Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 000-26727 | |
Entity Registrant Name | BioMarin Pharmaceutical Inc | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 68-0397820 | |
Entity Address, Address Line One | 770 Lindaro Street | |
Entity Address, City or Town | San Rafael | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94901 | |
City Area Code | 415 | |
Local Phone Number | 506-6700 | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Trading Symbol | BMRN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 188,368,171 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001048477 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 785,414 | $ 724,531 | |
Short-term investments | 340,431 | 567,006 | |
Accounts receivable, net | 572,498 | 461,316 | |
Inventory | 1,032,159 | 894,083 | |
Other current assets | 224,806 | 104,521 | |
Total current assets | 2,955,308 | 2,751,457 | |
Noncurrent assets: | |||
Long-term investments | 548,002 | 333,835 | |
Property, plant and equipment, net | 1,067,156 | 1,073,366 | |
Intangible assets, net | 302,476 | 338,569 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,523,953 | 1,505,412 | |
Other assets | 165,069 | 176,236 | |
Total assets | 6,758,163 | 6,375,074 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 669,825 | 572,959 | |
Short-term convertible debt, net | 493,398 | 0 | |
Short-term contingent consideration | 0 | 15,925 | |
Total current liabilities | 1,163,223 | 588,884 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 592,586 | 1,083,019 | |
Other long-term liabilities | 105,457 | 100,015 | |
Total liabilities | 1,861,266 | 1,771,918 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 188,339,482 and 186,250,719 shares issued and outstanding, respectively | 188 | 186 | |
Additional paid-in capital | 5,542,774 | 5,404,895 | |
Company common stock held by the Nonqualified Deferred Compensation Plan (the NQDC) | (10,393) | (8,859) | |
Accumulated other comprehensive income (loss) | 6,257 | (3,867) | |
Accumulated deficit | (641,929) | (789,199) | |
Total stockholders’ equity | 4,896,897 | 4,603,156 | [2] |
Total liabilities and stockholders’ equity | $ 6,758,163 | $ 6,375,074 | |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | 188,339,482 | 186,250,719 |
Common stock, shares outstanding (in shares) | 188,339,482 | 186,250,719 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
REVENUES: | ||||
Total revenues | $ 581,329 | $ 505,344 | $ 1,773,019 | $ 1,558,501 |
OPERATING EXPENSES: | ||||
Cost of sales | 124,745 | 116,288 | 379,376 | 356,379 |
Research and development | 191,314 | 157,829 | 540,523 | 476,855 |
Selling, general and administrative | 223,928 | 216,816 | 662,267 | 608,270 |
Intangible asset amortization and contingent consideration | 15,681 | 16,828 | 46,975 | 50,935 |
Gain on sale of nonfinancial assets, net | 0 | 0 | 0 | (108,000) |
Total operating expenses | 555,668 | 507,761 | 1,629,141 | 1,384,439 |
INCOME (LOSS) FROM OPERATIONS | 25,661 | (2,417) | 143,878 | 174,062 |
Interest income | 15,740 | 4,999 | 40,295 | 9,324 |
Interest expense | (3,779) | (4,679) | (11,237) | (12,344) |
Other income (expense), net | 4,047 | 193 | (3,700) | (3,908) |
INCOME (LOSS) BEFORE INCOME TAXES | 41,669 | (1,904) | 169,236 | 167,134 |
Provision for income taxes | 1,291 | 4,748 | 21,966 | 25,324 |
NET INCOME (LOSS) | $ 40,378 | $ (6,652) | $ 147,270 | $ 141,810 |
EARNINGS (LOSS) PER SHARE, BASIC (in dollars per share) | $ 0.21 | $ (0.04) | $ 0.78 | $ 0.77 |
EARNINGS (LOSS) PER SHARE, DILUTED (in dollars per share) | $ 0.21 | $ (0.04) | $ 0.77 | $ 0.75 |
Weighted average common shares outstanding, basic (in shares) | 188,219 | 185,597 | 187,617 | 185,009 |
Weighted average common shares outstanding, diluted (in shares) | 191,173 | 185,597 | 195,042 | 192,252 |
COMPREHENSIVE INCOME | $ 65,252 | $ 5,625 | $ 157,394 | $ 158,127 |
Net product revenues | ||||
REVENUES: | ||||
Total revenues | 568,266 | 493,348 | 1,739,390 | 1,516,533 |
Royalty and other revenues | ||||
REVENUES: | ||||
Total revenues | $ 13,063 | $ 11,996 | $ 33,629 | $ 41,968 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock: | Additional paid-in capital: | Company common stock held by the NQDC: | Accumulated other comprehensive income (loss): | Accumulated Deficit: | |||
Shares of common stock, beginning balances (in shares) at Dec. 31, 2021 | [1] | 183,913,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 1,912,000 | ||||||||
Shares of common stock, ending balances (in shares) at Sep. 30, 2022 | 185,825,000 | ||||||||
Beginning balances at Dec. 31, 2021 | [1] | $ 4,265,670 | $ 184 | $ 5,191,502 | $ (9,689) | $ 14,432 | $ (930,759) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 2 | (8,306) | |||||||
Stock-based compensation | 153,021 | ||||||||
Common stock held by the NQDC | (364) | 364 | |||||||
Other comprehensive income | 16,317 | 16,317 | |||||||
Net income (loss) | 141,810 | 141,810 | |||||||
Ending balances at Sep. 30, 2022 | 4,568,514 | $ 186 | 5,335,853 | (9,325) | 30,749 | (788,949) | |||
Shares of common stock, beginning balances (in shares) at Jun. 30, 2022 | [1] | 185,453,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 372,000 | ||||||||
Shares of common stock, ending balances (in shares) at Sep. 30, 2022 | 185,825,000 | ||||||||
Beginning balances at Jun. 30, 2022 | [1] | 4,499,737 | $ 186 | 5,272,666 | (9,290) | 18,472 | (782,297) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 6,847 | ||||||||
Stock-based compensation | 56,305 | ||||||||
Common stock held by the NQDC | 35 | (35) | |||||||
Other comprehensive income | 12,277 | 12,277 | |||||||
Net income (loss) | (6,652) | (6,652) | |||||||
Ending balances at Sep. 30, 2022 | $ 4,568,514 | $ 186 | 5,335,853 | (9,325) | 30,749 | (788,949) | |||
Shares of common stock, beginning balances (in shares) at Dec. 31, 2022 | 186,250,719 | 186,251,000 | [1] | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 2,088,000 | ||||||||
Shares of common stock, ending balances (in shares) at Sep. 30, 2023 | 188,339,482 | 188,339,000 | |||||||
Beginning balances at Dec. 31, 2022 | [1] | $ 4,603,156 | [2] | $ 186 | 5,404,895 | (8,859) | (3,867) | (789,199) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 2 | (19,778) | |||||||
Stock-based compensation | 156,123 | ||||||||
Common stock held by the NQDC | 1,534 | (1,534) | |||||||
Other comprehensive income | 10,124 | 10,124 | |||||||
Net income (loss) | 147,270 | 147,270 | |||||||
Ending balances at Sep. 30, 2023 | $ 4,896,897 | $ 188 | 5,542,774 | (10,393) | 6,257 | (641,929) | |||
Shares of common stock, beginning balances (in shares) at Jun. 30, 2023 | [1] | 188,152,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 187,000 | ||||||||
Shares of common stock, ending balances (in shares) at Sep. 30, 2023 | 188,339,482 | 188,339,000 | |||||||
Beginning balances at Jun. 30, 2023 | [1] | $ 4,782,827 | $ 188 | 5,493,956 | (10,393) | (18,617) | (682,307) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | (1,827) | ||||||||
Stock-based compensation | 50,645 | ||||||||
Other comprehensive income | 24,874 | 24,874 | |||||||
Net income (loss) | 40,378 | 40,378 | |||||||
Ending balances at Sep. 30, 2023 | $ 4,896,897 | $ 188 | $ 5,542,774 | $ (10,393) | $ 6,257 | $ (641,929) | |||
[1]The beginning balances for the nine-month periods were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 27, 2023.[2] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 147,270 | $ 141,810 |
Adjustments to reconcile net income to net cash used in operating activities: | ||
Depreciation and amortization | 77,525 | 77,416 |
Non-cash interest expense | 3,198 | 3,089 |
Amortization of premium (accretion of discount) on investments | (6,781) | 3,741 |
Stock-based compensation | 152,244 | 149,574 |
Gain on sale of nonfinancial assets, net | 0 | (108,000) |
Loss on equity investment | 12,650 | 0 |
Deferred income taxes | (20,137) | (743) |
Unrealized foreign exchange loss (gain) | 5,454 | (16,075) |
Non-cash changes in the fair value of contingent consideration | 0 | 2,243 |
Other | (224) | (700) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (131,940) | (53,752) |
Inventory | (97,948) | (27,419) |
Other current assets | (59,389) | (8,558) |
Other assets | (20,812) | 12,140 |
Accounts payable and other short-term liabilities | 56,333 | (2,398) |
Other long-term liabilities | 14,333 | (3,252) |
Net cash provided by operating activities | 131,776 | 169,116 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (67,774) | (85,271) |
Maturities and sales of investments | 751,677 | 477,244 |
Purchases of investments | (727,043) | (457,382) |
Proceeds from sale of nonfinancial assets | 0 | 110,000 |
Purchase of intangible assets | (3,141) | (9,910) |
Net cash provided by (used in) investing activities | (46,281) | 34,681 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercises of awards under equity incentive plans | 54,548 | 43,866 |
Taxes paid related to net share settlement of equity awards | (72,399) | (50,696) |
Payments of contingent consideration | (9,475) | (21,054) |
Principal repayments of financing leases | (2,241) | (1,635) |
Net cash used in financing activities | (29,567) | (29,519) |
Effect of exchange rate changes on cash | 4,955 | (39) |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 60,883 | 174,239 |
Cash and cash equivalents: | ||
Beginning of period | 724,531 | 587,276 |
End of period | 785,414 | 761,515 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | ||
Cash paid for interest | 6,640 | 6,575 |
Cash paid for income taxes | 51,687 | 13,425 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Increase (decrease) in accounts payable and accrued liabilities related to fixed assets | 7,977 | (5,240) |
Increase (decrease) in accounts payable and accrued liabilities related to intangible assets | $ 6,449 | $ (224) |
BUSINESS OVERVIEW AND SIGNIFICA
