Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2022 | Jan. 31, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38847 | ||
Entity Registrant Name | SILK ROAD MEDICAL, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-8777622 | ||
Entity Address, Address Line One | 1213 Innsbruck Dr. | ||
Entity Address, City or Town | Sunnyvale | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94089 | ||
City Area Code | 408 | ||
Local Phone Number | 720-9002 | ||
Entity 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 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | SILK | ||
Security Exchange Name | NASDAQ | ||
Entity Public Float | $ 1.3 | ||
Entity Common Stock, Shares Outstanding | 38,462,026 | ||
Entity Central Index Key | 0001397702 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Documents Incorporated by Reference [Text Block] | Portions of the definitive proxy statement for our 2023 Annual Meeting of Stockholders, or the 2023 Proxy Statement, are incorporated by reference into Part III of this report where indicated. The 2023 Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Location | San Jose, California | ||
Auditor Firm ID | 238 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 55,358 | $ 110,231 |
Short-term investments | 158,316 | |
Accounts receivable, net of allowances of $3 and $6 at December 31, 2022 and December 31, 2021, respectively | 18,007 | 11,832 |
Inventories | 19,293 | 17,851 |
Prepaid expenses and other current assets | 3,924 | 3,412 |
Total current assets | 254,898 | 143,326 |
Property and equipment, net | 9,372 | 7,697 |
Restricted cash | 155 | 232 |
Other non-current assets | 5,260 | 5,370 |
Total assets | 269,685 | 156,625 |
Current liabilities: | ||
Accounts payable | 2,523 | 2,379 |
Accrued liabilities | 21,965 | 19,802 |
Short-term debt | 3,905 | |
Total current liabilities | 24,488 | 26,086 |
Long-term debt | 74,596 | 44,786 |
Other liabilities | 6,726 | 6,513 |
Total liabilities | 105,810 | 77,385 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity): | ||
Preferred stock, $0.001 par value Shares authorized: 5,000,000 at December 31, 2022 and 2021 Shares issued and outstanding: none at December 31, 2022 and 2021 | ||
Common stock, $0.001 par value Shares authorized: 100,000,000 at December 31, 2022 and 2021 Shares issued and outstanding: 38,355,972 and 34,980,896 at December 31, 2022 and 2021, respectively | 38 | 35 |
Additional paid-in capital | 507,715 | 367,907 |
Accumulated other comprehensive income (loss) | (166) | |
Accumulated deficit | (343,712) | (288,702) |
Total stockholders’ equity | 163,875 | 79,240 |
Total liabilities and stockholders’ equity | $ 269,685 | $ 156,625 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Allowances for accounts receivables | $ 3 | $ 6 |
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 |
Common stock, $0.001 par value | ||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 38,355,972 | 34,980,896 |
Shares outstanding (in shares) | 38,355,972 | 34,980,896 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statements of Operations and Comprehensive Loss [Abstract] | |||
Revenue | $ 138,638 | $ 101,475 | $ 75,227 |
Cost of goods sold | 37,876 | 25,446 | 21,291 |
Gross profit | 100,762 | 76,029 | 53,936 |
Operating expenses: | |||
Research and development | 36,449 | 27,110 | 21,271 |
Selling, general and administrative | 116,317 | 96,387 | 75,524 |
Total operating expenses | 152,766 | 123,497 | 96,795 |
Loss from operations | (52,004) | (47,468) | (42,859) |
Interest income | 2,527 | 198 | 1,104 |
Interest expense | (5,098) | (2,518) | (4,411) |
Loss on debt extinguishment | (245) | (1,119) | |
Other income (expense), net | (190) | (23) | (80) |
Net loss | (55,010) | (49,811) | (47,365) |
Other comprehensive loss: | |||
Change in unrealized gain (loss) on investments, net | (166) | (39) | 37 |
Net change in other comprehensive loss | (166) | (39) | 37 |
Net loss and comprehensive loss | $ (55,176) | $ (49,850) | $ (47,328) |
Net loss per share, basic | $ (1.54) | $ (1.44) | $ (1.44) |
Net loss per share, diluted | $ (1.54) | $ (1.44) | $ (1.44) |
Weighted average common shares used to compute net loss per share, basic | 35,775,672 | 34,635,358 | 32,965,539 |
Weighted average common shares used to compute net loss per share, diluted | 35,775,672 | 34,635,358 | 32,965,539 |
Statements of Stockholders_ Equ
Statements of Stockholders’ Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total |
Beginning balance (in shares) at Dec. 31, 2019 | 31,255,267 | ||||
Beginning balance at Dec. 31, 2019 | $ 31 | $ 263,384 | $ (191,526) | $ 2 | $ 71,891 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock | $ 2 | 70,541 | 70,543 | ||
Issuance of common stock (in shares) | 1,923,076 | ||||
Exercise of stock options | $ 1 | 3,486 | $ 3,487 | ||
Exercise of stock options (in shares) | 1,018,779 | 1,018,779 | |||
Issuance of common stock under employee stock purchase plan | 1,681 | $ 1,681 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 52,527 | ||||
Stock-based compensation | 7,226 | 7,226 | |||
Net loss | (47,365) | (47,365) | |||
Change in unrealized loss on investments, net | 37 | 37 | |||
Ending balance (in shares) at Dec. 31, 2020 | 34,249,649 | ||||
Ending balance at Dec. 31, 2020 | $ 34 | 346,318 | (238,891) | 39 | 107,500 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | $ 1 | 4,841 | $ 4,842 | ||
Exercise of stock options (in shares) | 643,507 | 643,507 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 34,964 | ||||
Issuance of common stock under employee stock purchase plan | 2,104 | $ 2,104 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 52,776 | ||||
Stock-based compensation | 14,612 | 14,612 | |||
Disgorgement of short-swing profits, net | 32 | 32 | |||
Net loss | (49,811) | (49,811) | |||
Change in unrealized loss on investments, net | (39) | (39) | |||
Ending balance (in shares) at Dec. 31, 2021 | 34,980,896 | ||||
Ending balance at Dec. 31, 2021 | $ 35 | 367,907 | (288,702) | 79,240 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock | $ 3 | 108,989 | 108,992 | ||
Issuance of common stock (in shares) | 2,674,419 | ||||
Exercise of stock options | 3,364 | $ 3,364 | |||
Exercise of stock options (in shares) | 453,199 | 453,199 | |||
Issuance of common stock upon release of restricted stock units (in shares) | 148,239 | ||||
Issuance of common stock under employee stock purchase plan | 2,432 | $ 2,432 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 99,219 | ||||
Stock-based compensation | 25,023 | 25,023 | |||
Net loss | (55,010) | (55,010) | |||
Change in unrealized loss on investments, net | (166) | (166) | |||
Ending balance (in shares) at Dec. 31, 2022 | 38,355,972 | ||||
Ending balance at Dec. 31, 2022 | $ 38 | $ 507,715 | $ (343,712) | $ (166) | $ 163,875 |
Statements of Stockholders_ E_2
Statements of Stockholders’ Equity (Parenthetical) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2022 | May 31, 2020 | Dec. 31, 2022 | Dec. 31, 2020 | |
Statements of Stockholders' Equity [Abstract] | ||||
Offering costs | $ 258 | $ 707 | $ 6,008 | $ 4,457 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | |||
Net loss | $ (55,010) | $ (49,811) | $ (47,365) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization expense | 2,127 | 1,032 | 789 |
Stock-based compensation expense | 25,023 | 14,612 | 7,226 |
Amortization of premiums (accretion of discounts) on investments, net | (1,419) | 577 | 304 |
Amortization of debt discount and debt issuance costs | 218 | 158 | 66 |
Amortization of right-of-use asset | 1,041 | 887 | 602 |
Non-cash interest expense | 1,037 | 241 | |
Loss on extinguishment of debt | 245 | 1,119 | |
Loss on disposal of property and equipment | 180 | 9 | 52 |
Change in provision for doubtful accounts receivable | (3) | 6 | (32) |
Provision for excess and obsolete inventories | 6 | 77 | 117 |
Changes in assets and liabilities: | |||
Accounts receivable | (6,172) | (2,769) | (437) |
Inventories | (1,447) | (5,563) | (2,161) |
Prepaid expenses and other current assets | (525) | (772) | 250 |
Other assets | (27) | (117) | 210 |
Accounts payable | 967 | (1,159) | 592 |
Accrued liabilities | 1,868 | 4,418 | 146 |
Other liabilities | (690) | (520) | 26 |
Repayment of interest paid in kind | (3,813) | ||
Net cash used in operating activities | (32,581) | (38,935) | (42,068) |
Cash flows from investing activities | |||
Purchases of property and equipment | (5,005) | (4,758) | (842) |
Proceeds from sale of property and equipment | 2 | ||
Purchases of investments | (168,163) | (79,906) | |
Proceeds from maturity of investments | 11,100 | 77,400 | 71,355 |
Net cash provided by (used in) investing activities | (162,068) | 72,644 | (9,393) |
Cash flows from financing activities | |||
Proceeds from public offerings, net of underwriting discount, commissions and offering costs paid | 108,992 | 70,568 | |
Proceeds from long-term debt | 73,911 | 48,506 | |
Proceeds from issuance of common stock | 5,796 | 6,946 | 5,168 |
Principal repayment of debt | (49,000) | (40,000) | |
Payments of prepayment penalty and lender fees | (2,496) | ||
Proceeds from disgorgement of short-swing profits, net | 32 | ||
Net cash provided by financing activities | 139,699 | 6,978 | 81,746 |
Net change in cash, cash equivalents and restricted cash | (54,950) | 40,687 | 30,285 |
Cash, cash equivalents and restricted cash, beginning of period | 110,463 | 69,776 | 39,491 |
Cash, cash equivalents and restricted cash, end of period | 55,513 | 110,463 | 69,776 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 3,843 | 2,360 | 7,917 |
Noncash investing and financing activities: | |||
Accounts payable and accrued liabilities for purchases of property and equipment | 117 | 1,138 | 108 |
Unpaid deferred offering costs | $ 25 | ||
Right-of-use asset obtained in exchange for lease obligation | $ 903 | $ 3,307 |
Formation and Business of the C
Formation and Business of the Company | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Components [Abstract] | |
Formation and Business of the Company | 1. Formation and Business of the Company The Company Silk Road Medical, Inc., or 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 products enable a 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 beginning in late 2015. 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, 2022, the Company had an accumulated deficit of $ 343,712,000 . The Company expects to incur losses for the foreseeable future. The Company believes tha t its cash and cash equivalents and available-for-sale securities of $ 213,674,000 as of December 31, 2022, as well as its expected revenues will provide sufficient funds to allow the Company to fund its planned current operations for the next 12 months from the issuance of these financial statements. Public Offerings In October 2022, the Company completed an underwritten public offering of 2,674,419 shares of its common stock at a public offering price of $ 43.00 per share. The shares include the full exercise of the underwriters’ option to purchase an additional 348,837 shares pursuant to the underwriting agreement. The Company received cash proceeds of approximately $ 108,992,000 after deducting underwriting discounts and commissions of approximately $ 5,750,000 and expenses of approximately $ 258,000 . In May 2020, the Company completed an underwritten public offering of 6,808,154 shares of its common stock, of which 1,923,076 shares were offered for sale by the Company and the remaining 4,885,078 shares were offered for sale by certain selling stockholders, at a public offering price of $ 39.00 per share. The Company received cash proceeds of approximately $ 70,543,000 after deducting underwriting discounts and commissions of approximately $ 3,750,000 and expenses of approximately $ 707,000 . Also, in May 2020, the underwriters fully exercised their option to purchase 1,021,223 additional shares of common stock from the selling stockholders. The Company did not receive any of the proceeds from the sale of the shares of its common stock by the selling stockholders. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The accompanying financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America, or 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, and stock-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Due to the coronavirus, or COVID-19, pandemic, there has been continued uncertainty and disruption in the global economy, supply chain, financial markets and labor markets. New virus variants and varying infection rates continue to make the current COVID-related environment highly volatile and uncertain. T hese challenges continued to impact the number of TCAR procedures in 2022, with procedure volumes impacted by increased COVID-19 hospitalizations and hospital capacity and staffing constraints due to COVID-19 and its variants . 