Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 22, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.001 | |
Trading Symbol | BMRN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 189,879,803 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001048477 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
REVENUES: | ||
Total revenues | $ 648,833 | $ 596,415 |
OPERATING EXPENSES: | ||
Cost of sales | 125,180 | 135,472 |
Research and development | 204,987 | 171,846 |
Selling, general and administrative | 225,906 | 211,023 |
Intangible asset amortization | 14,298 | 15,670 |
Gain on sale of nonfinancial assets | (10,000) | 0 |
Total operating expenses | 560,371 | 534,011 |
INCOME FROM OPERATIONS | 88,462 | 62,404 |
Interest income | 19,365 | 11,943 |
Interest expense | (3,547) | (3,703) |
Other income (expense), net | 1,267 | (13,887) |
INCOME BEFORE INCOME TAXES | 105,547 | 56,757 |
Provision for income taxes | 16,885 | 5,905 |
NET INCOME | $ 88,662 | $ 50,852 |
EARNINGS PER SHARE, BASIC (in dollars per share) | $ 0.47 | $ 0.27 |
EARNINGS PER SHARE, DILUTED (in dollars per share) | $ 0.46 | $ 0.27 |
Weighted average common shares outstanding, basic (in shares) | 188,866 | 186,667 |
Weighted average common shares outstanding, diluted (in shares) | 199,262 | 194,363 |
COMPREHENSIVE INCOME | $ 116,404 | $ 43,997 |
Net product revenues | ||
REVENUES: | ||
Total revenues | 637,815 | 586,426 |
Royalty and other revenues | ||
REVENUES: | ||
Total revenues | $ 11,018 | $ 9,989 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 746,996 | $ 755,127 | |
Short-term investments | 299,584 | 318,683 | |
Accounts receivable, net | 637,163 | 633,704 | |
Inventory | 1,137,982 | 1,107,183 | |
Other current assets | 163,287 | 141,391 | |
Total current assets | 2,985,012 | 2,956,088 | |
Noncurrent assets: | |||
Long-term investments | 620,551 | 611,135 | |
Property, plant and equipment, net | 1,060,425 | 1,066,133 | |
Intangible assets, net | 279,653 | 294,701 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,546,043 | 1,545,809 | |
Other assets | 184,790 | 171,538 | |
Total assets | 6,872,673 | 6,841,603 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 593,543 | 683,147 | |
Short-term convertible debt, net | 494,357 | 493,877 | |
Total current liabilities | 1,087,900 | 1,177,024 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 593,605 | 593,095 | |
Other long-term liabilities | 117,352 | 119,935 | |
Total liabilities | 1,798,857 | 1,890,054 | |
Stockholders’ equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 189,776,577 and 188,598,154 shares issued and outstanding, respectively | 190 | 189 | |
Additional paid-in capital | 5,619,264 | 5,611,562 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,700) | (9,860) | |
Accumulated other comprehensive loss | (1,046) | (28,788) | |
Accumulated deficit | (532,892) | (621,554) | |
Total stockholders’ equity | 5,073,816 | 4,951,549 | [2] |
Total liabilities and stockholders’ equity | $ 6,872,673 | $ 6,841,603 | |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. The beginning balances for the three-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, 2023 filed with the SEC on February 26, 2024. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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) | 189,776,577 | 188,598,154 |
Common stock, shares outstanding (in shares) | 189,776,577 | 188,598,154 |
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 loss: | Accumulated Deficit: | |||
Shares of common stock, beginning balances (in shares) at Dec. 31, 2022 | [1] | 186,251,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 1,350,000 | ||||||||
Shares of common stock, ending balances (in shares) at Mar. 31, 2023 | 187,601,000 | ||||||||
Beginning balances at Dec. 31, 2022 | [1] | $ 4,603,156 | $ 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 | (42,440) | |||||||
Stock-based compensation | 54,328 | ||||||||
Change in Common stock held by the Nonqualified Deferred Compensation plan (NQDC) | 1,090 | (1,090) | |||||||
Other comprehensive income (loss) | (6,855) | (6,855) | |||||||
Net income | 50,852 | 50,852 | |||||||
Ending balances at Mar. 31, 2023 | $ 4,659,043 | $ 188 | 5,417,873 | (9,949) | (10,722) | (738,347) | |||
Shares of common stock, beginning balances (in shares) at Dec. 31, 2023 | 188,598,154 | 188,598,000 | [1] | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans (in shares) | 1,179,000 | ||||||||
Shares of common stock, ending balances (in shares) at Mar. 31, 2024 | 189,776,577 | 189,777,000 | |||||||
Beginning balances at Dec. 31, 2023 | [1] | $ 4,951,549 | [2] | $ 189 | 5,611,562 | (9,860) | (28,788) | (621,554) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuances under equity incentive plans, net of tax | 1 | (55,669) | |||||||
Stock-based compensation | 61,531 | ||||||||
Change in Common stock held by the Nonqualified Deferred Compensation plan (NQDC) | 1,840 | (1,840) | |||||||
Other comprehensive income (loss) | 27,742 | 27,742 | |||||||
Net income | 88,662 | 88,662 | |||||||
Ending balances at Mar. 31, 2024 | $ 5,073,816 | $ 190 | $ 5,619,264 | $ (11,700) | $ (1,046) | $ (532,892) | |||
[1] The beginning balances for the three-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, 2023 filed with the SEC on February 26, 2024. (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 88,662 | $ 50,852 |
Adjustments to reconcile net income to net cash used in operating activities: | ||
Depreciation and amortization | 27,350 | 26,421 |
Non-cash interest expense | 990 | 1,029 |
Accretion of discount on investments | (2,502) | (1,970) |
Stock-based compensation | 58,249 | 53,695 |
Gain on sale of nonfinancial assets | (10,000) | 0 |
Impairment of assets | 0 | 12,650 |
Deferred income taxes | 285 | (6,360) |
Unrealized foreign exchange loss (gain) | (10,804) | 6,615 |
Other | 127 | (222) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (3,386) | (138,796) |
Inventory | (16,820) | (14,098) |
Other current assets | (17,353) | (36,001) |
Other assets | (12,130) | (323) |
Accounts payable and other short-term liabilities | (59,006) | (31,686) |
Other long-term liabilities | 3,309 | 4,262 |
Net cash provided by (used in) operating activities | 46,971 | (73,932) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property, plant and equipment | (26,104) | (24,456) |
Maturities and sales of investments | 131,533 | 215,118 |
Purchases of investments | (121,665) | (220,364) |
Proceeds from sale of nonfinancial assets | 10,000 | 0 |
Purchase of intangible assets | (8,000) | (310) |
Net cash used in investing activities | (14,236) | (30,012) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercises of awards under equity incentive plans | 7,197 | 21,169 |
Taxes paid related to net share settlement of equity awards | (49,948) | (51,422) |
Payments of contingent consideration | 0 | (9,475) |
Principal repayments of financing leases | (42) | (1,014) |
Net cash used in financing activities | (42,793) | (40,742) |
Effect of exchange rate changes on cash | 1,927 | 229 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (8,131) | (144,457) |
Cash and cash equivalents: | ||
Beginning of period | 755,127 | 724,531 |
End of period | 746,996 | 580,074 |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | ||
Cash paid for interest | 1,420 | 1,437 |
Cash paid for income taxes | 2,301 | 4,364 |
