Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-38847 | |
Entity Registrant Name | SILK ROAD MEDICAL, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8777622 | |
Entity Address, Address Line One | 1213 Innsbruck Dr. | |
Entity Address, City or Town | Sunnyvale | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94089 | |
City Area Code | 408 | |
Local Phone Number | 720-9002 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | SILK | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 33,958,944 | |
Entity Central Index Key | 0001397702 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 62,468 | $ 39,181 |
Short-term investments | 91,442 | 51,508 |
Accounts receivable, net | 9,398 | 8,601 |
Inventories | 10,946 | 10,322 |
Prepaid expenses and other current assets | 3,443 | 2,878 |
Total current assets | 177,697 | 112,490 |
Long-term investments | 0 | 18,224 |
Property and equipment, net | 2,824 | 2,734 |
Restricted cash | 310 | 310 |
Other non-current assets | 2,997 | 3,644 |
Total assets | 183,828 | 137,402 |
Current liabilities: | ||
Accounts payable | 2,046 | 1,898 |
Accrued liabilities | 13,008 | 15,034 |
Total current liabilities | 15,054 | 16,932 |
Long-term debt | 45,160 | 44,879 |
Other liabilities | 3,876 | 3,700 |
Total liabilities | 64,090 | 65,511 |
Commitments and contingencies (Note 7) | ||
Preferred stock, $0.001 par value | ||
Shares issued and outstanding: none | 0 | 0 |
Common stock, $0.001 par value | ||
Shares issued and outstanding: 33,889,077 and 31,255,267 at September 30, 2020 and December 31, 2019, respectively | 34 | 31 |
Additional paid-in capital | 341,687 | 263,384 |
Accumulated other comprehensive income | 152 | 2 |
Accumulated deficit | (222,135) | (191,526) |
Total stockholders' equity | 119,738 | 71,891 |
Total liabilities and stockholders' equity | $ 183,828 | $ 137,402 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Preferred stock, $0.001 par value | ||
Preferred stock par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock, $0.001 par value | ||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 33,889,077 | 31,255,267 |
Common stock, shares outstanding (in shares) | 33,889,077 | 31,255,267 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenue | $ 20,067 | $ 17,026 | $ 54,093 | $ 44,721 |
Cost of goods sold | 5,488 | 4,170 | 16,074 | 11,206 |
Gross profit | 14,579 | 12,856 | 38,019 | 33,515 |
Operating expenses: | ||||
Research and development | 4,711 | 3,187 | 11,232 | 9,008 |
Selling, general and administrative | 19,202 | 17,064 | 54,652 | 45,064 |
Total operating expenses | 23,913 | 20,251 | 65,884 | 54,072 |
Loss from operations | (9,334) | (7,395) | (27,865) | (20,557) |
Interest income | 249 | 565 | 951 | 1,215 |
Interest expense | (1,215) | (1,176) | (3,620) | (3,736) |
Other income (expense), net | (15) | (1) | (74) | (21,046) |
Net loss | (10,315) | (8,007) | (30,608) | (44,124) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on investments, net | (164) | 0 | 150 | 0 |
Net change in other comprehensive loss | (164) | 0 | 150 | 0 |
Net loss and comprehensive loss | $ (10,479) | $ (8,007) | $ (30,458) | $ (44,124) |
Net loss per share, basic and diluted (in USD per share) | $ (0.31) | $ (0.26) | $ (0.94) | $ (2.18) |
Weighted average common shares used to compute net loss per share, basic and diluted (in shares) | 33,757,599 | 30,764,354 | 32,597,007 | 20,249,580 |
Condensed Statements of Redeema
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | IPO | Common Stock | Common StockIPO | Additional Paid-in Capital | Additional Paid-in CapitalIPO | Accumulated Deficit | Accumulated Other Comprehensive Income |
Temporary equity, beginning balance (in shares) at Dec. 31, 2018 | 21,233,190 | |||||||
Temporary equity, beginning balance at Dec. 31, 2018 | $ 105,235 | |||||||
Redeemable Convertible Preferred Stock | ||||||||
Exercise of Series C preferred stock warrants (in shares) | 4,915 | |||||||
Exercise of Series C preferred stock warrants | $ 30 | |||||||
Temporary equity, ending balance (in shares) at Mar. 31, 2019 | 21,238,105 | |||||||
Temporary equity, ending balance at Mar. 31, 2019 | $ 105,265 | |||||||
Beginning balance (in shares) at Dec. 31, 2018 | 1,135,310 | |||||||
Beginning balance at Dec. 31, 2018 | (134,553) | $ 1 | $ 4,557 | $ (139,111) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 251,305 | |||||||
Exercise of stock options | 375 | 375 | ||||||
Stock-based compensation | 262 | 262 | ||||||
Net loss and comprehensive loss | (24,158) | (24,158) | ||||||
Ending balance (in shares) at Mar. 31, 2019 | 1,386,615 | |||||||
Ending balance at Mar. 31, 2019 | $ (158,074) | $ 1 | 5,194 | (163,269) | ||||
Temporary equity, beginning balance (in shares) at Dec. 31, 2018 | 21,233,190 | |||||||
Temporary equity, beginning balance at Dec. 31, 2018 | $ 105,235 | |||||||
Temporary equity, ending balance (in shares) at Sep. 30, 2019 | 0 | |||||||
Temporary equity, ending balance at Sep. 30, 2019 | $ 0 | |||||||
Beginning balance (in shares) at Dec. 31, 2018 | 1,135,310 | |||||||
Beginning balance at Dec. 31, 2018 | (134,553) | $ 1 | 4,557 | (139,111) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net loss | (44,124) | |||||||
Net loss and comprehensive loss | (44,124) | |||||||
Ending balance (in shares) at Sep. 30, 2019 | 30,775,980 | |||||||
Ending balance at Sep. 30, 2019 | $ 77,443 | $ 31 | 260,647 | (183,235) | ||||
Temporary equity, beginning balance (in shares) at Mar. 31, 2019 | 21,238,105 | |||||||
Temporary equity, beginning balance at Mar. 31, 2019 | $ 105,265 | |||||||
Redeemable Convertible Preferred Stock | ||||||||
Exercise of Series C preferred stock warrants (in shares) | 287,446 | 1,653,004 | ||||||
Exercise of Series C preferred stock warrants | $ 1,754 | $ 37,121 | ||||||
Conversion of preferred stock to common stock issued upon the conversion of preferred stock into common stock in IPO (in shares) | (23,178,555) | |||||||
Conversion of preferred stock to common stock issued upon the conversion of preferred stock into common stock in IPO | $ (144,140) | |||||||
Temporary equity, ending balance (in shares) at Jun. 30, 2019 | 0 | |||||||
Temporary equity, ending balance at Jun. 30, 2019 | $ 0 | |||||||
Beginning balance (in shares) at Mar. 31, 2019 | 1,386,615 | |||||||
Beginning balance at Mar. 31, 2019 | (158,074) | $ 1 | 5,194 | (163,269) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of common stock warrants (in shares) | 3,764 | 2,204 | ||||||
Exercise of common stock warrants | 31 | 31 | ||||||
Exercise of stock options (in shares) | 176,576 | 6,000,000 | ||||||
Exercise of stock options | 364 | 109,039 | $ 1 | $ 6 | 363 | $ 109,033 | ||
Conversion of preferred stock to common stock issued upon the conversion of preferred stock into common stock in IPO (in shares) | 23,178,555 | |||||||
Conversion of preferred stock to common stock issued upon the conversion of preferred stock into common stock in IPO | 144,140 | $ 23 | 144,117 | |||||
Stock-based compensation | 836 | 836 | ||||||
Net loss and comprehensive loss | (11,959) | (11,959) | ||||||
Ending balance (in shares) at Jun. 30, 2019 | 30,747,714 | |||||||
Ending balance at Jun. 30, 2019 | $ 84,377 | $ 31 | 259,574 | (175,228) | ||||
Temporary equity, ending balance (in shares) at Sep. 30, 2019 | 0 | |||||||
Temporary equity, ending balance at Sep. 30, 2019 | $ 0 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 28,266 | |||||||
Exercise of stock options | 68 | 68 | ||||||
Decrease in IPO offering costs | 80 | 80 | ||||||
Stock-based compensation | 925 | 925 | ||||||
Net loss | (8,007) | |||||||
Net loss and comprehensive loss | (8,007) | (8,007) | ||||||
Ending balance (in shares) at Sep. 30, 2019 | 30,775,980 | |||||||
Ending balance at Sep. 30, 2019 | 77,443 | $ 31 | 260,647 | (183,235) | ||||
Beginning balance (in shares) at Dec. 31, 2019 | 31,255,267 | |||||||
Beginning balance at Dec. 31, 2019 | 71,891 | $ 31 | 263,384 | (191,526) | $ 2 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 140,370 | |||||||
Exercise of stock options | 274 | 274 | ||||||
Stock-based compensation | 1,293 | 1,293 | ||||||
Net loss | (9,941) | (9,941) | ||||||
Unrealized gain (loss) on investments, net | 440 | 440 | ||||||
Ending balance (in shares) at Mar. 31, 2020 | 31,395,637 | |||||||
Ending balance at Mar. 31, 2020 | 63,957 | $ 31 | 264,951 | (201,467) | 442 | |||
Beginning balance (in shares) at Dec. 31, 2019 | 31,255,267 | |||||||
Beginning balance at Dec. 31, 2019 | $ 71,891 | $ 31 | 263,384 | (191,526) | 2 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 684,815 | |||||||
Net loss | $ (30,608) | |||||||
Net loss and comprehensive loss | (30,458) | |||||||
Ending balance (in shares) at Sep. 30, 2020 | 33,889,077 | |||||||
Ending balance at Sep. 30, 2020 | 119,738 | $ 34 | 341,687 | (222,135) | 152 | |||
Beginning balance (in shares) at Mar. 31, 2020 | 31,395,637 | |||||||
Beginning balance at Mar. 31, 2020 | 63,957 | $ 31 | 264,951 | (201,467) | 442 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 265,467 | 1,923,076 | ||||||
Exercise of stock options | 604 | $ 70,543 | $ 1 | $ 2 | 603 | $ 70,541 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 25,919 | |||||||
Issuance of common stock under employee stock purchase plan | 801 | 801 | ||||||
Stock-based compensation | 1,654 | 1,654 | ||||||
Net loss | (10,353) | (10,353) | ||||||
Unrealized gain (loss) on investments, net | (126) | (126) | ||||||
Ending balance (in shares) at Jun. 30, 2020 | 33,610,099 | |||||||
Ending balance at Jun. 30, 2020 | 127,080 | $ 34 | 338,550 | (211,820) | 316 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | 278,978 | |||||||
Exercise of stock options | 1,131 | 1,131 | ||||||
Stock-based compensation | 2,006 | 2,006 | ||||||
Net loss | (10,315) | (10,315) | ||||||
Net loss and comprehensive loss | (10,479) | |||||||
Unrealized gain (loss) on investments, net | (164) | (164) | ||||||
Ending balance (in shares) at Sep. 30, 2020 | 33,889,077 | |||||||
Ending balance at Sep. 30, 2020 | $ 119,738 | $ 34 | $ 341,687 | $ (222,135) | $ 152 |
Condensed Statements of Redee_2
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Stockholders' Equity [Abstract] | ||
Payments of stock issuance costs | $ 4,457 | $ 10,961 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (30,608) | $ (44,124) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 563 | 530 |
Stock-based compensation expense | 4,953 | 2,023 |
Change in fair value of redeemable convertible preferred stock warrant liability | 0 | 21,030 |
Amortization of premiums (accretion of discounts) on investments, net | 145 | 0 |
Amortization of debt discount and debt issuance costs | 35 | 34 |
Amortization of right-of-use asset | 447 | 440 |
Non-cash interest expense | 249 | 595 |
Loss on disposal of property and equipment | 51 | 0 |
Change in provision for doubtful accounts receivable | (26) | 641 |
Provision for excess and obsolete inventories | 109 | 78 |
Changes in assets and liabilities | ||
Accounts receivable | (771) | (3,575) |
Inventories | (732) | (3,609) |
Prepaid expenses and other current assets | (565) | (2,096) |
Other assets | 200 | 764 |
Accounts payable | 29 | 712 |
Accrued liabilities | (2,054) | 2,777 |
Other liabilities | 176 | (569) |
Net cash used in operating activities | (27,799) | (24,349) |
Cash flows from investing activities | ||
Purchases of property and equipment | (587) | (337) |
Purchases of investments | (58,884) | 0 |
Proceeds from maturity of investments | 37,180 | 0 |
Net cash used in investing activities | (22,291) | (337) |
Cash flows from financing activities | ||
Proceeds from public offerings, net of underwriting discount, commissions and offering costs paid | 70,568 | 109,352 |
Proceeds from issuance of common stock | 2,809 | 806 |
Net cash provided by financing activities | 73,377 | 111,973 |
Net change in cash, cash equivalents and restricted cash | 23,287 | 87,287 |
Cash, cash equivalents and restricted cash, beginning of period | 39,491 | 25,300 |
Cash, cash equivalents and restricted cash, end of period | 62,778 | 112,587 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 3,336 | 3,107 |
Non-cash investing and financing activities: | ||
Accounts payable and accrued liabilities for purchases of property and equipment | 118 | 9 |
Offering costs in accounts payable and accrued liabilities | 25 | 0 |
Right-of-use asset obtained in exchange for lease obligation | 0 | 3,982 |
Net exercise of convertible preferred stock warrants to preferred stock | 0 | 37,121 |
Conversion of convertible preferred stock to common stock upon initial public offering | 0 | 144,140 |
Redeemable Convertible Preferred Stock | ||
Cash flows from financing activities | ||
Proceeds from exercise of stock warrants | 0 | 1,784 |
Common Stock Warrant | ||
Cash flows from financing activities | ||
Proceeds from exercise of stock warrants | $ 0 | $ 31 |
Formation and Business of the C
