Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 22, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
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 | 34,842,744 | ||
Entity Public Float | $ 1.3 | ||
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 $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Documents Incorporated by Reference | Portions of the registrant’s Proxy Statement for its 2021 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2020. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 50,423 | $ 139,045 |
Short-term investments | 151,931 | 56,304 |
Accounts receivable, net | 11,689 | 7,377 |
Inventory | 29,859 | 12,074 |
Prepaid expenses and other current assets | 2,398 | 1,897 |
Total current assets | 246,300 | 216,697 |
Operating lease right-of-use assets | 7,568 | 8,825 |
Property and equipment, net | 16,362 | 4,910 |
Other assets | 1,812 | 1,506 |
TOTAL ASSETS | 272,042 | 231,938 |
CURRENT LIABILITIES: | ||
Accounts payable | 1,466 | 2,790 |
Term notes, current portion | 3,300 | 6,667 |
Accrued liabilities | 19,942 | 13,777 |
Lease liability, current portion | 873 | 774 |
Total current liabilities | 25,581 | 24,008 |
Lease liability, noncurrent portion | 7,488 | 8,125 |
Term notes, noncurrent portion | 13,319 | 7,152 |
TOTAL LIABILITIES | 46,388 | 39,285 |
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, 2020 and 2019 | ||
Common stock, $0.001 par value; 281,274,838 shares authorized; 34,684,337 and 31,446,787 issued and outstanding as of December 31, 2020 and 2019 | 35 | 31 |
Additional paid-in capital | 469,283 | 370,561 |
Accumulated other comprehensive income | 9 | 35 |
Accumulated deficit | (243,673) | (177,974) |
TOTAL STOCKHOLDERS’ EQUITY | 225,654 | 192,653 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 272,042 | $ 231,938 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 34,684,337 | 31,446,787 |
Common stock, shares outstanding | 34,684,337 | 31,446,787 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||
Product revenue | $ 67,789,000 | $ 42,927,000 | $ 12,263,000 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Cost of revenue: | |||
Cost of product revenue | $ 20,991,000 | $ 17,159,000 | $ 7,250,000 |
Type of Cost, Good Or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Gross profit | $ 46,798,000 | $ 25,768,000 | $ 5,013,000 |
Operating expenses: | |||
Research and development | 36,926,000 | 32,853,000 | 22,698,000 |
Sales and marketing | 51,672,000 | 30,620,000 | 17,536,000 |
General and administrative | 23,863,000 | 14,134,000 | 5,979,000 |
Total operating expenses | 112,461,000 | 77,607,000 | 46,213,000 |
Loss from operations | (65,663,000) | (51,839,000) | (41,200,000) |
Interest expense | (1,212,000) | (944,000) | (401,000) |
Change in fair value of warrant liability | (609,000) | (52,000) | |
Other income, net | 1,256,000 | 2,345,000 | 589,000 |
Net loss before taxes | (65,619,000) | (51,047,000) | (41,064,000) |
Income tax provision | 80,000 | 62,000 | 38,000 |
Net loss | (65,699,000) | (51,109,000) | (41,102,000) |
Unrealized gain (loss) on available-for-sale securities | (5,000) | 35,000 | 1,000 |
Adjustment for net gain realized and included in other income, net | (21,000) | ||
Total comprehensive loss | $ (65,725,000) | $ (51,074,000) | $ (41,101,000) |
Net loss per share, basic and diluted | $ (1.99) | $ (2.14) | $ (23.39) |
Shares used in computing net loss per share, basic and diluted | 33,088,095 | 23,904,828 | 1,757,102 |
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, 2017 | $ (83,292,000) | $ 2,000 | $ 2,470,000 | $ (1,000) | $ (85,763,000) | |||||||
Temporary equity, Beginning balance, Shares at Dec. 31, 2017 | 17,510,045 | |||||||||||
Temporary equity, Beginning balance at Dec. 31, 2017 | $ 137,469,000 | |||||||||||
Beginning balance, Shares at Dec. 31, 2017 | 1,627,032 | |||||||||||
Issuance of common stock warrants | 104,000 | 104,000 | ||||||||||
Issuance of convertible preferred stock, net of issuance costs | $ 14,920,000 | |||||||||||
Issuance of convertible preferred stock, net of issuance costs, Shares | 1,090,608 | |||||||||||
Exercise of Series A-1 warrants | $ 417,000 | |||||||||||
Temporary equity, Exercise of Series A-1 warrants, Shares | 69,675 | |||||||||||
Exercise of stock options | $ 326,000 | 326,000 | ||||||||||
Exercise of stock options, Shares | 197,820 | 197,820 | ||||||||||
Unrealized gain (loss) on available-for-sale securities | $ 1,000 | 1,000 | ||||||||||
Vesting of early exercised options | 78,000 | 78,000 | ||||||||||
Stock-based compensation | 1,297,000 | 1,297,000 | ||||||||||
Net loss | (41,102,000) | (41,102,000) | ||||||||||
Ending balance at Dec. 31, 2018 | (122,588,000) | $ 2,000 | 4,275,000 | (126,865,000) | ||||||||
Temporary equity, Ending balance, Shares at Dec. 31, 2018 | 18,670,328 | |||||||||||
Temporary equity, Ending balance at Dec. 31, 2018 | $ 152,806,000 | |||||||||||
Ending 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 to common stock upon initial public offering, Shares | (18,670,328) | |||||||||||
Temporary equity, Conversion of preferred stock to common stock upon initial public offering | $ (152,806,000) | |||||||||||
Conversion of preferred stock 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 | $ 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 | ||||||||||
Unrealized gain (loss) on available-for-sale securities | $ 35,000 | 35,000 | ||||||||||
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) | |||||||||||
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 | $ 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 | |||||||||||
Unrealized gain (loss) on available-for-sale securities | (5,000) | (5,000) | ||||||||||
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 | ||||||||||
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 |
Consolidated Statements of Co_2
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Issuance cost | $ 80 | ||
Initial Public Offering | |||
Issuance costs | $ 11,500 | ||
Public Offering | |||
Issuance costs | $ 6,100 | $ 6,800 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (65,699) | $ (51,109) | $ (41,102) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,863 | 1,337 | 700 |
Stock-based compensation | 10,350 | 3,646 | 1,297 |
Amortization of right-of-use assets | 1,483 | 944 | |
Accretion of discount on available-for-sale securities | 300 | (543) | |
Loss on write down of fixed assets | 187 | 67 | 31 |
Change in fair value of warrant liability | 609 | 52 | |
Amortization of debt issuance costs | 646 | 436 | 206 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (4,312) | (4,527) | (2,211) |
Inventory | (17,056) | (6,824) | (2,608) |
Prepaid expenses and other current assets | (501) | (785) | (144) |
Other assets | (306) | 41 | (917) |
Accounts payable | (1,392) | 1,272 | 360 |
Accrued and other current liabilities | 4,017 | 8,339 | 2,773 |
Lease liabilities | (764) | (1,010) | |
Other liabilities | 98 | ||
Net cash used in operating activities | (71,184) | (48,107) | (41,465) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of available-for-sale securities | (167,953) | (119,476) | |
Proceeds from maturities of available-for-sale securities | 72,000 | 63,750 | 1,807 |
Purchase of property and equipment | (11,520) | (3,817) | (1,981) |
Net cash used in investing activities | (107,473) | (59,543) | (174) |
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 convertible preferred stock, net of issuance costs | 14,920 | ||
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 | (1,420) | ||
Proceeds from term loans | 3,265 | 14,988 | |
Payment of deferred offering costs | (179) | (626) | |
Proceeds from stock option exercises | 4,317 | 2,206 | 426 |
Proceeds from issuance of common stock under employee stock purchase plan | 1,795 | ||
Proceeds from warrant exercises | 110 | 101 | |
Principal payment of term loan | (1,111) | (1,667) | |
Net cash provided by financing activities | 90,035 | 208,052 | 29,809 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (88,622) | 100,402 | (11,830) |
Cash, cash equivalents and restricted cash at beginning of period | 140,495 | 40,093 | 51,923 |
Cash, cash equivalents and restricted cash equivalents at end of period | 51,873 | 140,495 | 40,093 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Interest paid | 549 | 534 | 156 |
Income tax paid | 22 | 120 | 5 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||
Common stock issued on conversion of convertible preferred stock | 152,806 | ||
Issuance of Series A-1 convertible preferred stock on net exercise of warrants | 316 | ||
Deferred offering cost included in account payable and accrued liabilities | 893 | ||
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 | 226 | 6,948 | |
Property and equipment purchases included in accounts payable and accrued liabilities | 2,448 | 52 | 55 |
Issuance of common stock warrants in connection with debt financing | $ 104 | ||
Transfer of fixed assets to inventory | $ 413 | $ 119 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
