Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 26, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
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 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | SILK | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,400 | ||
Entity Common Stock, Shares Outstanding | 34,365,398 | ||
Entity Central Index Key | 0001397702 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 69,466 | $ 39,181 |
Short-term investments | 78,016 | 51,508 |
Accounts receivable, net of allowances of $13 and $45 at December 31, 2020 and 2019, respectively | 9,070 | 8,601 |
Inventories | 9,989 | 10,322 |
Prepaid expenses and other current assets | 6,787 | 2,878 |
Total current assets | 173,328 | 112,490 |
Long-term investments | 0 | 18,224 |
Property and equipment, net | 2,844 | 2,734 |
Restricted cash | 310 | 310 |
Other non-current assets | 2,832 | 3,644 |
Total assets | 179,314 | 137,402 |
Current liabilities: | ||
Accounts payable | 2,598 | 1,898 |
Accrued liabilities | 16,957 | 15,034 |
Total current liabilities | 19,555 | 16,932 |
Long-term debt | 48,533 | 44,879 |
Other liabilities | 3,726 | 3,700 |
Total liabilities | 71,814 | 65,511 |
Commitments and contingencies (Note 7) | ||
Preferred stock, $0.001 par value | ||
Shares authorized: 5,000,000 at December 31, 2020 and 2019 | 0 | 0 |
Common stock, $0.001 par value | ||
Shares issued and outstanding: 34,249,649 and 31,255,267 at December 31, 2020 and 2019, respectively | 34 | 31 |
Additional paid-in capital | 346,318 | 263,384 |
Accumulated other comprehensive income | 39 | 2 |
Accumulated deficit | (238,891) | (191,526) |
Total stockholders’ equity | 107,500 | 71,891 |
Total liabilities and stockholders’ equity | $ 179,314 | $ 137,402 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Allowances for accounts receivables | $ 13 | $ 45 |
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 | |
Common stock, shares issued (in shares) | 34,249,649 | 31,255,267 |
Shares outstanding (in shares) | 34,249,649 | 31,255,267 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Revenue | $ 75,227 | $ 63,354 | $ 34,557 |
Cost of goods sold | 21,291 | 15,927 | 10,874 |
Gross profit | 53,936 | 47,427 | 23,683 |
Operating expenses: | |||
Research and development | 21,271 | 12,272 | 10,258 |
Selling, general and administrative | 75,524 | 63,220 | 34,820 |
Total operating expenses | 96,795 | 75,492 | 45,078 |
Loss from operations | (42,859) | (28,065) | (21,395) |
Interest income | 1,104 | 1,656 | 189 |
Interest expense | (4,411) | (4,952) | (4,361) |
Loss on debt extinguishment | (1,119) | 0 | 0 |
Other income (expense), net | (80) | (21,054) | (12,063) |
Net loss | (47,365) | (52,415) | (37,630) |
Net loss attributable to non-controlling interest | 0 | 0 | 1 |
Net loss attributable to Silk Road Medical, Inc. common stockholders | (47,365) | (52,415) | (37,629) |
Other comprehensive loss: | |||
Unrealized gain on investments, net | 37 | 2 | 0 |
Net change in other comprehensive loss | 37 | 2 | 0 |
Comprehensive loss attributable to Silk Road Medical, Inc. common stockholders | $ (47,328) | $ (52,413) | $ (37,629) |
Net loss per share attributable to Silk Road Medical, Inc. common stockholders, basic and diluted (in USD per share) | $ (1.44) | $ (2.28) | $ (39.16) |
Weighted average common shares used to compute net loss per share attributable to Silk Road Medical, Inc. common stockholders, basic and diluted (in shares) | 32,965,539 | 22,956,679 | 960,882 |
Statements of Redeemable Conver
Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment | IPO | Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred StockIPO | Common Stock | Common StockIPO | Additional Paid-in Capital | Additional Paid-in CapitalCumulative Effect, Period of Adoption, Adjustment | Additional Paid-in CapitalIPO | Accumulated Deficit | Accumulated DeficitCumulative Effect, Period of Adoption, Adjustment | Accumulated Other Comprehensive Income | Non-controlling Interest |
Temporary equity, beginning balance (in shares) at Dec. 31, 2017 | 21,233,190 | |||||||||||||
Temporary equity, beginning balance at Dec. 31, 2017 | $ 105,235 | |||||||||||||
Temporary equity, ending balance (in shares) at Dec. 31, 2018 | 21,233,190 | |||||||||||||
Temporary equity, ending balance at Dec. 31, 2018 | $ 105,235 | |||||||||||||
Beginning balance (in shares) at Dec. 31, 2017 | 663,270 | |||||||||||||
Beginning balance at Dec. 31, 2017 | $ (98,578) | $ 1 | $ 2,977 | $ (101,556) | $ 0 | $ 0 | ||||||||
Beginning balance (Cumulative effect of change in accounting principle - ASC 606 adoption) at Dec. 31, 2017 | $ 87 | $ 87 | ||||||||||||
Beginning balance (Cumulative effect of change in accounting treatment - ASU 2016-09) at Dec. 31, 2017 | $ 0 | $ 13 | $ (13) | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Exercise of stock options (in shares) | 438,578 | 438,578 | ||||||||||||
Exercise of stock options | $ 656 | 656 | ||||||||||||
Stock-based compensation | 911 | 911 | ||||||||||||
NeuroCo common stock issuance | 1 | 1 | ||||||||||||
Issuance of common stock in connection with NeuroCo merger (in shares) | 33,462 | |||||||||||||
Issuance of common stock in connection with NeuroCo merger | 0 | |||||||||||||
Net loss | (37,630) | |||||||||||||
Comprehensive loss | (37,630) | (37,629) | (1) | |||||||||||
Ending balance (in shares) at Dec. 31, 2018 | 1,135,310 | |||||||||||||
Ending balance at Dec. 31, 2018 | (134,553) | $ 1 | 4,557 | (139,111) | 0 | 0 | ||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||||||||||
Net exercise of Series C preferred stock warrants upon IPO (in shares) | 292,361 | 1,653,004 | ||||||||||||
Net exercise of Series C preferred stock warrants upon IPO | $ 1,784 | $ 37,121 | ||||||||||||
Conversion of preferred stock to common stock upon IPO (in shares) | (23,178,555) | |||||||||||||
Conversion of preferred stock to common stock upon IPO | $ (144,140) | |||||||||||||
Temporary equity, ending balance (in shares) at Dec. 31, 2019 | 0 | |||||||||||||
Temporary equity, ending balance at Dec. 31, 2019 | $ 0 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Exercise/issuance of common stock (in shares) | 3,764 | |||||||||||||
Exercise/issuance of common stock | $ 31 | 31 | ||||||||||||
Exercise of stock options (in shares) | 873,786 | 873,786 | 6,000,000 | |||||||||||
Exercise of stock options | $ 1,542 | $ 109,119 | $ 1 | $ 6 | 1,541 | $ 109,113 | ||||||||
Conversion of preferred stock to common stock upon IPO (in shares) | 23,178,555 | |||||||||||||
Conversion of preferred stock to common stock upon IPO | $ 144,140 | $ 23 | $ 144,117 | |||||||||||
Exercise of warrants (in shares) | 2,204 | |||||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 61,648 | |||||||||||||
Issuance of common stock under employee stock purchase plan | 1,048 | 1,048 | ||||||||||||
Stock-based compensation | 2,977 | 2,977 | ||||||||||||
Net loss | (52,415) | (52,415) | ||||||||||||
Unrealized gain on investments, net | 2 | 2 | ||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 31,255,267 | |||||||||||||
Ending balance at Dec. 31, 2019 | 71,891 | $ 31 | 263,384 | (191,526) | 2 | 0 | ||||||||
Temporary equity, ending balance (in shares) at Dec. 31, 2020 | 0 | |||||||||||||
Temporary equity, ending balance at Dec. 31, 2020 | $ 0 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Exercise/issuance of common stock (in shares) | 1,923,076 | |||||||||||||
Exercise/issuance of common stock | $ 70,543 | $ 2 | 70,541 | |||||||||||
Exercise of stock options (in shares) | 1,018,779 | 1,018,779 | ||||||||||||
Exercise of stock options | $ 3,487 | $ 1 | 3,486 | |||||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 52,527 | |||||||||||||
Issuance of common stock under employee stock purchase plan | 1,681 | 1,681 | ||||||||||||
Stock-based compensation | 7,226 | 7,226 | ||||||||||||
Net loss | (47,365) | (47,365) | ||||||||||||
Unrealized gain on investments, net | 37 | 37 | ||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 34,249,649 | |||||||||||||
Ending balance at Dec. 31, 2020 | $ 107,500 | $ 34 | $ 346,318 | $ (238,891) | $ 39 | $ 0 |
Statements of Redeemable Conv_2
Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Stockholders' Equity [Abstract] | ||
Offering costs | $ 4,457 | $ 233 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities | |||
Net loss | $ (47,365) | $ (52,415) | $ (37,630) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization expense | 789 | 712 | 517 |
Stock-based compensation expense | 7,226 | 2,977 | 911 |
Change in fair value of redeemable convertible preferred stock warrant liability | 0 | 21,030 | 11,906 |
Amortization of premiums (accretion of discounts) on investments, net | 304 | (309) | 0 |
Amortization of debt discount and debt issuance costs | 66 | 46 | 68 |
Amortization of right-of-use asset | 602 | 582 | |
Non-cash interest expense | 241 | 672 | 1,555 |
Loss on debt extinguishment | 1,119 | 0 | 0 |
Loss on disposal of property and equipment | 52 | 0 | 159 |
Change in provision for doubtful accounts receivable | (32) | 23 | (123) |
Provision for excess and obsolete inventories | 117 | 118 | 23 |
Changes in assets and liabilities | |||
Accounts receivable | (437) | (2,241) | (446) |
Inventories | (2,161) | (4,696) | (2,565) |
Prepaid expenses and other current assets | 250 | (1,471) | (1,128) |
Other assets | 210 | 552 | (62) |
Accounts payable | 592 | 615 | (309) |
Accrued liabilities | 146 | 4,964 | 5,023 |
Other liabilities | 26 | (769) | 406 |
Repayment of interest paid in kind | (3,813) | 0 | 0 |
Net cash used in operating activities | (42,068) | (29,610) | (21,695) |
Cash flows from investing activities | |||
Purchase of property and equipment | (842) | (535) | (2,276) |
Proceeds from sale of property and equipment | 0 | 0 | 6 |
Purchases of investments | (79,906) | (69,421) | 0 |
Proceeds from maturity of investments | 71,355 | 0 | 0 |
Net cash used in investing activities | (9,393) | (69,956) | (2,270) |
Cash flows from financing activities | |||
Proceeds from public offerings, net of underwriting discount, commissions and offering costs paid | 70,568 | 109,352 | (233) |
Proceeds from long-term debt, net | 48,506 | 0 | 15,000 |
Proceeds from issuance of common stock | 5,168 | 2,590 | 656 |
Principal repayment of long-term debt | (40,000) | 0 | 0 |
Payments of prepayment penalty and lender fees | (2,496) | 0 | 0 |
Non-controlling interest | 0 | 0 | 1 |
Net cash provided by financing activities | 81,746 | 113,757 | 15,424 |
Net change in cash, cash equivalents and restricted cash | 30,285 | 14,191 | (8,541) |
Cash, cash equivalents and restricted cash, beginning of year | 39,491 | 25,300 | 33,841 |
Cash, cash equivalents and restricted cash, end of year | 69,776 | 39,491 | 25,300 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 7,917 | 4,234 | 2,738 |
Non-cash investing and financing activities: | |||
Accounts payable and accrued liabilities for purchases of property and equipment | 108 | 32 | 6 |
Landlord paid tenant improvements | 0 | 0 | 794 |
Unpaid deferred offering costs | 25 | 0 | 717 |
Right-of-use asset obtained in exchange for lease obligation | 0 | 3,982 | |
Net exercise of redeemable convertible preferred stock warrants to preferred stock | 0 | 37,121 | 0 |
Conversion of redeemable convertible preferred stock to common stock upon initial public offering | 0 | 144,140 | 0 |
Redeemable convertible preferred stock warrants outstanding | |||
Cash flows from financing activities | |||
Proceeds from exercise of warrants | 0 | 1,784 | 0 |
Common stock warrants outstanding | |||
Cash flows from financing activities | |||
Proceeds from exercise of warrants | $ 0 | $ 31 | $ 0 |
Formation and Business of the C
Formation and Business of the Company | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Formation and Business of the Company | Formation and Business of the Company The Company Silk Road Medical, Inc. (the “Company”) was incorporated in the state of Delaware on March 21, 2007. The Company has developed a technologically advanced, minimally-invasive solution for patients with carotid artery disease who are at risk for stroke. The Company’s portfolio of TCAR products enable a new procedure, referred to as transcarotid artery revascularization, or TCAR, that combines the benefits of endovascular techniques and surgical principles. The Company manufactures and sells in the United States its portfolio of TCAR products which are designed to provide direct access to the carotid artery, effective reduction in stroke risk throughout the procedure, and long-term restraint of carotid plaque. The Company commercialized its products in the United States in 2016. Liquidity In the course of its activities, the Company has incurred losses and negative cash flows from operations since its inception. As of December 31, 2020, the Company had an accumulated deficit of $238,891,000. The Company expects to incur losses for the foreseeable future. The Company believes tha t its cash and cash equivalents of $69,466,000 and available-for-sale investments of $78,016,000 at December 31, 2020, as well as its expected revenues will provide sufficient funds to allow the Company to fund its planned current operations for the next twelve months from the issuance of these financial statements. Reverse Stock Split On March 13, 2019, the Company’s Board of Directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 1-for-2.7 reverse stock split of the Company’s common stock and redeemable convertible preferred stock to be consummated prior to the effectiveness of the Company’s planned initial public offering (“IPO”). The reverse stock split was effected on March 27, 2019. The par values of the common stock and redeemable convertible preferred stock were not adjusted as a result of the reverse stock split. All the common stock, redeemable convertible preferred stock, stock options and warrants, and related per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split. Public Offerings In April 2019, the Company issued and sold 6,000,000 shares of its common stock in its IPO at a public offering price of $20.00 per share, for net proceeds of approximately $109,119,000 after deducting underwriting discounts and commissions of approximately $8,400,000 and expenses of approximately $2,481,000. Upon the closing of the IPO, all shares of redeemable convertible preferred stock then outstanding converted into shares of common stock and the Company's outstanding warrants to purchase shares of common and redeemable convertible preferred stock were exercised, or automatically net exercised absent a prior election. The exercises resulted in the reclassification of the fair value of the related redeemable convertible preferred stock warrant liability to additional paid-in capital. In August 2019, the Company completed a secondary public offering of 4,200,000 shares of its common stock sold by certain selling stockholders, and the exercise in full of the underwriters' option to purchase 630,000 additional shares of its common stock from certain selling stockholders, at a public offering price of $39.50 per share. The Company did not receive any of the proceeds from the sale of the shares of its common stock from the selling stockholders. In May 2020, the Company completed an underwritten public offering of 6,808,154 shares of its common stock, of which 1,923,076 shares were offered for sale by the Company and the remaining 4,885,078 shares were offered for sale by certain selling stockholders, at a public offering price of $39.00 per share. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation The accompanying financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”). 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, stock-based compensation, and for periods prior to the Company's IPO, the valuation of common stock and redeemable convertible preferred stock warrants. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Due to the coronavirus (“COVID-19”) pandemic, there has been continued uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of December 31, 2020. The Company has also considered information available to it as of the date of issuance of these financial statements and is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. Actual results could differ materially from these estimates. Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of December 31, 2020 and 2019. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, long-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its long-term debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Prior to the Company's IPO, fair value accounting was applied to the redeemable convertible preferred stock warrant liability. