Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 13, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | BMRN | |
Entity Registrant Name | BIOMARIN PHARMACEUTICAL INC | |
Entity Central Index Key | 1,048,477 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 176,713,314 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2018 | [2] | Dec. 31, 2017 | [3] | |
Current assets: | |||||
Cash and cash equivalents | [1] | $ 473,980 | $ 598,028 | ||
Short-term investments | 908,815 | 797,940 | |||
Accounts receivable, net | 318,394 | 261,365 | |||
Inventory | 468,161 | 475,775 | |||
Other current assets | 71,760 | 74,036 | |||
Total current assets | 2,241,110 | 2,207,144 | |||
Noncurrent assets: | |||||
Long-term investments | 313,599 | 385,785 | |||
Property, plant and equipment, net | 895,392 | 896,700 | |||
Intangible assets, net | 509,902 | 517,510 | |||
Goodwill | 197,039 | 197,039 | |||
Deferred tax assets | 407,009 | 399,095 | |||
Other assets | 32,666 | 29,852 | |||
Total assets | 4,596,717 | 4,633,125 | |||
Current liabilities: | |||||
Accounts payable and accrued liabilities | 346,538 | 401,921 | |||
Short-term convertible debt, net | 365,326 | 360,949 | |||
Short-term contingent acquisition consideration payable | 61,607 | 53,648 | |||
Total current liabilities | 773,471 | 816,518 | |||
Noncurrent liabilities: | |||||
Long-term convertible debt, net | 817,672 | 813,521 | |||
Long-term contingent acquisition consideration payable | 137,618 | 135,318 | |||
Other long-term liabilities | 60,953 | 59,105 | |||
Total liabilities | 1,789,714 | 1,824,462 | |||
Stockholders’ equity: | |||||
Common stock, $0.001 par value: 500,000,000 shares authorized; 176,653,480 and 175,843,749 shares issued and outstanding, respectively. | 177 | 176 | |||
Additional paid-in capital | 4,510,451 | 4,483,220 | |||
Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (14,017) | (14,224) | |||
Accumulated other comprehensive loss | (28,545) | (22,961) | |||
Accumulated deficit | (1,661,063) | (1,637,548) | |||
Total stockholders’ equity | 2,807,003 | 2,808,663 | |||
Total liabilities and stockholders’ equity | $ 4,596,717 | $ 4,633,125 | |||
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||||
[2] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||||
[3] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2018 | [1] | Dec. 31, 2017 | [2] |
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 | 176,653,480 | 175,843,749 | ||
Common stock, shares outstanding | 176,653,480 | 175,843,749 | ||
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | [1] | Mar. 31, 2017 | |
REVENUES: | |||
Net product revenues | $ 369,099 | $ 302,190 | |
Royalty and other revenues | 4,348 | 1,555 | |
Total revenues | 373,447 | 303,745 | |
OPERATING EXPENSES: | |||
Cost of sales | 82,333 | 50,006 | |
Research and development | 183,948 | 145,003 | |
Selling, general and administrative | 138,336 | 120,019 | |
Intangible asset amortization and contingent consideration | 13,202 | 8,925 | |
Total operating expenses | 417,819 | 323,953 | |
LOSS FROM OPERATIONS | (44,372) | (20,208) | |
Equity in the income (loss) of BioMarin/Genzyme LLC | 68 | (523) | |
Interest income | 5,234 | 3,072 | |
Interest expense | (11,562) | (10,119) | |
Other income (expense) | (172) | 3,472 | |
LOSS BEFORE INCOME TAXES | (50,804) | (24,306) | |
Benefit from income taxes | (6,655) | (8,016) | |
NET LOSS | $ (44,149) | $ (16,290) | |
NET LOSS PER SHARE, BASIC | $ (0.25) | $ (0.09) | |
NET LOSS PER SHARE, DILUTED | $ (0.26) | $ (0.09) | |
Weighted average common shares outstanding, basic | 175,932 | 172,710 | |
Weighted average common shares outstanding, diluted | 176,150 | 172,710 | |
COMPREHENSIVE LOSS | $ (49,147) | $ (24,086) | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Company Common Stock Held By The NQDC | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | ||
Beginning Balance at Dec. 31, 2016 | $ 12,816 | |||||||
Net loss | $ (16,290) | |||||||
Ending Balance at Mar. 31, 2017 | 5,020 | |||||||
Beginning Balance at Dec. 31, 2017 | [1] | 2,808,663 | $ 176 | $ 4,483,220 | $ (14,224) | (22,961) | $ (1,637,548) | |
Beginning Balance (in shares) at Dec. 31, 2017 | [1] | 175,844 | ||||||
Impact of change in accounting principle at Dec. 31, 2017 | [2] | (586) | ||||||
Impact of change in accounting principle (ASC 606) at Dec. 31, 2017 | [3] | 20,048 | 20,048 | |||||
Impact of change in accounting principle (ASU 2018-02) at Dec. 31, 2017 | [4] | (586) | 586 | |||||
Adjusted balance at January 1, 2018 at Dec. 31, 2017 | 2,828,711 | $ 176 | 4,483,220 | (14,224) | (23,547) | (1,616,914) | ||
Net loss | (44,149) | [3] | (44,149) | |||||
Other comprehensive loss | (4,998) | (4,998) | ||||||
Issuances under equity incentive plans, net of tax | (9,765) | $ 1 | (9,766) | |||||
Issuances under equity incentive plans, net of tax (in share) | 809 | |||||||
Common stock held by the NQDC | 207 | 207 | ||||||
Stock-based compensation | 36,997 | 36,997 | ||||||
Ending Balance at Mar. 31, 2018 | $ 2,807,003 | [5] | $ 177 | $ 4,510,451 | $ (14,017) | $ (28,545) | $ (1,661,063) | |
Ending Balance (in shares) at Mar. 31, 2018 | 176,653 | |||||||
[1] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | |||||||
[2] | As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from Accumulated Other Comprehensive Loss to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion | |||||||
[3] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||||||
[4] | As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (ASU 2018-02). The amount represents the reclassification from Accumulated Other Comprehensive Loss to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion. | |||||||
[5] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | [1] | Mar. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (44,149) | $ (16,290) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 23,633 | 19,412 | |
Non-cash interest expense | 8,601 | 7,755 | |
Accretion of discount on investments | 761 | 660 | |
Stock-based compensation | 36,608 | 30,674 | |
Gain on the sale of equity investments | 0 | (3,252) | |
Deferred income taxes | (13,988) | (10,441) | |
Unrealized foreign exchange (gain) loss | 5,616 | (1,730) | |
Non-cash changes in the fair value of contingent acquisition consideration payable | 5,631 | 1,353 | |
Other | 662 | 969 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (26,257) | (14,051) | |
Inventory | 10,843 | (22,660) | |
Other current assets | 2,924 | 2,763 | |
Other assets | (1,099) | (527) | |
Accounts payable and accrued liabilities | (51,887) | (77,822) | |
Other long-term liabilities | (408) | 2,744 | |
Net cash used in operating activities | (42,509) | (80,443) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (30,164) | (69,090) | |
Maturities and sales of investments | 104,462 | 149,916 | |
Purchases of available-for-sale securities | (145,933) | (54,388) | |
Other | (99) | (1,391) | |
Net cash (used in) provided by investing activities | (71,734) | 25,047 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 13,134 | 13,086 | |
Taxes paid related to net share settlement of equity awards | (22,899) | (17,935) | |
Payment of contingent acquisition consideration payable | 0 | (1,894) | |
Net cash used in financing activities | (9,765) | (6,743) | |
Effect of exchange rate changes on cash | (40) | 2,043 | |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (124,048) | (60,096) | |
Cash and cash equivalents: | |||
Beginning of period | 598,028 | [2] | 408,330 |
End of period | 473,980 | [3] | 348,234 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |||
Cash paid for income taxes | 11,731 | 6,376 | |
Cash paid for interest | 1,528 | 0 | |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON CASH INVESTING AND FINANCING ACTIVITIES: | |||
Decrease in accounts payable and accrued liabilities related to fixed assets | $ (11,367) | $ (26,297) | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | ||
[3] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
NATURE OF OPERATIONS | (1) NATURE OF OPERATIONS BioMarin Pharmaceutical Inc. (the Company) is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company’s therapy portfolio consists of six 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. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | (2) BASIS OF PRESENTATION The accompanying Condensed Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by U.S. GAAP for complete financial statements, although the Company believes that the disclosures herein are adequate to ensure that the information presented is not misleading. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K. Effective January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method as discussed in Note 3 - Significant Accounting Policies U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. The results of operations for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2018 or any other period. Management performed an evaluation of the Company’s activities through the date of filing of this Quarterly Report on Form 10-Q, and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | (3) SIGNIFICANT ACCOUNTING POLICIES Except as detailed below, there have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2018, as compared to the significant accounting policies disclosed in Note 3 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Effective January 1, 2018, the Company adopted the provisions of ASC 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 606 guidance, while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition Under ASC 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 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 606. Net Product Revenues In the U.S., the Company’s commercial products are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Outside the U.S., the Company’s commercial products are sold to its authorized distributors or directly to government purchasers or hospitals, which act as the end-users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. Amounts collected from customers and remitted to governmental authorities, which primarily consist of value-added taxes related to product sales in foreign jurisdictions, are presented on a net basis in the Company’s Condensed Consolidated Statements of Comprehensive Loss, in that taxes billed to customers are not included as a component of Net Product Revenues. For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Genzyme Corporation (Genzyme) depending on sales volume, which is included in Net Product Revenues in the Company’s Condensed Consolidated Statements of Comprehensive Loss. Under the previous guidance the Company only recognized a portion of this amount 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. Under ASC 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, however the Company does not expect any such amounts to be material. If actual results in the future 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. 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, as such 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 which 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. 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 and the estimated costs of the Company’s patient co-payment assistance programs. Beginning in 2018, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on Kuvan or Brineura therapy. The branded co-pay assistance programs assist commercially insured patients who have coverage for Kuvan or Brineura and are intended to reduce each participating patient’s portion of the financial responsibility for Kuvan’s or Brineura’s 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 utilizes 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 . |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2018 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | (4) RECENT ACCOUNTING PRONOUNCEMENTS Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2018, as compared to the recent accounting pronouncements described in Note 4 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, that the Company believes are of significance or potential significance to the Company. Accounting Pronouncements Not Yet Adopted In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-02, Leases As of March 31, 2018, the Company’s task force formed in connection with the adoption of ASU 2016-02 was in the process of analyzing the Company’s lease contracts and the potential impact the standard may have on its Condensed Consolidated Financial Statements and related disclosures. After completing the analysis of the accounting for the Company’s lease contracts under the standard, management will assess the required changes to the Company’s accounting policies, systems and internal control over financial reporting. Based on management’s preliminary analysis, the Company anticipates the standard may have a material impact on the Company’s Condensed Consolidated Balance Sheets due to the requirement to recognize lease ROU assets and corresponding liabilities related to leases on the Company’s Condensed Consolidated Balance Sheets, but it is not anticipated to have a material impact on the