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 and Japan. Initial Public Offering On March 11, 2019, the Company completed an initial public offering (“IPO”) of its common stock. As part of the IPO, the Company issued and sold 6,555,000 shares of its common stock, which included 855,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $17.00 per share. The Company received net proceeds of approximately $99.9 million from the IPO, after deducting underwriters’ discounts and commissions. Prior to the completion of the IPO, all shares of Series A, A-1, B, C and D convertible preferred stock then outstanding were converted into 18,670,259 shares of common stock on a one-to-one basis. In addition, on the completion of the IPO, all the Company’s outstanding preferred stock warrants were converted into 54,903 common stock warrants, which resulted in the reclassification of the convertible preferred stock warrant liability to additional paid-in capital. Furthermore, 101,744 shares of common stock were issued upon net exercise of warrants at the time of the IPO. Concurrently with the IPO, the Company issued 588,235 shares of its common stock in a private placement for net proceeds of $10.0 million. Public Offerings On November 15, 2019, the Company completed an underwritten public offering of 2,854,048 shares of its common stock, including 372,267 shares sold pursuant to the underwriters’ exercise of their option to purchase additional shares, at a public offering price of $36.25 per share. The Company received net proceeds of $96.7 million from the follow-on offering after deducting underwriters’ discounts and commissions. On June 19, 2020, the Company completed an underwritten offering of 1,955,000 shares of its common stock, including 255,000 shares sold pursuant to the underwriters’ exercise of their option to purchase additional shares, at a public offering price of $45.75 per share. Upon completion of the June 2020 offering, the Company received net proceeds of $83.4 million, after deducting underwriting discounts and commissions and offering expenses. Liquidity As of December 31, 2020, the Company had cash, cash equivalents and short-term investments of $202.4 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, 2020 | |
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 (“U.S. GAAP”) 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, 2020 December 31, 2019 (in thousands) Cash and cash equivalents $ 50,423 $ 139,045 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 51,873 $ 140,495 Restricted cash as of December 31, 2020 and 2019 relates to letters of credit established for real property leases entered into in May 2018 and December 2019 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. 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 the Company’s investments have investment grade ratings when purchased. 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, 2020, 2019 and 2018 no customer accounted for 10% of the Company’s revenue. There was one customer which accounted for 15% of the Company’s accounts receivable as of December 31, 2020. There was one customer which accounted for 11% of the Company’s accounts receivable as of December 31, 2019. 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 our 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 our assessment of expected credit losses for our 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, 2020 2019 2018 (in thousands) Beginning balance $ 194 $ 76 $ — Amounts charged to costs and expenses 205 121 77 Write-offs (19 ) (3 ) (1 ) Ending balance $ 380 $ 194 $ 76 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 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 significant portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Under ASC 606, 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company elected to exclude taxes assessed by a governmental authority on revenue-producing transactions from the transaction price. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and certain customers that purchase stocking orders in the United States, 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 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. 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 The Company adopted ASU No. 2016-02, Leases Leases For its long-term operating lease, 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. Rent expense 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. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. The Company is authorized to make matching contributions. During 2020, the Company made matching contributions up to $3,000 of an employee’s eligible deferred compensation. The Company recognized expense related to its contributions to the plan of $1.1 million for the year-ended December 31, 2020. The Company did not make such contributions for the year ended December 31, 2019 or 2018. 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 gains of $261,000 and $56,000 for the years ended December 31, 2020 and 2019, respectively. In December 31, 2018, there were net foreign currency transaction losses of 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. The unvested portion of early exercised stock options are excluded from the computation of weighted-average shares as the continuing vesting of such shares is contingent on the holders’ continued service to the Company. 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. 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 all held in the United States with the exception of certain equipment on loan to customers held internationally, which was not material for the years-ended December 31, 2020 and 2019. Recently Adopted Accounting Pronouncements Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . In addition, Topic 326 also provides new guidance related to the measurement of expected credit losses on the Company’s allowance for bad debt for accounts receivable, which is estimated upon assessment of various factors including historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of the Company’s customers. As of March 31, 2020, the Company considered the current and expected future economic and market conditions surrounding the COVID-19 pandemic and increased the overall reserve for credit losses by $0.2 million in response to an assessment of the evolving credit environment under the COVID-19 pandemic. The Company continued to monitor our customer collections and credit risk, however, no additional material changes to the allowance for doubtful accounts, subsequent to March 31, 2020, were recorded for the year-ended December 31, 2020. Recent Accounting Pronouncements Not Yet Adopted In November 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
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, 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 December 31, 2019 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 43,245 $ — $ — $ 43,245 Money market funds 29,386 — — 29,386 Reverse repurchase agreements — 10,000 — $ 10,000 Commercial paper — 6,958 — $ 6,958 Corporate bonds — 8,096 — $ 8,096 Total assets $ 72,631 $ 25,054 $ — $ 97,685 |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 12 Months Ended |
Dec. 31, 2020 | |
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, 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 December 31, 2019 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 43,219 $ 27 $ (1 ) $ 43,245 Money market funds 29,386 — — 29,386 Reverse repurchase agreements 10,000 — — 10,000 Commercial paper 6,958 — — 6,958 Corporate bonds 8,087 9 — 8,096 Total $ 97,650 $ 36 $ (1 ) $ 97,685 Reported as: Cash equivalents $ 41,381 Short-term investments 56,304 Total $ 97,685 At December 31, 2020, the remaining contractual maturities for available-for-sale securities were less than one year. For the year ended December 31, 2020, the Company recognized $21,000 in realized gains on cash equivalents and short-term investments. There were no material realized gains or losses on cash equivalents and short-term investments for the years ended December 31, 2019 and 2018. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventory Inventory consists of the following: December 31, 2020 2019 (in thousands) Raw material $ 4,995 $ 2,501 Work in progress 6,051 1,364 Finished goods 16,952 6,642 Consigned inventory 1,861 1,567 Total inventory $ 29,859 $ 12,074 Property and Equipment, Net Property and equipment, net consists of the following: December 31, 2020 2019 (in thousands) Equipment $ 3,794 $ 3,759 Equipment on loan to customers 1,756 1,495 Office furniture 157 76 Software 175 97 Leasehold improvements 5,808 1,329 Construction in progress 7,800 553 Property and equipment, gross 19,490 7,309 Less accumulated depreciation and amortization (3,128 ) (2,399 ) Total property and equipment, net $ 16,362 $ 4,910 Depreciation and amortization expense amounted to $1.9 million, $1.3 million and $0.7 million for the years ended December 31, 2020, 2019 and 2018, respectively. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2020 2019 (in thousands) Accrued employee compensation $ 10,885 $ 8,139 Accrued research and development costs 3,057 3,090 Accrued asset purchases 2,527 — Accrued professional services 1,325 804 Other 2,148 1,744 Total accrued liabilities $ 19,942 $ 13,777 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Operating Leases In May 2018, the Company entered into a lease agreement for office, laboratory, and manufacturing space located at 5403 Betsy Ross Drive in Santa Clara, California, which consists of approximately 35,000 square feet (the “5403 Lease”). The term of the 5403 Lease commenced in September 2018 and ends in August 2022. In connection with the 5403 Lease, the Company maintains a letter of credit for the benefit of the landlord in the amount of $0.5 million, which is secured by restricted cash recorded as other assets on the consolidated balance sheets. In connection with the 5403 Lease, the Company has an operating lease right-of-use asset of $1.3 million as of December 31, 2020 and an aggregate lease liability of $1.4 million on its consolidated balance sheet. The remaining lease term is one year and eight months. In December 2019, the Company entered into a lease agreement (i) for additional office, laboratory and manufacturing space located at 5353 Betsy Ross Drive in Santa Clara, California, which consists of approximately 50,200 square feet (the “5353 Lease”); and (ii) to modify the terms of the 5403 Lease. The 5403 Lease will continue in its existing terms (and with no changes to its terms, including its base rent) until its expiration on August 31, 2022, at which point the leased space under the 5403 Lease will become subject to the terms of the 5353 Lease. The initial term of the 5353 Lease began in December 2019 and is for 96 months, with an option by the Company to extend for an additional five years on either or both of the 5403 and 5353 Betsy Ross buildings. The base rent of the first floor of the premises for the 5353 Betsy Ross building shall be abated for the first 19 months, and the base rent for the second floor of the 5353 Betsy Ross building shall be abated for the first four months. The landlord provided the Company with a tenant improvement allowance of up to $1.8 million for both 5403 and 5353 Betsy Ross buildings. In connection with the 5353 Lease, the Company provided an initial security deposit of $1.0 million in the form of a letter of credit, which is secured by restricted cash recorded as other assets on the consolidated balance sheets. While this amount will increase to $1.5 million on September 1, 2022 when the office, laboratory and manufacturing space of the 5403 Lease is included under the terms of the 5353 Lease, the letter of credit will be reduced annually from and after September 1, 2022 until the expiration of the 5353 Lease. In connection with the lease of the 5353 Betsy Ross building, the Company has recorded an operating lease right-of-use asset of $6.1 million as of December 31, 2020 and an aggregate lease liability of $6.8 million on its consolidated balance sheet. The remaining lease term is six years and eleven months. The Company also leases vehicles for use by employees. In connection with the vehicle leases, the Company has an operating lease right-of-use asset and an aggregate lease liability of $0.2 million as of December 31, 2020 on its consolidated balance sheet. The weighted average remaining lease term for these vehicle leases is two years and four months. The weighted average incremental borrowing rate used to measure the operating lease liability is 6.98%. As of December 31, 2020, the Company has no finance leases. 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. The following are minimum future rental payments owed under these agreements which have commenced as of December 31, 2020: (in thousands) 2021 $ 1,946 2022 2,123 2023 1,529 2024 1,546 2025 1,594 Thereafter 3,232 Total minimum lease payments $ 11,970 Less: imputed interest (3,609 ) Total lease liability $ 8,361 The following are minimum future rental payments owed for the modified 5403 Betsy Ross Lease which has not yet commenced as of December 31, 2020: (in thousands) 2021 $ — 2022 345 2023 1,044 2024 1,078 2025 1,112 Thereafter 2,253 Total minimum lease payments $ 5,832 Operating lease cost for the years ended December 31, 2020 and 2019 was $2.2 million and $1.2 million, respectively. Rent expense for the year ended December 31, 2018 was $0.9 million. |
Term Notes
Term Notes | 12 Months Ended |
Dec. 31, 2020 | |
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 was available in two tranches, of which the first tranche of $10.0 million was funded in June 2018 and the second tranche of $5.0 million was funded in December 2018. 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 its 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, 2020. The supplemental term loan matures on December 1, 2023. The Amended Credit Facility provides an interest-only payment period which will end on (a) June 30, 2021, if the Company’s revenue for the trailing 12-month period ended June 30, 2021 is not at least 75% of the Company’s projections; (b) December 31, 2021, if the Company achieves the financial performance target referred to in clause (a), but does not obtain premarket approval of the Company’s C 2 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. During the years ended December 31, 2020, 2019 and 2018 the Company recorded interest expense of $0.6 million, $0.5 million and $0.2 million, respectively. Debt discount amortized as interest expense was $0.6 million, $0.4 million and $0.2 million for the years ended December 31, 2020, 2019 and 2018, 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, 2020 2019 (in thousands) Principal amount of term note $ 16,500 $ 13,334 Net premium associated with accretion of final payment and other debt issuance costs 119 485 Term note, current and noncurrent 16,619 13,819 Less term note, current portion (3,300 ) (6,667 ) Term note, noncurrent portion $ 13,319 $ 7,152 Future minimum payments of principal and estimated payments of interest on the Company’s outstanding variable rate borrowings as of December 31, 2020 are as follows: Year ending December 31: (in thousands) 2021 $ 3,861 2022 6,961 2023 8,294 Total future payments 19,116 Less amounts representing interest (1,048 ) Less final payment (1,568 ) Total principal amount of term note payments $ 16,500 |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders’ Equity (Deficit) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders Equity [Abstract] | |
Convertible Preferred Stock and Stockholders’ Equity (Deficit) | 8. Convertible Preferred Stock and Stockholders’ Equity (Deficit) Convertible Preferred Stock Immediately prior to the closing of the Company’s IPO, 18,670,259 shares of outstanding convertible preferred stock converted into 18,670,259 shares of common stock. Preferred Stock The Company’s amended and restated certificate of incorporation, which became effective upon the completion of the IPO, authorizes 5,000,000 shares of preferred stock, of which no shares were issued or outstanding as of December 31, 2020 and 2019. Preferred Stock Warrants Upon the closing of the IPO, all of the outstanding convertible preferred stock warrants were converted into 54,903 common stock warrants, which resulted in the reclassification of the convertible preferred stock warrant liability of $0.8 million to additional paid-in capital. In April 2019, all of these common stock warrants were net exercised into 49,321 shares of common stock. There were no preferred stock warrants outstanding of December 31, 2020 and 2019. Common Stock Warrants Upon the IPO, 91,446 common stock warrants held by related parties were net exercised based on the IPO price of $17.00 per share into 79,632 shares of common stock. In February 2018, in connection with the execution of a Loan and Security Agreement with Silicon Valley Bank for a term loan and revolving line of credit, the Company issued warrants to purchase shares of the Company’s common stock. In April 2019, all of these common stock warrants were net exercised into 29,887 shares of common stock. There were no common stock warrants outstanding of December 31, 2020 and 2019. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation Total stock-based compensation was as follows: Year Ended December 31, 2020 2019 2018 (in thousands) Cost of product revenue $ 496 $ 268 $ 67 Research and development 2,464 943 235 Sales and marketing 3,478 972 294 General and administrative 3,912 1,463 701 Total stock-based compensation $ 10,350 $ 3,646 $ 1,297 Stock-based compensation of $316,000 was capitalized into inventory for the year ended December 31, 2020. No material stock-based compensation was capitalized into inventory for the years ended December 31, 2019 and 2018. 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 2018 Expected term (in years) 6.08 6.08 Expected volatility 42.4%-42.9% 40.8%-41.9% Risk-free interest rate 2.4%-2.6% 2.5%-3.1% Expected dividend yield 0% 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 “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 Stock Option and Incentive Plan (the “2019 Plan”), which became effective in connection with the IPO. 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 The Board has the authority to determine to whom options will be granted, the number of shares, the term and the exercise price. If an individual owns stock representing 10% or more of the outstanding shares, the price of each share shall be at least 110% of the fair market value, as determined by the Board. Options granted under the Plan have a term of up to 10 years and generally vest over a 4 year period with a straight-line vesting and a 25% one year cliff. As of December 31, 2020, the Company had reserved 2,689,624 shares of common stock for issuance under the 2019 Plan. Stock Options 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, 2017 426,370 3,108,604 $ 2.81 8.03 $ 3,647 Awards authorized 691,503 — Options granted (1,015,963 ) 1,015,963 5.25 Options exercised — (197,820 ) 2.20 Options cancelled 290,389 (290,389 ) 3.42 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 Vested and exercisable, December 31, 2020 1,360,650 $ 4.63 6.36 $ 134,825 Vested and expected to vest, December 31, 2020 2,087,202 $ 5.92 6.77 $ 204,137 There were no options granted during the year ended December 31, 2020. The weighted-average grant date fair value of options granted during the year ended December 31, 2019 and 2018 was $6.58 and $2.56 per share, respectively. The total grant date fair value of options vested was $2.3 million, $1.9 million and $1.6 million for the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, total unrecognized stock-based compensation related to unvested stock options was $2.5 million, which the Company expects to recognize over a remaining weighted-average period of 1.3 years. Restricted Stock Units Restricted stock units (“RSUs”) are share awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon vesting. The 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 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, provided the employee remains continuously employed with the Company. The fair value of the RSUs is equal to the closing price of the Company’s common stock on the grant date. 