Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | SWAV | |
Entity Registrant Name | Shockwave Medical, Inc. | |
Entity Central Index Key | 0001642545 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 35,304,469 | |
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 Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Shockwave Medical, Inc., common stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 91,195 | $ 50,423 |
Short-term investments | 91,759 | 151,931 |
Accounts receivable, net | 29,966 | 11,689 |
Inventory | 38,744 | 29,859 |
Prepaid expenses and other current assets | 4,364 | 2,398 |
Total current assets | 256,028 | 246,300 |
Operating lease right-of-use assets | 11,790 | 7,568 |
Property and equipment, net | 23,085 | 16,362 |
Equity method investment | 6,408 | |
Other assets | 1,684 | 1,812 |
TOTAL ASSETS | 298,995 | 272,042 |
CURRENT LIABILITIES: | ||
Accounts payable | 3,632 | 1,466 |
Term notes, current portion | 2,750 | 3,300 |
Accrued liabilities | 33,017 | 19,942 |
Lease liability, current portion | 867 | 873 |
Total current liabilities | 40,266 | 25,581 |
Lease liability, noncurrent portion | 11,939 | 7,488 |
Term notes, noncurrent portion | 14,226 | 13,319 |
Related party contract liability, noncurrent portion | 12,273 | |
TOTAL LIABILITIES | 78,704 | 46,388 |
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | ||
Common stock | 35 | 35 |
Additional paid-in capital | 486,014 | 469,283 |
Accumulated other comprehensive income (loss) | (7) | 9 |
Accumulated deficit | (265,751) | (243,673) |
TOTAL STOCKHOLDERS’ EQUITY | 220,291 | 225,654 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 298,995 | $ 272,042 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Product revenue | $ 65,155 | $ 19,590 | $ 152,963 | $ 45,073 |
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Cost of revenue: | ||||
Cost of product revenue | $ 10,949 | $ 5,277 | $ 28,775 | $ 14,520 |
Type of Cost, Good Or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Gross profit | $ 54,206 | $ 14,313 | $ 124,188 | $ 30,553 |
Operating expenses: | ||||
Research and development | 13,735 | 7,891 | 35,827 | 27,882 |
Sales and marketing | 28,393 | 13,619 | 78,098 | 35,236 |
General and administrative | 9,265 | 5,610 | 25,117 | 17,232 |
Total operating expenses | 51,393 | 27,120 | 139,042 | 80,350 |
Income (loss) from operations | 2,813 | (12,807) | (14,854) | (49,797) |
Share in net loss of equity method investment | (342) | (5,865) | ||
Interest expense | (165) | (314) | (795) | (897) |
Other income (expense), net | (280) | 218 | (369) | 942 |
Net income (loss) before taxes | 2,026 | (12,903) | (21,883) | (49,752) |
Income tax provision | 78 | 29 | 195 | 73 |
Net income (loss) | 1,948 | (12,932) | (22,078) | (49,825) |
Other comprehensive income (loss): | ||||
Unrealized gain/(loss) on available-for-sale securities | (17) | (16) | (14) | |
Adjustment for net gain realized and included in other income, net | (21) | (21) | ||
Total other comprehensive income (loss) | (17) | (21) | (16) | (35) |
Total comprehensive income (loss) | $ 1,931 | $ (12,953) | $ (22,094) | $ (49,860) |
Net income (loss) per share | ||||
Basic | $ 0.06 | $ (0.38) | $ (0.63) | $ (1.53) |
Diluted | $ 0.05 | $ (0.38) | $ (0.63) | $ (1.53) |
Shares used in computing net income (loss) per share | ||||
Basic | 35,207,276 | 34,078,726 | 35,013,072 | 32,631,715 |
Diluted | 37,567,176 | 34,078,726 | 35,013,072 | 32,631,715 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Public Offering | Common Stock | Common StockPublic Offering | Additional Paid-In Capital | Additional Paid-In CapitalPublic Offering | Accumulated Other Comprehensive Income | Accumulated Deficit |
Beginning balance at Dec. 31, 2019 | $ 192,653 | $ 31 | $ 370,561 | $ 35 | $ (177,974) | |||
Beginning balance, Shares at Dec. 31, 2019 | 31,446,787 | |||||||
Exercise of stock options | 1,113 | $ 1 | 1,112 | |||||
Exercise of stock options, Shares | 356,128 | |||||||
Unrealized gain (loss) on available-for- sale securities | 68 | 68 | ||||||
Issuance of common stock under employee stock purchase plan | 842 | 842 | ||||||
Issuance of common stock under employee stock purchase plan, Share | 24,691 | |||||||
Stock-based compensation | 1,871 | 1,871 | ||||||
Net income (loss) | (18,775) | (18,775) | ||||||
Ending balance at Mar. 31, 2020 | 177,772 | $ 32 | 374,386 | 103 | (196,749) | |||
Ending balance, shares at Mar. 31, 2020 | 31,827,606 | |||||||
Beginning balance at Dec. 31, 2019 | 192,653 | $ 31 | 370,561 | 35 | (177,974) | |||
Beginning balance, Shares at Dec. 31, 2019 | 31,446,787 | |||||||
Net gain reclassified from accumulated other comprehensive income | (21) | |||||||
Net income (loss) | (49,825) | |||||||
Ending balance at Sep. 30, 2020 | 237,047 | $ 34 | 464,812 | (227,799) | ||||
Ending balance, shares at Sep. 30, 2020 | 34,236,165 | |||||||
Beginning balance at Mar. 31, 2020 | 177,772 | $ 32 | 374,386 | 103 | (196,749) | |||
Beginning balance, Shares at Mar. 31, 2020 | 31,827,606 | |||||||
Exercise of stock options | 480 | 480 | ||||||
Exercise of stock options, Shares | 137,178 | |||||||
Unrealized gain (loss) on available-for- sale securities | (82) | (82) | ||||||
Issuance of common stock in connection with public offering, net of issuance costs | $ 83,382 | $ 2 | $ 83,380 | |||||
Issuance of common stock in connection with initial/public offering, Shares | 1,955,000 | |||||||
Restricted stock units withheld in net settlement for tax | (616) | (616) | ||||||
Restricted stock units withheld in net settlement for tax, Shares | (15,456) | |||||||
Issuance of common stock in connection with vesting of restricted stock, Shares | 41,229 | |||||||
Stock-based compensation | 2,605 | 2,605 | ||||||
Net income (loss) | (18,118) | (18,118) | ||||||
Ending balance at Jun. 30, 2020 | 245,423 | $ 34 | 460,235 | 21 | (214,867) | |||
Ending balance, shares at Jun. 30, 2020 | 33,945,557 | |||||||
Exercise of stock options | 993 | 993 | ||||||
Exercise of stock options, Shares | 254,523 | |||||||
Issuance of common stock under employee stock purchase plan | 953 | 953 | ||||||
Issuance of common stock under employee stock purchase plan, Share | 27,921 | |||||||
Issuance of common stock in connection with public offering, net of issuance costs | (14) | (14) | ||||||
Restricted stock units withheld in net settlement for tax | (246) | (246) | ||||||
Restricted stock units withheld in net settlement for tax, Shares | (4,611) | |||||||
Issuance of common stock in connection with vesting of restricted stock, Shares | 12,775 | |||||||
Stock-based compensation | 2,891 | 2,891 | ||||||
Net gain reclassified from accumulated other comprehensive income | (21) | (21) | ||||||
Net income (loss) | (12,932) | (12,932) | ||||||
Ending balance at Sep. 30, 2020 | 237,047 | $ 34 | 464,812 | (227,799) | ||||
Ending balance, shares at Sep. 30, 2020 | 34,236,165 | |||||||
Beginning balance at Dec. 31, 2020 | 225,654 | $ 35 | 469,283 | 9 | (243,673) | |||
Beginning balance, Shares at Dec. 31, 2020 | 34,684,337 | |||||||
Exercise of stock options | 773 | 773 | ||||||
Exercise of stock options, Shares | 159,325 | |||||||
Unrealized gain (loss) on available-for- sale securities | 7 | 7 | ||||||
Issuance of common stock under employee stock purchase plan | 1,141 | 1,141 | ||||||
Issuance of common stock under employee stock purchase plan, Share | 20,594 | |||||||
Restricted stock units withheld in net settlement for tax | (5,114) | (5,114) | ||||||
Restricted stock units withheld in net settlement for tax, Shares | (42,529) | |||||||
Issuance of common stock in connection with vesting of restricted stock, Shares | 107,237 | |||||||
Stock-based compensation | 5,394 | 5,394 | ||||||
Net income (loss) | (23,601) | (23,601) | ||||||
Ending balance at Mar. 31, 2021 | 204,254 | $ 35 | 471,477 | 16 | (267,274) | |||
Ending balance, shares at Mar. 31, 2021 | 34,928,964 | |||||||
Beginning balance at Dec. 31, 2020 | $ 225,654 | $ 35 | 469,283 | 9 | (243,673) | |||
Beginning balance, Shares at Dec. 31, 2020 | 34,684,337 | |||||||
Exercise of stock options, Shares | 431,041 | |||||||
Net income (loss) | $ (22,078) | |||||||
Ending balance at Sep. 30, 2021 | 220,291 | $ 35 | 486,014 | (7) | (265,751) | |||
Ending balance, shares at Sep. 30, 2021 | 35,294,952 | |||||||
Beginning balance at Mar. 31, 2021 | 204,254 | $ 35 | 471,477 | 16 | (267,274) | |||
Beginning balance, Shares at Mar. 31, 2021 | 34,928,964 | |||||||
Exercise of stock options | 1,085 | 1,085 | ||||||
Exercise of stock options, Shares | 149,101 | |||||||
Unrealized gain (loss) on available-for- sale securities | (6) | (6) | ||||||
Restricted stock units withheld in net settlement for tax | (3,223) | (3,223) | ||||||
Restricted stock units withheld in net settlement for tax, Shares | (20,537) | |||||||
Issuance of common stock in connection with vesting of restricted stock, Shares | 71,761 | |||||||
Stock-based compensation | 6,662 | 6,662 | ||||||
Net income (loss) | (425) | (425) | ||||||
Ending balance at Jun. 30, 2021 | 208,347 | $ 35 | 476,001 | 10 | (267,699) | |||
