Company records goodwill in a business combination when the total consideration exceeds the fair value of the net tangible and identifiable intangible assets acquired. Intangible assets with indefinite useful lives are related to purchased in-process research and development (IPR&D) projects and are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets are considered finite-lived and are amortized using the straight-line method based on their respective estimated useful lives at that point in time. The amortization of these intangible assets is included in Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Impairment The Company assesses its goodwill and indefinite-lived intangible assets for impairment annually in the fourth quarter, or more frequently as warranted by events or changes in circumstances that indicate that the carrying amount may not be recoverable. Goodwill is assessed for impairment by comparing the fair value of the Company’s reporting unit with its carrying amount. If the carrying value of the reporting unit exceeds its fair value, an impairment loss equal to the difference would be recorded. No impairment charges were recorded in the periods presented. Indefinite-lived intangible assets are assessed for impairment first by performing a qualitative assessment. If the qualitative assessment indicates that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, then the Company will perform a quantitative assessment and record an impairment loss. Impairment charges that are not material are recorded to Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Long-lived Assets The Company’s long-lived assets consist of property, plant and equipment and finite-lived intangible assets. Should there be an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset or asset group and its eventual disposition to the carrying amount of the asset or asset group. Any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. Impairment charges that are not material are recorded to depreciation expense and presented in SG&A in the Consolidated Statements of Operations. Revenue Recognition Effective January 1, 2018, the Company adopted the provisions of ASC Topic 606 using the modified retrospective method for all contracts not completed as of the date of adoption. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with available practical expedients. The reported results for 2018 reflect the application of ASC Topic 606 guidance, while the reported results for 2017 and 2016 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605), which is also referred to herein as "previous guidance." Under ASC Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC Topic 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in ASC Topic 606. Net Product Revenues In the U.S., the Company’s commercial products, except for Palynziq and Aldurazyme, are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Palynziq is distributed in the U.S. through certain certified specialty pharmacies For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Genzyme depending on sales volume, which is included in Net Product Revenues in the Company’s Consolidated Statements of Operations. Under ASC Topic 606, the Company recognizes its best estimate of the entire revenue that it expects to receive when the product is released and control is transferred to Genzyme. The Company records Aldurazyme net product revenues based on the estimated variable consideration payable when the product is sold through by Genzyme. Actual amounts of consideration ultimately received may differ from the Company’s estimates. Differences between the estimated variable consideration to be received from Genzyme and actual payments received are not expected to be material. If actual results vary from the Company’s estimates, the Company will make adjustments, which would affect Net Product Revenues and earnings in the period such variances become known. The adoption of ASC Topic 606 did not have an impact on the timing or amount of revenues from other sources. Under the previous guidance, the Company only recognized a portion of the tiered payment as product transfer revenue when the product was released to Genzyme because all of the Company’s performance obligations were fulfilled at that point, the prices were substantially fixed or determinable and title to, and risk of loss for, the product had transferred to Genzyme. The product transfer revenue only represented the fixed amount per unit of Aldurazyme that Genzyme was required to pay the Company if the product was unsold by Genzyme. The amount of product transfer revenue was eventually deducted from the calculated royalty recognized when the product was subsequently sold by Genzyme. The Company recorded the Aldurazyme revenues based on net sales information provided by Genzyme and recorded product transfer revenues based on the fulfillment of Genzyme purchase orders in accordance with the terms of the related agreements with Genzyme. Revenue Reserves Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from government rebates, sales returns, and other incentives that are offered within contracts between the Company and its customers, such as specialty pharmacies, hospitals, authorized distributors and government purchasers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates, however the Company does not expect any such difference to be material. If actual results in the future vary from the Company’s estimates, the Company will adjust its estimates, which would affect net product revenue and earnings in the period such variances become known. Government Rebates : The Company records reserves for rebates payable under Medicaid and other government programs as a reduction of revenue at the time product revenues are recorded. The Company’s reserve calculations require estimates, including estimates of customer mix, to determine which sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to its reserves. Sales Returns : The Company records allowances for product returns, if appropriate, as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including market exclusivity of the products based on their orphan drug status, the patient population, the customers’ limited return rights and the Company’s historical experience with returns. Because of the pricing of the Company’s commercial products, the limited number of patients and the customers’ limited return rights, most customers and retailers carry a limited inventory. The Company relies on historical return rates to estimate returns. Based on these factors and the fact that the Company has not experienced significant product returns to date, management has concluded that product returns will be minimal. In the future, if any of these factors and/or the history of product returns change, an allowance for product returns may be required. Other Incentives : Other incentives include fees paid to the Company’s distributors, discounts for prompt payment. Since 2018, the Company has also offered a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on Brineura, Kuvan or Palynziq therapy. The branded co-pay assistance programs assist commercially insured patients who have coverage for an eligible BioMarin product and are intended to reduce each participating patient’s portion of the financial responsibility of the purchase price up to a specified dollar amount of assistance. The Company records fees paid to distributors, cash discounts and amounts paid under the branded specific co-pay assistance program for each patient as a reduction of revenue. Royalty and Other Revenues Royalties : For arrangements that include the receipt of sales-based royalties, including milestone payments based on the level of sales when the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments : At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. Research and Development R&D costs are generally expensed as incurred. These expenses include contract R&D services provided by third parties, preclinical and clinical studies, raw materials costs associated with manufacturing clinical product, quality control and assurance, other R&D activities, facilities and regulatory costs and R&D-related personnel costs including salaries, benefits and stock-based compensation. Upfront and milestone payments made to third parties in connection with licensed intellectual property used in the Company’s development programs are expensed as incurred up to the point of regulatory approval. Convertible Debt For non-conventional convertible debt that may be settled entirely or partially in cash, the Company separately accounts for the liability and equity components by allocating the proceeds from issuance between the liability component and the embedded conversion option, or equity component. The value of the equity component is calculated by first measuring the fair value of the liability component, using the interest rate of a similar liability that does not have a conversion feature, as of the issuance date. The difference between the proceeds from the convertible debt issuance and the amount measured as the liability component is recorded as the equity component with a corresponding discount recorded on the debt. The liability component is presented net of any discounts and issuance costs. For conventional convertible debt that may only be settled with common shares, the Company accounts for the debt, net of any discounts or issuance costs, on the Consolidated Balance Sheet. The Company recognizes discount accretion and debt issuance cost amortization using the effective interest method as part of Interest Expense in the Consolidated Statements of Operations. Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted average shares of common stock outstanding during the period. Diluted net loss per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock; however, potential common equivalent shares are excluded if their effect is anti-dilutive. Stock-Based Compensation The Company has equity incentive plans, including an Employee Stock Purchase Plan (ESPP), under which various types of equity-based awards are granted or available to employees, including restricted stock units (RSUs) with both performance and service-based vesting conditions and stock options. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period for each award and is classified as Cost of Sales, R&D or SG&A, as appropriate, in the Consolidated Statements of Operations. The Company accounts for forfeitures as they occur. The fair value of RSUs with service-based vesting conditions and RSUs with performance conditions is determined to be the fair market value of the Company’s underlying common stock on the date of grant. The stock-based compensation for RSUs with service-based vesting is recognized ratably over the period during which the vesting restrictions lapse. Stock-based compensation for RSUs with performance conditions is recognized ratably over the service period beginning in the period the Company determines it is probable that the performance condition will be achieved. The fair value of each stock option award and the Company’s ESPP awards are estimated on the date of grant using the Black-Scholes valuation model and the following assumptions: expected life of a stock option, expected volatility, risk-free interest rate and expected dividend yield. 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. The expected life of stock options is based on observed historical exercise patterns. Groups of employees that have similar historical exercise patterns were considered separately for valuation purposes. The Company has identified two groups, executive and non-executive employees, with distinctly different exercise patterns. The executive employee group has a history of holding stock options for longer periods than non-executive employees. The determination of the fair value of stock-based payment awards using an option-pricing model is affected by the Company’s stock price and may use assumptions regarding a number of complex and subjective variables. Income Taxes The Company calculates and provides for income taxes in each of the tax jurisdictions in which it operates. Deferred tax assets and liabilities, measured using enacted tax rates, are recognized for the future tax consequences of temporary differences between the tax and financial statement basis of assets and liabilities. A valuation allowance reduces the deferred tax assets to the amount that is more likely than not to be realized. The Company establishes liabilities or reduces assets for uncertain tax positions when the Company believes certain tax positions are not more likely than not of being sustained if challenged. Each quarter, the Company evaluates these uncertain tax positions and adjusts the related tax assets and liabilities in light of changing facts and circumstances. The Company uses financial projections to support its net deferred tax assets, which contain significant assumptions and estimates of future operations. If such assumptions were to differ significantly, it may have a material impact on the Company’s ability to realize its deferred tax assets. At the end of each period, the Company will reassess the ability to realize its deferred tax benefits. If it is more likely than not that the Company would not realize the deferred tax benefits, a valuation allowance may need to be established against all or a portion of the deferred tax assets, which will result in a charge to tax expense. Foreign Currency For the Company and its subsidiaries, the functional currency has been determined to be the U.S. Dollar (USD). Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in SG&A in the Consolidated Statements of Operations. Derivatives and Hedging Activities The Company uses forward foreign currency exchange contracts (forward 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 USD, primarily the Euro. The Company designates certain of these forward contracts as hedging instruments and enters into some forward contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward 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 USD. To receive hedge accounting treatment, cash flow hedges must be highly effective in offsetting changes to expected future cash flows on hedged transactions. The Company does not hold or issue derivative instruments for trading or speculative purposes. The Company accounts for its derivative instruments as either assets or liabilities on the balance sheet and measures them at fair value, which is estimated using current exchange rates and interest rates, and takes into consideration the current creditworthiness of the counterparties or the Company, as applicable. For derivative instruments that hedge the exposure to variability in expected future cash flows that are designated as cash flow hedges, the effective portion of the gain or loss is reported as a component of AOCI in shareholders’ equity and reclassified to earnings in the same period or periods during which the hedged transaction affects earnings. The ineffective portion of the gain or loss on the derivative instrument, if any, is recognized in earnings in the current period. Derivatives that are not designated as hedging instruments are adjusted to fair value through earnings in Operating Expenses in the Consolidated Statements of Operations. See Note 4 to these Consolidated Financial Statements for further discussion on the Company’s adoption of Accounting Standards Update (ASU) No. 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities that are required to be recorded at fair value, the Company considers the principal or most advantageous market in which the Company would transact and the market-based risk measurements or assumptions that market participants would use to price the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. The Company’s fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs) • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities that are not active, or inputs other than quoted process that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs) • Unobservable inputs that reflect estimates and assumptions (Level 3 inputs) The Company’s Level 2 instruments 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. The Company’s Level 3 financial assets and liabilities include intangible assets and contingent consideration resulting from business acquisitions. The estimated fair value of long-lived and indefinite-lived intangible assets and contingent consideration are measured by applying a probability-based income approach utilizing an appropriate discount rate as of the acquisition date. Key assumptions used by management to estimate the fair value of contingent consideration include estimated probabilities, the estimated timing of when a milestone may be attained and assumed discount periods and rates. Changes in the fair value of the contingent consideration can result from changes to one or more inputs, including the estimated probability with respect to regulatory approval, changes in the assumed timing of when milestones are likely to be achieved and changes in assumed discount periods and rates. Contingent consideration is remeasured on a recurring basis and resulting changes in the fair value, due to the revision of key assumptions, are recorded in Intangible Asset Amortization and Contingent Consideration in the Company’s Consolidated Statements of Operations. The Company’s Level 3 instruments also include asset retirement obligation liabilities, and corresponding capital assets, which are measured at the estimated fair value of the obligation, when estimable, on a non-recurring basis. In subsequent periods, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciates each retirement obligation asset, both over the term of the associated lease agreement. See Notes 5, 10, 11 and 12 to these Consolidated Financial Statements for further information on the nature of these financial instruments. Segment Information The Company currently operates in one segment focused on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. A single management team reports to the chief operating decision maker who comprehensively manages the entire business. All products are included in one operating segment because the majority 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. The Company is not organized by market and is managed and operated as one business. The Company does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Company does not accumulate discrete financial information with respect to separate products, other than revenues, cost of sales and certain other operating expenses. Acquisitions Acquisitions of businesses are accounted for using the acquisition method of accounting. The Company allocates the purchase price of acquired businesses to t |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 12 Months Ended |
Dec. 31, 2018 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | (4) RECENT ACCOUNTING PRONOUNCEMENTS Accounting Pronouncements Not Yet Adopted Effective January 1, 2019, the Company will adopt ASU No. 2016-02, Leases As of December 31, 2018, the Company’s lease task force is in the process of finalizing the impact on its Consolidated Financial Statements and related disclosures for all leases as of the adoption date. During 2018, management assessed the required changes to the Company’s accounting policies, systems and internal control over financial reporting. In the first quarter of 2019, the Company expects the impact of adopting ASC Topic 842 to result in recognition of a lease liability of approximately $60.0 million and corresponding ROU asset, with the difference between these amounts recorded as an adjustment to Accumulated Deficit. The Company anticipates no material impact on its other Consolidated Financial Statements. Effective January 1, 2019, the Company will adopt ASU No. 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities Accounting Pronouncements Adopted Effective January 1, 2018, the Company adopted ASC Topic 606, which provides principles for recognizing revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company adopted ASC Topic 606 on a modified retrospective basis through a cumulative adjustment to Accumulated Deficit. See Note 3 – Significant Accounting Policies Revenue, Credit Concentrations and Geographic Information The cumulative effect of applying the new guidance of ASC Topic 606 As Reported Adjustments Adjusted December 31, 2017 Aldurazyme (1) Tax Provision (2) January 1, 2018 Balance Sheet Assets: Accounts receivable, net $ 261,365 $ 26,012 $ — $ 287,377 Deferred tax assets $ 399,095 $ — $ (5,973 ) $ 393,122 Total assets $ 4,633,125 $ 26,012 $ (5,973 ) $ 4,653,164 Equity: Accumulated deficit $ (1,637,548 ) $ 26,012 $ (5,973 ) $ (1,617,509 ) Total liabilities and stockholders' equity $ 4,633,125 $ 26,012 $ (5,973 ) $ 4,653,164 (1) This adjustment represents management’s estimate of the variable consideration to be earned on worldwide sales of Aldurazyme by Genzyme in excess of the product transfer revenue previously recognized for Genzyme’s ending inventory at December 31, 2017. The product transfer revenue previously recognized as revenue represents the fixed amount per unit of Aldurazyme that Genzyme was required to pay the Company if the product was unsold by Genzyme. (2) The adoption of ASC Topic 606 primarily resulted in an acceleration of the variable consideration components of revenue as of December 31, 2017, which in turn generated additional deferred tax liabilities that ultimately reduced the Company's net deferred tax asset position. The tax provision amount has been calculated using the Company’s estimated statutory rate. The impact of adoption on the Company’s Consolidated Statement of Operations for the year ended December 31, 2018 was as follows: Before Adoption of ASC Topic 606 Adjustments (1) As Reported Net product revenues $ 1,450,154 $ 20,202 $ 1,470,356 Provision for (benefit from) income taxes $ (70,132 ) $ 4,638 $ (65,494 ) Net loss $ (92,775 ) $ 15,564 $ (77,211 ) (1) The adoption of ASC Topic 606 resulted in additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced the Company’s benefit from income taxes. The benefit from income taxes amount has been calculated using the Company’s estimated statutory rate. The impact of adoption on the Company’s Consolidated Statement of Cash Flows for the year ended December 31, 2018 was as follows: Before Adoption of ASC Topic 606 Adjustments (1) As Reported Net loss $ (92,775 ) $ 15,564 $ (77,211 ) Deferred income taxes $ (73,016 ) $ 4,638 $ (68,378 ) Changes in operating assets and liabilities: Accounts receivable, net $ (74,476 ) $ (20,202 ) $ (54,274 ) Net cash used in operating activities $ 20,208 $ — $ 20,208 (1) The adoption of ASC Topic 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced net Deferred Tax Assets. The amount of deferred income taxes has been calculated using the Company’s estimated statutory rate. Effective January 1, 2018, the Company adopted ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | (5) FINANCIAL INSTRUMENTS The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of December 31, 2018 and 2017, respectively: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 228,809 $ — $ — $ 228,809 $ 228,809 $ — $ — Level 2: Money market instruments 205,736 — — 205,736 205,736 — — Corporate debt securities 564,852 214 (2,288 ) 562,778 2,000 376,545 184,233 Commercial paper 77,702 — — 77,702 21,964 55,738 — U.S. government agency securities 240,436 144 (697 ) 239,883 31,474 156,967 51,442 Foreign and other 5,126 139 (1 ) 5,264 3,999 1,076 189 Subtotal 1,093,852 497 (2,986 ) 1,091,363 265,173 590,326 235,864 Total $ 1,322,661 $ 497 $ (2,986 ) $ 1,320,172 $ 493,982 $ 590,326 $ 235,864 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 340,253 $ — $ — $ 340,253 $ 340,253 $ — $ — Level 2: Money market instruments 215,441 — — 215,441 215,441 — — Corporate debt securities 707,652 150 (2,553 ) 705,249 3,096 406,188 295,965 Commercial paper 24,566 — — 24,566 2,751 21,815 — U.S. government agency securities 472,593 — (1,975 ) 470,618 35,497 345,501 89,620 Foreign and other 25,540 150 (64 ) 25,626 990 24,436 200 Subtotal 1,445,792 300 (4,592 ) 1,441,500 257,775 797,940 385,785 Total $ 1,786,045 $ 300 $ (4,592 ) $ 1,781,753 $ 598,028 $ 797,940 $ 385,785 (1) (2) As of December 31, 2018, some of the Company’s investments were in an unrealized loss position. However, the Company has the ability and intent to hold all investments that have been in a continuous loss position until maturity or recovery, thus no other-than-temporary impairment was deemed to have occurred. See Note 3 to these Consolidated Financial Statements for additional discussion regarding the Company’s fair value measurements. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | (6) INTANGIBLE ASSETS Intangible assets consisted of the following: December 31, 2018 2017 Intangible assets: Finite-lived intangible assets $ 307,995 $ 303,298 Indefinite-lived intangible assets 326,359 326,359 Gross intangible assets: 634,354 629,657 Less: Accumulated amortization (142,546 ) (112,147 ) Net carrying value $ 491,808 $ 517,510 Finite-Lived Intangible Assets The following table summarizes the net-book-value and estimated remaining life of the Company’s finite-lived intangible assets as of December 31, 2018: Net Balance Average Remaining Life Acquired intellectual property $ 126,202 6.4 years Repurchased royalty rights 33,188 4.9 years Other (1) 6,059 2.2 - 5.6 years Total $ 165,449 (1) Other finite-lived intangible assets includes an asset that has not yet commenced amortizing. As of December 31, 2018, the estimated future amortization expense associated with the Company’s finite-lived intangible assets was as follows: Fiscal Year Amount 2019 $ 30,086 2020 27,605 2021 26,681 2022 26,657 2023 26,029 Thereafter 28,391 $ 165,449 Indefinite-Lived Intangible Assets The Company’s indefinite-lived intangible assets were $326.4 million as of December 31, 2018 and 2017 and consisted of IPR&D related to the Palynziq rights in Europe. In 2018, the Company received $50.0 million due to the achievement by a third party of development and regulatory milestones and commercial sales related to a previously sold intangible asset, which the Company recorded as a gain on the sale of intangible assets in the Consolidated Statements of Comprehensive Loss. In December 2017, the Company sold the Rare Pediatric Disease Priority Review Voucher (PRV) it received from the Federal Drug Administration in connection with the U.S. approval of Brineura. In exchange for the voucher, the Company received $125.0 million in proceeds from the sale of the PRV, which was recognized as a gain on the sale of intangible asset as the PRV did not have a carrying value on the Company’s Consolidated Balance Sheet at the time of sale. In the fourth quarter of 2017, the Company recognized an impairment charge of $5.8 million related to other acquired IPR&D assets. In 2016, the Company recorded impairment charges of $574.1 million related to the Kyndrisa and other exon IPR&D assets based on the status of development efforts. The impairment reduced the remaining book value to zero due to the termination of the programs. In 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. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | (7) PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, net, consisted of the following: December 31, 2018 2017 Building and improvements $ 694,447 $ 663,347 Manufacturing and laboratory equipment 345,947 294,521 Computer hardware and software 157,787 144,268 Leasehold improvements 41,188 42,572 Furniture and equipment 33,234 31,515 Land improvements 6,551 5,331 Land 77,993 62,369 Construction-in-progress 64,170 59,511 1,421,317 1,303,434 Accumulated depreciation (472,635 ) (406,734 ) Total property, plant and equipment, net $ 948,682 $ 896,700 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, Ireland. Depreciation for the years ended December 31, 2018, 2017 and 2016 was $90.4 million, $75.8 million and $73.2 million, respectively, of which $25.2 million, $24.1 million and $17.4 million was capitalized into inventory, respectively. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