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 The total grant date fair value of RSUs vested for the years ended December 31, 2020 and 2019 was $2.7 and $0.1 million, respectively. There were no RSUs granted prior to 2019. As of December 31, 2020, there was $35.3 million of unrecognized stock-based compensation expense related to RSUs to be recognized over a weighted-average period of 3.1 years. Employee Share Purchase Plan (ESPP) In February 2019, the Company adopted the 2019 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 $786,000 and $255,000 of stock-based compensation expense related to the ESPP for the years ended December 31, 2020 and 2019, respectively. Year Ended December 31, Year Ended December 31, 2020 2019 Expected term (in years) 0.5 0.5 Expected volatility 44.31%-74.03% 76.93% Risk-free interest rate 0.12%-0.3% 1.89% Expected dividend yield 0% 0% |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes The following table presents income (loss) before income taxes for the periods presented: December 31, 2020 2019 2018 (in thousands) Domestic $ (65,957 ) $ (51,179 ) $ (41,145 ) Foreign 338 132 81 Total loss before income taxes $ (65,619 ) $ (51,047 ) $ (41,064 ) Current income tax provision consists of the following: December 31, 2020 2019 2018 (in thousands) Domestic $ 3 $ — $ 3 Foreign 77 62 35 Total current income tax provision $ 80 $ 62 $ 38 The components of the deferred tax assets are as follows: December 31, 2020 2019 (in thousands) Deferred tax assets: Net operating loss carryovers $ 73,453 $ 49,862 Fixed and intangible assets 718 450 Accruals and reserves 2,245 1,619 Stock-based compensation 2,060 780 Research and development credits 3,379 2,336 Contributions 42 20 Lease liability 2,004 2,135 Total deferred tax assets 83,901 57,202 Less valuation allowance (82,087 ) (55,085 ) Gross deferred tax assets 1,814 2,117 Deferred tax liabilities: Right-of-use-assets (1,814 ) (2,117 ) Gross deferred tax liabilities (1,814 ) (2,117 ) Total net deferred tax assets $ — $ — Reconciliation of the statutory federal income tax to the Company’s effective tax is as follows: December 31, 2020 2019 2018 (in thousands) Income tax benefit at federal statutory rate $ (13,780 ) $ (10,720 ) $ (8,624 ) State and local income taxes net of federal tax benefit (9 ) (9 ) 3 Foreign tax rate differential 6 35 11 Change in valuation allowance 27,990 14,470 8,497 Stock-based compensation (13,425 ) (3,403 ) 123 R&D tax credits (611 ) (354 ) (313 ) Other (91 ) 43 341 Total current income tax provision $ 80 $ 62 $ 38 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 and other deferred tax assets. The valuation allowance increased by $27.0 million, As of December 31, 2020, the Company had net operating loss carryforwards available to reduce future federal, California and other state income of $301.9 million, $52.4 million and $123.7 million, respectively. The federal net operating loss carryforwards of $80.8 million and $221.1 million begin expiring in 2030 and never expire respectively, the California net operating loss carryforwards begin expiring in 2031 and other state net operating loss carryforwards begin expiring in various years, starting in 2029. As of December 31, 2020, the Company had research and development credit carryforwards of $4.0 million for federal income tax purposes and $3.5 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 net operating loss carryforward may be subject to an annual limitation due to the ownership change provided by the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitation may result in the expiration of the net operating loss before utilization. The Company has not prepared a Section 382 study to date to determine if a greater than 50% ownership change has occurred and to determine the annual Section 382 limitation if applicable. Thus, the Company has not determined if there are any limitations on the Company’s ability to utilize its net operating losses in the future and if any reduction in the net operating loss deferred tax assets is required until such study is performed. Upon completion of a 382 study, to the extent that our net operating losses are reduced due to ownership changes, the impact would result in a reduction of the net operating loss deferred tax assets offset by a reduction in the valuation allowance. Uncertain Tax Positions The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2020 2019 2018 (in thousands) Beginning balance $ 2,586 $ 1,896 $ 893 Additions (Reductions) based on tax positions related to prior years (3 ) — 394 Additions based on tax positions related to current years 1,163 690 609 Balance at end of year $ 3,746 $ 2,586 $ 1,896 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. It is the Company’s policy to include penalties and interest expense related to income taxes as a component of the income tax provision as necessary. The Company determined that no accrual for interest and penalties was required as of December 31, 2020. The Company is subject to taxation in the United States, Germany, and Japan. The Company’s income tax returns since inception remain subject to examination by U.S. federal and most state tax authorities due to its net operating loss. The income tax returns of Shockwave Medical GmbH for the 2016 through 2020 tax years remain subject to examination by the German taxing authorities and the income tax returns of Shockwave Medical Japan KK for the 2020 tax year will be subject to examination by the Japanese taxing authorities once filed. The Company is not currently under audit with either the IRS, foreign, or any 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 net operating loss or credits. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. 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, 2020 2019 2018 (in thousands) Convertible preferred stock on an as-converted basis — — 18,670,328 Common stock options issued and outstanding 2,087,202 3,315,001 3,636,358 Restricted stock units 859,577 280,904 — Employee stock purchase plan 15,251 16,420 — Early exercised options subject to future vesting — — 13,422 Convertible preferred stock warrants — — 54,903 Common stock warrants — — 176,218 Total 2,962,030 3,612,325 22,551,229 |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2020 | |
Disaggregation Of Revenue [Abstract] | |
Revenue | 12. Revenue Disaggregation of revenue The following table represents the Company’s product revenue based on product line: Year Ended December 31, 2020 2019 2018 (in thousands) Peripheral $ 41,994 $ 26,325 $ 8,828 Coronary 24,586 15,621 3,210 Other 1,209 981 225 Product revenue $ 67,789 $ 42,927 $ 12,263 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, 2020 2019 2018 (in thousands) United States $ 37,121 $ 22,699 $ 7,022 Germany 4,314 3,402 1,393 Rest of Europe 19,142 14,097 3,516 All other countries 7,212 2,729 332 Product revenue $ 67,789 $ 42,927 $ 12,263 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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 (“U.S. GAAP”) 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, 2020 December 31, 2019 (in thousands) Cash and cash equivalents $ 50,423 $ 139,045 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 51,873 $ 140,495 Restricted cash as of December 31, 2020 and 2019 relates to letters of credit established for real property leases entered into in May 2018 and December 2019 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. |
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 the Company’s investments have investment grade ratings when purchased. 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, 2020, 2019 and 2018 no customer accounted for 10% of the Company’s revenue. There was one customer which accounted for 15% of the Company’s accounts receivable as of December 31, 2020. There was one customer which accounted for 11% of the Company’s accounts receivable as of December 31, 2019. |
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 our 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 our assessment of expected credit losses for our 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, 2020 2019 2018 (in thousands) Beginning balance $ 194 $ 76 $ — Amounts charged to costs and expenses 205 121 77 Write-offs (19 ) (3 ) (1 ) Ending balance $ 380 $ 194 $ 76 |