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES Nature of Operations Founded in 1997, BioMarin Pharmaceutical Inc. (the Company or BioMarin) is a global biotechnology company dedicated to transforming lives through genetic discovery. The Company develops and commercializes targeted therapies that address the root cause of genetic conditions. The Company's robust research and development (R&D) capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders. The Company's distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. Basis of Presentation These Condensed Consolidated Financial Statements have been prepared pursuant to U.S. generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by U.S. GAAP for complete financial statements, although management believes that the disclosures herein are adequate to ensure that the information presented is not misleading. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2023 or any other period. Use of Estimates U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. Management performed an evaluation of the Company’s activities through the date of filing of this Quarterly Report on Form 10-Q and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements. Significant Accounting Policies There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2023, as compared to the significant accounting policies disclosed in Note 1 – Business Overview and Significant Accounting Policies to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Recent Accounting Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the nine months ended September 30, 2023, as compared to the recent accounting pronouncements described in Note 1 to the Company’s Consolidated Financial Statements of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, that the Company believes are of significance or potential significance to the Company. |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS All marketable securities were classified as available-for-sale as of September 30, 2023 and December 31, 2022. The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category for each period presented: September 30, 2023 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 451,294 $ — $ — $ 451,294 $ 451,294 $ — $ — Level 2: Money market instruments 291,425 — — 291,425 291,425 — — Corporate debt securities 563,598 31 (6,135) 557,494 731 217,306 339,457 U.S. government agency securities 281,045 4 (3,023) 278,026 29,981 112,714 135,331 Commercial paper 21,864 — (4) 21,860 11,983 9,877 — Asset-backed securities 74,168 26 (446) 73,748 — 534 73,214 Subtotal 1,232,100 61 (9,608) 1,222,553 334,120 340,431 548,002 Total $ 1,683,394 $ 61 $ (9,608) $ 1,673,847 $ 785,414 $ 340,431 $ 548,002 December 31, 2022 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 463,248 $ — $ — $ 463,248 $ 463,248 $ — $ — Level 2: Money market instruments 248,933 — — 248,933 248,933 — — Corporate debt securities 504,984 34 (11,541) 493,477 1,881 299,153 192,443 U.S. government agency securities 312,720 45 (3,771) 308,994 — 229,846 79,148 Commercial paper 48,103 11 (22) 48,092 10,469 37,623 — Asset-backed securities 63,151 69 (592) 62,628 — 384 62,244 Subtotal 1,177,891 159 (15,926) 1,162,124 261,283 567,006 333,835 Total $ 1,641,139 $ 159 $ (15,926) $ 1,625,372 $ 724,531 $ 567,006 $ 333,835 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one As of September 30, 2023, the Company had the ability and intent to hold all investments that were in an unrealized loss position until maturity. The Company considered its intent and ability to hold the securities until recovery of amortized cost basis, the extent to which fair value is less than amortized cost basis, conditions specifically related to the security’s industry and geography, payment structure and history and changes to the ratings (if any) in determining that the decline in fair value compared to carrying value is not related to a credit loss. The Company has certain investments in non-marketable equity securities, measured using unobservable valuation inputs and remeasured on a nonrecurring basis, which are collectively considered strategic investments. As of September 30, 2023 and December 31, 2022, the fair value of the Company’s strategic investments was $11.2 million and $23.9 million, respectively. These investments were recorded to Other Assets in the Company’s Condensed Consolidated Balance Sheets. In the first quarter of 2023, based on new developments, the Company concluded that factors existed indicating it would no longer realize a $12.6 million equity investment in its non-marketable securities. The loss on the equity investment due to impairment was recorded to Other Income (Expense), Net on the Company’s Condensed Consolidated Statements of Comprehensive Income. See Note 1 - Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 for additional information related to the Company’s non-marketable securities policy. |
SUPPLEMENTAL FINANCIAL STATEMEN
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION | SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION Supplemental Balance Sheet Information Inventory consisted of the following: September 30, December 31, Raw materials $ 142,133 $ 131,071 Work-in-process 518,893 410,656 Finished goods 371,133 352,356 Total inventory $ 1,032,159 $ 894,083 Property, Plant and Equipment, Net consisted of the following: September 30, December 31, Property, plant and equipment, gross $ 1,918,609 $ 1,875,511 Accumulated depreciation (851,453) (802,145) Total property, plant and equipment, net $ 1,067,156 $ 1,073,366 Depreciation expense, net of amounts capitalized into inventory, for the three and nine months ended September 30, 2023 was $9.9 million and $29.6 million, respectively. Depreciation expense, net of amounts capitalized into inventory, for the three and nine months ended September 30, 2022 was $8.7 million and $29.9 million, respectively. Intangible Assets, Net consisted of the following: September 30, December 31, Finite-lived intangible assets $ 701,793 $ 690,871 Accumulated amortization (399,317) (352,302) Net carrying value $ 302,476 $ 338,569 Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, Accounts payable and accrued operating expenses $ 301,369 $ 231,238 Accrued compensation expense 175,183 207,573 Accrued rebates payable 103,379 72,654 Accrued litigation expense 39,000 — Accrued royalties payable 12,293 13,306 Accrued income taxes 11,273 16,213 Foreign currency exchange forward contracts 10,584 12,601 Lease liability 9,324 10,375 Other 7,420 8,999 Total accounts payable and accrued liabilities $ 669,825 $ 572,959 Reorganization Plan On October 6, 2022, the Company announced a plan to simplify its organization that included a planned reduction in force of approximately 120 employees (representing approximately 4% of its global workforce), which was substantially completed as of December 31, 2022. The Company recorded costs of $23.0 million in 2022 and negligible adjustments in 2023 related to one-time severance and employee termination benefits within Selling, General and Administrative in the Company’s Condensed Consolidated Statements of Comprehensive Income. As of December 31, 2022 , $11.1 million was include d in Accounts Payable and Accrued Liabilities on the Company’s Consolidated Balance Sheet. As of September 30, 2023 , substantially all costs have been paid . |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company measures certain financial assets and liabilities at fair value in accordance with the policy described in Note 1 – Business Overview and Significant Accounting Policies to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Condensed Consolidated Financial Statements that are remeasured on a recurring basis as of September 30, 2023 and December 31, 2022. Other than the Company’s fixed-rate convertible debt disclosed in Note 6 – Debt , there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of September 30, 2023 or December 31, 2022. Fair Value Measurements as of September 30, 2023 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 1,836 $ — $ 1,836 Other assets: NQDC Plan assets 25,541 — 25,541 Restricted investments (1) 2,361 — 2,361 Total other assets 27,902 — 27,902 Total assets $ 29,738 $ — $ 29,738 Liabilities: Current liabilities: NQDC Plan liability $ 1,836 $ — $ 1,836 Other long-term liabilities: NQDC Plan liability 25,541 — 25,541 Total liabilities $ 27,377 $ — $ 27,377 Fair Value Measurements as of December 31, 2022 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,654 $ — $ 2,654 Other assets: NQDC Plan assets 19,867 — 19,867 Restricted investments (1) 2,429 — 2,429 Total other assets 22,296 — 22,296 Total assets $ 24,950 $ — $ 24,950 Liabilities: Current liabilities: NQDC Plan liability $ 2,654 $ — $ 2,654 Contingent consideration — 15,925 15,925 Total current liabilities 2,654 15,925 18,579 Other long-term liabilities: NQDC Plan liability 19,867 — 19,867 Total liabilities $ 22,521 $ 15,925 $ 38,446 (1) The restricted investments as of September 30, 2023 and December 31, 2022 secure the Company's irrevocable standby letters of credit obtained in connection with certain commercial agreements. There were no transfers between levels during the three and nine months ended September 30, 2023. Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following table represents a roll-forward of contingent consideration. Contingent consideration as of December 31, 2022 $ 15,925 Milestone payments to Ares Trading S.A. (Merck Serono) (16,255) Realized foreign exchange loss on settlement of contingent consideration 330 Contingent consideration as of September 30, 2023 $ — |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIESThe Company uses foreign currency exchange forward contracts (forward contracts) to protect against the impact of changes in the value of forecasted foreign currency cash flows resulting from revenues and operating expenses denominated in currencies other than the U.S. Dollar (USD), primarily the Euro. Certain of these forward contracts are designated as cash flow hedges and have maturities of up to two years. The Company also enters into forward contracts to manage foreign exchange risk related to asset or liability positions denominated in currencies other than USD. Such forward contracts are considered to be economic hedges, are not designated as hedging instruments and have maturities of up to six months. The Company does not use derivative instruments for speculative trading purposes. The Company is exposed to counterparty credit risk on its derivatives. The Company has established and maintains strict counterparty credit guidelines and enters into hedging agreements with financial institutions that are investment grade or better to minimize the Company’s exposure to potential defaults. The Company is not required to pledge collateral under these agreements. The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Forward Contracts September 30, December 31, Derivatives designated as hedging instruments: Sell $ 988,286 $ 808,635 Purchase $ 180,560 $ 177,393 Derivatives not designated as hedging instruments: Sell $ 301,825 $ 218,903 Purchase $ 6,517 $ 6,785 The fair value carrying amounts of the Company’s derivatives, which are classified as Level 2 within the fair value hierarchy, were as follows: Balance Sheet Location September 30, December 31, Derivatives designated as hedging instruments: Asset Derivatives Other current assets $ 21,267 $ 19,464 Other assets 7,620 2,059 Subtotal $ 28,887 $ 21,523 Liability Derivatives Accounts payable and accrued liabilities $ 9,918 $ 12,130 Other long-term liabilities 3,623 1,074 Subtotal $ 13,541 $ 13,204 Derivatives not designated as hedging instruments: Asset Derivatives Other current assets $ 5,210 $ 1,472 Liability Derivatives Accounts payable and accrued liabilities $ 666 $ 471 Total Derivatives Assets $ 34,097 $ 22,995 Total Derivatives Liabilities $ 14,207 $ 13,675 For additional discussion of fair value measurements, see Note 1 – Business Overview and Significant Accounting Policies to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The following tables summarize the impact of gains and losses from the Company's derivatives on its Condensed Consolidated Statements of Comprehensive Income for the periods presented. Three Months Ended September 30, 2023 2022 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (4,636) $ 15,280 Operating expenses $ 908 $ (3,936) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 6,559 $ 6,572 Nine Months Ended September 30, 2023 2022 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (489) $ 26,779 Operating expenses $ 426 $ (7,115) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 3,165 $ 12,812 As of September 30, 2023, the Company expects to reclassify unrealized gains of $9.6 million from Accumulated Other Comprehensive Income (AOCI) to earnings as the forecasted revenues and operating expense transactions occur over the next twelve months. For additional discussion of balances in AOCI see Note 7 – Accumulated Other Comprehensive Income . |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Notes As of September 30, 2023, the Company had outstanding fixed-rate notes with varying maturities for an undiscounted aggregate principal amount of $1.1 billion (collectively, the Notes). The Notes are senior subordinated convertible obligations, and interest is payable in arrears, semi-annually. The following table summarizes information regarding the Company’s convertible debt: September 30, December 31, 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (7,414) (8,941) 2027 Notes, net 592,586 591,059 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (1,602) (3,040) 2024 Notes, net (1) 493,398 491,960 Total convertible debt, net $ 1,085,984 $ 1,083,019 Fair value of fixed-rate convertible debt (2) : 2027 Notes $ 595,278 $ 647,370 2024 Notes 480,417 526,230 Total fair value of fixed-rate convertible debt $ 1,075,695 $ 1,173,600 (1) As the 2024 Notes mature in August 2024, the outstanding principal of the 2024 Notes is classified as a current liability as of September 30, 2023. (2) The fair value of the Company’s fixed-rate convertible debt is based on open-market trades and is classified as Level 1 in the fair value hierarchy. For additional discussion of fair value measurements, see Note 1 – Business Overview and Significant Accounting Policies to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Coupon interest expense $ 2,616 $ 2,616 $ 7,849 $ 7,849 Accretion of discount on convertible notes 841 838 2,519 2,511 Amortization of debt issuance costs 148 148 445 445 Total interest expense on convertible debt $ 3,605 $ 3,602 $ 10,813 $ 10,805 See Note 10 - Debt to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 for additional information related to the Company’s convertible debt. Revolving Credit Facility In October 2018, the Company entered into an unsecured revolving credit facility of up to $200.0 million which included a letter of credit subfacility and a swingline loan subfacility. The credit facility was intended to finance ongoing working capital needs and for other general corporate purposes. In May 2021, the credit facility was amended to extend the original maturity date from October 19, 2021 to May 28, 2024. The credit facility was terminated on August 4, 2023 and there were no amounts outstanding under the credit facility as of September 30, 2023. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
ACCUMULATED OTHER COMPREHENSIVE INCOME | ACCUMULATED OTHER COMPREHENSIVE INCOME The following tables summarize changes in the accumulated balances for each component of AOCI, including current-period other comprehensive income and reclassifications out of AOCI, for the periods presented. Three Months Ended September 30, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of June 30, 2023 $ (10,035) $ (8,582) $ (18,617) Other comprehensive income (loss) before 19,892 1,634 21,526 Less: gain (loss) reclassified from AOCI (3,728) — (3,728) Tax effect — (380) (380) Net current-period other comprehensive income (loss) 23,620 1,254 24,874 AOCI balance as of September 30, 2023 $ 13,585 $ (7,328) $ 6,257 Three Months Ended September 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance as of June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Other comprehensive income (loss) before 26,698 (4,011) 22,687 Less: gain (loss) reclassified from AOCI 11,344 — 11,344 Tax effect — 934 934 Net current-period other comprehensive income (loss) 15,354 (3,077) 12,277 AOCI balance as of September 30, 2022 $ 45,869 $ (15,120) $ 30,749 Nine Months Ended September 30, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2022 $ 8,226 $ (12,093) $ (3,867) Other comprehensive income (loss) before 5,296 6,220 11,516 Less: gain (loss) reclassified from AOCI (63) — (63) Tax effect — (1,455) (1,455) Net current-period other comprehensive income (loss) 5,359 4,765 10,124 AOCI balance as of September 30, 2023 $ 13,585 $ (7,328) $ 6,257 Nine Months Ended September 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2021 $ 15,805 $ (1,373) $ 14,432 Other comprehensive income (loss) before 49,728 (17,905) 31,823 Less: gain (loss) reclassified from AOCI 19,664 — 19,664 Tax effect — 4,158 4,158 Net current-period other comprehensive income (loss) 30,064 (13,747) 16,317 AOCI balance as of September 30, 2022 $ 45,869 $ (15,120) $ 30,749 For additional discussion of reclassifications from AOCI see Note 5 – Derivative Instruments and Hedging Strategies . |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 9 Months Ended |
Sep. 30, 2023 | |
Concentration Risk And Geographic Information [Abstract] | |
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The following table disaggregates total Net Product Revenues by product. Three Months Ended Nine Months Ended 2023 2022 2023 2022 Enzyme product revenues: VIMIZIM $ 158,869 $ 155,470 $ 525,453 $ 511,735 NAGLAZYME 108,916 99,506 322,040 343,320 PALYNZIQ 78,885 66,206 216,105 182,734 BRINEURA 41,042 37,793 118,244 111,691 ALDURAZYME 13,812 29,046 88,533 90,755 Total enzyme product revenues 401,524 388,021 1,270,375 1,240,235 VOXZOGO 122,973 48,289 324,146 102,321 KUVAN 42,947 57,038 144,047 173,977 ROCTAVIAN 822 — 822 — Total net product revenues 568,266 493,348 1,739,390 1,516,533 Royalty and other revenues 13,063 11,996 33,629 41,968 Total revenues $ 581,329 $ 505,344 $ 1,773,019 $ 1,558,501 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 marketed and sold exclusively by Sanofi worldwide. Three Months Ended Nine Months Ended 2023 2022 2023 2022 United States $ 194,745 $ 176,552 $ 553,184 $ 497,205 Europe 168,784 162,583 512,910 480,645 Latin America 81,524 60,791 224,716 213,246 Rest of world 109,401 64,376 360,047 234,682 Total net product revenues marketed by the Company $ 554,454 $ 464,302 $ 1,650,857 $ 1,425,778 ALDURAZYME net product revenues marketed by Sanofi 13,812 29,046 88,533 90,755 Total net product revenues $ 568,266 $ 493,348 $ 1,739,390 $ 1,516,533 The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented. Three Months Ended Nine Months Ended 2023 2022 2023 2022 Customer A 15 % 15 % 15 % 16 % Customer B 13 % 14 % 12 % 12 % Customer C 10 % 10 % 10 % 9 % Total 38 % 39 % 37 % 37 % On a consolidated basis, two customers accounted for 16% and 11% of the Company’s September 30, 2023 accounts receivable balance, respectively, compared to December 31, 2022, when two customers accounted for 22% and 15% of the accounts receivable balance, respectively. As of September 30, 2023, and December 31, 2022, the accounts receivable balance for Sanofi included $54.8 million and $68.8 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 is mindful that conditions in the current macroeconomic environment, such as inflation, changes in interest and foreign currency exchange rates, banking crises, natural disasters, the continuing effects of the COVID-19 pandemic, and supply chain disruptions, could affect the Company’s ability to achieve its goals. In addition, 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 may cause customers in those countries to delay payment or be unable to pay for the Company’s products. The Company believes that the allowances for doubtful accounts related to these countries, if any, are adequate based on its analysis of the specific business circumstances and expectations of collection for each of the underlying accounts in these countries. The Company will continue to monitor these conditions and will attempt to adjust its business processes, as appropriate, to mitigate macroeconomic risks to its business. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION The Company has stockholder-approved equity incentive plans that provide for the granting of restricted stock units (RSUs) and stock options as well as other forms of equity compensation to its employees, officers and non-employee directors. The Company also has an Employee Stock Purchase Plan (ESPP). Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income for all stock-based compensation arrangements was as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Cost of sales $ 4,042 $ 4,361 $ 13,094 $ 13,449 Research and development 14,490 17,055 49,373 47,878 Selling, general and administrative 29,855 33,247 89,777 88,247 Total stock-based compensation expense $ 48,387 $ 54,663 $ 152,244 $ 149,574 |
