Cover
Cover - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 21, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38829 | ||
Entity Registrant Name | Shockwave Medical, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 27-0494101 | ||
Entity Address, Address Line One | 5403 Betsy Ross Drive | ||
Entity Address, City or Town | Santa Clara | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 95054 | ||
City Area Code | 510 | ||
Local Phone Number | 279-4262 | ||
Title of 12(b) Security | Shockwave Medical, Inc., common stock, par value $0.001 per share | ||
Trading Symbol | SWAV | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 7.7 | ||
Entity Common Stock, Shares Outstanding | 37,396,816 | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive proxy statement for its 2024 Annual Meeting of Stockholders (the “Proxy Statement”) are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of the end of the Registrant’s fiscal year ended December 31, 2023. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement shall not be deemed to be filed as part hereof. | ||
Entity Central Index Key | 0001642545 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | San Mateo, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 328,422 | $ 156,586 |
Short-term investments | 662,132 | 147,907 |
Accounts receivable, net | 114,552 | 71,366 |
Inventory | 107,587 | 75,112 |
Prepaid expenses and other current assets | 12,567 | 8,292 |
Total current assets | 1,225,260 | 459,263 |
Operating lease right-of-use assets | 29,707 | 32,365 |
Property and equipment, net | 68,923 | 48,152 |
Equity method investment | 1,643 | 3,512 |
Intangible assets, net | 92,857 | 0 |
Goodwill | 39,568 | 0 |
Deferred tax assets | 99,169 | 97,568 |
Other assets | 9,436 | 5,229 |
TOTAL ASSETS | 1,566,563 | 646,089 |
CURRENT LIABILITIES: | ||
Accounts payable | 8,868 | 6,721 |
Accrued liabilities | 91,696 | 55,375 |
Lease liability, current portion | 3,641 | 1,278 |
Total current liabilities | 104,205 | 63,374 |
Lease liability, noncurrent portion | 35,103 | 34,928 |
Convertible Debt, Noncurrent | 731,863 | 0 |
Debt, noncurrent portion | 0 | 24,198 |
Related party contract liability, noncurrent portion | 12,273 | 12,273 |
Deferred tax liabilities | 3,609 | 0 |
Long-term income tax liability | 1,526 | 0 |
Other liabilities | 9,307 | 0 |
TOTAL LIABILITIES | 897,886 | 134,773 |
Commitments and contingencies (Note 8) | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; No shares issued and outstanding as of December 31, 2023 and 2022 | 0 | 0 |
Common stock, $0.001 par value per share; 281,274,838 shares authorized; 36,990,700 and 36,235,546 issued and outstanding as of December 31, 2023 and 2022, respectively | 37 | 36 |
Additional paid-in capital | 557,882 | 548,960 |
Accumulated other comprehensive income (loss) | 293 | (867) |
Retained earnings (accumulated deficit) | 110,465 | (36,813) |
TOTAL STOCKHOLDERS’ EQUITY | 668,677 | 511,316 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 1,566,563 | $ 646,089 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 281,274,838 | 281,274,838 |
Common stock, shares issued (in shares) | 36,990,700 | 36,235,546 |
Common stock, shares outstanding (in shares) | 36,990,700 | 36,235,546 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | |||
Product revenue | $ 730,230,000 | $ 489,733,000 | $ 237,146,000 |
Cost of revenue: | |||
Cost of product revenue | 95,388,000 | 64,996,000 | 41,438,000 |
Gross profit | 634,842,000 | 424,737,000 | 195,708,000 |
Operating expenses: | |||
Research and development | 145,647,000 | 81,679,000 | 50,544,000 |
Sales and marketing | 234,837,000 | 161,995,000 | 111,288,000 |
General and administrative | 95,265,000 | 56,929,000 | 34,747,000 |
Total operating expenses | 475,749,000 | 300,603,000 | 196,579,000 |
Income (loss) from operations | 159,093,000 | 124,134,000 | (871,000) |
Loss from equity method investment | (1,869,000) | (2,475,000) | (6,286,000) |
Interest expense | (6,905,000) | (1,886,000) | (1,096,000) |
Other income (expense), net | 23,962,000 | 1,055,000 | (582,000) |
Net income (loss) before taxes | 174,281,000 | 120,828,000 | (8,835,000) |
Income tax (benefit) provision | 27,003,000 | (95,168,000) | 301,000 |
Net income (loss) | 147,278,000 | 215,996,000 | (9,136,000) |
Other comprehensive income (loss) | |||
Unrealized gain (loss) on available-for-sale securities, net of tax | 1,165,000 | (659,000) | (211,000) |
Adjustment for net gain realized and included in other income, net | (5,000) | (6,000) | 0 |
Total comprehensive income (loss) | $ 148,438,000 | $ 215,331,000 | $ (9,347,000) |
Net income (loss) per share | |||
Basic (USD per share) | $ 4.01 | $ 6.02 | $ (0.26) |
Diluted (USD per share) | $ 3.85 | $ 5.70 | $ (0.26) |
Denominator: | |||
Basic (in shares) | 36,706,060 | 35,900,738 | 35,098,130 |
Diluted (in shares) | 38,206,269 | 37,881,590 | 35,098,130 |
Revenue, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] | Product [Member] |
Cost, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] | Product [Member] |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Retained Earnings (Accumulated Deficit) |
Beginning balance (in shares) at Dec. 31, 2020 | 34,684,337 | ||||
Beginning Balance at Dec. 31, 2020 | $ 225,654,000 | $ 35,000 | $ 469,283,000 | $ 9,000 | $ (243,673,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 547,155 | ||||
Exercise of stock options | 3,049,000 | 3,049,000 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 36,833 | ||||
Issuance of common stock under employee stock purchase plan | 2,837,000 | 2,837,000 | |||
Issuance of common stock in connection with vesting of restricted stock units (in shares) | 239,213 | ||||
Restricted stock units withheld in net settlement for tax (in shares) | (63,066) | ||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | (8,337,000) | (8,337,000) | |||
Stock-based compensation | 27,974,000 | 27,974,000 | |||
Unrealized gain (loss) on available-for-sale securities, net of tax | (211,000) | (211,000) | |||
Net gain reclassified from accumulated other comprehensive income | 0 | ||||
Net income (loss) | (9,136,000) | (9,136,000) | |||
Ending balance (in shares) at Dec. 31, 2021 | 35,444,472 | ||||
Ending balance at Dec. 31, 2021 | 241,830,000 | $ 35,000 | 494,806,000 | (202,000) | (252,809,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 401,757 | ||||
Exercise of stock options | 2,562,000 | $ 1,000 | 2,561,000 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 29,645 | ||||
Issuance of common stock under employee stock purchase plan | 4,487,000 | 4,487,000 | |||
Issuance of common stock in connection with vesting of restricted stock units (in shares) | 359,774 | ||||
Restricted stock units withheld in net settlement for tax (in shares) | (102) | ||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | (23,000) | (23,000) | |||
Stock-based compensation | 47,129,000 | 47,129,000 | |||
Unrealized gain (loss) on available-for-sale securities, net of tax | (659,000) | (659,000) | |||
Net gain reclassified from accumulated other comprehensive income | 6,000 | 6,000 | |||
Net income (loss) | 215,996,000 | 215,996,000 | |||
Ending balance (in shares) at Dec. 31, 2022 | 36,235,546 | ||||
Ending balance at Dec. 31, 2022 | $ 511,316,000 | $ 36,000 | 548,960,000 | (867,000) | (36,813,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 235,067 | 235,067 | |||
Exercise of stock options | $ 1,374,000 | $ 1,000 | 1,373,000 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 38,630 | ||||
Issuance of common stock under employee stock purchase plan | 6,230,000 | 6,230,000 | |||
Issuance of common stock in connection with vesting of restricted stock units (in shares) | 481,635 | ||||
Restricted stock units withheld in net settlement for tax (in shares) | (178) | ||||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | (43,000) | (43,000) | |||
Stock-based compensation | 73,633,000 | 73,633,000 | |||
Purchase of capped calls related to convertible debt, net of tax | (72,271,000) | (72,271,000) | |||
Unrealized gain (loss) on available-for-sale securities, net of tax | 1,165,000 | 1,165,000 | |||
Net gain reclassified from accumulated other comprehensive income | 5,000 | 5,000 | |||
Net income (loss) | 147,278,000 | 147,278,000 | |||
Ending balance (in shares) at Dec. 31, 2023 | 36,990,700 | ||||
Ending balance at Dec. 31, 2023 | $ 668,677,000 | $ 37,000 | $ 557,882,000 | $ 293,000 | $ 110,465,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income (loss) | $ 147,278,000 | $ 215,996,000 | $ (9,136,000) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||
Depreciation and amortization | 10,358,000 | 4,856,000 | 3,579,000 |
Loss from equity method investment | 1,869,000 | 2,475,000 | 6,286,000 |
Stock-based compensation | 73,234,000 | 44,890,000 | 27,257,000 |
Non-cash lease expense | 3,160,000 | 3,042,000 | 1,957,000 |
Amortization of premium and discount on available-for-sale securities | (11,956,000) | (68,000) | 1,093,000 |
Loss on write down of fixed assets | 271,000 | 81,000 | 7,000 |
Loss on extinguishment of debt | 710,000 | 562,000 | 0 |
Deferred income taxes | 14,760,000 | (97,276,000) | 0 |
Amortization of debt issuance costs | 1,507,000 | 533,000 | 511,000 |
Foreign currency remeasurement | (1,278,000) | 572,000 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (41,535,000) | (33,313,000) | (25,746,000) |
Inventory | (31,009,000) | (29,711,000) | (12,073,000) |
Prepaid expenses and other current assets | (3,417,000) | (3,786,000) | (2,110,000) |
Other assets | (4,486,000) | (3,243,000) | 91,000 |
Accounts payable | 112,000 | 1,945,000 | 1,870,000 |
Accrued and other current liabilities | 32,923,000 | 11,941,000 | 21,637,000 |
Lease liabilities | 2,026,000 | (1,764,000) | (187,000) |
Increase (Decrease) in Income Taxes Payable | 1,526,000 | 0 | 0 |
Net cash provided by operating activities | 196,053,000 | 117,732,000 | 15,036,000 |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of available-for-sale securities | (747,471,000) | (137,797,000) | (117,245,000) |
Proceeds from maturities of available-for-sale securities | 246,750,000 | 100,773,000 | 156,100,000 |
Purchase of property and equipment | (30,595,000) | (25,126,000) | (12,439,000) |
Payments to Acquire Businesses, Net of Cash Acquired | (94,411,000) | 0 | 0 |
Net cash (used in) provided by investing activities | (625,727,000) | (62,150,000) | 26,416,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Payments of taxes withheld on net settled vesting of restricted stock units | (43,000) | (23,000) | (8,337,000) |
Proceeds from debt financing | 80,000,000 | 24,169,000 | 0 |
Proceeds from Convertible Debt | 730,455,000 | 0 | 0 |
Purchases of capped calls related to convertible debt | (96,375,000) | 0 | 0 |
Payment For Assumed Warrant Liabilities | (16,240,000) | 0 | 0 |
Proceeds from stock option exercises | 1,374,000 | 2,562,000 | 3,049,000 |
Proceeds from issuance of common stock under employee stock purchase plan | 6,230,000 | 4,487,000 | 2,837,000 |
Repayments of long-term debt | 105,000,000 | 18,196,000 | 0 |
Net cash provided by (used in) financing activities | 600,401,000 | 12,999,000 | (2,451,000) |
Effect of exchange rate changes on cash and cash equivalents | 797,000 | (1,153,000) | 0 |
Net increase in cash, cash equivalents and restricted cash | 171,524,000 | 67,428,000 | 39,001,000 |
Cash, cash equivalents and restricted cash at beginning of period | 158,302,000 | 90,874,000 | 51,873,000 |
Cash, cash equivalents and restricted cash equivalents at end of period | 329,826,000 | 158,302,000 | 90,874,000 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Interest paid | 1,882,000 | 791,000 | 586,000 |
Income tax paid | 7,894,000 | 2,162,000 | 143,000 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Right-of-use asset obtained in exchange for lease liability | 195,000 | 7,911,000 | 21,885,000 |
Property and equipment purchases included in accounts payable and accrued liabilities | 3,733,000 | 5,709,000 | 1,923,000 |
Equity method investment obtained in exchange for related party contract liability | $ 0 | $ 0 | $ 12,273,000 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation Shockwave Medical, Inc. (the “Company”) was incorporated on June 17, 2009. The Company is primarily engaged in the development and commercialization of novel technologies that transform the care of patients with cardiovascular disease. The Company is focused on its intravascular lithotripsy (“IVL”) technology for the treatment of calcified plaque in patients with peripheral vascular, coronary vascular and heart valve disease. Built on a balloon catheter platform, the IVL technology uses lithotripsy to disrupt both superficial and deep vascular calcium, while minimizing soft tissue injury, and an integrated angioplasty balloon to dilate blockages at low pressures, restoring blood flow. Additionally, the Company continues to develop its coronary sinus reducer (“Reducer”) technology for the treatment of refractory angina. The Company, which is headquartered in Santa Clara, California and operates primarily in the United States, began commercial and manufacturing operations in 2016. The consolidated financial statements include the accounts of Shockwave Medical, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $990.6 million, which are available to fund future working capital requirements, investments, acquisitions, or repayments of outstanding indebtedness. The Company believes that its cash, cash equivalents, and short-term investments as of December 31, 2023, will be sufficient for the Company to continue as a going concern for at least 12 months from the date these consolidated financial statements are filed with the Securities and Exchange Commission. The Company’s future capital requirements will depend on many factors, including its growth rate, the timing and extent of its spending to support research and development activities, and the timing and cost of establishing additional sales and marketing capabilities. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include, but are not limited to the valuation of inventory, goodwill and intangible assets, the allowance for doubtful accounts, recoverability of the Company’s net deferred tax assets, and related valuation allowance amounts and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates . Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated statements of cash flows: December 31, 2023 2022 (in thousands) Cash and cash equivalents $ 328,422 $ 156,586 Restricted cash 1,404 1,716 Total cash, cash equivalents, and restricted cash $ 329,826 $ 158,302 Restricted cash as of December 31, 2023 and 2022 relates to corporate credit card security, customer bank guarantee security, and letters of credit established for the real estate property leases relating to the Company’s office buildings, and is recorded as other assets on the consolidated balance sheets. Short-Term Investments Short-term investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company determines the appropriate classification of its investments in debt securities at the time of purchase. Available-for-sale securities with original maturities beyond three months at the date of purchase are classified as current based on their availability for use in current operations. As the Company may sell its securities at any time for use in current operations even if the securities have not yet reached maturity, all marketable securities are classified as current assets in the Company’s consolidated balance sheets. The Company evaluates, on a quarterly basis, its marketable securities for potential impairment. For marketable securities in an unrealized loss position, the Company assesses whether such declines are due to credit loss based on factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If credit loss exists, the Company assess whether it has plans to sell the security or it is more likely than not it will be required to sell any marketable security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other income, net. The Company has not identified any such impairment losses to date. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other income, net. Any portion of unrealized loss that is not a result of a credit loss, is recognized in other comprehensive income. Realized gains and losses, if any, on marketable securities are included in other income, net. The cost of investments sold is based on the specific-identification method. Interest on marketable securities is included in other income, net. The Company elected to present accrued interest receivable separately from short-term and long-term investments on its consolidated balance sheets. Accrued interest receivable was recorded in prepaid expenses and other current assets as of December 31, 2023 and 2022. The Company also elected to exclude accrued interest receivable from the estimation of expected credit losses on its marketable securities and reverse accrued interest receivable through interest income (expense) when amounts are determined to be uncollectible. The Company did not write off any accrued interest receivable during the year ended December 31, 2023, 2022, and 2021. Equity Method Investments Entities for which the Company has significant influence over the activities of the entity, but does not control, are accounted for under the equity method of accounting in accordance with ASC 323, Investments - Equity Method and Joint Ventures ( “ ASC 323 ” ) . The Company’s carrying value in the equity method investment is reported as equity method investment on the Company’s consolidated balance sheets. The Company records its proportionate share of the underlying income or loss which is recognized in earnings or loss from the equity method investment. T he Company eliminates a portion of intra-entity profit to the extent the goods sold by the Company have not yet been sold through by the equity method investee to an end customer at the end of the reporting period. The profit earned by the Company from the equity method investee for items not yet sold through is eliminated through equity method earnings or loss which is recognized in income (loss) from equity method investment. The Company assesses its equity method investment for impairment when events or circumstances suggest that the carrying amount of the investment may be impaired. The Company considers all available evidence in assessing whether a decline in fair value is other than temporary. If the decline in fair value is determined to be other than temporary, the difference between the carrying amount of the investment and estimated fair value is recognized as an impairment charge. The Company has not identified any such impairment losses to date. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash, investments and trade receivables. Risks associated with cash, cash equivalents and restricted cash are mitigated by banking with creditworthy institutions and purchasing investments with investment grade ratings. The Company performs ongoing evaluations of its customers using its historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of its customers, and generally does not require collateral. Concentration of Customers For the years ended December 31, 2023, 2022 and 2021 no customer accounted for 10% or more of the Company’s revenue. There were no customers which accounted for 10% or more of the Company’s accounts receivable as of December 31, 2023 and 2022. Fair Value of Financial Instruments The Company’s cash and cash equivalents, restricted cash, short-term investments, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to their short maturities. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at invoice value, net of any allowance for credit losses. The Company’s expected loss allowance methodology for receivables is developed using its historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of its customers. Specific allowance amounts are established to record the appropriate allowance for customers that have an identified risk of default. General allowance amounts are established based upon the Company’s assessment of expected credit losses for its receivables by aging category. Balances are written off when they are ultimately determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: For the Year Ended December 31, 2023 2022 2021 (in thousands) Beginning balance $ 710 $ 350 $ 380 Amounts charged (reversed) to costs and expenses 1,479 364 (12) Write-offs (10) (4) (18) Ending balance $ 2,179 $ 710 $ 350 Inventory Inventory is stated at the lower of standard cost (which approximates actual cost on a first-in, first-out basis) and net realizable value. Inventory costs include direct materials, direct labor and normal manufacturing overhead. Prior to achieving normal capacity, excess capacity costs are expensed in cost of product revenue as period costs. Finished goods that are used for research and development are expensed as consumed. Provisions for slow-moving, excess or obsolete inventories are recorded when required to reduce inventory values to their estimated net realizable values based on product life cycle, development plans, product expiration or quality issues. Property, Plant, and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Land is carried at cost. Depreciation and amortization (other than land, which is not depreciated) is computed using the straight-line method over the estimated useful lives of the respective assets: Asset Category Useful Life Equipment 3 - 5 years Office Furniture 5 years Software 3 years Building 25 years Leasehold Improvement Lesser of useful life or remaining lease term When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheets and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows which the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date. Revenue To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers ( “ ASC 606 ” ) , the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Product Revenue The Company records product revenue primarily from the sale of its IVL catheters and Reducer. The Company sells its products to hospitals, primarily through direct sales, as well as through distributors in selected international markets. Product revenue is recognized when a customer obtains control of promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. For products sold through direct sales and distributors internationally, control is transferred based on the contractual or standard shipping terms. The Company has elected to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity, and not a separate performance obligation. The Company may provide for the use of an IVL generator and connector cable under an agreement to customers at no charge to facilitate the use of the IVL catheters. These agreements generally do not contain contractually enforceable minimum commitments and are generally cancellable by either party with 30 days’ notice. License Revenue For arrangements that contain a license of the Company’s functional intellectual property with a customer, the Company considers whether the license grant is distinct from other performance obligations in the arrangement. A license grant of functional intellectual property is generally considered to be capable of being distinct if a customer can benefit from the license on its own or together with other readily available resources. License revenue for licenses of functional intellectual property is recognized at a point in time when the Company satisfies its performance obligation of transferring the license to the customer. Consideration received in advance of the satisfaction of a performance obligation is recognized as a contract liability. No license revenues have been recognized for the years ended December 31, 2023, 2022, and 2021. Research and Development Costs Research and development costs, including new product development, regulatory compliance, and clinical research are expensed as incurred. Accrued Research and Development Costs The Company accrues liabilities for estimated costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The estimated costs of research and development activities are recorded based upon the estimated amount of services provided but not yet invoiced, and these costs are included in accrued liabilities on the consolidated balance sheets and within research and development expense on the consolidated statements of operations and comprehensive loss. These costs are accrued for based on factors such as estimates of the work completed and budget provided and in accordance with agreements established with third-party service providers. Significant judgments and estimates are made in determining the accrued liabilities balance in each reporting period. Accrued liabilities are adjusted as actual costs become known. There have not been any material differences between accrued costs and actual costs incurred since the Company’s inception. Stock-Based Compensation The Company accounts for share-based payments at fair value. The fair value of stock options is measured using the Black-Scholes option-pricing model. For share-based awards that vest subject to the satisfaction of a service requirement, the fair value measurement date for stock-based compensation awards is the date of grant and the expense is recognized on a straight-line basis, over the vesting period. For share-based awards that vest upon the satisfaction of a performance target, the related compensation cost is recognized over the requisite service period based on the expected achievement of the performance target. The Company accounts for forfeitures as they occur. Leases The Company determines if an arrangement is or contains a lease at contract inception by assessing whether the arrangement contains an identified asset and whether the lessee has the right to control such asset. The Company is required to classify leases as either finance or operating leases and to record a right-of-use asset and a lease liability for all leases with a term greater than 12 months regardless of the lease classification. The lease classification will determine whether the lease expense is recognized based on an effective interest rate method or on a straight-line basis over the term of the lease. The Company determines the initial classification and measurement of its right-of-use assets and lease liabilities at the lease commencement date and thereafter, if modified. The Company does not have material finance leases. For its operating leases with a lease term of 12 months or greater, the Company recognized a right-of-use asset and a lease liability on its consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise. Operating lease cost for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the consolidated statements of operations and comprehensive loss. Lease payments may be fixed or variable; however, only fixed payments are included in the Company’s lease liability calculation. Lease costs for the Company’s operating leases are recognized on a straight-line basis within operating expenses over the lease term. The Company’s lease agreements may contain variable non-lease components such as common area maintenance, operating expenses or other costs, which are expensed as incurred. The Company elected the practical expedients to exclude from its balance sheets recognition of leases having a term of 12 months or less (short-term leases) and to not separate lease components and non-lease components for its long-term real estate leases. Defined Contribution Plan The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code of 1986, as amended. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. The Company recognized expense related to its contributions to the plan of $5.3 million, $3.7 million, and $2.5 million for the years ended December 31, 2023, 2022, and 2021, respectively. Comprehensive Income (Loss) Comprehensive income (loss) is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments. Foreign Currency The functional currency of the Company’s foreign subsidiaries is the U.S. Dollar. Accordingly, all monetary assets and liabilities of the subsidiary are remeasured at the current exchange rate at the end of the period, nonmonetary assets and liabilities are remeasured at historical rates, and revenue and expenses are remeasured at average exchange rates during the period. There were net foreign currency transaction losses of $1.8 million, $1.1 million, and $0.8 million for the years ended December 31, 2023, 2022, and 2021 respectively. Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Diluted net income (loss) per share attributable to the Company’s stockholders is calculated based on the weighted-average number of shares of its common stock and other dilutive securities outstanding. Where the Company was in a loss position for any periods presented, basic net loss per share was the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. The Company uses the if-converted method of calculating diluted earnings per share. Under the “if-converted” method, diluted earnings per share will generally be calculated assuming that all the Notes (as defined below) were converted solely into shares of common stock at the beginning of the reporting period, unless the result would be anti-dilutive. Because the principal amount of the Notes upon conversion is required to be paid in cash, and only the excess is permitted to be settled in shares, the application of the if-converted method will produce a similar result as the treasury stock method prior to the adoption of ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity ’ s Own Equity (Subtopic 815-40)-Accounting For Convertible Instruments and Contracts in an Entity ’ s Own Equity (“ASU 2020-06”). The effect of the treasury stock method is that the shares issuable upon conversion of such Notes are not included in the calculation of diluted earnings per share except to the extent that the conversion value of such Notes exceeds their principal amount. Prior to conversion of the Company’s convertible debt, the Company will include, in the diluted net income per common share calculation, the effect of the additional shares that may be issued when the Company’s common stock price exceeds the conversion price using the if‐converted method. The Company’s convertible debt has no impact on diluted net income per common share unless the average price of the Company’s common stock exceeds the conversion price because the Company is required to settle the principal amount of the convertible debt in cash upon conversion. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred tax assets are evaluated for future realization and reduced by a valuation allowance to the extent the Company believes it is more likely than not that they will not be realized. The Company considers all available positive and negative evidence, including future reversals of existing taxable temporary reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, carryback potential if permitted under the tax law, and results of recent operations. The Company also accounts for uncertain tax positions in accordance with ASC 740, Income Taxes – Accounting for Income Taxes ( “ ASC 740 ” ) , which requires the Company to adjust the financial statements to reflect only those tax positions that are more-likely-than-not to be sustained upon review by federal or state examiners. The Company may recognize a tax benefit only if it is more likely than not the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such positions are then measured based on the largest benefit that has a greater than 50% likelihood of being realized upon settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of provision for income taxes. Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined that it operates in one segment. The Company’s long-lived assets are held predominantly in the United States with the exception of the Company ’ s long lived assets in Costa Rica and Japan which collectively encompass approximately 32% and 15%, respectively, of its consolidated net property, plant, and equipment as of December 31, 2023 and 2022. See the section titled “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K for a description of risk associated with the Company ’ s operations located outside of the United States. Internal-Use Software The Company has internal-use software consisting of cloud-based hosting arrangements with service contracts. The Company capitalizes certain costs incurred to implement such software within prepaid expenses and other current assets, or within other assets. Eligible costs of internal use software and implementation costs of certain hosting arrangements are capitalized. Once the software is ready for its intended use, the Company starts amortizing the capitalized implementation costs on a straight-line basis over the estimated service term or associated hosting arrangement, as applicable. Business combinations The Company applies the provisions of ASC 805, Business Combinations ( “ ASC 805 ” ) , in accounting of its acquisitions. ASC 805 requires recognition of assets acquired, liabilities assumed, and contingent consideration at their fair value on the acquisition date with subsequent changes recognized in earnings; requires acquisition-related expenses to be recognized separately from the business combination and expensed as incurred; requires in-process research and development to be capitalized at fair value as an indefinite-lived intangible asset until completion or abandonment; and requires that changes in accounting for deferred tax asset valuation allowances and acquired uncertain tax positions after the measurement period be recognized as a component of provision for taxes. When an integrated set of assets and activities does not meet the practical screen test and otherwise meets the definition of a “business” under ASC 805, the Company accounts for such acquisitions as business combinations. The purchase price of an acquisition is allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date. The Company bases the estimated fair value of identifiable intangible assets acquired in an acquisition on independent third-party valuations that use information and assumptions provided by the Company ’ s management and considers inputs and assumptions that a market participant would use. Any excess purchase price over the estimated fair values of the assets acquired and liabilities assumed is recorded as goodwill. During the measurement period, which may be up to one year from the acquisition date, the Company may record adjustments to the provisional amounts of assets acquired and liabilities assumed with the corresponding offset to goodwill. Upon the conclusion of the measurement period or final determination of the values of assets acquired or liabilities assumed, whichever comes first, any subsequent adjustments would be recorded in earnings. In addition, uncertain tax positions and tax related valuation allowances assumed in a business combination are initially estimated as of the acquisition date and therefore are also provisional by nature. The Company reevaluates these items quarterly based upon facts and circumstances that existed as of the acquisition date with any adjustments to its preliminary estimates being recorded to goodwill if identified within the measurement period. Goodwill In accordance with ASC 350, Intangibles-Goodwill and Other ( “ ASC 350 ” ) , acquired goodwill is not amortized but is tested for impairment on an annual basis or whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. The Company performs annual impairment reviews of its goodwill balance during the fourth fiscal quarter or more frequently if business factors indicate. In testing for impairment, the Company compares the fair value of its reporting unit to its carrying value including the goodwill of that unit. If the carrying value, including goodwill, exceeds the reporting unit’s fair value, the Company will recognize an impairment loss for the amount by which the carrying amount exceeds the reporting unit’s fair value. The loss recognized cannot exceed the total amount of goodwill allocated to that reporting unit. The Company did not incur any goodwill impairment losses during the year ended December 31, 2023. In-process research and development Intangible assets related to in-process research and development costs are considered indefinite-lived intangible assets until the completion or abandonment of the associated research and development efforts. If and when development is complete, the associated assets would be deemed finite-lived intangible assets and would then be amortized based on their respective estimated useful lives at that point in time. Prior to the completion or abandonment of the associated research and development efforts, the assets are not amortized but are tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate a reduction in the fair value of the in-process research and development projects below their respective carrying amounts. During the fourth fiscal quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of its in-process research and development projects. If the fair value exceeds the carrying value, there is no impairment. Impairment losses on indefinite-lived intangible assets are recognized based solely on a comparison of the fair value of an asset to its carrying value, without consideration of any recoverability test. The Company did not incur any impairment losses during the year ended December 31, 2023. Intangible assets Amortizable intangible assets include customer relationships and developed technology acquired as part of business combinations. Customer relationships and developed technology acquired through business combinations subject to amortization are amortized using the straight-line method over their estimated useful lives ranging from five to 20 years. All intangible assets subject to amortization are reviewed for impairment during the fourth fiscal quarter or more frequently if business factors indicate in accordance with ASC 360, Property, Plant and Equipment ( “ ASC 360 ” ) . The Company did not incur any impairment losses during the year ended December 31, 2023. Contingent Consideration Liabilities Related to Business Combination At each reporting period, the Company evaluates the likelihood of any expected future payments and the associated discount rate to determine the fair value of the contingent consideration. The Company remeasures the fair value of contingent consideration liabilities each reporting period, based on new developments, and records any necessary adjustments as a component of total operating expenses within the consolidated statements of operations until either the contingent consideration obligation is satisfied through payment upon the achievement of, or the obligation no longer exists due to the failure to achieve, the specified milestones. Contingent consideration liabilities are recorded within other liabilities in the consolidated balance sheets. Convertible Debt The Company applies the provisions of ASU 2020-06 which simplify the accounting related to convertible debt instruments by removing major separation models required under current GAAP. Accordingly, the Company does not bifurcate the liability and equity components of the convertible debt on the co |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments and Fair Value Measurements | Financial Instruments and Fair Value Measurements The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: December 31, 2023 Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 43,277 $ — $ — $ 43,277 U.S. treasury securities 109,310 — — 109,310 Marketable securities: U.S. treasury securities 575,203 — — 575,203 Commercial paper — 46,054 — 46,054 Corporate bonds — 20,073 — 20,073 U.S. agency securities — 14,946 — 14,946 Asset-backed securities — 5,856 — 5,856 Total assets $ 727,790 $ 86,929 $ — $ 814,719 Liabilities: Contingent consideration liability $ — $ — $ 9,307 $ 9,307 Convertible debt — 730,455 — 730,455 Total liabilities $ — $ 730,455 $ 9,307 $ 739,762 December 31, 2022 Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 12,076 $ — $ — $ 12,076 Marketable securities: U.S. treasury securities 111,631 — — 111,631 Commercial paper — 8,039 — 8,039 Corporate bonds — 18,808 — 18,808 U.S. agency securities — 9,429 — 9,429 Total assets $ 123,707 $ 36,276 $ — $ 159,983 During the year ended December 31, 2023 and 2022 there were no transfers between Level 1, Level 2 and Level 3. Contingent Consideration Liabilities Related to Business Combination In connection with the Company’s acquisition of Neovasc Inc. (“Neovasc”), a preliminary fair value of $9.3 million was recorded for the Neovasc contingent consideration, which consisted of estimated amounts in relation to the CVR (as defined below), on April 11, 2023, the date on which the closing conditions for the acquisition were met and the transaction was consummated. Assets acquired and liabilities assumed are recorded based on valuations derived from estimated fair value assessments and Level 3 inputs and assumptions used by the Company. There were no changes in the estimated fair value of the contingent consideration liability as of December 31, 2023. See Note 5 “Business Combination” for information regarding existing contingent consideration liabilities as of December 31, 2023. Convertible Debt As of December 31, 2023, the fair value of the Company’s convertible debt was $730.5 million. The Company measures the fair value of its convertible debt for disclosure purposes. The fair value was determined based on the quoted price of the convertible debt in an over-the-counter market on the last trading day of the reporting period and has been classified as Level 2 in the fair value hierarchy. See Note 10 “Convertible Debt” for information regarding the Company’s convertible debt as of December 31, 2023. |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 12 Months Ended |