Company’s other Condensed Consolidated Financial Statements. Accounting Pronouncements Adopted Effective January 1, 2018, the Company adopted ASC 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 606 on a modified retrospective basis through a cumulative adjustment to equity. See Note 3 – Significant Accounting Policies Revenue, Credit Concentrations and Geographic Information The cumulative effect of applying the new guidance of ASC 606 As Reported 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 $ — $ (5,964 ) $ 393,131 Total assets $ 4,633,125 $ 26,012 $ (5,964 ) $ 4,653,173 Equity: Accumulated deficit $ (1,637,548 ) $ 26,012 $ (5,964 ) $ (1,617,500 ) Total liabilities and stockholders' equity $ 4,633,125 $ 26,012 $ (5,964 ) $ 4,653,173 (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 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 estimate statutory rate. The impact of adoption on the Company’s Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2018 was as follows: Balance without Adoption of As Reported Adjustments (1) ASC 606 Statement of Comprehensive Loss Net product revenues $ 369,099 $ (27,197 ) $ 341,902 Benefit from income taxes $ (6,655 ) $ (6,236 ) $ (12,891 ) Net loss $ (44,149 ) $ (20,961 ) $ (65,110 ) (1) The adoption of ASC 606 resulted in additional revenues recognized in the first quarter of 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 Condensed Consolidated Statement of Cash Flows for the three months ended March 31, 2018 was as follows: Balance without Adoption of As Reported Adjustments (1) ASC 606 Statement of Cash Flows Net loss $ (44,149 ) $ (20,961 ) $ (65,110 ) Deferred income taxes $ (13,988 ) $ (6,236 ) $ (20,224 ) Changes in operating assets and liabilities: Accounts receivable, net $ (26,257 ) $ 27,197 $ 940 Net cash used in operating activities $ (42,509 ) $ — $ (42,509 ) (1) The adoption of ASC 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in the first quarter of 2018, which in turn generated additional deferred tax liabilities that reduced the Company's net Deferred Tax Assets. The Deferred Income Taxes amount has been calculated using the Company’s estimated statutory rate. In February 2018, the FASB issued ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 3 Months Ended |
Mar. 31, 2018 | |
Earnings Per Share [Abstract] | |
NET LOSS PER COMMON SHARE | (5) 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 Employee Stock Purchase Plan (ESPP), unvested restricted stock units (RSUs), common stock held by the NQDC and contingent issuances of common stock related to convertible debt. The following table sets forth the computation of basic and diluted earnings per common share (in thousands of common shares): Three Months Ended March 31, 2018 2017 Numerator: Net loss, basic $ (44,149 ) $ (16,290 ) Less: gain on common stock held by the NQDC 1,322 — Net loss, diluted $ (45,471 ) $ (16,290 ) Denominator: Weighted-average common shares outstanding, basic 175,932 172,710 Effect of dilutive securities: Common shares held by the NQDC 218 — Weighted-average common shares outstanding, diluted 176,150 172,710 Net loss per common share, basic $ (0.25 ) $ (0.09 ) Net loss per common share, diluted $ (0.26 ) $ (0.09 ) The table below presents potential shares of common stock that were excluded from the computation of basic and diluted earnings per common share as they were anti-dilutive using the if-converted or treasury stock method (in thousands): Three Months Ended March 31, 2018 2017 Options to purchase common stock 8,473 9,070 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 Common stock issuable under the 2024 Notes 3,970 — Unvested restricted stock units 3,734 3,274 Common stock potentially issuable for ESPP purchases 425 384 Common stock held by the NQDC — 228 Total number of potentially issuable shares 24,568 22,027 The potential effect of the capped call transactions with respect to the Company’s 0.75% senior subordinated convertible notes due in 2018 (the 2018 Notes) and the Company’s 1.50% senior subordinated convertible notes due in 2020 (the 2020 Notes) was excluded from the diluted net income/loss per share the Company’s senior subordinated convertible notes due in 2017 (the 2017 Notes), which matured in April 2017, or with respect to |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | (6) FINANCIAL INSTRUMENTS All marketable securities were classified as available-for-sale at March 31, 2018 and December 31, 2017. The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of March 31, 2018 and December 31, 2017: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 270,194 $ — $ — $ 270,194 $ 270,194 $ — $ — Level 2: Money market instruments 170,601 — — 170,601 170,601 — — Corporate debt securities 692,763 101 (4,371 ) 688,493 5,549 431,723 251,221 Commercial paper 53,584 — — 53,584 22,642 30,942 — U.S. government agency securities 486,014 1 (2,144 ) 483,871 4,994 416,707 62,170 Foreign and other 29,552 158 (59 ) 29,651 — 29,443 208 Subtotal 1,432,514 260 (6,574 ) 1,426,200 203,786 908,815 313,599 Total $ 1,702,708 $ 260 $ (6,574 ) $ 1,696,394 $ 473,980 $ 908,815 $ 313,599 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses 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) The Company’s cash equivalents and marketable securities are classified within Level 2 in the fair value hierarchy because they are valued using third-party pricing sources and remeasured on a recurring basis. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs. The Company validates the prices provided by its third-party pricing services by understanding the models used, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming those securities traded in active markets. See Note 12 to these Condensed Consolidated Financial Statements for additional information related to the Company’s fair value measurements. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is other-than-temporary and, if it is other-than-temporary, an impairment loss is recognized in earnings equal to the difference between the investment’s amortized cost and fair value at such date. As of March 31, 2018, the Company’s investments in an unrealized loss position were not significant and were considered to be temporary in nature. The Company has the ability and intent to hold all investments that have been in a continuous loss position until maturity or recovery, thus no other-than-temporary impairment is deemed to have occurred. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | (7) INTANGIBLE ASSETS Intangible assets consisted of the following: March 31, December 31, 2018 2017 Intangible assets: Finite-lived intangible assets $ 303,298 $ 303,298 Indefinite-lived intangible assets 326,359 326,359 Gross intangible assets: 629,657 629,657 Less: Accumulated amortization (119,755 ) (112,147 ) Net carrying value $ 509,902 $ 517,510 Indefinite-Lived Intangible Assets Intangible assets related to in-process research and development (IPR&D) assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development (R&D) efforts. During the first quarter of 2018, no amounts have been reclassified to definite-lived and no impairment charges were recorded. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | (8) PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, net consisted of the following: March 31, December 31, 2018 2017 Building and improvements $ 660,181 $ 663,347 Manufacturing and laboratory equipment 307,494 294,521 Computer hardware and software 149,313 144,268 Leasehold improvements 43,180 42,572 Furniture and equipment 31,794 31,515 Land improvements 5,376 5,331 Land 62,369 62,369 Construction-in-progress 61,952 59,511 1,321,659 1,303,434 Accumulated depreciation (426,267 ) (406,734 ) Total property, plant and equipment, net $ 895,392 $ 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 expense for the three months ended March 31, 2018 was $20.0 million, of which $4.0 million was capitalized into inventory. Depreciation expense for the three months ended March 31, 2017 was $17.5 million, of which $5.5 million was capitalized into inventory. Capitalized interest related to the Company’s property, plant and equipment purchases for each of the three months ended March 31, 2018 and 2017 was insignificant. |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 3 Months Ended |
Mar. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | (9) SUPPLEMENTAL BALANCE SHEET INFORMATION Inventory consisted of the following: March 31, December 31, 2018 2017 Raw materials $ 52,642 $ 49,877 Work-in-process 194,581 234,674 Finished goods 220,938 191,224 Total inventory $ 468,161 $ 475,775 Accounts Payable and Accrued Liabilities consisted of the following: March 31, December 31, 2018 2017 Accounts payable and accrued operating expenses $ 172,192 $ 166,616 Accrued compensation expense 76,600 140,781 Accrued rebates payable 38,447 36,472 Accrued royalties payable 16,496 18,820 Value added taxes payable 10,221 9,740 Forward foreign currency exchange contracts 20,623 14,464 Accrued income taxes — 5,528 Other 11,959 9,500 Total accounts payable and accrued liabilities $ 346,538 $ 401,921 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
DEBT | (10) DEBT Convertible Notes As of March 31, 2018, the Company had outstanding fixed-rate notes with varying maturities for an aggregate principal amount of $1.2 billion (collectively the Notes). The Notes are senior subordinated convertible obligations, and interest is payable in arrears, quarterly. The following table summarizes information regarding the Company’s convertible debt: March 31, December 31, 2018 2017 0.75% senior subordinated convertible notes due in 2018 $ 374,980 $ 374,980 Unamortized discount (8,597 ) (12,488 ) Unamortized deferred offering costs (1,057 ) (1,543 ) Convertible Notes due in 2018, net 365,326 360,949 1.50% senior subordinated convertible notes due in 2020 374,993 374,993 Unamortized discount (36,932 ) (40,287 ) Unamortized deferred offering costs (3,307 ) (3,631 ) Convertible Notes due in 2020, net 334,754 331,075 0.599% senior subordinated convertible notes due in 2024 495,000 495,000 Unamortized discount (9,004 ) (9,355 ) Unamortized deferred offering costs (3,078 ) (3,199 ) Convertible Notes due in 2024, net 482,918 482,446 Total convertible debt, net $ 1,182,998 $ 1,174,470 Fair value of fixed rate convertible debt Convertible Notes due in 2018 (1) $ 383,323 $ 403,955 Convertible Notes due in 2020 (1) 414,187 446,470 Convertible Notes due in 2024 (1) 465,803 493,894 Total $ 1,263,313 $ 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 12 to these Condensed Consolidated Financial Statements for additional information related to the Company’s fair value measurements. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended March 31, 2018 2017 Coupon interest expense $ 2,961 $ 2,364 Amortization of debt issuance costs 1,004 886 Accretion of discount on convertible notes 7,597 6,869 Total interest expense on convertible debt $ 11,562 $ 10,119 See Note 13 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 for additional information related to the Company’s convertible debt. Revolving Credit Facility The Company maintains a senior unsecured revolving credit facility (Credit Facility) that provides revolving credit of up to $100.0 million in revolving loans (the Revolving Credit Facility), a $10.0 million letter of credit subfacility and a $15.0 million swing line loan subfacility. The maturity date of the Revolving Credit Facility will occur on November 29, 2018. As of March 31, 2018 and December 31, 2017, there were no outstanding amounts due on nor any usage of the Credit Facility. As of March 31, 2018, the Company and certain of its subsidiaries that serve as guarantors were in compliance with all covenants. |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 3 Months Ended |