EARNINGS (LOSS) PER COMMON SHAR
EARNINGS (LOSS) PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
EARNINGS (LOSS) PER COMMON SHARE | EARNINGS (LOSS) PER COMMON SHAREPotentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the ESPP, unvested RSUs and contingent issuances of common stock related to the Company’s convertible debt. The following table sets forth the computation of basic and diluted earnings (loss) per common share (common shares in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net Income (loss), basic $ 40,378 $ (6,652) $ 147,270 $ 141,810 Add: Interest expense, net of tax, on the Company's convertible debt — — 2,810 2,806 Net Income (loss), diluted $ 40,378 $ (6,652) $ 150,080 $ 144,616 Denominator: Weighted-average common shares outstanding, basic 188,219 185,597 187,617 185,009 Effect of dilutive securities: Issuances under equity incentive plans 2,954 — 3,455 3,273 Common stock issuable under the Company’s convertible debt (1) — — 3,970 3,970 Weighted-average common shares outstanding, diluted 191,173 185,597 195,042 192,252 Earnings (loss) per common share, basic $ 0.21 $ (0.04) $ 0.78 $ 0.77 Earnings (loss) per common share, diluted $ 0.21 $ (0.04) $ 0.77 $ 0.75 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 diluted earnings per common share as they were anti-dilutive (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Issuances under equity incentive plans 8,547 12,221 8,045 8,948 Common stock issuable under the Company’s convertible debt (1) 8,335 8,335 4,365 4,365 Total number of potentially issuable shares 16,882 20,556 12,410 13,313 (1) If converted, the Company would issue 4.0 million shares under the 2024 Notes and 4.4 million shares under the 2027 Notes. For additional discussion of our convertible debt, see Note 6 - Debt. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
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 based on existing information. The Company accrues for the best estimate of a loss within a range; however, if no estimate in the range is better than any other, then the minimum amount in the range is accrued. Liabilities are evaluated and refined each reporting period as additional information is known. Any receivables for insurance recoveries for these liability claims are recorded as assets when it is probable that a recovery will be realized. The Company is involved in a purported shareholder class action lawsuit filed against the Company and certain officers and directors alleging violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as amended (the Exchange Act) for making materially false or misleading statements regarding the clinical trials and Biologics License Application (BLA) for ROCTAVIAN (formerly known as valoctocogene roxaparvovec) by purportedly failing to disclose that differences between the Company’s Phase 1/2 and Phase 3 clinical studies limited the ability of the Phase 1/2 study to support ROCTAVIAN’s durability of effect and, as a result, that it was foreseeable that the FDA would not approve the BLA without additional data. On March 21, 2023, the Court entered an order staying all proceedings and vacating all deadlines because the parties agreed to settle the case through a binding term sheet. The Court preliminarily approved the settlement on June 8, 2023. On October 4, 2023, plaintiff filed a motion for final approval of settlement. A final approval hearing is scheduled for November 8, 2023. The Company maintains directors and officers liability insurance that covers exposure related to this class action lawsuit. As of September 30, 2023, based on these terms the Company has recorded an estimated loss contingency of $39.0 million to Accounts Payable and Accrued Liabilities and the same amount recorded for expected insurance recoveries in Other Current Assets on the Company’s Condensed Consolidated Balance Sheets. As such, there was a net zero impact on the Company’s Condensed Consolidated Statement of Comprehensive Income in the three and nine months ended September 30, 2023. Contingent Payments As of September 30, 2023, the Company was subject to contingent payments considered reasonably possible of $788.3 million, of which $591.5 million related to early-stage development programs licensed from two third parties. Other Commitments The Company uses experts and laboratories at universities and other institutions to perform certain R&D activities. These amounts are recorded 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 September 30, 2023, such commitments were estimated at $246.0 million, of which $134.4 million is expected to be paid in 2023 as underlying goods and services are received. The Company has also licensed technology from third parties, for which it is required to pay royalties upon future sales, subject to certain annual minimums. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||
Net income | $ 40,378 | $ (6,652) | $ 147,270 | $ 141,810 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 shares | Sep. 30, 2023 shares | |
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | During the three months ended September 30, 2023, our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated the contracts, instructions or written plans for the purchase or sale of BioMarin securities set forth in the table below. Type of Trading Arrangement Name Position Action Adoption/Termination Rule 10b5-1* Non- Total Shares of Common Stock to be Sold*** Expiration Date Jean-Jacques Bienaimé Chairman and Chief Executive Officer Adoption August 7, 2023 X up to 191,000 June 3, 2024 G. Eric Davis Executive Vice President, Chief Legal Officer and Secretary Adoption September 13, 2023 X up to 164,429**** August 1, 2024 Henry J. Fuchs, M.D. President of Worldwide Research & Development Adoption August 17, 2023 X up to 64,659 November 15, 2024 Brian R. Mueller Executive Vice President and Chief Financial Officer Adoption August 23, 2023 X up to 12,495 July 30, 2024 * Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. ** “Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act. *** Represents the maximum number of shares that may be sold pursuant to the 10b5-1 arrangement. The number of shares sold will be dependent on the satisfaction of certain conditions as set forth in the written plan. **** Includes up to 41,680 shares subject to performance-based restricted stock units previously granted to Mr. Davis that may vest and be released to Mr. Davis on or before August 1, 2024 upon the satisfaction of the applicable vesting conditions. The actual number of shares that will be released to Mr. Davis pursuant to the performance-based restricted stock units and sold under the Rule 10b5-1 trading arrangement will be net of the number of shares withheld to satisfy tax withholding obligations arising from the vesting of such shares and is not yet determinable. | |
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Jean-Jacques Bienaimé [Member] | ||
Trading Arrangements, by Individual | ||
Name | Jean-Jacques Bienaimé | |
Title | Chairman and Chief Executive Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | August 7, 2023 | |
Arrangement Duration | 301 days | |
Aggregate Available | 191,000 | 191,000 |
G. Eric Davis [Member] | ||
Trading Arrangements, by Individual | ||
Name | G. Eric Davis | |
Title | Executive Vice President, Chief Legal Officer and Secretary | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | September 13, 2023 | |
Arrangement Duration | 323 days | |
Aggregate Available | 164,429 | 164,429 |
Henry J. Fuchs, M.D. [Member] | ||
Trading Arrangements, by Individual | ||
Name | Henry J. Fuchs, M.D. | |
Title | President of Worldwide Research & Development | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | August 17, 2023 | |
Arrangement Duration | 456 days | |
Aggregate Available | 64,659 | 64,659 |
Brian R. Mueller [Member] | ||
Trading Arrangements, by Individual | ||
Name | Brian R. Mueller | |
Title | Executive Vice President and Chief Financial Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | August 23, 2023 | |
Arrangement Duration | 342 days | |
Aggregate Available | 12,495 | 12,495 |
BUSINESS OVERVIEW AND SIGNIFI_2
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These Condensed Consolidated Financial Statements have been prepared pursuant to U.S. generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by U.S. GAAP for complete financial statements, although management believes that the disclosures herein are adequate to ensure that the information presented is not misleading. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2023 or any other period. |