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 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 significant portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Under ASC 606, 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. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company elected to exclude taxes assessed by a governmental authority on revenue-producing transactions from the transaction price. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and certain customers that purchase stocking orders in the United States, 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 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. |
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 The Company adopted ASU No. 2016-02, Leases Leases For its long-term operating lease, 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. Rent expense 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. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. The Company is authorized to make matching contributions. During 2020, the Company made matching contributions up to $3,000 of an employee’s eligible deferred compensation. The Company recognized expense related to its contributions to the plan of $1.1 million for the year-ended December 31, 2020. The Company did not make such contributions for the year ended December 31, 2019 or 2018. |
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 gains of $261,000 and $56,000 for the years ended December 31, 2020 and 2019, respectively. In December 31, 2018, there were net foreign currency transaction losses of |
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. The unvested portion of early exercised stock options are excluded from the computation of weighted-average shares as the continuing vesting of such shares is contingent on the holders’ continued service to the Company. 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. |
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 all held in the United States with the exception of certain equipment on loan to customers held internationally, which was not material for the years-ended December 31, 2020 and 2019. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . In addition, Topic 326 also provides new guidance related to the measurement of expected credit losses on the Company’s allowance for bad debt for accounts receivable, which is estimated upon assessment of various factors including historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of the Company’s customers. As of March 31, 2020, the Company considered the current and expected future economic and market conditions surrounding the COVID-19 pandemic and increased the overall reserve for credit losses by $0.2 million in response to an assessment of the evolving credit environment under the COVID-19 pandemic. The Company continued to monitor our customer collections and credit risk, however, no additional material changes to the allowance for doubtful accounts, subsequent to March 31, 2020, were recorded for the year-ended December 31, 2020. |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted In November 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 December 31, 2019 (in thousands) Cash and cash equivalents $ 50,423 $ 139,045 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 51,873 $ 140,495 |
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, 2020 2019 2018 (in thousands) Beginning balance $ 194 $ 76 $ — Amounts charged to costs and expenses 205 121 77 Write-offs (19 ) (3 ) (1 ) Ending balance $ 380 $ 194 $ 76 |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 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 December 31, 2019 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 43,245 $ — $ — $ 43,245 Money market funds 29,386 — — 29,386 Reverse repurchase agreements — 10,000 — $ 10,000 Commercial paper — 6,958 — $ 6,958 Corporate bonds — 8,096 — $ 8,096 Total assets $ 72,631 $ 25,054 $ — $ 97,685 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 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 December 31, 2019 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 43,219 $ 27 $ (1 ) $ 43,245 Money market funds 29,386 — — 29,386 Reverse repurchase agreements 10,000 — — 10,000 Commercial paper 6,958 — — 6,958 Corporate bonds 8,087 9 — 8,096 Total $ 97,650 $ 36 $ (1 ) $ 97,685 Reported as: Cash equivalents $ 41,381 Short-term investments 56,304 Total $ 97,685 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consists of the following: December 31, 2020 2019 (in thousands) Raw material $ 4,995 $ 2,501 Work in progress 6,051 1,364 Finished goods 16,952 6,642 Consigned inventory 1,861 1,567 Total inventory $ 29,859 $ 12,074 |
Schedule of Property and Equipment | Property and equipment, net consists of the following: December 31, 2020 2019 (in thousands) Equipment $ 3,794 $ 3,759 Equipment on loan to customers 1,756 1,495 Office furniture 157 76 Software 175 97 Leasehold improvements 5,808 1,329 Construction in progress 7,800 553 Property and equipment, gross 19,490 7,309 Less accumulated depreciation and amortization (3,128 ) (2,399 ) Total property and equipment, net $ 16,362 $ 4,910 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: December 31, 2020 2019 (in thousands) Accrued employee compensation $ 10,885 $ 8,139 Accrued research and development costs 3,057 3,090 Accrued asset purchases 2,527 — Accrued professional services 1,325 804 Other 2,148 1,744 Total accrued liabilities $ 19,942 $ 13,777 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Minimum Future Rental Payments | The following are minimum future rental payments owed under these agreements which have commenced as of December 31, 2020: (in thousands) 2021 $ 1,946 2022 2,123 2023 1,529 2024 1,546 2025 1,594 Thereafter 3,232 Total minimum lease payments $ 11,970 Less: imputed interest (3,609 ) Total lease liability $ 8,361 |
Schedule of Minimum Future Rental Payments Not Yet Commenced | The following are minimum future rental payments owed for the modified 5403 Betsy Ross Lease which has not yet commenced as of December 31, 2020: (in thousands) 2021 $ — 2022 345 2023 1,044 2024 1,078 2025 1,112 Thereafter 2,253 Total minimum lease payments $ 5,832 |
Term Notes (Tables)
Term Notes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long Term Debt and Net Premium Balance | Long-term debt and net premium balances are as follows: December 31, 2020 2019 (in thousands) Principal amount of term note $ 16,500 $ 13,334 Net premium associated with accretion of final payment and other debt issuance costs 119 485 Term note, current and noncurrent 16,619 13,819 Less term note, current portion (3,300 ) (6,667 ) Term note, noncurrent portion $ 13,319 $ 7,152 |
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, 2020 are as follows: Year ending December 31: (in thousands) 2021 $ 3,861 2022 6,961 2023 8,294 Total future payments 19,116 Less amounts representing interest (1,048 ) 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, 2020 | |
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, 2020 2019 2018 (in thousands) Cost of product revenue $ 496 $ 268 $ 67 Research and development 2,464 943 235 Sales and marketing 3,478 972 294 General and administrative 3,912 1,463 701 Total stock-based compensation $ 10,350 $ 3,646 $ 1,297 |
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 2018 Expected term (in years) 6.08 6.08 Expected volatility 42.4%-42.9% 40.8%-41.9% Risk-free interest rate 2.4%-2.6% 2.5%-3.1% Expected dividend yield 0% 0% |
Schedule of Option Activity under 2009 Plan and 2019 Plan | Stock Options Activity under the 2009 Plan and 2019 Plan is set forth below: |
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 |
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 $786,000 and $255,000 of stock-based compensation expense related to the ESPP for the years ended December 31, 2020 and 2019, respectively. Year Ended December 31, Year Ended December 31, 2020 2019 Expected term (in years) 0.5 0.5 Expected volatility 44.31%-74.03% 76.93% Risk-free interest rate 0.12%-0.3% 1.89% Expected dividend yield 0% 0% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 2018 (in thousands) Domestic $ (65,957 ) $ (51,179 ) $ (41,145 ) Foreign 338 132 81 Total loss before income taxes $ (65,619 ) $ (51,047 ) $ (41,064 ) |
Schedule of Current Income Tax Provision | Current income tax provision consists of the following: December 31, 2020 2019 2018 (in thousands) Domestic $ 3 $ — $ 3 Foreign 77 62 35 Total current income tax provision $ 80 $ 62 $ 38 |
Components of Deferred Tax Assets | The components of the deferred tax assets are as follows: December 31, 2020 2019 (in thousands) Deferred tax assets: Net operating loss carryovers $ 73,453 $ 49,862 Fixed and intangible assets 718 450 Accruals and reserves 2,245 1,619 Stock-based compensation 2,060 780 Research and development credits 3,379 2,336 Contributions 42 20 Lease liability 2,004 2,135 Total deferred tax assets 83,901 57,202 Less valuation allowance (82,087 ) (55,085 ) Gross deferred tax assets 1,814 2,117 Deferred tax liabilities: Right-of-use-assets (1,814 ) (2,117 ) Gross deferred tax liabilities (1,814 ) (2,117 ) 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, 2020 2019 2018 (in thousands) Income tax benefit at federal statutory rate $ (13,780 ) $ (10,720 ) $ (8,624 ) State and local income taxes net of federal tax benefit (9 ) (9 ) 3 Foreign tax rate differential 6 35 11 Change in valuation allowance 27,990 14,470 8,497 Stock-based compensation (13,425 ) (3,403 ) 123 R&D tax credits (611 ) (354 ) (313 ) Other (91 ) 43 341 Total current income tax provision $ 80 $ 62 $ 38 |