Mar. 31, 2018 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | (11) DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The Company uses forward foreign currency exchange contracts to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company’s forecasted revenues and operating expenses being denominated in currencies other than the U.S. dollar, primarily the Euro. The Company designates certain of these forward foreign currency exchange contracts as hedging instruments and enters into some forward foreign currency exchange contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward foreign currency exchange contracts protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues, operating expenses and asset or liability positions designated in currencies other than the U.S. dollar. The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates, and take into consideration the current creditworthiness of the counterparties or the Company, as applicable. Information regarding the specific instruments used by the Company to hedge its exposure to foreign currency exchange rate fluctuations is provided below. The Company enters into forward foreign currency exchange contracts in order to protect against the fluctuations in revenue and operating expenses associated with foreign currency-denominated cash flows. The Company has formally designated these forward foreign currency exchange contracts as cash flow hedges and expects them to be highly effective in offsetting fluctuations in operating expenses denominated in Euros and revenues denominated in currencies other than the U.S. dollar related to changes in foreign currency exchange rates. The following table summarizes the Company’s designated forward foreign currency exchange contracts outstanding as of March 31, 2018 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Brazilian Reais – Sell 6 160.0 May 2018 Canadian Dollars – Sell 18 21.3 Apr. 2018 - Dec. 2018 Colombian Pesos – Sell 9 73,000.0 Apr. 2018 - Dec. 2018 Euros – Purchase 87 121.2 Apr. 2018 - Mar. 2021 Euros – Sell 293 376.9 Apr. 2018 - Mar. 2021 Total 413 The maximum length of time over which the Company is hedging its exposure to the reduction in value of forecasted foreign currency revenues through forward foreign currency exchange contracts is through March 2021. Over the next twelve months, the Company expects to reclassify unrealized losses of $15.0 million from Accumulated Other Comprehensive Loss t The following table summarizes the Company’s non-designated forward foreign currency exchange contracts outstanding as of March 31, 2018 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Brazilian Reais – Purchase 1 2.8 May 2018 British Pounds – Sell 1 3.3 Apr. 2018 Colombian Pesos – Sell 1 20,000.0 Apr. 2018 Euros – Purchase 4 115.2 Apr. 2018 Total 7 The fair value carrying amounts of the Company’s derivative instruments, as classified within the fair value hierarchy, were as follows: Asset Derivatives Liability Derivatives March 31, 2018 March 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 $ 5,646 Accounts payable and accrued liabilities $ 19,632 Forward foreign currency exchange contracts Other assets 5,930 Other long- term liabilities 14,865 Total 11,576 34,497 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets 82 Accounts payable and accrued liabilities 991 Total 82 991 Total value of derivative contracts $ 11,658 $ 35,488 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 and 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 and accrued liabilities 44 Total 675 44 Total value of derivative contracts $ 9,663 $ 27,150 (1) See Note 12 to these Condensed Consolidated Financial Statements for additional information related to the Company’s fair value measurements. The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three months ended March 31, 2018 and 2017 was as follows: Three Months Ended March 31, 2018 2017 Derivatives Designated as Hedging Instruments: Net loss recognized in accumulated other comprehensive loss (1) $ (9,226 ) $ (4,199 ) Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings (2) $ (5,785 ) $ 2,516 Net gain (loss) recognized in net loss (3) $ (378 ) $ 880 Derivatives Not Designated as Hedging Instruments: Net gain recognized in net loss (4) $ 1,254 $ 258 (1) Net change in the fair value of the effective portion classified as accumulated other comprehensive loss. (2) Effective portion classified as Net Product Revenues and Operating expenses. (3) Ineffective portion and amount excluded from effectiveness testing classified as Operating expenses. (4) Classified as Operating expenses. 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 | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | (12) FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value on a recurring basis. In addition to available-for-sale debt securities, debt and foreign currency derivatives, which are disclosed in Notes 6, 10 and 11, respectively, the following tables below present the classification within fair value hierarchy of financial assets and liabilities not disclosed elsewhere. Fair Value Measurements at March 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 $ — $ 1,130 $ — $ 1,130 Restricted investments (1) — 13,684 — 13,684 Total other current assets — 14,814 — 14,814 Other assets: NQDC Plan assets — 12,515 — 12,515 Total other assets — 12,515 — 12,515 Total assets $ — $ 27,329 $ — $ 27,329 Liabilities: Current liabilities: NQDC Plan liability $ 1,850 $ 1,130 $ — $ 2,980 Contingent acquisition consideration payable — — 61,607 61,607 Total current liabilities 1,850 1,130 61,607 64,587 Other long-term liabilities: NQDC Plan liability $ 15,771 $ 12,515 — 28,286 Contingent acquisition consideration payable — — 137,618 137,618 Total other long-term liabilities 15,771 12,515 137,618 165,904 Total liabilities $ 17,621 $ 13,645 $ 199,225 $ 230,491 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 acquisition consideration payable — — 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 acquisition consideration payable — — 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 March 31, 2018 and December 31, 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. There were no transfers between levels during the three months ended March 31, 2018. 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. Liabilities measured at fair value using Level 3 inputs consisted of contingent acquisition consideration payable and asset retirement obligations. The following tables represent a roll-forward of contingent acquisition consideration payable. Contingent acquisition consideration payable at December 31, 2017 $ 188,966 Changes in the fair value of other contingent acquisition consideration payable 5,631 Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 4,628 Contingent acquisition consideration payable at March 31, 2018 $ 199,225 Under certain of the Company’s lease agreements, the Company is contractually obligated to return leased space to its original condition upon termination of the lease agreement. The Company records an asset retirement obligation liability and a corresponding capital asset in an amount equal to the estimated fair value of the obligation, when estimable. In subsequent periods, for each such lease, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciates each capitalized asset retirement obligation asset, both over the term of the associated lease agreement. As of March 31, 2018 and December 31, 2017, the balance of the asset retirement obligation liability was $4.3 million and $4.2 million, respectively. The Company acquired intangible assets as a result of various business acquisitions. The estimated fair value of these long-lived assets was measured using Level 3 inputs as of the acquisition date. Refer to Note 3 – Significant Accounting Policies |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
STOCK-BASED COMPENSATION | (13) STOCK-BASED COMPENSATION Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Loss for all stock-based compensation arrangements was as follows: Three Months Ended March 31, 2018 2017 Cost of sales $ 3,140 $ 2,286 R&D 13,269 11,494 SG&A 20,199 16,894 Total stock-based compensation expense $ 36,608 $ 30,674 Stock-based compensation expense of $3.5 million was capitalized into inventory for the three months ended March 31, 2018, compared to stock-based compensation expense of $3.2 million that was capitalized into inventory for the three months ended March 31, 2017. Capitalized stock-based compensation is recognized as cost of sales when the related product is sold. Equity Awards with Service-Based Vesting Conditions The assumptions used to estimate the per share fair value of stock options granted under the Company’s 2017 Equity Incentive Plan and the Company’s Amended and Restated 2006 Share Incentive Plan were as follows: Three Months Ended March 31, 2018 2017 Expected volatility 37.8 – 38.3% 37.6 – 39.7% Dividend yield 0.0% 0.0% Expected life 4.6 – 5.7 years 5.0 – 6.6 years Risk-free interest rate 2.3 – 2.7% 1.8 – 2.2% During the three The Company did not issue any new stock purchase rights under the ESPP during the three months ended March 31, 2018. During the three 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 of RSUs with performance-based vesting conditions with similar performance conditions were granted in 2017, 2016 and 2015. 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: Grant Date Date of Grant Base RSUs Granted Fair Value per RSU Multiplier Achieved RSUs Earned March 2018 129,680 $ 83.57 (1) (1) March 2017 133,250 $ 87.42 1.03 132,548 March 2016 130,310 $ 83.43 1.03 134,219 March 2015 58,300 $ 108.36 1.11 64,713 (1) The Company’s Compensation Committee is expected to approve the multiplier and total earned RSUs in the first quarter of 2019 based on the Company’s performance against the 2018 managed revenue target. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation Expense | Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Loss for all stock-based compensation arrangements was as follows: Three Months Ended March 31, 2018 2017 Cost of sales $ 3,140 $ 2,286 R&D 13,269 11,494 SG&A 20,199 16,894 Total stock-based compensation expense $ 36,608 $ 30,674 |
Stock Option Valuation Assumptions | The assumptions used to estimate the per share fair value of stock options granted under the Company’s 2017 Equity Incentive Plan and the Company’s Amended and Restated 2006 Share Incentive Plan were as follows: Three Months Ended March 31, 2018 2017 Expected volatility 37.8 – 38.3% 37.6 – 39.7% Dividend yield 0.0% 0.0% Expected life 4.6 – 5.7 years 5.0 – 6.6 years Risk-free interest rate 2.3 – 2.7% 1.8 – 2.2% |
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: Grant Date Date of Grant Base RSUs Granted Fair Value per RSU Multiplier Achieved RSUs Earned March 2018 129,680 $ 83.57 (1) (1) March 2017 133,250 $ 87.42 1.03 132,548 March 2016 130,310 $ 83.43 1.03 134,219 March 2015 58,300 $ 108.36 1.11 64,713 (1) The Company’s Compensation Committee is expected to approve the multiplier and total earned RSUs in the first quarter of 2019 based on the Company’s performance against the 2018 managed revenue target. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | (14) ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) The following table summarizes amounts reclassified out of AOCI and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2018 and 2017. Condensed Consolidated Three Months Ended March 31, Statement of Details about AOCI Components 2018 2017 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ (7,646 ) $ 3,542 Net product revenues Forward foreign currency exchange contracts 1,861 (1,026 ) Operating expenses Total gain (loss) on cash flow hedges (5,785 ) 2,516 Gain (loss) on sale of available-for-sale debt securities — 3,252 Other income Income tax effect of the above — (1,181 ) Benefit from income taxes Total gain (loss) on available-for-sale debt securities — 2,071 $ (5,785 ) $ 4,587 Net loss The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI for the three months ended March 31, 2018 and 2017. Three Months Ended March 31, 2018 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Foreign Currency Items Total 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 (9,226 ) (2,021 ) 1 (11,246 ) Less: net loss reclassified from AOCI (5,785 ) — — (5,785 ) Tax effect — 463 — 463 Net current-period other comprehensive income (loss) (3,441 ) (1,558 ) 1 (4,998 ) AOCI balance at March 31, 2018 $ (23,673 ) $ (4,866 ) $ (6 ) $ (28,545 ) (1) As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from Accumulated Other Comprehensive Loss to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion . Three Months Ended March 31, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Foreign Currency Items Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (4,199 ) 1,567 (1 ) (2,633 ) Less: gain reclassified from AOCI 2,516 3,252 — 5,768 Tax effect — 605 — 605 Net current-period other comprehensive income (loss) (6,715 ) (1,080 ) (1 ) (7,796 ) AOCI balance at March 31, 2017 $ 6,291 $ (1,258 ) $ (13 ) $ 5,020 |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 3 Months Ended |
Mar. 31, 2018 | |
Concentration Risk And Geographic Information [Abstract] | |