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, 2022. 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, 2022 and 2021. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are recorded at fair value, based on quoted market prices. As of December 31, 2022 and 2021, 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, 2022 2021 Cash and cash equivalents $ 55,358 $ 110,231 Restricted cash 155 232 Total cash, cash equivalents and restricted cash $ 55,513 $ 110,463 Restricted cash as of December 31, 2022 and 2021 consists of a letter of credit of $ 155,000 and $ 232,000 , respectively, representing collateral for the Company’s facility lease in California. Investments Short-term investments consist of debt securities classified as available-for-sale and have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). Realized gains and losses are included in earnings and are der ived based on the specific-identification method for determining the costs of investments sold and were insignificant for the years ended December 31, 2022, 2021 and 2020. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. The Company did no t recognize any credit losses on its available-for-sale securities during the years ended December 31, 2022, 2021 or 2020 and there were no impairment charges for unrealized losses in the periods presented. 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. 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 expected number of TCAR procedures performed. The total number of TCAR procedures performed, similar to other surgical procedures, has been significantly depressed during certain periods of time as health care organizations globally prioritized the treatment of patients with COVID-19 and managed through capacity and staffing issues. In the past governmental or hospital 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 and certain staff to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and may continue to negatively impact the Company’s revenue while the pandemic continues. New virus variants, and varying infection rates continue to make the current COVID-related environment highly volatile and uncertain. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, United States Government securities, United States Treasury bills, agency notes, 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, 2022, 2021 and 2020. The Company’s accounts receivable are due from a variety of hospitals and medical centers in the United States. As of December 31, 2022 and 2021, no customer represented 10% or more of the Company’s accounts receivable. For the years ended December 31, 2022, 2021 and 2020, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for expected credit losses on customer accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. Disruption in component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the U.S. Food and Drug Administration, or 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 expected credit losses. 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, 2022, 2021 and 2020, 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. 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 years to five years . Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or estimated useful economic life of the asset. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. 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 no t record any impairment of long-lived assets during the years ended December 31, 2022, 2021 and 2020. Leases The Company accounts for its leasing arrangements in accordance with Accounting Standards Codification, or ASC 842, “Leases.” The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the identified asset. The Company also evaluates the nature of each lease to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The Company considers renewal options in the determination of the lease term if the option to renew is reasonably certain. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease costs, which consists primarily of taxes, insurance and common area maintenance costs, are expensed as incurred. The Company elected to account for contracts that contain lease and non-lease components as a single component, consistent with its historical practice. The Company does not have any finance leases. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amou nt that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of December 31, 2022 and 2021, the Company recorded $ 148,000 and $ 87,000 , 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 collectability is probable. For sales which are sent directly from the Company to hospitals and medical centers, the transfer of control occurs at the time of shipment or delivery of the product. There are no further performance obligations by the Company or the sales representative to the customer after delivery under either method of sale. As allowed under the practical expedient, the Company does not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which it recognizes revenue at the amount to which it has the right to invoice for services performed. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales include commissions and royalties. The Company applies the practical expedient and recognizes commissions and royalties as expense when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its California and Minnesota facilities and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and sub-assemblies, 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 control, 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. The Company entered into the lease for its additional facility in Minnesota in May 2021 and did not begin commercial production until the third quarter of 2022. During this time, the Company experienced additional overhead expenses related to its investment in the start-up phase of its manufacturing capacity expansion, which were recorded as a period expense. 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, clinical studies include costs associated with 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 any 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 $ 347,000 , $ 221,000 and $ 194,000 were expensed during the years ended December 31, 2022, 2021 and 2020, 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, 2022, 2021 and 2020. Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board, or 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, performance 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. 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 performance stock units with market-based conditions at their fair value on the date of the award using the Monte Carlo simulation model. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period, regardless of the likelihood of achievement of the market-based performance criteria. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the 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, 2022, 2021 and 2020 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the statements of operations and comprehensive loss. Accumulated other comprehensive income (loss) is presented in the accompanying balance sheets as a component of stockholders' equity. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, restricted stock units and performance stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. Net loss per share was determined as follows (in thousands, except share and per share data): Year Ended December 31, 2022 2021 2020 Net loss $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 35,775,672 34,635,358 32,965,539 Net loss per share, basic and diluted $ ( 1.54 ) $ ( 1.44 ) $ ( 1.44 ) 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, 2022 2021 2020 Common stock options 3,839,858 3,780,939 4,237,828 Restricted stock units and performance stock units 1,329,824 530,274 68,396 Total 5,169,682 4,311,213 4,306,224 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, 2022, 2021 and 2020, based on the shipping location of the external customer. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2022 | |
Recent Accounting Pronouncements [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements Recently Adopted Accounting Standards In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, or ASU 2021-08, which creates an exception to the general recognition and measurement principle in ASC 805 by requiring companies to apply ASC 606 to recognize and measure contract assets and contract liabilities from contracts with customers acquired in a business combination. The guidance additionally clarifies that companies should apply the definition of a performance obligation in ASC 606 when recognizing contract liabilities assumed in a business combination. The Company early adopted ASU 2021-08 as of January 1, 2022, on a prospective basis. The adoption of ASU 2021-08 did not have a material impact on the Company’s financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and investments. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: • Level 1 – quoted prices in active markets are identical assets and liabilities; • Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; • Level 3 – unobservable inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s investments classified within Level 1 of the fair value hierarchy include money market funds valued using quoted market prices and U.S. government treasury bills valued using broker or dealer quotations with reasonable levels of price transparency. Investments classified within Level 2 include commercial paper, which are valued using model-based valuation techniques, and corporate bonds/notes, asset-backed securities, U.S. government securities, and agency notes which are valued based upon quoted market prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The following tables sets forth by level within the fair value hierarchy the Company’s assets that are reported at fair value as of December 31, 2022 and 2021 using the inputs defined above (in thousands): December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 55,158 $ — $ — $ 55,158 U.S. treasury bills 19,776 — — 19,776 Commercial paper — 48,875 — 48,875 Corporate bonds/notes — 1,515 — 1,515 U.S. government securities — 83,270 — 83,270 Asset-backed securities — 1,996 — 1,996 Agency notes — 2,884 — 2,884 $ 74,934 $ 138,540 $ — $ 213,474 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 21,062 $ — $ — $ 21,062 $ 21,062 $ — $ — $ 21,062 There were no transfers between fair value hierarchy levels during the years ended December 31, 2022, 2021, and 2020. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Components [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Investments The Company’s cash equivalents consists of $ 21,062,000 in money market funds as of December 31, 2021 and approximates fair value. The fair value of the Company's available-for-sale investments as of December 31, 2022 are as follows (in thousands): December 31, 2022 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 55,158 $ — $ — $ 55,158 U.S. treasury bills 19,772 4 — 19,776 Commercial paper 48,875 — — 48,875 Corporate bonds/notes 1,528 — ( 13 ) 1,515 U.S. government securities 83,432 2 ( 164 ) 83,270 Asset-backed securities 2,000 — ( 4 ) 1,996 Agency notes 2,876 8 — 2,884 $ 213,641 $ 14 $ ( 181 ) $ 213,474 Classified as: Cash equivalents $ 55,158 Short-term investments 158,316 $ 213,474 The following table summarizes the fair value of the Company’s cash equivalents and available-for-sale investments classified by maturity as of December 31, 2022 and 2021 (in thousands): December 31, 2022 December 31, 2021 Amounts maturing within one year $ 213,474 $ 21,062 Amounts maturing after one year through two years — — $ 213,474 $ 21,062 Available-for-sale investments held as of December 31, 2022 had a weighted average days to maturity of 163 days. The following table presents the Company's available-for-sale investments that were in an unrealized loss position as of December 31, 2022 (in thousands): December 31, 2022 Less than 12 months Assets: Fair Value Unrealized Loss Corporate bonds/notes $ 1,490 $ ( 13 ) U.S. government securities 73,329 ( 164 ) Asset-backed securities 1,994 ( 4 ) $ 76,813 $ ( 181 ) Inventories Components of inventories were as follows (in thousands): 2022 2021 Raw materials $ 4,913 $ 2,447 Finished products 14,380 15,404 $ 19,293 $ 17,851 As of December 31, 2022 and 2021, there were no work-in-process inventories. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): December 31, 2022 2021 Furniture and fixtures $ 1,822 $ 1,005 Equipment 5,046 2,945 Software 296 284 Leasehold improvements 7,246 2,050 14,410 6,284 Less: Accumulated depreciation ( 5,355 ) ( 3,330 ) Add: Construction-in-progress 317 4,743 $ 9,372 $ 7,697 Depreciation and amortization expense was $ 2,127,000 , $ 1,032,000 and $ 789,000 for the years ended December 31, 2022, 2021 and 2020, respectively. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued payroll and related expenses $ 15,216 $ 13,898 Operating lease liability 1,844 1,294 Accrued royalty expense 973 687 Accrued professional services 781 2,039 Accrued travel expenses 775 590 Provision for sales returns 540 359 Accrued interest payable 519 14 Deferred revenue 253 157 Accrued clinical expenses 249 99 Accrued other expenses 815 665 $ 21,965 $ 19,802 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Long-term Debt [Abstract] | |
