Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 28, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
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 $0.001 | |
Trading Symbol | BMRN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 185,473,867 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001048477 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 619,802 | $ 587,276 | |
Short-term investments | 489,945 | 426,599 | |
Accounts receivable, net | 466,507 | 373,399 | |
Inventory | 802,315 | 776,669 | |
Other current assets | 139,029 | 110,442 | |
Total current assets | 2,517,598 | 2,274,385 | |
Noncurrent assets: | |||
Long-term investments | 412,503 | 507,793 | |
Property, plant and equipment, net | 1,049,464 | 1,035,461 | |
Intangible assets, net | 369,368 | 388,652 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,448,912 | 1,449,075 | |
Other assets | 151,797 | 151,760 | |
Total assets | 6,145,841 | 6,003,325 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 434,773 | 491,590 | |
Short-term contingent consideration | 29,954 | 48,232 | |
Total current liabilities | 464,727 | 539,822 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 1,081,047 | 1,079,077 | |
Long-term contingent consideration | 0 | 15,167 | |
Other long-term liabilities | 95,260 | 98,519 | |
Total liabilities | 1,641,034 | 1,732,585 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 185,452,454 and 183,912,514 shares issued and outstanding, respectively | 186 | 184 | |
Additional paid-in capital | 5,272,666 | 5,191,502 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (9,290) | (9,689) | |
Accumulated other comprehensive income | 18,472 | 14,432 | |
Accumulated deficit | (777,227) | (925,689) | |
Total stockholders’ equity | 4,504,807 | 4,270,740 | [2] |
Total liabilities and stockholders’ equity | $ 6,145,841 | $ 6,003,325 | |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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) | 185,452,454 | 183,912,514 |
Common stock, shares outstanding (in shares) | 185,452,454 | 183,912,514 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
REVENUES: | ||||
Total revenues | $ 533,798 | $ 501,693 | $ 1,053,157 | $ 987,723 |
OPERATING EXPENSES: | ||||
Cost of sales | 123,126 | 127,062 | 240,091 | 247,228 |
Research and development | 158,190 | 161,107 | 319,026 | 309,832 |
Selling, general and administrative | 196,835 | 184,161 | 391,454 | 358,479 |
Intangible asset amortization and contingent consideration | 16,495 | 17,691 | 34,107 | 35,426 |
Gain on sale of nonfinancial assets, net | 0 | 0 | (108,000) | 0 |
Total operating expenses | 494,646 | 490,021 | 876,678 | 950,965 |
INCOME FROM OPERATIONS | 39,152 | 11,672 | 176,479 | 36,758 |
Interest income | 2,505 | 4,471 | 4,325 | 6,910 |
Interest expense | (3,859) | (3,817) | (7,665) | (7,621) |
Other income (expense), net | (2,947) | 1,830 | (4,101) | 1,337 |
INCOME BEFORE INCOME TAXES | 34,851 | 14,156 | 169,038 | 37,384 |
Provision for income taxes | 7,187 | 1,215 | 20,576 | 7,072 |
NET INCOME | $ 27,664 | $ 12,941 | $ 148,462 | $ 30,312 |
NET INCOME PER SHARE, BASIC (in dollars per share) | $ 0.15 | $ 0.07 | $ 0.80 | $ 0.17 |
NET INCOME PER SHARE, DILUTED (in dollars per share) | $ 0.15 | $ 0.07 | $ 0.79 | $ 0.16 |
Weighted average common shares outstanding, basic (in shares) | 185,254 | 182,844 | 184,710 | 182,311 |
Weighted average common shares outstanding, diluted (in shares) | 187,448 | 185,427 | 191,096 | 185,089 |
COMPREHENSIVE INCOME | $ 47,013 | $ 6,998 | $ 152,502 | $ 45,512 |
Net product revenues | ||||
REVENUES: | ||||
Total revenues | 517,660 | 486,670 | 1,023,185 | 954,439 |
Royalty and other revenues | ||||
REVENUES: | ||||
Total revenues | $ 16,138 | $ 15,023 | $ 29,972 | $ 33,284 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Company Stock Held By NQDC | Accumulated other comprehensive income (loss) | Accumulated Deficit | ||
Beginning balance (in shares) at Dec. 31, 2020 | [1] | 181,741 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans (in shares) | 1,581 | |||||||
Ending balance (in shares) at Jun. 30, 2021 | 183,322 | |||||||
Beginning balance at Dec. 31, 2020 | [1] | $ 4,106,002 | $ 182 | $ 4,993,407 | $ (9,839) | $ (16,139) | $ (861,609) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | 1 | (11,091) | ||||||
Stock-based compensation | 101,147 | |||||||
Common stock held by the Nonqualified Deferred Compensation Plan (the NQDC) | 368 | (368) | ||||||
Other comprehensive income (loss) | 15,200 | |||||||
Net income | 30,312 | 30,312 | ||||||
Ending balance at Jun. 30, 2021 | 4,241,571 | $ 183 | 5,083,831 | (10,207) | (939) | (831,297) | ||
Beginning balance (in shares) at Mar. 31, 2021 | 182,671 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans (in shares) | 651 | |||||||
Ending balance (in shares) at Jun. 30, 2021 | 183,322 | |||||||
Beginning balance at Mar. 31, 2021 | 4,162,010 | $ 183 | 5,010,619 | (9,558) | 5,004 | (844,238) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | 18,825 | |||||||
Stock-based compensation | 53,738 | |||||||
Common stock held by the Nonqualified Deferred Compensation Plan (the NQDC) | 649 | (649) | ||||||
Other comprehensive income (loss) | (5,943) | |||||||
Net income | 12,941 | 12,941 | ||||||
Ending balance at Jun. 30, 2021 | 4,241,571 | $ 183 | 5,083,831 | (10,207) | (939) | (831,297) | ||
Beginning balance (in shares) at Dec. 31, 2021 | [1] | 183,913 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans (in shares) | 1,540 | |||||||
Ending balance (in shares) at Jun. 30, 2022 | 185,453 | |||||||
Beginning balance at Dec. 31, 2021 | [1] | 4,270,740 | [2] | $ 184 | 5,191,502 | (9,689) | 14,432 | (925,689) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | 2 | (15,153) | ||||||
Stock-based compensation | 96,716 | |||||||
Common stock held by the Nonqualified Deferred Compensation Plan (the NQDC) | (399) | 399 | ||||||
Other comprehensive income (loss) | 4,040 | |||||||
Net income | 148,462 | 148,462 | ||||||
Ending balance at Jun. 30, 2022 | 4,504,807 | $ 186 | 5,272,666 | (9,290) | 18,472 | (777,227) | ||
Beginning balance (in shares) at Mar. 31, 2022 | 184,902 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans (in shares) | 551 | |||||||
Ending balance (in shares) at Jun. 30, 2022 | 185,453 | |||||||
Beginning balance at Mar. 31, 2022 | 4,391,315 | $ 185 | 5,206,287 | (9,389) | (877) | (804,891) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | 1 | 18,480 | ||||||
Stock-based compensation | 47,998 | |||||||
Common stock held by the Nonqualified Deferred Compensation Plan (the NQDC) | (99) | 99 | ||||||
Other comprehensive income (loss) | 19,349 | |||||||
Net income | 27,664 | 27,664 | ||||||
Ending balance at Jun. 30, 2022 | $ 4,504,807 | $ 186 | $ 5,272,666 | $ (9,290) | $ 18,472 | $ (777,227) | ||
[1]The beginning balances for the six-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, 2021, filed with the SEC on February 25, 2022.[2] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 148,462 | $ 30,312 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 52,614 | 55,214 |
Non-cash interest expense | 2,062 | 2,082 |
Amortization of premium on investments | 3,070 | 1,878 |
Stock-based compensation | 94,911 | 104,346 |
Gain on sale of nonfinancial assets, net | (108,000) | 0 |
Deferred income taxes | 3,455 | 1,204 |
Unrealized foreign exchange gain | (12,333) | (1,004) |
Non-cash changes in the fair value of contingent consideration | 1,338 | 4,488 |
Other | (18) | (376) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (92,562) | 17,420 |
Inventory | (1,431) | 6,379 |
Other current assets | (12,001) | 34,331 |
Other assets | 9,149 | 321 |
Accounts payable and other short-term liabilities | (76,345) | (60,884) |
Other long-term liabilities | (1,576) | 585 |
Net cash provided by operating activities | 10,795 | 196,296 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (55,971) | (48,106) |