SUPPLEMENTAL CASH FLOW DISCLOSURES FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Increase (decrease) in accounts payable and accrued liabilities related to fixed assets | 8,167 | (8,430) |
Decrease in accounts payable and accrued liabilities related to intangible assets | $ (8,512) | $ (1,478) |
BUSINESS OVERVIEW AND SIGNIFICA
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 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 months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024 or any other period. Change in Presentation Effective during the three months ended March 31, 2024, the Company changed its presentation for foreign currency transaction gains and losses resulting from remeasurement and idle plant costs within its Condensed Consolidated Statements of Comprehensive Income. Effective with this change in presentation, foreign currency transaction gains and losses resulting from remeasurement are presented in Other Income (Expense), Net and idle plant costs are presented in Cost of Sales. Prior to this change in presentation, both foreign currency transaction gains and losses resulting from remeasurement and idle plant costs were presented in Selling, General and Administrative (SG&A) expense. The Company believes that this change in presentation is preferable because the revised presentation is more consistent with how management measures the Company’s operating performance. Prior period amounts were revised to conform to current period presentation. The impact of the change in presentation resulted in an increase of $8.9 million to Cost of Sales, a decrease of $12.0 million to SG&A, a decrease of $3.1 million to Total Operating Expenses, and an increase of $3.1 million to Other Income (Expense), Net for the three months ended March 31, 2023. The change in presentation had no impact to Net Income, Total Stockholders’ Equity or earnings per share for the three months ended March 31, 2023. 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 three months ended March 31, 2024, 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, 2023. 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 (FASB) during the three months ended March 31, 2024, 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, 2023, that the Company believes are of significance or potential significance to the Company. The following paragraphs discuss new accounting pronouncements issued by the FASB, but not yet adopted by the Company. In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting Topic 280, Improvements to Reportable Segment Disclosures , to improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. The effective date for the update is for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024 and should be applied on a retrospective basis to all periods presented. The Company is currently evaluating the effect of adopting the update on its related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740, Improvements to Income Tax Disclosures . The guidance requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. The effective date for the update is for fiscal years beginning after December 15, 2024. The Company is currently evaluating the effect of the update on its related disclosures. |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
FINANCIAL INSTRUMENTS | FINANCIAL INSTRUMENTS All marketable securities were classified as available-for-sale as of March 31, 2024 and December 31, 2023. The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category for each period presented: March 31, 2024 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 402,091 $ — $ — $ 402,091 $ 402,091 $ — $ — Level 2: Money market instruments 313,928 — — 313,928 313,928 — — Corporate debt securities 609,615 1,533 (1,552) 609,596 — 177,583 432,013 U.S. government agency securities 218,811 107 (1,165) 217,753 14,982 115,568 87,203 Commercial paper 22,005 — — 22,005 15,995 6,010 — Asset-backed securities 101,806 147 (195) 101,758 — 423 101,335 Subtotal 1,266,165 1,787 (2,912) 1,265,040 344,905 299,584 620,551 Total $ 1,668,256 $ 1,787 $ (2,912) $ 1,667,131 $ 746,996 $ 299,584 $ 620,551 December 31, 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 $ 229,676 $ — $ — $ 229,676 $ 229,676 $ — $ — Level 2: Money market instruments 499,483 — — 499,483 499,483 — — Corporate debt securities 587,896 3,476 (1,996) 589,376 — 193,251 396,125 U.S. government agency securities 251,952 556 (1,140) 251,368 19,976 111,343 120,049 Commercial paper 20,076 5 — 20,081 5,992 14,089 — Asset-backed securities 94,744 351 (134) 94,961 — — 94,961 Subtotal 1,454,151 4,388 (3,270) 1,455,269 525,451 318,683 611,135 Total $ 1,683,827 $ 4,388 $ (3,270) $ 1,684,945 $ 755,127 $ 318,683 $ 611,135 (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 March 31, 2024, 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 March 31, 2024 and December 31, 2023, the fair value of the Company’s strategic investments was $11.3 million in each period. 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, 2023 for additional information related to the Company’s non-marketable securities policy. |
SUPPLEMENTAL FINANCIAL STATEMEN
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION | 3 Months Ended |
Mar. 31, 2024 | |
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: March 31, December 31, Raw materials $ 148,140 $ 155,704 Work-in-process 599,462 571,107 Finished goods 390,380 380,372 Total inventory $ 1,137,982 $ 1,107,183 Property, Plant and Equipment, Net consisted of the following: March 31, December 31, Property, plant and equipment, gross $ 1,948,434 $ 1,933,222 Accumulated depreciation (888,009) (867,089) Total property, plant and equipment, net $ 1,060,425 $ 1,066,133 Depreciation expense, net of amounts capitalized into inventory, for the three months ended March 31, 2024 and 2023 was $12.6 million and $10.3 million, respectively. Intangible Assets, Net consisted of the following: March 31, December 31, Finite-lived intangible assets $ 709,730 $ 710,011 Accumulated amortization (430,077) (415,310) Net carrying value $ 279,653 $ 294,701 In the first quarter of 2024, the Company received $10.0 million due to the achievement of a regulatory approval milestone by a third party related to previously sold intangible assets, which the Company recorded as a Gain on Sale of Nonfinancial Assets in the Condensed Consolidated Statements of Comprehensive Income. Accounts Payable and Accrued Liabilities consisted of the following: March 31, December 31, Accounts payable and accrued operating expenses $ 292,238 $ 315,509 Accrued compensation expense 148,479 201,067 Accrued rebates payable 101,599 96,179 Foreign currency exchange forward contracts 13,676 33,853 Accrued royalties payable 10,188 14,299 Lease liability 8,574 8,779 Accrued income taxes 6,071 2,651 Deferred revenue 5,151 4,620 Other 7,567 6,190 Total accounts payable and accrued liabilities $ 593,543 $ 683,147 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023. 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 March 31, 2024 and December 31, 2023. 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 quoted prices in active markets for identical assets (Level 1) as of March 31, 2024 or December 31, 2023. The Company had no financial assets or liabilities that are remeasured on a recurring basis using unobservable inputs that reflect estimates and assumptions (Level 3) as of March 31, 2024 or December 31, 2023. Fair Value Measurements as of March 31, 2024 Significant Other Assets: Other current assets: NQDC Plan assets $ 2,487 Other assets: NQDC Plan assets 31,993 Restricted investments (1) 2,405 Total other assets 34,398 Total assets $ 36,885 Liabilities: Current liabilities: NQDC Plan liability $ 2,487 Other long-term liabilities: NQDC Plan liability 31,993 Total liabilities $ 34,480 Fair Value Measurements as of December 31, 2023 Significant Other Assets: Other current assets: NQDC Plan assets $ 2,026 Other assets: NQDC Plan assets 28,119 Restricted investments (1) 2,393 Total other assets 30,512 Total assets $ 32,538 Liabilities: Current liabilities: NQDC Plan liability $ 2,026 Other long-term liabilities: NQDC Plan liability 28,119 Total liabilities $ 30,145 (1) The restricted investments as of March 31, 2024 and December 31, 2023 secure the Company's irrevocable standby letters of credit obtained in connection with certain commercial agreements. There were no transfers between levels during the three months ended March 31, 2024. |