Long-term Debt | 6. 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. The Company recognized a loss on debt extinguishment of $ 1,119,000 in connection with the early termination of its prior term loan agreement with CRG. Stifel Bank In October 2020, the Company entered into a Loan and Security Agreement with Stifel Bank which provided 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. Interest under the revolving credit facility was the greater of a) 0.5 % above the "Prime Rate" as published by The Wall Street Journal or b) 4.75 %. Interest under the term loan facility was the greater of a) 0.75 % above the "Prime Rate" as published by The Wall Street Journal or b) 4.75 %. The Company drew down $ 49,000,000 under the term loan facility in October 2020. Concurrent with the Loan and Security Agreement, the Company 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 and Security 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, 2022. On May 27, 2022, in connection with the consummation of the Loan and Security Agreement with Oxford Finance, as noted below, the Company repaid all amounts outstanding under the term loan with Stifel Bank. The Success Fee Agreement obligations, of $ 367,500 , survive the Stifel Bank debt repayment and terminate on October 29, 2025. Oxford Finance In May 2022, the Company entered into a Loan and Security Agreement, or Loan Agreement, with Oxford Finance LLC and its agents, or Oxford Finance, which provides for a $ 225,000,000 loan facility, comprised of a $ 25,000,000 secured revolving credit facility and a $ 200,000,000 secured term loan facility. The term loans are available in three tranches. The first $ 75,000,000 tranche of term loans was available at closing in May 2022. A second tranche of $ 75,000,000 of term loans is available through December 31, 2024. A third tranche of $ 50,000,000 would be available through December 31, 2024 so long as, at the time of draw, the Company has consolidated trailing 12-month revenues equal to at least 90 % of the sum of the outstanding term loans plus the amount of any requested third tranche term loans. Upon request of the Company, the revolving credit facility will be increased from $ 25,000,000 to $ 50,000,000 . The revolving loans are available subject to a borrowing base equal to 85 % of eligible receivables plus 50 % of eligible inventory, up to the lesser of 40 % of the borrowing base or $ 10,000,000 , in the case of eligible inventory. The revolving facility will be available to the Company upon completion of an initial collateral audit. The revolving loans and the term loans mature on May 1, 2027. The principal amount of outstanding revolving loans, together with accrued and unpaid interest, is due on the maturity date. The term loans begin to amortize in equal monthly installments beginning on July 1, 2026. As the Company achieved a specified consolidated trailing twelve-month revenue target, it has the option to extend the first amortization date for the term loans to July 1, 2027. Such election may be made no earlier than June 30, 2023 and no later than thirty (30) days prior to July 1, 2026. If the Company exercises this option, then the maturity date for both the revolving loans and the term loans will be May 1, 2028. The revolving loans accrue interest at the greater of 1-month Secured Overnight Financing Rate (SOFR), or the Index Rate, and 0.85 %, plus a margin of 3.00 %. The term loans accrue interest at the greater of the Index Rate and 0.85 %, plus a margin of 5.00 %. The Index Rate is capped at 2.50 % for purposes of the Loan Agreement. Interest on both revolving loans and term loans is payable monthly in arrears. The Company may borrow, prepay and reborrow revolving loans, without premium or penalty. The term loans once repaid or prepaid may not be reborrowed. Term loans may be prepaid in full, or in part in increments of $ 10,000,000 . The Company is required to pay a prepayment fee of 3.0 % for prepayments of term loans made in the first year after closing, 2.0 % for prepayments of term loans made in the second year after closing, 1.0 % for prepayments of term loans made in the third year after closing and no prepayment fees thereafter. Upon the earlier of prepayment or maturity of the term loans, the Company is required to pay a fee of 5.0 % of the aggregate original principal amount of the funded term loans, which fee increases to 6.75 % if the Company exercises its option to extend the amortization date and maturity date. The Company is also obligated to pay other customary fees for a loan facility of this size and type. Also in May 2022, the Company borrowed the first $ 75,000,000 tranche of the term loan and used a portion of the proceeds to pay off and terminate the prior term loan agreement with Stifel Bank totaling $ 49,181,000 , which included a final interest payment of $ 181,000 . The Company recognized a loss on debt extinguishment of $ 245,000 in connection with the early termination of its prior term loan agreement with Stifel Bank. Obligations under the Loan Agreement are secured by substantially all of the Company's assets. The Loan Agreement requires the Company to maintain consolidated trailing twelve-month revenues of at least 75 % of the outstanding principal amount of the term loans, measured as of the last day of each fiscal quarter; or if the revenue target is not achieved, the Company must have maintained unrestricted cash and cash equivalents (net of outstanding revolving loans) subject to control agreements in favor of Oxford Finance equal to at least 50 % of the outstanding principal amount of the term loans . 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 the Company’s obligations under the Loan Agreement, the termination of the lender’s commitments, a 5 % increase in the applicable rate of interest and the exercise by the lender of other rights and remedies provided for under the Loan Agreement. As of December 31, 2022, the aggregate outstanding principal balance under the Loan Agreement was $ 75,000,000 and the variable interest rate was 7.50 %. As of December 31, 2022, the Company was in compliance with all applicable financial covenants. Future maturities under the Oxford Finance term loan agreement as of December 31, 2022 are as follows (in thousands): Year Ending December 31: Amount 2023 $ 5,703 2024 5,719 2025 5,703 2026 45,699 2027 34,517 97,341 Add: Accretion of closing fees 531 97,872 Less: Amount representing interest ( 22,341 ) Less: Amount representing debt discount and debt issuance costs ( 935 ) Present value of minimum payments $ 74,596 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Lease and Rights-of-Use The Company’s operating lease obligation at its corporate headquarters in California consists of leased office, laboratory, and manufacturing space under a non-cancellable operating lease that expires in October 2024. The lease agreement includes a renewal provision allowing the Company to extend this lease for an additional period of five years . In May 2021, the Company entered into a new, non-cancelable operating lease for additional office, laboratory and manufacturing space in Minnesota that expires in November 2029. The lease agreement includes a renewal provision allowing the Company to extend this lease for two additional five year terms. In connection with the lease, the Company recognized a right-of-use asset and lease liability of $ 3,307,000 . In June 2022, the Company leased the remaining right- of-first refusal space at its Minnesota facility and recognized a right-of-use asset and lease liability of $903,000 for the additional space. Operating lease costs were $ 1,559,000 , $ 1,234,000 and $ 870,000 for the years ended December 31, 2022, 2021, and 2020, respectively. Cash paid (net of tenant improvement allowances received) for amounts included in the measurement of operating lease liabilities was $ 102,000 , $( 34,000 ) and $ 769,000 for the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31, 2022, the weighted average discount rate was approximately 6.57 % and the weighted average remaining lease term was 5.68 years. As of December 31, 2021, the weighted average discount rate was approximately 6.50 % and the weighted average remaining lease term was 5.86 years. Balance sheet information as of December 31, 2022 and 2021 consists of the following (in thousands): December 31, Operating Lease: 2022 2021 Operating lease right-of-use asset in other non-current assets $ 5,081 $ 5,219 Operating lease liability in accrued liabilities $ 1,844 $ 1,294 Operating lease liability in other liabilities 5,998 5,747 Total operating lease liabilities $ 7,842 $ 7,041 The following table summarizes the Company's operating lease maturities as of December 31, 2022 (in thousands): Year Ending December 31: Amount 2023 $ 1,967 2024 1,764 2025 1,079 2026 1,173 2027 1,202 Thereafter 2,391 Total lease payments 9,576 Less: imputed interest ( 1,734 ) Present value of lease liabilities $ 7,842 Purchase Obligations Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. As of December 31, 2022, the Company had non-cancellable purchase obligations to suppliers of $ 13,572,000 . 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 or officer 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 or officer may be subject to any proceeding arising out of acts or omissions of such director or officer in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer 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, 2022. 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 rights 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 as of December 31, 2022 and 2021. |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | 8. Stockholders' Equity Preferred Stock As of December 31, 2022, 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 As of December 31, 2022, 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 38,355,972 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, 2022, no dividends have been declared to date. Each share of common stock is entitled to one vote. As of December 31, 2022 and 2021, the Company had reserved common stock for future issuances as follows: December 31, 2022 2021 Outstanding stock options and equity awards 5,169,682 3,780,939 Reserved for grants of future stock options and equity awards 2,209,072 2,477,212 Reserved for Performance Stock Units for overperformance 207,468 — Reserved for employee stock purchase plan 1,172,686 922,097 8,758,908 7,180,248 Disgorgement Proceeds During the year ended December 31, 2021, the Company received net proceeds of $ 32,000 related to the disgorgement of short-swing profits under Section 16(b) of the Exchange Act. The amount was recorded as an increase to additional paid-in capital on the balance sheet. |
Stock-Based Compensation Plans
Stock-Based Compensation Plans | 12 Months Ended |
Dec. 31, 2022 | |
Stock-Based Compensation Plans [Abstract] | |