Dec. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash Equivalents and Short-Term Investments | Cash Equivalents and Short-Term Investments The following is a summary of the Company’s cash equivalents and short-term investments: December 31, 2023 Amortized Unrealized Unrealized Fair Value (in thousands) Cash equivalents: Money market funds $ 43,277 $ — $ — $ 43,277 U.S. treasury securities 109,292 18 — 109,310 Marketable securities: U.S. treasury securities 575,008 233 (38) 575,203 Commercial paper 46,015 52 (13) 46,054 Corporate bonds 19,995 86 (8) 20,073 U.S. agency securities 14,949 16 (19) 14,946 Asset-backed securities 5,792 64 — 5,856 Total $ 814,328 $ 469 $ (78) $ 814,719 Reported as: Cash equivalents $ 152,587 Short-term investments 662,132 Total $ 814,719 December 31, 2022 Amortized Unrealized Unrealized Fair Value (in thousands) Cash equivalents: Money market funds $ 12,076 $ — $ — $ 12,076 Marketable securities: U.S. treasury securities 112,719 3 (1,091) 111,631 Commercial paper 8,039 — — 8,039 Corporate bonds 18,876 8 (76) 18,808 U.S. agency securities 9,432 4 (7) 9,429 Total $ 161,142 $ 15 $ (1,174) $ 159,983 Reported as: Cash equivalents $ 12,076 Short-term investments 147,907 Total $ 159,983 There were $45.9 million and $123.8 million of investments in unrealized loss positions of $0.1 million and $1.2 million as of December 31, 2023 and 2022, respectively. During the years ended December 31, 2023, 2022, and 2021 the Company did not record any other-than-temporary impairment charges on its available-for-sale securities. Based on the Company’s procedures under the expected credit loss model, including an assessment of unrealized losses on the portfolio, the Company concluded that the unrealized losses for its marketable securities were not attributable to credit and therefore an allowance for credit losses for these securities has not been recorded as of December 31, 2023 and 2022. Also, based on the scheduled maturities of the investments, the Company was more likely than not to hold these investments for a period of time sufficient for a recovery of the Company’s cost basis. For the years ended December 31, 2023 and 2022 the Company recognized $5,000 and $6,000 in realized gains on cash equivalents and short-term investments. For the year ended December 31, 2021, the Company recognized no realized gains or losses on cash equivalents and short-term investments. The remaining contractual maturities of the Company’s cash equivalents and short-term investments were as follows: December 31, Fair Value (in thousands) Money market funds $ 43,277 One year or less 764,034 Greater than one year and less than two years 7,408 Total $ 814,719 |
Business Combinations
Business Combinations | 12 Months Ended |
Dec. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Combination | 5. Business Combination Neovasc Inc. On January 16, 2023, the Company entered into a definitive agreement to acquire Neovasc, a company focused on the minimally invasive treatment of refractory angina. On April 11, 2023, the closing conditions were met and the transaction was consummated. Upon the closing of the transaction, the Company acquired all of Neovasc’s issued and outstanding common stock equity for a cash payment of $27.25 per share. During the year ended December 31, 2023, the Company incurred $6.9 million of buyer related transaction costs related to the acquisition of Neovasc, which were recorded as general and administrative expenses. The purchase price consideration for the acquisition totaled $121.4 million, which was comprised of cash paid of $112.1 million to the selling shareholders, and the estimated fair value of the contingent consideration liability in the amount of $9.3 million. The contingent consideration liability consisted of estimated amounts in relation to a contingent value right (a “CVR”) entitling the holders of Neovasc common stock and eligible equity awards to receive an additional cash payment of up to $12.00 per share or per share underlying an eligible equity award (equivalent to a maximum cash payment of $47.0 million) contingent on the attainment of a milestone. The milestone is defined as the final approval by the FDA of the premarket approval application for the Reducer product for the treatment of angina. The milestone achievement timeline and respective payment per share ranges from $12.00 per CVR if the milestone is achieved on or prior to June 30, 2026, $8.00 per CVR if the milestone is achieved between July 1, 2026 and December 31, 2026 and $4.00 per CVR if the milestone is achieved between January 1, 2027 and December 31, 2027. The Company estimated the fair value of the contingent consideration liability using the probability-weighted discounted cash flow method based on the probability of achieving the milestone on each specified milestone date and consequently calculated the fair value of the CVR in the amount of $9.3 million as of the acquisition date. The material factors that may impact the fair value of the contingent consideration are (i) the number of diluted shares outstanding as of the acquisition date that are eligible for the CVR, (ii) the probabilities and timing of achievement of the milestone, and (iii) discount rates, all of which are unobservable Level 3 inputs not supported by market activity. Significant changes in any of these inputs may result in a significant change in fair value, which is estimated at each reporting date with changes reflected as general and administrative expense. The following table summarizes the purchase price consideration for Neovasc: Purchase Price (in thousands) Cash transferred $ 112,129 Contingent consideration liability 9,307 Total $ 121,436 Assets acquired and liabilities assumed are recorded based on valuations derived from estimated fair value assessments and Level 3 inputs and assumptions used by the Company. While the Company believes that its estimates and assumptions underlying the valuations are reasonable, different estimates and assumptions could result in different valuations assigned to the individual assets acquired and liabilities assumed, and the residual amount of goodwill. The following table summarizes the preliminary fair values of assets acquired and liabilities assumed through the Company ’ s Neovasc acquisition at the acquisition date based on management’s best estimates and assumptions as of the reporting date: Purchase Price (in thousands) Cash and cash equivalents $ 17,273 Accounts receivable, net 1,345 Inventory 918 Prepaid expenses and other current assets 841 Operating lease right-of-use assets 310 Property and equipment 156 Intangible assets 95,500 Other assets 502 Total identifiable assets acquired 116,845 Accounts payable 3,334 Accrued liabilities 4,082 Lease liability, current portion 253 Lease liability, noncurrent portion 64 Deferred tax liabilities 10,964 Other liabilities 16,280 Total liabilities assumed 34,977 Net identifiable assets acquired 81,868 Goodwill 39,568 Total purchase price $ 121,436 The purchase price allocation for the acquisition is preliminary and subject to revision as additional information about fair value of assets acquired and liabilities assumed becomes available, primarily related to the Company’s deferred tax liability and the related impact to goodwill. Adjustments recorded in the fourth quarter of 2023 to the amounts recorded as of the second quarter of 2023 included immaterial adjustments to the liabilities assumed. Additional information that existed as of the acquisition date but at the time was unknown to the Company may become known to the Company during the remainder of the measurement period, a period not to exceed 12 months from the acquisition date. The Company measured the identifiable assets and liabilities assumed at their acquisition date fair values separately from goodwill. The intangible assets acquired are the developed technology related to Neovasc’s Reducer, in-process research and development for its Reducer technology, and Neovasc’s customer relationships in place at the time of acquisition. The fair value of the intangible assets acquired as of the acquisition date and, the method used to value these assets as well as the estimated economic lives for amortizable intangible assets were as follows (in thousands, except estimated useful life which is in years): Fair value Estimated useful life Valuation method Customer relationships $ 2,900 5.0 years Avoided cost / lost profit Developed technology 61,200 20.0 years Multi-period excess earnings In-process research and development 31,400 N/A Multi-period excess earnings Total $ 95,500 Goodwill represents the excess of the purchase price over the fair value of the net assets acquired. The acquisition of Neovasc resulted in the recognition of $39.6 million of goodwill which the Company believes relates primarily to the anticipated benefits of synergies created through the acquisition and assembled workforce. The intangible assets and goodwill created as a result of the acquisition of Neovasc are not deductible for tax purposes. As such, the Company recorded deferred tax liabilities of $11.0 million related to the intangible assets in connection with the Company’s acquisition of Neovasc. Supplemental Unaudited Pro Forma Information The following are the supplemental consolidated financial results of the Company and Neovasc on an unaudited pro forma basis, as if the Neovasc acquisition had been consummated on January 1, 2022. Year Ended December 31, 2023 2022 (in thousands) Net revenue $731,699 $493,538 Net income $151,339 $173,596 |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 7. Balance Sheet Components Inventory Inventory consists of the following: December 31, 2023 2022 (in thousands) Raw material $ 25,670 $ 18,456 Work in progress 16,499 7,666 Finished goods 65,418 48,990 Total inventory $ 107,587 $ 75,112 Property and Equipment, Net Property and equipment, net consists of the following: December 31, 2023 2022 (in thousands) Equipment $ 19,687 $ 12,784 Office furniture 1,839 1,171 Software 848 904 Building 12,166 — Land 2,268 — Leasehold improvements 38,168 33,703 Construction in progress 11,016 9,765 Property and equipment, gross 85,992 58,327 Less: accumulated depreciation and amortization (17,069) (10,175) Total property and equipment, net $ 68,923 $ 48,152 Depreciation and amortization expense amounted to $7.7 million, $4.9 million and $3.6 million for the years ended December 31, 2023, 2022 and 2021, respectively. In July 2022, the Company purchased real property in the Coyol Free Trade Zone in Alajuela, Costa Rica, and began the construction of a new manufacturing facility. As of December 31, 2023, the first phase of the facility was completed and occupied and the second phase was still in process of construction. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2023 2022 (in thousands) Employee compensation $ 49,706 $ 32,885 Asset purchases 7,788 4,600 Professional services 6,269 4,044 Research and development costs 8,122 4,007 Excise, sales, income and other taxes 12,320 4,036 Sales and marketing 3,495 2,012 Other 3,996 3,791 Total accrued liabilities $ 91,696 $ 55,375 |
Goodwill and intangible assets
Goodwill and intangible assets | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and intangible assets | 6. Goodwill and intangible assets Goodwill The changes in the carrying amounts of goodwill were as follows: (in thousands) Balance as of December 31, 2022 $ — Goodwill acquired - Neovasc 39,568 Goodwill deductions or impairment — Balance as of December 31, 2023 $ 39,568 The Company performs annual impairment reviews of goodwill during the fourth fiscal quarter or more frequently if required. The Company did not incur any goodwill impairment losses during the year ended December 31, 2023. Intangible assets The following table presents details of the acquired intangible assets as of December 31, 2023 (in thousands, except useful life and estimated remaining useful life which are in years): Gross Carrying Amount Accumulated Impairment Intangible Assets, Net Customer relationships $ 2,900 $ 421 $ — $ 2,479 5.0 years 4.3 years Developed technology 61,200 2,222 — 58,978 20.0 years 19.3 years In-process research and development 31,400 — — 31,400 N/A N/A Total $ 95,500 $ 2,643 $ — $ 92,857 19.3 years 18.6 years Acquisition-related intangible assets included in the above table are finite-lived, other than in-process research and development which has an indefinite life , and are carried at cost less accumulated amortization. Customer relationships and developed technology are amortized on a straight-line basis over their estimated lives, which approximates the pattern in which the economic benefits of the intangible assets are expected to be realized. Amortization expense was $2.6 million for the year ended December 31, 2023, and was recorded to sales and marketing for customer relationships and to cost of revenue for developed technology. The following table summarizes the estimated future amortization expense of intangible assets with finite lives as of December 31, 2023: Years ending December 31, (in thousands) 2024 3,640 2025 3,640 2026 3,640 2027 3,640 2028 3,219 Thereafter 43,678 Total estimated future amortization expense $ 61,457 Actual amortization expense to be reported in future periods could differ from these estimates as a result of asset impairments, acquisitions, or other facts and circumstances. The Company performs annual impairment reviews of its intangible assets during the fourth fiscal quarter or more frequently if business factors indicate. The Company did not incur any impairment losses related to its intangible assets during the year ended December 31, 2023. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company’s operating leases consist of leased facilities for the Company’s headquarter offices, leased facilities for Neovasc, and leased facilities for laboratory and manufacturing space. Also included in operating leases are leases for vehicles, for use by certain employees of the Company, which were not material for the periods presented. Short-term leases are leases having a term of 12 months or less. The Company recognizes short-term leases on a straight-line basis and does not record a related lease asset or liability for such leases. As of December 31, 2023, the Company has no material finance leases. In September 2021, the Company entered into an office lease agreement (“3003 Bunker Hill Lease”) for the 3003 Bunker Hill facility which expires in December 2031. Concurrently, the Company entered into an Amendment to Office Lease (Net) (the “First Lease Amendment”) which extended the lease terms of the 5353 Betsy Ross and 5403 Betsy Ross facilities to December 2031. The 5403 Betsy Ross lease (“5403 Lease”) continued in its existing terms (and with no changes to its terms, including its base rent) until its expiration in August 2022, at which point the leased space under the 5403 Lease became subject to the terms of the First Lease Amendment. The 3003 Bunker Hill Lease and the First Lease Amendment contain options to extend the lease term at the respective facilities for up to two additional five-year terms at the then fair market rate. As of December 31, 2023, the Company is not reasonably certain it will exercise these extension options. Additionally, included in the First Lease Amendment was an expansion option that stipulated that the Company had an option to lease the space in the adjacent building located at 5303 Betsy Ross (“5303 Lease”). The Company exercised this expansion option by entering into a Second Amendment to Office Lease (Net) (the “Second Lease Amendment”) on May 26, 2023. The 5303 Lease will be accounted for as a separate lease and is expected to commence on February 1, 2024 and expire on December 31, 2031. The Company recognizes rent expense for these operating leases on a straight-line basis over the lease period. The components of lease costs, which the Company includes in operating expenses in the consolidated statements of operations and comprehensive income, were as follows: Year Ended December 31, 2023 2022 2021 (in thousands) Operating lease cost $ 5,110 $ 4,667 $ 2,891 Variable lease cost 1,243 1,186 496 Total lease cost $ 6,353 $ 5,853 $ 3,387 During the years ended December 31, 2023, 2022 and 2021, the Company recorded operating lease expense of $5.1 million, $4.7 million, and $2.9 million and paid $5.5 million, $3.4 million, and $2.2 million of operating lease payments respectively related to the lease liabilities. The Company includes operating lease payments in net cash used in operating activities in the consolidated statements of cash flows. The weighted average remaining lease term and discount rate used to measure the Company’s operating lease liabilities were 8 years and 5.2%, respectively. The Company estimated the discount rate using the incremental borrowing rate as the rate implicit in the lease was not readily determinable. As of December 31, 2023, the maturities of the payments due under the Company’s operating lease liabilities were as follows: (in thousands) 2024 $ 5,555 2025 5,526 2026 5,690 2027 5,832 2028 5,960 Thereafter 18,999 Total minimum lease payments $ 47,562 Less: imputed interest (8,818) Total lease liability $ 38,744 Less: current portion (3,641) Lease liability, noncurrent portion $ 35,103 The table below summarizes the undiscounted future non-cancellable lease payments for the 5303 Lease facility under the Second Lease Amendment, which had not yet commenced as of December 31, 2023. Years ending December 31, (in thousands) 2024 $ 476 2025 1,173 2026 1,207 2027 1,244 2028 1,282 Thereafter 4,077 Total undiscounted lease payments $ 9,459 Contingent Consideration Liabilities Related to Business Combination See Note 5 “Business Combination” for information regarding existing contingent consideration liabilities as of December 31, 2023. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt Amended SVB Credit Agreement In February 2020, the Company entered into a First Amendment to its Loan and Security Agreement with Silicon Valley Bank (the “Amended SVB Credit Agreement”) to, among other things, refinance its then-existing term loan, which is accounted for as a modification of the Loan and Security Agreement. The Amended SVB Credit Agreement provided the Company with a supplemental term loan in the amount of $16.5 million that was set to mature on December 1, 2023. The Amended SVB Credit Agreement provided an interest-only payment period through June 30, 2022. Credit Agreement On October 19, 2022, the Company entered into a Credit Agreement (the “Credit Agreement”) with Wells Fargo Bank, National Association, as administrative agent, Wells Fargo Bank, National Association, as swingline lender and an issuing lender, Wells Fargo Securities, LLC and Silicon Valley Bank, as joint lead arrangers and joint bookrunners, Silicon Valley Bank, as syndication agent, and the several lenders party thereto. The Credit Agreement provides for a revolving credit facility in an aggregate principal amount of $175.0 million with the right to request increases to the revolving commitments (subject to certain conditions) of up to the greater of (x) $100.0 million or (y) the Company’s consolidated EBITDA for the four fiscal quarter period most recently ended prior to the date of such increase. Concurrent with entering into the Credit Agreement, the Company drew down $25.0 million thereunder and prepaid in full all outstanding amounts and related expenses under the Amended SVB Credit Agreement, totaling $14.6 million, and terminated the credit facility thereunder. The Company recognized a loss on debt extinguishment of $0.6 million in connection with the early repayment of its Amended SVB Credit Agreement which is included in interest expense in the consolidated statement of operations for the year ended December 31, 2022. The Company repaid the $25.0 million drawn under the Credit Agreement on August 29, 2023. The Company recognized a loss on debt extinguishment of $0.7 million in connection with this repayment, which was included in interest expense in the consolidated statement of operations for the year ended December 31, 2023. On March 16, 2023, the Company drew down an additional $80.0 million under the Credit Agreement. The Company repaid the $80.0 million drawn under the Credit Agreement on April 26, 2023. The revolving credit facility accrues for interest, at the election of the Company, at (A) the Base Rate (as defined below) plus a margin ranging from 0% to 1% depending on the Company’s Consolidated Total Net Leverage Ratio (as defined in the Credit Agreement) (which rate is currently 0%) or (B) the applicable secured overnight financing rate (“SOFR”) plus a margin from 1% to 2%, depending on the Company’s Consolidated Total Net Leverage Ratio (which rate is currently 1.8%). Base Rate means, at any time, the highest of (a) the Wells Fargo Bank, National Association ’ s announced prime rate, (b) the federal funds rate plus 0.5% and (c) Term SOFR for a one-month tenor in effect on such day plus 1%. The Credit Agreement matures on October 19, 2027. The interest rate was 7.3% as of August 29, 2023. The Company recorded interest expense of $2.7 million, $1.9 million and $1.1 million for the years ended December 31, 2023, 2022 and 2021, respectively. |
Convertible Debt