INVENTORY | (8) INVENTORY Inventory consisted of the following: December 31, 2018 2017 Raw materials $ 74,616 $ 49,877 Work-in-process 231,064 234,674 Finished goods 225,191 191,224 Total inventory $ 530,871 $ 475,775 |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | (9) SUPPLEMENTAL BALANCE SHEET INFORMATION Accounts payable and accrued liabilities consisted of the following: December 31, 2018 2017 Accounts payable and accrued operating expenses $ 207,620 $ 166,616 Accrued compensation expense 149,937 140,781 Accrued rebates payable 43,116 36,472 Accrued royalties payable 19,977 18,820 Value added taxes payable 7,785 9,740 Forward foreign currency exchange contracts 4,178 14,464 Other 4,677 15,028 Total accounts payable and accrued liabilities $ 437,290 $ 401,921 The roll forward of significant estimated accrued rebates and reserve for cash discounts for the years ended December 31, 2018, 2017 and 2016 were as follows: Balance at Beginning of Period Provision for Current Period Sales Payments Balance at End of Period Year ended December 31, 2018: Accrued rebates $ 36,472 $ 67,843 $ (61,199 ) $ 43,116 Reserve for cash discounts 1,055 12,474 (12,332 ) 1,197 Year ended December 31, 2017: Accrued rebates $ 34,737 $ 52,596 $ (50,861 ) $ 36,472 Reserve for cash discounts 888 10,672 (10,505 ) 1,055 Year ended December 31, 2016: Accrued rebates $ 32,553 $ 39,142 $ (36,958 ) $ 34,737 Reserve for cash discounts 831 8,867 (8,810 ) 888 |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | (10) DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The following table summarizes the Company ’ Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Australian Dollars - Sell 12 5.1 Jan. 2019 - Jun. 2019 Brazilian Reais – Sell 4 61.0 May 2019 Canadian Dollars – Sell 12 14.9 Jan. 2019 - Jun. 2019 Colombian Pesos – Sell 6 53,300.0 Jan. 2019 - Jun. 2019 Euros – Purchase 147 170.1 Jan. 2019 - Sep. 2021 Euros – Sell 458 547.5 Jan. 2019 - Sep. 2021 Norwegian Krone - Sell 6 22.9 Jan. 2019 - Jun. 2019 Total 645 The maximum length of time over which the Company hedges its exposure to the reduction in value of forecasted foreign currency revenues through forward foreign currency exchange contracts is through September 2021. Over the next twelve months, the Company expects to reclassify $3.6 million from AOCI to earnings as the forecasted revenue and operating expense transactions occur. The following table summarizes the Company ’ Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Colombian Pesos – Sell 1 55,000.0 February 2019 Euros – Purchase 3 57.2 February 2019 Ruble – Sell 1 310.0 February 2019 Total 5 The fair value carrying amounts of the Company’s derivative instruments were as follows: Asset Derivatives Liability Derivatives December 31, 2018 December 31, 2018 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 12,686 Accounts payable & accrued liabilities $ 4,036 Forward foreign currency exchange contracts Other assets 10,324 Other long- term liabilities 3,653 Total $ 23,010 $ 7,689 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 168 Accounts payable & accrued liabilities $ 142 Total 168 142 Total value of derivative contracts $ 23,178 $ 7,831 Asset Derivatives Liability Derivatives December 31, 2017 December 31, 2017 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 4,015 Accounts payable & accrued liabilities $ 14,420 Forward foreign currency exchange contracts Other assets 4,973 Other long- term liabilities 12,686 Total $ 8,988 $ 27,106 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 675 Accounts payable & accrued liabilities $ 44 Total 675 44 Total value of derivative contracts $ 9,663 $ 27,150 (1) Se Not 3 t thes Consolidate Financia Statement fo additiona informatio relate t th Company’ fai value measurements. The effect of the Company’s derivative instruments on the Consolidated Financial Statements for the years ended December 31, 2018, 2017 and 2016 was as follows: Years Ended December 31, 2018 2017 2016 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in AOCI (1) $ 25,386 $ (38,351 ) $ 9,677 Net gain (loss) reclassified from AOCI into earnings (2) (2,047 ) (5,113 ) 6,529 Net gain recognized in net loss (3) 8,901 2,576 5,070 Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ (3,240 ) $ 8,255 $ (8,687 ) (1) Net change in the fair value of the effective portion classified as AOCI. (2) Effective portion classified as Net Product Revenues and Operating expenses. (3) Ineffective portion and amount excluded from effectiveness testing classified as Operating expense. (4) Classified as Operating 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 | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | (11) FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value in accordance with its policy in Note 3 – Significant Accounting Policies Fair Value Measurements at December 31, 2018 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Other Current Assets: NQDC Plan assets — 370 — 370 Restricted investments (1) — 9,581 — 9,581 Total other current assets — 9,951 — 9,951 Other Assets: NQDC Plan assets — 12,828 — 12,828 Restricted investments (1) — 2,450 — 2,450 Strategic investment (2) 942 — — 942 Total other assets 942 15,278 — 16,220 Total assets $ 942 $ 25,229 $ — $ 26,171 Liabilities: Current Liabilities: NQDC Plan liability $ 55 $ 370 $ — $ 425 Contingent consideration — — 85,951 85,951 Total current liabilities 55 370 85,951 86,376 Other long-term liabilities: NQDC Plan liability 17,598 12,828 — 30,426 Contingent consideration — — 46,883 46,883 Total other long-term liabilities 17,598 12,828 46,883 77,309 Total liabilities $ 17,653 $ 13,198 $ 132,834 $ 163,685 Fair Value Measurements at December 31, 2017 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Other Current Assets: NQDC Plan assets — 967 — 967 Restricted investments (1) — 15,647 — 15,647 Total other current assets — 16,614 — 16,614 Other Assets: NQDC Plan assets — 11,859 — 11,859 Total other assets — 11,859 — 11,859 Total assets $ — $ 28,473 $ — $ 28,473 Liabilities: Current Liabilities: NQDC Plan liability $ 1,356 $ 967 $ — $ 2,323 Contingent consideration — — 53,648 53,648 Total current liabilities 1,356 967 53,648 55,971 Other long-term liabilities: NQDC Plan liability 18,272 11,859 — 30,131 Contingent consideration — — 135,318 135,318 Total other long-term liabilities 18,272 11,859 135,318 165,449 Total liabilities $ 19,628 $ 12,826 $ 188,966 $ 221,420 (1) The restricted investments at December 31, 2018 and 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. (2) The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments and included in other assets on the Company’s Balance Sheets. There were no transfers between levels during the periods presented. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration and asset retirement obligations. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2017 $ 188,966 Milestone payments to Ares Trading S.A. (Merck Serono) (61,607 ) Milestone payments to former LEAD Therapeutics, Inc. shareholders (9,013 ) Changes in the fair value of other contingent consideration 18,525 Foreign exchange remeasurement of Euro denominated contingent acquisition consideration (4,037 ) Contingent consideration as of December 31, 2018 $ 132,834 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
DEBT | (12) DEBT As of December 31, 2018, the Company had outstanding fixed-rate notes with varying maturities for an undiscounted aggregate principal amount of $870.0 million (collectively the Notes). The Notes are senior subordinated convertible obligations, summarized as of December 31, as follows: 2018 2017 0.75% senior subordinated convertible notes due October 2018 (the 2018 Notes) $ — $ 374,980 Unamortized discount — (12,488 ) Unamortized deferred offering costs — (1,543 ) Convertible Notes due 2018, net — 360,949 1.50% senior subordinated convertible notes due in October 2020 (the 2020 Notes) 374,993 374,993 Unamortized discount (26,581 ) (40,287 ) Unamortized deferred offering costs (2,334 ) (3,631 ) Convertible Notes due 2020, net 346,078 331,075 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount (7,946 ) (9,355 ) Unamortized deferred offering costs (2,715 ) (3,199 ) Convertible Notes due in 2024, net 484,339 482,446 Total convertible debt, net $ 830,417 $ 1,174,470 Fair value of fixed rate convertible debt Convertible Notes due in 2018 (1) $ — $ 403,955 Convertible Notes due in 2020 (1) 419,722 446,470 Convertible Notes due in 2024 (1) 491,626 493,894 Total $ 911,348 $ 1,344,319 (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. See Note 3 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. Interest expense on the Company’s debt consisted of the following: Years Ended December 31, 2018 2017 2016 Coupon interest $ 12,452 $ 10,407 $ 9,555 Amortization of debt issuance costs 3,610 3,725 3,367 Accretion of discount on convertible notes 27,602 28,575 26,577 Total interest expense on convertible debt $ 43,664 $ 42,707 $ 39,499 2024 Convertible Notes In August 2017, the Company issued $495.0 million in aggregate principal amount of senior subordinated convertible notes with a maturity date of August 1, 2024. The 2024 Notes were issued to the public at 98% of face value and bear interest at the rate of 0.599% per annum. Interest is payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning February 1, 2018. The 2024 Notes are convertible, at the option of the holder into shares of the Company’s common stock. The initial conversion rate for the 2024 Notes is 8.0212 shares per $1,000 principal amount of the 2024 Notes, which represents a conversion price of approximately $124.67 per share, subject to adjustment under certain conditions. Following certain corporate transactions, the Company will, in certain circumstances, increase the conversion rate for a holder that elects to convert its 2024 Notes in connection with such corporate transactions by a number of additional shares of the Company’s common stock. A holder may convert fewer than all of such holder’s 2024 Notes so long as the amount of the 2024 Notes converted is an integral multiple of $1,000 principal amount. Net proceeds from the offering were $481.7 million. The 2024 Notes are senior subordinated, unsecured obligations, and rank (i) subordinated in right of payment to the prior payment in full of any of the Company’s existing and future senior debt, (ii) equal in right of payment to any of the Company’s existing and future senior subordinated debt, (iii) senior in right of payment to any of the Company’s existing and future indebtedness that is expressly subordinated in right of payment to the 2024 Notes, and (iv) effectively subordinated to any of the Company’s existing and future secured indebtedness, to the extent of the value of the collateral securing that indebtedness and structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables, and (to the extent the Company is not a holder thereof) preferred equity, if any, of the Company’s subsidiaries. Upon the occurrence of a “fundamental change,” as defined in the indenture governing the 2024 Notes, the holders may require the Company to repurchase all or a portion of such holder’s 2024 Notes for cash at 100% of the principal amount of the 2024 Notes being purchased, plus any accrued and unpaid interest. In connection with the issuance of the 2024 Notes, the Company recorded a discount on the 2024 Notes of $9.9 million, which will be accreted and recorded as additional interest expense over the life of the 2024 Notes. In connection with the issuance of the 2024 Notes, the Company incurred $3.4 million of issuance costs. These costs were deferred and are being amortized over the life of the 2024 Notes and recorded as additional interest expense. 2018/2020 Convertible Notes On October 15, 2013, the Company issued $750.0 million in aggregate principal amount of senior subordinated convertible notes consisting of $375.0 million in aggregate principal amount of 0.75% senior subordinated convertible notes that had a maturity date of October 15, 2018 and $375.0 million in aggregate principal amount of 1.50% senior subordinated convertible notes with a maturity date of October 15, 2020. Net proceeds from the offering were $726.2 million. Interest on the 2020 Notes is payable semiannually in arrears on April 15 and October 15 of each year. The Company’s 2018 Notes matured on October 15, 2018. Substantially all holders of the 2018 Notes converted at maturity and the 2018 Notes were settled with a combination of cash and shares of the Company’s common stock, consisting of approximately $375.0 million in cash and 190,220 in shares. The shares issued represented the value of the 2018 Notes in excess of the conversion price of $94.15, as measured over a 25-day averaging period. The cash payment comprised the principal, the value of fractional shares and the value of unconverted 2018 Notes. The 2020 Notes are senior unsecured obligations, and rank (i) subordinated to any of the Company’s existing and future unsecured senior debt, (ii) equally to any of the Company’s existing and future senior subordinated debt, (iii) senior to any of the Company’s future indebtedness that is expressly subordinated to the 2020 Notes, and (iv) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness. Upon the occurrence of a “fundamental change”, as defined in the indenture, the holders may require the Company to repurchase all or a portion of the 2020 Notes for cash at 100% of the principal amount of the Notes being purchased, plus any accrued and unpaid interest. The initial conversion rate for the 2020 Notes is 10.6213 shares per $1,000 principal amount of the 2020 Notes, which represents a conversion price of approximately $94.15 per share. Such conversion rates are subject to adjustment under certain conditions. Holders may convert their 2020 Notes at their option at any time prior to July 15, 2020 only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2014 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the applicable conversion price on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of the relevant notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the applicable conversion rate on each such trading day; or (3) upon the occurrence of specified corporate events. On or after July 15, 2020, in the case of the 2020 Notes, until the close of business on the second scheduled trading day immediately preceding the applicable maturity date, holders may convert their notes at any time, regardless of the foregoing circumstances. Upon conversion of the 2020 Notes, the Company may pay cash, shares of the Company’s common stock or a combination of cash and stock, as determined by the Company in its discretion. The Company separately accounted for the liability and equity components of the 2020 Notes by allocating the proceeds from issuance of the 2020 Notes between the liability component and the embedded conversion option, or equity component. This allocation was done by first estimating an interest rate at the time of issuance for similar notes that do not include the embedded conversion option. The Company allocated $156.2 million to the equity component, net of offering costs of $5.1 million. The Company recorded a discount on the 2018 Notes and 2020 Notes of $161.3 million which was accreted and recorded as additional interest expense over the lives of the 2018 Notes and 2020 Notes. Additionally, in connection with the issuance of the 2018 Notes and the 2020 Notes, the Company incurred $23.8 million of issuance costs, which were deferred and amortized over the lives of the 2018 Notes and 2020 Notes and recorded as additional interest expense. To minimize the impact of potential dilution upon conversion of the 2018 Notes and the 2020 Notes, the Company entered into capped call transactions separate from the issuance of the Notes with certain counterparties covering 3,982,988 shares of the Company’s common stock, subject to adjustment, which applies 50% to the 2018 Notes and 50% to the 2020 Notes. The capped calls have a strike price of $94.15 and a cap price of $121.05 and are exercisable when and if the Notes are converted. If upon conversion of the Notes, the price of the Company’s common stock is above the strike price of the capped calls, the counterparties will deliver shares of the Company’s common stock and/or cash with an aggregate value equal to the difference between the price of the Company’s common stock at the conversion date and the strike price, multiplied by the number of shares of the Company’s common stock related to the capped calls being exercised. The Company paid $29.8 million for these capped calls transactions, which was recorded as additional paid-in capital. Upon maturity of the 2018 Notes, the Company received from the capped call counterparties 95,127 shares of the Company’s common stock, which were accounted for as treasury shares and subsequently retired. The Company incurred no gain or loss upon the extinguishment of the 2018 Notes. See Note 13 to these Consolidated Financial Statements for further discussion of the effect of conversion on net loss per common share. Revolving Credit Facility In November 2016, the Company entered into a senior unsecured revolving credit facility (the 2016 Credit Facility) that provided revolving credit of up to $100.0 million in revolving loans, which included a $10.0 million letter of credit subfacility and a $15.0 million swingline loan subfacility. The maturity date of the 2016 Credit Facility would have occurred on November 29, 2018, but the Company terminated the 2016 Credit Facility before maturity as described below. In October 2018, the Company entered into an unsecured revolving credit facility of up to $200.0 million (the 2018 Credit Facility) and terminated the 2016 Credit Facility. The 2018 Credit Facility includes a letter of credit subfacility and a swingline loan subfacility and is intended to finance ongoing working capital needs and for other general corporate purposes , except that if at least $100.0 million aggregate principal amount of the 2020 Notes remain outstanding on August 1, 2020 and certain other conditions have not been met, the Company may be required to repay all amounts borrowed under the 2018 Credit Facility on August 1, 2020. The Company incurred approximately $1.0 million of issuance costs, which will be amortized to Interest Expense over the term of the 2018 Credit Facility. The Company incurred no gain or loss upon the termination of the 2016 Credit facility. As of December 31, 2018, there were no outstanding amounts due under the 2018 Credit Facility and the Company and certain of its subsidiaries that serve as guarantors were in compliance with all covenants. |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
NET LOSS PER COMMON SHARE | (13) NET LOSS PER COMMON SHARE Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the Company’s ESPP, unvested restricted stock units (RSUs), common stock held by the NQDC and contingent issuances of common stock related to convertible debt. The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Years Ended December 31, 2018 2017 2016 Numerator: Net loss, basic $ (77,211 ) $ (117,042 ) $ (630,210 ) Less: gain on common stock held by the NQDC (710 ) — (3,184 ) Net loss, diluted (77,921 ) (117,042 ) (633,394 ) Denominator: Weighted-average common shares outstanding, basic 177,061 174,427 165,985 Effect of dilutive securities: Common stock held by the NQDC 207 — 234 Weighted-average common shares outstanding, diluted 177,268 174,427 166,219 Net loss per common share, basic $ (0.44 ) $ (0.67 ) $ (3.80 ) Net loss per common share, diluted $ (0.44 ) $ (0.67 ) $ (3.81 ) 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): Years Ended December 31, 2018 2017 2016 Options to purchase common stock 7,364 8,108 8,856 Common stock issuable under the 2017 Notes — — 1,105 Common stock issuable under the 2018 Notes — 3,983 3,983 Common stock issuable under the 2020 Notes 3,983 3,983 3,983 Common stock issuable under the 2024 Notes 3,970 3,970 — Unvested restricted stock units 3,404 2,911 2,618 Common stock potentially issuable for ESPP purchases 435 436 404 Common stock held by the NQDC — 220 — Total number of potentially issuable shares 19,156 23,611 20,949 The potential effect of the capped call transactions with respect to the 2018 Notes and the 2020 Notes was excluded from the diluted net income/loss per share as the Company’s closing stock price on December 31, 2018, 2017 and 2016 did not exceed the conversion price of $94.15 per share for the 2018 Notes and the 2020 Notes. There is no similar capped call transaction associated with the 2024 Notes. See Note 12 to these Consolidated Financial Statements for information on the Company’s debt. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | (14) INCOME TAXES The provision for (benefit from) income taxes is based on loss before income taxes as follows: Years Ended December 31, 2018 2017 2016 U.S. Source $ (128,700 ) $ (19,461 ) $ 10,696 Non-U.S. Source (14,005 ) (16,414 ) (841,746 ) Loss before income taxes $ (142,705 ) $ (35,875 ) $ (831,050 ) The U.S. and foreign components of the provision for (benefit from) income taxes are as follows: Years Ended December 31, 2018 2017 2016 Provision for (benefit from) current income tax expense: Federal $ (2,660 ) $ 29,848 $ 22,239 State and local 588 2,880 1,418 Foreign 4,956 3,975 3,557 2,884 36,703 27,214 Provision for (benefit from) deferred income taxes: Federal (72,074 ) 12,446 (78,428 ) State and local (994 ) 32,336 (6,012 ) Foreign 4,690 (318 ) (143,614 ) (68,378 ) 44,464 (228,054 ) Provision for (benefit from) income taxes $ (65,494 ) $ 81,167 $ (200,840 ) On December 22, 2017, the bill known as the Tax Cuts and Jobs Act (the 2017 Tax Act) was signed into law. The new law has resulted in significant changes to the U.S. corporate income tax system. These changes include a federal statutory rate reduction from 35 In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act For the year ended December 31, 2016, the Company’s Dutch operations had a book net loss of $539.2 million, which included the impairment of the Kyndrisa IPR&D assets and a resulting deferred tax benefit of $143.5 million associated with the reversal of the deferred tax liability of such IPR&D assets. The following is a reconciliation of the statutory federal income tax rate to the Company’s effective income tax rate: Years Ended December 31, 2018 2017 2016 Federal statutory income tax rate $ (29,968 ) $ (12,556 ) $ (290,867 ) State and local taxes (276 ) 7,282 (2,978 ) Orphan Drug & General Business Credit (66,451 ) (33,683 ) (62,041 ) Stock compensation expense (5,647 ) (6,843 ) (38,263 ) Changes in the fair value of contingent consideration (2,361 ) 1,099 (7,616 ) Subpart F income 6,543 30,181 — Foreign tax rate differential 12,583 9,403 154,553 Section 162(m) limitation 7,440 9,492 45,056 Tax Cuts and Jobs Act of 2017 — 42,338 — Tax Reserves 8,545 2,262 2,294 Other (422 ) (2,938 ) (5,133 ) Valuation allowance/deferred benefit 4,521 35,132 4,155 Effective income tax rate $ (65,494 ) $ 81,167 $ (200,840 ) The significant components of the Company’s net deferred tax assets are as follows: December 31, 2018 2017 Net deferred tax assets: Net operating loss carryforwards $ 42,007 $ 48,374 Tax credit carryforwards 466,066 384,381 Accrued expenses, reserves, and prepaids 55,041 54,565 Intangible assets 18,734 17,556 Stock-based compensation 35,966 31,371 Inventory 12,859 13,206 Other 278 4,967 Valuation allowance (107,928 ) (111,001 ) Total deferred tax assets 523,023 443,419 Joint venture basis difference (1,010 ) (1,229 ) Acquired intangibles (6,508 ) (3,332 ) Deferred revenue (4,480 ) — Convertible notes discount (5,157 ) (10,100 ) Property, plant and equipment (44,916 ) (29,663 ) Total deferred tax liabilities (62,071 ) (44,324 ) Net deferred tax assets $ 460,952 $ 399,095 In 2018, the decrease in the valuation allowance was primarily due to the realization of deferred gains that had a full valuation allowance. As of December 31, 2018, the Company had the following net operating loss and tax credit carryforwards, which if not utilized, will expire as follows: Type Amount Year Federal net operating loss carryforwards $ 157,919 2028 – 2037 Federal R&D and orphan drug credit carryforwards $ 469,543 2030 – 2038 State net operating loss carryforwards $ 153,737 2019 – 2038 Dutch net operating loss carryforwards $ 118,225 2021 – 2025 $142.0 million of federal net operating losses and $96.1 million of state research credit carryovers will carry forward indefinitely. The Company’s net operating losses and credits could be subject to annual limitations due to ownership change limitations provided by IRC Section 382 and similar state provisions. An annual limitation could result in the expiration of net operating losses and tax credit carryforward before utilization. There are limitations on the tax attributes of acquired entities however, the Company does not believe the limitations will have a material impact on the utilization of the net operating losses or tax credits. The financial statement recognition of the benefit for a tax position is dependent upon the benefit being more likely than not to be sustainable upon audit by the applicable taxing authority. If this threshold is met, the tax benefit is then measured and recognized at the largest amount that is greater than 50% likely of being realized upon ultimate settlement. A reconciliation of the beginning and ending amount of unrecognized tax benefits for the years ended December 31, 2018 and 2017 is as follows: December 31, 2018 2017 Balance at beginning of period $ 113,486 $ 103,210 Additions based on tax positions related to the current year 30,811 11,042 (Deletions) Additions for tax positions of prior years 3,148 (766 ) Balance at end of period $ 147,445 $ 113,486 Included in the balance of unrecognized tax benefits at December 31, 2018 are potential benefits of $147.4 million that, if recognized, would affect the effective tax rate. The Company’s policy for classifying interest and penalties associated with unrecognized income tax benefits is to include such items in the income tax expense. The total amount of accrued interest and penalties was not significant as of December 31, 2018. The Company files income tax returns in the U.S. and various foreign jurisdictions. The U.S. and foreign jurisdictions have statute of limitations ranging from three to five years. However, carryforward tax attributes that were generated in 2014 and earlier may still be adjusted upon examination by tax authorities. U.S. income and foreign withholding taxes have not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries that are essentially permanent in duration. This excess totaled approximately $11.5 million as of December 31, 2018, which will be indefinitely reinvested; deferred income taxes have not been provided on such foreign earnings. |
