Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Current Fiscal Year End Date | --12-31 | |
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 | Large Accelerated Filer | |
Entity Small Business | false | |
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 | 34,896,409 | |
Entity Central Index Key | 0001397702 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 105,642 | $ 69,466 |
Short-term investments | 17,127 | 78,016 |
Accounts receivable, net | 10,976 | 9,070 |
Inventories | 16,049 | 9,989 |
Prepaid expenses and other current assets | 4,662 | 6,787 |
Total current assets | 154,456 | 173,328 |
Property and equipment, net | 5,132 | 2,844 |
Restricted cash | 232 | 310 |
Other non-current assets | 5,711 | 2,832 |
Total assets | 165,531 | 179,314 |
Current liabilities: | ||
Accounts payable | 4,908 | 2,598 |
Accrued liabilities | 16,011 | 16,957 |
Total current liabilities | 20,919 | 19,555 |
Long-term debt | 48,652 | 48,533 |
Other liabilities | 7,781 | 3,726 |
Total liabilities | 77,352 | 71,814 |
Commitments and contingencies (Note 7) | ||
Preferred stock, $0.001 par value | ||
Shares authorized: 5,000,000 at September 30, 2021 and December 31, 2020 Shares issued and outstanding: none at September 30, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value | ||
Shares authorized: 100,000,000 at September 30, 2021 and December 31, 2020 Shares issued and outstanding: 34,854,822 and 34,249,649 at September 30, 2021 and December 31, 2020, respectively | 35 | 34 |
Additional paid-in capital | 362,152 | 346,318 |
Accumulated other comprehensive income | 1 | 39 |
Accumulated deficit | (274,009) | (238,891) |
Total stockholders’ equity | 88,179 | 107,500 |
Total liabilities and stockholders’ equity | $ 165,531 | $ 179,314 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Preferred stock, $0.001 par value | ||
Preferred shares (in USD per share) | $ 0.001 | $ 0.001 |
Preferred shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, $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) | 34,854,822 | 34,249,649 |
Shares outstanding (in shares) | 34,854,822 | 34,249,649 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Condensed Statements of Operations and Comprehensive Loss [Abstract] | ||||
Revenue | $ 24,701 | $ 20,067 | $ 73,210 | $ 54,093 |
Cost of goods sold | 6,076 | 5,488 | 18,213 | 16,074 |
Gross profit | 18,625 | 14,579 | 54,997 | 38,019 |
Operating expenses: | ||||
Research and development | 6,867 | 4,711 | 19,611 | 11,232 |
Selling, general and administrative | 25,049 | 19,202 | 68,792 | 54,652 |
Total operating expenses | 31,916 | 23,913 | 88,403 | 65,884 |
Loss from operations | (13,291) | (9,334) | (33,406) | (27,865) |
Interest income | 42 | 249 | 183 | 951 |
Interest expense | (633) | (1,215) | (1,884) | (3,620) |
Other income (expense), net | (3) | (15) | (11) | (74) |
Net loss | (13,885) | (10,315) | (35,118) | (30,608) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on investments, net | (2) | (164) | (38) | 150 |
Net change in other comprehensive loss | (2) | (164) | (38) | 150 |
Net loss and comprehensive loss | $ (13,887) | $ (10,479) | $ (35,156) | $ (30,458) |
Net loss per share, basic and diluted | $ (0.40) | $ (0.31) | $ (1.02) | $ (0.94) |
Weighted average common shares used to compute net loss per share, basic and diluted | 34,736,015 | 33,757,599 | 34,536,980 | 32,597,007 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total |
Beginning balance (in shares) at Dec. 31, 2019 | 31,255,267 | ||||
Beginning balance at Dec. 31, 2019 | $ 31 | $ 263,384 | $ (191,526) | $ 2 | $ 71,891 |
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 | $ 31 | 264,951 | (201,467) | 442 | 63,957 |
Beginning balance (in shares) at Dec. 31, 2019 | 31,255,267 | ||||
Beginning balance at Dec. 31, 2019 | $ 31 | 263,384 | (191,526) | 2 | 71,891 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (30,608) | ||||
Ending balance (in shares) at Sep. 30, 2020 | 33,889,077 | ||||
Ending balance at Sep. 30, 2020 | $ 34 | 341,687 | (222,135) | 152 | 119,738 |
Beginning balance (in shares) at Mar. 31, 2020 | 31,395,637 | ||||
Beginning balance at Mar. 31, 2020 | $ 31 | 264,951 | (201,467) | 442 | 63,957 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise/issuance of common stock (in shares) | 1,923,076 | ||||
Exercise/issuance of common stock | $ 2 | 70,541 | 70,543 | ||
Exercise of stock options (in shares) | 265,467 | ||||
Exercise of stock options | $ 1 | 603 | 604 | ||
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 | $ 34 | 338,550 | (211,820) | 316 | 127,080 |
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) | |||
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 | $ 34 | 341,687 | (222,135) | 152 | 119,738 |
Beginning balance (in shares) at Dec. 31, 2020 | 34,249,649 | ||||
Beginning balance at Dec. 31, 2020 | $ 34 | 346,318 | (238,891) | 39 | 107,500 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 163,151 | ||||
Exercise of stock options | 848 | 848 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 25,490 | ||||
Stock-based compensation | 3,533 | 3,533 | |||
Net loss | (10,694) | (10,694) | |||
Unrealized gain (loss) on investments, net | (33) | (33) | |||
Ending balance (in shares) at Mar. 31, 2021 | 34,438,290 | ||||
Ending balance at Mar. 31, 2021 | $ 34 | 350,699 | (249,585) | 6 | 101,154 |
Beginning balance (in shares) at Dec. 31, 2020 | 34,249,649 | ||||
Beginning balance at Dec. 31, 2020 | $ 34 | 346,318 | (238,891) | 39 | $ 107,500 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 548,699 | ||||
Net loss | $ (35,118) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 34,854,822 | ||||
Ending balance at Sep. 30, 2021 | $ 35 | 362,152 | (274,009) | 1 | 88,179 |
Beginning balance (in shares) at Mar. 31, 2021 | 34,438,290 | ||||
Beginning balance at Mar. 31, 2021 | $ 34 | 350,699 | (249,585) | 6 | 101,154 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 155,443 | ||||
Exercise of stock options | $ 1 | 1,030 | 1,031 | ||
Issuance of common stock upon release of restricted stock units (in shares) | 2,792 | ||||
Issuance of common stock under employee stock purchase plan (in shares) | 26,884 | ||||
Issuance of common stock under employee stock purchase plan | 1,086 | 1,086 | |||
Stock-based compensation | 3,409 | 3,409 | |||
Net loss | (10,539) | (10,539) | |||
Unrealized gain (loss) on investments, net | (3) | (3) | |||
Ending balance (in shares) at Jun. 30, 2021 | 34,623,409 | ||||
Ending balance at Jun. 30, 2021 | $ 35 | 356,224 | (260,124) | 3 | 96,138 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 230,105 | ||||
Exercise of stock options | 2,242 | 2,242 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 1,308 | ||||
Stock-based compensation | 3,686 | 3,686 | |||
Net loss | (13,885) | (13,885) | |||
Unrealized gain (loss) on investments, net | (2) | (2) | |||
Ending balance (in shares) at Sep. 30, 2021 | 34,854,822 | ||||
Ending balance at Sep. 30, 2021 | $ 35 | $ 362,152 | $ (274,009) | $ 1 | $ 88,179 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Condensed Statements of Stockholders' Equity [Abstract] | |
Offering costs | $ 4,457 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (35,118) | $ (30,608) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 723 | 563 |
Stock-based compensation expense | 10,628 | 4,953 |
Amortization of premiums on investments, net | 451 | 145 |
Amortization of debt discount and debt issuance costs | 119 | 35 |
Amortization of right-of-use asset | 627 | 447 |
Non-cash interest expense | 193 | 249 |
Loss on disposal of property and equipment | 51 | |
Change in provision for doubtful accounts receivable | (26) | |
Provision for excess and obsolete inventories | 56 | 109 |
Changes in assets and liabilities: | ||
Accounts receivable | (1,906) | (771) |
Inventories | (3,744) | (732) |
Prepaid expenses and other current assets | (2,014) | (565) |
Other assets | (107) | 200 |
Accounts payable | 1,304 | 29 |
Accrued liabilities | 629 | (2,054) |
Other liabilities | 656 | 176 |
Net cash used in operating activities | (27,503) | (27,799) |
Cash flows from investing activities | ||
Purchases of property and equipment | (2,006) | (587) |
Purchases of investments | (58,884) | |