Maturities and sales of investments | 311,598 | 348,941 |
Purchases of investments | (304,805) | (484,572) |
Proceeds from sale of nonfinancial assets | 110,000 | 0 |
Purchase of intangible assets | (2,739) | (6,400) |
Other | 0 | (908) |
Net cash provided by (used in) investing activities | 58,083 | (191,045) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercises of awards under equity incentive plans | 29,493 | 27,640 |
Taxes paid related to net share settlement of equity awards | (44,377) | (38,731) |
Payment of contingent consideration | (21,054) | 0 |
Principal repayments of financing leases | (1,122) | (1,941) |
Other | 0 | (381) |
Net cash used in financing activities | (37,060) | (13,413) |
Effect of exchange rate changes on cash | 708 | 537 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 32,526 | (7,625) |
Cash and cash equivalents: | ||
Beginning of period | 587,276 | 649,158 |
End of period | 619,802 | 641,533 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | ||
Cash paid for income taxes | 11,821 | 10,159 |
Cash paid for interest | 5,137 | 5,195 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Increase (decrease) in accounts payable and accrued liabilities related to fixed assets | 1,012 | (9,393) |
Increase in accounts payable and accrued liabilities related to intangible assets | $ 6,563 | $ 1,397 |
BUSINESS OVERVIEW AND SIGNIFICA
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES 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 seven commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. 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, 2021 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 six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2022 or any other period. Use of Estimates 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 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. Significant Accounting Policies There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2022, as compared to the significant accounting policies disclosed in Note 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Recent Accounting Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the six months ended June 30, 2022, as compared to the recent accounting pronouncements described in Note 1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, that the Company believes are of significance or potential significance to the Company. |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS All marketable securities were classified as available-for-sale at June 30, 2022 and December 31, 2021. The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category for each period presented: June 30, 2022 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 355,318 $ — $ — $ 355,318 $ 355,318 $ — $ — Level 2: Money market instruments 264,484 — — 264,484 264,484 — — Corporate debt securities 560,401 3 (12,450) 547,954 — 273,400 274,554 U.S. government agency securities 263,184 15 (2,734) 260,465 — 180,952 79,513 Commercial paper 33,107 — (23) 33,084 — 33,084 — Asset-backed securities 58,888 8 (633) 58,263 — — 58,263 Foreign and other 2,562 124 (4) 2,682 — 2,509 173 Subtotal 1,182,626 150 (15,844) 1,166,932 264,484 489,945 412,503 Total $ 1,537,944 $ 150 $ (15,844) $ 1,522,250 $ 619,802 $ 489,945 $ 412,503 December 31, 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 $ 301,177 $ — $ — $ 301,177 $ 301,177 $ — $ — Level 2: Money market instruments 285,099 — — 285,099 285,099 — — Corporate debt securities 584,000 386 (2,086) 582,300 — 200,304 381,996 U.S. government agency securities 224,774 182 (325) 224,631 — 146,421 78,210 Commercial paper 68,384 — — 68,384 1,000 67,384 — Asset-backed securities 56,936 10 (95) 56,851 — 9,451 47,400 Foreign and other 3,097 141 (12) 3,226 — 3,039 187 Subtotal 1,222,290 719 (2,518) 1,220,491 286,099 426,599 507,793 Total $ 1,523,467 $ 719 $ (2,518) $ 1,521,668 $ 587,276 $ 426,599 $ 507,793 (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 June 30, 2022, 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. |
SUPPLEMENTAL FINANCIAL STATEMEN
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION | SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION Supplemental Balance Sheet Information Inventory consisted of the following: June 30, December 31, Raw materials $ 104,493 $ 80,269 Work-in-process 429,486 415,261 Finished goods 268,336 281,139 Total inventory $ 802,315 $ 776,669 Inventory as of June 30, 2022, included manufacturing-related costs for the commercial production of valoctocogene roxaparvovec totaling $31.8 million. Valoctocogene roxaparvovec is an investigational gene therapy product candidate for the treatment of severe hemophilia A. The Company must receive marketing approval from the applicable regulators before the valoctocogene roxaparvovec inventory can be sold commercially. Starting in the first quarter of 2022, the Company believed that material uncertainties related to the ultimate regulatory approval of valoctocogene roxaparvovec by the European Medicines Agency had been significantly reduced and the Company expects to realize economic benefit in the future. 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 and correspondence with the relevant regulatory authority following the submission of the additional two-year follow-up safety and efficacy data requested by the regulatory authority in the third quarter of 2020, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, and commercialization and marketplace trends. See Note 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 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: June 30, December 31, Property, plant and equipment, gross $ 1,811,263 $ 1,756,035 Accumulated depreciation (761,799) (720,574) Total property, plant and equipment, net $ 1,049,464 $ 1,035,461 Depreciation expense, net of amounts capitalized into inventory, for the three and six months ended June 30, 2022 was $9.5 million and $21.2 million, respectively. Depreciation expense, net of amounts capitalized into inventory, for the three and six months ended June 30, 2021 was $11.8 million and $24.3 million, respectively. Intangible Assets, Net consisted of the following: June 30, December 31, Finite-lived intangible assets $ 689,499 $ 677,350 Accumulated amortization (320,131) (288,698) Net carrying value $ 369,368 $ 388,652 Accounts Payable and Accrued Liabilities consisted of the following: June 30, December 31, Accounts payable and accrued operating expenses $ 199,251 $ 193,003 Accrued compensation expense 127,929 204,446 Accrued rebates payable 62,485 47,987 Accrued royalties payable 15,620 15,215 Foreign currency exchange forward contracts 10,224 6,263 Lease liabilities 10,611 10,464 Value added taxes payable 2,472 1,935 Accrued income taxes 1,568 1,213 Deferred revenue 305 6,956 Other 4,308 4,108 Total accounts payable and accrued liabilities $ 434,773 $ 491,590 Supplemental Statement of Comprehensive Income Information Gain on Sale of Nonfinancial Assets, Net for the six months ended June 30, 2022 consisted of the completed sale of a Rare Pediatric Disease Priority Review Voucher (PRV) the Company received from the Food and Drug Administration (FDA) in connection with the U.S. approval of Voxzogo. As a result of the PRV sale, the Company recognized a $108.0 million net gain on sale of nonfinancial assets in the Company's Consolidated Statement of Comprehensive Income. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 2022 | |
