Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 18, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | SWAV | ||
Entity Registrant Name | Shockwave Medical, Inc. | ||
Entity Central Index Key | 0001642545 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 35,653,563 | ||
Entity Public Float | $ 3.7 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity File Number | 001-38829 | ||
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 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Shockwave Medical Inc., common stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | San Jose, California | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive proxy statement for its 2022 Annual Meeting of Stockholders (the “Proxy Statement”) are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of the Registrant’s fiscal year ended December 31, 2021. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement shall not be deemed to be filed as part hereof. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 89,209 | $ 50,423 |
Short-term investments | 111,772 | 151,931 |
Accounts receivable, net | 37,435 | 11,689 |
Inventory | 42,978 | 29,859 |
Prepaid expenses and other current assets | 4,508 | 2,398 |
Total current assets | 285,902 | 246,300 |
Operating lease right-of-use assets | 27,496 | 7,568 |
Property and equipment, net | 24,361 | 16,362 |
Equity method investment | 5,987 | |
Other assets | 1,936 | 1,812 |
TOTAL ASSETS | 345,682 | 272,042 |
CURRENT LIABILITIES: | ||
Accounts payable | 3,520 | 1,466 |
Term notes, current portion | 5,500 | 3,300 |
Accrued liabilities | 40,870 | 19,942 |
Lease liability, current portion | 1,738 | 873 |
Total current liabilities | 51,628 | 25,581 |
Lease liability, noncurrent portion | 28,321 | 7,488 |
Term notes, noncurrent portion | 11,630 | 13,319 |
Related party contract liability, noncurrent portion | 12,273 | |
TOTAL LIABILITIES | 103,852 | 46,388 |
Commitments and contingencies (Note 6) | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; No shares issued and outstanding as of December 31, 2021 and 2020 | ||
Common stock, $0.001 par value; 281,274,838 shares authorized; 35,444,472 and 34,684,337 issued and outstanding as of December 31, 2021 and 2020 | 35 | 35 |
Additional paid-in capital | 494,806 | 469,283 |
Accumulated other comprehensive income (loss) | (202) | 9 |
Accumulated deficit | (252,809) | (243,673) |
TOTAL STOCKHOLDERS’ EQUITY | 241,830 | 225,654 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 345,682 | $ 272,042 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 281,274,838 | 281,274,838 |
Common stock, shares issued | 35,444,472 | 34,684,337 |
Common stock, shares outstanding | 35,444,472 | 34,684,337 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | |||
Product revenue | $ 237,146,000 | $ 67,789,000 | $ 42,927,000 |
Cost of revenue: | |||
Cost of product revenue | 41,438,000 | 20,991,000 | 17,159,000 |
Gross profit | 195,708,000 | 46,798,000 | 25,768,000 |
Operating expenses: | |||
Research and development | 50,544,000 | 36,926,000 | 32,853,000 |
Sales and marketing | 111,288,000 | 51,672,000 | 30,620,000 |
General and administrative | 34,747,000 | 23,863,000 | 14,134,000 |
Total operating expenses | 196,579,000 | 112,461,000 | 77,607,000 |
Loss from operations | (871,000) | (65,663,000) | (51,839,000) |
Interest expense | (1,096,000) | (1,212,000) | (944,000) |
Change in fair value of warrant liability | (609,000) | ||
Share in net loss of equity method investment | (6,286,000) | ||
Other income (expense), net | (582,000) | 1,256,000 | 2,345,000 |
Net loss before taxes | (8,835,000) | (65,619,000) | (51,047,000) |
Income tax provision | 301,000 | 80,000 | 62,000 |
Net loss | (9,136,000) | (65,699,000) | (51,109,000) |
Unrealized gain (loss) on available-for-sale securities | (211,000) | (5,000) | 35,000 |
Adjustment for net gain realized and included in other income, net | (21,000) | ||
Total comprehensive loss | $ (9,347,000) | $ (65,725,000) | $ (51,074,000) |
Net loss per share, basic and diluted | $ (0.26) | $ (1.99) | $ (2.14) |
Shares used in computing net loss per share, basic and diluted | 35,098,130 | 33,088,095 | 23,904,828 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) | Total | Initial Public Offering | Public Offering | Convertible Preferred Stock | Common Stock | Common StockInitial Public Offering | Common StockPublic Offering | Additional Paid-In Capital | Additional Paid-In CapitalInitial Public Offering | Additional Paid-In CapitalPublic Offering | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2018 | $ (122,588,000) | $ 2,000 | $ 4,275,000 | $ (126,865,000) | ||||||||
Temporary equity, Beginning balance, Shares at Dec. 31, 2018 | 18,670,328 | |||||||||||
Temporary equity, Beginning balance at Dec. 31, 2018 | $ 152,806,000 | |||||||||||
Beginning balance, Shares at Dec. 31, 2018 | 1,824,852 | |||||||||||
Exercise of common stock warrants for cash | 110,000 | 110,000 | ||||||||||
Exercise of common stock warrants for cash, Shares | 50,331 | |||||||||||
Issuance of common stock upon net exercise of warrants | 133,000 | 133,000 | ||||||||||
Issuance of common stock upon net exercise of warrants, Shares | 180,952 | |||||||||||
Conversion of preferred stock to common stock upon initial public offering | 152,806,000 | $ 18,000 | 152,788,000 | |||||||||
Temporary equity conversion of preferred stock shares to common stock upon initial public offering, Shares | (18,670,328) | |||||||||||
Temporary equity conversion of preferred stock value to common stock upon initial public offering | $ (152,806,000) | |||||||||||
Conversion of preferred to common stock upon initial public offering, Shares | 18,670,328 | |||||||||||
Conversion of Series A-1 warrants to common stock warrants upon initial public offering | 789,000 | 789,000 | ||||||||||
Issuance of common stock in connection with initial/public offering | $ 99,924,000 | $ 96,677,000 | $ 7,000 | $ 3,000 | $ 99,917,000 | $ 96,674,000 | ||||||
Issuance of common stock, Shares | 6,555,000 | 2,854,048 | ||||||||||
Issuance of common stock in connection with private placement | 10,000,000 | $ 1,000 | 9,999,000 | |||||||||
Issuance of common stock in connection with private placement, Shares | 588,235 | |||||||||||
Exercise of stock options | $ 2,206,000 | 2,206,000 | ||||||||||
Exercise of stock options, Shares | 722,242 | 723,155 | ||||||||||
Vesting of early exercised options | $ 27,000 | 27,000 | ||||||||||
Stock-based compensation | 3,646,000 | 3,646,000 | ||||||||||
Adjustment for fractional shares resulting from reverse stock split | (3,000) | (3,000) | ||||||||||
Adjustment for fractional shares resulting from reverse stock split, Shares | (114) | |||||||||||
Unrealized gain (loss) on available-for-sale securities | 35,000 | $ 35,000 | ||||||||||
Net loss | (51,109,000) | (51,109,000) | ||||||||||
Ending balance at Dec. 31, 2019 | 192,653,000 | $ 31,000 | 370,561,000 | 35,000 | (177,974,000) | |||||||
Ending balance, Shares at Dec. 31, 2019 | 31,446,787 | |||||||||||
Issuance of common stock in connection with initial/public offering | $ 83,368,000 | $ 2,000 | $ 83,366,000 | |||||||||
Issuance of common stock, Shares | 1,955,000 | |||||||||||
Exercise of stock options | $ 4,317,000 | $ 2,000 | 4,315,000 | |||||||||
Exercise of stock options, Shares | 1,185,764 | 1,185,764 | ||||||||||
Issuance of common stock under employee stock purchase plan | $ 1,795,000 | 1,795,000 | ||||||||||
Issuance of common stock under employee stock purchase plan, Share | 52,612 | |||||||||||
Issuance of common stock in connection with vesting of restricted stock units, Shares | 69,900 | |||||||||||
Restricted stock units withheld in net settlement for tax | (1,420,000) | (1,420,000) | ||||||||||
Restricted stock units withheld in net settlement for tax, Shares | (25,726) | |||||||||||
Stock-based compensation | 10,666,000 | 10,666,000 | ||||||||||
Unrealized gain (loss) on available-for-sale securities | (5,000) | (5,000) | ||||||||||
Net gain reclassified from accumulated other comprehensive income | (21,000) | (21,000) | ||||||||||
Net loss | (65,699,000) | (65,699,000) | ||||||||||
Ending balance at Dec. 31, 2020 | 225,654,000 | $ 35,000 | 469,283,000 | 9,000 | (243,673,000) | |||||||
Ending balance, Shares at Dec. 31, 2020 | 34,684,337 | |||||||||||
Exercise of stock options | $ 3,049,000 | 3,049,000 | ||||||||||
Exercise of stock options, Shares | 547,155 | 547,155 | ||||||||||
Issuance of common stock under employee stock purchase plan | $ 2,837,000 | $ 36,833,000 | 2,837,000 | |||||||||
Issuance of common stock in connection with vesting of restricted stock units | 239,213,000 | |||||||||||
Restricted stock units withheld in net settlement for tax | (8,337,000) | (63,066,000) | (8,337,000) | |||||||||
Stock-based compensation | 27,974,000 | 27,974,000 | ||||||||||
Unrealized gain (loss) on available-for-sale securities | (211,000) | (211,000) | ||||||||||
Net loss | (9,136,000) | (9,136,000) | ||||||||||
Ending balance at Dec. 31, 2021 | $ 241,830,000 | $ 35,000 | $ 494,806,000 | $ (202,000) | $ (252,809,000) | |||||||
Ending balance, Shares at Dec. 31, 2021 | 35,444,472 |
Consolidated Statements of Co_2
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Initial Public Offering | ||
Issuance costs | $ 11.5 | |
Public Offering | ||
Issuance costs | $ 6.1 | $ 6.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (9,136) | $ (65,699) | $ (51,109) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 3,579 | 1,863 | 1,337 |
Share in net loss of equity method investment | 6,286 | ||
Stock-based compensation | 27,257 | 10,350 | 3,646 |
Amortization of right-of-use assets | 1,957 | 1,483 | 944 |
Accretion of discount on available-for-sale securities | 1,093 | 300 | (543) |
Loss on write down of fixed assets | 7 | 187 | 67 |
Change in fair value of warrant liability | 609 | ||
Amortization of debt issuance costs | 511 | 646 | 436 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (25,746) | (4,312) | (4,527) |
Inventory | (12,073) | (17,056) | (6,824) |
Prepaid expenses and other current assets | (2,110) | (501) | (785) |
Other assets | 91 | (306) | 41 |
Accounts payable | 1,870 | (1,392) | 1,272 |
Accrued and other current liabilities | 21,637 | 4,017 | 8,339 |
Lease liabilities | (187) | (764) | (1,010) |