Proceeds from maturity of investments | 60,400 | 37,180 |
Net cash provided by (used in) investing activities | 58,394 | (22,291) |
Cash flows from financing activities | ||
Proceeds from public offerings, net of underwriting discount, commissions and offering costs paid | 70,568 | |
Proceeds from issuance of common stock | 5,207 | 2,809 |
Net cash provided by financing activities | 5,207 | 73,377 |
Net change in cash, cash equivalents and restricted cash | 36,098 | 23,287 |
Cash, cash equivalents and restricted cash, beginning of period | 69,776 | 39,491 |
Cash, cash equivalents and restricted cash, end of period | 105,874 | 62,778 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,571 | 3,336 |
Noncash investing and financing activities: | ||
Accounts payable and accrued liabilities for purchases of property and equipment | 1,298 | 118 |
Offering costs in accrued liabilities | $ 25 | |
Right-of-use asset obtained in exchange for lease obligation | $ 3,398 |
Formation and Business of the C
Formation and Business of the Company | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components [Abstract] | |
Formation and Business of the Company | 1. 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. Public Offering 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, 2021 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. 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, 2020, 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, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 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, 2020 included in the Company's annual report on Form 10-K filed with the SEC on March 1, 2021. 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 reserves for sales returns, and stock-based compensation. 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. While some of the uncertainties began to lift throughout the first half of 2021, new virus variants, and increased infection rates during this period make the current COVID-related environment highly volatile and uncertain. The Company expect these challenges to continue to impact the number of TCAR procedures in 2021, with procedure volumes impacted by increased COVID-19 hospitalizations and hospital capacity constraints due to the COVID-19 Delta variant. 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, 2021. 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, 2021 and December 31, 2020. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-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. 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, 2021 and December 31, 2020, the Company’s cash equivalents are entirely comprised of investments in money market funds. Restricted cash as of September 30, 2021 and December 31, 2020 consists of a letter of credit of $232,000 and $310,000, respectively, representing collateral for the Company's facility lease in California. 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 derived for specific-identification method for determining the costs of investments sold and were insignificant for the three and nine months ended September 30, 2021 and 2020. 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. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. Concentration of Credit Risk, and Other Risks and Uncertainties The Company is subject to risks related to public health crises 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 prioritized the treatment of patients with COVID-19. In the past 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. New virus variants, and increased infection rates continue to make the current COVID-related environment highly volatile and uncertain. 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, 2021 and 2020. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At September 30, 2021 and December 31, 2020, no customer represented 10% or more of the Company’s accounts receivable. For the three and nine months ended September 30, 2021 and 2020, 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 expected credit losses on customer 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 Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. 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. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. Voluntary Recall In January and February 2021, the Company announced the voluntary recall of certain lots of its ENROUTE Transcarotid Stent System, manufactured by one of its third-party suppliers, Cordis. The decision to recall these lots was based on complaints received about tips detaching from the stent delivery system as well as internal testing that the Company conducted. The Company believes the root cause of the detachment was a single operator at Cordis, who, over a specific timeframe, produced lots in which a small number of units were not reliably manufactured to specification. As a result of the voluntary recall the Company reflected a current asset of $4,160,000 on its balance sheet as of December 31, 2020, relating to the replacement lots and other direct costs to be received from Cordis. This amount includes $2,227,000 of recalled ENROUTE stent delivery systems held in the Company's inventory as of December 31, 2020, $1,696,000 of ENROUTE stent delivery systems in the process of being returned from its customers and other direct costs of $237,000. In addition, the Company established an accrual of $1,696,000 relating to its obligation to provide replacement ENROUTE stent delivery systems to its customers as of December 31, 2020. As of September 30, 2021, the Company has a current asset of $334,000 on its balance sheet, relating to other direct costs to be reimbursed from Cordis. In addition, as of September 30, 2021, the Company has a remaining accrual of $15,000 relating to its obligation to provide replacement ENROUTE stent delivery systems to its customers. Leases The Company accounts for leases in accordance with Accounting Standards Codification (“ASC”) 842, "Leases." 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 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. Revenue 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 amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of September 30, 2021 and December 31, 2020, the Company recorded $164,000 and $71,000, 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 California 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, "Accounting 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, 2021 and 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 sheets as a component of stockholders' equity. 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, 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. Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net loss$ (13,885) $ (10,315) $ (35,118) $ (30,608)Weighted average common stock outstanding used to compute net loss per share, basic and diluted 34,736,015 33,757,599 34,536,980 32,597,007Net loss, basic and diluted$ (0.40) $ (0.31) $ (1.02) $ (0.94) 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, 2021 2020Common stock options 3,930,140 4,451,768Restricted stock units 350,249 44,109 4,280,389 4,495,877 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. Primarily 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 assets. All of the Company’s revenue was in the United States for the three and nine months ended September 30, 2021 and 2020, based on the shipping location of the external customer. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2021 | |