EQUITY COMPENSATION PLANS AND S
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION | (15) EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION Equity Compensation Plans Shares Available Under Equity Compensation Plans As of December 31, 2018, an aggregate of approximately 27.2 million unissued shares was authorized for future issuance under the Company’s stock plans, which primarily includes shares issuable under the 2017 Equity Incentive Plan, the ESPP. Under the 2017 Equity Incentive Plan, shares issued under the 2006 Share Incentive Plan and the 2017 Equity Incentive Plan that expire or are forfeited generally become available for future issuance under the 2017 Equity Incentive Plan. See Note 3 to these Consolidated Financial Statements for discussion regarding the valuation of equity awards. 2017 Equity Incentive Plan The 2017 Equity Incentive Plan 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 twelve months after the grant date and then monthly thereafter. The contractual term of stock option awards is generally ten years from the grant date. RSUs granted to employees generally vest annually over a straight-line 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 (the Board), 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. As of December 31, 2018, options to purchase approximately 7.4 million shares were outstanding under the Company’s stock option plans and approximately 10.9 million shares were authorized for future issuance under the 2017 Equity Incentive Plan. Employee Stock Purchase Plan The ESPP was initially approved in June 2006, replacing the Company’s previous plan, and was further amended on March 5, 2014. Under BioMarin’s ESPP, employees meeting specific employment qualifications are eligible to participate and can purchase shares on established dates (each purchase date) semi-annually through payroll deductions at the lower of 85% of the fair market value of the stock at the commencement of the offering period or each purchase date of the offering period. Each offering period will span up to two years. The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 10% of qualified compensation, up to an annual limit of $25,000. The ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the IRC. During the year ended December 31, 2018, the Company issued 0.2 million shares under the ESPP. As of December 31, 2018, there were approximately 3.5 million shares were authorized and 0.4 million shares reserved for future issuance under the ESPP. Board of Director Grants On September 28, 2017, the Board approved revised compensation for the Independent Directors of the Company as follows. On the date of the Company’s annual meeting of stockholders for a given year, each re-elected Independent Director receives an RSU grant valued at $375,000, with the number of RSUs to be granted calculated based on the three month trailing average closing price of the Company’s common stock on the Nasdaq Global Select Market Stock-based Compensation Compensation expense included in the Company’s Consolidated Statements of Operations for all stock-based compensation arrangements was as follows: Years Ended December 31, 2018 2017 2016 Cost of sales $ 13,558 $ 10,636 $ 9,121 Research and development 57,557 53,112 58,279 Selling, general and administrative 77,704 76,515 67,241 Total stock-based compensation expense $ 148,819 $ 140,263 $ 134,641 Stock-based compensation of $20.0 million, $16.1 million and $11.4 million was capitalized into inventory, for the years ended December 31, 2018, 2017 and 2016, respectively. Capitalized stock-based compensation is recognized as cost of sales when the related product is sold. Restricted Stock Unit Awards with Service-Based Vesting Conditions Below is a summary of RSU activity under the plan for the year ended December 31, 2018: Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Years Aggregate Intrinsic Value Non-vested units as of December 31, 2017 2,679,534 $ 90.04 2.5 $ 238,934 Granted 1,681,120 $ 84.63 Vested (963,062 ) $ 89.53 Forfeited (250,069 ) $ 88.68 Non-vested units as of December 31, 2018 3,147,523 $ 87.42 2.6 $ 268,012 The weighted-average grant date fair value per share of RSUs granted during the years ended December 31, 2018, 2017 and 2016, was $84.63, $87.88 and $84.18, respectively. The total intrinsic value of restricted stock that vested and was released in the years ended December 31, 2018, 2017 and 2016 was $84.5 million, $76.5 million and $63.5 million, respectively. The Company recorded $102.0 million, $86.5 million and $74.7 million of compensation costs related to RSUs with service-based vesting conditions for the years ended December 31, 2018, 2017 and 2016, respectively. As of December 31, 2018, there was $192.5 million of total unrecognized compensation cost related to unvested RSUs with service-based vesting conditions. These costs are expected to be recognized over a weighted average period of 2.6 years. Stock Options The following table summarizes activity under the Company’s stock option plans, including the 2012 and 2014 Inducement Plans and those suspended upon the adoption of the 2017 Share Incentive Plan, for the year ended December 31, 2018. All option grants presented in the table had exercise prices not less than the fair value of the underlying common stock on the grant date: Shares Weighted Average Exercise Price Weighted Average Remaining Years Aggregate Intrinsic Value (1) Options outstanding as of December 31, 2017 8,107,981 $ 56.53 5.1 $ 281,141 Granted 782,240 $ 83.77 Exercised (1,456,274 ) $ 36.71 Expired and forfeited (70,338 ) $ 86.46 Options outstanding as of December 31, 2018 7,363,609 $ 63.06 5.1 $ 183,091 Options unvested at December 31, 2018 1,441,416 $ 85.75 8.6 $ 1,559 Exercisable at December 31, 2018 5,922,193 $ 57.57 4.2 $ 181,532 (1) The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the Nasdaq Global Select Market as of the last trading day for the respective year. The aggregate intrinsic value of options outstanding and exercisable includes options with an exercise price below $85.15, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2018. The weighted-average fair value per option granted in the years ended December 31, 2018, 2017 and 2016 were $33.40, $36.07 and $40.70, respectively. The total intrinsic value of options exercised during the years ended December 31, 2018, 2017 and 2016 was $79.9 million, $77.0 million and $127.4 million, respectively. The aggregate intrinsic value of options exercised was determined as of the date of option exercise. Upon the exercise of the options, the Company issues new common stock from its authorized shares. The assumptions used to estimate the per share fair value of stock options granted during the periods presented were as follows: Years Ended December 31, 2018 2017 2016 Expected volatility 36.8 – 38.4% 37.6 – 39.7% 35.7 – 44.2% Dividend yield 0.00% 0.00% 0.00% Expected life 4.6 – 5.7 years 4.9 – 6.6 years 5.0 – 8.1 years Risk-free interest rate 2.3 – 2.8% 1.8 – 2.2% 1.1 – 2.3% The Company recorded $32.0 million, $36.7 million and $45.5 million of compensation costs related to current period vesting of stock options for the years ended December 31, 2018, 2017 and 2016, respectively. As of December 31, 2018, the total unrecognized compensation cost related to unvested stock options was $42.7 million. These costs are expected to be recognized over a weighted average period of 2.4 years. The net tax benefit from stock options exercised during the year ended December 31, 2018 was $5.8 million. The assumptions used to estimate the per share fair value of stock purchase rights granted under the ESPP were as follows: Years Ended December 31, 2018 2017 2016 Expected volatility 29.7 – 35.0% 27.7 – 42.3% 41.5 – 49.7% Dividend yield 0.00% 0.00% 0.00% Expected life 6 – 24 months 6 – 24 months 6 – 24 months Risk-free interest rate 1.2 – 2.8% 1.0 – 1.6% 0.4 – 0.8% The Company recorded $10.4 million, $11.7 million and $10.1 million of compensation costs related to shares granted under the ESPP for the years ended December 31, 2018, 2017 and 2016, respectively. As of December 31, 2018, there was $10.8 million of total unrecognized compensation cost related to unvested stock options issuable under the ESPP. These costs are expected to be recognized over a weighted average period of 1.3 years. Restricted Stock Unit Awards with Performance Conditions The Compensation Committee of the Board (with respect to awards to certain executive officers other than the Chief Executive Officer) and the Board (with respect to awards to the Chief Executive Officer) may grant RSUs with performance-based vesting conditions to certain executive officers. In March 2018, the Compensation Committee and Board approved the grant of 129,680 RSUs (base RSUs) with performance-based vesting conditions. This award is contingent upon the achievement of a 2018 revenue target and the awarded RSUs, if any, vest ratably over a three-year service period. The number of shares that may be earned range between of the base RSUs, dependent on the percentage of 2018 “managed revenues” (defined as the Company’s net product revenues, excluding net revenues attributable to Aldurazyme, and determined using fixed foreign currency exchange rates) achieved against the target managed revenues, with a threshold achievement level The following table details the base RSUs granted, RSUs earned and expected to vest and the performance multiplier achieved for the RSUs with performance-based vesting conditions for the years ended December 31, 2017, 2016 and 2015, respectively, as well as the base RSUs granted in March 2018: Compensation Expense for the Years Ended December 31, Date of Grant Base RSUs Granted Grant Date Fair Value per RSU Multiplier Achieved RSUs Earned 2018 2017 2016 March 2018 (1) 129,680 $ 83.57 (1) (1) $ 3,829 $ — $ — March 2017 (2) 133,250 $ 87.42 103 % 131,651 $ 3,446 $ 4,141 $ — March 2016 (2) 130,310 $ 83.43 103 % 134,219 $ 3,125 $ 3,928 $ 2,956 March 2015 (2) 58,300 $ 108.36 111 % 64,713 $ 340 $ 2,291 $ 2,342 (1) Based on the Company’s performance against the 2018 revenue target, the Company expects its Compensation Committee to approve a multiplier of 97.8% and the participating executive officers to earn 126,814 RSUs. The Company evaluated the 2018 revenue target in the context of its current 2018 revenue forecast, and related confidence level in the forecast, and determined that attainment of the revenue target was probable for accounting purposes commencing in the first quarter of 2018. (2) The RSUs with performance-based vesting conditions granted in 2015, 2016 and 2017 were earned on the one year anniversary upon achievement of the respective performance target and vest ratably over a three-year service period. As of December 31, 2018, total unrecognized compensation expense of $11.6 million related to RSU awards with performance-vesting conditions is expected to be recognized over a weighted average period of 1.7 years. |
OTHER EMPLOYEE BENEFITS
OTHER EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2018 | |
Compensation Related Costs [Abstract] | |
OTHER EMPLOYEE BENEFITS | (16) OTHER EMPLOYEE BENEFITS Employment Agreements The Company has entered into employment agreements with certain officers. Generally, these agreements can be terminated without cause by the Company upon prior written notice and payment of specified severance, or by the officer upon four weeks’ prior written notice to the Company. 401(k) Plan The Company sponsors the BioMarin Retirement Savings Plan (the 401(k) Plan). Most employees (Participants) are eligible to participate following the start of their employment, at the beginning of each calendar month. Participants may contribute to the 401(k) Plan up to the lesser of 100% of their current compensation or an amount up to a statutorily prescribed annual limit. The Company pays the direct expenses of the 401(k) Plan and matched 100% of each Participant’s contributions, up to a maximum of the lesser of 6% of the employee’s annual compensation or $16,000 per year ($19,000 per year effective January 1, 2019). The Company’s matching contribution vests over four years from employment commencement and was approximately $23.0 million, $19.8 million and $16.0 million for the years ended December 31, 2018, 2017 and 2016, respectively. Employer contributions not vested upon employee termination are forfeited. Deferred Compensation Plan In December 2005, the Company adopted the Deferred Compensation Plan. All of the investments held in the NQDC Plan are classified as trading securities and recorded at fair value with changes in the investments’ fair values recognized as earnings in the period they occur. Company stock issued and held by the NQDC Plan is accounted for similarly to treasury stock in that the value of the employer stock is determined on the date the restricted stock vests and the shares are issued into the NQDC Plan. The restricted stock issued into the NQDC Plan is recorded as stockholders’ equity and changes in the fair value of the corresponding liability are recognized in earnings as incurred. The corresponding liabilities for the NQDC Plan are included in Accounts Payable and Accrued Liabilities and Other Long-Term Liabilities in the Company’s Consolidated Balance Sheets. The corresponding assets for the NQDC Plan are included in Other Current Assets and Other Assets in the Company’s Consolidated Balance Sheets. As of December 31, 2018 and 2017, the fair value of Company stock held by the Deferred Compensation Plan, was $17.7 million and $19.6 million, respectively, which is included in current and non-current liabilities. The change in market value amounted to a gain of $0.9 million, a loss of $1.4 million and a gain of $5.0 million in the years 2018, 2017 and 2016, respectively. |
COMPREHENSIVE INCOME (LOSS)
COMPREHENSIVE INCOME (LOSS) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
COMPREHENSIVE INCOME (LOSS) | (16) COMPREHENSIVE INCOME (LOSS) The following table summarizes amounts reclassified out of AOCI and their effect on the Company’s Consolidated Statements of Operations for the years ended December 31, 2018 and 2017. Years Ended December 31, Consolidated Statement of Details about AOCI Components 2018 2017 2016 Operations Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ (6,005 ) $ (5,377 ) $ 6,112 Net product revenues Forward foreign currency exchange contracts 3,958 264 4,161 Operating expenses Total gain (loss) on cash flow hedges (2,047 ) (5,113 ) 10,273 Gain (loss) on sale of available-for- sale debt securities — 3,252 (115 ) Other income, net Income tax effect of the above — (1,191 ) (42 ) Provision for (benefit from) income taxes Total gain (loss) on available-for-sale debt securities — 2,061 (157 ) $ (2,047 ) $ (3,052 ) $ 10,116 Net loss The following table summarizes changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Gains and Losses on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Other Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (38,351 ) (755 ) 5 (39,101 ) Less: net gain (loss) reclassified from AOCI (5,113 ) 3,252 (1,861 ) Tax effect — 1,463 — 1,463 Net current-period other comprehensive loss (33,238 ) (2,544 ) 5 (35,777 ) AOCI balance at December 31, 2017 (20,232 ) (2,722 ) (7 ) (22,961 ) Impact of change in accounting principle (1) — (586 ) — (586 ) AOCI balance at January 1, 2018 (20,232 ) (3,308 ) (7 ) (23,547 ) Other comprehensive income (loss) before reclassifications 25,386 1,804 (6 ) 27,184 Less: loss reclassified from AOCI (2,047 ) — — (2,047 ) Tax effect — (413 ) — (413 ) Net current-period other comprehensive income (loss) 27,433 1,391 (6 ) 28,818 AOCI balance at December 31, 2018 $ 7,201 $ (1,917 ) $ (13 ) $ 5,271 (1) As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from AOCI to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion. |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 12 Months Ended |
Dec. 31, 2018 | |
Concentration Risk And Geographic Information [Abstract] | |
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | (17) REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company considers there to be revenue concentration risks for regions where net product revenues exceed 10% of consolidated net product revenues. The concentration of the Company’s net product revenues within the regions below may have a material adverse effect on the Company’s revenues and results of operations if sales in the respective regions experience difficulties . The Company adopted the requirements of ASC Topic 606 on January 1, 2018 using the modified retrospective method, therefore there is a lack of comparability to the prior periods presented. See Note 4 – Recent Accounting Pronouncements The following table disaggregates 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. 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 is located in the U.S. Years Ended December 31, 2018 2017 2016 Total revenues by geographic region: United States $ 696,793 $ 588,243 $ 507,539 Europe 436,434 398,814 340,775 Latin America 185,046 181,970 147,474 Rest of world 172,939 144,619 121,066 Total revenues $ 1,491,212 $ 1,313,646 $ 1,116,854 The following table disaggregates total Net Product Revenues from external customers by product. Years Ended December 31, 2018 2017 2016 Net product revenues by product: Aldurazyme $ 135,097 $ 89,959 $ 93,749 Brineura 39,889 8,595 — Firdapse 21,787 18,890 18,028 Kuvan 433,582 407,542 348,009 Naglazyme 345,851 332,208 296,537 Palynziq 12,173 — — Vimizim 481,977 413,251 354,058 Total net product revenues $ 1,470,356 $ 1,270,445 $ 1,110,381 The table below disaggregates total Net Product Revenues based on patient location for products sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Genzyme is the Company’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Years Ended December 31, 2018 2017 2016 Region: United States $ 560,030 $ 495,741 $ 411,877 Europe 424,357 363,538 340,775 Latin America 184,984 181,963 147,474 Rest of world 165,888 139,244 116,506 Total net product revenues marketed by the Company 1,335,259 1,180,486 1,016,632 Aldurazyme net product revenues marketed by Genzyme 135,097 89,959 93,749 Total net product revenue $ 1,470,356 $ 1,270,445 $ 1,110,381 The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers. For the Years Ended December 31, 2018 2017 2016 Customer A 18 % 18 % 19 % Customer B 12 % 14 % 13 % Customer C 10 % 10 % 10 % Total 40 % 42 % 42 % On a consolidated basis, two customers accounted for 30% and 16% of the Company’s December 31, 2018 accounts receivable balance, respectively, compared to December 31, 2017 when two customers accounted for 21% and 18% of the accounts receivable balance, respectively. As of December 31, 2018 and 2017, the accounts receivable balance for Genzyme included $73.9 million and $18.1 million, respectively, of unbilled accounts receivable, which become payable to the Company when the product is sold through by 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 sells its products in countries that face economic volatility and weakness. Although the Company has historically collected receivables from customers in such 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. The following table summarizes non-monetary long-lived assets by geographic region. Non-monetary long-lived assets primarily consist of property, plant and equipment, intangible assets, deferred tax assets and goodwill. December 31, 2018 2017 Long-lived assets by geography: United States $ 1,719,733 $ 1,653,944 Ireland 220,878 198,781 Rest of world 158,583 158,530 Total long-lived assets $ 2,099,194 $ 2,011,255 |
COLLABORATION AND LICENSE AGREE
COLLABORATION AND LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