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 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. 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 June 30, 2022 and December 31, 2021. Other than the Company’s fixed-rate convertible debt disclosed in Note 6 – 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 June 30, 2022 or December 31, 2021. Fair Value Measurements as of June 30, 2022 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,232 $ — $ 2,232 Other assets: NQDC Plan assets 19,336 — 19,336 Restricted investments (1) 2,468 — 2,468 Total other assets 21,804 — 21,804 Total assets $ 24,036 $ — $ 24,036 Liabilities: Current liabilities: NQDC Plan liability $ 2,232 $ — $ 2,232 Contingent consideration — 29,954 29,954 Total current liabilities 2,232 29,954 32,186 Other long-term liabilities: NQDC Plan liability 19,336 — 19,336 Total liabilities $ 21,568 $ 29,954 $ 51,522 Fair Value Measurements as of December 31, 2021 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,043 $ — $ 2,043 Other assets: NQDC Plan assets 23,929 — 23,929 Restricted investments (1) 2,940 — 2,940 Total other assets 26,869 — 26,869 Total assets $ 28,912 $ — $ 28,912 Liabilities: Current liabilities: NQDC Plan liability $ 2,043 $ — $ 2,043 Contingent consideration — 48,232 48,232 Total current liabilities 2,043 48,232 50,275 Other long-term liabilities: NQDC Plan liability 23,929 — 23,929 Contingent consideration — 15,167 15,167 Total other long-term liabilities 23,929 15,167 39,096 Total liabilities $ 25,972 $ 63,399 $ 89,371 (1) The restricted investments at June 30, 2022 and December 31, 2021 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 six months ended June 30, 2022. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following table represents a roll-forward of contingent consideration. Contingent consideration as of December 31, 2021 $ 63,399 Milestone payments to Ares Trading S.A. (Merck Serono) (33,293) Realized foreign exchange gain on settlement of contingent consideration (133) Changes in fair value of contingent consideration 2,860 Foreign exchange remeasurement of Euro denominated contingent consideration (2,879) Contingent consideration as of June 30, 2022 $ 29,954 |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 6 Months Ended |
Jun. 30, 2022 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The Company uses foreign currency exchange forward contracts (forward contracts) to protect against the reduction in value of forecasted foreign currency cash flows resulting from 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 flow 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. Forward Contracts June 30, December 31, 2021 Derivatives designated as hedging instruments: Sell $ 585,370 $ 740,667 Purchase $ 121,257 $ 183,256 Derivatives not designated as hedging instruments: Sell $ 113,793 $ 113,257 Purchase $ — $ 31,068 The fair value carrying amounts of the Company’s derivatives, as classified within the fair value hierarchy, were as follows: Balance Sheet Location June 30, December 31, 2021 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 35,654 $ 17,357 Other assets 6,853 4,991 Subtotal $ 42,507 $ 22,348 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 10,151 $ 5,487 Other long-term liabilities 1,848 1,378 Subtotal $ 11,999 $ 6,865 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 18 $ 427 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 73 $ 776 Total Derivatives Assets $ 42,525 $ 22,775 Total Derivatives Liabilities $ 12,072 $ 7,641 (1) For additional discussion of fair value measurements, see Note 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. The following tables summarize the impact of gains and losses from the Company's derivatives on its Condensed Consolidated Statements of Comprehensive Income for the periods presented. Three Months Ended June 30, 2022 2021 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 517,660 $ 5,927 $ 486,670 $ (2,678) Operating expenses as reported $ 494,646 $ (1,800) $ 490,021 $ 344 Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 4,950 $ (3,260) Six Months Ended June 30, 2022 2021 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,023,185 $ 11,499 $ 954,439 $ (5,435) Operating expenses as reported $ 876,678 $ (3,179) $ 950,965 $ 349 Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 6,241 $ 1,009 As of June 30, 2022, the Company expects to reclassify unrealized gains of $25.5 million from Accumulated Other Comprehensive Income (AOCI) to earnings as the forecasted revenues and operating expense transactions occur over the next twelve months. For additional discussion of balances in AOCI see Note 7 – Accumulated Other Comprehensive Income . |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Notes As of June 30, 2022, 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: June 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 (9,957) (10,971) 2027 Notes, net 590,043 589,029 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (3,996) (4,952) 2024 Notes, net 491,004 490,048 Total convertible debt, net $ 1,081,047 $ 1,079,077 Fair value of fixed-rate convertible debt (1) : 2027 Notes $ 602,436 $ 625,122 2024 Notes 490,401 521,082 Total fair value of fixed-rate convertible debt $ 1,092,837 $ 1,146,204 (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 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Six Months Ended 2022 2021 2022 2021 Coupon interest expense $ 2,617 $ 2,616 $ 5,233 $ 5,232 Accretion of discount on convertible notes 837 834 1,673 1,668 Amortization of debt issuance costs 148 148 297 296 Total interest expense on convertible debt $ 3,602 $ 3,598 $ 7,203 $ 7,196 See Note 10 - Debt included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 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 June 30, 2022, 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 | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME | ACCUMULATED OTHER COMPREHENSIVE INCOME The following tables summarize changes in the accumulated balances for each component of AOCI, including current-period other comprehensive income and reclassifications out of AOCI, for the periods presented. Three Months Ended June 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance at March 31, 2022 $ 8,387 $ (9,264) $ (877) Other comprehensive income (loss) before 26,255 (3,620) 22,635 Less: gain (loss) reclassified from AOCI 4,127 — 4,127 Tax effect — 841 841 Net current-period other comprehensive income (loss) 22,128 (2,779) 19,349 AOCI balance at June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Three Months Ended June 30, 2021 Unrealized Gains Unrealized Gains Total AOCI balance at March 31, 2021 $ 2,617 $ 2,387 $ 5,004 Other comprehensive income (loss) before (7,711) (739) (8,450) Less: gain (loss) reclassified from AOCI (2,334) — (2,334) Tax effect — 173 173 Net current-period other comprehensive income (loss) (5,377) (566) (5,943) AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ (939) Six Months Ended June 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance at December 31, 2021 $ 15,805 $ (1,373) $ 14,432 Other comprehensive income (loss) before 23,030 (13,894) 9,136 Less: gain (loss) reclassified from AOCI 8,320 — 8,320 Tax effect — 3,224 3,224 Net current-period other comprehensive income (loss) 14,710 (10,670) 4,040 AOCI balance at June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Six Months Ended June 30, 2021 Unrealized Gains Unrealized Gains Total AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ (16,139) Other comprehensive income (loss) before 12,182 (2,684) 9,498 Less: gain (loss) reclassified from AOCI (5,086) — (5,086) Tax effect — 616 616 Net current-period other comprehensive income (loss) 17,268 (2,068) 15,200 AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ (939) For additional discussion of reclassifications from AOCI see Note 5 – Derivative Instruments and Hedging Strategies . |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 6 Months Ended |
Jun. 30, 2022 | |