Ending balance, shares at Jun. 30, 2021 | 35,129,289 | |||||||
Exercise of stock options | 691 | 691 | ||||||
Exercise of stock options, Shares | 122,615 | |||||||
Unrealized gain (loss) on available-for- sale securities | (17) | (17) | ||||||
Issuance of common stock under employee stock purchase plan | 1,696 | 1,696 | ||||||
Issuance of common stock under employee stock purchase plan, Share | 16,239 | |||||||
Issuance of common stock in connection with vesting of restricted stock, Shares | 26,809 | |||||||
Stock-based compensation | 7,626 | 7,626 | ||||||
Net income (loss) | 1,948 | 1,948 | ||||||
Ending balance at Sep. 30, 2021 | $ 220,291 | $ 35 | $ 486,014 | $ (7) | $ (265,751) | |||
Ending balance, shares at Sep. 30, 2021 | 35,294,952 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) $ in Millions | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Public Offering | |
Issuance costs | $ 6.1 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ (22,078) | $ (49,825) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,685 | 1,361 |
Share in net loss of equity method investment | 5,865 | |
Stock-based compensation | 19,049 | 7,108 |
Amortization of right-of-use assets | 1,184 | 1,105 |
Accretion of discount on available-for-sale securities | 1,022 | 289 |
Loss on write down of fixed assets | 97 | |
Amortization of debt issuance costs | 357 | 478 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (18,277) | (3,334) |
Inventory | (7,982) | (16,338) |
Prepaid expenses and other current assets | (1,966) | (1,136) |
Other assets | 128 | (161) |
Accounts payable | 2,168 | (776) |
Accrued and other current liabilities | 13,011 | 2,841 |
Lease liabilities | (961) | (494) |
Net cash used in operating activities | (5,795) | (58,785) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of available-for-sale securities | (75,566) | (16,020) |
Proceeds from maturities of available-for-sale securities | 134,700 | 72,000 |
Purchase of property and equipment | (9,616) | (9,846) |
Net cash provided by investing activities | 49,518 | 46,134 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payments of offering costs | (179) | |
Proceed from issuance of common stock from public offering, net of issuance cost paid | 83,368 | |
Payments of taxes withheld on net settled vesting of restricted stock units | (8,337) | (862) |
Principal payments of term loan | (1,111) | |
Net proceeds from term loan | 3,265 | |
Proceeds from stock option exercises | 2,549 | 2,586 |
Proceeds from issuance of common stock under employee stock purchase plan | 2,837 | 1,795 |
Net cash provided by (used in) financing activities | (2,951) | 88,862 |
Net increase in cash, cash equivalents and restricted cash | 40,772 | 76,211 |
Cash, cash equivalents and restricted cash at beginning of period | 51,873 | 140,495 |
Cash, cash equivalents and restricted cash equivalents at end of period | 92,645 | 216,706 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Interest paid | 440 | 403 |
Income tax paid | 114 | 22 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Right-of-use asset obtained in exchange for lease liability | 5,406 | 121 |
Property and equipment purchases included in accounts payable and accrued liabilities | 2,510 | 233 |
Equity method investment obtained in exchange for related party contract liability | 12,273 | |
Transfer of fixed assets to inventory | $ 270 | $ 197 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Shockwave Medical, Inc. (the “Company”) was incorporated on June 17, 2009. The Company is primarily engaged in the development of Intravascular Lithotripsy (“IVL”) technology for the treatment of calcified plaque in patients with peripheral vascular, coronary vascular and heart valve disease. Built on a balloon catheter platform, the IVL technology uses lithotripsy to disrupt both superficial and deep vascular calcium, while minimizing soft tissue injury, and an integrated angioplasty balloon to dilate blockages at low pressures, restoring blood flow. In 2016, the Company began commercial and manufacturing operations, and began selling catheters based on the IVL technology. The Company’s headquarters are in Santa Clara, California. The Company is located and operates primarily in the United States and has subsidiaries in Germany, the United Kingdom, Japan and France. Need for Additional Capital The Company has incurred significant losses to date, and as of September 30, 2021, had an accumulated deficit of $265.8 million. Although the Company had positive net income for the quarter ended September 30, 2021, it had a net loss for the nine months ended September 30, 2021. The Company may continue to incur losses in the future, which may vary significantly from period to period. The Company expects to continue to incur significant expenses as it (i) expands its marketing efforts to increase adoption of its products, (ii) expands existing relationships with its customers, (iii) obtains regulatory clearances or approvals for its planned or future products, (iv) conducts clinical trials on its existing and planned or future products, and (v) develops new products or adds new features to its existing products. The Company will need to continue to generate significant revenue in order to sustain profitability as it continues to grow its business. Even if it achieves profitability for any period, the Company cannot be sure that it will remain profitable for any substantial period of time. As of September 30, 2021, the Company had cash, cash equivalents and short-term investments of $183.0 million, which are available to fund future operations. The Company believes that its cash and cash equivalents as of September 30, 2021, will be sufficient for the Company to continue as a going concern for at least 12 months from the date the unaudited condensed consolidated financial statements are filed with the Securities and Exchange Commission (“SEC”). The Company’s future capital requirements will depend on many factors, including its growth rate, the timing and extent of its spending to support research and development activities, the timing and cost of establishing additional sales and marketing capabilities and the scope, duration and continuing impact of the COVID-19 pandemic. Risk and Uncertainties The Company is subject to continuing risks and uncertainties as a result of the COVID-19 pandemic, and is closely monitoring the impact of the pandemic on all aspects of its business, including the impacts on its customers, patients that would benefit from procedures utilizing the Company’s products, employees, suppliers, vendors, business partners and distribution channels. Specifically, the Company has recently seen some disruptions in the operations of certain of its third-party suppliers, resulting in increased lead-times, higher component costs and lower allocations for our purchase of some components and, in certain cases, requiring the Company to procure materials from alternate suppliers or incur higher logistical expenses. The Company is continuing to work closely with its manufacturing partners and suppliers to enable the Company to source key components and maintain appropriate inventory levels to meet customer demand. The Company, however, has not experienced material disruptions in its supply chain to date. Economies worldwide continue to be negatively impacted by the COVID-19 pandemic and the Company anticipates these disruptions will continue. As such the Company's future results of operations and liquidity could be adversely impacted by a variety of factors related to the COVID-19 pandemic, including those discussed in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's financial condition, liquidity, or results of operations remains uncertain. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and cash flows. The results of operations for the three and nine months ended September 30 , 202 1 are not necessarily indicative of the results to be expected for the year ending December 31, 202 1 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 20 20 included herein was derived from the audited financial statements as of that date. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 20 20 , filed with the SEC on February 26 , 202 1 . 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. Restricted cash as of September 30, 2021 and December 31, 2020 relates to a letter of credit established for the Company’s office lease and is recorded as other assets on the condensed consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: September 30, 2021 December 31, 2020 (in thousands) Cash and cash equivalents $ 91,195 $ 50,423 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 92,645 $ 51,873 Equity Method Investments Entities which the Company has significant influence over activities of the entity, but does not control, are accounted for under the equity method of accounting in accordance with Topic 323, Investments - Equity Method and Joint Ventures . The Company’s carrying value in the equity method investment is reported as equity method investment on the Company’s consolidated balance sheet. The Company records its proportionate of the underlying income or loss which is recognized in share in net loss of equity method investment. For the three and nine months ended September 30, 2021, the Company’s share in the losses incurred by the equity method investee was $0.3 and $ 5.9 We assess our equity method investment for impairment when events or circumstances suggest that the carrying amount of the investment may be impaired. We consider all available evidence in assessing whether a decline in fair value is other than temporary. If the decline in fair value is determined to be other than temporary, the difference between the carrying amount of the investment and estimated fair value is recognized as an impairment charge. 