COLLABORATION AND LICENSE AGREEMENTS | (18) COLLABORATION AND LICENSE AGREEMENTS In July 2017, the Company executed a license agreement and a settlement agreement (the Sarepta 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 Sarepta 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. Pursuant to the Sarepta Agreements, Sarepta paid the Company a net one-time upfront fee of $31.5 million, which was recognized as license revenue. Under the Sarepta Agreements, Sarepta may pay certain additional regulatory and commercial milestone fees for exons 51, 45, 53 and possibly on future exon-skipping products to the Company if certain development and sales milestones are achieved. Additionally, the Company receives from Sarepta royalties based on 5% of net sales in the U.S. through the end of 2023 and 8% of net sales in the EU and in other countries, where certain of the Company’s patents exist, through September 30, 2024. 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. 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. The Company and Merck Serono have no further rights or obligations under the License Agreement with respect to Kuvan or Palynziq. 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 Palynziq. As a result, the Company acquired all global rights to Kuvan and Palynziq 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 Palynziq in the U.S. and Japan. Pursuant to the A&R Kuvan Agreement, the Company paid Merck Serono $374.5 million in cash and is obligated to pay Merck Serono up to a maximum of €60.0 million, in cash, if future sales milestones are met. Pursuant to the Pegvaliase Agreement, as of December 31, 2018, the Company is obligated to pay Merck Serono up to a maximum of €75.0 million, in cash, if future development milestones are met. On October 6, 2015, the Company completed the sale of talazoparib to Medivation Inc. (Medivation) pursuant to an asset purchase agreement (the Medivation Asset Purchase Agreement). Pursuant to the Medivation Asset Purchase Agreement, Medivation paid the Company an upfront payment of $410.0 million upon the closing of the transaction. In September 2016, Pfizer Inc. acquired Medivation, therefore obligations under the Medivation Asset Purchase Agreement (“Medivation Agreement”) transferred to Pfizer. During the fourth quarter of 2015, the Company recognized a net gain of $369.5 million related to the sale of the talazoparib intangible assets. In accordance with the Medivation Agreement, Pfizer shall pay the Company milestone payments of up to $160.0 million, of which $50.0 million was paid in 2018 pursuant to achievement of development and regulatory approval milestones. Commencing in 2018, pursuant to the Medivation Agreement, the Company receives mid-single digit percentage royalties on net sales of talazoparib. In October 2012, the Company licensed to Catalyst Pharmaceutical Partners, Inc., (Catalyst) the North American rights to develop and market Firdapse. In consideration of this licensing arrangement, the Company received from Catalyst a $5.0 million convertible promissory note. Under the terms of the note agreement, the Company received 6.7 million shares of Catalyst common stock upon the automatic conversion of the convertible promissory note on December 10, 2012. In exchange for the North American rights to Firdapse, the Company will receive royalties of 7% to 10% on net product sales of Firdapse in North America, which is expected to commence in the first quarter of 2019. As of December 31, 2018 and 2017, there were no amounts due from Catalyst for reimbursable development costs and the Company held no shares of Catalyst common stock. In September 2007, the Company licensed to Asubio Pharma Co., Ltd. (a subsidiary of Daiichi Sankyo) exclusive rights to data and intellectual property contained in the Kuvan new drug application. The Company receives royalties on net sales of the product in Japan. The Company is engaged in R&D collaborations with various other entities. These provide for sponsorship of R&D by the Company and may also provide for exclusive royalty-bearing intellectual property licenses or rights of first negotiation regarding licenses to intellectual property development under the collaborations. Typically, these agreements can be terminated for cause by either party upon 90 days written notice. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | (19) COMMITMENTS AND CONTINGENCIES Lease Commitments The Company leases office space and research, testing and manufacturing laboratory space in various facilities under operating agreements expiring at various dates through 2031. Certain of the leases provide for options by the Company to extend the lease for multiple five-year renewal periods and also provide for annual minimum increases in rent, usually based on a consumer price index or annual minimum increases. Minimum lease payments for future years are as follows: 2019 $ 12,976 2020 12,549 2021 11,198 2022 10,574 2023 9,993 Thereafter 27,701 Total $ 84,991 Rent expense for the years ended December 31, 2018, 2017 and 2016 was $12.2 million, $11.4 million and $11.6 million, respectively. Deferred rent accruals at December 31, 2018 totaled $2.1 million, of which $0.5 million was current. Deferred rent accruals at December 31, 2017 totaled $2.3 million, of which $2.0 million was current. 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 applicable lease agreement. As of December 31 2018 and 2017, the balance of the asset retirement obligation liability was $4.9 million and $4.2 million, respectively. See Note 3 to these Consolidated Financial Statements for further information on the fair value measurement of asset retirement obligations. Research and Development Funding and Technology Licenses The Company uses experts and laboratories at universities and other institutions to perform certain R&D activities. These amounts are included as R&D expense as services are provided. The Company has also licensed technology, for which it is required to pay royalties upon future sales, subject to certain annual minimums. Other Commitments In the normal course of business, the Company enters into various firm purchase commitments primarily related to active pharmaceutical ingredients, certain inventory related items and certain third-party R&D services. As of December 31, 2018, these commitments for the next five years were approximately $91.8 million. Contingencies From time to time the Company is involved in legal actions arising in the normal course of its business. 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. Contingent Payments As of December 31, 2018, the Company is also subject to contingent payments totaling approximately $477.3 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, $154.5 million relates to the acquisition of certain rights and other assets with respect to Kuvan and Palynziq from Merck Serono and $80.7 million relates to programs that are no longer being developed. As of December 31, 2018, the Company has recorded $132.8 million of contingent consideration on its Consolidated Balance Sheets. |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange Commission (the SEC) for Annual Reports on Form 10-K and include the accounts of BioMarin and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Certain amounts in these notes to the Company’s Consolidated Financial Statements have been reclassified to conform to the current period presentation. Management performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and has concluded that there are no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing this Annual Report on Form 10-K that would require recognition or disclosure in the Consolidated Financial Statements. Effective January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting period. 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. |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments The Company treats liquid investments with maturities of three months or less as cash equivalents. Cash and cash equivalents primarily consist of cash on deposit with banks, investments in money market funds and debt securities with original maturities of three months or less when purchased. The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such designations at each balance sheet date. The Company classifies its debt and equity securities with original maturities greater than three months when purchased as either short-term or long-term investments based on each instrument’s underlying contractual maturity date and its availability for use in current operations. Available-for-sale debt securities, which primarily consist of corporate securities, commercial paper, and U.S. federal government agency securities, are recorded at fair market value with unrealized gains and losses included in Accumulated Other Comprehensive Income (Loss) (AOCI) on the Company’s Consolidated Balance Sheets, with the exception of unrealized losses believed to be other-than-temporary, which, if any, are reported in Other Income, Net in the current period. 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. |
Inventory | Inventory The Company values inventory at the lower of cost and net realizable value and determines the cost of inventory using the average-cost method. The Company analyzes its inventory levels quarterly and adjusts inventory to its net realizable value, if required, for obsolete, or has a cost basis in excess of its expected net realizable value or for quantities in excess of expected requirements. These adjustments are recognized as Cost of Sales in the Consolidated Statements of Operations. When future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment, the Company capitalizes pre-launch inventory costs prior to regulatory approval. A number of factors are taken into consideration, including the current status in the regulatory approval process, pivotal clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, commercialization and marketplace trends. |
Property, Plant And Equipment | Property, Plant and Equipment Property, plant and equipment are stated at historical cost net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Depreciation of property, plant and equipment are included in Cost of Sales, Research and Development (R&D) and Selling, General and Administrative (SG&A), as appropriate, in the Consolidated Statements of Operations. Property and equipment purchased for specific R&D projects with no alternative uses are expensed as incurred and recorded to R&D expense in the Consolidated Statements of Operations. Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 5 years Office furniture and equipment 5 years Vehicles 5 years Land improvements 10 years Land Not applicable Construction-in-progress Not applicable |
Leases | Leases Certain of the Company’s operating lease agreements include scheduled rent escalations over the lease term. Scheduled increases in rent expense are recognized on a straight-line basis over the lease term. The difference between rent expense and rent paid is recorded as deferred rent and included in Other Liabilities in the Consolidated Balance Sheets. The free rent periods are recognized as a reduction of rent expense over the lease term on a straight-line basis. Rent expense is recorded to Cost of Sales, R&D expense and/or SG&A expense, as appropriate, in the Consolidated Statements of Operations. See Note 4 to these Consolidated Financial Statements for further discussion on the Company’s planned adoption of Accounting Standards Codification (ASC) Topic 842, Leases |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company records goodwill in a business combination when the total consideration exceeds the fair value of the net tangible and identifiable intangible assets acquired. Intangible assets with indefinite useful lives are related to purchased in-process research and development (IPR&D) projects and are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets are considered finite-lived and are amortized using the straight-line method based on their respective estimated useful lives at that point in time. The amortization of these intangible assets is included in Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. |
Impairment | Impairment The Company assesses its goodwill and indefinite-lived intangible assets for impairment annually in the fourth quarter, or more frequently as warranted by events or changes in circumstances that indicate that the carrying amount may not be recoverable. Goodwill is assessed for impairment by comparing the fair value of the Company’s reporting unit with its carrying amount. If the carrying value of the reporting unit exceeds its fair value, an impairment loss equal to the difference would be recorded. No impairment charges were recorded in the periods presented. Indefinite-lived intangible assets are assessed for impairment first by performing a qualitative assessment. If the qualitative assessment indicates that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, then the Company will perform a quantitative assessment and record an impairment loss. Impairment charges that are not material are recorded to Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Long-lived Assets The Company’s long-lived assets consist of property, plant and equipment and finite-lived intangible assets. Should there be an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset or asset group and its eventual disposition to the carrying amount of the asset or asset group. Any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. Impairment charges that are not material are recorded to depreciation expense and presented in SG&A in the Consolidated Statements of Operations. |
Revenue Recognition | Revenue Recognition Effective January 1, 2018, the Company adopted the provisions of ASC Topic 606 using the modified retrospective method for all contracts not completed as of the date of adoption. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with available practical expedients. The reported results for 2018 reflect the application of ASC Topic 606 guidance, while the reported results for 2017 and 2016 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605), which is also referred to herein as "previous guidance." Under ASC Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC Topic 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in ASC Topic 606. Net Product Revenues In the U.S., the Company’s commercial products, except for Palynziq and Aldurazyme, are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Palynziq is distributed in the U.S. through certain certified specialty pharmacies For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Genzyme depending on sales volume, which is included in Net Product Revenues in the Company’s Consolidated Statements of Operations. Under ASC Topic 606, the Company recognizes its best estimate of the entire revenue that it expects to receive when the product is released and control is transferred to Genzyme. The Company records Aldurazyme net product revenues based on the estimated variable consideration payable when the product is sold through by Genzyme. Actual amounts of consideration ultimately received may differ from the Company’s estimates. Differences between the estimated variable consideration to be received from Genzyme and actual payments received are not expected to be material. If actual results vary from the Company’s estimates, the Company will make adjustments, which would affect Net Product Revenues and earnings in the period such variances become known. The adoption of ASC Topic 606 did not have an impact on the timing or amount of revenues from other sources. Under the previous guidance, the Company only recognized a portion of the tiered payment as product transfer revenue when the product was released to Genzyme because all of the Company’s performance obligations were fulfilled at that point, the prices were substantially fixed or determinable and title to, and risk of loss for, the product had transferred to Genzyme. The product transfer revenue only represented the fixed amount per unit of Aldurazyme that Genzyme was required to pay the Company if the product was unsold by Genzyme. The amount of product transfer revenue was eventually deducted from the calculated royalty recognized when the product was subsequently sold by Genzyme. The Company recorded the Aldurazyme revenues based on net sales information provided by Genzyme and recorded product transfer revenues based on the fulfillment of Genzyme purchase orders in accordance with the terms of the related agreements with Genzyme. Revenue Reserves Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from government rebates, sales returns, and other incentives that are offered within contracts between the Company and its customers, such as specialty pharmacies, hospitals, authorized distributors and government purchasers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates, however the Company does not expect any such difference to be material. If actual results in the future vary from the Company’s estimates, the Company will adjust its estimates, which would affect net product revenue and earnings in the period such variances become known. Government Rebates : The Company records reserves for rebates payable under Medicaid and other government programs as a reduction of revenue at the time product revenues are recorded. The Company’s reserve calculations require estimates, including estimates of customer mix, to determine which sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to its reserves. Sales Returns : The Company records allowances for product returns, if appropriate, as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including market exclusivity of the products based on their orphan drug status, the patient population, the customers’ limited return rights and the Company’s historical experience with returns. Because of the pricing of the Company’s commercial products, the limited number of patients and the customers’ limited return rights, most customers and retailers carry a limited inventory. The Company relies on historical return rates to estimate returns. Based on these factors and the fact that the Company has not experienced significant product returns to date, management has concluded that product returns will be minimal. In the future, if any of these factors and/or the history of product returns change, an allowance for product returns may be required. Other Incentives : Other incentives include fees paid to the Company’s distributors, discounts for prompt payment. Since 2018, the Company has also offered a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on Brineura, Kuvan or Palynziq therapy. The branded co-pay assistance programs assist commercially insured patients who have coverage for an eligible BioMarin product and are intended to reduce each participating patient’s portion of the financial responsibility of the purchase price up to a specified dollar amount of assistance. The Company records fees paid to distributors, cash discounts and amounts paid under the branded specific co-pay assistance program for each patient as a reduction of revenue. Royalty and Other Revenues Royalties : For arrangements that include the receipt of sales-based royalties, including milestone payments based on the level of sales when the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments : At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. |
Research and Development | Research and Development R&D costs are generally expensed as incurred. These expenses include contract R&D services provided by third parties, preclinical and clinical studies, raw materials costs associated with manufacturing clinical product, quality control and assurance, other R&D activities, facilities and regulatory costs and R&D-related personnel costs including salaries, benefits and stock-based compensation. Upfront and milestone payments made to third parties in connection with licensed intellectual property used in the Company’s development programs are expensed as incurred up to the point of regulatory approval. |
Convertible Debt | Convertible Debt For non-conventional convertible debt that may be settled entirely or partially in cash, the Company separately accounts for the liability and equity components by allocating the proceeds from issuance between the liability component and the embedded conversion option, or equity component. The value of the equity component is calculated by first measuring the fair value of the liability component, using the interest rate of a similar liability that does not have a conversion feature, as of the issuance date. The difference between the proceeds from the convertible debt issuance and the amount measured as the liability component is recorded as the equity component with a corresponding discount recorded on the debt. The liability component is presented net of any discounts and issuance costs. For conventional convertible debt that may only be settled with common shares, the Company accounts for the debt, net of any discounts or issuance costs, on the Consolidated Balance Sheet. The Company recognizes discount accretion and debt issuance cost amortization using the effective interest method as part of Interest Expense in the Consolidated Statements of Operations. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted average shares of common stock outstanding during the period. Diluted net loss per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock; however, potential common equivalent shares are excluded if their effect is anti-dilutive. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans, including an Employee Stock Purchase Plan (ESPP), under which various types of equity-based awards are granted or available to employees, including restricted stock units (RSUs) with both performance and service-based vesting conditions and stock options. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period for each award and is classified as Cost of Sales, R&D or SG&A, as appropriate, in the Consolidated Statements of Operations. The Company accounts for forfeitures as they occur. The fair value of RSUs with service-based vesting conditions and RSUs with performance conditions is determined to be the fair market value of the Company’s underlying common stock on the date of grant. The stock-based compensation for RSUs with service-based vesting is recognized ratably over the period during which the vesting restrictions lapse. Stock-based compensation for RSUs with performance conditions is recognized ratably over the service period beginning in the period the Company determines it is probable that the performance condition will be achieved. The fair value of each stock option award and the Company’s ESPP awards are estimated on the date of grant using the Black-Scholes valuation model and the following assumptions: expected life of a stock option, expected volatility, risk-free interest rate and expected dividend yield. 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. The expected life of stock options is based on observed historical exercise patterns. Groups of employees that have similar historical exercise patterns were considered separately for valuation purposes. The Company has identified two groups, executive and non-executive employees, with distinctly different exercise patterns. The executive employee group has a history of holding stock options for longer periods than non-executive employees. The determination of the fair value of stock-based payment awards using an option-pricing model is affected by the Company’s stock price and may use assumptions regarding a number of complex and subjective variables. |
Income Taxes | Income Taxes The Company calculates and provides for income taxes in each of the tax jurisdictions in which it operates. Deferred tax assets and liabilities, measured using enacted tax rates, are recognized for the future tax consequences of temporary differences between the tax and financial statement basis of assets and liabilities. A valuation allowance reduces the deferred tax assets to the amount that is more likely than not to be realized. The Company establishes liabilities or reduces assets for uncertain tax positions when the Company believes certain tax positions are not more likely than not of being sustained if challenged. Each quarter, the Company evaluates these uncertain tax positions and adjusts the related tax assets and liabilities in light of changing facts and circumstances. The Company uses financial projections to support its net deferred tax assets, which contain significant assumptions and estimates of future operations. If such assumptions were to differ significantly, it may have a material impact on the Company’s ability to realize its deferred tax assets. At the end of each period, the Company will reassess the ability to realize its deferred tax benefits. If it is more likely than not that the Company would not realize the deferred tax benefits, a valuation allowance may need to be established against all or a portion of the deferred tax assets, which will result in a charge to tax expense. |
Foreign Currency | Foreign Currency For the Company and its subsidiaries, the functional currency has been determined to be the U.S. Dollar (USD). Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in SG&A in the Consolidated Statements of Operations. |
Derivatives and Hedging Activities | Derivatives and Hedging Activities The Company uses forward foreign currency exchange contracts (forward 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 USD, primarily the Euro. The Company designates certain of these forward contracts as hedging instruments and enters into some forward contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward 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 USD. To receive hedge accounting treatment, cash flow hedges must be highly effective in offsetting changes to expected future cash flows on hedged transactions. The Company does not hold or issue derivative instruments for trading or speculative purposes. The Company accounts for its derivative instruments as either assets or liabilities on the balance sheet and measures them at fair value, which is estimated using current exchange rates and interest rates, and takes into consideration the current creditworthiness of the counterparties or the Company, as applicable. For derivative instruments that hedge the exposure to variability in expected future cash flows that are designated as cash flow hedges, the effective portion of the gain or loss is reported as a component of AOCI in shareholders’ equity and reclassified to earnings in the same period or periods during which the hedged transaction affects earnings. The ineffective portion of the gain or loss on the derivative instrument, if any, is recognized in earnings in the current period. Derivatives that are not designated as hedging instruments are adjusted to fair value through earnings in Operating Expenses in the Consolidated Statements of Operations. See Note 4 to these Consolidated Financial Statements for further discussion on the Company’s adoption of Accounting Standards Update (ASU) No. 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities that are required to be recorded at fair value, the Company considers the principal or most advantageous market in which the Company would transact and the market-based risk measurements or assumptions that market participants would use to price the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. The Company’s fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs) • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities that are not active, or inputs other than quoted process that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs) • Unobservable inputs that reflect estimates and assumptions (Level 3 inputs) The Company’s Level 2 instruments 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. The Company’s Level 3 financial assets and liabilities include intangible assets and contingent consideration resulting from business acquisitions. The estimated fair value of long-lived and indefinite-lived intangible assets and contingent consideration are measured by applying a probability-based income approach utilizing an appropriate discount rate as of the acquisition date. Key assumptions used by management to estimate the fair value of contingent consideration include estimated probabilities, the estimated timing of when a milestone may be attained and assumed discount periods and rates. Changes in the fair value of the contingent consideration can result from changes to one or more inputs, including the estimated probability with respect to regulatory approval, changes in the assumed timing of when milestones are likely to be achieved and changes in assumed discount periods and rates. Contingent consideration is remeasured on a recurring basis and resulting changes in the fair value, due to the revision of key assumptions, are recorded in Intangible Asset Amortization and Contingent Consideration in the Company’s Consolidated Statements of Operations. The Company’s Level 3 instruments also include asset retirement obligation liabilities, and corresponding capital assets, which are measured at the estimated fair value of the obligation, when estimable, on a non-recurring basis. In subsequent periods, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciates each retirement obligation asset, both over the term of the associated lease agreement. See Notes 5, 10, 11 and 12 to these Consolidated Financial Statements for further information on the nature of these financial instruments. |
