Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 26, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-26727 | |
Entity Registrant Name | BioMarin Pharmaceutical Inc | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 68-0397820 | |
Entity Address, Address Line One | 770 Lindaro Street | |
Entity Address, City or Town | San Rafael | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94901 | |
City Area Code | 415 | |
Local Phone Number | 506-6700 | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Trading Symbol | BMRN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 183,593,434 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001048477 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 617,143 | $ 649,158 | |
Short-term investments | 462,333 | 416,228 | |
Accounts receivable, net | 374,937 | 448,351 | |
Inventory | 749,406 | 698,548 | |
Other current assets | 107,751 | 129,934 | |
Total current assets | 2,311,570 | 2,342,219 | |
Noncurrent assets: | |||
Long-term investments | 466,618 | 285,473 | |
Property, plant and equipment, net | 1,024,787 | 1,032,471 | |
Intangible assets, net | 388,487 | 417,271 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,445,109 | 1,432,150 | |
Other assets | 144,705 | 142,237 | |
Total assets | 5,977,475 | 5,848,020 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 466,711 | 492,548 | |
Short-term contingent consideration | 48,187 | 0 | |
Total current liabilities | 514,898 | 492,548 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 1,078,093 | 1,075,145 | |
Long-term contingent consideration | 15,204 | 60,130 | |
Other long-term liabilities | 103,131 | 114,195 | |
Total liabilities | 1,711,326 | 1,742,018 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 183,567,424 and 181,740,999 shares issued and outstanding, respectively. | 184 | 182 | |
Additional paid-in capital | 5,133,742 | 4,993,407 | |
Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (10,225) | (9,839) | |
Accumulated other comprehensive income (loss) | 10,239 | (16,139) | |
Accumulated deficit | (867,791) | (861,609) | |
Total stockholders’ equity | 4,266,149 | 4,106,002 | [2] |
Total liabilities and stockholders’ equity | $ 5,977,475 | $ 5,848,020 | |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. | ||
[2] | The beginning balances for the nine-month periods were derived from the audited Consolidated Financial Statements included in Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 26, 2021. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, shares issued (in shares) | 183,567,424 | 181,740,999 |
Common stock, shares outstanding (in shares) | 183,567,424 | 181,740,999 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
REVENUES: | ||||
Total revenues | $ 408,742 | $ 476,784 | $ 1,396,465 | $ 1,408,338 |
OPERATING EXPENSES: | ||||
Cost of sales | 103,537 | 188,793 | 350,765 | 398,134 |
Research and development | 157,869 | 147,053 | 467,701 | 471,449 |
Selling, general and administrative | 183,333 | 179,450 | 541,812 | 542,157 |
Intangible asset amortization and contingent consideration | 17,222 | 17,429 | 52,648 | 48,018 |
Gain on sale of nonfinancial assets | 0 | 0 | 0 | (59,495) |
Total operating expenses | 461,961 | 532,725 | 1,412,926 | 1,400,263 |
INCOME (LOSS) FROM OPERATIONS | (53,219) | (55,941) | (16,461) | 8,075 |
Equity in the income (loss) of BioMarin/Genzyme LLC | 177 | (921) | (1,349) | (1,077) |
Interest income | 1,827 | 4,004 | 8,737 | 13,539 |
Interest expense | (3,870) | (9,597) | (11,491) | (24,560) |
Other income, net | 8,925 | 1,239 | 11,788 | 1,886 |
INCOME (LOSS) BEFORE INCOME TAXES | (46,160) | (61,216) | (8,776) | (2,137) |
Benefit from income taxes | (9,666) | (846,019) | (2,594) | (839,138) |
NET INCOME (LOSS) | $ (36,494) | $ 784,803 | $ (6,182) | $ 837,001 |
NET INCOME (LOSS) PER SHARE, BASIC (in dollars per share) | $ (0.20) | $ 4.33 | $ (0.03) | $ 4.63 |
NET INCOME (LOSS) PER SHARE, DILUTED (in dollars per share) | $ (0.20) | $ 4.01 | $ (0.03) | $ 4.39 |
Weighted average common shares outstanding, basic (in shares) | 183,214 | 181,142 | 182,616 | 180,592 |
Weighted average common shares outstanding, diluted (in shares) | 183,214 | 197,674 | 182,616 | 194,959 |
COMPREHENSIVE INCOME (LOSS) | $ (25,316) | $ 765,138 | $ 20,196 | $ 827,222 |
Net product revenues | ||||
REVENUES: | ||||
Total revenues | 393,840 | 460,741 | 1,348,279 | 1,368,816 |
Royalty and other revenues | ||||
REVENUES: | ||||
Total revenues | $ 14,902 | $ 16,043 | $ 48,186 | $ 39,522 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Company Stock Held By NQDC | Accumulated other comprehensive income (loss) | Accumulated Deficit | ||
Beginning balance (in shares) at Dec. 31, 2019 | [1] | 179,838 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 2,172 | ||||||||
Repurchase of common stock (in shares) | (518) | ||||||||
Ending balance (in shares) at Sep. 30, 2020 | 181,492 | ||||||||
Beginning balance at Dec. 31, 2019 | [1] | $ 3,122,381 | $ 180 | $ 4,832,707 | $ 0 | $ (9,961) | $ 20,164 | $ (1,720,709) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 1 | 17,601 | |||||||
Stock-based compensation | 136,688 | ||||||||
Repurchase of common stock | (50,000) | (50,000) | |||||||
Retirement of treasury stock | 50,000 | ||||||||
Common stock held by the NQDC | 795 | (795) | |||||||
Other comprehensive income (loss) | (9,779) | ||||||||
Net income (loss) | 837,001 | 837,001 | |||||||
Ending balance at Sep. 30, 2020 | 4,053,893 | $ 181 | 4,937,791 | 0 | (10,756) | 10,385 | (883,708) | ||
Beginning balance (in shares) at Jun. 30, 2020 | [1] | 181,148 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 344 | ||||||||
Repurchase of common stock (in shares) | 0 | ||||||||
Ending balance (in shares) at Sep. 30, 2020 | 181,492 | ||||||||
Beginning balance at Jun. 30, 2020 | [1] | 3,236,679 | $ 181 | 4,885,637 | 0 | (10,678) | 30,050 | (1,668,511) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 0 | 7,319 | |||||||
Stock-based compensation | 44,757 | ||||||||
Repurchase of common stock | 0 | 0 | |||||||
Retirement of treasury stock | 0 | ||||||||
Common stock held by the NQDC | 78 | (78) | |||||||
Other comprehensive income (loss) | (19,665) | ||||||||
Net income (loss) | 784,803 | 784,803 | |||||||
Ending balance at Sep. 30, 2020 | 4,053,893 | $ 181 | 4,937,791 | 0 | (10,756) | 10,385 | (883,708) | ||
Beginning balance (in shares) at Dec. 31, 2020 | [1] | 181,741 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 1,827 | ||||||||
Repurchase of common stock (in shares) | 0 | ||||||||
Ending balance (in shares) at Sep. 30, 2021 | 183,568 | ||||||||
Beginning balance at Dec. 31, 2020 | [1] | 4,106,002 | [2] | $ 182 | 4,993,407 | 0 | (9,839) | (16,139) | (861,609) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 2 | (11,551) | |||||||
Stock-based compensation | 151,500 | ||||||||
Repurchase of common stock | 0 | 0 | |||||||
Retirement of treasury stock | 0 | ||||||||
Common stock held by the NQDC | 386 | (386) | |||||||
Other comprehensive income (loss) | 26,378 | ||||||||
Net income (loss) | (6,182) | (6,182) | |||||||
Ending balance at Sep. 30, 2021 | 4,266,149 | $ 184 | 5,133,742 | 0 | (10,225) | 10,239 | (867,791) | ||
Beginning balance (in shares) at Jun. 30, 2021 | [1] | 183,322 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 246 | ||||||||
Repurchase of common stock (in shares) | 0 | ||||||||
Ending balance (in shares) at Sep. 30, 2021 | 183,568 | ||||||||
Beginning balance at Jun. 30, 2021 | [1] | 4,241,571 | $ 183 | 5,083,831 | 0 | (10,207) | (939) | (831,297) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 1 | (460) | |||||||
Stock-based compensation | 50,353 | ||||||||
Repurchase of common stock | 0 | 0 | |||||||
Retirement of treasury stock | 0 | ||||||||
Common stock held by the NQDC | 18 | (18) | |||||||
Other comprehensive income (loss) | 11,178 | ||||||||
Net income (loss) | (36,494) | (36,494) | |||||||
Ending balance at Sep. 30, 2021 | $ 4,266,149 | $ 184 | $ 5,133,742 | $ 0 | $ (10,225) | $ 10,239 | $ (867,791) | ||
[1] | The beginning balances for the nine-month periods were derived from the audited Consolidated Financial Statements included in Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 26, 2021. | ||||||||
[2] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ (6,182) | $ 837,001 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 82,053 | 77,814 |
Non-cash interest expense | 3,114 | 14,766 |
Amortization of premium on investments | 3,279 | 175 |
Stock-based compensation | 153,372 | 142,125 |
Gain on sale of nonfinancial assets | 0 | (59,495) |
Inventory reserves, net of stock-based compensation | 0 | 75,609 |
Deferred income taxes | (12,020) | (854,199) |
Unrealized foreign exchange (gain) loss | (1,347) | 9,082 |
Non-cash changes in the fair value of contingent consideration | 6,254 | 1,352 |
Other | (1,317) | 388 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 65,513 | (32,915) |
Inventory | (19,125) | (73,310) |
Other current assets | 27,029 | 32,848 |
Other assets | (407) | (5,543) |
Accounts payable and accrued liabilities | (7,129) | (76,174) |
Other long-term liabilities | 269 | 9,225 |
Net cash provided by operating activities | 293,356 | 98,749 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (66,840) | (83,286) |
Maturities and sales of investments | 502,112 | 345,224 |
Purchases of available-for-sale securities | (737,144) | (369,942) |
Proceeds from sale of nonfinancial assets | 0 | 67,159 |
Purchase of intangible assets | (8,026) | (14,369) |
Investment in convertible note | 0 | (8,709) |
Other | (994) | (725) |
Net cash used in investing activities | (310,892) | (64,648) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercises of awards under equity incentive plans | 32,877 | 60,268 |
Taxes paid related to net share settlement of equity awards | (44,428) | (42,667) |
Repurchase of common stock | 0 | (50,000) |
Proceeds from convertible senior subordinated note offering, net | 0 | 585,752 |
Principal repayments of financing leases | (2,492) | (6,080) |
Other | (401) | 0 |