Stock-Based Compensation Plans | 9. Stock-Based Compensation Plans In March 2019, the Company's Board of Directors [and stockholders] approved the 2019 Equity Incentive Plan, or 2019 Plan, effective immediately prior to the Company’s IPO. The 2019 Plan replaced the prior 2007 Stock Option Plan, or 2007 Plan, and the NeuroCo 2015 Equity Incentive Plan, which the Company assumed in connection with its acquisition of NeuroCo in December 2018, with respect to future grants. 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 also include shares reserved but not issued under the prior 2007 Plan, plus any share awards granted under the 2007 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 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, 2022, the Company has reserved 6,417,317 shares of common stock for issuance under the 2019 Plan. A summary of the shares available for issuance under the 2019 Plan is as follows: Number of Shares Balances, December 31, 2019 1,554,690 Authorized 1,250,210 Granted/Awarded ( 1,079,883 ) Cancelled 65,670 Balances, December 31, 2020 1,790,687 Authorized 1,369,985 Granted/Awarded ( 847,080 ) Cancelled 163,620 Balances, December 31, 2021 2,477,212 Authorized 1,399,235 Allowance for Performance Stock Units for overperformance ( 207,468 ) Granted/Awarded ( 1,600,996 ) Cancelled 141,089 Balances, December 31, 2022 2,209,072 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 four years from the date of grant. Stock option activity under the 2019 Plan, the 2007 Plan, and the NeuroCo 2015 Equity Incentive Plan, or the Plans, is set forth below: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 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 Options granted 323,057 $ 53.94 Options exercised ( 643,507 ) $ 7.49 Options cancelled ( 136,439 ) $ 40.30 Balances, December 31, 2021 3,780,939 $ 20.45 6.71 $ 91,900 Options granted 587,015 $ 37.69 Options exercised ( 453,199 ) $ 7.42 Options cancelled ( 74,897 ) $ 41.16 Balances, December 31, 2022 3,839,858 $ 24.22 6.41 $ 112,755 Vested and exercisable at December 31, 2022 2,894,714 $ 18.82 5.76 $ 100,024 Vested and expected to vest at December 31, 2022 3,839,858 $ 24.22 6.41 $ 112,755 The aggregate intrinsic value of options exercised during the years ended December 31, 2022, 2021 and 2020 was $ 17,575,000 , $ 29,355,000 and $ 47,861,000 , 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, 2022, 2021 and 2020 was $ 37.69 , $ 23.83 and $ 18.22 per share, respectively. The total fair value of options vested during the years ended December 31, 2022, 2021 and 2020 was $ 9,816,000 , $ 9,076,000 and $ 5,138,000 , respectively, based on the grant date fair value. The following table summarizes information about stock options outstanding and vested as of December 31, 2022: 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 $ 1.38 - $ 3.16 583,253 3.76 $ 2.18 583,253 $ 2.18 $ 4.73 - $ 7.10 503,468 5.16 $ 5.75 503,468 $ 5.75 $ 8.27 - $ 12.41 475,911 5.07 $ 11.76 475,522 $ 11.76 $ 20.00 - $ 30.00 581,673 6.26 $ 20.00 532,068 $ 20.00 $ 30.93 - $ 46.55 1,142,735 8.17 $ 35.20 508,451 $ 34.43 $ 47.20 - $ 70.80 552,818 8.02 $ 56.73 291,952 $ 56.74 3,839,858 6.41 $ 24.22 2,894,714 $ 18.82 Restricted Stock Units and Performance Stock Units In March 2020, the Company began granting restricted stock units, or RSUs, under the 2019 Plan. RSUs generally vest and are settled in shares of common stock over four years in annual equal increments. The total grant date fair value of awards granted during the year ended December 31, 2022 and 2021 was $ 30,486,000 and $ 28,110,000 , respectively. The total fair value of awards vested during the year ended December 31, 2022 and 2021 was $ 6,135,000 and $ 1,893,000 , respectively. No awards vested during the year ended December 31, 2020. The fair value of RSUs is based on the closing price of the Company’s common stock on the date of grant. In November 2022, the Company awarded an aggregate of 207,468 performance stock units, or PSUs, under the 2019 Plan to certain executive officers, which PSUs vest at the end of a three year service period, subject to the officer’s continued service to the Company. The total number of shares of common stock to be issued upon vesting and settlement of the PSUs will be determined based on the total stockholder return, or TSR, of the Company’s common stock price relative to a group of Benchmark Companies over a three year performance period and range from 0 % to 200 % of the target value of shares granted, depending on the Company’s performance against the targeted Benchmark Companies. The total grant date fair value of awards granted during the year ended December 31, 2022 was $ 16,000,000 . A summary of RSUs and PSUs activity for the years ended December 31, 2022, 2021 and 2020 is as follows: Number of RSUs/PSUs Weighted Average Grant Date Fair Value Balances, December 31, 2019 — $ — Awards granted 69,040 $ 46.14 Awards vested — $ — Awards forfeited ( 644 ) $ 44.62 Balances, December 31, 2020 68,396 $ 46.16 Awards granted 524,023 $ 53.64 Awards vested ( 34,964 ) $ 49.95 Awards forfeited ( 27,181 ) $ 51.99 Balances, December 31, 2021 530,274 $ 53.01 Awards granted 1,013,981 $ 45.84 Awards vested ( 148,239 ) $ 52.14 Awards forfeited ( 66,192 ) $ 44.38 Balances, December 31, 2022 1,329,824 $ 48.07 Expected to vest at December 31, 2022 1,329,824 $ 48.07 The shares expected to vest as of December 31, 2022 reflects PSUs awards performance and vesting at 100 % of the target value of shares granted. 2019 Employee Stock Purchase Plan In March 2019, the Company's Board of Directors [and stockholders] adopted the 2019 Employee Stock Purchase Plan, or the 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, 2022, the Company has reserved 1,438,856 shares of common stock for issuance under the 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 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 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, 2022, 266,170 shares of common stock have been issued to employees participating in the ESPP and 1,172,686 shares were available for future issuance under the ESPP. Stock-Based Compensation The Company estimated the fair value of stock options using the Black–Scholes option pricing model. The fair value of stock options is being amortized on a straight–line basis over the requisite service period of the awards. The fair value of stock options was estimated using the following assumptions for the years ended December 31, 2022, 2021 and 2020: Year Ended December 31, 2022 2021 2020 Expected term (in years) 5.25 - 6.25 5.25 - 6.25 5.00 - 6.25 Expected volatility 48.2 % - 51.4 % 45.0 % - 50.4 % 43.0 % - 50.3 % Risk-free interest rate 1.60 % - 3.84 % 0.41 % - 1.08 % 0.32 % - 1.41 % Dividend yield —% —% —% 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 supplementing its historical stock trading volatility with 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. The Company has elected to recognize forfeitures of share-based payment awards as they occur. In November 2022, the Company awarded an aggregate of 207,468 PSUs to certain executive officers that vest at the end of a three year service period based on the TSR of the Company’s common stock price relative to a group of Benchmark Companies measured over three performance periods. The Company estimated the fair value of the PSUs using the Monte Carlo simulation model, which is being amortized over the requisite service period of the awards. The fair value of the PSUs was estimated using the following assumptions for the year ended December 31, 2022: Benchmark companies volatility of 59.4 %, Company volatility of 60.6 %, risk-free interest rate of 4.09 %- 4.20 %, correlation with index of 0.41 , and dividend yield of 0 %. The fair value of the shares to be issued under the Company’s ESPP was estimated using the Black-Scholes valuation model with the following assumptions for the years ended December 31, 2022, 2021 and 2020: Year Ended December 31, 2022 2021 2020 Expected term (in years) 0.50 0.50 0.50 Expected volatility 51.6 % - 74.5 % 46.9 % - 51.6 % 44.4 % - 76.4 % Risk-free interest rate 0.07 % - 4.64 % 0.03 % - 0.10 % 0.10 % - 1.58 % Dividend yield —% —% —% The following table summarizes the total stock-based compensation expense included in the statements of operations and comprehensive loss for all periods presented (in thousands): Year Ended December 31, 2022 2021 2020 Cost of goods sold $ 1,138 $ 635 $ 339 Research and development expenses 5,240 2,909 1,110 Selling, general and administrative expenses 18,645 11,068 5,777 $ 25,023 $ 14,612 $ 7,226 As of December 31, 2022, there was total unrecognized compensation costs of $ 16,784,000 related to stock options expected to be recognized over a period of approximately 2.33 years, a total of $ 53,784,000 of unrecognized compensation costs related to unvested RSUs and PSUs expected to be recognized over a period of approximately 2.83 years and $ 423,000 of unrecognized compensation costs related to the ESPP, which the Company will recognize over 0.38 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes The components of income before taxes are as follows (in thousands): Year Ended December 31, 2022 2021 2020 United States $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) International — — — $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) 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, 2022 2021 2020 Tax at federal statutory rate $ ( 11,552 ) $ ( 10,460 ) $ ( 9,947 ) State taxes, net of federal benefit ( 2,206 ) ( 1,852 ) ( 1,958 ) Permanent differences ( 2,883 ) ( 5,224 ) ( 8,489 ) Change in valuation allowance 18,237 17,918 22,164 General business credits ( 1,166 ) ( 852 ) ( 1,268 ) Other ( 401 ) 490 ( 491 ) Provision for income taxes $ 29 $ 20 $ 11 The Company's provision for income taxes amounts are not significant and 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, 2022 and 2021 consist of the following (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 82,768 $ 77,616 Research and development credits 8,898 7,732 Capitalized start-up costs/Intangibles 1 4 Section 174 R&D capitalization 7,816 — Accruals and reserves 2,820 2,301 Stock-based compensation 8,209 4,392 Operating lease liability 1,973 1,751 Interest limitation 2,013 1,314 Total deferred tax assets 114,498 95,110 Less: Valuation allowance ( 111,444 ) ( 93,207 ) Deferred tax liabilities: Operating lease asset ( 1,278 ) ( 1,297 ) Property and equipment ( 1,776 ) ( 606 ) Total deferred tax liabilities ( 3,054 ) ( 1,903 ) 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 $ 18,237,000 during the year ended December 31, 2022 and increased by $ 17,918,000 during the year ended December 31, 2021. As of December 31, 2022, the Company had net operating loss carryforwards of approximately $ 320,140,000 and $ 271,494,000 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. Under the Tax Cuts and Jobs Act, research and development expenditures are no longer fully deductible and are required to be capitalized and amortized under Section 174 of the Internal Revenue Code in tax years beginning on or after January 1, 2022. The capitalized research expenses must be amortized over five years for research performed in the U.S. and 15 years for research performed outside the U.S. The mandatory capitalization requirement increased the Company’s deferred tax assets, which were fully offset by a valuation allowance. At December 31, 2022, the Company had $ 8,395,000 and $ 5,022,000 of federal and state research and development credit carryforwards, respectively, on a tax return basis. 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, 2022, the Company had $ 3,788,000 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 tax benefits would increase or decrease within twelve months of the year ended December 31, 2022. 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, 2022, 2021 and 2020. A reconciliation of the unrecognized tax benefits from January 1, 2020 to December 31, 2022 is as follows (in thousands) December 31, 2022 2021 2020 Balance at the beginning of year $ 3,314 $ 2,019 $ 1,436 Increases related to current years’ tax positions 474 704 342 Increases related to prior years’ tax positions — 591 241 Balance at end of year $ 3,788 $ 3,314 $ 2,019 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. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2022 | |
401(k) Plan [Abstract] | |
401(k) Plan | 11. 401(k) Plan The Company has a qualified retirement plan under section 401(k) of the Internal Revenue Code, or the 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. 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 and at 50 % of the first 6 % of compensation deferred effective January 1, 2022. The Company's matching contributions were $ 1,872,000 , $ 1,313,000 and $ 959,000 for the years ended December 31, 2022, 2021 and 2020, respectively. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2022 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | 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 credit losses for the years ended December 31, 2022, 2021 and 2020 (in thousands): Description Balance at Beginning of Year Charged to expenses Write offs Balance at End of Year Allowance for credit losses: Year ended December 31, 2022 $ 6 $ ( 3 ) $ — $ 3 Year ended December 31, 2021 $ 13 $ 6 $ 13 $ 6 Year ended December 31, 2020 $ 45 $ ( 32 ) $ — $ 13 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The accompanying financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America, or 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, and stock-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Due to the coronavirus, or COVID-19, pandemic, there has been continued uncertainty and disruption in the global economy, supply chain, financial markets and labor markets. New virus variants and varying infection rates continue to make the current COVID-related environment highly volatile and uncertain. T hese challenges continued to impact the number of TCAR procedures in 2022, with procedure volumes impacted by increased COVID-19 hospitalizations and hospital capacity and staffing constraints due to COVID-19 and its variants . 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, 2022. 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, 2022 and 2021. The carrying amounts of certain of the Company’s financial instruments, which include cash equivalents, short-term investments, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are recorded at fair value, based on quoted market prices. As of December 31, 2022 and 2021, 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, 2022 2021 Cash and cash equivalents $ 55,358 $ 110,231 Restricted cash 155 232 Total cash, cash equivalents and restricted cash $ 55,513 $ 110,463 Restricted cash as of December 31, 2022 and 2021 consists of a letter of credit of $ 155,000 and $ 232,000 , respectively, representing collateral for the Company’s facility lease in California. |