Segment Information | Segment Information The Company currently operates in one segment focused on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. A single management team reports to the chief operating decision maker who comprehensively manages the entire business. All products are included in one operating segment because the majority 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. The Company is not organized by market and is managed and operated as one business. The Company does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Company does not accumulate discrete financial information with respect to separate products, other than revenues, cost of sales and certain other operating expenses. |
Acquisitions | Acquisitions Acquisitions of businesses are accounted for using the acquisition method of accounting. The Company allocates the purchase price of acquired businesses to the tangible and intangible assets acquired and liabilities assumed based upon their estimated fair values on the acquisition date. The purchase price allocation process requires management to make significant estimates and assumptions, especially at the acquisition date with respect to intangible assets and IPR&D. There were no acquisitions or business combinations in the periods presented. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule Of Property, Plant And Equipment Estimated Useful Lives | Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 5 years Office furniture and equipment 5 years Vehicles 5 years Land improvements 10 years Land Not applicable Construction-in-progress Not applicable |
RECENT ACCOUNTING PRONOUNCEME_2
RECENT ACCOUNTING PRONOUNCEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Summary of Adjustments to Accounts on Consolidated Balance Sheet, Comprehensive Loss Statements and Cash Flows Statement | The cumulative effect of applying the new guidance of ASC Topic 606 As Reported Adjustments Adjusted December 31, 2017 Aldurazyme (1) Tax Provision (2) January 1, 2018 Balance Sheet Assets: Accounts receivable, net $ 261,365 $ 26,012 $ — $ 287,377 Deferred tax assets $ 399,095 $ — $ (5,973 ) $ 393,122 Total assets $ 4,633,125 $ 26,012 $ (5,973 ) $ 4,653,164 Equity: Accumulated deficit $ (1,637,548 ) $ 26,012 $ (5,973 ) $ (1,617,509 ) Total liabilities and stockholders' equity $ 4,633,125 $ 26,012 $ (5,973 ) $ 4,653,164 (1) This adjustment represents management’s estimate of the variable consideration to be earned on worldwide sales of Aldurazyme by Genzyme in excess of the product transfer revenue previously recognized for Genzyme’s ending inventory at December 31, 2017. The product transfer revenue previously recognized as revenue represents the fixed amount per unit of Aldurazyme that Genzyme was required to pay the Company if the product was unsold by Genzyme. (2) The adoption of ASC Topic 606 primarily resulted in an acceleration of the variable consideration components of revenue as of December 31, 2017, which in turn generated additional deferred tax liabilities that ultimately reduced the Company's net deferred tax asset position. The tax provision amount has been calculated using the Company’s estimated statutory rate. The impact of adoption on the Company’s Consolidated Statement of Operations for the year ended December 31, 2018 was as follows: Before Adoption of ASC Topic 606 Adjustments (1) As Reported Net product revenues $ 1,450,154 $ 20,202 $ 1,470,356 Provision for (benefit from) income taxes $ (70,132 ) $ 4,638 $ (65,494 ) Net loss $ (92,775 ) $ 15,564 $ (77,211 ) (1) The adoption of ASC Topic 606 resulted in additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced the Company’s benefit from income taxes. The benefit from income taxes amount has been calculated using the Company’s estimated statutory rate. The impact of adoption on the Company’s Consolidated Statement of Cash Flows for the year ended December 31, 2018 was as follows: Before Adoption of ASC Topic 606 Adjustments (1) As Reported Net loss $ (92,775 ) $ 15,564 $ (77,211 ) Deferred income taxes $ (73,016 ) $ 4,638 $ (68,378 ) Changes in operating assets and liabilities: Accounts receivable, net $ (74,476 ) $ (20,202 ) $ (54,274 ) Net cash used in operating activities $ 20,208 $ — $ 20,208 (1) The adoption of ASC Topic 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced net Deferred Tax Assets. The amount of deferred income taxes has been calculated using the Company’s estimated statutory rate. |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Cash Cash Equivalents and Available-for-Sale Securities by Significant Investment Category | The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of December 31, 2018 and 2017, respectively: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 228,809 $ — $ — $ 228,809 $ 228,809 $ — $ — Level 2: Money market instruments 205,736 — — 205,736 205,736 — — Corporate debt securities 564,852 214 (2,288 ) 562,778 2,000 376,545 184,233 Commercial paper 77,702 — — 77,702 21,964 55,738 — U.S. government agency securities 240,436 144 (697 ) 239,883 31,474 156,967 51,442 Foreign and other 5,126 139 (1 ) 5,264 3,999 1,076 189 Subtotal 1,093,852 497 (2,986 ) 1,091,363 265,173 590,326 235,864 Total $ 1,322,661 $ 497 $ (2,986 ) $ 1,320,172 $ 493,982 $ 590,326 $ 235,864 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 340,253 $ — $ — $ 340,253 $ 340,253 $ — $ — Level 2: Money market instruments 215,441 — — 215,441 215,441 — — Corporate debt securities 707,652 150 (2,553 ) 705,249 3,096 406,188 295,965 Commercial paper 24,566 — — 24,566 2,751 21,815 — U.S. government agency securities 472,593 — (1,975 ) 470,618 35,497 345,501 89,620 Foreign and other 25,540 150 (64 ) 25,626 990 24,436 200 Subtotal 1,445,792 300 (4,592 ) 1,441,500 257,775 797,940 385,785 Total $ 1,786,045 $ 300 $ (4,592 ) $ 1,781,753 $ 598,028 $ 797,940 $ 385,785 (1) (2) |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: December 31, 2018 2017 Intangible assets: Finite-lived intangible assets $ 307,995 $ 303,298 Indefinite-lived intangible assets 326,359 326,359 Gross intangible assets: 634,354 629,657 Less: Accumulated amortization (142,546 ) (112,147 ) Net carrying value $ 491,808 $ 517,510 |
Schedule of Net-Book-Value and Estimated Remaining Life of Finite-Lived Intangible Assets | The following table summarizes the net-book-value and estimated remaining life of the Company’s finite-lived intangible assets as of December 31, 2018: Net Balance Average Remaining Life Acquired intellectual property $ 126,202 6.4 years Repurchased royalty rights 33,188 4.9 years Other (1) 6,059 2.2 - 5.6 years Total $ 165,449 (1) Other finite-lived intangible assets includes an asset that has not yet commenced amortizing. |
Schedule of Future Amortization Expense of Finite-Lived Intangible Assets | As of December 31, 2018, the estimated future amortization expense associated with the Company’s finite-lived intangible assets was as follows: Fiscal Year Amount 2019 $ 30,086 2020 27,605 2021 26,681 2022 26,657 2023 26,029 Thereafter 28,391 $ 165,449 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property Plant and Equipment Net | Property, plant and equipment, net, consisted of the following: December 31, 2018 2017 Building and improvements $ 694,447 $ 663,347 Manufacturing and laboratory equipment 345,947 294,521 Computer hardware and software 157,787 144,268 Leasehold improvements 41,188 42,572 Furniture and equipment 33,234 31,515 Land improvements 6,551 5,331 Land 77,993 62,369 Construction-in-progress 64,170 59,511 1,421,317 1,303,434 Accumulated depreciation (472,635 ) (406,734 ) Total property, plant and equipment, net $ 948,682 $ 896,700 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule Of Inventory | Inventory consisted of the following: December 31, 2018 2017 Raw materials $ 74,616 $ 49,877 Work-in-process 231,064 234,674 Finished goods 225,191 191,224 Total inventory $ 530,871 $ 475,775 |
SUPPLEMENTAL BALANCE SHEET IN_2
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities consisted of the following: December 31, 2018 2017 Accounts payable and accrued operating expenses $ 207,620 $ 166,616 Accrued compensation expense 149,937 140,781 Accrued rebates payable 43,116 36,472 Accrued royalties payable 19,977 18,820 Value added taxes payable 7,785 9,740 Forward foreign currency exchange contracts 4,178 14,464 Other 4,677 15,028 Total accounts payable and accrued liabilities $ 437,290 $ 401,921 |
Schedule of Estimated Accrued Rebates and Reserve for Cash Discounts | The roll forward of significant estimated accrued rebates and reserve for cash discounts for the years ended December 31, 2018, 2017 and 2016 were as follows: Balance at Beginning of Period Provision for Current Period Sales Payments Balance at End of Period Year ended December 31, 2018: Accrued rebates $ 36,472 $ 67,843 $ (61,199 ) $ 43,116 Reserve for cash discounts 1,055 12,474 (12,332 ) 1,197 Year ended December 31, 2017: Accrued rebates $ 34,737 $ 52,596 $ (50,861 ) $ 36,472 Reserve for cash discounts 888 10,672 (10,505 ) 1,055 Year ended December 31, 2016: Accrued rebates $ 32,553 $ 39,142 $ (36,958 ) $ 34,737 Reserve for cash discounts 831 8,867 (8,810 ) 888 |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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 December 31, 2018 December 31, 2018 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 12,686 Accounts payable & accrued liabilities $ 4,036 Forward foreign currency exchange contracts Other assets 10,324 Other long- term liabilities 3,653 Total $ 23,010 $ 7,689 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 168 Accounts payable & accrued liabilities $ 142 Total 168 142 Total value of derivative contracts $ 23,178 $ 7,831 Asset Derivatives Liability Derivatives December 31, 2017 December 31, 2017 Balance Sheet Location Fair Value Balance Sheet Location Fair Value Derivatives designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 4,015 Accounts payable & accrued liabilities $ 14,420 Forward foreign currency exchange contracts Other assets 4,973 Other long- term liabilities 12,686 Total $ 8,988 $ 27,106 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets $ 675 Accounts payable & accrued liabilities $ 44 Total 675 44 Total value of derivative contracts $ 9,663 $ 27,150 (1) Se Not 3 t thes Consolidate Financia Statement fo additiona informatio relate t th Company’ fai value measurements. |
Effect of Derivative Instruments | The effect of the Company’s derivative instruments on the Consolidated Financial Statements for the years ended December 31, 2018, 2017 and 2016 was as follows: Years Ended December 31, 2018 2017 2016 Derivatives Designated as Hedging Instruments: Net gain (loss) recognized in AOCI (1) $ 25,386 $ (38,351 ) $ 9,677 Net gain (loss) reclassified from AOCI into earnings (2) (2,047 ) (5,113 ) 6,529 Net gain recognized in net loss (3) 8,901 2,576 5,070 Derivatives Not Designated as Hedging Instruments: Net gain (loss) recognized in net loss (4) $ (3,240 ) $ 8,255 $ (8,687 ) (1) Net change in the fair value of the effective portion classified as AOCI. (2) Effective portion classified as Net Product Revenues and Operating expenses. (3) Ineffective portion and amount excluded from effectiveness testing classified as Operating expense. (4) Classified as Operating expense. |
Derivatives Designated As Hedging Instruments | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company ’ Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Australian Dollars - Sell 12 5.1 Jan. 2019 - Jun. 2019 Brazilian Reais – Sell 4 61.0 May 2019 Canadian Dollars – Sell 12 14.9 Jan. 2019 - Jun. 2019 Colombian Pesos – Sell 6 53,300.0 Jan. 2019 - Jun. 2019 Euros – Purchase 147 170.1 Jan. 2019 - Sep. 2021 Euros – Sell 458 547.5 Jan. 2019 - Sep. 2021 Norwegian Krone - Sell 6 22.9 Jan. 2019 - Jun. 2019 Total 645 |
Not Designated as Hedging Instrument | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company ’ Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Colombian Pesos – Sell 1 55,000.0 February 2019 Euros – Purchase 3 57.2 February 2019 Ruble – Sell 1 310.0 February 2019 Total 5 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The Company measures certain financial assets and liabilities at fair value in accordance with its policy in Note 3 – Significant Accounting Policies Fair Value Measurements at December 31, 2018 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Other Current Assets: NQDC Plan assets — 370 — 370 Restricted investments (1) — 9,581 — 9,581 Total other current assets — 9,951 — 9,951 Other Assets: NQDC Plan assets — 12,828 — 12,828 Restricted investments (1) — 2,450 — 2,450 Strategic investment (2) 942 — — 942 Total other assets 942 15,278 — 16,220 Total assets $ 942 $ 25,229 $ — $ 26,171 Liabilities: Current Liabilities: NQDC Plan liability $ 55 $ 370 $ — $ 425 Contingent consideration — — 85,951 85,951 Total current liabilities 55 370 85,951 86,376 Other long-term liabilities: NQDC Plan liability 17,598 12,828 — 30,426 Contingent consideration — — 46,883 46,883 Total other long-term liabilities 17,598 12,828 46,883 77,309 Total liabilities $ 17,653 $ 13,198 $ 132,834 $ 163,685 Fair Value Measurements at December 31, 2017 Quoted Price in Active Markets For Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Other Current Assets: NQDC Plan assets — 967 — 967 Restricted investments (1) — 15,647 — 15,647 Total other current assets — 16,614 — 16,614 Other Assets: NQDC Plan assets — 11,859 — 11,859 Total other assets — 11,859 — 11,859 Total assets $ — $ 28,473 $ — $ 28,473 Liabilities: Current Liabilities: NQDC Plan liability $ 1,356 $ 967 $ — $ 2,323 Contingent consideration — — 53,648 53,648 Total current liabilities 1,356 967 53,648 55,971 Other long-term liabilities: NQDC Plan liability 18,272 11,859 — 30,131 Contingent consideration — — 135,318 135,318 Total other long-term liabilities 18,272 11,859 135,318 165,449 Total liabilities $ 19,628 $ 12,826 $ 188,966 $ 221,420 (1) The restricted investments at December 31, 2018 and 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. (2) The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments and included in other assets on the Company’s Balance Sheets. |
Liabilities Measured at Fair Value Using Level 3 Inputs | Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration and asset retirement obligations. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2017 $ 188,966 Milestone payments to Ares Trading S.A. (Merck Serono) (61,607 ) Milestone payments to former LEAD Therapeutics, Inc. shareholders (9,013 ) Changes in the fair value of other contingent consideration 18,525 Foreign exchange remeasurement of Euro denominated contingent acquisition consideration (4,037 ) Contingent consideration as of December 31, 2018 $ 132,834 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Senior Subordinated Convertible Obligations | The Notes are senior subordinated convertible obligations, summarized as of December 31, as follows: 2018 2017 0.75% senior subordinated convertible notes due October 2018 (the 2018 Notes) $ — $ 374,980 Unamortized discount — (12,488 ) Unamortized deferred offering costs — (1,543 ) Convertible Notes due 2018, net — 360,949 1.50% senior subordinated convertible notes due in October 2020 (the 2020 Notes) 374,993 374,993 Unamortized discount (26,581 ) (40,287 ) Unamortized deferred offering costs (2,334 ) (3,631 ) Convertible Notes due 2020, net 346,078 331,075 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount (7,946 ) (9,355 ) Unamortized deferred offering costs (2,715 ) (3,199 ) Convertible Notes due in 2024, net 484,339 482,446 Total convertible debt, net $ 830,417 $ 1,174,470 Fair value of fixed rate convertible debt Convertible Notes due in 2018 (1) $ — $ 403,955 Convertible Notes due in 2020 (1) 419,722 446,470 Convertible Notes due in 2024 (1) 491,626 493,894 Total $ 911,348 $ 1,344,319 (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. See Note 3 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Summary of Interest Expense on Debt | Interest expense on the Company’s debt consisted of the following: Years Ended December 31, 2018 2017 2016 Coupon interest $ 12,452 $ 10,407 $ 9,555 Amortization of debt issuance costs 3,610 3,725 3,367 Accretion of discount on convertible notes 27,602 28,575 26,577 Total interest expense on convertible debt $ 43,664 $ 42,707 $ 39,499 |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings per Common Share | The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Years Ended December 31, 2018 2017 2016 Numerator: Net loss, basic $ (77,211 ) $ (117,042 ) $ (630,210 ) Less: gain on common stock held by the NQDC (710 ) — (3,184 ) Net loss, diluted (77,921 ) (117,042 ) (633,394 ) Denominator: Weighted-average common shares outstanding, basic 177,061 174,427 165,985 Effect of dilutive securities: Common stock held by the NQDC 207 — 234 Weighted-average common shares outstanding, diluted 177,268 174,427 166,219 Net loss per common share, basic $ (0.44 ) $ (0.67 ) $ (3.80 ) Net loss per common share, diluted $ (0.44 ) $ (0.67 ) $ (3.81 ) |
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): Years Ended December 31, 2018 2017 2016 Options to purchase common stock 7,364 8,108 8,856 Common stock issuable under the 2017 Notes — — 1,105 Common stock issuable under the 2018 Notes — 3,983 3,983 Common stock issuable under the 2020 Notes 3,983 3,983 3,983 Common stock issuable under the 2024 Notes 3,970 3,970 — Unvested restricted stock units 3,404 2,911 2,618 Common stock potentially issuable for ESPP purchases 435 436 404 Common stock held by the NQDC — 220 — Total number of potentially issuable shares 19,156 23,611 20,949 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for (Benefit from) Income Taxes Based on Loss Before Income Taxes | The provision for (benefit from) income taxes is based on loss before income taxes as follows: Years Ended December 31, 2018 2017 2016 U.S. Source $ (128,700 ) $ (19,461 ) $ 10,696 Non-U.S. Source (14,005 ) (16,414 ) (841,746 ) Loss before income taxes $ (142,705 ) $ (35,875 ) $ (831,050 ) |
Schedule of Components of Provision for (Benefit From) Income Taxes | The U.S. and foreign components of the provision for (benefit from) income taxes are as follows: Years Ended December 31, 2018 2017 2016 Provision for (benefit from) current income tax expense: Federal $ (2,660 ) $ 29,848 $ 22,239 State and local 588 2,880 1,418 Foreign 4,956 3,975 3,557 2,884 36,703 27,214 Provision for (benefit from) deferred income taxes: Federal (72,074 ) 12,446 (78,428 ) State and local (994 ) 32,336 (6,012 ) Foreign 4,690 (318 ) (143,614 ) (68,378 ) 44,464 (228,054 ) Provision for (benefit from) income taxes $ (65,494 ) $ 81,167 $ (200,840 ) |
Schedule of Reconciliation of Statutory Federal Income Tax Rate to Company's Effective Income Tax Rate | The following is a reconciliation of the statutory federal income tax rate to the Company’s effective income tax rate: Years Ended December 31, 2018 2017 2016 Federal statutory income tax rate $ (29,968 ) $ (12,556 ) $ (290,867 ) State and local taxes (276 ) 7,282 (2,978 ) Orphan Drug & General Business Credit (66,451 ) (33,683 ) (62,041 ) Stock compensation expense (5,647 ) (6,843 ) (38,263 ) Changes in the fair value of contingent consideration (2,361 ) 1,099 (7,616 ) Subpart F income 6,543 30,181 — Foreign tax rate differential 12,583 9,403 154,553 Section 162(m) limitation 7,440 9,492 45,056 Tax Cuts and Jobs Act of 2017 — 42,338 — Tax Reserves 8,545 2,262 2,294 Other (422 ) (2,938 ) (5,133 ) Valuation allowance/deferred benefit 4,521 35,132 4,155 Effective income tax rate $ (65,494 ) $ 81,167 $ (200,840 ) |
Schedule of Components of Net Deferred Tax Assets | The significant components of the Company’s net deferred tax assets are as follows: December 31, 2018 2017 Net deferred tax assets: Net operating loss carryforwards $ 42,007 $ 48,374 Tax credit carryforwards 466,066 384,381 Accrued expenses, reserves, and prepaids 55,041 54,565 Intangible assets 18,734 17,556 Stock-based compensation 35,966 31,371 Inventory 12,859 13,206 Other 278 4,967 Valuation allowance (107,928 ) (111,001 ) Total deferred tax assets 523,023 443,419 Joint venture basis difference (1,010 ) (1,229 ) Acquired intangibles (6,508 ) (3,332 ) Deferred revenue (4,480 ) — Convertible notes discount (5,157 ) (10,100 ) Property, plant and equipment (44,916 ) (29,663 ) Total deferred tax liabilities (62,071 ) (44,324 ) Net deferred tax assets $ 460,952 $ 399,095 |
Summary of Expiration of not Utilized Net Operating Loss and Tax Credit Carryforwards | As of December 31, 2018, the Company had the following net operating loss and tax credit carryforwards, which if not utilized, will expire as follows: Type Amount Year Federal net operating loss carryforwards $ 157,919 2028 – 2037 Federal R&D and orphan drug credit carryforwards $ 469,543 2030 – 2038 State net operating loss carryforwards $ 153,737 2019 – 2038 Dutch net operating loss carryforwards $ 118,225 2021 – 2025 |
Schedule of Reconciliation of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits for the years ended December 31, 2018 and 2017 is as follows: December 31, 2018 2017 Balance at beginning of period $ 113,486 $ 103,210 Additions based on tax positions related to the current year 30,811 11,042 (Deletions) Additions for tax positions of prior years 3,148 (766 ) Balance at end of period $ 147,445 $ 113,486 |
EQUITY COMPENSATION PLANS AND_2
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation Expense | Compensation expense included in the Company’s Consolidated Statements of Operations for all stock-based compensation arrangements was as follows: Years Ended December 31, 2018 2017 2016 Cost of sales $ 13,558 $ 10,636 $ 9,121 Research and development 57,557 53,112 58,279 Selling, general and administrative 77,704 76,515 67,241 Total stock-based compensation expense $ 148,819 $ 140,263 $ 134,641 |
Summary of Restricted Stock Unit Activity | Below is a summary of RSU activity under the plan for the year ended December 31, 2018: Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Years Aggregate Intrinsic Value Non-vested units as of December 31, 2017 2,679,534 $ 90.04 2.5 $ 238,934 Granted 1,681,120 $ 84.63 Vested (963,062 ) $ 89.53 Forfeited (250,069 ) $ 88.68 Non-vested units as of December 31, 2018 3,147,523 $ 87.42 2.6 $ 268,012 |
Summary of Stock Option Activity | The following table summarizes activity under the Company’s stock option plans, including the 2012 and 2014 Inducement Plans and those suspended upon the adoption of the 2017 Share Incentive Plan, for the year ended December 31, 2018. All option grants presented in the table had exercise prices not less than the fair value of the underlying common stock on the grant date: Shares Weighted Average Exercise Price Weighted Average Remaining Years Aggregate Intrinsic Value (1) Options outstanding as of December 31, 2017 8,107,981 $ 56.53 5.1 $ 281,141 Granted 782,240 $ 83.77 Exercised (1,456,274 ) $ 36.71 Expired and forfeited (70,338 ) $ 86.46 Options outstanding as of December 31, 2018 7,363,609 $ 63.06 5.1 $ 183,091 Options unvested at December 31, 2018 1,441,416 $ 85.75 8.6 $ 1,559 Exercisable at December 31, 2018 5,922,193 $ 57.57 4.2 $ 181,532 (1) The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the Nasdaq Global Select Market as of the last trading day for the respective year. The aggregate intrinsic value of options outstanding and exercisable includes options with an exercise price below $85.15, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2018. |
Stock Option Valuation Assumptions | The assumptions used to estimate the per share fair value of stock options granted during the periods presented were as follows: Years Ended December 31, 2018 2017 2016 Expected volatility 36.8 – 38.4% 37.6 – 39.7% 35.7 – 44.2% Dividend yield 0.00% 0.00% 0.00% Expected life 4.6 – 5.7 years 4.9 – 6.6 years 5.0 – 8.1 years Risk-free interest rate 2.3 – 2.8% 1.8 – 2.2% 1.1 – 2.3% |
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: Years Ended December 31, 2018 2017 2016 Expected volatility 29.7 – 35.0% 27.7 – 42.3% 41.5 – 49.7% Dividend yield 0.00% 0.00% 0.00% Expected life 6 – 24 months 6 – 24 months 6 – 24 months Risk-free interest rate 1.2 – 2.8% 1.0 – 1.6% 0.4 – 0.8% |
Summary of Restricted Stock Unit Awards with Performance Conditions | The following table details the base RSUs granted, RSUs earned and expected to vest and the performance multiplier achieved for the RSUs with performance-based vesting conditions for the years ended December 31, 2017, 2016 and 2015, respectively, as well as the base RSUs granted in March 2018: Compensation Expense for the Years Ended December 31, Date of Grant Base RSUs Granted Grant Date Fair Value per RSU Multiplier Achieved RSUs Earned 2018 2017 2016 March 2018 (1) 129,680 $ 83.57 (1) (1) $ 3,829 $ — $ — March 2017 (2) 133,250 $ 87.42 103 % 131,651 $ 3,446 $ 4,141 $ — March 2016 (2) 130,310 $ 83.43 103 % 134,219 $ 3,125 $ 3,928 $ 2,956 March 2015 (2) 58,300 $ 108.36 111 % 64,713 $ 340 $ 2,291 $ 2,342 (1) Based on the Company’s performance against the 2018 revenue target, the Company expects its Compensation Committee to approve a multiplier of 97.8% and the participating executive officers to earn 126,814 RSUs. The Company evaluated the 2018 revenue target in the context of its current 2018 revenue forecast, and related confidence level in the forecast, and determined that attainment of the revenue target was probable for accounting purposes commencing in the first quarter of 2018. (2) The RSUs with performance-based vesting conditions granted in 2015, 2016 and 2017 were earned on the one year anniversary upon achievement of the respective performance target and vest ratably over a three-year service period. |