Recent Accounting Pronouncements [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements Effective January 1, 2021, the Company adopted ASU 2016-13, Financial Instruments-Credit Losses (Topic 326):"Measurement of Credit Losses on Financial Instruments," which requires measurement and recognition of expected credit losses for most financial assets and certain other instruments. Unrealized losses on available-for-sale debt securities that are attributed to credit risk are recorded through earnings rather than to other comprehensive income. Credit losses relating to available-for-sale debt securities are now recorded through an allowance for credit losses. In addition, Topic 326 also provides new guidance related to the measurement of expected credit losses on the Company’s allowance for bad debt for accounts receivable, which is estimated upon assessment of various factors including historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of the Company’s customers. The Company adopted the new standard using a modified retrospective transition method, which required a cumulative-effect adjustment, if any, to the opening balance of accumulated deficit to be recognized on the date of adoption. The Company did not have any cumulative-effect adjustments as of the date of adoption. Effective January 1, 2021, the Company adopted 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. The adoption did not have a material impact on the Company's financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and investments. 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, 2021 and December 31, 2020, using the inputs defined above (in thousands): September 30, 2021 Level 1 Level 2 Level 3 TotalAssets: Money market funds$ 105,629 $— $— $ 105,629 Commercial paper — 2,000 — 2,000 U.S. government securities — 15,127 — 15,127 $ 105,629 $ 17,127 $— $ 122,756 December 31, 2020 Level 1 Level 2 Level 3 TotalAssets: Money market funds$ 60,295 $— $— $ 60,295 Commercial paper — 39,577 — 39,577 Corporate bonds/notes — 7,969 — 7,969 U.S. government securities — 38,470 — 38,470 $ 60,295 $ 86,016 $— $ 146,311 There were no transfers between fair value hierarchy levels during the three and nine months ended September 30, 2021 and 2020. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Investments The fair value of the Company's available-for-sale investments as of September 30, 2021 and December 31, 2020 are as follows (in thousands): September 30, 2021 Gross Unrealized Estimated Amortized Cost Gains Losses Fair ValueMoney market funds $ 105,629 $— $— $ 105,629 Commercial paper 2,000 — — 2,000 U.S. government securities 15,126 1 — 15,127 $ 122,755 $ 1 $ — $ 122,756 Classified as: Cash equivalents $ 105,629 Short-term investments 17,127 $ 122,756 December 31, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair ValueMoney market funds $ 60,295 $— $— $ 60,295 Commercial paper 39,577 — — 39,577 Corporate bonds/notes 7,970 — (1) 7,969 U.S. government securities 38,430 42 (2) 38,470 $ 146,272 $ 42 $ (3) $ 146,311 Classified as: Cash equivalents $ 68,295 Short-term investments 78,016 $ 146,311 All of the Company’s cash equivalents and short-term investments mature within one year as of September 30, 2021 and December 31, 2020. Available-for-sale investments held as of September 30, 2021 had a weighted average days to maturity of 41 days. The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 December 31, 2020 Less than 12 months Less than 12 monthsAssets:Fair Value Unrealized Loss Fair Value Unrealized LossCorporate bonds/notes $ — $ — $ 5,369 $ (1)U.S. government securities — — 10,128 (2) $ — $ — $ 15,497 $ (3) Inventories Components of inventories were as follows (in thousands): September 30, December 31, 2021 2020Raw materials$ 2,195 $ 1,785 Finished products 13,876 10,599 16,071 12,384 Less: Reserve for excess and obsolete (23) (2,395) $ 16,049 $ 9,989 As of September 30, 2021 and December 31, 2020, there were no work-in-process inventories. The reserve for excess and obsolete inventory at September 30, 2021 and December 31, 2020, included $5,000 and $2,377,000, respectively, associated with the Company's voluntary product recall. Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, 2021 2020Accrued payroll and related expenses$ 10,228 $ 9,573 Provision for sales returns 410 820 Accrued professional services 1,909 2,520 Recall replacement obligation 15 1,696 Operating lease liability 1,003 850 Accrued royalty expense 608 518 Deferred revenue 448 206 Accrued travel expenses 552 237 Accrued clinical expenses 150 113 Accrued other expenses 688 424 Total$ 16,011 $ 16,957 |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2021 | |
Long-term Debt [Abstract] | |
Long-term Debt | 6. Long-term Debt CRGIn 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 term loan agreement was amended to provide for additional term loans in an aggregate principal amount of up to $25,000,000. In September 2018, the Company drew down an additional $15,000,000 under the amended term loan agreement with CRG, no additional draw was taken. Under the terms of the amended term loan agreement, the related fixed interest rate was 10.0%, 8.0% of the interest was 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. All unpaid principal, and accrued and unpaid interest, was due and payable in full on December 31, 2022. On October 29, 2020, in connection with the consummation of the Loan and Security agreement with Stifel Bank as noted below, the Company repaid all amounts outstanding under the term loan with CRG. Stifel BankIn October 2020, the Company entered into a Loan and Security Agreement, or Loan Agreement, with Stifel Bank which 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. Any borrowings under the revolving loan facility mature on October 29, 2022, or October 29, 2023 if as of October 29, 2022, no event of default has occurred and we are in compliance with the terms of the Loan Agreement. Borrowings under the term loan facility mature on October 29, 2024. Interest under the revolving credit facility is the greater of a) 0.5% above the "Prime Rate" as published by The Wall Street Journal or b) 4.75%. Also in October 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 the prior term loan agreement with CRG totaling $46,674,000, which included a prepayment premium of $305,000, a final interest payment of $365,000 and a facility fee of $2,191,000. The Company recognized a loss on debt extinguishment of $1,119,000 in connection with the early termination of the term loan agreement with CRG. The principal amount of outstanding term loans under the Loan Agreement with Stifel Bank shall be repaid in equal monthly installments beginning on May 29, 2022, or November 29, 2022 if the Company achieves revenue for the year ending December 31, 2021 of at least 80% of the board-approved financial projections for such fiscal year. Interest under the term loan facility is the greater of a) 0.75% above the "Prime Rate" as published by The Wall Street Journal or b) 4.75%. The term loan may not be reborrowed once repaid, but the Company may prepay the term loan at any time without premium or penalty. The Company also concurrently entered in a Success Fee Agreement in October 2020 with Stifel Bank, which requires that the Company pay Stifel Bank the lesser of 0.75% of the original principal amount of all credit extensions made under the Loan Agreement or $375,000 in the event the Company completes a Liquidity Event (liquidation, merger, sale of the Company or change in control). The Success Fee Agreement terminates on October 29, 2025. The Company has determined the probability of a Liquidity Event to be remote and accordingly, has not recognized a liability as of September 30, 2021. Obligations under the Loan Agreement are secured by substantially all of the Company's assets. Beginning on January 15, 2021, the Loan Agreement required that the Company maintain unrestricted cash and cash equivalents with Stifel Bank or at Stifel Bank Affiliates of at least $20,000,000. In addition, for any fiscal quarter where the Company's unrestricted cash and cash equivalents maintained with Stifel Bank or at Stifel Bank Affiliates are 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 Company's ability and the ability of the Company's subsidiaries to, among other things, dispose of assets, effect certain mergers, incur debt, grant liens, pay dividends and distributions on 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 our 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. As of September 30, 2021, the aggregate outstanding principal balance under the Loan Agreement was $49,000,000 and the annual interest rate was 4.75%. As of September 30, 2021, the Company was in compliance with all applicable financial covenants. As of September 30, 