Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 28, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Lucira Health, Inc. | ||
Entity Interactive Data Current | Yes | ||
Entity Central Index Key | 0001652724 | ||
Entity Tax Identification Number | 27-2491037 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity File Number | 001-39976 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Small Business | true | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 1412 62nd Street | ||
Entity Address, City or Town | Emeryville | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94608 | ||
City Area Code | 510 | ||
Local Phone Number | 350-8071 | ||
Trading Symbol | LHDX | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 39,825,333 | ||
Entity Public Float | $ 192.9 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 243 | ||
Auditor Name | BDO USA, LLP | ||
Auditor Location | San Jose, California | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant’s definitive proxy statement for its 2022 Annual Meeting of Stockholders, which the Registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the Registrant’s fiscal year ended December 31, 2021, are incorporated by reference into Part III of this Annual Report on Form 10-K. |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 105,982 | $ 58,212 |
Accounts receivable, net | 27,245 | 293 |
Inventory | 50,776 | 4,865 |
Other receivable | 8,188 | 798 |
Prepaid expenses | 10,274 | 3,496 |
Other current assets | 3,817 | 229 |
Restricted cash equivalents | 2,338 | |
Total current assets | 206,282 | 70,231 |
Property and equipment, net | 30,974 | 19,408 |
Operating lease right-of-use assets | 2,714 | 748 |
Other assets | 384 | 2,316 |
Total assets | 240,354 | 92,703 |
Current liabilities: | ||
Accounts payable | 19,371 | 3,981 |
Accrued liabilities | 29,162 | 4,445 |
Operating lease liabilities, current | 1,609 | 431 |
Customer deposits | 189 | |
Total current liabilities | 50,331 | 8,857 |
Convertible notes payable | 24,694 | |
Operating lease liabilities, net of current portion | 1,220 | 380 |
Total liabilities | 51,551 | 33,931 |
Commitments and contingencies (Note 5) | ||
Redeemable convertible preferred stock $0.001 par value; 0 and 103,355,827 shares authorized as of December 31, 2021 and 2020, respectively; 0 and 23,978,747 shares issued and outstanding as of December 31, 2021 and 2020, respectively; aggregate liquidation preference of $0 as of December 31, 2021 | 121,080 | |
Stockholders’ equity (deficit): | ||
Preferred stock $0.001 par value; 10,000,000 and 0 shares authorized as of December 31, 2021 and 2020, respectively; 0 shares issued and outstanding as of December 31, 2021 and 2020 | ||
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares authorized as of December 31, 2021 and 2020, respectively; 39,663,645 and 2,712,694 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 40 | 3 |
Additional paid-in capital | 317,304 | 1,403 |
Accumulated deficit | (128,541) | (63,714) |
Total stockholders’ equity (deficit) | 188,803 | (62,308) |
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | $ 240,354 | $ 92,703 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Redeemable convertible preferred stock par value | $ 0.001 | $ 0.001 |
Redeemable convertible preferred stock shares authorized | 0 | 103,355,827 |
Redeemable convertible preferred stock shares issued | 0 | 23,978,747 |
Redeemable convertible preferred stock shares outstanding | 0 | 23,978,747 |
Redeemable convertible preferred stock, aggregate liquidation preference | $ 0 | $ 123,126 |
Preferred stock par value | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 10,000,000 | 0 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock par value | $ 0.001 | $ 0.001 |
Common stock shares authorized | 200,000,000 | 150,000,000 |
Common stock shares issued | 39,663,645 | 2,712,694 |
Common stock shares outstanding | 39,663,645 | 2,712,694 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Net sales | $ 93,055 | $ 269 |
Cost of products sold | 81,392 | 1,941 |
Impairment of long-lived assets | 1,439 | |
Gross profit (loss) | 10,224 | (1,672) |
Operating expenses: | ||
Research and development | 39,840 | 24,620 |
Selling, general and administrative | 35,521 | 5,633 |
Total operating expenses | 75,361 | 30,253 |
Loss from operations | (65,137) | (31,925) |
Other income (expense), net: | ||
Grant income | 597 | 2,145 |
Interest expense | (3) | (53) |
Interest income | 14 | |
Remeasurement of derivative liabilities and convertible notes | (281) | (7,515) |
Total other income (expense), net | 327 | (5,423) |
Loss before provision for income taxes | (64,810) | (37,348) |
Provision for income taxes | 17 | |
Net loss | $ (64,827) | $ (37,348) |
Net loss per share of common stock, basic and diluted | $ (1.86) | $ (15.58) |
Weighted-average number of shares used in net loss per share of common stock, basic and diluted | 34,768,542 | 2,396,798 |
CONDENSED STATEMENTS OF REDEEMA
CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2019 | $ (25,665) | $ 2 | $ 699 | $ (26,366) | |
Beginning balance, shares at Dec. 31, 2019 | 6,712,085 | ||||
Beginning balance at Dec. 31, 2019 | $ 30,960 | ||||
Beginning balance, Shares at Dec. 31, 2019 | 2,257,740 | ||||
Issuance of Series B redeemable convertible preferred stock, net of $34 issuance costs | $ 17,466 | ||||
Issuance of Series B redeemable convertible preferred stock, net of $34 issuance costs, shares | 3,754,084 | ||||
Issuance of Series C redeemable convertible preferred stock, net of $186 issuance costs | $ 58,676 | ||||
Issuance of Series C redeemable convertible preferred stock, net of $186 issuance costs, shares | 10,919,468 | ||||
Conversion of convertible notes to Series C redeemable convertible preferred stock | $ 13,978 | ||||
Conversion of convertible notes to Series C redeemable convertible preferred stock, shares | 2,593,110 | ||||
Issuance of common stock upon exercise of stock options | 268 | $ 1 | 267 | ||
Issuance of common stock upon exercise of stock options, shares | 454,954 | ||||
Stock-based compensation | 437 | 437 | |||
Net loss | (37,348) | (37,348) | |||
Ending balance at Dec. 31, 2020 | $ (62,308) | $ 3 | 1,403 | (63,714) | |
Ending balance, Shares at Dec. 31, 2020 | 23,978,747 | 23,978,747 | |||
Ending balance at Dec. 31, 2020 | $ 121,080 | $ 121,080 | |||
Ending balance, Shares at Dec. 31, 2020 | 2,712,694 | ||||
Conversion of redeemable convertible preferred shares into common stock | 121,080 | $ 24 | 121,056 | ||
Conversion of redeemable convertible preferred shares into common stock, shares | (23,978,747) | ||||
Conversion of redeemable convertible preferred shares into common stock | $ (121,080) | ||||
Conversion of redeemable convertible preferred shares into common stock, shares | 23,978,747 | ||||
Conversion of convertible notes into common stock | 24,982 | $ 2 | 24,980 | ||
Conversion of convertible notes into common stock, shares | 1,470,947 | ||||
Issuance of common stock upon IPO, net of $16 million of issuance costs | 159,898 | $ 10 | 159,888 | ||
Issuance of common stock upon IPO, net of $16 million of issuance costs, shares | 10,350,000 | ||||
Issuance of common stock upon exercise of stock options | $ 1,541 | $ 1 | 1,540 | ||
Issuance of common stock upon exercise of stock options, shares | 1,100,196 | 1,100,196 | |||
Issuance of common stock under Employee Stock Purchase Plan (ESPP) | $ 332 | 332 | |||
Issuance of common stock under Employee Stock Purchase Plan, shares | 39,811 | ||||
Issuance of common stock for settlement of restricted stock units, Shares | 11,250 | ||||
Stock-based compensation | 8,105 | 8,105 | |||
Net loss | (64,827) | (64,827) | |||
Ending balance at Dec. 31, 2021 | $ 188,803 | $ 40 | $ 317,304 | $ (128,541) | |
Ending balance, Shares at Dec. 31, 2021 | 0 | 0 | |||
Ending balance, Shares at Dec. 31, 2021 | 39,663,645 |
CONDENSED STATEMENTS OF REDEE_2
CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Series B | ||
Stock issuance costs | $ 34 | |
Series C | ||
Stock issuance costs | $ 186 | |