DERIVATIVE INSTRUMENTS AND HEDG
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | 3 Months Ended |
Mar. 31, 2024 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES | DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES The Company uses foreign currency exchange forward contracts (forward contracts) to protect against the 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 21 months. The Company also enters into forward contracts to manage foreign exchange risk related to asset or liability positions denominated in currencies other than USD. Such forward contracts are considered to be economic hedges, are not designated as hedging instruments and have maturities of up to three months. The Company does not use derivative instruments for speculative trading purposes. The Company is exposed to counterparty credit risk on its derivatives. The Company has established and maintains strict counterparty credit guidelines and enters into hedging agreements with financial institutions that are investment grade or better to minimize the Company’s exposure to potential defaults. The Company is not required to pledge collateral under these agreements. The following table summarizes the aggregate notional amounts for the Company’s derivatives outstanding as of the periods presented. Forward Contracts March 31, December 31, Derivatives designated as hedging instruments: Sell $ 1,019,379 $ 1,249,662 Purchase $ 157,832 $ 198,408 Derivatives not designated as hedging instruments: Sell $ 318,213 $ 350,269 Purchase $ 10,955 $ 90,102 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 March 31, December 31, Derivatives designated as hedging instruments: Asset Derivatives Other current assets $ 11,937 $ 6,663 Other assets 2,489 1,855 Subtotal $ 14,426 $ 8,518 Liability Derivatives Accounts payable and accrued liabilities $ 11,883 $ 30,005 Other long-term liabilities 2,512 8,171 Subtotal $ 14,395 $ 38,176 Derivatives not designated as hedging instruments: Asset Derivatives Other current assets $ 930 $ 547 Liability Derivatives Accounts payable and accrued liabilities $ 1,793 $ 3,848 Total Derivatives Assets $ 15,356 $ 9,065 Total Derivatives Liabilities $ 16,188 $ 42,024 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, 2023. 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 March 31, 2024 2023 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (1,119) $ 3,470 Operating expenses $ 504 $ (456) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 7,728 $ (4,163) As of March 31, 2024, the amounts expected to be reclassified from Accumulated Other Comprehensive Income (AOCI) to earnings as the forecasted revenues and operating expense transactions occur over the next twelve months, were not material. For additional discussion of balances in AOCI see Note 7 – Accumulated Other Comprehensive Income . |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Convertible Notes As of March 31, 2024, 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: March 31, December 31, 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) $ 495,000 $ 495,000 Unamortized discount net of deferred offering costs (643) (1,123) 2024 Notes, net (1) 494,357 493,877 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) 600,000 600,000 Unamortized discount net of deferred offering costs (6,395) (6,905) 2027 Notes, net 593,605 593,095 Total convertible debt, net $ 1,087,962 $ 1,086,972 Fair value of fixed-rate convertible debt (2) : 2024 Notes $ 487,055 $ 488,288 2027 Notes 596,622 619,260 Total fair value of fixed-rate convertible debt $ 1,083,677 $ 1,107,548 (1) As the 2024 Notes mature in August 2024, the outstanding principal of the 2024 Notes is classified as a current liability as of March 31, 2024. (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, 2023. Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended 2024 2023 Coupon interest expense $ 2,616 $ 2,616 Accretion of discount on convertible notes 841 839 Amortization of debt issuance costs 149 148 Total interest expense on convertible debt $ 3,606 $ 3,603 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, 2023 for additional information related to the Company’s convertible debt. |
ACCUMULATED OTHER COMPREHENSIVE
ACCUMULATED OTHER COMPREHENSIVE INCOME | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2023 $ (29,658) $ 870 $ (28,788) Other comprehensive income (loss) before 28,860 (2,242) 26,618 Less: gain (loss) reclassified from AOCI (615) — (615) Tax effect — 509 509 Net current-period other comprehensive income (loss) 29,475 (1,733) 27,742 AOCI balance as of March 31, 2024 $ (183) $ (863) $ (1,046) Three Months Ended March 31, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2022 $ 8,226 $ (12,093) $ (3,867) Other comprehensive income (loss) before (7,859) 5,247 (2,612) Less: gain (loss) reclassified from AOCI 3,014 — 3,014 Tax effect — (1,229) (1,229) Net current-period other comprehensive income (loss) (10,873) 4,018 (6,855) AOCI balance as of March 31, 2023 $ (2,647) $ (8,075) $ (10,722) For additional discussion of reclassifications from AOCI see Note 5 – Derivative Instruments and Hedging Strategies . |
REVENUE, CREDIT CONCENTRATIONS
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION | 3 Months Ended |
Mar. 31, 2024 | |
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 focuses on the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The following table presents Total Revenues and disaggregates Net Product Revenues by product. Three Months Ended 2024 2023 VIMIZIM $ 192,520 $ 189,192 VOXZOGO 152,889 87,836 NAGLAZYME 105,629 123,021 PALYNZIQ 75,709 62,352 BRINEURA 39,047 39,144 KUVAN 35,910 50,478 ALDURAZYME 35,262 34,403 ROCTAVIAN 849 — Total net product revenues 637,815 586,426 Royalty and other revenues 11,018 9,989 Total revenues $ 648,833 $ 596,415 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 the Company's commercial products sold directly by the Company, except for ALDURAZYME, which is marketed and sold exclusively by Sanofi worldwide. Three Months Ended 2024 2023 United States $ 192,999 $ 166,761 Europe 195,748 160,692 Latin America 78,594 67,748 Middle East 57,075 91,642 Rest of world 78,137 65,180 Total net product revenues marketed by the Company 602,553 552,023 ALDURAZYME net product revenues marketed by Sanofi 35,262 34,403 Total net product revenues $ 637,815 $ 586,426 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 2024 2023 Customer A 14 % 14 % Customer B 11 % 10 % Total 25 % 24 % On a consolidated basis, two customers accounted for 15% and 11% of the Company’s March 31, 2024 accounts receivable balance, respectively, compared to December 31, 2023, when two customers accounted for 15% and 12% of the accounts receivable balance, respectively. As of March 31, 2024, and December 31, 2023, the accounts receivable balance for Sanofi included $63.1 million and $63.4 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, natural disasters 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 | 3 Months Ended |