Convertible Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 10. Convertible Debt On August 15, 2023, the Company issued $750.0 million in aggregate principal amount of 1.0% convertible senior notes due 2028 (the “Notes”). The issuance included the full exercise of an option granted by the Company to the initial purchasers of the Notes to purchase an additional $100.0 million in aggregate principal amount of Notes. The Notes were issued pursuant to and subject to the terms of an indenture, dated August 15, 2023, between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Indenture”). The Indenture includes customary covenants and sets forth certain events of default, including certain types of bankruptcy and insolvency events, after which the Notes may be declared immediately due and payable. The Notes were offered and sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The Notes are senior, unsecured obligations of the Company. The Notes will mature on August 15, 2028, unless earlier converted, redeemed, or repurchased in accordance with their terms. The Notes bear interest at a rate of 1.0% per year, payable semiannually in arrears on February 15 and August 15 of each year, beginning on February 15, 2024. The Notes are convertible, in multiples of $1,000 principal amount and at the option of the noteholder, on or after May 15, 2028. Prior to May 15, 2028, holders of the Notes may convert all or a portion of their Notes, in multiples of $1,000 principal amount, only under the following circumstances: (1) during any calendar quarter commencing after December 31, 2023 (and only during such calendar quarter) if the closing price of the Company’s common stock for at least 20 trading days (whether or not consecutive) in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the then applicable conversion price for the Notes on each applicable trading day; (2) during the five business days immediately after any five consecutive trading day period in which the trading price (as defined in the Indenture) per $1,000 principal amount of Notes for each day of that period was less than 98% of the product of the closing price of the Company’s common stock and the then applicable conversion rate; (3) if the Company calls such Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date, but only with respect to the Notes called (or deemed called) for redemption; or (4) upon the occurrence of specific corporate events as specified in the Indenture. The Company will settle any conversions of Notes by paying or delivering, as applicable, cash up to the aggregate principal amount of the Notes to be converted and by paying or delivering, as the case may be, cash, shares of common stock or a combination of cash and shares of common stock, at the election of the Company, in respect of the remainder, if any, of the Company’s conversion obligation in excess of the aggregate principal amount of the Notes being converted. The conversion rate for the Notes was initially 3.4595 shares of common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $289.06 per share of common stock. The initial conversion price of the Notes represents a premium of approximately 30% over the $222.35 per share last reported sale price of common stock on August 10, 2023. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture, with a maximum conversion rate of 4.4974 shares of common stock per $1,000 principal amount of Notes. The Company may not redeem the Notes prior to August 20, 2026. The Company may redeem, for cash equal to 100% of the principal amount of the Notes being redeemed plus accrued and unpaid interest, all or any portion of the Notes, at its option, on or after August 20, 2026, if the last reported sales price of its common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of the redemption. No sinking fund is provided for the Notes and therefore the Company is not required to redeem or retire the Notes periodically. If the Company undergoes a fundamental change, as defined in the Indenture, then subject to certain conditions, holders may require the Company to repurchase for cash all or any portion of their Notes at a price equal to 100% of the principal amount of the Notes to be repurchased plus any accrued and unpaid interest to, but excluding, the repurchase date. In addition, under certain circumstances, holders of the Notes are entitled to an increase in the conversion rate. The conditions allowing holders of the Notes to convert were not met this quarter. As of December 31, 2023, the Notes were classified as a long-term liability, net of issuance costs of $19.6 million, on the consolidated balance sheets. As of December 31, 2023, the net carrying amount of the Notes was $731.9 million. Interest expense recognized related to the Notes for the year ended December 31, 2023 was $4.2 million. The Notes were issued at par and costs associated with the issuance of the Notes are amortized to interest expense over the contractual term of the Notes through the application of the effective interest method. As of December 31, 2023, the effective interest rate of the Notes was 1.5%. Capped Call Transactions On August 10, 2023, in connection with the pricing of the Notes and the initial purchasers’ exercise of their option to purchase additional Notes, the Company entered into privately negotiated capped call transactions (“Capped Call Transactions”). The Capped Call Transactions initially covered, subject to customary anti-dilution adjustments, the number of shares of common stock that underlie the Notes. The cap price of the Capped Call Transactions was initially $444.7 per share, which represents a premium of 100% over the last reported sale price of the Company ’ s common stock of $222.35 per share on August 10, 2023, and is subject to certain adjustments under the terms of the Capped Call Transactions. The Company used approximately $96.4 million of the proceeds from the offering of Notes to pay the cost of the Capped Call Transactions. The Company evaluated the Capped Call Transactions and determined that they should be accounted for separately from the Notes. The cost of $96.4 million to purchase the Capped Call Transactions was recorded as a reduction to additional paid-in capital in the consolidated balance sheets as of December 31, 2023 as the Capped Call Transactions are indexed to the Company ’ s own stock and met the criteria to be classified in stockholders ’ equity. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Total stock-based compensation was as follows: Year Ended December 31, 2023 2022 2021 (in thousands) Cost of product revenue $ 5,003 $ 2,193 $ 1,153 Research and development 17,160 10,354 6,240 Sales and marketing 27,945 18,387 11,043 General and administrative 23,126 13,956 8,821 Total stock-based compensation $ 73,234 $ 44,890 $ 27,257 Stock-based compensation of $2.3 million, $2.2 million, and $0.7 million was capitalized into inventory for the years ended December 31, 2023, 2022, and 2021, respectively. Stock-based compensation capitalized into inventory is recognized as cost of product revenue when the related product is sold. 2009 Equity Incentive Plan and 2019 Equity Incentive Plan On June 17, 2009, the Company adopted the 2009 Equity Incentive Plan (the “2009 Plan”) under which the Company’s board of directors (the “Board”) may issue stock options to employees, directors and consultants. In February 2019, the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”), which became effective in connection with the Company’s initial public offering. As a result, effective as of March 6, 2019, the Company may not grant any additional awards under the 2009 Plan. The 2009 Plan will continue to govern outstanding equity awards granted thereunder. The Company initially reserved 2,000,430 shares of common stock for the issuance of a variety of awards under the 2019 Plan, including stock options, stock appreciation rights, awards of restricted stock and awards of restricted stock units (“RSUs”) . In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years, which commenced on January 1, 2020, in an amount equal to 3% of the total number of shares of the Company’s common stock outstanding on the last day of the preceding year, or a lesser number of shares determined by the Board. As of December 31, 2023, there were 3,516,750 shares of common stock available for issuance under the 2019 Plan. Stock Options Option activity under the 2009 Plan and 2019 Plan is set forth below: Number Weighted- Weighted- Aggregate (in years) (in thousands) Balance, December 31, 2022 1,122,009 $ 5.87 4.60 $ 224,115 Options exercised (235,067) 5.84 Options cancelled (6,133) 2.41 Balance, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 Vested and exercisable, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 Vested and expected to vest, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 There were no options granted during the years ended December 31, 2023, 2022, and 2021. The total grant date fair value of options vested was $0.1 million, $1.0 million and $1.6 million for the years ended December 31, 2023, 2022, and 2021, respectively. As of December 31, 2023 there was no unrecognized stock-based compensation related to unvested stock options. Restricted Stock Units RSUs are share awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon vesting. RSUs cannot be transferred and the awards are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. RSUs generally vest over a four-year period with straight-line quarterly vesting with a one year cliff or straight-line annual vesting, provided the employee remains continuously employed with the Company. The fair value of RSUs is equal to the closing price of the Company’s common stock on the grant date. In February 2022 and 2023, the Company granted performance-based restricted stock units (“PRSUs”) to certain key executives. The vesting of these PRSUs is dependent on the achievement of certain performance targets related to the Company’s compound annual growth rate of revenue over a two RSU and PRSU activity under the 2019 Plan is set forth below. Grant activity for all PRSUs is disclosed at target (100%): Restricted Stock Units Performance-Based Restricted Stock Units Number Weighted- Number Weighted- Balance, December 31, 2022 1,125,991 $ 127.39 38,797 $ 165.74 RSUs and PRSUs granted 606,187 210.54 29,473 191.36 RSUs and PRSUs forfeited (83,916) 172.66 (867) 267.54 RSUs and PRSUs vested (481,240) 117.14 (395) 267.41 Balance, December 31, 2023 1,167,022 171.55 67,008 175.09 The total grant date fair value of RSUs vested was $56.5 million, $30.9 million, and $11.3 million, for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, there was $175.3 million of unrecognized stock-based compensation expense related to RSUs to be recognized over a weighted-average period of 2.3 years. Employee Share Purchase Plan (ESPP) In February 2019, the Company adopted the Employee Stock Purchase Plan (“ESPP”), which became effective as of March 6, 2019. The Company initially reserved 300,650 shares of the Company’s common stock for purchase under the ESPP. In addition, the number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years, which commenced on January 1, 2020, in an amount equal to 1% of the total number of shares of the Company’s common stock outstanding on the last day of the preceding year, or a lesser number of shares determined by the Board. Each offering to the employees to purchase stock under the ESPP will begin on each September 1 and March 1 and will end on the following February 28 or 29 and August 31, respectively. On each purchase date, which falls on the last date of each offering period, ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the offering date or (2) the fair market value of the common stock on the purchase date. The occurrence and duration of offering periods under the ESPP are subject to the determinations of the Compensation Committee of the Board, in its sole discretion. The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model based on the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term— The expected term represents the period that stock-based awards are expected to be outstanding. The Company’s historical share option exercise information is limited due to a lack of sufficient data points, and did not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the simplified method. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards. Expected Volatility— The expected volatility is measured using the historical daily changes in the market price of the Company ’ s common stock over a period consistent with the expected term. Risk-Free Interest Rate— The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term. Expected Dividend Yield— The expected dividend yield is zero as the Company has not paid nor does it anticipate paying any dividends on its common stock in the foreseeable future. The Company recorded $3.3 million, $2.3 million and $1.3 million of stock-based compensation expense related to the ESPP for the years ended December 31, 2023, 2022 and 2021, respectively. At December 31, 2023, a total of 1,521,021 shares of common stock were available for issuance under the ESPP. Years Ended December 31, 2023 2022 2021 Expected term (in years) 0.5 0.5 0.5 Expected volatility 44.3%-73.8% 61.8%-73.8% 48.9%-64.8% Risk-free interest rate 3.7%-5.5% 0.1%-3.7% 0.1% Expected dividend yield 0% 0% 0% |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The following table presents income (loss) before income taxes for the periods presented: December 31, 2023 2022 2021 (in thousands) Domestic $ 194,406 $ 119,901 $ (9,388) Foreign (20,125) 927 553 Total income (loss) before income taxes $ 174,281 $ 120,828 $ (8,835) The income tax expense (benefit) for the periods presented consisted of the following: December 31, 2023 2022 2021 (in thousands) Current provision for income taxes: Federal $ 1,638 $ 403 $ — State 5,418 1,446 84 Foreign 5,239 259 217 Total current tax provision: 12,295 2,108 301 Deferred tax provision: Federal 21,855 (85,618) — State 1,625 (11,658) — Foreign (8,772) — — Total deferred tax (benefit) provision 14,708 (97,276) — Total (benefit) provision for income taxes $ 27,003 $ (95,168) $ 301 The components of the deferred tax assets and liabilities are as follows: December 31, 2023 2022 (in thousands) Deferred tax assets: Net operating loss carryovers $ 60,636 $ 60,467 Accruals and reserves 12,856 10,876 Stock-based compensation 8,745 8,504 Research and development credits 20,736 15,250 Lease liability 9,816 9,316 Capitalized research and development 34,511 17,791 Convertible note 22,841 — Other 92 — Total deferred tax assets 170,233 122,204 Less valuation allowance (57,848) (13,371) Gross deferred tax assets 112,385 108,833 Deferred tax liabilities: Fixed and intangible assets (5,624) (1,105) Right-of-use-assets (7,592) (8,327) In process research and development (3,609) — Other — (1,833) Gross deferred tax liabilities (16,825) (11,265) Total net deferred tax assets $ 95,560 $ 97,568 Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Each quarter, the Company assesses its ability to use the deferred tax assets to offset its expected federal and state taxable income based on the weight of all available evidence, including such factors as the history of recent earnings and expected future taxable income on a jurisdiction by jurisdiction basis. Until the quarter ended December 31, 2022, the Company maintained a full valuation allowance against its deferred tax assets due to the Company’s cumulative loss position and uncertainties regarding sustainable future profitability since inception. The Company released the valuation allowance against all of the U.S. federal deferred tax assets and other-than-California state deferred tax assets during the fourth quarter of fiscal year 2022. The valuation allowance increased by $44.5 million for the year ended December 31, 2023, and decreased by $91.4 million for the year ended December 31, 2022, and increased by $22.7 million for the year ended December 31, 2021. The significant increase in the valuation allowance during 2023 was primarily the result of the acquired deferred tax asset with valuation allowance from acquisition of Neovasc. The significant decrease in the valuation allowance during 2022 was the result of the Company’s release of the entire valuation allowance previously established on its federal and non-California state deferred tax assets. For fiscal year 2023, the Company reported a total of $27.0 million of worldwide income tax expenses comprised of $23.5 million for U.S. federal and $7.0 million for other states, respectively. The remaining $3.5 million of income tax benefits are from foreign entities. The Company continues to maintain a full valuation allowance of $8.1 million, $16.2 million, $0.2 million, and $33.3 million on federal (Neovasc), California, other states (Neovasc), and various Neovasc foreign entities deferred tax assets, respectively, which the Company believes are not more likely than not to be realized in future periods. As of December 31, 2023, the Company had net operating loss (“NOL”) carryforwards of approximately $103.1 million for federal income tax purposes, $45.6 million for California income tax purposes, $31.8 million for other state income tax purposes, and $126.6 million for foreign entities. The federal NOL carryforwards (generated prior to 2018) of $15.2 million begin expiring in 2037 and are subject to Section 382 limitation. The federal NOL carryforwards (generated after 2018) of $87.9 million will never expire. The California NOL begin expiring in 2034 and other state NOL carryforwards begin expiring in various years, starting in 2024. The foreign NOL will begin to expire in 2026. As of December 31, 2023, the Company had research and development credit carryforwards of $14.6 million for federal income tax purposes and $14.6 million for California state income tax purposes available to reduce future taxable income, if any. The federal research and development credit carryforwards expire beginning 2041 and California credits can be carried forward indefinitely. Utilization of the Company ’ s net operating losses and tax credit carryforwards may be subject to substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code and similar state provisions. The Company experienced ownership changes in 2013 and 2017 and its operating losses and tax credits generated prior to the 2017 ownership change are subject to utilization limitation. The Company indefinitely reinvests earnings from its foreign subsidiaries and therefore no deferred tax liability has been recognized on the basis difference created by such earnings. The Company has not provided foreign withholding taxes for any undistributed earnings of its foreign subsidiaries. Reconciliation of the statutory federal income tax to the Company’s effective tax is as follows: December 31, 2023 2022 2021 (in thousands) Income tax provision (benefit) at federal statutory rate $ 36,601 $ 25,378 $ (1,856) State and local income 5,937 (10,516) 36 Foreign tax rate differential 926 47 101 Change in valuation allowance 3,331 (87,568) 19,027 Stock-based compensation (14,043) (18,273) (17,968) Section 250 FDII deduction (2,065) (984) — Research and development credits (6,974) (3,937) (808) Section 382 limitation — — 575 Equity method investment 393 520 1,320 Section 162(m) limitation 2,633 — — Acquisition tax structuring (2,418) — — Other 2,682 165 (126) Total current income tax (benefit) provision $ 27,003 $ (95,168) $ 301 The Company maintains liabilities for uncertain tax positions. The measurement of these liabilities involves considerable judgment and estimation and are continuously monitored by management based on the best information available, including changes in tax regulations, the outcome of relevant court cases, and other pertinent information. The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2023 2022 2021 (in thousands) Beginning balance $ 5,264 $ 5,221 $ 3,746 Additions based on tax positions related to prior years 283 — — Reductions based on tax positions related to prior years — (1,861) (79) Additions based on tax positions related to current years 4,418 1,904 1,554 Balance at end of year $ 9,965 $ 5,264 $ 5,221 As of December 31, 2023, 2022 and 2021, the total amount of unrecognized tax benefits was approximately $10.0 million, $5.3 million and $5.2 million, respectively. The unrecognized tax benefit of $6.5 million would impact the effective tax rate, if recognized. A valuation allowance is maintained on the tax benefits related to California deferred tax assets and if these tax benefits were recognized it would not impact the effective tax rate. The Company had immaterial amounts of accrued interest and no accrued penalties related to unrecognized tax benefits as of December 31, 2023, 2022 and 2021. The Company does not expect its unrecognized tax benefits to change materially over the next 12 months. While the Company believes it has adequately provided for all tax positions, amounts asserted by tax authorities could be greater or less than the recorded position. Accordingly, the Company ’ s provisions on federal and state tax-related matters to be recorded in the future may change as revised estimates are made or the underlying matters are settled or otherwise resolved. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The following table represents the Company’s product revenue based on product line: Year Ended December 31, 2023 2022 2021 (in thousands) Coronary $ 528,845 $ 353,859 $ 161,463 Peripheral 194,346 132,284 74,064 Reducer 4,368 — — Other 2,671 3,590 1,619 Product revenue $ 730,230 $ 489,733 $ 237,146 Coronary product revenue encompasses sales of the Company’s C 2 catheter and C 2+ catheter. Peripheral product revenue encompasses sales of the Company’s M 5 catheter, M 5+ catheter, S 4 catheter, and L 6 catheter. Reducer revenue encompasses sales of the Company’s Reducer product, resulting from the Neovasc acquisition. Other product revenue encompasses sales of the Company’s generators and related accessories. The following table represents the Company’s product revenue based on the location to which the product is shipped: Year Ended December 31, 2023 2022 2021 (in thousands) United States $ 581,548 $ 407,425 $ 186,324 Europe 77,515 51,010 38,571 All other countries 71,167 31,298 12,251 Product revenue $ 730,230 $ 489,733 $ 237,146 |