COMPREHENSIVE INCOME (LOSS) (Ta
COMPREHENSIVE INCOME (LOSS) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Amounts Reclassified out of Accumulated Other Comprehensive Income | The following table summarizes amounts reclassified out of AOCI and their effect on the Company’s Consolidated Statements of Operations for the years ended December 31, 2018 and 2017. Years Ended December 31, Consolidated Statement of Details about AOCI Components 2018 2017 2016 Operations Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ (6,005 ) $ (5,377 ) $ 6,112 Net product revenues Forward foreign currency exchange contracts 3,958 264 4,161 Operating expenses Total gain (loss) on cash flow hedges (2,047 ) (5,113 ) 10,273 Gain (loss) on sale of available-for- sale debt securities — 3,252 (115 ) Other income, net Income tax effect of the above — (1,191 ) (42 ) Provision for (benefit from) income taxes Total gain (loss) on available-for-sale debt securities — 2,061 (157 ) $ (2,047 ) $ (3,052 ) $ 10,116 Net loss |
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI | The following table summarizes changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Gains and Losses on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Other Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (38,351 ) (755 ) 5 (39,101 ) Less: net gain (loss) reclassified from AOCI (5,113 ) 3,252 (1,861 ) Tax effect — 1,463 — 1,463 Net current-period other comprehensive loss (33,238 ) (2,544 ) 5 (35,777 ) AOCI balance at December 31, 2017 (20,232 ) (2,722 ) (7 ) (22,961 ) Impact of change in accounting principle (1) — (586 ) — (586 ) AOCI balance at January 1, 2018 (20,232 ) (3,308 ) (7 ) (23,547 ) Other comprehensive income (loss) before reclassifications 25,386 1,804 (6 ) 27,184 Less: loss reclassified from AOCI (2,047 ) — — (2,047 ) Tax effect — (413 ) — (413 ) Net current-period other comprehensive income (loss) 27,433 1,391 (6 ) 28,818 AOCI balance at December 31, 2018 $ 7,201 $ (1,917 ) $ (13 ) $ 5,271 (1) As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from AOCI to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion. |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Concentration Risk And Geographic Information [Abstract] | |
Disaggregates of Total Revenues from External Customers and Collaborative Partners by Geographic Region | The following table disaggregates 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. 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 is located in the U.S. Years Ended December 31, 2018 2017 2016 Total revenues by geographic region: United States $ 696,793 $ 588,243 $ 507,539 Europe 436,434 398,814 340,775 Latin America 185,046 181,970 147,474 Rest of world 172,939 144,619 121,066 Total revenues $ 1,491,212 $ 1,313,646 $ 1,116,854 |
Disaggregates of Total Net Product Revenues from External Customers by Product | The following table disaggregates total Net Product Revenues from external customers by product. Years Ended December 31, 2018 2017 2016 Net product revenues by product: Aldurazyme $ 135,097 $ 89,959 $ 93,749 Brineura 39,889 8,595 — Firdapse 21,787 18,890 18,028 Kuvan 433,582 407,542 348,009 Naglazyme 345,851 332,208 296,537 Palynziq 12,173 — — Vimizim 481,977 413,251 354,058 Total net product revenues $ 1,470,356 $ 1,270,445 $ 1,110,381 |
Disaggregates of Total Net Product Revenues Based on Patient Location | The table below disaggregates total Net Product Revenues based on patient location for products sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Genzyme is the Company’s sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Years Ended December 31, 2018 2017 2016 Region: United States $ 560,030 $ 495,741 $ 411,877 Europe 424,357 363,538 340,775 Latin America 184,984 181,963 147,474 Rest of world 165,888 139,244 116,506 Total net product revenues marketed by the Company 1,335,259 1,180,486 1,016,632 Aldurazyme net product revenues marketed by Genzyme 135,097 89,959 93,749 Total net product revenue $ 1,470,356 $ 1,270,445 $ 1,110,381 |
Total Net Product Revenue Concentrations Attributed to Largest Customers | The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers. For the Years Ended December 31, 2018 2017 2016 Customer A 18 % 18 % 19 % Customer B 12 % 14 % 13 % Customer C 10 % 10 % 10 % Total 40 % 42 % 42 % |
Summary of Non-Monetary Long-Lived Assets by Geographic Region | The following table summarizes non-monetary long-lived assets by geographic region. Non-monetary long-lived assets primarily consist of property, plant and equipment, intangible assets, deferred tax assets and goodwill. December 31, 2018 2017 Long-lived assets by geography: United States $ 1,719,733 $ 1,653,944 Ireland 220,878 198,781 Rest of world 158,583 158,530 Total long-lived assets $ 2,099,194 $ 2,011,255 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Minimum Lease Payments for Future Years | Minimum lease payments for future years are as follows: 2019 $ 12,976 2020 12,549 2021 11,198 2022 10,574 2023 9,993 Thereafter 27,701 Total $ 84,991 |
Schedule of Property Plant and
Schedule of Property Plant and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2018 | |
Leasehold Improvements | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | Shorter of life of asset or lease term |
Building and Improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 20 years |
Building and Improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 50 years |
Manufacturing and Laboratory Equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Manufacturing and Laboratory Equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 15 years |
Computer Hardware and Software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 3 years |
Computer Hardware and Software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Office Furniture and Equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Vehicles | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Land Improvements | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 10 years |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Significant Accounting Policies [Line Items] | |||
Goodwill, impairment charges | $ | $ 0 | $ 0 | $ 599,118,000 |
Number of reportable segment | 1 | ||
Number of operating segments | 1 | ||
Aldurazyme | Minimum | |||
Significant Accounting Policies [Line Items] | |||
Payment received as percentage of net product sales | 39.50% | ||
Aldurazyme | Maximum | |||
Significant Accounting Policies [Line Items] | |||
Payment received as percentage of net product sales | 50.00% |
Recent Accounting Pronounceme_3
Recent Accounting Pronouncements - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
ASU 2016-02 | Scenario Forecast | ||
Recent Accounting Pronouncements [Line Items] | ||
Lease liability | $ 60 | |
ASU 2018-02 | ||
Recent Accounting Pronouncements [Line Items] | ||
Reclassification from AOCI to accumulated deficit | $ 0.6 |
Recent Accounting Pronounceme_4
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | |
ASSETS | ||||
Accounts receivable, net | $ 342,633 | $ 261,365 | ||
Deferred tax assets | 460,952 | 399,095 | ||
Total assets | 4,427,128 | 4,633,125 | ||
Equity: | ||||
Accumulated deficit | (1,694,134) | (1,637,548) | ||
Total liabilities and stockholders' equity | $ 4,427,128 | $ 4,633,125 | ||
ASC 606 | ||||
ASSETS | ||||
Accounts receivable, net | $ 287,377 | |||
Deferred tax assets | 393,122 | |||
Total assets | 4,653,164 | |||
Equity: | ||||
Accumulated deficit | (1,617,509) | |||
Total liabilities and stockholders' equity | 4,653,164 | |||
Adjustments | ASC 606 | Tax Provision | ||||
ASSETS | ||||
Accounts receivable, net | [1] | 0 | ||
Deferred tax assets | [1] | (5,973) | ||
Total assets | [1] | (5,973) | ||
Equity: | ||||
Accumulated deficit | [1] | (5,973) | ||
Total liabilities and stockholders' equity | [1] | (5,973) | ||
Adjustments | ASC 606 | Aldurazyme | ||||
ASSETS | ||||
Accounts receivable, net | [2] | 26,012 | ||
Deferred tax assets | [2] | 0 | ||
Total assets | [2] | 26,012 | ||
Equity: | ||||
Accumulated deficit | [2] | 26,012 | ||
Total liabilities and stockholders' equity | [2] | $ 26,012 | ||
[1] | The adoption of ASC Topic 606 primarily resulted in an acceleration of the variable consideration components of revenue as of December 31, 2017, which in turn generated additional deferred tax liabilities that ultimately reduced the Company's net deferred tax asset position. The tax provision amount has been calculated using the Company’s estimated statutory rate. | |||
[2] | This adjustment represents management’s estimate of the variable consideration to be earned on worldwide sales of Aldurazyme by Genzyme in excess of the product transfer revenue previously recognized for Genzyme’s ending inventory at December 31, 2017. The product transfer revenue previously recognized as revenue represents the fixed amount per unit of Aldurazyme that Genzyme was required to pay the Company if the product was unsold by Genzyme. |
Recent Accounting Pronounceme_5
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Consolidated Statements of Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 | |
Provision for (benefit from) income taxes | (65,494) | 81,167 | (200,840) | |
Net loss | (77,211) | (117,042) | (630,210) | |
Net Product Revenues | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | 1,470,356 | $ 1,270,445 | $ 1,110,381 | |
Before Adoption of ASC Topic 606 | ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Provision for (benefit from) income taxes | (70,132) | |||
Net loss | (92,775) | |||
Before Adoption of ASC Topic 606 | ASC 606 | Net Product Revenues | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | 1,450,154 | |||
Adjustments | ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Provision for (benefit from) income taxes | [1] | 4,638 | ||
Net loss | [1],[2] | 15,564 | ||
Adjustments | ASC 606 | Net Product Revenues | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | [1] | $ 20,202 | ||
[1] | The adoption of ASC Topic 606 resulted in additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced the Company’s benefit from income taxes. The benefit from income taxes amount has been calculated using the Company’s estimated statutory rate. | |||
[2] | The adoption of ASC Topic 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced net Deferred Tax Assets. The amount of deferred income taxes has been calculated using the Company’s estimated statutory rate. |
Recent Accounting Pronounceme_6
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Consolidated Statement of Cash Flows (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | $ (77,211) | $ (117,042) | $ (630,210) | |
Deferred income taxes | (68,378) | 44,464 | (228,054) | |
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | (54,274) | $ (25,256) | $ (51,483) | |
Net cash used in operating activities | 20,208 | |||
Before Adoption of ASC Topic 606 | ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | (92,775) | |||
Deferred income taxes | (73,016) | |||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | (74,476) | |||
Net cash used in operating activities | 20,208 | |||
Adjustments | ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | [1],[2] | 15,564 | ||
Deferred income taxes | [2] | 4,638 | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | [2] | (20,202) | ||
Net cash used in operating activities | [2] | $ 0 | ||
[1] | The adoption of ASC Topic 606 resulted in additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced the Company’s benefit from income taxes. The benefit from income taxes amount has been calculated using the Company’s estimated statutory rate. | |||
[2] | The adoption of ASC Topic 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in 2018, which in turn generated additional deferred tax liabilities that reduced net Deferred Tax Assets. The amount of deferred income taxes has been calculated using the Company’s estimated statutory rate. |
Schedule of Cash, Cash Equivale
Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | $ 1,322,661 | $ 1,786,045 | |||
Gross Unrealized Gains | 497 | 300 | |||
Gross Unrealized Losses | (2,986) | (4,592) | |||
Aggregate Fair Value | 1,320,172 | 1,781,753 | |||
Cash and Cash Equivalents | 493,982 | 598,028 | $ 408,330 | $ 397,040 | |
Short-term Marketable Securities | [1] | 590,326 | 797,940 | ||
Long-term Marketable Securities | [2] | 235,864 | 385,785 | ||
Level 1 | Cash | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Cash | 228,809 | 340,253 | |||
Gross Unrealized Gains | 0 | 0 | |||
Gross Unrealized Losses | 0 | 0 | |||
Cash and Cash Equivalents | 228,809 | 340,253 | |||
Short-term Marketable Securities | [1] | 0 | 0 | ||
Long-term Marketable Securities | [2] | 0 | 0 | ||
Level 2 | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 1,093,852 | 1,445,792 | |||
Gross Unrealized Gains | 497 | 300 | |||
Gross Unrealized Losses | (2,986) | (4,592) | |||
Aggregate Fair Value | 1,091,363 | 1,441,500 | |||
Cash and Cash Equivalents | 265,173 | 257,775 | |||
Short-term Marketable Securities | [1] | 590,326 | 797,940 | ||
Long-term Marketable Securities | [2] | 235,864 | 385,785 | ||
Level 2 | Corporate Debt Securities | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 564,852 | 707,652 | |||
Gross Unrealized Gains | 214 | 150 | |||
Gross Unrealized Losses | (2,288) | (2,553) | |||
Aggregate Fair Value | 562,778 | 705,249 | |||
Cash and Cash Equivalents | 2,000 | 3,096 | |||
Short-term Marketable Securities | [1] | 376,545 | 406,188 | ||
Long-term Marketable Securities | [2] | 184,233 | 295,965 | ||
Level 2 | Commercial Paper | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 77,702 | 24,566 | |||
Gross Unrealized Gains | 0 | 0 | |||
Gross Unrealized Losses | 0 | 0 | |||
Aggregate Fair Value | 77,702 | 24,566 | |||
Cash and Cash Equivalents | 21,964 | 2,751 | |||
Short-term Marketable Securities | [1] | 55,738 | 21,815 | ||
Long-term Marketable Securities | [2] | 0 | 0 | ||
Level 2 | U.S. Government Agency Securities | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 240,436 | 472,593 | |||
Gross Unrealized Gains | 144 | 0 | |||
Gross Unrealized Losses | (697) | (1,975) | |||
Aggregate Fair Value | 239,883 | 470,618 | |||
Cash and Cash Equivalents | 31,474 | 35,497 | |||
Short-term Marketable Securities | [1] | 156,967 | 345,501 | ||
Long-term Marketable Securities | [2] | 51,442 | 89,620 | ||
Level 2 | Money Market Instruments | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 205,736 | 215,441 | |||
Gross Unrealized Gains | 0 | 0 | |||
Gross Unrealized Losses | 0 | 0 | |||
Aggregate Fair Value | 205,736 | 215,441 | |||
Cash and Cash Equivalents | 205,736 | 215,441 | |||
Short-term Marketable Securities | [1] | 0 | 0 | ||
Long-term Marketable Securities | [2] | 0 | 0 | ||
Level 2 | Foreign and Other | |||||
Schedule of Available-for-sale Securities [Line Items] | |||||
Amortized Cost | 5,126 | 25,540 | |||
Gross Unrealized Gains | 139 | 150 | |||
Gross Unrealized Losses | (1) | (64) | |||
Aggregate Fair Value | 5,264 | 25,626 | |||
Cash and Cash Equivalents | 3,999 | 990 | |||
Short-term Marketable Securities | [1] | 1,076 | 24,436 | ||
Long-term Marketable Securities | [2] | $ 189 | $ 200 | ||
[1] | The Company’s short-term marketable securities mature in one year or less. | ||||
[2] | The Company’s long-term marketable securities mature between one and five years. |
Schedule of Cash, Cash Equiva_2
Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Parenthetical) (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Minimum | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Long-term marketable securities maturity period | 1 year | 1 year |
Maximum | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Short-term marketable securities maturity period | 1 year | 1 year |
Long-term marketable securities maturity period | 5 years | 5 years |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Investments Debt And Equity Securities [Abstract] | |
Other- than- temporary impairment | $ 0 |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Intangible assets: | ||
Finite-lived intangible assets | $ 307,995 | $ 303,298 |
Indefinite-lived intangible assets | 326,359 | 326,359 |
Gross intangible assets: | 634,354 | 629,657 |
Less: Accumulated amortization | (142,546) | (112,147) |
Net carrying value | $ 491,808 | $ 517,510 |
Schedule of Net-Book-Value and
Schedule of Net-Book-Value and Estimated Remaining Life of Finite-Lived Intangible Assets (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($) | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Balance | $ 165,449 | |
Acquired intellectual property | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Balance | $ 126,202 | |
Average Remaining Life | 6 years 4 months 24 days | |
Repurchased royalty rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Balance | $ 33,188 | |
Average Remaining Life | 4 years 10 months 24 days | |
Other | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Balance | $ 6,059 | [1] |
Other | Minimum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Average Remaining Life | 2 years 2 months 12 days | [1] |
Other | Maximum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Average Remaining Life | 5 years 7 months 6 days | [1] |
[1] | Other finite-lived intangible assets includes an asset that has not yet commenced amortizing. |
Schedule of Future Amortization
Schedule of Future Amortization Expense of Finite-Lived Intangible Assets (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Goodwill And Intangible Assets Disclosure [Abstract] | |
2,019 | $ 30,086 |
2,020 | 27,605 |
2,021 | 26,681 |
2,022 | 26,657 |
2,023 | 26,029 |
Thereafter | 28,391 |
Finite-lived intangible assets, net | $ 165,449 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Goodwill And Intangible Assets [Line Items] | ||||
Indefinite-lived intangible assets | $ 326,359,000 | $ 326,359,000 | $ 326,359,000 | |
Impairment charge | 0 | 0 | $ 599,118,000 | |
Proceeds from sale of intangible asset | 50,000,000 | 125,000,000 | 0 | |
Medivation | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Milestone Payments Received | 50,000,000 | |||
In Process Research and Development of Palynziq | Europe | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Indefinite-lived intangible assets | 326,400,000 | 326,400,000 | 326,400,000 | |
In Process Research and Development | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Impairment charge | $ 5,800,000 | |||
Rare Pediatric Disease Priority Review Voucher | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Proceeds from sale of intangible asset | $ 125,000,000 | |||
IPR&D of Kyndrisa and Other Exon | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Indefinite-lived intangible assets | $ 0 | |||
Impairment charge | 574,100,000 | |||
IPR&D of Reveglucosidase Alfa | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Impairment charge | $ 25,000,000 |
Schedule of Property Plant an_2
Schedule of Property Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,421,317 | $ 1,303,434 |
Accumulated depreciation | (472,635) | (406,734) |
Total property, plant and equipment, net | 948,682 | 896,700 |
Building and Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 694,447 | 663,347 |
Manufacturing and Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 345,947 | 294,521 |
Computer Hardware and Software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 157,787 | 144,268 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 41,188 | 42,572 |
Furniture and Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 33,234 | 31,515 |
Land Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 6,551 | 5,331 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 77,993 | 62,369 |
Construction-in-Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 64,170 | $ 59,511 |
Property Plant and Equipment -
Property Plant and Equipment - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expense | $ 90.4 | $ 75.8 | $ 73.2 |
Depreciation capitalized into inventory | $ 25.2 | $ 24.1 | $ 17.4 |
Schedule of Inventory (Detail)
Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 74,616 | $ 49,877 |
Work-in-process | 231,064 | 234,674 |
Finished goods | 225,191 | 191,224 |
Total inventory | $ 530,871 | $ 475,775 |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Condensed Financial Information Of Parent Company Only Disclosure [Abstract] | ||
Accounts payable and accrued operating expenses | $ 207,620 | $ 166,616 |
Accrued compensation expense | 149,937 | 140,781 |
Accrued rebates payable | 43,116 | 36,472 |
Accrued royalties payable | 19,977 | 18,820 |
Value added taxes payable | 7,785 | 9,740 |
Forward foreign currency exchange contracts | 4,178 | 14,464 |
Other | 4,677 | 15,028 |
Total accounts payable and accrued liabilities | $ 437,290 | $ 401,921 |
Schedule of Estimated Accrued R
Schedule of Estimated Accrued Rebates and Reserve for Cash Discounts (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accrued Rebates | |||
Supplemental Balance Sheet Information [Line Items] | |||
Balance at Beginning of Period | $ 36,472 | $ 34,737 | $ 32,553 |
Provision for Current Period Sales | 67,843 | 52,596 | 39,142 |
Payments | (61,199) | (50,861) | (36,958) |
Balance at End of Period | 43,116 | 36,472 | 34,737 |
Reserve for Cash Discount | |||
Supplemental Balance Sheet Information [Line Items] | |||
Balance at Beginning of Period | 1,055 | 888 | 831 |
Provision for Current Period Sales | 12,474 | 10,672 | 8,867 |
Payments | (12,332) | (10,505) | (8,810) |
Balance at End of Period | $ 1,197 | $ 1,055 | $ 888 |
Summary of Designated Forward F
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 12 Months Ended | |||||
Dec. 31, 2018AUD ($)Derivative | Dec. 31, 2018BRL (R$)Derivative | Dec. 31, 2018CAD ($)Derivative | Dec. 31, 2018COP ($)Derivative | Dec. 31, 2018EUR (€)Derivative | Dec. 31, 2018NOK (kr)Derivative | |
Maximum | ||||||
Derivative [Line Items] | ||||||
Maturity | Sep. 30, 2021 | |||||
Derivatives Designated As Hedging Instruments | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 645 | 645 | 645 | 645 | 645 | 645 |
Derivatives Designated As Hedging Instruments | Australian Dollars | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 12 | 12 | 12 | 12 | 12 | 12 |
Aggregate Notional Amount in Foreign Currency | $ | $ 5,100,000 | |||||
Derivatives Designated As Hedging Instruments | Australian Dollars | Minimum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Australian Dollars | Maximum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jun. 30, 2019 | |||||
Derivatives Designated As Hedging Instruments | Euros | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 458 | 458 | 458 | 458 | 458 | 458 |
Aggregate Notional Amount in Foreign Currency | € | € 547,500,000 | |||||
Derivatives Designated As Hedging Instruments | Euros | Purchase | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 147 | 147 | 147 | 147 | 147 | 147 |
Aggregate Notional Amount in Foreign Currency | € | € 170,100,000 | |||||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Purchase | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Sep. 30, 2021 | |||||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Purchase | ||||||
Derivative [Line Items] | ||||||
Maturity | Sep. 30, 2021 | |||||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 12 | 12 | 12 | 12 | 12 | 12 |
Aggregate Notional Amount in Foreign Currency | $ | $ 14,900,000 | |||||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Minimum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Maximum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jun. 30, 2019 | |||||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 6 | 6 | 6 | 6 | 6 | 6 |
Aggregate Notional Amount in Foreign Currency | $ | $ 53,300,000,000 | |||||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Minimum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Maximum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jun. 30, 2019 | |||||
Derivatives Designated As Hedging Instruments | Brazilian Reais | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 4 | 4 | 4 | 4 | 4 | 4 |
Aggregate Notional Amount in Foreign Currency | R$ | R$ 61000000 | |||||
Maturity | May 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Norwegian Krone | Sell | ||||||
Derivative [Line Items] | ||||||
Number of Contracts | 6 | 6 | 6 | 6 | 6 | 6 |
Aggregate Notional Amount in Foreign Currency | kr | kr 22,900,000 | |||||
Derivatives Designated As Hedging Instruments | Norwegian Krone | Minimum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jan. 31, 2019 | |||||
Derivatives Designated As Hedging Instruments | Norwegian Krone | Maximum | Sell | ||||||
Derivative [Line Items] | ||||||
Maturity | Jun. 30, 2019 |
Derivative Instruments and He_3
Derivative Instruments and Hedging Strategies - Additional Information (Detail) - Foreign Currency Derivatives $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Derivative [Line Items] | |
Amount reclassified from AOCI to earnings as related to forecasted revenue and operating expense transactions | $ 3.6 |
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 |
Maximum | |
Derivative [Line Items] | |
Maturity period of foreign currency derivatives | Sep. 30, 2021 |
Summary of Non-Designated Forwa
Summary of Non-Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) | 12 Months Ended | ||
Dec. 31, 2018COP ($)Derivative | Dec. 31, 2018EUR (€)Derivative | Dec. 31, 2018RUB (₽)Derivative | |
Foreign exchange contracts | Maximum | |||
Derivative [Line Items] | |||
Maturity | Sep. 30, 2021 | ||
Not Designated as Hedging Instrument | |||
Derivative [Line Items] | |||
Number of Contracts | 5 | 5 | 5 |
Not Designated as Hedging Instrument | Colombian Pesos | Foreign exchange contracts | Sell | |||
Derivative [Line Items] | |||
Number of Contracts | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | $ | $ 55,000,000,000 | ||