Formation and Business of the Company | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Formation and Business of the Company | Formation and Business of the Company The Company Silk Road Medical, Inc. (the “Company”) was incorporated in the state of Delaware on March 21, 2007. The Company has developed a technologically advanced, minimally-invasive solution for patients with carotid artery disease who are at risk for stroke. The Company's portfolio of TCAR products enable a new procedure, referred to as transcarotid artery revascularization, or TCAR, that combines the benefits of endovascular techniques and surgical principles. The Company manufactures and sells in the United States its portfolio of TCAR products which are designed to provide direct access to the carotid artery, effective reduction in stroke risk throughout the procedure, and long-term restraint of carotid plaque. The Company commercialized its products in the United States in late 2015. Reverse Stock Split On March 13, 2019, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 1-for-2.7 reverse stock split of the Company’s common stock and redeemable convertible preferred stock to be consummated prior to the effectiveness of the Company’s planned initial public offering, or IPO. The reverse stock split was effected on March 27, 2019. The par values of the common stock and redeemable convertible preferred stock were not adjusted as a result of the reverse stock split. All the common stock, redeemable convertible preferred stock, stock options and warrants, and related per share amounts in the condensed financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split. Public Offerings In April 2019, the Company issued and sold 6,000,000 shares of its common stock in its IPO at a public offering price of $20.00 per share, for net proceeds of approximately $109,119,000 after deducting underwriting discounts and commissions of approximately $8,400,000 and expenses of approximately $2,481,000. Upon the closing of the IPO, all shares of redeemable convertible preferred stock then outstanding converted into shares of common stock and the Company's outstanding warrants to purchase shares of common and redeemable convertible preferred stock were exercised, or automatically net exercised absent a prior election. The exercises resulted in the reclassification of the fair value of the related redeemable convertible preferred stock warrant liability to additional paid-in capital. In August 2019, the Company completed a secondary public offering of 4,200,000 shares of its common stock sold by certain selling stockholders, and the exercise in full of the underwriters' option to purchase 630,000 additional shares of its common stock from certain selling stockholders, at a public offering price of $39.50 per share. The Company did not receive any of the proceeds from the sale of the shares of its common stock by the selling stockholders. In May 2020, the Company completed an underwritten public offering of 6,808,154 shares of its common stock, of which 1,923,076 shares were offered for sale by the Company and the remaining 4,885,078 shares were offered for sale by certain selling stockholders, at a public offering price of $39.00 per share. The Company received cash proceeds of approximately $70,543,000 after deducting underwriting discounts and commissions of approximately $3,750,000 and expenses of approximately $707,000. Also in May 2020, the underwriters fully exercised their option to purchase 1,021,223 additional shares of common stock from the selling stockholders. The Company did not receive any of the proceeds from the sale of the shares of its common stock by the selling stockholders. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2019, and related disclosures, have been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s condensed financial information. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2019 included in the Company's annual report on Form 10-K filed with the SEC on March 2, 2020. Adjustment to Prior Period Financial Statements The Company has adjusted the accompanying Condensed Statement of Cash Flows for the nine months ended September 30, 2019 to increase each of the accounts receivable, net, and accrued liabilities amounts by $522,000 for an immaterial prior period error in the classification of provisions for returns from customers. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses judgment when making estimates related to provisions for accounts receivable and excess and obsolete inventories, the valuation of deferred tax assets, the provision for sales returns, stock-based compensation, and for periods prior to the Company's IPO, the valuation of common stock and redeemable convertible preferred stock warrants. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Due to the coronavirus (“COVID-19”) pandemic, there has been continued uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of September 30, 2020. The Company has also considered information available to it as of the date of issuance of these financial statements and is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. Actual results could differ materially from these estimates. Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of September 30, 2020 and December 31, 2019. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, long-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its long-term debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Prior to the Company's IPO, fair value accounting was applied to the redeemable convertible preferred stock warrant liability. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. As of September 30, 2020 and December 31, 2019, the Company’s cash equivalents are entirely comprised of investments in money market funds. Restricted cash as of September 30, 2020 and December 31, 2019 consists of a letter of credit of $310,000 representing collateral for the Company's facility lease. Investments Short-term investments consist of debt securities classified as available-for-sale and have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Money market funds and United States treasury bills with an original maturity less than 90 days are classified within Level 1 of the fair value hierarchy, and commercial paper, corporate bonds/notes, United States Government securities, and asset-backed securities are classified within Level 2 of the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). The cost of available-for-sale investments sold is based on the specific-identification method. Realized gains and losses are included in earnings, and are der ived for specific-identification method for determining the costs of investments sold. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. Concentration of Credit Risk, and Other Risks and Uncertainties The Company is subject to risks related to public health criseses such as the global pandemic associated with COVID-19, which has spread to most countries and all 50 states within the United States. The COVID-19 outbreak has negatively impacted, and may continue to negatively impact the Company’s operations, its revenue and overall financial condition by significantly decreasing the number of TCAR procedures performed. The number of TCAR procedures performed, similar to other surgical procedures, has significantly decreased as health care organizations globally have prioritized the treatment of patients with COVID-19. For example, in the United States, governmental authorities have recommended, and in certain cases required, that elective, specialty and other procedures and appointments, be suspended or canceled to focus limited resources and personnel and hospital capacity toward the treatment of COVID-19 and to avoid exposing patients to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and will continue to negatively impact the Company’s revenue while the pandemic continues. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds and United States treasury bills. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, United States Government securities, asset-backed securities and, by policy, limits the amount of credit exposure with any one financial institution or commercial issuer. The Company has not experienced any material losses on its deposits of cash and cash equivalents or investments during the three and nine months ended September 30, 2020 and 2019. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At September 30, 2020 and December 31, 2019, no customer represented 10% or more of the Company’s accounts receivable. For the three and nine months ended September 30, 2020 and 2019, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for doubtful accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE stent. Disruption in component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the FDA or international regulatory agencies. In addition, in order to continue the Company’s operations, compliance with various federal and state laws is required. If the Company were denied or delayed in receiving such approvals or clearances, it may be necessary to adjust operations to align with the Company’s currently approved portfolio of products. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. Leases The Company adopted Accounting Standards Codification (“ASC”) 842, "Leases," on January 1, 2019 and used the modified retrospective method for all leases not substantially completed as of the date of adoption and the package of practical expedients available in the standard. The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the identified asset. The Company also evaluates the nature of each lease to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The Company’s considers renewal options in the determination of the lease term if the option to renew is reasonably certain. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease costs, which consists primarily of taxes, insurance and common area maintenance costs, are expensed as incurred, as the Company has elected to account separately for contracts that contain lease and non-lease components, consistent with its historical practice. The Company does not have any finance leases. Redeemable Convertible Preferred Stock Warrant Liability Prior to its IPO, the Company accounted for its warrants for shares of redeemable convertible preferred stock as a liability based upon the characteristics and provisions of each instrument. Redeemable convertible preferred stock warrants classified as a liability were initially recorded at their fair value on the date of issuance and are subject to remeasurement at each subsequent balance sheet date. Any change in fair value as a result of a remeasurement was recognized as a component of other income (expense), net in the condensed statements of operations and comprehensive loss. The Company recorded adjustments to the estimated fair value of the redeemable convertible preferred stock warrants until they were exercised. Upon their exercise, the final fair value of the warrant liability was reclassified to stockholders’ equity. Subsequent to its IPO, the Company no longer recorded any related periodic fair value adjustments. Redeemable Convertible Preferred Stock Prior to its IPO, the Company recorded its redeemable convertible preferred stock at fair value on the dates of issuance, net of issuance costs, and classified the redeemable convertible preferred stock outside of stockholders’ equity on the condensed balance sheet as events triggering the liquidation preferences were not solely within the Company’s control. Upon the closing of the Company's IPO, all shares of convertible preferred stock then outstanding converted into an aggregate of 23,178,555 shares of common stock resulting in the reclassification of $144,140,000 from outside of stockholders’ equity to additional paid-in capital. Reven ue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amou nt that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of September 30, 2020 and December 31, 2019, the Company recorded $131,000 and $102,000, respectively, of unbilled receivables, which are included in accounts receivable, net on the condensed balance sheet, as the Company has an unconditional right to payment as of the end of the applicable period. The Company’s revenue is generated from the sale of its products to hospitals and medical centers in the United States through direct sales representatives. Revenue is recognized when obligations under the terms of a contract with customers are satisfied, which occurs with the transfer of control of the Company’s products to its customers, either upon shipment of the product or delivery of the product to the customer under the Company’s standard terms and conditions. The Company’s products are readily available for usage as soon as the customer possesses it. Upon receipt, the customer controls the economic benefits of the product, has significant risks and rewards, and the legal title. The Company has present right to payment; therefore, the transfer of control is deemed to happen at a point in time. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring the goods. For sales where the Company’s sales representative hand delivers product directly to the hospital or medical center from the sales representative’s trunk stock inventory, the Company recognizes revenue upon delivery, which represents the point in time when control transfers to the customer. Upon delivery there are legally-enforceable rights and obligations between the parties which can be identified, commercial substance exists and collectability is probable. For sales which are sent directly from the Company to hospitals and medical centers, the transfer of control occurs at the time of shipment or delivery of the product. There are no further performance obligations by the Company or the sales representative to the customer after delivery under either method of sale. As allowed under the practical expedient, the Company does not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which it recognizes revenue at the amount to which it has the right to invoice for services performed. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales include commissions and royalties. The Company applies the practical expedient and recognizes commissions and royalties as expense when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the condensed statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the condensed balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its facility and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and subassemblies, manufacturing overhead costs, direct labor, reserves for excess, obsolete and non-sellable inventories as well as distribution-related expenses. A significant portion of the Company’s cost of goods sold currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalties. Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board (“FASB”) ASC 718, "Compensation-Stock Compensation." ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options, restricted stock units and shares issued under its employee stock purchase plan. ASC 718 requires companies to estimate the fair value of all share-based payment option awards on the date of grant using an option pricing model. The fair value of stock options is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period), on a straight-line basis. For performance-based stock options, the Company will assess the probability of performance conditions being achieved in each reporting period. The amount of stock-based compensation expense recognized in any one period related to performance-based stock options can vary based on the achievement or anticipated achievement of the performance conditions. The Company accounts for option forfeitures as they occur. The Company accounts for stock-based compensation for restricted stock units at their fair value, based on the closing market price of the Company's common stock on the date of grant. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the condensed financial statements and tax bases of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company has historically incurred operating losses, it has established a full valuation allowance against its net deferred tax assets, and there is no provision for income taxes. The Company also follows the provisions of ASC 740-10, "A ccounting for Uncertainty in Income Taxes." ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. No liability related to uncertain tax positions is recorded on the condensed financial statements. It is the Company's policy to include penalties and interest expense related to income taxes as part of the provision for income taxes. Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on investments classified as available-for-sale. For the three and nine months ended September 30, 2020 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the condensed statements of operations and comprehensive loss. Accumulated other comprehensive income or loss is presented in the accompanying condensed balance sheet as a component of stockholders' equity. For the three and nine months ended September 30, 2019 , there was no difference between the Company's comprehensive loss and its net loss. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock and warrants, common stock options, and restricted stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. The Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The shares of the Company’s redeemable convertible preferred stock participate in any dividends declared by the Company and were therefore considered to be participating securities. Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended Nine Months Ended 2020 2019 2020 2019 Net loss $ (10,315) $ (8,007) $ (30,608) $ (44,124) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 33,757,599 30,764,354 32,597,007 20,249,580 Net loss, basic and diluted $ (0.31) $ (0.26) $ (0.94) $ (2.18) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company's net loss: September 30, 2020 2019 Common stock options 4,451,768 4,677,878 Restricted stock units 44,109 — 4,495,877 4,677,878 Segment and Geographical Information The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s long-lived assets are based in the United States. Long-lived assets are comprised of property and equipment and the Company's right-of-use asset. All of the Company’s revenue was in the United States for the three and nine months ended September 30, 2020 and 2019, based on the shipping location of the external customer. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-13, "Fair Value Measurement," which changed the disclosure requirements for fair value measurements by removing, adding and modifying certain disclosures. The Company adopted the new standard effective January 1, 2020. The adoption did not have a material impact on the Company's financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-15, "Cloud Computing Arrangements," which aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license. The Company adopted the new standard effective January 1, 2020 on a prospective basis. The adoption did not have a material impact on the Company's financial statements and related disclosures. Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, "Measurement of Credit Losses on Financial Statements." This update provides financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. The update replaces the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. In October 2019, the FASB delayed the effective date of this standard for smaller reporting companies, as such ASU 2016-13 would originally be effective for the Company on January 1, 2023. As of June 30, 2020, the Company no longer qualified as a smaller reporting company, accordingly ASU 2016-13 will become effective for the Company on January 1, 2021. The Company is evaluating the impact of adopting this guidance to the Company's financial statements and related disclosures. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which enhances and simplifies various aspects of the income tax accounting guidance related to intra-period tax allocation, interim period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim period tax accounting. ASU 2019-12 also amends other aspects of the guidance to reduce complexity in certain areas. ASU 2019-12 will become effective for the Company on January 1, 2021. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance to the Company's financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, investments, and the Company's previously outstanding preferred stock warrants . Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: • Level 1 – quoted prices in active markets for identical assets or liabilities; • Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; • Level 3 – unobservable inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. The corporate bonds/notes, commercial paper, asset-backed securities and U.S. government securities are classified as Level 2 as they are valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The following tables sets forth by level within the fair value hierarchy the Company’s assets that are reported at fair value as of September 30, 2020 and December 31, 2019, using the inputs defined above (in thousands): September 30, 2020 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 61,078 $ — $ — $ 61,078 U.S. treasury bills — 9,999 — 9,999 Commercial paper — 31,863 — 31,863 Corporate bonds/notes — 16,186 — 16,186 U.S. government securities — 33,394 — 33,394 $ 61,078 $ 91,442 $ — $ 152,520 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper — 9,919 — 9,919 Corporate bonds/notes — 10,176 — 10,176 U.S. government securities — 44,456 — 44,456 Asset-backed securities — 5,181 — 5,181 $ 34,363 $ 69,732 $ — $ 104,095 There were no transfers between fair value hierarchy levels during the three and nine months ended September 30, 2020 and 2019. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Investments The fair value of the Company's available-for-sale investments as of September 30, 2020 and December 31, 2019 are as follows (in thousands): September 30, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 61,078 $ — $ — $ 61,078 U.S. treasury bills 9,998 1 — 9,999 Commercial paper 31,863 — — 31,863 Corporate bonds/notes 16,179 7 — 16,186 U.S. government securities 33,250 144 — 33,394 Asset-backed securities — — — — $ 152,368 $ 152 $ — $ 152,520 Classified as: Cash equivalents $ 61,078 Short-term investments 91,442 $ 152,520 December 31, 2019 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper 9,919 — — 9,919 Corporate bonds/notes 10,180 — (4) 10,176 U.S. government securities 44,450 9 (3) 44,456 Asset-backed securities 5,181 — — 5,181 $ 104,093 $ 9 $ (7) $ 104,095 Classified as: Cash equivalents $ 34,363 Short-term investments 51,508 Long-term investments 18,224 $ 104,095 The following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term investments classified by maturity as of September 30, 2020 and December 31, 2019 (in thousands): September 30, December 31, 2020 2019 Amounts maturing within one year $ 152,520 $ 85,871 Amounts maturing after one year through two years — 18,224 $ 152,520 $ 104,095 Available-for-sale investments held as of September 30, 2020 had a weighted average days to maturity of 136 days. The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds/notes $ — $ — $ 10,128 $ (4) U.S. government securities — — 19,067 (3) $ — $ — $ 29,195 $ (7) Inventories Components of inventories were as follows: (in thousands) September 30, December 31, 2020 2019 Raw materials $ 1,725 $ 1,203 Finished products 9,221 9,119 Total $ 10,946 $ 10,322 As of September 30, 2020 and December 31, 2019, there were no work-in-process inventories. Accrued Liabilities Accrued liabilities consist of the following: (in thousands) September 30, December 31, 2020 2019 Accrued payroll and related expenses $ 8,538 $ 9,151 Provision for sales returns 1,109 2,419 Accrued professional services 942 682 Operating lease liability 829 769 Accrued royalty expense 491 470 Deferred revenue 384 304 Accrued travel expenses 259 431 Accrued clinical expenses 169 241 Accrued other expenses 287 567 Total $ 13,008 $ 15,034 |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt In October 2015, the Company entered into a term loan agreement with CRG. The term loan agreement provides for up to $30,000,000 in term loans split into two tranches as follows: (i) the Tranche A Loans provided for $20,000,000 in term loans, and (ii) the Tranche B Loans provided for up to $10,000,000 in term loans. The Company drew down the Tranche A Loans on October 13, 2015. The Tranche B Loans were available to be drawn prior to March 29, 2017. In January 2017, the term loan agreement was amended to extend the commitment period of the Tranche B Loans to April 28, 2017. In April 2017, the Company drew down $5,000,000 of the available Tranche B Loans. In September 2018, the Company entered into Amendment No. 5 to the term loan agreement with CRG. Under the amended terms of the amended loan agreement the maturity date was extended to December 31, 2022 and the repayment schedule of the existing term loans were changed to interest only so that the outstanding principal amount of the term loans will be payable in a single installment at maturity. The related fixed interest rate was changed to equal 10.75% per annum, due and payable quarterly in arrears. At the election of the Company, 2.75% of the interest due and payable may be “paid in kind” and added to the then outstanding principal and 8.0% of the interest due and payable paid in cash. All unpaid principal, and accrued and unpaid interest, is due and payable in full on December 31, 2022. The amended term loan agreement also provided for additional term loans in an aggregate principal amount of up to $25,000,000 and allowed for the conversion into shares of common stock, at the Company’s option, of up to 25% of the outstanding loans under the term loan agreement in connection with an initial public offering of the Company’s common stock which results in market capitalization of at least $250,000,000. In September 2018, the Company drew down an additional $15,000,000 under the term loan agreement with CRG. As provided for under the terms of the amended term loan agreement, the related fixed interest rate was further reduced to 10.0% upon the consummation of the Company's IPO in April 2019. Also, post consummation of the Company's IPO, 8.0% of the interest is due and payable in cash and at the election of the Company, 2.0% of the interest due and payable may be "paid in kind". In June 2019, the Company entered into Amendment No. 7 to the term loan agreeme nt with CRG to reflect flexibility with respect to permitted cash investments. The Company may voluntarily prepay the borrowings in full. The Tranche A borrowing required a payment, on the borrowing date, of a financing fee equal to 1.75% of the borrowed loan principal, which is recorded as a discount to the debt. In addition, a facility fee equal to 5.0% of the amounts borrowed plus any "paid in kind" is payable at the end of the term or when the borrowings are repaid in full. A long-term liability is being accreted using the effective interest method for the facility fee over the term of the loan agreement. The borrowings are collateralized by a security interest in substantially all of the Company’s assets. The Company is subject to financial covenants