2021, management does not believe that it is probable that the above events of default will be triggered within the next twelve months, therefore, the debt is classified as long-term on the condensed balance sheet. Future maturities under the Loan Agreement as of September 30, 2021 are as follows (in thousands): Period Ending December 31: Amount2021 $ 5882022 6,2572023 25,7492024 21,457 54,051Less: Amount representing interest (5,051)Less: Amount representing debt discount and debt issuance costs (348)Present value of minimum payments $ 48,652 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Lease and Rights-of-Use The Company’s operating lease obligation at its corporate headquarters in California 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. In May 2021, the Company entered into a new, non-cancelable operating lease for additional office, laboratory and manufacturing space in Minnesota that expires in November 2029. The lease agreement includes a renewal provision allowing the Company to extend this lease for two additional five year terms. In connection with the lease, the Company recognized a right-of-use asset and lease liability of $3,398,000. Operating lease costs were $369,000 and $217,000 for the three months ended September 30, 2021 and 2020, respectively, and $875,000 and $652,000 for the nine months ended September 30, 2021 and 2020, respectively. Cash paid (net of tenant improvement allowances receivable) for amounts included in the measurement of operating lease liabilities was $(1,043,000) and $197,000 for the three months ended September 30, 2021 and 2020, respectively, and $(650,000) and $569,000 for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, the weighted average discount rate was approximately 6.50% and the weighted average remaining lease term was 6.15 years. Balance sheet information as of September 30, 2021 and December 31, 2020 consists of the following (in thousands): September 30, December 31,Operating Lease: 2021 2020Operating lease right-of-use assets in other non-current assets $ 5,569 $ 2,798 Operating lease liabilities in accrued liabilities $ 1,003 $ 850 Operating lease liabilities in other liabilities 6,574 2,850 Total operating lease liabilities $ 7,577 $ 3,700 The following table summarizes the Company’s operating lease maturities as of September 30, 2021 (in thousands): Period Ending December 31: Amount2021 $ (300)2022 1,5762023 1,970 2024 1,7672025 8862026 and thereafter 3,686Total lease payments $ 9,585Less: interest (2,008)Total lease liabilities $ 7,577 Purchase Obligations Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. As of September 30, 2021, the Company had non-cancellable purchase obligations to suppliers of $11,471,000. Indemnification In the normal course of business, the Company enters into contracts and agreements with suppliers and other parties 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, 2021. 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, 2021 and December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Preferred Stock At September 30, 2021, 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, 2021, 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 34,854,822 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, 2021, no dividends have been declared to date. Each share of common stock is entitled to one vote. |
Stock Option Plans
Stock Option Plans | 9 Months Ended |
Sep. 30, 2021 | |
Stock Option Plans [Abstract] | |
Stock Option Plans | 9. 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 initial public offering in April 2019. The 2019 Plan replaced the 2007 Stock Option Plan which was terminated immediately prior to consummation of the Company’s initial public offering, 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, 2021, the Company has reserved 5,015,486 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 SharesBalances, December 31, 2020 1,790,687Authorized 1,369,985Granted / Awarded (643,960)Cancelled 91,506Balances, September 30, 2021 2,608,218 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 Weighted Average Weighted AverageRemainingContractual Term Aggregate Intrinsic Shares Exercise Price (Years) ValueBalances, December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407Options granted 323,057 53.94 Options exercised (548,699) 7.46 Options cancelled (82,046) 37.61 Balances, September 30, 2021 3,930,140 $ 20.47 6.97 $ 137,958Vested and exercisable at September 30, 2021 2,660,361 $ 12.41 6.28 $ 113,810Vested and expected to vest at September 30, 2021 3,930,140 $ 20.47 6.97 $ 137,958 The aggregate intrinsic value of options exercised during the nine months ended September 30, 2021 was $25,146,000. 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. 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, 2021 is as follows: Number ofRestrictedStock Units Weighted AverageGrant DateFair ValueBalances, December 31, 2020 68,396 $ 46.16 Awards granted 320,903 53.30 Awards vested (29,590) 46.32 Awards canceled (9,460) 55.21 Balances, September 30, 2021 350,249 $ 52.45 Expected to vest at September 30, 2021 350,249 $ 52.45 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, 2021, the Company has reserved 1,089,048 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 initial public offering 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, 2021, 141,059 shares of common stock have been issued to employees participating in the 2019 ESPP and 947,989 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, 2021 and 2020: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Expected term (in years)5.25 - 6.00 5.25 - 6.25 5.25 - 6.25 5.25 - 6.25Expected volatility46.7% - 47.3% 48.0% - 49.1% 45.0% - 50.4% 43.0% - 49.1%Risk-free interest rate0.75% - 0.82% 0.32% - 0.42% 0.41% - 1.08% 0.32% - 1.41%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, 2021 and 2020: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Expected term (in years)0.50 0.50 0.50 0.50Expected volatility51.5% 76.4% 44.4% - 76.4% 44.4% - 76.4%Risk-free interest rate0.03% 0.14% 0.03% - 1.58% 0.14% - 1.58%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, 2021 and 2020 is as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Cost of goods sold$ 144 $ 91 $ 452 $ 244Research and development expenses 695 304 2,020 726Selling, general and administrative expenses 2,847 1,611 8,156 3,983 $ 3,686 $ 2,006 $ 10,628 $ 4,953 As of September 30, 2021, there was total unrecognized compensation costs of $19,994,000 related to stock options expected to be recognized over a period of approximately 2.60 years, a total of $15,830,000 of unrecognized compensation costs related to unvested RSUs expected to be recognized over a period of approximately 3.18 years and $105,000 of unrecognized compensation costs related to the ESPP, which the Company will recognize over 0.13 years. |
401(k) Plan
401(k) Plan | 9 Months Ended |
Sep. 30, 2021 | |
401(k) Plan [Abstract] | |
401(k) Plan | 10. 401(k) Plan The 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 $308,000 and $195,000 for the three months ended September 30, 2021 and 2020, respectively, and $1,003,000 and $717,000 for the nine months ended September 30, 2021 and 2020, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant 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, 2020, 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, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 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, 2020 included in the Company's annual report on Form 10-K filed with the SEC on March 1, 2021. |
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 reserves for sales returns, and stock-based compensation. 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. While some of the uncertainties began to lift throughout the first half of 2021, new virus variants, and increased infection rates during this period make the current COVID-related environment highly volatile and uncertain. The Company expect these challenges to continue to impact the number of TCAR procedures in 2021, with procedure volumes impacted by increased COVID-19 hospitalizations and hospital capacity constraints due to the COVID-19 Delta variant. 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, 2021. 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, 2021 and December 31, 2020. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-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. |