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 following table disaggregates total Net Product Revenues by product. Three Months Ended Six Months Ended 2022 2021 2022 2021 Net product revenues by product: Vimizim $ 173,206 $ 171,655 $ 356,265 $ 329,953 Naglazyme 115,783 118,813 243,814 226,149 Palynziq 61,643 58,935 116,528 112,973 Kuvan 57,602 78,807 116,939 149,570 Brineura 37,725 30,332 73,898 57,657 Voxzogo 34,374 — 54,032 — Total net product revenues marketed by the Company 480,333 458,542 961,476 876,302 Aldurazyme net product revenues marketed by Sanofi 37,327 28,128 61,709 78,137 Total net product revenues 517,660 486,670 1,023,185 954,439 Royalty and other revenues 16,138 15,023 29,972 33,284 Total revenues $ 533,798 $ 501,693 $ 1,053,157 $ 987,723 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 table below disaggregates total Net Product Revenues by geographic region, which is based on patient location for Company's commercial products sold directly by the Company, except for Aldurazyme, which is sold exclusively by Sanofi worldwide. Three Months Ended Six Months Ended 2022 2021 2022 2021 United States $ 169,838 $ 169,411 $ 320,653 $ 324,474 Europe 161,230 166,704 318,062 315,576 Latin America 89,911 42,248 152,455 101,953 Rest of world 59,354 80,179 170,306 134,299 Total net product revenues marketed by the Company $ 480,333 $ 458,542 $ 961,476 $ 876,302 Aldurazyme net product revenues marketed by Sanofi 37,327 28,128 61,709 78,137 Total net product revenues $ 517,660 $ 486,670 $ 1,023,185 $ 954,439 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 Six Months Ended 2022 2021 2022 2021 Customer A 16 % 16 % 16 % 16 % Customer B 12 % 13 % 12 % 13 % Customer C 5 % 12 % 5 % 10 % Total 33 % 41 % 33 % 39 % On a consolidated basis, two customers accounted for 21% and 16% of the Company’s June 30, 2022 accounts receivable balance, respectively, compared to December 31, 2021, when two customers accounted for 28% and 16% of the accounts receivable balance, respectively. As of June 30, 2022, and December 31, 2021, the accounts receivable balance for Sanofi included $69.5 million and $67.9 million, respectively, of unbilled accounts receivable, which becomes payable to the Company when the product is sold through by Sanofi. 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 Company's global revenue sources and its business operations were impacted by the COVID-19 pandemic during the six months ended June 30, 2022 and 2021, mostly in the form of demand interruptions such as missed patient infusions and delayed treatment starts for new patients, and the Company anticipates a continued impact due to COVID-19 on its financial results in 2022. 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. 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 | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION The 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 common stock granted under the Company’s Employee Share Purchase Plan (ESPP) to its employees, officers and non-employee directors. Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income for all stock-based compensation arrangements was as follows: Three Months Ended Six Months Ended 2022 2021 2022 2021 Cost of sales $ 4,762 $ 6,087 $ 9,088 $ 12,568 Research and development 13,633 20,816 30,823 38,333 Selling, general and administrative 28,683 27,940 55,000 53,445 Total stock-based compensation expense $ 47,078 $ 54,843 $ 94,911 $ 104,346 |
NET INCOME PER COMMON SHARE
NET INCOME PER COMMON SHARE | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
NET INCOME PER COMMON SHARE | NET INCOME 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 ESPP, unvested RSUs 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 Six Months Ended 2022 2021 2022 2021 Numerator: Net Income, basic $ 27,664 $ 12,941 $ 148,462 $ 30,312 Add: Interest expense, net of tax, on convertible notes — — 1,871 — Net Income, diluted $ 27,664 $ 12,941 $ 150,333 $ 30,312 Denominator: Weighted-average common shares outstanding, basic 185,254 182,844 184,710 182,311 Effect of dilutive securities: Issuances under equity incentive plans 2,194 2,583 2,416 2,778 Common stock issuable under the 2024 Notes — — 3,970 — Weighted-average common shares outstanding, diluted 187,448 185,427 191,096 185,089 Net income per common share, basic $ 0.15 $ 0.07 $ 0.80 $ 0.17 Net income per common share, diluted $ 0.15 $ 0.07 $ 0.79 $ 0.16 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 per common share as they were anti-dilutive (in thousands): Three Months Ended June 30, Six Months Ended 2022 2021 2022 2021 Issuances under equity incentive plans 10,659 10,169 10,438 9,975 Common stock issuable under the Company's convertible notes 8,335 8,335 4,365 8,335 Total number of potentially issuable shares 18,994 18,504 14,803 18,310 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022, the Company was subject to contingent payments considered reasonably possible of $778.0 million, including $381.5 million related to an early-stage development program licensed from a third party in the fourth quarter of 2021 and $225.0 million related to an early-stage development program licensed from a third party in the second quarter of 2020. 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 to procure active pharmaceutical ingredients, certain inventory-related items and certain third-party R&D services, production services and facility construction services. As of June 30, 2022, such commitments were estimated at approximately $140.8 million. The Company has also licensed technology from third parties, for which it is required to pay royalties upon future sales, subject to certain annual minimums. |
BUSINESS OVERVIEW AND SIGNIFI_2
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2021 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 six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2022 or any other period. |
Use of Estimates | Use of Estimates 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 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the six months ended June 30, 2022, as compared to the recent accounting pronouncements described in Note 1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, that the Company believes are of significance or potential significance to the Company. |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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: June 30, 2022 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 355,318 $ — $ — $ 355,318 $ 355,318 $ — $ — Level 2: Money market instruments 264,484 — — 264,484 264,484 — — Corporate debt securities 560,401 3 (12,450) 547,954 — 273,400 274,554 U.S. government agency securities 263,184 15 (2,734) 260,465 — 180,952 79,513 Commercial paper 33,107 — (23) 33,084 — 33,084 — Asset-backed securities 58,888 8 (633) 58,263 — — 58,263 Foreign and other 2,562 124 (4) 2,682 — 2,509 173 Subtotal 1,182,626 150 (15,844) 1,166,932 264,484 489,945 412,503 Total $ 1,537,944 $ 150 $ (15,844) $ 1,522,250 $ 619,802 $ 489,945 $ 412,503 December 31, 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 $ 301,177 $ — $ — $ 301,177 $ 301,177 $ — $ — Level 2: Money market instruments 285,099 — — 285,099 285,099 — — Corporate debt securities 584,000 386 (2,086) 582,300 — 200,304 381,996 U.S. government agency securities 224,774 182 (325) 224,631 — 146,421 78,210 Commercial paper 68,384 — — 68,384 1,000 67,384 — Asset-backed securities 56,936 10 (95) 56,851 — 9,451 47,400 Foreign and other 3,097 141 (12) 3,226 — 3,039 187 Subtotal 1,222,290 719 (2,518) 1,220,491 286,099 426,599 507,793 Total $ 1,523,467 $ 719 $ (2,518) $ 1,521,668 $ 587,276 $ 426,599 $ 507,793 (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 FINANCIAL STATEM_2
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: June 30, December 31, Raw materials $ 104,493 $ 80,269 Work-in-process 429,486 415,261 Finished goods 268,336 281,139 Total inventory $ 802,315 $ 776,669 |
Schedule of Property Plant and Equipment Net | Property, Plant and Equipment, Net consisted of the following: June 30, December 31, Property, plant and equipment, gross $ 1,811,263 $ 1,756,035 Accumulated depreciation (761,799) (720,574) Total property, plant and equipment, net $ 1,049,464 $ 1,035,461 |