Schedule of Unrecognized Tax Benefits | The activity related to the gross amount of unrecognized tax benefits is as follows: December 31, 2020 2019 2018 (in thousands) Beginning balance $ 2,586 $ 1,896 $ 893 Additions (Reductions) based on tax positions related to prior years (3 ) — 394 Additions based on tax positions related to current years 1,163 690 609 Balance at end of year $ 3,746 $ 2,586 $ 1,896 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
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, 2020 2019 2018 (in thousands) Convertible preferred stock on an as-converted basis — — 18,670,328 Common stock options issued and outstanding 2,087,202 3,315,001 3,636,358 Restricted stock units 859,577 280,904 — Employee stock purchase plan 15,251 16,420 — Early exercised options subject to future vesting — — 13,422 Convertible preferred stock warrants — — 54,903 Common stock warrants — — 176,218 Total 2,962,030 3,612,325 22,551,229 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disaggregation Of Revenue [Abstract] | |
Schedule of Product Revenue Based on Product Line and Location | Disaggregation of revenue The following table represents the Company’s product revenue based on product line: Year Ended December 31, 2020 2019 2018 (in thousands) Peripheral $ 41,994 $ 26,325 $ 8,828 Coronary 24,586 15,621 3,210 Other 1,209 981 225 Product revenue $ 67,789 $ 42,927 $ 12,263 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, 2020 2019 2018 (in thousands) United States $ 37,121 $ 22,699 $ 7,022 Germany 4,314 3,402 1,393 Rest of Europe 19,142 14,097 3,516 All other countries 7,212 2,729 332 Product revenue $ 67,789 $ 42,927 $ 12,263 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Thousands | Jun. 19, 2020USD ($)$ / sharesshares | Nov. 15, 2019USD ($)$ / sharesshares | Mar. 11, 2019USD ($)$ / sharesshares | Apr. 30, 2019shares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | Mar. 05, 2019shares |
Organization and Basis of Presentation [Line Items] | |||||||
Entity incorporation, date of incorporation | Jun. 17, 2009 | ||||||
Common stock, conversion basis | one-to-one basis | ||||||
Proceeds from issuance of common stock in public offering, net of issuance costs paid | $ | $ 83,368 | $ 96,856 | |||||
Cash, cash equivalents and short-term investments | $ | $ 202,400 | ||||||
Common Stock | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Proceeds from initial public offering | $ | $ 99,900 | ||||||
Issuance of common stock upon net exercise of warrants, shares | 101,744 | 29,887 | 180,952 | ||||
Net proceeds from issuance on follow-on offering | $ | $ 83,400 | $ 96,700 | |||||
Warrants | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Convertible preferred stock, shares issued upon conversion | 54,903 | ||||||
Initial Public Offering | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 6,555,000 | ||||||
Common stock, offering price per share | $ / shares | $ 17 | ||||||
Stock split, conversion ratio | 1 | ||||||
Initial Public Offering | Common Stock | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 6,555,000 | ||||||
Convertible preferred stock, shares issued upon conversion | 18,670,259 | ||||||
Over-Allotment Option | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 855,000 | ||||||
Over-Allotment Option | Common Stock | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 1,955,000 | 2,854,048 | |||||
Private Placement | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 588,235 | ||||||
Proceeds from issuance of common stock in public offering, net of issuance costs paid | $ | $ 10,000 | ||||||
Underwritten Public Offering | Common Stock | |||||||
Organization and Basis of Presentation [Line Items] | |||||||
Common stock issued | 1,955,000 | 2,854,048 | |||||
Common stock, offering price per share | $ / shares | $ 45.75 | $ 36.25 | |||||
Shares sold to underwriters option to purchase additional shares | 255,000 | 372,267 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 50,423 | $ 139,045 | ||
Restricted cash | 1,450 | 1,450 | ||
Total cash, cash equivalents, and restricted cash | $ 51,873 | $ 140,495 | $ 40,093 | $ 51,923 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2020USD ($)CustomerSegment | Dec. 31, 2019USD ($)Customer | Dec. 31, 2018USD ($) | Mar. 31, 2020USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Notice period for cancellation of agreement | 30 days | |||
Defined contribution plan, maximum amount of matching contributions amount | $ 3,000 | |||
Defined contribution plan, contribution amount | 1,100,000 | $ 0 | $ 0 | |
Foreign currency transaction realized and unrealized gain (loss) | $ 261,000 | $ 56,000 | $ (46,000) | |
Number of Operating Segments | Segment | 1 | |||
Reserve for credit losses | $ 200,000 | |||
ASU 2016-13 | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Change in accounting principle, accounting standards update, adopted [true false] | true | |||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | |||
Change in accounting principle accounting standards update immaterial effect [true false] | true | |||
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 | 1 | 1 | ||
Customer | Revenue Benchmark | Customer One | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 10.00% | 10.00% | 10.00% | |
Credit Concentration Risk | Accounts Receivable | Customer One | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 15.00% | 11.00% |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |||
Beginning balance | $ 194 | $ 76 | |
Amounts charged to costs and expenses | 205 | 121 | $ 77 |
Write-offs | (19) | (3) | (1) |
Ending balance | $ 380 | $ 194 | $ 76 |
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, 2020 | Dec. 31, 2019 |
Assets: | ||
Total assets | $ 193,384 | $ 97,685 |
Level 1 | ||
Assets: | ||
Total assets | 161,416 | 72,631 |
Level 2 | ||
Assets: | ||
Total assets | 31,968 | 25,054 |
U.S. Treasury securities | ||
Assets: | ||
Total assets | 126,363 | 43,245 |
U.S. Treasury securities | Level 1 | ||
Assets: | ||
Total assets | 126,363 | 43,245 |
Money Market Funds | ||
Assets: | ||
Total assets | 35,053 | 29,386 |
Money Market Funds | Level 1 | ||
Assets: | ||
Total assets | 35,053 | 29,386 |
Reverse Repurchase Agreements | ||
Assets: | ||
Total assets | 10,000 | |
Reverse Repurchase Agreements | Level 2 | ||
Assets: | ||
Total assets | 10,000 | |
Commercial Paper | ||
Assets: | ||
Total assets | 31,968 | 6,958 |
Commercial Paper | Level 2 | ||
Assets: | ||
Total assets | $ 31,968 | 6,958 |
Corporate Bonds | ||
Assets: | ||
Total assets | 8,096 | |
Corporate Bonds | Level 2 | ||
Assets: | ||
Total assets | $ 8,096 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Cash And Cash Equivalents [Line Items] | |
Realized gains on cash equivalents and short-term investments | $ 21,000 |
Maximum | |
Cash And Cash Equivalents [Line Items] | |
Available for sale securities remaining contractual maturities | 1 year |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Summary of Cash Equivalents and Short-Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents, Fair Value | $ 41,453 | $ 41,381 |
Cash equivalents and short-term investments, Amortized Cost Basis | 193,375 | 97,650 |
Cash equivalents and short-term investments, Unrealized Gains | 11 | 36 |
Cash equivalents and short-term investments, Unrealized losses | (2) | (1) |
Cash equivalents and short-term investments, Fair Value | 193,384 | 97,685 |
Short-term investments | 151,931 | 56,304 |
U.S. Treasury securities | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 126,354 | 43,219 |
Short-term investments Unrealized Gains | 11 | 27 |
Short-term investments Unrealized Losses | (2) | (1) |
Short-term investments, Fair Value | 126,363 | 43,245 |
Commercial Paper | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 31,968 | 6,958 |
Short-term investments, Fair Value | 31,968 | 6,958 |
Reverse Repurchase Agreements | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 10,000 | |
Short-term investments, Fair Value | 10,000 | |
Corporate Bonds | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 8,087 | |
Short-term investments Unrealized Gains | 9 | |
Short-term investments, Fair Value | 8,096 | |
Money Market Funds | ||
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents Amortized Cost Basis | 35,053 | 29,386 |
Cash equivalents, Fair Value | $ 35,053 | $ 29,386 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 4,995 | $ 2,501 |
Work in progress | 6,051 | 1,364 |
Finished goods | 16,952 | 6,642 |
Consigned inventory | 1,861 | 1,567 |
Total inventory | $ 29,859 | $ 12,074 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 19,490 | $ 7,309 |
Less accumulated depreciation and amortization | (3,128) | (2,399) |
Total property and equipment, net | 16,362 | 4,910 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,794 | 3,759 |
Equipment Loan To Customer | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,756 | 1,495 |
Office Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 157 | 76 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 175 | 97 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,808 | 1,329 |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 7,800 | $ 553 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |||
Depreciation and amortization expense | $ 1,863 | $ 1,337 | $ 700 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued employee compensation | $ 10,885 | $ 8,139 |
Accrued research and development costs | 3,057 | 3,090 |
Accrued asset purchases | 2,527 | |
Accrued professional services | 1,325 | 804 |
Other | 2,148 | 1,744 |
Total accrued liabilities | $ 19,942 | $ 13,777 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2019USD ($)ft² | May 31, 2018ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)ft² | Dec. 31, 2018USD ($) | Sep. 01, 2022USD ($) | |