Maturity | Feb. 28, 2019 | ||
Not Designated as Hedging Instrument | Euros | Foreign exchange contracts | Purchase | |||
Derivative [Line Items] | |||
Number of Contracts | 3 | 3 | 3 |
Aggregate Notional Amount in Foreign Currency | € | € 57,200,000 | ||
Maturity | Feb. 28, 2019 | ||
Not Designated as Hedging Instrument | Ruble | Foreign exchange contracts | Sell | |||
Derivative [Line Items] | |||
Number of Contracts | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | ₽ | ₽ 310,000,000 | ||
Maturity | Feb. 28, 2019 |
Fair Value Carrying Amount of D
Fair Value Carrying Amount of Derivative Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | $ 23,178 | $ 9,663 |
Derivative Liability, Fair Value | [1] | 7,831 | 27,150 |
Derivatives Designated As Hedging Instruments | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 23,010 | 8,988 |
Derivative Liability, Fair Value | [1] | 7,689 | 27,106 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Current Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 12,686 | 4,015 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 10,324 | 4,973 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | |||
Derivative [Line Items] | |||
Derivative Liability, Fair Value | [1] | 4,036 | 14,420 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Long-Term Liabilities | |||
Derivative [Line Items] | |||
Derivative Liability, Fair Value | [1] | 3,653 | 12,686 |
Not Designated as Hedging Instrument | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 168 | 675 |
Derivative Liability, Fair Value | [1] | 142 | 44 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Current Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 168 | 675 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | |||
Derivative [Line Items] | |||
Derivative Liability, Fair Value | [1] | $ 142 | $ 44 |
[1] | See Note 3 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Effect of Derivative Instrument
Effect of Derivative Instruments (Detail) - Forward Foreign Currency Exchange Contracts - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||
Derivatives Designated As Hedging Instruments | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Net gain (loss) recognized in AOCI | [1] | $ 25,386 | $ (38,351) | $ 9,677 |
Net gain (loss) reclassified from AOCI into earnings | [2] | (2,047) | (5,113) | 6,529 |
Net gain (loss) recognized in net loss | [3] | 8,901 | 2,576 | 5,070 |
Not Designated as Hedging Instrument | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Net gain (loss) recognized in net loss | [4] | $ (3,240) | $ 8,255 | $ (8,687) |
[1] | Net change in the fair value of the effective portion classified as AOCI. | |||
[2] | Effective portion classified as Net Product Revenues and Operating expenses. | |||
[3] | Ineffective portion and amount excluded from effectiveness testing classified as Operating expense. | |||
[4] | Classified as Operating expense. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | $ 9,951 | $ 16,614 | |
Fair value of other non-current assets | 16,220 | 11,859 | |
Fair value of financial assets, Total | 26,171 | 28,473 | |
Fair value of other current liabilities | 86,376 | 55,971 | |
Fair value of other non-current liabilities | 77,309 | 165,449 | |
Fair value of financial liabilities, Total | 163,685 | 221,420 | |
Contingent Consideration | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 85,951 | 53,648 | |
Fair value of other non-current liabilities | 46,883 | 135,318 | |
NQDC Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 425 | 2,323 | |
Fair value of other non-current liabilities | 30,426 | 30,131 | |
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 other current assets | 0 | 0 | |
Fair value of other non-current assets | 942 | 0 | |
Fair value of financial assets, Total | 942 | 0 | |
Fair value of other current liabilities | 55 | 1,356 | |
Fair value of other non-current liabilities | 17,598 | 18,272 | |
Fair value of financial liabilities, Total | 17,653 | 19,628 | |
Quoted Price In Active Markets For Identical Assets (Level 1) | Contingent Consideration | |||
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 | |
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 | 55 | 1,356 | |
Fair value of other non-current liabilities | 17,598 | 18,272 | |
Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 9,951 | 16,614 | |
Fair value of other non-current assets | 15,278 | 11,859 | |
Fair value of financial assets, Total | 25,229 | 28,473 | |
Fair value of other current liabilities | 370 | 967 | |
Fair value of other non-current liabilities | 12,828 | 11,859 | |
Fair value of financial liabilities, Total | 13,198 | 12,826 | |
Significant Other Observable Inputs (Level 2) | Contingent Consideration | |||
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 | |
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 | 370 | 967 | |
Fair value of other non-current liabilities | 12,828 | 11,859 | |
Significant Unobservable Inputs (Level 3) | |||
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 of financial assets, Total | 0 | 0 | |
Fair value of other current liabilities | 85,951 | 53,648 | |
Fair value of other non-current liabilities | 46,883 | 135,318 | |
Fair value of financial liabilities, Total | 132,834 | 188,966 | |
Significant Unobservable Inputs (Level 3) | Contingent Consideration | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 85,951 | 53,648 | |
Fair value of other non-current liabilities | 46,883 | 135,318 | |
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 | |
Restricted Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 9,581 | 15,647 |
Fair value of other non-current assets | [1] | 2,450 | |
Restricted Investments | 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 other current assets | [1] | 0 | 0 |
Fair value of other non-current assets | [1] | 0 | |
Restricted Investments | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 9,581 | 15,647 |
Fair value of other non-current assets | [1] | 2,450 | |
Restricted Investments | Significant Unobservable Inputs (Level 3) | |||
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 | |
Strategic Investment | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [2] | 942 | |
Strategic Investment | 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 other non-current assets | [2] | 942 | |
Strategic Investment | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [2] | 0 | |
Strategic Investment | Significant Unobservable Inputs (Level 3) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other non-current assets | [2] | 0 | |
NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 370 | 967 | |
Fair value of other non-current assets | 12,828 | 11,859 | |
NQDC Plan Assets | 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 other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
NQDC Plan Assets | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 370 | 967 | |
Fair value of other non-current assets | 12,828 | 11,859 | |
NQDC Plan Assets | Significant Unobservable Inputs (Level 3) | |||
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 | |
[1] | The restricted investments at December 31, 2018 and 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. | ||
[2] | The Company has investments in marketable equity securities measured using quoted prices in an active market that are considered strategic investments and included in other assets on the Company’s Balance Sheets. |
Liabilities Measured at Fair Va
Liabilities Measured at Fair Value Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Contingent consideration, Beginning balance | $ 188,966 |
Changes in the fair value of other contingent consideration | 18,525 |
Foreign exchange remeasurement of Euro denominated contingent acquisition consideration | (4,037) |
Contingent consideration, Ending balance | 132,834 |
Merck Serono | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Milestone payments | (61,607) |
Lead Therapeutics, Inc | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Milestone payments | $ (9,013) |
Debt - Additional Information (
Debt - Additional Information (Detail) | Oct. 15, 2018USD ($)$ / sharesshares | Oct. 15, 2013USD ($)$ / shares | Oct. 31, 2018USD ($) | Aug. 31, 2017USD ($)$ / shares | Nov. 30, 2016USD ($) | Oct. 31, 2013USD ($) | Dec. 31, 2018USD ($)d$ / shares$ / Optionshares | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2016USD ($)$ / shares |
Debt Instrument [Line Items] | |||||||||
Carrying value of equity component | $ 870,000,000 | ||||||||
Debt conversion, principal cash settlement amount | 374,953,000 | $ 26,000 | $ 0 | ||||||
Convertible Notes due in 2024 | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of equity component | $ 495,000,000 | 495,000,000 | |||||||
Debt instrument, aggregate principal amount | $ 495,000,000 | ||||||||
Maturity date of convertible debt | Aug. 1, 2024 | ||||||||
Frequency of periodic payment | semi-annually in cash in arrears on February 1 and August 1 of each year | ||||||||
Interest payable beginning date | Feb. 1, 2018 | ||||||||
Debt instrument percentage of face value | 98.00% | ||||||||
Debt instrument, interest rate, stated percentage, per annum | 0.599% | 0.599% | |||||||
Conversion rate of shares | 8.0212 | ||||||||
Principal amount on conversion rate | $ 1,000,000 | ||||||||
Debt instrument, convertible, conversion price, per share | $ / shares | $ 124.67 | ||||||||
Net proceeds from offering debt | $ 481,700,000 | ||||||||
Repurchase of note principal amount | 100.00% | ||||||||
Debt issuance costs | $ 3,400,000 | ||||||||
Debt Instrument, unamortized discount | $ 9,900,000 | 7,946,000 | 9,355,000 | ||||||
Offering costs | 2,715,000 | $ 3,199,000 | |||||||
Convertible Notes due 2018 and due 2020 | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of equity component | $ 156,200,000 | ||||||||
Debt instrument, aggregate principal amount | $ 750,000,000 | ||||||||
Debt instrument, convertible, conversion price, per share | $ / shares | $ 94.15 | $ 94.15 | $ 94.15 | ||||||
Net proceeds from offering debt | 726,200,000 | ||||||||
Repurchase of note principal amount | 100.00% | ||||||||
Debt issuance costs | $ 23,800,000 | ||||||||
Common stock shares covered under capped call transactions | shares | 3,982,988 | ||||||||
Strike price | $ / Option | 94.15 | ||||||||
Cap price | $ / Option | 121.05 | ||||||||
Payment for capped calls transactions | $ 29,800,000 | ||||||||
Convertible Notes due 2018 and due 2020 | Convertible Senior Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt Instrument, unamortized discount | $ 161,300,000 | ||||||||
Offering costs | 5,100,000 | ||||||||
Convertible Notes due 2018 | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of equity component | $ 0 | $ 374,980,000 | |||||||
Debt instrument, aggregate principal amount | $ 375,000,000 | ||||||||
Maturity date of convertible debt | Oct. 15, 2018 | ||||||||
Debt instrument, interest rate, stated percentage, per annum | 0.75% | 0.75% | |||||||
Debt instrument, convertible, conversion price, per share | $ / shares | $ 94.15 | ||||||||
Debt Instrument, unamortized discount | $ 0 | 12,488,000 | |||||||
Debt conversion, principal cash settlement amount | $ 375,000,000 | ||||||||
Common stock, shares, issued to converting holders | shares | 190,220 | ||||||||
Debt Instrument, conversion price measuring average period | 25 days | ||||||||
Offering costs | 0 | 1,543,000 | |||||||
Common stock shares covered under capped call transactions | shares | 95,127 | ||||||||
Gain (loss) on extinguishment or termination of debt | $ 0 | ||||||||
Convertible Notes due 2020 | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of equity component | $ 374,993,000 | 374,993,000 | |||||||
Debt instrument, aggregate principal amount | $ 375,000,000 | ||||||||
Maturity date of convertible debt | Oct. 15, 2020 | ||||||||
Debt instrument, interest rate, stated percentage, per annum | 1.50% | 1.50% | |||||||
Conversion rate of shares | 10.6213 | ||||||||
Principal amount on conversion rate | $ 1,000 | ||||||||
Debt instrument, convertible, conversion price, per share | $ / shares | $ 94.15 | ||||||||
Debt Instrument, unamortized discount | $ 26,581,000 | 40,287,000 | |||||||
Common stock trading day | d | 20 | ||||||||
Consecutive common stock trading days | d | 30 | ||||||||
Debt instrument convertible threshold percentage | 130.00% | ||||||||
Number of business day period | 5 days | ||||||||
Trading price percentage on reported sale price of common stock | 98.00% | ||||||||
Offering costs | $ 2,334,000 | $ 3,631,000 | |||||||
2018 Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Common stock shares covered under capped call transactions, percentage | 50.00% | ||||||||
2020 Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Common stock shares covered under capped call transactions, percentage | 50.00% | ||||||||
The 2016 Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Gain (loss) on extinguishment or termination of debt | $ 0 | ||||||||
Maximum borrowing capacity | $ 200,000,000 | ||||||||
The 2016 Credit Facility | Revolving Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Maturity date of convertible debt | Nov. 29, 2018 | ||||||||
Maximum borrowing capacity | $ 100,000,000 | ||||||||
The 2016 Credit Facility | Letter of credit subfacility | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | 10,000,000 | ||||||||
The 2016 Credit Facility | Swingline loan subfacility | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | $ 15,000,000 | ||||||||
The 2018 Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Maturity date of convertible debt | Oct. 19, 2021 | ||||||||
To repay early, minimum required amount outstanding with certain other conditions have not been met | $ 100,000,000 | ||||||||
Maturity date of credit facility, if certain other conditions have not been met | Aug. 1, 2020 | ||||||||
Debt issuance costs | $ 1,000,000 | ||||||||
Outstanding amount | $ 0 | ||||||||
The 2018 Credit Facility | LIBOR Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate on deemed loan description | the LIBOR rate (except that if LIBOR is less than zero it shall be deemed to be zero for purposes of the 2018 Credit Facility) | ||||||||
The 2018 Credit Facility | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of commitment fees payable on undrawn amount | 0.15% | ||||||||
The 2018 Credit Facility | Minimum | LIBOR Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate percentage | 1.00% | ||||||||
The 2018 Credit Facility | Minimum | Base Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate percentage | 0.00% | ||||||||
The 2018 Credit Facility | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of commitment fees payable on undrawn amount | 0.35% | ||||||||
The 2018 Credit Facility | Maximum | LIBOR Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate percentage | 1.95% | ||||||||
The 2018 Credit Facility | Maximum | Base Rate | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate percentage | 0.95% |
Summary of Senior Subordinated
Summary of Senior Subordinated Convertible Obligations (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 31, 2017 | |
Debt Instrument [Line Items] | ||||
Convertible Notes | $ 870,000 | |||
Convertible Notes, net of unamortized discount and deferred offering costs | 0 | $ 360,949 | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 830,417 | 813,521 | ||
Total convertible debt, net | 830,417 | 1,174,470 | ||
Convertible Notes, fair value | 911,348 | 1,344,319 | ||
0.75% Senior Subordinated Convertible Notes Due in October 2018 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 0 | 374,980 | ||
Convertible debt, unamortized discount | 0 | (12,488) | ||
Convertible debt, Unamortized deferred offering costs | 0 | (1,543) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 0 | 360,949 | ||
Convertible Notes, fair value | [1] | 0 | 403,955 | |
1.50% Senior Subordinated Convertible Notes Due in October 2020 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 374,993 | 374,993 | ||
Convertible debt, unamortized discount | (26,581) | (40,287) | ||
Convertible debt, Unamortized deferred offering costs | (2,334) | (3,631) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 346,078 | 331,075 | ||
Convertible Notes, fair value | [1] | 419,722 | 446,470 | |
0.599% Senior Subordinated Convertible Notes Due in August 2024 | ||||
Debt Instrument [Line Items] | ||||
Convertible Notes | 495,000 | 495,000 | ||
Convertible debt, unamortized discount | (7,946) | (9,355) | $ (9,900) | |
Convertible debt, Unamortized deferred offering costs | (2,715) | (3,199) | ||
Convertible Notes, net of unamortized discount and deferred offering costs | 484,339 | 482,446 | ||
Convertible Notes, fair value | [1] | $ 491,626 | $ 493,894 | |
[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. See Note 3 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Summary of Senior Subordinate_2
Summary of Senior Subordinated Convertible Obligations (Parenthetical) (Detail) | Dec. 31, 2018 | Aug. 31, 2017 | Oct. 15, 2013 |
0.75% Senior Subordinated Convertible Notes Due in October 2018 | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 0.75% | 0.75% | |
1.50% Senior Subordinated Convertible Notes Due in October 2020 | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 1.50% | 1.50% | |
0.599% Senior Subordinated Convertible Notes Due in August 2024 | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, stated percentage | 0.599% | 0.599% |
Summary of Interest Expense on
Summary of Interest Expense on Debt (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule Of Interest Expenses [Line Items] | |||
Total interest expense on convertible debt | $ 43,664 | $ 42,707 | $ 39,499 |
Convertible Senior Notes | |||
Schedule Of Interest Expenses [Line Items] | |||
Coupon interest | 12,452 | 10,407 | 9,555 |
Amortization of debt issuance costs | 3,610 | 3,725 | 3,367 |
Accretion of discount on convertible notes | 27,602 | 28,575 | 26,577 |
Total interest expense on convertible debt | $ 43,664 | $ 42,707 | $ 39,499 |
Computation of Basic and Dilute
Computation of Basic and Diluted Earnings per Common Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |||
Net loss, basic | $ (77,211) | $ (117,042) | $ (630,210) |
Less: gain on common stock held by the NQDC | (710) | 0 | (3,184) |
Net loss, diluted | $ (77,921) | $ (117,042) | $ (633,394) |
Weighted-average common shares outstanding, basic | 177,061 | 174,427 | 165,985 |
Common stock held by the NQDC | 207 | 0 | 234 |
Weighted-average common shares outstanding, diluted | 177,268 | 174,427 | 166,219 |
Net loss per common share, basic | $ (0.44) | $ (0.67) | $ (3.80) |
Net loss per common share, diluted | $ (0.44) | $ (0.67) | $ (3.81) |
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 | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 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 | 19,156 | 23,611 | 20,949 |
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 | 7,364 | 8,108 | 8,856 |
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 | 0 | 1,105 |
Common stock issuable under the 2018 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 | 3,983 | 3,983 |
Common stock issuable under the 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 | 3,983 | 3,983 | 3,983 |
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 | 3,404 | 2,911 | 2,618 |
Common stock issuable under the 2024 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 | 3,970 | 3,970 | 0 |
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 | 435 | 436 | 404 |
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 | 0 | 220 | 0 |
Net Loss Per Common Share - Add
Net Loss Per Common Share - Additional Information (Detail) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Convertible Notes due 2018 and due 2020 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, convertible, conversion price, per share | $ 94.15 | $ 94.15 | $ 94.15 |
Provision for Benefit from Inco
Provision for Benefit from Income Taxes Based Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
U.S. Source | $ (128,700) | $ (19,461) | $ 10,696 |
Non-U.S. Source | (14,005) | (16,414) | (841,746) |
Loss before income taxes | $ (142,705) | $ (35,875) | $ (831,050) |
Components of Provision for (Be
Components of Provision for (Benefit from) Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Components Of Income Tax Expense Benefit Continuing Operations [Abstract] | |||
Federal | $ (2,660) | $ 29,848 | $ 22,239 |
State and local | 588 | 2,880 | 1,418 |
Foreign | 4,956 | 3,975 | 3,557 |
Current income tax expense, total | 2,884 | 36,703 | 27,214 |
Federal | (72,074) | 12,446 | (78,428) |
State and local | (994) | 32,336 | (6,012) |
Foreign | 4,690 | (318) | (143,614) |
Deferred income tax expense (benefit), total | (68,378) | 44,464 | (228,054) |
Provision for (benefit from) income taxes | $ (65,494) | $ 81,167 | $ (200,840) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Contingency [Line Items] | |||
Corporate income tax rate | 21.00% | 35.00% | |
Deferred income taxes | $ (68,378) | $ 44,464 | $ (228,054) |
Unrecognized tax benefits that would affect the effective tax rate if recognized | 147,400 | ||
Undistributed earnings of foreign subsidiaries | $ 11,500 | ||
Minimum | |||
Income Tax Contingency [Line Items] | |||
Income Tax Statute Of Limitations Period | 3 years | ||
Maximum | |||
Income Tax Contingency [Line Items] | |||
Income Tax Statute Of Limitations Period | 5 years | ||
Dutch | Kyndrisa | IPR&D | |||
Income Tax Contingency [Line Items] | |||
Impairment | 539,200 | ||
Deferred income taxes | $ (143,500) | ||
Federal | |||
Income Tax Contingency [Line Items] | |||
Reduction in orphan drug credit benefit due to change in tax rate | 50.00% | ||
Net operating loss carryforwards | $ 142,000 | ||
Research credit carry forward | 469,543 | ||
State | |||
Income Tax Contingency [Line Items] | |||
Research credit carry forward | $ 96,100 |
Reconciliation of Statutory Fed
Reconciliation of Statutory Federal Income Tax Rate to Company Effective Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Federal statutory income tax rate | $ (29,968) | $ (12,556) | $ (290,867) |
State and local taxes | (276) | 7,282 | (2,978) |
Orphan Drug & General Business Credit | (66,451) | (33,683) | (62,041) |
Stock compensation expense | (5,647) | (6,843) | (38,263) |
Changes in the fair value of contingent consideration | (2,361) | 1,099 | (7,616) |
Subpart F income | 6,543 | 30,181 | 0 |
Foreign tax rate differential | 12,583 | 9,403 | 154,553 |
Section 162(m) limitation | 7,440 | 9,492 | 45,056 |
Tax Cuts and Jobs Act of 2017 | 0 | 42,338 | 0 |
Tax Reserves | 8,545 | 2,262 | 2,294 |
Other | (422) | (2,938) | (5,133) |
Valuation allowance/deferred benefit | 4,521 | 35,132 | 4,155 |
Provision for (benefit from) income taxes | $ (65,494) | $ 81,167 | $ (200,840) |
Components of Company Net Defer
Components of Company Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 42,007 | $ 48,374 |
Tax credit carryforwards | 466,066 | 384,381 |
Accrued expenses, reserves, and prepaids | 55,041 | 54,565 |
Intangible assets | 18,734 | 17,556 |
Stock-based compensation | 35,966 | 31,371 |
Inventory | 12,859 | 13,206 |
Other | 278 | 4,967 |
Valuation allowance | (107,928) | (111,001) |
Total deferred tax assets | 523,023 | 443,419 |
Joint venture basis difference | (1,010) | (1,229) |
Acquired intangibles | (6,508) | (3,332) |
Deferred revenue | (4,480) | 0 |
Convertible notes discount | (5,157) | (10,100) |
Property, plant and equipment | (44,916) | (29,663) |
Total deferred tax liabilities | (62,071) | (44,324) |
Net deferred tax assets | $ 460,952 | $ 399,095 |
Summary of Expiration of not Ut
Summary of Expiration of not Utilized Net Operating Loss and Tax Credit Carryforwards (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Federal | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 157,919 |
Federal R&D and orphan drug credit carryforwards | $ 469,543 |
Federal | Minimum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,028 |
Federal R&D and orphan drug credit carryforwards, expiration date | 2,030 |
Federal | Maximum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,037 |
Federal R&D and orphan drug credit carryforwards, expiration date | 2,038 |
State | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 153,737 |
Federal R&D and orphan drug credit carryforwards | $ 96,100 |
State | Minimum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,019 |
State | Maximum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,038 |
Dutch | Foreign | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 118,225 |
Dutch | Foreign | Minimum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,021 |
Dutch | Foreign | Maximum | |
Income Tax Contingency [Line Items] | |
Operating loss carry forward if not utilized, expiration date | 2,025 |
Reconciliation of Unrecognized
Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Balance at beginning of period | $ 113,486 | $ 103,210 |
Additions based on tax positions related to the current year | 30,811 | 11,042 |
(Deletions) Additions for tax positions of prior years | 3,148 | (766) |
Balance at end of period | $ 147,445 | $ 113,486 |
Equity Compensation Plans and_3
Equity Compensation Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) | Sep. 28, 2017 | Mar. 31, 2018 | Mar. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based awards, authorized | 27,200,000 | |||||
Options outstanding | 7,363,609 | 8,107,981 | ||||
Stock-based compensation expense capitalized to inventory | $ 20,000,000 | $ 16,100,000 | $ 11,400,000 | |||
Recognized compensation costs | $ 148,819,000 | $ 140,263,000 | $ 134,641,000 | |||
Weighted-average fair value per option granted | $ 33.40 | $ 36.07 | $ 40.70 | |||
Total intrinsic value of options exercised | $ 79,900,000 | $ 77,000,000 | $ 127,400,000 | |||
Net tax benefit from stock options exercised | $ 5,800,000 | |||||
Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based awards, authorized | 3,500,000 | |||||
Shares reserved for future issuance | 400,000 | |||||