Net cash provided by (used in) operating activities | 15,036 | (71,184) | (48,107) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of available-for-sale securities | (117,245) | (167,953) | (119,476) |
Proceeds from maturities of available-for-sale securities | 156,100 | 72,000 | 63,750 |
Purchase of property and equipment | (12,439) | (11,520) | (3,817) |
Net cash provided by (used in) investing activities | 26,416 | (107,473) | (59,543) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock upon initial public offering, net of issuance costs paid | 100,547 | ||
Proceeds from issuance of common stock in private placement | 10,000 | ||
Proceeds from issuance of common stock in public offering, net of issuance costs paid | 83,368 | 96,856 | |
Payments of taxes withheld on net settled vesting of restricted stock units | (8,337) | (1,420) | |
Proceeds from term loans | 3,265 | ||
Payment of deferred offering costs | (179) | ||
Proceeds from stock option exercises | 3,049 | 4,317 | 2,206 |
Proceeds from issuance of common stock under employee stock purchase plan | 2,837 | 1,795 | |
Proceeds from warrant exercises | 110 | ||
Principal payment of term loan | (1,111) | (1,667) | |
Net cash provided by (used in) financing activities | (2,451) | 90,035 | 208,052 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 39,001 | (88,622) | 100,402 |
Cash, cash equivalents and restricted cash at beginning of period | 51,873 | 140,495 | 40,093 |
Cash, cash equivalents and restricted cash equivalents at end of period | 90,874 | 51,873 | 140,495 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Interest paid | 586 | 549 | 534 |
Income tax paid | 143 | 22 | 120 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Common stock issued on conversion of convertible preferred stock | 152,806 | ||
Offering cost included in account payable and accrued liabilities | 179 | ||
Common stock warrants issued on conversion of preferred stock warrants and the reclassification of the warrant liability | 789 | ||
Right-of-use asset obtained in exchange for lease liability | 21,885 | 226 | 6,948 |
Property and equipment purchases included in accounts payable and accrued liabilities | 1,923 | 2,448 | 52 |
Equity method investment obtained in exchange for related party contract liability | 12,273 | ||
Transfer of fixed assets to inventory | $ 329 | $ 413 | $ 119 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Shock w In 2016, the Company began commercial and manufacturing operations, and began selling catheters based on the IVL technology. The Company’s headquarters are in Santa Clara, California. The Company is located and operates primarily in the United States and has subsidiaries in Germany, the United Kingdom, Japan and France. As of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $201.0 million, which are available to fund future operations. The Company believes that |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. 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 in 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, the allowance for doubtful accounts, the fair value of stock options, recoverability of the Company’s net deferred tax assets, and related valuation allowance 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 balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 2020 (in thousands) Cash and cash equivalents $ 89,209 $ 50,423 Restricted cash 1,665 1,450 Total cash, cash equivalents, and restricted cash $ 90,874 $ 51,873 Restricted cash as of December 31, 2021 and 2020 relates to letters of credit established for real property leases relating to buildings housing the Company’s corporate offices and manufacturing facilities, 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. 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. 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. Equity Method Investments Entities which the Company has significant influence over activities of the entity, but do not control, are accounted for under the equity method of accounting in accordance with Topic 323, Investments - Equity Method and Joint Ventures . 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 of the underlying income or loss which is recognized in share in net loss of equity method investment. For the year ended December 31, 2021, the Company’s share in the losses incurred by the equity method investee was $ 6.3 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. 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, 2021, 2020 and 2019 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, 2021. One customer accounted for 15% of the Company’s accounts receivable as of December 31, 2020. 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. Management believes that its term notes bear interest at the prevailing market rates for instruments with similar characteristics; accordingly, the carrying value of this instrument approximates its fair value. 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 T he Company adopted Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , effective January 1, 2020 using the modified retrospective method. The adoption of this standard did not have a cumulative effect on opening accumulated deficit as of January 1, 2020 and did not have a material impact on the Company’s financial statements. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company’s historic accounting prior to the adoption of ASU 2016-13. 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, 2021 2020 2019 (in thousands) Beginning balance $ 380 $ 194 $ 76 Amounts charged (reversed) to costs and expenses (12 ) 205 121 Write-offs (18 ) (19 ) (3 ) Ending balance $ 350 $ 380 $ 194 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 and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet 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 Topic 606, Revenue from Contracts with Customers Product Revenue The Company records product revenue primarily from the sale of its IVL catheters. The Company sells its products to hospitals, primarily through direct sales representatives, as well as through distributors in selected international markets. Additionally, a portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Product revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and products sold to customers that utilize stocking orders, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms. For consignment inventory, control is transferred at the time the IVL catheters are consumed in a procedure. The Company 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 use of the IVL catheters. These agreements 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 year ended December 31, 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. The Company accounts for forfeitures as they occur. 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 sheet. 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. Variable lease payments include lease operating expenses. 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 $2.5 million and $1.1 million for the years ended December 31, 2021 and 2020, respectively. The Company did not make such contributions for the year ended December 31, 2019. Comprehensive Loss Comprehensive 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 $0.8 million for the year ended December 31, 2021. There were net foreign currency transaction gains of $ 0.3 million and $ 0.1 million for the year s ended December 31, 20 20 and 2019, respectively. Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Because the Company was in a loss position for the period presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect: December 31, 2021 2020 2019 Common stock options issued and outstanding 1,524,985 2,087,202 3,315,001 Restricted stock units 1,156,683 859,577 280,904 Employee stock purchase plan 10,028 15,251 16,420 Total 2,691,696 2,962,030 3,612,325 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. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. 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 certain equipment on loan to customers held internationally, which was not material for the periods presented. |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments and Fair Value Measurements | 3. 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, 2021 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 80,155 $ — $ — $ 80,155 Money market funds 47,541 — — 47,541 Commercial paper — 20,472 — 20,472 Corporate bonds — 11,145 — 11,145 Total assets $ 127,696 $ 31,617 $ — $ 159,313 December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 126,363 $ — $ — $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper — 31,968 — 31,968 Total assets $ 161,416 $ 31,968 $ — $ 193,384 |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 12 Months Ended |
Dec. 31, 2021 | |
Cash And Cash Equivalents [Abstract] | |
Cash Equivalents and Short-Term Investments | 4. Cash Equivalents and Short-Term Investments The following is a summary of the Company’s cash equivalents and short-term investments: December 31, 2021 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 80,353 $ — $ (198 ) $ 80,155 Money market funds 47,541 — — 47,541 Commercial paper 20,472 — — 20,472 Corporate bonds 11,149 — (4 ) 11,145 Total $ 159,515 $ — $ (202 ) $ 159,313 Reported as: Cash equivalents $ 47,541 Short-term investments 111,772 Total $ 159,313 December 31, 2020 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 126,354 $ 11 $ (2 ) $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper 31,968 — — 31,968 Total $ 193,375 $ 11 $ (2 ) $ 193,384 Reported as: Cash equivalents $ 41,453 Short-term investments 151,931 Total $ 193,384 As of December 31, 2021, the fair value of the Company’s available-for-sale securities, by remaining contractual maturities, were as follows (in thousands): One year or less $ 113,330 Greater than one year and less than two years 45,983 Total $ 159,313 For the years ended December 31, 2021 and 2019, the Company recognized no material realized gains or losses on cash equivalents and short-term investments. For the year ended December 31, 2020, the Company recognized $21,000 in realized gains on cash equivalents and short-term investments. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventory Inventory consists of the following: December 31, 2021 2020 (in thousands) Raw material $ 7,685 $ 4,995 Work in progress 13,315 6,051 Finished goods 20,326 16,952 Consigned inventory 1,652 1,861 Total inventory $ 42,978 $ 29,859 Property and Equipment, Net Property and equipment, net consists of the following: December 31, 2021 2020 (in thousands) Equipment $ 6,234 $ 3,794 Equipment on loan to customers 1,714 1,756 Office furniture 549 157 Software 742 175 Leasehold improvements 17,742 5,808 Construction in progress 3,544 7,800 Property and equipment, gross 30,525 19,490 Less: accumulated depreciation and amortization (6,164 ) (3,128 ) Total property and equipment, net $ 24,361 $ 16,362 Depreciation and amortization expense amounted to $3.6 million, $1.9 million and $1.3 million for the years ended December 31, 2021, 2020 and 2019, respectively. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2021 2020 (in thousands) Accrued employee compensation $ 25,749 $ 10,885 Accrued research and development costs 4,605 3,057 Accrued asset purchases 4,101 2,527 Accrued professional services 2,636 1,325 Other 3,779 2,148 Total accrued liabilities $ 40,870 $ 19,942 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Operating Leases The Company’s operating leases consist of leased facilities for the Company’s headquarter offices, laboratory, and manufacturing space. Also included in operating leases are leases for vehicles, for use by certain of the Company’s employees, which were not material for the periods presented. 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 a First Amendment to Office Lease (Net) (the “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”) will continue 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 will become subject to the terms of the Lease Amendment. The 3003 Bunker Hill Lease and the Lease Amendment contain options to extend the lease term at the respective facilities for up to two additional five-year The weighted average remaining lease term and discount rate used to measure the Company’s operating lease liabilities were 9.9 years and 5.0%, respectively. The Company estimated the discount rate using the incremental borrowing rate as the rate implicit in the lease was not readily determinable. 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, 2021, the Company has no material finance leases. Operating lease cost was $2.9 million, $2.2 million and $1.2 million, for the years ended December 31, 2021, 2020, and 2019, respectively. The following are minimum future rental payments owed under lease agreements which have commenced as of December 31, 2021: (in thousands) 2022 $ 3,204 2023 4,194 2024 4,289 2025 4,415 2026 4,545 Thereafter 24,664 Total minimum lease payments $ 45,311 Less: imputed interest and adjustments (15,252 ) Total lease liability $ 30,059 The total minimum future rental payments owed for the 5403 Betsy Ross facility under the terms of the Lease Amendment which has not yet commenced as of December 31, 2021 is $10.8 million. |
Term Notes
Term Notes | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Term Notes | 7. Term Notes Loan and Security Agreement In February 2018, the Company entered into a Loan and Security Agreement with Silicon Valley Bank (the “Loan and Security Agreement”). The terms of the Loan and Security Agreement included a term loan of $15.0 million and a revolving line of credit of $2.0 million. The term loan accrued interest at a floating per annum rate equal to the greater of (a) the Wall Street Journal prime rate minus 1.75% and (b) 2.75%. There was a final payment equal to 6.75% of the original aggregate principal amount, or $1.0 million, of the term loan advances, which was being accrued over the term of the loan using the effective-interest method. In connection with the execution of the Loan and Security Agreement, the Company issued warrants to purchase 34,440 shares of the Company’s common stock. Upon issuance, the fair value of the warrants of $0.1 million was recorded as a debt issuance cost. The debt issuance cost will be amortized to interest expense, net over the term of the loan. In February 2020, the Company entered into a First Amendment to the Loan and Security Agreement (the “Amended Credit Facility”) to, among other things, refinance its existing term loan, which is accounted for as a modification of the Loan and Security Agreement. Under the Amended Credit Facility, the existing revolving line of credit of $2.0 million was terminated and the termination fee of less than $0.1 million was waived. The Amended Credit Facility provides the Company with a supplemental term loan in the amount of $16.5 million. After repayment of the outstanding amount of the term loan, the Company received net proceeds of $3.3 million, which reflects an additional $4.3 million in principal as of the date of the modification less the final balloon payment fee of $1.0 million. The principal amount outstanding under the supplemental term loan accrues interest at a floating per annum rate equal to the greater of (a) the prime rate minus 1.25% and (b) 3.5%. The interest rate was 3.5% as of December 31, 2021. The supplemental term loan matures on December 1, 2023. The Amended Credit Facility provides an interest-only payment period through June 30, 2022. The additional final payment for the Amended Credit Facility is $1.6 million, which is currently being accrued over the term of the supplemental term loan using an effective interest rate that reflects the revised cash flows of the modified term loan. The Company recorded interest expense of $1.1 million, $1.2 million and $0.9 million, for the years ended December 31, 2021, 2020 and 2019, respectively. The supplemental term loan is secured by all of the Company’s assets, excluding intellectual property and certain other assets. The loan contains customary affirmative and restrictive covenants, including with respect to the Company’s ability to enter into fundamental transactions, incur additional indebtedness, grant liens, pay any dividend or make any distributions to its holders, make investments, merge or consolidate with any other person or engage in transactions with the Company’s affiliates, but does not include any financial covenants. Long-term debt and net premium balances are as follows: December 31, 2021 2020 (in thousands) Principal amount of term note $ 16,500 $ 16,500 Net premium associated with accretion of final payment, and other debt issuance costs 630 119 Term note, current and noncurrent 17,130 16,619 Less: term note, current portion (5,500 ) (3,300 ) Term note, noncurrent portion $ 11,630 $ 13,319 Future minimum payments of principal and estimated payments of interest on the Company’s outstanding variable rate borrowings as of December 31, 2021 are as follows: Year ending December 31: (in thousands) 2022 6,045 2023 12,779 Total future payments 18,824 Less: amounts representing interest (756 ) Less: final payment (1,568 ) Total principal amount of term note payments $ 16,500 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Total stock-based compensation was as follows: Year Ended December 31, 2021 2020 2019 (in thousands) Cost of product revenue $ 1,153 $ 496 $ 268 Research and development 6,240 2,464 943 Sales and marketing 11,043 3,478 972 General and administrative 8,821 3,912 1,463 Total stock-based compensation $ 27,257 $ 10,350 $ 3,646 Stock-based compensation of $717,000 and $316,000 was capitalized into inventory for the years ended December 31, 2021 and 2020, respectively. No material stock-based compensation was capitalized into inventory for the year ended December 31, 2019. Stock-based compensation capitalized into inventory is recognized as cost of product revenue when the related product is sold. Determination of Fair Value The estimated grant-date fair value of all the Company’s stock-based awards was calculated using the Black-Scholes option pricing model, based on the following assumptions: Year Ended December 31, 2019 Expected term (in years) 6.08 Expected volatility 42.4%-42.9% Risk-free interest rate 2.4%-2.6% Expected dividend yield 0% The fair value of each stock option grant was determined by the Company using 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— Since the Company has limited trading history for its common stock due to its short trading history, the expected volatility was estimated based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. 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 has elected to recognize forfeitures of share-based payment awards as they occur. 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”) As of December 31, 2021, the Company had reserved 3,745,216 shares of common stock for issuance under the 2019 Plan. Stock Options Option activity under the 2009 Plan and 2019 Plan is set forth below: Shares Available for Grant Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Term Aggregate Intrinsic Value (in years) (in thousands) Balance, December 31, 2018 392,299 3,636,358 $ 3.54 7.79 $ 11,267 Awards authorized 2,000,430 — Options expired (287,600 ) — Options granted (442,858 ) 442,858 14.69 Options exercised — (722,242 ) 3.10 Options cancelled 41,973 (41,973 ) 3.85 Balance, December 31, 2019 1,704,244 3,315,001 $ 5.08 7.28 $ 128,744 Awards authorized 943,345 — Options exercised — (1,185,764 ) 3.64 Options cancelled 42,035 (42,035 ) 4.45 Balance, December 31, 2020 2,689,624 2,087,202 $ 5.92 6.77 $ 204,137 Awards authorized 1,040,530 — Options exercised — (547,155 ) 5.57 Options cancelled 15,062 (15,062 ) 9.33 Balance, December 31, 2021 3,745,216 1,524,985 $ 6.01 5.76 $ 262,793 Vested and exercisable, December 31, 2021 1,295,974 $ 5.12 5.55 $ 224,475 Vested and expected to vest, December 31, 2021 1,524,985 $ 6.01 5.76 $ 262,793 There were no options granted during the years ended December 31, 2021 and 2020. The weighted-average grant date fair value of options granted during the year ended December 31, 2019, was $6.58. The total grant date fair value of options vested was $1.6 million, $2.3 million and $1.9 million for the years ended December 31, 2021, 2020, and 2019, respectively. As of December 31, 2021, total unrecognized stock-based compensation related to unvested stock options was $1.0 million, which the Company expects to recognize over a remaining weighted-average period of 0.8 years. 