Equity Method Investments
Equity Method Investments | 12 Months Ended |
Dec. 31, 2023 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Equity Method Investments | Equity Method Investments Genesis Shockwave Private Limited On March 19, 2021, the Company entered into the Joint Venture Deed (or “JV Agreement”) with Genesis MedTech International Private Limited (“Genesis”) to establish a long-term strategic partnership to develop, manufacture and commercialize certain of the Company’s interventional products in the People’s Republic of China, excluding the Special Administrative Regions of Hong Kong and Macau (the “PRC”). On the same date, Genesis and the Company entered into a Share Subscription Agreement pursuant to which, among other things, the JV issued (i) 54,900 ordinary shares which represents 55% of the total equity of the JV, to Genesis in exchange for a cash contribution of $15.0 million, and (ii) 45,000 ordinary shares which represents 45% of the total equity of the JV, to the Company as consideration for the Shockwave License Agreement (the “License Agreement”). Under the License Agreement, the Company has agreed to contribute to the JV an exclusive license under certain of the Company’s intellectual property rights to develop, manufacture, distribute and commercialize certain products in the PRC and is entitled to receive royalties on the sales of the licensed products in the PRC. Further, the Company entered into a Distribution Agreement, pursuant to which the Company has agreed to sell certain Company-manufactured products to the JV or a PRC subsidiary of the JV for commercialization and distribution in the PRC. As of December 31, 2023, the carrying value of the Company’s investment in the JV was $1.6 million and the Company owned a 45% interest in the entity. The Company ’ s product revenue for products sold to the JV during the year ended December 31, 2023 and related accounts receivable from the JV as of December 31, 2023 were immaterial. Intra-entity profit, which was recorded as a reduction to equity method investment as of and for the year ended December 31, 2023, was also immaterial. For the years ended December 31, 2023, 2022, and 2021, the Company’s loss from the equity method was $1.9 million, $2.5 million, and $6.3 million, respectively. As of December 31, 2023, the associated manufacturing technology transfer to the JV has not yet been completed. The Company maintains a related party contract liability, noncurrent, of $12.3 million for the outstanding performance obligation. The Company will satisfy the outstanding performance obligation upon the completion of training provided by the Company to the JV, and successful regulatory approval for the JV manufactured product from the China National Medical Products Administration. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income per share is calculated by dividing net income by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Diluted net income per share attributable to the Company’s stockholders is calculated based on the weighted-average number of shares of its common stock and other dilutive securities outstanding. Potentially dilutive common shares from employee equity incentive plans are determined by applying the treasury stock method to the assumed exercise of outstanding stock options and the assumed vesting of outstanding RSUs. Prior to conversion of the Company’s convertible debt, the Company will include, in the diluted net income per common share calculation, the effect of the additional shares that may be issued when the Company’s common stock price exceeds the conversion price using the if‐converted method. The Company’s convertible debt has no impact on diluted net income per common share unless the average price of the Company’s common stock exceeds the conversion price because the Company is required to settle the principal amount of the convertible debt in cash upon conversion. The components of basic and diluted net income (loss) per share were as follows (in thousands, except share and per share amounts): Year Ended December 31, 2023 2022 2021 Numerator: Net income (loss) $ 147,278 $ 215,996 $ (9,136) Denominator: Basic: Weighted average number of common shares outstanding - basic 36,706,060 35,900,738 35,098,130 Diluted: Weighted average number of common shares outstanding - basic 36,706,060 35,900,738 35,098,130 Dilutive effect of outstanding common stock options 960,436 1,294,052 — Dilutive effect of restricted stock units 535,483 684,696 — Dilutive effect of common stock pursuant to employee stock purchase plan 4,290 2,104 — Weighted average number of common shares outstanding - diluted 38,206,269 37,881,590 35,098,130 Net income (loss) per share: Basic $ 4.01 $ 6.02 $ (0.26) Diluted $ 3.85 $ 5.70 $ (0.26) All restricted shares, purchase rights under the employee stock purchase plan, and capped call options for the year ended December 31, 2023, 2022, and 2021 have been excluded from the calculation of the diluted net income per share, because all such securities are anti-dilutive for all periods presented. The total number of potential shares excluded from the calculation of diluted net income per share are as follows: Year Ended December 31, 2023 2022 2021 Common stock options issued and outstanding — — 1,524,985 Restricted stock units 105,726 21,537 1,156,683 Employee stock purchase plan — 2,122 10,028 Capped call options 333,409 — — Total 439,135 23,659 2,691,696 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net income (loss) | $ 147,278 | $ 215,996 | $ (9,136) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include, but are not limited to the valuation of inventory, goodwill and intangible assets, the allowance for doubtful accounts, recoverability of the Company’s net deferred tax assets, and related valuation allowance amounts and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates . |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated statements of cash flows: December 31, 2023 2022 (in thousands) Cash and cash equivalents $ 328,422 $ 156,586 Restricted cash 1,404 1,716 Total cash, cash equivalents, and restricted cash $ 329,826 $ 158,302 Restricted cash as of December 31, 2023 and 2022 relates to corporate credit card security, customer bank guarantee security, and letters of credit established for the real estate property leases relating to the Company’s office buildings, and is recorded as other assets on the consolidated balance sheets. |
Short-Term Investments | Short-Term Investments Short-term investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company determines the appropriate classification of its investments in debt securities at the time of purchase. Available-for-sale securities with original maturities beyond three months at the date of purchase are classified as current based on their availability for use in current operations. As the Company may sell its securities at any time for use in current operations even if the securities have not yet reached maturity, all marketable securities are classified as current assets in the Company’s consolidated balance sheets. The Company evaluates, on a quarterly basis, its marketable securities for potential impairment. For marketable securities in an unrealized loss position, the Company assesses whether such declines are due to credit loss based on factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If credit loss exists, the Company assess whether it has plans to sell the security or it is more likely than not it will be required to sell any marketable security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other income, net. The Company has not identified any such impairment losses to date. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other income, net. Any portion of unrealized loss that is not a result of a credit loss, is recognized in other comprehensive income. Realized gains and losses, if any, on marketable securities are included in other income, net. The cost of investments sold is based on the specific-identification method. Interest on marketable securities is included in other income, net. The Company elected to present accrued interest receivable separately from short-term and long-term investments on its consolidated balance sheets. Accrued interest receivable was recorded in prepaid expenses and other current assets as of December 31, 2023 and 2022. The Company also elected to exclude accrued interest receivable from the estimation of expected credit losses on its marketable securities and reverse accrued interest receivable through interest income (expense) when amounts are determined to be uncollectible. The Company did not write off any accrued interest receivable during the year ended December 31, 2023, 2022, and 2021. |
Equity Method Investments | Equity Method Investments Entities for which the Company has significant influence over the activities of the entity, but does not control, are accounted for under the equity method of accounting in accordance with ASC 323, Investments - Equity Method and Joint Ventures ( “ ASC 323 ” ) . The Company’s carrying value in the equity method investment is reported as equity method investment on the Company’s consolidated balance sheets. The Company records its proportionate share of the underlying income or loss which is recognized in earnings or loss from the equity method investment. T he Company eliminates a portion of intra-entity profit to the extent the goods sold by the Company have not yet been sold through by the equity method investee to an end customer at the end of the reporting period. The profit earned by the Company from the equity method investee for items not yet sold through is eliminated through equity method earnings or loss which is recognized in income (loss) from equity method investment. The Company assesses its equity method investment for impairment when events or circumstances suggest that the carrying amount of the investment may be impaired. The Company considers all available evidence in assessing whether a decline in fair value is other than temporary. If the decline in fair value is determined to be other than temporary, the difference between the carrying amount of the investment and estimated fair value is recognized as an impairment charge. The Company has not identified any such impairment losses to date. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash, investments and trade receivables. Risks associated with cash, cash equivalents and restricted cash are mitigated by banking with creditworthy institutions and purchasing investments with investment grade ratings. The Company performs ongoing evaluations of its customers using its historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of its customers, and generally does not require collateral. |
Concentration of Customers | Concentration of Customers |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s cash and cash equivalents, restricted cash, short-term investments, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to their short maturities. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at invoice value, net of any allowance for credit losses. The Company’s expected loss allowance methodology for receivables is developed using its historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of its customers. Specific allowance amounts are established to record the appropriate allowance for customers that have an identified risk of default. General allowance amounts are established based upon the Company’s assessment of expected credit losses for its receivables by aging category. Balances are written off when they are ultimately determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: For the Year Ended December 31, 2023 2022 2021 (in thousands) Beginning balance $ 710 $ 350 $ 380 Amounts charged (reversed) to costs and expenses 1,479 364 (12) Write-offs (10) (4) (18) Ending balance $ 2,179 $ 710 $ 350 |
Inventory | Inventory |
Property and Equipment | Property, Plant, and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Land is carried at cost. Depreciation and amortization (other than land, which is not depreciated) is computed using the straight-line method over the estimated useful lives of the respective assets: Asset Category Useful Life Equipment 3 - 5 years Office Furniture 5 years Software 3 years Building 25 years Leasehold Improvement Lesser of useful life or remaining lease term |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Revenue | Revenue To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers ( “ ASC 606 ” ) , the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Product Revenue The Company records product revenue primarily from the sale of its IVL catheters and Reducer. The Company sells its products to hospitals, primarily through direct sales, as well as through distributors in selected international markets. Product revenue is recognized when a customer obtains control of promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. For products sold through direct sales and distributors internationally, control is transferred based on the contractual or standard shipping terms. The Company has elected to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity, and not a separate performance obligation. The Company may provide for the use of an IVL generator and connector cable under an agreement to customers at no charge to facilitate the use of the IVL catheters. These agreements generally do not contain contractually enforceable minimum commitments and are generally cancellable by either party with 30 days’ notice. License Revenue For arrangements that contain a license of the Company’s functional intellectual property with a customer, the Company considers whether the license grant is distinct from other performance obligations in the arrangement. A license grant of functional intellectual property is generally considered to be capable of being distinct if a customer can benefit from the license on its own or together with other readily available resources. License revenue for licenses of functional intellectual property is recognized at a point in time when the Company satisfies its performance obligation of transferring the license to the customer. Consideration received in advance of the satisfaction of a performance obligation is recognized as a contract liability. No license revenues have been recognized for the years ended December 31, 2023, 2022, and 2021. |
Research and Development Costs and Accrued Research and Development Costs | Research and Development Costs Research and development costs, including new product development, regulatory compliance, and clinical research are expensed as incurred. Accrued Research and Development Costs The Company accrues liabilities for estimated costs of research and development activities conducted by its third-party service providers, which include the conduct of preclinical and clinical studies. The estimated costs of research and development activities are recorded based upon the estimated amount of services provided but not yet invoiced, and these costs are included in accrued liabilities on the consolidated balance sheets and within research and development expense on the consolidated statements of operations and comprehensive loss. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based payments at fair value. The fair value of stock options is measured using the Black-Scholes option-pricing model. For share-based awards that vest subject to the satisfaction of a service requirement, the fair value measurement date for stock-based compensation awards is the date of grant and the expense is recognized on a straight-line basis, over the vesting period. For share-based awards that vest upon the satisfaction of a performance target, the related compensation cost is recognized over the requisite service period based on the expected achievement of the performance target. The Company accounts for forfeitures as they occur. |
Leases | Leases The Company determines if an arrangement is or contains a lease at contract inception by assessing whether the arrangement contains an identified asset and whether the lessee has the right to control such asset. The Company is required to classify leases as either finance or operating leases and to record a right-of-use asset and a lease liability for all leases with a term greater than 12 months regardless of the lease classification. The lease classification will determine whether the lease expense is recognized based on an effective interest rate method or on a straight-line basis over the term of the lease. The Company determines the initial classification and measurement of its right-of-use assets and lease liabilities at the lease commencement date and thereafter, if modified. The Company does not have material finance leases. For its operating leases with a lease term of 12 months or greater, the Company recognized a right-of-use asset and a lease liability on its consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise. Operating lease cost for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the consolidated statements of operations and comprehensive loss. Lease payments may be fixed or variable; however, only fixed payments are included in the Company’s lease liability calculation. Lease costs for the Company’s operating leases are recognized on a straight-line basis within operating expenses over the lease term. The Company’s lease agreements may contain variable non-lease components such as common area maintenance, operating expenses or other costs, which are expensed as incurred. The Company elected the practical expedients to exclude from its balance sheets recognition of leases having a term of 12 months or less (short-term leases) and to not separate lease components and non-lease components for its long-term real estate leases. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) |
Foreign Currency | Foreign Currency |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Diluted net income (loss) per share attributable to the Company’s stockholders is calculated based on the weighted-average number of shares of its common stock and other dilutive securities outstanding. Where the Company was in a loss position for any periods presented, basic net loss per share was the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. The Company uses the if-converted method of calculating diluted earnings per share. Under the “if-converted” method, diluted earnings per share will generally be calculated assuming that all the Notes (as defined below) were converted solely into shares of common stock at the beginning of the reporting period, unless the result would be anti-dilutive. Because the principal amount of the Notes upon conversion is required to be paid in cash, and only the excess is permitted to be settled in shares, the application of the if-converted method will produce a similar result as the treasury stock method prior to the adoption of ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity ’ s Own Equity (Subtopic 815-40)-Accounting For Convertible Instruments and Contracts in an Entity ’ s Own Equity (“ASU 2020-06”). The effect of the treasury stock method is that the shares issuable upon conversion of such Notes are not included in the calculation of diluted earnings per share except to the extent that the conversion value of such Notes exceeds their principal amount. Prior to conversion of the Company’s convertible debt, the Company will include, in the diluted net income per common share calculation, the effect of the additional shares that may be issued when the Company’s common stock price exceeds the conversion price using the if‐converted method. The Company’s convertible debt has no impact on diluted net income per common share unless the average price of the Company’s common stock exceeds the conversion price because the Company is required to settle the principal amount of the convertible debt in cash upon conversion. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred tax assets are evaluated for future realization and reduced by a valuation allowance to the extent the Company believes it is more likely than not that they will not be realized. The Company considers all available positive and negative evidence, including future reversals of existing taxable temporary reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, carryback potential if permitted under the tax law, and results of recent operations. The Company also accounts for uncertain tax positions in accordance with ASC 740, Income Taxes – Accounting for Income Taxes ( “ ASC 740 ” ) , which requires the Company to adjust the financial statements to reflect only those tax positions that are more-likely-than-not to be sustained upon review by federal or state examiners. The Company may recognize a tax benefit only if it is more likely than not the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such positions are then measured based on the largest benefit that has a greater than 50% likelihood of being realized upon settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of provision for income taxes. |