Schedule of Intangible Assets | Intangible Assets, Net consisted of the following: June 30, December 31, Finite-lived intangible assets $ 689,499 $ 677,350 Accumulated amortization (320,131) (288,698) Net carrying value $ 369,368 $ 388,652 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: June 30, December 31, Accounts payable and accrued operating expenses $ 199,251 $ 193,003 Accrued compensation expense 127,929 204,446 Accrued rebates payable 62,485 47,987 Accrued royalties payable 15,620 15,215 Foreign currency exchange forward contracts 10,224 6,263 Lease liabilities 10,611 10,464 Value added taxes payable 2,472 1,935 Accrued income taxes 1,568 1,213 Deferred revenue 305 6,956 Other 4,308 4,108 Total accounts payable and accrued liabilities $ 434,773 $ 491,590 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022 and December 31, 2021. Other than the Company’s fixed-rate convertible debt disclosed in Note 6 – 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 June 30, 2022 or December 31, 2021. Fair Value Measurements as of June 30, 2022 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,232 $ — $ 2,232 Other assets: NQDC Plan assets 19,336 — 19,336 Restricted investments (1) 2,468 — 2,468 Total other assets 21,804 — 21,804 Total assets $ 24,036 $ — $ 24,036 Liabilities: Current liabilities: NQDC Plan liability $ 2,232 $ — $ 2,232 Contingent consideration — 29,954 29,954 Total current liabilities 2,232 29,954 32,186 Other long-term liabilities: NQDC Plan liability 19,336 — 19,336 Total liabilities $ 21,568 $ 29,954 $ 51,522 Fair Value Measurements as of December 31, 2021 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,043 $ — $ 2,043 Other assets: NQDC Plan assets 23,929 — 23,929 Restricted investments (1) 2,940 — 2,940 Total other assets 26,869 — 26,869 Total assets $ 28,912 $ — $ 28,912 Liabilities: Current liabilities: NQDC Plan liability $ 2,043 $ — $ 2,043 Contingent consideration — 48,232 48,232 Total current liabilities 2,043 48,232 50,275 Other long-term liabilities: NQDC Plan liability 23,929 — 23,929 Contingent consideration — 15,167 15,167 Total other long-term liabilities 23,929 15,167 39,096 Total liabilities $ 25,972 $ 63,399 $ 89,371 |
Liabilities Measured at Fair Value on Recurring Basis Using Level 3 Inputs | Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following table represents a roll-forward of contingent consideration. Contingent consideration as of December 31, 2021 $ 63,399 Milestone payments to Ares Trading S.A. (Merck Serono) (33,293) Realized foreign exchange gain on settlement of contingent consideration (133) Changes in fair value of contingent consideration 2,860 Foreign exchange remeasurement of Euro denominated contingent consideration (2,879) Contingent consideration as of June 30, 2022 $ 29,954 |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
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. Forward Contracts June 30, December 31, 2021 Derivatives designated as hedging instruments: Sell $ 585,370 $ 740,667 Purchase $ 121,257 $ 183,256 Derivatives not designated as hedging instruments: Sell $ 113,793 $ 113,257 Purchase $ — $ 31,068 |
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 June 30, December 31, 2021 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 35,654 $ 17,357 Other assets 6,853 4,991 Subtotal $ 42,507 $ 22,348 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 10,151 $ 5,487 Other long-term liabilities 1,848 1,378 Subtotal $ 11,999 $ 6,865 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 18 $ 427 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 73 $ 776 Total Derivatives Assets $ 42,525 $ 22,775 Total Derivatives Liabilities $ 12,072 $ 7,641 (1) For additional discussion of fair value measurements, see Note 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. |
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 for the periods presented. Three Months Ended June 30, 2022 2021 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 517,660 $ 5,927 $ 486,670 $ (2,678) Operating expenses as reported $ 494,646 $ (1,800) $ 490,021 $ 344 Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 4,950 $ (3,260) Six Months Ended June 30, 2022 2021 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,023,185 $ 11,499 $ 954,439 $ (5,435) Operating expenses as reported $ 876,678 $ (3,179) $ 950,965 $ 349 Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 6,241 $ 1,009 |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: June 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 (9,957) (10,971) 2027 Notes, net 590,043 589,029 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (3,996) (4,952) 2024 Notes, net 491,004 490,048 Total convertible debt, net $ 1,081,047 $ 1,079,077 Fair value of fixed-rate convertible debt (1) : 2027 Notes $ 602,436 $ 625,122 2024 Notes 490,401 521,082 Total fair value of fixed-rate convertible debt $ 1,092,837 $ 1,146,204 (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 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. |
Summary of Interest Expense on Debt | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Six Months Ended 2022 2021 2022 2021 Coupon interest expense $ 2,617 $ 2,616 $ 5,233 $ 5,232 Accretion of discount on convertible notes 837 834 1,673 1,668 Amortization of debt issuance costs 148 148 297 296 Total interest expense on convertible debt $ 3,602 $ 3,598 $ 7,203 $ 7,196 |
ACCUMULATED OTHER COMPREHENSI_2
ACCUMULATED OTHER COMPREHENSIVE INCOME (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 AOCI, including current-period other comprehensive income and reclassifications out of AOCI, for the periods presented. Three Months Ended June 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance at March 31, 2022 $ 8,387 $ (9,264) $ (877) Other comprehensive income (loss) before 26,255 (3,620) 22,635 Less: gain (loss) reclassified from AOCI 4,127 — 4,127 Tax effect — 841 841 Net current-period other comprehensive income (loss) 22,128 (2,779) 19,349 AOCI balance at June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Three Months Ended June 30, 2021 Unrealized Gains Unrealized Gains Total AOCI balance at March 31, 2021 $ 2,617 $ 2,387 $ 5,004 Other comprehensive income (loss) before (7,711) (739) (8,450) Less: gain (loss) reclassified from AOCI (2,334) — (2,334) Tax effect — 173 173 Net current-period other comprehensive income (loss) (5,377) (566) (5,943) AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ (939) Six Months Ended June 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance at December 31, 2021 $ 15,805 $ (1,373) $ 14,432 Other comprehensive income (loss) before 23,030 (13,894) 9,136 Less: gain (loss) reclassified from AOCI 8,320 — 8,320 Tax effect — 3,224 3,224 Net current-period other comprehensive income (loss) 14,710 (10,670) 4,040 AOCI balance at June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Six Months Ended June 30, 2021 Unrealized Gains Unrealized Gains Total AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ (16,139) Other comprehensive income (loss) before 12,182 (2,684) 9,498 Less: gain (loss) reclassified from AOCI (5,086) — (5,086) Tax effect — 616 616 Net current-period other comprehensive income (loss) 17,268 (2,068) 15,200 AOCI balance at June 30, 2021 $ (2,760) $ 1,821 $ (939) |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Concentration Risk And Geographic Information [Abstract] | |
Schedule of Net Product Revenues by Product | The following table disaggregates total Net Product Revenues by product. Three Months Ended Six Months Ended 2022 2021 2022 2021 Net product revenues by product: Vimizim $ 173,206 $ 171,655 $ 356,265 $ 329,953 Naglazyme 115,783 118,813 243,814 226,149 Palynziq 61,643 58,935 116,528 112,973 Kuvan 57,602 78,807 116,939 149,570 Brineura 37,725 30,332 73,898 57,657 Voxzogo 34,374 — 54,032 — Total net product revenues marketed by the Company 480,333 458,542 961,476 876,302 Aldurazyme net product revenues marketed by Sanofi 37,327 28,128 61,709 78,137 Total net product revenues 517,660 486,670 1,023,185 954,439 Royalty and other revenues 16,138 15,023 29,972 33,284 Total revenues $ 533,798 $ 501,693 $ 1,053,157 $ 987,723 |