Mar. 31, 2024 | |
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 2024 2023 Cost of sales $ 3,244 $ 4,331 Research and development 20,677 19,828 Selling, general and administrative 34,328 29,536 Total stock-based compensation expense $ 58,249 $ 53,695 |
EARNINGS PER COMMON SHARE
EARNINGS PER COMMON SHARE | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
EARNINGS PER COMMON SHARE | EARNINGS PER COMMON SHARE Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the ESPP, unvested RSUs and contingent issuances of common stock related to the Company’s convertible debt. The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Three Months Ended 2024 2023 Numerator: Net Income, basic $ 88,662 $ 50,852 Add: Interest expense, net of tax, on the Company's convertible debt 2,769 937 Net Income, diluted $ 91,431 $ 51,789 Denominator: Weighted-average common shares outstanding, basic 188,866 186,667 Effect of dilutive securities: Common stock issuable under the Company's equity incentive plans 2,061 3,726 Common stock issuable under the Company’s convertible debt (1) 8,335 3,970 Weighted-average common shares outstanding, diluted 199,262 194,363 Earnings per common share, basic $ 0.47 $ 0.27 Earnings per common share, diluted $ 0.46 $ 0.27 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 2024 2023 Common stock issuable under the Company's equity incentive plans 10,947 8,610 Common stock issuable under the Company’s convertible debt (1) — 4,365 Total number of potentially issuable shares 10,947 12,975 (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 the Company’s convertible debt, see Note 6 - Debt. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
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 recently received a subpoena from the U.S. Department of Justice (DOJ) requesting that the Company produce certain documents regarding sponsored testing programs relating to VIMIZIM and NAGLAZYME. The Company has produced the requested documents in response to the subpoena and is cooperating fully. The Company is unable to make any assurances regarding the outcome of the investigation by the DOJ, or the impact, if any, that such investigation may have on the Company’s business, Condensed Consolidated Balance Sheets, Condensed Consolidated Statements of Comprehensive Income or Condensed Consolidated Statements of Cash Flows. Contingent Payments As of March 31, 2024, the Company was subject to contingent payments, primarily comprised of development, regulatory and commercial milestones. Those considered reasonably possible totaled $738.6 million, of this amount the Company may pay up to $16.4 million in the next year if certain contingencies are met. $576.5 million of the total balance 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 March 31, 2024, such commitments were estimated at $386.7 million, of which $340.6 million is expected to be paid during the remainder of 2024 as underlying goods and services are received. The Company has also licensed technology from third parties, for which it is required to pay royalties upon future sales, subject to certain annual minimums. The amount also includes hosting fees and other enterprise resource planning (ERP) system implementation costs for which the Company is committed. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net income | $ 88,662 | $ 50,852 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 shares | |
Trading Arrangements, by Individual | |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
V. Bryan Lawlis [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the three months ended March 31, 2024, 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 (1) Non- Rule 10b5-1 (2) Total Shares of Common Stock to be Sold (3) Expiration Date V. Bryan Lawlis Director Adoption February 28, 2024 X up to 6,600 August 30, 2024 (1) Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. (2) “Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act. (3) 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. |
Name | V. Bryan Lawlis |
Title | Director |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | February 28, 2024 |
Arrangement Duration | 184 days |
Aggregate Available | 6,600 |
BUSINESS OVERVIEW AND SIGNIFI_2
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 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 months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024 or any other period. |
Change in Presentation | Change in Presentation Effective during the three months ended March 31, 2024, the Company changed its presentation for foreign currency transaction gains and losses resulting from remeasurement and idle plant costs within its Condensed Consolidated Statements of Comprehensive Income. Effective with this change in presentation, foreign currency transaction gains and losses resulting from remeasurement are presented in Other Income (Expense), Net and idle plant costs are presented in Cost of Sales. Prior to this change in presentation, both foreign currency transaction gains and losses resulting from remeasurement and idle plant costs were presented in Selling, General and Administrative (SG&A) expense. The Company believes that this change in presentation is preferable because the revised presentation is more consistent with how management measures the Company’s operating performance. |
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 (FASB) during the three months ended March 31, 2024, 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, 2023, that the Company believes are of significance or potential significance to the Company. The following paragraphs discuss new accounting pronouncements issued by the FASB, but not yet adopted by the Company. In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting Topic 280, Improvements to Reportable Segment Disclosures , to improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. The effective date for the update is for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024 and should be applied on a retrospective basis to all periods presented. The Company is currently evaluating the effect of adopting the update on its related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740, Improvements to Income Tax Disclosures . The guidance requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. The effective date for the update is for fiscal years beginning after December 15, 2024. The Company is currently evaluating the effect of the update on its related disclosures. |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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: March 31, 2024 Amortized Cost Gross Gross Aggregate Fair Value Cash and Cash Equivalents Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash $ 402,091 $ — $ — $ 402,091 $ 402,091 $ — $ — Level 2: Money market instruments 313,928 — — 313,928 313,928 — — Corporate debt securities 609,615 1,533 (1,552) 609,596 — 177,583 432,013 