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, 2021 and December 31, 2020, the Company’s cash equivalents are entirely comprised of investments in money market funds. Restricted cash as of September 30, 2021 and December 31, 2020 consists of a letter of credit of $232,000 and $310,000, respectively, representing collateral for the Company's facility lease in California. |
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 derived for specific-identification method for determining the costs of investments sold and were insignificant for the three and nine months ended September 30, 2021 and 2020. 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. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. |
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 crises 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 prioritized the treatment of patients with COVID-19. In the past 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. New virus variants, and increased infection rates continue to make the current COVID-related environment highly volatile and uncertain. 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, 2021 and 2020. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At September 30, 2021 and December 31, 2020, no customer represented 10% or more of the Company’s accounts receivable. For the three and nine months ended September 30, 2021 and 2020, 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 expected credit losses on customer 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 Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. 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. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. |
Voluntary Recall | Voluntary Recall In January and February 2021, the Company announced the voluntary recall of certain lots of its ENROUTE Transcarotid Stent System, manufactured by one of its third-party suppliers, Cordis. The decision to recall these lots was based on complaints received about tips detaching from the stent delivery system as well as internal testing that the Company conducted. The Company believes the root cause of the detachment was a single operator at Cordis, who, over a specific timeframe, produced lots in which a small number of units were not reliably manufactured to specification. As a result of the voluntary recall the Company reflected a current asset of $4,160,000 on its balance sheet as of December 31, 2020, relating to the replacement lots and other direct costs to be received from Cordis. This amount includes $2,227,000 of recalled ENROUTE stent delivery systems held in the Company's inventory as of December 31, 2020, $1,696,000 of ENROUTE stent delivery systems in the process of being returned from its customers and other direct costs of $237,000. In addition, the Company established an accrual of $1,696,000 relating to its obligation to provide replacement ENROUTE stent delivery systems to its customers as of December 31, 2020. As of September 30, 2021, the Company has a current asset of $334,000 on its balance sheet, relating to other direct costs to be reimbursed from Cordis. In addition, as of September 30, 2021, the Company has a remaining accrual of $15,000 relating to its obligation to provide replacement ENROUTE stent delivery systems to its customers. |
Leases | Leases The Company accounts for leases in accordance with Accounting Standards Codification (“ASC”) 842, "Leases." 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 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. |
Revenue Recognition and Cost of Goods Sold | Revenue 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 amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of September 30, 2021 and December 31, 2020, the Company recorded $164,000 and $71,000, 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 California 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 | 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, "Accounting 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, 2021 and 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 sheets as a component of stockholders' equity. |
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, 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. Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net loss$ (13,885) $ (10,315) $ (35,118) $ (30,608)Weighted average common stock outstanding used to compute net loss per share, basic and diluted 34,736,015 33,757,599 34,536,980 32,597,007Net loss, basic and diluted$ (0.40) $ (0.31) $ (1.02) $ (0.94) 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, 2021 2020Common stock options 3,930,140 4,451,768Restricted stock units 350,249 44,109 4,280,389 4,495,877 |
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. Primarily 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 assets. All of the Company’s revenue was in the United States for the three and nine months ended September 30, 2021 and 2020, based on the shipping location of the external customer. |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Recent Accounting Pronouncements [Abstract] | |
Recent Accounting Pronouncements | Effective January 1, 2021, the Company adopted ASU 2016-13, Financial Instruments-Credit Losses (Topic 326):"Measurement of Credit Losses on Financial Instruments," which requires measurement and recognition of expected credit losses for most financial assets and certain other instruments. Unrealized losses on available-for-sale debt securities that are attributed to credit risk are recorded through earnings rather than to other comprehensive income. Credit losses relating to available-for-sale debt securities are now recorded through an allowance for credit losses. In addition, Topic 326 also provides new guidance related to the measurement of expected credit losses on the Company’s allowance for bad debt for accounts receivable, which is estimated upon assessment of various factors including historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of the Company’s customers. The Company adopted the new standard using a modified retrospective transition method, which required a cumulative-effect adjustment, if any, to the opening balance of accumulated deficit to be recognized on the date of adoption. The Company did not have any cumulative-effect adjustments as of the date of adoption. Effective January 1, 2021, the Company adopted 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. The adoption did not have a material impact on the Company's financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies [Abstract] | |
Net Loss Per Share Determination | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Net loss$ (13,885) $ (10,315) $ (35,118) $ (30,608)Weighted average common stock outstanding used to compute net loss per share, basic and diluted 34,736,015 33,757,599 34,536,980 32,597,007Net loss, basic and diluted$ (0.40) $ (0.31) $ (1.02) $ (0.94) |
Schedule of Potentially Dilutive Securities Outstanding Excluded from Diluted Weighted Average Shares Outstanding | September 30, 2021 2020Common stock options 3,930,140 4,451,768Restricted stock units 350,249 44,109 4,280,389 4,495,877 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Financial Liabilities Measure on a Recurring Basis | September 30, 2021 Level 1 Level 2 Level 3 TotalAssets: Money market funds$ 105,629 $— $— $ 105,629 Commercial paper — 2,000 — 2,000 U.S. government securities — 15,127 — 15,127 $ 105,629 $ 17,127 $— $ 122,756 December 31, 2020 Level 1 Level 2 Level 3 TotalAssets: Money market funds$ 60,295 $— $— $ 60,295 Commercial paper — 39,577 — 39,577 Corporate bonds/notes — 7,969 — 7,969 U.S. government securities — 38,470 — 38,470 $ 60,295 $ 86,016 $— $ 146,311 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components [Abstract] | |