IPO | Common Stock | ||
Stock issuance costs | $ 16,000 |
Statements of Cash Flows
Statements of Cash Flows | 12 Months Ended | |
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Cash flows from operating activities: | ||
Net loss | $ (64,827,000) | $ (37,348,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 8,105,000 | 437,000 |
Allowance for doubtful accounts | 358,000 | |
Depreciation and amortization | 3,671,000 | 280,000 |
Long-lived asset impairment | 1,439,000 | 0 |
Inventory obsolescence charges | 6,508,000 | |
Remeasurement of derivative liabilities and convertible notes payable | 281,000 | 7,515,000 |
Noncash interest expense | 3,000 | 46,000 |
Noncash lease expense | 802,000 | 311,000 |
Changes in operating assets and liabilities: | ||
Inventory | (52,419,000) | (4,865,000) |
Accounts receivable | (27,310,000) | (293,000) |
Other receivable | (7,390,000) | (798,000) |
Prepaid expenses | (6,778,000) | (3,302,000) |
Other current assets | (1,656,000) | (172,000) |
Accounts payable | 14,921,000 | 3,196,000 |
Customer deposits | 189,000 | |
Accrued liabilities | 23,975,000 | 2,768,000 |
Operating lease liabilities | (750,000) | (299,000) |
Net cash used in operating activities | (100,878,000) | (32,524,000) |
Cash flows from investing activities: | ||
Acquisition of property and equipment | (15,391,000) | (18,812,000) |
Net cash used in investing activities | (15,391,000) | (18,812,000) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock on IPO, net of issuance costs | 159,898,000 | |
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 76,142,000 | |
Proceeds from issuance of convertible notes payable | 31,113,000 | |
Proceeds from exercise of stock options | 1,471,000 | 531,000 |
Proceeds from the issuance of common stock under Employee Stock Purchase Plan (ESPP) | 332,000 | |
Net cash provided by financing activities | 161,701,000 | 107,786,000 |
Net increase in cash and restricted cash equivalents | 45,432,000 | 56,450,000 |
Cash and restricted cash equivalents, beginning of year | 60,550,000 | 4,100,000 |
Cash and restricted cash equivalents, end of year | 105,982,000 | 60,550,000 |
Reconciliation to amounts on the Balance Sheets: | ||
Cash | 105,982,000 | 58,212,000 |
Restricted cash equivalents | 2,338,000 | |
Cash and restricted cash equivalents, end of year | 105,982,000 | 60,550,000 |
Supplemental disclosures of cash flow information: | ||
Cash paid for income taxes | 28,000 | 10,000 |
Supplemental disclosures of noncash financing and investing activities: | ||
Purchase of property and equipment included in accounts payable and accrued liabilities | 1,285,000 | 508,000 |
Deferred offering costs included in accrued liabilities | 487,000 | |
Acquisition of right-of-use asset through operating lease obligation | 2,768,000 | |
Vesting of early exercise options | 69,000 | |
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | 24,982,000 | |
Conversion of convertible redeemable preferred stock into common stock on IPO | $ 121,080,000 | |
Conversion of convertible notes payable principal and interest for redeemable convertible preferred stock | $ 13,978,000 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | Note 1. Organization Description of Business Lucira Health, Inc. (the “Company”) was incorporated under the laws of the state of Delaware on February 20, 2013 under the name DiAssess Inc. The Company changed its name to Lucira Health, Inc. in January 2020. The Company is located in Emeryville, California. The Company is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. The Company has developed a testing platform that produces high-complexity-laboratory-accurate molecular testing in a single-use and user-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. The Company’s initial focus is within respiratory diseases, and initially for COVID-19 and influenza Types A and B indications. On November 17, 2020, the Company received an Emergency Use Authorization (“EUA”) from the Food and Drug Administration (“FDA”) for (1) prescription at-home use with self-collected nasal swab specimens in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider and (2) use at the point-of-care (“POC”), with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. People who are suspected of COVID-19 are those who are either symptomatic or are thought to have been exposed to COVID-19. On April 9, 2021, the Company received its first FDA EUA authorization for over-the-counter (“OTC”) non-prescription use among symptomatic and asymptomatic individuals aged 14 and older (with self-collection) and children aged two to 13 (with parent collection). Reverse Stock Split On January 28, 2021, the Company’s board of directors approved a 1-for-4.3103 Initial Public Offering On February 9, 2021, the Company closed its IPO of 10,350,000 shares of its common stock, including 1,350,000 shares of common stock issued pursuant to the full exercise of the underwriters’ option to purchase additional shares in the IPO, at a price to the public of $17.00 per share. The net proceeds to the Company from the IPO were $159.9 million, after deducting underwriting discounts and commissions of $12.3 million and offering expenses of $3.7 million. In connection with the IPO, all shares of Series A, Series B and Series C redeemable convertible preferred stock and outstanding convertible notes converted into 25,449,694 shares of common stock. Liquidity and Going Concern The Company has incurred recurring losses and negative cash flows from operating activities since inception. As of December 31, 2021, the Company had cash of $106.0 million and had an accumulated deficit of $128.5 million. Since inception through December 31, 2021, the Company generated $93.3 million of revenue from the sales of its test kits. On February 4, 2022, the Company closed a debt financing of up to $80.0 million. The first tranche of $30.0 million was funded upon close. See Note 13 Subsequent Events. The Company believes that cash as of December 31, 2021, cash to be collected from customers related to sales of the Company’s COVID-19 test kit, and cash draws from the bank financing arrangement (see Note 13) will be sufficient to fund its planned operations for a period of at least 12 months from the date of the issuance of the accompanying financial statements. The ability to continue as a going concern is dependent upon the Company generating revenue and profit in the future and/or upon obtaining necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. The Company may raise additional capital through the issuance of equity securities, debt financings or other sources in order to further implement its business plan. However, if such financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of new test kits. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company performed an evaluation of its activities through the date of filing this Annual Report and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing of this Annual Report, except for the transactions disclosed in Note 13 Subsequent Events. Use of Estimates The preparation of the accompanying financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, income and expenses as well as the related disclosure of contingent assets and liabilities. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Company’s Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results. The full extent to which the COVID-19 pandemic could continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing and distribution will depend on future developments that remain uncertain at this time, particularly as virus variants continue to spread. Reclassifications Certain prior-period amounts have been reclassified to conform to the current presentation. Such reclassifications had no impact on previously reported net loss, total assets, total liabilities, or stockholders’ equity. Concentration of Credit Risk and Significant Suppliers and Distributors Financial instruments that potentially subject the Company to credit risk consist principally of cash held by financial institutions, grant income receivables and account receivables. Substantially all of the Company’s cash is held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. As of and during the year ended December 31, 2021 , Customers A, B and C represented 18 % , 17 % and 12 % , respectively, of the Company’s accounts receivable , and Customers C and A accounted for % and 10 %, respectively, of the Company’s revenue . As of and during the year ended December 31, 2020, there was only one customer which represented 100% of the Company’s accounts receivable and revenue. The Company is dependent on one contract manufacturer for commercial manufacturing of the Company’s test kits, key suppliers for certain laboratory materials and inventory items and certain key partners for distribution and fulfillment of customer orders. An interruption in the supply of these materials or disruption of the fulfillment and distribution operations, could temporarily impact the Company’s ability to manufacture its commercial inventory and perform development, testing and clinical trials related to its products. On July 14, 2021, the Company entered into a Distribution Agreement with Switch Health Solutions Inc. (“Switch”), which agreement was subsequently amended on December 21, 2021 (such agreement as amended, the “Distribution Agreement”). Under the Distribution Agreement, the Company appointed Switch as a non-exclusive distributor for the Company’s CHECK IT COVID-19 Test Kits (the “Test Kits”) in Canada. Under the Distribution Agreement, Switch is required to provide the Company with forecasts of the quantity of Test Kits that Switch expects to order for each of the coming 12 calendar months through December 2022 and each six-month period following December 2022 (each, a “Rolling Forecast”). For each calendar month in the Rolling Forecast, Switch is required to purchase at least the quantity of Test Kits set forth in the Rolling Forecast for such month. If the Company fails to fulfill the quantity of Test Kits set forth in any part of the Rolling Forecast for which Switch submits a purchase order(s), then Switch will not be required to purchase the remaining quantity of Test Kits set forth in the Rolling Forecast. If Switch fails to purchase the quantity of Test Kits in any month, or in the aggregate for the 12 month period, in each case as set forth in the Rolling Forecast, then Switch is liable to the Company for a low double-digit percentage of the total price applicable to the quantity of Test Kits set forth in the Rolling Forecast for the two months following such failure by Switch. The Distribution Agreement is for a one-year term and either party has the right to renew the Distribution Agreement for successive periods of one-year each by providing written notice to the other party prior to the expiration of the current term. Either party may terminate the Distribution Agreement (a) for uncured material breach by the other party, (b) if the other party enters into insolvency or bankruptcy or a trustee or receiver or the equivalent is appointed for the other party or proceedings are instituted against the other party relating to dissolution, liquidation, winding up, bankruptcy, insolvency, etc. or (c) for convenience upon 30 days’ notice to the other party. Additionally, either party may terminate immediately upon written notice if a regulatory or governmental agency or court takes action the result of which would prohibit or significantly restrict the sale, distribution, use or manufacture of the Test Kits in accordance with the Distribution Agreement. Fair Value Measurements The carrying value of the Company’s cash, accounts receivable, prepaid expenses, other current assets and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s derivative liabilities and convertible notes were measured at fair value on a recurring basis and were classified as Level 3 liabilities. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable consist primarily of amounts due to the Company related to product sales. It is the practice of the Company to provide for uncollectible accounts in the year the accounts are determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: Years Ended December 31, 2021 2020 Beginning balance $ — $ — Amounts charged to costs and expenses 358 — Write-offs (259 ) — Ending balance $ 99 $ — Cash and Restricted Cash Equivalents The Company considers highly liquid investments purchased with a remaining maturity date upon acquisition of three months or less to be cash equivalents and are stated at cost, which approximates fair value. As of December 31, 2021 and 2020, there were no cash equivalents. As of December 31, 2020, the Company held a restricted cash balance of $2.3 million which was used to secure a letter of credit in relation to the Company’s contract manufacturer to secure certain purchases made on the Company’s behalf. The cash was deposited in a money market account with maturities of three months or less and classified as restricted cash equivalents on the Company’s Balance Sheets. The letter of credit matured in November 2021 and as of December 31, 2021, the Company held no restricted cash. Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company determines are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive clinical test results for the underlying product, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the submission of the regulatory application. The Company closely monitors the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. As of December 31, 2020, the Company held $1.3 million that met criteria for capitalization. As of December 31, 2021, the Company utilized all of the preapproval inventory write-offs for cost of sales of $1.0 million and for selling, general and administrative and research and development activities of $0.3 million. Inventories The Company values its inventory at the lower of cost or net realizable value and determines the cost of inventory using standard costs which closely resembles the first-in, first-out method. Lower of cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. Inventory held as of December 31, 2021 is in the form of raw materials, work in process and finished goods. In order to assess the ultimate realization of inventories, the Company is required to make judgments as to future demand requirements compared to current or committed inventory levels. The Company periodically reviews its inventories for shelf life, excess or obsolescence and writes-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Amounts written-down due to unmarketable inventory are recorded in cost of revenue and a new lower-cost basis for the inventory is established. The Company recorded $6.5 million of inventory obsolescence charges during the year ended December 31, 2021 related to an issue during transit and quality control exceptions related to one of the key raw material components of its product. Warranty The Company offers a standard product warranty that our products will perform as intended upon the date of original delivery for a reasonable period of time, which typically coincides with product shelf life. The Company has the obligation, at its option, to either refund, repair or replace a defective product. At the time revenue is recognized, an estimate of future warranty costs is recorded as a component of cost of products sold. The estimate of future warranty costs is based on historical as well as current product failure rates, service delivery costs incurred in correcting product failures, and warranty policies. The Company regularly reviews these estimates to assess the appropriateness of our recorded warranty liabilities and adjust the amounts as necessary. As of December 31, 2021 and 2020, the accrued liability for warranty returns was not significant. Property and Equipment, Net Property and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and seven years. Leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining term of the related lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the Balance Sheets and any resulting gain or loss is reflected in Other income (expense), net in the Statements of Operations in the period realized. Leases The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as operating or finance. Operating leases are included in Operating lease right-of-use (“ROU”) assets and Operating lease liabilities on the Balance Sheets. The Company did not have any finance leases as of December 31, 2021 and 2020. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and exclude lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases. Impairment of Long-Lived Assets The Company’s long-lived assets are comprised principally of its property and equipment, including leasehold improvements and ROU assets. The Company reviews long-lived assets whenever events or changes in circumstances indicate that the carrying amount of the asset group may not be fully recoverable. The Company identifies impairments related to long-lived assets when management determines that the remaining carrying value will not be realized through future use. The Company evaluates events or circumstances, including competition in the markets where it operates, that would indicate the carrying value of assets may not be fully recoverable. If an event or circumstance is identified indicating carrying value may not be recoverable, the sum of future undiscounted cash flows is compared to the carrying value. If the carrying value exceeds the future undiscounted cash flows, the carrying value of the asset is reduced to fair value, with the difference recorded as an impairment charge. Assets are evaluated for impairment on an individual basis, which management believes is the lowest level for which there are identifiable cash flows. The Company evaluates assets for impairment by assessing if long-lived assets will be sold or otherwise disposed of significantly before the end of their previously estimated useful life as its primary indicator of potential impairment. The fair value of assets is determined as the present value of the estimated future cash flows, adjusted as necessary for market participant factors. Any required impairment loss would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. During the year ended December 31, 2021, a $1.4 million impairment of long-lived assets charge was recorded, there was no impairment charge recorded during the same period in 2020. See additional discussion in Note 4, Other Financial Information. Redeemable Convertible Preferred Stock The Company’s shares of preferred stock were assessed at issuance for classification and redemption features requiring bifurcation. The Company’s preferred stock was not mandatorily redeemable. The Company presents as temporary equity any stock which (i) the Company undertakes to redeem at a fixed or determinable price on the fixed or determinable date or dates; (ii) is redeemable at the option of the holders, or (iii) has conditions for redemption which are not solely within the control of the Company. The Company’s preferred stock was redeemable if the Company had not been dissolved within 90 days following the occurrence of certain deemed liquidation events, which the Company determined was not solely within its control and thus had classified shares of redeemable convertible preferred stock as temporary equity until such time as the conditions were removed or lapse. The Company initially recorded redeemable convertible preferred stock at fair value, net of issuance costs. In connection with the IPO on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock . Deferred Offering Costs The Company capitalized certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are recorded as a reduction of the proceeds received from the equity financing. There was $2.2 million of deferred offering costs related to the Company’s IPO recorded as Other assets on the Company’s Balance Sheet as of December 31, 2020. The Company recorded additional offering costs between December 31, 2020 and February 9, 2021 and recorded $3.7 million as an offset to the IPO proceeds. Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”), “Revenue from Contracts with Customers” when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Under ASC 606, assuming all other revenue recognition criteria have been met, the Company will recognize revenue for arrangements upon the transfer of risk and title of the Company’s products and upon customer obtaining control of the product, which occurs at a point in time and is generally upon shipment to the customer, unless terms of contractual arrangements with customers state otherwise in which case the control is transferred upon completion of delivery and customer acceptance of products. Upon transfer of risk and title to the customer, no further performance obligations by the Company to the customer after shipment of the product are present. Revenue is measured based on the amount of consideration that the Company expects to receive as reduced by estimated discounts and allowances. The Company's performance obligations relate to contracts with a duration of less than one year. The Company elected to apply the practical expedient provided in ASC 606, therefore, the Company is not required to disclose the aggregate amount of transaction price allocated to performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period. All of the Company’s revenue has been derived from sales of its test kits through its healthcare, business-to-business, international and direct-to-consumer (e-commerce) channels. Since receiving the initial EUA in the fourth quarter 2020, the Company marketed its test products to physicians and licensed healthcare providers through its healthcare channel in the United States. On April 9, 2021, the Company received its first FDA EUA authorization for OTC non-prescription use and expanded its marketing to include domestic testing providers, distributors, businesses within its business-to-business channel, and direct-to-consumer through its partnerships with e-commerce sales and distribution platforms. In 2021, the Company also sold tests internationally through international distributors in Canada, Taiwan, Singapore, and Israel through its international channel. The following table sets forth the Company’s net sales by channel: Years Ended December 31, 2021 2020 Healthcare $ 27,205 $ 269 Business-to-business 41,439 — International 18,262 — Direct-to-consumer (e-commerce) 6,149 — Net sales $ 93,055 $ 269 Collection of the Company’s net revenue generally occurs within 30 days of billing. Contracts do not contain significant financing components based on the typical period of time between delivery of products and collection of consideration. Collections of revenue from customers in the Company’s e-commerce channel generally occurs instantaneously or within a few days as customers pay using credit cards. Customers in certain countries outside of the United States pay in advance of product delivery. In those instances, payment and delivery typically occur in the same month. Costs to obtain or fulfill a contract are currently expensed when incurred because our performance obligation is satisfied at a point in time. These costs are recorded as Cost of products sold in the Statements of Operations. The Company invoices its customers upon shipment of product and records its sales upon shipment in accordance with its standard terms and conditions, unless underlying customer contracts specify otherwise. In those instances, the Company records revenue upon delivery and upon customer acceptance of products to customers when control of products is transferred to customers. When necessary, the Company invoices and collects sales tax from its customers for sales of products. The Company has elected to exclude sales tax from the measurement of the transaction price. The following table sets forth the Company’s net sales by geographic area based on the customers’ locations: Years Ended December 31, 2021 2020 United States $ 74,793 $ 269 Canada 13,066 — All other countries 5,196 — Net sales $ 93,055 $ 269 Shipping and Handling Costs Shipping and handling costs are included in cost of goods sold. Research and Development Grants In July 2018, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), a division within the U.S. Department of Health and Human Services (“HHS”), for an award of up to $10 million to demonstrate the feasibility of a novel in-home, disposable, point-of-care rapid diagnostic assay for the detection of Influenza A and B for work performed through July 2020. In September 2019, the Company amended its agreement with BARDA to increase the award to $21.5 million and extend the reporting period through July 2022. The Company earns grant income for performing tasks under research and development agreements with governmental agencies. Grant income derived from reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with government contracts and grants are recorded at the gross amount within grant income. The costs associated with these reimbursements are reflected as a component of research and development expense in the Company’s S tatements of O perations. The Company recognized grant income from BARDA of $0.0 million and $1.8 million during the years ended December 31, 2021 and 2020, respectively. In July 2021, BARDA terminated the influenza contract for convenience. The Company recognized grant income from other governmental agencies of $0.6 million and $0.3 million during the years ended December 31, 2021 and 2020, respectively. The Company records a receivable included in Other current assets on the Balance Sheets, which consists of billed and unbilled amounts earned from various government grants for costs incurred prior to the period end under reimbursement contracts. The amounts are billed to the respective government agencies. As collection is deemed probable, no allowance for doubtful accounts has been established. If amounts become uncollectible, they are recorded as operating expense in the Company’s Statements of Operations. As of December 31, 2021 and 2020, $0.2 million and $0.2 million were unbilled, respectively. Research and Development Costs associated with research and development activities are expensed as incurred and include, but are not limited to, personnel-related expenses including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. The Company records accrued expenses for estimated costs of its research and development activities conducted by third-party service providers, which include clinical trial activities. The Company records the estimated costs of research and development activities based upon the estimated value of services or supplies provided but not yet invoiced and include these costs in accrued liabilities in the Balance Sheets and within research and development expense in the Statements of Operations. The Company records accrued expenses for these costs based on factors such as estimates of the work completed or supplies received and in accordance with agreements established with these vendors. Any payments made in advance of services or supplies provided are recorded as prepaid assets, which are expensed as the services or supplies are received. The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. Such estimates in determining the accrued balance in each reporting period are subject to management judgment. As actual costs become known, the Company adjusts its accrued estimates. Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were $1.7 million and immaterial for the years ended December 31, 2021 and 2020, respectively, and are included in Selling, general and administrative expenses in the accompanying Statements of Operations. Stock-Based Compensation The Company’s stock-based awards consist of stock options issued to employees and non-employees and restricted stock units issued to employees. The Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur. The Company classifies stock-based compensation expense in its S tatements of O perations in the same manner in which the award recipient’s cash compensation costs are classified. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of complex assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option. Prior to the Company’s initial public offering, the Company was a private company and lacked company-specific historical and implied fair value information. Therefore, the Board of Directors (the “Board”) of the Company considered numerous objective and subjective factors to determine the fair value of the Company’s common stock options at each meeting in which awards were approved. The factors considered include, but are not limited to (i) the results of contemporaneous independent third-party valuations of the Company’s common stock and the prices, rights, preferences and privileges of the Company’s redeemable convertible preferred stock relative to those of its common stock; (ii) the lack of marketability of the Company’s common stock; (iii) actual operating and financial results;(iv) current business conditions and projections; (v) the likelihood of achieving a liquidity event, such as an IPO or sale of the Company, given prevailing market conditions, and (vi) precedent transactions involving the Company’s shares. The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The expected term was estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise data to estimate the expected term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 3. Fair Value Measurements The Company did not have any financial instruments measured at fair value on a recurring basis as of December 31, 2021. The Company’s restricted cash equivalent was measured at fair value on recurring basis as of December 31, 2020 and is classified as Level 1 input. The restricted cash equivalent is a money market account that the Company opened in August 2020 with a maturity date of 12 months. The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — 2,338 — — Liabilities Convertible notes payable $ — $ — $ 24,694 — — 24,694 The change in the fair value of the derivative liabilities and convertible notes accounted for at fair value is summarized below for the years ended December 31: Year ended December 31 2021 2020 Fair value at beginning of the year $ 24,694 $ — Initial fair value of instruments issued — 31,139 Change in fair value of instruments and accrued interest, net 288 7,533 Extinguishment of instruments held at fair value (24,982 ) (13,978 ) Fair value at end of the year $ — $ 24,694 The convertible notes issued in June and July of 2020 were recorded at the fair value which was the principal balance of the notes at a fixed price of 80% of the price paid per share for equity securities by the Series C holders. The Company determined this approach to be the most suitable method as the time between issuance and Series C issuance was two months and a next equity financing was highly probable at time of issuance. In order to determine the fair value of the convertible notes issued in December 2020, (“2020B Notes”), the Company utilized the probability-weighted expected return method (“PWERM”). See additional information on the 2020B Notes in Note 7. The PWERM relies on a forward-looking analysis to determine the fair value. Under this method, discrete future outcomes, including an IPO and non-IPO scenarios, are weighted based on the estimated the probability of each scenario. The PWERM is used when discrete future outcomes can be predicted with reasonable certainty based on a probability distribution. The fair value estimate relied upon in the PWERM scenario was based on likelihood of achieving four liquidity events, i) an initial public offering ii) merger or acquisition of the Company given prevailing market conditions iii) change of control iv) maturity of the convertible notes. Estimates and assumptions impacting the fair value measurement include future value under the various conversion scenarios, discount rate, discount period, discount factor and probability of occurrence of each scenario, as best estimated by management. The estimated future value of the notes for each scenario is then discounted to present value using a discount rate. The future value was determined based on the estimated term to the event from valuation date as determined by management. The exit value in an IPO scenario is based on banker indications as well as an analysis of guideline companies that went public within the past few years that are broadly comparable to the Company. The exit value of an M&A scenario is determined by management with an estimated premium applied to the IPO value estimate. The discount rate, discount period, and probability of the occurrence of liquidity scenarios are estimates made by the management. See Note 7 Convertible Notes Payable for additional information. The convertible notes were measured at fair value upon extinguishment on February 9, 2021 in connection with the Company’s IPO. |