Investments | Investments Short-term investments consist of debt securities classified as available-for-sale and have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). Realized gains and losses are included in earnings and are der ived based on the specific-identification method for determining the costs of investments sold and were insignificant for the years ended December 31, 2022, 2021 and 2020. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. |
Concentration of Credit Risk, and Other Risks and Uncertainties | Concentration of Credit Risk, and Other Risks and Uncertainties The Company is subject to risks related to public health crises such as the global pandemic associated with COVID-19. 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 expected number of TCAR procedures performed. The total number of TCAR procedures performed, similar to other surgical procedures, has been significantly depressed during certain periods of time as health care organizations globally prioritized the treatment of patients with COVID-19 and managed through capacity and staffing issues. In the past governmental or hospital 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 and certain staff to COVID-19. These measures and challenges will likely continue for the duration of the pandemic, which is uncertain, and may continue to negatively impact the Company’s revenue while the pandemic continues. New virus variants, and varying infection rates continue to make the current COVID-related environment highly volatile and uncertain. Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, United States Government securities, United States Treasury bills, agency notes, 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, 2022, 2021 and 2020. The Company’s accounts receivable are due from a variety of hospitals and medical centers in the United States. As of December 31, 2022 and 2021, no customer represented 10% or more of the Company’s accounts receivable. For the years ended December 31, 2022, 2021 and 2020, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for expected credit losses on customer accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s product components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. Disruption in component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the U.S. Food and Drug Administration, or 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 expected credit losses. 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, 2022, 2021 and 2020, the Company did not experience any material credit-related losses. |
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 years to five years . Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or estimated useful economic life of the asset. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. |
Impairment of Long-Lived Assets | 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 no t record any impairment of long-lived assets during the years ended December 31, 2022, 2021 and 2020. |
Leases | Leases The Company accounts for its leasing arrangements in accordance with Accounting Standards Codification, or ASC 842, “Leases.” The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the identified asset. The Company also evaluates the nature of each lease to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The Company considers renewal options in the determination of the lease term if the option to renew is reasonably certain. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease costs, which consists primarily of taxes, insurance and common area maintenance costs, are expensed as incurred. The Company elected to account for contracts that contain lease and non-lease components as a single component, consistent with its historical practice. The Company does not have any finance leases. |
Revenue Recognition and Cost of Goods Sold | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amou nt that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. As of December 31, 2022 and 2021, the Company recorded $ 148,000 and $ 87,000 , 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 collectability is probable. For sales which are sent directly from the Company to hospitals and medical centers, the transfer of control occurs at the time of shipment or delivery of the product. There are no further performance obligations by the Company or the sales representative to the customer after delivery under either method of sale. As allowed under the practical expedient, the Company does not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which it recognizes revenue at the amount to which it has the right to invoice for services performed. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales include commissions and royalties. The Company applies the practical expedient and recognizes commissions and royalties as expense when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its California and Minnesota facilities and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and sub-assemblies, 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 control, 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. The Company entered into the lease for its additional facility in Minnesota in May 2021 and did not begin commercial production until the third quarter of 2022. During this time, the Company experienced additional overhead expenses related to its investment in the start-up phase of its manufacturing capacity expansion, which were recorded as a period expense. |
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, clinical studies include costs associated with 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 any 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 | 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 $ 347,000 , $ 221,000 and $ 194,000 were expensed during the years ended December 31, 2022, 2021 and 2020, respectively. |
Foreign Currency | 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, 2022, 2021 and 2020. |
Stock-Based Compensation | Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board, or 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, performance 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. 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 performance stock units with market-based conditions at their fair value on the date of the award using the Monte Carlo simulation model. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period, regardless of the likelihood of achievement of the market-based performance criteria. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. |
Income Taxes | Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the 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, 2022, 2021 and 2020 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the statements of operations and comprehensive loss. Accumulated other comprehensive income (loss) is presented in the accompanying balance sheets as a component of stockholders' equity. |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, restricted stock units and performance stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. Net loss per share was determined as follows (in thousands, except share and per share data): Year Ended December 31, 2022 2021 2020 Net loss $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 35,775,672 34,635,358 32,965,539 Net loss per share, basic and diluted $ ( 1.54 ) $ ( 1.44 ) $ ( 1.44 ) 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, 2022 2021 2020 Common stock options 3,839,858 3,780,939 4,237,828 Restricted stock units and performance stock units 1,329,824 530,274 68,396 Total 5,169,682 4,311,213 4,306,224 |
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, 2022, 2021 and 2020, based on the shipping location of the external customer. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | December 31, 2022 2021 Cash and cash equivalents $ 55,358 $ 110,231 Restricted cash 155 232 Total cash, cash equivalents and restricted cash $ 55,513 $ 110,463 |
Net Loss Per Share Determination | Year Ended December 31, 2022 2021 2020 Net loss $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 35,775,672 34,635,358 32,965,539 Net loss per share, basic and diluted $ ( 1.54 ) $ ( 1.44 ) $ ( 1.44 ) |
Schedule of Potentially Dilutive Securities Outstanding Excluded from Diluted Weighted Average Shares Outstanding | December 31, 2022 2021 2020 Common stock options 3,839,858 3,780,939 4,237,828 Restricted stock units and performance stock units 1,329,824 530,274 68,396 Total 5,169,682 4,311,213 4,306,224 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements [Abstract] | |
Financial Liabilities Measure on a Recurring Basis | December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 55,158 $ — $ — $ 55,158 U.S. treasury bills 19,776 — — 19,776 Commercial paper — 48,875 — 48,875 Corporate bonds/notes — 1,515 — 1,515 U.S. government securities — 83,270 — 83,270 Asset-backed securities — 1,996 — 1,996 Agency notes — 2,884 — 2,884 $ 74,934 $ 138,540 $ — $ 213,474 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 21,062 $ — $ — $ 21,062 $ 21,062 $ — $ — $ 21,062 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Components [Abstract] | |
Fair Value of the Available-For-Sale Investments | December 31, 2022 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 55,158 $ — $ — $ 55,158 U.S. treasury bills 19,772 4 — 19,776 Commercial paper 48,875 — — 48,875 Corporate bonds/notes 1,528 — ( 13 ) 1,515 U.S. government securities 83,432 2 ( 164 ) 83,270 Asset-backed securities 2,000 — ( 4 ) 1,996 Agency notes 2,876 8 — 2,884 $ 213,641 $ 14 $ ( 181 ) $ 213,474 Classified as: Cash equivalents $ 55,158 Short-term investments 158,316 $ 213,474 |
Fair Value of Cash Equivalents, Short-Term and Long-Term Equivalents | December 31, 2022 December 31, 2021 Amounts maturing within one year $ 213,474 $ 21,062 Amounts maturing after one year through two years — — $ 213,474 $ 21,062 |
Available-For-Sale Investments in Unrealized Loss Position | December 31, 2022 Less than 12 months Assets: Fair Value Unrealized Loss Corporate bonds/notes $ 1,490 $ ( 13 ) U.S. government securities 73,329 ( 164 ) Asset-backed securities 1,994 ( 4 ) $ 76,813 $ ( 181 ) |
Schedule of Inventories | 2022 2021 Raw materials $ 4,913 $ 2,447 Finished products 14,380 15,404 $ 19,293 $ 17,851 |
Property, Plant and Equipment | December 31, 2022 2021 Furniture and fixtures $ 1,822 $ 1,005 Equipment 5,046 2,945 Software 296 284 Leasehold improvements 7,246 2,050 14,410 6,284 Less: Accumulated depreciation ( 5,355 ) ( 3,330 ) Add: Construction-in-progress 317 4,743 $ 9,372 $ 7,697 |
Schedule of Accrued Liabilities | December 31, 2022 2021 Accrued payroll and related expenses $ 15,216 $ 13,898 Operating lease liability 1,844 1,294 Accrued royalty expense 973 687 Accrued professional services 781 2,039 Accrued travel expenses 775 590 Provision for sales returns 540 359 Accrued interest payable 519 14 Deferred revenue 253 157 Accrued clinical expenses 249 99 Accrued other expenses 815 665 $ 21,965 $ 19,802 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Long-term Debt [Abstract] | |
Future Maturities Under the Term Loan Agreement | Year Ending December 31: Amount 2023 $ 5,703 2024 5,719 2025 5,703 2026 45,699 2027 34,517 97,341 Add: Accretion of closing fees 531 97,872 Less: Amount representing interest ( 22,341 ) Less: Amount representing debt discount and debt issuance costs ( 935 ) Present value of minimum payments $ 74,596 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | |
Balance Sheet Information | December 31, Operating Lease: 2022 2021 Operating lease right-of-use asset in other non-current assets $ 5,081 $ 5,219 Operating lease liability in accrued liabilities $ 1,844 $ 1,294 Operating lease liability in other liabilities 5,998 5,747 Total operating lease liabilities $ 7,842 $ 7,041 |
Operating Lease Maturities | Year Ending December 31: Amount 2023 $ 1,967 2024 1,764 2025 1,079 2026 1,173 2027 1,202 Thereafter 2,391 Total lease payments 9,576 Less: imputed interest ( 1,734 ) Present value of lease liabilities $ 7,842 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders’ Equity [Abstract] | |