Schedule of Total Net Product Revenues Based on Patient Location | The table below disaggregates total Net Product Revenues by geographic region, which is based on patient location for Company's commercial products sold directly by the Company, except for Aldurazyme, which is sold exclusively by Sanofi worldwide. Three Months Ended Six Months Ended 2022 2021 2022 2021 United States $ 169,838 $ 169,411 $ 320,653 $ 324,474 Europe 161,230 166,704 318,062 315,576 Latin America 89,911 42,248 152,455 101,953 Rest of world 59,354 80,179 170,306 134,299 Total net product revenues marketed by the Company $ 480,333 $ 458,542 $ 961,476 $ 876,302 Aldurazyme net product revenues marketed by Sanofi 37,327 28,128 61,709 78,137 Total net product revenues $ 517,660 $ 486,670 $ 1,023,185 $ 954,439 |
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 Six Months Ended 2022 2021 2022 2021 Customer A 16 % 16 % 16 % 16 % Customer B 12 % 13 % 12 % 13 % Customer C 5 % 12 % 5 % 10 % Total 33 % 41 % 33 % 39 % |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income for all stock-based compensation arrangements was as follows: Three Months Ended Six Months Ended 2022 2021 2022 2021 Cost of sales $ 4,762 $ 6,087 $ 9,088 $ 12,568 Research and development 13,633 20,816 30,823 38,333 Selling, general and administrative 28,683 27,940 55,000 53,445 Total stock-based compensation expense $ 47,078 $ 54,843 $ 94,911 $ 104,346 |
NET INCOME PER COMMON SHARE (Ta
NET INCOME PER COMMON SHARE (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 Six Months Ended 2022 2021 2022 2021 Numerator: Net Income, basic $ 27,664 $ 12,941 $ 148,462 $ 30,312 Add: Interest expense, net of tax, on convertible notes — — 1,871 — Net Income, diluted $ 27,664 $ 12,941 $ 150,333 $ 30,312 Denominator: Weighted-average common shares outstanding, basic 185,254 182,844 184,710 182,311 Effect of dilutive securities: Issuances under equity incentive plans 2,194 2,583 2,416 2,778 Common stock issuable under the 2024 Notes — — 3,970 — Weighted-average common shares outstanding, diluted 187,448 185,427 191,096 185,089 Net income per common share, basic $ 0.15 $ 0.07 $ 0.80 $ 0.17 Net income per common share, diluted $ 0.15 $ 0.07 $ 0.79 $ 0.16 |
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 per common share as they were anti-dilutive (in thousands): Three Months Ended June 30, Six Months Ended 2022 2021 2022 2021 Issuances under equity incentive plans 10,659 10,169 10,438 9,975 Common stock issuable under the Company's convertible notes 8,335 8,335 4,365 8,335 Total number of potentially issuable shares 18,994 18,504 14,803 18,310 |
BUSINESS OVERVIEW AND SIGNIFI_3
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Details) | 6 Months Ended |
Jun. 30, 2022 commercial_product | |
Accounting Policies [Abstract] | |
Number of commercial products in portfolio | 7 |
Financial Instruments - Schedul
Financial Instruments - Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | ||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 1,537,944 | $ 1,523,467 | |
Gross Unrealized Gains | 150 | 719 | |
Gross Unrealized Losses | (15,844) | (2,518) | |
Aggregate Fair Value | 1,522,250 | 1,521,668 | |
Cash and Cash Equivalents | 619,802 | 587,276 | [1] |
Short-term Marketable Securities | 489,945 | 426,599 | [1] |
Long-term Marketable Securities | 412,503 | 507,793 | [1] |
Level 1: | Cash | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Cash | 355,318 | 301,177 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 355,318 | 301,177 | |
Cash and Cash Equivalents | 355,318 | 301,177 | |
Short-term Marketable Securities | 0 | 0 | |
Long-term Marketable Securities | 0 | 0 | |
Level 2: | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,182,626 | 1,222,290 | |
Gross Unrealized Gains | 150 | 719 | |
Gross Unrealized Losses | (15,844) | (2,518) | |
Aggregate Fair Value | 1,166,932 | 1,220,491 | |
Cash and Cash Equivalents | 264,484 | 286,099 | |
Short-term Marketable Securities | 489,945 | 426,599 | |
Long-term Marketable Securities | 412,503 | 507,793 | |
Level 2: | Money market instruments | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 264,484 | 285,099 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 264,484 | 285,099 | |
Cash and Cash Equivalents | 264,484 | 285,099 | |
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 | 560,401 | 584,000 | |
Gross Unrealized Gains | 3 | 386 | |
Gross Unrealized Losses | (12,450) | (2,086) | |
Aggregate Fair Value | 547,954 | 582,300 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 273,400 | 200,304 | |
Long-term Marketable Securities | 274,554 | 381,996 | |
Level 2: | U.S. government agency securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 263,184 | 224,774 | |
Gross Unrealized Gains | 15 | 182 | |
Gross Unrealized Losses | (2,734) | (325) | |
Aggregate Fair Value | 260,465 | 224,631 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 180,952 | 146,421 | |
Long-term Marketable Securities | 79,513 | 78,210 | |
Level 2: | Commercial paper | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 33,107 | 68,384 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | (23) | 0 | |
Aggregate Fair Value | 33,084 | 68,384 | |
Cash and Cash Equivalents | 0 | 1,000 | |
Short-term Marketable Securities | 33,084 | 67,384 | |
Long-term Marketable Securities | 0 | 0 | |
Level 2: | Asset-backed securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 58,888 | 56,936 | |
Gross Unrealized Gains | 8 | 10 | |
Gross Unrealized Losses | (633) | (95) | |
Aggregate Fair Value | 58,263 | 56,851 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 0 | 9,451 | |
Long-term Marketable Securities | 58,263 | 47,400 | |
Level 2: | Foreign and other | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 2,562 | 3,097 | |
Gross Unrealized Gains | 124 | 141 | |
Gross Unrealized Losses | (4) | (12) | |
Aggregate Fair Value | 2,682 | 3,226 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 2,509 | 3,039 | |
Long-term Marketable Securities | $ 173 | $ 187 | |
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, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) $ in Millions | Jun. 30, 2022 | Dec. 31, 2021 |
Strategic Investment | Fair Value, Measurements, Recurring | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Strategic investments fair value | $ 23.8 | $ 16.5 |
Supplemental Financial Statem_3
Supplemental Financial Statements Information - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Raw materials | $ 104,493 | $ 80,269 | |
Work-in-process | 429,486 | 415,261 | |
Finished goods | 268,336 | 281,139 | |
Total inventory | $ 802,315 | $ 776,669 | [1] |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Supplemental Financial Statem_4
Supplemental Financial Statements Information - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | [1] | |
Inventory [Line Items] | ||||||
Inventory | $ 802,315 | $ 802,315 | $ 776,669 | |||
Depreciation expense, net of amounts capitalized into inventory | 9,500 | $ 11,800 | 21,200 | $ 24,300 | ||
Gain on sale of nonfinancial assets, net | 0 | $ 0 | 108,000 | $ 0 | ||
Valoctocogene Roxaparvovec | ||||||
Inventory [Line Items] | ||||||
Inventory | $ 31,800 | $ 31,800 | ||||
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Supplemental Financial Statem_5
Supplemental Financial Statements Information - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Property, plant and equipment, gross | $ 1,811,263 | $ 1,756,035 | |
Accumulated depreciation | (761,799) | (720,574) | |
Property, plant and equipment, net | $ 1,049,464 | $ 1,035,461 | [1] |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Supplemental Financial Statem_6
Supplemental Financial Statements Information - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Finite-lived intangible assets | $ 689,499 | $ 677,350 | |