Other Financial Information
Other Financial Information | 12 Months Ended |
Dec. 31, 2021 | |
Other Financial Information [Abstract] | |
Other Financial Information | Note 4. Other Financial Information Inventory December 31, 2021 2020 Raw materials $ 35,923 $ 4,725 Work in process 10,539 140 Finished goods 4,314 — Total $ 50,776 $ 4,865 Other Receivables December 31, 2021 2020 Other receivable $ 8,188 $ 798 The other receivable balance as of December 31, 2021 represents amounts due from Jabil, the manufacturer of the Company’s test kits in connection with procurement of component parts. Prepaid Expenses December 31, 2021 2020 Prepaid expenses $ 10,274 $ 3,496 As of December 31, 2021, prepaid expenses includes $9.4 million of advanced payments related to procurement of inventories of components such as circuit boards to be used in assembling test kits. Property and Equipment, Net December 31, 2021 2020 Construction in progress $ 3,466 $ 15,308 Machinery and equipment 29,333 4,679 Website development costs 1,110 — Furniture and fixtures 200 88 Leasehold improvements 1,702 501 Total, at cost 35,811 20,576 Accumulated depreciation and amortization (4,837 ) (1,168 ) Property and equipment, net $ 30,974 $ 19,408 Depreciation and amortization expense for the years ended December 31, 2021 and 2020 was approximately $3.7 million and $0.3 million, respectively. Construction in progress is related to the setup of manufacturing infrastructure and the purchase of long lead time manufacturing equipment as the Company grows its manufacturing capacity and invests in semi-automation. Construction in progress amounts recorded are not subject to depreciation as such assets are not yet available for their intended use. During the year ended December 31, 2021, the Company identified a trigger for impairment assessment related to certain long-lived assets in the Auburn Hills, Michigan manufacturing facility. This facility is operated by Jabil, the commercial manufacturing provider of the Company’s COVID-19 test kit. Facts and circumstances indicate that the costs of certain assets, primarily those associated with a dry room affixed to the Auburn Hills facility, will not be recovered before the end of their previously estimated useful life. As a result, the Company has recorded an impairment charge of $ 1.4 million during the year ended December 31, 2021, related to these assets. The Company has terminated its manufacturing activities at this facility as of December 31, 2021. The following table sets forth the Company’s long-lived assets, including right-of-use assets by geographic area: December 31, 2021 2020 United States $ 16,730 $ 7,528 Dominican Republic 15,753 12,432 All other countries 1,205 196 Total long-lived assets $ 33,688 $ 20,156 Accrued Liabilities Accrued liabilities consist of the following: December 31, 2021 2020 Professional fees $ 612 $ 1,577 Accrued manufacturing and inventory purchases 17,200 1,165 Canada Importation Taxes 1,551 — Payroll liabilities 4,466 604 Royalty liabilities 1,662 — Accrued sales tax 2,215 204 Early exercise liability 189 263 Accrued deferred offering costs — 487 Other 1,267 145 Total $ 29,162 $ 4,445 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 5. Commitments and Contingencies Commitments License Agreement with Eiken Chemical Co., Ltd. In July 2020, the Company entered into a patent license agreement (“Eiken Agreement”), with Eiken Chemical Co., Ltd. (“Eiken”). Pursuant to the terms of the Eiken Agreement, Eiken granted the Company a royalty bearing non-transferable, non-assignable, sublicensable (to the Company’s affiliates), non-exclusive license under certain patents, which the Company refers to collectively as the Eiken Licensed Patents, relating, in part, to loop-mediated isothermal amplification, to develop, make, use, sell, offer for sale and dispose of any reagent, product, kit, device, equipment and/or system for nucleic acid-based in-vitro diagnostic tests for detection of SARS-CoV-2, which causes COVID-19, which the Company collectively refers to as the Initial Licensed Products, in the United States. The Company also has limited have-made rights with respect to the Eiken Licensed Patents. Under the terms of the Eiken Agreement, the Company also has an option to expand the license to the Eiken Licensed Patents for the Initial Licensed Products outside of the United States for a payment of additional fees. In addition, the Company also has an option to expand the license to the Eiken Licensed Patents for new targets beyond the purpose of testing COVID-19 in the United States, which the Company collectively refer to as the Additional Licensed Products, and together with the Initial Licensed Products, the Licensed Products, for a payment of a one-time fee for each Additional Licensed Product and an additional fee for the expansion of the licensed territory outside of the United States for each Additional Licensed Product. As partial consideration of the rights granted to the Company under the Eiken Agreement, the Company made payments of $24 thousand during the years ended December 31, 2021 and 2020, which was recorded as research and development expense on the Statements of Operations. In April 2021, the Company paid the first installment of the world-wide license in the amount of $9 thousand. The second installment for the world-wide license of $9 thousand was paid in July 2021. In addition, the Company is obligated to pay a royalty in the low single-digit percentage on total net sales of all Licensed Products, that will be recorded as a Cost of products sold. Royalty expense for the year ended December 31, 2021 was $2.7 million and included in Cost of products sold on the Statements of Operations. The Eiken Agreement will terminate on the expiration date of the last to expire valid claim of the Eiken Licensed Patents in all countries, the latest of which is June 2031. The Company may also terminate the Eiken Agreement at any time upon a certain number of days’ prior written notice to Eiken after Eiken has received the payment due July 2021 mentioned above and all royalties accrued up to the termination date. Eiken may terminate the Eiken Agreement upon (1) not receiving any royalties on Licensed Products for a certain period of time after the Company commences sale of such Licensed Product, (2) a breach by the Company or its affiliates that is not cured within a certain number of days after receiving written notice of the breach, (3) our bankruptcy or insolvency or certain other bankruptcy or insolvency events, (4) the assignment or attempt to assign the Eiken Agreement by the Company in violation of the Eiken Agreement or (5) a challenge by the Company or its affiliates of the validity of any of the Eiken Licensed Patents. Technology Services Agreement with Jabil On September 10, 2020, the Company entered into a technical services agreement (“Jabil TSA”), with Jabil, Inc. (“Jabil”), pursuant to which Jabil will use commercially reasonable efforts to perform certain technical services related