Net cash provided by (used in) financing activities | (14,444) | 547,273 |
Effect of exchange rate changes on cash | (35) | (3,145) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (32,015) | 578,229 |
Cash and cash equivalents: | ||
Beginning of period | 649,158 | 437,446 |
End of period | 617,143 | 1,015,675 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | ||
Cash paid for income taxes | 15,531 | 4,355 |
Cash paid for interest | 6,673 | 5,615 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Decrease in accounts payable and accrued liabilities related to fixed assets | (7,690) | (13,281) |
Increase (decrease) in accounts payable and accrued liabilities related to intangible assets | $ 9,389 | $ (3,043) |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
NATURE OF OPERATIONS | 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 portfolio consists of several commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. Voxzogo (formerly known as vosoritide) was granted marketing approval in the European Union (EU) on August 27, 2021. 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 | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | 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 Securities and Exchange Commission (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, 2020 included in the Company’s Annual Report on Form 10-K. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated. The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other period. 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 full extent to which the novel coronavirus (referred to as COVID-19) pandemic could continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing, clinical trials and research and development costs, will depend on future developments that remain uncertain at this time, particularly as virus variants continue to spread. As events continue to evolve and additional information becomes available, the Company’s estimates may change materially in future periods. 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2021, as compared to the significant accounting policies disclosed in Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | RECENT ACCOUNTING PRONOUNCEMENTSThere have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the nine months ended September 30, 2021, 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, 2020, that the Company believes are of significance or potential significance to the Company. |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS All marketable securities were classified as available-for-sale at September 30, 2021 and December 31, 2020. The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category for each period presented: September 30, 2021 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 294,209 $ — $ — $ 294,209 $ 294,209 $ — $ — Level 2: Money market instruments 291,735 — — 291,735 291,735 — — Corporate debt securities 560,004 1,230 (198) 561,036 703 177,468 382,865 U.S. government agency securities 210,444 416 (7) 210,853 12,999 161,207 36,647 Commercial paper 129,818 1 (1) 129,818 17,497 112,321 — Asset-backed securities 55,182 26 (23) 55,185 — 8,272 46,913 Foreign and other 3,114 150 (6) 3,258 — 3,065 193 Subtotal 1,250,297 1,823 (235) 1,251,885 322,934 462,333 466,618 Total $ 1,544,506 $ 1,823 $ (235) $ 1,546,094 $ 617,143 $ 462,333 $ 466,618 December 31, 2020 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 370,325 $ — $ — $ 370,325 $ 370,325 $ — $ — Level 2: Money market instruments 264,833 — — 264,833 264,833 — — Corporate debt securities 413,137 3,261 (8) 416,390 — 220,551 195,839 U.S. government agency securities 265,298 1,555 (1) 266,852 14,000 192,488 60,364 Asset-backed securities 31,659 85 (2) 31,742 — 3,189 28,553 Foreign and other 549 168 — 717 — — 717 Subtotal 975,476 5,069 (11) 980,534 278,833 416,228 285,473 Total $ 1,345,801 $ 5,069 $ (11) $ 1,350,859 $ 649,158 $ 416,228 $ 285,473 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one As of September 30, 2021, the Company had the ability and intent to hold all investments that were in an unrealized loss position until maturity. The Company considered its intent and ability to hold the securities until recovery of amortized cost basis, the extent to which fair value is less than amortized cost basis, conditions specifically related to the security’s industry and geography, payment structure and history and changes to the ratings (if any) in determining that the decline in fair value compared to carrying value is not related to a credit loss. The Company has certain investments in non-marketable equity securities, measured using unobservable valuation inputs and remeasured on a nonrecurring basis, which are collectively considered strategic investments. As of September 30, 2021 and |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | SUPPLEMENTAL BALANCE SHEET INFORMATION Inventory consisted of the following: September 30, December 31, Raw materials $ 75,328 $ 76,673 Work-in-process 412,434 308,286 Finished goods 261,644 313,589 Total inventory $ 749,406 $ 698,548 Inventory as of September 30, 2021 included $4.8 million of Voxzogo pre-launch manufacturing-related costs incurred during the third quarter of 2021 that are intended for the U.S. Voxzogo, which was granted marketing approval in the EU on August 27, 2021, is still a product candidate in other regions, including the U.S., for the treatment of achondroplasia in children, the most common form of disproportionate short stature in humans. The Company must receive marketing approval from the U.S. Food and Drug Administration (FDA) before the Voxzogo inventory can be sold commercially in the U.S. Starting in 2021, the Company believed that material uncertainties related to the ultimate regulatory approval of Voxzogo had been significantly reduced. A number of factors were taken into consideration, including the current status in the drug development process, pivotal clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, as well as commercialization and marketplace trends. See Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 for additional information related to the Company’s policies on inventory produced prior to regulatory approval. Property, Plant and Equipment, Net consisted of the following: September 30, December 31, Property, plant and equipment, gross $ 1,724,702 $ 1,668,066 Accumulated depreciation (699,915) (635,595) Total property, plant and equipment, net $ 1,024,787 $ 1,032,471 Depreciation expense, net of amounts capitalized into inventory, for the three and nine months ended September 30, 2021 was $11.4 million and $35.7 million, respectively. Depreciation expense, net of amounts capitalized into inventory, for the three and nine months ended September 30, 2020 was $11.1 million and $31.1 million, respectively. Intangible Assets, Net consisted of the following: September 30, December 31, Finite-lived intangible assets $ 661,781 $ 644,087 Less: Accumulated amortization (273,294) (226,816) Net carrying value $ 388,487 $ 417,271 Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, Accounts payable and accrued operating expenses $ 203,321 $ 191,429 Accrued compensation expense 158,130 165,023 Accrued rebates payable 68,329 65,526 Accrued royalties payable 14,512 17,155 Lease liabilities 9,659 11,754 Forward foreign currency exchange contracts 5,323 17,798 Value added taxes payable 1,412 9,562 Accrued income taxes 564 9,661 Other 5,461 4,640 Total accounts payable and accrued liabilities $ 466,711 $ 492,548 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value in accordance with the policy described in Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Condensed Consolidated Financial Statements that are remeasured on a recurring basis as of September 30, 2021 and December 31, 2020. Other than the Company’s fixed-rate convertible debt disclosed in Note 9 – Debt , there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of September 30, 2021 or December 31, 2020. Fair Value Measurements as of September 30, 2021 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,089 $ — $ 2,089 Other assets: NQDC Plan assets 22,521 — 22,521 Restricted investments (1) 2,835 — 2,835 Total other assets 25,356 — 25,356 Total assets $ 27,445 $ — $ 27,445 Liabilities: Current liabilities: NQDC Plan liability $ 2,089 $ — $ 2,089 Contingent consideration — 48,187 48,187 Total current liabilities 2,089 48,187 50,276 Other long-term liabilities: NQDC Plan liability 22,521 — 22,521 Contingent consideration — 15,204 15,204 Total other long-term liabilities 22,521 15,204 37,725 Total liabilities $ 24,610 $ 63,391 $ 88,001 Fair Value Measurements as of December 31, 2020 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,415 $ — $ 2,415 Other assets: NQDC Plan assets 19,962 — 19,962 Restricted investments (1) 4,487 — 4,487 Total other assets 24,449 — 24,449 Total assets $ 26,864 $ — $ 26,864 Liabilities: Current liabilities: NQDC Plan liability $ 2,415 $ — $ 2,415 Other long-term liabilities: NQDC Plan liability 19,962 — 19,962 Contingent consideration — 60,130 60,130 Total other long-term liabilities 19,962 60,130 80,092 Total liabilities $ 22,377 $ 60,130 $ 82,507 (1) The restricted investments at September 30, 2021 and December 31, 2020 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 and nine months ended September 30, 2021. Liabilities measured at fair value using Level 3 inputs primarily consisted of contingent consideration. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2020 $ 60,130 Changes in the fair value of contingent consideration 6,254 Foreign exchange remeasurement of Euro denominated contingent consideration (2,993) Contingent consideration as of September 30, 2021 $ 63,391 |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 9 Months Ended |