related to liquidity and minimum trailing revenue targets that began in December 31, 2016 and are tested on an annual basis. The liquidity covenant requires the Company to maintain an amount which shall exceed the greater of (i) $3,000,000 and (ii) the minimum cash balance, if any, required of the Company by a creditor to the extent the Company has incurred permitted priority debt. The Company had to achieve minimum net revenue of $1,000,000 in 2016, $5,000,000 in 2017, $15,000,000 in 2018, $30,000,000 in 2019 and must achieve minimum net revenue of $40,000,000 in 2020. The liquidity financial covenant has a 90-day equity cure period following end of the calendar year to issue additional shares of equity interests in exchange for cash, or to borrow permitted cure debt. In addition, the term loan agreement prohibits the payment of cash dividends on the Company’s capital stock and also places restrictions on mergers, sales of assets, investments, incurrence of liens, incurrence of indebtedness and transactions with affiliates. CRG may accelerate the payment terms of the term loan agreement upon the occurrence of certain events of default set forth therein, which include the failure of the Company to make timely payments of amounts due under the term loan agreement, the failure of the Company to adhere to the covenants set forth in the term loan agreement, the insolvency of the Company or upon the occurrence of a material adverse change. As of September 30, 2020, the Company was in compliance with all applicable financial covenants. As of September 30, 2020, management does not believe that it is probable that the above clauses will be triggered within the next twelve months, and therefore, the debt is classified as long-term on the condensed balance sheet. See Note 12. Future maturities under the term loan agreement as of September 30, 2020 are as follows (in thousands): Period Ending December 31: Amount 2020 $ 1,120 2021 4,442 2022 48,255 53,817 Add: Accretion of closing fees 1,452 55,269 Less: Amount representing interest (10,004) Less: Amount representing debt discount and debt issuance costs (105) Present value of minimum payments $ 45,160 In October 2015, CRG purchased 327,759 shares of the Company’s Series C redeemable convertible preferred stock at $6.11 per share. In addition, CRG received warrants to purchase 163,877 shares of the Company’s Series C redeemable convertible preferred stock at an exercise price of $6.11 per share. Upon the closing of the IPO, the warrants were net exercised, based on the initial public offering price of $20.00 per share, into shares of common stock. In July 2017, CRG purchased an additional 163,877 shares of the Company’s Series C convertible preferred stock at $6.11 per share. Upon the closing of the IPO, the Series C redeemable convertible preferred stock shares were converted into shares of common stock. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Lease and Rights-of-Use The Company’s operating lease obligation consists of leased office, laboratory, and manufacturing space under a non-cancellable operating lease that expires in October 2024. The lease agreement includes a renewal provision allowing the Company to extend this lease for an additional period of five years. Operating lease costs were $217,000 for each of the three months ended September 30, 2020 and 2019 and $652,000 for each of the nine months ended September 30, 2020 and 2019. Cash paid for amounts included in the measurement of operating lease liabilities was $197,000, $569,000, $178,000 and $540,000 for the three and nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the weighted average discount rate was approximately 6.50% and the weighted average remaining lease term was 4.08 years. Balance sheet information as of September 30, 2020 consists of the following (in thousands): Operating Lease: September 30, 2020 Operating lease right-of-use asset in other non-current assets $ 2,953 Operating lease liability in accrued liabilities $ 829 Operating lease liability in other liabilities 3,071 Total operating lease liabilities $ 3,900 The following table summarizes the Company’s operating lease maturities as of September 30, 2020 (in thousands): Period Ending December 31: Amount 2020 $ 262 2021 1,066 2022 1,096 2023 1,127 2024 904 Total lease payments 4,455 Less: imputed interest (555) Present value of lease liabilities $ 3,900 Purchase Obligations Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. As of September 30, 2020, the Company had non-cancellable purchase obligations to suppliers of $10,015,000. In November 2020, the Company entered into an agreement for the purchase of services resulting in an additional non-cancellable purchase obligation of $1,500,000. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. To date, the Company has not been subject to any claims or been required to defend any action related to its indemnification obligations. The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as a director may be subject to any proceeding arising out of acts or omissions of such director in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director liability insurance. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of September 30, 2020. Contingencies The Company is not involved in any pending legal proceedings that it believes could have a material adverse effect on its financial condition, results of operations or cash flows. From time to time, the Company may pursue litigation to assert its legal right and such litigation may be costly and divert the efforts and attention of its management and technical personnel which could adversely affect its business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual at September 30, 2020 and December 31, 2019. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2020 | |
Temporary Equity Disclosure [Abstract] | |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock Upon the closing of the IPO, all shares of convertible preferred stock then outstanding converted into shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any convertible preferred stock issued or outstanding. Preferred Stock Warrant s Upon the closing of the Company's IPO, all of the outstanding convertible preferred stock warrants were exercised, or net exercised based on the IPO price of $20.00 per share, into 1,945,365 shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any convertible preferred stock warrants outstanding. Preferred Stock At September 30, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 5,000,000 shares of preferred stock with $0.001 par value per share, of which no shares were issued and outstanding. Common Stock At September 30, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 100,000,000 shares of common stock with $0.001 par value per share, of which 33,889,077 shares were issued and outstanding. The holders of common stock are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. As of September 30, 2020, no dividends have been declared to date. Each share of common stock is entitled to one vote. Common Stock Warrant s In connection with the IPO, the common stock warrants were cash, or net exercised based on the IPO price of $20.00 per share, into 5,968 shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any common stock warrants outstanding. |
Stockholders Equity
Stockholders Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Stockholders Equity | Redeemable Convertible Preferred Stock Upon the closing of the IPO, all shares of convertible preferred stock then outstanding converted into shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any convertible preferred stock issued or outstanding. Preferred Stock Warrant s Upon the closing of the Company's IPO, all of the outstanding convertible preferred stock warrants were exercised, or net exercised based on the IPO price of $20.00 per share, into 1,945,365 shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any convertible preferred stock warrants outstanding. Preferred Stock At September 30, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 5,000,000 shares of preferred stock with $0.001 par value per share, of which no shares were issued and outstanding. Common Stock At September 30, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 100,000,000 shares of common stock with $0.001 par value per share, of which 33,889,077 shares were issued and outstanding. The holders of common stock are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. As of September 30, 2020, no dividends have been declared to date. Each share of common stock is entitled to one vote. Common Stock Warrant s In connection with the IPO, the common stock warrants were cash, or net exercised based on the IPO price of $20.00 per share, into 5,968 shares of common stock. As of September 30, 2020 and December 31, 2019, the Company does not have any common stock warrants outstanding. |
Stock Option Plans
Stock Option Plans | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Plans | Stock Option Plans In March 2019, the Company’s Board of Directors approved the adoption of the 2019 Equity Incentive Plan, or the 2019 Plan, which became effective immediately prior to the Company's IPO. The 2019 Plan replaced the 2007 Stock Option Plan which was terminated immediately prior to consummation of the Company’s IPO, collectively the “Plans.” The 2019 Plan provides for the grant of incentive stock options, or ISOs, to employees and for the grant of nonqualified stock options, or NSOs, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to employees, directors and consultants. A total of 2,317,000 shares of common stock were initially reserved for issuance pursuant to the 2019 Plan. In addition, the shares reserved for issuance under the 2019 Plan will also include shares reserved but not issued under the 2007 Stock Option Plan, plus any share awards granted under the 2007 Stock Option Plan that expire or terminate without having been exercised in full or that are forfeited or repurchased. In addition, the number of shares available for issuance under the 2019 Plan includes an annual increase on the first day of each fiscal year beginning fiscal 2020, equal to the lesser of (i) 3,000,000 shares; (ii) 4.0% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) an amount as determined by the Board of Directors. As of September 30, 2020, the Company has reserved 3,633,180 shares of common stock for issuance under the 2019 Plan. A summary of the shares available for issuance under the 2019 Plan is as follows: Number of Shares Balances, December 31, 2019 1,554,690 Authorized 1,250,210 Granted / Awarded (915,518) Cancelled 45,616 Balances, September 30, 2020 1,934,998 The exercise price of ISOs and NSOs shall not be less than 100% and 85%, respectively, of the estimated fair value of the shares on the date of grant as determined by the Board of Directors. The exercise price of ISOs and NSOs granted to a 10% stockholder shall not be less than 110% of the estimated fair value of the shares on the date of grant as determined by the Board of Directors. To date, options have a term of 10 years and generally vest over 4 years from the date of grant. Stock option activity under the Company’s Plans is set forth below: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 871,409 $ 36.39 Options exercised (684,815) $ 2.93 Options cancelled (45,616) $ 20.34 Balances, September 30, 2020 4,451,768 $ 14.12 7.39 $ 236,344 Vested and exercisable at September 30, 2020 2,505,631 $ 7.04 6.46 $ 150,776 Vested and expected to vest at September 30, 2020 4,451,768 $ 14.12 7.39 $ 236,344 The aggregate intrinsic value of options exercised during the nine months ended September 30, 2020, was $28,880,000. The aggregate intrinsic value was calculated as the difference between the exercise prices of the underlying options and the estimated fair value of the common stock on the date of exercise. Restricted Stock Units In March 2020, the Company began granting restricted stock units, or RSUs, under the 2019 Plan. RSUs generally vest over four years in annual equal increments, no RSUs vested during the nine months ended September 30, 2020. The fair value of RSUs is based on the Company’s closing stock price on the date of grant. A summary of RSUs activity for the nine months ended September 30, 2020 is as follows: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2019 — $ — Restricted stock granted 44,109 $ 33.01 Restricted stock vested — $ — Restricted stock forfeited — $ — Balances, September 30, 2020 44,109 $ 33.01 Expected to vest at September 30, 2020 44,109 $ 33.01 2019 Employee Stock Purchase Plan In March 2019, the Company's Board of Directors adopted the 2019 Employee Stock Purchase Plan, or 2019 ESPP, under which eligible employees are permitted to purchase common stock at a discount through payroll deductions. A total of 434,000 shares of common stock were initially reserved for issuance and is increased on the first day of each fiscal year, beginning in 2020, by an amount equal to the lesser of (i) 1,200,000 shares (ii) 1.0% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) an amount as determined by the Board of Directors. As of September 30, 2020, the Company has reserved 746,552 shares of common stock for issuance under the 2019 ESPP. The price of the common stock purchased will be the lower of 85% of the fair market value of the common stock at the beginning of an offering period or at the end of a purchase