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. As of December 31, 2020, the Company’s cash equivalents are comprised of investments in money market funds and commercial paper. As of December 31, 2019, the Company’s cash equivalents are entirely comprised of investments in money market funds. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the statements of cash flows (in thousands): December 31, 2020 2019 Cash and cash equivalents $ 69,466 $ 39,181 Restricted cash 310 310 Total cash, cash equivalents and restricted cash $ 69,776 $ 39,491 Restricted cash as of December 31, 2020 and 2019 consists of a letter of credit of $310,000 representing collateral for the Company’s facility lease. Investments Short-term investments consist of debt securities classified as available-for-sale and have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Money market funds are classified within Level 1 of the fair value hierarchy, and commercial paper, corporate bonds/notes, United States Government securities, and asset-backed securities are classified within Level 2 of the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). The cost of available-for-sale investments sold is based on the specific-identification method. Realized gains and losses are included in earnings and are der ived for specific-identification method for determining the costs of investments sold and were insignificant for the year ended December 31, 2020 and 2019. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. Concentration of Credit Risk, and Other Risks and Uncertainties The Company is subject to risks related to public health 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 have prioritized the treatment of patients with COVID-19. For example, in the United States, governmental authorities have recommended, and in certain cases required, that elective, specialty and other procedures and appointments, be suspended or canceled to focus limited resources and personnel and hospital capacity toward the treatment of COVID-19 and to avoid exposing patients to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and will continue to negatively impact the Company’s revenue while the pandemic continues. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds and commercial paper. 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 years ended December 31, 2020 and 2019. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At December 31, 2020 and 2019, no customer represented 10% or more of the Company’s accounts receivable. For the years ended December 31, 2020, 2019 and 2018, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for doubtful accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis, a Cardinal Health Company (see Note 14 - Subsequent Events). 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. Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company estimates allowances for doubtful accounts. Specifically, the Company makes estimates on the collectability of customer accounts based primarily on analysis of historical trends and experience and changes in customers’ financial condition. The Company uses its judgment, based on the best available facts and circumstances, and records an allowance against amounts due to reduce the receivable to the amount that is expected to be collected. These specific allowances are reevaluated and adjusted as additional information is received that impacts the amount reserved. During the years ended December 31, 2020, 2019 and 2018, the Company did not experience any material credit-related losses. Inventories Inventories are valued at the lower of cost to purchase or manufacture the inventory or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Net realizable value is determined as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company regularly reviews inventory quantities in consideration of actual loss experiences, projected future demand, and remaining shelf life prior to sale to record a provision for excess and obsolete inventory when appropriate. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected lower of cost or net realizable value, and inventory in excess of expected requirements. The estimate of excess quantities is judgmental and primarily dependent on the Company’s estimates of future demand for a particular product. If the estimate of future demand is too high, the Company may have to increase the reserve for excess inventory for that product and record a charge to the cost of goods sold. Other Current Assets The prepaid expenses and other current assets balance at December 31, 2020 included $4,160,000 associated with the Company's voluntary recall (see Note 14 - Subsequent Events). The amount relates to the replacement lots and other direct costs to be received from Cord is. Property and Equipment Property and equipment are recorded at cost less accumulated depreciation or amortization. Repairs and maintenance costs are expensed as incurred. Depreciation and amortization are calculated using the straight-line method over the estimated useful lives of the assets, typically three Deferred Public Offering Costs Specific incremental legal, accounting and other fees and costs directly attributable to a proposed or actual offering of securities may properly be deferred and charged against the gross proceeds of the offering. No deferred offering costs were capitalized as of December 31, 2020 . As of December 31, 2019, there were $950,000 of offering costs primarily consisting of legal and accounting fees that were capitalized in other non-current assets on the balance sheet of which $233,000 had been paid. Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. If indicators of impairment exist, an impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the assets and their eventual disposition are less than their carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of the long-lived assets exceeds their fair value. The Company did not record any impairment of long-lived assets during the years ended December 31, 2020, 2019 and 2018. Leases The Company adopted Accounting Standards Codification (“ASC”) 842, "Leases," on January 1, 2019 and used the modified retrospective method for all leases not substantially completed as of the date of adoption and the package of practical expedients available in the standard. As a result of adopting ASC 842, the Company recorded an operating lease right-of-use ("ROU") asset of $3,982,000 included within other non-current assets and operating lease liabilities of $5,190,000 included within accrued liabilities and other liabilities on the balance sheet related to its facility lease, based on the present value of the future lease payments on the date of adoption. The operating lease right-of-use asset also includes adjustments for prepayments and excludes lease incentives. The adoption did not have an impact on prior periods or on the Company's statements of operations and comprehensive loss. The disclosure impact of the adoption of ASC 842 on the balance sheet was as follows (in thousands): Balance Sheet: Balance at December 31, 2018 Adjustments Due to ASC 842 Balance at January 1, 2019 Other non-current assets $ — $ 3,982 $ 3,982 Accrued liabilities 139 582 721 Other liabilities 1,069 3,400 4,469 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. Redeemable Convertible Preferred Stock Warrant Liability Prior to its IPO, the Company accounted for its warrants for shares of redeemable convertible preferred stock as a liability based upon the characteristics and provisions of each instrument. Redeemable convertible preferred stock warrants classified as a liability were initially recorded at their fair value on the date of issuance and are subject to remeasurement at each subsequent balance sheet date. Any change in fair value as a result of a remeasurement was recognized as a component of other income (expense), net in the statements of operations and comprehensive loss. The Company recorded adjustments to the estimated fair value of the redeemable convertible preferred stock warrants until they were exercised. Upon their exercise, the final fair value of the warrant liability was reclassified to stockholders’ equity. Subsequent to its IPO, the Company no longer recorded any related periodic fair value adjustments. Redeemable Convertible Preferred Stock Prior to its IPO, the Company recorded its redeemable convertible preferred stock at fair value on the dates of issuance, net of issuance costs, and classified the redeemable convertible preferred stock outside of stockholders’ equity on the balance sheet as events triggering the liquidation preferences were not solely within the Company’s control. Upon the closing of the Company's IPO, all shares of convertible preferred stock then outstanding converted into an aggregate of 23,178,555 shares of common stock resulting in the reclassification of $144,140,000 from outside of stockholders’ equity to additional paid-in capital. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers.” As of January 1, 2018, the date of adoption, the Company recognized the cumulative-effect of initially applying ASC 606 as an adjustment to decrease accumulated deficit by $87,000. 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 December 31, 2020 and 2019, the Company recorded $71,000 and $102,000, respectively, of unbilled receivables, which are included in accounts receivable, net on the 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 collectibility 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 revenue in the 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 our balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its facility and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and subassemblies, manufacturing overhead costs, direct labor, reserves for excess, obsolete and non-sellable inventories as well as distribution-related expenses. A significant portion of the Company’s cost of goods sold currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalties. Research and Development The Company expenses research and development costs as incurred. Research and development expenses consist primarily of engineering, product development, clinical studies to develop and support the Company’s products, regulatory expenses, medical affairs and other costs associated with products and technologies that are in development. Research and development expenses include employee compensation, including stock-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation and an allocation of facility overhead expenses. Additionally, research and development expenses include costs associated with our clinical studies including clinical trial design, clinical site reimbursement, data management, travel expenses and the cost of products used for clinical trials and internal and external costs associated with the Company’s regulatory compliance and quality assurance functions, including the costs of outside consultants and contractors that assist in the process of submitting and maintaining regulatory filings, and overhead costs. Clinical Trials The Company accrues and expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company determines these accruals through discussion with internal personnel and outside service providers as to progress or stage of completion of trials or services pursuant to contracts with clinical research organizations and other service providers and the agreed-upon fee to be paid for such services. Advertising Costs The Company expenses advertising costs as incurred. Advertising costs include design and production costs, including website development, physician and patient testimonial videos, written media campaigns, and other items. Advertising costs of $194,000, $362,000 and $186,000 were expensed during the years ended December 31, 2020, 2019 and 2018, respectively. Foreign Currency The Company records net gains and losses resulting from foreign exchange transactions as a component of foreign currency exchange gains or losses in other income (expense), net. The Company had no material foreign currency exchange gains or losses during the years ended December 31, 2020, 2019 and 2018. 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. The Company made an accounting policy election under Accounting Standards Update (ASU) No. 2016-09, "Stock Compensation (Topic 718): Improvements to Employee Shared-Based Payment Accounting to account for forfeitures as they occur, resulting in a cumulative-effect adjustment to increase accumulated deficit by $13,000 as of January 1, 2018, the date of adoption. 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 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 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 years ended December 31, 2020 and 2019 , 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 statements of operations and comprehensive income. Accumulated other comprehensive loss is presented in the accompanying balance sheets as a component of stockholders' equity. For the year ended December 31, 2018, there was no difference between the Company's comprehensive loss and its net loss. Net Loss per Share Attributable to Common Stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders 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 attributable to common stockholders by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock and warrants, common stock options, and restricted stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. The Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The shares of the Company’s redeemable convertible preferred stock participate in any dividends declared by the Company and are therefore considered to be participating securities. Net loss per share was determined as follows (in thousands, except share and per share data): Year Ended December 31, 2020 2019 2018 Net loss attributable to Silk Road Medical, Inc. common stockholders $ (47,365) $ (52,415) $ (37,629) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 32,965,539 22,956,679 960,882 Net loss per share attributable to Silk Road Medical, Inc. common stockholders, basic and diluted $ (1.44) $ (2.28) $ (39.16) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such secur |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-13, "Fair Value Measurement," which changed the disclosure requirements for fair value measurements by removing, adding and modifying certain disclosures. The Company adopted the new standard effective January 1, 2020. The adoption did not have a material impact on the Company's financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-15, "Cloud Computing Arrangements," which aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license. The Company adopted the new standard effective January 1, 2020 on a prospective basis. The adoption did not have a material impact on the Company's financial statements and related disclosures. Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, "Measurement of Credit Losses on Financial Statements." This update provides financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. The update replaces the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. In October 2019, the FASB delayed the effective date of this standard for smaller reporting companies, as such ASU 2016-13 was determined to originally be effective for the Company on January 1, 2023. During the year ended December 31, 2020, the Company no longer qualified as a smaller reporting company, accordingly ASU 2016-13 became effective for the Company on January 1, 2021. The Company does not believe that the adoption of this new guidance will have a material impact on its financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which enhances and simplifies various aspects of the income tax accounting guidance related to intra-period tax allocation, interim period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim period tax accounting. ASU 2019-12 also amends other aspects of the guidance to reduce complexity in certain areas. ASU 2019-12 became effective for the Company on January 1, 2021. The Company does not believe that the adoption of this new guidance will have a material impact on its financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, investments, and the Company's previously outstanding preferred stock warrants. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: • Level 1 – quoted prices in active markets are identical assets and liabilities; • Level 2 – observable inputs other than quotes prizes 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 and liabilities that are reported at fair value as of December 31, 2020 and 2019, using the inputs defined above (in thousands): December 31, 2020 Level 1 Level 2 Level 3 Total Assets: 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 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper — 9,919 — 9,919 Corporate bonds/notes — 10,176 — 10,176 U.S. government securities — 44,456 — 44,456 Asset-backed securities — 5,181 — 5,181 $ 34,363 $ 69,732 $ — $ 104,095 There were no transfers between fair value hierarchy levels during the years ended December 31, 2020 and 2019. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Investments The fair value of the Company's available-for-sale investments as of December 31, 2020 and 2019 are as follows (in thousands): December 31, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money 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 December 31, 2019 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper 9,919 — — 9,919 Corporate bonds/notes 10,180 — (4) 10,176 U.S. government securities 44,450 9 (3) 44,456 Asset-backed securities 5,181 — — 5,181 $ 104,093 $ 9 $ (7) $ 104,095 Classified as: Cash equivalents $ 34,363 Short-term investments 51,508 Long-term investments 18,224 $ 104,095 The following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term investments classified by maturity as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Amounts maturing within one year $ 146,311 $ 85,871 Amounts maturing after one year through two years — 18,224 $ 146,311 $ 104,095 Available-for-sale investments held as of December 31, 2020 had a weighted average days to maturity of 135 days. The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of December 31, 2020 and 2019 (in thousands): December 31, 2020 December 31, 2019 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds/notes $ 5,369 $ (1) $ 10,128 $ (4) U.S. government securities 10,128 (2) 19,067 (3) $ 15,497 $ (3) $ 29,195 $ (7) Inventories Components of inventories were as follows (in thousands): December 31, 2020 2019 Raw materials $ 1,785 $ 1,203 Finished products 10,599 9,163 12,384 10,366 Less: Reserve for excess and obsolete (2,395) (44) $ 9,989 $ 10,322 As of December 31, 2020 and 2019, there were no work-in-process inventories. The reserve for excess and obsolete inventory at December 31, 2020, included $2,377,000 associated with the Company's voluntary product recall (see Note 14 - Subsequent Events). Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): December 31, 2020 2019 Furniture and fixtures $ 726 $ 657 Equipment 1,699 1,295 Software 226 18 Leasehold improvements 2,043 1,991 4,694 3,961 Less: Accumulated depreciation and amortization (2,332) (1,550) Add: Construction-in-progress 482 323 $ 2,844 $ 2,734 Depreciation and amortization expense was $789,000, $712,000 and $517,000 for the years ended December 31, 2020, 2019 and 2018, respectively. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued payroll and related expenses $ 9,573 $ 9,151 Provision for sales returns 820 2,419 Accrued professional services 2,520 682 Recall replacement obligation 1,696 — Operating lease liability 850 769 Accrued royalty expense 518 470 Deferred revenue 206 304 Accrued travel expenses 237 431 Accrued clinical expenses 113 241 Accrued other expenses 424 567 $ 16,957 $ 15,034 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt CRG In October 2015, the Company entered into a term loan agreement with CRG. The term loan agreement provides for up to $30,000,000 in term loans split into two tranches as follows: (i) the Tranche A Loans provided for $20,000,000 in term loans, and (ii) the Tranche B Loans provided for up to $10,000,000 in term loans. The Company drew down the Tranche A Loans on October 13, 2015. The Tranche B Loans were available to be drawn prior to March 29, 2017. In January 2017, the term loan agreement was amended to extend the commitment period of the Tranche B Loans to April 28, 2017. In April 2017, the Company drew down $5,000,000 of the available Tranche B Loans. In September 2018, the 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. U nder 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 Bank In 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 December 31, 2020. Obligations under the Loan Agreement are secured by substantially all of the Company's assets. Beginning on January 15, 2021, the Loan Agreement requires 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 (or prior to January 15, 2021, Stifel Bank or certain other banks) 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 December 31, 2020, the aggregate outstanding principal balance under the Loan Agreement was $49,000,000 and the annual interest rate was 4.75%. As of December 31, 2020, the Company was in compliance with all applicable financial covenants. As of December 31, 2020, 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 balance sheet. Future maturities under the Stifel Bank term loan agreement as of December 31, 2020 are as follows (in thousands): Year Ending December 31: Amount 2021 $ 2,360 2022 14,679 2023 20,845 2024 17,370 55,254 Less: Amount representing interest (6,254) Less: Amount representing debt discount and debt issuance costs (467) Present value of minimum payments $ 48,533 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Lease and Rights of Use The Company’s operating lease obligation consists of leased office, laboratory, and manufacturing space under a non-cancellable operating lease that expires in October 2024. The lease agreement includes a renewal provision allowing the Company to extend this lease for an additional period of five years. Operating lease costs were $870,000 for each of the years ended December 31, 2020 and 2019. Cash paid for amounts included in the measurement of operating lease liabilities was $769,000 and $721,000 for the years ended December 31, 2020 and 2019. As of December 31, 2020, the weighted average discount rate was approximately 6.50% and the weighted average remaining lease term was 3.83 years. As of December 31, 2019, the weighted average discount rate was approximately 6.50% and the weighted average remaining lease term was 4.83 years. Balance sheet information as of December 31, 2020 consists of the following (in thousands): December 31, Operating Lease: 2020 2019 Operating lease right-of-use asset in other non-current assets $ 2,798 $ 3,400 Operating lease liability in accrued liabilities $ 850 $ 769 Operating lease liability in other liabilities 2,850 3,700 Total operating lease liabilities $ 3,700 $ 4,469 The following table summarizes the Company's operating lease maturities as of December 31, 2020 (in thousands): Year Ending December 31: Amount 2021 $ 1,066 2022 1,096 2023 1,127 2024 904 Total lease payments 4,193 Less: imputed interest (493) Present value of lease liabilities $ 3,700 Purchase Obligations Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. As of December 31, 2020, the Company had non-cancellable purchase obligations to suppliers of $6,601,000. 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 December 31, 2020. Contingencies The Company is not involved in any pending legal proceedings that it believes could have a material adverse effect on its financial condition, results of operations or cash flows. From time to time, the Company may pursue litigation to assert its legal right and such litigation may be costly and divert the efforts and attention of its management and technical personnel which could adversely affect its business. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual at December 31, 2020 and 2019. Legal Matters In February 2019, a former employee, through counsel, advised the Company that he had filed a charge of discrimination against the Company with the California Department of Fair Employment & Housing, or DFEH. The former employee’s complaint alleged sexual harassment and retaliation in violation of the California Department of Fair Employment & Housing Act. The complaint did not allege specific damages. The Company and the former employee participated in mediation on July 30, 2019 and reached a settlement that required the Company to pay an amount that was not material to its financial statements, which amount was fully paid as of December 31, 2019. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2020 | |
Temporary Equity Disclosure [Abstract] | |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock Upon the closing of the Company's IPO, all shares of redeemable convertible preferred stock then outstanding converted into shares of common stock. As of December 31, 2020 and 2019, the Company does not have any redeemable convertible preferred stock issued or outstanding. Redeemable Convertible Preferred Stock Warrant s Upon the closing of the Company's IPO, all of the outstanding redeemable convertible preferred stock warrants were exercised, or net exercised based on the IPO price of $20.00 per share, into 1,945,365 shares of common stock. As of December 31, 2020 and 2019, the Company does not have any redeemable convertible preferred stock warrants outstanding. Preferred Stock At December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 5,000,000 shares of preferred stock with $0.001 par value per share, of which no shares were issued and outstanding. Common Stock At December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 100,000,000 shares of common stock with $0.001 par value per share, of which 34,249,649 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 December 31, 2020, no dividends have been declared to date. Each share of common stock is entitled to one vote. At December 31, 2020 and 2019, the Company had reserved common stock for future issuances as follows: December 31, 2020 2019 Exercise of options under stock plan 4,237,828 4,310,790 Issuance of options and restricted stock units under stock plan 1,790,687 1,554,690 Issuance of common stock under employee stock purchase plan 632,377 372,352 6,660,892 6,237,832 Common Stock Warrant s In connection with the IPO, the common stock warrants were cash, or net exercised based on the IPO price of $20.00 per share into 5,968 shares of common stock. As of December 31, 2020 and 2019, the Company does not have any common stock warrants outstanding. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | Redeemable Convertible Preferred Stock Upon the closing of the Company's IPO, all shares of redeemable convertible preferred stock then outstanding converted into shares of common stock. As of December 31, 2020 and 2019, the Company does not have any redeemable convertible preferred stock issued or outstanding. Redeemable Convertible Preferred Stock Warrant s Upon the closing of the Company's IPO, all of the outstanding redeemable convertible preferred stock warrants were exercised, or net exercised based on the IPO price of $20.00 per share, into 1,945,365 shares of common stock. As of December 31, 2020 and 2019, the Company does not have any redeemable convertible preferred stock warrants outstanding. Preferred Stock At December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 5,000,000 shares of preferred stock with $0.001 par value per share, of which no shares were issued and outstanding. Common Stock At December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to 100,000,000 shares of common stock with $0.001 par value per share, of which 34,249,649 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 December 31, 2020, no dividends have been declared to date. Each share of common stock is entitled to one vote. At December 31, 2020 and 2019, the Company had reserved common stock for future issuances as follows: December 31, 2020 2019 Exercise of options under stock plan 4,237,828 4,310,790 Issuance of options and restricted stock units under stock plan 1,790,687 1,554,690 Issuance of common stock under employee stock purchase plan 632,377 372,352 6,660,892 6,237,832 Common Stock Warrant s In connection with the IPO, the common stock warrants were cash, or net exercised based on the IPO price of $20.00 per share into 5,968 shares of common stock. As of December 31, 2020 and 2019, the Company does not have any common stock warrants outstanding. |
Stock Option Plans
Stock Option Plans | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Plans | Stock Option Plans In 2007, the Company established its 2007 Stock Option Plan which provided for the granting of stock options to employees, directors and consultants of the Company. In connection with its acquisition of NeuroCo in December 2018, the Company also assumed NeuroCo’s 2015 Equity Incentive Plan. In March 2019, the Company's Board of Directors approved the termination of the 2007 Stock Option Plan and the NeuroCo 2015 Equity Incentive Plan and the adoption of the 2019 Equity Incentive Plan, or the 2019 Plan, which became effective immediately prior to the Company's IPO. The 2019 Plan provides for the grant of ISOs to employees and for the grant of 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 will also include an annual increase on the first day of each fiscal year, 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 December 31, 2020, the Company has reserved 3,635,009 shares of common stock for issuance under the 2019 Plan. A summary of the shares available for issuance under the 2007 Stock Option Plan, NeuroCo 2015 Equity Incentive Plan and 2019 Plan, or the Plans, is as follows: Number of Shares Balances, December 31, 2017 328,290 Authorized 223,664 Granted (629,716) Canceled 135,651 Balances, December 31, 2018 57,889 Authorized 2,317,000 Granted (848,023) Canceled 27,824 Balances, December 31, 2019 1,554,690 Authorized 1,250,210 Granted/Awarded (1,079,883) Cancelled 65,670 Balances, December 31, 2020 1,790,687 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 ten years and generally vest over 4 years from the date of grant. Stock option activity under the Company's Plans is set forth below: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2017 4,308,890 $ 3.09 7.81 $ 5,073 Options granted 629,716 $ 6.51 Options exercised (438,578) $ 1.50 Options cancelled (135,651) $ 1.56 Balances, December 31, 2018 4,364,377 $ 3.79 7.36 $ 33,132 Options granted 848,023 $ 22.77 Options exercised (873,786) $ 1.77 Options cancelled (27,824) $ 8.71 Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 1,010,843 $ 40.67 Options exercised (1,018,779) $ 3.42 Options cancelled (65,026) $ 23.32 Balances, December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407 Vested and exercisable at December 31, 2020 2,392,563 $ 8.48 6.53 $ 130,417 Vested and expected to vest at December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407 The aggregate intrinsic value of options exercised during the years ended December 31, 2020, 2019 and 2018 was $47,861,000, $24,867,000 and $787,000, respectively. 