Sep. 30, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIESThe Company uses foreign currency exchange forward contracts (forward contracts) to protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues and operating expenses denominated in currencies other than the U.S. Dollar (USD), primarily the Euro. Certain of these forward contracts are designated as cash flows hedges and have maturities of up to two years. The Company also enters into forward contracts to manage foreign exchange risk related to asset or liability positions denominated in currencies other than USD. Such forward contracts are considered to be economic hedges, are not designated as hedging instruments and have maturities of up to three months. The Company does not use derivative instruments for speculative trading purposes. The Company is exposed to counterparty credit risk on its derivatives. The Company has established and maintains strict counterparty credit guidelines and enters into hedging agreements with financial institutions that are investment grade or better to minimize the Company’s exposure to potential defaults. The Company is not required to pledge collateral under these agreements. The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Foreign Exchange Contracts September 30, 2021 December 31, 2020 Derivatives designated as hedging instruments: Sell $ 654,516 $ 782,327 Purchase $ 168,080 $ 189,540 Derivatives not designated as hedging instruments: Sell $ 77,040 $ 98,343 Purchase $ 37,285 $ 12,277 The fair value carrying amounts of the Company’s derivatives, as classified within the fair value hierarchy, were as follows: Balance Sheet Location September 30, 2021 December 31, 2020 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 11,883 $ 6,268 Other assets 4,320 3,148 Subtotal $ 16,203 $ 9,416 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 5,257 $ 17,551 Other long-term liabilities 1,486 11,020 Subtotal $ 6,743 $ 28,571 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 252 $ 84 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 66 $ 247 Total Derivatives Assets $ 16,455 $ 9,500 Total Derivatives Liabilities $ 6,809 $ 28,818 (1) For additional discussion of fair value measurements, see Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The following tables summarize the impact of gains and losses from the Company's derivatives on its Condensed Consolidated Statements of Comprehensive Income (Loss) for the periods presented. Three Months Ended September 30, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 393,840 $ 401 $ 460,741 $ 2,693 Operating expenses as reported $ 461,961 $ (268) $ 532,725 $ (815) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 1,302 $ 4,166 Nine Months Ended September 30, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,348,279 $ (5,034) $ 1,368,816 $ 17,301 Operating expenses as reported $ 1,412,926 $ 81 $ 1,400,263 $ (4,274) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 2,310 $ 9,600 As of September 30, 2021, the Company expects to reclassify unrealized gains of $6.2 million from Accumulated Other Comprehensive Income (AOCI) to earnings as the forecasted revenues and operating expense transactions occur over the next 12 months. For additional discussion of balances in AOCI see Note 10 – Accumulated Other Comprehensive Income . |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Notes As of September 30, 2021, the Company had outstanding fixed-rate notes with varying maturities for an undiscounted aggregate principal amount of $1.1 billion (collectively the Notes). The Notes are senior subordinated convertible obligations, and interest is payable in arrears, semi-annually. The following table summarizes information regarding the Company’s convertible debt: September 30, December 31, 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (11,478) (12,995) 2027 Notes, net 588,522 587,005 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (5,429) (6,860) 2024 Notes, net 489,571 488,140 Total convertible debt, net $ 1,078,093 $ 1,075,145 Fair value of fixed rate convertible debt (1) : 2027 Notes $ 600,858 $ 627,090 2024 Notes 510,954 530,714 Total fair value of fixed rate convertible debt $ 1,111,812 $ 1,157,804 (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. For additional discussion of fair value measurements, see Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Nine Months Ended September 30, 2021 2020 2021 2020 Coupon interest expense $ 2,617 $ 4,255 $ 7,849 $ 9,443 Accretion of discount on convertible notes 835 4,696 2,503 13,201 Amortization of debt issuance costs 148 535 445 1,565 Total interest expense on convertible debt $ 3,600 $ 9,486 $ 10,797 $ 24,209 See Note 13 - Debt included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 for additional information related to the Company’s convertible debt. Revolving Credit Facility In October 2018, the Company entered into an unsecured revolving credit facility of up to $200.0 million which includes a letter of credit subfacility and a swingline loan subfacility. The credit facility is intended to finance ongoing working capital needs and for other general corporate purposes. In May 2021, the Company entered into an amendment agreement in respect of the credit facility, extending the maturity date from October 19, 2021 to May 28, 2024, among other changes. The amended credit facility contains financial covenants including a maximum leverage ratio and a minimum interest coverage ratio. As of September 30, 2021, there were no amounts outstanding under the credit facility and the Company and certain of its subsidiaries that serve as guarantors were in compliance with all covenants. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) The following tables summarize changes in the accumulated balances for each component of Accumulated Other Comprehensive Income (Loss) (AOCI), including current-period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Three Months Ended September 30, 2021 Unrealized Gains Unrealized Gains Other Total AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ — $ (939) Other comprehensive income (loss) before 11,914 (786) — 11,128 Less: gain (loss) reclassified from AOCI 133 — — 133 Tax effect — 183 — 183 Net current-period other comprehensive income (loss) 11,781 (603) — 11,178 AOCI balance at September 30, 2021 $ 9,021 $ 1,218 $ — $ 10,239 Three Months Ended September 30, 2020 Unrealized Gains Unrealized Gains Other Total AOCI balance at June 30, 2020 $ 22,963 $ 7,087 $ — $ 30,050 Other comprehensive income (loss) before (16,094) (2,201) — (18,295) Less: gain (loss) reclassified from AOCI 1,878 — — 1,878 Tax effect — 508 — 508 Net current-period other comprehensive income (loss) (17,972) (1,693) — (19,665) AOCI balance at September 30, 2020 $ 4,991 $ 5,394 $ — $ 10,385 Nine Months Ended September 30, 2021 Unrealized Gains Unrealized Gains Other Total AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ — $ (16,139) Other comprehensive income (loss) before 24,096 (3,470) — 20,626 Less: gain (loss) reclassified from AOCI (4,953) — — (4,953) Tax effect — 799 — 799 Net current-period other comprehensive income (loss) 29,049 (2,671) — 26,378 AOCI balance at September 30, 2021 $ 9,021 $ 1,218 $ — $ 10,239 Nine Months Ended September 30, 2020 Unrealized Gains Unrealized Gains Other Total AOCI balance at December 31, 2019 $ 16,614 $ 3,565 $ (15) $ 20,164 Other comprehensive income (loss) before 1,404 2,379 15 3,798 Less: gain (loss) reclassified from AOCI 13,027 — — 13,027 Tax effect — (550) — (550) Net current-period other comprehensive income (loss) (11,623) 1,829 15 (9,779) AOCI balance at September 30, 2020 $ 4,991 $ 5,394 $ — $ 10,385 For additional discussion of reclassifications from AOCI see Note 8 – Derivative Instruments and Hedging Strategies . |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 9 Months Ended |
Sep. 30, 2021 | |
Concentration Risk And Geographic Information [Abstract] | |
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 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 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, which is sold exclusively to Sanofi Genzyme (Genzyme) who markets and sells Aldurazyme worldwide. Aldurazyme revenues earned by the Company are included in the U.S. region as the transactions are with Genzyme, whose headquarters is located in the U.S. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Total revenues by geographic region: United States $ 196,239 $ 252,948 $ 608,670 $ 729,672 Europe 115,497 121,158 450,016 375,453 Latin America 38,958 44,064 140,911 141,852 Rest of world 58,048 58,614 196,868 161,361 Total revenues $ 408,742 $ 476,784 $ 1,396,465 $ 1,408,338 The following table disaggregates total Net Product Revenues by product. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Net product revenues by product: Vimizim $ 136,744 $ 147,891 $ 466,697 $ 401,789 Naglazyme 71,172 76,323 297,321 271,585 Kuvan 67,687 123,993 217,257 368,604 Palynziq 60,729 46,092 173,702 121,354 Brineura 32,984 25,455 90,641 75,223 Voxzogo 144 — 144 — Firdapse — — — 1,316 Total net product revenues marketed by the Company $ 369,460 $ 419,754 $ 1,245,762 $ 1,239,871 Aldurazyme net product revenues marketed by Genzyme 24,380 40,987 $ 102,517 $ 128,945 Total net product revenues $ 393,840 $ 460,741 $ 1,348,279 $ 1,368,816 The table below disaggregates total Net Product Revenues based on patient location for products sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Three Months Ended Nine Months Ended 2021 2020 2021 2020 United States $ 166,554 $ 203,892 $ 491,028 $ 582,734 Europe 108,568 115,548 424,144 360,718 Latin America 38,958 44,064 140,911 141,852 Rest of world 55,380 56,250 189,679 154,567 Total net product revenues marketed by the Company $ 369,460 $ 419,754 $ 1,245,762 $ 1,239,871 Aldurazyme net product revenues marketed by Genzyme 24,380 40,987 102,517 128,945 Total net product revenues $ 393,840 $ 460,741 $ 1,348,279 $ 1,368,816 The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Customer A 20 % 16 % 17 % 15 % Customer B 16 % 14 % 14 % 14 % Customer C 11 % 11 % 10 % 12 % Total 47 % 41 % 41 % 41 % On a consolidated basis, two customers accounted for 31% and 14% of the Company’s September 30, 2021 accounts receivable balance, respectively, compared to December 31, 2020, when two customers accounted for 24% and 22% of the accounts receivable balance, respectively. As of September 30, 2021, and December 31, 2020, the accounts receivable balance for Genzyme included $83.9 million and $72.1 million, respectively, of unbilled accounts receivable, which becomes 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 prepayments in certain circumstances. The COVID-19 pandemic continues to affect economies and business around the world. The Company’s global revenue sources, mostly in the form of demand interruptions such as missed patient infusions and delayed treatment starts for new patients, and its business operations were impacted by the COVID-19 pandemic during the nine months ended September 30, 2021 and 2020, and the Company anticipates a continued impact due to COVID-19 on its financial results in the remainder of 2021. The extent and duration of such effects remain uncertain and difficult to predict, particularly as virus variants continue to spread. The Company is actively monitoring and managing its response and assessing actual and potential impacts to its operating results and financial condition, as well as developments in its business, which could further impact developments, trends and expectations. See the risk factor related to the impact of the coronavirus pandemic, “The COVID-19 pandemic could continue to materially adversely affect our business, results of operations and financial condition.” described in “Risk Factors” in Part II, Item 1A of this Quarterly Report, for additional details on the impact of the COVID-19 pandemic. The Company is mindful that conditions in the current macroeconomic environment could affect the Company’s ability to achieve its goals. The Company sells its products in countries that face economic volatility and weakness. Although the Company has historically collected receivables from customers in certain countries, sustained weakness or further deterioration of the local economies and currencies and effects of the impact of the ongoing COVID-19 pandemic may cause customers in those countries to delay payment or be unable to pay for the Company’s products. The Company believes that the allowances for doubtful accounts related to these countries, if any, are adequate based on its analysis of the specific business circumstances and expectations of collection for each of the underlying accounts in these countries. The Company will continue to monitor these conditions and will attempt to adjust its business processes, as appropriate, to mitigate macroeconomic risks to its business. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATIONThe Company has stockholder-approved equity incentive plans that provide for the granting of service-based restricted stock units (RSUs), market-based RSUs, performance-based RSUs, stock options and other types of awards to its employees, officers and non-employee directors. Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income (Loss) for all stock-based compensation arrangements was as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Cost of sales $ 4,339 $ 10,342 $ 16,907 $ 20,381 Research and development 17,866 15,705 56,199 45,333 Selling, general and administrative 26,821 24,122 80,266 76,411 Total stock-based compensation expense $ 49,026 $ 50,169 $ 153,372 $ 142,125 |
NET INCOME (LOSS) PER COMMON SH
NET INCOME (LOSS) PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
NET INCOME (LOSS) PER COMMON SHARE | NET INCOME (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 Share Purchase Plan (ESPP), unvested RSUs, the Company’s common stock held by the NQDC and contingent issuances of common stock related to the Company’s convertible debt. The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Numerator: Net Income (loss), basic $ (36,494) $ 784,803 $ (6,182) $ 837,001 Add: Interest on convertible notes — 7,070 — 18,333 Net Income (loss), diluted $ (36,494) $ 791,873 $ (6,182) $ 855,334 Denominator: Weighted-average common shares outstanding, basic 183,214 181,142 182,616 180,592 Effect of dilutive securities: Options to purchase common stock — 1,731 — 1,728 Common stock issuable under the 2020 notes — 3,983 — 3,983 Common stock issuable under the 2024 notes — 3,970 — 3,970 Common stock issuable under the 2027 notes — 4,365 — 2,373 Unvested RSUs — 1,926 — 1,765 Common stock potentially issuable for ESPP purchases — 346 — 337 The Company’s common stock held by the NQDC — 211 — 211 Weighted-average common shares outstanding, diluted 183,214 197,674 182,616 194,959 Net income (loss) per common share, basic $ (0.20) $ 4.33 $ (0.03) $ 4.63 Net income (loss) per common share, diluted $ (0.20) $ 4.01 $ (0.03) $ 4.39 In addition to the equity instruments included in the table above, the table below presents potential shares of common stock that were excluded from the computation of basic and diluted income (loss) per common share as they were anti-dilutive (in thousands): Three Months Ended September 30, Nine Months Ended 2021 2020 2021 2020 Options to purchase common stock 6,649 5,172 6,649 5,175 Common stock issuable under the 2024 Notes 3,970 — 3,970 — Common stock issuable under the 2027 Notes 4,365 — 4,365 — Unvested RSUs 5,292 2,900 5,292 3,060 Common stock potentially issuable for ESPP purchases 582 193 582 204 The Company’s common stock held by the NQDC 197 — 197 — Total number of potentially issuable shares 21,055 8,265 21,055 8,439 The Company’s 1.50% senior subordinated convertible notes due in October 2020 (the 2020 Notes) matured on October 15, 2020 and were settled in cash. The potential effect of the capped call transactions and potential shares issuable under the 2020 Notes were excluded from the calculation of diluted net income (loss) per share in the three and nine months ended September 30, 2020, as the Company’s closing price on September 30, 2020 did not exceed the conversion price of $94.15 per share. There is no similar capped call transaction associated with the 2024 Notes or the 2027 Notes. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 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 or 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 September 30, 2021, the Company was subject to contingent payments totaling approximately $708.8 million upon achievement of certain development and regulatory activities and commercial sales milestones if they occur before certain dates in the future. Of this amount, $70.0 million were considered probable and comprised of commercial milestones related to the acquisition of certain rights and other assets with respect to Kuvan and Palynziq from a third party, $405.5 million were considered reasonably possible and primarily related to development milestones and $233.3 million were considered remote as the Company is no longer developing the related programs. As of September 30, 2021, the fair value of contingent liabilities recorded on the Company’s Condensed Consolidated Balance Sheet was $63.4 million of which $48.2 million was short term. See Note 7 – Fair Value Measurements to these Condensed Consolidated Financial Statements for further information regarding the fair value of the Company’s contingent consideration. Other Commitments The Company uses experts and laboratories at universities and other institutions to perform certain research and development (R&D) activities. These amounts are included as R&D expense as services are provided. In the normal course of business, the Company enters into various firm purchase commitments primarily related to active pharmaceutical ingredients, certain inventory-related items and certain third-party R&D services. As of September 30, 2021, such commitments and other minimum contractual obligations for clinical and post-marketing services were estimated at approximately $107.7 million. The Company has also licensed technology, for which it is required to pay royalties upon future sales, subject to certain annual minimums. |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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 Securities and Exchange Commission (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, 2020 included in the Company’s Annual Report on Form 10-K. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated. The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other period. 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 full extent to which the novel coronavirus (referred to as COVID-19) pandemic could continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing, clinical trials and research and development costs, will depend on future developments that remain uncertain at this time, particularly as virus variants continue to spread. As events continue to evolve and additional information becomes available, the Company’s estimates may change materially in future periods. |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 for each period presented: September 30, 2021 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 294,209 $ — $ — $ 294,209 $ 294,209 $ — $ — Level 2: Money market instruments 291,735 — — 291,735 291,735 — — Corporate debt securities 560,004 1,230 (198) 561,036 703 177,468 382,865 U.S. government agency securities 210,444 416 (7) 210,853 12,999 161,207 36,647 Commercial paper 129,818 1 (1) 129,818 17,497 112,321 — Asset-backed securities 55,182 26 (23) 55,185 — 8,272 46,913 Foreign and other 3,114 150 (6) 3,258 — 3,065 193 Subtotal 1,250,297 1,823 (235) 1,251,885 322,934 462,333 466,618 Total $ 1,544,506 $ 1,823 $ (235) $ 1,546,094 $ 617,143 $ 462,333 $ 466,618 December 31, 2020 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 370,325 $ — $ — $ 370,325 $ 370,325 $ — $ — Level 2: Money market instruments 264,833 — — 264,833 264,833 — — Corporate debt securities 413,137 3,261 (8) 416,390 — 220,551 195,839 U.S. government agency securities 265,298 1,555 (1) 266,852 14,000 192,488 60,364 Asset-backed securities 31,659 85 (2) 31,742 — 3,189 28,553 Foreign and other 549 168 — 717 — — 717 Subtotal 975,476 5,069 (11) 980,534 278,833 416,228 285,473 Total $ 1,345,801 $ 5,069 $ (11) $ 1,350,859 $ 649,158 $ 416,228 $ 285,473 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one |