period. The 2019 ESPP was effective upon adoption by the Company's Board of Directors but was not in use until the completion of the Company's IPO in April 2019. The 2019 ESPP is intended to qualify as an "employee stock purchase plan" within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended. As of September 30, 2020, 87,567 shares of common stock have been issued to employees participating in the 2019 ESPP and 658,985 shares were available for future issuance under the 2019 ESPP. Stock-Based Compensation The Company estimated the fair value of stock options using the Black–Scholes option pricing model. The fair value of employee and nonemployee stock options is being amortized on a straight–line basis over the requisite service period of the awards. The fair value of employee and nonemployee stock options was estimated using the following assumptions for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended 2020 2019 2020 2019 Expected term (in years) 5.25 - 6.25 6.25 5.25 - 6.25 5.00 - 6.25 Expected volatility 48.0% - 49.1% 42.4% 43.0% - 49.1% 42.4% - 42.9% Risk-free interest rate 0.32% - 0.42% 1.47% 0.32% - 1.41% 1.47% - 2.54% Dividend yield —% —% —% —% The fair value of the shares to be issued under the Company’s 2019 ESPP was estimated using the Black-Scholes valuation model with the following assumptions for the three and nine months ended September 30, 2020: Three Months Ended Nine Months Ended 2020 2019 2020 2019 Expected term (in years) 0.50 0.63 0.50 0.63 Expected volatility 76.4% 47.8% 44.4% - 76.4% 47.8% Risk-free interest rate 0.14% 2.45% 0.14% - 1.58% 2.45% Dividend yield —% —% —% —% Total stock-based compensation expense relating to the Company's stock options, RSUs and 2019 ESPP during the three and nine months ended September 30, 2020 and stock-based compensation expense related to the Company's stock options and 2019 ESPP during the three and nine months ended September 30, 2019, is as follows (in thousands): Three Months Ended September 30, Nine Months Ended 2020 2019 2020 2019 Cost of goods sold $ 91 $ 61 $ 244 $ 129 Research and development expenses 304 134 726 288 Selling, general and administrative expenses 1,611 730 3,983 1,606 $ 2,006 $ 925 $ 4,953 $ 2,023 |
401(k) Plan
401(k) Plan | 9 Months Ended |
Sep. 30, 2020 | |
Retirement Benefits [Abstract] | |
401(k) Plan | 401(k) PlanThe Company has a qualified retirement plan under section 401(k) of the Internal Revenue Code (“IRC”) under which participants may contribute up to 90% of their eligible compensation, subject to maximum deferral limits specified by the IRC. Beginning in January 2020, the Company started matching employees' contributions to the 401(k) plan at 50% of the first 5% of compensation deferred to the 401(k) plan. The Company's matching contributions were $195,000 and $717,000 for the three and nine months ended September 30, 2020, respectively. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event Debt Refinancing On October 29, 2020, the Company entered into a Loan and Security Agreement ("Loan Agreement") with Stifel Bank. The Loan Agreement provides for a $50,000,000 loan facility, comprised of a $50,000,000 secured revolving credit facility, with a $2,000,000 subfacility for the issuance of letters of credit and other ancillary banking services, and a $50,000,000 secured term loan facility, provided that amounts outstanding under both facilities may not exceed an aggregate principal amount of $50,000,000 at any time. Under the terms of the Loan Agreement any borrowings under the revolving credit facility mature on October 29, 2022, or October 29, 2023 if as of October 29, 2022, no event of default has occurred and the Company is in compliance with the terms of the Loan Agreement. Term loans mature on October 29, 2024. Borrowings under the revolving loans accrue interest at a rate equal to the greater of (a) the prime rate plus a margin of 0.50% and (b) 4.75%, and the term loans accrue interest at a rate equal to the greater of (a) the prime rate plus a margin of 0.75% and (b) 4.75%. Interest on both loans is payable monthly in arrears. The Company may borrow, prepay and reborrow revolving loans, without premium or penalty. The principal amount of outstanding revolving loans, together with accrued and unpaid interest, is due on the revolving loan maturity date. The principal amount of outstanding term loans shall be repaid in equal monthly installments beginning on May 29, 2022, or November 29, 2022 if the Company achieves revenues for the Company’s fiscal year ending December 31, 2021 of at least 80% of its board-approved financial projections for such fiscal year. The term loans may not be reborrowed once repaid, but the Company may prepay term loans at any time without premium or penalty. The Company is also obligated to pay a fee to the lender upon the occurrence of certain liquidity events, along with other customary fees for a loan facility of this size and type. The Company’s obligations under the Loan Agreement are secured by substantially all of the Company’s assets. Beginning on January 15, 2021, the Loan Agreement requires the Company to maintain unrestricted cash and cash equivalents with the lender of at least $20,000,000. In addition, for any fiscal quarter where the Company’s unrestricted cash and cash equivalents maintained with the lender (or prior to January 15, 2021, the lender or certain other banks) is less than $60,000,000 for any day during such fiscal quarter, the Company must comply with a minimum revenue covenant. Additionally, the Loan Agreement contains customary affirmative and negative covenants, including covenants limiting the ability of the Company and its subsidiaries to, among other things, dispose of assets, effect certain mergers, incur debt, grant liens, pay dividends and distributions on their capital stock, make investments and acquisitions, and enter into transactions with affiliates, in each case subject to customary exceptions for a loan facility of this size and type. The events of default under the Loan Agreement include, among others, payment defaults, material misrepresentations, breaches of covenants, cross defaults with certain other material indebtedness, bankruptcy and insolvency events, and judgment defaults. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the Loan Agreement, the termination of the lender’s commitments, a 5% increase in the applicable rate of interest and the exercise by the lender of other rights and remedies provided for under the Loan Agreement. Also on October 29, 2020, the Company drew down $49,000,000 under the term loan facility and used the majority of the proceeds to pay off and terminate its loan agreement with CRG, totaling $43,813,000. Additionally, the Company incurred a prepayment premium fee of $305,000, accrued interest of $365,000 and a facility fee of $2,191,000. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2019, and related disclosures, have been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s condensed financial information. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2019 included in the Company's annual report on Form 10-K filed with the SEC on March 2, 2020. Adjustment to Prior Period Financial Statements The Company has adjusted the accompanying Condensed Statement of Cash Flows for the nine months ended September 30, 2019 to increase each of the accounts receivable, net, and accrued liabilities amounts by $522,000 for an immaterial prior period error in the classification of provisions for returns from customers. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses judgment when making estimates related to provisions for accounts receivable and excess and obsolete inventories, the valuation of deferred tax assets, the provision for sales returns, stock-based compensation, and for periods prior to the Company's IPO, the valuation of common stock and redeemable convertible preferred stock warrants. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Due to the coronavirus (“COVID-19”) pandemic, there has been continued uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of September 30, 2020. The Company has also considered information available to it as of the date of issuance of these financial statements and is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. Actual results could differ materially from these estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of September 30, 2020 and December 31, 2019. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, long-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its long-term debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Prior to the Company's IPO, fair value accounting was applied to the redeemable convertible preferred stock warrant liability. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. As of September 30, 2020 and December 31, 2019, the Company’s cash equivalents are entirely comprised of investments in money market funds. |
Investments | Investments Short-term investments consist of debt securities classified as available-for-sale and have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Money market funds and United States treasury bills with an original maturity less than 90 days are classified within Level 1 of the fair value hierarchy, and commercial paper, corporate bonds/notes, United States Government securities, and asset-backed securities are classified within Level 2 of the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). The cost of available-for-sale investments sold is based on the specific-identification method. Realized gains and losses are included in earnings, and are der ived for specific-identification method for determining the costs of investments sold. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. |
Concentration of Credit Risk, and Other Risks and Uncertainties | Concentration of Credit Risk, and Other Risks and Uncertainties The Company is subject to risks related to public health criseses such as the global pandemic associated with COVID-19, which has spread to most countries and all 50 states within the United States. The COVID-19 outbreak has negatively impacted, and may continue to negatively impact the Company’s operations, its revenue and overall financial condition by significantly decreasing the number of TCAR procedures performed. The number of TCAR procedures performed, similar to other surgical procedures, has significantly decreased as health care organizations globally have prioritized the treatment of patients with COVID-19. For example, in the United States, governmental authorities have recommended, and in certain cases required, that elective, specialty and other procedures and appointments, be suspended or canceled to focus limited resources and personnel and hospital capacity toward the treatment of COVID-19 and to avoid exposing patients to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and will continue to negatively impact the Company’s revenue while the pandemic continues. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds and United States treasury bills. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, United States Government securities, asset-backed securities and, by policy, limits the amount of credit exposure with any one financial institution or commercial issuer. The Company has not experienced any material losses on its deposits of cash and cash equivalents or investments during the three and nine months ended September 30, 2020 and 2019. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At September 30, 2020 and December 31, 2019, no customer represented 10% or more of the Company’s accounts receivable. For the three and nine months ended September 30, 2020 and 2019, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for doubtful accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE stent. Disruption in component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the FDA or international regulatory agencies. In addition, in order to continue the Company’s operations, compliance with various federal and state laws is required. If the Company were denied or delayed in receiving such approvals or clearances, it may be necessary to adjust operations to align with the Company’s currently approved portfolio of products. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. |
Leases | Leases The Company adopted Accounting Standards Codification (“ASC”) 842, "Leases," on January 1, 2019 and used the modified retrospective method for all leases not substantially completed as of the date of adoption and the package of practical expedients available in the standard. The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract |
Redeemable Convertible Preferred Stock Warrant Liability | Redeemable Convertible Preferred Stock Warrant Liability Prior to its IPO, the Company accounted for its warrants for shares of redeemable convertible preferred stock as a liability based upon the characteristics and provisions of each instrument. Redeemable convertible preferred stock warrants classified as a liability were initially recorded at their fair value on the date of issuance and are subject to remeasurement at each subsequent balance sheet date. Any change in fair value as a result of a remeasurement was recognized as a component of other income (expense), net in the condensed statements of operations and comprehensive loss. The Company recorded adjustments to the estimated fair value of the redeemable convertible preferred stock warrants until they were exercised. Upon their exercise, the final fair value of the warrant liability was reclassified to stockholders’ equity. Subsequent to its IPO, the Company no longer recorded any related periodic fair value adjustments. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred StockPrior to its IPO, the Company recorded its redeemable convertible preferred stock at fair value on the dates of issuance, net of issuance costs, and classified the redeemable convertible preferred stock outside of stockholders’ equity on the condensed balance sheet as events triggering the liquidation preferences were not solely within the Company’s control. |