Use of Estimates | Use of Estimates U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. Management performed an evaluation of the Company’s activities through the date of filing of this Quarterly Report on Form 10-Q and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the nine months ended September 30, 2023, as compared to the recent accounting pronouncements described in Note 1 to the Company’s Consolidated Financial Statements of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, that the Company believes are of significance or potential significance to the Company. |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category | The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category for each period presented: September 30, 2023 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 451,294 $ — $ — $ 451,294 $ 451,294 $ — $ — Level 2: Money market instruments 291,425 — — 291,425 291,425 — — Corporate debt securities 563,598 31 (6,135) 557,494 731 217,306 339,457 U.S. government agency securities 281,045 4 (3,023) 278,026 29,981 112,714 135,331 Commercial paper 21,864 — (4) 21,860 11,983 9,877 — Asset-backed securities 74,168 26 (446) 73,748 — 534 73,214 Subtotal 1,232,100 61 (9,608) 1,222,553 334,120 340,431 548,002 Total $ 1,683,394 $ 61 $ (9,608) $ 1,673,847 $ 785,414 $ 340,431 $ 548,002 December 31, 2022 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 463,248 $ — $ — $ 463,248 $ 463,248 $ — $ — Level 2: Money market instruments 248,933 — — 248,933 248,933 — — Corporate debt securities 504,984 34 (11,541) 493,477 1,881 299,153 192,443 U.S. government agency securities 312,720 45 (3,771) 308,994 — 229,846 79,148 Commercial paper 48,103 11 (22) 48,092 10,469 37,623 — Asset-backed securities 63,151 69 (592) 62,628 — 384 62,244 Subtotal 1,177,891 159 (15,926) 1,162,124 261,283 567,006 333,835 Total $ 1,641,139 $ 159 $ (15,926) $ 1,625,372 $ 724,531 $ 567,006 $ 333,835 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company’s long-term marketable securities mature between one |
SUPPLEMENTAL FINANCIAL STATEM_2
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: September 30, December 31, Raw materials $ 142,133 $ 131,071 Work-in-process 518,893 410,656 Finished goods 371,133 352,356 Total inventory $ 1,032,159 $ 894,083 |
Schedule of Property, Plant and Equipment, Net | Property, Plant and Equipment, Net consisted of the following: September 30, December 31, Property, plant and equipment, gross $ 1,918,609 $ 1,875,511 Accumulated depreciation (851,453) (802,145) Total property, plant and equipment, net $ 1,067,156 $ 1,073,366 |
Schedule of Intangible Assets | Intangible Assets, Net consisted of the following: September 30, December 31, Finite-lived intangible assets $ 701,793 $ 690,871 Accumulated amortization (399,317) (352,302) Net carrying value $ 302,476 $ 338,569 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: September 30, December 31, Accounts payable and accrued operating expenses $ 301,369 $ 231,238 Accrued compensation expense 175,183 207,573 Accrued rebates payable 103,379 72,654 Accrued litigation expense 39,000 — Accrued royalties payable 12,293 13,306 Accrued income taxes 11,273 16,213 Foreign currency exchange forward contracts 10,584 12,601 Lease liability 9,324 10,375 Other 7,420 8,999 Total accounts payable and accrued liabilities $ 669,825 $ 572,959 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets and Liabilities | The following tables present the classification within the fair value hierarchy of financial assets and liabilities not disclosed elsewhere in these Condensed Consolidated Financial Statements that are remeasured on a recurring basis as of September 30, 2023 and December 31, 2022. Other than the Company’s fixed-rate convertible debt disclosed in Note 6 – Debt , there were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 1) as of September 30, 2023 or December 31, 2022. Fair Value Measurements as of September 30, 2023 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 1,836 $ — $ 1,836 Other assets: NQDC Plan assets 25,541 — 25,541 Restricted investments (1) 2,361 — 2,361 Total other assets 27,902 — 27,902 Total assets $ 29,738 $ — $ 29,738 Liabilities: Current liabilities: NQDC Plan liability $ 1,836 $ — $ 1,836 Other long-term liabilities: NQDC Plan liability 25,541 — 25,541 Total liabilities $ 27,377 $ — $ 27,377 Fair Value Measurements as of December 31, 2022 Significant Other Significant Total Assets: Other current assets: NQDC Plan assets $ 2,654 $ — $ 2,654 Other assets: NQDC Plan assets 19,867 — 19,867 Restricted investments (1) 2,429 — 2,429 Total other assets 22,296 — 22,296 Total assets $ 24,950 $ — $ 24,950 Liabilities: Current liabilities: NQDC Plan liability $ 2,654 $ — $ 2,654 Contingent consideration — 15,925 15,925 Total current liabilities 2,654 15,925 18,579 Other long-term liabilities: NQDC Plan liability 19,867 — 19,867 Total liabilities $ 22,521 $ 15,925 $ 38,446 (1) The restricted investments as of September 30, 2023 and December 31, 2022 secure the Company's irrevocable standby letters of credit obtained in connection with certain commercial agreements. |
Schedule of Liabilities Measured at Fair Value on Recurring Basis Using Level 3 Inputs | Liabilities measured at fair value using Level 3 inputs consisted of contingent consideration. The following table represents a roll-forward of contingent consideration. Contingent consideration as of December 31, 2022 $ 15,925 Milestone payments to Ares Trading S.A. (Merck Serono) (16,255) Realized foreign exchange loss on settlement of contingent consideration 330 Contingent consideration as of September 30, 2023 $ — |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Aggregate Notional Amounts for the Derivatives Outstanding | The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Forward Contracts September 30, December 31, Derivatives designated as hedging instruments: Sell $ 988,286 $ 808,635 Purchase $ 180,560 $ 177,393 Derivatives not designated as hedging instruments: Sell $ 301,825 $ 218,903 Purchase $ 6,517 $ 6,785 |
Schedule of Fair Value Carrying Amounts of Derivatives | The fair value carrying amounts of the Company’s derivatives, which are classified as Level 2 within the fair value hierarchy, were as follows: Balance Sheet Location September 30, December 31, Derivatives designated as hedging instruments: Asset Derivatives Other current assets $ 21,267 $ 19,464 Other assets 7,620 2,059 Subtotal $ 28,887 $ 21,523 Liability Derivatives Accounts payable and accrued liabilities $ 9,918 $ 12,130 Other long-term liabilities 3,623 1,074 Subtotal $ 13,541 $ 13,204 Derivatives not designated as hedging instruments: Asset Derivatives Other current assets $ 5,210 $ 1,472 Liability Derivatives Accounts payable and accrued liabilities $ 666 $ 471 Total Derivatives Assets $ 34,097 $ 22,995 Total Derivatives Liabilities $ 14,207 $ 13,675 |
Schedule of Impact of Gains and Losses from Derivatives Designated as Hedging Instruments | The following tables summarize the impact of gains and losses from the Company's derivatives on its Condensed Consolidated Statements of Comprehensive Income for the periods presented. Three Months Ended September 30, 2023 2022 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (4,636) $ 15,280 Operating expenses $ 908 $ (3,936) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 6,559 $ 6,572 Nine Months Ended September 30, 2023 2022 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (489) $ 26,779 Operating expenses $ 426 $ (7,115) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 3,165 $ 12,812 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: September 30, December 31, 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) $ 600,000 $ 600,000 Unamortized discount net of deferred offering costs (7,414) (8,941) 2027 Notes, net 592,586 591,059 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) 495,000 495,000 Unamortized discount net of deferred offering costs (1,602) (3,040) 2024 Notes, net (1) 493,398 491,960 Total convertible debt, net $ 1,085,984 $ 1,083,019 Fair value of fixed-rate convertible debt (2) : 2027 Notes $ 595,278 $ 647,370 2024 Notes 480,417 526,230 Total fair value of fixed-rate convertible debt $ 1,075,695 $ 1,173,600 (1) As the 2024 Notes mature in August 2024, the outstanding principal of the 2024 Notes is classified as a current liability as of September 30, 2023. (2) The fair value of the Company’s fixed-rate convertible debt is based on open-market trades and is classified as Level 1 in the fair value hierarchy. For additional discussion of fair value measurements, see Note 1 – Business Overview and Significant Accounting Policies to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. |
Schedule of Interest Expense on Convertible Debt | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Coupon interest expense $ 2,616 $ 2,616 $ 7,849 $ 7,849 Accretion of discount on convertible notes 841 838 2,519 2,511 Amortization of debt issuance costs 148 148 445 445 Total interest expense on convertible debt $ 3,605 $ 3,602 $ 10,813 $ 10,805 |
ACCUMULATED OTHER COMPREHENSI_2