SUPPLEMENTAL BALANCE SHEET IN_2
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: September 30, December 31, Raw materials $ 75,328 $ 76,673 Work-in-process 412,434 308,286 Finished goods 261,644 313,589 Total inventory $ 749,406 $ 698,548 |
Schedule of Property Plant and Equipment Net | Property, Plant and Equipment, Net consisted of the following: September 30, December 31, Property, plant and equipment, gross $ 1,724,702 $ 1,668,066 Accumulated depreciation (699,915) (635,595) Total property, plant and equipment, net $ 1,024,787 $ 1,032,471 |
Schedule of Intangible Assets | Intangible Assets, Net consisted of the following: September 30, December 31, Finite-lived intangible assets $ 661,781 $ 644,087 Less: Accumulated amortization (273,294) (226,816) Net carrying value $ 388,487 $ 417,271 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, Accounts payable and accrued operating expenses $ 203,321 $ 191,429 Accrued compensation expense 158,130 165,023 Accrued rebates payable 68,329 65,526 Accrued royalties payable 14,512 17,155 Lease liabilities 9,659 11,754 Forward foreign currency exchange contracts 5,323 17,798 Value added taxes payable 1,412 9,562 Accrued income taxes 564 9,661 Other 5,461 4,640 Total accounts payable and accrued liabilities $ 466,711 $ 492,548 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Condensed Consolidated Financial Statements that are remeasured on a recurring basis as of September 30, 2021 and December 31, 2020. Other than the Company’s fixed-rate convertible debt disclosed in Note 9 – Debt , there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of September 30, 2021 or December 31, 2020. Fair Value Measurements as of September 30, 2021 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,089 $ — $ 2,089 Other assets: NQDC Plan assets 22,521 — 22,521 Restricted investments (1) 2,835 — 2,835 Total other assets 25,356 — 25,356 Total assets $ 27,445 $ — $ 27,445 Liabilities: Current liabilities: NQDC Plan liability $ 2,089 $ — $ 2,089 Contingent consideration — 48,187 48,187 Total current liabilities 2,089 48,187 50,276 Other long-term liabilities: NQDC Plan liability 22,521 — 22,521 Contingent consideration — 15,204 15,204 Total other long-term liabilities 22,521 15,204 37,725 Total liabilities $ 24,610 $ 63,391 $ 88,001 Fair Value Measurements as of December 31, 2020 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,415 $ — $ 2,415 Other assets: NQDC Plan assets 19,962 — 19,962 Restricted investments (1) 4,487 — 4,487 Total other assets 24,449 — 24,449 Total assets $ 26,864 $ — $ 26,864 Liabilities: Current liabilities: NQDC Plan liability $ 2,415 $ — $ 2,415 Other long-term liabilities: NQDC Plan liability 19,962 — 19,962 Contingent consideration — 60,130 60,130 Total other long-term liabilities 19,962 60,130 80,092 Total liabilities $ 22,377 $ 60,130 $ 82,507 (1) The restricted investments at September 30, 2021 and December 31, 2020 secure the Company's irrevocable standby letters of credit obtained in connection with certain commercial agreements. |
Liabilities Measured at Fair Value on Recurring Basis Using Level 3 Inputs | Liabilities measured at fair value using Level 3 inputs primarily consisted of contingent consideration. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2020 $ 60,130 Changes in the fair value of contingent consideration 6,254 Foreign exchange remeasurement of Euro denominated contingent consideration (2,993) Contingent consideration as of September 30, 2021 $ 63,391 |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Derivative [Line Items] | |
Fair Value Carrying Amount of Derivatives | The fair value carrying amounts of the Company’s derivatives, as classified within the fair value hierarchy, were as follows: Balance Sheet Location September 30, 2021 December 31, 2020 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 11,883 $ 6,268 Other assets 4,320 3,148 Subtotal $ 16,203 $ 9,416 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 5,257 $ 17,551 Other long-term liabilities 1,486 11,020 Subtotal $ 6,743 $ 28,571 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 252 $ 84 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 66 $ 247 Total Derivatives Assets $ 16,455 $ 9,500 Total Derivatives Liabilities $ 6,809 $ 28,818 (1) For additional discussion of fair value measurements, see Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. |
Summary of Impact of Gains and Losses from Derivatives Designated as Hedging Instruments | The following tables summarize the impact of gains and losses from the Company's derivatives on its Condensed Consolidated Statements of Comprehensive Income (Loss) for the periods presented. Three Months Ended September 30, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 393,840 $ 401 $ 460,741 $ 2,693 Operating expenses as reported $ 461,961 $ (268) $ 532,725 $ (815) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 1,302 $ 4,166 Nine Months Ended September 30, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,348,279 $ (5,034) $ 1,368,816 $ 17,301 Operating expenses as reported $ 1,412,926 $ 81 $ 1,400,263 $ (4,274) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 2,310 $ 9,600 |
Derivatives Designated As Hedging Instruments | |
Derivative [Line Items] | |
Summary of Derivatives Designated as Hedging Instruments Outstanding | The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Foreign Exchange Contracts September 30, 2021 December 31, 2020 Derivatives designated as hedging instruments: Sell $ 654,516 $ 782,327 Purchase $ 168,080 $ 189,540 Derivatives not designated as hedging instruments: Sell $ 77,040 $ 98,343 Purchase $ 37,285 $ 12,277 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: September 30, December 31, 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (11,478) (12,995) 2027 Notes, net 588,522 587,005 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (5,429) (6,860) 2024 Notes, net 489,571 488,140 Total convertible debt, net $ 1,078,093 $ 1,075,145 Fair value of fixed rate convertible debt (1) : 2027 Notes $ 600,858 $ 627,090 2024 Notes 510,954 530,714 Total fair value of fixed rate convertible debt $ 1,111,812 $ 1,157,804 (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. For additional discussion of fair value measurements, see Note 3 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. |
Summary of Interest Expense on Debt | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Nine Months Ended September 30, 2021 2020 2021 2020 Coupon interest expense $ 2,617 $ 4,255 $ 7,849 $ 9,443 Accretion of discount on convertible notes 835 4,696 2,503 13,201 Amortization of debt issuance costs 148 535 445 1,565 Total interest expense on convertible debt $ 3,600 $ 9,486 $ 10,797 $ 24,209 |
ACCUMULATED OTHER COMPREHENSI_2
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
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 Accumulated Other Comprehensive Income (Loss) (AOCI), including current-period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Three Months Ended September 30, 2021 Unrealized Gains Unrealized Gains Other Total AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ — $ (939) Other comprehensive income (loss) before 11,914 (786) — 11,128 Less: gain (loss) reclassified from AOCI 133 — — 133 Tax effect — 183 — 183 Net current-period other comprehensive income (loss) 11,781 (603) — 11,178 AOCI balance at September 30, 2021 $ 9,021 $ 1,218 $ — $ 10,239 Three Months Ended September 30, 2020 Unrealized Gains Unrealized Gains Other Total AOCI balance at June 30, 2020 $ 22,963 $ 7,087 $ — $ 30,050 Other comprehensive income (loss) before (16,094) (2,201) — (18,295) Less: gain (loss) reclassified from AOCI 1,878 — — 1,878 Tax effect — 508 — 508 Net current-period other comprehensive income (loss) (17,972) (1,693) — (19,665) AOCI balance at September 30, 2020 $ 4,991 $ 5,394 $ — $ 10,385 Nine Months Ended September 30, 2021 Unrealized Gains Unrealized Gains Other Total AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ — $ (16,139) Other comprehensive income (loss) before 24,096 (3,470) — 20,626 Less: gain (loss) reclassified from AOCI (4,953) — — (4,953) Tax effect — 799 — 799 Net current-period other comprehensive income (loss) 29,049 (2,671) — 26,378 AOCI balance at September 30, 2021 $ 9,021 $ 1,218 $ — $ 10,239 Nine Months Ended September 30, 2020 Unrealized Gains Unrealized Gains Other Total AOCI balance at December 31, 2019 $ 16,614 $ 3,565 $ (15) $ 20,164 Other comprehensive income (loss) before 1,404 2,379 15 3,798 Less: gain (loss) reclassified from AOCI 13,027 — — 13,027 Tax effect — (550) — (550) Net current-period other comprehensive income (loss) (11,623) 1,829 15 (9,779) AOCI balance at September 30, 2020 $ 4,991 $ 5,394 $ — $ 10,385 |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Concentration Risk And Geographic Information [Abstract] | |
Schedule 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, which is sold exclusively to Sanofi Genzyme (Genzyme) who markets and sells Aldurazyme worldwide. Aldurazyme revenues earned by the Company are included in the U.S. region as the transactions are with Genzyme, whose headquarters is located in the U.S. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Total revenues by geographic region: United States $ 196,239 $ 252,948 $ 608,670 $ 729,672 Europe 115,497 121,158 450,016 375,453 Latin America 38,958 44,064 140,911 141,852 Rest of world 58,048 58,614 196,868 161,361 Total revenues $ 408,742 $ 476,784 $ 1,396,465 $ 1,408,338 |
