Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 22, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
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 $.001 | ||
Trading Symbol | BMRN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 8.4 | ||
Entity Common Stock, Shares Outstanding | 184,032,162 | ||
Documents Incorporated by Reference | Specified portions of the registrant's definitive proxy statement for the registrant's 2022 annual meeting of stockholders, which will be filed with the Commission no later than 120 days after the end of the registrant's fiscal year ended December 31, 2021, are incorporated by reference under Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001048477 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Firm ID | 185 |
Auditor Name | KPMG LLP |
Auditor Location | San Francisco, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 587,276 | $ 649,158 |
Short-term investments | 426,599 | 416,228 |
Accounts receivable, net | 373,399 | 448,351 |
Inventory | 776,669 | 698,548 |
Other current assets | 110,442 | 129,934 |
Total current assets | 2,274,385 | 2,342,219 |
Noncurrent assets: | ||
Long-term investments | 507,793 | 285,473 |
Property, plant and equipment, net | 1,035,461 | 1,032,471 |
Intangible assets, net | 388,652 | 417,271 |
Goodwill | 196,199 | 196,199 |
Deferred tax assets | 1,449,075 | 1,432,150 |
Other assets | 151,760 | 142,237 |
Total assets | 6,003,325 | 5,848,020 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 491,590 | 492,548 |
Short-term contingent consideration | 48,232 | 0 |
Total current liabilities | 539,822 | 492,548 |
Noncurrent liabilities: | ||
Long-term convertible debt, net | 1,079,077 | 1,075,145 |
Long-term contingent consideration | 15,167 | 60,130 |
Other long-term liabilities | 98,519 | 114,195 |
Total liabilities | 1,732,585 | 1,742,018 |
Stockholders’ equity: | ||
Common stock, $0.001 par value: 500,000,000 shares authorized; 183,912,514 and 181,740,999 shares issued and outstanding, respectively | 184 | 182 |
Additional paid-in capital | 5,191,502 | 4,993,407 |
Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (9,689) | (9,839) |
Accumulated other comprehensive income (loss) | 14,432 | (16,139) |
Accumulated deficit | (925,689) | (861,609) |
Total stockholders’ equity | 4,270,740 | 4,106,002 |
Total liabilities and stockholders’ equity | $ 6,003,325 | $ 5,848,020 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, shares issued (in shares) | 183,912,514 | 181,740,999 |
Common stock, shares outstanding (in shares) | 183,912,514 | 181,740,999 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
REVENUES: | |||
Total revenues | $ 1,846,275 | $ 1,860,455 | $ 1,704,048 |
OPERATING EXPENSES: | |||
Cost of sales | 470,515 | 524,272 | 359,466 |
Research and development | 628,793 | 628,116 | 715,007 |
Selling, general and administrative | 759,375 | 737,669 | 680,924 |
Intangible asset amortization and contingent consideration | 69,933 | 66,658 | 74,108 |
Gain on sale of nonfinancial assets | 0 | (59,495) | (25,000) |
Total operating expenses | 1,928,616 | 1,897,220 | 1,804,505 |
LOSS FROM OPERATIONS | (82,341) | (36,765) | (100,457) |
Interest income | 10,482 | 16,610 | 22,748 |
Interest expense | (15,337) | (29,309) | (23,460) |
Other income, net | 11,846 | 7,142 | 6,358 |
LOSS BEFORE INCOME TAXES | (75,350) | (42,322) | (94,811) |
Benefit from income taxes | (11,270) | (901,422) | (70,963) |
NET INCOME (LOSS) | $ (64,080) | $ 859,100 | $ (23,848) |
NET INCOME (LOSS) PER SHARE, BASIC (in usd per share) | $ (0.35) | $ 4.75 | $ (0.13) |
NET INCOME (LOSS) PER SHARE, DILUTED (in usd per share) | $ (0.35) | $ 4.53 | $ (0.13) |
Weighted average common shares outstanding, basic (in shares) | 182,852 | 180,804 | 179,039 |
Weighted average common shares outstanding, diluted (in shares) | 182,852 | 191,678 | 179,039 |
Product | |||
REVENUES: | |||
Total revenues | $ 1,783,498 | $ 1,805,861 | $ 1,661,043 |
Royalty and Other Revenues | |||
REVENUES: | |||
Total revenues | $ 62,777 | $ 54,594 | $ 43,005 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net Income (Loss) | $ (64,080) | $ 859,100 | $ (23,848) |
Available-for-sale debt securities: | |||
Unrealized holding gain (loss) arising during the period, net of tax impact of $1,596, $(227) and $(1,640), respectively. | (5,262) | 749 | 5,482 |
Less: reclassifications to net income (loss), net of tax impact of $0, $(127) and $0, respectively. | 0 | 425 | 0 |
Net change in unrealized holding gain (loss), net of tax | (5,262) | 324 | 5,482 |
Cash flow hedges: | |||
Unrealized holding gain (loss) arising during the period, net of tax impact of $0 for all periods presented. | 34,379 | (23,462) | 25,266 |
Less: reclassifications to net income (loss), net of tax impact of $0 for all periods presented. | (1,454) | 13,180 | 15,853 |
Net change in unrealized holding gain (loss), net of tax | 35,833 | (36,642) | 9,413 |
Other | 0 | 15 | (2) |
OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX | 30,571 | (36,303) | 14,893 |
COMPREHENSIVE INCOME (LOSS) | $ (33,509) | $ 822,797 | $ (8,955) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Parenthetical) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Unrealized holding gain (loss) arising during the period, tax | $ 1,596,000 | $ (227,000) | $ (1,640,000) |
Reclassification, tax | 0 | (127,000) | 0 |
Unrealized holding gain (loss) arising during the period, tax | 0 | 0 | 0 |
Reclassifications to net loss, tax | $ 0 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Company Stock Held By NQDC | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Accumulated DeficitCumulative Effect, Period of Adoption, Adjustment |
Beginning Balance (in shares) at Dec. 31, 2018 | 178,253 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax (in shares) | 1,585 | |||||||
Repurchase of common stock (in shares) | 0 | |||||||
Ending Balance (in shares) at Dec. 31, 2019 | 179,838 | |||||||
Beginning balance at Dec. 31, 2018 | $ 2,967,940 | $ 178 | $ 4,669,926 | $ 0 | $ (13,301) | $ 5,271 | $ (1,694,134) | $ (2,727) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | 2 | (11,071) | ||||||
Stock-based compensation | 163,891 | |||||||
Repurchase of common stock | 0 | 0 | ||||||
Common stock held by the NQDC | (692) | 692 | ||||||
Accounting impact of NQDC Plan Change | 10,653 | 2,648 | ||||||
Retirement of treasury stock | 0 | |||||||
Other comprehensive income (loss) | 14,893 | 14,893 | ||||||
Net Income (Loss) | (23,848) | (23,848) | ||||||
Ending balance at Dec. 31, 2019 | 3,122,381 | $ 180 | 4,832,707 | 0 | (9,961) | 20,164 | (1,720,709) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax (in shares) | 2,421 | |||||||
Repurchase of common stock (in shares) | (518) | |||||||
Ending Balance (in shares) at Dec. 31, 2020 | 181,741 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | $ 2 | 27,275 | ||||||
Stock-based compensation | 183,547 | |||||||
Repurchase of common stock | (50,000) | (50,000) | ||||||
Common stock held by the NQDC | (122) | 122 | ||||||
Accounting impact of NQDC Plan Change | 0 | 0 | ||||||
Retirement of treasury stock | 50,000 | |||||||
Other comprehensive income (loss) | (36,303) | (36,303) | ||||||
Net Income (Loss) | 859,100 | 859,100 | ||||||
Ending balance at Dec. 31, 2020 | 4,106,002 | $ 182 | 4,993,407 | 0 | (9,839) | (16,139) | (861,609) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax (in shares) | 2,172 | |||||||
Repurchase of common stock (in shares) | 0 | |||||||
Ending Balance (in shares) at Dec. 31, 2021 | 183,913 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuances under equity incentive plans, net of tax | $ 2 | 3,389 | ||||||
Stock-based compensation | 194,856 | |||||||
Repurchase of common stock | 0 | 0 | ||||||
Common stock held by the NQDC | (150) | 150 | ||||||
Accounting impact of NQDC Plan Change | 0 | 0 | ||||||
Retirement of treasury stock | 0 | |||||||
Other comprehensive income (loss) | 30,571 | 30,571 | ||||||
Net Income (Loss) | (64,080) | (64,080) | ||||||
Ending balance at Dec. 31, 2021 | $ 4,270,740 | $ 184 | $ 5,191,502 | $ 0 | $ (9,689) | $ 14,432 | $ (925,689) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net Income (Loss) | $ (64,080) | $ 859,100 | $ (23,848) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||
Depreciation and amortization | 108,039 | 105,172 | 105,300 |
Non-cash interest expense | 4,146 | 16,511 | 13,960 |
Amortization of premium on investments (accretion of discount) | 5,155 | 567 | (2,000) |
Stock-based compensation expense | 197,263 | 189,711 | 159,865 |
Gain on sale of nonfinancial assets | 0 | (59,495) | (25,000) |
Inventory reserves, net of stock-based compensation | 0 | 75,609 | 0 |
Deferred income taxes | (15,608) | (888,907) | (82,760) |
Unrealized foreign exchange loss (gain) | (1,810) | 8,011 | 1,025 |
Non-cash changes in the fair value of contingent consideration | 8,026 | 4,500 | 5,205 |
Other | (2,629) | (997) | (2,393) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 65,574 | (59,035) | (37,852) |
Inventory | (35,060) | (61,151) | (107,554) |
Other current assets | 29,760 | 18,312 | (27,008) |
Other assets | (6,593) | (28,647) | (8,895) |
Accounts payable and accrued liabilities | 15,689 | (87,025) | 77,089 |
Other long-term liabilities | (3,336) | (6,871) | 3,128 |
Net cash provided by operating activities | 304,536 | 85,365 | 48,262 |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (95,578) | (114,312) | (145,026) |
Maturities and sales of investments | 691,049 | 555,834 | 740,211 |
Purchase of available-for-sale debt securities | (937,143) | (529,663) | (632,023) |
Proceeds from sale of nonfinancial assets | 0 | 67,159 | 25,000 |
Purchase of intangible assets | (23,647) | (23,207) | (18,380) |
Investment in convertible note | 0 | (8,709) | 0 |
Other | (994) | (723) | (808) |
Net cash used in investing activities | (366,313) | (53,621) | (31,026) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 49,194 | 71,913 | 31,611 |
Taxes paid related to net share settlement of equity awards | (45,805) | (44,638) | (42,680) |
Repurchase of common stock | 0 | (50,000) | 0 |
Proceeds from convertible senior subordinated note offering, net | 0 | 585,752 | 0 |
Repayments of convertible debt | 0 | (374,991) | 0 |
Payment of contingent consideration | 0 | 0 | (58,518) |
Principal repayments of financing leases | (3,039) | (6,918) | (5,087) |
Other | (398) | 0 | 0 |
Net cash provided by (used in) financing activities | (48) | 181,118 | (74,674) |
Effect of exchange rate changes on cash | (57) | (1,150) | 902 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (61,882) | 211,712 | (56,536) |
Cash and cash equivalents: | |||
Beginning of period | 649,158 | 437,446 | 493,982 |
End of period | 587,276 | 649,158 | 437,446 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |||
Cash paid for interest, net of interest capitalized into fixed assets | 10,395 | 12,178 | 8,552 |
Cash paid for income taxes | 18,153 | 8,977 | 9,726 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Increase (decrease) in accounts payable and accrued liabilities related to fixed assets | (4,749) | (5,184) | 7,589 |
Increase (decrease) in accounts payable and accrued liabilities related to intangible assets | $ 9,428 | $ (292) | $ 4,247 |
BUSINESS OVERVIEW AND SIGNIFICA
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES Nature of Operations BioMarin Pharmaceutical Inc. (the Company or BioMarin) is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company’s portfolio consists of seven commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. Voxzogo (formerly known as vosoritide) was granted marketing approval in the European Union (EU) and the United States (U.S.) on August 27, 2021 and November 19, 2021, respectively. Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange Commission (the SEC) for Annual Reports on Form 10-K and include the accounts of BioMarin and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Management performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing of this Annual Report on Form 10-K except for the transaction disclosed in Note 19 to these Consolidated Financial Statements. Use of Estimates U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Company’s 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 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. 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. Significant Accounting Policies Cash and Cash Equivalents The Company treats highly liquid investments, readily convertible to cash, with original maturities of three months or less on the purchase date as cash equivalents. Marketable and Non-Marketable Securities On January 1, 2020, the Company adopted Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments (ASU 2016-13), as amended, using a modified retrospective approach. The adoption of this standard had no impact on the Company’s Financial Statements. Marketable Securities The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such designations at each reporting period. The Company classifies its debt and equity securities with original maturities greater than three months when purchased as either short-term or long-term investments based on each instrument’s underlying contractual maturity date and its availability for use in current operations. All marketable securities are classified as available-for-sale. Available-for-sale debt securities are measured and recorded at fair market value with unrealized gains and losses included in Accumulated Other Comprehensive Income (AOCI) on the Company’s Consolidated Balance Sheets, with the exception of any declines in fair value below the cost basis that are a result of a credit loss, which, if any, are reported in Other Income, Net in the current period through an allowance for credit losses. Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if so, an impairment loss is recognized in earnings equal to the difference between the investment’s amortized cost and fair value at such date. Non-Marketable Equity Securities The Company records investments in equity securities, other than equity method investments, at fair market value, if fair value is readily determinable. Equity securities with no readily determinable fair values are recorded using the measurement alternative of cost adjusted for observable price changes in orderly transactions for identical or similar investments of the same issuer less impairment, if any. Investments in equity securities are recorded in Other Assets on the Company's Consolidated Balance Sheets. Unrealized gains and losses are reported in Other Income, Net. The Company regularly reviews its non-marketable equity securities for indicators of impairment. Inventory Commercial Inventory The Company values inventory at the lower of cost and net realizable value and determines the cost of inventory using the average-cost method. The Company analyzes its inventory levels quarterly for obsolescence and, if required, adjusts inventory to its net realizable value if the cost basis of inventory is in excess of its expected net realizable value, or for quantities in excess of expected demand. If the Company determines cost exceeds its net realizable value, the resulting adjustments are recognized as Cost of Sales in the Consolidated Statements of Operations. Inventory Produced Prior to Regulatory Approval When future commercialization for a product candidate is considered probable and management believes that material uncertainties related to the ultimate regulatory approval have been significantly reduced and the Company expects to realize economic benefit in the future, the Company capitalizes pre-launch or pre-qualification manufacturing costs prior to regulatory approval. For inventories that are capitalized in preparation of product launch, a number of factors are taken into consideration based on information available at the time, including the product candidate’s current status in the drug development and regulatory approval process, results from the related pivotal clinical trial, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, as well as commercialization and market trends. If additional requirements are subsequently presented by the regulatory authorities, prior to their final decision thus extending anticipated regulatory approval timelines resulting in expiration of the product prior to revised demand forecasts, the pre-launch inventory costs are expensed to Cost of Sales. If the marketing application is ultimately rejected by the applicable regulators and the pre-launch inventory cannot be sold for commercial use, the pre-launch inventory costs are expensed to Research and Development (R&D). Property, Plant and Equipment Property, plant and equipment are stated at historical cost net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives, as presented in the table below. Significant additions and improvements are capitalized, whereas repairs and maintenance are expensed as incurred. Depreciation of property, plant and equipment are included in Cost of Sales, R&D and Selling, General and Administrative (SG&A), as appropriate, in the Consolidated Statements of Operations. Property and equipment purchased for specific R&D projects with no alternative future uses are expensed as incurred and recorded to R&D in the Consolidated Statements of Operations. Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 7 years Office furniture and equipment 5 years Land improvements 10 to 20 years Land Not applicable Construction-in-progress Not applicable Leases The Company determines if an arrangement is a lease at contract inception. For leases where the Company is the lessee, ROU assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent the lease payment obligation. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the accelerated interest method of recognition. When an arrangement requires payments for lease and non-lease components, the Company has elected to account for lease and non-lease components separately. Lease expense for leases with a term of twelve months or less is recognized on a straight-line basis and are not included in the recognized ROU assets and lease liabilities. Goodwill and Intangible Assets The Company records goodwill in a business combination when the total consideration exceeds the fair value of the assets acquired. Intangible assets with indefinite useful lives are related to purchased in-process research and development (IPR&D) projects and are measured at their respective fair values as of the acquisition date. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets are considered finite-lived and are amortized using the straight-line method based on their respective estimated useful lives at that point in time. The amortization of these intangible assets is included in Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Impairment The Company assesses goodwill and indefinite-lived intangible assets for impairment annually in the fourth quarter, or more frequently as warranted by events or changes in circumstances that indicate that the carrying amount may not be recoverable. Goodwill is assessed for impairment by comparing the fair value of the Company’s reporting unit with its carrying amount. If the carrying value of the reporting unit exceeds its fair value, an impairment loss equal to the difference would be recorded. Indefinite-lived intangible assets are assessed for impairment first by performing a qualitative assessment. If the qualitative assessment indicates that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, then the Company will perform a quantitative assessment and record an impairment loss. Impairment charges that are not material are recorded to Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Long-lived Asset Impairment The Company’s long-lived assets consist of property, plant and equipment, leased ROU assets and finite-lived intangible assets. Should there be an indication of impairment, the Company tests for recoverability by comparing the estimated undiscounted future cash flows expected to result from the use of the asset or asset group and its eventual disposition to the carrying amount of the asset or asset group. Any excess of the carrying value of the asset or asset group over its estimated fair value is recognized as an impairment loss. Impairment charges related to property, plant or equipment that are not material are recorded to depreciation expense and presented in SG&A in the Consolidated Statements of Operations. Impairment charges related to finite-lived intangible assets that are not material are recorded to Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC Topic 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account. Net Product Revenues In the U.S., the Company’s commercial products, except for Palynziq and Aldurazyme, are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Palynziq is distributed in the U.S. through certain certified specialty pharmacies under the Palynziq Risk Evaluation and Mitigation Strategy (REMS) and Aldurazyme is marketed world-wide by Sanofi (formerly referred to as Sanofi Genzyme). Outside the U.S., the Company’s commercial products are sold to its authorized distributors or directly to government purchasers or hospitals, which act as the end-users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. Amounts collected from customers and remitted to governmental authorities, which primarily consist of value-added taxes related to product sales in foreign jurisdictions, are presented on a net basis on the Company’s Consolidated Statements of Operations, in that taxes billed to customers are not included as a component of Net Product Revenues. For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Sanofi depending on sales volume, which is included in Net Product Revenues on the Company’s Consolidated Statements of Operations. The Company recognizes its best estimate of the revenue it expects to earn when the product is released and control is transferred to Sanofi. The Company records Aldurazyme net product revenues based on the estimated variable consideration payable when the product is sold through by Sanofi. Actual amounts of consideration ultimately received may differ from the Company’s estimates. Differences between the estimated variable consideration to be received from Sanofi and actual payments received are not expected to be material. If actual results vary from the Company’s estimates, the Company will make adjustments, which would affect Net Product Revenues and earnings in the period such variances become known. Revenue Reserves Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from government rebates, sales returns, and other incentives that are offered within contracts between the Company and its customers, such as specialty pharmacies, hospitals, authorized distributors and government purchasers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates, however the Company does not expect any such difference to be material. If actual results in the future vary from the Company’s estimates, the Company will adjust its estimates, which would affect net product revenue and earnings in the period such variances become known. Government Rebates : The Company records reserves for rebates payable under Medicaid and other government programs as a reduction of revenue at the time product revenues are recorded. The Company’s reserve calculations require estimates, including estimates of customer mix, to determine which sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to its reserves. Sales Returns : The Company records allowances for product returns, if appropriate, as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including market exclusivity of the products based on their orphan drug status, the patient population, the customers’ limited return rights and the Company’s historical experience with returns. Because of the pricing of the Company’s commercial products, the limited number of patients and the customers’ limited return rights, most customers and retailers carry a limited inventory. The Company relies on historical return rates to estimate a reserve for returns. Based on these factors and the fact that the Company has not experienced significant product returns to date, return allowances are not material. Other Incentives : Other incentives include fees paid to the Company’s distributors and discounts for prompt payment. The Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on an eligible BioMarin product. The branded co-pay assistance programs assist commercially insured patients who have coverage for an eligible BioMarin product and are intended to reduce each participating patient’s portion of the financial responsibility of the purchase price up to a specified dollar amount of assistance. The Company records fees paid to distributors, cash discounts and amounts paid under the brand specific co-pay assistance program for each patient as a reduction of revenue. Royalty and Other Revenues Royalties : For arrangements that include the receipt of sales-based royalties, including milestone payments based on the level of sales when the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Licenses of intellectual property : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments : At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. Research and Development R&D costs are generally expensed as incurred. These expenses include contract R&D services provided by third parties, preclinical and clinical studies, raw materials costs associated with manufacturing clinical product, quality control and assurance, other R&D activities, facilities and regulatory costs and R&D-related personnel costs including salaries, benefits and stock-based compensation. Upfront and milestone payments made to third parties in connection with licensed intellectual property, which does not have an alternative future use or does not reach technological feasibility, are expensed as incurred up to the point of regulatory approval. Net Income (Loss) Per Common Share Basic net income (loss) per share is calculated by dividing Net Income (Loss) by the weighted average shares of common stock outstanding during the period. Diluted net income (loss) per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock; however, potential common equivalent shares are excluded if their effect is anti-dilutive. Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards may be granted to employees. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting, and is classified as Cost of Sales, R&D or SG&A, as appropriate, in the Consolidated Statements of Operations. The Company accounts for forfeitures as they occur. Restricted Stock Units The fair value of restricted stock units (RSUs) with service-based vesting conditions and RSUs with performance conditions is determined to be the fair market value of the Company’s underlying common stock on the date of grant. The stock-based compensation expense for RSUs with service-based vesting is recognized over the period during which the vesting restrictions lapse. Stock-based compensation expense for RSUs with performance conditions is recognized beginning in the period the Company determines it is probable that the performance condition will be achieved. Management expectations related to the achievement of performance goals associated with RSUs with performance conditions are assessed regularly to determine whether such grants are expected to vest. The fair value for RSUs with market conditions is estimated using the Monte Carlo valuation model, utilizing expected volatility rates derived from those of the Company and the members of the referenced peer group. Related stock-based compensation is recognized, beginning on the grant date, on a straight-line basis regardless of whether the market condition is met unless the required service is not performed. Stock Options and Purchase Rights The fair value of each stock option award and purchase rights under the Company’s Employee Stock Purchase Plan (ESPP) are estimated on the date of grant using the Black-Scholes valuation model and the following assumptions: expected term, expected volatility, risk-free interest rate and expected dividend yield. The dividend yield reflects that the Company has not paid any cash dividends since inception and does not intend to pay any cash dividends in the foreseeable future. The expected term of stock options is based on observed historical exercise patterns. In estimating the life of stock options, the Company has identified two employee groups with distinctly different historical exercise patterns: executive and non-executive. The executive employee group has a history of holding stock options for longer periods than non-executive employees. The expected term of purchase rights for ESPP is based on each tranche of an offering period, which is four tranches in a twenty-four The determination of the fair value of stock-based payment awards using an option-pricing model is affected by the Company’s stock price and may use assumptions regarding a number of complex and subjective variables. Income Taxes The Company calculates and provides for income taxes in each of the tax jurisdictions in which it operates. Deferred tax assets and liabilities, measured using enacted tax rates, are recognized for the future tax consequences of temporary differences between the tax and financial statement basis of assets and liabilities. A valuation allowance reduces the deferred tax assets to the amount that is more likely than not to be realized. The Company establishes liabilities or reduces assets for uncertain tax positions when the Company believes certain tax positions are not more likely than not of being sustained if challenged. Each quarter, the Company evaluates these uncertain tax positions and adjusts the related tax assets and liabilities in light of changing facts and circumstances. The Company uses financial projections to support its net deferred tax assets, which contain significant assumptions and estimates of future operations. If such assumptions were to differ significantly, it may have a material impact on the Company’s ability to realize its deferred tax assets. At the end of each period, the Company will reassess the ability to realize its deferred tax benefits. If it is more likely than not that the Company would not realize the deferred tax benefits, a valuation allowance may need to be established against all or a portion of the deferred tax assets, which will result in a charge to tax expense. Foreign Currency For the Company and its subsidiaries, the functional currency has been determined to be the U.S. Dollar (USD). Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in SG&A in the Consolidated Statements of Operations. Derivatives and Hedging Activities The Company uses foreign currency exchange forward contracts (forward contracts) to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company’s forecasted revenues and operating expenses being denominated in currencies other than the USD, primarily the Euro. The Company designates certain of these forward contracts as hedging instruments and also enters into forward contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward contracts protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues, operating expenses and asset or liability positions designated in currencies other than the USD. To receive hedge accounting treatment, cash flow hedges must be highly effective in offsetting changes to expected future cash flows on hedged transactions. The Company does not hold or issue derivative instruments for trading or speculative purposes. The Company 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 Company accounts for its derivative instruments as either assets or liabilities on its Consolidated Balance Sheets and measures them at fair value, which is estimated using current exchange rates and interest rates and takes into consideration the current creditworthiness of the counterparties or the Company, as applicable. For derivatives designated as hedging instruments, the entire change in the fair value of qualifying derivative instruments is recorded in AOCI and amounts deferred in AOCI are reclassified to earnings in the same line item in which the earnings effect of the hedged item is reported. Derivatives not designated as hedging instruments are adjusted to fair value through earnings in SG&A in the Consolidated Statements of Operations. Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities that are required to be recorded at fair value, the Company considers the principal or most advantageous market in which the Company would transact and the market-based risk measurements or assumptions that market participants would use to price the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. The Company’s fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs) • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities that are not active, or inputs other than quoted process that are directly |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of December 31, 2021 and 2020, respectively: December 31, 2021 Amortized Cost Gross Gross Aggregate Fair 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 December 31, 2020 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 370,325 $ — $ — $ 370,325 $ 370,325 $ — $ — Level 2: Money market instruments 264,833 — — 264,833 264,833 — — Corporate debt securities 413,137 3,261 (8) 416,390 — 220,551 195,839 U.S. government agency securities 265,298 1,555 (1) 266,852 14,000 192,488 60,364 Asset-backed securities 31,659 85 (2) 31,742 — 3,189 28,553 Foreign and other 549 168 — 717 — — 717 Subtotal 975,476 5,069 (11) 980,534 278,833 416,228 285,473 Total $ 1,345,801 $ 5,069 $ (11) $ 1,350,859 $ 649,158 $ 416,228 $ 285,473 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one As of December 31, 2021, the Company had the ability and intent to hold all investments that were in an unrealized loss position until maturity. The Company considered its intent and ability to hold the securities until recovery of amortized cost basis, the extent to which fair value is less than amortized cost basis, conditions specifically related to the security’s industry and geography, payment structure and history and changes to the ratings (if any) in determining that the decline in fair value compared to carrying value is not related to a credit loss. The Company has certain investments in non-marketable equity securities, measured using unobservable valuation inputs and remeasured on a nonrecurring basis, which are collectively considered strategic investments. As of December 31, 2021 and 2020, the fair value of the Company’s strategic investments was $16.5 million and $10.5 million, respectively. These investments were recorded in Other Assets in the Company’s Consolidated Balance Sheets. See Note 1 to these Consolidated Financial Statements for additional discussion regarding the Company’s fair value measurements. |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
GOODWILL AND INTANGIBLE ASSETS | GOODWILL AND INTANGIBLE ASSETS The change in the carrying value of Goodwill was as follows: December 31, 2021 2020 Beginning balance $ 196,199 $ 197,039 Disposition — (840) Ending carrying value $ 196,199 $ 196,199 In January 2020, the Company completed the sale of worldwide rights to Firdapse, the Company's commercial product for the treatment of Lambert-Eaton myasthenic syndrome, to a third party in exchange for a one-time cash payment of $67.2 million plus residual royalties. Under the terms of the agreement, the Company agreed to provide certain transition services to the third-party purchaser, such as customer sales and support, for up to 12 months after the closing of the transaction. During the first quarter of 2020, the Company recognized a before-tax net gain of $59.5 million related to the sale of the Firdapse intellectual property (IP) and existing inventory. As a result of the sale of Firdapse, in the first quarter of 2020 the Company recognized a $0.8 million reduction to Goodwill and disposed of $32.2 million in intangible assets, including related accumulated amortization of $31.6 million. The Company performed its annual assessment for goodwill impairment for the year ended December 31, 2021 and no goodwill impairment charges were recorded. Intangible Assets, Net consisted of the following: December 31, 2021 2020 Finite-lived intangible assets $ 677,350 $ 644,087 Accumulated amortization (288,698) (226,816) Net carrying value $ 388,652 $ 417,271 During the fourth quarter of 2021 the Company capitalized a $6.0 million Voxzogo regulatory approval milestone payment as a finite-lived intangible asset in the Company's Consolidated Balance Sheet following the FDA's approval of Voxzogo. The following table summarizes the carrying value and estimated remaining life of the Company’s finite-lived intangible assets as of December 31, 2021: Net Balance Average Remaining Life Acquired intellectual property $ 295,299 6.0 years Technology transfer 74,055 Not applicable (1) Repurchased royalty rights 12,937 1.9 years License payments 6,203 8.7 years Other 158 1.4 years Total $ 388,652 (1) The technology transfer intangible asset has not yet been placed into service. As of December 31, 2021, the estimated future amortization expense associated with the Company’s finite-lived intangible assets, exclusive of the technology transfer asset that has not been placed into service, was as follows: Fiscal Year Amount 2022 $ 62,606 2023 61,978 2024 55,702 2025 36,426 2026 36,426 Thereafter 61,459 $ 314,597 In 2019, the Company received $25.0 million due to the achievement by a third party of development and regulatory milestones and commercial sales milestones related to a previously sold intangible asset, which the Company recorded as a Gain on Sale of Nonfinancial Assets in the Consolidated Statements of Operations. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | PROPERTY, PLANT AND EQUIPMENT Property, Plant and Equipment, Net, consisted of the following: December 31, 2021 2020 Building and improvements $ 774,923 $ 761,560 Manufacturing and laboratory equipment 444,182 414,439 Computer hardware and software 201,382 189,740 Land 90,418 90,418 Leasehold improvements 55,279 55,134 Furniture and equipment 42,976 40,223 Land improvements 10,132 7,412 Construction-in-progress 136,743 109,140 1,756,035 1,668,066 Accumulated depreciation (720,574) (635,595) Total property, plant and equipment, net $ 1,035,461 $ 1,032,471 Depreciation expense, net of amounts capitalized into inventory, was $46.1 million, $43.0 million and $51.8 million for the years ended December 31, 2021, 2020 and 2019, respectively. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following: December 31, 2021 2020 Raw materials $ 80,269 $ 76,673 Work-in-process 415,261 308,286 Finished goods 281,139 313,589 Total inventory $ 776,669 $ 698,548 In the third quarter of 2020, the Company unexpectedly received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) and a Joint Assessment Report from the European Medicines Agency (EMA) respectively, both indicating that the Company’s regulatory applications for valoctocogene roxaparvovec could not be approved in their present form and requesting additional safety and efficacy data from the ongoing Phase 3 study. The Company evaluated the impact of the new requirement for Phase 3 data that is currently unknown and determined the value of the pre-launch inventory was no longer recoverable due to delays in anticipated regulatory approvals. As a result, the Company adjusted the pre-launch inventory to zero, its net realizable value, as of December 31, 2020. The Company recorded $24.3 million and $87.2 million to Cost of Sales during the years ended December 31, 2021 and December 31, 2020. The Company had no pre-launch inventory balance as of December 31, 2021. See Note 1 to these Consolidated Financial Statements for additional information related to the Company’s policy on inventory produced prior to regulatory approval. |
SUPPLEMENTAL BALANCE SHEET INFO
SUPPLEMENTAL BALANCE SHEET INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SUPPLEMENTAL BALANCE SHEET INFORMATION | SUPPLEMENTAL BALANCE SHEET INFORMATION Accounts Payable and Accrued Liabilities consisted of the following: December 31, 2021 2020 Accrued compensation expense $ 204,446 $ 165,023 Accounts payable and accrued operating expenses 193,003 191,429 Accrued rebates payable 47,987 65,526 Accrued royalties payable 15,215 17,155 Lease liabilities 10,464 11,754 Deferred revenue 6,956 152 Forward foreign currency exchange contracts 6,263 17,798 Value added taxes payable 1,935 9,562 Accrued income taxes 1,213 9,661 Other 4,108 4,488 Total accounts payable and accrued liabilities $ 491,590 $ 492,548 The roll forward of significant estimated accrued rebates and reserve for cash discounts for the years ended December 31, 2021, 2020 and 2019, were as follows: Balance at Beginning of Period Provision for Current Period Sales Payments Balance at End of Period Year ended December 31, 2021: Accrued rebates $ 65,526 $ 116,691 $ (134,230) $ 47,987 Reserve for cash discounts $ 1,716 $ 16,003 $ (15,706) $ 2,013 Year ended December 31, 2020: Accrued rebates $ 57,163 $ 113,165 $ (104,802) $ 65,526 Reserve for cash discounts $ 1,889 $ 17,191 $ (17,364) $ 1,716 Year ended December 31, 2019: Accrued rebates $ 43,116 $ 91,748 $ (77,701) $ 57,163 Reserve for cash discounts $ 1,197 $ 15,335 $ (14,643) $ 1,889 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value in accordance with the policy described in Note 1 to these Consolidated Financial Statements. The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Consolidated Financial Statements that are remeasured on a recurring basis as of December 31, 2021 and 2020. Other than the Company’s fixed-rate convertible debt disclosed in Note 10 to these Consolidated Financial Statements, there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of December 31, 2021 and 2020. 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 Fair Value Measurements as of December 31, 2020 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,415 $ — $ 2,415 Other assets: NQDC Plan assets 19,962 — 19,962 Restricted investments (1) 4,487 — 4,487 Total other assets 24,449 — 24,449 Total assets $ 26,864 $ — $ 26,864 Liabilities: Current liabilities: NQDC Plan liability $ 2,415 $ — $ 2,415 Other long-term liabilities: NQDC Plan liability 19,962 — 19,962 Contingent consideration — 60,130 60,130 Total other long-term liabilities 19,962 60,130 80,092 Total liabilities $ 22,377 $ 60,130 $ 82,507 (1) The restricted investments as of December 31, 2021 and 2020 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. There were no transfers between levels during the periods presented. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2020 $ 60,130 Changes in the fair value of contingent consideration 8,026 Foreign exchange remeasurement of Euro denominated contingent consideration (4,757) Contingent consideration as of December 31, 2021 $ 63,399 |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The Company's forward contracts designated as hedging instruments have maturities up 2 years. The Company's forward contracts that are considered to be economic hedges that are not designated as hedging instruments have maturities up to 3 months. The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Forward Foreign Exchange Contracts December 31, 2021 December 31, 2020 Derivatives designated as hedging instruments: Sell $ 740,667 $ 782,327 Purchase $ 183,256 $ 189,540 Derivatives not designated as hedging instruments: Sell $ 113,257 $ 98,343 Purchase $ 31,068 $ 12,277 The fair value carrying amounts of the Company’s derivatives, as classified within the fair value hierarchy, were as follows: Balance Sheet Location December 31, 2021 December 31, 2020 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 17,357 $ 6,268 Other assets 4,991 3,148 Subtotal $ 22,348 $ 9,416 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 5,487 $ 17,551 Other long-term liabilities 1,378 11,020 Subtotal $ 6,865 $ 28,571 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 427 $ 84 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 776 $ 247 Total Derivatives Assets $ 22,775 $ 9,500 Total Derivatives Liabilities $ 7,641 $ 28,818 (1) See Note 1 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. The following tables summarize the impact of gains and losses from the Company's derivatives on its Consolidated Statements of Operations for the periods presented. Years Ended December 31, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,783,498 $ 196 $ 1,805,861 $ 18,122 Operating expenses as reported $ 1,928,616 $ (1,650) $ 1,897,220 $ (4,942) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 1,548 $ 115 As of December 31, 2021, the Company expects to reclassify unrealized losses of $12.2 million from AOCI to earnings as the forecasted revenue and operating expense transactions occur over the next twelve months. For additional discussion of balances in AOCI see Note 11 to these Consolidated Financial Statements. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
LEASES | LEASES The following table presents the Company’s ROU assets and lease liabilities for the periods presented. December 31, Lease Classification Classification 2021 2020 Assets: Operating Other assets $ 38,198 $ 46,014 Financing Other assets 8,220 11,095 Total ROU assets $ 46,418 $ 57,109 Liabilities: Current: Operating Accounts payable and accrued liabilities $ 8,198 $ 8,889 Financing Accounts payable and accrued liabilities 2,266 2,865 Noncurrent: Operating Other long-term liabilities 31,882 40,483 Financing Other long-term liabilities 1,960 4,006 Total lease liabilities $ 44,306 $ 56,243 Maturities of lease liabilities as of December 31, 2021 by fiscal year were as follows: Maturity of Lease Liabilities Operating Financing Total 2022 $ 10,193 $ 2,427 $ 12,620 2023 8,493 1,869 10,362 2024 6,490 85 6,575 2025 5,802 41 5,843 2026 4,304 11 4,315 Thereafter 11,811 — 11,811 Total lease payments 47,093 4,433 51,526 Less: Interest (7,013) (207) (7,220) Present value of lease liabilities $ 40,080 $ 4,226 $ 44,306 Lease costs associated with payments under the Company’s leases for the periods presented were as follows: Years Ended December 31, Lease Cost Classification 2021 2020 Operating (1) Operating expenses $ 13,962 $ 12,841 Financing: Amortization Operating expenses 3,339 3,271 Interest expense Operating expenses 283 448 Total lease costs $ 17,584 $ 16,560 (1) Includes short-term leases and variable lease costs, both of which were not material in the periods presented. The following table includes the weighted average remaining lease terms and the weighted average discount rate used to calculate the present value of the Company’s lease liabilities: Years Ended December 31, Other Information 2021 2020 Weighted average remaining lease term (in years): Operating leases 6.2 6.8 Financing leases 1.9 2.6 Weighted average discount rate: Operating leases 5.0 % 4.9 % Financing leases 5.1 % 5.2 % As of December 31, 2021 , no leases were expected to commence that would create significant rights and obligations for the Company. Years Ended December 31, Supplemental Cash Flow Information 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Cash used in operating activities: Operating leases $ 10,664 $ 10,536 Financing leases $ 283 $ 450 Cash used in financing activities: Financing leases $ 3,039 $ 6,918 ROU assets obtained in exchange for lease obligations: Operating leases $ 760 $ 4,779 Financing leases $ 462 $ 3,941 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Notes As of December 31, 2021, the Company had outstanding fixed-rate notes with varying maturities for an undiscounted aggregate principal amount of $1.1 billion (collectively the Notes). The Notes are senior subordinated convertible obligations, and interest is payable in arrears, semi-annually. The following table summarizes information regarding the Company’s convertible debt: December 31, 2021 2020 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (10,971) (12,995) 2027 Notes, net 589,029 587,005 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (4,952) (6,860) 2024 Notes, net 490,048 488,140 Total convertible debt, net $ 1,079,077 $ 1,075,145 Fair value of fixed rate convertible debt (1) : 2027 Notes $ 625,122 $ 627,090 2024 Notes 521,082 530,714 Total fair value of fixed rate convertible debt $ 1,146,204 $ 1,157,804 (1) The fair value of the Company’s fixed-rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. See Note 1 to these Consolidated Financial Statements for additional discussion of fair value measurements. Interest expense on the Company’s convertible debt consisted of the following: Years Ended December 31, 2021 2020 2019 Coupon interest expense $ 10,465 $ 12,350 $ 4,907 Accretion of discount on convertible notes 