Schedule of Common Stokc Reserved for Future Issuances | December 31, 2022 2021 Outstanding stock options and equity awards 5,169,682 3,780,939 Reserved for grants of future stock options and equity awards 2,209,072 2,477,212 Reserved for Performance Stock Units for overperformance 207,468 — Reserved for employee stock purchase plan 1,172,686 922,097 8,758,908 7,180,248 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Shares Available for Issuance | Number of Shares 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 Authorized 1,369,985 Granted/Awarded ( 847,080 ) Cancelled 163,620 Balances, December 31, 2021 2,477,212 Authorized 1,399,235 Allowance for Performance Stock Units for overperformance ( 207,468 ) Granted/Awarded ( 1,600,996 ) Cancelled 141,089 Balances, December 31, 2022 2,209,072 |
Stock Option Activity | Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in Years) Aggregate Intrinsic Value (in thousands) Balances, December 31, 2019 4,310,790 $ 7.91 7.27 $ 140,234 Options granted 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 Options granted 323,057 $ 53.94 Options exercised ( 643,507 ) $ 7.49 Options cancelled ( 136,439 ) $ 40.30 Balances, December 31, 2021 3,780,939 $ 20.45 6.71 $ 91,900 Options granted 587,015 $ 37.69 Options exercised ( 453,199 ) $ 7.42 Options cancelled ( 74,897 ) $ 41.16 Balances, December 31, 2022 3,839,858 $ 24.22 6.41 $ 112,755 Vested and exercisable at December 31, 2022 2,894,714 $ 18.82 5.76 $ 100,024 Vested and expected to vest at December 31, 2022 3,839,858 $ 24.22 6.41 $ 112,755 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Table Text Block] | 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 $ 1.38 - $ 3.16 583,253 3.76 $ 2.18 583,253 $ 2.18 $ 4.73 - $ 7.10 503,468 5.16 $ 5.75 503,468 $ 5.75 $ 8.27 - $ 12.41 475,911 5.07 $ 11.76 475,522 $ 11.76 $ 20.00 - $ 30.00 581,673 6.26 $ 20.00 532,068 $ 20.00 $ 30.93 - $ 46.55 1,142,735 8.17 $ 35.20 508,451 $ 34.43 $ 47.20 - $ 70.80 552,818 8.02 $ 56.73 291,952 $ 56.74 3,839,858 6.41 $ 24.22 2,894,714 $ 18.82 |
Summary of RSU Activity | Number of RSUs/PSUs Weighted Average Grant Date Fair Value Balances, December 31, 2019 — $ — Awards granted 69,040 $ 46.14 Awards vested — $ — Awards forfeited ( 644 ) $ 44.62 Balances, December 31, 2020 68,396 $ 46.16 Awards granted 524,023 $ 53.64 Awards vested ( 34,964 ) $ 49.95 Awards forfeited ( 27,181 ) $ 51.99 Balances, December 31, 2021 530,274 $ 53.01 Awards granted 1,013,981 $ 45.84 Awards vested ( 148,239 ) $ 52.14 Awards forfeited ( 66,192 ) $ 44.38 Balances, December 31, 2022 1,329,824 $ 48.07 Expected to vest at December 31, 2022 1,329,824 $ 48.07 |
Stock-Based Compensation Expense Relating to Stock Options to Employees and Nonemployees | Year Ended December 31, 2022 2021 2020 Cost of goods sold $ 1,138 $ 635 $ 339 Research and development expenses 5,240 2,909 1,110 Selling, general and administrative expenses 18,645 11,068 5,777 $ 25,023 $ 14,612 $ 7,226 |
Common Stock Options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Fair Value Assumptions | Year Ended December 31, 2022 2021 2020 Expected term (in years) 5.25 - 6.25 5.25 - 6.25 5.00 - 6.25 Expected volatility 48.2 % - 51.4 % 45.0 % - 50.4 % 43.0 % - 50.3 % Risk-free interest rate 1.60 % - 3.84 % 0.41 % - 1.08 % 0.32 % - 1.41 % Dividend yield —% —% —% |
ESPP [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Fair Value Assumptions | Year Ended December 31, 2022 2021 2020 Expected term (in years) 0.50 0.50 0.50 Expected volatility 51.6 % - 74.5 % 46.9 % - 51.6 % 44.4 % - 76.4 % Risk-free interest rate 0.07 % - 4.64 % 0.03 % - 0.10 % 0.10 % - 1.58 % Dividend yield —% —% —% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | Year Ended December 31, 2022 2021 2020 United States $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) International — — — $ ( 55,010 ) $ ( 49,811 ) $ ( 47,365 ) |
Schedule of Effective Income Tax Rate Reconciliation | Year Ended December 31, 2022 2021 2020 Tax at federal statutory rate $ ( 11,552 ) $ ( 10,460 ) $ ( 9,947 ) State taxes, net of federal benefit ( 2,206 ) ( 1,852 ) ( 1,958 ) Permanent differences ( 2,883 ) ( 5,224 ) ( 8,489 ) Change in valuation allowance 18,237 17,918 22,164 General business credits ( 1,166 ) ( 852 ) ( 1,268 ) Other ( 401 ) 490 ( 491 ) Provision for income taxes $ 29 $ 20 $ 11 |
Schedule of Deferred Tax Assets and Liabilities | December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 82,768 $ 77,616 Research and development credits 8,898 7,732 Capitalized start-up costs/Intangibles 1 4 Section 174 R&D capitalization 7,816 — Accruals and reserves 2,820 2,301 Stock-based compensation 8,209 4,392 Operating lease liability 1,973 1,751 Interest limitation 2,013 1,314 Total deferred tax assets 114,498 95,110 Less: Valuation allowance ( 111,444 ) ( 93,207 ) Deferred tax liabilities: Operating lease asset ( 1,278 ) ( 1,297 ) Property and equipment ( 1,776 ) ( 606 ) Total deferred tax liabilities ( 3,054 ) ( 1,903 ) Net deferred tax assets $ — $ — |
Reconciliation of Unrecognized Tax Benefits | December 31, 2022 2021 2020 Balance at the beginning of year $ 3,314 $ 2,019 $ 1,436 Increases related to current years’ tax positions 474 704 342 Increases related to prior years’ tax positions — 591 241 Balance at end of year $ 3,788 $ 3,314 $ 2,019 |
Formation and Business of the_2
Formation and Business of the Company (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2022 | May 31, 2020 | Dec. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | |||||
Accumulated deficit | $ (343,712) | $ (288,702) | |||
Cash and cash equivalents | 55,358 | $ 110,231 | |||
Cash, Cash Equivalents, and Short-Term Investments | 213,474 | ||||
Cash Cash Equivalents And Available For Sale Investments | 213,674 | ||||
Issued and sold common stock (in shares) | 2,674,419 | 6,808,154 | |||
Net proceeds | $ 108,992 | $ 70,543 | |||
Stock issued, price per share (in USD per share) | $ 43 | $ 39 | |||
Payments of deferred offering costs | $ 258 | $ 707 | $ 6,008 | $ 4,457 | |
Payment of stock issuance underwriting discounts and commissions | $ 5,750 | $ 3,750 | |||
Public Stock Offering Shares From Company [Member] | |||||
Subsequent Event [Line Items] | |||||
Issued and sold common stock (in shares) | 1,923,076 | ||||
Public Stock Offering Shares From Existing Shareholders [Member] | |||||
Subsequent Event [Line Items] | |||||
Issued and sold common stock (in shares) | 4,885,078 | ||||
Over Allotment [Member] | |||||
Subsequent Event [Line Items] | |||||
Issued and sold common stock (in shares) | 1,021,223 | ||||
Underwriters' Option [Member] | |||||
Subsequent Event [Line Items] | |||||
Issued and sold common stock (in shares) | 348,837 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Unbilled receivables | $ 148,000 | $ 87,000 | |
Provision for income taxes | |||
Liability for uncertain tax positions | $ 0 | ||
Number of reportable segments | segment | 1 | ||
Number of operating segments | segment | 1 | ||
Advertising expense | $ 347,000 | 221,000 | $ 194,000 |
Asset Impairment Charges | 0 | 0 | 0 |
Debt Securities, Available-for-Sale, Allowance for Credit Loss, Writeoff | 0 | 0 | $ 0 |
Restricted cash | $ 155,000 | 232,000 | |
Minimum [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property and equipment, useful life | 3 years | ||
Maximum [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property and equipment, useful life | 5 years | ||
Letter of Credit [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Restricted cash | $ 155,000 | $ 232,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Cash and Cash Equivalents) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 55,358 | $ 110,231 | ||
Restricted cash | 155 | 232 | ||
Total cash, cash equivalents and restricted cash | $ 55,513 | $ 110,463 | $ 69,776 | $ 39,491 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Earnings Per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies [Abstract] | |||
Net loss | $ (55,010) | $ (49,811) | $ (47,365) |
Weighted average common stock outstanding used to compute net loss per share, basic (in shares) | 35,775,672 | 34,635,358 | 32,965,539 |
Weighted average common stock outstanding used to compute net loss per share,diluted (in shares) | 35,775,672 | 34,635,358 | 32,965,539 |
Net loss per share, basic | $ (1.54) | $ (1.44) | $ (1.44) |
Net loss per share, diluted | $ (1.54) | $ (1.44) | $ (1.44) |
Summary of Significant Accoun_7
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 5,169,682 | 4,311,213 | 4,306,224 |
Common Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,839,858 | 3,780,939 | 4,237,828 |
Restricted Stock Units [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,329,824 | 530,274 | 68,396 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 213,474 | $ 21,062 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 55,158 | 21,062 |
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 19,776 | |
Commercial Papers [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 48,875 | |
Corporate Bonds/Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 1,515 | |
U.S. Government Securitie [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 83,270 | |
Asset-Backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 1,996 | |
Agency Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 2,884 | |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 74,934 | 21,062 |
Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 55,158 | $ 21,062 |
Level 1 [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 19,776 | |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 138,540 | |
Level 2 [Member] | Commercial Papers [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 48,875 | |
Level 2 [Member] | Corporate Bonds/Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 1,515 | |
Level 2 [Member] | U.S. Government Securitie [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 83,270 | |
Level 2 [Member] | Asset-Backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 1,996 | |
Level 2 [Member] | Agency Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 2,884 |
Balance Sheet Components (Narra
Balance Sheet Components (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Inventory [Line Items] | |||
Work-in-process inventories | $ 0 | $ 0 | |
Depreciation and amortization | 2,127,000 | 1,032,000 | $ 789,000 |
Short-term Investments | 158,316,000 | ||
Cash Equivalents, at Carrying Value | 55,158,000 | ||
Estimated Fair Value | $ 213,474,000 | ||
Money Market Funds [Member] | |||
Inventory [Line Items] | |||
Cash Equivalents, at Carrying Value | $ 21,062,000 |
Balance Sheet Components (Fair
Balance Sheet Components (Fair Value of Available-For-Sale Investments) (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | $ 213,641 |
Gross Unrealized Gains | 14 |
Gross Unrealized Losses | (181) |
Estimated Fair Value | 213,474 |
Cash equivalents | 55,158 |
Short-term investments | 158,316 |
Total | 213,474 |
Money Market Funds [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 55,158 |
Estimated Fair Value | 55,158 |
US Treasury Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 19,772 |
Gross Unrealized Gains | 4 |
Estimated Fair Value | 19,776 |
Commercial Paper [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 48,875 |
Estimated Fair Value | 48,875 |
Corporate Bonds/Notes [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 1,528 |
Gross Unrealized Losses | (13) |
Estimated Fair Value | 1,515 |
U.S. Government Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 83,432 |
Gross Unrealized Gains | 2 |
Gross Unrealized Losses | (164) |
Estimated Fair Value | 83,270 |
Asset-Backed Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 2,000 |
Gross Unrealized Losses | (4) |
Estimated Fair Value | 1,996 |
Agency Notes [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 2,876 |
Gross Unrealized Gains | 8 |
Estimated Fair Value | $ 2,884 |
Balance Sheet Components (Fai_2
Balance Sheet Components (Fair Value of Cash Equivalents, Short-Term and Long-Term Investments) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Amounts maturing within one year | $ 213,474 | $ 21,062 |
Total | $ 213,474 | $ 21,062 |
Balance Sheet Components (Avail
Balance Sheet Components (Available-for-Sale Investments in Unrealized Loss Position) (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | $ 76,813 |
Unrealized Loss, Less than 12 months | (181) |
Corporate Bonds/Notes [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | 1,490 |
Unrealized Loss, Less than 12 months | (13) |
U.S. Government Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | 73,329 |
Unrealized Loss, Less than 12 months | (164) |
Asset-Backed Securities [Member] | |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value, Less than 12 months | 1,994 |
Unrealized Loss, Less than 12 months | $ (4) |
Balance Sheet Components (Sched