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. Revenue To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, Revenue from Contracts with Customers Product Revenue The Company records product revenue primarily from the sale of its IVL catheters. The Company sells its products to hospitals, primarily through direct sales representatives, as well as through distributors in selected international markets. Additionally, a portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Product revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and products sold to customers that utilize stocking orders, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms. For consignment inventory, control is transferred at the time the IVL catheters are consumed in a procedure. The Company elected to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity, and not a separate performance obligation. The Company may provide for the use of an IVL generator and connector cable under an agreement to customers at no charge to facilitate use of the IVL catheters. These agreements do not contain contractually enforceable minimum commitments and are generally cancellable by either party with 30 days’ notice. License Revenue For arrangements that contain a license of our functional intellectual property with a customer, we consider whether the license grant is distinct from other performance obligations in the arrangement. A license grant of functional intellectual property is generally considered to be capable of being distinct if a customer can benefit from the license on its own or together with other readily available resources. License revenue for licenses of functional intellectual property is recognized at a point in time when the Company satisfies its performance obligation of transferring the license to the customer. Consideration received in advance of the satisfaction of a performance obligation is recognized as a contract liability. No license revenues have been recognized for the three and nine months ended September 30, 2021. |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments and Fair Value Measurements | 3. Financial Instruments and Fair Value Measurements The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2021 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 65,235 $ — $ — $ 65,235 Money market funds 67,705 — — 67,705 Commercial paper — 21,385 — 21,385 Corporate bonds — 5,139 — 5,139 Total assets $ 132,940 $ 26,524 $ — $ 159,464 December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 126,363 $ — $ — $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper — 31,968 — 31,968 Total assets $ 161,416 $ 31,968 $ — $ 193,384 |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 9 Months Ended |
Sep. 30, 2021 | |
Cash And Cash Equivalents [Abstract] | |
Cash Equivalents and Short-Term Investments | 4. Cash Equivalents and Short-Term Investments The following is a summary of the Company’s cash equivalents and short-term investments: September 30, 2021 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 65,242 $ 2 $ (9 ) $ 65,235 Money market funds 67,705 — — 67,705 Commercial paper 21,385 — — $ 21,385 Corporate bonds 5,139 — — 5,139 Total $ 159,471 $ 2 $ (9 ) $ 159,464 Reported as: Cash equivalents $ 67,705 Short-term investments 91,759 Total $ 159,464 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 The Company recognized no material gains or losses on its cash equivalents and short-term investments in the periods presented. The remaining contractual maturities for available-for-sale securities were as follows: September 30, 2021 Fair Value One year or less $ 134,384 Greater than one year and less than two years 25,080 Total $ 159,464 |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Inventory Inventory consists of the following: September 30, December 31, 2021 2020 (in thousands) Raw material $ 6,781 $ 4,995 Work in progress 11,066 6,051 Finished goods 19,000 16,952 Consigned inventory 1,897 1,861 Total inventory $ 38,744 $ 29,859 Accrued Liabilities Accrued liabilities consist of the following: September 30, December 31, 2021 2020 (in thousands) Accrued employee compensation $ 20,713 $ 10,885 Accrued research and development costs 3,839 3,057 Accrued asset purchases 3,451 2,527 Accrued professional services 1,819 1,325 Other 3,195 2,148 Total accrued liabilities $ 33,017 $ 19,942 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
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 $0.7 million as of September 30, 2021 and an aggregate lease liability of $0.8 million on its consolidated balance sheet. The remaining lease term is eleven 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 was initially for 96 months. 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 September 2021, the Company amended the 5353 Lease (the “Amended Lease”), which extended the initial lease terms for both 5403 and 5353 Betsy Ross buildings by approximately 48.5 months to December 31, 2031. The Company accounted for this amendment as a lease modification for the lease of the 5353 Building. As of September 30, 2021, the lease of the 5403 Betsy Ross building under the modified terms has not yet commenced. The Amended Lease also contains an expansion option, which can be exercised after June 1, 2023, to lease an adjacent building consisting of approximately 35,000 square feet. In connection with the lease of the 5353 Betsy Ross building, the Company has recorded an operating lease right-of-use asset of $10.9 million as of September 30, 2021 and an aggregate lease liability of $11.9 million on its consolidated balance sheet. The remaining lease term is ten years and three months. Additionally, in September 2021, the Company entered into a ten-year improvement allowance of up to $ 5.5 million. In connection with the lease, the Company shall provide an initial security deposit of $ 0.2 million in the form of a letter of credit and a prepayment for the same amount which will be applied to the first month’s rent. The lease is due to expire in December 2031 , and contains two optional extension periods of sixty months each at the then fair market rent for the space . As of September 30, 2021, the Company has not taken control of the leased facility and anticipates that it will take control of the leased facility in the fourth quarter of 2021. The Company also leases vehicles for use by certain of its 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 September 30, 2021 on its consolidated balance sheet. The weighted average remaining lease term for these vehicle leases is one year and seven months. The weighted average incremental borrowing rate used to measure the operating lease liability is 5.14%. As of September 30, 2021, the Company has no material 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 September 30, 2021: Year ending December 31, (in thousands) 2021 (remainder) $ 602 2022 2,128 2023 1,535 2024 1,552 2025 1,600 2026 1,643 Thereafter 8,787 Total minimum lease payments $ 17,847 Less: imputed interest and adjustments (5,041 ) Total lease liability $ 12,806 The following are minimum undiscounted future rental payments owed for the modified 5403 Betsy Ross Lease and 3003 Bunker Hill Lease which have not yet commenced as of September 30, 2021: Year ending December 31, (in thousands) 2021 (remainder) $ 215 2022 1,420 2023 3,704 2024 3,815 2025 3,926 2026 4,047 Thereafter 22,004 Total minimum lease payments $ 39,131 Operating lease cost for the three and nine months ended September 30, 2021 and 2020 was $0.5 million and $1.5 million, respectively, and $0.5 million and $1.5 million, respectively. |
Term Notes