3,339 14,682 15,917 Amortization of debt issuance costs 593 1,829 2,031 Total interest expense on convertible debt $ 14,397 $ 28,861 $ 22,855 2027 Notes In May 2020, the Company issued $600.0 million in aggregate principal amount of senior subordinated unsecured convertible notes with a maturity date of May 15, 2027. The 2027 Notes were issued to the public at par value and bear interest at the rate of 1.25% per annum. Interest is payable semi-annually in cash in arrears on May 15 and November 15 of each year, beginning November 15, 2020. The 2027 Notes are convertible, at the option of the holder into shares of the Company’s common stock. The initial conversion rate for the 2027 Notes is 7.2743 shares per $1,000 principal amount of the 2027 Notes, which represents a conversion price of approximately $137.47 per share, subject to adjustment under certain conditions. Following certain corporate transactions, the Company will, in certain circumstances, increase the conversion rate for a holder that elects to convert its 2027 Notes in connection with such corporate transactions by a number of additional shares of the Company’s common stock. A holder may convert fewer than all of such holder’s 2027 Notes so long as the amount of the 2027 Notes converted is an integral multiple of $1,000 principal amount. Net proceeds from the offering were $585.8 million. In connection with the issuance of the 2027 Notes, the Company recorded a discount on the 2027 Notes of $13.5 million, which will be accreted and recorded as additional interest expense over the life of the 2027 Notes. The 2027 Notes are senior subordinated, unsecured obligations, and rank (i) subordinated in right of payment to the prior payment in full of all of the Company’s existing and future senior debt, (ii) equal in right of payment with the Company’s existing and future senior subordinated debt, (iii) senior in right of payment to the Company’s existing and future indebtedness that is expressly subordinated in right of payment to the notes, (vi) effectively subordinated to the Company’s existing and future secured indebtedness, to the extent of the value of the collateral securing that indebtedness, and (v) structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables, and (to the extent the Company is not a holder thereof) preferred equity, if any, of the Company’s subsidiaries. Upon the occurrence of a “fundamental change,” as defined in the indenture governing the 2027 Notes, the holders may require the Company to repurchase all or a portion of such holder’s 2027 Notes for cash at 100% of the principal amount of the 2027 Notes being purchased, plus any accrued and unpaid interest. The offer and sale of the 2027 Notes and the shares of the Company’s common stock issuable upon conversion of the 2027 Notes have not been registered under the Securities Act or any state securities laws and the 2027 Notes were offered only to qualified institutional buyers as defined in Rule 144A under the Securities Act. 2024 Notes In August 2017, the Company issued $495.0 million in aggregate principal amount of senior subordinated convertible notes with a maturity date of August 1, 2024. The 2024 Notes were issued to the public at 98% of face value and bear interest at the rate of 0.599% per annum. Interest is payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning February 1, 2018. The 2024 Notes are convertible, at the option of the holder into shares of the Company’s common stock. The initial conversion rate for the 2024 Notes is 8.0212 shares per $1,000 principal amount of the 2024 Notes, which represents a conversion price of approximately $124.67 per share, subject to adjustment under certain conditions. Following certain corporate transactions, the Company will, in certain circumstances, increase the conversion rate for a holder that elects to convert its 2024 Notes in connection with such corporate transactions by a number of additional shares of the Company’s common stock. A holder may convert fewer than all of such holder’s 2024 Notes so long as the amount of the 2024 Notes converted is an integral multiple of $1,000 principal amount. Net proceeds from the offering were $481.7 million. In connection with the issuance of the 2024 Notes, the Company recorded a discount on the 2024 Notes of $9.9 million, which will be accreted and recorded as additional interest expense over the life of the 2024 Notes. The 2024 Notes are senior subordinated, unsecured obligations, and rank (i) subordinated in right of payment to the prior payment in full of any of the Company’s existing and future senior debt, (ii) equal in right of payment to any of the Company’s existing and future senior subordinated debt, (iii) senior in right of payment to any of the Company’s existing and future indebtedness that is expressly subordinated in right of payment to the 2024 Notes, and (iv) effectively subordinated to any of the Company’s existing and future secured indebtedness, to the extent of the value of the collateral securing that indebtedness and structurally subordinated to all existing and future indebtedness and other liabilities, including trade payables, and (to the extent the Company is not a holder thereof) preferred equity, if any, of the Company’s subsidiaries. Upon the occurrence of a “fundamental change,” as defined in the indenture governing the 2024 Notes, the holders may require the Company to repurchase all or a portion of such holder’s 2024 Notes for cash at 100% of the principal amount of the 2024 Notes being purchased, plus any accrued and unpaid interest. See Note 16 to these Consolidated Financial Statements for further discussion of the effect of conversion of the Company's convertible debt on net income (loss) per common share. 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 December 31, 2021, there were no amounts outstanding under the credit facility and the Company and certain of its subsidiaries that serve as guarantors were in compliance with all covenants. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) The following table summarizes changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Other Total AOCI balance as of December 31, 2018 $ 7,201 $ (1,917) $ (13) $ 5,271 Other comprehensive income (loss) before 25,266 7,122 (2) 32,386 Less: gain (loss) reclassified from AOCI 15,853 — — 15,853 Tax effect — (1,640) — (1,640) Net current-period other comprehensive income (loss) 9,413 5,482 (2) 14,893 AOCI balance at December 31, 2019 $ 16,614 $ 3,565 $ (15) $ 20,164 Other comprehensive income (loss) before (23,462) 976 15 (22,471) Less: gain (loss) reclassified from AOCI 13,180 552 — 13,732 Tax effect — (100) — (100) Net current-period other comprehensive income (loss) (36,642) 324 15 (36,303) AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ — $ (16,139) Other comprehensive income (loss) before 34,379 (6,858) — 27,521 Less: gain (loss) reclassified from AOCI (1,454) — — (1,454) Tax effect — 1,596 — 1,596 Net current-period other comprehensive income (loss) 35,833 (5,262) — 30,571 AOCI balance at December 31, 2021 $ 15,805 $ (1,373) $ — $ 14,432 |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
Risks and Uncertainties [Abstract] | |
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION The following table presents Total Revenues and disaggregates Net Product Revenues by product. Years Ended December 31, 2021 2020 2019 Net product revenues by product: Vimizim $ 623,145 $ 544,257 $ 544,345 Naglazyme 380,449 391,298 374,334 Kuvan 285,776 457,736 463,353 Palynziq 237,474 170,983 86,857 Brineura 128,034 110,192 71,997 Voxzogo 5,855 — — Firdapse — 1,288 22,348 Total net product revenues marketed by the Company 1,660,733 1,675,754 1,563,234 Aldurazyme net product revenues marketed by Sanofi 122,765 130,107 97,809 Total net product revenues 1,783,498 1,805,861 1,661,043 Royalty and other revenues 62,777 54,594 43,005 Total revenues $ 1,846,275 $ 1,860,455 $ 1,704,048 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. Years Ended December 31, 2021 2020 2019 United States $ 657,700 $ 756,863 $ 669,171 Europe 558,952 498,725 485,596 Latin America 191,151 205,862 218,792 Rest of world 252,930 214,304 189,675 Total net product revenues marketed by the Company 1,660,733 1,675,754 1,563,234 Aldurazyme net product revenues marketed by Sanofi 122,765 130,107 97,809 Total net product revenues $ 1,783,498 $ 1,805,861 $ 1,661,043 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. Years Ended December 31, 2021 2020 2019 Customer A 18 % 16 % 17 % Customer B 14 % 15 % 13 % Customer C 10 % 12 % 11 % Total 42 % 43 % 41 % On a consolidated basis, two customers accounted for 28% and 16% of the Company’s December 31, 2021 accounts receivable balance, respectively, compared to December 31, 2020 when two customers accounted for 24% and 22% of the accounts receivable balance, respectively. As of December 31, 2021 and 2020, the accounts receivable balance for Sanofi included $67.9 million and $72.1 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 year ended December 31, 2021 and 2020, 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. Long-lived assets, which consist of net property, plant and equipment and ROU assets are summarized by geographic region in the following table. December 31, 2021 2020 Long-lived assets by geography: United States $ 763,847 $ 771,286 Ireland 304,748 300,555 Rest of world 13,284 17,739 Total long-lived assets $ 1,081,879 $ 1,089,580 |
EQUITY COMPENSATION PLANS AND S
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION | EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION Equity Compensation Plans Shares Available Under Equity Compensation Plans As of December 31, 2021, an aggregate of approximately 44.5 million unissued shares was authorized for future issuance under the Company’s stock plans, which primarily includes shares issuable under the 2017 Equity Incentive Plan (2017 EIP) and the ESPP. Under the 2017 EIP, shares issued and outstanding under the Amended and Restated 2006 Share Incentive Plan (the 2006 Share Incentive Plan) and the 2017 Equity Incentive Plan that expire or are forfeited generally become available for future issuance under the 2017 Equity Incentive Plan. No additional awards will be granted under the 2006 Share Incentive Plan; however, there are vested and unvested awards outstanding under the 2006 Share Incentive Plan. The Company’s stock-based compensation plans are administered by the Company’s Board of Directors (the Board), or designated Committee thereof, which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the awards. See Note 1 to these Consolidated Financial Statements for discussion regarding the valuation of equity awards. 2017 Equity Incentive Plan The 2017 Equity Incentive Plan provides for awards of RSUs and stock options as well as other forms of equity compensation. Stock option awards granted to employees generally vest over a four-year period on a cliff basis 12 months after the grant date and then monthly thereafter. The contractual term of stock option awards is generally 10 years from the grant date. RSUs granted to employees generally vest annually over a straight-line four-year period after the grant date. PRSUs generally vest over a three Employee Stock Purchase Plan The ESPP was initially approved in June 2006, replacing the Company’s previous plan, and was most recently amended in June 2019. Under BioMarin’s ESPP, employees meeting specific employment qualifications are eligible to participate and can purchase shares on established dates (each purchase date) semi-annually through payroll deductions at the lower of 85% of the fair market value of the stock at the commencement of the offering period or each purchase date of the offering period. Each offering period will span up to two years. The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 10% of qualified compensation, up to an annual limit of $25,000. The ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. During the year ended December 31, 2021, the Company issued 0.3 million shares under the ESPP. As of December 31, 2021, approximately 7.0 million shares were authorized and 3.1 million shares reserved for future issuance under the ESPP. Board of Director Grants On the date of the Company’s annual meeting of stockholders for a given year, each re-elected Independent Director receives an RSU grant valued at $400,000, with the number of RSUs to be granted calculated based on the three-month trailing average closing price of the Company’s common stock on the Nasdaq Global Select Market. The annual RSU grant for a director who has served for less than a year is prorated to the nearest quarter of the calendar year. The RSUs subject to the annual award vest in full on the one-year anniversary of the grant date, subject to each respective Director providing service to the Company through such vesting date. Upon election or appointment, a new Independent Director will receive an RSU grant on the same terms as the annual award, pro-rated for amount and vesting to the nearest quarter for the time such new Independent Director will serve prior to the Company’s next annual meeting of stockholders. Stock-based Compensation Stock-based compensation expense included on the Company’s Consolidated Statements of Operations for all stock-based compensation arrangements was as follows: Years Ended December 31, 2021 2020 2019 Cost of sales $ 22,357 $ 26,246 $ 16,146 Research and development 67,196 61,942 56,649 Selling, general and administrative 107,710 101,523 87,070 Total stock-based compensation expense $ 197,263 $ 189,711 $ 159,865 Stock-based compensation of $20.0 million, $20.1 million and $20.3 million was capitalized into inventory for the years ended December 31, 2021, 2020 and 2019, respectively. Capitalized stock-based compensation is recognized in Cost of Sales when the related product is sold. Restricted Stock Units Restricted Stock Unit Awards with Service-Based Vesting Conditions Below is a summary of activity related to RSUs with service-based vesting conditions under the plan for the year ended December 31, 2021: Shares Weighted Non-vested units as of December 31, 2020 4,173,124 $ 83.41 Granted 2,338,270 $ 78.46 Vested (1,499,408) $ 85.74 Forfeited (574,474) $ 80.57 Non-vested units as of December 31, 2021 4,437,512 $ 80.38 The weighted-average grant date fair value per share of RSUs granted during the years ended December 31, 2021, 2020 and 2019, was $78.46, $77.13 and $91.28, respectively. The total intrinsic value of restricted stock that vested and released in the years ended December 31, 2021, 2020 and 2019, was $117.2 million, $109.9 million and $101.0 million respectively. As of December 31, 2021, total unrecognized compensation cost related to unvested RSUs with service-based vesting conditions of $250.6 million was expected to be recognized over a weighted average period of 2.6 years. Restricted Stock Unit Awards with Performance-based Vesting Conditions Revenue PRSUs: Although no PRSUs with vesting conditions based on revenue performance were granted during the year ended December 31, 2021 or 2020, awards granted during prior periods presented were contingent upon the achievement of an annual revenue target and the earned RSUs vest over a three-year service period. The number of shares that may be earned ranged between 50% and 200% of the base RSUs, depending on the percentage of the respective annual year's Net Product Revenues, excluding net revenues attributable to Aldurazyme, and determined using fixed foreign currency exchange rates achieved against the target, with a threshold achievement level of 75% of target and a ceiling achievement level of 125% of target. Below is a summary of activity related to Revenue PRSUs under the Company's equity plan for the year ended December 31, 2021: Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 99,351 $ 90.31 Granted — $ — Vested (68,773) $ 88.44 Forfeited — $ — Non-vested units as of December 31, 2021 30,578 $ 94.53 The weighted-average grant date fair value of Revenue PRSUs granted during the year ended December 31, 2019, was $94.53. As of December 31, 2021, total unrecognized compensation expense of $0.4 million related to Revenue PRSUs was expected to be recognized over a weighted average period of approximately three months. Other PRSUs : Below is a summary of activity related to RSUs with vesting conditions based on other performance targets under the Company's equity plan for the year ended December 31, 2021: Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 220,665 $ 83.83 Granted 234,120 $ 78.09 Vested (8,310) $ 116.83 Forfeited (40,004) $ 61.09 Non-vested units as of December 31, 2021 406,471 $ 70.82 The weighted-average grant date fair value of Other PRSUs for the years ended December 31, 2021, 2020 and 2019, was $78.09, $84.17 and $81.00, respectively. Non-vested Other PRSUs included grants with vesting contingent upon the achievement of a three-year Non-GAAP income target and grants with vesting contingent upon achievement of a three-year strategic goal target. The awarded PRSUs, if any, vest ratably over a three-year service period. The Company evaluated the targets in the context of its current long-range financial plan, its product candidate development pipeline and planned regulatory activity and determined that attainment of each grant target was probable for accounting purposes commencing in the quarter granted. The number of shares that may be earned range between 50% and 200% of the base RSUs. Also included in non-vested Other PRSUs were awards that vest contingent upon achievement of certain regulatory milestones some of which, for accounting purposes, were deemed not yet probable of vesting as of December 31, 2021. Therefore, as of December 31, 2021, total unrecognized compensation expense of $10.9 million related to awards deemed probable of vesting and $10.6 million related to awards not yet deemed probable of vesting. The expected weighted average period over which expense is to be recognized for the awards that are considered probable of vesting as of December 31, 2021 was 1.7 years. Restricted Stock Unit Awards with Market-based Vesting Conditions The Compensation Committee and Board may grant RSUs with market-based vesting conditions (base TSR-RSUs) to certain executives. These base TSR-RSUs vest, if at all, in full following a three-year service period only if certain total shareholder return (TSR) results relative to the Nasdaq Biotechnology Index comparative companies are achieved. The number of shares that may be earned range between zero percent and 200% of the base TSR-RSUs with a ceiling achievement level of 100% of the base TSR-RSUs in the event the Company’s TSR is above the 50th percentile but negative on an absolute basis. Below is a summary of activity related to RSUs with market-based vesting conditions under the Company's equity plan for the year ended December 31, 2021: Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 220,990 $ 127.23 Granted 141,610 $ 117.52 Vested — $ — Forfeited (11,740) $ 114.94 Non-vested units as of December 31, 2021 350,860 $ 123.73 The grant date fair values and assumptions used to determine the grant date fair value of TSR-RSUs granted during the periods presented were as follows: Years Ended December 31, 2021 2020 2019 Grant date fair value $117.52 $112.12 – $217.65 $143.92 Expected volatility 24.7% – 161.7% 21.3% – 159.9% 21.7% – 155.6% Dividend yield 0.0% 0.0% 0.0% Expected term 2.8 years 2.5 – 2.8 years 2.8 years Risk-free interest rate 0.3% 0.2 – 0.4% 2.4% As of December 31, 2021, total unrecognized compensation expense of $14.9 million related to base TSR-RSUs was expected to be recognized over a weighted average period of 1.9 years. Stock Options and Purchase Rights Stock Options The following table summarizes activity under the Company’s stock option plans for the year ended December 31, 2021. All stock option grants presented in the table had exercise prices not less than the fair value of the underlying common stock on the grant date: Shares Weighted Average Exercise Price Weighted Average Remaining Years Aggregate Intrinsic Value (1) Options outstanding as of December 31, 2020 6,829,437 $ 73.19 $ 119,607 Granted 665,610 $ 78.33 Exercised (892,890) $ 34.99 Expired and forfeited (152,465) $ 82.26 Options outstanding as of December 31, 2021 6,449,692 $ 78.79 4.8 $ 80,857 Options unvested as of December 31, 2021 1,287,835 $ 79.82 8.6 $ 12,334 Exercisable at December 31, 2021 5,161,857 $ 78.54 3.8 $ 68,523 (1) The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the Nasdaq Global Select Market as of the last trading day for the respective year. The aggregate intrinsic value of options outstanding and exercisable includes options with an exercise price below $88.35, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2021. The weighted-average fair value per stock option granted in the years ended December 31, 2021, 2020 and 2019, were $31.61, $27.47 and $36.84, respectively. The total intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019, was $40.7 million, $71.9 million and $32.5 million, respectively, determined as of the date of option exercise. Upon the exercise of the options, the Company issues new common stock from its authorized shares. The assumptions used to estimate the per share fair value of stock options granted during the periods presented were as follows: Years Ended December 31, 2021 2020 2019 Expected volatility 39.4 – 41.6% 36.5 – 42.2% 37.1 – 37.4% Dividend yield 0.0% 0.0% 0.0% Expected term 4.7 – 6.0 years 4.6 – 5.9 years 4.6 – 5.8 years Risk-free interest rate 0.7 – 1.3% 0.3 – 1.7% 2.2 – 3.0% As of December 31, 2021, total unrecognized compensation cost related to unvested stock options of $31.3 million was expected to be recognized over a weighted average period of 2.5 years. The net tax expense from stock options exercised during the year ended December 31, 2021 was $0.5 million. Stock Purchase Rights The assumptions used to estimate the per share fair value of stock purchase rights granted under the ESPP were as follows: Years Ended December 31, 2021 2020 2019 Expected volatility 23.7 – 69.2% 30.6 – 69.2% 27.7% – 35.0% Dividend yield 0.00% 0.00% 0.00% Expected term 0.5 – 2.0 years 0.5 – 2.0 years 0.5 – 2.0 years Risk-free interest rate 0.04% – 2.4% 0.1 – 2.8% 1.2 – 2.8% As of December 31, 2021, total unrecognized compensation cost related to unvested stock purchase rights under the ESPP of $17.0 million was expected to be recognized over a weighted average period of 1.4 years. |
OTHER EMPLOYEE BENEFITS
OTHER EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2021 | |
Compensation Related Costs [Abstract] | |