Balance Sheet Components (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 4,913 | $ 2,447 |
Finished products | 14,380 | 15,404 |
Inventory, gross | $ 19,293 | $ 17,851 |
Balance Sheet Components (Prope
Balance Sheet Components (Property, Plant and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 14,410 | $ 6,284 |
Less: Accumulated depreciation and amortization | (5,355) | (3,330) |
Property and equipment, net | 9,372 | 7,697 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,822 | 1,005 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,046 | 2,945 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 296 | 284 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,246 | 2,050 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 317 | $ 4,743 |
Balance Sheet Components (Accru
Balance Sheet Components (Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Components [Abstract] | ||
Accrued payroll and related expenses | $ 15,216 | $ 13,898 |
Operating lease liability | 1,844 | 1,294 |
Accrued royalty expense | 973 | 687 |
Accrued professional services | 781 | 2,039 |
Accrued travel expenses | 775 | 590 |
Provision for sales returns | 540 | 359 |
Accrued interest payable | 519 | 14 |
Deferred revenue | 253 | 157 |
Accrued clinical expenses | 249 | 99 |
Accrued other expenses | 815 | 665 |
Total | $ 21,965 | $ 19,802 |
Long-term Debt (Narrative) (Det
Long-term Debt (Narrative) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Oct. 29, 2020 | May 31, 2022 | Oct. 31, 2020 | Sep. 30, 2018 | Apr. 30, 2017 | Dec. 31, 2022 | Dec. 31, 2020 | May 27, 2022 | |
Subsequent Event [Line Items] | ||||||||
Prepayment premium fee | $ 2,496,000 | |||||||
Loss on debt extinguishment | $ (245,000) | $ (1,119,000) | ||||||
Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from debt | $ 49,000,000 | |||||||
Percent of original principal threshold | 0.75% | |||||||
Redemption amount | $ 375,000 | |||||||
Term Loan [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | 50,000,000 | |||||||
Loan Facility [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | 50,000,000 | |||||||
Loan Facility [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Repayment of outstanding loan amount | $ 49,181,000 | |||||||
Debt pay off | 181,000 | |||||||
Facility fee | $ 367,500 | |||||||
Loss on debt extinguishment | 245,000 | |||||||
Debt Instrument, Fee Amount | $ 367,500 | |||||||
Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | 225,000,000 | |||||||
Aggregate outstanding principal balance | $ 75,000,000 | |||||||
Annual interest rate | 7.50% | |||||||
Aggregate principal amount | 50% | |||||||
Percentage of prepayment fees | 5% | |||||||
Debt, Covenant, Revenue Covenant | 75% | |||||||
Loan Facility [Member] | Term Loan [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Stated interest rate | 4.75% | |||||||
Loan Facility [Member] | Term Loan [Member] | Prime Rate [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Variable interest rate | 0.75% | |||||||
Secured Revolving Credit Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 25,000,000 | |||||||
Secured Revolving Credit Facility [Member] | Index Rate [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Variable interest rate | 0.85% | |||||||
Debt instrument margin rate | 3% | |||||||
Secured Revolving Credit Facility [Member] | Secured Debt [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 50,000,000 | |||||||
Secured Revolving Credit Facility, Amended [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 50,000,000 | |||||||
Percent of borrowing base of eligible receivables | 85% | |||||||
Percent of eligible inventory | 50% | |||||||
Percent of borrowing base in case eligible inventory | 40% | |||||||
Borrowing base amount in case eligible inventory | $ 10,000,000 | |||||||
Secured Term Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 200,000,000 | |||||||
Percentage of prepayment fees | 3% | |||||||
Percentage of prepayment fees in second year | 2% | |||||||
Percentage of prepayment fees in third year | 1% | |||||||
Percent aggregate original principal amount | 5% | |||||||
Term loan prepaid in increments | $ 10,000,000 | |||||||
Secured Term Loan Facility [Member] | Index Rate [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Variable interest rate | 0.85% | |||||||
Debt instrument margin rate | 5% | |||||||
Secured Revolving Credit Facility, Subfacility [Member] | Term Loan [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 2,000,000 | |||||||
Loan Agreement [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 50,000,000 | |||||||
Stated interest rate | 4.75% | |||||||
Loan Agreement [Member] | Prime Rate [Member] | Stifel Bank [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Variable interest rate | 0.50% | |||||||
Loan Agreement [Member] | Term Loan [Member] | CRG [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Loss on debt extinguishment | $ 1,119,000 | |||||||
Debt, face amount | $ 30,000,000 | |||||||
Term Loan, First Tranche [Member] | Term Loan [Member] | CRG [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Debt, face amount | 20,000,000 | |||||||
Term Loan, First Tranche [Member] | Secured Term Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | 75,000,000 | |||||||
Proceeds from debt | $ 75,000,000 | |||||||
Term Loan, Second Tranche [Member] | Term Loan [Member] | CRG [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from debt | $ 5,000,000 | |||||||
Debt, face amount | 10,000,000 | |||||||
Term Loan, Second Tranche [Member] | Secured Term Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | 75,000,000 | |||||||
Term Loan, Third Tranche [Member] | Secured Term Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Facility amount | $ 50,000,000 | |||||||
Debt, Covenant, Revenue Covenant | 90% | |||||||
Term Loan, Amended [Member] | Term Loan [Member] | CRG [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from debt | $ 15,000,000 | |||||||
Stated interest rate | 10% | |||||||
Debt Instrument, Interest Rate, Stated Percentage, Payable In Cash | 8% | |||||||
Debt Instrument, Interest Rate, Stated Percentage, Paid In Kind | 2% | |||||||
Debt, face amount | $ 25,000,000 | |||||||
Maximum [Member] | Loan Facility [Member] | Index Rate [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Variable interest rate | 2.50% | |||||||
Maximum [Member] | Secured Term Loan Facility [Member] | Oxford Finance [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Percent aggregate original principal amount | 6.75% |
Long-term Debt (Future Maturiti
Long-term Debt (Future Maturities Under the Term Loan) (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Long-term Debt [Abstract] | |
2023 | $ 5,703 |
2024 | 5,719 |
2025 | 5,703 |
2026 | 45,699 |
2027 | 34,517 |
Long-term debt, gross before accretion of closing fees | 97,341 |
Accretion Of CLosing Costs | 531 |
Long-Term Debt, Gross, After Accretion Of Closing Fees | 97,872 |
Less: Amount representing interest | (22,341) |
Less: Amount representing debt discount and debt issuance costs | (935) |
Present value of minimum payments | $ 74,596 |
Commitments and Contingencies_2
Commitments and Contingencies (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | |||
Operating Lease, Right-of-Use Asset | $ 5,081,000 | $ 5,219,000 | |
Operating Lease, Liability | 7,842,000 | 7,041,000 | |
Operating lease costs | 1,559,000 | 1,234,000 | $ 870,000 |
Operating Lease Payments, Net Of Tenant Improvements | $ 102,000 | $ (34,000) | $ 769,000 |
Weighted average discount rate | 6.57% | 6.50% | |
Weighted average remaining lease term | 5 years 8 months 4 days | ||
Purchase obligation | $ 13,572,000 | ||
Contingent liabilities requiring accrual | $ 0 | $ 0 | |
Headquarters [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Renewal term | 5 years | ||
Additional Office, Laboratory And Manufacturing Space [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Renewal term | 5 years | ||
Operating Lease, Right-of-Use Asset | $ 3,307,000 | ||
Operating Lease, Liability | $ 3,307,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Balance Sheet Information) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies [Abstract] | ||
Operating lease right-of-use asset in other non-current assets | $ 5,081 | $ 5,219 |
Operating lease liability in accrued liabilities | 1,844 | 1,294 |
Operating lease liability in other liabilities | 5,998 | 5,747 |
Total operating lease liabilities | $ 7,842 | $ 7,041 |
Operating lease, right-of-use asset, statement of financial position extensible list | Other non-current assets | Other non-current assets |
Operating lease, liability, current, statement of financial position extensible list | Accrued liabilities | Accrued liabilities |
Operating lease, liability, noncurrent, statement of financial position extensible list | Other liabilities | Other liabilities |
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Liabilities | Liabilities |
Commitments and Contingencies_4
Commitments and Contingencies (Operating Lease Maturities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies [Abstract] | ||
2023 | $ 1,967 | |
2024 | 1,764 | |
2025 | 1,079 | |
2026 | 1,173 | |
2027 | 1,202 | |
Thereafter | 2,391 | |
Total lease payments | 9,576 | |
Less: interest | (1,734) | |
Total lease liabilities | $ 7,842 | $ 7,041 |
Stockholders_ Equity (Narrative
Stockholders’ Equity (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders’ Equity [Abstract] | ||
Preferred shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred shares (in USD per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 100,000,000 | 100,000,000 |
Par value (in USD per share) | $ 0.001 | $ 0.001 |
Shares issued (in shares) | 38,355,972 | 34,980,896 |
Shares outstanding (in shares) | 38,355,972 | 34,980,896 |
Dividends declared | $ 0 | |
Stockholder Short Swing Profits | $ 32,000 |
Stockholders' Equity (Shares Re
Stockholders' Equity (Shares Reserved for Future Issuance) (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 8,758,908 | 7,180,248 |
Exercise of options under stock plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 5,169,682 | 3,780,939 |
Issuance of options and restricted stock units under stock plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 2,209,072 | 2,477,212 |
Performance Stock Units, Overperformance [Member] | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 207,468 | |
ESPP [Member] | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance (in shares) | 1,172,686 | 922,097 |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plans (Narrative) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2022 | Mar. 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2007 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Aggregate intrinsic value of options exercised | $ 17,575,000 | $ 29,355,000 | $ 47,861,000 | |||
Weighted average grant date fair value (in USD per share) | $ 37.69 | $ 23.83 | $ 18.22 | |||
Fair value of options vested | $ 9,816,000 | $ 9,076,000 | $ 5,138,000 | |||
Common stock reserved for future issuance (in shares) | 8,758,908 | 7,180,248 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grant Date Fair Value | $ 30,486,000 | $ 28,110,000 | ||||
ISO and NSO [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting term | 4 years | |||||
ISO [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Exercise threshold as a percentage of fair value of shares | 100% | |||||
Percent of purchase of price of common stock | 10% | |||||
NSO [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Exercise threshold as a percentage of fair value of shares | 85% | |||||
Percent of purchase of price of common stock | 110% | |||||
2019 ESPP | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expensed not yet recognized, period for recognition | 4 months 17 days | |||||
Unrecognized compensation costs related to the ESPP | $ 423,000 | |||||
Common Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expensed not yet recognized | $ 16,784,000 | |||||
Compensation expensed not yet recognized, period for recognition | 2 years 3 months 29 days | |||||
Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expensed not yet recognized, period for recognition | 2 years 9 months 29 days | |||||
Unrecognized compensation costs of unvested RSUs | $ 53,784,000 | |||||
Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 207,468 | |||||
Expected volatility | 60.60% | |||||
Risk-free interest rate | 0.41% | |||||
Dividend yield | 0% | |||||
Performance Shares [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting term | 3 years | |||||
Performance Shares [Member] | Benchmark [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected volatility | 59.40% | |||||
Minimum [Member] | Common Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected volatility | 48.20% | 45% | 43% | |||
Risk-free interest rate | 1.60% | 0.41% | 0.32% | |||