to the development of components, assemblies and systems in relation to each project under the agreement as set forth in one or more statement of work, which may include the Company’s COVID-19 test kit and any of its future product candidates. The Company is obligated to pay Jabil all amounts as set forth in each statement of work, which will specify the timeline and schedule for the performance of each service, the compensation to be paid by the Company to Jabil and other relevant terms and conditions. After the initial term of three years, the Jabil TSA will automatically be renewed for successive periods of one year unless a party provides the other party with notice of its intention not to renew the agreement at least 180 days prior to the expiration of the then current term. Either party may terminate the Jabil TSA at any time upon the mutual written consent of both parties. In addition, the agreement may be terminated by either party (a) at will upon at least 180 days’ written notice to the other party, (b) for cause based on a material breach by the other party, subject to a 60-day cure period and (c) for certain bankruptcy or insolvency events enumerated under the agreement. Manufacturing Services Agreement with Jabil On September 10, 2020, the Company entered into a manufacturing services agreement (“Jabil MSA”) with Jabil, pursuant to which Jabil will manufacture, test, pack and ship certain electronic assemblies and systems in accordance with the Company’s specifications. Jabil may not subcontract any of its manufacturing services under the Jabil MSA without the Company’s prior written consent. The Company is obligated to provide, on a monthly basis, a rolling 12-month forecast to Jabil as well as 12-months of historical aggregate end customer demand at the finished product level, when available, which will be used to constitute written purchase orders from the Company, and the Company is obligated to purchase the quantity of products that is required by the first four months of each forecast. Jabil is entitled to reject any purchase orders that are not placed in accordance with the forecast. As of December 31, 2021, the Company has an outstanding non-cancellable purchase commitment of $26.5 million related to the Jabil MSA. The Company is obligated to pay Jabil upon the completion of test kit purchase orders based on a volume pricing matrix, pursuant to which Jabil will review the actual purchases during the then-ending quarter and compare against the forecasted orders in the upcoming quarter. If Jabil determines that the actual purchases correspond to a different pricing band in the volume pricing matrix, Jabil will either issue (a) a credit for any excess price paid by us if the actual price is lower than the invoiced price or (b) an invoice for any shortfall if the actual price is higher than the invoiced price. Jabil may adjust the volume pricing matrix to reflect changes in costs on the first anniversary of its notice to the Company that production qualification can commence, or after the addition of new equipment or labor. The parties will review the prices on a quarterly basis and may revise them based on applicable costs and expenses. The agreement is for an initial term of three years and automatically renewed for successive periods of one year, subject to either party’s notice of intent not to renew, delivered at least 180 days prior to the expiration of the then-current term. The Jabil MSA may be terminated at any time upon the mutual written consent of the parties. In addition, the agreement may be terminated by either party (a) at will upon at least 180 days’ written notice to the other party, (b) for cause based on a material breach by the other party, subject to a 30-day cure period and (c) for certain bankruptcy or insolvency events enumerated under the agreement. Other Commitments As of December 31, 2021, the Company has additional outstanding non-cancellable purchase commitments for $68.5 million for raw material purchases and fixed assets related to expanding the Company’s manufacturing capacity. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not been subject to any claims or required to defend any action related to its indemnification obligations. The Company’s amended and restated certificate of incorporation contains provisions limiting the liability of directors, and its amended and restated bylaws provide that the Company will indemnify each of its directors to the fullest extent permitted under Delaware law. The Company’s amended and restated certificate of incorporation and amended and restated bylaws also provide the Board with discretion to indemnify its officers and employees when determined appropriate by the Board. In addition, the Company has entered and expects to continue to enter into agreements to indemnify its directors and executive officers. Legal Proceedings From time to time, the Company may become involved in legal proceedings arising out of the ordinary course of its business. Management is currently not aware of any matters that will have a material adverse effect on the financial position, results of operations or cash flows of the Company. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Note 6. Leases The Company has operating leases for corporate offices, operations and research and development facilities. These leases have remaining lease terms of 1 to 3 years. The lease of operations and research and development facilities includes costs for utilities and common area maintenance which are not included in the calculation of lease payments. In July 2021, the Company entered into an operating lease agreement for space within a building in Emeryville, California. The lease commenced in July 2021 and has a lease term expiring in June 2024 with two options to extend the lease term for a period of 3 years each. In August 2021, the Company entered into an operating lease agreement for space within a building in San Jose, California. The lease commenced in August 2021 and has a 2-year term with an auto renewal for another 2-year period upon expiration of every such bi-annual term. The Company amended the original operating lease for San Jose, in September 2021 and December 2021, to increase the amount of leased space. Leases with an initial term of 12 months or less are not recorded on the Balance Sheets, and the Company recognizes lease expense for these leases on a straight-line basis over the lease terms. Operating leases with terms greater than 12 months are included in operating lease ROU assets and operating lease liabilities in the Company’s Balance Sheets as of December 31, 2021 and 2020. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Maturities of lease liabilities as of December 31, 2021, are as follows: Operating Leases Year ending December 31: 2022 $ 1,659 2023 1,205 2024 147 2025 — 2026 — Total 3,011 Less: imputed interest (182 ) Operating lease liabilities $ 2,829 The Company made operating lease payments of $0.9 million and $0.4 million during the years ended December 31, 2021 and 2020, respectively, which are included as cash flow from operating activities on the statements of cash flows. Additional information related to the Company’s leases was as follows for the years ended December 31: 2021 2020 Operating lease cost $ 943 $ 435 Short-term lease cost $ 1,663 $ 536 Weighted-average remaining lease term (years) 1.82 2.36 Weighted-average discount rate 7.15 % 13.14 % |
Convertible Notes Payable