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | (15) 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 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. Three Months Ended March 31, 2018 2017 Total revenues by geographic region: United States $ 190,571 $ 132,484 Europe 71,341 65,770 Latin America 27,773 37,304 Rest of world 83,762 68,187 Total revenues $ 373,447 $ 303,745 The following table disaggregates total Net Product Revenues from external customers by product. Three Months Ended March 31, 2018 2017 Net product revenues by product: Aldurazyme $ 66,056 $ 19,355 Brineura 6,917 — Firdapse 4,926 4,110 Kuvan 99,115 92,346 Naglazyme 74,996 80,558 Vimizim 117,089 105,821 Total net product revenues $ 369,099 $ 302,190 The table below disaggregates total Net Product Revenues based on patient location for Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim, which are sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Genzyme is the Company ’ Three Months Ended March 31, 2018 2017 United States $ 124,141 $ 112,706 Europe 68,798 65,770 Latin America 27,773 37,304 Rest of world 82,331 67,055 Total net product revenue marketed by the Company 303,043 282,835 Aldurazyme net product revenues marketed by Genzyme 66,056 19,355 Total net product revenues $ 369,099 $ 302,190 The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the three months ended March 31, 2018 and 2017. Three Months Ended March 31, 2018 2017 Customer A 18 % 6 % Customer B 17 % 17 % Customer C 12 % 13 % Customer D 8 % 10 % Total 55 % 46 % On a consolidated basis, the Company’s two largest customer accounts receivable balances accounted for 34% and 17% of the March 31, 2018 total accounts receivable balance, respectively, compared to December 31, 2017, when the two largest customer accounts receivable balances accounted for 21% and 18% of the total accounts receivable balance, respectively. As of March 31, 2018, and December 31, 2017, the accounts receivable balance for Genzyme included $85.0 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 Company 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. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | (16) COMMITMENTS AND CONTINGENCIES 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 March 31, 2018, the Company is subject to contingent payments totaling approximately $613.8 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, $227.6 million relates to the acquisition of certain rights and other assets with respect to Kuvan and pegvaliase from Ares Trading S.A. (Merck Serono) and its affiliates and $55.0 million relates to programs that are no longer being developed. As of March 31, 2018, the Company has recorded a total of $199.2 million of contingent acquisition consideration payable on its Condensed Consolidated Balances Sheet. The Company paid $61.6 million of the total liability in April 2018 related to the filing of the European Marketing Authorization Application for pegvaliase. See Note 12 to these Condensed Consolidated Financial Statements for further information regarding the Company’s contingent acquisition consideration payable. Other Commitments In the normal course of business, the Company enters into various firm purchase commitments primarily related to active pharmaceutical ingredients March 31, 2018 |
BENEFIT FROM INCOME TAXES
BENEFIT FROM INCOME TAXES | 3 Months Ended |
Mar. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
BENEFIT FROM INCOME TAXES | (17) BENEFIT FROM INCOME TAXES On December 22, 2017, the 2017 Tax Act was signed into law. The new law resulted in significant changes to the U.S. corporate income tax system. These changes included a federal statutory rate reduction from 35% to 21% and the elimination or reduction of certain domestic deductions and credits, including a 50% reduction in the orphan drug credit benefit. The 2017 Tax Act changed U.S. international taxation from a worldwide basis to a modified territorial system that includes base erosion prevention measures on foreign earnings. This will result in the Company’s foreign subsidiaries being subject to U.S. taxation in the future. These changes are effective in 2018. U.S. and foreign tax expense was computed using a forecasted annual effective tax rate for the three months ended March 31, 2018 from income taxes for the three months ended March 31, 2017 using an actual year-to-date tax calculation. Foreign tax expense was computed using a forecasted annual effective tax rate for the three months ended March 31, 2017. The 2017 provisional charge related to the 2017 Tax Act was an estimate and the measurement of net deferred tax assets is subject to further analysis and potential correlative adjustments as developing interpretations and guidance from the U.S. Treasury Department, the Internal Revenue Service, and other standard setting bodies provide additional clarifications of the provisions of the 2017 Tax Act. Updated guidance and regulations could result in changes to this provisional charge during 2018 when the analysis is complete, and, in accordance with the guidance in Staff Accounting Bulletin 118, the Company will continue to monitor guidance and make necessary adjustments. In the first quarter of 2018, the Company recorded a tax benefit of $4.6 million associated with a measurement-period adjustment related to the remeasurement of deferred taxes as a result of the 2017 Tax Act. The Company continues to gather additional information related to the deferred tax adjustments resulting from the 2107 Tax Act to more precisely compute the remeasurement of deferred taxes. The Company has not yet elected an accounting method regarding whether to record deferred tax assets and liabilities for expected amounts of Global Intangible Low-Taxed Income (GILTI) inclusions or whether to treat such amounts as a period cost. |
SIGNIFICANT ACCOUNTING POLICI25
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying Condensed Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by U.S. GAAP for complete financial statements, although the Company believes that the disclosures herein are adequate to ensure that the information presented is not misleading. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K. Effective January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method as discussed in Note 3 - Significant Accounting Policies U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. The results of operations for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2018 or any other period. Management performed an evaluation of the Company’s activities through the date of filing of this Quarterly Report on Form 10-Q, and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements. |
Net Product Revenues | Net Product Revenues In the U.S., the Company’s commercial products are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Outside the U.S., the Company’s commercial products are sold to its authorized distributors or directly to government purchasers or hospitals, which act as the end-users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. Amounts collected from customers and remitted to governmental authorities, which primarily consist of value-added taxes related to product sales in foreign jurisdictions, are presented on a net basis in the Company’s Condensed Consolidated Statements of Comprehensive Loss, in that taxes billed to customers are not included as a component of Net Product Revenues. For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Genzyme Corporation (Genzyme) depending on sales volume, which is included in Net Product Revenues in the Company’s Condensed Consolidated Statements of Comprehensive Loss. Under the previous guidance the Company only recognized a portion of this amount 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. Under ASC 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, however the Company does not expect any such amounts to be material. If actual results in the future 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. |
Revenue Reserves | 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, as such 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 which 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. 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 and the estimated costs of the Company’s patient co-payment assistance programs. Beginning in 2018, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on Kuvan or Brineura therapy. The branded co-pay assistance programs assist commercially insured patients who have coverage for Kuvan or Brineura and are intended to reduce each participating patient’s portion of the financial responsibility for Kuvan’s or Brineura’s 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 | 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 utilizes 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 . |
RECENT ACCOUNTING PRONOUNCEME26
RECENT ACCOUNTING PRONOUNCEMENTS (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Summary of Adjustments to Accounts on Condensed Consolidated Balance Sheet, Comprehensive Loss Statements and Cash Flows Statement | The cumulative effect of applying the new guidance of ASC 606 As Reported 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 $ — $ (5,964 ) $ 393,131 Total assets $ 4,633,125 $ 26,012 $ (5,964 ) $ 4,653,173 Equity: Accumulated deficit $ (1,637,548 ) $ 26,012 $ (5,964 ) $ (1,617,500 ) Total liabilities and stockholders' equity $ 4,633,125 $ 26,012 $ (5,964 ) $ 4,653,173 (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 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 estimate statutory rate. The impact of adoption on the Company’s Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2018 was as follows: Balance without Adoption of As Reported Adjustments (1) ASC 606 Statement of Comprehensive Loss Net product revenues $ 369,099 $ (27,197 ) $ 341,902 Benefit from income taxes $ (6,655 ) $ (6,236 ) $ (12,891 ) Net loss $ (44,149 ) $ (20,961 ) $ (65,110 ) (1) The adoption of ASC 606 resulted in additional revenues recognized in the first quarter of 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 Condensed Consolidated Statement of Cash Flows for the three months ended March 31, 2018 was as follows: Balance without Adoption of As Reported Adjustments (1) ASC 606 Statement of Cash Flows Net loss $ (44,149 ) $ (20,961 ) $ (65,110 ) Deferred income taxes $ (13,988 ) $ (6,236 ) $ (20,224 ) Changes in operating assets and liabilities: Accounts receivable, net $ (26,257 ) $ 27,197 $ 940 Net cash used in operating activities $ (42,509 ) $ — $ (42,509 ) (1) The adoption of ASC 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in the first quarter of 2018, which in turn generated additional deferred tax liabilities that reduced the Company's net Deferred Tax Assets. The Deferred Income Taxes amount has been calculated using the Company’s estimated statutory rate. |
NET LOSS PER COMMON SHARE (Tabl
NET LOSS PER COMMON SHARE (Tables) | 3 Months Ended |
Mar. 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 (in thousands of common shares): Three Months Ended March 31, 2018 2017 Numerator: Net loss, basic $ (44,149 ) $ (16,290 ) Less: gain on common stock held by the NQDC 1,322 — Net loss, diluted $ (45,471 ) $ (16,290 ) Denominator: Weighted-average common shares outstanding, basic 175,932 172,710 Effect of dilutive securities: Common shares held by the NQDC 218 — Weighted-average common shares outstanding, diluted 176,150 172,710 Net loss per common share, basic $ (0.25 ) $ (0.09 ) Net loss per common share, diluted $ (0.26 ) $ (0.09 ) |
Schedule Of Anti-Dilutive Common Stock Excluded From Computation of Basic and Diluted Net Loss Per Share | The table below presents potential shares of common stock that were excluded from the computation of basic and diluted earnings per common share as they were anti-dilutive using the if-converted or treasury stock method (in thousands): Three Months Ended March 31, 2018 2017 Options to purchase common stock 8,473 9,070 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 Common stock issuable under the 2024 Notes 3,970 — Unvested restricted stock units 3,734 3,274 Common stock potentially issuable for ESPP purchases 425 384 Common stock held by the NQDC — 228 Total number of potentially issuable shares 24,568 22,027 |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended |
Mar. 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 March 31, 2018 and December 31, 2017: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 270,194 $ — $ — $ 270,194 $ 270,194 $ — $ — Level 2: Money market instruments 170,601 — — 170,601 170,601 — — Corporate debt securities 692,763 101 (4,371 ) 688,493 5,549 431,723 251,221 Commercial paper 53,584 — — 53,584 22,642 30,942 — U.S. government agency securities 486,014 1 (2,144 ) 483,871 4,994 416,707 62,170 Foreign and other 29,552 158 (59 ) 29,651 — 29,443 208 Subtotal 1,432,514 260 (6,574 ) 1,426,200 203,786 908,815 313,599 Total $ 1,702,708 $ 260 $ (6,574 ) $ 1,696,394 $ 473,980 $ 908,815 $ 313,599 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses 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) | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: March 31, December 31, 2018 2017 Intangible assets: Finite-lived intangible assets $ 303,298 $ 303,298 Indefinite-lived intangible assets 326,359 326,359 Gross intangible assets: 629,657 629,657 Less: Accumulated amortization (119,755 ) (112,147 ) Net carrying value $ 509,902 $ 517,510 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property Plant and Equipment Net | Property, plant and equipment, net consisted of the following: March 31, December 31, 2018 2017 Building and improvements $ 660,181 $ 663,347 Manufacturing and laboratory equipment 307,494 294,521 Computer hardware and software 149,313 144,268 Leasehold improvements 43,180 42,572 Furniture and equipment 31,794 31,515 Land improvements 5,376 5,331 Land 62,369 62,369 Construction-in-progress 61,952 59,511 1,321,659 1,303,434 Accumulated depreciation (426,267 ) (406,734 ) Total property, plant and equipment, net $ 895,392 $ 896,700 |
SUPPLEMENTAL BALANCE SHEET IN31