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. The weighted-average grant date fair value of options granted during the years ended December 31, 2020, 2019 and 2018 was $18.22, $10.17 and $2.93 per share, respectively. The total fair value of options vested during the years ended December 31, 2020, 2019 and 2018 was $5,138,000, $2,221,000 and $569,000, respectively, based on the grant date fair value. The following table summarizes information about stock options outstanding and vested as of December 31, 2020: Options Outstanding Options Vested Exercise Price Options Outstanding Weighted Average Remaining Contractual Term (in Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $1.35 - $3.16 1,214,279 5.45 $ 1.97 1,128,865 $ 1.88 $4.73 - $7.10 722,615 7.17 $ 5.64 443,670 $ 5.69 $8.27 - $12.41 564,188 7.08 $ 11.67 394,727 $ 11.81 $20.00 - $30.00 656,009 8.26 $ 20.00 270,305 $ 20.00 $30.93 - $46.40 771,966 9.21 $ 33.50 136,151 $ 33.76 $47.20 - $70.80 308,771 9.53 $ 58.86 18,845 $ 51.99 4,237,828 7.38 $ 16.56 2,392,563 $ 8.48 Restricted Stock Units In March 2020, the Company began granting restricted stock units, or RSUs, under the 2019 Plan. RSUs generally vest over four years in annual equal increments, no RSUs vested during the year ended December 31, 2020. The fair value of RSUs is based on the Company’s closing stock price on the date of grant. A summary of RSUs activity for the year ended December 31, 2020 is as follows: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2019 — Restricted stock granted 69,040 $ 46.14 Restricted stock vested — Restricted stock forfeited (644) $ 44.62 Balances, December 31, 2020 68,396 $ 46.16 Expected to vest at December 31, 2020 68,396 $ 46.16 2019 Employee Stock Purchase Plan In March 2019, the Company's Board of Directors adopted the 2019 Employee Stock Purchase Plan, or the 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 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 December 31, 2020, the Company has reserved 746,552 shares of common stock for issuance under the 2019 ESPP. The price of the common stock purchased will be the lower of 85% of the fair market value of the common stock at the beginning of an offering period or at the end of a purchase period. The 2019 ESPP was effective upon adoption by the Company's Board of Directors but was not in use until the completion of the Company's IPO in April 2019. The 2019 ESPP is intended to qualify as an "employee stock purchase plan" within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended. As of December 31, 2020, 114,175 shares of common stock have been issued to employees participating in the 2019 ESPP and 632,377 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 years ended December 31, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Expected term (in years) 5.25 - 6.25 5.00 - 6.25 5.00 - 6.25 Expected volatility 43.0% - 50.3% 42.4% - 42.9% 38.0% - 38.8% Risk-free interest rate 0.32% - 1.41% 1.47% - 2.54% 2.68% - 2.98% Dividend yield —% —% —% Prior to completion of the Company's IPO, the fair value of common stock was determined by the Company’s Board of Directors, who considered, among other things, contemporaneous valuations of the Company’s common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. For stock options granted after the completion of the IPO, the fair value of the underlying common stock is based on the closing price of the Company's common stock on The NASDAQ Global Market on the date of grant. The expected term of stock options represents the weighted-average period the stock options are expected to remain outstanding. The Company does not have sufficient historical exercise and post-vesting termination activity to provide accurate data for estimating the expected term of options and has opted to use the “simplified method,” whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company does not have sufficient trading history for the Company’s common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the Company’s common stock becomes available. The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. Effective January 1, 2018, the Company made an accounting policy election to account for forfeitures as they occur. 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 years ended December 31, 2020 and 2019: Year Ended December 31, 2020 2019 Expected term (in years) 0.50 0.50 - 0.63 Expected volatility 44.4% - 76.4% 44.4% - 47.8% Risk-free interest rate 0.10% - 1.58% 1.58% - 2.45% Dividend yield —% —% The following table summarizes the total stock-based compensation expense included in the statements of operations for all periods presented (in thousands): Year Ended December 31, 2020 2019 2018 Cost of goods sold $ 339 $ 179 $ 51 Research and development expenses 1,110 426 256 Selling, general and administrative expenses 5,777 2,372 604 $ 7,226 $ 2,977 $ 911 As of December 31, 2020, there was total unrecognized compensation costs of $20,188,000 related to stock options expected to be recognized over a period of approximately 3.02 years, a total of $2,716,000 of unrecognized compensation costs related to unvested RSUs expected to be recognized over a period of approximately 3.48 years and $295,000 related to the ESPP, which the Company will recognize over 0.38 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of income before taxes are as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ (47,365) $ (52,415) $ (37,630) International — — — $ (47,365) $ (52,415) $ (37,630) A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Tax at federal statutory rate $ (9,947) $ (11,007) $ (7,902) State taxes, net of federal benefit (1,958) (2,270) (1,582) Permanent differences (8,489) (4,731) 289 Loss on Series C warrant liability — 5,330 2,500 Change in valuation allowance 22,164 12,797 6,197 General business credits (1,268) (319) 136 Other (491) 208 376 Provision for income taxes $ 11 $ 8 $ 14 The Company's provision for income taxes are included within other income (expense) on the statements of operations and comprehensive loss. Significant components of the Company’s net deferred tax assets as of December 31, 2020 and 2019 consist of the following (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 63,069 $ 44,574 Research and development credits 7,191 5,287 Capitalized start-up costs/Intangibles 8 11 Accruals and reserves 2,337 2,227 Property and equipment — 188 Stock-based compensation 1,859 568 Operating lease liability 935 1,133 Interest limitation 813 — Total deferred tax assets 76,212 53,988 Less: Valuation allowance (75,289) (53,126) Deferred tax liabilities: Operating lease asset (707) (862) Property and equipment (216) — Total deferred tax liabilities (923) (862) Net deferred tax assets $ — $ — In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management believes it is more likely than not that the deferred tax assets will not be realized; accordingly, a valuation allowance has been established on U.S. net deferred tax assets. The valuation allowance increased $22,163,000 during the year ended December 31, 2020 and increased by $12,826,000 during the year ended December 31, 2019. As of December 31, 2020, the Company had net operating loss carryforwards of approximately $241,908,000 and $209,771,000 for federal and state income tax purposes, respectively. The federal and state net operating loss carryforwards begin to expire in 2027 and 2028, respectively. Federal NOL carryforwards generated in tax years beginning in 2018 are not subject to expiration. Federal NOLs that arose on or after January 1, 2018 can be carried forward indefinitely against future income, but can only be used to offset a maximum of 80% of the Company's federal taxable income in any year. The federal and state net operating loss carryforwards may be subject to significant limitations under Section 382 and Section 383 of the Internal Revenue Code and similar provisions under state law. Federal tax legislation enacted in December 2017, commonly known as the Tax Cuts and Jobs Act, contains provisions that limit the federal net operating loss carryforwards that may be used in any given year in the event of special occurrences, including significant ownership changes. A Section 382 “ownership change” generally occurs if one or more stockholders or groups of stockholders, who own at least 5% of the Company’s stock, increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The Company may have previously experienced, and may in the future experience, one or more Section 382 “ownership changes,” including in connection with the Company’s initial public offering. If so, the Company may lose some or all of the tax benefits of its NOLs and tax credits. The extent of such limitations for prior years, if any, has not yet been formally determined. At December 31, 2020, the Company had $6,275,000 and $3,463,000 of federal and state research and development credit carryforwards, respectively. If not utilized, the federal credits will expire beginning in 2027. The California Research and Development credits can be carried forward indefinitely. As of December 31, 2020, the Company had $2,019,000 of unrecognized tax benefits. The Company does not have any tax positions for which it is reasonably possible that the total amount of gross unrecognized would increase or decrease within twelve months of the year ended December 31, 2020. If recognized, $0 would affect the effective tax rate. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. There was no such expense recorded during the years ended December 31, 2020, 2019 and 2018. A reconciliation of the unrecognized tax benefits from January 1, 2018 to December 31, 2020 is as follows (in thousands): December 31, 2020 2019 2018 Balance at the beginning of year $ 1,436 $ 1,348 $ 615 Increases related to current years’ tax positions 342 88 118 Increases related to prior years’ tax positions 241 — 615 Balance at end of year $ 2,019 $ 1,436 $ 1,348 The Company currently has no federal or state tax examinations in progress nor has it had any federal or state tax examinations since its inception. As a result of the Company’s net operating loss carryforwards, all of its tax years are subject to federal and state tax examination. |
Acquisition of Variable Interes
Acquisition of Variable Interest Entity - NeuroCo | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Acquisition of Variable Interest Entity - NeuroCo | Acquisition of Variable Interest Entity - NeuroCo In December 2014, the Board of Directors of the Company approved the sale of certain intellectual property of Silk Road Medical, Inc., to a newly incorporated entity, NeuroCo, Inc. In consideration for the intellectual property, a promissory note was executed between the two parties for the principal sum of $498,000 with an interest rate of 2.74% per annum, payable on the earlier of 10 years from the date of promissory note, or upon the occurrence of an event of default. The intellectual property transfer was recorded at its carrying value of zero as of December 31, 2014. During 2015 NeuroCo issued $154,000 in common stock to stockholders of the Company. During the year ended December 31, 2018, NeuroCo issued common stock upon the exercise of stock options. These common stock issuance amounts, as they are related to non-controlling investors, were reported as non-controlling interests in subsidiary in the Company’s financial statements and are offset by NeuroCo losses consolidated by the Company. Additionally, NeuroCo incurred research and development related expenses paid for by the Company which were added into the original promissory note. The Company had identified NeuroCo as a VIE of which the Company is the primary beneficiary. Pursuant to the accounting guidance for consolidating VIEs the main consideration was given to the fact that the amount of total equity investment at risk is not sufficient to permit NeuroCo to finance its activities without additional subordinated financial support. Additionally, NeuroCo and Silk Road Medical had the same Board of Directors and senior management composition, determining the Company to have the power to direct the activities that most significantly impact NeuroCo’s economic performance and the obligation to absorb losses and the right to receive benefits. Accordingly, the financial results of NeuroCo were included in the Company’s financial statements. On December 17, 2018, the Company and NeuroCo entered into the Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the Company acquired all assets and assumed all liabilities of NeuroCo (the “Merger”). The Merger closed on the same day (the “Closing”) and was consummated through a stock-for-stock transaction based on the relative values of the Company’s and NeuroCo’s equity. In consideration for 100% equity interest of NeuroCo, the Company issued 33,462 shares of its common stock and the above promissory note in the amount of approximately $1,600,000 as of the Closing was settled and canceled. As a result of the Merger, NeuroCo merged into the Company with the Company being the surviving corporation. As the Company already controlled and consolidated NeuroCo and retained the control over NeuroCo’s business after the Merger, the Company accounted for the acquisition of equity interest in NeuroCo as an equity transaction. Therefore, the Company did not recognize a gain or loss in its net loss or comprehensive loss for acquisition of NeuroCo. As the carrying amount of the non-controlling interest as of the Closing was zero, the Company recorded the consideration paid as a decrease to the Company’s additional paid-in capital within stockholder’s equity. As part of the Merger, the Company assumed NeuroCo’s 2015 Equity Incentive Plan (the “NeuroCo Plan”) along with all of NeuroCo’s rights and obligations under the NeuroCo Plan, except that the number of shares and exercise price of the assumed options have been adjusted based on the Merger exchange ratio of the Company’s common stock and NeuroCo’s common stock. Similarly, the Company assumed outstanding warrants to purchase NeuroCo’s common stock such that the number of shares and exercise price of the assumed warrants have been adjusted based on the Merger exchange ratio of the Company’s common stock and NeuroCo’s common stock. The options and warrants to purchase shares of the Company’s common stock were fully vested upon issuance, as they were replacing fully vested options and warrants to purchase NeuroCo common stock. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
401(k) Plan | 401(k) PlanThe Company has a qualified retirement plan under section 401(k) of the Internal Revenue Code (“IRC”) under which participants may contribute up to 90% of their eligible compensation, subject to maximum deferral limits specified by the IRC. The Company may make a discretionary matching contribution to the 401(k) plan and may make a discretionary employer contribution to each eligible employee each year. Through December 31, 2019, the Company has made no contributions to the 401(k) plan. 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 $959,000 for the year ended December 31, 2020. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events 2019 Equity Incentive Plan In January 2021, the number of shares of common stock authorized for issuance under the 2019 Plan was automatically increased by 1,369,985 shares, which was ratified by the Company's Board of Directors in January 2021. In February 2021, the Company’s Board of Directors approved the grant of options to purch ase 19,305 shares of common stock under the 2019 Plan with an exercise price of $59.33 per share. 2019 Employee Stock Purchase Plan In January 2021, the number of shares of common stock authorized for issuance under the 2019 ESPP was automatically increased by 342,496 shares, which was ratified by the Company's Board of Directors in January 2021. Voluntary Recall In January and February 2021, the Company announced the voluntary recall of certain lots of our 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. Employee Bonus to be Settled in Shares On February 9, 2021, the Company's Compensation Committee of the Board of Directors approved that the bonus for certain employees would partially be paid in RSUs. Actual shares were awarded to employees on February 26, 2021 as a fixed dollar amount converted to 14,952 fully vested RSUs using the trailing 30-day average stock price. |
Quarterly Financial Information
Quarterly Financial Information (unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (unaudited) | Quarterly Financial Information (unaudited) The following table provides selected unaudited quarterly financial data for the years ended December 31, 2020, and 2019 (in thousands, except per share data): Three Months Ended December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 Revenue $ 21,133 $ 20,067 $ 15,094 $ 18,933 Gross profit $ 15,916 $ 14,579 $ 9,758 $ 13,683 Net loss $ (16,756) $ (10,315) $ (10,353) $ (9,941) Net loss per share, basic and diluted $ (0.49) $ (0.31) $ (0.32) $ (0.32) Three Months Ended December 31, 2019 September 30, 2019 June 30, 2019 March 31, 2019 Revenue $ 18,634 $ 17,026 $ 14,928 $ 12,766 Gross profit $ 13,913 $ 12,856 $ 11,231 $ 9,427 Net loss $ (8,291) $ (8,007) $ (11,959) $ (24,158) Net loss per share, basic and diluted $ (0.27) $ (0.26) $ (0.42) $ (20.12) |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Financial Statement Schedule. All other schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto. The table below presents Schedule II, Valuation and Qualifying Accounts, detailing the activity of the allowance for doubtful accounts receivable for the years ended December 31, 2020, 2019 and 2018 (in thousands): Description Balance at Beginning of Year Charged to expenses Write offs Balance at End of Year Allowance for doubtful accounts receivable: Year ended December 31, 2020 $ 45 $ (32) $ — $ 13 Year ended December 31, 2019 $ 22 $ 23 $ — $ 45 Year ended December 31, 2018 $ 149 $ (123) $ 4 $ 22 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Adjustment to Prior Period Financial Statements | Basis of PreparationThe accompanying financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