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. The Company’s RSUs generally vest over a four-year RSU activity under the 2019 Plan is set forth below : Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance, December 31, 2018 — $ — RSUs granted 288,170 38.28 RSUs forfeited (5,600 ) 40.01 RSUs vested (1,666 ) 59.79 Balance, December 31, 2019 280,904 $ 38.12 RSUs granted 687,223 51.34 RSUs forfeited (38,650 ) 41.55 RSUs vested (69,900 ) 38.46 Balance, December 31, 2020 859,577 $ 48.50 RSUs granted 588,305 138.52 RSUs forfeited (51,986 ) 77.13 RSUs vested (239,213 ) 47.18 Balance, December 31, 2021 1,156,683 $ 93.27 The total grant date fair value of RSUs vested was $11.3 million, $2.7 million, and $0.1 million, for the years ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021, there was $87.6 million of unrecognized stock-based compensation expense related to RSUs to be recognized over a weighted-average period of 2.7 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 30, 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. The Company recorded $1.3 million, $0.8 million and $0.3 million of stock-based compensation expense related to the ESPP for the years ended December 31, 2021, 2020 and 2019, respectively. Years Ended December 31, 2021 2020 2019 Expected term (in years) 0.5 0.5 0.5 Expected volatility 48.9%-64.8% 44.3%-74.0% 76.9% Risk-free interest rate 0.1% 0.1%-0.3% 1.9% Expected dividend yield 0% 0% 0% |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes The following table presents income (loss) before income taxes for the periods presented: December 31, 2021 2020 2019 (in thousands) Domestic $ (9,388 ) $ (65,957 ) $ (51,179 ) Foreign 553 338 132 Total loss before income taxes $ (8,835 ) $ (65,619 ) $ (51,047 ) Current income tax provision consists of the following: December 31, 2021 2020 2019 (in thousands) Domestic $ 84 $ 3 $ — Foreign 217 77 62 Total current income tax provision $ 301 $ 80 $ 62 The components of the deferred tax assets and liabilities are as follows: December 31, 2021 2020 (in thousands) Deferred tax assets: Net operating loss carryovers $ 85,764 $ 73,453 Fixed and intangible assets 512 718 Accruals and reserves 7,603 2,245 Stock-based compensation 5,523 2,060 Research and development credits 4,698 3,379 Contributions 42 42 Lease liability 7,398 2,004 Total deferred tax assets 111,540 83,901 Less valuation allowance (104,773 ) (82,087 ) Gross deferred tax assets 6,767 1,814 Deferred tax liabilities: Right-of-use-assets (6,767 ) (1,814 ) Gross deferred tax liabilities (6,767 ) (1,814 ) Total net deferred tax assets $ — $ — Reconciliation of the statutory federal income tax to the Company’s effective tax is as follows: December 31, 2021 2020 2019 (in thousands) Income tax benefit at federal statutory rate $ (1,856 ) $ (13,780 ) $ (10,720 ) State and local income taxes net of federal tax benefit 36 (9 ) (9 ) Foreign tax rate differential 101 6 35 Change in valuation allowance 19,027 27,990 14,470 Stock-based compensation (17,968 ) (13,425 ) (3,403 ) Research and development credits (808 ) (611 ) (354 ) Section 382 limitation 575 — — Equity method investment 1,320 — — Other (126 ) (91 ) 43 Total current income tax provision $ 301 $ 80 $ 62 Due to the uncertainties surrounding the realization of deferred assets through future taxable income, the Company has provided a full valuation allowance and, therefore, no benefit has been recognized for the net operating loss (“NOL”) and other deferred tax assets. The valuation allowance increased by $22.7 million, As of December 31, 2021, the Company had NOL carryforwards available to reduce future federal, California and other state income of $351.0 million, $54.0 million and $160.6 million, respectively. The federal NOL carryforwards of $78.4 million and $272.6 million begin expiring in 2030 and never expire respectively, the California NOL carryforwards begin expiring in 2031 and other state NOL carryforwards begin expiring in various years, starting in 2029. As of December 31, 2021, the Company had research and development credit carryforwards of $5.5 million for federal income tax purposes and $5.0 million for California state income tax purposes available to reduce future taxable income, if any. The federal research and development credit carryforwards expire beginning 2033 and California credits can be carried forward indefinitely. Utilization of the NOL carryforward may be subject to an annual limitation due to the ownership change provided by the Internal Revenue Code of 1986, as amended (the “Code”), and similar state provisions. The annual limitation may result in the expiration of the NOL before utilization. The Company has completed a study under Section 382 of the Code through December 31, 2020, and determined there was a $2.4 million loss of federal NOLs and a $0.1 million loss of federal research and development credits as a result of ownership changes. Utilization of the NOL or tax credit carryforwards to offset future taxable income and taxes, respectively, are subject to an annual limitation under the Code and similar state provisions, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term, tax-exempt rate, and then could be subject to additional adjustments such as built-in gain or built-in loss, as required. Any limitation may result in expiration of all or a portion of its NOLs losses and or tax credit carryforwards before utilization. Uncertain Tax Positions The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2021 2020 2019 (in thousands) Beginning balance $ 3,746 $ 2,586 $ 1,896 Additions (Reductions) based on tax positions related to prior years (79 ) (3 ) — Additions based on tax positions related to current years 1,554 1,163 690 Balance at end of year $ 5,221 $ 3,746 $ 2,586 If recognized, gross unrecognized tax benefits would not have an impact on the Company’s effective tax rate due to the Company’s full valuation allowance position. While it is often difficult to predict the final outcome of any particular uncertain tax position, the Company does not believe that the amount of gross unrecognized tax benefits will change significantly in the next twelve months. The Company is subject to taxation in the United States, Germany, the United Kingdom (the “UK”), Japan and France. The Company is subject to examination of its income tax returns since inception by U.S. federal and certain state tax authorities due to its NOLs. The income tax returns of the German entity are open to examination for the tax years 2017 and forward. The income tax returns for the entities in Japan, the UK and France are open to examination for the tax years starting 2020, 2021 and 2021, respectively. The Company is not currently under audit with the Internal Revenue Service, or any foreign, state or local jurisdictions, nor has it been notified of any other potential future income tax audit. The federal and California statute of limitations remains open for three and four years, respectively, from the date of utilization of any NOL or credits. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2021 | |
Disaggregation Of Revenue [Abstract] | |
Revenue | 10. Revenue The following table represents the Company’s product revenue based on product line: Year Ended December 31, 2021 2020 2019 (in thousands) Coronary $ 161,463 $ 24,586 $ 15,621 Peripheral 74,064 41,994 26,325 Other 1,619 1,209 981 Product revenue $ 237,146 $ 67,789 $ 42,927 Peripheral product revenue encompasses sales of the Company’s M 5 4 2 The following table represents the Company’s product revenue based on the location to which the product is shipped: Year Ended December 31, 2021 2020 2019 (in thousands) United States $ 186,324 $ 37,121 $ 22,699 Europe 38,571 23,456 17,499 All other countries 12,251 7,212 2,729 Product revenue $ 237,146 $ 67,789 $ 42,927 |
Equity Method Investments
Equity Method Investments | 12 Months Ended |
Dec. 31, 2021 | |
Equity Method Investments And Joint Ventures [Abstract] | |
Equity Method Investments | 11. 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 (“China”). Under the JV Agreement, Genesis Shockwave Private Ltd. (the “JV”) was formed under the laws of Singapore to serve as a joint venture of Genesis and the Company for the purpose of establishing and managing such a strategic partnership. 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 total equity of the JV, to Genesis in exchange for a cash contribution of $15.0 million, of which 50% was paid upon signing and the remaining 50% will be due within one year of signing, and (ii) 45,000 ordinary shares which represents 45% of total equity, to the Company as consideration for the Shockwave License Agreement (or “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 China and is entitled to receive royalties on the sales of the licensed products in China. Further, the Company entered into a Distribution Agreement, pursuant to which the Company has agreed to sell certain Company-manufactured products to the JV and/or a to-be formed Chinese subsidiary of the JV for commercialization and distribution in China. The Company has accounted for its investment in the JV under the equity method of accounting. As of December 31, 2021, the carrying value of the Company’s investment in the JV was $6.0 million. The Company’s share of losses generated by the JV for the year ended December 31, 2021 was $6.3 million which was recorded in share in net loss of equity method investment. The JV has not generated any revenues to date. The following table summarizes the unaudited balance sheet for the JV: December 31, 2021 Balance sheet: (in thousands) Current assets $ 14,854 Current liabilities (1,539 ) Net assets $ 13,315 The following table summarizes the unaudited results of operations for the JV: For the Year Ended December 31, 2021 (in thousands) Revenues $ — Loss from operations 14,043 Net loss $ 14,043 Upon execution of the License Agreement, on March 19, 2021, the Company received a 45% equity stake in the JV. The Company determined that the JV met the definition of a customer under Topic 606, and that the promised goods and services of the contribution of the license of intellectual property and associated manufacturing technology transfer to the JV were considered to be a single performance obligation. The transaction price of $12.3 million was estimated by reference to the cash value of the shares which were issued at the formation of the JV. For the year ended December 31, 2021, the Company sold approximately $184,000 in product to the JV for use in ongoing clinical trials. As of December 31, 2021, approximately $138,000 was owed by the JV to the Company for the sale of the product. As of December 31, 2021, the associated manufacturing technology transfer to the JV had not yet been completed. The Company maintains a related party contract liability, noncurrent, of $12.3 million for the outstanding performance obligation. The Company expects to satisfy the outstanding performance obligation upon the completion of training provided by the Company to the JV, and successful regulatory approval from the China National Medical Products Administration. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | 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 in 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, the allowance for doubtful accounts, the fair value of stock options, recoverability of the Company’s net deferred tax assets, and related valuation allowance 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 balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 2020 (in thousands) Cash and cash equivalents $ 89,209 $ 50,423 Restricted cash 1,665 1,450 Total cash, cash equivalents, and restricted cash $ 90,874 $ 51,873 Restricted cash as of December 31, 2021 and 2020 relates to letters of credit established for real property leases relating to buildings housing the Company’s corporate offices and manufacturing facilities, 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. 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. 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. |