ACCUMULATED OTHER COMPREHENSIVE INCOME (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income and Reclassifications Out of AOCI | The following tables summarize changes in the accumulated balances for each component of AOCI, including current-period other comprehensive income and reclassifications out of AOCI, for the periods presented. Three Months Ended September 30, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of June 30, 2023 $ (10,035) $ (8,582) $ (18,617) Other comprehensive income (loss) before 19,892 1,634 21,526 Less: gain (loss) reclassified from AOCI (3,728) — (3,728) Tax effect — (380) (380) Net current-period other comprehensive income (loss) 23,620 1,254 24,874 AOCI balance as of September 30, 2023 $ 13,585 $ (7,328) $ 6,257 Three Months Ended September 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance as of June 30, 2022 $ 30,515 $ (12,043) $ 18,472 Other comprehensive income (loss) before 26,698 (4,011) 22,687 Less: gain (loss) reclassified from AOCI 11,344 — 11,344 Tax effect — 934 934 Net current-period other comprehensive income (loss) 15,354 (3,077) 12,277 AOCI balance as of September 30, 2022 $ 45,869 $ (15,120) $ 30,749 Nine Months Ended September 30, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2022 $ 8,226 $ (12,093) $ (3,867) Other comprehensive income (loss) before 5,296 6,220 11,516 Less: gain (loss) reclassified from AOCI (63) — (63) Tax effect — (1,455) (1,455) Net current-period other comprehensive income (loss) 5,359 4,765 10,124 AOCI balance as of September 30, 2023 $ 13,585 $ (7,328) $ 6,257 Nine Months Ended September 30, 2022 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2021 $ 15,805 $ (1,373) $ 14,432 Other comprehensive income (loss) before 49,728 (17,905) 31,823 Less: gain (loss) reclassified from AOCI 19,664 — 19,664 Tax effect — 4,158 4,158 Net current-period other comprehensive income (loss) 30,064 (13,747) 16,317 AOCI balance as of September 30, 2022 $ 45,869 $ (15,120) $ 30,749 |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Concentration Risk And Geographic Information [Abstract] | |
Schedule of Net Product Revenues by Product | The following table disaggregates total Net Product Revenues by product. Three Months Ended Nine Months Ended 2023 2022 2023 2022 Enzyme product revenues: VIMIZIM $ 158,869 $ 155,470 $ 525,453 $ 511,735 NAGLAZYME 108,916 99,506 322,040 343,320 PALYNZIQ 78,885 66,206 216,105 182,734 BRINEURA 41,042 37,793 118,244 111,691 ALDURAZYME 13,812 29,046 88,533 90,755 Total enzyme product revenues 401,524 388,021 1,270,375 1,240,235 VOXZOGO 122,973 48,289 324,146 102,321 KUVAN 42,947 57,038 144,047 173,977 ROCTAVIAN 822 — 822 — Total net product revenues 568,266 493,348 1,739,390 1,516,533 Royalty and other revenues 13,063 11,996 33,629 41,968 Total revenues $ 581,329 $ 505,344 $ 1,773,019 $ 1,558,501 |
Schedule of Total Net Product Revenues Based on Patient Location | The table below disaggregates total Net Product Revenues by geographic region, which is based on patient location for Company's commercial products sold directly by the Company, except for ALDURAZYME, which is marketed and sold exclusively by Sanofi worldwide. Three Months Ended Nine Months Ended 2023 2022 2023 2022 United States $ 194,745 $ 176,552 $ 553,184 $ 497,205 Europe 168,784 162,583 512,910 480,645 Latin America 81,524 60,791 224,716 213,246 Rest of world 109,401 64,376 360,047 234,682 Total net product revenues marketed by the Company $ 554,454 $ 464,302 $ 1,650,857 $ 1,425,778 ALDURAZYME net product revenues marketed by Sanofi 13,812 29,046 88,533 90,755 Total net product revenues $ 568,266 $ 493,348 $ 1,739,390 $ 1,516,533 |
Schedule of Net Product Revenue Concentrations Attributed to Largest Customers | The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented. Three Months Ended Nine Months Ended 2023 2022 2023 2022 Customer A 15 % 15 % 15 % 16 % Customer B 13 % 14 % 12 % 12 % Customer C 10 % 10 % 10 % 9 % Total 38 % 39 % 37 % 37 % |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | Compensation expense included in the Company’s Condensed Consolidated Statements of Comprehensive Income for all stock-based compensation arrangements was as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Cost of sales $ 4,042 $ 4,361 $ 13,094 $ 13,449 Research and development 14,490 17,055 49,373 47,878 Selling, general and administrative 29,855 33,247 89,777 88,247 Total stock-based compensation expense $ 48,387 $ 54,663 $ 152,244 $ 149,574 |
EARNINGS (LOSS) PER COMMON SH_2
EARNINGS (LOSS) PER COMMON SHARE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Earnings (Loss) Per Common Share | The following table sets forth the computation of basic and diluted earnings (loss) per common share (common shares in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net Income (loss), basic $ 40,378 $ (6,652) $ 147,270 $ 141,810 Add: Interest expense, net of tax, on the Company's convertible debt — — 2,810 2,806 Net Income (loss), diluted $ 40,378 $ (6,652) $ 150,080 $ 144,616 Denominator: Weighted-average common shares outstanding, basic 188,219 185,597 187,617 185,009 Effect of dilutive securities: Issuances under equity incentive plans 2,954 — 3,455 3,273 Common stock issuable under the Company’s convertible debt (1) — — 3,970 3,970 Weighted-average common shares outstanding, diluted 191,173 185,597 195,042 192,252 Earnings (loss) per common share, basic $ 0.21 $ (0.04) $ 0.78 $ 0.77 Earnings (loss) per common share, diluted $ 0.21 $ (0.04) $ 0.77 $ 0.75 |
Schedule of Anti-Dilutive Common Stock Excluded from Computation of Diluted Earnings 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 diluted earnings per common share as they were anti-dilutive (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Issuances under equity incentive plans 8,547 12,221 8,045 8,948 Common stock issuable under the Company’s convertible debt (1) 8,335 8,335 4,365 4,365 Total number of potentially issuable shares 16,882 20,556 12,410 13,313 (1) If converted, the Company would issue 4.0 million shares under the 2024 Notes and 4.4 million shares under the 2027 Notes. For additional discussion of our convertible debt, see Note 6 - Debt. |
FINANCIAL INSTRUMENTS - Schedul
FINANCIAL INSTRUMENTS - Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | ||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 1,683,394 | $ 1,641,139 | |
Gross Unrealized Gains | 61 | 159 | |
Gross Unrealized Losses | (9,608) | (15,926) | |
Aggregate Fair Value | 1,673,847 | 1,625,372 | |
Cash and Cash Equivalents | 785,414 | 724,531 | [1] |
Short-term Marketable Securities | 340,431 | 567,006 | [1] |
Long-term Marketable Securities | $ 548,002 | $ 333,835 | [1] |
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 | |
Level 1: | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Cash | $ 451,294 | $ 463,248 | |
Cash, Aggregate Fair Value | 451,294 | 463,248 | |
Level 2: | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,232,100 | 1,177,891 | |
Gross Unrealized Gains | 61 | 159 | |
Gross Unrealized Losses | (9,608) | (15,926) | |
Aggregate Fair Value | 1,222,553 | 1,162,124 | |
Cash and Cash Equivalents | 334,120 | 261,283 | |
Short-term Marketable Securities | 340,431 | 567,006 | |
Long-term Marketable Securities | 548,002 | 333,835 | |
Level 2: | Money market instruments | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 291,425 | 248,933 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 291,425 | 248,933 | |
Cash and Cash Equivalents | 291,425 | 248,933 | |
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 | 563,598 | 504,984 | |
Gross Unrealized Gains | 31 | 34 | |
Gross Unrealized Losses | (6,135) | (11,541) | |
Aggregate Fair Value | 557,494 | 493,477 | |
Cash and Cash Equivalents | 731 | 1,881 | |
Short-term Marketable Securities | 217,306 | 299,153 | |
Long-term Marketable Securities | 339,457 | 192,443 | |
Level 2: | U.S. government agency securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 281,045 | 312,720 | |
Gross Unrealized Gains | 4 | 45 | |
Gross Unrealized Losses | (3,023) | (3,771) | |
Aggregate Fair Value | 278,026 | 308,994 | |
Cash and Cash Equivalents | 29,981 | 0 | |
Short-term Marketable Securities | 112,714 | 229,846 | |
Long-term Marketable Securities | 135,331 | 79,148 | |
Level 2: | Commercial paper | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 21,864 | 48,103 | |
Gross Unrealized Gains | 0 | 11 | |
Gross Unrealized Losses | (4) | (22) | |
Aggregate Fair Value | 21,860 | 48,092 | |
Cash and Cash Equivalents | 11,983 | 10,469 | |
Short-term Marketable Securities | 9,877 | 37,623 | |
Long-term Marketable Securities | 0 | 0 | |
Level 2: | Asset-backed securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 74,168 | 63,151 | |
Gross Unrealized Gains | 26 | 69 | |
Gross Unrealized Losses | (446) | (592) | |
Aggregate Fair Value | 73,748 | 62,628 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term Marketable Securities | 534 | 384 | |
Long-term Marketable Securities | $ 73,214 | $ 62,244 | |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
FINANCIAL INSTRUMENTS - Narrati
FINANCIAL INSTRUMENTS - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Schedule of Available-for-sale Securities [Line Items] | ||||
Loss on equity investment | $ 12,600 | $ 12,650 | $ 0 | |
Strategic Investment | Fair Value, Measurements, Recurring | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Strategic investments fair value | $ 11,200 | $ 23,900 |
SUPPLEMENTAL FINANCIAL STATEM_3
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Raw materials | $ 142,133 | $ 131,071 | |
Work-in-process | 518,893 | 410,656 | |
Finished goods | 371,133 | 352,356 | |
Total inventory | $ 1,032,159 | $ 894,083 | [1] |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
SUPPLEMENTAL FINANCIAL STATEM_4
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Property, plant and equipment, gross | $ 1,918,609 | $ 1,875,511 | |
Accumulated depreciation | (851,453) | (802,145) | |
Property, plant and equipment, net | $ 1,067,156 | $ 1,073,366 | [1] |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
SUPPLEMENTAL FINANCIAL STATEM_5
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Narrative (Details) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Oct. 06, 2022 employee | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Supplemental Balance Sheet Information [Line Items] | ||||||
Depreciation expense, net of amounts capitalized into inventory | $ 9.9 | $ 8.7 | $ 29.6 | $ 29.9 | ||
2022 Restructuring Plan | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Reduction in force | employee | 120 | |||||