Fair Value of the Available-For-Sale Investments | September 30, 2021 Gross Unrealized Estimated Amortized Cost Gains Losses Fair ValueMoney market funds $ 105,629 $— $— $ 105,629 Commercial paper 2,000 — — 2,000 U.S. government securities 15,126 1 — 15,127 $ 122,755 $ 1 $ — $ 122,756 Classified as: Cash equivalents $ 105,629 Short-term investments 17,127 $ 122,756 December 31, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair ValueMoney market funds $ 60,295 $— $— $ 60,295 Commercial paper 39,577 — — 39,577 Corporate bonds/notes 7,970 — (1) 7,969 U.S. government securities 38,430 42 (2) 38,470 $ 146,272 $ 42 $ (3) $ 146,311 Classified as: Cash equivalents $ 68,295 Short-term investments 78,016 $ 146,311 |
Available-For-Sale Investments in Unrealized Loss Position | September 30, 2021 December 31, 2020 Less than 12 months Less than 12 monthsAssets:Fair Value Unrealized Loss Fair Value Unrealized LossCorporate bonds/notes $ — $ — $ 5,369 $ (1)U.S. government securities — — 10,128 (2) $ — $ — $ 15,497 $ (3) |
Schedule of Inventories | September 30, December 31, 2021 2020Raw materials$ 2,195 $ 1,785 Finished products 13,876 10,599 16,071 12,384 Less: Reserve for excess and obsolete (23) (2,395) $ 16,049 $ 9,989 |
Schedule of Accrued Liabilities | September 30, December 31, 2021 2020Accrued payroll and related expenses$ 10,228 $ 9,573 Provision for sales returns 410 820 Accrued professional services 1,909 2,520 Recall replacement obligation 15 1,696 Operating lease liability 1,003 850 Accrued royalty expense 608 518 Deferred revenue 448 206 Accrued travel expenses 552 237 Accrued clinical expenses 150 113 Accrued other expenses 688 424 Total$ 16,011 $ 16,957 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Long-term Debt [Abstract] | |
Future Maturities Under the Term Loan Agreement | Period Ending December 31: Amount2021 $ 5882022 6,2572023 25,7492024 21,457 54,051Less: Amount representing interest (5,051)Less: Amount representing debt discount and debt issuance costs (348)Present value of minimum payments $ 48,652 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies [Abstract] | |
Balance Sheet Information | September 30, December 31,Operating Lease: 2021 2020Operating lease right-of-use assets in other non-current assets $ 5,569 $ 2,798 Operating lease liabilities in accrued liabilities $ 1,003 $ 850 Operating lease liabilities in other liabilities 6,574 2,850 Total operating lease liabilities $ 7,577 $ 3,700 |
Operating Lease Maturities | Period Ending December 31: Amount2021 $ (300)2022 1,5762023 1,970 2024 1,7672025 8862026 and thereafter 3,686Total lease payments $ 9,585Less: interest (2,008)Total lease liabilities $ 7,577 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Shares Available for Issuance | Number of SharesBalances, December 31, 2020 1,790,687Authorized 1,369,985Granted / Awarded (643,960)Cancelled 91,506Balances, September 30, 2021 2,608,218 |
Stock Option Activity | Options Outstanding Number of Weighted Average Weighted AverageRemainingContractual Term Aggregate Intrinsic Shares Exercise Price (Years) ValueBalances, December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407Options granted 323,057 53.94 Options exercised (548,699) 7.46 Options cancelled (82,046) 37.61 Balances, September 30, 2021 3,930,140 $ 20.47 6.97 $ 137,958Vested and exercisable at September 30, 2021 2,660,361 $ 12.41 6.28 $ 113,810Vested and expected to vest at September 30, 2021 3,930,140 $ 20.47 6.97 $ 137,958 |
Summary of RSU Activity | Number ofRestrictedStock Units Weighted AverageGrant DateFair ValueBalances, December 31, 2020 68,396 $ 46.16 Awards granted 320,903 53.30 Awards vested (29,590) 46.32 Awards canceled (9,460) 55.21 Balances, September 30, 2021 350,249 $ 52.45 Expected to vest at September 30, 2021 350,249 $ 52.45 |
Stock-Based Compensation Expense Relating to Stock Options to Employees and Nonemployees | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Cost of goods sold$ 144 $ 91 $ 452 $ 244Research and development expenses 695 304 2,020 726Selling, general and administrative expenses 2,847 1,611 8,156 3,983 $ 3,686 $ 2,006 $ 10,628 $ 4,953 |
Common Stock Options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Fair Value Assumptions | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Expected term (in years)5.25 - 6.00 5.25 - 6.25 5.25 - 6.25 5.25 - 6.25Expected volatility46.7% - 47.3% 48.0% - 49.1% 45.0% - 50.4% 43.0% - 49.1%Risk-free interest rate0.75% - 0.82% 0.32% - 0.42% 0.41% - 1.08% 0.32% - 1.41%Dividend yield—% —% —% —% |
ESPP [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Fair Value Assumptions | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020Expected term (in years)0.50 0.50 0.50 0.50Expected volatility51.5% 76.4% 44.4% - 76.4% 44.4% - 76.4%Risk-free interest rate0.03% 0.14% 0.03% - 1.58% 0.14% - 1.58%Dividend yield—% —% —% —% |
Formation and Business of the_2
Formation and Business of the Company (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended |
May 31, 2020 | Jun. 30, 2020 | |
Subsequent Event [Line Items] | ||
Issued and sold common stock (in shares) | 6,808,154 | |
Stock issued, price per share (in USD per share) | $ 39 | |
Payments of deferred offering costs | $ 4,457 | |
Public Stock Offering Shares From Company [Member] | ||
Subsequent Event [Line Items] | ||
Issued and sold common stock (in shares) | 1,923,076 | |
Public Stock Offering Shares From Existing Shareholders [Member] | ||
Subsequent Event [Line Items] | ||
Issued and sold common stock (in shares) | 4,885,078 | |
Over Allotment [Member] | ||
Subsequent Event [Line Items] | ||
Issued and sold common stock (in shares) | 1,021,223 | |
Net proceeds | $ 70,543 | |
Payments of deferred offering costs | 707 | |
Payment of stock issuance underwriting discounts and commissions | $ 3,750 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Narrative) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Summary of Significant Accounting Policies [Abstract] | ||
Restricted cash | $ 232 | $ 310 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Voluntary Recall (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Sep. 30, 2021 | |
Inventory [Line Items] | ||
Inventories | $ 9,989 | $ 16,049 |
ENROUTE [Member] | ||
Inventory [Line Items] | ||
Inventories | 2,227 | |
Inventory Recall Expense | 237 | |
Contingent liabilities requiring accrual | 1,696 | 15 |
ENROUTE, Held By Customer [Member] | ||
Inventory [Line Items] | ||
Inventories | 1,696 | |
Voluntary Recall | ||
Inventory [Line Items] | ||
Inventories | $ 4,160 | $ 334 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Revenue Recognition (Narrative) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Summary of Significant Accounting Policies [Abstract] | ||
Unbilled receivables | $ 164 | $ 71 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Income Taxes (Narrative) (Details) | Sep. 30, 2021USD ($) |
Summary of Significant Accounting Policies [Abstract] | |
Provision for income taxes | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Segment and Geographical Information (Narrative) (Details) | 9 Months Ended |
Sep. 30, 2021segment | |
Summary of Significant Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
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, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Summary of Significant Accounting Policies [Abstract] | ||||
Net loss | $ (13,885) | $ (10,315) | $ (35,118) | $ (30,608) |
Weighted average common stock outstanding used to compute net loss per share, basic and diluted (in shares) | 34,736,015 | 33,757,599 | 34,536,980 | 32,597,007 |
Net loss, basic and diluted (in USD per share) | $ (0.40) | $ (0.31) | $ (1.02) | $ (0.94) |
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, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,280,389 | 4,495,877 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,930,140 | 4,451,768 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 350,249 | 44,109 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 | $ 0 | |
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | 0 | $ 0 | |
Recurring [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 122,756,000 | $ 146,311,000 | |
Recurring [Member] | Money Market Funds [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 105,629,000 | 60,295,000 | |