Term Notes | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Term Notes | 7. Term Notes Loan and Security Agreement In February 2018, the Company entered into a Loan and Security Agreement with Silicon Valley Bank (the “Loan and Security Agreement”). The terms of the Loan and Security Agreement included a term loan of $15.0 million and a revolving line of credit of $2.0 million. The term loan 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 expected 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 Silicon Valley Bank 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 was being amortized to interest expense, net over the expected repayment period 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 September 30, 2021. The supplemental term loan matures on December 1, 2023. The Amended Credit Facility provides an interest-only payment period through June 30, 2022. The additional final payment for the Amended Credit Facility is $1.6 million, which will be accrued over the term of the supplemental term loan using an effective interest rate that reflects the revised cash flows of the modified term loan. The 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. Current and noncurrent debt and net discount or premium balances are as follows: September 30, December 31, 2021 2020 (in thousands) Principal amount of term note $ 16,500 $ 16,500 Net premium associated with accretion of final payment, and other debt issuance costs 476 119 Term note, current and noncurrent 16,976 16,619 Less term note, current portion (2,750 ) (3,300 ) Term note, noncurrent portion $ 14,226 $ 13,319 Future minimum payments of principal and estimated payments of interest on the Company’s outstanding variable rate borrowings as of September 30, 2021 are as follows: Year ending December 31: (in thousands) 2021 (remainder) 146 2022 6,045 2023 12,779 Total future payments 18,970 Less amounts representing interest (902 ) Less final payment (1,568 ) Total principal amount of term note payments $ 16,500 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Total stock-based compensation was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) Cost of product revenue $ 263 $ 162 $ 718 $ 303 Research and development 1,686 631 4,343 1,769 Sales and marketing 3,051 913 7,693 2,309 General and administrative 2,387 1,140 6,295 2,727 Total stock-based compensation $ 7,387 $ 2,846 $ 19,049 $ 7,108 Stock-based compensation of $239,000 and $45,000 was capitalized into inventory for the three months ended September 30, 2021 and 2020, respectively. Stock-based compensation of $633,000 and $259,000 was capitalized into inventory for the nine months ended September 30, 2021 and 2020, respectively. Stock-based compensation capitalized into inventory is recognized as cost of product revenue when the related product is sold. 2009 Equity Incentive Plan and 2019 Equity Incentive Plan On June 17, 2009, the Company adopted the 2009 Equity Incentive Plan (the “2009 Plan”) under which the Board had the authority to issue stock options to employees, directors and consultants. In February 2019, the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”), which became effective in connection with the initial public offering (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 In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years, which commenced on January 1, 2020, in an amount equal to 3% of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year, or a lesser number of shares determined by the Company’s Board of Directors. Stock Options Option activity under the 2009 Plan and 2019 Plan is set forth below: Shares Available for Grant Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Term Aggregate Intrinsic Value (in years) (in thousands) Balance, December 31, 2020 2,689,624 2,087,202 $ 5.92 6.77 $ 204,137 Awards authorized 1,040,530 — Options exercised — (431,041 ) 5.91 Options forfeited 15,062 (15,062 ) 9.33 Balance, September 30, 2021 3,745,216 1,641,099 $ 5.88 5.98 $ 328,212 Vested and exercisable, September 30, 2021 1,339,978 $ 4.88 5.72 $ 269,338 Vested and expected to vest, September 30, 2021 1,641,099 $ 5.88 5.98 $ 328,212 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 RSU activity under the 2019 Plan is set forth below : Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance, December 31, 2020 859,577 $ 48.50 RSUs granted 557,355 137.41 RSUs vested (205,807 ) 42.98 RSUs forfeited (47,266 ) 75.16 Balance, September 30, 2021 1,163,859 $ 90.97 Employee Stock Purchase Plan In February 2019, the Company adopted the 2019 Employee Stock Purchase Plan (“ESPP”), which became effective in connection with the IPO on March 6, 2019. The Company initially reserved 300,650 shares of common stock for purchase under the ESPP. Each offering under the ESPP to Company employees to purchase stock under the ESPP begins on each September 1 and March 1 and ends on the following February 28 or 29 and August 31, respectively. On each purchase date, which falls on the last date of each offering period, ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the offering date or (2) the fair market value of the common stock on the purchase date. The occurrence and duration of offering periods under the ESPP are subject to the determinations of the Company’s Compensation Committee, in its sole discretion. The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model. The Company recorded $333,000 and $890,000 of stock-based compensation expense related to the ESPP for the three and nine months ended September 30, 2021, respectively. The Company recorded $118,000 and $516,000 of stock-based compensation expense related to the ESPP for the three and nine months ended September 30, 2020, respectively. At September 30, 2021, a total of 872,496 shares were available for issuance under the ESPP. |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 9. Net Income (Loss) Per Share The components of basic and diluted net income (loss) per share are as follows (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net income (loss) $ 1,948 $ (12,932 ) $ (22,078 ) $ (49,825 ) Denominator: Basic: Weighted average number of common shares outstanding - basic 35,207,276 34,078,726 35,013,072 32,631,715 Diluted: Weighted average number of common shares outstanding - basic 35,207,276 34,078,726 35,013,072 32,631,715 Dilutive effect of outstanding common stock options 1,645,968 — — — Dilutive effect of restricted stock units 708,788 — — — Dilutive effect of common stock pursuant to employee stock purchase plan 5,144 — — — Weighted average number of common shares outstanding - diluted 37,567,176 34,078,726 35,013,072 32,631,715 Net income (loss) per share: Basic $ 0.06 $ (0.38 ) $ (0.63 ) $ (1.53 ) Diluted $ 0.05 $ (0.38 ) $ (0.63 ) $ (1.53 ) The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net income (loss) per share for the periods presented due to their anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Common stock options issued and outstanding — 2,529,433 1,641,099 2,529,433 Restricted stock units 18,539 798,708 1,163,859 798,708 Employee stock purchase plan 596 3,911 1,976 3,911 Total 19,135 3,332,052 2,806,934 3,332,052 |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Disaggregation Of Revenue [Abstract] | |
Revenue | 10. Revenue The following table represents the Company’s product revenue based on product line: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) Coronary $ 47,165 $ 6,983 $ 99,175 $ 16,403 Peripheral 17,725 12,337 52,659 27,927 Other 265 270 1,129 743 Product revenue $ 65,155 $ 19,590 $ 152,963 $ 45,073 Coronary product revenue encompasses sales of the Company’s C 2 5 4 The following table represents the Company’s product revenue based on the location to which the product is shipped: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) United States $ 52,771 $ 11,144 $ 116,729 $ 24,450 Europe 8,624 6,370 27,266 15,962 All other countries 3,760 2,076 8,968 4,661 Product revenue $ 65,155 $ 19,590 $ 152,963 $ 45,073 |
Equity Method Investments
Equity Method Investments | 9 Months Ended |
Sep. 30, 2021 | |
Equity Method Investments And Joint Ventures [Abstract] | |
Equity Method Investments | 11. Equity Method Investments Genesis Shockwave Private Limited On March 19, 2021, the Company entered into the Joint Venture Deed (or “JV Agreement”) with Genesis MedTech International Private Limited (“Genesis”) to establish a long-term strategic partnership to develop, manufacture and commercialize certain of the Company’s interventional products in the People’s Republic of China, excluding the Special Administrative Regions of Hong Kong and Macau (“PRC”). Under the JV Agreement, Genesis Shockwave Private Ltd. (the “JV”) was formed under the laws of Singapore to serve as a joint venture of Genesis and the Company for the purpose of establishing and managing such a strategic partnership. On the same date, Genesis and the Company entered into a Share Subscription Agreement pursuant to which, among other things, the JV issued (i) 54,900 ordinary shares which represents 55% of total equity of the JV, to Genesis in exchange for a cash contribution of $15.0 million, of which 50% was paid upon signing and the remaining 50% will be due within one year of signing, and (ii) 45,000 ordinary shares which represents 45% of total equity, to the Company as consideration for the Shockwave License Agreement (or “License Agreement”). Under the License Agreement, the Company has agreed to contribute to the JV an exclusive license under certain of the Company’s intellectual property rights to develop, manufacture, distribute and commercialize certain products in the PRC and is entitled to receive royalties on the sales of the licensed products