Options to purchase shares of common stock, percentage | 85.00% | |||||
Span of offering period, in years | 2 years | |||||
Maximum percentage of qualified compensation to be used for purchase | 10.00% | |||||
Maximum payroll deductions | $ 25,000 | |||||
Shares issued under the Employee Stock Purchase Plan | 200,000 | |||||
Recognized compensation costs | $ 10,400,000 | 11,700,000 | 10,100,000 | |||
Unrecognized compensation cost related to unvested awards | $ 10,800,000 | |||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 1 year 3 months 18 days | |||||
Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Recognized compensation costs | $ 32,000,000 | $ 36,700,000 | $ 45,500,000 | |||
Unrecognized compensation cost related to unvested awards | $ 42,700,000 | |||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 2 years 4 months 24 days | |||||
Restricted Stock With Service Based Vesting Conditions | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average fair value per RSU granted | $ 84.63 | $ 87.88 | $ 84.18 | |||
The total fair value of restricted stock vested and released | $ 84,500,000 | $ 76,500,000 | $ 63,500,000 | |||
Recognized compensation costs | 102,000,000 | $ 86,500,000 | 74,700,000 | |||
Unrecognized compensation cost related to unvested awards | $ 192,500,000 | |||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 2 years 7 months 6 days | |||||
Granted restricted stock units | 3,147,523 | 2,679,534 | ||||
Unvested restricted stock units | Independent Director | Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period, years | 1 year | |||||
Initial equity grant value | $ 375,000 | |||||
Average closing price of common stock, trailing period | 3 months | |||||
March 2018 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 | $ 83.57 | |||||
Recognized compensation costs | $ 3,829,000 | $ 0 | 0 | |||
Granted restricted stock units | 129,680 | |||||
Award vesting service period | 3 years | |||||
Percentage of threshold achievement | 70.00% | |||||
Percentage of ceiling achievement | 125.00% | |||||
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Percentage of, number of shares may earned | 50.00% | |||||
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Percentage of, number of shares may earned | 200.00% | |||||
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 | $ 108.36 | |||||
Recognized compensation costs | 340,000 | $ 2,291,000 | $ 2,342,000 | |||
Unrecognized compensation cost related to unvested awards | $ 11,600,000 | |||||
Granted restricted stock units | 58,300 | |||||
Award vesting service period | 3 years | 1 year 8 months 12 days | ||||
2017 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved for future issuance | 10,900,000 | |||||
Options outstanding | 7,400,000 | |||||
2017 Equity 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 | 12 months | |||||
Contractual term of stock option awards, years | 10 years | |||||
2017 Equity 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 | |||||
2017 Equity 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 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 148,819 | $ 140,263 | $ 134,641 |
Cost of Sales | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | 13,558 | 10,636 | 9,121 |
Research and Development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | 57,557 | 53,112 | 58,279 |
Selling, General and Administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 77,704 | $ 76,515 | $ 67,241 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock With Service Based Vesting Conditions - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule of Share based Compensation Arrangements by Share based Payment Award, Equity Instruments, Other Than Options, Restricted Stock Units [Line Items] | |||
Shares, Non-vested units as of December 31, 2017 | 2,679,534 | ||
Shares, Granted | 1,681,120 | ||
Shares, Vested | (963,062) | ||
Shares, Forfeited | (250,069) | ||
Shares, Non-vested units as of December 31, 2018 | 3,147,523 | 2,679,534 | |
Weighted Average Grant Date Fair Value, Non-vested units as of December 31, 2017 | $ 90.04 | ||
Weighted Average Grant Date Fair Value, Granted | 84.63 | $ 87.88 | $ 84.18 |
Weighted Average Grant Date Fair Value, Vested | 89.53 | ||
Weighted Average Grant Date Fair Value, Forfeited | 88.68 | ||
Weighted Average Grant Date Fair Value, Non-vested units as of December 31, 2018 | $ 87.42 | $ 90.04 | |
Weighted Average Remaining Years, Non-vested units | 2 years 7 months 6 days | 2 years 6 months | |
Aggregate Intrinsic Value, Non-vested units | $ 268,012 | $ 238,934 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | ||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Shares, Options outstanding as of December 31, 2017 | 8,107,981 | ||
Shares, Granted | 782,240 | ||
Shares, Exercised | (1,456,274) | ||
Shares, Expired and forfeited | (70,338) | ||
Shares, Options outstanding as of December 31, 2018 | 7,363,609 | 8,107,981 | |
Shares, Options unvested at December 31, 2018 | 1,441,416 | ||
Shares, Exercisable at December 31, 2018 | 5,922,193 | ||
Weighted Average Exercise Price, Outstanding as of December 31, 2017 | $ 56.53 | ||
Weighted Average Exercise Price, Granted | 83.77 | ||
Weighted Average Exercise Price, Exercised | 36.71 | ||
Weighted Average Exercise Price, Expired and forfeited | 86.46 | ||
Weighted Average Exercise Price, Outstanding as of December 31, 2018 | 63.06 | $ 56.53 | |
Weighted Average Exercise Price, Options unvested at December 31, 2018 | 85.75 | ||
Weighted Average Exercise Price, Exercisable at December 31, 2018 | $ 57.57 | ||
Weighted Average Remaining Years, Options outstanding | 5 years 1 month 6 days | 5 years 1 month 6 days | |
Weighted Average Remaining Years, Options unvested at December 31, 2018 | 8 years 7 months 6 days | ||
Weighted Average Remaining Years, Exercisable at December 31, 2018 | 4 years 2 months 12 days | ||
Aggregate Intrinsic Value, Options outstanding | [1] | $ 183,091 | $ 281,141 |
Aggregate Intrinsic Value, Options unvested at December 31, 2018 | [1] | 1,559 | |
Aggregate Intrinsic Value, Exercisable at December 31, 2018 | [1] | $ 181,532 | |
[1] | The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the Nasdaq Global Select Market as of the last trading day for the respective year. The aggregate intrinsic value of options outstanding and exercisable includes options with an exercise price below $85.15, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2018. |
Summary of Stock Option Activ_2
Summary of Stock Option Activity (Parenthetical) (Detail) | Dec. 31, 2018$ / shares |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Closing price of common stock | $ 85.15 |
Stock Option Valuation Assumpti
Stock Option Valuation Assumptions (Detail) - Stock Option | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 36.80% | 37.60% | 35.70% |
Expected volatility, maximum | 38.40% | 39.70% | 44.20% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 2.30% | 1.80% | 1.10% |
Risk-free interest rate, maximum | 2.80% | 2.20% | 2.30% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 4 years 7 months 6 days | 4 years 10 months 24 days | 5 years |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 5 years 8 months 12 days | 6 years 7 months 6 days | 8 years 1 month 6 days |
Employee Stock Purchase Plan Va
Employee Stock Purchase Plan Valuation Assumptions (Detail) - Employee Stock Purchase Plan | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 29.70% | 27.70% | 41.50% |
Expected volatility, maximum | 35.00% | 42.30% | 49.70% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.20% | 1.00% | 0.40% |
Risk-free interest rate, maximum | 2.80% | 1.60% | 0.80% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 6 months | 6 months | 6 months |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected life | 24 months | 24 months | 24 months |
Summary of Restricted Stock U_2
Summary of Restricted Stock Unit Awards with Performance Conditions (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Mar. 31, 2018$ / sharesshares | Mar. 31, 2017$ / sharesshares | Mar. 31, 2016$ / sharesshares | Mar. 31, 2015$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation Expense | $ | $ 148,819 | $ 140,263 | $ 134,641 | ||||
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Base RSUs Granted | 129,680 | ||||||
Grant Date Fair Value per RSU | $ / shares | $ 83.57 | ||||||
RSUs Earned | 126,814 | ||||||
Compensation Expense | $ | 3,829 | 0 | 0 | ||||
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Multiplier Achieved | 97.8 | ||||||
March 2017 Base Restricted Stock Unit Awards with Performance Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Base RSUs Granted | 133,250 | ||||||
Grant Date Fair Value per RSU | $ / shares | $ 87.42 | ||||||
RSUs Earned | 131,651 | ||||||
Compensation Expense | $ | 3,446 | 4,141 | 0 | ||||
March 2017 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Multiplier Achieved | 103 | ||||||
March 2016 Base Restricted Stock Unit Awards with Performance Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Base RSUs Granted | 130,310 | ||||||
Grant Date Fair Value per RSU | $ / shares | $ 83.43 | ||||||
RSUs Earned | 134,219 | ||||||
Compensation Expense | $ | 3,125 | 3,928 | 2,956 | ||||
March 2016 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Multiplier Achieved | 103 | ||||||
2015 Base Restricted Stock Unit Awards with Performance Conditions | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Base RSUs Granted | 58,300 | ||||||
Grant Date Fair Value per RSU | $ / shares | $ 108.36 | ||||||
RSUs Earned | 64,713 | ||||||
Compensation Expense | $ | $ 340 | $ 2,291 | $ 2,342 | ||||
2015 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Multiplier Achieved | 111 |
Summary of Restricted Stock U_3
Summary of Restricted Stock Unit Awards with Performance Conditions (Paranthetical) (Detail) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2018shares | Mar. 31, 2017shares | Mar. 31, 2016shares | Mar. 31, 2015shares | Dec. 31, 2018 | |
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
RSUs Earned | 126,814 | ||||
Award vesting service period | 3 years | ||||
March 2018 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Multiplier Achieved | 97.8 | ||||
March 2017 Base Restricted Stock Unit Awards with Performance Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
RSUs Earned | 131,651 | ||||
Award vesting service period | 3 years | ||||
March 2017 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Multiplier Achieved | 103 | ||||
March 2016 Base Restricted Stock Unit Awards with Performance Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
RSUs Earned | 134,219 | ||||
Award vesting service period | 3 years | ||||
March 2016 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Multiplier Achieved | 103 | ||||
2015 Base Restricted Stock Unit Awards with Performance Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
RSUs Earned | 64,713 | ||||
Award vesting service period | 3 years | 1 year 8 months 12 days | |||
2015 Base Restricted Stock Unit Awards with Performance Conditions | Measurement Input, Revenue Multiple | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Multiplier Achieved | 111 |
Other Employee Benefits - Addit
Other Employee Benefits - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Gain (loss) in fair value of restricted stock issued | $ 900,000 | $ (1,400,000) | $ 5,000,000 |
BioMarin Retirement Savings Plan | |||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Employee contribution of their current compensation | 100.00% | ||
Company's contribution to match employees contribution | 100.00% | ||
Employer contribution of maximum percentage over employee's annual compensation | 6.00% | ||
Employer contribution over employee's annual compensation | $ 16,000 | ||
Employer contribution over employee's annual compensation starting next fiscal year | $ 19,000 | ||
Company's savings plan contribution vesting period, years | 4 years | ||
Company's contribution from employment commencement | $ 23,000,000 | 19,800,000 | $ 16,000,000 |
Deferred Compensation Plan | |||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Fair value of company stock held | $ 17,700,000 | $ 19,600,000 |
Amounts Reclassified out of Acc
Amounts Reclassified out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Net product revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 |
LOSS FROM OPERATIONS | (123,524) | (14,700) | (803,429) |
Other income | 2,205 | 7,970 | 4,929 |
Provision for (benefit from) income taxes | (65,494) | 81,167 | (200,840) |
NET LOSS | (77,211) | (117,042) | (630,210) |
Net Product Revenues | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Net product revenues | 1,470,356 | 1,270,445 | 1,110,381 |
Amount Reclassified from AOCI (Gain) Loss | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Provision for (benefit from) income taxes | 0 | (1,191) | (42) |
Total gain (loss) on available-for-sale debt securities | 0 | 2,061 | (157) |
NET LOSS | (2,047) | (3,052) | 10,116 |
Amount Reclassified from AOCI (Gain) Loss | Gains (losses) on Cash Flow Hedges | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
LOSS FROM OPERATIONS | (2,047) | (5,113) | 10,273 |
Amount Reclassified from AOCI (Gain) Loss | Gains (losses) on Cash Flow Hedges | Forward Foreign Currency Exchange Contracts | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Operating expenses | 3,958 | 264 | 4,161 |
Amount Reclassified from AOCI (Gain) Loss | Gains (losses) on Cash Flow Hedges | Net Product Revenues | Forward Foreign Currency Exchange Contracts | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Net product revenues | (6,005) | (5,377) | 6,112 |
Amount Reclassified from AOCI (Gain) Loss | Gain (Loss) on Sale of Available-for-Sale Debt Securities | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Other income | $ 0 | $ 3,252 | $ (115) |
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 | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | ||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Beginning Balance | $ 2,808,663 | $ 2,766,275 | |
Other comprehensive income (loss) before reclassifications | 27,184 | (39,101) | |
Less: net gain (loss) reclassified from AOCI | (2,047) | (1,861) | |
Tax effect | (413) | 1,463 | |
Net current-period other comprehensive income (loss) | 28,818 | (35,777) | |
Ending Balance | 2,967,940 | 2,808,663 | |
Ending Balance | 2,828,702 | ||
ASU 2018-02 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Impact of change in accounting principle | [1] | (586) | |
Gains and Losses on Cash Flow Hedges | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Beginning Balance | (20,232) | 13,006 | |
Other comprehensive income (loss) before reclassifications | 25,386 | (38,351) | |
Less: net gain (loss) reclassified from AOCI | (2,047) | (5,113) | |
Tax effect | 0 | 0 | |
Net current-period other comprehensive income (loss) | 27,433 | (33,238) | |
Ending Balance | 7,201 | (20,232) | |
Ending Balance | (20,232) | ||
Gains and Losses on Cash Flow Hedges | ASU 2018-02 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Impact of change in accounting principle | [1] | 0 | |
Accumulated Gain Loss from Other | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Beginning Balance | (2,722) | (178) | |
Other comprehensive income (loss) before reclassifications | 1,804 | (755) | |
Less: net gain (loss) reclassified from AOCI | 0 | 3,252 | |
Tax effect | (413) | 1,463 | |
Net current-period other comprehensive income (loss) | 1,391 | (2,544) | |
Ending Balance | (1,917) | (2,722) | |
Ending Balance | (3,308) | ||
Accumulated Gain Loss from Other | ASU 2018-02 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Impact of change in accounting principle | [1] | (586) | |
Accumulated Gain Loss from Other | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Beginning Balance | (7) | (12) | |
Other comprehensive income (loss) before reclassifications | (6) | 5 | |
Less: net gain (loss) reclassified from AOCI | 0 | 0 | |
Tax effect | 0 | 0 | |
Net current-period other comprehensive income (loss) | (6) | 5 | |
Ending Balance | (13) | (7) | |
Ending Balance | (7) | ||
Accumulated Gain Loss from Other | ASU 2018-02 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Impact of change in accounting principle | [1] | 0 | |
Accumulated Other Comprehensive Income (Loss) | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Beginning Balance | (22,961) | 12,816 | |
Ending Balance | $ 5,271 | (22,961) | |
Ending Balance | (23,547) | ||
Accumulated Other Comprehensive Income (Loss) | ASU 2018-02 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | |||
Impact of change in accounting principle | $ (586) | ||
[1] | As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from AOCI to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion. |
Revenue, Credit Concentration_3
Revenue, Credit Concentrations and Geographic Information - Additional Information (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)SegmentCustomer | Dec. 31, 2017USD ($)Customer | |
Concentration Risk And Geographic Information [Line Items] | ||
Number of operating business segment | Segment | 1 | |
Accounts receivable, net | $ 342,633 | $ 261,365 |
Customer | ||
Concentration Risk And Geographic Information [Line Items] | ||
Accounts receivable, net | $ 73,900 | $ 18,100 |
Accounts Receivable Balance | ||
Concentration Risk And Geographic Information [Line Items] | ||
Number of customers accounted for balance in accounts receivable | Customer | 2 | 2 |
Geographic Concentration Risk | Net Product Revenue | Minimum | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 10.00% | |
Credit Concentration Risk | Accounts Receivable Balance | Customer One | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 30.00% | 21.00% |
Credit Concentration Risk | Accounts Receivable Balance | Customer Two | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 16.00% | 18.00% |
Disaggregates of Total Revenues
Disaggregates of Total Revenues from External Customers and Collaborative Partners by Geographic Region (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue from External Customer [Line Items] | |||
Total revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 |
United States | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 696,793 | 588,243 | 507,539 |
Europe | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 436,434 | 398,814 | 340,775 |
Latin America | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 185,046 | 181,970 | 147,474 |
Rest of World | |||
Revenue from External Customer [Line Items] | |||
Total revenues | $ 172,939 | $ 144,619 | $ 121,066 |
Disaggregates of Total Net Prod
Disaggregates of Total Net Product Revenues from External Customers by Product (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue from External Customer [Line Items] | |||
Net product revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 |
Aldurazyme | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 135,097 | 89,959 | 93,749 |
Brineura | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 39,889 | 8,595 | 0 |
Firdapse | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 21,787 | 18,890 | 18,028 |
Kuvan | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 433,582 | 407,542 | 348,009 |
Naglazyme | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 345,851 | 332,208 | 296,537 |
Palynziq | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 12,173 | 0 | 0 |
Vimizim | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 481,977 | 413,251 | 354,058 |
Net Product Revenues | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | $ 1,470,356 | $ 1,270,445 | $ 1,110,381 |
Disaggregates of Total Net Pr_2
Disaggregates of Total Net Product Revenues Based on Patient Location (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | $ 1,491,212 | $ 1,313,646 | $ 1,116,854 |
United States | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 696,793 | 588,243 | 507,539 |
Europe | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 436,434 | 398,814 | 340,775 |
Latin America | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 185,046 | 181,970 | 147,474 |
Rest of World | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 172,939 | 144,619 | 121,066 |
Aldurazyme | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 135,097 | 89,959 | 93,749 |
Net Product Revenues | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 1,470,356 | 1,270,445 | 1,110,381 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 1,335,259 | 1,180,486 | 1,016,632 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim | United States | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 560,030 | 495,741 | 411,877 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim | Europe | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 424,357 | 363,538 | 340,775 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim | Latin America | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 184,984 | 181,963 | 147,474 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim | Rest of World | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | 165,888 | 139,244 | 116,506 |
Marketed by Genzyme | Aldurazyme | |||
Disaggregation Of Revenue [Line Items] | |||
Net product revenues | $ 135,097 | $ 89,959 | $ 93,749 |
Total Net Product Revenue Conce
Total Net Product Revenue Concentrations Attributed to Largest Customers (Detail) - Customer Concentration Risk - Net Product Revenue | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 40.00% | 42.00% | 42.00% |
Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 18.00% | 18.00% | 19.00% |
Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 12.00% | 14.00% | 13.00% |
Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 10.00% | 10.00% | 10.00% |
Summary of Non-Monetary Long-Li
Summary of Non-Monetary Long-Lived Assets by Geographic Region (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Revenue from External Customer [Line Items] | ||
Total long-lived assets | $ 2,099,194 | $ 2,011,255 |
United States | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | 1,719,733 | 1,653,944 |
Ireland | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | 220,878 | 198,781 |
Rest of World | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | $ 158,583 | $ 158,530 |
Collaboration and License Agr_2
Collaboration and License Agreements - Additional Information (Detail) | Oct. 06, 2015USD ($) | Jul. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($) | Dec. 31, 2012USD ($)shares | Dec. 31, 2018EUR (€) | Sep. 30, 2016USD ($) | Oct. 31, 2012 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
License revenue | $ 1,491,212,000 | $ 1,313,646,000 | $ 1,116,854,000 | |||||||
Net gain on sale of intangible assets | $ 50,000,000 | 125,000,000 | 0 | |||||||
Royalties on net product sales | 7.00% | |||||||||
Royalties on net product sales | 10.00% | |||||||||
Termination of collaborative agreement prior to written notice in number of days | 90 days | |||||||||
Talazoparib | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Net gain on sale of intangible assets | $ 369,500,000 | |||||||||
Medivation | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront payment received | $ 410,000,000 | |||||||||
Milestone payments | $ 160,000,000 | |||||||||
Payment for achievement of development and regulatory approval milestones | $ 50,000,000 | |||||||||
Merck Serono | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Business acquisition, cash paid | 374,500,000 | |||||||||
A&R Kuvan Agreement | Merck Serono | Maximum | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Business acquisition contingent consideration potential cash payments upon achievement of sales milestone | € | € 60,000,000 | |||||||||
Pegvaliase Agreement | Merck Serono | Maximum | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Business acquisition contingent consideration potential cash payments upon achievement of sales milestone | € | € 75,000,000 | |||||||||
Catalyst Pharmaceutical Partners, Inc. | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Licensing arrangement, convertible promissory note received | $ 5,000,000 | |||||||||
Licensing arrangement, shares received upon conversion promissory note | shares | 6,700,000 | |||||||||
Accounts receivable | $ 0 | |||||||||
Common stock shares held | shares | 0 | |||||||||
United States | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
License revenue | $ 696,793,000 | $ 588,243,000 | $ 507,539,000 | |||||||
Sarepta Therapeutics | License Agreement And Settlement Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
License revenue | $ 31,500,000 | |||||||||
Type of Revenue [Extensible List] | us-gaap:LicenseMember | |||||||||
Sarepta Therapeutics | United States | License Agreement And Settlement Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Royalties receivable percentage of net sales | 5.00% | |||||||||
Sarepta Therapeutics | EU and Other Countries | License Agreement And Settlement Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Royalties receivable percentage of net sales | 8.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Commitments and Contingencies [Line Items] | |||
Lease expiration date | 2,031 | ||
Lease extension option, renewal period | 5 years | ||
Rent expense | $ 12.2 | $ 11.4 | $ 11.6 |
Deferred rent accruals | 2.1 | 2.3 | |
Deferred rent accruals, current | 0.5 | 2 | |
Asset retirement obligation | 4.9 | $ 4.2 | |
Purchase commitment for the next five years | 91.8 | ||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 477.3 | ||
Contingent consideration | 132.8 | ||
Merck Serono | |||
Commitments and Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 154.5 | ||
Completed Programs | Merck Serono | |||
Commitments and Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 80.7 |
Minimum Lease Payments for Futu
Minimum Lease Payments for Future Years (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,019 | $ 12,976 |
2,020 | 12,549 |
2,021 | 11,198 |
2,022 | 10,574 |
2,023 | 9,993 |
Thereafter | 27,701 |
Total | $ 84,991 |