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, stock-based compensation, and for periods prior to the Company's IPO, the valuation of common stock and redeemable convertible preferred stock warrants. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Due to the coronavirus (“COVID-19”) pandemic, there has been continued uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of December 31, 2020. The Company has also considered information available to it as of the date of issuance of these financial statements and is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. Actual results could differ materially from these estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of December 31, 2020 and 2019. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, long-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its long-term debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Prior to the Company's IPO, fair value accounting was applied to the redeemable convertible preferred stock warrant liability. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. As of December 31, |
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 are classified within Level 1 of the fair value hierarchy, and commercial paper, corporate bonds/notes, United States Government securities, and asset-backed securities are classified within Level 2 of the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). The cost of available-for-sale investments sold is based on the specific-identification method. Realized gains and losses are included in earnings and are der ived for specific-identification method for determining the costs of investments sold and were insignificant for the year ended December 31, 2020 and 2019. Amortization of premiums and accretion of discounts are reported as a component of interest income. |
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 have prioritized the treatment of patients with COVID-19. For example, in the United States, governmental authorities have recommended, and in certain cases required, that elective, specialty and other procedures and appointments, be suspended or canceled to focus limited resources and personnel and hospital capacity toward the treatment of COVID-19 and to avoid exposing patients to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and will continue to negatively impact the Company’s revenue while the pandemic continues. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds and commercial paper. 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 years ended December 31, 2020 and 2019. The Company’s accounts receivable are due from a variety of health care organizations in the United States. At December 31, 2020 and 2019, no customer represented 10% or more of the Company’s accounts receivable. For the years ended December 31, 2020, 2019 and 2018, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for doubtful accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis, a Cardinal Health Company (see Note 14 - Subsequent Events). 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. |
Accounts Receivable | Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company estimates allowances for doubtful accounts. Specifically, the Company makes estimates on the collectability of customer accounts based primarily on analysis of historical trends and experience and changes in customers’ financial condition. The Company uses its judgment, based on the best available facts and circumstances, and records an allowance against amounts due to reduce the receivable to the amount that is expected to be collected. These specific allowances are reevaluated and adjusted as |
Inventories | Inventories Inventories are valued at the lower of cost to purchase or manufacture the inventory or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Net realizable value is determined as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The Company regularly reviews inventory quantities in consideration of actual loss experiences, projected future demand, and remaining shelf life prior to sale to record a provision for excess and obsolete inventory when appropriate. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected lower of cost or net realizable value, and inventory in excess of expected requirements. The estimate of excess quantities is judgmental and primarily dependent on the Company’s estimates of future demand for a particular product. If the estimate of future demand is too high, the Company may have to increase the reserve for excess inventory for that product and record a charge to the cost of goods sold. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost less accumulated depreciation or amortization. Repairs and maintenance costs are expensed as incurred. Depreciation and amortization are calculated using the straight-line method over the estimated useful lives of the assets, typically three |
Deferred Public Offering Costs | Deferred Public Offering CostsSpecific incremental legal, accounting and other fees and costs directly attributable to a proposed or actual offering of securities may properly be deferred and charged against the gross proceeds of the offering. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsThe Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. If indicators of impairment exist, an impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the assets and their eventual disposition are less than their carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of the long-lived assets exceeds their fair value. |
Leases | Leases The Company adopted Accounting Standards Codification (“ASC”) 842, "Leases," on January 1, 2019 and used the modified retrospective method for all leases not substantially completed as of the date of adoption and the package of practical expedients available in the standard. As a result of adopting ASC 842, the Company recorded an operating lease right-of-use ("ROU") asset of $3,982,000 included within other non-current assets and operating lease liabilities of $5,190,000 included within accrued liabilities and other liabilities on the balance sheet related to its facility lease, based on the present value of the future lease payments on the date of adoption. The operating lease right-of-use asset also includes adjustments for prepayments and excludes lease incentives. The adoption did not have an impact on prior periods or on the Company's statements of operations and comprehensive loss. The disclosure impact of the adoption of ASC 842 on the balance sheet was as follows (in thousands): Balance Sheet: Balance at December 31, 2018 Adjustments Due to ASC 842 Balance at January 1, 2019 Other non-current assets $ — $ 3,982 $ 3,982 Accrued liabilities 139 582 721 Other liabilities 1,069 3,400 4,469 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. |
Redeemable Convertible Preferred Stock Warrant Liability | Redeemable Convertible Preferred Stock Warrant Liability Prior to its IPO, the Company accounted for its warrants for shares of redeemable convertible preferred stock as a liability based upon the characteristics and provisions of each instrument. Redeemable convertible preferred stock warrants classified as a liability were initially recorded at their fair value on the date of issuance and are subject to remeasurement at each subsequent balance sheet date. Any change in fair value as a result of a remeasurement was recognized as a component of other income (expense), net in the statements of operations and comprehensive loss. The Company recorded adjustments to the estimated fair value of the redeemable convertible preferred stock warrants until they were exercised. Upon their exercise, the final fair value of the warrant liability was reclassified to stockholders’ equity. Subsequent to its IPO, the Company no longer recorded any related periodic fair value adjustments. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred StockPrior to its IPO, the Company recorded its redeemable convertible preferred stock at fair value on the dates of issuance, net of issuance costs, and classified the redeemable convertible preferred stock outside of stockholders’ equity on the balance sheet as events triggering the liquidation preferences were not solely within the Company’s control. |
Revenue Recognition and Cost of Goods Sold | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers.” As of January 1, 2018, the date of adoption, the Company recognized the cumulative-effect of initially applying ASC 606 as an adjustment to decrease accumulated deficit by $87,000. 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 December 31, 2020 and 2019, the Company recorded $71,000 and $102,000, respectively, of unbilled receivables, which are included in accounts receivable, net on the 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 collectibility 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 revenue in the 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 our balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its facility and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and subassemblies, manufacturing overhead costs, direct labor, reserves for excess, obsolete and non-sellable inventories as well as distribution-related expenses. A significant portion of the Company’s cost of goods sold currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalties. |
Research and Development and Clinical Trials | Research and Development The Company expenses research and development costs as incurred. Research and development expenses consist primarily of engineering, product development, clinical studies to develop and support the Company’s products, regulatory expenses, medical affairs and other costs associated with products and technologies that are in development. Research and development expenses include employee compensation, including stock-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation and an allocation of facility overhead expenses. Additionally, research and development expenses include costs associated with our clinical studies including clinical trial design, clinical site reimbursement, data management, travel expenses and the cost of products used for clinical trials and internal and external costs associated with the Company’s regulatory compliance and quality assurance functions, including the costs of outside consultants and contractors that assist in the process of submitting and maintaining regulatory filings, and overhead costs. Clinical Trials The Company accrues and expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company |
Advertising Costs | Advertising CostsThe Company expenses advertising costs as incurred. Advertising costs include design and production costs, including website development, physician and patient testimonial videos, written media campaigns, and other items. |
Foreign Currency | Foreign CurrencyThe Company records net gains and losses resulting from foreign exchange transactions as a component of foreign currency exchange gains or losses in other income (expense), net. |
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. The Company made an accounting policy election under Accounting Standards Update (ASU) No. 2016-09, "Stock Compensation (Topic 718): Improvements to Employee Shared-Based Payment Accounting to account for forfeitures as they occur, resulting in a cumulative-effect adjustment to increase accumulated deficit by $13,000 as of January 1, 2018, the date of adoption. |
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 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 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 years ended December 31, 2020 and 2019 |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders 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 attributable to common stockholders by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock and warrants, common stock options, and restricted stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. The Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The shares of the Company’s redeemable convertible preferred stock participate in any dividends declared by the Company and are therefore considered to be participating securities. |
Segment and Geographical Information | Segment and Geographical Information The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Primarily all of the Company’s long-lived assets are based in the United States. Long-lived assets are comprised of property and equipment. All of the Company’s revenue was in the United State s for the years ended December 31, 2020, 2019 and 2018, based on the shipping location of the external customer. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2018, the FASB issued ASU 2018-13, "Fair Value Measurement," which changed the disclosure requirements for fair value measurements by removing, adding and modifying certain disclosures. The Company adopted the new standard effective January 1, 2020. The adoption did not have a material impact on the Company's financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-15, "Cloud Computing Arrangements," which aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license. The Company adopted the new standard effective January 1, 2020 on a prospective basis. The adoption did not have a material impact on the Company's financial statements and related disclosures. Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, "Measurement of Credit Losses on Financial Statements." This update provides financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. The update replaces the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. In October 2019, the FASB delayed the effective date of this standard for smaller reporting companies, as such ASU 2016-13 was determined to originally be effective for the Company on January 1, 2023. During the year ended December 31, 2020, the Company no longer qualified as a smaller reporting company, accordingly ASU 2016-13 became effective for the Company on January 1, 2021. The Company does not believe that the adoption of this new guidance will have a material impact on its financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which enhances and simplifies various aspects of the income tax accounting guidance related to intra-period tax allocation, interim period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim period tax accounting. ASU 2019-12 also amends other aspects of the guidance to reduce complexity in certain areas. ASU 2019-12 became effective for the Company on January 1, 2021. The Company does not believe that the adoption of this new guidance will have a material impact on its financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the statements of cash flows (in thousands): December 31, 2020 2019 Cash and cash equivalents $ 69,466 $ 39,181 Restricted cash 310 310 Total cash, cash equivalents and restricted cash $ 69,776 $ 39,491 |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the statements of cash flows (in thousands): December 31, 2020 2019 Cash and cash equivalents $ 69,466 $ 39,181 Restricted cash 310 310 Total cash, cash equivalents and restricted cash $ 69,776 $ 39,491 |
Schedule of ASC 842 Impact of Adoption on Condensed Consolidated Balance Sheet | The disclosure impact of the adoption of ASC 842 on the balance sheet was as follows (in thousands): Balance Sheet: Balance at December 31, 2018 Adjustments Due to ASC 842 Balance at January 1, 2019 Other non-current assets $ — $ 3,982 $ 3,982 Accrued liabilities 139 582 721 Other liabilities 1,069 3,400 4,469 December 31, Operating Lease: 2020 2019 Operating lease right-of-use asset in other non-current assets $ 2,798 $ 3,400 Operating lease liability in accrued liabilities $ 850 $ 769 Operating lease liability in other liabilities 2,850 3,700 Total operating lease liabilities $ 3,700 $ 4,469 |
Net Loss Per Share Determination | Net loss per share was determined as follows (in thousands, except share and per share data): Year Ended December 31, 2020 2019 2018 Net loss attributable to Silk Road Medical, Inc. common stockholders $ (47,365) $ (52,415) $ (37,629) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 32,965,539 22,956,679 960,882 Net loss per share attributable to Silk Road Medical, Inc. common stockholders, basic and diluted $ (1.44) $ (2.28) $ (39.16) |