in the PRC. Further, the Company entered into a Distribution Agreement, pursuant to which the Company has agreed to sell certain Company-manufactured products to the JV and/or a to-be formed PRC subsidiary of the JV for commercialization and distribution in the PRC. The Company has accounted for its investment in the JV under the equity method of accounting. As of September 30, 2021, the carrying value of the Company’s investment in the JV was $6.4 million. The Company’s share of losses generated by the JV for the three and nine months ended September 30, 2021 was $0.3 and $5.9 million, respectively, which was recorded in share in net loss of equity method investment. The JV has not generated any revenues to date. The following table summarizes the unaudited balance sheet for the JV: September 30, 2021 Balance sheet: (in thousands) Current assets $ 14,991 Current liabilities (757 ) Net assets $ 14,234 The following table summarizes the unaudited results of operations for the JV: Three Months Ended September 30, Nine Months Ended September 30, 2021 2021 (in thousands) Revenues $ — $ — Loss from operations 758 13,033 Net loss $ 758 $ 13,033 Upon execution of the License Agreement, on March 19, 2021, the Company received a 45% equity stake in the JV. The Company determined that the JV met the definition of a customer under Topic 606, and that the promised goods and services of the contribution of the license of intellectual property and associated manufacturing technology transfer to the JV were considered to be a single performance obligation. The transaction price of $12.3 million was estimated by reference to the cash value of the shares which were issued at the formation of the JV. As of September 30, 2021, the contribution of the license of intellectual property and associated manufacturing technology transfer to the JV has not yet been completed. The Company maintains a related party contract liability, noncurrent, of $12.3 million for the outstanding performance obligation. The Company will satisfy the outstanding performance obligation upon the completion of training provided by the Company to the JV, and successful regulatory approval from the PRC National Medical Products Administration. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Risk and Uncertainties | Risk and Uncertainties The Company is subject to continuing risks and uncertainties as a result of the COVID-19 pandemic, and is closely monitoring the impact of the pandemic on all aspects of its business, including the impacts on its customers, patients that would benefit from procedures utilizing the Company’s products, employees, suppliers, vendors, business partners and distribution channels. Specifically, the Company has recently seen some disruptions in the operations of certain of its third-party suppliers, resulting in increased lead-times, higher component costs and lower allocations for our purchase of some components and, in certain cases, requiring the Company to procure materials from alternate suppliers or incur higher logistical expenses. The Company is continuing to work closely with its manufacturing partners and suppliers to enable the Company to source key components and maintain appropriate inventory levels to meet customer demand. The Company, however, has not experienced material disruptions in its supply chain to date. Economies worldwide continue to be negatively impacted by the COVID-19 pandemic and the Company anticipates these disruptions will continue. As such the Company's future results of operations and liquidity could be adversely impacted by a variety of factors related to the COVID-19 pandemic, including those discussed in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's financial condition, liquidity, or results of operations remains uncertain. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and cash flows. The results of operations for the three and nine months ended September 30 , 202 1 are not necessarily indicative of the results to be expected for the year ending December 31, 202 1 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 20 20 included herein was derived from the audited financial statements as of that date. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 20 20 , filed with the SEC on February 26 , 202 1 . |
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. Restricted cash as of September 30, 2021 and December 31, 2020 relates to a letter of credit established for the Company’s office lease and is recorded as other assets on the condensed consolidated balance sheets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: September 30, 2021 December 31, 2020 (in thousands) Cash and cash equivalents $ 91,195 $ 50,423 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 92,645 $ 51,873 |
Equity Method Investments | Equity Method Investments Entities which the Company has significant influence over activities of the entity, but does not control, are accounted for under the equity method of accounting in accordance with Topic 323, Investments - Equity Method and Joint Ventures . The Company’s carrying value in the equity method investment is reported as equity method investment on the Company’s consolidated balance sheet. The Company records its proportionate of the underlying income or loss which is recognized in share in net loss of equity method investment. For the three and nine months ended September 30, 2021, the Company’s share in the losses incurred by the equity method investee was $0.3 and $ 5.9 We assess our equity method investment for impairment when events or circumstances suggest that the carrying amount of the investment may be impaired. We consider all available evidence in assessing whether a decline in fair value is other than temporary. If the decline in fair value is determined to be other than temporary, the difference between the carrying amount of the investment and estimated fair value is recognized as an impairment charge. |
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. |
Revenue | Revenue To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, Revenue from Contracts with Customers Product Revenue The Company records product revenue primarily from the sale of its IVL catheters. The Company sells its products to hospitals, primarily through direct sales representatives, as well as through distributors in selected international markets. Additionally, a portion of the Company’s revenue is generated through a consignment model under which inventory is maintained at hospitals. Product revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. For products sold through direct sales representatives, control is transferred upon delivery to customers. For products sold to distributors internationally and products sold to customers that utilize stocking orders, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms. For consignment inventory, control is transferred at the time the IVL catheters are consumed in a procedure. The Company elected to account for shipping and handling activities that occur after the customer has obtained control as a fulfillment activity, and not a separate performance obligation. The Company may provide for the use of an IVL generator and connector cable under an agreement to customers at no charge to facilitate use of the IVL catheters. These agreements do not contain contractually enforceable minimum commitments and are generally cancellable by either party with 30 days’ notice. License Revenue For arrangements that contain a license of our functional intellectual property with a customer, we consider whether the license grant is distinct from other performance obligations in the arrangement. A license grant of functional intellectual property is generally considered to be capable of being distinct if a customer can benefit from the license on its own or together with other readily available resources. License revenue for licenses of functional intellectual property is recognized at a point in time when the Company satisfies its performance obligation of transferring the license to the customer. Consideration received in advance of the satisfaction of a performance obligation is recognized as a contract liability. No license revenues have been recognized for the three and nine months ended September 30, 2021. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: September 30, 2021 December 31, 2020 (in thousands) Cash and cash equivalents $ 91,195 $ 50,423 Restricted cash 1,450 1,450 Total cash, cash equivalents, and restricted cash $ 92,645 $ 51,873 |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value | The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2021 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 65,235 $ — $ — $ 65,235 Money market funds 67,705 — — 67,705 Commercial paper — 21,385 — 21,385 Corporate bonds — 5,139 — 5,139 Total assets $ 132,940 $ 26,524 $ — $ 159,464 December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Assets: U.S. Treasury securities $ 126,363 $ — $ — $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper — 31,968 — 31,968 Total assets $ 161,416 $ 31,968 $ — $ 193,384 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Cash And Cash Equivalents [Abstract] | |