Schedule of Net Product Revenues by Product | The following table disaggregates total Net Product Revenues by product. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Net product revenues by product: Vimizim $ 136,744 $ 147,891 $ 466,697 $ 401,789 Naglazyme 71,172 76,323 297,321 271,585 Kuvan 67,687 123,993 217,257 368,604 Palynziq 60,729 46,092 173,702 121,354 Brineura 32,984 25,455 90,641 75,223 Voxzogo 144 — 144 — Firdapse — — — 1,316 Total net product revenues marketed by the Company $ 369,460 $ 419,754 $ 1,245,762 $ 1,239,871 Aldurazyme net product revenues marketed by Genzyme 24,380 40,987 $ 102,517 $ 128,945 Total net product revenues $ 393,840 $ 460,741 $ 1,348,279 $ 1,368,816 |
Schedule of Total Net Product Revenues Based on Patient Location | The table below disaggregates total Net Product Revenues based on patient location for products sold directly by the Company, and global sales of Aldurazyme, which is marketed by Genzyme. Three Months Ended Nine Months Ended 2021 2020 2021 2020 United States $ 166,554 $ 203,892 $ 491,028 $ 582,734 Europe 108,568 115,548 424,144 360,718 Latin America 38,958 44,064 140,911 141,852 Rest of world 55,380 56,250 189,679 154,567 Total net product revenues marketed by the Company $ 369,460 $ 419,754 $ 1,245,762 $ 1,239,871 Aldurazyme net product revenues marketed by Genzyme 24,380 40,987 102,517 128,945 Total net product revenues $ 393,840 $ 460,741 $ 1,348,279 $ 1,368,816 |
Schedule of 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 periods presented. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Customer A 20 % 16 % 17 % 15 % Customer B 16 % 14 % 14 % 14 % Customer C 11 % 11 % 10 % 12 % Total 47 % 41 % 41 % 41 % |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income (Loss) for all stock-based compensation arrangements was as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Cost of sales $ 4,339 $ 10,342 $ 16,907 $ 20,381 Research and development 17,866 15,705 56,199 45,333 Selling, general and administrative 26,821 24,122 80,266 76,411 Total stock-based compensation expense $ 49,026 $ 50,169 $ 153,372 $ 142,125 |
NET INCOME (LOSS) PER COMMON _2
NET INCOME (LOSS) PER COMMON SHARE (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share | The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Three Months Ended Nine Months Ended 2021 2020 2021 2020 Numerator: Net Income (loss), basic $ (36,494) $ 784,803 $ (6,182) $ 837,001 Add: Interest on convertible notes — 7,070 — 18,333 Net Income (loss), diluted $ (36,494) $ 791,873 $ (6,182) $ 855,334 Denominator: Weighted-average common shares outstanding, basic 183,214 181,142 182,616 180,592 Effect of dilutive securities: Options to purchase common stock — 1,731 — 1,728 Common stock issuable under the 2020 notes — 3,983 — 3,983 Common stock issuable under the 2024 notes — 3,970 — 3,970 Common stock issuable under the 2027 notes — 4,365 — 2,373 Unvested RSUs — 1,926 — 1,765 Common stock potentially issuable for ESPP purchases — 346 — 337 The Company’s common stock held by the NQDC — 211 — 211 Weighted-average common shares outstanding, diluted 183,214 197,674 182,616 194,959 Net income (loss) per common share, basic $ (0.20) $ 4.33 $ (0.03) $ 4.63 Net income (loss) per common share, diluted $ (0.20) $ 4.01 $ (0.03) $ 4.39 |
Schedule Of Anti-Dilutive Common Stock Excluded From Computation of Diluted Net Loss Per Share | In addition to the equity instruments included in the table above, the table below presents potential shares of common stock that were excluded from the computation of basic and diluted income (loss) per common share as they were anti-dilutive (in thousands): Three Months Ended September 30, Nine Months Ended 2021 2020 2021 2020 Options to purchase common stock 6,649 5,172 6,649 5,175 Common stock issuable under the 2024 Notes 3,970 — 3,970 — Common stock issuable under the 2027 Notes 4,365 — 4,365 — Unvested RSUs 5,292 2,900 5,292 3,060 Common stock potentially issuable for ESPP purchases 582 193 582 204 The Company’s common stock held by the NQDC 197 — 197 — Total number of potentially issuable shares 21,055 8,265 21,055 8,439 |
Financial Instruments - Schedul
Financial Instruments - Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | ||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 1,544,506 | $ 1,345,801 | |
Gross Unrealized Gains | 1,823 | 5,069 | |
Gross Unrealized Losses | (235) | (11) | |
Aggregate Fair Value | 1,546,094 | 1,350,859 | |
Cash and Cash Equivalents | 617,143 | 649,158 | [1] |
Short-term Marketable Securities | 462,333 | 416,228 | [1] |
Long-term Marketable Securities | 466,618 | 285,473 | [1] |
Level 1: | Cash | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Cash | 294,209 | 370,325 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 294,209 | 370,325 | |
Cash and Cash Equivalents | 294,209 | 370,325 | |
Short-term Marketable Securities | 0 | 0 | |
Long-term Marketable Securities | 0 | 0 | |
Level 2: | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,250,297 | 975,476 | |
Gross Unrealized Gains | 1,823 | 5,069 | |
Gross Unrealized Losses | (235) | (11) | |
Aggregate Fair Value | 1,251,885 | 980,534 | |
Cash and Cash Equivalents | 322,934 | 278,833 | |
Short-term Marketable Securities | 462,333 | 416,228 | |
Long-term Marketable Securities | 466,618 | 285,473 | |
Level 2: | Money market instruments | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 291,735 | 264,833 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 291,735 | 264,833 | |
Cash and Cash Equivalents | 291,735 | 264,833 | |
Short-term Marketable Securities | 0 | 0 | |
Long-term Marketable Securities | 0 | 0 | |
Level 2: | Corporate debt securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 560,004 | 413,137 | |
Gross Unrealized Gains | 1,230 | 3,261 | |
Gross Unrealized Losses | (198) | (8) | |
Aggregate Fair Value | 561,036 | 416,390 | |
Cash and Cash Equivalents | 703 | 0 | |
Short-term Marketable Securities | 177,468 | 220,551 | |
Long-term Marketable Securities | 382,865 | 195,839 | |
Level 2: | U.S. government agency securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 210,444 | 265,298 | |
Gross Unrealized Gains | 416 | 1,555 | |
Gross Unrealized Losses | (7) | (1) | |
Aggregate Fair Value | 210,853 | 266,852 | |
Cash and Cash Equivalents | 12,999 | 14,000 | |
Short-term Marketable Securities | 161,207 | 192,488 | |
Long-term Marketable Securities | 36,647 | 60,364 | |
Level 2: | Commercial paper | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 129,818 | ||
Gross Unrealized Gains | 1 | ||
Gross Unrealized Losses | (1) | ||
Aggregate Fair Value | 129,818 | ||
Cash and Cash Equivalents | 17,497 | ||
Short-term Marketable Securities | 112,321 | ||
Long-term Marketable Securities | 0 | ||
Level 2: | Asset-backed securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 55,182 | 31,659 | |
Gross Unrealized Gains | 26 | 85 | |
Gross Unrealized Losses | (23) | (2) | |
Aggregate Fair Value | 55,185 | 31,742 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 8,272 | 3,189 | |
Long-term Marketable Securities | 46,913 | 28,553 | |
Level 2: | Foreign and other | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 3,114 | 549 | |
Gross Unrealized Gains | 150 | 168 | |
Gross Unrealized Losses | (6) | 0 | |
Aggregate Fair Value | 3,258 | 717 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 3,065 | 0 | |
Long-term Marketable Securities | $ 193 | $ 717 | |
Minimum | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Long term marketable securities maturity period | 1 year | 1 year | |
Maximum | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Short term marketable securities maturity period | 1 year | 1 year | |
Long term marketable securities maturity period | 5 years | 5 years | |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) $ in Millions | Sep. 30, 2021 | Dec. 31, 2020 |
Strategic Investment | Fair Value, Measurements, Recurring | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Strategic investments fair value | $ 16.3 | $ 10.5 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Raw materials | $ 75,328 | $ 76,673 | |
Work-in-process | 412,434 | 308,286 | |
Finished goods | 261,644 | 313,589 | |
Total inventory | $ 749,406 | $ 698,548 | [1] |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | [1] | |
Inventory [Line Items] | ||||||
Inventory | $ 749,406 | $ 749,406 | $ 698,548 | |||
Depreciation expense, net of amounts capitalized into inventory | 11,400 | $ 11,100 | 35,700 | $ 31,100 | ||
Voxzogo | ||||||
Inventory [Line Items] | ||||||
Inventory | $ 4,800 | $ 4,800 | ||||
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |||
Property, plant and equipment, gross | $ 1,724,702 | $ 1,668,066 | |
Accumulated depreciation | (699,915) | (635,595) | |
Property, plant and equipment, net | $ 1,024,787 | $ 1,032,471 | [1] |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |||
Finite-lived intangible assets | $ 661,781 | $ 644,087 | |
Less: Accumulated amortization | (273,294) | (226,816) | |
Net carrying value | $ 388,487 | $ 417,271 | [1] |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Supplemental Balance Sheet In_7
Supplemental Balance Sheet Information - Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accounts payable and accrued operating expenses | $ 203,321 | $ 191,429 | |
Accrued compensation expense | 158,130 | 165,023 | |
Accrued rebates payable | 68,329 | 65,526 | |
Accrued royalties payable | 14,512 | 17,155 | |
Forward foreign currency exchange contracts | 5,323 | 17,798 | |
Lease liabilities | 9,659 | 11,754 | |
Value added taxes payable | 1,412 | 9,562 | |
Accrued income taxes | 564 | 9,661 | |
Other | 5,461 | 4,640 | |
Total accounts payable and accrued liabilities | $ 466,711 | $ 492,548 | [1] |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets and Liabilities (Detail) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Quoted Price in Active Markets For Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets remeasured | $ 0 | $ 0 |
Liabilities remeasured | 0 | 0 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 25,356,000 | 24,449,000 |
Fair value of financial assets, Total | 27,445,000 | 26,864,000 |
Fair value of other current liabilities | 50,276,000 | |
Fair value of other non-current liabilities | 37,725,000 | 80,092,000 |