Revenue Recognition and Cost of Goods Sold | Reven ue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amou nt that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of September 30, 2020 and December 31, 2019, the Company recorded $131,000 and $102,000, respectively, of unbilled receivables, which are included in accounts receivable, net on the condensed balance sheet, as the Company has an unconditional right to payment as of the end of the applicable period. The Company’s revenue is generated from the sale of its products to hospitals and medical centers in the United States through direct sales representatives. Revenue is recognized when obligations under the terms of a contract with customers are satisfied, which occurs with the transfer of control of the Company’s products to its customers, either upon shipment of the product or delivery of the product to the customer under the Company’s standard terms and conditions. The Company’s products are readily available for usage as soon as the customer possesses it. Upon receipt, the customer controls the economic benefits of the product, has significant risks and rewards, and the legal title. The Company has present right to payment; therefore, the transfer of control is deemed to happen at a point in time. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring the goods. For sales where the Company’s sales representative hand delivers product directly to the hospital or medical center from the sales representative’s trunk stock inventory, the Company recognizes revenue upon delivery, which represents the point in time when control transfers to the customer. Upon delivery there are legally-enforceable rights and obligations between the parties which can be identified, commercial substance exists and collectability is probable. For sales which are sent directly from the Company to hospitals and medical centers, the transfer of control occurs at the time of shipment or delivery of the product. There are no further performance obligations by the Company or the sales representative to the customer after delivery under either method of sale. As allowed under the practical expedient, the Company does not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which it recognizes revenue at the amount to which it has the right to invoice for services performed. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales include commissions and royalties. The Company applies the practical expedient and recognizes commissions and royalties as expense when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the condensed statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the condensed balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its facility and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and subassemblies, manufacturing overhead costs, direct labor, reserves for |
Stock-Based Compensation | Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board (“FASB”) ASC 718, "Compensation-Stock Compensation." ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options, restricted stock units and shares issued under its employee stock purchase plan. ASC 718 requires companies to estimate the fair value of all share-based payment option awards on the date of grant using an option pricing model. The fair value of stock options is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period), on a straight-line basis. For performance-based stock options, the Company will assess the probability of performance conditions being achieved in each reporting period. The amount of stock-based compensation expense recognized in any one period related to performance-based stock options can vary based on the achievement or anticipated achievement of the performance conditions. The Company accounts for option forfeitures as they occur. The Company accounts for stock-based compensation for restricted stock units at their fair value, based on the closing market price of the Company's common stock on the date of grant. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. |
Income Taxes | Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the condensed financial statements and tax bases of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company has historically incurred operating losses, it has established a full valuation allowance against its net deferred tax assets, and there is no provision for income taxes. The Company also follows the provisions of ASC 740-10, "A ccounting for Uncertainty in Income Taxes." ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. No liability related to uncertain tax positions is recorded on the condensed financial statements. It is the Company's policy to include penalties and interest expense related to income taxes as part of the provision for income taxes. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on investments classified as available-for-sale. For the three and nine months ended September 30, 2020 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock and warrants, common stock options, and restricted stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. The Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The shares of the Company’s redeemable convertible preferred stock participate in any dividends declared by the Company and were therefore considered to be participating securities. |
Segment and Geographical Information | Segment and Geographical Information The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s long-lived assets are based in the United States. Long-lived assets are comprised of property and equipment and the Company's right-of-use asset. All of the Company’s revenue was in the United States for the three and nine months ended September 30, 2020 and 2019, based on the shipping location of the external customer. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-13, "Fair Value Measurement," which changed the disclosure requirements for fair value measurements by removing, adding and modifying certain disclosures. The Company adopted the new standard effective January 1, 2020. The adoption did not have a material impact on the Company's financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-15, "Cloud Computing Arrangements," which aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license. The Company adopted the new standard effective January 1, 2020 on a prospective basis. The adoption did not have a material impact on the Company's financial statements and related disclosures. Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, "Measurement of Credit Losses on Financial Statements." This update provides financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. The update replaces the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. In October 2019, the FASB delayed the effective date of this standard for smaller reporting companies, as such ASU 2016-13 would originally be effective for the Company on January 1, 2023. As of June 30, 2020, the Company no longer qualified as a smaller reporting company, accordingly ASU 2016-13 will become effective for the Company on January 1, 2021. The Company is evaluating the impact of adopting this guidance to the Company's financial statements and related disclosures. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which enhances and simplifies various aspects of the income tax accounting guidance related to intra-period tax allocation, interim period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim period tax accounting. ASU 2019-12 also amends other aspects of the guidance to reduce complexity in certain areas. ASU 2019-12 will become effective for the Company on January 1, 2021. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance to the Company's financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Net Loss Per Share Determination | Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended Nine Months Ended 2020 2019 2020 2019 Net loss $ (10,315) $ (8,007) $ (30,608) $ (44,124) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 33,757,599 30,764,354 32,597,007 20,249,580 Net loss, basic and diluted $ (0.31) $ (0.26) $ (0.94) $ (2.18) |
Schedule of Potentially Dilutive Securities Outstanding Excluded from Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company's net loss: September 30, 2020 2019 Common stock options 4,451,768 4,677,878 Restricted stock units 44,109 — 4,495,877 4,677,878 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Financial Liabilities Measure on a Recurring Basis | The following tables sets forth by level within the fair value hierarchy the Company’s assets that are reported at fair value as of September 30, 2020 and December 31, 2019, using the inputs defined above (in thousands): September 30, 2020 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 61,078 $ — $ — $ 61,078 U.S. treasury bills — 9,999 — 9,999 Commercial paper — 31,863 — 31,863 Corporate bonds/notes — 16,186 — 16,186 U.S. government securities — 33,394 — 33,394 $ 61,078 $ 91,442 $ — $ 152,520 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper — 9,919 — 9,919 Corporate bonds/notes — 10,176 — 10,176 U.S. government securities — 44,456 — 44,456 Asset-backed securities — 5,181 — 5,181 $ 34,363 $ 69,732 $ — $ 104,095 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Fair Value of the Available-For-Sale Investments | The fair value of the Company's available-for-sale investments as of September 30, 2020 and December 31, 2019 are as follows (in thousands): September 30, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 61,078 $ — $ — $ 61,078 U.S. treasury bills 9,998 1 — 9,999 Commercial paper 31,863 — — 31,863 Corporate bonds/notes 16,179 7 — 16,186 U.S. government securities 33,250 144 — 33,394 Asset-backed securities — — — — $ 152,368 $ 152 $ — $ 152,520 Classified as: Cash equivalents $ 61,078 Short-term investments 91,442 $ 152,520 December 31, 2019 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper 9,919 — — 9,919 Corporate bonds/notes 10,180 — (4) 10,176 U.S. government securities 44,450 9 (3) 44,456 Asset-backed securities 5,181 — — 5,181 $ 104,093 $ 9 $ (7) $ 104,095 Classified as: Cash equivalents $ 34,363 Short-term investments 51,508 Long-term investments 18,224 $ 104,095 |
Fair Value of Cash Equivalents, Short-Term and Long-Term Equivalents | The following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term investments classified by maturity as of September 30, 2020 and December 31, 2019 (in thousands): September 30, December 31, 2020 2019 Amounts maturing within one year $ 152,520 $ 85,871 Amounts maturing after one year through two years — 18,224 $ 152,520 $ 104,095 |
Schedule of Unrealized Loss on Investments | The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of September 30, 2020 and December 31, 2019 (in thousands): September 30, 2020 December 31, 2019 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds/notes $ — $ — $ 10,128 $ (4) U.S. government securities — — 19,067 (3) $ — $ — $ 29,195 $ (7) |
Schedule of Inventories | Components of inventories were as follows: (in thousands) September 30, December 31, 2020 2019 Raw materials $ 1,725 $ 1,203 Finished products 9,221 9,119 Total $ 10,946 $ 10,322 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: (in thousands) September 30, December 31, 2020 2019 Accrued payroll and related expenses $ 8,538 $ 9,151 Provision for sales returns 1,109 2,419 Accrued professional services 942 682 Operating lease liability 829 769 Accrued royalty expense 491 470 Deferred revenue 384 304 Accrued travel expenses 259 431 Accrued clinical expenses 169 241 Accrued other expenses 287 567 Total $ 13,008 $ 15,034 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Future Maturities Under the Term Loan Agreement | Future maturities under the term loan agreement as of September 30, 2020 are as follows (in thousands): Period Ending December 31: Amount 2020 $ 1,120 2021 4,442 2022 48,255 53,817 Add: Accretion of closing fees 1,452 55,269 Less: Amount representing interest (10,004) Less: Amount representing debt discount and debt issuance costs (105) Present value of minimum payments $ 45,160 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Balance Sheet Information | Balance sheet information as of September 30, 2020 consists of the following (in thousands): Operating Lease: September 30, 2020 Operating lease right-of-use asset in other non-current assets $ 2,953 Operating lease liability in accrued liabilities $ 829 Operating lease liability in other liabilities 3,071 Total operating lease liabilities $ 3,900 |