OTHER EMPLOYEE BENEFITS | OTHER EMPLOYEE BENEFITS 401(k) Plan The Company sponsors the BioMarin Retirement Savings Plan (the 401(k) Plan) for eligible U.S. employees. The Company pays the direct expenses of the 401(k) Plan and matches 100% of each participating employee’s eligible contributions, up to a maximum of the lesser of 6% of the employee’s annual compensation or the annual statutory contribution limit. The Company’s matching contribution vests immediately and was approximately $31.6 million, $26.4 million and $28.5 million for the years ended December 31, 2021, 2020 and 2019, respectively. Deferred Compensation Plan The Company maintains the NQDC under which eligible directors and key employee may defer compensation. The NQDC prohibits the diversification of deferrals of Company stock. Company stock issued and held by the NQDC is accounted for similarly to treasury stock in that the fair value of the employer stock was determined on the grant date and the shares are issued into the NQDC when the restricted stock vests. The corresponding deferred compensation obligation is classified as equity with no changes in the fair value of Company stock held in the NQDC recognized in earnings. Other contributions held in the NQDC are classified |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The benefit from income taxes was based on loss before income taxes as follows: Years Ended December 31 2021 2020 2019 U.S. Source $ (259,258) $ (162,939) $ (182,112) Non-U.S. Source 183,908 120,617 87,301 Loss before income taxes $ (75,350) $ (42,322) $ (94,811) The U.S. and foreign components of the benefit from income taxes were as follows: Years Ended December 31, 2021 2020 2019 Provision for (benefit from) current income tax expense: Federal $ (2,038) $ (14,758) $ 5,127 State and local 1,339 1,201 1,331 Foreign 5,037 1,042 5,339 4,338 (12,515) 11,797 Provision for (benefit from) deferred income taxes: Federal (29,895) (45,038) (58,311) State and local (1,230) (5,321) (5,394) Foreign 15,517 (838,548) (19,055) (15,608) (888,907) (82,760) Benefit from income taxes $ (11,270) $ (901,422) $ (70,963) In the third quarter of 2020, the Company completed an intra-entity transfer of certain intellectual property rights from a wholly owned foreign subsidiary (tax resident in the Bahamas) to its wholly owned Irish subsidiary. The rights were sold to the Company’s Irish subsidiary where its ex-U.S. regional headquarters are located and has significant manufacturing and commercial operations, to better align ownership of intellectual property rights with how the business operates. The intra-entity transfer did not result in a taxable gain in 2020 in any jurisdiction including the U.S. as the transaction was disregarded for U.S. tax purposes. The Company filed an election to treat the Irish subsidiary as a disregarded entity for U.S. income tax purposes in 2011. The transaction resulted in a step-up in the tax basis in the transferred intellectual property rights and the Company’s Irish subsidiary recognized a deferred tax asset for the book and tax basis difference of the transferred intellectual property rights. As a result, the Company recognized a deferred tax asset of $835.1 million and related tax benefit on its Consolidated Financial Statements based on the fair value of the transferred intellectual property rights. The fair value of the transferred intellectual property rights was determined utilizing the income approach which relied on projections of product-specific revenues and the inclusion or exclusion of a terminal value for each product. The tax deductions related to the amortization of these transferred intellectual property rights will be recognized in the future and any amortization not deducted for tax purposes will be carried forward indefinitely under Irish tax laws. The Company expects to be able to realize the deferred tax asset resulting from this transaction and has not recorded a valuation allowance as of December 31, 2021 and 2020. The following is a reconciliation of the statutory federal income tax benefit to the Company’s effective tax rate: December 31, 2021 2020 2019 Federal statutory income tax benefit $ (15,824) $ (8,888) $ (19,911) State and local taxes 509 (3,264) (2,784) Orphan Drug & General Business Credit (29,363) (44,114) (43,124) Stock compensation expense 7,859 (1,101) 239 Changes in the fair value of contingent consideration — — (1,804) Foreign Source Income Subject to U.S. Tax 16,878 6,266 (52) Foreign tax rate differential (1) (2) (16,971) (16,238) (30,639) Section 162(m) limitation 6,304 9,571 8,294 Tax Reserves 15,530 2,166 12,123 Intra-entity transfer of assets (3,920) (852,338) — CARES Act carryback claim — (2,201) — Valuation allowance/deferred benefit 6,821 6,876 7,827 Other 907 1,843 (1,132) Effective income tax benefit $ (11,270) $ (901,422) $ (70,963) (1) For the year ended December 31, 2021, the foreign rate differential included foreign local tax expense which was at an effective rate lower than the U.S. statutory rate and includes the recognition of the valuation allowance against a portion of the deferred tax assets of the Company’s Dutch subsidiary of $9.3 million. (2) For the year ended December 31, 2019, the foreign rate differential included foreign local tax expense which was at an effective rate lower than the U.S. statutory rate and was offset by the benefit of the valuation allowance release against the deferred tax assets of the Company’s Dutch subsidiary of $29.6 million. The significant components of the Company’s net deferred tax assets were as follows: December 31, 2021 2020 Net deferred tax assets: Net operating loss carryforwards $ 25,936 $ 30,718 Tax credit carryforwards 563,022 532,394 Accrued expenses, reserves, and prepaids 72,759 66,889 Intangible assets 875,311 873,575 Stock-based compensation 50,910 47,011 Lease liabilities 7,422 8,991 Inventory 25,169 32,012 Other 1,943 454 Valuation allowance (109,176) (93,075) Total deferred tax assets 1,513,296 1,498,969 Joint venture basis difference (1,665) (1,164) Acquired intangibles (1,250) (1,364) Deferred revenue — (1,517) ROU assets (6,808) (8,280) Property, plant and equipment (54,498) (54,682) Total deferred tax liabilities (64,221) (67,007) Net deferred tax assets $ 1,449,075 $ 1,431,962 Valuation allowances are provided to reduce the amounts of the Company's deferred tax assets to an amount that is more likely than not to be realized based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts. At the end of each period, the Company will reassess the ability to realize its deferred tax benefits. If it is more likely than not that the Company would not realize the deferred tax benefits, a valuation allowance may need to be established against all or a portion of the deferred tax assets, which will result in a charge to tax expense. In the fourth quarter of 2021, the Company renegotiated a license agreement that resulted in lower royalty projections for its Dutch subsidiary. The revised royalty projections required establishment of a valuation allowance on net operating loss deferred tax assets that were no longer expected to be realizable. The valuation allowance also increased in 2021 due to the Company’s expectation that state R&D credits will not be utilized. As of December 31, 2021, the Company had the following net operating loss and tax credit carryforwards, which if not utilized, will expire as follows: Type Amount Year Federal net operating loss carryforwards $ 4,147 2030-2033 Federal R&D and orphan drug credit carryforwards $ 592,710 2024-2041 State net operating loss carryforwards $ 230,500 2023-2041 Dutch net operating loss carryforwards $ 48,903 Indefinite Not included in the table above are $137.3 million of state research credit carryovers that will carry forward indefinitely. The Company’s net operating losses and credits could be subject to annual limitations due to ownership change limitations provided by IRC Section 382 and similar state provisions. An annual limitation could result in the expiration of net operating losses and tax credit carryforward before utilization. There are limitations on the tax attributes of acquired entities however, the Company does not believe the limitations will have a material impact on the utilization of the net operating losses or tax credits. The financial statement recognition of the benefit for a tax position is dependent upon the benefit being more likely than not to be sustainable upon audit by the applicable taxing authority. If this threshold is met, the tax benefit is then measured and recognized at the largest amount that is greater than 50% likely of being realized upon ultimate settlement. A reconciliation of the beginning and ending amount of unrecognized tax benefits for the years ended December 31, 2021 and 2020, is as follows: December 31, 2021 2020 Balance at beginning of period $ 182,564 $ 168,748 Additions based on tax positions related to the current year 23,499 16,481 (Deletions) Additions for tax positions of prior years (786) (2,527) Lapse of statute of limitations (182) (138) Balance at end of period $ 205,095 $ 182,564 Included in the balance of unrecognized tax benefits as of December 31, 2021 were potential benefits of $196.7 million that, if recognized, would affect the effective tax rate. The Company’s policy for classifying interest and penalties associated with unrecognized income tax benefits is to include such items in the income tax expense. The total amount of accrued interest and penalties was not significant as of December 31, 2021. The Company believes it will not have any material decreases in its previously unrecognized tax benefits within the next twelve months. The Company files income tax returns in the U.S., Ireland and various foreign jurisdictions. The U.S. and foreign jurisdictions have statute of limitations ranging from three U.S. income and foreign withholding taxes have not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries that are essentially permanent in duration. This excess totaled approximately $16.3 million as of December 31, 2021, which will be indefinitely reinvested; deferred income taxes have not been provided on such foreign earnings. |
NET INCOME (LOSS) PER COMMON SH
NET INCOME (LOSS) PER COMMON SHARE | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
NET INCOME (LOSS) PER COMMON SHARE | NET INCOME (LOSS) PER COMMON SHARE Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the Company’s ESPP, unvested RSUs, the Company's common stock held by the NQDC and contingent issuances of common stock related to the Company's convertible debt. The following table sets forth the computation of basic and diluted income (loss) per common share (common shares in thousands): Years Ended December 31, 2021 2020 2019 Numerator: Net income (loss), basic $ (64,080) $ 859,100 $ (23,848) Add: Interest on convertible notes — 8,313 — Net income (loss), diluted $ (64,080) $ 867,413 $ (23,848) Denominator: Weighted-average common shares outstanding, basic 182,852 180,804 179,039 Effect of dilutive securities: Options to purchase common stock — 1,543 — Common stock issuable under the 2027 notes — 2,874 — Common stock issuable under the 2024 notes — 3,970 — Unvested RSUs — 1,938 — Common stock potentially issuable for ESPP purchases — 353 — The Company's common stock held by the NQDC — 196 — Weighted-average common shares outstanding, diluted 182,852 191,678 179,039 Net income (loss) per common share, basic $ (0.35) $ 4.75 $ (0.13) Net income (loss) per common share, diluted $ (0.35) $ 4.53 $ (0.13) In addition to the equity instruments included in the table above, the table below presents potential shares of common stock that were excluded from the computation of basic and diluted income (loss) per common share as they were anti-dilutive (in thousands): Years Ended December 31, 2021 2020 2019 Options to purchase common stock 6,450 5,287 7,264 Common stock issuable under the 2027 Notes 4,365 — — Common stock issuable under the 2024 Notes 3,970 — 3,970 Common stock issuable under the 2020 Notes — — 3,983 Unvested RSUs 5,225 2,235 3,956 Common stock potentially issuable for ESPP purchases 594 314 587 The Company's common stock held by the NQDC 181 — 205 Total number of potentially issuable shares 20,785 7,836 19,965 The 1.50% senior subordinated convertible notes that matured on October 15, 2020 (the 2020 Notes) were settled in cash for approximately $375.0 million. The potential effect of the capped call transactions with respect to the 2020 Notes was excluded from the diluted net income (loss) per share as the Company’s closing stock price on December 31, 2019 did not exceed the conversion price of $94.15 per share for the 2020 Notes. There is no similar capped call transaction associated with the 2024 Notes or 2027 Notes. See Note 10 to these Consolidated Financial Statements for information on the Company’s convertible debt. |
LICENSE AND COLLABORATION AGREE
LICENSE AND COLLABORATION AGREEMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AND COLLABORATION AGREEMENTS | LICENSE AND COLLABORATION AGREEMENTS In October 2019, the Company entered into a worldwide, exclusive licensing agreement with a third party for tralesinidase alfa (formerly referred to as BMN 250), an investigational enzyme replacement therapy to treat Sanfilippo Syndrome Type B. In consideration, the Company received an upfront payment of $3.0 million, a minority 15% equity ownership interest in the licensee, and is entitled to receive royalties on net sales of tralesinidase alfa and milestone payments if certain development, regulatory and sales milestones are met by the licensee. The Company evaluated the design and purpose of the third-party licensee and determined that it is a variable interest entity (VIE), as the equity-at-risk is insufficient to support the licensee’s operations. The Company has concluded that it is not the primary beneficiary of the VIE as the Company does not have the power to direct the activities of the VIE that most significantly impact its performance. The Company is accounting for the minority equity investment at cost, less impairment, if any, adjusted for observable price changes, as it does not exercise significant influence over the operations of the licensee. Other than providing the licensee with specified transition services, the Company has no other involvement with the operations of the VIE as of December 31, 2021. As a result, the Company's loss exposure is limited to the value of the equity investment of $12.6 million which is included in Other Assets on the Company’s Consolidated Balance Sheets as of December 31, 2021. In July 2017, the Company executed a license agreement with Sarepta Therapeutics (Sarepta) that provides Sarepta with global exclusive rights to the Company’s Duchenne muscular dystrophy (DMD) patent estate for EXONDYS 51 and all future exon-skipping products. Under the license agreement, Sarepta pays the Company royalties and may pay the Company certain milestone payments for exons 51, 45, 53 and possibly other exon-skipping products. In the fourth quarter of 2021, the Company and Sarepta amended the license agreement to, among other things, make the license co-exclusive at a future date and reduce future royalty rates. On October 1, 2015, the Company entered into an agreement with Ares Trading S.A. (Merck Serono) under which the Company acquired all global rights to Kuvan and Palynziq from Merck Serono, with the exception of Kuvan in Japan. Previously, the Company had exclusive rights to Kuvan in the U.S. and Canada and Palynziq in the U.S. and Japan. Pursuant to the A&R Kuvan Agreement, if future sales milestones are met, the Company is obligated to pay Merck Serono up to a maximum of €60.0 million, in cash, which was an estimated value of $68.1 million using the current exchange rate as of December 31, 2021. Pursuant to the Pegvaliase Agreement, the Company paid Merck Serono €125.0 million in cash when the Palynziq development milestones were achieved. In October 2012, the Company licensed to Catalyst Pharmaceutical Partners, Inc. (Catalyst) the North American rights to develop and market Firdapse, the Company's former commercial product for the treatment of Lambert-Eaton myasthenic syndrome. In exchange for the North American rights to Firdapse, commencing in the first quarter of 2019 the Company receives royalties of 7% to 10% on net product sales of Firdapse in North America. In January 2020, the Company completed the sale of worldwide rights to Firdapse to a third party. The Company retained the rights to receive the royalties from Catalyst. See Note 3 to these Consolidated Financial Statements for further information about the Firdapse sale. In September 2007, the Company licensed to Asubio Pharma Co., Ltd. (a subsidiary of Daiichi Sankyo) exclusive rights to data and intellectual property contained in the Kuvan new drug application. The Company receives royalties on net sales of the product in Japan. The Company is engaged in R&D collaborations with various other entities. These provide for sponsorship of R&D by the Company and may also provide for exclusive royalty-bearing intellectual property licenses or rights of first negotiation regarding licenses to intellectual property development under the collaborations. Typically, these agreements can be terminated for cause by either party upon written notice. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Contingencies From time to time the Company is involved in legal actions arising in the normal course of its business. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters could adversely affect the Company, its results of operations, financial condition or cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable. Contingent Payments As of December 31, 2021, the Company was subject to contingent payments considered reasonably possible of $788.5 million, including $389.0 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 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 December 31, 2021, such commitments were estimated at approximately $133.3 million, all of which were short-term. The Company has also licensed technology, for which it is required to pay royalties upon future sales, subject to certain annual minimums. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENTOn February 9, 2022, the Company entered into an agreement to sell the Rare Pediatric Disease Priority Review Voucher (PRV) it received from the FDA in connection with the U.S. approval of Voxzogo. In exchange for the PRV the Company will receive a lump sum payment of $110.0 million. The transaction remains subject to customary closing conditions, including anti-trust review. The proceeds from the sale of the PRV will be recognized as a gain on the sale of nonfinancial assets on the Company's Consolidated Statement of Operations. |
BUSINESS OVERVIEW AND SIGNIFI_2
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to United States generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange Commission (the SEC) for Annual Reports on Form 10-K and include the accounts of BioMarin and its wholly owned subsidiaries. All intercompany transactions have been eliminated. Management performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing of this Annual Report on Form 10-K except for the transaction disclosed in Note 19 to these 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 FASB during 2021 that the Company believes are of significance or potential significance to the Company. |
Use of Estimates | Use of Estimates U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Company’s 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 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. 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. |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company treats highly liquid investments, readily convertible to cash, with original maturities of three months or less on the purchase date as cash equivalents. |
Marketable Securities | Marketable Securities The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such designations at each reporting period. The Company classifies its debt and equity securities with original maturities greater than three months when purchased as either short-term or long-term investments based on each instrument’s underlying contractual maturity date and its availability for use in current operations. All marketable securities are classified as available-for-sale. Available-for-sale debt securities are measured and recorded at fair market value with unrealized gains and losses included in Accumulated Other Comprehensive Income (AOCI) on the Company’s Consolidated Balance Sheets, with the exception of any declines in fair value below the cost basis that are a result of a |
Non-Marketable Equity Securities | Non-Marketable Equity SecuritiesThe Company records investments in equity securities, other than equity method investments, at fair market value, if fair value is readily determinable. Equity securities with no readily determinable fair values are recorded using the measurement alternative of cost adjusted for observable price changes in orderly transactions for identical or similar investments of the same issuer less impairment, if any. Investments in equity securities are recorded in Other Assets on the Company's Consolidated Balance Sheets. Unrealized gains and losses are reported in Other Income, Net. The Company regularly reviews its non-marketable equity securities for indicators of impairment. |
Inventory | Inventory Commercial Inventory The Company values inventory at the lower of cost and net realizable value and determines the cost of inventory using the average-cost method. The Company analyzes its inventory levels quarterly for obsolescence and, if required, adjusts inventory to its net realizable value if the cost basis of inventory is in excess of its expected net realizable value, or for quantities in excess of expected demand. If the Company determines cost exceeds its net realizable value, the resulting adjustments are recognized as Cost of Sales in the Consolidated Statements of Operations. Inventory Produced Prior to Regulatory Approval When future commercialization for a product candidate is considered probable and management believes that material uncertainties related to the ultimate regulatory approval have been significantly reduced and the Company expects to realize economic benefit in the future, the Company capitalizes pre-launch or pre-qualification manufacturing costs prior to regulatory approval. For inventories that are capitalized in preparation of product launch, a number of factors are taken into consideration based on information available at the time, including the product candidate’s current status in the drug development and regulatory approval process, results from the related pivotal clinical trial, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, as well as commercialization and market trends. If additional requirements are subsequently presented by the regulatory authorities, prior to their final decision thus extending anticipated regulatory approval timelines resulting in expiration of the product prior to revised demand forecasts, the pre-launch inventory costs are expensed to Cost of Sales. If the marketing application is ultimately rejected by the applicable regulators and the pre-launch inventory cannot be sold for commercial use, the pre-launch inventory costs are expensed to Research and Development (R&D). |
Property, Plant And Equipment | Property, Plant and Equipment Property, plant and equipment are stated at historical cost net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives, as presented in the table below. Significant additions and improvements are capitalized, whereas repairs and maintenance are expensed as incurred. Depreciation of property, plant and equipment are included in Cost of Sales, R&D and Selling, General and Administrative (SG&A), as appropriate, in the Consolidated Statements of Operations. Property and equipment purchased for specific R&D projects with no alternative future uses are expensed as incurred and recorded to R&D in the Consolidated Statements of Operations. Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 7 years Office furniture and equipment 5 years Land improvements 10 to 20 years Land Not applicable Construction-in-progress Not applicable |
Leases | Leases The Company determines if an arrangement is a lease at contract inception. For leases where the Company is the lessee, ROU assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent the lease payment obligation. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the accelerated interest method of recognition. When an arrangement requires payments for lease and non-lease components, the Company has elected to account for lease and non-lease components separately. Lease expense for leases with a term of twelve months or less is recognized on a straight-line basis and are not included in the recognized ROU assets and lease liabilities. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company records goodwill in a business combination when the total consideration exceeds the fair value of the assets acquired. Intangible assets with indefinite useful lives are related to purchased in-process research and development (IPR&D) projects and are measured at their respective fair values as of the acquisition date. Intangible assets related to IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets are considered finite-lived and are amortized using the straight-line method based on their respective estimated useful lives at that point in time. The amortization of these intangible assets is included in Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. |