Minimum [Member] | Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Risk-free interest rate | 4.09% | |||||
Maximum [Member] | Common Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected volatility | 51.40% | 50.40% | 50.30% | |||
Risk-free interest rate | 3.84% | 1.08% | 1.41% | |||
Maximum [Member] | Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Risk-free interest rate | 4.20% | |||||
2019 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock reserved for issuance (in shares) | 2,317,000 | |||||
Number of additional shares allowable under the plan (in shares) | 3,000,000 | |||||
Percent of outstanding shares of common stock | 4% | |||||
Common stock reserved for future issuance (in shares) | 434,000 | 6,417,317 | ||||
Additional Common Stock Capital Shares Reserved For Future Issuance | 1,200,000 | |||||
Percent Of Outstanding Shares | 1% | |||||
2019 Equity Incentive Plan [Member] | Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting term | 4 years | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Fair Value | $ 6,135,000 | $ 1,893,000 | $ 0 | |||
2019 Equity Incentive Plan [Member] | Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting term | 3 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grant Date Fair Value | $ 16,000,000 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period, Fair Value | $ 207,468 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Performance | 100% | |||||
2019 Equity Incentive Plan [Member] | Minimum [Member] | Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Performance | 0% | |||||
2019 Equity Incentive Plan [Member] | Maximum [Member] | Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Performance | 200% | |||||
ESPP, 2019 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock reserved for future issuance (in shares) | 1,438,856 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued | 266,170 | |||||
Shares available for future issuance (in shares) | 1,172,686 | |||||
Fair Market Value Of Common Stock | 85% |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plans (Activity Under Compensation Plan) (Details) - 2019 Equity Incentive Plan [Member] - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Available for Grant | |||
Beginning balance (in shares) | 2,477,212 | 1,790,687 | 1,554,690 |
Authorized (in shares) | 1,399,235 | 1,369,985 | 1,250,210 |
Allowance for Performance Stock Units for overperformance (in shares) | (207,468) | ||
Granted/Awarded (in shares) | (1,600,996) | (847,080) | (1,079,883) |
Canceled (in shares) | 141,089 | 163,620 | 65,670 |
Ending balance (in shares) | 2,209,072 | 2,477,212 | 1,790,687 |
Stock-Based Compensation Plan_4
Stock-Based Compensation Plans (Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | ||||
Beginning balance (in shares) | 3,780,939 | 4,237,828 | 4,310,790 | |
Options granted (in shares) | 587,015 | 323,057 | 1,010,843 | |
Options exercised (in shares) | (453,199) | (643,507) | (1,018,779) | |
Options cancelled (in shares) | (74,897) | (136,439) | (65,026) | |
Ending balance (in shares) | 3,839,858 | 3,780,939 | 4,237,828 | 4,310,790 |
Vested and exercisable (in shares) | 2,894,714 | |||
Vested and expect to vest (in shares) | 3,839,858 | |||
Weighted Average Exercise Price | ||||
Beginning balance (in USD per share) | $ 20.45 | $ 16.56 | $ 7.91 | |
Options granted (in USD per share) | 37.69 | 53.94 | 40.67 | |
Options exercised (in USD per share) | 7.42 | 7.49 | 3.42 | |
Options cancelled (in USD per share) | 41.16 | 40.30 | 23.32 | |
Ending balance (in USD per share) | 24.22 | $ 20.45 | $ 16.56 | $ 7.91 |
Vested and exercisable (in USD per share) | 18.82 | |||
Vested and expected to vest (in USD per share) | $ 24.22 | |||
Weighted Average Remaining Contractual Term (in Years) | ||||
Awards outstanding | 6 years 4 months 28 days | 6 years 8 months 15 days | 7 years 4 months 17 days | 7 years 3 months 7 days |
Vested and exercisable | 5 years 9 months 3 days | |||
Vested and expected to vest | 6 years 4 months 28 days | |||
Aggregate Intrinsic Value (in thousands) | ||||
Awards outstanding | $ 112,755 | $ 91,900 | $ 197,407 | $ 140,234 |
Vested and exercisable | 100,024 | |||
Vested and expected to vest | $ 112,755 |
Stock-Based Compensation Plan_5
Stock-Based Compensation Plans (Information by Exercise Price) (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding (in shares) | 3,839,858 | 3,780,939 | 4,237,828 | 4,310,790 |
Weighted Average Remaining Contractual Term (in Years) | 6 years 4 months 28 days | 6 years 8 months 15 days | 7 years 4 months 17 days | 7 years 3 months 7 days |
Weighted Average Exercise Price (in USD per share) | $ 24.22 | $ 20.45 | $ 16.56 | $ 7.91 |
Number Exercisable (in shares) | 2,894,714 | |||
Weighted Average Exercise Price (in USD per share) | $ 18.82 | |||
Exercise Price One | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 1.38 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 3.16 | |||
Options Outstanding (in shares) | 583,253 | |||
Weighted Average Remaining Contractual Term (in Years) | 3 years 9 months 3 days | |||
Weighted Average Exercise Price (in USD per share) | $ 2.18 | |||
Number Exercisable (in shares) | 583,253 | |||
Weighted Average Exercise Price (in USD per share) | $ 2.18 | |||
Exercise Price Two [Member] | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 4.73 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 7.10 | |||
Options Outstanding (in shares) | 503,468 | |||
Weighted Average Remaining Contractual Term (in Years) | 5 years 1 month 28 days | |||
Weighted Average Exercise Price (in USD per share) | $ 5.75 | |||
Number Exercisable (in shares) | 503,468 | |||
Weighted Average Exercise Price (in USD per share) | $ 5.75 | |||
Exercise Price Three [Member] | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 8.27 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 12.41 | |||
Options Outstanding (in shares) | 475,911 | |||
Weighted Average Remaining Contractual Term (in Years) | 5 years 25 days | |||
Weighted Average Exercise Price (in USD per share) | $ 11.76 | |||
Number Exercisable (in shares) | 475,522 | |||
Weighted Average Exercise Price (in USD per share) | $ 11.76 | |||
Exercise Price Four [Member] | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 20 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 30 | |||
Options Outstanding (in shares) | 581,673 | |||
Weighted Average Remaining Contractual Term (in Years) | 6 years 3 months 3 days | |||
Weighted Average Exercise Price (in USD per share) | $ 20 | |||
Number Exercisable (in shares) | 532,068 | |||
Weighted Average Exercise Price (in USD per share) | $ 20 | |||
Exercise Price Five | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 30.93 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 46.55 | |||
Options Outstanding (in shares) | 1,142,735 | |||
Weighted Average Remaining Contractual Term (in Years) | 8 years 2 months 1 day | |||
Weighted Average Exercise Price (in USD per share) | $ 35.20 | |||
Number Exercisable (in shares) | 508,451 | |||
Weighted Average Exercise Price (in USD per share) | $ 34.43 | |||
Exercise Price Six | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 47.20 | |||
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 70.80 | |||
Options Outstanding (in shares) | 552,818 | |||
Weighted Average Remaining Contractual Term (in Years) | 8 years 7 days | |||
Weighted Average Exercise Price (in USD per share) | $ 56.73 | |||
Number Exercisable (in shares) | 291,952 | |||
Weighted Average Exercise Price (in USD per share) | $ 56.74 |
Stock-Based Compensation Plan_6
Stock-Based Compensation Plans (RSUs) (Details) - RSU/PSU [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Restricted Stock Units | |||
Beginning balance (in shares) | 530,274 | 68,396 | |
Restricted stock granted (in shares) | 1,013,981 | 524,023 | 69,040 |
Restricted stock vested (in shares) | (148,239) | (34,964) | |
Restricted stock forfeited (in shares) | (66,192) | (27,181) | (644) |
Ending balance (in shares) | 1,329,824 | 530,274 | 68,396 |
Expected to vest (in shares) | 1,329,824 | ||
Weighted Average Grant Date Fair Value | |||
Beginning balance (in USD per share) | $ 53.01 | $ 46.16 | |
Restricted stock granted (in USD per share) | 45.84 | 53.64 | $ 46.14 |
Restricted stock vested (in USD per share) | 52.14 | 49.95 | |
Restricted stock forfeited (in USD per share) | 44.38 | 51.99 | 44.62 |
Ending balance (in USD per share) | 48.07 | $ 53.01 | $ 46.16 |
Expected to vest (in USD per share) | $ 48.07 |
Stock-Based Compensation Plan_7
Stock-Based Compensation Plans (Fair Value of Stock Options) (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Common Stock Options [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 3 months | 5 years 3 months | 5 years |
Expected volatility | 48.20% | 45% | 43% |
Risk-free interest rate | 1.60% | 0.41% | 0.32% |
Common Stock Options [Member] | Maximum [Member] | |||
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 |
Expected volatility | 51.40% | 50.40% | 50.30% |
Risk-free interest rate | 3.84% | 1.08% | 1.41% |
ESPP [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | 6 months | |
ESPP [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 months | ||
Expected volatility | 51.60% | 46.90% | 44.40% |
Risk-free interest rate | 0.07% | 0.03% | 0.10% |
ESPP [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 74.50% | 51.60% | 76.40% |
Risk-free interest rate | 4.64% | 0.10% | 1.58% |
Stock-Based Compensation Plan_8
Stock-Based Compensation Plans (Stock-based Compensation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 25,023 | $ 14,612 | $ 7,226 |
Cost of Goods Sold [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 1,138 | 635 | 339 |
Research and Development Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 5,240 | 2,909 | 1,110 |
Selling, General and Administrative Expenses [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 18,645 | $ 11,068 | $ 5,777 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||||
Increase (decrease) in deferred tax asset valuation allowance | $ 18,237,000 | $ 17,918,000 | ||
Unrecognized tax benefits | 3,788,000 | 3,314,000 | $ 2,019,000 | $ 1,436,000 |
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 | 320,140,000 | |||
State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 271,494,000 | |||
Research Tax Credit Carryforward | Domestic Tax Authority | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 8,395,000 | |||
Research Tax Credit Carryforward | State and Local Jurisdiction | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | $ 5,022,000 |
Income Taxes - Components of In
Income Taxes - Components of Income Before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (55,010) | $ (49,811) | $ (47,365) |
Total | $ (55,010) | $ (49,811) | $ (47,365) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S Statutory Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Tax at federal statutory rate | $ (11,552) | $ (10,460) | $ (9,947) |
State taxes, net of federal benefit | (2,206) | (1,852) | (1,958) |
Permanent differences | (2,883) | (5,224) | (8,489) |
Change in valuation allowance | 18,237 | 17,918 | 22,164 |
General business credits | (1,166) | (852) | (1,268) |
Other | (401) | 490 | (491) |
Provision for income taxes | $ 29 | $ 20 | $ 11 |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 82,768 | $ 77,616 |
Research and development credits | 8,898 | 7,732 |
Capitalized start-up costs/Intangibles | 1 | 4 |
Deferred Tax Assets, Section 174 | 7,816 | |
Accruals and reserves | 2,820 | 2,301 |
Stock-based compensation | 8,209 | 4,392 |
Operating lease liability | 1,973 | 1,751 |
Interest limitation | 2,013 | 1,314 |
Total deferred tax assets | 114,498 | 95,110 |
Less: Valuation allowance | (111,444) | (93,207) |
Deferred tax liabilities: | ||
Operating lease asset | (1,278) | (1,297) |
Property and equipment | (1,776) | (606) |
Total deferred tax liabilities | (3,054) | (1,903) |
Net deferred tax assets |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at the beginning of year | $ 3,314 | $ 2,019 | $ 1,436 |
Increases related to current years’ tax positions | 474 | 704 | 342 |
Increases related to prior years’ tax positions | 591 | 241 | |
Balance at end of year | $ 3,788 | $ 3,314 | $ 2,019 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Percentage employee contribution | 90% | |||
Employer discretionary contribution | $ 1,872 | $ 1,313 | $ 959 | |
Employer contribution match percentage | 50% | |||
Percent of matching contribution of the employee's pay | 5% | |||
Subsequent Event | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Employer contribution match percentage | 50% | |||
Percent of matching contribution of the employee's pay | 6% |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | $ 6 | $ 13 | $ 45 |
Charged to expenses | (3) | 6 | (32) |
Write offs | 13 | ||
Balance at End of Year | $ 3 | $ 6 | $ 13 |