Schedule of Potentially Dilutive Securities Outstanding Excluded from Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company’s net loss: December 31, 2020 2019 2018 Redeemable convertible preferred stock outstanding — — 21,233,190 Redeemable convertible preferred stock warrants outstanding — — 2,672,502 Common stock options 4,237,828 4,310,790 4,364,377 Common stock warrants outstanding — — 7,527 Restricted stock units 68,396 — — Total 4,306,224 4,310,790 28,277,596 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Financial Liabilities Measure on a Recurring Basis | The following tables sets forth by level within the fair value hierarchy the Company’s assets and liabilities that are reported at fair value as of December 31, 2020 and 2019, using the inputs defined above (in thousands): December 31, 2020 Level 1 Level 2 Level 3 Total Assets: 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 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper — 9,919 — 9,919 Corporate bonds/notes — 10,176 — 10,176 U.S. government securities — 44,456 — 44,456 Asset-backed securities — 5,181 — 5,181 $ 34,363 $ 69,732 $ — $ 104,095 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Fair Value of the Available-For-Sale Investments | The fair value of the Company's available-for-sale investments as of December 31, 2020 and 2019 are as follows (in thousands): December 31, 2020 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money 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 December 31, 2019 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 34,363 $ — $ — $ 34,363 Commercial paper 9,919 — — 9,919 Corporate bonds/notes 10,180 — (4) 10,176 U.S. government securities 44,450 9 (3) 44,456 Asset-backed securities 5,181 — — 5,181 $ 104,093 $ 9 $ (7) $ 104,095 Classified as: Cash equivalents $ 34,363 Short-term investments 51,508 Long-term investments 18,224 $ 104,095 |
Fair Value of Cash Equivalents, Short-Term and Long-Term Equivalents | The following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term investments classified by maturity as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Amounts maturing within one year $ 146,311 $ 85,871 Amounts maturing after one year through two years — 18,224 $ 146,311 $ 104,095 |
Available-For-Sale Investments in Unrealized Loss Position | The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of December 31, 2020 and 2019 (in thousands): December 31, 2020 December 31, 2019 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds/notes $ 5,369 $ (1) $ 10,128 $ (4) U.S. government securities 10,128 (2) 19,067 (3) $ 15,497 $ (3) $ 29,195 $ (7) |
Schedule of Inventories | Components of inventories were as follows (in thousands): December 31, 2020 2019 Raw materials $ 1,785 $ 1,203 Finished products 10,599 9,163 12,384 10,366 Less: Reserve for excess and obsolete (2,395) (44) $ 9,989 $ 10,322 |
Property, Plant and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, 2020 2019 Furniture and fixtures $ 726 $ 657 Equipment 1,699 1,295 Software 226 18 Leasehold improvements 2,043 1,991 4,694 3,961 Less: Accumulated depreciation and amortization (2,332) (1,550) Add: Construction-in-progress 482 323 $ 2,844 $ 2,734 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2020 2019 Accrued payroll and related expenses $ 9,573 $ 9,151 Provision for sales returns 820 2,419 Accrued professional services 2,520 682 Recall replacement obligation 1,696 — Operating lease liability 850 769 Accrued royalty expense 518 470 Deferred revenue 206 304 Accrued travel expenses 237 431 Accrued clinical expenses 113 241 Accrued other expenses 424 567 $ 16,957 $ 15,034 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Future Maturities Under the Term Loan Agreement | Future maturities under the Stifel Bank term loan agreement as of December 31, 2020 are as follows (in thousands): Year Ending December 31: Amount 2021 $ 2,360 2022 14,679 2023 20,845 2024 17,370 55,254 Less: Amount representing interest (6,254) Less: Amount representing debt discount and debt issuance costs (467) Present value of minimum payments $ 48,533 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Balance Sheet Information | The disclosure impact of the adoption of ASC 842 on the balance sheet was as follows (in thousands): Balance Sheet: Balance at December 31, 2018 Adjustments Due to ASC 842 Balance at January 1, 2019 Other non-current assets $ — $ 3,982 $ 3,982 Accrued liabilities 139 582 721 Other liabilities 1,069 3,400 4,469 December 31, Operating Lease: 2020 2019 Operating lease right-of-use asset in other non-current assets $ 2,798 $ 3,400 Operating lease liability in accrued liabilities $ 850 $ 769 Operating lease liability in other liabilities 2,850 3,700 Total operating lease liabilities $ 3,700 $ 4,469 |
Operating Lease Maturities | The following table summarizes the Company's operating lease maturities as of December 31, 2020 (in thousands): Year Ending December 31: Amount 2021 $ 1,066 2022 1,096 2023 1,127 2024 904 Total lease payments 4,193 Less: imputed interest (493) Present value of lease liabilities $ 3,700 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Reserved Common Stock for Future Issuances | At December 31, 2020 and 2019, the Company had reserved common stock for future issuances as follows: December 31, 2020 2019 Exercise of options under stock plan 4,237,828 4,310,790 Issuance of options and restricted stock units under stock plan 1,790,687 1,554,690 Issuance of common stock under employee stock purchase plan 632,377 372,352 6,660,892 6,237,832 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Shares Available for Issuance | A summary of the shares available for issuance under the 2007 Stock Option Plan, NeuroCo 2015 Equity Incentive Plan and 2019 Plan, or the Plans, is as follows: Number of Shares Balances, December 31, 2017 328,290 Authorized 223,664 Granted (629,716) Canceled 135,651 Balances, December 31, 2018 57,889 Authorized 2,317,000 Granted (848,023) Canceled 27,824 Balances, December 31, 2019 1,554,690 Authorized 1,250,210 Granted/Awarded (1,079,883) Cancelled 65,670 Balances, December 31, 2020 1,790,687 Stock option activity under the Company's Plans is set forth below: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2017 4,308,890 $ 3.09 7.81 $ 5,073 Options granted 629,716 $ 6.51 Options exercised (438,578) $ 1.50 Options cancelled (135,651) $ 1.56 Balances, December 31, 2018 4,364,377 $ 3.79 7.36 $ 33,132 Options granted 848,023 $ 22.77 Options exercised (873,786) $ 1.77 Options cancelled (27,824) $ 8.71 Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 1,010,843 $ 40.67 Options exercised (1,018,779) $ 3.42 Options cancelled (65,026) $ 23.32 Balances, December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407 Vested and exercisable at December 31, 2020 2,392,563 $ 8.48 6.53 $ 130,417 Vested and expected to vest at December 31, 2020 4,237,828 $ 16.56 7.38 $ 197,407 The following table summarizes information about stock options outstanding and vested as of December 31, 2020: Options Outstanding Options Vested Exercise Price Options Outstanding Weighted Average Remaining Contractual Term (in Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $1.35 - $3.16 1,214,279 5.45 $ 1.97 1,128,865 $ 1.88 $4.73 - $7.10 722,615 7.17 $ 5.64 443,670 $ 5.69 $8.27 - $12.41 564,188 7.08 $ 11.67 394,727 $ 11.81 $20.00 - $30.00 656,009 8.26 $ 20.00 270,305 $ 20.00 $30.93 - $46.40 771,966 9.21 $ 33.50 136,151 $ 33.76 $47.20 - $70.80 308,771 9.53 $ 58.86 18,845 $ 51.99 4,237,828 7.38 $ 16.56 2,392,563 $ 8.48 |
Summary of RSU Activity | A summary of RSUs activity for the year ended December 31, 2020 is as follows: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2019 — Restricted stock granted 69,040 $ 46.14 Restricted stock vested — Restricted stock forfeited (644) $ 44.62 Balances, December 31, 2020 68,396 $ 46.16 Expected to vest at December 31, 2020 68,396 $ 46.16 |
Schedule of Fair Value Assumptions | The fair value of employee and nonemployee stock options was estimated using the following assumptions for the years ended December 31, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Expected term (in years) 5.25 - 6.25 5.00 - 6.25 5.00 - 6.25 Expected volatility 43.0% - 50.3% 42.4% - 42.9% 38.0% - 38.8% Risk-free interest rate 0.32% - 1.41% 1.47% - 2.54% 2.68% - 2.98% Dividend yield —% —% —% |
Schedule of Fair Value Assumptions | The fair value of the shares to be issued under the Company’s 2019 ESPP was estimated using the Black-Scholes valuation model with the following assumptions for the years ended December 31, 2020 and 2019: Year Ended December 31, 2020 2019 Expected term (in years) 0.50 0.50 - 0.63 Expected volatility 44.4% - 76.4% 44.4% - 47.8% Risk-free interest rate 0.10% - 1.58% 1.58% - 2.45% Dividend yield —% —% |
Stock-Based Compensation Expense Relating to Stock Options to Employees and Nonemployees | The following table summarizes the total stock-based compensation expense included in the statements of operations for all periods presented (in thousands): Year Ended December 31, 2020 2019 2018 Cost of goods sold $ 339 $ 179 $ 51 Research and development expenses 1,110 426 256 Selling, general and administrative expenses 5,777 2,372 604 $ 7,226 $ 2,977 $ 911 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of income before taxes are as follows (in thousands): Year Ended December 31, 2020 2019 2018 United States $ (47,365) $ (52,415) $ (37,630) International — — — $ (47,365) $ (52,415) $ (37,630) |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Tax at federal statutory rate $ (9,947) $ (11,007) $ (7,902) State taxes, net of federal benefit (1,958) (2,270) (1,582) Permanent differences (8,489) (4,731) 289 Loss on Series C warrant liability — 5,330 2,500 Change in valuation allowance 22,164 12,797 6,197 General business credits (1,268) (319) 136 Other (491) 208 376 Provision for income taxes $ 11 $ 8 $ 14 |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s net deferred tax assets as of December 31, 2020 and 2019 consist of the following (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 63,069 $ 44,574 Research and development credits 7,191 5,287 Capitalized start-up costs/Intangibles 8 11 Accruals and reserves 2,337 2,227 Property and equipment — 188 Stock-based compensation 1,859 568 Operating lease liability 935 1,133 Interest limitation 813 — Total deferred tax assets 76,212 53,988 Less: Valuation allowance (75,289) (53,126) Deferred tax liabilities: Operating lease asset (707) (862) Property and equipment (216) — Total deferred tax liabilities (923) (862) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of the unrecognized tax benefits from January 1, 2018 to December 31, 2020 is as follows (in thousands): December 31, 2020 2019 2018 Balance at the beginning of year $ 1,436 $ 1,348 $ 615 Increases related to current years’ tax positions 342 88 118 Increases related to prior years’ tax positions 241 — 615 Balance at end of year $ 2,019 $ 1,436 $ 1,348 |
Quarterly Financial Informati_2
Quarterly Financial Information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | The following table provides selected unaudited quarterly financial data for the years ended December 31, 2020, and 2019 (in thousands, except per share data): Three Months Ended December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 Revenue $ 21,133 $ 20,067 $ 15,094 $ 18,933 Gross profit $ 15,916 $ 14,579 $ 9,758 $ 13,683 Net loss $ (16,756) $ (10,315) $ (10,353) $ (9,941) Net loss per share, basic and diluted $ (0.49) $ (0.31) $ (0.32) $ (0.32) Three Months Ended December 31, 2019 September 30, 2019 June 30, 2019 March 31, 2019 Revenue $ 18,634 $ 17,026 $ 14,928 $ 12,766 Gross profit $ 13,913 $ 12,856 $ 11,231 $ 9,427 Net loss $ (8,291) $ (8,007) $ (11,959) $ (24,158) Net loss per share, basic and diluted $ (0.27) $ (0.26) $ (0.42) $ (20.12) |
Formation and Business of the_2
Formation and Business of the Company (Details) $ / shares in Units, $ in Thousands | Mar. 13, 2019 | May 31, 2020USD ($)$ / sharesshares | Aug. 31, 2019$ / sharesshares | Apr. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($) |
Subsequent Event [Line Items] | ||||||
Accumulated deficit | $ 238,891 | $ 191,526 | ||||
Cash and cash equivalents | 69,466 | 39,181 | ||||
Available-for-sale investments | 78,016 | |||||
Reverse stock split | 0.3704 | |||||
Payments of deferred offering costs | $ 4,457 | 233 | ||||
IPO | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 6,000,000 | |||||
Net proceeds | $ 109,119 | |||||
Stock issued, price per share (in USD per share) | $ / shares | $ 20 | $ 20 | ||||
Payments of deferred offering costs | $ 2,481 | $ 10,961 | ||||
Payment of stock issuance underwriting discounts and commissions | $ 8,400 | |||||
Second Public Offering | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 4,200,000 | |||||
Stock issued, price per share (in USD per share) | $ / shares | $ 39.50 | |||||
Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 1,021,223 | 630,000 | ||||
Net proceeds | $ 70,543 | |||||
Payments of deferred offering costs | 707 | |||||
Payment of stock issuance underwriting discounts and commissions | $ 3,750 | |||||
Public Stock Offering | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 6,808,154 | |||||
Stock issued, price per share (in USD per share) | $ / shares | $ 39 | |||||
Public Stock Offering - Shares From Company | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 1,923,076 | |||||
Public Stock Offering - Shares From Existing Shareholders | ||||||
Subsequent Event [Line Items] | ||||||
Issued and sold common stock (in shares) | shares | 4,885,078 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Cash and cash equivalents | $ 69,466 | $ 39,181 | ||
Restricted cash | 310 | 310 | ||
Total cash, cash equivalents and restricted cash | 69,776 | 39,491 | $ 25,300 | $ 33,841 |
Letter of Credit | ||||
Restricted Cash and Cash Equivalents Items [Line Items] | ||||
Restricted cash | $ 310 | $ 310 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Other Current Assets (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Voluntary Recall | |
Valuation Allowance [Line Items] | |
Loss contingency receivable | $ 4,160 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Deferred Initial Public Offering Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Deferred initial public offering costs | $ 0 | $ 950,000 |
Offering costs | $ 4,457,000 | $ 233,000 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use asset | $ 2,798 | $ 3,400 | |
Operating lease liabilities | $ 3,700 | $ 4,469 | |
Adjustments Due to ASC 842 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease right-of-use asset | $ 3,982 | ||
Operating lease liabilities | $ 5,190 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - ASC 842 Impact on Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Other non-current assets | $ 2,832 | $ 3,644 | $ 3,982 |
Accrued liabilities | 16,957 | 15,034 | 721 |
Other liabilities | $ 3,726 | 3,700 | 4,469 |
Previously Reported | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Other non-current assets | 0 | ||
Accrued liabilities | 139 | ||
Other liabilities | $ 1,069 | ||
Restatement Adjustment | Adjustments Due to ASC 842 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Other non-current assets | 3,982 | ||
Accrued liabilities | 582 | ||
Other liabilities | $ 3,400 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Redeemable Convertible Preferred Stock (Details) $ in Thousands | 20 Months Ended |
Dec. 31, 2020USD ($)shares | |
Class of Stock [Line Items] | |
Conversion of preferred stock to common stock upon IPO | $ | $ 144,140 |
Common Stock | |
Class of Stock [Line Items] | |
Conversion of preferred stock to common stock upon IPO (in shares) | shares | 23,178,555 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Revenue Recognition (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ 107,500 | $ 71,891 | $ (134,553) | $ (98,578) | |
Unbilled receivables | 71 | 102 | |||
Accumulated Deficit | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ (238,891) | $ (191,526) | $ (139,111) | (101,556) | |
Cumulative effect of change in accounting principle - ASC 606 adoption | Cumulative Effect, Period of Adoption, Adjustment | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | 87 | ||||
Cumulative effect of change in accounting principle - ASC 606 adoption | Cumulative Effect, Period of Adoption, Adjustment | Accumulated Deficit | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ 87 | $ 87 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | |||
Advertising expense | $ 194 | $ 362 | $ 186 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ 107,500 | $ 71,891 | $ (134,553) | $ (98,578) | |