Loss Contingencies [Line Items] | ||||||
Operating lease right-of-use asset | $ 8,825 | $ 7,568 | $ 8,825 | |||
Operating lease liabilities | 8,361 | |||||
Operating lease cost | 2,200 | $ 1,200 | ||||
Rent expense | $ 900 | |||||
Germany | ||||||
Loss Contingencies [Line Items] | ||||||
Operating lease right-of-use asset | 200 | |||||
Operating lease liabilities | $ 200 | |||||
Operating lease, weighted average remaining lease term | 2 years 4 months | |||||
Operating lease liability, weighted average incremental borrowing rate | 6.98% | |||||
5403 Lease | Santa Clara, California | ||||||
Loss Contingencies [Line Items] | ||||||
Area of office and laboratory space | ft² | 35,000 | |||||
Lease term expiration date | Aug. 31, 2022 | |||||
Lease commencement date | 2018-09 | |||||
Letter of credit secured by restricted cash | $ 500 | |||||
Operating lease right-of-use asset | 1,300 | |||||
Operating lease liabilities | $ 1,400 | |||||
Operating lease, remaining lease term | 1 year 8 months | |||||
5353 Lease | Santa Clara, California | ||||||
Loss Contingencies [Line Items] | ||||||
Area of office and laboratory space | ft² | 50,200 | 50,200 | ||||
Lease term expiration date | Aug. 31, 2022 | |||||
Lease commencement date | 2019-12 | |||||
Operating lease right-of-use asset | $ 6,100 | |||||
Operating lease liabilities | $ 6,800 | |||||
Operating lease, remaining lease term | 6 years 11 months | |||||
Initial term of first building | 96 months | 96 months | ||||
Lessee, Operating Lease, Existence of Option to Extend | true | |||||
Lease rent abatement term for first building | 19 months | |||||
Lease rent abatement term for second floor | 4 months | |||||
5353 Lease | Santa Clara, California | Initial Security Deposit | ||||||
Loss Contingencies [Line Items] | ||||||
Letter of credit secured by restricted cash | $ 1,000 | $ 1,000 | ||||
5353 Lease | Santa Clara, California | Scenario Forecast | ||||||
Loss Contingencies [Line Items] | ||||||
Letter of credit secured by restricted cash | $ 1,500 | |||||
5403 and 5353 Lease | Santa Clara, California | ||||||
Loss Contingencies [Line Items] | ||||||
Option to extend term on one or both buildings | 5 years | 5 years | ||||
5403 and 5353 Lease | Santa Clara, California | Maximum | ||||||
Loss Contingencies [Line Items] | ||||||
Tenant improvements allowance | $ 1,800 | $ 1,800 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Minimum Future Rental Payments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
2021 | $ 1,946 |
2022 | 2,123 |
2023 | 1,529 |
2024 | 1,546 |
2025 | 1,594 |
Thereafter | 3,232 |
Total minimum lease payments | 11,970 |
Less: imputed interest | (3,609) |
Total lease liability | $ 8,361 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Minimum Future Rental Payments Not Yet Commenced (Details) - 5403 Betsy Ross Lease $ in Thousands | Dec. 31, 2020USD ($) |
Lessee, Operating Lease, Not yet Commenced, Description [Abstract] | |
2022 | $ 345 |
2023 | 1,044 |
2024 | 1,078 |
2025 | 1,112 |
Thereafter | 2,253 |
Total minimum lease payments | $ 5,832 |
Term Notes - Additional Informa
Term Notes - Additional Information (Details) - USD ($) | Feb. 29, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Feb. 28, 2018 |
Debt Instrument [Line Items] | ||||||
Debt Amount | $ 16,500,000 | $ 13,334,000 | ||||
Debt, final payment amount | 1,568,000 | |||||
Interest expense | $ 1,212,000 | 944,000 | $ 401,000 | |||
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 which will end on (a) June 30, 2021, if the Company’s revenue for the trailing 12-month period ended June 30, 2021 is not at least 75% of the Company’s projections; (b) December 31, 2021, if the Company achieves the financial performance target referred to in clause (a), but does not obtain premarket approval of the Company’s C2 catheters from the FDA by such date and/or the Company’s trailing 12-month revenue for the period ending December 31, 2021 is not at least 75% of the Company’s projections; or (c) June 30, 2022, if the Company achieves the milestones referred to in clauses (a) and (b). | |||||
Interest expense | $ 600,000 | 500,000 | 200,000 | |||
Amortization of debt discount | $ 600,000 | $ 400,000 | 200,000 | |||
Loan and Security Agreement | Interest Payment End On June 30, 2021 | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument percentage of projected revenue to be achieved | 75.00% | |||||
Loan and Security Agreement | Interest Payment End On December 31, 2021 | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument percentage of projected financial performance target | 75.00% | |||||
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 | Short Term Notes | Tranche One | ||||||
Debt Instrument [Line Items] | ||||||
Debt Amount | $ 10,000,000 | |||||
Loan and Security Agreement | Silicon Valley Bank | Short Term Notes | Tranche Two | ||||||
Debt Instrument [Line Items] | ||||||
Debt Amount | $ 5,000,000 | |||||
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, 2020 | Dec. 31, 2019 |
Debt Instrument Periodic Payment [Abstract] | ||
Principal amount of term note | $ 16,500 | $ 13,334 |
Net premium associated with accretion of final payment and other debt issuance costs | 119 | 485 |
Term note, current and noncurrent | 16,619 | 13,819 |
Less term note, current portion | (3,300) | (6,667) |
Term note, noncurrent portion | $ 13,319 | $ 7,152 |
Term Notes - Schedule of Future
Term Notes - Schedule of Future Minimum and Estimated Payments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Disclosure [Abstract] | ||
2021 | $ 3,861 | |
2022 | 6,961 | |
2023 | 8,294 | |
Total future payments | 19,116 | |
Less amounts representing interest | (1,048) | |
Less final payment | (1,568) | |
Total principal amount of term note payments | $ 16,500 | $ 13,334 |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 11, 2019 | Mar. 06, 2019 | Mar. 05, 2019 | Apr. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 |
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||||
Preferred stock, shares issued | 0 | 0 | ||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||
Preferred Stock Warrants | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Debt, warrants issued | 0 | 0 | ||||||
Common Stock Warrants | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Debt, warrants issued | 0 | 0 | ||||||
Initial Public Offering | Common Stock Warrants Related to Convertible Preferred Stock Warrants | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Common stock warrant issued | 54,903 | |||||||
Adjustments to additional paid in capital | $ 0.8 | |||||||
Issuance of common stock upon net exercise of warrants, Shares | 49,321 | |||||||
Initial Public Offering | Related Party Common Stock Warrants | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Common stock warrants exercised | 91,446 | |||||||
Warrants exercised price | $ 17 | |||||||
Common stock issued upon exercise of common stock warrants | 79,632 | |||||||
Convertible Preferred Stock | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Convertible preferred stock, shares outstanding | 18,670,259 | 18,670,328 | 17,510,045 | |||||
Common Stock | ||||||||
Temporary Equity And Stockholders Equity [Line Items] | ||||||||
Conversion of stock, common stock issued | 18,670,259 | |||||||
Issuance of common stock upon net exercise of warrants, Shares | 101,744 | 29,887 | 180,952 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 10,350 | $ 3,646 | $ 1,297 |
Cost of Product Revenue | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 496 | 268 | 67 |
Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 2,464 | 943 | 235 |
Sales and Marketing | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 3,478 | 972 | 294 |
General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 3,912 | $ 1,463 | $ 701 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | Jun. 17, 2009 | Feb. 28, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 06, 2019 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share-based compensation expenses capitalized amount | $ 316,000 | $ 0 | $ 0 | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |||
Options granted | 0 | 442,858 | 1,015,963 | |||
Weighted-average grant date fair value of options granted | $ 6.58 | $ 2.56 | ||||
Grant date fair value of options vested | $ 2,300,000 | $ 1,900,000 | $ 1,600,000 | |||
Unvested stock options | $ 2,500,000 | |||||
Unvested stock options, remaining weighted-average period | 1 year 3 months 18 days | |||||
Stock-based compensation | $ 10,350,000 | 3,646,000 | $ 1,297,000 | |||
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 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 | 3 years 1 month 6 days | |||||
Grant date fair value of RSU vested | $ 2,700,000 | $ 100,000 | ||||
Number of Shares, RSUs granted | 687,223 | 288,170 | 0 | |||
Unrecognized stock-based compensation | $ 35,300,000 | |||||
2019 Stock Option and Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock reserved for issuance | 2,000,430 | 2,689,624 | ||||
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 | |||||
2009 Equity Incentive Plan and 2019 Stock Option and Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of stock owned by individual | 10.00% | |||||
Vesting period | 4 years | |||||
Cliff vesting, percentage | 25.00% | |||||