Equity Method Investments | Equity Method Investments Entities which the Company has significant influence over activities of the entity, but do not control, are accounted for under the equity method of accounting in accordance with Topic 323, Investments - Equity Method and Joint Ventures . 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 of the underlying income or loss which is recognized in share in net loss of equity method investment. For the year ended December 31, 2021, the Company’s share in the losses incurred by the equity method investee was $ 6.3 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. |
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 For the years ended December 31, 2021, 2020 and 2019 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, 2021. One customer accounted for 15% of the Company’s accounts receivable as of December 31, 2020. |
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. Management believes that its term notes bear interest at the prevailing market rates for instruments with similar characteristics; accordingly, the carrying value of this instrument approximates its fair value. 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 and Allowance for Doubtful Accounts T he Company adopted Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , effective January 1, 2020 using the modified retrospective method. The adoption of this standard did not have a cumulative effect on opening accumulated deficit as of January 1, 2020 and did not have a material impact on the Company’s financial statements. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company’s historic accounting prior to the adoption of ASU 2016-13. 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, 2021 2020 2019 (in thousands) Beginning balance $ 380 $ 194 $ 76 Amounts charged (reversed) to costs and expenses (12 ) 205 121 Write-offs (18 ) (19 ) (3 ) Ending balance $ 350 $ 380 $ 194 |
Inventory | 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 and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet 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 | 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 | Revenue To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, Revenue from Contracts with Customers Product Revenue The Company records product revenue primarily from the sale of its IVL catheters. The Company sells its products to hospitals, primarily through direct sales representatives, as well as through distributors in selected international markets. Additionally, a portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Product revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and products sold to customers that utilize stocking orders, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms. For consignment inventory, control is transferred at the time the IVL catheters are consumed in a procedure. The Company 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 use of the IVL catheters. These agreements 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 year ended December 31, 2021. |
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 | 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 | 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. The Company accounts for forfeitures as they occur. |
Leases | 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 sheet. 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. Variable lease payments include lease operating expenses. 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 | 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 $2.5 million and $1.1 million for the years ended December 31, 2021 and 2020, respectively. The Company did not make such contributions for the year ended December 31, 2019. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments. |
Foreign Currency | 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 $0.8 million for the year ended December 31, 2021. There were net foreign currency transaction gains of $ 0.3 million and $ 0.1 million for the year s ended December 31, 20 20 and 2019, respectively. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Because the Company was in a loss position for the period presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect: December 31, 2021 2020 2019 Common stock options issued and outstanding 1,524,985 2,087,202 3,315,001 Restricted stock units 1,156,683 859,577 280,904 Employee stock purchase plan 10,028 15,251 16,420 Total 2,691,696 2,962,030 3,612,325 |
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. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. 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 certain equipment on loan to customers held internationally, which was not material for the periods presented. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 2020 (in thousands) Cash and cash equivalents $ 89,209 $ 50,423 Restricted cash 1,665 1,450 Total cash, cash equivalents, and restricted cash $ 90,874 $ 51,873 |
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, 2021 2020 2019 (in thousands) Beginning balance $ 380 $ 194 $ 76 Amounts charged (reversed) to costs and expenses (12 ) 205 121 Write-offs (18 ) (19 ) (3 ) Ending balance $ 350 $ 380 $ 194 |
Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share | The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect: December 31, 2021 2020 2019 Common stock options issued and outstanding 1,524,985 2,087,202 3,315,001 Restricted stock units 1,156,683 859,577 280,904 Employee stock purchase plan 10,028 15,251 16,420 Total 2,691,696 2,962,030 3,612,325 |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 80,155 $ — $ — $ 80,155 Money market funds 47,541 — — 47,541 Commercial paper — 20,472 — 20,472 Corporate bonds — 11,145 — 11,145 Total assets $ 127,696 $ 31,617 $ — $ 159,313 December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 126,363 $ — $ — $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper — 31,968 — 31,968 Total assets $ 161,416 $ 31,968 $ — $ 193,384 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 80,353 $ — $ (198 ) $ 80,155 Money market funds 47,541 — — 47,541 Commercial paper 20,472 — — 20,472 Corporate bonds 11,149 — (4 ) 11,145 Total $ 159,515 $ — $ (202 ) $ 159,313 Reported as: Cash equivalents $ 47,541 Short-term investments 111,772 Total $ 159,313 December 31, 2020 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 126,354 $ 11 $ (2 ) $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper 31,968 — — 31,968 Total $ 193,375 $ 11 $ (2 ) $ 193,384 Reported as: Cash equivalents $ 41,453 Short-term investments 151,931 Total $ 193,384 |
Summary of Remaining Contractual Maturities for Available-for-sale Securities | As of December 31, 2021, the fair value of the Company’s available-for-sale securities, by remaining contractual maturities, were as follows (in thousands): One year or less $ 113,330 Greater than one year and less than two years 45,983 Total $ 159,313 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consists of the following: December 31, 2021 2020 (in thousands) Raw material $ 7,685 $ 4,995 Work in progress 13,315 6,051 Finished goods 20,326 16,952 Consigned inventory 1,652 1,861 Total inventory $ 42,978 $ 29,859 |
Schedule of Property and Equipment | Property and equipment, net consists of the following: December 31, 2021 2020 (in thousands) Equipment $ 6,234 $ 3,794 Equipment on loan to customers 1,714 1,756 Office furniture 549 157 Software 742 175 Leasehold improvements 17,742 5,808 Construction in progress 3,544 7,800 Property and equipment, gross 30,525 19,490 Less: accumulated depreciation and amortization (6,164 ) (3,128 ) Total property and equipment, net $ 24,361 $ 16,362 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: December 31, 2021 2020 (in thousands) Accrued employee compensation $ 25,749 $ 10,885 Accrued research and development costs 4,605 3,057 Accrued asset purchases 4,101 2,527 Accrued professional services 2,636 1,325 Other 3,779 2,148 Total accrued liabilities $ 40,870 $ 19,942 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Minimum Future Rental Payments | The following are minimum future rental payments owed under lease agreements which have commenced as of December 31, 2021: (in thousands) 2022 $ 3,204 2023 4,194 2024 4,289 2025 4,415 2026 4,545 Thereafter 24,664 Total minimum lease payments $ 45,311 Less: imputed interest and adjustments (15,252 ) Total lease liability $ 30,059 |
Term Notes (Tables)
Term Notes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long Term Debt and Net Premium Balance | Long-term debt and net premium balances are as follows: December 31, 2021 2020 (in thousands) Principal amount of term note $ 16,500 $ 16,500 Net premium associated with accretion of final payment, and other debt issuance costs 630 119 Term note, current and noncurrent 17,130 16,619 Less: term note, current portion (5,500 ) (3,300 ) Term note, noncurrent portion $ 11,630 $ 13,319 |