Accounting Standards Update 2016-09 | Cumulative Effect, Period of Adoption, Adjustment | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | 0 | ||||
Accumulated Deficit | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ (238,891) | $ (191,526) | $ (139,111) | (101,556) | |
Accumulated Deficit | Accounting Standards Update 2016-09 | Cumulative Effect, Period of Adoption, Adjustment | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Adjustment | $ 13 | $ (13) |
Summary of Significant Accou_14
Summary of Significant Accounting Policies - Income Taxes (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | |||
Provision for income taxes | $ 0 | $ 0 | |
Liability for uncertain tax positions | $ 0 | $ 0 | $ 0 |
Summary of Significant Accou_15
Summary of Significant Accounting Policies - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | |||||||||||
Net loss attributable to Silk Road Medical, Inc. common stockholders | $ (47,365) | $ (52,415) | $ (37,629) | ||||||||
Weighted average common stock outstanding used to compute net loss per share, basic and diluted (in shares) | 32,965,539 | 22,956,679 | 960,882 | ||||||||
Net loss per share, basic and diluted (in USD per share) | $ (0.49) | $ (0.31) | $ (0.32) | $ (0.32) | $ (0.27) | $ (0.26) | $ (0.42) | $ (20.12) | $ (1.44) | $ (2.28) | $ (39.16) |
Summary of Significant Accou_16
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Earnings per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,306,224 | 4,310,790 | 28,277,596 |
Redeemable convertible preferred stock outstanding | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 0 | 21,233,190 |
Redeemable convertible preferred stock warrants outstanding | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 0 | 2,672,502 |
Common stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,237,828 | 4,310,790 | 4,364,377 |
Common stock warrants outstanding | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 0 | 7,527 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 68,396 | 0 | 0 |
Summary of Significant Accou_17
Summary of Significant Accounting Policies - Segment and Geographical Information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Accounting Policies [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | $ 146,311 | $ 104,095 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 60,295 | 34,363 |
Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 7,969 | 10,176 |
Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 5,181 | |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 146,311 | 104,095 |
Recurring | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 60,295 | 34,363 |
Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 39,577 | 9,919 |
Recurring | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 7,969 | 10,176 |
Recurring | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 38,470 | 44,456 |
Recurring | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 5,181 | |
Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 60,295 | 34,363 |
Recurring | Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 60,295 | 34,363 |
Recurring | Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 1 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 1 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 1 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | |
Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 86,016 | 69,732 |
Recurring | Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 39,577 | 9,919 |
Recurring | Level 2 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 7,969 | 10,176 |
Recurring | Level 2 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 38,470 | 44,456 |
Recurring | Level 2 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 5,181 | |
Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 0 | 0 |
Recurring | Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 3 | Corporate bonds/notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 0 | 0 |
Recurring | Level 3 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | $ 0 | 0 |
Recurring | Level 3 | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | $ 0 |
Balance Sheet Components - Fair
Balance Sheet Components - Fair Value of Available-For-Sale Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 146,272 | $ 104,093 |
Gross Unrealized Gains | 42 | 9 |
Gross Unrealized Losses | (3) | (7) |
Estimated Fair Value | 146,311 | 104,095 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 60,295 | 34,363 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 60,295 | 34,363 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 39,577 | 9,919 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 39,577 | 9,919 |
Corporate bonds/notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 7,970 | 10,180 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (1) | (4) |
Estimated Fair Value | 7,969 | 10,176 |
U.S. government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 38,430 | 44,450 |
Gross Unrealized Gains | 42 | 9 |
Gross Unrealized Losses | (2) | (3) |
Estimated Fair Value | 38,470 | 44,456 |
Asset-backed securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 5,181 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Estimated Fair Value | 5,181 | |
Cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | 68,295 | 34,363 |
Short-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | $ 78,016 | 51,508 |
Long-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Estimated Fair Value | $ 18,224 |
Balance Sheet Components - Fa_2
Balance Sheet Components - Fair Value of Cash Equivalents, Short-Term and Long-Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Amounts maturing within one year | $ 146,311 | $ 85,871 |
Amounts maturing after one year through two years | 0 | 18,224 |
Total | $ 146,311 | $ 104,095 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Inventory [Line Items] | |||
Weighted average days to maturity | 135 days | ||
Work-in-process inventories | $ 0 | $ 0 | |
Depreciation and amortization | 789,000,000 | $ 712,000,000 | $ 517,000,000 |
Voluntary Recall | |||
Inventory [Line Items] | |||
Loss contingency receivable | 4,160,000 | ||
Inventory Excess and Obsolescence | Voluntary Recall | |||
Inventory [Line Items] | |||
Loss contingency receivable | $ 2,377,000 |
Balance Sheet Components - Avai
Balance Sheet Components - Available-for-Sale Investments in Unrealized Loss Position (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | $ 15,497 | $ 29,195 |
Unrealized Loss, Less than 12 months | (3) | (7) |
Corporate bonds/notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 5,369 | 10,128 |
Unrealized Loss, Less than 12 months | (1) | (4) |
U.S. government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 10,128 | 19,067 |
Unrealized Loss, Less than 12 months | $ (2) | $ (3) |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory [Line Items] | ||
Raw materials | $ 1,785 | $ 1,203 |
Finished products | 10,599 | 9,163 |
Inventory, gross | 12,384 | 10,366 |
Less: Reserve for excess and obsolete | (2,395) | (44) |
Inventories | 9,989 | 10,322 |
Valuation reserve | $ 2,395 | $ 44 |
Balance Sheet Components - Prop
Balance Sheet Components - Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,694 | $ 3,961 |
Less: Accumulated depreciation and amortization | (2,332) | (1,550) |
Property and equipment, net | 2,844 | 2,734 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 726 | 657 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,699 | 1,295 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 226 | 18 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,043 | 1,991 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 482 | $ 323 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accrued payroll and related expenses | $ 9,573 | $ 9,151 | |
Provision for sales returns | 820 | 2,419 | |
Accrued professional services | 2,520 | 682 | |
Recall replacement obligation | 1,696 | 0 | |
Operating lease liability | 850 | 769 | |
Accrued royalty expense | 518 | 470 | |
Deferred revenue | 206 | 304 | |
Accrued travel expenses | 237 | 431 | |
Accrued clinical expenses | 113 | 241 | |
Accrued other expenses | 424 | 567 | |
Accrued liabilities | $ 16,957 | $ 15,034 | $ 721 |
Long-term Debt - CRG Narrative
Long-term Debt - CRG Narrative (Details) - USD ($) | 1 Months Ended | ||||
Sep. 30, 2018 | Apr. 30, 2017 | May 01, 2019 | Apr. 30, 2019 | Oct. 31, 2015 | |
Debt Instrument [Line Items] | |||||
Proceeds from debt | $ 15,000,000 | ||||
Term Loan | |||||
Debt Instrument [Line Items] | |||||
Term loan agreement amount | $ 25,000,000 | $ 30,000,000 | |||
Stated interest rate | 10.00% | ||||
Interest rate paid-in-kind | 2.00% | ||||
Interest rate paid in cash | 8.00% | ||||
Term Loan, Tranche A | |||||
Debt Instrument [Line Items] | |||||
Term loan agreement amount | 20,000,000 | ||||
Term Loan, Tranche B | |||||
Debt Instrument [Line Items] | |||||
Term loan agreement amount | $ 10,000,000 | ||||
Proceeds from debt | $ 5,000,000 |
Long-term Debt - Stifel Bank Na
Long-term Debt - Stifel Bank Narrative (Details) - USD ($) | Oct. 29, 2020 | Oct. 31, 2020 | Sep. 30, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | ||||||
Proceeds from debt | $ 15,000,000 | |||||
Prepayment premium fee | $ 2,496,000 | $ 0 | $ 0 | |||
Loss on debt extinguishment | (1,119,000) | $ 0 | $ 0 | |||
Loan Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Facility amount | $ 50,000,000 | |||||
Debt amount | 50,000,000 | |||||
Minimum unrestricted cash and cash equivalents | 20,000,000 | |||||
Maximum unrestricted cash and cash equivalents | 60,000,000 | |||||
Debt default rate | 5.00% | |||||
Loan Agreement | Term Loan | ||||||
Subsequent Event [Line Items] | ||||||
Aggregate principal amount | 50,000,000 | |||||
Proceeds from debt | $ 49,000,000 | |||||
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) | |||||
Percentage of revenue for debt repayment | 80.00% | |||||
Stated interest rate | 4.75% | |||||
Loan Agreement | Term Loan | Prime Rate | Rate Scenario One | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate | 0.75% | |||||
Loan Agreement | Term Loan | Prime Rate | Rate Scenario Two | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate | 4.75% | |||||
Loan Agreement | Secured Revolving Credit Facility | Line of Credit | ||||||
Subsequent Event [Line Items] | ||||||
Facility amount | $ 50,000,000 | |||||
Loan Agreement | Secured Revolving Credit Facility | Line of Credit | Prime Rate | Rate Scenario One | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate | 0.50% | |||||
Loan Agreement | Secured Revolving Credit Facility | Line of Credit | Prime Rate | Rate Scenario Two | ||||||
Subsequent Event [Line Items] | ||||||
Variable interest rate | 4.75% | |||||
Loan Agreement | Letter of Credit | Line of Credit | ||||||
Subsequent Event [Line Items] | ||||||
Facility amount | $ 2,000,000 | |||||
Success Fee Agreement | Line of Credit | ||||||
Subsequent Event [Line Items] | ||||||
Percent of original principal threshold | 0.75% | |||||
Redemption amount | $ 375,000 |
Long-term Debt - Future Maturit
Long-term Debt - Future Maturities Under the Term Loan (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Debt Disclosure [Abstract] | |
2021 | $ 2,360 |
2022 | 14,679 |
2023 | 20,845 |
2024 | 17,370 |
Long-term debt, gross before accretion of closing fees | 55,254 |
Less: Amount representing interest | (6,254) |
Less: Amount representing debt discount and debt issuance costs | (467) |
Present value of minimum payments | $ 48,533 |
Commitments and Contingencies -
Commitments and Contingencies - Lease Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Renewal term | 5 years | |
Operating lease costs | $ 870 | $ 870 |
Operating lease liabilities | $ 769 | $ 721 |
Weighted average discount rate | 6.50% | 6.50% |
Weighted average remaining lease term | 3 years 9 months 29 days | 4 years 9 months 29 days |
Commitments and Contingencies_2
Commitments and Contingencies - Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset in other non-current assets | $ 2,798 | $ 3,400 |
Operating lease liability in accrued liabilities | 850 | 769 |
Operating lease liability in other liabilities | 2,850 | 3,700 |
Total operating lease liabilities | $ 3,700 | $ 4,469 |
Operating lease, right-of-use asset, statement of financial position extensible list | us-gaap:OtherAssets | us-gaap:OtherAssets |
Operating lease, liability, current, statement of financial position extensible list | us-gaap:AccountsPayableAndAccruedLiabilitiesCurrent | us-gaap:AccountsPayableAndAccruedLiabilitiesCurrent |
Operating lease, liability, noncurrent, statement of financial position extensible list | us-gaap:OtherLiabilitiesNoncurrent | us-gaap:OtherLiabilitiesNoncurrent |
Commitments and Contingencies_3
Commitments and Contingencies - Operating Lease Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
2021 | $ 1,066 | |
2022 | 1,096 | |
2023 | 1,127 | |
2024 | 904 | |
Total lease payments | 4,193 | |
Less: imputed interest | (493) | |
Present value of lease liabilities | $ 3,700 | $ 4,469 |
Commitments and Contingencies_4
Commitments and Contingencies - Purchase Obligation and Contingencies Narrative (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Purchase obligation | $ 6,601,000,000 | |
Contingent liabilities requiring accrual | $ 0 | $ 0 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock - Narrative (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2019 | |
IPO | |||
Temporary Equity [Line Items] | |||
Stock issued, price per share (in USD per share) | $ 20 | $ 20 | |
Preferred Stock Warrants | |||
Temporary Equity [Line Items] | |||
Temporary equity, shares issued (in shares) | 0 | 0 | |
Temporary equity, shares outstanding (in shares) | 0 | 0 | |
Preferred Stock Warrants | IPO | |||
Temporary Equity [Line Items] | |||
Shares of common stock converted (in shares) | 1,945,365 | ||
Convertible Preferred Stock | |||
Temporary Equity [Line Items] | |||
Temporary equity, shares issued (in shares) | 0 | 0 | |
Temporary equity, shares outstanding (in shares) | 0 | 0 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Narrative (Details) | 12 Months Ended | ||
Dec. 31, 2020USD ($)vote$ / sharesshares | Dec. 31, 2019$ / sharesshares | Apr. 30, 2019$ / shares | |
Class of Warrant or Right [Line Items] | |||
Preferred shares authorized (in shares) | 5,000,000 | 5,000,000 | |
Preferred shares (in USD per share) | $ / shares | $ 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 | ||
Par value (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | |
Shares issued (in shares) | 34,249,649 | 31,255,267 | |
Shares outstanding (in shares) | 34,249,649 | 31,255,267 | |
Dividends declared | $ | $ 0 | ||
Number of votes entitled per share of common stock | vote | 1 | ||
IPO | |||
Class of Warrant or Right [Line Items] | |||
Stock issued, price per share (in USD per share) | $ / shares | $ 20 | $ 20 | |
Common stock warrants outstanding | |||
Class of Warrant or Right [Line Items] | |||
Warrants outstanding (in shares) | 0 | 0 | |
Common stock warrants outstanding | IPO | |||
Class of Warrant or Right [Line Items] | |||
Shares of common stock converted (in shares) | 5,968 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Shares Reserved for Future Issuance (Details) - shares | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 6,660,892 | 6,237,832 |
Exercise of options under stock plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 4,237,828 | 4,310,790 |
Issuance of options and restricted stock units under stock plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 1,790,687 | 1,554,690 |
Issuance of common stock under employee stock purchase plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 632,377 | 372,352 |
Stock Option Plans - Narrative
Stock Option Plans - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate intrinsic value of options exercised | $ 47,861 | $ 24,867 | $ 787 | |
Weighted average grant date fair value (in USD per share) | $ 18.22 | $ 10.17 | $ 2.93 | |
Fair value of options vested | $ 5,138 | $ 2,221 | $ 569 | |
Common stock reserved for future issuance (in shares) | 6,660,892 | 6,237,832 | ||
Compensation expensed not yet recognized | $ 20,188 | |||
ISO and NSO | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Option term | 10 years | |||
Option vesting term | 4 years | |||
ISO and NSO | 10% Stockholders | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise threshold as a percentage of fair value of shares | 110.00% | |||
ISO | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise threshold as a percentage of fair value of shares | 100.00% | |||