Segment Reporting | Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined that it operates in one segment. The Company’s long-lived assets are held predominantly in the United States with the exception of the Company ’ s long lived assets in Costa Rica and Japan which collectively encompass approximately 32% and 15%, respectively, of its consolidated net property, plant, and equipment as of December 31, 2023 and 2022. See the section titled “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K for a description of risk associated with the Company ’ |
Internal-Use Software | Internal-Use Software The Company has internal-use software consisting of cloud-based hosting arrangements with service contracts. The Company capitalizes certain costs incurred to implement such software within prepaid expenses and other current assets, or within other assets. Eligible costs of internal use software and implementation costs of certain hosting arrangements are capitalized. Once the software is ready for its intended use, the Company starts amortizing the capitalized implementation costs on a straight-line basis over the estimated service term or associated hosting arrangement, as applicable. |
Pension and Other Postretirement Plans, Pensions, Policy | Defined Contribution Plan |
Business Combinations Policy | Business combinations The Company applies the provisions of ASC 805, Business Combinations ( “ ASC 805 ” ) , in accounting of its acquisitions. ASC 805 requires recognition of assets acquired, liabilities assumed, and contingent consideration at their fair value on the acquisition date with subsequent changes recognized in earnings; requires acquisition-related expenses to be recognized separately from the business combination and expensed as incurred; requires in-process research and development to be capitalized at fair value as an indefinite-lived intangible asset until completion or abandonment; and requires that changes in accounting for deferred tax asset valuation allowances and acquired uncertain tax positions after the measurement period be recognized as a component of provision for taxes. When an integrated set of assets and activities does not meet the practical screen test and otherwise meets the definition of a “business” under ASC 805, the Company accounts for such acquisitions as business combinations. The purchase price of an acquisition is allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date. The Company bases the estimated fair value of identifiable intangible assets acquired in an acquisition on independent third-party valuations that use information and assumptions provided by the Company ’ s management and considers inputs and assumptions that a market participant would use. Any excess purchase price over the estimated fair values of the assets acquired and liabilities assumed is recorded as goodwill. During the measurement period, which may be up to one year from the acquisition date, the Company may record adjustments to the provisional amounts of assets acquired and liabilities assumed with the corresponding offset to goodwill. Upon the conclusion of the measurement period or final determination of the values of assets acquired or liabilities assumed, whichever comes first, any subsequent adjustments would be recorded in earnings. |
Goodwill and Intangible Assets, Goodwill, Policy | Goodwill In accordance with ASC 350, Intangibles-Goodwill and Other ( “ ASC 350 ” ) , acquired goodwill is not amortized but is tested for impairment on an annual basis or whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. The Company performs annual impairment reviews of its goodwill balance during the fourth fiscal quarter or more frequently if business factors indicate. In testing for impairment, the Company compares the fair value of its reporting unit to its carrying value including the goodwill of that unit. If the carrying value, including goodwill, exceeds the reporting unit’s fair value, the Company will recognize an impairment loss for the amount by which the carrying amount exceeds the reporting unit’s fair value. The loss recognized cannot exceed the total amount of goodwill allocated to that reporting unit. The Company did not incur any goodwill impairment losses during the year ended December 31, 2023. |
Intangible Assets, Finite-Lived, Policy | In-process research and development Intangible assets related to in-process research and development costs are considered indefinite-lived intangible assets until the completion or abandonment of the associated research and development efforts. If and when development is complete, the associated assets would be deemed finite-lived intangible assets and would then be amortized based on their respective estimated useful lives at that point in time. Prior to the completion or abandonment of the associated research and development efforts, the assets are not amortized but are tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate a reduction in the fair value of the in-process research and development projects below their respective carrying amounts. During the fourth fiscal quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of its in-process research and development projects. If the fair value exceeds the carrying value, there is no impairment. Impairment losses on indefinite-lived intangible assets are recognized based solely on a comparison of the fair value of an asset to its carrying value, without consideration of any recoverability test. The Company did not incur any impairment losses during the year ended December 31, 2023. |
Goodwill and Intangible Assets, Intangible Assets, Policy | Intangible assets Amortizable intangible assets include customer relationships and developed technology acquired as part of business combinations. Customer relationships and developed technology acquired through business combinations subject to amortization are amortized using the straight-line method over their estimated useful lives ranging from five to 20 years. All intangible assets subject to amortization are reviewed for impairment during the fourth fiscal quarter or more frequently if business factors indicate in accordance with ASC 360, Property, Plant and Equipment ( “ ASC 360 ” ) . The Company did not incur any impairment losses during the year ended December 31, 2023. |
Contingent Consideration Liabilities | Contingent Consideration Liabilities Related to Business Combination At each reporting period, the Company evaluates the likelihood of any expected future payments and the associated discount rate to determine the fair value of the contingent consideration. The Company remeasures the fair value of contingent consideration liabilities each reporting period, based on new developments, and records any necessary adjustments as a component of total operating expenses within the consolidated statements of operations until either the contingent consideration obligation is satisfied through payment upon the achievement of, or the obligation no longer exists due to the failure to achieve, the specified milestones. Contingent consideration liabilities are recorded within other liabilities in the consolidated balance sheets. |
Convertible Debt Policy | Convertible Debt The Company applies the provisions of ASU 2020-06 which simplify the accounting related to convertible debt instruments by removing major separation models required under current GAAP. Accordingly, the Company does not bifurcate the liability and equity components of the convertible debt on the consolidated balance sheets. The Company’s convertible debt is reflected as a liability on the Company’s consolidated balance sheets, with the initial carrying amount equal to the principal amount of the debt, net of issuance costs. The issuance costs are treated as a debt discount for accounting purposes, which will be amortized into interest expense over the term of the instruments utilizing the effective interest method. |
New Accounting Pronouncements, Policy | Recently Issued Accounting Pronouncements Not Yet Adopted In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting ( “ ASC 280 ” ): Improvements to Reportable Segment Disclosures ( “ ASU 2023-07 ” ) , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on its related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes ( “ ASC 740 ” ): Improvements to Income Tax Disclosures ( “ ASU 2023-09 ” ) , which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures. The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting pronouncements issued through the date of this report will have a material impact on the Company’s financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Restrictions on Cash and Cash Equivalents | December 31, 2023 2022 (in thousands) Cash and cash equivalents $ 328,422 $ 156,586 Restricted cash 1,404 1,716 Total cash, cash equivalents, and restricted cash $ 329,826 $ 158,302 |
Schedule of Cash and Cash Equivalents | December 31, 2023 2022 (in thousands) Cash and cash equivalents $ 328,422 $ 156,586 Restricted cash 1,404 1,716 Total cash, cash equivalents, and restricted cash $ 329,826 $ 158,302 |
Summary of Activity in Allowance for Doubtful Accounts | The following table summarizes the activity in the allowance for doubtful accounts: For the Year Ended December 31, 2023 2022 2021 (in thousands) Beginning balance $ 710 $ 350 $ 380 Amounts charged (reversed) to costs and expenses 1,479 364 (12) Write-offs (10) (4) (18) Ending balance $ 2,179 $ 710 $ 350 |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value | The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: December 31, 2023 Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 43,277 $ — $ — $ 43,277 U.S. treasury securities 109,310 — — 109,310 Marketable securities: U.S. treasury securities 575,203 — — 575,203 Commercial paper — 46,054 — 46,054 Corporate bonds — 20,073 — 20,073 U.S. agency securities — 14,946 — 14,946 Asset-backed securities — 5,856 — 5,856 Total assets $ 727,790 $ 86,929 $ — $ 814,719 Liabilities: Contingent consideration liability $ — $ — $ 9,307 $ 9,307 Convertible debt — 730,455 — 730,455 Total liabilities $ — $ 730,455 $ 9,307 $ 739,762 December 31, 2022 Level 1 Level 2 Level 3 Total (in thousands) Assets: Cash equivalents: Money market funds $ 12,076 $ — $ — $ 12,076 Marketable securities: U.S. treasury securities 111,631 — — 111,631 Commercial paper — 8,039 — 8,039 Corporate bonds — 18,808 — 18,808 U.S. agency securities — 9,429 — 9,429 Total assets $ 123,707 $ 36,276 $ — $ 159,983 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Cash Equivalents and Short-Term Investments | The following is a summary of the Company’s cash equivalents and short-term investments: December 31, 2023 Amortized Unrealized Unrealized Fair Value (in thousands) Cash equivalents: Money market funds $ 43,277 $ — $ — $ 43,277 U.S. treasury securities 109,292 18 — 109,310 Marketable securities: U.S. treasury securities 575,008 233 (38) 575,203 Commercial paper 46,015 52 (13) 46,054 Corporate bonds 19,995 86 (8) 20,073 U.S. agency securities 14,949 16 (19) 14,946 Asset-backed securities 5,792 64 — 5,856 Total $ 814,328 $ 469 $ (78) $ 814,719 Reported as: Cash equivalents $ 152,587 Short-term investments 662,132 Total $ 814,719 December 31, 2022 Amortized Unrealized Unrealized Fair Value (in thousands) Cash equivalents: Money market funds $ 12,076 $ — $ — $ 12,076 Marketable securities: U.S. treasury securities 112,719 3 (1,091) 111,631 Commercial paper 8,039 — — 8,039 Corporate bonds 18,876 8 (76) 18,808 U.S. agency securities 9,432 4 (7) 9,429 Total $ 161,142 $ 15 $ (1,174) $ 159,983 Reported as: Cash equivalents $ 12,076 Short-term investments 147,907 Total $ 159,983 |
Summary of Remaining Contractual Maturities for Available-for-sale Securities | The remaining contractual maturities of the Company’s cash equivalents and short-term investments were as follows: December 31, Fair Value (in thousands) Money market funds $ 43,277 One year or less 764,034 Greater than one year and less than two years 7,408 Total $ 814,719 |
Business Combinations (Tables)
Business Combinations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of Business Acquisitions, by Acquisition | The following table summarizes the purchase price consideration for Neovasc: Purchase Price (in thousands) Cash transferred $ 112,129 Contingent consideration liability 9,307 Total $ 121,436 |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed | The following table summarizes the preliminary fair values of assets acquired and liabilities assumed through the Company ’ s Neovasc acquisition at the acquisition date based on management’s best estimates and assumptions as of the reporting date: Purchase Price (in thousands) Cash and cash equivalents $ 17,273 Accounts receivable, net 1,345 Inventory 918 Prepaid expenses and other current assets 841 Operating lease right-of-use assets 310 Property and equipment 156 Intangible assets 95,500 Other assets 502 Total identifiable assets acquired 116,845 Accounts payable 3,334 Accrued liabilities 4,082 Lease liability, current portion 253 Lease liability, noncurrent portion 64 Deferred tax liabilities 10,964 Other liabilities 16,280 Total liabilities assumed 34,977 Net identifiable assets acquired 81,868 Goodwill 39,568 Total purchase price $ 121,436 |
Finite-Lived and Indefinite-Lived Intangible Assets Acquired as Part of Business Combination | The fair value of the intangible assets acquired as of the acquisition date and, the method used to value these assets as well as the estimated economic lives for amortizable intangible assets were as follows (in thousands, except estimated useful life which is in years): Fair value Estimated useful life Valuation method Customer relationships $ 2,900 5.0 years Avoided cost / lost profit Developed technology 61,200 20.0 years Multi-period excess earnings In-process research and development 31,400 N/A Multi-period excess earnings Total $ 95,500 |
Business Acquisition, Pro Forma Information | Supplemental Unaudited Pro Forma Information The following are the supplemental consolidated financial results of the Company and Neovasc on an unaudited pro forma basis, as if the Neovasc acquisition had been consummated on January 1, 2022. Year Ended December 31, 2023 2022 (in thousands) Net revenue $731,699 $493,538 Net income $151,339 $173,596 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consists of the following: December 31, 2023 2022 (in thousands) Raw material $ 25,670 $ 18,456 Work in progress 16,499 7,666 Finished goods 65,418 48,990 Total inventory $ 107,587 $ 75,112 |
Schedule of Property and Equipment | Property and equipment, net consists of the following: December 31, 2023 2022 (in thousands) Equipment $ 19,687 $ 12,784 Office furniture 1,839 1,171 Software 848 904 Building 12,166 — Land 2,268 — Leasehold improvements 38,168 33,703 Construction in progress 11,016 9,765 Property and equipment, gross 85,992 58,327 Less: accumulated depreciation and amortization (17,069) (10,175) Total property and equipment, net $ 68,923 $ 48,152 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: December 31, 2023 2022 (in thousands) Employee compensation $ 49,706 $ 32,885 Asset purchases 7,788 4,600 Professional services 6,269 4,044 Research and development costs 8,122 4,007 Excise, sales, income and other taxes 12,320 4,036 Sales and marketing 3,495 2,012 Other 3,996 3,791 Total accrued liabilities $ 91,696 $ 55,375 |
Goodwill and intangible assets
Goodwill and intangible assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The changes in the carrying amounts of goodwill were as follows: (in thousands) Balance as of December 31, 2022 $ — Goodwill acquired - Neovasc 39,568 Goodwill deductions or impairment — Balance as of December 31, 2023 $ 39,568 |
Schedule of Finite-Lived Intangible Assets | The following table presents details of the acquired intangible assets as of December 31, 2023 (in thousands, except useful life and estimated remaining useful life which are in years): Gross Carrying Amount Accumulated Impairment Intangible Assets, Net Customer relationships $ 2,900 $ 421 $ — $ 2,479 5.0 years 4.3 years Developed technology 61,200 2,222 — 58,978 20.0 years 19.3 years In-process research and development 31,400 — — 31,400 N/A N/A Total $ 95,500 $ 2,643 $ — $ 92,857 19.3 years 18.6 years |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The following table summarizes the estimated future amortization expense of intangible assets with finite lives as of December 31, 2023: Years ending December 31, (in thousands) 2024 3,640 2025 3,640 2026 3,640 2027 3,640 2028 3,219 Thereafter 43,678 Total estimated future amortization expense $ 61,457 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Components of Lease Costs | The Company recognizes rent expense for these operating leases on a straight-line basis over the lease period. The components of lease costs, which the Company includes in operating expenses in the consolidated statements of operations and comprehensive income, were as follows: Year Ended December 31, 2023 2022 2021 (in thousands) Operating lease cost $ 5,110 $ 4,667 $ 2,891 Variable lease cost 1,243 1,186 496 Total lease cost $ 6,353 $ 5,853 $ 3,387 |
Schedule of Minimum Future Rental Payments | As of December 31, 2023, the maturities of the payments due under the Company’s operating lease liabilities were as follows: (in thousands) 2024 $ 5,555 2025 5,526 2026 5,690 2027 5,832 2028 5,960 Thereafter 18,999 Total minimum lease payments $ 47,562 Less: imputed interest (8,818) Total lease liability $ 38,744 Less: current portion (3,641) Lease liability, noncurrent portion $ 35,103 |
Lessor, Operating Lease, Payment to be Received, Maturity | The table below summarizes the undiscounted future non-cancellable lease payments for the 5303 Lease facility under the Second Lease Amendment, which had not yet commenced as of December 31, 2023. Years ending December 31, (in thousands) 2024 $ 476 2025 1,173 2026 1,207 2027 1,244 2028 1,282 Thereafter 4,077 Total undiscounted lease payments $ 9,459 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Total Stock-Based Compensation | Total stock-based compensation was as follows: Year Ended December 31, 2023 2022 2021 (in thousands) Cost of product revenue $ 5,003 $ 2,193 $ 1,153 Research and development 17,160 10,354 6,240 Sales and marketing 27,945 18,387 11,043 General and administrative 23,126 13,956 8,821 Total stock-based compensation $ 73,234 $ 44,890 $ 27,257 |
Schedule of Option Activity under 2009 Plan and 2019 Plan | Option activity under the 2009 Plan and 2019 Plan is set forth below: Number Weighted- Weighted- Aggregate (in years) (in thousands) Balance, December 31, 2022 1,122,009 $ 5.87 4.60 $ 224,115 Options exercised (235,067) 5.84 Options cancelled (6,133) 2.41 Balance, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 Vested and exercisable, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 Vested and expected to vest, December 31, 2023 880,809 $ 5.90 3.60 $ 162,653 |
Schedule of RSU Activity under 2019 Plan | RSU and PRSU activity under the 2019 Plan is set forth below. Grant activity for all PRSUs is disclosed at target (100%): Restricted Stock Units Performance-Based Restricted Stock Units Number Weighted- Number Weighted- Balance, December 31, 2022 1,125,991 $ 127.39 38,797 $ 165.74 RSUs and PRSUs granted 606,187 210.54 29,473 191.36 RSUs and PRSUs forfeited (83,916) 172.66 (867) 267.54 RSUs and PRSUs vested (481,240) 117.14 (395) 267.41 Balance, December 31, 2023 1,167,022 171.55 67,008 175.09 |
Schedule of Fair Value of ESPP Shares Estimated Using Black-Scholes Option Pricing Model Assumptions | At December 31, 2023, a total of 1,521,021 shares of common stock were available for issuance under the ESPP. Years Ended December 31, 2023 2022 2021 Expected term (in years) 0.5 0.5 0.5 Expected volatility 44.3%-73.8% 61.8%-73.8% 48.9%-64.8% Risk-free interest rate 3.7%-5.5% 0.1%-3.7% 0.1% Expected dividend yield 0% 0% 0% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income (Loss) Before Income Taxes | The following table presents income (loss) before income taxes for the periods presented: December 31, 2023 2022 2021 (in thousands) Domestic $ 194,406 $ 119,901 $ (9,388) Foreign (20,125) 927 553 Total income (loss) before income taxes $ 174,281 $ 120,828 $ (8,835) |