Impairment | Impairment The Company assesses goodwill and indefinite-lived intangible assets for impairment annually in the fourth quarter, or more frequently as warranted by events or changes in circumstances that indicate that the carrying amount may not be recoverable. Goodwill is assessed for impairment by comparing the fair value of the Company’s reporting unit with its carrying amount. If the carrying value of the reporting unit exceeds its fair value, an impairment loss equal to the difference would be recorded. Indefinite-lived intangible assets are assessed for impairment first by performing a qualitative assessment. If the qualitative assessment indicates that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, then the Company will perform a quantitative assessment and record an impairment loss. Impairment charges that are not material are recorded to Intangible Asset Amortization and Contingent Consideration in the Consolidated Statements of Operations. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC Topic 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account. Net Product Revenues In the U.S., the Company’s commercial products, except for Palynziq and Aldurazyme, are generally sold to specialty pharmacies or end-users, such as hospitals, which act as retailers. Palynziq is distributed in the U.S. through certain certified specialty pharmacies under the Palynziq Risk Evaluation and Mitigation Strategy (REMS) and Aldurazyme is marketed world-wide by Sanofi (formerly referred to as Sanofi Genzyme). Outside the U.S., the Company’s commercial products are sold to its authorized distributors or directly to government purchasers or hospitals, which act as the end-users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon shipment to the customer. Amounts collected from customers and remitted to governmental authorities, which primarily consist of value-added taxes related to product sales in foreign jurisdictions, are presented on a net basis on the Company’s Consolidated Statements of Operations, in that taxes billed to customers are not included as a component of Net Product Revenues. For Aldurazyme revenues, the Company receives a payment ranging from 39.5% to 50% on worldwide net Aldurazyme sales by Sanofi depending on sales volume, which is included in Net Product Revenues on the Company’s Consolidated Statements of Operations. The Company recognizes its best estimate of the revenue it expects to earn when the product is released and control is transferred to Sanofi. The Company records Aldurazyme net product revenues based on the estimated variable consideration payable when the product is sold through by Sanofi. Actual amounts of consideration ultimately received may differ from the Company’s estimates. Differences between the estimated variable consideration to be received from Sanofi and actual payments received are not expected to be material. If actual results vary from the Company’s estimates, the Company will make adjustments, which would affect Net Product Revenues and earnings in the period such variances become known. Revenue Reserves Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from government rebates, sales returns, and other incentives that are offered within contracts between the Company and its customers, such as specialty pharmacies, hospitals, authorized distributors and government purchasers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates, however the Company does not expect any such difference to be material. If actual results in the future vary from the Company’s estimates, the Company will adjust its estimates, which would affect net product revenue and earnings in the period such variances become known. Government Rebates : The Company records reserves for rebates payable under Medicaid and other government programs as a reduction of revenue at the time product revenues are recorded. The Company’s reserve calculations require estimates, including estimates of customer mix, to determine which sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to its reserves. Sales Returns : The Company records allowances for product returns, if appropriate, as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including market exclusivity of the products based on their orphan drug status, the patient population, the customers’ limited return rights and the Company’s historical experience with returns. Because of the pricing of the Company’s commercial products, the limited number of patients and the customers’ limited return rights, most customers and retailers carry a limited inventory. The Company relies on historical return rates to estimate a reserve for returns. Based on these factors and the fact that the Company has not experienced significant product returns to date, return allowances are not material. Other Incentives : Other incentives include fees paid to the Company’s distributors and discounts for prompt payment. The Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are on an eligible BioMarin product. The branded co-pay assistance programs assist commercially insured patients who have coverage for an eligible BioMarin product and are intended to reduce each participating patient’s portion of the financial responsibility of the purchase price up to a specified dollar amount of assistance. The Company records fees paid to distributors, cash discounts and amounts paid under the brand specific co-pay assistance program for each patient as a reduction of revenue. Royalty and Other Revenues Royalties : For arrangements that include the receipt of sales-based royalties, including milestone payments based on the level of sales when the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Licenses of intellectual property : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments : At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. |
Research and Development | Research and Development R&D costs are generally expensed as incurred. These expenses include contract R&D services provided by third parties, preclinical and clinical studies, raw materials costs associated with manufacturing clinical product, quality control and assurance, other R&D activities, facilities and regulatory costs and R&D-related personnel costs including salaries, benefits and stock-based compensation. Upfront and milestone payments made to third parties in connection with licensed intellectual property, which does |
Net Income (Loss) Per Common Share | Net Income (Loss) Per Common Share Basic net income (loss) per share is calculated by dividing Net Income (Loss) by the weighted average shares of common stock outstanding during the period. Diluted net income (loss) per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock; however, potential common equivalent shares are excluded if their effect is anti-dilutive. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards may be granted to employees. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting, and is classified as Cost of Sales, R&D or SG&A, as appropriate, in the Consolidated Statements of Operations. The Company accounts for forfeitures as they occur. Restricted Stock Units The fair value of restricted stock units (RSUs) with service-based vesting conditions and RSUs with performance conditions is determined to be the fair market value of the Company’s underlying common stock on the date of grant. The stock-based compensation expense for RSUs with service-based vesting is recognized over the period during which the vesting restrictions lapse. Stock-based compensation expense for RSUs with performance conditions is recognized beginning in the period the Company determines it is probable that the performance condition will be achieved. Management expectations related to the achievement of performance goals associated with RSUs with performance conditions are assessed regularly to determine whether such grants are expected to vest. The fair value for RSUs with market conditions is estimated using the Monte Carlo valuation model, utilizing expected volatility rates derived from those of the Company and the members of the referenced peer group. Related stock-based compensation is recognized, beginning on the grant date, on a straight-line basis regardless of whether the market condition is met unless the required service is not performed. Stock Options and Purchase Rights The fair value of each stock option award and purchase rights under the Company’s Employee Stock Purchase Plan (ESPP) are estimated on the date of grant using the Black-Scholes valuation model and the following assumptions: expected term, expected volatility, risk-free interest rate and expected dividend yield. The dividend yield reflects that the Company has not paid any cash dividends since inception and does not intend to pay any cash dividends in the foreseeable future. The expected term of stock options is based on observed historical exercise patterns. In estimating the life of stock options, the Company has identified two employee groups with distinctly different historical exercise patterns: executive and non-executive. The executive employee group has a history of holding stock options for longer periods than non-executive employees. The expected term of purchase rights for ESPP is based on each tranche of an offering period, which is four tranches in a twenty-four The determination of the fair value of stock-based payment awards using an option-pricing model is affected by the Company’s stock price and may use assumptions regarding a number of complex and subjective variables. |
Income Taxes | Income Taxes The Company calculates and provides for income taxes in each of the tax jurisdictions in which it operates. Deferred tax assets and liabilities, measured using enacted tax rates, are recognized for the future tax consequences of temporary differences between the tax and financial statement basis of assets and liabilities. A valuation allowance reduces the deferred tax assets to the amount that is more likely than not to be realized. The Company establishes liabilities or reduces assets for uncertain tax positions when the Company believes certain tax positions are not more likely than not of being sustained if challenged. Each quarter, the Company evaluates these uncertain tax positions and adjusts the related tax assets and liabilities in light of changing facts and circumstances. The Company uses financial projections to support its net deferred tax assets, which contain significant assumptions and estimates of future operations. If such assumptions were to differ significantly, it may have a material impact on the Company’s ability to realize its deferred tax assets. At the end of each period, the Company will reassess the ability to realize its deferred tax benefits. If it is more likely than not that the Company would not realize the deferred tax benefits, a valuation allowance may need to be established against all or a portion of the deferred tax assets, which will result in a charge to tax expense. |
Foreign Currency | Foreign Currency For the Company and its subsidiaries, the functional currency has been determined to be the U.S. Dollar (USD). Assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates for monetary assets. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in SG&A in the Consolidated Statements of Operations. |
Derivatives and Hedging Activities | Derivatives and Hedging Activities The Company uses foreign currency exchange forward contracts (forward contracts) to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company’s forecasted revenues and operating expenses being denominated in currencies other than the USD, primarily the Euro. The Company designates certain of these forward contracts as hedging instruments and also enters into forward contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward contracts protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues, operating expenses and asset or liability positions designated in currencies other than the USD. To receive hedge accounting treatment, cash flow hedges must be highly effective in offsetting changes to expected future cash flows on hedged transactions. The Company does not hold or issue derivative instruments for trading or speculative purposes. The Company 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 Company accounts for its derivative instruments as either assets or liabilities on its Consolidated Balance Sheets and measures them at fair value, which is estimated using current exchange rates and interest rates and takes into consideration the current creditworthiness of the counterparties or the Company, as applicable. For derivatives designated as hedging instruments, the entire change in the fair value of qualifying derivative instruments is recorded in AOCI and amounts deferred in AOCI are reclassified to earnings in the same line item in which the earnings effect of the hedged item is reported. Derivatives not designated as hedging instruments are adjusted to fair value through earnings in SG&A in the Consolidated Statements of Operations. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities that are required to be recorded at fair value, the Company considers the principal or most advantageous market in which the Company would transact and the market-based risk measurements or assumptions that market participants would use to price the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. The Company’s fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs) • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities that are not active, or inputs other than quoted process that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs) • Unobservable inputs that reflect estimates and assumptions (Level 3 inputs) The Company’s Level 2 instruments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs. The Company validates the prices provided by its third-party pricing services by understanding the models used, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming those securities traded in active markets. The Company’s Level 3 financial assets and liabilities include acquired intangible assets and contingent consideration resulting from business acquisitions. The estimated fair value of acquired finite-lived and indefinite-lived intangible assets and contingent consideration are measured by applying a probability-based income approach utilizing an appropriate discount rate as of the acquisition date. Key assumptions used by management to estimate the fair value of contingent consideration include estimated probabilities, the estimated timing of when a milestone may be attained and assumed discount periods and rates. Changes in the fair value of the contingent consideration can result from changes to one or more inputs, including the estimated probability with respect to regulatory approval, changes in the assumed timing of when milestones are likely to be achieved and changes in assumed discount periods and rates. Contingent consideration is remeasured on a recurring basis and resulting changes in the fair value, due to the revision of key assumptions, are recorded in Intangible Asset Amortization and Contingent Consideration on the Company’s Consolidated Statements of Operations. See Notes 2, 7, 8, 10 and 17 to these Consolidated Financial Statements for further information on the nature of these financial instruments. |
Segment Information | Segment Information The Company currently operates in one segment focused on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. A single management team reports to the chief operating decision maker who comprehensively manages the entire business. All products are included in one operating segment because the majority of the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. The Company is not organized by market and is managed and operated as one business. The Company does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Company does not accumulate discrete financial information with respect to separate products, other than revenues, cost of sales and certain other operating expenses. Recent Accounting Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the FASB during 2021 that the Company believes are of significance or potential significance to the Company. |
BUSINESS OVERVIEW AND SIGNIFI_3
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule Of Property, Plant And Equipment Estimated Useful Lives | Leasehold improvements Shorter of life of asset or lease term Building and improvements 20 to 50 years Manufacturing and laboratory equipment 5 to 15 years Computer hardware and software 3 to 7 years Office furniture and equipment 5 years Land improvements 10 to 20 years Land Not applicable Construction-in-progress Not applicable |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Cash Cash Equivalents and Available-for-Sale Securities by Significant Investment Category | The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of December 31, 2021 and 2020, respectively: December 31, 2021 Amortized Cost Gross Gross Aggregate Fair 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 December 31, 2020 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 370,325 $ — $ — $ 370,325 $ 370,325 $ — $ — Level 2: Money market instruments 264,833 — — 264,833 264,833 — — Corporate debt securities 413,137 3,261 (8) 416,390 — 220,551 195,839 U.S. government agency securities 265,298 1,555 (1) 266,852 14,000 192,488 60,364 Asset-backed securities 31,659 85 (2) 31,742 — 3,189 28,553 Foreign and other 549 168 — 717 — — 717 Subtotal 975,476 5,069 (11) 980,534 278,833 416,228 285,473 Total $ 1,345,801 $ 5,069 $ (11) $ 1,350,859 $ 649,158 $ 416,228 $ 285,473 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one |
GOODWILL AND INTANGIBLE ASSETS
GOODWILL AND INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The change in the carrying value of Goodwill was as follows: December 31, 2021 2020 Beginning balance $ 196,199 $ 197,039 Disposition — (840) Ending carrying value $ 196,199 $ 196,199 |
Schedule of Intangible Assets | Intangible Assets, Net consisted of the following: December 31, 2021 2020 Finite-lived intangible assets $ 677,350 $ 644,087 Accumulated amortization (288,698) (226,816) Net carrying value $ 388,652 $ 417,271 |
Schedule of Net-Book-Value and Estimated Remaining Life of Finite-Lived Intangible Assets | The following table summarizes the carrying value and estimated remaining life of the Company’s finite-lived intangible assets as of December 31, 2021: Net Balance Average Remaining Life Acquired intellectual property $ 295,299 6.0 years Technology transfer 74,055 Not applicable (1) Repurchased royalty rights 12,937 1.9 years License payments 6,203 8.7 years Other 158 1.4 years Total $ 388,652 (1) The technology transfer intangible asset has not yet been placed into service. |
Schedule of Future Amortization Expense of Finite-Lived Intangible Assets | As of December 31, 2021, the estimated future amortization expense associated with the Company’s finite-lived intangible assets, exclusive of the technology transfer asset that has not been placed into service, was as follows: Fiscal Year Amount 2022 $ 62,606 2023 61,978 2024 55,702 2025 36,426 2026 36,426 Thereafter 61,459 $ 314,597 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property Plant and Equipment Net | Property, Plant and Equipment, Net, consisted of the following: December 31, 2021 2020 Building and improvements $ 774,923 $ 761,560 Manufacturing and laboratory equipment 444,182 414,439 Computer hardware and software 201,382 189,740 Land 90,418 90,418 Leasehold improvements 55,279 55,134 Furniture and equipment 42,976 40,223 Land improvements 10,132 7,412 Construction-in-progress 136,743 109,140 1,756,035 1,668,066 Accumulated depreciation (720,574) (635,595) Total property, plant and equipment, net $ 1,035,461 $ 1,032,471 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, 2021 2020 Raw materials $ 80,269 $ 76,673 Work-in-process 415,261 308,286 Finished goods 281,139 313,589 Total inventory $ 776,669 $ 698,548 |
SUPPLEMENTAL BALANCE SHEET IN_2
SUPPLEMENTAL BALANCE SHEET INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: December 31, 2021 2020 Accrued compensation expense $ 204,446 $ 165,023 Accounts payable and accrued operating expenses 193,003 191,429 Accrued rebates payable 47,987 65,526 Accrued royalties payable 15,215 17,155 Lease liabilities 10,464 11,754 Deferred revenue 6,956 152 Forward foreign currency exchange contracts 6,263 17,798 Value added taxes payable 1,935 9,562 Accrued income taxes 1,213 9,661 Other 4,108 4,488 Total accounts payable and accrued liabilities $ 491,590 $ 492,548 |
Schedule of Estimated Accrued Rebates and Reserve for Cash Discounts | The roll forward of significant estimated accrued rebates and reserve for cash discounts for the years ended December 31, 2021, 2020 and 2019, were as follows: Balance at Beginning of Period Provision for Current Period Sales Payments Balance at End of Period Year ended December 31, 2021: Accrued rebates $ 65,526 $ 116,691 $ (134,230) $ 47,987 Reserve for cash discounts $ 1,716 $ 16,003 $ (15,706) $ 2,013 Year ended December 31, 2020: Accrued rebates $ 57,163 $ 113,165 $ (104,802) $ 65,526 Reserve for cash discounts $ 1,889 $ 17,191 $ (17,364) $ 1,716 Year ended December 31, 2019: Accrued rebates $ 43,116 $ 91,748 $ (77,701) $ 57,163 Reserve for cash discounts $ 1,197 $ 15,335 $ (14,643) $ 1,889 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Consolidated Financial Statements that are remeasured on a recurring basis as of December 31, 2021 and 2020. Other than the Company’s fixed-rate convertible debt disclosed in Note 10 to these Consolidated Financial Statements, there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of December 31, 2021 and 2020. 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 Fair Value Measurements as of December 31, 2020 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,415 $ — $ 2,415 Other assets: NQDC Plan assets 19,962 — 19,962 Restricted investments (1) 4,487 — 4,487 Total other assets 24,449 — 24,449 Total assets $ 26,864 $ — $ 26,864 Liabilities: Current liabilities: NQDC Plan liability $ 2,415 $ — $ 2,415 Other long-term liabilities: NQDC Plan liability 19,962 — 19,962 Contingent consideration — 60,130 60,130 Total other long-term liabilities 19,962 60,130 80,092 Total liabilities $ 22,377 $ 60,130 $ 82,507 (1) The restricted investments as of December 31, 2021 and 2020 secure the Company’s irrevocable standby letters of credit obtained in connection with certain commercial agreements. |
Liabilities Measured at Fair Value Using Level 3 Inputs | Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following tables represent a roll-forward of contingent consideration. Contingent consideration as of December 31, 2020 $ 60,130 Changes in the fair value of contingent consideration 8,026 Foreign exchange remeasurement of Euro denominated contingent consideration (4,757) Contingent consideration as of December 31, 2021 $ 63,399 |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Summary of Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Forward Foreign Exchange Contracts December 31, 2021 December 31, 2020 Derivatives designated as hedging instruments: Sell $ 740,667 $ 782,327 Purchase $ 183,256 $ 189,540 Derivatives not designated as hedging instruments: Sell $ 113,257 $ 98,343 Purchase $ 31,068 $ 12,277 |
Fair Value Carrying Amount of Derivative Instruments | The fair value carrying amounts of the Company’s derivatives, as classified within the fair value hierarchy, were as follows: Balance Sheet Location December 31, 2021 December 31, 2020 Derivatives designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 17,357 $ 6,268 Other assets 4,991 3,148 Subtotal $ 22,348 $ 9,416 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 5,487 $ 17,551 Other long-term liabilities 1,378 11,020 Subtotal $ 6,865 $ 28,571 Derivatives not designated as hedging instruments: Asset Derivatives - Level 2 (1) Other current assets $ 427 $ 84 Liability Derivatives - Level 2 (1) Accounts payable and accrued liabilities $ 776 $ 247 Total Derivatives Assets $ 22,775 $ 9,500 Total Derivatives Liabilities $ 7,641 $ 28,818 (1) See Note 1 to these Consolidated Financial Statements for additional information related to the Company’s fair value measurements. |
Effect of Derivative Instruments | The following tables summarize the impact of gains and losses from the Company's derivatives on its Consolidated Statements of Operations for the periods presented. Years Ended December 31, 2021 2020 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues as reported $ 1,783,498 $ 196 $ 1,805,861 $ 18,122 Operating expenses as reported $ 1,928,616 $ (1,650) $ 1,897,220 $ (4,942) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 1,548 $ 115 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule Of Lessee Lease Assets And Liabilities | The following table presents the Company’s ROU assets and lease liabilities for the periods presented. December 31, Lease Classification Classification 2021 2020 Assets: Operating Other assets $ 38,198 $ 46,014 Financing Other assets 8,220 11,095 Total ROU assets $ 46,418 $ 57,109 Liabilities: Current: Operating Accounts payable and accrued liabilities $ 8,198 $ 8,889 Financing Accounts payable and accrued liabilities 2,266 2,865 Noncurrent: Operating Other long-term liabilities 31,882 40,483 Financing Other long-term liabilities 1,960 4,006 Total lease liabilities $ 44,306 $ 56,243 |