Operating Lease Maturities | The following table summarizes the Company’s operating lease maturities as of September 30, 2020 (in thousands): Period Ending December 31: Amount 2020 $ 262 2021 1,066 2022 1,096 2023 1,127 2024 904 Total lease payments 4,455 Less: imputed interest (555) Present value of lease liabilities $ 3,900 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Activity Under Stock Option Plans | A summary of the shares available for issuance under the 2019 Plan is as follows: Number of Shares Balances, December 31, 2019 1,554,690 Authorized 1,250,210 Granted / Awarded (915,518) Cancelled 45,616 Balances, September 30, 2020 1,934,998 Stock option activity under the Company’s Plans is set forth below: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 871,409 $ 36.39 Options exercised (684,815) $ 2.93 Options cancelled (45,616) $ 20.34 Balances, September 30, 2020 4,451,768 $ 14.12 7.39 $ 236,344 Vested and exercisable at September 30, 2020 2,505,631 $ 7.04 6.46 $ 150,776 Vested and expected to vest at September 30, 2020 4,451,768 $ 14.12 7.39 $ 236,344 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The fair value of RSUs is based on the Company’s closing stock price on the date of grant. A summary of RSUs activity for the nine months ended September 30, 2020 is as follows: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2019 — $ — Restricted stock granted 44,109 $ 33.01 Restricted stock vested — $ — Restricted stock forfeited — $ — Balances, September 30, 2020 44,109 $ 33.01 Expected to vest at September 30, 2020 44,109 $ 33.01 |
Assumptions Used for Estimating Fair Value of Employee Stock Options | The fair value of employee and nonemployee stock options was estimated using the following assumptions for the three and nine months ended September 30, 2020 and 2019: Three Months Ended Nine Months Ended 2020 2019 2020 2019 Expected term (in years) 5.25 - 6.25 6.25 5.25 - 6.25 5.00 - 6.25 Expected volatility 48.0% - 49.1% 42.4% 43.0% - 49.1% 42.4% - 42.9% Risk-free interest rate 0.32% - 0.42% 1.47% 0.32% - 1.41% 1.47% - 2.54% Dividend yield —% —% —% —% |
Schedule of Fair Value Assumptions | The fair value of the shares to be issued under the Company’s 2019 ESPP was estimated using the Black-Scholes valuation model with the following assumptions for the three and nine months ended September 30, 2020: Three Months Ended Nine Months Ended 2020 2019 2020 2019 Expected term (in years) 0.50 0.63 0.50 0.63 Expected volatility 76.4% 47.8% 44.4% - 76.4% 47.8% Risk-free interest rate 0.14% 2.45% 0.14% - 1.58% 2.45% Dividend yield —% —% —% —% |
Stock-Based Compensation Expense Relating to Stock Options to Employees and Nonemployees | Total stock-based compensation expense relating to the Company's stock options, RSUs and 2019 ESPP during the three and nine months ended September 30, 2020 and stock-based compensation expense related to the Company's stock options and 2019 ESPP during the three and nine months ended September 30, 2019, is as follows (in thousands): Three Months Ended September 30, Nine Months Ended 2020 2019 2020 2019 Cost of goods sold $ 91 $ 61 $ 244 $ 129 Research and development expenses 304 134 726 288 Selling, general and administrative expenses 1,611 730 3,983 1,606 $ 2,006 $ 925 $ 4,953 $ 2,023 |
Formation and Business of the_2
Formation and Business of the Company (Details) $ / shares in Units, $ in Thousands | Mar. 13, 2019 | May 31, 2020USD ($)$ / sharesshares | Aug. 31, 2019$ / sharesshares | Apr. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2020$ / shares | Oct. 31, 2015$ / shares |
Subsequent Event [Line Items] | ||||||||
Reverse stock split | 0.3704 | |||||||
Payments of stock issuance costs | $ 4,457 | $ 10,961 | ||||||
IPO | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 6,000,000 | |||||||
Stock issued, price per share (in USD per share) | $ / shares | $ 20 | $ 20 | $ 20 | |||||
Proceeds from stock issued, net of issuance costs | $ 109,119 | |||||||
Underwriting discounts and commissions | 8,400 | |||||||
Payments of stock issuance costs | $ 2,481 | |||||||
Second Public Offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 4,200,000 | |||||||
Stock issued, price per share (in USD per share) | $ / shares | $ 39.50 | |||||||
Public Stock Offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 6,808,154 | |||||||
Stock issued, price per share (in USD per share) | $ / shares | $ 39 | |||||||
Public Stock Offering - Shares From Company | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 1,923,076 | |||||||
Public Stock Offering - Shares From Existing Shareholders | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 4,885,078 | |||||||
Over-Allotment Option | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | shares | 1,021,223 | 630,000 | ||||||
Proceeds from stock issued, net of issuance costs | $ 70,543 | |||||||
Underwriting discounts and commissions | 3,750 | |||||||
Payments of stock issuance costs | $ 707 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Adjustment to Prior Period Financial Statements (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Increase in accounts receivable | $ 771 | $ 3,575 |
Increase in accrued liabilities | $ (2,054) | 2,777 |
Restatement Adjustment | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Increase in accounts receivable | 522 | |
Increase in accrued liabilities | $ 522 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Restricted cash | $ 310 | $ 310 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Redeemable Convertible Preferred Stock (Details) $ in Thousands | 2 Months Ended |
Jun. 30, 2019USD ($)shares | |
Class of Stock [Line Items] | |
Conversion of preferred stock to common stock upon IPO | $ | $ 144,140 |
Common Stock | |
Class of Stock [Line Items] | |
Conversion of preferred stock to common stock upon IPO (in shares) | shares | 23,178,555 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Revenue Recognition (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Unbilled receivables | $ 131 | $ 102 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Income Taxes (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Provision for income taxes | $ 0 | |
Uncertain tax positions | $ 0 | $ 0 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Accounting Policies [Abstract] | ||||||
Net loss | $ (10,315) | $ (10,353) | $ (9,941) | $ (8,007) | $ (30,608) | $ (44,124) |
Weighted average common stock outstanding used to compute net loss per share, basic and diluted (in shares) | 33,757,599 | 30,764,354 | 32,597,007 | 20,249,580 | ||
Net loss per share, basic and diluted (in USD per share) | $ (0.31) | $ (0.26) | $ (0.94) | $ (2.18) |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Earnings per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,495,877 | 4,677,878 |
Common stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,451,768 | 4,677,878 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 44,109 | 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Segment and Geographical Information (Details) | 9 Months Ended |
Sep. 30, 2020segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Number of reportable segments | 1 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | $ 152,520 | $ 104,095 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 61,078 | 34,363 |
U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 9,999 | |
Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 16,186 | 10,176 |
Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 5,181 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 152,520 | 104,095 |
Recurring | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 61,078 | 34,363 |
Recurring | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 9,999 | |
Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 31,863 | 9,919 |
Recurring | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 16,186 | 10,176 |
Recurring | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 33,394 | 44,456 |
Recurring | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 5,181 | |
Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 61,078 | 34,363 |
Recurring | Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 61,078 | 34,363 |
Recurring | Level 1 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | |
Recurring | Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 1 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 1 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 1 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | |
Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 91,442 | 69,732 |
Recurring | Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 2 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 9,999 | |
Recurring | Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 31,863 | 9,919 |
Recurring | Level 2 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 16,186 | 10,176 |
Recurring | Level 2 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 33,394 | 44,456 |
Recurring | Level 2 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 5,181 | |
Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 0 | 0 |
Recurring | Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 3 | U.S. treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | |
Recurring | Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 3 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | 0 | 0 |
Recurring | Level 3 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | $ 0 | 0 |
Recurring | Level 3 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, gross | $ 0 |
Balance Sheet Components - Fair
Balance Sheet Components - Fair Value of Available-For-Sale Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 152,368 | $ 104,093 |
Gross Unrealized Gains | 152 | 9 |
Gross Unrealized Losses | 0 | (7) |
Estimated Fair Value | 152,520 | 104,095 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 61,078 | 34,363 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 61,078 | 34,363 |
U.S. treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 9,998 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | 0 | |
Estimated Fair Value | 9,999 | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 31,863 | 9,919 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 31,863 | 9,919 |
Corporate bonds/notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 16,179 | 10,180 |
Gross Unrealized Gains | 7 | 0 |
Gross Unrealized Losses | 0 | (4) |
Estimated Fair Value | 16,186 | 10,176 |
U.S. government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 33,250 | 44,450 |
Gross Unrealized Gains | 144 | 9 |
Gross Unrealized Losses | 0 | (3) |
Estimated Fair Value | 33,394 | 44,456 |
Asset-backed securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 0 | 5,181 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 0 | 5,181 |
Cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | 61,078 | 34,363 |
Short-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | $ 91,442 | 51,508 |
Long-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | $ 18,224 |
Balance Sheet Components - Fa_2
Balance Sheet Components - Fair Value of Cash Equivalents, Short-Term and Long-Term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Amounts maturing within one year | $ 152,520 | $ 85,871 |
Amounts maturing after one year through two years | 0 | 18,224 |
Total | $ 152,520 | $ 104,095 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Weighted average days to maturity | 136 days | |
Work-in-process | $ 0 | $ 0 |
Balance Sheet Components - Avai
Balance Sheet Components - Available-for-Sale Investments in Unrealized Loss Position (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, Fair Value | $ 0 | $ 29,195 |
Less than 12 months, Unrealized Loss | 0 | (7) |
Corporate bonds/notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, Fair Value | 0 | 10,128 |
Less than 12 months, Unrealized Loss | 0 | (4) |
U.S. government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 12 months, Fair Value | 0 | 19,067 |
Less than 12 months, Unrealized Loss | $ 0 | $ (3) |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 1,725 | $ 1,203 |
Finished products | 9,221 | 9,119 |
Total | $ 10,946 | $ 10,322 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued payroll and related expenses | $ 8,538 | $ 9,151 |
Provision for sales returns | 1,109 | 2,419 |
Accrued professional services | 942 | 682 |
Operating lease liability | 829 | 769 |
Accrued royalty expense | 491 | 470 |
Deferred revenue | 384 | 304 |
Accrued travel expenses | 259 | 431 |
Accrued clinical expenses | 169 | 241 |
Accrued other expenses | 287 | 567 |
Total | $ 13,008 | $ 15,034 |
Long-term Debt - Term Loan Narr
Long-term Debt - Term Loan Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2018 | Apr. 30, 2017 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2019 | May 01, 2019 | Apr. 30, 2019 | Oct. 31, 2015 | |
Debt Instrument [Line Items] | ||||||||||||
Debt draw down | $ 15,000,000 | |||||||||||
Minimum liquidity amount | $ 3,000,000 | |||||||||||
Minimum net revenue target | $ 30,000,000 | $ 15,000,000 | $ 5,000,000 | $ 1,000,000 | ||||||||
Equity cure period | 90 days | |||||||||||
Scenario, Forecast | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Minimum net revenue target | $ 40,000,000 | |||||||||||
Term Loan | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Term loan agreement amount | $ 25,000,000 | $ 30,000,000 | ||||||||||
Stated interest rate | 10.75% | 10.00% | ||||||||||
Interest rate paid-in-kind | 2.75% | 2.00% | ||||||||||
Interest rate paid in cash | 8.00% | 8.00% | ||||||||||
Percentage of outstanding loans | 25.00% | |||||||||||
Market capitalization (greater than) | $ 250,000,000 | |||||||||||