Schedule of Current Income Tax Provision | The income tax expense (benefit) for the periods presented consisted of the following: December 31, 2023 2022 2021 (in thousands) Current provision for income taxes: Federal $ 1,638 $ 403 $ — State 5,418 1,446 84 Foreign 5,239 259 217 Total current tax provision: 12,295 2,108 301 Deferred tax provision: Federal 21,855 (85,618) — State 1,625 (11,658) — Foreign (8,772) — — Total deferred tax (benefit) provision 14,708 (97,276) — Total (benefit) provision for income taxes $ 27,003 $ (95,168) $ 301 |
Components of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities are as follows: December 31, 2023 2022 (in thousands) Deferred tax assets: Net operating loss carryovers $ 60,636 $ 60,467 Accruals and reserves 12,856 10,876 Stock-based compensation 8,745 8,504 Research and development credits 20,736 15,250 Lease liability 9,816 9,316 Capitalized research and development 34,511 17,791 Convertible note 22,841 — Other 92 — Total deferred tax assets 170,233 122,204 Less valuation allowance (57,848) (13,371) Gross deferred tax assets 112,385 108,833 Deferred tax liabilities: Fixed and intangible assets (5,624) (1,105) Right-of-use-assets (7,592) (8,327) In process research and development (3,609) — Other — (1,833) Gross deferred tax liabilities (16,825) (11,265) Total net deferred tax assets $ 95,560 $ 97,568 |
Reconciliation of Statutory Federal Income Tax | Reconciliation of the statutory federal income tax to the Company’s effective tax is as follows: December 31, 2023 2022 2021 (in thousands) Income tax provision (benefit) at federal statutory rate $ 36,601 $ 25,378 $ (1,856) State and local income 5,937 (10,516) 36 Foreign tax rate differential 926 47 101 Change in valuation allowance 3,331 (87,568) 19,027 Stock-based compensation (14,043) (18,273) (17,968) Section 250 FDII deduction (2,065) (984) — Research and development credits (6,974) (3,937) (808) Section 382 limitation — — 575 Equity method investment 393 520 1,320 Section 162(m) limitation 2,633 — — Acquisition tax structuring (2,418) — — Other 2,682 165 (126) Total current income tax (benefit) provision $ 27,003 $ (95,168) $ 301 |
Schedule of Unrecognized Tax Benefits | The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2023 2022 2021 (in thousands) Beginning balance $ 5,264 $ 5,221 $ 3,746 Additions based on tax positions related to prior years 283 — — Reductions based on tax positions related to prior years — (1,861) (79) Additions based on tax positions related to current years 4,418 1,904 1,554 Balance at end of year $ 9,965 $ 5,264 $ 5,221 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Product Revenue Based on Product Line and Location | The following table represents the Company’s product revenue based on product line: Year Ended December 31, 2023 2022 2021 (in thousands) Coronary $ 528,845 $ 353,859 $ 161,463 Peripheral 194,346 132,284 74,064 Reducer 4,368 — — Other 2,671 3,590 1,619 Product revenue $ 730,230 $ 489,733 $ 237,146 The following table represents the Company’s product revenue based on the location to which the product is shipped: Year Ended December 31, 2023 2022 2021 (in thousands) United States $ 581,548 $ 407,425 $ 186,324 Europe 77,515 51,010 38,571 All other countries 71,167 31,298 12,251 Product revenue $ 730,230 $ 489,733 $ 237,146 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Components of Basic and Diluted Net Income (Loss) Per Share | Year Ended December 31, 2023 2022 2021 Numerator: Net income (loss) $ 147,278 $ 215,996 $ (9,136) Denominator: Basic: Weighted average number of common shares outstanding - basic 36,706,060 35,900,738 35,098,130 Diluted: Weighted average number of common shares outstanding - basic 36,706,060 35,900,738 35,098,130 Dilutive effect of outstanding common stock options 960,436 1,294,052 — Dilutive effect of restricted stock units 535,483 684,696 — Dilutive effect of common stock pursuant to employee stock purchase plan 4,290 2,104 — Weighted average number of common shares outstanding - diluted 38,206,269 37,881,590 35,098,130 Net income (loss) per share: Basic $ 4.01 $ 6.02 $ (0.26) Diluted $ 3.85 $ 5.70 $ (0.26) |
Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share | Year Ended December 31, 2023 2022 2021 Common stock options issued and outstanding — — 1,524,985 Restricted stock units 105,726 21,537 1,156,683 Employee stock purchase plan — 2,122 10,028 Capped call options 333,409 — — Total 439,135 23,659 2,691,696 |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents and short-term investments | $ 990.6 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents | $ 328,422 | $ 156,586 |
Restricted cash | 1,404 | 1,716 |
Total cash, cash equivalents, and restricted cash | $ 329,826 | $ 158,302 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Notice period for cancellation of agreement | 30 days | ||
License revenue recognized | $ 0 | $ 0 | $ 0 |
Defined contribution plan, contribution amount | 5,300,000 | 3,700,000 | 2,500,000 |
Foreign currency transaction gain (loss), before Tax | $ (1,800,000) | $ (1,100,000) | $ 800,000 |
Percentage of income tax position required to recognize uncertain income tax position | 50% | ||
Number of operating segments | segment | 1 | ||
Geographic Concentration Risk | Geographical Benchmark | Japan and Costa Rica | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 32% | 15% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Activity in Allowance for Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |||
Beginning balance | $ 710 | $ 350 | $ 380 |
Amounts charged (reversed) to costs and expenses | 1,479 | 364 | (12) |
Write-offs | (10) | (4) | (18) |
Ending balance | $ 2,179 | $ 710 | $ 350 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) | Dec. 31, 2023 |
Equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful life | 3 years |
Equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful life | 5 years |
2520 Office Furniture | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful life | 5 years |
Building | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful life | 25 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful life | 3 years |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Recurring | ||
Assets: | ||
Total assets | $ 814,719 | $ 159,983 |
Liabilities, Fair Value Disclosure | 739,762 | |
Fair Value, Recurring | Contingent Consideration | ||
Assets: | ||
Obligations, Fair Value Disclosure | 9,307 | |
Fair Value, Recurring | Borrowings | ||
Assets: | ||
Obligations, Fair Value Disclosure | 730,455 | |
Level 1 | Fair Value, Recurring | ||
Assets: | ||
Total assets | 727,790 | 123,707 |
Liabilities, Fair Value Disclosure | 0 | |
Level 1 | Fair Value, Recurring | Contingent Consideration | ||
Assets: | ||
Obligations, Fair Value Disclosure | 0 | |
Level 1 | Fair Value, Recurring | Borrowings | ||
Assets: | ||
Obligations, Fair Value Disclosure | 0 | |
Level 2 | Fair Value, Recurring | ||
Assets: | ||
Total assets | 86,929 | 36,276 |
Liabilities, Fair Value Disclosure | 730,455 | |
Level 2 | Fair Value, Recurring | Contingent Consideration | ||
Assets: | ||
Obligations, Fair Value Disclosure | 0 | |
Level 2 | Fair Value, Recurring | Borrowings | ||
Assets: | ||
Obligations, Fair Value Disclosure | 730,455 | |
Level 3 | Fair Value, Recurring | ||
Assets: | ||
Total assets | 0 | 0 |
Liabilities, Fair Value Disclosure | 9,307 | |
Level 3 | Fair Value, Recurring | Contingent Consideration | ||
Assets: | ||
Obligations, Fair Value Disclosure | 9,307 | |
Level 3 | Fair Value, Recurring | Borrowings | ||
Assets: | ||
Obligations, Fair Value Disclosure | 0 | |
Money market funds | ||
Assets: | ||
Cash equivalents | 43,277 | |
Money market funds | Cash equivalents: | ||
Assets: | ||
Marketable securities: | 43,277 | 12,076 |
Money market funds | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 43,277 | 12,076 |
Money market funds | Level 1 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 43,277 | 12,076 |
Money market funds | Level 2 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Money market funds | Level 3 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 0 | 0 |
U.S. treasury securities | Cash equivalents: | ||
Assets: | ||
Marketable securities: | 109,310 | |
U.S. treasury securities | Marketable securities: | ||
Assets: | ||
Marketable securities: | 575,203 | 111,631 |
U.S. treasury securities | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 109,310 | |
U.S. treasury securities | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 575,203 | 111,631 |
U.S. treasury securities | Level 1 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 109,310 | |
U.S. treasury securities | Level 1 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 575,203 | 111,631 |
U.S. treasury securities | Level 2 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 0 | |
U.S. treasury securities | Level 2 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
U.S. treasury securities | Level 3 | Fair Value, Recurring | Cash equivalents: | ||
Assets: | ||
Cash equivalents | 0 | |
U.S. treasury securities | Level 3 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Commercial paper | Marketable securities: | ||
Assets: | ||
Marketable securities: | 46,054 | 8,039 |
Commercial paper | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 46,054 | 8,039 |
Commercial paper | Level 1 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Commercial paper | Level 2 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 46,054 | 8,039 |
Commercial paper | Level 3 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Corporate bonds | Marketable securities: | ||
Assets: | ||
Marketable securities: | 20,073 | 18,808 |
Corporate bonds | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 20,073 | 18,808 |
Corporate bonds | Level 1 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Corporate bonds | Level 2 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 20,073 | 18,808 |
Corporate bonds | Level 3 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
U.S. agency securities | Marketable securities: | ||
Assets: | ||
Marketable securities: | 14,946 | |
U.S. agency securities | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 14,946 | 9,429 |
U.S. agency securities | Level 1 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
U.S. agency securities | Level 2 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 14,946 | 9,429 |
U.S. agency securities | Level 3 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Asset-Backed Securities | Marketable securities: | ||
Assets: | ||
Marketable securities: | 5,856 | $ 9,429 |
Asset-Backed Securities | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 5,856 | |
Asset-Backed Securities | Level 1 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 0 | |
Asset-Backed Securities | Level 2 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | 5,856 | |
Asset-Backed Securities | Level 3 | Fair Value, Recurring | Marketable securities: | ||
Assets: | ||
Marketable securities: | $ 0 |
Financial Instruments and Fai_4
Financial Instruments and Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Apr. 11, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Unrealized Gains | $ 469 | $ 15 | |
Cash equivalents: | Money market funds | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Unrealized Gains | 0 | $ 0 | |
Convertible Senior Notes Due 2028 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Convertible Debt | $ 730,500 | ||
Neovasc Inc. | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Contingent consideration liability | $ 9,307 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments - Summary of Cash Equivalents and Short-Term Investments (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents and short-term investments, Amortized Cost Basis | $ 814,328,000 | $ 161,142,000 |
Unrealized Gains | 469,000 | 15,000 |
Unrealized Losses | (78,000) | (1,174,000) |
Cash equivalents and short-term investments, fair value | 814,719,000 | 159,983,000 |
Cash equivalents | 152,587,000 | 12,076,000 |
Short-term investments | 662,132,000 | 147,907,000 |
U.S. treasury securities | Cash equivalents: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 109,292,000 | |
Unrealized Gains | 18,000 | |
Unrealized Losses | 0 | |
Fair Value | 109,310,000 | |
U.S. treasury securities | Marketable securities: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 575,008,000 | 112,719,000 |
Unrealized Gains | 233,000 | 3,000 |
Unrealized Losses | (38,000) | (1,091,000) |
Fair Value | 575,203,000 | 111,631,000 |
Money market funds | Cash equivalents: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 43,277,000 | 12,076,000 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | 43,277,000 | 12,076,000 |
Commercial paper | Marketable securities: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 46,015,000 | 8,039,000 |
Unrealized Gains | 52,000 | 0 |
Unrealized Losses | (13,000) | 0 |
Fair Value | 46,054,000 | 8,039,000 |
Corporate bonds | Marketable securities: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 19,995,000 | 18,876,000 |
Unrealized Gains | 86,000 | 8,000 |
Unrealized Losses | (8,000) | (76,000) |
Fair Value | 20,073,000 | 18,808,000 |
U.S. agency securities | Marketable securities: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 14,949,000 | 9,432,000 |
Unrealized Gains | 16,000 | |
Unrealized Losses | (19,000) | |
Fair Value | 14,946,000 | |
Asset-Backed Securities | Marketable securities: | ||
Cash And Cash Equivalents [Line Items] | ||
Amortized Cost Basis | 5,792,000 | |
Unrealized Gains | 64,000 | 4,000 |
Unrealized Losses | 0 | (7,000) |
Fair Value | $ 5,856,000 | $ 9,429,000 |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |||
Debt securities, available-for-sale, unrealized loss position | $ 45,900,000 | $ 123,800,000 | |
Debt securities, available-for-sale, unrealized loss position, accumulated Loss | 100,000 | 1,200,000 | |
Adjustment for net gain realized and included in other income, net | $ 5,000 | $ 6,000 | $ 0 |
Cash Equivalents and Short-Te_5
Cash Equivalents and Short-Term Investments - Summary of Remaining Contractual Maturities for Available-for-sale Securities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Cash And Cash Equivalents [Line Items] | |
One year or less | $ 764,034 |
Greater than one year and less than two years | 7,408 |
Total | 814,719 |
Money market funds | |
Cash And Cash Equivalents [Line Items] | |
Cash equivalents | $ 43,277 |
Business Combination - Narrativ
Business Combination - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Apr. 11, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Business Acquisition [Line Items] | |||
Goodwill | $ 39,568 | $ 0 | |
Neovasc Inc. | |||
Business Acquisition [Line Items] | |||
Business acquisition, share price (in dollars per share) | $ 27.25 | ||
Business Combination, Acquisition Related Costs | 6,900 | ||
Total | $ 121,436 | ||
Cash transferred | 112,129 | ||
Contingent consideration liability | 9,307 | ||
Business Combination, Contingent Consideration Arrangements, Range of Outcomes, Value, High | 47,000 | ||
Goodwill | 39,568 | 39,600 | |
Deferred tax liabilities | $ 10,964 | $ 11,000 | |
Neovasc Inc. | June 30, 2026 Milestone | |||
Business Acquisition [Line Items] | |||
Business Combination, Contingent Consideration, Per Share | $ 12 | ||
Neovasc Inc. | December 31, 2026 Milestone | |||
Business Acquisition [Line Items] | |||
Business Combination, Contingent Consideration, Per Share | 8 | ||
Neovasc Inc. | December 31, 2027 Milestone | |||
Business Acquisition [Line Items] | |||
Business Combination, Contingent Consideration, Per Share | $ 4 |
Business Combination - Calculat
Business Combination - Calculation of Consideration Transferred (Details) - Neovasc Inc. $ in Thousands | Apr. 11, 2023 USD ($) |
Business Acquisition [Line Items] | |
Cash transferred | $ 112,129 |
Contingent consideration liability | 9,307 |
Total | $ 121,436 |
Business Combination - Assets A
Business Combination - Assets Acquired, Liabilities Assumed (Details) - USD ($) | Dec. 31, 2023 | Apr. 11, 2023 | Dec. 31, 2022 |
Business Acquisition [Line Items] | |||
Goodwill | $ 39,568,000 | $ 0 | |
Neovasc Inc. | |||
Business Acquisition [Line Items] | |||
Cash and cash equivalents | $ 17,273,000 | ||
Accounts receivable, net | 1,345,000 | ||
Inventory | 918,000 | ||
Prepaid expenses and other current assets | 841,000 | ||
Operating lease right-of-use assets | 310,000 | ||
Property and equipment | 156,000 | ||
Intangible assets | 95,500,000 | 95,500,000 | |
Other assets | 502,000 | ||
Total identifiable assets acquired | 116,845,000 | ||
Accounts payable | 3,334,000 | ||
Accrued liabilities | 4,082,000 | ||
Lease liability, current portion | 253,000 | ||
Lease liability, noncurrent portion | 64,000 | ||
Deferred tax liabilities | 11,000,000 | 10,964,000 | |
Other liabilities | 16,280,000 | ||
Total liabilities assumed | 34,977,000 | ||
Net identifiable assets acquired | 81,868,000 | ||
Goodwill | $ 39,600,000 | 39,568,000 | |
Total purchase price | $ 121,436,000 |
Business Combination - Intangib
Business Combination - Intangible Assets (Details) - Neovasc Inc. - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Apr. 11, 2023 | |
Business Acquisition [Line Items] | ||
Intangible assets | $ 95,500,000 | $ 95,500,000 |
In-process research and development | ||
Business Acquisition [Line Items] | ||
Intangible assets | 31,400,000 | |
Customer Relationships | ||
Business Acquisition [Line Items] | ||
Intangible assets | $ 2,900,000 | |
Acquired Finite-Lived Intangible Assets, Weighted Average Useful Life | 5 years | |
Developed technology | ||
Business Acquisition [Line Items] | ||
Intangible assets | $ 61,200,000 | |
Acquired Finite-Lived Intangible Assets, Weighted Average Useful Life | 20 years |
Business Combination - Pro Form
Business Combination - Pro Forma Information (Details) - Neovasc Inc. - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Business Acquisition [Line Items] | ||
Net revenue | $ 731,699 | $ 493,538 |
Net income | $ 151,339 | $ 173,596 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw material | $ 25,670 | $ 18,456 |
Work in progress | 16,499 | 7,666 |
Finished goods | 65,418 | 48,990 |
Total inventory | $ 107,587 | $ 75,112 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 85,992 | $ 58,327 |
Less: accumulated depreciation and amortization | (17,069) | (10,175) |
Total property and equipment, net | 68,923 | 48,152 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 19,687 | 12,784 |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,839 | 1,171 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 848 | 904 |
Building | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 12,166 | 0 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,268 | 0 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 38,168 | 33,703 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 11,016 | $ 9,765 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Depreciation and amortization | $ 7.7 | $ 4.9 | $ 3.6 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Employee compensation | $ 49,706,000 | $ 32,885,000 |
Asset purchases | 7,788,000 | 4,600,000 |
Professional services | 6,269,000 | 4,044,000 |
Research and development costs | 8,122,000 | 4,007,000 |
Excise, sales, income and other taxes | 12,320,000 | 4,036,000 |
Sales and marketing | 3,495,000 | 2,012,000 |
Other | 3,996,000 | 3,791,000 |
Total accrued liabilities | $ 91,696,000 | $ 55,375,000 |
Goodwill and intangible asset_2
Goodwill and intangible assets - Changes in Carrying Amount of Goodwill (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Goodwill [Roll Forward] | |
Balance as of December 31, 2022 | $ 0 |
Goodwill acquired - Neovasc | 39,568 |
Goodwill deductions or impairment | 0 |
Balance as of September 30, 2023 | $ 39,568 |
Goodwill and intangible asset_3
Goodwill and intangible assets - Schedule of Finite and Indefinite-Lived Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Accumulated Amortization | $ 2,600 | |
Intangible Assets, Net | 61,457 | |
Intangible assets, net | 92,857 | $ 0 |
Neovasc Inc. | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total intangibles, gross carrying amount | 95,500 | |
Accumulated Amortization | 2,643 | |
Impairment | 0 | |
Intangible assets, net | $ 92,857 | |
Useful Life | 19 years 3 months 18 days | |
Estimated Remaining Useful Life | 18 years 7 months 6 days | |
In-process research and development | Neovasc Inc. | ||
Finite-Lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets | $ 31,400 | |
Customer relationships | Neovasc Inc. | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 2,900 | |
Accumulated Amortization | 421 | |
Impairment | 0 | |
Intangible Assets, Net | $ 2,479 | |
Useful Life | 5 years | |