Schedule of Future Minimum Payments for Principal and Interest | Future minimum payments of principal and estimated payments of interest on the Company’s outstanding variable rate borrowings as of December 31, 2021 are as follows: Year ending December 31: (in thousands) 2022 6,045 2023 12,779 Total future payments 18,824 Less: amounts representing interest (756 ) Less: final payment (1,568 ) Total principal amount of term note payments $ 16,500 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Total Stock-Based Compensation | Total stock-based compensation was as follows: Year Ended December 31, 2021 2020 2019 (in thousands) Cost of product revenue $ 1,153 $ 496 $ 268 Research and development 6,240 2,464 943 Sales and marketing 11,043 3,478 972 General and administrative 8,821 3,912 1,463 Total stock-based compensation $ 27,257 $ 10,350 $ 3,646 |
Schedule of Estimates Grant-Date Fair Value of Option Awards Using Black-Scholes Option Pricing Model with Assumptions | The estimated grant-date fair value of all the Company’s stock-based awards was calculated using the Black-Scholes option pricing model, based on the following assumptions: Year Ended December 31, 2019 Expected term (in years) 6.08 Expected volatility 42.4%-42.9% Risk-free interest rate 2.4%-2.6% Expected dividend yield 0% |
Schedule of Option Activity under 2009 Plan and 2019 Plan | Option activity under the 2009 Plan and 2019 Plan is set forth below: Shares Available for Grant Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Term Aggregate Intrinsic Value (in years) (in thousands) Balance, December 31, 2018 392,299 3,636,358 $ 3.54 7.79 $ 11,267 Awards authorized 2,000,430 — Options expired (287,600 ) — Options granted (442,858 ) 442,858 14.69 Options exercised — (722,242 ) 3.10 Options cancelled 41,973 (41,973 ) 3.85 Balance, December 31, 2019 1,704,244 3,315,001 $ 5.08 7.28 $ 128,744 Awards authorized 943,345 — Options exercised — (1,185,764 ) 3.64 Options cancelled 42,035 (42,035 ) 4.45 Balance, December 31, 2020 2,689,624 2,087,202 $ 5.92 6.77 $ 204,137 Awards authorized 1,040,530 — Options exercised — (547,155 ) 5.57 Options cancelled 15,062 (15,062 ) 9.33 Balance, December 31, 2021 3,745,216 1,524,985 $ 6.01 5.76 $ 262,793 Vested and exercisable, December 31, 2021 1,295,974 $ 5.12 5.55 $ 224,475 Vested and expected to vest, December 31, 2021 1,524,985 $ 6.01 5.76 $ 262,793 |
Schedule of RSU Activity under 2019 Plan | RSU activity under the 2019 Plan is set forth below : Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance, December 31, 2018 — $ — RSUs granted 288,170 38.28 RSUs forfeited (5,600 ) 40.01 RSUs vested (1,666 ) 59.79 Balance, December 31, 2019 280,904 $ 38.12 RSUs granted 687,223 51.34 RSUs forfeited (38,650 ) 41.55 RSUs vested (69,900 ) 38.46 Balance, December 31, 2020 859,577 $ 48.50 RSUs granted 588,305 138.52 RSUs forfeited (51,986 ) 77.13 RSUs vested (239,213 ) 47.18 Balance, December 31, 2021 1,156,683 $ 93.27 |
Schedule of Fair Value of ESPP Shares Estimated Using Black-Scholes Option Pricing Model Assumptions | The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model. The Company recorded $1.3 million, $0.8 million and $0.3 million of stock-based compensation expense related to the ESPP for the years ended December 31, 2021, 2020 and 2019, respectively. Years Ended December 31, 2021 2020 2019 Expected term (in years) 0.5 0.5 0.5 Expected volatility 48.9%-64.8% 44.3%-74.0% 76.9% Risk-free interest rate 0.1% 0.1%-0.3% 1.9% Expected dividend yield 0% 0% 0% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 2020 2019 (in thousands) Domestic $ (9,388 ) $ (65,957 ) $ (51,179 ) Foreign 553 338 132 Total loss before income taxes $ (8,835 ) $ (65,619 ) $ (51,047 ) |
Schedule of Current Income Tax Provision | Current income tax provision consists of the following: December 31, 2021 2020 2019 (in thousands) Domestic $ 84 $ 3 $ — Foreign 217 77 62 Total current income tax provision $ 301 $ 80 $ 62 |
Components of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities are as follows: December 31, 2021 2020 (in thousands) Deferred tax assets: Net operating loss carryovers $ 85,764 $ 73,453 Fixed and intangible assets 512 718 Accruals and reserves 7,603 2,245 Stock-based compensation 5,523 2,060 Research and development credits 4,698 3,379 Contributions 42 42 Lease liability 7,398 2,004 Total deferred tax assets 111,540 83,901 Less valuation allowance (104,773 ) (82,087 ) Gross deferred tax assets 6,767 1,814 Deferred tax liabilities: Right-of-use-assets (6,767 ) (1,814 ) Gross deferred tax liabilities (6,767 ) (1,814 ) Total net deferred tax assets $ — $ — |
Reconciliation of Statutory Federal Income Tax | Reconciliation of the statutory federal income tax to the Company’s effective tax is as follows: December 31, 2021 2020 2019 (in thousands) Income tax benefit at federal statutory rate $ (1,856 ) $ (13,780 ) $ (10,720 ) State and local income taxes net of federal tax benefit 36 (9 ) (9 ) Foreign tax rate differential 101 6 35 Change in valuation allowance 19,027 27,990 14,470 Stock-based compensation (17,968 ) (13,425 ) (3,403 ) Research and development credits (808 ) (611 ) (354 ) Section 382 limitation 575 — — Equity method investment 1,320 — — Other (126 ) (91 ) 43 Total current income tax provision $ 301 $ 80 $ 62 |
Schedule of Unrecognized Tax Benefits | The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2021 2020 2019 (in thousands) Beginning balance $ 3,746 $ 2,586 $ 1,896 Additions (Reductions) based on tax positions related to prior years (79 ) (3 ) — Additions based on tax positions related to current years 1,554 1,163 690 Balance at end of year $ 5,221 $ 3,746 $ 2,586 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disaggregation Of Revenue [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, 2021 2020 2019 (in thousands) Coronary $ 161,463 $ 24,586 $ 15,621 Peripheral 74,064 41,994 26,325 Other 1,619 1,209 981 Product revenue $ 237,146 $ 67,789 $ 42,927 The following table represents the Company’s product revenue based on the location to which the product is shipped: Year Ended December 31, 2021 2020 2019 (in thousands) United States $ 186,324 $ 37,121 $ 22,699 Europe 38,571 23,456 17,499 All other countries 12,251 7,212 2,729 Product revenue $ 237,146 $ 67,789 $ 42,927 |
Equity Method Investments (Tabl
Equity Method Investments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity Method Investments And Joint Ventures [Abstract] | |
Summary of Unaudited Balance Sheet | The following table summarizes the unaudited balance sheet for the JV: December 31, 2021 Balance sheet: (in thousands) Current assets $ 14,854 Current liabilities (1,539 ) Net assets $ 13,315 |
Summary of Unaudited Results of Operations | The following table summarizes the unaudited results of operations for the JV: For the Year Ended December 31, 2021 (in thousands) Revenues $ — Loss from operations 14,043 Net loss $ 14,043 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Entity incorporation, date of incorporation | Jun. 17, 2009 |
Cash, cash equivalents and short-term investments | $ 201 |
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, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 89,209 | $ 50,423 | ||
Restricted cash | 1,665 | 1,450 | ||
Total cash, cash equivalents, and restricted cash | $ 90,874 | $ 51,873 | $ 140,495 | $ 40,093 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($)CustomerSegment | Dec. 31, 2020USD ($)Customer | Dec. 31, 2019USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Share in net loss of equity method investment | $ 6,286,000 | ||
Notice period for cancellation of agreement | 30 days | ||
Defined contribution plan, contribution amount | $ 2,500,000 | $ 1,100,000 | $ 0 |
Foreign currency transaction realized and unrealized gain (loss) | $ (800,000) | $ 300,000 | $ 100,000 |
Number of Operating Segments | Segment | 1 | ||
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful life | 3 years | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment useful life | 5 years | ||
Percentage of income tax position required to recognize uncertain income tax position | 50.00% | ||
Accounts Receivable | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Number of customers | Customer | 0 | 1 | |
Customer | Revenue Benchmark | No Customer | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 10.00% | 10.00% | 10.00% |
Credit Concentration Risk | Accounts Receivable | No Customer | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 10.00% | ||
Credit Concentration Risk | Accounts Receivable | Customer One | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 15.00% |
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, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |||
Beginning balance | $ 380 | $ 194 | $ 76 |
Amounts charged (reversed) to costs and expenses | (12) | 205 | 121 |
Write-offs | (18) | (19) | (3) |
Ending balance | $ 350 | $ 380 | $ 194 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 2,691,696 | 2,962,030 | 3,612,325 |
Common Stock Options Issued and Outstanding | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 1,524,985 | 2,087,202 | 3,315,001 |
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 | 1,156,683 | 859,577 | 280,904 |
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 | 10,028 | 15,251 | 16,420 |
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, 2021 | Dec. 31, 2020 |
Assets: | ||
Total assets | $ 159,313 | $ 193,384 |
Level 1 | ||
Assets: | ||
Total assets | 127,696 | 161,416 |
Level 2 | ||
Assets: | ||
Total assets | 31,617 | 31,968 |
U.S. Treasury securities | ||
Assets: | ||
Total assets | 80,155 | 126,363 |
U.S. Treasury securities | Level 1 | ||
Assets: | ||
Total assets | 80,155 | 126,363 |
Money Market Funds | ||
Assets: | ||
Total assets | 47,541 | 35,053 |
Money Market Funds | Level 1 | ||
Assets: | ||
Total assets | 47,541 | 35,053 |
Commercial Paper | ||
Assets: | ||
Total assets | 20,472 | 31,968 |
Commercial Paper | Level 2 | ||
Assets: | ||
Total assets | 20,472 | $ 31,968 |
Corporate Bonds | ||
Assets: | ||
Total assets | 11,145 | |
Corporate Bonds | Level 2 | ||
Assets: | ||