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: March 31, December 31, 2018 2017 Raw materials $ 52,642 $ 49,877 Work-in-process 194,581 234,674 Finished goods 220,938 191,224 Total inventory $ 468,161 $ 475,775 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: March 31, December 31, 2018 2017 Accounts payable and accrued operating expenses $ 172,192 $ 166,616 Accrued compensation expense 76,600 140,781 Accrued rebates payable 38,447 36,472 Accrued royalties payable 16,496 18,820 Value added taxes payable 10,221 9,740 Forward foreign currency exchange contracts 20,623 14,464 Accrued income taxes — 5,528 Other 11,959 9,500 Total accounts payable and accrued liabilities $ 346,538 $ 401,921 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: March 31, December 31, 2018 2017 0.75% senior subordinated convertible notes due in 2018 $ 374,980 $ 374,980 Unamortized discount (8,597 ) (12,488 ) Unamortized deferred offering costs (1,057 ) (1,543 ) Convertible Notes due in 2018, net 365,326 360,949 1.50% senior subordinated convertible notes due in 2020 374,993 374,993 Unamortized discount (36,932 ) (40,287 ) Unamortized deferred offering costs (3,307 ) (3,631 ) Convertible Notes due in 2020, net 334,754 331,075 0.599% senior subordinated convertible notes due in 2024 495,000 495,000 Unamortized discount (9,004 ) (9,355 ) Unamortized deferred offering costs (3,078 ) (3,199 ) Convertible Notes due in 2024, net 482,918 482,446 Total convertible debt, net $ 1,182,998 $ 1,174,470 Fair value of fixed rate convertible debt Convertible Notes due in 2018 (1) $ 383,323 $ 403,955 Convertible Notes due in 2020 (1) 414,187 446,470 Convertible Notes due in 2024 (1) 465,803 493,894 Total $ 1,263,313 $ 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 12 to these Condensed 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 convertible debt consisted of the following: Three Months Ended March 31, 2018 2017 Coupon interest expense $ 2,961 $ 2,364 Amortization of debt issuance costs 1,004 886 Accretion of discount on convertible notes 7,597 6,869 Total interest expense on convertible debt $ 11,562 $ 10,119 |
DERIVATIVE INSTRUMENTS AND HE33
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Derivative [Line Items] | |
Fair Value Carrying Amount of Derivative Instruments | The fair value carrying amounts of the Company’s derivative instruments, as classified within the fair value hierarchy, were as follows: Asset Derivatives Liability Derivatives March 31, 2018 March 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 $ 5,646 Accounts payable and accrued liabilities $ 19,632 Forward foreign currency exchange contracts Other assets 5,930 Other long- term liabilities 14,865 Total 11,576 34,497 Derivatives not designated as hedging instruments: Level 2 (1) Forward foreign currency exchange contracts Other current assets 82 Accounts payable and accrued liabilities 991 Total 82 991 Total value of derivative contracts $ 11,658 $ 35,488 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 and 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 and accrued liabilities 44 Total 675 44 Total value of derivative contracts $ 9,663 $ 27,150 (1) See Note 12 to these Condensed Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Effect of Derivative Instruments | The effect of the Company’s derivative instruments on the Condensed Consolidated Financial Statements for the three months ended March 31, 2018 and 2017 was as follows: Three Months Ended March 31, 2018 2017 Derivatives Designated as Hedging Instruments: Net loss recognized in accumulated other comprehensive loss (1) $ (9,226 ) $ (4,199 ) Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings (2) $ (5,785 ) $ 2,516 Net gain (loss) recognized in net loss (3) $ (378 ) $ 880 Derivatives Not Designated as Hedging Instruments: Net gain recognized in net loss (4) $ 1,254 $ 258 (1) Net change in the fair value of the effective portion classified as accumulated other comprehensive loss. (2) Effective portion classified as Net Product Revenues and Operating expenses. (3) Ineffective portion and amount excluded from effectiveness testing classified as Operating expenses. (4) Classified as Operating expenses. |
Derivatives Designated As Hedging Instruments | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company’s designated forward foreign currency exchange contracts outstanding as of March 31, 2018 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Brazilian Reais – Sell 6 160.0 May 2018 Canadian Dollars – Sell 18 21.3 Apr. 2018 - Dec. 2018 Colombian Pesos – Sell 9 73,000.0 Apr. 2018 - Dec. 2018 Euros – Purchase 87 121.2 Apr. 2018 - Mar. 2021 Euros – Sell 293 376.9 Apr. 2018 - Mar. 2021 Total 413 |
Not Designated as Hedging Instrument | |
Derivative [Line Items] | |
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company’s non-designated forward foreign currency exchange contracts outstanding as of March 31, 2018 (notional amounts in millions): Aggregate Notional Number of Amount in Foreign Exchange Contracts Contracts Foreign Currency Maturity Brazilian Reais – Purchase 1 2.8 May 2018 British Pounds – Sell 1 3.3 Apr. 2018 Colombian Pesos – Sell 1 20,000.0 Apr. 2018 Euros – Purchase 4 115.2 Apr. 2018 Total 7 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The Company measures certain financial assets and liabilities at fair value on a recurring basis. In addition to available-for-sale debt securities, debt and foreign currency derivatives, which are disclosed in Notes 6, 10 and 11, respectively, the following tables below present the classification within fair value hierarchy of financial assets and liabilities not disclosed elsewhere. Fair Value Measurements at March 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 $ — $ 1,130 $ — $ 1,130 Restricted investments (1) — 13,684 — 13,684 Total other current assets — 14,814 — 14,814 Other assets: NQDC Plan assets — 12,515 — 12,515 Total other assets — 12,515 — 12,515 Total assets $ — $ 27,329 $ — $ 27,329 Liabilities: Current liabilities: NQDC Plan liability $ 1,850 $ 1,130 $ — $ 2,980 Contingent acquisition consideration payable — — 61,607 61,607 Total current liabilities 1,850 1,130 61,607 64,587 Other long-term liabilities: NQDC Plan liability $ 15,771 $ 12,515 — 28,286 Contingent acquisition consideration payable — — 137,618 137,618 Total other long-term liabilities 15,771 12,515 137,618 165,904 Total liabilities $ 17,621 $ 13,645 $ 199,225 $ 230,491 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 acquisition consideration payable — — 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 acquisition consideration payable — — 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 March 31, 2018 and December 31, 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. |
Liabilities Measured at Fair Value Using Level 3 Inputs | Contingent acquisition consideration payable at December 31, 2017 $ 188,966 Changes in the fair value of other contingent acquisition consideration payable 5,631 Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable 4,628 Contingent acquisition consideration payable at March 31, 2018 $ 199,225 |
ACCUMULATED OTHER COMPREHENSI35
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Amounts Reclassified out of AOCI | The following table summarizes amounts reclassified out of AOCI and their effect on the Company’s Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2018 and 2017. Condensed Consolidated Three Months Ended March 31, Statement of Details about AOCI Components 2018 2017 Comprehensive Loss Classification Gains (losses) on cash flow hedges: Forward foreign currency exchange contracts $ (7,646 ) $ 3,542 Net product revenues Forward foreign currency exchange contracts 1,861 (1,026 ) Operating expenses Total gain (loss) on cash flow hedges (5,785 ) 2,516 Gain (loss) on sale of available-for-sale debt securities — 3,252 Other income Income tax effect of the above — (1,181 ) Benefit from income taxes Total gain (loss) on available-for-sale debt securities — 2,071 $ (5,785 ) $ 4,587 Net loss |
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI | The following tables summarize changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI for the three months ended March 31, 2018 and 2017. Three Months Ended March 31, 2018 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Foreign Currency Items Total 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 (9,226 ) (2,021 ) 1 (11,246 ) Less: net loss reclassified from AOCI (5,785 ) — — (5,785 ) Tax effect — 463 — 463 Net current-period other comprehensive income (loss) (3,441 ) (1,558 ) 1 (4,998 ) AOCI balance at March 31, 2018 $ (23,673 ) $ (4,866 ) $ (6 ) $ (28,545 ) (1) As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from Accumulated Other Comprehensive Loss to Accumulated Deficit in the first quarter of 2018 related to the adoption of ASU 2018-02. See Note 4 for additional discussion . Three Months Ended March 31, 2017 Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Foreign Currency Items Total AOCI balance at December 31, 2016 $ 13,006 $ (178 ) $ (12 ) $ 12,816 Other comprehensive income (loss) before reclassifications (4,199 ) 1,567 (1 ) (2,633 ) Less: gain reclassified from AOCI 2,516 3,252 — 5,768 Tax effect — 605 — 605 Net current-period other comprehensive income (loss) (6,715 ) (1,080 ) (1 ) (7,796 ) AOCI balance at March 31, 2017 $ 6,291 $ (1,258 ) $ (13 ) $ 5,020 |
REVENUE, CREDIT CONCENTRATION36
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 3 Months Ended |
Mar. 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. Three Months Ended March 31, 2018 2017 Total revenues by geographic region: United States $ 190,571 $ 132,484 Europe 71,341 65,770 Latin America 27,773 37,304 Rest of world 83,762 68,187 Total revenues $ 373,447 $ 303,745 |
Disaggregates of Total Net Product Revenues from External Customers by Product | The following table disaggregates total Net Product Revenues from external customers by product. Three Months Ended March 31, 2018 2017 Net product revenues by product: Aldurazyme $ 66,056 $ 19,355 Brineura 6,917 — Firdapse 4,926 4,110 Kuvan 99,115 92,346 Naglazyme 74,996 80,558 Vimizim 117,089 105,821 Total net product revenues $ 369,099 $ 302,190 |
Disaggregates of Total Net Product Revenues Based on Patient Location | The table below disaggregates total Net Product Revenues based on patient location for Brineura, Firdapse, Kuvan, Naglazyme, and Vimizim, which are sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Genzyme is the Company ’ Three Months Ended March 31, 2018 2017 United States $ 124,141 $ 112,706 Europe 68,798 65,770 Latin America 27,773 37,304 Rest of world 82,331 67,055 Total net product revenue marketed by the Company 303,043 282,835 Aldurazyme net product revenues marketed by Genzyme 66,056 19,355 Total net product revenues $ 369,099 $ 302,190 |
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 three months ended March 31, 2018 and 2017. Three Months Ended March 31, 2018 2017 Customer A 18 % 6 % Customer B 17 % 17 % Customer C 12 % 13 % Customer D 8 % 10 % Total 55 % 46 % |
Nature of Operations - Addition
Nature of Operations - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2018Product | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of approved commercial products | 6 |
Summary of Significant Accounti
Summary of Significant Accounting Policies - Additional Information (Detail) - Aldurazyme | Mar. 31, 2018 |
Minimum | |
Significant Accounting Policies [Line Items] | |
Payment received as percentage of net product sales | 39.50% |
Maximum | |
Significant Accounting Policies [Line Items] | |
Payment received as percentage of net product sales | 50.00% |
Recent Accounting Pronounceme39
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Condensed Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | [1] | Jan. 01, 2018 | Dec. 31, 2017 | [2] | |
ASSETS | ||||||
Accounts receivable, net | $ 318,394 | $ 261,365 | ||||
Deferred tax assets | 407,009 | 399,095 | ||||
Total assets | 4,596,717 | 4,633,125 | ||||
Equity: | ||||||
Accumulated deficit | (1,661,063) | (1,637,548) | ||||
Total liabilities and stockholders' equity | $ 4,596,717 | $ 4,633,125 | ||||
ASC 606 | ||||||
ASSETS | ||||||
Accounts receivable, net | $ 287,377 | |||||
Deferred tax assets | 393,131 | |||||
Total assets | 4,653,173 | |||||
Equity: | ||||||
Accumulated deficit | (1,617,500) | |||||
Total liabilities and stockholders' equity | 4,653,173 | |||||
Adjustments | ASC 606 | Tax Provision | ||||||
ASSETS | ||||||
Accounts receivable, net | [3] | 0 | ||||
Deferred tax assets | [3] | (5,964) | ||||
Total assets | [3] | (5,964) | ||||
Equity: | ||||||
Accumulated deficit | [3] | (5,964) | ||||
Total liabilities and stockholders' equity | [3] | (5,964) | ||||
Adjustments | ASC 606 | Aldurazyme | ||||||
ASSETS | ||||||
Accounts receivable, net | [4] | 26,012 | ||||
Deferred tax assets | [4] | 0 | ||||
Total assets | [4] | 26,012 | ||||
Equity: | ||||||
Accumulated deficit | [4] | 26,012 | ||||
Total liabilities and stockholders' equity | [4] | $ 26,012 | ||||
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | |||||
[3] | The adoption of ASC 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 estimate statutory rate. | |||||
[4] | 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 Pronounceme40
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Condensed Consolidated Statement of Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | |||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | $ 369,099 | [1] | $ 302,190 | |