Schedule of Maturities of Finance Lease Liabilities | Maturities of lease liabilities as of December 31, 2021 by fiscal year were as follows: Maturity of Lease Liabilities Operating Financing Total 2022 $ 10,193 $ 2,427 $ 12,620 2023 8,493 1,869 10,362 2024 6,490 85 6,575 2025 5,802 41 5,843 2026 4,304 11 4,315 Thereafter 11,811 — 11,811 Total lease payments 47,093 4,433 51,526 Less: Interest (7,013) (207) (7,220) Present value of lease liabilities $ 40,080 $ 4,226 $ 44,306 |
Schedule of Maturities of Operating Lease Liabilities | Maturities of lease liabilities as of December 31, 2021 by fiscal year were as follows: Maturity of Lease Liabilities Operating Financing Total 2022 $ 10,193 $ 2,427 $ 12,620 2023 8,493 1,869 10,362 2024 6,490 85 6,575 2025 5,802 41 5,843 2026 4,304 11 4,315 Thereafter 11,811 — 11,811 Total lease payments 47,093 4,433 51,526 Less: Interest (7,013) (207) (7,220) Present value of lease liabilities $ 40,080 $ 4,226 $ 44,306 |
Schedule of Lease Cost | Lease costs associated with payments under the Company’s leases for the periods presented were as follows: Years Ended December 31, Lease Cost Classification 2021 2020 Operating (1) Operating expenses $ 13,962 $ 12,841 Financing: Amortization Operating expenses 3,339 3,271 Interest expense Operating expenses 283 448 Total lease costs $ 17,584 $ 16,560 (1) Includes short-term leases and variable lease costs, both of which were not material in the periods presented. Years Ended December 31, Supplemental Cash Flow Information 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Cash used in operating activities: Operating leases $ 10,664 $ 10,536 Financing leases $ 283 $ 450 Cash used in financing activities: Financing leases $ 3,039 $ 6,918 ROU assets obtained in exchange for lease obligations: Operating leases $ 760 $ 4,779 Financing leases $ 462 $ 3,941 |
Schedule of Other Information | The following table includes the weighted average remaining lease terms and the weighted average discount rate used to calculate the present value of the Company’s lease liabilities: Years Ended December 31, Other Information 2021 2020 Weighted average remaining lease term (in years): Operating leases 6.2 6.8 Financing leases 1.9 2.6 Weighted average discount rate: Operating leases 5.0 % 4.9 % Financing leases 5.1 % 5.2 % |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Senior Subordinated Convertible Obligations | 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: December 31, 2021 2020 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (10,971) (12,995) 2027 Notes, net 589,029 587,005 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (4,952) (6,860) 2024 Notes, net 490,048 488,140 Total convertible debt, net $ 1,079,077 $ 1,075,145 Fair value of fixed rate convertible debt (1) : 2027 Notes $ 625,122 $ 627,090 2024 Notes 521,082 530,714 Total fair value of fixed rate convertible debt $ 1,146,204 $ 1,157,804 (1) The fair value of the Company’s fixed-rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. See Note 1 to these Consolidated Financial Statements for additional discussion of fair value measurements. |
Summary of Interest Expense on Debt | Interest expense on the Company’s convertible debt consisted of the following: Years Ended December 31, 2021 2020 2019 Coupon interest expense $ 10,465 $ 12,350 $ 4,907 Accretion of discount on convertible notes 3,339 14,682 15,917 Amortization of debt issuance costs 593 1,829 2,031 Total interest expense on convertible debt $ 14,397 $ 28,861 $ 22,855 |
ACCUMULATED OTHER COMPREHENSI_2
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI | The following table summarizes changes in the accumulated balances for each component of AOCI, including current period other comprehensive income (loss) and reclassifications out of AOCI, for the periods presented. Unrealized Gains (Losses) on Cash Flow Hedges Unrealized Gains (Losses) on Available-for-Sale Debt Securities Other Total AOCI balance as of December 31, 2018 $ 7,201 $ (1,917) $ (13) $ 5,271 Other comprehensive income (loss) before 25,266 7,122 (2) 32,386 Less: gain (loss) reclassified from AOCI 15,853 — — 15,853 Tax effect — (1,640) — (1,640) Net current-period other comprehensive income (loss) 9,413 5,482 (2) 14,893 AOCI balance at December 31, 2019 $ 16,614 $ 3,565 $ (15) $ 20,164 Other comprehensive income (loss) before (23,462) 976 15 (22,471) Less: gain (loss) reclassified from AOCI 13,180 552 — 13,732 Tax effect — (100) — (100) Net current-period other comprehensive income (loss) (36,642) 324 15 (36,303) AOCI balance at December 31, 2020 $ (20,028) $ 3,889 $ — $ (16,139) Other comprehensive income (loss) before 34,379 (6,858) — 27,521 Less: gain (loss) reclassified from AOCI (1,454) — — (1,454) Tax effect — 1,596 — 1,596 Net current-period other comprehensive income (loss) 35,833 (5,262) — 30,571 AOCI balance at December 31, 2021 $ 15,805 $ (1,373) $ — $ 14,432 |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Risks and Uncertainties [Abstract] | |
Disaggregates of Total Net Product Revenues from External Customers by Product | The following table presents Total Revenues and disaggregates Net Product Revenues by product. Years Ended December 31, 2021 2020 2019 Net product revenues by product: Vimizim $ 623,145 $ 544,257 $ 544,345 Naglazyme 380,449 391,298 374,334 Kuvan 285,776 457,736 463,353 Palynziq 237,474 170,983 86,857 Brineura 128,034 110,192 71,997 Voxzogo 5,855 — — Firdapse — 1,288 22,348 Total net product revenues marketed by the Company 1,660,733 1,675,754 1,563,234 Aldurazyme net product revenues marketed by Sanofi 122,765 130,107 97,809 Total net product revenues 1,783,498 1,805,861 1,661,043 Royalty and other revenues 62,777 54,594 43,005 Total revenues $ 1,846,275 $ 1,860,455 $ 1,704,048 |
Disaggregates 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. Years Ended December 31, 2021 2020 2019 United States $ 657,700 $ 756,863 $ 669,171 Europe 558,952 498,725 485,596 Latin America 191,151 205,862 218,792 Rest of world 252,930 214,304 189,675 Total net product revenues marketed by the Company 1,660,733 1,675,754 1,563,234 Aldurazyme net product revenues marketed by Sanofi 122,765 130,107 97,809 Total net product revenues $ 1,783,498 $ 1,805,861 $ 1,661,043 |
Total Net Product Revenue Concentrations Attributed to Largest Customers | The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented. Years Ended December 31, 2021 2020 2019 Customer A 18 % 16 % 17 % Customer B 14 % 15 % 13 % Customer C 10 % 12 % 11 % Total 42 % 43 % 41 % |
Summary of Non-Monetary Long-Lived Assets by Geographic Region | Long-lived assets, which consist of net property, plant and equipment and ROU assets are summarized by geographic region in the following table. December 31, 2021 2020 Long-lived assets by geography: United States $ 763,847 $ 771,286 Ireland 304,748 300,555 Rest of world 13,284 17,739 Total long-lived assets $ 1,081,879 $ 1,089,580 |
EQUITY COMPENSATION PLANS AND_2
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | Stock-based compensation expense included on the Company’s Consolidated Statements of Operations for all stock-based compensation arrangements was as follows: Years Ended December 31, 2021 2020 2019 Cost of sales $ 22,357 $ 26,246 $ 16,146 Research and development 67,196 61,942 56,649 Selling, general and administrative 107,710 101,523 87,070 Total stock-based compensation expense $ 197,263 $ 189,711 $ 159,865 |
Summary of Restricted Stock Unit Activity | Below is a summary of activity related to RSUs with service-based vesting conditions under the plan for the year ended December 31, 2021: Shares Weighted Non-vested units as of December 31, 2020 4,173,124 $ 83.41 Granted 2,338,270 $ 78.46 Vested (1,499,408) $ 85.74 Forfeited (574,474) $ 80.57 Non-vested units as of December 31, 2021 4,437,512 $ 80.38 Below is a summary of activity related to Revenue PRSUs under the Company's equity plan for the year ended December 31, 2021: Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 99,351 $ 90.31 Granted — $ — Vested (68,773) $ 88.44 Forfeited — $ — Non-vested units as of December 31, 2021 30,578 $ 94.53 Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 220,665 $ 83.83 Granted 234,120 $ 78.09 Vested (8,310) $ 116.83 Forfeited (40,004) $ 61.09 Non-vested units as of December 31, 2021 406,471 $ 70.82 Below is a summary of activity related to RSUs with market-based vesting conditions under the Company's equity plan for the year ended December 31, 2021: Shares Weighted Average Grant Date Fair Value Non-vested units as of December 31, 2020 220,990 $ 127.23 Granted 141,610 $ 117.52 Vested — $ — Forfeited (11,740) $ 114.94 Non-vested units as of December 31, 2021 350,860 $ 123.73 |
Summary of TSR-RSU Valuation Assumptions | The grant date fair values and assumptions used to determine the grant date fair value of TSR-RSUs granted during the periods presented were as follows: Years Ended December 31, 2021 2020 2019 Grant date fair value $117.52 $112.12 – $217.65 $143.92 Expected volatility 24.7% – 161.7% 21.3% – 159.9% 21.7% – 155.6% Dividend yield 0.0% 0.0% 0.0% Expected term 2.8 years 2.5 – 2.8 years 2.8 years Risk-free interest rate 0.3% 0.2 – 0.4% 2.4% |
Summary of Stock Option Activity | The following table summarizes activity under the Company’s stock option plans for the year ended December 31, 2021. All stock option grants presented in the table had exercise prices not less than the fair value of the underlying common stock on the grant date: Shares Weighted Average Exercise Price Weighted Average Remaining Years Aggregate Intrinsic Value (1) Options outstanding as of December 31, 2020 6,829,437 $ 73.19 $ 119,607 Granted 665,610 $ 78.33 Exercised (892,890) $ 34.99 Expired and forfeited (152,465) $ 82.26 Options outstanding as of December 31, 2021 6,449,692 $ 78.79 4.8 $ 80,857 Options unvested as of December 31, 2021 1,287,835 $ 79.82 8.6 $ 12,334 Exercisable at December 31, 2021 5,161,857 $ 78.54 3.8 $ 68,523 (1) The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the Nasdaq Global Select Market as of the last trading day for the respective year. The aggregate intrinsic value of options outstanding and exercisable includes options with an exercise price below $88.35, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2021. |
Stock Option Valuation Assumptions | The assumptions used to estimate the per share fair value of stock options granted during the periods presented were as follows: Years Ended December 31, 2021 2020 2019 Expected volatility 39.4 – 41.6% 36.5 – 42.2% 37.1 – 37.4% Dividend yield 0.0% 0.0% 0.0% Expected term 4.7 – 6.0 years 4.6 – 5.9 years 4.6 – 5.8 years Risk-free interest rate 0.7 – 1.3% 0.3 – 1.7% 2.2 – 3.0% |
Employee Stock Purchase Plan Valuation Assumptions | The assumptions used to estimate the per share fair value of stock purchase rights granted under the ESPP were as follows: Years Ended December 31, 2021 2020 2019 Expected volatility 23.7 – 69.2% 30.6 – 69.2% 27.7% – 35.0% Dividend yield 0.00% 0.00% 0.00% Expected term 0.5 – 2.0 years 0.5 – 2.0 years 0.5 – 2.0 years Risk-free interest rate 0.04% – 2.4% 0.1 – 2.8% 1.2 – 2.8% |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Benefit from Income Taxes Based on Loss Before Income Taxes | The benefit from income taxes was based on loss before income taxes as follows: Years Ended December 31 2021 2020 2019 U.S. Source $ (259,258) $ (162,939) $ (182,112) Non-U.S. Source 183,908 120,617 87,301 Loss before income taxes $ (75,350) $ (42,322) $ (94,811) |
Schedule of Components of Provision for (Benefit From) Income Taxes | The U.S. and foreign components of the benefit from income taxes were as follows: Years Ended December 31, 2021 2020 2019 Provision for (benefit from) current income tax expense: Federal $ (2,038) $ (14,758) $ 5,127 State and local 1,339 1,201 1,331 Foreign 5,037 1,042 5,339 4,338 (12,515) 11,797 Provision for (benefit from) deferred income taxes: Federal (29,895) (45,038) (58,311) State and local (1,230) (5,321) (5,394) Foreign 15,517 (838,548) (19,055) (15,608) (888,907) (82,760) Benefit from income taxes $ (11,270) $ (901,422) $ (70,963) |
Schedule of Reconciliation of Statutory Federal Income Tax Rate to Company's Effective Income Tax Rate | The following is a reconciliation of the statutory federal income tax benefit to the Company’s effective tax rate: December 31, 2021 2020 2019 Federal statutory income tax benefit $ (15,824) $ (8,888) $ (19,911) State and local taxes 509 (3,264) (2,784) Orphan Drug & General Business Credit (29,363) (44,114) (43,124) Stock compensation expense 7,859 (1,101) 239 Changes in the fair value of contingent consideration — — (1,804) Foreign Source Income Subject to U.S. Tax 16,878 6,266 (52) Foreign tax rate differential (1) (2) (16,971) (16,238) (30,639) Section 162(m) limitation 6,304 9,571 8,294 Tax Reserves 15,530 2,166 12,123 Intra-entity transfer of assets (3,920) (852,338) — CARES Act carryback claim — (2,201) — Valuation allowance/deferred benefit 6,821 6,876 7,827 Other 907 1,843 (1,132) Effective income tax benefit $ (11,270) $ (901,422) $ (70,963) (1) For the year ended December 31, 2021, the foreign rate differential included foreign local tax expense which was at an effective rate lower than the U.S. statutory rate and includes the recognition of the valuation allowance against a portion of the deferred tax assets of the Company’s Dutch subsidiary of $9.3 million. (2) For the year ended December 31, 2019, the foreign rate differential included foreign local tax expense which was at an effective rate lower than the U.S. statutory rate and was offset by the benefit of the valuation allowance release against the deferred tax assets of the Company’s Dutch subsidiary of $29.6 million. |
Schedule of Components of Net Deferred Tax Assets | The significant components of the Company’s net deferred tax assets were as follows: December 31, 2021 2020 Net deferred tax assets: Net operating loss carryforwards $ 25,936 $ 30,718 Tax credit carryforwards 563,022 532,394 Accrued expenses, reserves, and prepaids 72,759 66,889 Intangible assets 875,311 873,575 Stock-based compensation 50,910 47,011 Lease liabilities 7,422 8,991 Inventory 25,169 32,012 Other 1,943 454 Valuation allowance (109,176) (93,075) Total deferred tax assets 1,513,296 1,498,969 Joint venture basis difference (1,665) (1,164) Acquired intangibles (1,250) (1,364) Deferred revenue — (1,517) ROU assets (6,808) (8,280) Property, plant and equipment (54,498) (54,682) Total deferred tax liabilities (64,221) (67,007) Net deferred tax assets $ 1,449,075 $ 1,431,962 |
Summary of Expiration of not Utilized Net Operating Loss and Tax Credit Carryforwards | As of December 31, 2021, the Company had the following net operating loss and tax credit carryforwards, which if not utilized, will expire as follows: Type Amount Year Federal net operating loss carryforwards $ 4,147 2030-2033 Federal R&D and orphan drug credit carryforwards $ 592,710 2024-2041 State net operating loss carryforwards $ 230,500 2023-2041 Dutch net operating loss carryforwards $ 48,903 Indefinite |
Schedule of Reconciliation of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits for the years ended December 31, 2021 and 2020, is as follows: December 31, 2021 2020 Balance at beginning of period $ 182,564 $ 168,748 Additions based on tax positions related to the current year 23,499 16,481 (Deletions) Additions for tax positions of prior years (786) (2,527) Lapse of statute of limitations (182) (138) Balance at end of period $ 205,095 $ 182,564 |
NET INCOME (LOSS) PER COMMON _2
NET INCOME (LOSS) PER COMMON SHARE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings per Common Share | The following table sets forth the computation of basic and diluted income (loss) per common share (common shares in thousands): Years Ended December 31, 2021 2020 2019 Numerator: Net income (loss), basic $ (64,080) $ 859,100 $ (23,848) Add: Interest on convertible notes — 8,313 — Net income (loss), diluted $ (64,080) $ 867,413 $ (23,848) Denominator: Weighted-average common shares outstanding, basic 182,852 180,804 179,039 Effect of dilutive securities: Options to purchase common stock — 1,543 — Common stock issuable under the 2027 notes — 2,874 — Common stock issuable under the 2024 notes — 3,970 — Unvested RSUs — 1,938 — Common stock potentially issuable for ESPP purchases — 353 — The Company's common stock held by the NQDC — 196 — Weighted-average common shares outstanding, diluted 182,852 191,678 179,039 Net income (loss) per common share, basic $ (0.35) $ 4.75 $ (0.13) Net income (loss) per common share, diluted $ (0.35) $ 4.53 $ (0.13) |
Schedule Of Shares Excluded From Computation of Basic and Diluted Net Loss Per Share | In addition to the equity instruments included in the table above, the table below presents potential shares of common stock that were excluded from the computation of basic and diluted income (loss) per common share as they were anti-dilutive (in thousands): Years Ended December 31, 2021 2020 2019 Options to purchase common stock 6,450 5,287 7,264 Common stock issuable under the 2027 Notes 4,365 — — Common stock issuable under the 2024 Notes 3,970 — 3,970 Common stock issuable under the 2020 Notes — — 3,983 Unvested RSUs 5,225 2,235 3,956 Common stock potentially issuable for ESPP purchases 594 314 587 The Company's common stock held by the NQDC 181 — 205 Total number of potentially issuable shares 20,785 7,836 19,965 |
BUSINESS OVERVIEW AND SIGNIFI_4
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2021Segmenttranchecommercial_product | |
Significant Accounting Policies [Line Items] | |
Number of commercial products in portfolio | commercial_product | 7 |
Number of tranches in offering period | tranche | 4 |
Span of offering period | 24 months |
Number of reportable segment | 1 |
Number of operating segments | 1 |
Aldurazyme | Minimum | |
Significant Accounting Policies [Line Items] | |
Payment received as percentage of net product sales | 39.50% |
Aldurazyme | Maximum | |
Significant Accounting Policies [Line Items] | |
Payment received as percentage of net product sales | 50.00% |
BUSINESS OVERVIEW AND SIGNIFI_5
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES - Schedule of Property Plant and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | Shorter of life of asset or lease term |
Building and improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 20 years |
Building and improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 50 years |
Manufacturing and laboratory equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Manufacturing and laboratory equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 15 years |
Computer hardware and software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 3 years |
Computer hardware and software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 7 years |
Office Furniture and Equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 5 years |
Land improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 10 years |
Land improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life, (in years) | 20 years |
FINANCIAL INSTRUMENTS - Schedul
FINANCIAL INSTRUMENTS - Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 1,523,467 | $ 1,345,801 |
Gross Unrealized Gains | 719 | 5,069 |
Gross Unrealized Losses | (2,518) | (11) |
Aggregate Fair Value | 1,521,668 | 1,350,859 |
Cash and Cash Equivalents | 587,276 | 649,158 |
Short-term Marketable Securities | 426,599 | 416,228 |
Long-term Marketable Securities | $ 507,793 | $ 285,473 |
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 |
Minimum | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Long-term marketable securities maturity period | 1 year | 1 year |
Quoted Price in Active Markets For Identical Assets (Level 1) | Cash | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cash | $ 301,177 | $ 370,325 |
Cash aggregate fair value | 301,177 | 370,325 |
Cash and Cash Equivalents | 301,177 | 370,325 |
Level 2 | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,222,290 | 975,476 |
Gross Unrealized Gains | 719 | 5,069 |
Gross Unrealized Losses | (2,518) | (11) |
Aggregate Fair Value | 1,220,491 | 980,534 |
Cash and Cash Equivalents | 286,099 | 278,833 |
Short-term Marketable Securities | 426,599 | 416,228 |
Long-term Marketable Securities | 507,793 | 285,473 |
Level 2 | Money Market Instruments | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 285,099 | 264,833 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Aggregate Fair Value | 285,099 | 264,833 |
Cash and Cash Equivalents | 285,099 | 264,833 |
Short-term Marketable Securities | 0 | 0 |
Long-term Marketable Securities | 0 | 0 |
Level 2 | Corporate Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 584,000 | 413,137 |
Gross Unrealized Gains | 386 | 3,261 |
Gross Unrealized Losses | (2,086) | (8) |
Aggregate Fair Value | 582,300 | 416,390 |
Cash and Cash Equivalents | 0 | 0 |
Short-term Marketable Securities | 200,304 | 220,551 |
Long-term Marketable Securities | 381,996 | 195,839 |
Level 2 | U.S. Government Agency Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 224,774 | 265,298 |
Gross Unrealized Gains | 182 | 1,555 |
Gross Unrealized Losses | (325) | (1) |
Aggregate Fair Value | 224,631 | 266,852 |
Cash and Cash Equivalents | 0 | 14,000 |
Short-term Marketable Securities | 146,421 | 192,488 |
Long-term Marketable Securities | 78,210 | 60,364 |
Level 2 | Commercial Paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 68,384 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Aggregate Fair Value | 68,384 | |
Cash and Cash Equivalents | 1,000 | |
Short-term Marketable Securities | 67,384 | |
Long-term Marketable Securities | 0 | |
Level 2 | Asset-backed Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 56,936 | 31,659 |
Gross Unrealized Gains | 10 | 85 |
Gross Unrealized Losses | (95) | (2) |
Aggregate Fair Value | 56,851 | 31,742 |
Cash and Cash Equivalents | 0 | 0 |
Short-term Marketable Securities | 9,451 | 3,189 |
Long-term Marketable Securities | 47,400 | 28,553 |
Level 2 | Foreign and Other | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 3,097 | 549 |
Gross Unrealized Gains | 141 | 168 |
Gross Unrealized Losses | (12) | 0 |
Aggregate Fair Value | 3,226 | 717 |
Cash and Cash Equivalents | 0 | 0 |
Short-term Marketable Securities | 3,039 | 0 |
Long-term Marketable Securities | $ 187 | $ 717 |
FINANCIAL INSTRUMENTS - Additio
FINANCIAL INSTRUMENTS - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Measurements, Recurring | Strategic Investment | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Strategic investments fair value | $ 16.5 | $ 10.5 |
GOODWILL AND INTANGIBLE ASSET_2
GOODWILL AND INTANGIBLE ASSETS - Schedule of Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill [Roll Forward] | ||
Goodwill, beginning balance | $ 196,199 | $ 197,039 |
Disposition | 0 | (840) |
Goodwill, ending balance | $ 196,199 | $ 196,199 |
GOODWILL AND INTANGIBLE ASSET_3
GOODWILL AND INTANGIBLE ASSETS - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2020 | |
Goodwill And Intangible Assets [Line Items] | |||||
Gain (loss) on disposition of other assets | $ 0 | $ 59,495,000 | $ 25,000,000 | ||
Finite-lived intangible assets | 677,350,000 | 644,087,000 | |||
Accumulated amortization | 288,698,000 | $ 226,816,000 | |||
Goodwill impairment charge | 0 | ||||
Finite lived intangible assets | 388,652,000 | ||||
License payments | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Finite lived intangible assets | 6,203,000 | ||||
License payments | Voxzogo | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Finite lived intangible assets | $ 6,000,000 | ||||
Disposal Group, Disposed of by Sale, Not Discontinued Operations | Firdapse | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Consideration received | $ 67,200,000 | ||||
Gain (loss) on disposition of other assets | $ 59,500,000 | ||||
Decrease in goodwill | 800,000 | ||||
Finite-lived intangible assets | 32,200,000 | ||||