Fair value of financial liabilities, Total | 88,001,000 | 82,507,000 |
Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 2,089,000 | 2,415,000 |
Fair value of other non-current liabilities | 22,521,000 | 19,962,000 |
Fair Value, Measurements, Recurring | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 48,187,000 | |
Fair value of other non-current liabilities | 15,204,000 | 60,130,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 25,356,000 | 24,449,000 |
Fair value of financial assets, Total | 27,445,000 | 26,864,000 |
Fair value of other current liabilities | 2,089,000 | |
Fair value of other non-current liabilities | 22,521,000 | 19,962,000 |
Fair value of financial liabilities, Total | 24,610,000 | 22,377,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 2,089,000 | 2,415,000 |
Fair value of other non-current liabilities | 22,521,000 | 19,962,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 0 | |
Fair value of other non-current liabilities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 0 | 0 |
Fair value of financial assets, Total | 0 | 0 |
Fair value of other current liabilities | 48,187,000 | |
Fair value of other non-current liabilities | 15,204,000 | 60,130,000 |
Fair value of financial liabilities, Total | 63,391,000 | 60,130,000 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 0 | 0 |
Fair value of other non-current liabilities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 48,187,000 | |
Fair value of other non-current liabilities | 15,204,000 | 60,130,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 2,089,000 | 2,415,000 |
Fair value of other non-current assets | 22,521,000 | 19,962,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 2,089,000 | 2,415,000 |
Fair value of other non-current assets | 22,521,000 | 19,962,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 0 | 0 |
Fair value of other non-current assets | 0 | 0 |
Fair Value, Measurements, Recurring | Restricted Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 2,835,000 | 4,487,000 |
Fair Value, Measurements, Recurring | Restricted Investments | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 2,835,000 | 4,487,000 |
Fair Value, Measurements, Recurring | Restricted Investments | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | $ 0 | $ 0 |
Fair Value Measurements - Liabi
Fair Value Measurements - Liabilities Measured at Fair Value on Recurring Basis Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Contingent consideration as of December 31, 2020 | $ 60,130 |
Changes in the fair value of contingent consideration | 6,254 |
Foreign exchange remeasurement of Euro denominated contingent consideration | (2,993) |
Contingent consideration as of September 30, 2021 | $ 63,391 |
Derivative Instruments and He_3
Derivative Instruments and Hedging Strategies - Additional Information (Detail) $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Derivative [Line Items] | |
Amount reclassified from AOCI to earnings as related to forecasted revenue and operating expense transactions | $ 6.2 |
Derivatives Designated As Hedging Instruments | |
Derivative [Line Items] | |
Maturity of derivatives | 2 years |
Not Designated as Hedging Instrument | |
Derivative [Line Items] | |
Maturity of derivatives | 3 months |
Derivative Instruments and He_4
Derivative Instruments and Hedging Strategies - Summary of Derivatives Designated as and Not Designated as Hedging Instruments Outstanding (Detail) - Foreign exchange contracts - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Derivatives Designated As Hedging Instruments | Sell | ||
Derivative [Line Items] | ||
Notional amount | $ 654,516 | $ 782,327 |
Derivatives Designated As Hedging Instruments | Purchase | ||
Derivative [Line Items] | ||
Notional amount | 168,080 | 189,540 |
Not Designated as Hedging Instrument | Sell | ||
Derivative [Line Items] | ||
Notional amount | 77,040 | 98,343 |
Not Designated as Hedging Instrument | Purchase | ||
Derivative [Line Items] | ||
Notional amount | $ 37,285 | $ 12,277 |
Derivative Instruments and He_5
Derivative Instruments and Hedging Strategies - Fair Value Carrying Amount of Derivatives (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Derivative [Line Items] | ||
Derivative asset, fair value | $ 16,455 | $ 9,500 |
Derivative liability, fair value | 6,809 | 28,818 |
Level 2: | Derivatives Designated As Hedging Instruments | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 16,203 | 9,416 |
Derivative liability, fair value | 6,743 | 28,571 |
Level 2: | Derivatives Designated As Hedging Instruments | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 11,883 | 6,268 |
Level 2: | Derivatives Designated As Hedging Instruments | Other assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 4,320 | 3,148 |
Level 2: | Derivatives Designated As Hedging Instruments | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 5,257 | 17,551 |
Level 2: | Derivatives Designated As Hedging Instruments | Other long-term liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 1,486 | 11,020 |
Level 2: | Not Designated as Hedging Instrument | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 252 | 84 |
Level 2: | Not Designated as Hedging Instrument | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | $ 66 | $ 247 |
Derivative Instruments and He_6
Derivative Instruments and Hedging Strategies - Summary of Impact of Gains and Losses from Derivatives Designated as Hedging Instruments (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Revenue | $ 408,742 | $ 476,784 | $ 1,396,465 | $ 1,408,338 |
Operating expenses as reported | 461,961 | 532,725 | 1,412,926 | 1,400,263 |
Not Designated as Hedging Instrument | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Gains (Losses) Recognized in Earnings | 1,302 | 4,166 | 2,310 | 9,600 |
Operating expenses as reported | Derivatives Designated As Hedging Instruments | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Cash Flow Hedging Gains (Losses) Reclassified into Earnings | (268) | (815) | 81 | (4,274) |
Net product revenues | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Revenue | 393,840 | 460,741 | 1,348,279 | 1,368,816 |
Net product revenues | Derivatives Designated As Hedging Instruments | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Cash Flow Hedging Gains (Losses) Reclassified into Earnings | $ 401 | $ 2,693 | $ (5,034) | $ 17,301 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Sep. 30, 2021 | Oct. 31, 2018 |
Debt Instrument [Line Items] | ||
Carrying value of equity component | $ 1,100,000,000 | |
The 2018 Credit Facility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 200,000,000 | |
Outstanding amount | $ 0 |
Debt - Summary of Convertible D
Debt - Summary of Convertible Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Convertible notes | $ 1,100,000 | ||
Convertible notes, net of unamortized discount and deferred offering costs | 1,078,093 | $ 1,075,145 | [1] |
Total convertible debt, net | 1,078,093 | 1,075,145 | |
Total fair value of fixed rate convertible debt | $ 1,111,812 | $ 1,157,804 | |
1.25% Senior Subordinated Convertible Notes Due in May 2027 | |||
Debt Instrument [Line Items] | |||
Convertible notes stated rate | 1.25% | 1.25% | |
Convertible notes | $ 600,000 | $ 600,000 | |
Unamortized discount net of deferred offering costs | (11,478) | (12,995) | |
Short-term contingent consideration | 588,522 | 587,005 | |
Total fair value of fixed rate convertible debt | $ 600,858 | $ 627,090 | |
0.599% Senior Subordinated Convertible Notes Due in August 2024 | |||
Debt Instrument [Line Items] | |||
Convertible notes stated rate | 0.599% | 0.599% | |
Convertible notes | $ 495,000 | $ 495,000 | |
Unamortized discount net of deferred offering costs | (5,429) | (6,860) | |
Convertible notes, net of unamortized discount and deferred offering costs | 489,571 | 488,140 | |
Total fair value of fixed rate convertible debt | $ 510,954 | $ 530,714 | |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Debt - Summary of Interest Expe
Debt - Summary of Interest Expense on Convertible Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Schedule Of Interest Expenses [Line Items] | ||||
Total interest expense on convertible debt | $ 3,870 | $ 9,597 | $ 11,491 | $ 24,560 |
Convertible Senior Notes | ||||
Schedule Of Interest Expenses [Line Items] | ||||
Coupon interest expense | 2,617 | 4,255 | 7,849 | 9,443 |
Accretion of discount on convertible notes | 835 | 4,696 | 2,503 | 13,201 |
Amortization of debt issuance costs | 148 | 535 | 445 | 1,565 |
Total interest expense on convertible debt | $ 3,600 | $ 9,486 | $ 10,797 | $ 24,209 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Loss) - 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 | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | [1] | $ 4,241,571 | $ 3,236,679 | $ 4,106,002 | [2] | $ 3,122,381 |
Other comprehensive income (loss) before reclassifications | 11,128 | (18,295) | 20,626 | 3,798 | ||
Less: gain (loss) reclassified from AOCI | 133 | 1,878 | (4,953) | 13,027 | ||
Tax effect | 183 | 508 | 799 | (550) | ||
Net current-period other comprehensive income (loss) | 11,178 | (19,665) | 26,378 | (9,779) | ||
Ending balance | 4,266,149 | 4,053,893 | 4,266,149 | 4,053,893 | ||
Unrealized Gains (Losses) on Cash Flow Hedges | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | (2,760) | 22,963 | (20,028) | 16,614 | ||
Other comprehensive income (loss) before reclassifications | 11,914 | (16,094) | 24,096 | 1,404 | ||
Less: gain (loss) reclassified from AOCI | 133 | 1,878 | (4,953) | 13,027 | ||
Tax effect | 0 | 0 | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 11,781 | (17,972) | 29,049 | (11,623) | ||
Ending balance | 9,021 | 4,991 | 9,021 | 4,991 | ||
Unrealized Gains (Losses) on Available for-Sale Debt Securities | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | 1,821 | 7,087 | 3,889 | 3,565 | ||
Other comprehensive income (loss) before reclassifications | (786) | (2,201) | (3,470) | 2,379 | ||
Less: gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | ||