U.S. government agency securities 218,811 107 (1,165) 217,753 14,982 115,568 87,203 Commercial paper 22,005 — — 22,005 15,995 6,010 — Asset-backed securities 101,806 147 (195) 101,758 — 423 101,335 Subtotal 1,266,165 1,787 (2,912) 1,265,040 344,905 299,584 620,551 Total $ 1,668,256 $ 1,787 $ (2,912) $ 1,667,131 $ 746,996 $ 299,584 $ 620,551 December 31, 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 $ 229,676 $ — $ — $ 229,676 $ 229,676 $ — $ — Level 2: Money market instruments 499,483 — — 499,483 499,483 — — Corporate debt securities 587,896 3,476 (1,996) 589,376 — 193,251 396,125 U.S. government agency securities 251,952 556 (1,140) 251,368 19,976 111,343 120,049 Commercial paper 20,076 5 — 20,081 5,992 14,089 — Asset-backed securities 94,744 351 (134) 94,961 — — 94,961 Subtotal 1,454,151 4,388 (3,270) 1,455,269 525,451 318,683 611,135 Total $ 1,683,827 $ 4,388 $ (3,270) $ 1,684,945 $ 755,127 $ 318,683 $ 611,135 (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) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: March 31, December 31, Raw materials $ 148,140 $ 155,704 Work-in-process 599,462 571,107 Finished goods 390,380 380,372 Total inventory $ 1,137,982 $ 1,107,183 |
Schedule of Property, Plant and Equipment, Net | Property, Plant and Equipment, Net consisted of the following: March 31, December 31, Property, plant and equipment, gross $ 1,948,434 $ 1,933,222 Accumulated depreciation (888,009) (867,089) Total property, plant and equipment, net $ 1,060,425 $ 1,066,133 |
Schedule of Intangible Assets, Net | Intangible Assets, Net consisted of the following: March 31, December 31, Finite-lived intangible assets $ 709,730 $ 710,011 Accumulated amortization (430,077) (415,310) Net carrying value $ 279,653 $ 294,701 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities consisted of the following: March 31, December 31, Accounts payable and accrued operating expenses $ 292,238 $ 315,509 Accrued compensation expense 148,479 201,067 Accrued rebates payable 101,599 96,179 Foreign currency exchange forward contracts 13,676 33,853 Accrued royalties payable 10,188 14,299 Lease liability 8,574 8,779 Accrued income taxes 6,071 2,651 Deferred revenue 5,151 4,620 Other 7,567 6,190 Total accounts payable and accrued liabilities $ 593,543 $ 683,147 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023. 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 quoted prices in active markets for identical assets (Level 1) as of March 31, 2024 or December 31, 2023. The Company had no financial assets or liabilities that are remeasured on a recurring basis using unobservable inputs that reflect estimates and assumptions (Level 3) as of March 31, 2024 or December 31, 2023. Fair Value Measurements as of March 31, 2024 Significant Other Assets: Other current assets: NQDC Plan assets $ 2,487 Other assets: NQDC Plan assets 31,993 Restricted investments (1) 2,405 Total other assets 34,398 Total assets $ 36,885 Liabilities: Current liabilities: NQDC Plan liability $ 2,487 Other long-term liabilities: NQDC Plan liability 31,993 Total liabilities $ 34,480 Fair Value Measurements as of December 31, 2023 Significant Other Assets: Other current assets: NQDC Plan assets $ 2,026 Other assets: NQDC Plan assets 28,119 Restricted investments (1) 2,393 Total other assets 30,512 Total assets $ 32,538 Liabilities: Current liabilities: NQDC Plan liability $ 2,026 Other long-term liabilities: NQDC Plan liability 28,119 Total liabilities $ 30,145 (1) The restricted investments as of March 31, 2024 and December 31, 2023 secure the Company's irrevocable standby letters of credit obtained in connection with certain commercial agreements. |
DERIVATIVE INSTRUMENTS AND HE_2
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, December 31, Derivatives designated as hedging instruments: Sell $ 1,019,379 $ 1,249,662 Purchase $ 157,832 $ 198,408 Derivatives not designated as hedging instruments: Sell $ 318,213 $ 350,269 Purchase $ 10,955 $ 90,102 |
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 March 31, December 31, Derivatives designated as hedging instruments: Asset Derivatives Other current assets $ 11,937 $ 6,663 Other assets 2,489 1,855 Subtotal $ 14,426 $ 8,518 Liability Derivatives Accounts payable and accrued liabilities $ 11,883 $ 30,005 Other long-term liabilities 2,512 8,171 Subtotal $ 14,395 $ 38,176 Derivatives not designated as hedging instruments: Asset Derivatives Other current assets $ 930 $ 547 Liability Derivatives Accounts payable and accrued liabilities $ 1,793 $ 3,848 Total Derivatives Assets $ 15,356 $ 9,065 Total Derivatives Liabilities $ 16,188 $ 42,024 |
Schedule of Impact of Gains and Losses from Derivatives Designated and Not 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 March 31, 2024 2023 Derivatives Designated as Cash Flow Hedging Instruments Cash Flow Hedging Gains (Losses) Cash Flow Hedging Gains (Losses) Net product revenues $ (1,119) $ 3,470 Operating expenses $ 504 $ (456) Derivatives Not Designated as Hedging Instruments Gains (Losses) Recognized in Earnings Gains (Losses) Recognized in Earnings Operating expenses $ 7,728 $ (4,163) |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Convertible Debt | The following table summarizes information regarding the Company’s convertible debt: March 31, December 31, 0.599% senior subordinated convertible notes due in August 2024 (the 2024 Notes) $ 495,000 $ 495,000 Unamortized discount net of deferred offering costs (643) (1,123) 2024 Notes, net (1) 494,357 493,877 1.25% senior subordinated convertible notes due in May 2027 (the 2027 Notes) 600,000 600,000 Unamortized discount net of deferred offering costs (6,395) (6,905) 2027 Notes, net 593,605 593,095 Total convertible debt, net $ 1,087,962 $ 1,086,972 Fair value of fixed-rate convertible debt (2) : 2024 Notes $ 487,055 $ 488,288 2027 Notes 596,622 619,260 Total fair value of fixed-rate convertible debt $ 1,083,677 $ 1,107,548 (1) As the 2024 Notes mature in August 2024, the outstanding principal of the 2024 Notes is classified as a current liability as of March 31, 2024. (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, 2023. |
Schedule of Interest Expense on Convertible Debt | Interest expense on the Company’s convertible debt consisted of the following: Three Months Ended 2024 2023 Coupon interest expense $ 2,616 $ 2,616 Accretion of discount on convertible notes 841 839 Amortization of debt issuance costs 149 148 Total interest expense on convertible debt $ 3,606 $ 3,603 |
ACCUMULATED OTHER COMPREHENSI_2
ACCUMULATED OTHER COMPREHENSIVE INCOME (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2023 $ (29,658) $ 870 $ (28,788) Other comprehensive income (loss) before 28,860 (2,242) 26,618 Less: gain (loss) reclassified from AOCI (615) — (615) Tax effect — 509 509 Net current-period other comprehensive income (loss) 29,475 (1,733) 27,742 AOCI balance as of March 31, 2024 $ (183) $ (863) $ (1,046) Three Months Ended March 31, 2023 Unrealized Gains Unrealized Gains Total AOCI balance as of December 31, 2022 $ 8,226 $ (12,093) $ (3,867) Other comprehensive income (loss) before (7,859) 5,247 (2,612) Less: gain (loss) reclassified from AOCI 3,014 — 3,014 Tax effect — (1,229) (1,229) Net current-period other comprehensive income (loss) (10,873) 4,018 (6,855) AOCI balance as of March 31, 2023 $ (2,647) $ (8,075) $ (10,722) |
REVENUE, CREDIT CONCENTRATION_2
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Concentration Risk And Geographic Information [Abstract] | |