Accumulated amortization | $ 31,600,000 | ||||
Medivation | |||||
Goodwill And Intangible Assets [Line Items] | |||||
Milestone payments received | $ 25,000,000 |
GOODWILL AND INTANGIBLE ASSET_4
GOODWILL AND INTANGIBLE ASSETS - Schedule of Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Finite-lived intangible assets | $ 677,350 | $ 644,087 |
Accumulated amortization | (288,698) | (226,816) |
Intangible assets, net | $ 388,652 | $ 417,271 |
GOODWILL AND INTANGIBLE ASSET_5
GOODWILL AND INTANGIBLE ASSETS - Schedule of Net-Book-Value and Estimated Remaining Life of Finite-Lived Intangible Assets (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 388,652 |
Acquired intellectual property | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 295,299 |
Average Remaining Life (in years) | 6 years |
Repurchased royalty rights | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 12,937 |
Average Remaining Life (in years) | 1 year 10 months 24 days |
Technology transfer | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 74,055 |
License payments | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 6,203 |
Average Remaining Life (in years) | 8 years 8 months 12 days |
Other | |
Finite-Lived Intangible Assets [Line Items] | |
Net Balance | $ 158 |
Average Remaining Life (in years) | 1 year 4 months 24 days |
GOODWILL AND INTANGIBLE ASSET_6
GOODWILL AND INTANGIBLE ASSETS - Schedule of Future Amortization Expense of Finite-Lived Intangible Assets (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2022 | $ 62,606 |
2023 | 61,978 |
2024 | 55,702 |
2025 | 36,426 |
2026 | 36,426 |
Thereafter | 61,459 |
Finite-Lived Intangible Asset | $ 314,597 |
PROPERTY, PLANT AND EQUIPMENT -
PROPERTY, PLANT AND EQUIPMENT - Schedule of Property Plant and Equipment Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,756,035 | $ 1,668,066 |
Accumulated depreciation | (720,574) | (635,595) |
Total property, plant and equipment, net | 1,035,461 | 1,032,471 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 774,923 | 761,560 |
Manufacturing and laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 444,182 | 414,439 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 201,382 | 189,740 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 90,418 | 90,418 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 55,279 | 55,134 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 42,976 | 40,223 |
Land improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 10,132 | 7,412 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 136,743 | $ 109,140 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT - Narrative (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 46.1 | $ 43 | $ 51.8 |
INVENTORY - Schedule of Invento
INVENTORY - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 80,269 | $ 76,673 |
Work-in-process | 415,261 | 308,286 |
Finished goods | 281,139 | 313,589 |
Total inventory | $ 776,669 | $ 698,548 |
INVENTORY - Narrative (Details)
INVENTORY - Narrative (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Inventory | $ 776,669,000 | $ 698,548,000 |
Pre-Launch Valoctocogene Roxaparvovec | ||
Inventory [Line Items] | ||
Inventory | 0 | 0 |
Inventory valuation reserves | $ 24,300,000 | $ 87,200,000 |
SUPPLEMENTAL BALANCE SHEET IN_3
SUPPLEMENTAL BALANCE SHEET INFORMATION - Schedule of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accounts payable and accrued operating expenses | $ 193,003 | $ 191,429 |
Accrued compensation expense | 204,446 | 165,023 |
Accrued rebates payable | 47,987 | 65,526 |
Forward foreign currency exchange contracts | 6,263 | 17,798 |
Accrued royalties payable | 15,215 | 17,155 |
Lease liabilities | 10,464 | 11,754 |
Accrued income taxes | 1,213 | 9,661 |
Value added taxes payable | 1,935 | 9,562 |
Deferred revenue | 6,956 | 152 |
Other | 4,108 | 4,488 |
Total accounts payable and accrued liabilities | $ 491,590 | $ 492,548 |
SUPPLEMENTAL BALANCE SHEET IN_4
SUPPLEMENTAL BALANCE SHEET INFORMATION - Schedule of Estimated Accrued Rebates and Reserve for Cash Discounts (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accrued rebates | |||
Supplemental Balance Sheet Information [Line Items] | |||
Balance at Beginning of Period | $ 65,526 | $ 57,163 | $ 43,116 |
Provision for Current Period Sales | 116,691 | 113,165 | 91,748 |
Payments | (134,230) | (104,802) | (77,701) |
Balance at End of Period | 47,987 | 65,526 | 57,163 |
Reserve for cash discounts | |||
Supplemental Balance Sheet Information [Line Items] | |||
Balance at Beginning of Period | 1,716 | 1,889 | 1,197 |
Provision for Current Period Sales | 16,003 | 17,191 | 15,335 |
Payments | (15,706) | (17,364) | (14,643) |
Balance at End of Period | $ 2,013 | $ 1,716 | $ 1,889 |
FAIR VALUE MEASUREMENTS - Fair
FAIR VALUE MEASUREMENTS - Fair Value of Financial Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Quoted Price in Active Markets For Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets remeasured | $ 0 | $ 0 |
Liabilities remeasured | 0 | 0 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 26,869,000 | 24,449,000 |
Fair value of financial assets, Total | 28,912,000 | 26,864,000 |
Fair value of other current liabilities | 50,275,000 | |
Fair value of other non-current liabilities | 39,096,000 | 80,092,000 |
Fair value of financial liabilities, Total | 89,371,000 | 82,507,000 |
Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 2,043,000 | 2,415,000 |
Fair value of other non-current liabilities | 23,929,000 | 19,962,000 |
Fair Value, Measurements, Recurring | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 48,232,000 | |
Fair value of other non-current liabilities | 15,167,000 | 60,130,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 26,869,000 | 24,449,000 |
Fair value of financial assets, Total | 28,912,000 | 26,864,000 |
Fair value of other current liabilities | 2,043,000 | |
Fair value of other non-current liabilities | 23,929,000 | 19,962,000 |
Fair value of financial liabilities, Total | 25,972,000 | 22,377,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 2,043,000 | 2,415,000 |
Fair value of other non-current liabilities | 23,929,000 | 19,962,000 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 0 | |
Fair value of other non-current liabilities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 0 | 0 |
Fair value of financial assets, Total | 0 | 0 |
Fair value of other current liabilities | 48,232,000 | |
Fair value of other non-current liabilities | 15,167,000 | 60,130,000 |
Fair value of financial liabilities, Total | 63,399,000 | 60,130,000 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | NQDC Plan liability | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 0 | 0 |
Fair value of other non-current liabilities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current liabilities | 48,232,000 | |
Fair value of other non-current liabilities | 15,167,000 | 60,130,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 2,043,000 | 2,415,000 |
Fair value of other non-current assets | 23,929,000 | 19,962,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 2,043,000 | 2,415,000 |
Fair value of other non-current assets | 23,929,000 | 19,962,000 |
Fair Value, Measurements, Recurring | NQDC Plan assets | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other current assets | 0 | 0 |
Fair value of other non-current assets | 0 | 0 |
Fair Value, Measurements, Recurring | Restricted Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 2,940,000 | 4,487,000 |
Fair Value, Measurements, Recurring | Restricted Investments | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | 2,940,000 | 4,487,000 |
Fair Value, Measurements, Recurring | Restricted Investments | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value of other non-current assets | $ 0 | $ 0 |
FAIR VALUE MEASUREMENTS - Liabi
FAIR VALUE MEASUREMENTS - Liabilities Measured at Fair Value Using Level 3 Inputs (Detail) - Contingent Payment $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Contingent consideration, beginning balance | $ 60,130 |
Changes in the fair value of contingent consideration | 8,026 |
Foreign exchange remeasurement of Euro denominated contingent consideration | (4,757) |
Contingent consideration, ending balance | $ 63,399 |
DERIVATIVE INSTRUMENTS AND HE_3
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
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 |
Foreign Currency Derivatives | |
Derivative [Line Items] | |
Unrealized losses reclassified from AOCI to earnings | $ 12.2 |
DERIVATIVE INSTRUMENTS AND HE_4
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Summary of Forward Foreign Currency Exchange Contracts Outstanding (Detail) - Foreign exchange contracts - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Derivatives Designated As Hedging Instruments | Sell | ||
Derivative [Line Items] | ||
Notional amount | $ 740,667 | $ 782,327 |
Derivatives Designated As Hedging Instruments | Purchase | ||
Derivative [Line Items] | ||
Notional amount | 183,256 | 189,540 |
Not Designated as Hedging Instrument | Sell | ||
Derivative [Line Items] | ||
Notional amount | 113,257 | 98,343 |
Not Designated as Hedging Instrument | Purchase | ||
Derivative [Line Items] | ||
Notional amount | $ 31,068 | $ 12,277 |
DERIVATIVE INSTRUMENTS AND HE_5
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Fair Value Carrying Amount of Derivative Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Derivative [Line Items] | ||
Derivative asset, fair value | $ 22,775 | $ 9,500 |
Derivative liability, fair value | 7,641 | 28,818 |
Derivatives Designated As Hedging Instruments | Level 2 | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 22,348 | 9,416 |
Derivative liability, fair value | 6,865 | 28,571 |
Derivatives Designated As Hedging Instruments | Level 2 | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 17,357 | 6,268 |
Derivatives Designated As Hedging Instruments | Level 2 | Other Assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 4,991 | 3,148 |
Derivatives Designated As Hedging Instruments | Level 2 | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 5,487 | 17,551 |
Derivatives Designated As Hedging Instruments | Level 2 | Other Long-Term Liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 1,378 | 11,020 |
Not Designated as Hedging Instrument | Level 2 | Other Current Assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 427 | 84 |
Not Designated as Hedging Instrument | Level 2 | Accounts Payable and Accrued Liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | $ 776 | $ 247 |
DERIVATIVE INSTRUMENTS AND HE_6
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Effect of Derivative Instruments (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Derivative Instruments, Gain (Loss) [Line Items] | |||
Revenue | $ 1,846,275 | $ 1,860,455 | $ 1,704,048 |
Operating expenses as reported | 1,928,616 | 1,897,220 | 1,804,505 |
Product | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Revenue | 1,783,498 | 1,805,861 | $ 1,661,043 |
Derivatives Designated As Hedging Instruments | Operating expenses | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Cash Flow Hedging Gains (Losses) Reclassified into Earnings | (1,650) | (4,942) | |
Derivatives Designated As Hedging Instruments | Product | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Cash Flow Hedging Gains (Losses) Reclassified into Earnings | 196 | 18,122 | |
Not Designated as Hedging Instrument | |||
Derivative Instruments, Gain (Loss) [Line Items] | |||
Gains (Losses) Recognized in Earnings | $ 1,548 | $ 115 |
LEASES - Schedule of ROU Assets
LEASES - Schedule of ROU Assets and Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other assets | Other assets |
Operating | $ 38,198 | $ 46,014 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other assets | Other assets |
Financing | $ 8,220 | $ 11,095 |
Total ROU assets | $ 46,418 | $ 57,109 |
Liabilities: | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and accrued liabilities | Accounts payable and accrued liabilities |
Operating, Current | $ 8,198 | $ 8,889 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accounts payable and accrued liabilities | Accounts payable and accrued liabilities |
Finance, Current | $ 2,266 | $ 2,865 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Operating, Noncurrent | $ 31,882 | $ 40,483 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Finance, Noncurrent | $ 1,960 | $ 4,006 |
Total lease liabilities | $ 44,306 | $ 56,243 |
LEASES - Schedule of Maturities
LEASES - Schedule of Maturities of Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating | ||
2022 | $ 10,193 | |
2023 | 8,493 | |
2024 | 6,490 | |
2025 | 5,802 | |
2026 | 4,304 | |
Thereafter | 11,811 | |
Total lease payments | 47,093 | |
Less: Interest | (7,013) | |
Present value of lease liabilities | 40,080 | |
Financing | ||
2022 | 2,427 | |
2023 | 1,869 | |
2024 | 85 | |
2025 | 41 | |
2026 | 11 | |
Thereafter | 0 | |
Total lease payments | 4,433 | |
Less: Interest | (207) | |
Present value of lease liabilities | 4,226 | |
Total | ||
2022 | 12,620 | |
2023 | 10,362 | |
2024 | 6,575 | |
2025 | 5,843 | |
2026 | 4,315 | |
Thereafter | 11,811 | |
Total lease payments | 51,526 | |
Total lease payments | (7,220) | |
Present value of operating and financing leases | $ 44,306 | $ 56,243 |
LEASES - Schedule of Lease Cost
LEASES - Schedule of Lease Cost (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lease Cost | ||
Total lease costs | $ 17,584 | $ 16,560 |
Operating expenses | ||
Lease Cost | ||
Operating | 13,962 | 12,841 |
Amortization | 3,339 | 3,271 |
Interest expense | $ 283 | $ 448 |
LEASES - Schedule of Other Info
LEASES - Schedule of Other Information (Detail) | Dec. 31, 2021 | Dec. 31, 2020 |
Weighted average remaining lease term (in years): | ||
Operating leases | 6 years 2 months 12 days | 6 years 9 months 18 days |
Financing leases | 1 year 10 months 24 days | 2 years 7 months 6 days |
Weighted Average Discount Rate [Abstract] | ||
Operating leases | 5.00% | 4.90% |
Financing leases | 5.10% | 5.20% |
LEASES - Schedule of Supplement
LEASES - Schedule of Supplemental Cash Flow Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash used in operating activities: | |||
Operating leases | $ 10,664 | $ 10,536 | |
Financing leases | 283 | 450 | |
Cash Flow, Financing Activities, Lessee [Abstract] | |||
Financing leases | 3,039 | 6,918 | $ 5,087 |
Right Of Use Assets Obtained In Exchange For Lease Obligations [Abstract] | |||
Operating leases | 760 | 4,779 | |
Financing leases | $ 462 | $ 3,941 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||
May 31, 2020USD ($)$ / shares | Aug. 31, 2017USD ($)$ / shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Oct. 31, 2018USD ($) | |
Debt Instrument [Line Items] | |||||
Carrying value of equity component | $ 1,100,000,000 | ||||
1.25% Senior Subordinated Convertible Notes Due in May 2027 | |||||
Debt Instrument [Line Items] | |||||
Carrying value of equity component | $ 600,000,000 | $ 600,000,000 | |||
Debt instrument, interest rate, stated percentage, per annum | 1.25% | ||||
Repurchase of note principal amount | 100.00% | ||||
1.25% Senior Subordinated Convertible Notes Due in May 2027 | Senior Subordinated Notes | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, aggregate principal amount | $ 600,000,000 | ||||
Conversion rate of shares | 7.2743 | ||||
Debt instrument, convertible, conversion price, per share (in dollars per share) | $ / shares | $ 137.47 | ||||
Proceeds from issuance of notes | $ 585,800,000 | ||||
Debt Instrument, unamortized discount | $ 13,500,000 | ||||
0.599% Senior Subordinated Convertible Notes Due in August 2024 | |||||
Debt Instrument [Line Items] | |||||
Carrying value of equity component | $ 495,000,000 | $ 495,000,000 | |||
Debt instrument, aggregate principal amount | $ 495,000,000 | ||||
Debt instrument, interest rate, stated percentage, per annum | 0.599% | ||||
Conversion rate of shares | 8.0212 | ||||
Debt instrument, convertible, conversion price, per share (in dollars per share) | $ / shares | $ 124.67 | ||||
Debt instrument percentage of face value | 98.00% | ||||
Principal amount on conversion rate | $ 1,000,000 | ||||
Net proceeds from offering debt | 481,700,000 | ||||
Repurchase of note principal amount | 100.00% | ||||
0.599% Senior Subordinated Convertible Notes Due in August 2024 | Senior Subordinated Notes | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, unamortized discount | 9,900,000 | ||||
1.50% Senior Subordinated Convertible Notes Due in October 2020 | |||||
Debt Instrument [Line Items] | |||||
Principal amount on conversion rate | $ 1,000 | ||||
The 2018 Credit Facility | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 200,000,000 | ||||
Outstanding amount | $ 0 |
DEBT - Summary of Senior Subord
DEBT - Summary of Senior Subordinated Convertible Obligations (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Convertible notes | $ 1,100,000 | |
Convertible Notes, net of unamortized discount and deferred offering costs | 1,079,077 | $ 1,075,145 |
Total convertible debt, net | 1,079,077 | 1,075,145 |
Total fair value of fixed rate convertible debt | $ 1,146,204 | 1,157,804 |
1.25% Senior Subordinated Convertible Notes Due in May 2027 | ||
Debt Instrument [Line Items] | ||
Debt instrument, interest rate, stated percentage, per annum | 1.25% | |
Convertible notes | $ 600,000 | 600,000 |
Unamortized discount net of deferred offering costs | (10,971) | (12,995) |
Convertible Notes, net of unamortized discount and deferred offering costs | 589,029 | 587,005 |
Total fair value of fixed rate convertible debt | $ 625,122 | 627,090 |
0.599% Senior Subordinated Convertible Notes Due in August 2024 | ||
Debt Instrument [Line Items] | ||
Debt instrument, interest rate, stated percentage, per annum | 0.599% | |
Convertible notes | $ 495,000 | 495,000 |
Unamortized discount net of deferred offering costs | (4,952) | (6,860) |
Convertible Notes, net of unamortized discount and deferred offering costs | 490,048 | 488,140 |
Total fair value of fixed rate convertible debt | $ 521,082 | $ 530,714 |
DEBT - Summary of Interest Expe
DEBT - Summary of Interest Expense on Debt (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule Of Interest Expenses [Line Items] | |||
Total interest expense on convertible debt | $ 15,337 | $ 29,309 | $ 23,460 |
Convertible Senior Notes | |||
Schedule Of Interest Expenses [Line Items] | |||
Coupon interest expense | 10,465 | 12,350 | 4,907 |
Accretion of discount on convertible notes | 3,339 | 14,682 | 15,917 |
Amortization of debt issuance costs | 593 | 1,829 | 2,031 |
Total interest expense on convertible debt | $ 14,397 | $ 28,861 | $ 22,855 |
ACCUMULATED OTHER COMPREHENSI_3
ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) - Summary of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income (Loss) and Reclassifications Out of AOCI (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Beginning balance | $ 4,106,002 | $ 3,122,381 | $ 2,967,940 |
Other comprehensive income (loss) before reclassifications | 27,521 | (22,471) | 32,386 |
Less: gain (loss) reclassified from AOCI | (1,454) | 13,732 | 15,853 |
Tax effect | 1,596 | (100) | (1,640) |
Net change in unrealized holding gain (loss), net of tax | 30,571 | (36,303) | 14,893 |
Ending balance | 4,270,740 | 4,106,002 | 3,122,381 |
Unrealized Gains (Losses) on Cash Flow Hedges | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Beginning balance | (20,028) | 16,614 | 7,201 |
Other comprehensive income (loss) before reclassifications | 34,379 | (23,462) | 25,266 |
Less: gain (loss) reclassified from AOCI | (1,454) | 13,180 | 15,853 |
Tax effect | 0 | 0 | 0 |
Net change in unrealized holding gain (loss), net of tax | 35,833 | (36,642) | 9,413 |
Ending balance | 15,805 | (20,028) | 16,614 |
Unrealized Gains (Losses) on Available-for-Sale Debt Securities | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Beginning balance | 3,889 | 3,565 | (1,917) |
Other comprehensive income (loss) before reclassifications | (6,858) | 976 | 7,122 |
Less: gain (loss) reclassified from AOCI | 0 | 552 | 0 |
Tax effect | 1,596 | (100) | (1,640) |
Net change in unrealized holding gain (loss), net of tax | (5,262) | 324 | 5,482 |
Ending balance | (1,373) | 3,889 | 3,565 |
Accumulated Gain Loss from Other | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Beginning balance | 0 | (15) | (13) |
Other comprehensive income (loss) before reclassifications | 0 | 15 | (2) |
Less: gain (loss) reclassified from AOCI | 0 | 0 | 0 |
Tax effect | 0 | 0 | 0 |
Net change in unrealized holding gain (loss), net of tax | 0 | 15 | (2) |
Ending balance | 0 | 0 | (15) |
Accumulated Other Comprehensive Income (Loss) | |||
Accumulated Other Comprehensive Income (Loss) [Roll Forward] | |||
Beginning balance | (16,139) | 20,164 | 5,271 |
Ending balance | $ 14,432 | $ (16,139) | $ 20,164 |
REVENUE, CREDIT CONCENTRATION_3
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Disaggregates of Total Net Product Revenues from External Customers by Product (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue from External Customer [Line Items] | |||
Revenue | $ 1,846,275 | $ 1,860,455 | $ 1,704,048 |
Product | |||
Revenue from External Customer [Line Items] | |||
Revenue | 1,783,498 | 1,805,861 | 1,661,043 |
Vimizim | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 623,145 | 544,257 | 544,345 |
Kuvan | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 285,776 | 457,736 | 463,353 |
Naglazyme | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 380,449 | 391,298 | 374,334 |
Palynziq | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 237,474 | 170,983 | 86,857 |
Brineura | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 128,034 | 110,192 | 71,997 |
Voxzogo | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 5,855 | 0 | 0 |
Firdapse | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 0 | 1,288 | 22,348 |
Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | Marketed by Company | |||
Revenue from External Customer [Line Items] | |||
Revenue | 1,660,733 | 1,675,754 | 1,563,234 |
Aldurazyme | Marketed by Sanofi | |||
Revenue from External Customer [Line Items] | |||
Revenue | 122,765 | 130,107 | 97,809 |
Royalty and Other Revenues | |||
Revenue from External Customer [Line Items] | |||
Revenue | $ 62,777 | $ 54,594 | $ 43,005 |
REVENUE, CREDIT CONCENTRATION_4
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Concentration Risk And Geographic Information [Line Items] | ||
Accounts receivable, net | $ 373,399 | $ 448,351 |
Customer | ||
Concentration Risk And Geographic Information [Line Items] | ||
Accounts receivable, net | $ 67,900 | $ 72,100 |
Geographic Concentration Risk | Net Product Revenue | Minimum | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 10.00% | |
Credit Concentration Risk | Accounts Receivable Balance | Customer One | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 28.00% | 24.00% |
Credit Concentration Risk | Accounts Receivable Balance | Customer Two | ||
Concentration Risk And Geographic Information [Line Items] | ||
Concentration risk, percentage | 16.00% | 22.00% |
REVENUE, CREDIT CONCENTRATION_5
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Disaggregates of Total Net Product Revenues Based on Patient Location (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Revenue | $ 1,846,275 | $ 1,860,455 | $ 1,704,048 |
Product | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 1,783,498 | 1,805,861 | 1,661,043 |
Marketed by Company | Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 1,660,733 | 1,675,754 | 1,563,234 |
Marketed by Company | Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | United States | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 657,700 | 756,863 | 669,171 |
Marketed by Company | Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | Europe | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 558,952 | 498,725 | 485,596 |
Marketed by Company | Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | Latin America | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 191,151 | 205,862 | 218,792 |
Marketed by Company | Vimizim, Kuvan, Naglazyme, Palynziq, Brineura, and Firdapse | Rest of world | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | 252,930 | 214,304 | 189,675 |
Marketed by Sanofi | Aldurazyme | |||
Disaggregation of Revenue [Line Items] | |||
Revenue | $ 122,765 | $ 130,107 | $ 97,809 |