Benefit from income taxes | (6,655) | [1] | (8,016) | |
Net loss | (44,149) | [1] | $ (16,290) | |
Adjustments | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | [2] | (27,197) | ||
Benefit from income taxes | [2] | (6,236) | ||
Net loss | [2],[3] | (20,961) | ||
Balance Without Adoption of ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net product revenues | 341,902 | |||
Benefit from income taxes | (12,891) | |||
Net loss | $ (65,110) | |||
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | The adoption of ASC 606 resulted in additional revenues recognized in the first quarter of 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. | |||
[3] | The adoption of ASC 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in the first quarter of 2018, which in turn generated additional deferred tax liabilities that reduced the Company's net Deferred Tax Assets. The Deferred Income Taxes amount has been calculated using the Company’s estimated statutory rate. |
Recent Accounting Pronounceme41
Recent Accounting Pronouncements - Summary of Adjustments to Accounts on Condensed Consolidated Statement of Cash Flows (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | |||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | $ (44,149) | [1] | $ (16,290) | |
Deferred income taxes | (13,988) | [1] | (10,441) | |
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | (26,257) | [1] | (14,051) | |
Net cash used in operating activities | (42,509) | [1] | $ (80,443) | |
Adjustments | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | [2],[3] | (20,961) | ||
Deferred income taxes | [3] | (6,236) | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | [3] | 27,197 | ||
Net cash used in operating activities | [3] | 0 | ||
Balance Without Adoption of ASC 606 | ||||
Recent Accounting Pronouncements [Line Items] | ||||
Net loss | (65,110) | |||
Deferred income taxes | (20,224) | |||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | 940 | |||
Net cash used in operating activities | $ (42,509) | |||
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | The adoption of ASC 606 resulted in additional revenues recognized in the first quarter of 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. | |||
[3] | The adoption of ASC 606 resulted in decreased Net Loss and increased Accounts Receivable, Net due to additional revenues recognized in the first quarter of 2018, which in turn generated additional deferred tax liabilities that reduced the Company's net Deferred Tax Assets. The Deferred Income Taxes amount has been calculated using the Company’s estimated statutory rate. |
Recent Accounting Pronounceme42
Recent Accounting Pronouncements - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2018USD ($) | |
ASU 2018-02 | |
Recent Accounting Pronouncements [Line Items] | |
Reclassification from AOCI to accumulated deficit | $ 0.6 |
Computation of Basic and Dilute
Computation of Basic and Diluted Earnings per Common Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Earnings Per Share [Abstract] | |||
Net loss, basic | $ (44,149) | $ (16,290) | |
Less: gain on common stock held by the NQDC | 1,322 | 0 | |
Net loss, diluted | $ (45,471) | $ (16,290) | |
Weighted-average common shares outstanding, basic | 175,932 | [1] | 172,710 |
Common shares held by the NQDC | 218 | 0 | |
Weighted-average common shares outstanding, diluted | 176,150 | [1] | 172,710 |
Net loss per common share, basic | $ (0.25) | [1] | $ (0.09) |
Net loss per common share, diluted | $ (0.26) | [1] | $ (0.09) |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Anti-Dilutive Common Stock Excl
Anti-Dilutive Common Stock Excluded From Computation of Basic and Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
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 | 24,568 | 22,027 |
Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 8,473 | 9,070 |
Common stock issuable under the 2017 Notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive | 0 | 1,105 |
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 | 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 |
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 | 3,734 | 3,274 |
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 | 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 | 425 | 384 |
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 | 228 |
Net Loss Per Common Share - Add
Net Loss Per Common Share - Additional Information (Detail) - $ / shares | 1 Months Ended | ||
Apr. 30, 2017 | Mar. 31, 2018 | Mar. 31, 2017 | |
Convertible Notes due 2018 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, interest rate, stated percentage, per annum | 0.75% | ||
Convertible Notes due 2020 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, interest rate, stated percentage, per annum | 1.50% | ||
Convertible Notes due 2018 and due 2020 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, convertible, conversion price, per share | $ 94.15 | $ 94.15 | |
Convertible Notes due in 2017 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, interest rate, stated percentage, per annum | 1.875% | ||
Debt Instrument, maturity month and year | 2017-04 | ||
Convertible Notes due in 2024 | |||
Earnings Per Share [Line Items] | |||
Debt instrument, interest rate, stated percentage, per annum | 0.599% |
Schedule of Cash, Cash Equivale
Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | |||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | $ 1,702,708 | $ 1,786,045 | |||||
Gross Unrealized Gains | 260 | 300 | |||||
Gross Unrealized Losses | (6,574) | (4,592) | |||||
Fair Value | 1,696,394 | 1,781,753 | |||||
Cash and Cash Equivalents | 473,980 | [1],[2] | 598,028 | [1],[3] | $ 348,234 | $ 408,330 | |
Short-term Marketable Securities | [4] | 908,815 | 797,940 | ||||
Long-term Marketable Securities | [5] | 313,599 | 385,785 | ||||
Level 1 | Cash | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Cash | 270,194 | 340,253 | |||||
Gross Unrealized Gains | 0 | 0 | |||||
Gross Unrealized Losses | 0 | 0 | |||||
Cash and Cash Equivalents | 270,194 | 340,253 | |||||
Short-term Marketable Securities | [4] | 0 | 0 | ||||
Long-term Marketable Securities | [5] | 0 | 0 | ||||
Level 2 | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 1,432,514 | 1,445,792 | |||||
Gross Unrealized Gains | 260 | 300 | |||||
Gross Unrealized Losses | (6,574) | (4,592) | |||||
Fair Value | 1,426,200 | 1,441,500 | |||||
Cash and Cash Equivalents | 203,786 | 257,775 | |||||
Short-term Marketable Securities | [4] | 908,815 | 797,940 | ||||
Long-term Marketable Securities | [5] | 313,599 | 385,785 | ||||
Level 2 | Money Market Instruments | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 170,601 | 215,441 | |||||
Gross Unrealized Gains | 0 | 0 | |||||
Gross Unrealized Losses | 0 | 0 | |||||
Fair Value | 170,601 | 215,441 | |||||
Cash and Cash Equivalents | 170,601 | 215,441 | |||||
Short-term Marketable Securities | [4] | 0 | 0 | ||||
Long-term Marketable Securities | [5] | 0 | 0 | ||||
Level 2 | Corporate Debt Securities | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 692,763 | 707,652 | |||||
Gross Unrealized Gains | 101 | 150 | |||||
Gross Unrealized Losses | (4,371) | (2,553) | |||||
Fair Value | 688,493 | 705,249 | |||||
Cash and Cash Equivalents | 5,549 | 3,096 | |||||
Short-term Marketable Securities | [4] | 431,723 | 406,188 | ||||
Long-term Marketable Securities | [5] | 251,221 | 295,965 | ||||
Level 2 | Commercial Paper | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 53,584 | 24,566 | |||||
Gross Unrealized Gains | 0 | 0 | |||||
Gross Unrealized Losses | 0 | 0 | |||||
Fair Value | 53,584 | 24,566 | |||||
Cash and Cash Equivalents | 22,642 | 2,751 | |||||
Short-term Marketable Securities | [4] | 30,942 | 21,815 | ||||
Long-term Marketable Securities | [5] | 0 | 0 | ||||
Level 2 | U.S. Government Agency Securities | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 486,014 | 472,593 | |||||
Gross Unrealized Gains | 1 | 0 | |||||
Gross Unrealized Losses | (2,144) | (1,975) | |||||
Fair Value | 483,871 | 470,618 | |||||
Cash and Cash Equivalents | 4,994 | 35,497 | |||||
Short-term Marketable Securities | [4] | 416,707 | 345,501 | ||||
Long-term Marketable Securities | [5] | 62,170 | 89,620 | ||||
Level 2 | Foreign and Other | |||||||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | |||||||
Amortized Cost | 29,552 | 25,540 | |||||
Gross Unrealized Gains | 158 | 150 | |||||
Gross Unrealized Losses | (59) | (64) | |||||
Fair Value | 29,651 | 25,626 | |||||
Cash and Cash Equivalents | 0 | 990 | |||||
Short-term Marketable Securities | [4] | 29,443 | 24,436 | ||||
Long-term Marketable Securities | [5] | $ 208 | $ 200 | ||||
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||||||
[2] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||||||
[3] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | ||||||
[4] | The Company’s short-term marketable securities mature in one year or less. | ||||||
[5] | The Company’s long-term marketable securities mature between one and five years. |
Schedule of Cash, Cash Equiva47
Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Parenthetical) (Detail) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Minimum | ||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | ||
Long-term marketable securities maturity period | 1 year | 1 year |
Maximum | ||
Schedule Of Cash Cash Equivalents And 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) | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Investments Debt And Equity Securities [Abstract] | |
Other- than- temporary impairment | $ 0 |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | ||
Intangible assets: | ||||
Finite-lived intangible assets | $ 303,298 | $ 303,298 | ||
Indefinite-lived intangible assets | 326,359 | 326,359 | ||
Gross intangible assets: | 629,657 | 629,657 | ||
Less: Accumulated amortization | (119,755) | (112,147) | ||
Net carrying value | $ 509,902 | [1] | $ 517,510 | [2] |
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - IPR&D | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Goodwill And Intangible Assets [Line Items] | |
Amount reclassified to definite-lived intangible assets | $ 0 |
Impairment charges on definite-lived intangible assets | $ 0 |
Schedule of Property Plant and
Schedule of Property Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | ||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | $ 1,321,659 | $ 1,303,434 | ||
Accumulated depreciation | (426,267) | (406,734) | ||
Total property, plant and equipment, net | 895,392 | [1] | 896,700 | [2] |
Building and Improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 660,181 | 663,347 | ||
Manufacturing and Laboratory Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 307,494 | 294,521 | ||
Computer Hardware and Software | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 149,313 | 144,268 | ||
Leasehold Improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 43,180 | 42,572 | ||
Furniture and Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 31,794 | 31,515 | ||
Land Improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 5,376 | 5,331 | ||
Land | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | 62,369 | 62,369 | ||
Construction-in-Progress | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant and equipment, gross | $ 61,952 | $ 59,511 | ||
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
Property Plant and Equipment -
Property Plant and Equipment - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 20 | $ 17.5 |
Depreciation capitalized into inventory | $ 4 | $ 5.5 |
Schedule of Inventory (Detail)
Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | ||
Inventory Disclosure [Abstract] | ||||
Raw materials | $ 52,642 | $ 49,877 | ||
Work-in-process | 194,581 | 234,674 | ||
Finished goods | 220,938 | 191,224 | ||
Total inventory | $ 468,161 | [1] | $ 475,775 | [2] |
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | ||
Condensed Financial Information Of Parent Company Only Disclosure [Abstract] | ||||
Accounts payable and accrued operating expenses | $ 172,192 | $ 166,616 | ||
Accrued compensation expense | 76,600 | 140,781 | ||
Accrued rebates payable | 38,447 | 36,472 | ||
Accrued royalties payable | 16,496 | 18,820 | ||
Value added taxes payable | 10,221 | 9,740 | ||
Forward foreign currency exchange contracts | 20,623 | 14,464 | ||
Accrued income taxes | 0 | 5,528 | ||
Other | 11,959 | 9,500 | ||
Total accounts payable and accrued liabilities | $ 346,538 | [1] | $ 401,921 | [2] |
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||
Convertible notes outstanding | $ 1,182,998,000 | $ 1,174,470,000 |
Revolving Credit Facility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 100,000,000 | |
Maturity date of convertible debt | Nov. 29, 2018 | |
Letter of credit subfacility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 10,000,000 | |
Swing line loan subfacility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | 15,000,000 | |
Credit Facility [Member] | ||
Debt Instrument [Line Items] | ||
Outstanding amount | $ 0 | $ 0 |