Total assets | $ 11,145 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments - Summary of Cash Equivalents and Short-Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents, Fair Value | $ 47,541 | $ 41,453 |
Cash equivalents and short-term investments, Amortized Cost Basis | 159,515 | 193,375 |
Cash equivalents and short-term investments, Unrealized Gains | 11 | |
Cash equivalents and short-term investments, Unrealized losses | (202) | (2) |
Cash equivalents and short-term investments, Fair Value | 159,313 | 193,384 |
Short-term investments | 111,772 | 151,931 |
U.S. Treasury securities | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 80,353 | 126,354 |
Short-term investments Unrealized Gains | 11 | |
Short-term investments Unrealized Losses | (198) | (2) |
Short-term investments, Fair Value | 80,155 | 126,363 |
Money Market Funds | ||
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents Amortized Cost Basis | 47,541 | 35,053 |
Cash equivalents, Fair Value | 47,541 | 35,053 |
Corporate Bonds | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 11,149 | |
Short-term investments Unrealized Losses | (4) | |
Short-term investments, Fair Value | 11,145 | |
Commercial Paper | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 20,472 | 31,968 |
Short-term investments, Fair Value | $ 20,472 | $ 31,968 |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Summary of Remaining Contractual Maturities for Available-for-sale Securities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Cash And Cash Equivalents [Abstract] | |
One year or less | $ 113,330 |
Greater than one year and less than two years | 45,983 |
Total | $ 159,313 |
Cash Equivalents and Short-Te_5
Cash Equivalents and Short-Term Investments - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Cash And Cash Equivalents [Abstract] | |
Realized gains on cash equivalents and short-term investments | $ 21,000 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 7,685 | $ 4,995 |
Work in progress | 13,315 | 6,051 |
Finished goods | 20,326 | 16,952 |
Consigned inventory | 1,652 | 1,861 |
Total inventory | $ 42,978 | $ 29,859 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 30,525 | $ 19,490 |
Less: accumulated depreciation and amortization | (6,164) | (3,128) |
Total property and equipment, net | 24,361 | 16,362 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 6,234 | 3,794 |
Equipment Loan To Customer | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,714 | 1,756 |
Office Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 549 | 157 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 742 | 175 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 17,742 | 5,808 |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,544 | $ 7,800 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |||
Depreciation and amortization expense | $ 3,579 | $ 1,863 | $ 1,337 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued employee compensation | $ 25,749 | $ 10,885 |
Accrued research and development costs | 4,605 | 3,057 |
Accrued asset purchases | 4,101 | 2,527 |
Accrued professional services | 2,636 | 1,325 |
Other | 3,779 | 2,148 |
Total accrued liabilities | $ 40,870 | $ 19,942 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2021Term | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Loss Contingencies [Line Items] | ||||
Operating lease liabilities, weighted average remaining lease term | 9 years 10 months 24 days | |||
Operating lease liabilities, weighted average incremental borrowing rate | 5.00% | |||
Operating lease cost | $ 2.9 | $ 2.2 | $ 1.2 | |
3003 Lease | ||||
Loss Contingencies [Line Items] | ||||
Lease term expiration month and year | 2031-12 | |||
Number of additional five year term | Term | 2 | |||
Operating lease, extended period | 5 years | |||
5403 Lease | ||||
Loss Contingencies [Line Items] | ||||
Lease term expiration month and year | 2022-08 | |||
Total minimum lease payments | $ 10.8 | |||
5403 and 5353 Lease | ||||
Loss Contingencies [Line Items] | ||||
Extended lease term expiration month and year | 2031-12 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Minimum Future Rental Payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
2022 | $ 3,204 |
2023 | 4,194 |
2024 | 4,289 |
2025 | 4,415 |
2026 | 4,545 |
Thereafter | 24,664 |
Total minimum lease payments | 45,311 |
Less: imputed interest and adjustments | (15,252) |
Total lease liability | $ 30,059 |
Term Notes - Additional Informa
Term Notes - Additional Information (Details) - USD ($) | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2018 |
Debt Instrument [Line Items] | |||||
Debt Amount | $ 16,500,000 | $ 16,500,000 | |||
Debt, final payment amount | 1,568,000 | ||||
Interest expense | $ 1,096,000 | 1,212,000 | $ 944,000 | ||
Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt, final payment as percentage of original aggregate principal amount | 6.75% | ||||
Debt, final payment amount | $ 1,000,000 | $ 1,000,000 | |||
Debt, warrants issued | 34,440 | ||||
Debt, fair value of warrants issued | $ 100,000 | ||||
Proceeds of supplemental term loan | $ 4,300,000 | ||||
Debt payments description | The Amended Credit Facility provides an interest-only payment period through June 30, 2022. | ||||
Interest expense | $ 1,100,000 | $ 1,200,000 | $ 900,000 | ||
Loan and Security Agreement | Supplemental Term Loan | |||||
Debt Instrument [Line Items] | |||||
Debt Amount | 16,500,000 | ||||
Debt interest rate | 3.50% | ||||
Debt, final payment amount | $ 1,600,000 | ||||
Proceeds of supplemental term loan, net of final balloon payment fee | $ 3,300,000 | ||||
Debt maturity date | Dec. 1, 2023 | ||||
Loan and Security Agreement | Minimum | |||||
Debt Instrument [Line Items] | |||||
Debt interest rate | 1.75% | ||||
Loan and Security Agreement | Minimum | Prime Rate | Supplemental Term Loan | |||||
Debt Instrument [Line Items] | |||||
Debt interest rate basis | 1.25% | ||||
Loan and Security Agreement | Maximum | |||||
Debt Instrument [Line Items] | |||||
Debt interest rate basis | 2.75% | ||||
Loan and Security Agreement | Maximum | Supplemental Term Loan | |||||
Debt Instrument [Line Items] | |||||
Debt interest rate | 3.50% | ||||
Loan and Security Agreement | Revolving Credit Facility | |||||
Debt Instrument [Line Items] | |||||
Termination of Line of Credit Facility | $ 2,000,000 | ||||
Loan and Security Agreement | Revolving Credit Facility | Maximum | |||||
Debt Instrument [Line Items] | |||||
Line of credit facility termination fee | $ 100,000 | ||||
Loan and Security Agreement | Silicon Valley Bank | Short Term Notes | |||||
Debt Instrument [Line Items] | |||||
Debt Amount | 15,000,000 | ||||
Loan and Security Agreement | Silicon Valley Bank | Revolving Credit Facility | |||||
Debt Instrument [Line Items] | |||||
Debt Amount | $ 2,000,000 |
Term Notes - Schedule of Long T
Term Notes - Schedule of Long Term Debt and Net Premium Balance (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument Periodic Payment [Abstract] | ||
Principal amount of term note | $ 16,500 | $ 16,500 |
Net premium associated with accretion of final payment, and other debt issuance costs | 630 | 119 |
Term note, current and noncurrent | 17,130 | 16,619 |
Less: term note, current portion | (5,500) | (3,300) |
Term note, noncurrent portion | $ 11,630 | $ 13,319 |
Term Notes - Schedule of Future
Term Notes - Schedule of Future Minimum and Estimated Payments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Disclosure [Abstract] | ||
2022 | $ 6,045 | |
2023 | 12,779 | |
Total future payments | 18,824 | |
Less: amounts representing interest | (756) | |
Less: final payment | (1,568) | |
Total principal amount of term note payments | $ 16,500 | $ 16,500 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 27,257 | $ 10,350 | $ 3,646 |
Cost of Product Revenue | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 1,153 | 496 | 268 |
Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 6,240 | 2,464 | 943 |
Sales and Marketing | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 11,043 | 3,478 | 972 |
General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 8,821 | $ 3,912 | $ 1,463 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 06, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based compensation expenses capitalized amount | $ 717,000 | $ 316,000 | $ 0 | ||
Expected dividend yield | 0.00% | 0.00% | |||
Options granted | 0 | 0 | 442,858 | ||
Weighted-average grant date fair value of options granted | $ 6.58 | ||||
Grant date fair value of options vested | $ 1,600,000 | $ 2,300,000 | $ 1,900,000 | ||
Unvested stock options | $ 1,000,000 | ||||
Unvested stock options, remaining weighted-average period | 9 months 18 days | ||||
Stock-based compensation | $ 27,257,000 | 10,350,000 | 3,646,000 | ||
Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Cliff vesting, percentage | 25.00% | ||||
Share-based compensation vesting rights, terms | The Company’s RSUs generally vest over a four-year period with a 25% one-year cliff or over a three-year period in equal amounts on a semi-annual basis, | ||||
Unvested stock options, remaining weighted-average period | 2 years 8 months 12 days | ||||
Grant date fair value of RSU vested | $ 11,300,000 | $ 2,700,000 | $ 100,000 | ||
Number of Shares, RSUs granted | 588,305 | 687,223 | 288,170 | ||
Unrecognized stock-based compensation | $ 87,600,000 | ||||
2019 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for issuance | 2,000,430 | 3,745,216 | |||
Maximum period of automatic annual increase in common stock reserved for issuance | 10 years | ||||
Automatic annual increase in common stock reserved for issuance | 3.00% | ||||
Start date for automatic annual increase for common stock reserved for issuance under plan | Jan. 1, 2020 | ||||
2019 Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Common stock reserved for issuance | 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 | 1.00% | ||||
Start date for automatic annual increase for common stock reserved for issuance under plan | Jan. 1, 2020 | ||||
Purchase shares of common stock, price per share, percentage of fair market value | 85.00% | ||||
Stock-based compensation | $ 1,300,000 | $ 800,000 | $ 300,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Estimates Grant-Date Fair Value of Option Awards Using Black-Scholes Option Pricing Model with Assumptions (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Expected term (in years) | 6 years 29 days | |