Estimated Remaining Useful Life | 4 years 3 months 18 days | |
Developed technology | Neovasc Inc. | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 61,200 | |
Accumulated Amortization | 2,222 | |
Impairment | 0 | |
Intangible Assets, Net | $ 58,978 | |
Useful Life | 20 years | |
Estimated Remaining Useful Life | 19 years 3 months 18 days |
Goodwill and intangible asset_4
Goodwill and intangible assets - Narrative (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Accumulated Amortization | $ 2.6 |
Goodwill and intangible asset_5
Goodwill and intangible assets - Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2024 | $ 3,640 |
2025 | 3,640 |
2026 | 3,640 |
2027 | 3,640 |
2028 | 3,219 |
Thereafter | 43,678 |
Intangible Assets, Net | $ 61,457 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 term | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Loss Contingencies [Line Items] | ||||
Operating lease expense | $ 5.1 | $ 4.7 | $ 2.9 | |
Operating lease payments | $ 5.5 | $ 3.4 | $ 2.2 | |
Operating lease, weighted average remaining lease term | 8 years | |||
Operating lease, weighted average discount rate | 5.20% | |||
3003 Lease | ||||
Loss Contingencies [Line Items] | ||||
Number of additional five year term | term | 2 | |||
Operating lease, extended period | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Components of Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease cost | $ 5,110 | $ 4,667 | $ 2,891 |
Variable lease cost | 1,243 | 1,186 | 496 |
Total lease cost | $ 6,353 | $ 5,853 | $ 3,387 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Minimum Future Rental Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Operating Lease Liabilities Payments Due [Abstract] | ||
2024 | $ 5,555 | |
2025 | 5,526 | |
2026 | 5,690 | |
2027 | 5,832 | |
2028 | 5,960 | |
Thereafter | 18,999 | |
Total minimum lease payments | 47,562 | |
Less: imputed interest | (8,818) | |
Total lease liability | 38,744 | |
Lease liability, current portion | (3,641) | $ (1,278) |
Lease liability, noncurrent portion | $ 35,103 | $ 34,928 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Leases, Lease Payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 476 |
2025 | 1,173 |
2026 | 1,207 |
2027 | 1,244 |
2028 | 1,282 |
Thereafter | 4,077 |
Total undiscounted lease payments | $ 9,459 |
Debt (Details)
Debt (Details) - USD ($) | 12 Months Ended | |||||||
Aug. 29, 2023 | Apr. 26, 2023 | Mar. 16, 2023 | Oct. 19, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Feb. 29, 2020 | |
Debt Instrument [Line Items] | ||||||||
Repayments of long-term debt | $ 105,000,000 | $ 18,196,000 | $ 0 | |||||
Loss on extinguishment of debt | 710,000 | 562,000 | 0 | |||||
Interest Expense, Debt | 2,700,000 | 1,900,000 | $ 1,100,000 | |||||
Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Loss on extinguishment of debt | $ (700,000) | |||||||
Repayments of Debt | $ 25,000,000 | |||||||
Extinguishment of Debt, Amount | $ 80,000,000 | |||||||
SVB Credit Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Loss on extinguishment of debt | $ 600,000 | |||||||
Supplemental Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt amount | $ 16,500,000 | |||||||
Repayments of long-term debt | $ 14,600,000 | |||||||
Revolving Credit Facility | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | 175,000,000 | |||||||
Line of credit facility, accordion feature, increase limit | 100,000,000 | |||||||
Proceeds of supplemental term loan | $ 80,000,000 | $ 25,000,000 | ||||||
Line of credit facility, interest rate at period end | 7.30% | |||||||
Revolving Credit Facility | Secured Overnight Financing Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 1% | |||||||
Revolving Credit Facility | Fed Funds Effective Rate Overnight Index Swap Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 0.50% | |||||||
Revolving Credit Facility | Minimum | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 0% | |||||||
Revolving Credit Facility | Minimum | Base Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 0% | |||||||
Revolving Credit Facility | Minimum | Secured Overnight Financing Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 1% | |||||||
Revolving Credit Facility | Maximum | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 1.80% | |||||||
Revolving Credit Facility | Maximum | Base Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 1% | |||||||
Revolving Credit Facility | Maximum | Secured Overnight Financing Rate | Line of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate basis | 2% |
Convertible Debt (Details)
Convertible Debt (Details) | 12 Months Ended | ||||
Aug. 15, 2023 USD ($) d $ / shares shares | Aug. 10, 2023 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||
Common stock, par value (USD per share) | $ / shares | $ 0.001 | $ 0.001 | |||
Interest expense | $ 6,905,000 | $ 1,886,000 | $ 1,096,000 | ||
Convertible Debt, Noncurrent | 731,863,000 | $ 0 | |||
Convertible Senior Notes Due 2028 | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Interest Rate Terms | The Notes bear interest at a rate of 1.0% per year, payable semiannually in arrears on February 15 and August 15 of each year, beginning on February 15, 2024. | ||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 3.4595 | ||||
Debt Conversion, Converted Instrument, Maximum Shares Issued | shares | 4.4974 | ||||
Debt Instrument, Redemption Price, Percentage | 100% | ||||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 130% | ||||
Interest expense | 4,200,000 | ||||
Convertible Senior Notes Due 2028 | Convertible Debt | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Issued, Principal | $ 750,000,000 | ||||
Debt Instrument, Interest Rate During Period | 1% | ||||
Debt amount | $ 100,000,000 | ||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 289.06 | ||||
Debt Conversion, Converted Instrument, Rate | 30% | ||||
Common stock, par value (USD per share) | $ / shares | $ 222.35 | ||||
Debt Instrument, Convertible, Threshold Trading Days | d | 20 | ||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | d | 30 | ||||
Debt Issuance Costs, Gross | $ 19,600,000 | ||||
Debt interest rate | 1.50% | ||||
Convertible Debt, Noncurrent | $ 731,900,000 | ||||
Convertible Senior Notes Due 2028 | Convertible Debt | Debt Instrument, Period One | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 130% | ||||
Debt Instrument, Convertible, Threshold Trading Days | d | 20 | ||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | d | 30 | ||||
Convertible Senior Notes Due 2028 | Convertible Debt | Debt Instrument, Period Two | |||||
Debt Instrument [Line Items] | |||||
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger | 98% | ||||
Debt Instrument, Convertible, Threshold Trading Days | d | 5 | ||||
Call Option | Convertible Debt | |||||
Debt Instrument [Line Items] | |||||
Common stock, par value (USD per share) | $ / shares | $ 222.35 | ||||
Share Price | $ / shares | $ 444.7 | ||||
Premium Recognized On Capped Call Transactions | $ 1 | ||||
Purchases Of Capped Calls Related To Convertible Senior Notes | $ 96,400,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 73,234 | $ 44,890 | $ 27,257 |
Cost of product revenue | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 5,003 | 2,193 | 1,153 |
Research and development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 17,160 | 10,354 | 6,240 |
Sales and marketing | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 27,945 | 18,387 | 11,043 |
General and administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 23,126 | $ 13,956 | $ 8,821 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 06, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based compensation expenses capitalized amount | $ 2,300,000 | $ 2,200,000 | $ 700,000 | ||
Expected dividend yield | 0% | ||||
Common stock reserved for issuance (in shares) | 2,000,430 | ||||
Maximum period of automatic annual increase in common stock reserved for issuance | 10 years | ||||
Automatic annual increase in common stock reserved for issuance | 3% | ||||
Share-based compensation, number of shares available for grant | 3,516,750 | ||||
Options granted (in shares) | 0 | 0 | 0 | ||
Grant date fair value of options vested | $ 100,000 | $ 1,000,000 | $ 1,600,000 | ||
Stock-based compensation | 73,234,000 | 44,890,000 | 27,257,000 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 0 | ||||
Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Unvested stock options, remaining weighted-average period | 2 years 3 months 18 days | ||||
Grant date fair value of RSU vested | $ 56,500,000 | $ 30,900,000 | $ 11,300,000 | ||
Unrecognized stock-based compensation | $ 175,300,000 | ||||
Restricted Stock Units | Minimum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 1 year | ||||
Cliff vesting, percentage | 0% | ||||
Restricted Stock Units | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Cliff vesting, percentage | 200% | ||||
Performance-Based Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Cliff vesting, percentage | 100% | ||||
Performance-Based Restricted Stock Units | Minimum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 2 years | ||||
Performance-Based Restricted Stock Units | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Expected dividend yield | 0% | 0% | 0% | ||
Common stock reserved for issuance (in shares) | 300,650 | ||||
Maximum period of automatic annual increase in common stock reserved for issuance | 10 years | ||||
Automatic annual increase in common stock reserved for issuance | 1% | ||||
Purchase shares of common stock, price per share, percentage of fair market value | 85% | ||||
Stock-based compensation | $ 3,300,000 | $ 2,300,000 | $ 1,300,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Option Activity under 2009 Plan and 2019 Plan (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Balance beginning of period (in shares) | 1,122,009 | |
Exercise of stock options (in shares) | (235,067) | |
Options cancelled (in shares) | (6,133) | |
Balance end of period (in shares) | 880,809 | 1,122,009 |
Vested and exercisable shares (in shares) | 880,809 | |
Vested and expected to vest shares (in shares) | 880,809 | |
Weighted- Average Exercise Price Per Share | ||
Beginning balance of period (USD per share) | $ 5.87 | |
Options exercised (USD per share) | 5.84 | |
Options cancelled (USD per share) | 2.41 | |
Ending balance of period (USD per share) | 5.90 | $ 5.87 |
Vested and exercisable shares (USD per share) | 5.90 | |
Vested and expected to vest shares (USD per share) | $ 5.90 | |
Weighted- Average Remaining Term | ||
Balance (USD per share) | 3 years 7 months 6 days | 4 years 7 months 6 days |
Vested and exercisable (USD per share) | 3 years 7 months 6 days | |
Vested and expected to vest (USD per share) | 3 years 7 months 6 days | |
Aggregate Intrinsic Value | ||
Balance | $ 162,653,000 | $ 224,115,000 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Intrinsic Value | 162,653,000 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 162,653,000 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of RSU Activity under 2019 Plan (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Restricted Stock Units | |
Number of Shares | |
Beginning balance of period (in shares) | shares | 1,125,991 |
RSUs granted (in shares) | shares | 606,187 |
RSUs forfeited (in shares) | shares | (83,916) |
RSUs vested (in shares) | shares | (481,240) |
Ending balance of period (in shares) | shares | 1,167,022 |
Weighted- Average Grant Date Fair Value Per Share | |
Beginning balance of period (USD per share) | $ / shares | $ 127.39 |
RSUs granted (USD per share) | $ / shares | 210.54 |
RSUs forfeited (USD per share) | $ / shares | 172.66 |
RSUs vested (USD per share) | $ / shares | 117.14 |
Ending balance of period (USD per share) | $ / shares | $ 171.55 |
Performance-Based Restricted Stock Units | |
Number of Shares | |
Beginning balance of period (in shares) | shares | 38,797 |
RSUs granted (in shares) | shares | 29,473 |
RSUs forfeited (in shares) | shares | (867) |
RSUs vested (in shares) | shares | (395) |
Ending balance of period (in shares) | shares | 67,008 |
Weighted- Average Grant Date Fair Value Per Share | |
Beginning balance of period (USD per share) | $ / shares | $ 165.74 |
RSUs granted (USD per share) | $ / shares | 191.36 |
RSUs forfeited (USD per share) | $ / shares | 267.54 |
RSUs vested (USD per share) | $ / shares | 267.41 |
Ending balance of period (USD per share) | $ / shares | $ 175.09 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of Fair Value of ESPP Shares Estimated Using Black-Scholes Option Pricing Model Assumptions (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected dividend yield | 0% | ||
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-Based compensation arrangement, number of shares authorized | 1,521,021 | ||
Expected term (in years) | 6 months | 6 months | 6 months |
Expected volatility, minimum | 44.30% | 61.80% | 48.90% |
Expected volatility, maximum | 73.80% | 73.80% | 64.80% |
Risk-free interest rate, minimum | 3.70% | 0.10% | |
Risk-free interest rate, maximum | 5.50% | 3.70% | |
Expected dividend yield | 0% | 0% | 0% |
Risk-free interest rate | 0.10% |
Income Taxes -Schedule of Incom
Income Taxes -Schedule of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ 194,406 | $ 119,901 | $ (9,388) |
Foreign | (20,125) | 927 | 553 |
Net income (loss) before taxes | $ 174,281 | $ 120,828 | $ (8,835) |
Income Taxes - Schedule of Curr
Income Taxes - Schedule of Current Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current provision for income taxes: | |||
Federal | $ 1,638 | $ 403 | $ 0 |
State | 5,418 | 1,446 | 84 |
Foreign | 5,239 | 259 | 217 |
Total (benefit) provision for income taxes | 12,295 | 2,108 | 301 |
Deferred tax provision: | |||
Federal | 21,855 | (85,618) | 0 |
State | 1,625 | (11,658) | 0 |
Foreign | (8,772) | 0 | 0 |
Total deferred tax (benefit) provision | 14,708 | (97,276) | 0 |
Total current income tax (benefit) provision | $ 27,003 | $ (95,168) | $ 301 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryovers | $ 60,636 | $ 60,467 |
Accruals and reserves | 12,856 | 10,876 |
Stock-based compensation | 8,745 | 8,504 |
Research and development credits | 20,736 | 15,250 |
Lease liability | 9,816 | 9,316 |
Capitalized research and development | 34,511 | 17,791 |
Deferred tax asset, convertible note | 22,841 | 0 |
Total deferred tax assets | 170,233 | 122,204 |
Less valuation allowance | (57,848) | (13,371) |
Gross deferred tax assets | 112,385 | 108,833 |
Deferred tax liabilities: | ||
Fixed and intangible assets | (5,624) | (1,105) |
Right-of-use-assets | (7,592) | (8,327) |
Deferred tax liabilities, in process research and development | (3,609) | 0 |
Other | 0 | (1,833) |
Gross deferred tax liabilities | (16,825) | (11,265) |
Total net deferred tax assets | 95,560 | 97,568 |
Deferred Tax Assets, Other | $ 92 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation | |||
Income tax provision (benefit) at federal statutory rate | $ 36,601 | $ 25,378 | $ (1,856) |
State and local income | 5,937 | (10,516) | 36 |
Foreign tax rate differential | 926 | 47 | 101 |
Change in valuation allowance | 3,331 | (87,568) | 19,027 |
Stock-based compensation | (14,043) | (18,273) | (17,968) |
Section 250 FDII deduction | (2,065) | (984) | 0 |
Research and development credits | (6,974) | (3,937) | (808) |
Section 382 limitation | 0 | 0 | 575 |
Equity method investment | 393 | 520 | 1,320 |
Effective Income Tax Rate Reconciliation Section162 Limitation | 2,633 | 0 | 0 |
Effective Income Tax Rate Reconciliation Acquisition Tax Structuring | (2,418) | 0 | 0 |
Other | 2,682 | 165 | (126) |
Total current income tax (benefit) provision | $ 27,003 | $ (95,168) | $ 301 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes Disclosure [Line Items] | |||||
Increase (decrease) in valuation allowance | $ 44,500 | $ (91,400) | $ (22,700) | ||
Valuation allowance | 57,848 | 13,371 | |||
Unrecognized tax benefits | 9,965 | 5,264 | 5,221 | $ 3,746 | |
Unrecognized tax benefits that would impact effective tax rate | 6,500 | ||||
Income Tax Expense (Benefit) | (27,003) | $ 95,168 | $ (301) | ||
Domestic Tax Authority And State And Local Jurisdiction, Excluding California | |||||
Income Taxes Disclosure [Line Items] | |||||
Income Tax Expense (Benefit) | 27,000 | ||||
Domestic Tax Authority | |||||
Income Taxes Disclosure [Line Items] | |||||
Valuation allowance | 8,100 | ||||
NOL carryforwards | 103,100 | ||||
NOL carryforwards subject to expiration in 2030 | $ 15,200 | ||||
NOL carryforwards never expire | $ 87,900 | ||||
Research and development credit carryforwards | 14,600 | ||||
Income Tax Expense (Benefit) | 23,500 | ||||
State and Local Jurisdiction Excluding California | |||||
Income Taxes Disclosure [Line Items] | |||||
Valuation allowance | 200 | ||||
NOL carryforwards | 31,800 | ||||
Income Tax Expense (Benefit) | 7,000 | ||||
California Franchise Tax Board | |||||
Income Taxes Disclosure [Line Items] | |||||
Valuation allowance | 16,200 | ||||
NOL carryforwards | 45,600 | ||||
Research and development credit carryforwards | 14,600 | ||||
Federal | |||||
Income Taxes Disclosure [Line Items] | |||||
Valuation allowance | 33,300 | ||||
NOL carryforwards | 126,600 | ||||
Income Tax Expense (Benefit) | $ (3,500) |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Unrecognized tax benefits [Abstract] | |||
Beginning balance | $ 5,264 | $ 5,221 | $ 3,746 |
Additions based on tax positions related to prior years | 283 | 0 | 0 |
Reductions based on tax positions related to prior years | 0 | (1,861) | (79) |
Additions based on tax positions related to current years | 4,418 | 1,904 | 1,554 |
Balance at end of year | $ 9,965 | $ 5,264 | $ 5,221 |
Revenue - Schedule of Product R
Revenue - Schedule of Product Revenue Based on Product Line and Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 730,230 | $ 489,733 | $ 237,146 |
Coronary | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 528,845 | 353,859 | 161,463 |
Peripheral | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 194,346 | 132,284 | 74,064 |
Reducer | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 4,368 | 0 | 0 |
Other | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 2,671 | $ 3,590 | $ 1,619 |
Revenue - Schedule of Product_2
Revenue - Schedule of Product Revenue Based on Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 730,230 | $ 489,733 | $ 237,146 |
United States | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 581,548 | 407,425 | 186,324 |
Europe | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 77,515 | 51,010 | 38,571 |
All other countries | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 71,167 | $ 31,298 | $ 12,251 |
Equity Method Investments (Deta
Equity Method Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Mar. 19, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Equity Method Investments [Line Items] | ||||
Equity method investment | $ 1,643 | $ 3,512 | ||
Loss from equity method investment | 1,869 | $ 2,475 | $ 6,286 | |
Joint Venture | ||||
Schedule Of Equity Method Investments [Line Items] | ||||
Related party transaction. transaction price | $ 12,300 | |||
JV Agreement with Genesis MedTech | ||||
Schedule Of Equity Method Investments [Line Items] | ||||
Equity method investment | $ 1,600 | |||
JV Agreement with Genesis MedTech | Share Subscription Agreement | ||||
Schedule Of Equity Method Investments [Line Items] | ||||
Ordinary shares issued (in shares) | 54,900 | |||
Equity percentage | 55% | |||
Cash contribution from exchange of equity | $ 15,000 | |||
JV Agreement with Genesis MedTech | License Agreement | ||||
Schedule Of Equity Method Investments [Line Items] | ||||
Ordinary shares issued (in shares) | 45,000 | |||
Equity percentage | 45% |
Net Income (Loss) Per Share - C
Net Income (Loss) Per Share - Components of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | |||
Net income (loss) | $ 147,278 | $ 215,996 | $ (9,136) |
Denominator: | |||
Basic (in shares) | 36,706,060 | 35,900,738 | 35,098,130 |
Diluted (in shares) | 38,206,269 | 37,881,590 | 35,098,130 |
Net income (loss) per share: | |||
Basic (USD per share) | $ 4.01 | $ 6.02 | $ (0.26) |
Diluted (USD per share) | $ 3.85 | $ 5.70 | $ (0.26) |
Stock Options | |||
Denominator: | |||
Dilutive effect of share-based payment arrangements (in shares) | 960,436 | 1,294,052 | 0 |
Restricted Stock Units | |||
Denominator: | |||
Dilutive effect of share-based payment arrangements (in shares) | 535,483 | 684,696 | 0 |
Employee Stock Purchase Plan | |||
Denominator: | |||
Dilutive effect of share-based payment arrangements (in shares) | 4,290 | 2,104 | 0 |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Income (Loss) Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 439,135 | 23,659 | 2,691,696 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 0 | 0 | 1,524,985 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 105,726 | 21,537 | 1,156,683 |
Employee Stock Purchase Plan | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 0 | 2,122 | 10,028 |
Capped Call Securities | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share (in shares) | 333,409 | 0 | 0 |