Summary of Convertible Debt (De
Summary of Convertible Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | |||
Debt Instrument [Line Items] | |||||
Convertible Notes, net of unamortized discount and deferred offering costs | $ 365,326 | [1] | $ 360,949 | [2] | |
Convertible Notes, net of unamortized discount and deferred offering costs | 817,672 | [1] | 813,521 | [2] | |
Total convertible debt, net | 1,182,998 | 1,174,470 | |||
Convertible Notes, fair value | 1,263,313 | 1,344,319 | |||
0.75% Senior Subordinated Convertible Notes Due in 2018 | |||||
Debt Instrument [Line Items] | |||||
Convertible Notes | 374,980 | 374,980 | |||
Convertible debt, unamortized discount | (8,597) | (12,488) | |||
Convertible debt, Unamortized deferred offering costs | (1,057) | (1,543) | |||
Convertible Notes, net of unamortized discount and deferred offering costs | 365,326 | 360,949 | |||
Convertible Notes, fair value | [3] | 383,323 | 403,955 | ||
1.50% Senior Subordinated Convertible Notes Due in 2020 | |||||
Debt Instrument [Line Items] | |||||
Convertible Notes | 374,993 | 374,993 | |||
Convertible debt, unamortized discount | (36,932) | (40,287) | |||
Convertible debt, Unamortized deferred offering costs | (3,307) | (3,631) | |||
Convertible Notes, net of unamortized discount and deferred offering costs | 334,754 | 331,075 | |||
Convertible Notes, fair value | [3] | 414,187 | 446,470 | ||
0.599% Senior Subordinated Convertible Notes Due in 2024 | |||||
Debt Instrument [Line Items] | |||||
Convertible Notes | 495,000 | 495,000 | |||
Convertible debt, unamortized discount | (9,004) | (9,355) | |||
Convertible debt, Unamortized deferred offering costs | (3,078) | (3,199) | |||
Convertible Notes, net of unamortized discount and deferred offering costs | 482,918 | 482,446 | |||
Convertible Notes, fair value | [3] | $ 465,803 | $ 493,894 | ||
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | ||||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | ||||
[3] | 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 12 to these Condensed Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Summary of Convertible Debt (Pa
Summary of Convertible Debt (Parenthetical) (Detail) | Mar. 31, 2018 |
0.75% Senior Subordinated Convertible Notes Due in 2018 | |
Debt Instrument [Line Items] | |
Debt instrument, interest rate, stated percentage | 0.75% |
1.50% Senior Subordinated Convertible Notes Due in 2020 | |
Debt Instrument [Line Items] | |
Debt instrument, interest rate, stated percentage | 1.50% |
0.599% Senior Subordinated Convertible Notes Due in 2024 | |
Debt Instrument [Line Items] | |
Debt instrument, interest rate, stated percentage | 0.599% |
Summary of Interest Expense on
Summary of Interest Expense on Convertible Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Schedule Of Interest Expenses [Line Items] | |||
Total interest expense on convertible debt | $ 11,562 | [1] | $ 10,119 |
Convertible Senior Notes | |||
Schedule Of Interest Expenses [Line Items] | |||
Coupon interest expense | 2,961 | 2,364 | |
Amortization of debt issuance costs | 1,004 | 886 | |
Accretion of discount on convertible notes | 7,597 | 6,869 | |
Total interest expense on convertible debt | $ 11,562 | $ 10,119 | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Summary of Designated Forward F
Summary of Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 3 Months Ended | |||
Mar. 31, 2018BRL (R$)Derivative | Mar. 31, 2018CAD ($)Derivative | Mar. 31, 2018COP ($)Derivative | Mar. 31, 2018EUR (€)Derivative | |
Maximum | ||||
Derivative [Line Items] | ||||
Maturity | Mar. 31, 2021 | |||
Derivatives Designated As Hedging Instruments | ||||
Derivative [Line Items] | ||||
Number of Contracts | 413 | 413 | 413 | 413 |
Derivatives Designated As Hedging Instruments | Euros | Purchase | ||||
Derivative [Line Items] | ||||
Number of Contracts | 87 | 87 | 87 | 87 |
Aggregate Notional Amount in Foreign Currency | € | € 121,200,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 293 | 293 | 293 | 293 |
Aggregate Notional Amount in Foreign Currency | € | € 376,900,000 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Apr. 30, 2018 | |||
Derivatives Designated As Hedging Instruments | Euros | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Apr. 30, 2018 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Purchase | ||||
Derivative [Line Items] | ||||
Maturity | Mar. 31, 2021 | |||
Derivatives Designated As Hedging Instruments | Euros | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Mar. 31, 2021 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 18 | 18 | 18 | 18 |
Aggregate Notional Amount in Foreign Currency | $ | $ 21,300,000 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Apr. 30, 2018 | |||
Derivatives Designated As Hedging Instruments | Canadian Dollars | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2018 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 9 | 9 | 9 | 9 |
Aggregate Notional Amount in Foreign Currency | $ | $ 73,000,000,000 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Minimum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Apr. 30, 2018 | |||
Derivatives Designated As Hedging Instruments | Colombian Pesos | Maximum | Sell | ||||
Derivative [Line Items] | ||||
Maturity | Dec. 31, 2018 | |||
Derivatives Designated As Hedging Instruments | Brazilian Reais | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 6 | 6 | 6 | 6 |
Aggregate Notional Amount in Foreign Currency | R$ | R$ 160000000 | |||
Maturity | May 31, 2018 |
Derivative Instruments and He60
Derivative Instruments and Hedging Strategies - Additional Information (Detail) - Foreign Currency Derivatives $ in Millions | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Derivative [Line Items] | |
Amount reclassified from accumulated other comprehensive loss to earnings as related to forecasted revenue and operating expense transactions | $ 15 |
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 | Mar. 31, 2021 |
Summary of Non-Designated Forwa
Summary of Non-Designated Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts | 3 Months Ended | |||
Mar. 31, 2018BRL (R$)Derivative | Mar. 31, 2018COP ($)Derivative | Mar. 31, 2018EUR (€)Derivative | Mar. 31, 2018GBP (£)Derivative | |
Maximum | ||||
Derivative [Line Items] | ||||
Maturity | Mar. 31, 2021 | |||
Not Designated as Hedging Instrument | ||||
Derivative [Line Items] | ||||
Number of Contracts | 7 | 7 | 7 | 7 |
Not Designated as Hedging Instrument | Euros | Purchase | ||||
Derivative [Line Items] | ||||
Number of Contracts | 4 | 4 | 4 | 4 |
Aggregate Notional Amount in Foreign Currency | € | € 115,200,000 | |||
Maturity | Apr. 30, 2018 | |||
Not Designated as Hedging Instrument | Brazilian Reais | Purchase | ||||
Derivative [Line Items] | ||||
Number of Contracts | 1 | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | R$ | R$ 2800000 | |||
Maturity | May 31, 2018 | |||
Not Designated as Hedging Instrument | United Kingdom, Pounds | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 1 | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | £ | £ 3,300,000 | |||
Maturity | Apr. 30, 2018 | |||
Not Designated as Hedging Instrument | Colombian Pesos | Sell | ||||
Derivative [Line Items] | ||||
Number of Contracts | 1 | 1 | 1 | 1 |
Aggregate Notional Amount in Foreign Currency | $ | $ 20,000,000,000 | |||
Maturity | Apr. 30, 2018 |
Fair Value Carrying Amount of D
Fair Value Carrying Amount of Derivative Instruments (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | |
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | $ 11,658 | $ 9,663 |
Derivative Liability, Fair Value | [1] | 35,488 | 27,150 |
Derivatives Designated As Hedging Instruments | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 11,576 | 8,988 |
Derivative Liability, Fair Value | [1] | 34,497 | 27,106 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Current Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 5,646 | 4,015 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 5,930 | 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] | 19,632 | 14,420 |
Derivatives Designated As Hedging Instruments | Forward Foreign Currency Exchange Contracts | Other Long-Term Liabilities | |||
Derivative [Line Items] | |||
Derivative Liability, Fair Value | [1] | 14,865 | 12,686 |
Not Designated as Hedging Instrument | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 82 | 675 |
Derivative Liability, Fair Value | [1] | 991 | 44 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Other Current Assets | |||
Derivative [Line Items] | |||
Derivative Asset, Fair Value | [1] | 82 | 675 |
Not Designated as Hedging Instrument | Forward Foreign Currency Exchange Contracts | Accounts Payable and Accrued Liabilities | |||
Derivative [Line Items] | |||
Derivative Liability, Fair Value | [1] | $ 991 | $ 44 |
[1] | See Note 12 to these Condensed 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 | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Derivatives Designated As Hedging Instruments | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net loss recognized in accumulated other comprehensive loss | [1] | $ (9,226) | $ (4,199) |
Net gain (loss) reclassified from accumulated other comprehensive income (loss) into earnings | [2] | (5,785) | 2,516 |
Net gain (loss) recognized in net loss | [3] | (378) | 880 |
Not Designated as Hedging Instrument | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Net gain (loss) recognized in net loss | [4] | $ 1,254 | $ 258 |
[1] | Net change in the fair value of the effective portion classified as accumulated other comprehensive loss. | ||
[2] | Effective portion classified as Net Product Revenues and Operating expenses. | ||
[3] | Classified as Operating expenses. | ||
[4] | Ineffective portion and amount excluded from effectiveness testing classified as Operating expenses. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | $ 14,814 | $ 16,614 | |
Fair value of other non-current assets | 12,515 | 11,859 | |
Fair value of financial assets, Total | 27,329 | 28,473 | |
Fair value of other current liabilities | 64,587 | 55,971 | |
Fair value of other non-current liabilities | 165,904 | 165,449 | |
Fair value of financial liabilities, Total | 230,491 | 221,420 | |
NQDC Plan Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 2,980 | 2,323 | |
Fair value of other non-current liabilities | 28,286 | 30,131 | |
Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 61,607 | 53,648 | |
Fair value of other non-current liabilities | 137,618 | 135,318 | |
NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 1,130 | 967 | |
Fair value of other non-current assets | 12,515 | 11,859 | |
Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 13,684 | 15,647 |
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 | |
Fair value of financial assets, Total | 0 | 0 | |
Fair value of other current liabilities | 1,850 | 1,356 | |
Fair value of other non-current liabilities | 15,771 | 18,272 | |
Fair value of financial liabilities, Total | 17,621 | 19,628 | |
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 | 1,850 | 1,356 | |
Fair value of other non-current liabilities | 15,771 | 18,272 | |
Quoted Price In Active Markets For Identical Assets (Level 1) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 0 | 0 | |
Fair value of other non-current liabilities | 0 | 0 | |
Quoted Price In Active Markets For Identical Assets (Level 1) | NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
Quoted Price In Active Markets For Identical Assets (Level 1) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 0 | 0 |
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 | 14,814 | 16,614 | |
Fair value of other non-current assets | 12,515 | 11,859 | |
Fair value of financial assets, Total | 27,329 | 28,473 | |
Fair value of other current liabilities | 1,130 | 967 | |
Fair value of other non-current liabilities | 12,515 | 11,859 | |
Fair value of financial liabilities, Total | 13,645 | 12,826 | |
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 | 1,130 | 967 | |
Fair value of other non-current liabilities | 12,515 | 11,859 | |
Significant Other Observable Inputs (Level 2) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 0 | 0 | |
Fair value of other non-current liabilities | 0 | 0 | |
Significant Other Observable Inputs (Level 2) | NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 1,130 | 967 | |
Fair value of other non-current assets | 12,515 | 11,859 | |
Significant Other Observable Inputs (Level 2) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | 13,684 | 15,647 |
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 | 61,607 | 53,648 | |
Fair value of other non-current liabilities | 137,618 | 135,318 | |
Fair value of financial liabilities, Total | 199,225 | 188,966 | |
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 | |
Significant Unobservable Inputs (Level 3) | Contingent Acquisition Consideration Payable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current liabilities | 61,607 | 53,648 | |
Fair value of other non-current liabilities | 137,618 | 135,318 | |
Significant Unobservable Inputs (Level 3) | NQDC Plan Assets | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | 0 | 0 | |