Summary of Cash Equivalents and Short-Term Investments | The following is a summary of the Company’s cash equivalents and short-term investments: September 30, 2021 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 65,242 $ 2 $ (9 ) $ 65,235 Money market funds 67,705 — — 67,705 Commercial paper 21,385 — — $ 21,385 Corporate bonds 5,139 — — 5,139 Total $ 159,471 $ 2 $ (9 ) $ 159,464 Reported as: Cash equivalents $ 67,705 Short-term investments 91,759 Total $ 159,464 December 31, 2020 Amortized Cost Basis Unrealized Gains Unrealized Losses Fair Value (in thousands) U.S. Treasury securities $ 126,354 $ 11 $ (2 ) $ 126,363 Money market funds 35,053 — — 35,053 Commercial paper 31,968 — — 31,968 Total $ 193,375 $ 11 $ (2 ) $ 193,384 Reported as: Cash equivalents $ 41,453 Short-term investments 151,931 Total $ 193,384 |
Summary of Remaining Contractual Maturities for Available-for-sale Securities | The remaining contractual maturities for available-for-sale securities were as follows: September 30, 2021 Fair Value One year or less $ 134,384 Greater than one year and less than two years 25,080 Total $ 159,464 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consists of the following: September 30, December 31, 2021 2020 (in thousands) Raw material $ 6,781 $ 4,995 Work in progress 11,066 6,051 Finished goods 19,000 16,952 Consigned inventory 1,897 1,861 Total inventory $ 38,744 $ 29,859 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: September 30, December 31, 2021 2020 (in thousands) Accrued employee compensation $ 20,713 $ 10,885 Accrued research and development costs 3,839 3,057 Accrued asset purchases 3,451 2,527 Accrued professional services 1,819 1,325 Other 3,195 2,148 Total accrued liabilities $ 33,017 $ 19,942 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021: Year ending December 31, (in thousands) 2021 (remainder) $ 602 2022 2,128 2023 1,535 2024 1,552 2025 1,600 2026 1,643 Thereafter 8,787 Total minimum lease payments $ 17,847 Less: imputed interest and adjustments (5,041 ) Total lease liability $ 12,806 |
Schedule of Minimum Undiscounted Future Rental Payments Not Yet Commenced | The following are minimum undiscounted future rental payments owed for the modified 5403 Betsy Ross Lease and 3003 Bunker Hill Lease which have not yet commenced as of September 30, 2021: Year ending December 31, (in thousands) 2021 (remainder) $ 215 2022 1,420 2023 3,704 2024 3,815 2025 3,926 2026 4,047 Thereafter 22,004 Total minimum lease payments $ 39,131 |
Term Notes (Tables)
Term Notes (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Current and Noncurrent Debt and Net Discount or Premium Balances | Current and noncurrent debt and net discount or premium balances are as follows: September 30, December 31, 2021 2020 (in thousands) Principal amount of term note $ 16,500 $ 16,500 Net premium associated with accretion of final payment, and other debt issuance costs 476 119 Term note, current and noncurrent 16,976 16,619 Less term note, current portion (2,750 ) (3,300 ) Term note, noncurrent portion $ 14,226 $ 13,319 |
Schedule of Future Minimum Payments for Principal and Interest | Future minimum payments of principal and estimated payments of interest on the Company’s outstanding variable rate borrowings as of September 30, 2021 are as follows: Year ending December 31: (in thousands) 2021 (remainder) 146 2022 6,045 2023 12,779 Total future payments 18,970 Less amounts representing interest (902 ) Less final payment (1,568 ) Total principal amount of term note payments $ 16,500 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Total Stock-Based Compensation | Total stock-based compensation was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) Cost of product revenue $ 263 $ 162 $ 718 $ 303 Research and development 1,686 631 4,343 1,769 Sales and marketing 3,051 913 7,693 2,309 General and administrative 2,387 1,140 6,295 2,727 Total stock-based compensation $ 7,387 $ 2,846 $ 19,049 $ 7,108 |
Schedule of Option Activity under 2009 Plan and 2019 Plan | Stock Options Option activity under the 2009 Plan and 2019 Plan is set forth below: Shares Available for Grant Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Term Aggregate Intrinsic Value (in years) (in thousands) Balance, December 31, 2020 2,689,624 2,087,202 $ 5.92 6.77 $ 204,137 Awards authorized 1,040,530 — Options exercised — (431,041 ) 5.91 Options forfeited 15,062 (15,062 ) 9.33 Balance, September 30, 2021 3,745,216 1,641,099 $ 5.88 5.98 $ 328,212 Vested and exercisable, September 30, 2021 1,339,978 $ 4.88 5.72 $ 269,338 Vested and expected to vest, September 30, 2021 1,641,099 $ 5.88 5.98 $ 328,212 |
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, 2020 859,577 $ 48.50 RSUs granted 557,355 137.41 RSUs vested (205,807 ) 42.98 RSUs forfeited (47,266 ) 75.16 Balance, September 30, 2021 1,163,859 $ 90.97 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Components of Basic and Diluted Net Income (Loss) Per Share | The components of basic and diluted net income (loss) per share are as follows (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net income (loss) $ 1,948 $ (12,932 ) $ (22,078 ) $ (49,825 ) Denominator: Basic: Weighted average number of common shares outstanding - basic 35,207,276 34,078,726 35,013,072 32,631,715 Diluted: Weighted average number of common shares outstanding - basic 35,207,276 34,078,726 35,013,072 32,631,715 Dilutive effect of outstanding common stock options 1,645,968 — — — Dilutive effect of restricted stock units 708,788 — — — Dilutive effect of common stock pursuant to employee stock purchase plan 5,144 — — — Weighted average number of common shares outstanding - diluted 37,567,176 34,078,726 35,013,072 32,631,715 Net income (loss) per share: Basic $ 0.06 $ (0.38 ) $ (0.63 ) $ (1.53 ) Diluted $ 0.05 $ (0.38 ) $ (0.63 ) $ (1.53 ) |
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 income (loss) per share for the periods presented due to their anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Common stock options issued and outstanding — 2,529,433 1,641,099 2,529,433 Restricted stock units 18,539 798,708 1,163,859 798,708 Employee stock purchase plan 596 3,911 1,976 3,911 Total 19,135 3,332,052 2,806,934 3,332,052 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Disaggregation Of Revenue [Abstract] | |
Schedule of Product Revenue Based on Product Line and Location | The following table represents the Company’s product revenue based on product line: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) Coronary $ 47,165 $ 6,983 $ 99,175 $ 16,403 Peripheral 17,725 12,337 52,659 27,927 Other 265 270 1,129 743 Product revenue $ 65,155 $ 19,590 $ 152,963 $ 45,073 Coronary product revenue encompasses sales of the Company’s C 2 5 4 The following table represents the Company’s product revenue based on the location to which the product is shipped: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) (in thousands) United States $ 52,771 $ 11,144 $ 116,729 $ 24,450 Europe 8,624 6,370 27,266 15,962 All other countries 3,760 2,076 8,968 4,661 Product revenue $ 65,155 $ 19,590 $ 152,963 $ 45,073 |
Equity Method Investments (Tabl
Equity Method Investments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity Method Investments And Joint Ventures [Abstract] | |
Summary of Unaudited Balance Sheet | The following table summarizes the unaudited balance sheet for the JV: September 30, 2021 Balance sheet: (in thousands) Current assets $ 14,991 Current liabilities (757 ) Net assets $ 14,234 |
Summary of Unaudited Results of Operations | The following table summarizes the unaudited results of operations for the JV: Three Months Ended September 30, Nine Months Ended September 30, 2021 2021 (in thousands) Revenues $ — $ — Loss from operations 758 13,033 Net loss $ 758 $ 13,033 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Entity incorporation, date of incorporation | Jun. 17, 2009 | |
Accumulated deficit | $ 265,751 | $ 243,673 |
Cash, cash equivalents and short-term investments | $ 183,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 91,195 | $ 50,423 | ||
Restricted cash | 1,450 | 1,450 | ||
Total cash, cash equivalents, and restricted cash | $ 92,645 | $ 51,873 | $ 216,706 | $ 140,495 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Share in net loss of equity method investment | $ 342,000 | $ 5,865,000 | ||
Notice period for cancellation of agreement | 30 days | |||
Revenue | 65,155,000 | $ 19,590,000 | $ 152,963,000 | $ 45,073,000 |
License | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Revenue | $ 0 | $ 0 |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Total assets | $ 159,464 | $ 193,384 |
Level 1 | ||
Assets: | ||
Total assets | 132,940 | 161,416 |
Level 2 | ||
Assets: | ||
Total assets | 26,524 | 31,968 |
U.S. Treasury Securities | ||
Assets: | ||
Total assets | 65,235 | 126,363 |
U.S. Treasury Securities | Level 1 | ||
Assets: | ||