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 | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Customer A, B, & C | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 42.00% | 43.00% | 41.00% |
Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 18.00% | 16.00% | 17.00% |
Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 14.00% | 15.00% | 13.00% |
Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 10.00% | 12.00% | 11.00% |
REVENUE, CREDIT CONCENTRATION_7
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Summary of Non-Monetary Long-Lived Assets by Geographic Region (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue from External Customer [Line Items] | ||
Total long-lived assets | $ 1,081,879 | $ 1,089,580 |
United States | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | 763,847 | 771,286 |
Ireland | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | 304,748 | 300,555 |
Rest of world | ||
Revenue from External Customer [Line Items] | ||
Total long-lived assets | $ 13,284 | $ 17,739 |
EQUITY COMPENSATION PLANS AND_3
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions | Sep. 19, 2019 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based awards, authorized (in shares) | 44.5 | ||||
Span of offering period, in years | 24 months | ||||
Stock-based compensation expense capitalized to inventory | $ 20,000,000 | $ 20,100,000 | $ 20,300,000 | ||
Weighted-average fair value per option granted (in dollars per share) | $ 31.61 | $ 27.47 | $ 36.84 | ||
Total intrinsic value of options exercised | $ 40,700,000 | $ 71,900,000 | $ 32,500,000 | ||
Net tax benefit from stock options exercised | $ 500,000 | ||||
Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share based awards, authorized (in shares) | 7 | ||||
Shares reserved for future issuance (in shares) | 3.1 | ||||
Options to purchase shares of common stock, percentage | 85.00% | ||||
Span of offering period, in years | 2 years | ||||
Maximum percentage of qualified compensation to be used for purchase | 10.00% | ||||
Maximum payroll deductions | $ 25,000 | ||||
Shares issued under the employee stock purchase plan (in shares) | 0.3 | ||||
Unrecognized compensation cost related to unvested awards | $ 17,000,000 | ||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 1 year 4 months 24 days | ||||
Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost related to unvested awards | $ 31,300,000 | ||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 2 years 6 months | ||||
Restricted Stock With Service Based Vesting Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | $ 78.46 | $ 77.13 | $ 91.28 | ||
The total intrinsic value of restricted stock vested and released | $ 117,200,000 | $ 109,900,000 | $ 101,000,000 | ||
Unrecognized compensation cost related to unvested awards | $ 250,600,000 | ||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 2 years 7 months 6 days | ||||
Restricted Stock Unit Awards with Performance-Based Vesting Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | $ 0 | $ 94.53 | |||
Unrecognized compensation cost related to unvested awards | $ 400,000 | ||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 3 months | ||||
Award vesting service period | 3 years | ||||
Percentage of threshold achievement | 75.00% | ||||
Percentage of ceiling achievement | 125.00% | ||||
Restricted Stock Unit Awards with Performance-Based Vesting Conditions | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of, number of shares may earned | 50.00% | ||||
Restricted Stock Unit Awards with Performance-Based Vesting Conditions | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of, number of shares may earned | 200.00% | ||||
Unvested RSUs | Independent Director | Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period, years | 1 year | ||||
Initial equity grant value | $ 400,000 | ||||
Average closing price of common stock, trailing period | 3 months | ||||
Restricted Stock Unit Awards with non-Revenue based Performance Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | $ 78.09 | $ 84.17 | 81 | ||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 1 year 8 months 12 days | ||||
Award vesting service period | 3 years | ||||
Restricted Stock Unit Awards with non-Revenue based Performance Conditions | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares earned range | 50.00% | ||||
Restricted Stock Unit Awards with non-Revenue based Performance Conditions | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares earned range | 200.00% | ||||
Restricted Stock Unit Awards with non-Revenue based Performance Conditions, Probable Of Vesting | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost related to unvested awards | $ 10,900,000 | ||||
Restricted Stock Unit Awards with non-Revenue based Performance Conditions, Not Probable Of Vesting | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost related to unvested awards | $ 10,600,000 | ||||
March 2019 Base Restricted Stock Unit Awards With Market Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | $ 117.52 | $ 143.92 | |||
Unrecognized compensation cost related to unvested awards | $ 14,900,000 | ||||
Unrecognized compensation cost expected to recognized over weighted average period, in years | 1 year 10 months 24 days | ||||
Award vesting service period | 3 years | ||||
Ceiling achievement level | 100.00% | ||||
March 2019 Base Restricted Stock Unit Awards With Market Conditions | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | 112.12 | ||||
Shares earned range | 0.00% | ||||
Annual shareholder return multiplier | 50.00% | ||||
March 2019 Base Restricted Stock Unit Awards With Market Conditions | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted-average fair value per RSU granted (in dollars per share) | $ 217.65 | ||||
Shares earned range | 200.00% | ||||
2017 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares reserved for future issuance (in shares) | 29.6 | ||||
2017 Equity Incentive Plan | Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period, years | 4 years | ||||
Initial time period vesting requirements | 12 months | ||||
Contractual term of stock option awards, years | 10 years | ||||
2017 Equity Incentive Plan | Restricted Stock With Service Based Vesting Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period, years | 4 years | ||||
2017 Equity Incentive Plan | Restricted Stock Unit Awards with Performance-Based Vesting Conditions | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Initial time period vesting requirements | 3 years |
EQUITY COMPENSATION PLANS AND_4
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 197,263 | $ 189,711 | $ 159,865 |
Cost of sales | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | 22,357 | 26,246 | 16,146 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | 67,196 | 61,942 | 56,649 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 107,710 | $ 101,523 | $ 87,070 |
EQUITY COMPENSATION PLANS AND_5
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Summary of Restricted Stock Unit Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted Stock With Service Based Vesting Conditions | |||
Shares | |||
Shares, Non-vested units beginning balance (in shares) | 4,173,124 | ||
Shares, Granted (in shares) | 2,338,270 | ||
Shares, Vested (in shares) | (1,499,408) | ||
Shares, Forfeited (in shares) | (574,474) | ||
Shares, Non-vested units ending balance (in shares) | 4,437,512 | 4,173,124 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, Non-vested units beginning balance (in dollars per share) | $ 83.41 | ||
Grant date fair value (in dollars per share) | 78.46 | $ 77.13 | $ 91.28 |
Weighted Average Grant Date Fair Value, Vested (in dollars per share) | 85.74 | ||
Weighted Average Grant Date Fair Value, Forfeited (in dollars per share) | 80.57 | ||
Weighted Average Grant Date Fair Value, Non-vested units ending balance (in dollars per share) | $ 80.38 | $ 83.41 | |
Restricted Stock Unit Awards with Performance-Based Vesting Conditions | |||
Shares | |||
Shares, Non-vested units beginning balance (in shares) | 99,351 | ||
Shares, Granted (in shares) | 0 | ||
Shares, Vested (in shares) | (68,773) | ||
Shares, Forfeited (in shares) | 0 | ||
Shares, Non-vested units ending balance (in shares) | 30,578 | 99,351 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, Non-vested units beginning balance (in dollars per share) | $ 90.31 | ||
Grant date fair value (in dollars per share) | 0 | 94.53 | |
Weighted Average Grant Date Fair Value, Vested (in dollars per share) | 88.44 | ||
Weighted Average Grant Date Fair Value, Forfeited (in dollars per share) | 0 | ||
Weighted Average Grant Date Fair Value, Non-vested units ending balance (in dollars per share) | $ 94.53 | $ 90.31 | |
Restricted Stock Unit Awards with non-Revenue based Performance Conditions | |||
Shares | |||
Shares, Non-vested units beginning balance (in shares) | 220,665 | ||
Shares, Granted (in shares) | 234,120 | ||
Shares, Vested (in shares) | (8,310) | ||
Shares, Forfeited (in shares) | (40,004) | ||
Shares, Non-vested units ending balance (in shares) | 406,471 | 220,665 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, Non-vested units beginning balance (in dollars per share) | $ 83.83 | ||
Grant date fair value (in dollars per share) | 78.09 | $ 84.17 | $ 81 |
Weighted Average Grant Date Fair Value, Vested (in dollars per share) | 116.83 | ||
Weighted Average Grant Date Fair Value, Forfeited (in dollars per share) | 61.09 | ||
Weighted Average Grant Date Fair Value, Non-vested units ending balance (in dollars per share) | $ 70.82 | $ 83.83 | |
Restricted Stock Unit Awards with Market Conditions | |||
Shares | |||
Shares, Non-vested units beginning balance (in shares) | 220,990 | ||
Shares, Granted (in shares) | 141,610 | ||
Shares, Vested (in shares) | 0 | ||
Shares, Forfeited (in shares) | (11,740) | ||
Shares, Non-vested units ending balance (in shares) | 350,860 | 220,990 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, Non-vested units beginning balance (in dollars per share) | $ 127.23 | ||
Grant date fair value (in dollars per share) | 117.52 | ||
Weighted Average Grant Date Fair Value, Vested (in dollars per share) | 0 | ||
Weighted Average Grant Date Fair Value, Forfeited (in dollars per share) | 114.94 | ||
Weighted Average Grant Date Fair Value, Non-vested units ending balance (in dollars per share) | $ 123.73 | $ 127.23 |
EQUITY COMPENSATION PLANS AND_6
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - TSR-RSUs Valuation Assumptions (Detail) - TSR-RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Grant date fair value (in dollars per share) | $ 117.52 | $ 143.92 | |
Expected volatility, minimum | 24.70% | 21.30% | 21.70% |
Expected volatility, maximum | 161.70% | 159.90% | 155.60% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected term | 2 years 9 months 18 days | 2 years 9 months 18 days | |
Risk-free interest rate | 0.30% | 2.40% | |
Risk-free interest rate, minimum | 0.20% | ||
Risk-free interest rate, maximum | 0.40% | ||
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Grant date fair value (in dollars per share) | $ 112.12 | ||
Expected term | 2 years 6 months | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Grant date fair value (in dollars per share) | $ 217.65 | ||
Expected term | 2 years 9 months 18 days |
EQUITY COMPENSATION PLANS AND_7
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Shares | ||
Shares, Options outstanding beginning balance (in shares) | 6,829,437 | |
Shares, Granted (in shares) | 665,610 | |
Shares, Exercised (in shares) | (892,890) | |
Shares, Expired and forfeited (in shares) | (152,465) | |
Shares, Options outstanding ending balance (in shares) | 6,449,692 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||
Weighted Average Exercise Price, Outstanding beginning balance (in dollars per share) | $ 73.19 | |
Weighted Average Exercise Price, Granted (in dollars per share) | 78.33 | |
Weighted Average Exercise Price, Exercised (in dollars per share) | 34.99 | |
Weighted Average Exercise Price, Expired and forfeited (in dollars per share) | 82.26 | |
Weighted Average Exercise Price, Outstanding ending balance (in dollars per share) | $ 78.79 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||
Shares, Options unvested (in shares) | 1,287,835 | |
Shares, Exercisable (in shares) | 5,161,857 | |
Weighted Average Exercise Price, Options unvested (in dollars per share) | $ 79.82 | |
Weighted Average Exercise Price, Exercisable (in dollars per share) | $ 78.54 | |
Weighted Average Remaining Years, Options outstanding | 4 years 9 months 18 days | |
Weighted Average Remaining Years, Options unvested at December 31, 2020 | 8 years 7 months 6 days | |
Weighted Average Remaining Years, Exercisable at December 31, 2020 | 3 years 9 months 18 days | |
Aggregate Intrinsic Value, Options outstanding | $ 80,857 | $ 119,607 |
Aggregate Intrinsic Value, Options unvested at December 31, 2020 | 12,334 | |
Aggregate Intrinsic Value, Exercisable at December 31, 2020 | $ 68,523 | |
Closing price of common stock (in dollars per share) | $ 88.35 |
EQUITY COMPENSATION PLANS AND_8
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Stock Option Valuation Assumptions (Detail) - Stock Option | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 39.40% | 36.50% | 37.10% |
Expected volatility, maximum | 41.60% | 42.20% | 37.40% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 0.70% | 0.30% | 2.20% |
Risk-free interest rate, maximum | 1.30% | 1.70% | 3.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 4 years 8 months 12 days | 4 years 7 months 6 days | 4 years 7 months 6 days |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 6 years | 5 years 10 months 24 days | 5 years 9 months 18 days |
EQUITY COMPENSATION PLANS AND_9
EQUITY COMPENSATION PLANS AND STOCK-BASED COMPENSATION - Employee Stock Purchase Plan Valuation Assumptions (Detail) - Employee Stock Purchase Plan | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 23.70% | 30.60% | 27.70% |
Expected volatility, maximum | 69.20% | 69.20% | 35.00% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Risk-free interest rate, minimum | 0.04% | 0.10% | 1.20% |
Risk-free interest rate, maximum | 2.40% | 2.80% | 2.80% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 6 months | 6 months | 6 months |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 2 years | 2 years | 2 years |
OTHER EMPLOYEE BENEFITS - Addit
OTHER EMPLOYEE BENEFITS - Additional Information (Detail) - BioMarin Retirement Savings Plan - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Company's contribution to match employees contribution | 100.00% | ||
Employer contribution of maximum percentage over employee's annual compensation | 6.00% | ||
Company's contribution from employment commencement | $ 31.6 | $ 26.4 | $ 28.5 |
INCOME TAXES - Benefit from Inc
INCOME TAXES - Benefit from Income Taxes Based Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
U.S. Source | $ (259,258) | $ (162,939) | $ (182,112) |
Non-U.S. Source | 183,908 | 120,617 | 87,301 |
LOSS BEFORE INCOME TAXES | $ (75,350) | $ (42,322) | $ (94,811) |
INCOME TAXES - Components of Pr
INCOME TAXES - Components of Provision for (Benefit from) Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Benefit from income taxes | |||
Federal | $ (2,038) | $ (14,758) | $ 5,127 |
State and local | 1,339 | 1,201 | 1,331 |
Foreign | 5,037 | 1,042 | 5,339 |
Current income tax expense, total | 4,338 | (12,515) | 11,797 |
Provision for (benefit from) deferred income taxes: | |||
Federal | (29,895) | (45,038) | (58,311) |
State and local | (1,230) | (5,321) | (5,394) |
Foreign | 15,517 | (838,548) | (19,055) |
Deferred income tax expense (benefit), total | (15,608) | (888,907) | (82,760) |
Benefit from income taxes | $ (11,270) | $ (901,422) | $ (70,963) |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | |
Income Tax Contingency [Line Items] | |||
Deferred tax assets | $ 1,449,075 | $ 1,432,150 | |
Unrecognized tax benefits that would affect the effective tax rate if recognized | 196,700 | ||
Undistributed earnings of foreign subsidiaries | $ 16,300 | ||
Ireland | |||
Income Tax Contingency [Line Items] | |||
Deferred tax assets | $ 835,100 | ||
Minimum | |||
Income Tax Contingency [Line Items] | |||
Income tax statute of limitations period | 3 years | ||
Maximum | |||
Income Tax Contingency [Line Items] | |||
Income tax statute of limitations period | 5 years | ||
State | |||
Income Tax Contingency [Line Items] | |||
Research credit carry forward | $ 137,300 |
INCOME TAXES - Schedule of Effe
INCOME TAXES - Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Contingency [Line Items] | |||
Federal statutory income tax benefit | $ (15,824) | $ (8,888) | $ (19,911) |
State and local taxes | 509 | (3,264) | (2,784) |
Orphan Drug & General Business Credit | (29,363) | (44,114) | (43,124) |
Stock compensation expense | 7,859 | (1,101) | 239 |
Changes in the fair value of contingent consideration | 0 | 0 | (1,804) |
Foreign Source Income Subject to U.S. Tax | 16,878 | 6,266 | (52) |
Foreign tax rate differential | (16,971) | (16,238) | (30,639) |
Section 162(m) limitation | 6,304 | 9,571 | 8,294 |
Tax Reserves | 15,530 | 2,166 | 12,123 |
Intra-entity transfer of assets | (3,920) | (852,338) | 0 |
CARES Act carryback claim | 0 | (2,201) | 0 |
Valuation allowance/deferred benefit | 6,821 | 6,876 | 7,827 |
Other | 907 | 1,843 | (1,132) |
Benefit from income taxes | (11,270) | (901,422) | (70,963) |
Valuation allowance | 109,176 | $ 93,075 | |
Dutch | |||
Income Tax Contingency [Line Items] | |||
Valuation allowance | $ 9,300 | $ 29,600 |
INCOME TAXES - Components of Co
INCOME TAXES - Components of Company Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Tax Assets, Gross [Abstract] | ||
Net operating loss carryforwards | $ 25,936 | $ 30,718 |
Tax credit carryforwards | 563,022 | 532,394 |
Accrued expenses, reserves, and prepaids | 72,759 | 66,889 |
Intangible assets | 875,311 | 873,575 |
Stock-based compensation | 50,910 | 47,011 |
Lease liabilities | 7,422 | 8,991 |
Inventory | 25,169 | 32,012 |
Other | 1,943 | 454 |
Valuation allowance | (109,176) | (93,075) |
Total deferred tax assets | 1,513,296 | 1,498,969 |
Deferred Tax Liabilities, Gross [Abstract] | ||
Joint venture basis difference | (1,665) | (1,164) |
Acquired intangibles | (1,250) | (1,364) |
Deferred revenue | 0 | (1,517) |
ROU assets | (6,808) | (8,280) |
Property, plant and equipment | (54,498) | (54,682) |
Total deferred tax liabilities | (64,221) | (67,007) |
Net deferred tax assets | $ 1,449,075 | $ 1,431,962 |
INCOME TAXES - Summary of Expir
INCOME TAXES - Summary of Expiration of not Utilized Net Operating Loss and Tax Credit Carryforwards (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Federal | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 4,147 |
Federal R&D and orphan drug credit carryforwards | 592,710 |
State | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | 230,500 |
Federal R&D and orphan drug credit carryforwards | 137,300 |
Dutch | Foreign | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 48,903 |
INCOME TAXES - Reconciliation o
INCOME TAXES - Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of period | $ 182,564 | $ 168,748 |
Additions based on tax positions related to the current year | 23,499 | 16,481 |
(Deletions) Additions for tax positions of prior years | (786) | (2,527) |
Lapse of statute of limitations | (182) | (138) |
Balance at end of period | $ 205,095 | $ 182,564 |
NET INCOME (LOSS) PER COMMON _3
NET INCOME (LOSS) PER COMMON SHARE - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | |||
Net income (loss), basic | $ (64,080) | $ 859,100 | $ (23,848) |
Add: Interest on convertible notes | 0 | 8,313 | 0 |
Net income (loss), diluted | $ (64,080) | $ 867,413 | $ (23,848) |
Denominator: | |||
Weighted average common shares outstanding, basic (in shares) | 182,852 | 180,804 | 179,039 |
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Weighted average common shares outstanding, diluted (in shares) | 182,852 | 191,678 | 179,039 |
Net loss per common share, basic (in usd per share) | $ (0.35) | $ 4.75 | $ (0.13) |
Net loss per common share, diluted (in usd per share) | $ (0.35) | $ 4.53 | $ (0.13) |
Stock Option | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 1,543 | 0 |
Common stock issuable under the 2027 Notes | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 2,874 | 0 |
Common stock issuable under the 2024 Notes | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 3,970 | 0 |
Unvested RSUs | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 1,938 | 0 |
Common stock potentially issuable for ESPP purchases | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 353 | 0 |
The Company's common stock held by the NQDC | |||
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract] | |||
Effect of dilutive securities | 0 | 196 | 0 |
NET INCOME (LOSS) PER COMMON _4
NET INCOME (LOSS) PER COMMON SHARE - Anti-Dilutive Common Stock Excluded From Computation of Basic and Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 20,785 | 7,836 | 19,965 |
Stock Option | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 6,450 | 5,287 | 7,264 |
Common stock issuable under the 2027 Notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 4,365 | 0 | 0 |
Common stock issuable under the 2024 Notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 3,970 | 0 | 3,970 |
Common stock issuable under the 2020 Notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 0 | 0 | 3,983 |
Unvested RSUs | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 5,225 | 2,235 | 3,956 |
Common stock potentially issuable for ESPP purchases | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 594 | 314 | 587 |
The Company's common stock held by the NQDC | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential shares of common stock excluded from computation of earnings (loss) per share as they are anti-dilutive (in shares) | 181 | 0 | 205 |
NET INCOME (LOSS) PER COMMON _5
NET INCOME (LOSS) PER COMMON SHARE - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Oct. 15, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Earnings Per Share [Line Items] | ||||
Debt conversion, principal cash settlement amount | $ 0 | $ 374,991 | $ 0 | |
Convertible Senior Notes Due 2020 | ||||
Earnings Per Share [Line Items] | ||||
Debt instrument, interest rate, stated percentage, per annum | 1.50% | |||
Debt conversion, principal cash settlement amount | $ 375,000 | |||
Debt instrument, convertible, conversion price, per share (in dollars per share) | $ 94.15 | $ 94.15 |
LICENSE AND COLLABORATION AGR_2
LICENSE AND COLLABORATION AGREEMENTS - Additional Information (Detail) $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | |||||
Oct. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2021EUR (€) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2021EUR (€) | Mar. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 1,846,275 | $ 1,860,455 | $ 1,704,048 | ||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 788,500 | ||||||
Firdapse | Disposal Group, Disposed of by Sale, Not Discontinued Operations | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Royalties on net product sales | 7.00% | ||||||
Royalties on net product sales | 10.00% | ||||||
Merck Serono | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | 68,100 | ||||||
Exclusive Licensing Agreement For Tralesinidase Alfa | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 3,000 | ||||||
Investment in equity | $ 12,600 | ||||||
Exclusive Licensing Agreement For Tralesinidase Alfa | Variable Interest Entity, Not Primary Beneficiary | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Minority equity ownership | 15.00% | ||||||
A&R Kuvan Agreement | Merck Serono | Maximum | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Business acquisition contingent consideration potential cash payments upon achievement of sales milestone | € | € 60 | ||||||
Pegvaliase Agreement | Merck Serono | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Business acquisition, cash paid | € | € 125 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2021 | Jun. 30, 2020 | Dec. 31, 2021 | |
Commitments and Contingencies [Line Items] | |||
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 788.5 | ||
Purchase commitment | $ 133.3 | $ 133.3 | |
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 | $ 389 | $ 225 |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) $ in Millions | Feb. 09, 2022USD ($) |
Subsequent Event | |
Subsequent Event [Line Items] | |
Proceeds from sale of voucher | $ 110 |