Recurring [Member] | Commercial Papers [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 2,000,000 | 39,577,000 | |
Recurring [Member] | Corporate Bonds/Notes [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 7,969,000 | ||
Recurring [Member] | U.S. Government Securitie [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 15,127,000 | 38,470,000 | |
Recurring [Member] | Level 1 [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 105,629,000 | 60,295,000 | |
Recurring [Member] | Level 1 [Member] | Money Market Funds [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 105,629,000 | 60,295,000 | |
Recurring [Member] | Level 2 [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 17,127,000 | 86,016,000 | |
Recurring [Member] | Level 2 [Member] | Commercial Papers [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 2,000,000 | 39,577,000 | |
Recurring [Member] | Level 2 [Member] | Corporate Bonds/Notes [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | 7,969,000 | ||
Recurring [Member] | Level 2 [Member] | U.S. Government Securitie [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets | $ 15,127,000 | $ 38,470,000 |
Balance Sheet Components (Narra
Balance Sheet Components (Narrative) (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Weighted average days to maturity | 41 days | |
Work-in-process inventories | $ 0 | |
Excess And Obsolete Inventory [Member] | ||
Inventory [Line Items] | ||
Loss contingency receivable | $ 5,000 | $ 2,377,000 |
Balance Sheet Components (Fair
Balance Sheet Components (Fair Value of Available-For-Sale Investments) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 105,629 | $ 60,295 |
Estimated Fair Value | 105,629 | 60,295 |
Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 2,000 | 39,577 |
Estimated Fair Value | 2,000 | 39,577 |
Corporate Bonds/Notes [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 7,970 | |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 7,969 | |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 15,126 | 38,430 |
Gross Unrealized Gains | 1 | 42 |
Gross Unrealized Losses | (2) | |
Estimated Fair Value | 15,127 | 38,470 |
Asset-Backed Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 122,755 | 146,272 |
Gross Unrealized Gains | 1 | 42 |
Gross Unrealized Losses | (3) | |
Estimated Fair Value | 122,756 | 146,311 |
Cash Equivalents [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | 105,629 | 68,295 |
Short-Term Investments [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | 17,127 | 78,016 |
Long-Term Investments [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | $ 122,756 | $ 146,311 |
Balance Sheet Components (Avail
Balance Sheet Components (Available-for-Sale Investments in Unrealized Loss Position) (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | $ 15,497 |
Unrealized Loss, Less than 12 months | (3) |
Corporate Bonds/Notes [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | 5,369 |
Unrealized Loss, Less than 12 months | (1) |
U.S. Government Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | 10,128 |
Unrealized Loss, Less than 12 months | $ (2) |
Balance Sheet Components (Sched
Balance Sheet Components (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 2,195 | $ 1,785 |
Finished products | 13,876 | 10,599 |
Inventory, gross | 16,071 | 12,384 |
Less: Reserve for excess and obsolete | (23) | (2,395) |
Inventories | $ 16,049 | $ 9,989 |
Balance Sheet Components (Accru
Balance Sheet Components (Accrued Liabilities) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Accrued payroll and related expenses | $ 10,228 | $ 9,573 |
Provision for sales returns | 410 | 820 |
Accrued professional services | 1,909 | 2,520 |
Recall replacement obligation | 15 | 1,696 |
Operating lease liability | 1,003 | 850 |
Accrued royalty expense | 608 | 518 |
Deferred revenue | 448 | 206 |
Accrued travel expenses | 552 | 237 |
Accrued clinical expenses | 150 | 113 |
Accrued other expenses | 688 | 424 |
Total | $ 16,011 | $ 16,957 |
Long-term Debt - CRG (Narrative
Long-term Debt - CRG (Narrative) (Details) - Term Loan [Member] - USD ($) | 1 Months Ended | ||
Sep. 30, 2018 | Apr. 30, 2017 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | |||
Debt, face amount | $ 30,000,000 | ||
Term Loan, Tranche A [Member] | |||
Debt Instrument [Line Items] | |||
Debt, face amount | 20,000,000 | ||
Term Loan, Tranche B [Member] | |||
Debt Instrument [Line Items] | |||
Debt, face amount | $ 10,000,000 | ||
Proceeds from debt | $ 5,000,000 | ||
Term Loan, Additional [Member] | |||
Debt Instrument [Line Items] | |||
Proceeds from debt | $ 0 | ||
Term Loan, Amended [Member] | |||
Debt Instrument [Line Items] | |||
Debt, face amount | 25,000,000 | ||
Proceeds from debt | $ 15,000,000 | ||
Stated interest rate | 10.00% | ||
Interest rate paid-in-kind | 8.00% | ||
Interest rate paid in cash | 2.00% |
Long-term Debt - Stifel Bank (N
Long-term Debt - Stifel Bank (Narrative) (Details) - USD ($) | 1 Months Ended | 9 Months Ended |
Oct. 31, 2020 | Sep. 30, 2021 | |
Term Loan [Member] | ||
Subsequent Event [Line Items] | ||
Debt pay off | $ 46,674,000 | |
Prepayment premium fee | 305,000 | |
Debt interest | 365,000 | |
Facility fee | 2,191,000 | |
Loss on debt extinguishment | (1,119,000) | |
Letter of Credit [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Facility amount | $ 50,000,000 | |
Amount drawn on facility | $ 49,000,000 | |
Aggregate outstanding principal balance | $ 49,000,000 | |
Annual interest rate | 4.75% | |
Percentage of revenue for debt repayment | 80.00% | |
Percent of original principal threshold | 0.75% | |
Redemption amount | $ 375,000 | |
Debt default rate | 5.00% | |
Stated interest rate | 4.75% | |
Secured Revolving Credit Facility [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Facility amount | $ 50,000,000 | |
Secured Revolving Credit Facility, Subfacility [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Facility amount | 2,000,000 | |
Minimum [Member] | Letter of Credit [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Restricted Cash | $ 20,000,000 | |
Minimum [Member] | Letter of Credit [Member] | Prime Rate [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 0.50% | |
Maximum [Member] | Letter of Credit [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Restricted Cash | $ 60,000,000 | |
Maximum [Member] | Letter of Credit [Member] | Prime Rate [Member] | Stifel Bank [Member] | ||
Subsequent Event [Line Items] | ||
Variable interest rate | 0.75% |
Long-term Debt (Future Maturiti
Long-term Debt (Future Maturities Under the Term Loan) (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Long-term Debt [Abstract] | |
2021 | $ 588 |
2022 | 6,257 |
2023 | 25,749 |
2024 | 21,457 |
Long-term debt, gross before accretion of closing fees | 54,051 |
Less: Amount representing interest | (5,051) |
Less: Amount representing debt discount and debt issuance costs | (348) |
Present value of minimum payments | $ 48,652 |
Commitments and Contingencies -
Commitments and Contingencies - Lease (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | May 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | ||||||
Operating Lease, Right-of-Use Asset | $ 5,569 | $ 5,569 | $ 3,398 | $ 2,798 | ||
Operating Lease, Liability | 7,577 | 7,577 | $ 3,398 | $ 3,700 | ||
Operating lease costs | $ 369 | $ 217 | $ 875 | $ 652 | ||
Weighted average discount rate | 6.50% | 6.50% | ||||
Weighted average remaining lease term | 6 years 1 month 24 days | 6 years 1 month 24 days | ||||
Operating Lease, Cash Paid | $ (1,043) | $ 197 | $ (650) | $ 569 | ||
Headquarters [Member] | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Renewal term | 5 years | 5 years | ||||
Additional Office, Laboratory And Manufacturing Space [Member] | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Renewal term | 5 years | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Purchase Obligation and Contingencies (Narrative) (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments and Contingencies [Abstract] | |
Purchase obligation | $ 11,471 |
Commitments and Contingencies_3
Commitments and Contingencies (Balance Sheet Information) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | May 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies [Abstract] | |||