NSO | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise threshold as a percentage of fair value of shares | 85.00% | |||
2019 ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of additional shares allowable under the plan (in shares) | 1,200,000 | |||
Percent of outstanding shares of common stock | 1.00% | |||
Common stock reserved for future issuance (in shares) | 434,000 | 746,552 | ||
Percent of purchase of price of common stock | 85.00% | |||
Issuance of common stock under employee stock purchase plan (in shares) | 114,175,000 | |||
Shares available for future issuance (in shares) | 632,377,000 | |||
Compensation expensed not yet recognized, period for recognition | 4 months 17 days | |||
Unrecognized compensation costs related to the ESPP | $ 295 | |||
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation expensed not yet recognized, period for recognition | 3 years 7 days | |||
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Option vesting term | 4 years | |||
Restricted stock vested (in shares) | 0 | |||
Compensation expensed not yet recognized, period for recognition | 3 years 5 months 23 days | |||
Unrecognized compensation costs of unvested RSUs | $ 2,716 | |||
2019 Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance (in shares) | 2,317,000 | 3,635,009 | ||
Percent of outstanding shares of common stock | 4.00% | |||
2019 Equity Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of additional shares allowable under the plan (in shares) | 3,000,000 |
Stock Option Plans - Activity U
Stock Option Plans - Activity Under Compensation Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | ||||
Beginning balance (in shares) | 4,310,790 | 4,364,377 | 4,308,890 | |
Options granted (in shares) | 1,010,843 | 848,023 | 629,716 | |
Options exercised (in shares) | (1,018,779) | (873,786) | (438,578) | |
Options cancelled (in shares) | (65,026) | (27,824) | (135,651) | |
Ending balance (in shares) | 4,237,828 | 4,310,790 | 4,364,377 | 4,308,890 |
Vested and exercisable (in shares) | 2,392,563 | |||
Vested and expect to vest (in shares) | 4,237,828 | |||
Weighted Average Exercise Price | ||||
Beginning balance (in USD per share) | $ 7.91 | $ 3.79 | $ 3.09 | |
Options granted (in USD per share) | 40.67 | 22.77 | 6.51 | |
Options exercised (in USD per share) | 3.42 | 1.77 | 1.50 | |
Options cancelled (in USD per share) | 23.32 | 8.71 | 1.56 | |
Ending balance (in USD per share) | 16.56 | $ 7.91 | $ 3.79 | $ 3.09 |
Vested and exercisable (in USD per share) | 8.48 | |||
Vested and expected to vest (in USD per share) | $ 16.56 | |||
Weighted Average Remaining Contractual Term (in Years) | ||||
Awards outstanding | 7 years 4 months 17 days | 7 years 3 months 7 days | 7 years 4 months 9 days | 7 years 9 months 21 days |
Vested and exercisable | 6 years 6 months 10 days | |||
Vested and expected to vest | 7 years 4 months 17 days | |||
Aggregate Intrinsic Value (in thousands) | ||||
Awards outstanding | $ 197,407 | $ 140,234 | $ 33,132 | $ 5,073 |
Vested and exercisable | 130,417 | |||
Vested and expected to vest | $ 197,407 | |||
2019 Equity Incentive Plan | ||||
Shares Available for Grant | ||||
Beginning balance (in shares) | 1,554,690 | 57,889 | 328,290 | |
Authorized (in shares) | 1,250,210 | 2,317,000 | 223,664 | |
Granted/Awarded (in shares) | (1,079,883) | (848,023) | (629,716) | |
Canceled (in shares) | 65,670 | 27,824 | 135,651 | |
Ending balance (in shares) | 1,790,687 | 1,554,690 | 57,889 | 328,290 |
Stock Option Plans - Informatio
Stock Option Plans - Information by Exercise Price (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 4,237,828 | 4,310,790 | 4,364,377 | 4,308,890 |
Weighted Average Remaining Contractual Term (in Years) | 7 years 4 months 17 days | 7 years 3 months 7 days | 7 years 4 months 9 days | 7 years 9 months 21 days |
Weighted Average Exercise Price (in USD per share) | $ 16.56 | $ 7.91 | $ 3.79 | $ 3.09 |
Number Exercisable (in shares) | 2,392,563 | |||
Weighted Average Exercise Price (in USD per share) | $ 8.48 | |||
Exercise Price One | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 1,214,279 | |||
Weighted Average Remaining Contractual Term (in Years) | 5 years 5 months 12 days | |||
Weighted Average Exercise Price (in USD per share) | $ 1.97 | |||
Number Exercisable (in shares) | 1,128,865 | |||
Weighted Average Exercise Price (in USD per share) | $ 1.88 | |||
Exercise Price One | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 1.35 | |||
Exercise Price One | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 3.16 | |||
Exercise Price Two | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 722,615 | |||
Weighted Average Remaining Contractual Term (in Years) | 7 years 2 months 1 day | |||
Weighted Average Exercise Price (in USD per share) | $ 5.64 | |||
Number Exercisable (in shares) | 443,670 | |||
Weighted Average Exercise Price (in USD per share) | $ 5.69 | |||
Exercise Price Two | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 4.73 | |||
Exercise Price Two | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 7.10 | |||
Exercise Price Three | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 564,188 | |||
Weighted Average Remaining Contractual Term (in Years) | 7 years 29 days | |||
Weighted Average Exercise Price (in USD per share) | $ 11.67 | |||
Number Exercisable (in shares) | 394,727 | |||
Weighted Average Exercise Price (in USD per share) | $ 11.81 | |||
Exercise Price Three | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 8.27 | |||
Exercise Price Three | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 12.41 | |||
Exercise Price Four | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 656,009 | |||
Weighted Average Remaining Contractual Term (in Years) | 8 years 3 months 3 days | |||
Weighted Average Exercise Price (in USD per share) | $ 20 | |||
Number Exercisable (in shares) | 270,305 | |||
Weighted Average Exercise Price (in USD per share) | $ 20 | |||
Exercise Price Four | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 20 | |||
Exercise Price Four | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 30 | |||
Exercise Price Five | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 771,966 | |||
Weighted Average Remaining Contractual Term (in Years) | 9 years 2 months 15 days | |||
Weighted Average Exercise Price (in USD per share) | $ 33.50 | |||
Number Exercisable (in shares) | 136,151 | |||
Weighted Average Exercise Price (in USD per share) | $ 33.76 | |||
Exercise Price Five | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 30.93 | |||
Exercise Price Five | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 46.40 | |||
Exercise Price Six | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 308,771 | |||
Weighted Average Remaining Contractual Term (in Years) | 9 years 6 months 10 days | |||
Weighted Average Exercise Price (in USD per share) | $ 58.86 | |||
Number Exercisable (in shares) | 18,845 | |||
Weighted Average Exercise Price (in USD per share) | $ 51.99 | |||
Exercise Price Six | Minimum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | 47.20 | |||
Exercise Price Six | Maximum | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price (in USD per share) | $ 70.80 |
Stock Option Plans - RSUs (Deta
Stock Option Plans - RSUs (Details) - Restricted stock units | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Number of Restricted Stock Units | |
Beginning balance (in shares) | shares | 0 |
Restricted stock granted (in shares) | shares | 69,040 |
Restricted stock vested (in shares) | shares | 0 |
Restricted stock forfeited (in shares) | shares | (644) |
Ending balance (in shares) | shares | 68,396 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | |
Restricted stock granted (in USD per share) | $ / shares | 46.14 |
Restricted stock vested (in USD per share) | $ / shares | |
Restricted stock forfeited (in USD per share) | $ / shares | 44.62 |
Ending balance (in USD per share) | $ / shares | $ 46.16 |
Stock Option Plans - Fair Value
Stock Option Plans - Fair Value of Stock Options (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, minimum | 43.00% | 42.40% | 38.00% |
Expected volatility, maximum | 50.30% | 42.90% | 38.80% |
Risk-free interest rate, minimum | 0.32% | 1.47% | 2.68% |
Risk-free interest rate, maximum | 1.41% | 2.54% | 2.98% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 3 months | 5 years | 5 years |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
2019 ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | ||
Expected volatility, minimum | 44.40% | 44.40% | |
Expected volatility, maximum | 76.40% | 47.80% | |
Risk-free interest rate, minimum | 0.10% | 1.58% | |
Risk-free interest rate, maximum | 1.58% | 2.45% | |
Dividend yield | 0.00% | 0.00% | |
2019 ESPP | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | ||
2019 ESPP | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 7 months 17 days |
Stock Option Plans - Stock-base
Stock Option Plans - Stock-based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 7,226 | $ 2,977 | $ 911 |
Cost of goods sold | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 339 | 179 | 51 |
Research and development expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 1,110 | 426 | 256 |
Selling, general and administrative expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 5,777 | $ 2,372 | $ 604 |
Income Taxes - Components of In
Income Taxes - Components of Income Before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (47,365) | $ (52,415) | $ (37,630) |
International | 0 | 0 | 0 |
Total | $ (47,365) | $ (52,415) | $ (37,630) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S Statutory Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Tax at federal statutory rate | $ (9,947) | $ (11,007) | $ (7,902) |
State taxes, net of federal benefit | (1,958) | (2,270) | (1,582) |
Permanent differences | (8,489) | (4,731) | 289 |
Loss on Series C warrant liability | 0 | 5,330 | 2,500 |
Change in valuation allowance | 22,164 | 12,797 | 6,197 |
General business credits | (1,268) | (319) | 136 |
Other | (491) | 208 | 376 |
Provision for income taxes | $ 11 | $ 8 | $ 14 |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 63,069,000 | $ 44,574,000 |
Research and development credits | 7,191,000 | 5,287,000 |
Capitalized start-up costs/Intangibles | 8,000 | 11,000 |
Accruals and reserves | 2,337,000 | 2,227,000 |
Property and equipment | 0 | 188,000 |
Stock-based compensation | 1,859,000 | 568,000 |
Operating lease liability | 935,000 | 1,133,000 |
Interest limitation | 813,000 | 0 |
Total deferred tax assets | 76,212,000 | 53,988,000 |
Less: Valuation allowance | (75,289,000) | (53,126,000) |
Deferred tax liabilities: | ||
Operating lease asset | (707,000) | (862,000) |
Property and equipment | (216,000) | 0 |
Total deferred tax liabilities | (923,000) | (862,000) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||||
Increase (decrease) in deferred tax asset valuation allowance | $ 22,163,000 | $ 12,826,000 | ||
Percent maximum of federal taxable income to offset with net operating losses | 80.00% | |||
Unrecognized tax benefits | $ 2,019,000 | 1,436,000 | $ 1,348,000 | $ 615,000 |
Unrecognized tax benefits that would impact effective tax rate | 0 | |||
Unrecognized tax benefits, income tax penalties and interest expense | 0 | $ 0 | $ 0 | |
Domestic Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 241,908,000 | |||
State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 209,771,000 | |||
Research Tax Credit Carryforward | Domestic Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Research and development tax credits | 6,275,000 | |||
Research Tax Credit Carryforward | State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Research and development tax credits | $ 3,463,000 |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at the beginning of year | $ 1,436 | $ 1,348 | $ 615 |
Increases related to current years’ tax positions | 342 | 88 | 118 |
Increases related to prior years’ tax positions | 241 | 0 | 615 |
Balance at end of year | $ 2,019 | $ 1,436 | $ 1,348 |
Acquisition of Variable Inter_2
Acquisition of Variable Interest Entity - NeuroCo (Details) - USD ($) | Dec. 17, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2015 | Dec. 31, 2014 |
Business Acquisition [Line Items] | |||||
Value of common stock issued | $ 70,543,000 | $ 31,000 | |||
Carrying amount of the non-controlling interest | $ 0 | ||||
NeuroCo, Inc | |||||
Business Acquisition [Line Items] | |||||
Equity interest acquired | 100.00% | ||||
Shares issued as consideration (in shares) | 33,462 | ||||
Consideration given, amount of notes payable forgiven | $ 1,600,000 | ||||
NeuroCo, Inc | |||||
Business Acquisition [Line Items] | |||||
Promissory note amount | $ 498,000 | ||||
Notes receivable, interest rate | 2.74% | ||||
Notes receivable, term | 10 years | ||||
Value of common stock issued | $ 154,000 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) | Jan. 01, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Retirement Benefits [Abstract] | |||
Percentage employee contribution | 90.00% | ||
Employer discretionary contribution | $ 959,000 | $ 0 | |
Employer contribution match percentage | 50.00% | ||
Percent of matching contribution of the employee's pay | 5.00% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Feb. 26, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2021 | Mar. 31, 2019 |
Subsequent Event [Line Items] | |||||||
Shares of common stock reserved for issuance (in shares) | 1,010,843 | 848,023 | 629,716 | ||||
Weighted average grant date fair value (in USD per share) | $ 18.22 | $ 10.17 | $ 2.93 | ||||
Exercise price (in USD per share) | $ 40.67 | $ 22.77 | $ 6.51 | ||||
Common stock reserved for future issuance (in shares) | 6,660,892 | 6,237,832 | |||||
Contingent liabilities requiring accrual | $ 0 | $ 0 | |||||
Voluntary Recall | |||||||
Subsequent Event [Line Items] | |||||||
Loss contingency receivable | 4,160,000 | ||||||
Contingent liabilities requiring accrual | 1,696,000 | ||||||
Loss Contingency Receivable, Inventory Held | Voluntary Recall | |||||||
Subsequent Event [Line Items] | |||||||
Loss contingency receivable | 2,227,000 | ||||||
Loss Contingency Receivable, Inventory in Process of Recall | Voluntary Recall | |||||||
Subsequent Event [Line Items] | |||||||
Loss contingency receivable | 1,696,000 | ||||||
Loss Contingency Receivable, Direct Costs | Voluntary Recall | |||||||
Subsequent Event [Line Items] | |||||||
Loss contingency receivable | $ 237,000 | ||||||
2019 ESPP | |||||||
Subsequent Event [Line Items] | |||||||
Common stock reserved for future issuance (in shares) | 746,552 | 434,000 | |||||
Restricted stock units | |||||||
Subsequent Event [Line Items] | |||||||
Restricted stock vested (in shares) | 0 | ||||||
2019 Equity Incentive Plan | |||||||
Subsequent Event [Line Items] | |||||||
Shares of common stock reserved for issuance (in shares) | 3,635,009 | 2,317,000 | |||||
Subsequent Event | 2019 ESPP | |||||||
Subsequent Event [Line Items] | |||||||
Common stock reserved for future issuance (in shares) | 342,496 | ||||||
Subsequent Event | Restricted stock units | |||||||
Subsequent Event [Line Items] | |||||||
Restricted stock vested (in shares) | 14,952 | ||||||
Trailing stock price period | 30 days | ||||||
Subsequent Event | 2019 Equity Incentive Plan | |||||||
Subsequent Event [Line Items] | |||||||
Shares of common stock reserved for issuance (in shares) | 1,369,985 | ||||||
Shares of common stock reserved for issuance (in shares) | 19,305 | ||||||
Exercise price (in USD per share) | $ 59.33 |
Quarterly Financial Informati_3
Quarterly Financial Information (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 21,133 | $ 20,067 | $ 15,094 | $ 18,933 | $ 18,634 | $ 17,026 | $ 14,928 | $ 12,766 | $ 75,227 | $ 63,354 | $ 34,557 |
Gross profit | 15,916 | 14,579 | 9,758 | 13,683 | 13,913 | 12,856 | 11,231 | 9,427 | 53,936 | 47,427 | 23,683 |
Net loss | $ (16,756) | $ (10,315) | $ (10,353) | $ (9,941) | $ (8,291) | $ (8,007) | $ (11,959) | $ (24,158) | $ (47,365) | $ (52,415) | $ (37,630) |
Net loss per share, basic and diluted (in USD per share) | $ (0.49) | $ (0.31) | $ (0.32) | $ (0.32) | $ (0.27) | $ (0.26) | $ (0.42) | $ (20.12) | $ (1.44) | $ (2.28) | $ (39.16) |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts - Schedule II (Details) - Allowance for doubtful accounts receivable: - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | $ 45 | $ 22 | $ 149 |
Charged to expenses | (32) | 23 | (123) |
Write offs | 0 | 0 | 4 |
Balance at End of Year | $ 13 | $ 45 | $ 22 |