Schedule of Disaggregation of Total Net Product Revenues by Product | The following table presents Total Revenues and disaggregates Net Product Revenues by product. Three Months Ended 2024 2023 VIMIZIM $ 192,520 $ 189,192 VOXZOGO 152,889 87,836 NAGLAZYME 105,629 123,021 PALYNZIQ 75,709 62,352 BRINEURA 39,047 39,144 KUVAN 35,910 50,478 ALDURAZYME 35,262 34,403 ROCTAVIAN 849 — Total net product revenues 637,815 586,426 Royalty and other revenues 11,018 9,989 Total revenues $ 648,833 $ 596,415 |
Schedule of Disaggregation of Total Net Product Revenues by Geographic Region | The table below disaggregates total Net Product Revenues by geographic region, which is based on patient location for the Company's commercial products sold directly by the Company, except for ALDURAZYME, which is marketed and sold exclusively by Sanofi worldwide. Three Months Ended 2024 2023 United States $ 192,999 $ 166,761 Europe 195,748 160,692 Latin America 78,594 67,748 Middle East 57,075 91,642 Rest of world 78,137 65,180 Total net product revenues marketed by the Company 602,553 552,023 ALDURAZYME net product revenues marketed by Sanofi 35,262 34,403 Total net product revenues $ 637,815 $ 586,426 |
Schedule of Total Net Product Revenue Concentrations Attributed to Largest Customers | The following table illustrates the percentage of the Company’s total Net Product Revenues attributed to the Company’s largest customers for the periods presented. Three Months Ended 2024 2023 Customer A 14 % 14 % Customer B 11 % 10 % Total 25 % 24 % |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 2024 2023 Cost of sales $ 3,244 $ 4,331 Research and development 20,677 19,828 Selling, general and administrative 34,328 29,536 Total stock-based compensation expense $ 58,249 $ 53,695 |
EARNINGS PER COMMON SHARE (Tabl
EARNINGS PER COMMON SHARE (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Earnings Per Common Share | The following table sets forth the computation of basic and diluted earnings per common share (common shares in thousands): Three Months Ended 2024 2023 Numerator: Net Income, basic $ 88,662 $ 50,852 Add: Interest expense, net of tax, on the Company's convertible debt 2,769 937 Net Income, diluted $ 91,431 $ 51,789 Denominator: Weighted-average common shares outstanding, basic 188,866 186,667 Effect of dilutive securities: Common stock issuable under the Company's equity incentive plans 2,061 3,726 Common stock issuable under the Company’s convertible debt (1) 8,335 3,970 Weighted-average common shares outstanding, diluted 199,262 194,363 Earnings per common share, basic $ 0.47 $ 0.27 Earnings per common share, diluted $ 0.46 $ 0.27 |
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 2024 2023 Common stock issuable under the Company's equity incentive plans 10,947 8,610 Common stock issuable under the Company’s convertible debt (1) — 4,365 Total number of potentially issuable shares 10,947 12,975 (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 the Company’s convertible debt, see Note 6 - Debt. |
BUSINESS OVERVIEW AND SIGNIFI_3
BUSINESS OVERVIEW AND SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Cost of sales | $ 125,180 | $ 135,472 |
Selling, general and administrative expense | (225,906) | (211,023) |
Costs and expenses | (560,371) | (534,011) |
Other income (expense), net | $ 1,267 | (13,887) |
Revision of Prior Period, Adjustment | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Cost of sales | 8,900 | |
Selling, general and administrative expense | 12,000 | |
Costs and expenses | 3,100 | |
Other income (expense), net | $ 3,100 |
FINANCIAL INSTRUMENTS - Schedul
FINANCIAL INSTRUMENTS - Schedule of Cash, Cash Equivalents and Available-for-Sale Securities by Significant Investment Category (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | ||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 1,668,256 | $ 1,683,827 | |
Gross Unrealized Gains | 1,787 | 4,388 | |
Gross Unrealized Losses | (2,912) | (3,270) | |
Aggregate Fair Value | 1,667,131 | 1,684,945 | |
Cash and Cash Equivalents | 746,996 | 755,127 | [1] |
Short-term marketable securities | 299,584 | 318,683 | [1] |
Long-term marketable securities | $ 620,551 | $ 611,135 | [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 | $ 402,091 | $ 229,676 | |
Cash, aggregate fair value | 402,091 | 229,676 | |
Level 2: | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,266,165 | 1,454,151 | |
Gross Unrealized Gains | 1,787 | 4,388 | |
Gross Unrealized Losses | (2,912) | (3,270) | |
Aggregate Fair Value | 1,265,040 | 1,455,269 | |
Cash and Cash Equivalents | 344,905 | 525,451 | |
Short-term marketable securities | 299,584 | 318,683 | |
Long-term marketable securities | 620,551 | 611,135 | |
Level 2: | Money market instruments | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 313,928 | 499,483 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 313,928 | 499,483 | |
Cash and Cash Equivalents | 313,928 | 499,483 | |
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 | 609,615 | 587,896 | |
Gross Unrealized Gains | 1,533 | 3,476 | |
Gross Unrealized Losses | (1,552) | (1,996) | |
Aggregate Fair Value | 609,596 | 589,376 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term marketable securities | 177,583 | 193,251 | |
Long-term marketable securities | 432,013 | 396,125 | |
Level 2: | U.S. government agency securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 218,811 | 251,952 | |
Gross Unrealized Gains | 107 | 556 | |
Gross Unrealized Losses | (1,165) | (1,140) | |
Aggregate Fair Value | 217,753 | 251,368 | |
Cash and Cash Equivalents | 14,982 | 19,976 | |
Short-term marketable securities | 115,568 | 111,343 | |
Long-term marketable securities | 87,203 | 120,049 | |
Level 2: | Commercial paper | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 22,005 | 20,076 | |
Gross Unrealized Gains | 0 | 5 | |
Gross Unrealized Losses | 0 | 0 | |
Aggregate Fair Value | 22,005 | 20,081 | |
Cash and Cash Equivalents | 15,995 | 5,992 | |
Short-term marketable securities | 6,010 | 14,089 | |
Long-term marketable securities | 0 | 0 | |
Level 2: | Asset-backed securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 101,806 | 94,744 | |
Gross Unrealized Gains | 147 | 351 | |
Gross Unrealized Losses | (195) | (134) | |
Aggregate Fair Value | 101,758 | 94,961 | |
Cash and Cash Equivalents | 0 | 0 | |
Short-term marketable securities | 423 | 0 | |
Long-term marketable securities | $ 101,335 | $ 94,961 | |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
FINANCIAL INSTRUMENTS - Narrati
FINANCIAL INSTRUMENTS - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Impairment of assets | $ 12.6 | ||
Strategic Investment | Fair Value, Measurements, Recurring | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Strategic investments fair value | $ 11.3 | $ 11.3 |
SUPPLEMENTAL FINANCIAL STATEM_3
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Raw materials | $ 148,140 | $ 155,704 | |
Work-in-process | 599,462 | 571,107 | |
Finished goods | 390,380 | 380,372 | |
Total inventory | $ 1,137,982 | $ 1,107,183 | [1] |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
SUPPLEMENTAL FINANCIAL STATEM_4
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Property, plant and equipment, gross | $ 1,948,434 | $ 1,933,222 | |
Accumulated depreciation | (888,009) | (867,089) | |
Total property, plant and equipment, net | $ 1,060,425 | $ 1,066,133 | [1] |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