Expected volatility, minimum | 42.40% | |
Expected volatility, maximum | 42.90% | |
Risk-free interest rate, minimum | 2.40% | |
Risk-free interest rate, maximum | 2.60% | |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Option Activity under 2009 Plan and 2019 Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Shares Available for Grant | ||||
Shares Available for Grant, Beginning balance | 2,689,624 | 1,704,244 | 392,299 | |
Shares Available for Grant, Awards authorized | 1,040,530 | 943,345 | 2,000,430 | |
Shares Available for Grant, Options expired | (287,600) | |||
Shares Available for Grant, Options granted | (442,858) | |||
Shares Available for Grant, Options cancelled | 15,062 | 42,035 | 41,973 | |
Shares Available for Grant, Ending balance | 3,745,216 | 2,689,624 | 1,704,244 | 392,299 |
Number of Shares | ||||
Number of Shares, Beginning balance | 2,087,202 | 3,315,001 | 3,636,358 | |
Number of Shares, Options granted | 0 | 0 | 442,858 | |
Number of Shares, Options exercised | (547,155) | (1,185,764) | (722,242) | |
Number of Shares, Options cancelled | (15,062) | (42,035) | (41,973) | |
Number of Shares, Ending balance | 1,524,985 | 2,087,202 | 3,315,001 | 3,636,358 |
Number of Shares, Vested and exercisable | 1,295,974 | |||
Number of Shares, Vested and expected to vest | 1,524,985 | |||
Weighted-Average Exercise Price Per Share | ||||
Weighted-Average Exercise Price Per Share, Beginning balance | $ 5.92 | $ 5.08 | $ 3.54 | |
Weighted-Average Exercise Price Per Share, Options granted | 14.69 | |||
Weighted-Average Exercise Price Per Share, Options exercised | 5.57 | 3.64 | 3.10 | |
Weighted-Average Exercise Price Per Share, Options cancelled | 9.33 | 4.45 | 3.85 | |
Weighted-Average Exercise Price Per Share, Ending balance | 6.01 | $ 5.92 | $ 5.08 | $ 3.54 |
Weighted-Average Exercise Price Per Share, Vested and exercisable | 5.12 | |||
Weighted-Average Exercise Price Per Share, Vested and expected to vest | $ 6.01 | |||
Weighted-Average Remaining Term | ||||
Weighted-Average Remaining Term (in years), Balance | 5 years 9 months 3 days | 6 years 9 months 7 days | 7 years 3 months 10 days | 7 years 9 months 14 days |
Weighted-Average Remaining Term, Vested and exercisable | 5 years 6 months 18 days | |||
Weighted-Average Remaining Term, Vested and expected to vest | 5 years 9 months 3 days | |||
Aggregate Intrinsic Value | ||||
Aggregate Intrinsic Value, Balance | $ 262,793 | $ 204,137 | $ 128,744 | $ 11,267 |
Aggregate Intrinsic Value, Vested and exercisable | 224,475 | |||
Aggregate Intrinsic Value, Vested and expected to vest | $ 262,793 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of RSU Activity under 2019 Plan (Details) - Restricted Stock Units - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | |||
Number of Shares, Beginning balance | 859,577 | 280,904 | |
Number of Shares, RSUs granted | 588,305 | 687,223 | 288,170 |
Number of Shares, RSUs forfeited | (51,986) | (38,650) | (5,600) |
Number of Shares, RSUs vested | (239,213) | (69,900) | (1,666) |
Number of Shares, Ending balance | 1,156,683 | 859,577 | 280,904 |
Weighted-Average Grant Date Fair Value Per Share | |||
Weighted-Average Grant Date Fair Value Per Share, Beginning balance | $ 48.50 | $ 38.12 | |
Weighted-Average Grant Date Fair Value Per Share, RSUs granted | 138.52 | 51.34 | $ 38.28 |
Weighted-Average Grant Date Fair Value Per Share, RSUs forfeited | 77.13 | 41.55 | 40.01 |
Weighted-Average Grant Date Fair Value Per Share, RSUs vested | 47.18 | 38.46 | 59.79 |
Weighted-Average Grant Date Fair Value Per Share, Ending balance | $ 93.27 | $ 48.50 | $ 38.12 |
Stock-Based Compensation - Sc_5
Stock-Based Compensation - Schedule of Fair Value of ESPP Shares Estimated Using Black-Scholes Option Pricing Model Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | ||
Expected volatility, minimum | 42.40% | ||
Expected volatility, maximum | 42.90% | ||
Risk-free interest rate, minimum | 2.40% | ||
Risk-free interest rate, maximum | 2.60% | ||
Expected dividend yield | 0.00% | 0.00% | |
2019 Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | 6 months | 6 months |
Expected volatility, minimum | 48.90% | 44.30% | |
Expected volatility | 76.90% | ||
Expected volatility, maximum | 64.80% | 74.00% | |
Risk-free interest rate, minimum | 0.10% | ||
Risk-free interest rate | 0.10% | 1.90% | |
Risk-free interest rate, maximum | 0.30% | ||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Income Taxes -Schedule of Incom
Income Taxes -Schedule of Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (9,388) | $ (65,957) | $ (51,179) |
Foreign | 553 | 338 | 132 |
Net loss before taxes | $ (8,835) | $ (65,619) | $ (51,047) |
Income Taxes - Schedule of Curr
Income Taxes - Schedule of Current Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | $ 301 | $ 80 | $ 62 |
Domestic Federal | |||
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | 84 | 3 | |
Foreign Tax Authority | |||
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | $ 217 | $ 77 | $ 62 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets | ||
Net operating loss carryovers | $ 85,764 | $ 73,453 |
Fixed and intangible assets | 512 | 718 |
Accruals and reserves | 7,603 | 2,245 |
Stock-based compensation | 5,523 | 2,060 |
Research and development credits | 4,698 | 3,379 |
Contributions | 42 | 42 |
Lease liability | 7,398 | 2,004 |
Total deferred tax assets | 111,540 | 83,901 |
Less valuation allowance | (104,773) | (82,087) |
Gross deferred tax assets | 6,767 | 1,814 |
Deferred tax liabilities: | ||
Right-of-use-assets | (6,767) | (1,814) |
Gross deferred tax liabilities | $ (6,767) | $ (1,814) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Reconciliation | |||
Income tax benefit at federal statutory rate | $ (1,856) | $ (13,780) | $ (10,720) |
State and local income taxes net of federal tax benefit | 36 | (9) | (9) |
Foreign tax rate differential | 101 | 6 | 35 |
Change in valuation allowance | 19,027 | 27,990 | 14,470 |
Stock-based compensation | (17,968) | (13,425) | (3,403) |
Research and development credits | (808) | (611) | (354) |
Section 382 limitation | 575 | ||
Equity method investment | 1,320 | ||
Other | (126) | (91) | 43 |
Total current income tax provision | $ 301 | $ 80 | $ 62 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes Disclosure [Line Items] | |||
Increase in valuation allowance | $ 22.7 | $ 27 | $ 22.8 |
Research and development credit carryforwards | 0.1 | ||
Federal net operating losses | 2.4 | ||
Domestic Federal | |||
Income Taxes Disclosure [Line Items] | |||
NOL carryforwards | $ 351 | ||
NOL carryforwards | 2030 | ||
NOL carryforwards subject to expiration in 2030 | 78.4 | ||
NOL carryforwards never expire | $ 272.6 | ||
Research and development credit carryforwards | $ 5.5 | ||
California | State and Local Jurisdiction | |||
Income Taxes Disclosure [Line Items] | |||
NOL carryforwards | $ 54 | ||
NOL carryforwards | 2031 | ||
Research and development credit carryforwards | $ 5 | ||
All Other States | State and Local Jurisdiction | |||
Income Taxes Disclosure [Line Items] | |||
NOL carryforwards | $ 160.6 | ||
NOL carryforwards | 2029 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized tax benefits [Abstract] | |||
Beginning balance | $ 3,746 | $ 2,586 | $ 1,896 |
Reductions based on tax positions related to prior years | (79) | (3) | |
Additions based on tax positions related to current years | 1,554 | 1,163 | 690 |
Balance at end of year | $ 5,221 | $ 3,746 | $ 2,586 |
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, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 237,146 | $ 67,789 | $ 42,927 |
United States | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 186,324 | 37,121 | 22,699 |
Europe | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 38,571 | 23,456 | 17,499 |
All Other Countries | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 12,251 | 7,212 | 2,729 |
Coronary | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 161,463 | 24,586 | 15,621 |
Peripheral | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 74,064 | 41,994 | 26,325 |
Other | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 1,619 | $ 1,209 | $ 981 |
Equity Method Investments - Add
Equity Method Investments - Additional Information (Details) - USD ($) | Mar. 19, 2021 | Dec. 31, 2021 |
Schedule Of Equity Method Investments [Line Items] | ||
Equity method investment | $ 5,987,000 | |
Share in net loss of equity method investment | 6,286,000 | |
Related party contract liability, noncurrent portion | 12,273,000 | |
Joint Venture | ||
Schedule Of Equity Method Investments [Line Items] | ||
Percentage of equity stake received | 45.00% | |
Related party transaction. transaction price | $ 12,300,000 | |
Related party contract liability, noncurrent portion | 12,300,000 | |
Related party, sold | 184,000 | |
Related party, owned for sale of product | $ 138,000 | |
JV Agreement with Genesis MedTech | Share Subscription Agreement | ||
Schedule Of Equity Method Investments [Line Items] | ||
Ordinary shares issued | 54,900 | |
Equity percentage | 55.00% | |
Cash contribution from exchange of equity | $ 15,000,000 | |
Percentage of cash contribution received from exchange of equity upon signing of agreement | 50.00% | |
Percentage of cash contribution receivable from exchange of equity within one year | 50.00% | |
JV Agreement with Genesis MedTech | License Agreement | ||
Schedule Of Equity Method Investments [Line Items] | ||
Ordinary shares issued | 45,000 | |
Equity percentage | 45.00% |
Equity Method Investments - Sum
Equity Method Investments - Summary of Unaudited Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Balance sheet: | ||
Current assets | $ 285,902 | $ 246,300 |
Current liabilities | (51,628) | $ (25,581) |
JV Agreement with Genesis MedTech | ||
Balance sheet: | ||
Current assets | 14,854 | |
Current liabilities | (1,539) | |
Net assets | $ 13,315 |
Equity Method Investments - S_2
Equity Method Investments - Summary of Unaudited Results of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule Of Equity Method Investments [Line Items] | |||
Product revenue | $ 237,146 | $ 67,789 | $ 42,927 |
Loss from operations | (871) | (65,663) | (51,839) |
Net loss | (9,136) | $ (65,699) | $ (51,109) |
JV Agreement with Genesis MedTech | |||
Schedule Of Equity Method Investments [Line Items] | |||
Loss from operations | 14,043 | ||
Net loss | $ 14,043 |