Total assets | 65,235 | 126,363 |
Money Market Funds | ||
Assets: | ||
Total assets | 67,705 | 35,053 |
Money Market Funds | Level 1 | ||
Assets: | ||
Total assets | 67,705 | 35,053 |
Commercial Paper | ||
Assets: | ||
Total assets | 21,385 | 31,968 |
Commercial Paper | Level 2 | ||
Assets: | ||
Total assets | 21,385 | $ 31,968 |
Corporate Bonds | ||
Assets: | ||
Total assets | 5,139 | |
Corporate Bonds | Level 2 | ||
Assets: | ||
Total assets | $ 5,139 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments - Summary of Cash Equivalents and Short-Term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents, Fair Value | $ 67,705 | $ 41,453 |
Cash equivalents and short-term investments, Amortized Cost Basis | 159,471 | 193,375 |
Cash equivalents and short-term investments, Unrealized Gains | 2 | 11 |
Cash equivalents and short-term investments, Unrealized losses | (9) | (2) |
Cash equivalents and short-term investments, Fair Value | 159,464 | 193,384 |
Short-term investments | 91,759 | 151,931 |
U.S. Treasury Securities | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 65,242 | 126,354 |
Short-term investments Unrealized Gains | 2 | 11 |
Short-term investments Unrealized Losses | (9) | (2) |
Short-term investments, Fair Value | 65,235 | 126,363 |
Money Market Funds | ||
Cash And Cash Equivalents [Line Items] | ||
Cash equivalents Amortized Cost Basis | 67,705 | 35,053 |
Cash equivalents, Fair Value | 67,705 | 35,053 |
Commercial Paper | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 21,385 | 31,968 |
Short-term investments, Fair Value | 21,385 | $ 31,968 |
Corporate Bonds | ||
Cash And Cash Equivalents [Line Items] | ||
Short-term investments Amortized Cost Basis | 5,139 | |
Short-term investments, Fair Value | $ 5,139 |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Summary of Remaining Contractual Maturities for Available-for-sale Securities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Cash And Cash Equivalents [Abstract] | |
One year or less | $ 134,384 |
Greater than one year and less than two years | 25,080 |
Total | $ 159,464 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 6,781 | $ 4,995 |
Work in progress | 11,066 | 6,051 |
Finished goods | 19,000 | 16,952 |
Consigned inventory | 1,897 | 1,861 |
Total inventory | $ 38,744 | $ 29,859 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued employee compensation | $ 20,713 | $ 10,885 |
Accrued research and development costs | 3,839 | 3,057 |
Accrued asset purchases | 3,451 | 2,527 |
Accrued professional services | 1,819 | 1,325 |
Other | 3,195 | 2,148 |
Total accrued liabilities | $ 33,017 | $ 19,942 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2021USD ($)ft²Option | Dec. 31, 2019USD ($)ft² | May 31, 2018ft² | Sep. 30, 2021USD ($)ft² | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)ft² | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($)ft² | Jun. 01, 2023ft² | Sep. 01, 2022USD ($) | Dec. 31, 2020USD ($) | |
Loss Contingencies [Line Items] | |||||||||||
Operating lease right-of-use asset | $ 11,790 | $ 11,790 | $ 11,790 | $ 7,568 | |||||||
Operating lease liabilities | 12,806 | 12,806 | 12,806 | ||||||||
Operating lease cost | 500 | $ 1,500 | 500 | $ 1,500 | |||||||
Germany | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Operating lease right-of-use asset | 200 | 200 | 200 | ||||||||
Operating lease liabilities | $ 200 | $ 200 | $ 200 | ||||||||
Operating lease, weighted average remaining lease term | 1 year 7 months | 1 year 7 months | 1 year 7 months | ||||||||
Operating lease liability, weighted average incremental borrowing rate | 5.14% | ||||||||||
5403 Lease | Santa Clara, California | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Area of office and laboratory space | ft² | 35,000 | ||||||||||
Lease term expiration month and year | 2022-08 | ||||||||||
Lease commencement date | 2018-09 | ||||||||||
Letter of credit secured by restricted cash | $ 500 | $ 500 | $ 500 | ||||||||
Operating lease right-of-use asset | 700 | 700 | 700 | ||||||||
Operating lease liabilities | 800 | 800 | $ 800 | ||||||||
Operating lease, remaining lease term | 11 months | ||||||||||
5403 Lease | Santa Clara, California | Scenario Forecast | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Area of office and laboratory space | ft² | 35,000 | ||||||||||
5353 Lease | Santa Clara, California | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Area of office and laboratory space | ft² | 50,200 | 50,200 | |||||||||
Lease commencement date | 2019-12 | ||||||||||
Operating lease right-of-use asset | 10,900 | 10,900 | $ 10,900 | ||||||||
Operating lease liabilities | $ 11,900 | $ 11,900 | $ 11,900 | ||||||||
Operating lease, remaining lease term | 10 years 3 months | ||||||||||
Lease term expiration date | Aug. 31, 2022 | ||||||||||
Initial term of 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 | ||||||||||
Operating lease, extended period | 48 months 15 days | ||||||||||
Operating lease extended term date | Dec. 31, 2031 | ||||||||||
Lessee, Operating Lease, Existence of Option to Extend | true | ||||||||||
5353 Lease | Santa Clara, California | Scenario Forecast | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Letter of credit secured by restricted cash | $ 1,500 | ||||||||||
5353 Lease | Santa Clara, California | Initial Security Deposit | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Letter of credit secured by restricted cash | $ 1,000 | $ 1,000 | |||||||||
5403 and 5353 Lease | Santa Clara, California | Maximum | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Tenant improvements allowance | $ 1,800 | $ 1,800 | |||||||||
3003 Lease | Santa Clara, California | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Area of office and laboratory space | ft² | 81,000 | 81,000 | 81,000 | ||||||||
Lease term expiration month and year | 2031-12 | ||||||||||
Initial term of building | 10 years | 10 years | 10 years | ||||||||
Number of operating lease optional extension | Option | 2 | ||||||||||
Operating lease, optional extension term | 60 months | ||||||||||
3003 Lease | Santa Clara, California | Initial Security Deposit | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Line of credit | $ 200 | $ 200 | $ 200 | ||||||||
Prepayment for rent | 200 | 200 | 200 | ||||||||
3003 Lease | Santa Clara, California | Maximum | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Tenant improvements allowance | $ 5,500 | $ 5,500 | $ 5,500 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Minimum Future Rental Payments (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
2021 (remainder) | $ 602 |
2022 | 2,128 |
2023 | 1,535 |
2024 | 1,552 |
2025 | 1,600 |
2026 | 1,643 |
Thereafter | 8,787 |
Total minimum lease payments | 17,847 |
Less: imputed interest and adjustments | (5,041) |
Operating lease liabilities | $ 12,806 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Minimum Undiscounted Future Rental Payments Not Yet Commenced (Details) - 5403 and 3003 Lease $ in Thousands | Sep. 30, 2021USD ($) |
Lessee, Operating Lease, Not yet Commenced, Description [Abstract] | |
2021 (remainder) | $ 215 |
2022 | 1,420 |
2023 | 3,704 |
2024 | 3,815 |
2025 | 3,926 |
2026 | 4,047 |
Thereafter | 22,004 |
Total minimum lease payments | $ 39,131 |
Term Notes - Additional Informa
Term Notes - Additional Information (Details) - USD ($) | Feb. 29, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Jun. 30, 2018 | Feb. 28, 2018 |
Debt Instrument [Line Items] | ||||||
Debt Amount | $ 16,500,000 | $ 16,500,000 | ||||
Debt, final payment amount | $ 1,568,000 | |||||
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 | |||||
Proceeds of supplemental term loan | $ 4,300,000 | |||||
Debt payments description | The Amended Credit Facility provides an interest-only payment period through June 30, 2022. | |||||
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 | ||||||
Debt Instrument [Line Items] | ||||||
Debt, warrants issued | 34,440 | |||||
Debt, fair value of warrants issued | $ 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 Curren
Term Notes - Schedule of Current and Noncurrent Debt and Net Discount or Premium Balances (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Instrument Periodic Payment [Abstract] | ||
Principal amount of term note | $ 16,500 | $ 16,500 |
Net premium associated with accretion of final payment, and other debt issuance costs | 476 | 119 |
Term note, current and noncurrent | 16,976 | 16,619 |
Less term note, current portion | (2,750) | (3,300) |
Term note, noncurrent portion | $ 14,226 | $ 13,319 |
Term Notes - Schedule of Future
Term Notes - Schedule of Future Minimum and Estimated Payments (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Debt Disclosure [Abstract] | ||
2021 (remainder) | $ 146 | |
2022 | 6,045 | |
2023 | 12,779 | |
Total future payments | 18,970 | |
Less amounts representing interest | (902) | |
Less final payment | (1,568) | |
Total principal amount of term note payments | $ 16,500 | $ 16,500 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 7,387 | $ 2,846 | $ 19,049 | $ 7,108 |