SUPPLEMENTAL FINANCIAL STATEM_5
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Depreciation | $ 12.6 | $ 10.3 |
Milestone payments received | $ 10 |
SUPPLEMENTAL FINANCIAL STATEM_6
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Intangible Assets, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Finite-lived intangible assets | $ 709,730 | $ 710,011 |
Accumulated amortization | (430,077) | (415,310) |
Net carrying value | $ 279,653 | $ 294,701 |
SUPPLEMENTAL FINANCIAL STATEM_7
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accounts payable and accrued operating expenses | $ 292,238 | $ 315,509 | |
Accrued compensation expense | 148,479 | 201,067 | |
Accrued rebates payable | 101,599 | 96,179 | |
Foreign currency exchange forward contracts | 13,676 | 33,853 | |
Accrued royalties payable | 10,188 | 14,299 | |
Lease liability | 8,574 | 8,779 | |
Accrued income taxes | 6,071 | 2,651 | |
Deferred revenue | 5,151 | 4,620 | |
Other | 7,567 | 6,190 | |
Accounts payable and accrued liabilities | $ 593,543 | $ 683,147 | [1] |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
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 |
Financial liabilities remeasured | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets remeasured | 0 | 0 |
Financial liabilities remeasured | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | ||
Assets: | ||
Fair value of other assets | 34,398,000 | 30,512,000 |
Fair value of total financial assets | 36,885,000 | 32,538,000 |
Liabilities: | ||
Fair value of total financial liabilities | 34,480,000 | 30,145,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | NQDC Plan liability | ||
Liabilities: | ||
Fair value of other current liabilities | 2,487,000 | 2,026,000 |
Fair value of other long-term liabilities | 31,993,000 | 28,119,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | NQDC Plan assets | ||
Assets: | ||
Fair value of other current assets | 2,487,000 | 2,026,000 |
Fair value of other assets | 31,993,000 | 28,119,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Restricted Investments | ||
Assets: | ||
Fair value of other assets | $ 2,405,000 | $ 2,393,000 |
DERIVATIVE INSTRUMENTS AND HE_3
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Narrative (Details) | Mar. 31, 2024 |
Derivatives designated as hedging instruments: | |
Derivative [Line Items] | |
Maturity of derivatives | 21 months |
Derivatives not designated as hedging instruments: | |
Derivative [Line Items] | |
Maturity of derivatives | 3 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 | Mar. 31, 2024 | Dec. 31, 2023 |
Derivatives designated as hedging instruments: | Sell | ||
Derivative [Line Items] | ||
Notional amount | $ 1,019,379 | $ 1,249,662 |
Derivatives designated as hedging instruments: | Purchase | ||
Derivative [Line Items] | ||
Notional amount | 157,832 | 198,408 |
Derivatives not designated as hedging instruments: | Sell | ||
Derivative [Line Items] | ||
Notional amount | 318,213 | 350,269 |
Derivatives not designated as hedging instruments: | Purchase | ||
Derivative [Line Items] | ||
Notional amount | $ 10,955 | $ 90,102 |
DERIVATIVE INSTRUMENTS AND HE_5
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Schedule of Fair Value Carrying Amounts of Derivatives (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Derivative [Line Items] | ||
Derivative asset, fair value | $ 15,356 | $ 9,065 |
Derivative liability, fair value | 16,188 | 42,024 |
Level 2: | Derivatives designated as hedging instruments: | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 14,426 | 8,518 |
Derivative liability, fair value | 14,395 | 38,176 |
Level 2: | Derivatives designated as hedging instruments: | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 11,937 | 6,663 |
Level 2: | Derivatives designated as hedging instruments: | Other assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 2,489 | 1,855 |
Level 2: | Derivatives designated as hedging instruments: | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 11,883 | 30,005 |
Level 2: | Derivatives designated as hedging instruments: | Other long-term liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | 2,512 | 8,171 |
Level 2: | Derivatives not designated as hedging instruments: | Other current assets | ||
Derivative [Line Items] | ||
Derivative asset, fair value | 930 | 547 |
Level 2: | Derivatives not designated as hedging instruments: | Accounts payable and accrued liabilities | ||
Derivative [Line Items] | ||
Derivative liability, fair value | $ 1,793 | $ 3,848 |
DERIVATIVE INSTRUMENTS AND HE_6
DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES - Schedule of Impact of Gains and Losses from Derivatives Designated and Not Designated as Hedging Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
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 | $ 504 | $ (456) |
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 | (1,119) | 3,470 |
Derivatives not designated as hedging instruments: | ||
Derivative Instruments, Gain (Loss) [Line Items] | ||
Derivatives Not Designated as Hedging Instruments | $ 7,728 | $ (4,163) |
DEBT - Narrative (Details)
DEBT - Narrative (Details) $ in Billions | Mar. 31, 2024 USD ($) |
Debt Disclosure [Abstract] | |
Carrying value of equity component | $ 1.1 |
DEBT - Schedule of Convertible
DEBT - Schedule of Convertible Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | |
Debt Instrument [Line Items] | |||
Convertible notes | $ 1,100,000 | ||
Convertible debt, current | 494,357 | $ 493,877 | [1] |
Convertible debt, noncurrent | 593,605 | 593,095 | [1] |
Total convertible debt, net | 1,087,962 | 1,086,972 | |
Total fair value of fixed-rate convertible debt | $ 1,083,677 | $ 1,107,548 | |
$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 | (643) | (1,123) | |
Convertible debt, current | 494,357 | 493,877 | |
Total fair value of fixed-rate convertible debt | $ 487,055 | $ 488,288 | |
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 | (6,395) | (6,905) | |
Convertible debt, noncurrent | 593,605 | 593,095 | |
Total fair value of fixed-rate convertible debt | $ 596,622 | $ 619,260 | |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
DEBT - Schedule of Interest Exp
DEBT - Schedule of Interest Expense on Convertible Debt (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule Of Interest Expenses [Line Items] | ||
Total interest expense on convertible debt | $ 3,547 | $ 3,703 |
Convertible Senior Notes | ||
Schedule Of Interest Expenses [Line Items] | ||
Coupon interest expense | 2,616 | 2,616 |
Accretion of discount on convertible notes | 841 | 839 |
Amortization of debt issuance costs | 149 | 148 |
Total interest expense on convertible debt | $ 3,606 | $ 3,603 |
ACCUMULATED OTHER COMPREHENSI_3
ACCUMULATED OTHER COMPREHENSIVE INCOME (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balances | [2] | $ 4,951,549 | [1] | $ 4,603,156 |
Other comprehensive income (loss) before reclassifications | 26,618 | (2,612) | ||
Less: gain (loss) reclassified from AOCI | (615) | 3,014 | ||
Tax effect | 509 | (1,229) | ||
Net current-period other comprehensive income (loss) | 27,742 | (6,855) | ||
Ending balances | 5,073,816 | 4,659,043 | ||
AOCI attributable to parent | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balances | [2] | (28,788) | (3,867) | |
Net current-period other comprehensive income (loss) | 27,742 | (6,855) | ||
Ending balances | (1,046) | (10,722) | ||