Percentage of global workforce | 4% | |||||
Restructuring costs | $ 23 | |||||
2022 Restructuring Plan | Accounts payable and accrued liabilities | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Restructuring reserve | $ 11.1 |
SUPPLEMENTAL FINANCIAL STATEM_6
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Finite-lived intangible assets | $ 701,793 | $ 690,871 |
Accumulated amortization | (399,317) | (352,302) |
Net carrying value | $ 302,476 | $ 338,569 |
SUPPLEMENTAL FINANCIAL STATEM_7
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accounts payable and accrued operating expenses | $ 301,369 | $ 231,238 | |
Accrued compensation expense | 175,183 | 207,573 | |
Accrued rebates payable | 103,379 | 72,654 | |
Accrued litigation expense | 39,000 | 0 | |
Accrued royalties payable | 12,293 | 13,306 | |
Accrued income taxes | 11,273 | 16,213 | |
Foreign currency exchange forward contracts | 10,584 | 12,601 | |
Lease liability | 9,324 | 10,375 | |
Other | 7,420 | 8,999 | |
Accounts payable and accrued liabilities | $ 669,825 | $ 572,959 | [1] |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
FAIR VALUE MEASUREMENTS - Sched
FAIR VALUE MEASUREMENTS - Schedule of Fair Value of Financial Assets and Liabilities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Measurements, Recurring | ||
Assets: | ||
Fair value of other non-current assets | $ 27,902,000 | $ 22,296,000 |
Fair value of financial assets, Total | 29,738,000 | 24,950,000 |
Liabilities: | ||
Fair value of other current liabilities | 18,579,000 | |
Fair value of financial liabilities, Total | 27,377,000 | 38,446,000 |
Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Liabilities: | ||
Fair value of other current liabilities | 1,836,000 | 2,654,000 |
Fair value of other non-current liabilities | 25,541,000 | 19,867,000 |
Fair Value, Measurements, Recurring | Contingent consideration | ||
Liabilities: | ||
Fair value of other current liabilities | 15,925,000 | |
Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Assets: | ||
Fair value of other current assets | 1,836,000 | 2,654,000 |
Fair value of other non-current assets | 25,541,000 | 19,867,000 |
Fair Value, Measurements, Recurring | Restricted Investments | ||
Assets: | ||
Fair value of other non-current assets | 2,361,000 | 2,429,000 |
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 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | ||
Assets: | ||
Fair value of other non-current assets | 27,902,000 | 22,296,000 |
Fair value of financial assets, Total | 29,738,000 | 24,950,000 |
Liabilities: | ||
Fair value of other current liabilities | 2,654,000 | |
Fair value of financial liabilities, Total | 27,377,000 | 22,521,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Liabilities: | ||
Fair value of other current liabilities | 1,836,000 | 2,654,000 |
Fair value of other non-current liabilities | 25,541,000 | 19,867,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Contingent consideration | ||
Liabilities: | ||
Fair value of other current liabilities | 0 | |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Assets: | ||
Fair value of other current assets | 1,836,000 | 2,654,000 |
Fair value of other non-current assets | 25,541,000 | 19,867,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Restricted Investments | ||
Assets: | ||
Fair value of other non-current assets | 2,361,000 | 2,429,000 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | ||
Assets: | ||
Fair value of other non-current assets | 0 | 0 |
Fair value of financial assets, Total | 0 | 0 |
Liabilities: | ||
Fair value of other current liabilities | 15,925,000 | |
Fair value of financial liabilities, Total | 0 | 15,925,000 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Liabilities: | ||
Fair value of other current liabilities | 0 | 0 |
Fair value of other non-current liabilities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Contingent consideration | ||
Liabilities: | ||
Fair value of other current liabilities | 15,925,000 | |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Assets: | ||
Fair value of other current assets | 0 | 0 |
Fair value of other non-current assets | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Restricted Investments | ||
Assets: | ||
Fair value of other non-current assets | $ 0 | $ 0 |
FAIR VALUE MEASUREMENTS - Sch_2
FAIR VALUE MEASUREMENTS - Schedule of Liabilities Measured at Fair Value on Recurring Basis Using Level 3 Inputs (Details) - Contingent Payment $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Contingent consideration, beginning balance | $ 15,925 |
Milestone payments to Ares Trading S.A. (Merck Serono) | (16,255) |
Realized foreign exchange loss on settlement of contingent consideration | 330 |
Contingent consideration, ending balance | $ 0 |
DERIVATIVE INSTRUMENTS AND HE_3
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Narrative (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Derivative [Line Items] | |
Accumulated other comprehensive income (AOCI) to earnings | $ 9.6 |
Derivatives designated as hedging instruments: | |
Derivative [Line Items] | |
Maturity of derivatives | 2 years |
Derivatives Not Designated as Hedging Instruments | |
Derivative [Line Items] | |
Maturity of derivatives | 6 months |
DERIVATIVE INSTRUMENTS AND HE_4
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Schedule of Aggregate Notional Amounts for the Derivatives Outstanding (Details) - Forward Foreign Exchange Contracts - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Derivatives designated as hedging instruments: | Sell | ||
Derivative [Line Items] | ||
Notional amount | $ 988,286 | $ 808,635 |
Derivatives designated as hedging instruments: | Purchase | ||
Derivative [Line Items] | ||
Notional amount | 180,560 | 177,393 |
Derivatives Not Designated as Hedging Instruments | Sell | ||
Derivative [Line Items] | ||
Notional amount | 301,825 | 218,903 |
Derivatives Not Designated as Hedging Instruments | Purchase | ||
Derivative [Line Items] | ||
Notional amount | $ 6,517 | $ 6,785 |
DERIVATIVE INSTRUMENTS AND HE_5
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Schedule of Fair Value Carrying Amounts of Derivatives (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Derivative [Line Items] | ||
Derivative asset, fair value | $ 34,097 | $ 22,995 |
Derivative liability, fair value | 14,207 | 13,675 |
Level 2: | Derivatives designated as hedging instruments: | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 28,887 | 21,523 |
Derivative liability, fair value | 13,541 | 13,204 |
Level 2: | Derivatives designated as hedging instruments: | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 21,267 | 19,464 |
Level 2: | Derivatives designated as hedging instruments: | Other assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 7,620 | 2,059 |
Level 2: | Derivatives designated as hedging instruments: | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 9,918 | 12,130 |
Level 2: | Derivatives designated as hedging instruments: | Other long-term liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 3,623 | 1,074 |
Level 2: | Derivatives Not Designated as Hedging Instruments | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 5,210 | 1,472 |
Level 2: | Derivatives Not Designated as Hedging Instruments | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | $ 666 | $ 471 |
DERIVATIVE INSTRUMENTS AND HE_6
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Schedule of Impact of Gains and Losses from Derivatives Designated as Hedging Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Derivatives designated as hedging instruments: | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | Operating expenses | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Derivatives Designated as Cash Flow Hedging Instruments | $ 908 | $ (3,936) | $ 426 | $ (7,115) |
Derivatives designated as hedging instruments: | Accumulated Gain (Loss), Net, Cash Flow Hedge, Parent | Net product revenues | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Derivatives Designated as Cash Flow Hedging Instruments | (4,636) | 15,280 | (489) | 26,779 |
Derivatives Not Designated as Hedging Instruments | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Derivatives Not Designated as Hedging Instruments | $ 6,559 | $ 6,572 | $ 3,165 | $ 12,812 |
DEBT - Narrative (Details)
DEBT - Narrative (Details) - USD ($) | Sep. 30, 2023 | Oct. 31, 2018 |
Debt Instrument [Line Items] | ||
Carrying value of equity component | $ 1,100,000,000 | |
The 2018 Credit Facility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 200,000,000 | |
Outstanding amount | $ 0 |
DEBT - Schedule of Convertible
DEBT - Schedule of Convertible Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||
Convertible notes | $ 1,100,000 | ||
Convertible debt, noncurrent | 592,586 | $ 1,083,019 | [1] |
Convertible debt, current | 493,398 | 0 | [1] |
Total convertible debt, net | 1,085,984 | 1,083,019 | |
Total fair value of fixed-rate convertible debt | $ 1,075,695 | $ 1,173,600 | |
1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) | |||
Debt Instrument [Line Items] | |||
Convertible notes stated rate | 1.25% | 1.25% | |
Convertible notes | $ 600,000 | $ 600,000 | |
Unamortized discount net of deferred offering costs | (7,414) | (8,941) | |
Convertible debt, noncurrent | 592,586 | 591,059 | |
Total fair value of fixed-rate convertible debt | $ 595,278 | $ 647,370 | |
0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) | |||
Debt Instrument [Line Items] | |||
Convertible notes stated rate | 0.599% | 0.599% | |
Convertible notes | $ 495,000 | $ 495,000 | |
Unamortized discount net of deferred offering costs | (1,602) | (3,040) | |
Convertible debt, noncurrent | 491,960 | ||
Convertible debt, current | 493,398 | ||
Total fair value of fixed-rate convertible debt | $ 480,417 | $ 526,230 | |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