Accumulated amortization | (320,131) | (288,698) | |
Net carrying value | $ 369,368 | $ 388,652 | [1] |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Supplemental Financial Statem_7
Supplemental Financial Statements Information - Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accounts payable and accrued operating expenses | $ 199,251 | $ 193,003 | |
Accrued compensation expense | 127,929 | 204,446 | |
Accrued rebates payable | 62,485 | 47,987 | |
Accrued royalties payable | 15,620 | 15,215 | |
Foreign currency exchange forward contracts | 10,224 | 6,263 | |
Lease liabilities | 10,611 | 10,464 | |
Value added taxes payable | 2,472 | 1,935 | |
Accrued income taxes | 1,568 | 1,213 | |
Deferred revenue | 305 | 6,956 | |
Other | 4,308 | 4,108 | |
Total accounts payable and accrued liabilities | $ 434,773 | $ 491,590 | [1] |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets and Liabilities (Detail) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 21,804,000 | 26,869,000 |
Fair value of financial assets, Total | 24,036,000 | 28,912,000 |
Fair value of other current liabilities | 32,186,000 | 50,275,000 |
Fair value of other non-current liabilities | 39,096,000 | |
Fair value of financial liabilities, Total | 51,522,000 | 89,371,000 |
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 | 2,232,000 | 2,043,000 |
Fair value of other non-current liabilities | 19,336,000 | 23,929,000 |
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 | 29,954,000 | 48,232,000 |
Fair value of other non-current liabilities | 15,167,000 | |
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 | 21,804,000 | 26,869,000 |
Fair value of financial assets, Total | 24,036,000 | 28,912,000 |
Fair value of other current liabilities | 2,232,000 | 2,043,000 |
Fair value of other non-current liabilities | 23,929,000 | |
Fair value of financial liabilities, Total | 21,568,000 | 25,972,000 |
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 | 2,232,000 | 2,043,000 |
Fair value of other non-current liabilities | 19,336,000 | 23,929,000 |
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 | 0 |
Fair value of other non-current liabilities | 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 | 29,954,000 | 48,232,000 |
Fair value of other non-current liabilities | 15,167,000 | |
Fair value of financial liabilities, Total | 29,954,000 | 63,399,000 |
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 | 29,954,000 | 48,232,000 |
Fair value of other non-current liabilities | 15,167,000 | |
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 | 2,232,000 | 2,043,000 |
Fair value of other non-current assets | 19,336,000 | 23,929,000 |
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 | 2,232,000 | 2,043,000 |
Fair value of other non-current assets | 19,336,000 | 23,929,000 |
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 | 2,468,000 | 2,940,000 |
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 | 2,468,000 | 2,940,000 |
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 | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Contingent consideration as of December 31, 2021 | $ 63,399 |
Milestone payments to Ares Trading S.A. (Merck Serono) | (33,293) |
Realized foreign exchange gain on settlement of contingent consideration | (133) |
Changes in fair value of contingent consideration | 2,860 |
Foreign exchange remeasurement of Euro denominated contingent consideration | (2,879) |
Contingent consideration as of June 30, 2022 | $ 29,954 |
Derivative Instruments and He_3
Derivative Instruments and Hedging Strategies - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Derivative [Line Items] | |
Amount reclassified from AOCI to earnings as related to forecasted revenue and operating expense transactions | $ 25.5 |
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) - Forward Foreign Exchange Contracts - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Derivatives Designated As Hedging Instruments | Sell | ||
Derivative [Line Items] | ||
Notional amount | $ 585,370 | $ 740,667 |
Derivatives Designated As Hedging Instruments | Purchase | ||
Derivative [Line Items] | ||
Notional amount | 121,257 | 183,256 |
Not Designated as Hedging Instrument | Sell | ||
Derivative [Line Items] | ||
Notional amount | 113,793 | 113,257 |
Not Designated as Hedging Instrument | Purchase | ||
Derivative [Line Items] | ||
Notional amount | $ 0 | $ 31,068 |
Derivative Instruments and He_5
Derivative Instruments and Hedging Strategies - Fair Value Carrying Amount of Derivatives (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Derivative [Line Items] | ||
Derivative asset, fair value | $ 42,525 | $ 22,775 |
Derivative liability, fair value | 12,072 | 7,641 |
Level 2: | Derivatives Designated As Hedging Instruments | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 42,507 | 22,348 |
Derivative liability, fair value | 11,999 | 6,865 |
Level 2: | Derivatives Designated As Hedging Instruments | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 35,654 | 17,357 |
Level 2: | Derivatives Designated As Hedging Instruments | Other assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 6,853 | 4,991 |
Level 2: | Derivatives Designated As Hedging Instruments | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 10,151 | 5,487 |
Level 2: | Derivatives Designated As Hedging Instruments | Other long-term liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 1,848 | 1,378 |
Level 2: | Not Designated as Hedging Instrument | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 18 | 427 |
Level 2: | Not Designated as Hedging Instrument | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | $ 73 | $ 776 |
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Revenue | $ 533,798 | $ 501,693 | $ 1,053,157 | $ 987,723 |
Operating expenses | 494,646 | 490,021 | 876,678 | 950,965 |
Not Designated as Hedging Instrument | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Gains (Losses) Recognized in Earnings | 4,950 | (3,260) | 6,241 | 1,009 |
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 | (1,800) | 344 | (3,179) | 349 |
Net product revenues | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Revenue | 517,660 | 486,670 | 1,023,185 | 954,439 |
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 | $ 5,927 | $ (2,678) | $ 11,499 | $ (5,435) |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Jun. 30, 2022 | 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 | Jun. 30, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||
Convertible notes | $ 1,100,000 | ||
Convertible notes, net of unamortized discount and deferred offering costs | 1,081,047 | $ 1,079,077 | [1] |
Total convertible debt, net | 1,081,047 | 1,079,077 | |
Total fair value of fixed-rate convertible debt | $ 1,092,837 | $ 1,146,204 | |
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 | (9,957) | (10,971) | |
Convertible notes, net of unamortized discount and deferred offering costs | 590,043 | 589,029 | |
Total fair value of fixed-rate convertible debt | $ 602,436 | $ 625,122 | |
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 | (3,996) | (4,952) | |
Convertible notes, net of unamortized discount and deferred offering costs | 491,004 | 490,048 | |
Total fair value of fixed-rate convertible debt | $ 490,401 | $ 521,082 | |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Debt - Summary of Interest Expe
Debt - Summary of Interest Expense on Convertible Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Schedule Of Interest Expenses [Line Items] | ||||
Total interest expense on convertible debt | $ 3,859 | $ 3,817 | $ 7,665 | $ 7,621 |
Convertible Senior Notes | ||||
Schedule Of Interest Expenses [Line Items] | ||||
Coupon interest expense | 2,617 | 2,616 | 5,233 | 5,232 |
Accretion of discount on convertible notes | 837 | 834 | 1,673 | 1,668 |
Amortization of debt issuance costs | 148 | 148 | 297 | 296 |