Fair value of other non-current assets | 0 | 0 | |
Significant Unobservable Inputs (Level 3) | Restrictive Investments | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of other current assets | [1] | $ 0 | $ 0 |
[1] | The restricted investments at March 31, 2018 and December 31, 2017 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements |
Liabilities Measured at Fair Va
Liabilities Measured at Fair Value Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Contingent acquisition consideration payable, Beginning balance | $ 188,966 |
Changes in the fair value of other contingent acquisition consideration payable | 5,631 |
Foreign exchange remeasurement of Euro denominated contingent acquisition consideration payable | 4,628 |
Contingent acquisition consideration payable, Ending balance | $ 199,225 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Asset retirement obligations | $ 4.3 | $ 4.2 |
Compensation Expense (Detail)
Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 36,608 | $ 30,674 |
Cost of Sales | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 3,140 | 2,286 |
R&D | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 13,269 | 11,494 |
SG&A | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 20,199 | $ 16,894 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense capitalized to inventory | $ 3.5 | $ 3.2 | |
Shares, granted | 766,810 | ||
Weighted-average fair value per share granted | $ 33.34 | ||
New stock purchase rights issued under ESPP | 0 | ||
Restricted Stock With Service Based Vesting Conditions | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares, granted | 1,382,090 | ||
Weighted-average fair value per RSU granted | $ 83.68 | ||
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 | ||
Granted restricted stock units | 129,680 | 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% |
Assumptions Used to Estimate Pe
Assumptions Used to Estimate Per Share Fair Value of Stock Options Granted (Detail) - Stock Option | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 37.80% | 37.60% |
Expected volatility, maximum | 38.30% | 39.70% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate, minimum | 2.30% | 1.80% |
Risk-free interest rate, maximum | 2.70% | 2.20% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life | 4 years 7 months 6 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 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Unit Awards with Performance Conditions (Detail) | 1 Months Ended | |||
Mar. 31, 2018$ / sharesshares | Mar. 31, 2017$ / sharesshares | Mar. 31, 2016$ / sharesshares | Mar. 31, 2015$ / sharesshares | |
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 | |||
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 | |||
Multiplier Achieved | 1.03 | |||
RSUs Earned | 132,548 | |||
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 | |||
Multiplier Achieved | 1.03 | |||
RSUs Earned | 134,219 | |||
March 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 | |||
Multiplier Achieved | 1.11 | |||
RSUs Earned | 64,713 |
Amounts Reclassified out of AOC
Amounts Reclassified out of AOCI (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Net product revenues | $ 369,099 | [1] | $ 302,190 |
LOSS FROM OPERATIONS | (44,372) | [1] | (20,208) |
Other income | (172) | [1] | 3,472 |
Benefit from income taxes | (6,655) | [1] | (8,016) |
NET LOSS | (44,149) | [1] | (16,290) |
Reclassified out of Accumulated Other Comprehensive Income | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Benefit from income taxes | 0 | (1,181) | |
NET LOSS | (5,785) | 4,587 | |
Reclassified out of Accumulated Other Comprehensive Income | Gains (losses) on Cash Flow Hedges | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
LOSS FROM OPERATIONS | (5,785) | 2,516 | |
Reclassified out of Accumulated Other Comprehensive Income | Gains (losses) on Cash Flow Hedges | Forward Foreign Currency Exchange Contracts | |||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | |||
Net product revenues | (7,646) | 3,542 | |
Operating expenses | 1,861 | (1,026) | |
Reclassified out of Accumulated Other Comprehensive Income | 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 | |
Total gain (loss) on available-for-sale debt securities | $ 0 | $ 2,071 | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Summary of Changes in Accumulat
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2018 | Mar. 31, 2017 | |||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning Balance | [1] | $ 2,808,663 | ||
Adjusted balance at January 1, 2018 | 2,828,711 | |||
Other comprehensive income (loss) before reclassifications | (11,246) | $ (2,633) | ||
Less: net gain (loss) reclassified from AOCI | (5,785) | 5,768 | ||
Tax effect | 463 | 605 | ||
Net current-period other comprehensive income (loss) | (4,998) | (7,796) | ||
Ending Balance | [2] | 2,807,003 | ||
Unrealized Gains (Losses) on Cash Flow Hedges | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning Balance | (20,232) | 13,006 | ||
Impact of change in accounting principle | [3] | 0 | ||
Adjusted balance at January 1, 2018 | (20,232) | |||
Other comprehensive income (loss) before reclassifications | (9,226) | (4,199) | ||
Less: net gain (loss) reclassified from AOCI | (5,785) | 2,516 | ||
Tax effect | 0 | 0 | ||
Net current-period other comprehensive income (loss) | (3,441) | (6,715) | ||
Ending Balance | (23,673) | 6,291 | ||
Unrealized Gains (Losses) on Available-for-Sale Debt Securities | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning Balance | (2,722) | (178) | ||
Impact of change in accounting principle | [3] | (586) | ||
Adjusted balance at January 1, 2018 | (3,308) | |||
Other comprehensive income (loss) before reclassifications | (2,021) | 1,567 | ||
Less: net gain (loss) reclassified from AOCI | 0 | 3,252 | ||
Tax effect | 463 | 605 | ||
Net current-period other comprehensive income (loss) | (1,558) | (1,080) | ||
Ending Balance | (4,866) | (1,258) | ||
Foreign Currency Items | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning Balance | (7) | (12) | ||
Impact of change in accounting principle | [3] | 0 | ||
Adjusted balance at January 1, 2018 | (7) | |||
Other comprehensive income (loss) before reclassifications | 1 | (1) | ||
Less: net gain (loss) reclassified from AOCI | 0 | 0 | ||
Tax effect | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 1 | (1) | ||
Ending Balance | (6) | (13) | ||
Accumulated Other Comprehensive Income (Loss) | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Beginning Balance | (22,961) | [1] | 12,816 | |
Impact of change in accounting principle | [3] | (586) | ||
Adjusted balance at January 1, 2018 | (23,547) | |||
Ending Balance | $ (28,545) | $ 5,020 | ||
[1] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. | |||
[2] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[3] | As of January 1, 2018, the Company early adopted the requirements of ASU 2018-02. The amount represents the reclassification from Accumulated Other Comprehensive Loss 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 Concentration73
Revenue, Credit Concentrations and Geographic Information - Additional Information (Detail) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018USD ($)SegmentCustomer | Dec. 31, 2017USD ($)Customer | |||
Concentration Risk And Geographic Information [Line Items] | ||||
Number of operating business segment | Segment | 1 | |||
Accounts receivable, net | $ 318,394 | [1] | $ 261,365 | [2] |
Largest Customers | ||||
Concentration Risk And Geographic Information [Line Items] | ||||
Accounts receivable, net | $ 85,000 | $ 18,100 | ||
Accounts Receivable | Largest Customers | ||||
Concentration Risk And Geographic Information [Line Items] | ||||
Number of customers accounted for largest 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 | Larger Customer One | ||||
Concentration Risk And Geographic Information [Line Items] | ||||
Concentration risk, percentage | 34.00% | 21.00% | ||
Credit Concentration Risk | Accounts Receivable | Larger Customer Two | ||||
Concentration Risk And Geographic Information [Line Items] | ||||
Concentration risk, percentage | 17.00% | 18.00% | ||
[1] | As of January 1, 2018, the Company adopted the requirements of Accounting Standards Codification 606, Revenue from Contracts with Customers, (ASC 606) using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. | |||
[2] | December 31, 2017 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 26, 2018. |
Disaggregates of Total Revenues
Disaggregates of Total Revenues from External Customers and Collaborative Partners by Geographic Region (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Revenue from External Customer [Line Items] | |||
Total revenues | $ 373,447 | [1] | $ 303,745 |
United States | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 190,571 | 132,484 | |
Europe | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 71,341 | 65,770 | |
Latin America | |||
Revenue from External Customer [Line Items] | |||
Total revenues | 27,773 | 37,304 | |
Rest of World | |||
Revenue from External Customer [Line Items] | |||
Total revenues | $ 83,762 | $ 68,187 | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Disaggregates of Total Net Prod
Disaggregates of Total Net Product Revenues from External Customers by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Revenue from External Customer [Line Items] | |||
Net product revenues | $ 369,099 | [1] | $ 302,190 |
Aldurazyme | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 66,056 | 19,355 | |
Brineura | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 6,917 | 0 | |
Firdapse | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 4,926 | 4,110 | |
Kuvan | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 99,115 | 92,346 | |
Naglazyme | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | 74,996 | 80,558 | |
Vimizim | |||
Revenue from External Customer [Line Items] | |||
Net product revenues | $ 117,089 | $ 105,821 | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Disaggregates of Total Net Pr76
Disaggregates of Total Net Product Revenues Based on Patient Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | ||
Concentration Risk [Line Items] | |||
Net product revenues | $ 369,099 | [1] | $ 302,190 |
Aldurazyme | |||
Concentration Risk [Line Items] | |||
Net product revenues | 66,056 | 19,355 | |
Geographic Concentration Risk | Net Product Revenue | |||
Concentration Risk [Line Items] | |||
Net product revenues | 303,043 | 282,835 | |
Geographic Concentration Risk | Net Product Revenue | United States | |||
Concentration Risk [Line Items] | |||
Net product revenues | 124,141 | 112,706 | |
Geographic Concentration Risk | Net Product Revenue | Europe | |||
Concentration Risk [Line Items] | |||
Net product revenues | 68,798 | 65,770 | |
Geographic Concentration Risk | Net Product Revenue | Latin America | |||
Concentration Risk [Line Items] | |||
Net product revenues | 27,773 | 37,304 | |
Geographic Concentration Risk | Net Product Revenue | Rest of World | |||
Concentration Risk [Line Items] | |||
Net product revenues | 82,331 | 67,055 | |
Customer Concentration Risk | Net Product Revenue | Genzyme | Aldurazyme | |||
Concentration Risk [Line Items] | |||
Net product revenues | 66,056 | 19,355 | |
Credit Concentration Risk | Net Product Revenue | |||
Concentration Risk [Line Items] | |||
Net product revenues | $ 369,099 | $ 302,190 | |
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Total Net Product Revenue Conce
Total Net Product Revenue Concentrations Attributed to Largest Customers (Detail) - Customer Concentration Risk - Net Product Revenue | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 55.00% | 46.00% |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 18.00% | 6.00% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 17.00% | 17.00% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 12.00% | 13.00% |
Customer D | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 8.00% | 10.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 27, 2018 | Mar. 31, 2018 | Mar. 31, 2017 | |
Commitments And Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 613,800 | |||
Contingent consideration payable | 199,200 | |||
Contingent consideration of total liability | 0 | [1] | $ 1,894 | |
Purchase commitment for the next five years | 53,200 | |||
Subsequent Event | ||||
Commitments And Contingencies [Line Items] | ||||
Contingent consideration of total liability | $ 61,600 | |||
Merck Serono | ||||
Commitments And Contingencies [Line Items] | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 227,600 | |||
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 | $ 55,000 | |||
[1] | As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 4 for additional discussion. |
Benefit From Income Taxes - Add
Benefit From Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2018 | Dec. 31, 2017 | |
Income Tax Contingency [Line Items] | ||
Corporate income tax rate | 21.00% | 35.00% |
Amount for remeasurement of deferred taxes | $ 4.6 | |
Domestic | ||
Income Tax Contingency [Line Items] | ||
Reduction in orphan drug credit benefit due to change in tax rate | 50.00% |