Share-based compensation vesting rights, terms | If an individual owns stock representing 10% or more of the outstanding shares, the price of each share shall be at least 110% of the fair market value, as determined by the Board. Options granted under the Plan have a term of up to 10 years and generally vest over a 4 year period with a straight-line vesting and a 25% one year cliff. | |||||
2009 Equity Incentive Plan and 2019 Stock Option and Incentive Plan | Minimum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Price of stock as percentage of fair value | 110.00% | |||||
2009 Equity Incentive Plan and 2019 Stock Option and Incentive Plan | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Options granted term | 10 years | |||||
2019 Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Expected dividend yield | 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 | $ 786,000 | $ 255,000 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | |
Expected volatility, minimum | 42.40% | 40.80% | |
Expected volatility, maximum | 42.90% | 41.90% | |
Risk-free interest rate, minimum | 2.40% | 2.50% | |
Risk-free interest rate, maximum | 2.60% | 3.10% | |
Expected dividend yield | 0.00% | 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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Shares Available for Grant | ||||
Shares Available for Grant, Beginning balance | 1,704,244 | 392,299 | 426,370 | |
Shares Available for Grant, Awards authorized | 943,345 | 2,000,430 | 691,503 | |
Shares Available for Grant, Options expired | (287,600) | |||
Shares Available for Grant, Options granted | (442,858) | (1,015,963) | ||
Shares Available for Grant, Options cancelled | 42,035 | 41,973 | 290,389 | |
Shares Available for Grant, Ending balance | 2,689,624 | 1,704,244 | 392,299 | 426,370 |
Number of Shares | ||||
Number of Shares, Beginning balance | 3,315,001 | 3,636,358 | 3,108,604 | |
Number of Shares, Options granted | 0 | 442,858 | 1,015,963 | |
Number of Shares, Options exercised | (1,185,764) | (722,242) | (197,820) | |
Number of Shares, Options cancelled | (42,035) | (41,973) | (290,389) | |
Number of Shares, Ending balance | 2,087,202 | 3,315,001 | 3,636,358 | 3,108,604 |
Number of Shares, Vested and exercisable | 1,360,650 | |||
Number of Shares, Vested and expected to vest | 2,087,202 | |||
Weighted-Average Exercise Price Per Share | ||||
Weighted-Average Exercise Price Per Share, Beginning balance | $ 5.08 | $ 3.54 | $ 2.81 | |
Weighted-Average Exercise Price Per Share, Options granted | 14.69 | 5.25 | ||
Weighted-Average Exercise Price Per Share, Options exercised | 3.64 | 3.10 | 2.20 | |
Weighted-Average Exercise Price Per Share, Options cancelled | 4.45 | 3.85 | 3.42 | |
Weighted-Average Exercise Price Per Share, Ending balance | 5.92 | $ 5.08 | $ 3.54 | $ 2.81 |
Weighted-Average Exercise Price Per Share, Vested and exercisable | 4.63 | |||
Weighted-Average Exercise Price Per Share, Vested and expected to vest | $ 5.92 | |||
Weighted-Average Remaining Term | ||||
Weighted-Average Remaining Term (in years), Balance | 6 years 9 months 7 days | 7 years 3 months 10 days | 7 years 9 months 14 days | 8 years 10 days |
Weighted-Average Remaining Term, Vested and exercisable | 6 years 4 months 9 days | |||
Weighted-Average Remaining Term, Vested and expected to vest | 6 years 9 months 7 days | |||
Aggregate Intrinsic Value | ||||
Aggregate Intrinsic Value, Balance | $ 204,137 | $ 128,744 | $ 11,267 | $ 3,647 |
Aggregate Intrinsic Value, Vested and exercisable | 134,825 | |||
Aggregate Intrinsic Value, Vested and expected to vest | $ 204,137 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of RSU Activity under 2019 Plan (Detail) - Restricted Stock Units - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | |||
Number of Shares, Beginning balance | 280,904 | ||
Number of Shares, RSUs granted | 687,223 | 288,170 | 0 |
Number of Shares, RSUs forfeited | (38,650) | (5,600) | |
Number of Shares, RSUs vested | (69,900) | (1,666) | |
Number of Shares, Ending balance | 859,577 | 280,904 | |
Weighted-Average Grant Date Fair Value Per Share | |||
Weighted-Average Grant Date Fair Value Per Share, Beginning balance | $ 38.12 | ||
Weighted-Average Grant Date Fair Value Per Share, RSUs granted | 51.34 | $ 38.28 | |
Weighted-Average Grant Date Fair Value Per Share, RSUs forfeited | 41.55 | 40.01 | |
Weighted-Average Grant Date Fair Value Per Share, RSUs vested | 38.46 | 59.79 | |
Weighted-Average Grant Date Fair Value Per Share, Ending balance | $ 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 (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | |
Expected volatility, minimum | 42.40% | 40.80% | |
Expected volatility, maximum | 42.90% | 41.90% | |
Risk-free interest rate, minimum | 2.40% | 2.50% | |
Risk-free interest rate, maximum | 2.60% | 3.10% | |
Expected dividend yield | 0.00% | 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 | |
Expected volatility, minimum | 44.31% | ||
Expected volatility | 76.93% | ||
Expected volatility, maximum | 74.03% | ||
Risk-free interest rate, minimum | 0.12% | ||
Risk-free interest rate | 1.89% | ||
Risk-free interest rate, maximum | 0.30% | ||
Expected dividend yield | 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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (65,957) | $ (51,179) | $ (41,145) |
Foreign | 338 | 132 | 81 |
Total loss before income taxes | $ (65,619) | $ (51,047) | $ (41,064) |
Income Taxes - Schedule of Curr
Income Taxes - Schedule of Current Income Tax Provision (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | $ 80 | $ 62 | $ 38 |
Domestic Federal | |||
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | 3 | 3 | |
Foreign Tax Authority | |||
Income Taxes Disclosure [Line Items] | |||
Total current income tax provision | $ 77 | $ 62 | $ 35 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets | ||
Net operating loss carryovers | $ 73,453 | $ 49,862 |
Fixed and intangible assets | 718 | 450 |
Accruals and reserves | 2,245 | 1,619 |
Stock-based compensation | 2,060 | 780 |
Research and development credits | 3,379 | 2,336 |
Contributions | 42 | 20 |
Lease liability | 2,004 | 2,135 |
Total deferred tax assets | 83,901 | 57,202 |
Less valuation allowance | (82,087) | (55,085) |
Gross deferred tax assets | 1,814 | 2,117 |
Deferred tax liabilities: | ||
Right-of-use-assets | (1,814) | (2,117) |
Gross deferred tax liabilities | $ (1,814) | $ (2,117) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation | |||
Income tax benefit at federal statutory rate | $ (13,780) | $ (10,720) | $ (8,624) |
State and local income taxes net of federal tax benefit | (9) | (9) | 3 |
Foreign tax rate differential | 6 | 35 | 11 |
Change in valuation allowance | 27,990 | 14,470 | 8,497 |
Stock-based compensation | (13,425) | (3,403) | 123 |
R&D tax credits | (611) | (354) | (313) |
Other | (91) | 43 | 341 |
Total current income tax provision | $ 80 | $ 62 | $ 38 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes Disclosure [Line Items] | |||
Increase in valuation allowance | $ 27 | $ 22.8 | $ 10 |
Domestic Federal | |||
Income Taxes Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 301.9 | ||
Net operating loss carryforwards | 2030 | ||
Net operating loss carryforwards subject to expiration in 2031 | 80.8 | ||
Net operating loss carryforwards never expire | $ 221.1 | ||
Research and development credit carryforwards, california | $ 4 | ||
California | State and Local Jurisdiction | |||
Income Taxes Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 52.4 | ||
Net operating loss carryforwards | 2031 | ||
Research and development credit carryforwards, california | $ 3.5 | ||
All Other States | State and Local Jurisdiction | |||
Income Taxes Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 123.7 | ||
Net operating loss carryforwards | 2029 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Unrecognized tax benefits [Abstract] | |||
Beginning balance | $ 2,586 | $ 1,896 | $ 893 |
Reductions based on tax positions related to prior years | (3) | ||
Additions based on tax positions related to prior years | 394 | ||
Additions based on tax positions related to current years | 1,163 | 690 | 609 |
Balance at end of year | $ 3,746 | $ 2,586 | $ 1,896 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 2,962,030 | 3,612,325 | 22,551,229 |
Convertible Preferred Stock | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 18,670,328 | ||
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 | 2,087,202 | 3,315,001 | 3,636,358 |
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 | 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 | 15,251 | 16,420 | |
Early Exercised Options Subject to Future Vesting | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 13,422 | ||
Convertible Preferred Stock Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 54,903 | ||
Common Stock Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 176,218 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 67,789 | $ 42,927 | $ 12,263 |
United States | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 37,121 | 22,699 | 7,022 |
Germany | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 4,314 | 3,402 | 1,393 |
Rest of Europe | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 19,142 | 14,097 | 3,516 |
All Other Countries | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 7,212 | 2,729 | 332 |
Peripheral | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 41,994 | 26,325 | 8,828 |
Coronary | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | 24,586 | 15,621 | 3,210 |
Other | |||
Disaggregation Of Revenue [Line Items] | |||
Product revenue | $ 1,209 | $ 981 | $ 225 |