Cost of Product Revenue | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 263 | 162 | 718 | 303 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 1,686 | 631 | 4,343 | 1,769 |
Sales and Marketing | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 3,051 | 913 | 7,693 | 2,309 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 2,387 | $ 1,140 | $ 6,295 | $ 2,727 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Feb. 28, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Mar. 06, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Share-based compensation expenses capitalized amount | $ 239,000 | $ 45,000 | $ 633,000 | $ 259,000 | |||
Shares available for issuance | 3,745,216 | 3,745,216 | 2,689,624 | ||||
Stock-based compensation | $ 19,049,000 | 7,108,000 | |||||
Restricted Stock Units | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Vesting period | 4 years | ||||||
Share-based compensation vesting rights, terms | The RSUs generally vest over a four-year period with straight-line annual vesting, | ||||||
2019 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock reserved for issuance | 2,000,430 | ||||||
Automatic annual increase in common stock reserved for issuance | 3.00% | ||||||
Maximum period of automatic annual increase in common stock reserved for issuance | 10 years | ||||||
Shares available for issuance | 3,745,216 | 3,745,216 | |||||
2019 Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock reserved for issuance | 300,650 | ||||||
Shares available for issuance | 872,496 | 872,496 | |||||
Purchase shares of common stock, price per share, percentage of fair market value | 85.00% | ||||||
Stock-based compensation | $ 333,000 | $ 118,000 | $ 890,000 | $ 516,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Option Activity under 2009 Plan and 2019 Plan (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Shares Available for Grant | ||
Shares Available for Grant, Beginning balance | 2,689,624 | |
Shares Available for Grant, Awards authorized | 1,040,530 | |
Shares Available for Grant, Options forfeited | 15,062 | |
Shares Available for Grant, Ending balance | 3,745,216 | 2,689,624 |
Number of Shares | ||
Number of Shares, Beginning balance | 2,087,202 | |
Number of Shares, Options exercised | (431,041) | |
Number of Shares, Options forfeited | (15,062) | |
Number of Shares, Ending balance | 1,641,099 | 2,087,202 |
Number of Shares, Vested and exercisable | 1,339,978 | |
Number of Shares, Vested and expected to vest | 1,641,099 | |
Weighted-Average Exercise Price Per Share | ||
Weighted-Average Exercise Price Per Share, Beginning balance | $ / shares | $ 5.92 | |
Weighted-Average Exercise Price Per Share, Options exercised | $ / shares | 5.91 | |
Weighted-Average Exercise Price Per Share, Options forfeited | $ / shares | 9.33 | |
Weighted-Average Exercise Price Per Share, Ending balance | $ / shares | 5.88 | $ 5.92 |
Weighted-Average Exercise Price Per Share, Vested and exercisable | $ / shares | 4.88 | |
Weighted-Average Exercise Price Per Share, Vested and expected to vest | $ / shares | $ 5.88 | |
Weighted-Average Remaining Term | ||
Weighted-Average Remaining Term, Balance | 5 years 11 months 23 days | 6 years 9 months 7 days |
Weighted-Average Remaining Term, Vested and exercisable | 5 years 8 months 19 days | |
Weighted-Average Remaining Term, Vested and expected to vest | 5 years 11 months 23 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Balance | $ | $ 328,212 | $ 204,137 |
Aggregate Intrinsic Value, Vested and exercisable | $ | 269,338 | |
Aggregate Intrinsic Value, Vested and expected to vest | $ | $ 328,212 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of RSU Activity under 2019 Plan (Details) - Restricted Stock Units | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Number of Shares | |
Number of Shares, Beginning balance | shares | 859,577 |
Number of Shares, RSUs granted | shares | 557,355 |
Number of Shares, RSUs vested | shares | (205,807) |
Number of Shares, RSUs forfeited | shares | (47,266) |
Number of Shares, Ending balance | shares | 1,163,859 |
Weighted-Average Grant Date Fair Value Per Share | |
Weighted-Average Grant Date Fair Value Per Share, Beginning balance | $ / shares | $ 48.50 |
Weighted-Average Grant Date Fair Value Per Share, RSUs granted | $ / shares | 137.41 |
Weighted-Average Grant Date Fair Value Per Share, RSUs vested | $ / shares | 42.98 |
Weighted-Average Grant Date Fair Value Per Share, RSUs forfeited | $ / shares | 75.16 |
Weighted-Average Grant Date Fair Value Per Share, Ending balance | $ / shares | $ 90.97 |
Net Income (Loss) Per Share - C
Net Income (Loss) Per Share - Components of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||
Net income (loss) | $ 1,948 | $ (12,932) | $ (22,078) | $ (49,825) |
Basic: | ||||
Basic | 35,207,276 | 34,078,726 | 35,013,072 | 32,631,715 |
Shares used in computing net income (loss) per share | ||||
Basic | 35,207,276 | 34,078,726 | 35,013,072 | 32,631,715 |
Dilutive effect of outstanding common stock options | 1,645,968 | |||
Dilutive effect of restricted stock units | 708,788 | |||
Dilutive effect of common stock pursuant to employee stock purchase plan | 5,144 | |||
Weighted average number of common shares outstanding - diluted | 37,567,176 | 34,078,726 | 35,013,072 | 32,631,715 |
Net income (loss) per share: | ||||
Basic | $ 0.06 | $ (0.38) | $ (0.63) | $ (1.53) |
Diluted | $ 0.05 | $ (0.38) | $ (0.63) | $ (1.53) |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Summary of Outstanding Potentially Dilutive Common Stock Equivalents Excluded from Calculation of Diluted Net Income (Loss) Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 19,135 | 3,332,052 | 2,806,934 | 3,332,052 |
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 | 2,529,433 | 1,641,099 | 2,529,433 | |
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 | 18,539 | 798,708 | 1,163,859 | 798,708 |
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 | 596 | 3,911 | 1,976 | 3,911 |
Revenue - Schedule of Product R
Revenue - Schedule of Product Revenue Based on Product Line and Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | $ 65,155 | $ 19,590 | $ 152,963 | $ 45,073 |
United States | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | 52,771 | 11,144 | 116,729 | 24,450 |
Europe | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | 8,624 | 6,370 | 27,266 | 15,962 |
All Other Countries | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | 3,760 | 2,076 | 8,968 | 4,661 |
Coronary | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | 47,165 | 6,983 | 99,175 | 16,403 |
Peripheral | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | 17,725 | 12,337 | 52,659 | 27,927 |
Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product revenue | $ 265 | $ 270 | $ 1,129 | $ 743 |
Equity Method Investments - Add
Equity Method Investments - Additional Information (Details) - USD ($) $ in Thousands | Mar. 19, 2021 | Sep. 30, 2021 | Sep. 30, 2021 |
Schedule Of Equity Method Investments [Line Items] | |||
Equity method investment | $ 6,408 | $ 6,408 | |
Share in net loss of equity method investment | 342 | 5,865 | |
Related party contract liability, noncurrent portion | 12,273 | 12,273 | |
Joint Venture | |||
Schedule Of Equity Method Investments [Line Items] | |||
Percentage of equity stake received | 45.00% | ||
Related party transaction. transaction price | $ 12,300 | ||
Related party contract liability, noncurrent portion | $ 12,300 | $ 12,300 | |
JV Agreement with Genesis MedTech | Share Subscription Agreement | |||
Schedule Of Equity Method Investments [Line Items] | |||
Ordinary shares issued | 54,900 | ||
Equity percentage | 55.00% | ||
Cash contribution from exchange of equity | $ 15,000 | ||
Percentage of cash contribution received from exchange of equity upon signing of agreement | 50.00% | ||
Percentage of cash contribution receivable from exchange of equity within one year | 50.00% | ||
JV Agreement with Genesis MedTech | License Agreement | |||
Schedule Of Equity Method Investments [Line Items] | |||
Ordinary shares issued | 45,000 | ||
Equity percentage | 45.00% |
Equity Method Investments - Sum
Equity Method Investments - Summary of Unaudited Balance Sheet (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance sheet: | ||
Current assets | $ 256,028 | $ 246,300 |
Current liabilities | (40,266) | $ (25,581) |
JV Agreement with Genesis MedTech | ||
Balance sheet: | ||
Current assets | 14,991 | |
Current liabilities | (757) | |
Net assets | $ 14,234 |
Equity Method Investments - S_2
Equity Method Investments - Summary of Unaudited Results of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Schedule Of Equity Method Investments [Line Items] | ||||
Product revenue | $ 65,155 | $ 19,590 | $ 152,963 | $ 45,073 |
Loss from operations | 2,813 | (12,807) | (14,854) | (49,797) |
Net income (loss) | 1,948 | $ (12,932) | (22,078) | $ (49,825) |
JV Agreement with Genesis MedTech | ||||
Schedule Of Equity Method Investments [Line Items] | ||||
Loss from operations | 758 | 13,033 | ||
Net income (loss) | $ 758 | $ 13,033 |