Operating lease right-of-use asset in other non-current assets | $ 5,569 | $ 3,398 | $ 2,798 |
Operating lease liability in accrued liabilities | 1,003 | 850 | |
Operating lease liability in other liabilities | 6,574 | 2,850 | |
Total operating lease liabilities | $ 7,577 | $ 3,398 | $ 3,700 |
Commitments and Contingencies_4
Commitments and Contingencies (Operating Lease Maturities) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | May 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies [Abstract] | |||
2021 | $ (300) | ||
2022 | 1,576 | ||
2023 | 1,970 | ||
2024 | 1,767 | ||
2025 | 886 | ||
2026 and thereafter | 3,686 | ||
Total lease payments | 9,585 | ||
Less: interest | (2,008) | ||
Total lease liabilities | $ 7,577 | $ 3,398 | $ 3,700 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stockholders' Equity [Abstract] | ||
Preferred shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred shares (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Shares authorized (in shares) | 100,000,000 | 100,000,000 |
Par value (in USD per share) | $ 0.001 | $ 0.001 |
Shares issued (in shares) | 34,854,822 | 34,249,649 |
Shares outstanding (in shares) | 34,854,822 | 34,249,649 |
Dividends declared | $ 0 |
Stock Option Plans (Narrative)
Stock Option Plans (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended |
Mar. 31, 2019 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Compensation expensed not yet recognized | $ 19,994 | |
Compensation expensed not yet recognized, period for recognition | 2 years 7 months 6 days | |
ISO and NSO [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 10.00% | |
Option term | 10 years | |
Option vesting term | 4 years | |
ISO [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 100.00% | |
NSO [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 85.00% | |
Common Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value of options exercised | $ 25,146 | |
Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option vesting term | 4 years | |
Compensation expensed not yet recognized, period for recognition | 3 years 2 months 4 days | |
Unrecognized compensation costs of unvested RSUs | $ 15,830 | |
Maximum [Member] | ISO and NSO [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise threshold as a percentage of fair value of shares | 110.00% | |
2019 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved for issuance (in shares) | 2,317,000 | 5,015,486 |
Common stock reserved for future issuance (in shares) | 434,000 | |
Percent of purchase of price of common stock | 1.00% | |
Compensation expensed not yet recognized, period for recognition | 1 month 17 days | |
Unrecognized compensation costs related to the ESPP | $ 105 | |
2019 Equity Incentive Plan [Member] | Scenario, Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of additional shares allowable under the plan (in shares) | 3,000,000 | |
Percent of outstanding shares of common stock | 4.00% | |
2019 Equity Incentive Plan [Member] | Common Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for future issuance (in shares) | 1,089,048 | |
Percent of purchase of price of common stock | 85.00% | |
Issuance of common stock under employee stock purchase plan (in shares) | 141,059 | |
Shares available for future issuance (in shares) | 947,989 | |
2019 Equity Incentive Plan [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for future issuance (in shares) | 1,200,000 |
Stock Option Plans (Activity Un
Stock Option Plans (Activity Under Compensation Plan) (Details) - 2019 Equity Incentive Plan [Member] | 9 Months Ended |
Sep. 30, 2021shares | |
Shares Available for Grant | |
Beginning balance (in shares) | 1,790,687 |
Authorized (in shares) | 1,369,985 |
Granted/Awarded (in shares) | (643,960) |
Canceled (in shares) | 91,506 |
Ending balance (in shares) | 2,608,218 |
Stock Option Plans (Stock Optio
Stock Option Plans (Stock Option Activity) (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Number of Shares | ||
Beginning balance (in shares) | shares | 4,237,828 | |
Options granted (in shares) | shares | 323,057 | |
Options exercised (in shares) | shares | (548,699) | |
Options cancelled (in shares) | shares | (82,046) | |
Ending balance (in shares) | shares | 3,930,140 | 4,237,828 |
Vested and exercisable (in shares) | shares | 2,660,361 | |
Vested and expect to vest (in shares) | shares | 3,930,140 | |
Weighted Average Exercise Price | ||
Beginning balance (in USD per share) | $ / shares | $ 16.56 | |
Options granted (in USD per share) | $ / shares | 53.94 | |
Options exercised (in USD per share) | $ / shares | 7.46 | |
Options cancelled (in USD per share) | $ / shares | 37.61 | |
Ending balance (in USD per share) | $ / shares | 20.47 | $ 16.56 |
Vested and exercisable (in USD per share) | $ / shares | 12.41 | |
Vested and expected to vest (in USD per share) | $ / shares | $ 20.47 | |
Weighted Average Remaining Contractual Term (in Years) | ||
Awards outstanding | 6 years 11 months 19 days | 7 years 4 months 17 days |
Vested and exercisable | 6 years 3 months 10 days | |
Vested and expected to vest | 6 years 11 months 19 days | |
Aggregate Intrinsic Value (in thousands) | ||
Awards outstanding | $ | $ 137,958 | $ 197,407 |
Vested and exercisable | $ | 113,810 | |
Vested and expected to vest | $ | $ 137,958 |
Stock Option Plans (RSUs) (Deta
Stock Option Plans (RSUs) (Details) - Restricted Stock Units [Member] | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Number of Restricted Stock Units | |
Beginning balance (in shares) | shares | 68,396 |
Restricted stock granted (in shares) | shares | 320,903 |
Restricted stock vested (in shares) | shares | (29,590) |
Restricted stock forfeited (in shares) | shares | (9,460) |
Ending balance (in shares) | shares | 350,249 |
Expected to vest (in shares) | shares | 350,249 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 46.16 |
Restricted stock granted (in USD per share) | $ / shares | 53.30 |
Restricted stock vested (in USD per share) | $ / shares | 46.32 |
Restricted stock forfeited (in USD per share) | $ / shares | 55.21 |
Ending balance (in USD per share) | $ / shares | 52.45 |
Expected to vest (in USD per share) | $ / shares | $ 52.45 |
Stock Option Plans (Fair Value
Stock Option Plans (Fair Value of Stock Options) (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Dividend yield | ||||
Common Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility, minimum | 46.70% | 48.00% | 45.00% | 43.00% |
Expected volatility, maximum | 47.30% | 49.10% | 50.40% | 49.10% |
Risk-free interest rate, minimum | 0.75% | 0.32% | 0.41% | 0.32% |
Risk-free interest rate, maximum | 0.82% | 0.42% | 1.08% | 1.41% |
Dividend yield | ||||
Common Stock Options [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months | 5 years 3 months | 5 years 3 months | 5 years 3 months |
Common Stock Options [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years | 6 years 3 months | 6 years 3 months | 6 years 3 months |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
Expected volatility | 51.50% | 76.40% | ||
Expected volatility, minimum | 44.40% | 44.40% | ||
Expected volatility, maximum | 76.40% | 76.40% | ||
Risk-free interest rate | 0.03% | 0.14% | ||
Risk-free interest rate, minimum | 0.03% | 0.14% | ||
Risk-free interest rate, maximum | 1.58% | 1.58% | ||
Dividend yield |
Stock Option Plans (Stock-based
Stock Option Plans (Stock-based Compensation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 3,686 | $ 2,006 | $ 10,628 | $ 4,953 |
Cost of Goods Sold [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 144 | 91 | 452 | 244 |
Research and Development Expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 695 | 304 | 2,020 | 726 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 2,847 | $ 1,611 | $ 8,156 | $ 3,983 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
401(k) Plan [Abstract] | ||||
Percentage employee contribution | 90.00% | |||
Employer discretionary contribution | $ 308 | $ 195 | $ 1,003 | $ 717 |
Employer contribution match percentage | 50.00% | |||
Percent of matching contribution of the employee's pay | 5.00% |