DEBT - Schedule of Interest Exp
DEBT - Schedule of Interest Expense on Convertible Debt (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule Of Interest Expenses [Line Items] | ||||
Total interest expense on convertible debt | $ 3,779 | $ 4,679 | $ 11,237 | $ 12,344 |
Convertible Senior Notes | ||||
Schedule Of Interest Expenses [Line Items] | ||||
Coupon interest expense | 2,616 | 2,616 | 7,849 | 7,849 |
Accretion of discount on convertible notes | 841 | 838 | 2,519 | 2,511 |
Amortization of debt issuance costs | 148 | 148 | 445 | 445 |
Total interest expense on convertible debt | $ 3,605 | $ 3,602 | $ 10,813 | $ 10,805 |
ACCUMULATED OTHER COMPREHENSI_3
ACCUMULATED OTHER COMPREHENSIVE INCOME - Schedule of Changes in Accumulated Balances of AOCI Including Current Period Other Comprehensive Income and Reclassifications Out of AOCI (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balances | [1] | $ 4,782,827 | $ 4,499,737 | $ 4,603,156 | [2] | $ 4,265,670 |
Other comprehensive income (loss) before reclassifications | 21,526 | 22,687 | 11,516 | 31,823 | ||
Less: gain (loss) reclassified from AOCI | (3,728) | 11,344 | (63) | 19,664 | ||
Tax effect | (380) | 934 | (1,455) | 4,158 | ||
Net current-period other comprehensive income (loss) | 24,874 | 12,277 | 10,124 | 16,317 | ||
Ending balances | 4,896,897 | 4,568,514 | 4,896,897 | 4,568,514 | ||
AOCI attributable to parent | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balances | [1] | (18,617) | 18,472 | (3,867) | 14,432 | |
Net current-period other comprehensive income (loss) | 24,874 | 12,277 | 10,124 | 16,317 | ||
Ending balances | 6,257 | 30,749 | 6,257 | 30,749 | ||
Unrealized Gains (Losses) on Cash Flow Hedges | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balances | (10,035) | 30,515 | 8,226 | 15,805 | ||
Other comprehensive income (loss) before reclassifications | 19,892 | 26,698 | 5,296 | 49,728 | ||
Less: gain (loss) reclassified from AOCI | (3,728) | 11,344 | (63) | 19,664 | ||
Tax effect | 0 | 0 | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 23,620 | 15,354 | 5,359 | 30,064 | ||
Ending balances | 13,585 | 45,869 | 13,585 | 45,869 | ||
Unrealized Gains (Losses) on Available-for-Sale Debt Securities | ||||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||||
Beginning balances | (8,582) | (12,043) | (12,093) | (1,373) | ||
Other comprehensive income (loss) before reclassifications | 1,634 | (4,011) | 6,220 | (17,905) | ||
Less: gain (loss) reclassified from AOCI | 0 | 0 | 0 | 0 | ||
Tax effect | (380) | 934 | (1,455) | 4,158 | ||
Net current-period other comprehensive income (loss) | 1,254 | (3,077) | 4,765 | (13,747) | ||
Ending balances | $ (7,328) | $ (15,120) | $ (7,328) | $ (15,120) | ||
[1]The beginning balances for the nine-month periods were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 27, 2023.[2] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
REVENUE, CREDIT CONCENTRATION_3
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Narrative (Details) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | ||
Concentration Risk And Geographic Information [Line Items] | |||
Number of operating business segment | segment | 1 | ||
Accounts receivable, net | $ 572,498 | $ 461,316 | [1] |
Sanofi | |||
Concentration Risk And Geographic Information [Line Items] | |||
Accounts receivable, net | $ 54,800 | $ 68,800 | |
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 16% | 22% | |
Credit Concentration Risk | Accounts Receivable | Customer Two | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 11% | 15% | |
[1] (1) December 31, 2022 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. |
REVENUE, CREDIT CONCENTRATION_4
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Net Product Revenues by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 581,329 | $ 505,344 | $ 1,773,019 | $ 1,558,501 |
Product | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 568,266 | 493,348 | 1,739,390 | 1,516,533 |
Total enzyme product revenues | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 401,524 | 388,021 | 1,270,375 | 1,240,235 |
VIMIZIM | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 158,869 | 155,470 | 525,453 | 511,735 |
NAGLAZYME | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 108,916 | 99,506 | 322,040 | 343,320 |
PALYNZIQ | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 78,885 | 66,206 | 216,105 | 182,734 |
BRINEURA | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 41,042 | 37,793 | 118,244 | 111,691 |
ALDURAZYME | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 13,812 | 29,046 | 88,533 | 90,755 |
VOXZOGO | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 122,973 | 48,289 | 324,146 | 102,321 |
KUVAN | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 42,947 | 57,038 | 144,047 | 173,977 |
ROCTAVIAN | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 822 | 0 | 822 | 0 |
Royalty and other revenues | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 13,063 | $ 11,996 | $ 33,629 | $ 41,968 |
REVENUE, CREDIT CONCENTRATION_5
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Total Net Product Revenues Based on Patient Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 581,329 | $ 505,344 | $ 1,773,019 | $ 1,558,501 |
ALDURAZYME | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 13,812 | 29,046 | 88,533 | 90,755 |
Product | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 568,266 | 493,348 | 1,739,390 | 1,516,533 |
Marketed by Company | Products excluding ALDURAZYME | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 554,454 | 464,302 | 1,650,857 | 1,425,778 |
Marketed by Company | Products excluding ALDURAZYME | United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 194,745 | 176,552 | 553,184 | 497,205 |
Marketed by Company | Products excluding ALDURAZYME | Europe | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 168,784 | 162,583 | 512,910 | 480,645 |
Marketed by Company | Products excluding ALDURAZYME | Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 81,524 | 60,791 | 224,716 | 213,246 |
Marketed by Company | Products excluding ALDURAZYME | Rest of world | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 109,401 | 64,376 | 360,047 | 234,682 |
Marketed by Sanofi | ALDURAZYME | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 13,812 | $ 29,046 | $ 88,533 | $ 90,755 |
REVENUE, CREDIT CONCENTRATION_6
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Net Product Revenue Concentrations Attributed to Largest Customers (Details) - Customer Concentration Risk - Net Product Revenue | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Customer A, B & C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 38% | 39% | 37% | 37% |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 15% | 15% | 15% | 16% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 13% | 14% | 12% | 12% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk, percentage | 10% | 10% | 10% | 9% |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 48,387 | $ 54,663 | $ 152,244 | $ 149,574 |
Cost of sales | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,042 | 4,361 | 13,094 | 13,449 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 14,490 | 17,055 | 49,373 | 47,878 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 29,855 | $ 33,247 | $ 89,777 | $ 88,247 |
EARNINGS (LOSS) PER COMMON SH_3
EARNINGS (LOSS) PER COMMON SHARE - Schedule of Computation of Basic and Diluted Earnings (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||
Net Income (loss), basic | $ 40,378 | $ (6,652) | $ 147,270 | $ 141,810 |
Add: Interest expense, net of tax, on the Company's convertible debt | 0 | 0 | 2,810 | 2,806 |
Net Income (loss), diluted | $ 40,378 | $ (6,652) | $ 150,080 | $ 144,616 |
Denominator: | ||||
Weighted-average common shares outstanding, basic (in shares) | 188,219 | 185,597 | 187,617 | 185,009 |
Effect of dilutive securities: | ||||
Weighted-average common shares outstanding, diluted (in shares) | 191,173 | 185,597 | 195,042 | 192,252 |
Earnings (loss) per common share, basic (in dollars per share) | $ 0.21 | $ (0.04) | $ 0.78 | $ 0.77 |
Earnings (loss) per common share, diluted (in dollars per share) | $ 0.21 | $ (0.04) | $ 0.77 | $ 0.75 |
Issuances under equity incentive plans | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 2,954 | 0 | 3,455 | 3,273 |
Common stock issuable under the Company’s convertible debt | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 0 | 0 | 3,970 | 3,970 |
EARNINGS (LOSS) PER COMMON SH_4
EARNINGS (LOSS) PER COMMON SHARE - Schedule of Anti-Dilutive Common Stock Excluded from Computation of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 16,882 | 20,556 | 12,410 | 13,313 |
0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) | Convertible Senior Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potential shares issued if converted (in shares) | 4,000 | |||
1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) | Convertible Senior Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potential shares issued if converted (in shares) | 4,400 | |||
Issuances under equity incentive plans | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 8,547 | 12,221 | 8,045 | 8,948 |
Common stock issuable under the Company’s convertible debt | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total number of potentially issuable shares (in shares) | 8,335 | 8,335 | 4,365 | 4,365 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) third_party | |
Commitments And Contingencies [Line Items] | |
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 788.3 |
Purchase commitment | 246 |
Purchase commitments expected to be paid in 2023 | 134.4 |
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 | $ 591.5 |
Number of third parties | third_party | 2 |
Shareholder vs BioMarin Pharmaceutical Inc | |
Commitments And Contingencies [Line Items] | |
Loss contingency | $ 39 |