Term Loan, Tranche A | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Term loan agreement amount | 20,000,000 | |||||||||||
Financing fee | 1.75% | |||||||||||
Facility fee | 5.00% | |||||||||||
Term Loan, Tranche B | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Term loan agreement amount | $ 10,000,000 | |||||||||||
Debt draw down | $ 5,000,000 |
Long-term Debt - Future Maturit
Long-term Debt - Future Maturities Under the Term Loan (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Debt Disclosure [Abstract] | |
2020 | $ 1,120 |
2021 | 4,442 |
2022 | 48,255 |
Long-term debt, gross before accretion of closing fees | 53,817 |
Add: Accretion of closing fees | 1,452 |
Long-term debt, gross | 55,269 |
Less: Amount representing interest | (10,004) |
Less: Amount representing debt discount and debt issuance costs | (105) |
Present value of minimum payments | $ 45,160 |
Long-term Debt - Series C Narra
Long-term Debt - Series C Narrative (Details) - $ / shares | 1 Months Ended | |||
Apr. 30, 2019 | Jul. 31, 2017 | Oct. 31, 2015 | Sep. 30, 2020 | |
IPO | ||||
Class of Stock [Line Items] | ||||
Temporary equity, shares issued (in shares) | 6,000,000 | |||
Stock issued, price per share (in USD per share) | $ 20 | $ 20 | $ 20 | |
Preferred Stock Warrants | ||||
Class of Stock [Line Items] | ||||
Warrants outstanding (in shares) | 163,877 | |||
Series C Preferred Stock | ||||
Class of Stock [Line Items] | ||||
Temporary equity, shares issued (in shares) | 163,877 | 327,759 | ||
Stock issued, price per share (in USD per share) | $ 6.11 | $ 6.11 |
Commitments and Contingencies -
Commitments and Contingencies - Lease Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Renewal term | 5 years | 5 years | ||
Operating lease costs | $ 217 | $ 217 | $ 652,000 | $ 652,000 |
Operating lease liabilities | $ 197 | $ 178,000 | $ 569 | $ 540 |
Weighted average discount rate | 6.50% | 6.50% | ||
Weighted average remaining lease term | 4 years 29 days | 4 years 29 days |
Commitments and Contingencies_2
Commitments and Contingencies - Balance Sheet Information (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset in other non-current assets | $ 2,953 | |
Operating lease liability in accrued liabilities | 829 | $ 769 |
Operating lease liability in other liabilities | 3,071 | |
Total operating lease liabilities | $ 3,900 |
Commitments and Contingencies_3
Commitments and Contingencies - Operating Lease Maturities (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 | $ 262 |
2021 | 1,066 |
2022 | 1,096 |
2023 | 1,127 |
2024 | 904 |
Total lease payments | 4,455 |
Less: imputed interest | (555) |
Present value of lease liabilities | $ 3,900 |
Commitments and Contingencies_4
Commitments and Contingencies - Purchase Obligation Narrative (Details) - USD ($) $ in Thousands | Nov. 30, 2020 | Sep. 30, 2020 |
Unrecorded Unconditional Purchase Obligation [Line Items] | ||
Non-cancellable purchase obligation | $ 10,015 | |
Scenario, Forecast | ||
Unrecorded Unconditional Purchase Obligation [Line Items] | ||
Non-cancellable purchase obligation | $ 1,500 |
Commitments and Contingencies_5
Commitments and Contingencies - Contingencies Narrative (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Contingent liabilities accrual | $ 0 | $ 0 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock - Narrative (Details) - $ / shares | 9 Months Ended | |||||||
Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Apr. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Oct. 31, 2015 | |
Temporary Equity [Line Items] | ||||||||
Temporary equity, shares outstanding (in shares) | 0 | 0 | 21,238,105 | 21,233,190 | ||||
Preferred Stock Warrants | ||||||||
Temporary Equity [Line Items] | ||||||||
Temporary equity, shares issued (in shares) | 0 | 0 | ||||||
Temporary equity, shares outstanding (in shares) | 0 | 0 | ||||||
IPO | ||||||||
Temporary Equity [Line Items] | ||||||||
Stock issued, price per share (in USD per share) | $ 20 | $ 20 | $ 20 | |||||
IPO | Preferred Stock Warrants | ||||||||
Temporary Equity [Line Items] | ||||||||
Shares converted (in shares) | 1,945,365 | |||||||
Convertible Preferred Stock | ||||||||
Temporary Equity [Line Items] | ||||||||
Temporary equity, shares issued (in shares) | 0 | 0 | ||||||
Temporary equity, shares outstanding (in shares) | 0 | 0 |
Stockholders Equity - Narrative
Stockholders Equity - Narrative (Details) | 9 Months Ended | |||
Sep. 30, 2020USD ($)vote$ / sharesshares | Dec. 31, 2019$ / sharesshares | Apr. 30, 2019$ / shares | Oct. 31, 2015$ / shares | |
Class of Warrant or Right [Line Items] | ||||
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 | ||
Preferred stock par value (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Preferred stock issued (in shares) | 0 | 0 | ||
Preferred stock outstanding (in shares) | 0 | 0 | ||
Shares authorized (in shares) | 100,000,000 | 100,000,000 | ||
Par value (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Shares issued (in shares) | 33,889,077 | 31,255,267 | ||
Shares outstanding (in shares) | 33,889,077 | 31,255,267 | ||
Dividends declared | $ | $ 0 | |||
Number of votes entitled per share of common stock | vote | 1 | |||
Common Stock Warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding (in shares) | 0 | 0 | ||
IPO | ||||
Class of Warrant or Right [Line Items] | ||||
Stock issued, price per share (in USD per share) | $ / shares | $ 20 | $ 20 | $ 20 | |
IPO | Common Stock Warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Shares converted (in shares) | 5,968 |
Stock Option Plans - Narrative
Stock Option Plans - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended |
Mar. 31, 2019 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value of options exercised | $ 28,880 | |
Compensation expensed not yet recognized | $ 17,920 | |
ISO and NSO | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option term | 10 years | |
Vesting term | 4 years | |
ISO and NSO | 10% Stockholders | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 110.00% | |
ISO | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 100.00% | |
NSO | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 85.00% | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting term | 4 years | |
Restricted stock vested (in shares) | 0 | |
Compensation expensed not yet recognized, period for recognition | 3 years 2 months 23 days | |
Unrecognized compensation costs of unvested RSUs | $ 1,228 | |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Compensation expensed not yet recognized, period for recognition | 3 years 18 days | |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares allowable under the plan (in shares) | 1,200,000 | |
Percent of outstanding shares of common stock | 1.00% | |
Common stock reserved for future issuance (in shares) | 434,000 | 746,552 |
Percent of purchase of price of common stock | 85.00% | |
Share of stock issued in ESPP (in shares) | 87,567 | |
Shares available for future issuance (in shares) | 658,985 | |
Compensation expensed not yet recognized, period for recognition | 1 month 6 days | |
Unrecognized compensation costs related to the ESPP | $ 106 | |
2019 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved for issuance (in shares) | 2,317,000 | 3,633,180 |
Percent of outstanding shares of common stock | 4.00% | |
2019 Equity Incentive Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares allowable under the plan (in shares) | 3,000,000 |
Stock Option Plans - Activity U
Stock Option Plans - Activity Under Compensation Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Options Outstanding | |||
Beginning balance (in shares) | 4,310,790 | 4,310,790 | |
Options granted (in shares) | 871,409 | ||
Options exercised (in shares) | (684,815) | ||
Options cancelled (in shares) | (45,616) | ||
Ending balance (in shares) | 4,451,768 | ||
Number of Shares, vested and exercisable (in shares) | 2,505,631 | ||
Number of Shares, vested and expect to vest (in shares) | 4,451,768 | ||
Weighted Average Exercise Price | |||
Beginning balance (in USD per share) | $ 7.91 | $ 7.91 | |
Options granted (in USD per share) | 36.39 | ||
Options exercised (in USD per share) | 2.93 | ||
Options cancelled (in USD per share) | 20.34 | ||
Ending balance (in USD per share) | 14.12 | ||
Vested and exercisable (in USD per share) | 7.04 | ||
Vested and expected to vest (in USD per share) | $ 14.12 | ||
Weighted Average Remaining Contractual Term (in Years) | |||
Awards outstanding | 7 years 3 months 7 days | 7 years 4 months 20 days | |
Vested and exercisable | 6 years 5 months 15 days | ||
Vested and expected to vest | 7 years 4 months 20 days | ||
Aggregate Intrinsic Value (in thousands) | |||
Awards outstanding | $ 236,344 | $ 140,234 | |
Vested and exercisable | 150,776 | ||
Vested and expected to vest | $ 236,344 | ||
2019 Equity Incentive Plan | |||
Number of Shares | |||
Beginning balance (in shares) | 1,554,690 | 1,554,690 | |
Authorized (in shares) | 1,250,210 | ||
Options granted / awarded (in shares) | (915,518) | ||
Options cancelled (in shares) | 45,616 | ||
Ending balance (in shares) | 1,934,998 |
Stock Option Plans - RSUs (Deta
Stock Option Plans - RSUs (Details) - Restricted stock units | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Number of Restricted Stock Units | |
Beginning balance (in shares) | shares | 0 |
Restricted stock granted (in shares) | shares | 44,109 |
Restricted stock vested (in shares) | shares | 0 |
Restricted stock forfeited (in shares) | shares | 0 |
Ending balance (in shares) | shares | 44,109 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 0 |
Restricted stock granted (in USD per share) | $ / shares | 33.01 |
Restricted stock vested (in USD per share) | $ / shares | 0 |
Restricted stock forfeited (in USD per share) | $ / shares | 0 |
Ending balance (in USD per share) | $ / shares | $ 33.01 |
Stock Option Plans - Fair Value
Stock Option Plans - Fair Value of Stock Options (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 42.40% | |||
Expected volatility, minimum | 48.00% | 43.00% | 42.40% | |
Expected volatility, maximum | 49.10% | 49.10% | 42.90% | |
Risk-free interest rate | 1.47% | |||
Risk-free interest rate, minimum | 0.32% | 0.32% | 1.47% | |
Risk-free interest rate, maximum | 0.42% | 1.41% | 2.54% | |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months | 6 years 3 months | 5 years 3 months | 5 years |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months | |
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 7 months 17 days | 6 months | 7 months 17 days |
Expected volatility | 76.40% | 47.80% | 47.80% | |
Expected volatility, minimum | 44.40% | |||
Expected volatility, maximum | 76.40% | |||
Risk-free interest rate | 0.14% | 2.45% | 2.45% | |
Risk-free interest rate, minimum | 0.14% | |||
Risk-free interest rate, maximum | 1.58% | |||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock Option Plans - Stock-base
Stock Option Plans - Stock-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 2,006 | $ 925 | $ 4,953 | $ 2,023 |
Cost of goods sold | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 91 | 61 | 244 | 129 |
Research and development expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 304 | 134 | 726 | 288 |
Selling, general and administrative expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1,611 | $ 730 | $ 3,983 | $ 1,606 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) $ in Thousands | Jan. 01, 2020 | Sep. 30, 2020 | Sep. 30, 2020 |
Retirement Benefits [Abstract] | |||
Percentage employee contribution | 90.00% | ||
Employer contribution match percentage | 50.00% | ||
Percent of matching contribution of the employee's pay | 5.00% | ||
Employer discretionary contribution | $ 195,000 | $ 717,000 |
Subsequent Event - Narrative (D
Subsequent Event - Narrative (Details) - USD ($) | Oct. 29, 2020 | Sep. 30, 2018 |
Subsequent Event [Line Items] | ||
Debt draw down | $ 15,000,000 | |
Subsequent Event | Loan Agreement | ||
Subsequent Event [Line Items] | ||
Facility amount | $ 50,000,000 | |
Debt amount | 50,000,000 | |
Minimum unrestricted cash and cash equivalents | 20,000,000 | |
Maximum unrestricted cash and cash equivalents | $ 60,000,000 | |
Debt default rate | 5.00% | |
Subsequent Event | Loan Agreement | Term Loan | ||
Subsequent Event [Line Items] | ||
Aggregate principal amount | $ 50,000,000 | |
Percentage of revenue for debt repayment | 80.00% | |
Debt draw down | $ 49,000,000 | |
Debt pay off | 43,813,000 | |
Prepayment premium fee | 305,000 | |
Debt interest | 365,000 | |
Facility fee | $ 2,191,000 | |
Subsequent Event | Loan Agreement | Term Loan | Prime Rate | Rate Scenario One | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 0.75% | |
Subsequent Event | Loan Agreement | Term Loan | Prime Rate | Rate Scenario Two | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 4.75% | |
Subsequent Event | Loan Agreement | Secured Revolving Credit Facility | Line of Credit | ||
Subsequent Event [Line Items] | ||
Facility amount | $ 50,000,000 | |
Subsequent Event | Loan Agreement | Secured Revolving Credit Facility | Line of Credit | Prime Rate | Rate Scenario One | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 0.50% | |
Subsequent Event | Loan Agreement | Secured Revolving Credit Facility | Line of Credit | Prime Rate | Rate Scenario Two | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 4.75% | |
Subsequent Event | Loan Agreement | Letter of Credit | Line of Credit | ||
Subsequent Event [Line Items] | ||
Facility amount | $ 2,000,000 |