Tax effect | 183 | 508 | 799 | (550) | ||
Net current-period other comprehensive income (loss) | (603) | (1,693) | (2,671) | 1,829 | ||
Ending balance | 1,218 | 5,394 | 1,218 | 5,394 | ||
Other | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | 0 | 0 | 0 | (15) | ||
Other comprehensive income (loss) before reclassifications | 0 | 0 | 0 | 15 | ||
Less: gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | ||
Tax effect | 0 | 0 | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 0 | 0 | 0 | 15 | ||
Ending balance | 0 | 0 | 0 | 0 | ||
Total | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | [1] | (939) | 30,050 | (16,139) | 20,164 | |
Ending balance | $ 10,239 | $ 10,385 | $ 10,239 | $ 10,385 | ||
[1] | The beginning balances for the nine-month periods were derived from the audited Consolidated Financial Statements included in Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 26, 2021. | |||||
[2] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Revenue, Credit Concentration_3
Revenue, Credit Concentrations and Geographic Information - Additional Information (Detail) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021USD ($)Segment | Dec. 31, 2020USD ($) | ||
Concentration Risk And Geographic Information [Line Items] | |||
Number of operating business segment | Segment | 1 | ||
Accounts receivable, net | $ 374,937 | $ 448,351 | [1] |
Customers | |||
Concentration Risk And Geographic Information [Line Items] | |||
Accounts receivable, net | $ 83,900 | $ 72,100 | |
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 31.00% | 24.00% | |
Credit Concentration Risk | Accounts Receivable | Customer Two | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 14.00% | 22.00% | |
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |
Revenue, Credit Concentration_4
Revenue, Credit Concentrations and Geographic Information - Disaggregates of Total Revenues from External Customers and Collaborative Partners by Geographic Region (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 408,742 | $ 476,784 | $ 1,396,465 | $ 1,408,338 |
United States | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 196,239 | 252,948 | 608,670 | 729,672 |
Europe | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 115,497 | 121,158 | 450,016 | 375,453 |
Latin America | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | 38,958 | 44,064 | 140,911 | 141,852 |
Rest of world | ||||
Revenue from External Customer [Line Items] | ||||
Total revenues | $ 58,048 | $ 58,614 | $ 196,868 | $ 161,361 |
Revenue, Credit Concentration_5
Revenue, Credit Concentrations and Geographic Information - Disaggregates of Net Product Revenues by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 408,742 | $ 476,784 | $ 1,396,465 | $ 1,408,338 |
Vimizim | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 136,744 | 147,891 | 466,697 | 401,789 |
Naglazyme | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 71,172 | 76,323 | 297,321 | 271,585 |
Kuvan | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 67,687 | 123,993 | 217,257 | 368,604 |
Palynziq | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 60,729 | 46,092 | 173,702 | 121,354 |
Brineura | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 32,984 | 25,455 | 90,641 | 75,223 |
Voxzogo | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 144 | 0 | 144 | 0 |
Firdapse | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 0 | 0 | 0 | 1,316 |
Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 369,460 | 419,754 | 1,245,762 | 1,239,871 |
Aldurazyme | Marketed by Genzyme | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 24,380 | 40,987 | 102,517 | 128,945 |
Total net product revenues | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 393,840 | $ 460,741 | $ 1,348,279 | $ 1,368,816 |
Revenue, Credit Concentration_6
Revenue, Credit Concentrations and Geographic Information - Disaggregates of Total Net Product Revenues Based on Patient Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 408,742 | $ 476,784 | $ 1,396,465 | $ 1,408,338 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 196,239 | 252,948 | 608,670 | 729,672 |
Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 115,497 | 121,158 | 450,016 | 375,453 |
Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 38,958 | 44,064 | 140,911 | 141,852 |
Rest of world | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 58,048 | 58,614 | 196,868 | 161,361 |
Total net product revenues | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 393,840 | 460,741 | 1,348,279 | 1,368,816 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 369,460 | 419,754 | 1,245,762 | 1,239,871 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 166,554 | 203,892 | 491,028 | 582,734 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 108,568 | 115,548 | 424,144 | 360,718 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 38,958 | 44,064 | 140,911 | 141,852 |
Marketed by Company | Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim | Rest of world | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 55,380 | 56,250 | 189,679 | 154,567 |
Marketed by Genzyme | Aldurazyme | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 24,380 | $ 40,987 | $ 102,517 | $ 128,945 |
Revenue, Credit Concentration_7
Revenue, Credit Concentrations and Geographic Information - Total Net Product Revenue Concentrations Attributed to Largest Customers (Detail) - Customer Concentration Risk - Net Product Revenue | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Customer A, B, & C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 47.00% | 41.00% | 41.00% | 41.00% |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 20.00% | 16.00% | 17.00% | 15.00% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 16.00% | 14.00% | 14.00% | 14.00% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 11.00% | 11.00% | 10.00% | 12.00% |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 49,026 | $ 50,169 | $ 153,372 | $ 142,125 |
Cost of sales | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,339 | 10,342 | 16,907 | 20,381 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 17,866 | 15,705 | 56,199 | 45,333 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 26,821 | $ 24,122 | $ 80,266 | $ 76,411 |
Net Income (Loss) Per Common _3
Net Income (Loss) Per Common Share - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||
Net Income (loss), basic | $ (36,494) | $ 784,803 | $ (6,182) | $ 837,001 |
Add: Interest on convertible notes | 0 | 7,070 | 0 | 18,333 |
Net Income (loss), diluted | $ (36,494) | $ 791,873 | $ (6,182) | $ 855,334 |
Denominator: | ||||
Weighted average common shares outstanding, basic (in shares) | 183,214 | 181,142 | 182,616 | 180,592 |
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Weighted average common shares outstanding, diluted (in shares) | 183,214 | 197,674 | 182,616 | 194,959 |
Net income (loss) per common share, basic (in dollars per share) | $ (0.20) | $ 4.33 | $ (0.03) | $ 4.63 |
Net income (loss) per common share, diluted (in dollars per share) | $ (0.20) | $ 4.01 | $ (0.03) | $ 4.39 |
Options to purchase common stock | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 1,731 | 0 | 1,728 |
Common stock issuable under the 2020 Notes | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 3,983 | 0 | 3,983 |
Common stock issuable under the 2024 notes | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 3,970 | 0 | 3,970 |
Common stock issuable under the 2027 Notes | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 4,365 | 0 | 2,373 |
Unvested RSUs | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 1,926 | 0 | 1,765 |
Common stock potentially issuable for ESPP purchases | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 346 | 0 | 337 |
The Company’s common stock held by the NQDC | ||||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | ||||
Effect of dilutive securities (in shares) | 0 | 211 | 0 | 211 |
Net Income (Loss) Per Common _4
Net Income (Loss) Per Common Share - Schedule Of Anti-Dilutive Common Stock Excluded From Computation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 21,055 | 8,265 | 21,055 | 8,439 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 6,649 | 5,172 | 6,649 | 5,175 |
Common stock issuable under the 2024 notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 3,970 | 0 | 3,970 | 0 |
Common stock issuable under the 2027 Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 4,365 | 0 | 4,365 | 0 |
Unvested RSUs | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 5,292 | 2,900 | 5,292 | 3,060 |
Common stock potentially issuable for ESPP purchases | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 582 | 193 | 582 | 204 |
The Company’s common stock held by the NQDC | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 197 | 0 | 197 | 0 |
Net Income (Loss) Per Common _5
Net Income (Loss) Per Common Share - Additional Information (Detail) - 1.50% Senior Subordinated Convertible Notes Due in October 2020 - $ / shares | Sep. 30, 2021 | Sep. 30, 2020 |
Earnings Per Share [Line Items] | ||
Convertible notes stated rate | 1.50% | |
Debt instrument, convertible, conversion price, per share (in dollars per share) | $ 94.15 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | [1] |
Commitments And Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 708,800 | ||
Contingent liabilities | 63,400 | ||
Short-term contingent consideration | 48,187 | $ 0 | |
Purchase commitments and other minimum contractual obligations | 107,700 | ||
Kuvan And Palynziq | Third Party | |||
Commitments And Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 70,000 | ||
Early Stage Development Program | Third Party | |||
Commitments And Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 405,500 | ||
Programs No Longer Being Developed | Third Party | |||
Commitments And Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 233,300 | ||
[1] | (1) December 31, 2020 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, 2020, filed with the SEC on February 26, 2021. |