Total interest expense on convertible debt | $ 3,602 | $ 3,598 | $ 7,203 | $ 7,196 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income - Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | $ 4,391,315 | $ 4,162,010 | $ 4,270,740 | [1],[2] | $ 4,106,002 | [2] |
Other comprehensive income (loss) before reclassifications | 22,635 | (8,450) | 9,136 | 9,498 | ||
Less: gain (loss) reclassified from AOCI | 4,127 | (2,334) | 8,320 | (5,086) | ||
Tax effect | 841 | 173 | 3,224 | 616 | ||
Net current-period other comprehensive income (loss) | 19,349 | (5,943) | 4,040 | 15,200 | ||
Ending balance | 4,504,807 | 4,241,571 | 4,504,807 | 4,241,571 | ||
Unrealized Gains (Losses) on Cash Flow Hedges | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | 8,387 | 2,617 | 15,805 | (20,028) | ||
Other comprehensive income (loss) before reclassifications | 26,255 | (7,711) | 23,030 | 12,182 | ||
Less: gain (loss) reclassified from AOCI | 4,127 | (2,334) | 8,320 | (5,086) | ||
Tax effect | 0 | 0 | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 22,128 | (5,377) | 14,710 | 17,268 | ||
Ending balance | 30,515 | (2,760) | 30,515 | (2,760) | ||
Unrealized Gains (Losses) on Available for-Sale Debt Securities | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | (9,264) | 2,387 | (1,373) | 3,889 | ||
Other comprehensive income (loss) before reclassifications | (3,620) | (739) | (13,894) | (2,684) | ||
Less: gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | ||
Tax effect | 841 | 173 | 3,224 | 616 | ||
Net current-period other comprehensive income (loss) | (2,779) | (566) | (10,670) | (2,068) | ||
Ending balance | (12,043) | 1,821 | (12,043) | 1,821 | ||
AOCI attributable to parent | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balance | (877) | 5,004 | 14,432 | [2] | (16,139) | [2] |
Ending balance | $ 18,472 | $ (939) | $ 18,472 | $ (939) | ||
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Revenue, Credit Concentration_3
Revenue, Credit Concentrations and Geographic Information - Additional Information (Detail) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | ||
Concentration Risk And Geographic Information [Line Items] | |||
Number of operating business segment | Segment | 1 | ||
Accounts receivable, net | $ 466,507 | $ 373,399 | [1] |
Customers | |||
Concentration Risk And Geographic Information [Line Items] | |||
Accounts receivable, net | $ 69,500 | $ 67,900 | |
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 21% | 28% | |
Credit Concentration Risk | Accounts Receivable | Customer Two | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 16% | 16% | |
[1] (1) December 31, 2021 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, 2021, filed with the SEC on February 25, 2022. |
Revenue, Credit Concentration_4
Revenue, Credit Concentrations and Geographic Information - Disaggregates of Net Product Revenues by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 533,798 | $ 501,693 | $ 1,053,157 | $ 987,723 |
Product | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 517,660 | 486,670 | 1,023,185 | 954,439 |
Vimizim | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 173,206 | 171,655 | 356,265 | 329,953 |
Naglazyme | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 115,783 | 118,813 | 243,814 | 226,149 |
Palynziq | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 61,643 | 58,935 | 116,528 | 112,973 |
Kuvan | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 57,602 | 78,807 | 116,939 | 149,570 |
Brineura | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 37,725 | 30,332 | 73,898 | 57,657 |
Voxzogo | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 34,374 | 0 | 54,032 | 0 |
Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | Marketed by Company | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 480,333 | 458,542 | 961,476 | 876,302 |
Aldurazyme | Marketed by Sanofi | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 37,327 | 28,128 | 61,709 | 78,137 |
Royalty and other revenues | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 16,138 | $ 15,023 | $ 29,972 | $ 33,284 |
Revenue, Credit Concentration_5
Revenue, Credit Concentrations and Geographic Information - Disaggregates of Total Net Product Revenues Based on Patient Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 533,798 | $ 501,693 | $ 1,053,157 | $ 987,723 |
Product | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 517,660 | 486,670 | 1,023,185 | 954,439 |
Marketed by Company | Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 480,333 | 458,542 | 961,476 | 876,302 |
Marketed by Company | Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 169,838 | 169,411 | 320,653 | 324,474 |
Marketed by Company | Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 161,230 | 166,704 | 318,062 | 315,576 |
Marketed by Company | Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 89,911 | 42,248 | 152,455 | 101,953 |
Marketed by Company | Brineura, Kuvan, Naglazyme, Palynziq, and Vimizim | Rest of world | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 59,354 | 80,179 | 170,306 | 134,299 |
Marketed by Sanofi | Aldurazyme | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 37,327 | $ 28,128 | $ 61,709 | $ 78,137 |
Revenue, Credit Concentration_6
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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Customer A, B, & C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 33% | 41% | 33% | 39% |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 16% | 16% | 16% | 16% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 12% | 13% | 12% | 13% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 5% | 12% | 5% | 10% |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 47,078 | $ 54,843 | $ 94,911 | $ 104,346 |
Cost of sales | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,762 | 6,087 | 9,088 | 12,568 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 13,633 | 20,816 | 30,823 | 38,333 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 28,683 | $ 27,940 | $ 55,000 | $ 53,445 |
Net Income Per Common Share - S
Net Income Per Common Share - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||
Net Income, basic | $ 27,664 | $ 12,941 | $ 148,462 | $ 30,312 |
Add: Interest expense, net of tax, on convertible notes | 0 | 0 | 1,871 | 0 |
Net Income, diluted | $ 27,664 | $ 12,941 | $ 150,333 | $ 30,312 |
Denominator: | ||||
Weighted average common shares outstanding, basic (in shares) | 185,254 | 182,844 | 184,710 | 182,311 |
Effect of dilutive securities: | ||||
Weighted average common shares outstanding, diluted (in shares) | 187,448 | 185,427 | 191,096 | 185,089 |
Net income per common share, basic (in dollars per share) | $ 0.15 | $ 0.07 | $ 0.80 | $ 0.17 |
Net income per common share, diluted (in dollars per share) | $ 0.15 | $ 0.07 | $ 0.79 | $ 0.16 |
Issuances under equity incentive plans | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 2,194 | 2,583 | 2,416 | 2,778 |
Common stock issuable under the 2024 Notes | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 0 | 0 | 3,970 | 0 |
Net Income Per Common Share -_2
Net Income 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 | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 18,994 | 18,504 | 14,803 | 18,310 |
Issuances under equity incentive plans | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 10,659 | 10,169 | 10,438 | 9,975 |
Common stock issuable under the Company's convertible notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 8,335 | 8,335 | 8,335 | |
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 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |
Dec. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2022 | |
Commitments And Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 778 | ||
Purchase commitments and other minimum contractual obligations | $ 140.8 | ||
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 | $ 381.5 | $ 225 |