Unrealized Gains (Losses) on Cash Flow Hedges | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balances | (29,658) | 8,226 | ||
Other comprehensive income (loss) before reclassifications | 28,860 | (7,859) | ||
Less: gain (loss) reclassified from AOCI | (615) | 3,014 | ||
Tax effect | 0 | 0 | ||
Net current-period other comprehensive income (loss) | 29,475 | (10,873) | ||
Ending balances | (183) | (2,647) | ||
Unrealized Gains (Losses) on Available-for-Sale Debt Securities | ||||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | ||||
Beginning balances | 870 | (12,093) | ||
Other comprehensive income (loss) before reclassifications | (2,242) | 5,247 | ||
Less: gain (loss) reclassified from AOCI | 0 | 0 | ||
Tax effect | 509 | (1,229) | ||
Net current-period other comprehensive income (loss) | (1,733) | 4,018 | ||
Ending balances | $ (863) | $ (8,075) | ||
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. The beginning balances for the three-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, 2023 filed with the SEC on February 26, 2024. |
REVENUE, CREDIT CONCENTRATION_3
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Narrative (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 USD ($) segment | Dec. 31, 2023 USD ($) | ||
Concentration Risk And Geographic Information [Line Items] | |||
Number of operating business segment | segment | 1 | ||
Accounts receivable, net | $ 637,163 | $ 633,704 | [1] |
Sanofi | |||
Concentration Risk And Geographic Information [Line Items] | |||
Accounts receivable, net | $ 63,100 | $ 63,400 | |
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 15% | 15% | |
Credit Concentration Risk | Accounts Receivable | Customer Two | |||
Concentration Risk And Geographic Information [Line Items] | |||
Concentration risk, percentage | 11% | 12% | |
[1] (1) December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
REVENUE, CREDIT CONCENTRATION_4
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Disaggregation of Total Net Product Revenues by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue from External Customer [Line Items] | ||
Revenue | $ 648,833 | $ 596,415 |
Product | ||
Revenue from External Customer [Line Items] | ||
Revenue | 637,815 | 586,426 |
VIMIZIM | ||
Revenue from External Customer [Line Items] | ||
Revenue | 192,520 | 189,192 |
VOXZOGO | ||
Revenue from External Customer [Line Items] | ||
Revenue | 152,889 | 87,836 |
NAGLAZYME | ||
Revenue from External Customer [Line Items] | ||
Revenue | 105,629 | 123,021 |
PALYNZIQ | ||
Revenue from External Customer [Line Items] | ||
Revenue | 75,709 | 62,352 |
BRINEURA | ||
Revenue from External Customer [Line Items] | ||
Revenue | 39,047 | 39,144 |
KUVAN | ||
Revenue from External Customer [Line Items] | ||
Revenue | 35,910 | 50,478 |
ALDURAZYME | ||
Revenue from External Customer [Line Items] | ||
Revenue | 35,262 | 34,403 |
ROCTAVIAN | ||
Revenue from External Customer [Line Items] | ||
Revenue | 849 | 0 |
Royalty and other revenues | ||
Revenue from External Customer [Line Items] | ||
Revenue | $ 11,018 | $ 9,989 |
REVENUE, CREDIT CONCENTRATION_5
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Disaggregation of Total Net Product Revenues by Geographic Region (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 648,833 | $ 596,415 |
ALDURAZYME | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 35,262 | 34,403 |
Product | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 637,815 | 586,426 |
Marketed by Company | Products excluding ALDURAZYME | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 602,553 | 552,023 |
Marketed by Company | Products excluding ALDURAZYME | United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 192,999 | 166,761 |
Marketed by Company | Products excluding ALDURAZYME | Europe | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 195,748 | 160,692 |
Marketed by Company | Products excluding ALDURAZYME | Latin America | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 78,594 | 67,748 |
Marketed by Company | Products excluding ALDURAZYME | Middle East | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 57,075 | 91,642 |
Marketed by Company | Products excluding ALDURAZYME | Rest of world | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 78,137 | 65,180 |
Marketed by Sanofi | ALDURAZYME | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 35,262 | $ 34,403 |
REVENUE, CREDIT CONCENTRATION_6
REVENUE, CREDIT CONCENTRATIONS AND GEOGRAPHIC INFORMATION - Schedule of Total Net Product Revenue Concentrations Attributed to Largest Customers (Details) - Customer Concentration Risk - Net Product Revenue | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Customer A & B | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 25% | 24% |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 14% | 14% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 11% | 10% |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 58,249 | $ 53,695 |
Cost of sales | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 3,244 | 4,331 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 20,677 | 19,828 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 34,328 | $ 29,536 |
EARNINGS PER COMMON SHARE - Sch
EARNINGS PER COMMON SHARE - Schedule of Computation of Basic and Diluted Earnings Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net Income, basic | $ 88,662 | $ 50,852 |
Add: Interest expense, net of tax, on the Company's convertible debt | 2,769 | 937 |
Net Income, diluted | $ 91,431 | $ 51,789 |
Denominator: | ||
Weighted-average common shares outstanding, basic (in shares) | 188,866 | 186,667 |
Effect of dilutive securities: | ||
Weighted-average common shares outstanding, diluted (in shares) | 199,262 | 194,363 |
Earnings per common share, basic (in dollars per share) | $ 0.47 | $ 0.27 |
Earnings per common share, diluted (in dollars per share) | $ 0.46 | $ 0.27 |
Common stock issuable under the Company's equity incentive plans | ||
Effect of dilutive securities: | ||
Effect of dilutive securities (in shares) | 2,061 | 3,726 |
Common stock issuable under the Company’s convertible debt | ||
Effect of dilutive securities: | ||
Effect of dilutive securities (in shares) | 8,335 | 3,970 |
EARNINGS PER COMMON SHARE - S_2
EARNINGS PER COMMON SHARE - Schedule of Anti-Dilutive Common Stock Excluded from Computation of Diluted Earnings Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total number of potentially issuable shares (in shares) | 10,947 | 12,975 |
$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 | |
Common stock issuable under the Company's equity incentive plans | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total number of potentially issuable shares (in shares) | 10,947 | 8,610 |
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) | 0 | 4,365 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) third_party | |
Commitments And Contingencies [Line Items] | |
Contingent payments upon achievement of certain development and regulatory activities and commercial sales and licensing milestones | $ 738.6 |
Contingent payments reasonably possible upon achievement of certain development and regulatory activities commercial sales and licensing milestones, to be paid, year one | 16.4 |
Purchase commitment | 386.7 |
Purchase commitments expected to be paid in 2024 | 340.6 |
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 | $ 576.5 |
Number of third parties | third_party | 2 |