Convertible Notes Payable | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes Payable | Note 7. Convertible Notes Payable 2020A Notes The Company entered into convertible promissory notes (the “2020A Notes”) in June and July 2020, with several lenders, including current investors. The lenders provided in aggregate $11.1 million in cash consideration to the Company. The 2020A Notes accrued simple interest at 4% per annum that was due and payable upon the request of the holders of a majority of the then outstanding principal amount of the 2020A Notes on or after June 12, 2021. Pursuant to the 2020A Notes, the outstanding principal balance and unpaid accrued interest was automatically convertible into equity shares in the next equity financing round of at least $10 million (“2020A Qualified Financing”) at a price per share equal to the lower of (i) 80% of the price paid per share for equity securities by the investors in the 2020A Qualified Financing or (ii) the quotient resulting from dividing $95 million by the number of shares of outstanding common shares on a diluted basis immediately prior to the closing of the 2020A Qualified Financing. If the next financing was not a 2020A Qualified Financing (“2020A Non-Qualified Financing”), the holders of a majority of the outstanding principal of the 2020A Notes also had the option to convert the outstanding principal balance and unpaid accrued interest into equity shares issued in the 2020A Non-Qualified Financing on the same terms set forth for a 2020A Qualified Financing. In addition, if the Company consummated a change of control, it would be required to convert the outstanding principal balance of the 2020A Notes and any unpaid accrued interest into shares of a newly created series of preferred stock having the identical rights, privileges, preferences and restrictions as the Series B. Additionally, in the event that the 2020A Notes had not converted into equity securities by June 12, 2021, the outstanding principal and unpaid accrued interest of each of the 2020A Notes would have automatically converted into shares of Series B at a conversion price equal to the original issuance price. In August 2020, the Company issued Series C for proceeds of approximately $58.7 million (see Note 8), which met the definition of a 2020A Qualified Financing. Additionally, the 2020A Notes and accrued and unpaid interest of $11.2 million were extinguished and converted into 2,593,110 shares of Series C at $4.3124 per share, which is 80% of the Series C issuance price of $5.3905. The Series C had a fair value of $5.3905 per share on the date of conversion. The Company extinguished the 2020A Notes at fair value along with the accrued interest of $44. 2020B Notes The Company issued and sold convertible promissory notes (the “2020B Notes” and together with the “2020A Notes”, the “2020 Notes”) in December 2020, with several lenders, including current investors. The lenders provided an aggregate amount of $20 million in cash consideration to the Company. The 2020B Notes accrue simple interest at 0.15% per annum and this interest is due and payable upon the request of the holders of a majority of the then outstanding principal amount of the 2020B Notes on or after December 11, 2022. The outstanding principal and unpaid accrued interest of each Note is convertible upon occurrence of one of the following events: Maturity or Change in Control. In the event of an equity financing including an IPO with proceeds of not less than $10 million (“2020B Qualified Financing”), 2020B notes automatically convert into equity securities sold in the 2020B Qualified Financing at 80% of the price paid for securities sold in the 2020B Qualified Financing. In the event of an equity financing or IPO of less than $10 million, the majority holders of the 2020B Notes have the option to treat the offering as a 2020B Qualified Financing at 80% of the price paid for securities sold in the round (“2020B Non-Qualified Financing”). In the case of maturity, all unpaid interest and principal shall be due and payable on the maturity date. If the notes remain outstanding on the maturity date, then the outstanding principal balance and any unpaid accrued interest is automatically converted in Series C Preferred stock based on the Series C original issue price of $5.3905. In addition, if the Company consummates a change of control as defined in Note 8, the holders of the 2020B Notes will receive shares of the Company’s common stock at 70% of the price paid for shares of common stock. The 2020 Notes are considered freestanding instruments that qualify as liabilities under ASC Topic 480, Distinguishing Liabilities from Equity as the Company is committed to issue an instrument that ultimately may require a transfer of assets. The 2020 Notes were accounted for at fair value and re-measured at each reporting date. Accordingly, the Company classified the 2020 Notes as a liability at their fair value and adjusts the instruments to fair value at each balance sheet date until the 2020 Notes are converted. The Company recorded a change in the fair value of the 2020A Notes of $2.8 million recognized as remeasurement of derivative liabilities and convertible notes in Other income (expense), net in the Statements of Operations prior to their extinguishment in August 2020. The Company recorded a change in the fair value of the 2020B Notes of $4.7 million recognized as remeasurement of derivative liabilities and convertible notes in Other income (expense), net in the Statements of Operations during the year ended December 31, 2020. The Company recorded a change in the fair value of the 2020B Notes of $0.3 million recognized as Remeasurement of derivative liabilities and convertible notes in Other income (expense), net in the Statement of Operations during the first quarter of 2021. |
Capital Stock
Capital Stock | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Capital Stock | Note 8. Capital Stock Redeemable Convertible Preferred Stock As a result of the IPO, and the conversion of the Company’s then outstanding redeemable convertible preferred stock into the requisite number of shares of the Company’s common stock, there were no shares of the redeemable convertible preferred stock issued or outstanding as of December 31, 2021. The following disclosures provide the historical terms of the redeemable convertible preferred stock up to the date of the IPO on February 9, 2021. On January 9, 2020, the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock to 45,389,864 including increasing the shares designated as Series B to 31,273,966. On August 6, 2020, the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock to 103,355,827, of which 30,996,574 shares are designated as Series B and 58,243,355 of shares are designated as Series C and set forth the rights, preferences and privileges of Series C. In August 2020, the Company entered into an agreement with new and existing preferred stockholders, to issue 13,512,578 shares of Series C for $69.8 million in proceeds from the sale of Series C and the conversion of convertible notes and related accrued interest in the amount into 2,593,110 shares of Series C. On February 9, 2021, in connection with the closing of the IPO, all shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. As of December 31, 2020, the Company’s redeemable convertible preferred stock consisted of the following: Shares Shares Issued and Net Carrying Liquidation Authorized Outstanding Value Value Series A 14,115,898 3,274,913 $ 15,020 $ 16,763 Series B 30,996,574 7,191,256 33,406 33,523 Series C 58,243,355 13,512,578 72,654 72,840 Total 103,355,827 23,978,747 $ 121,080 $ 123,126 Dividends The Company did not declare, pay, or set aside any dividends on shares of the Company unless the holders of the outstanding Series C first receive a dividend on each outstanding share of Series C in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series C. After payment or setting aside dividends to Series C, Series B was entitled to receive, prior and in preference to holders of common stock, a dividend on each outstanding share of Series B in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series B. After payment or setting aside dividends to Series B, Series A was entitled to receive, prior and in preference to holders of common stock, a dividend on each outstanding share of Series A in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series A. Up to the date of the IPO, February 9, 2021, no dividends had been declared by the Board related to the redeemable convertible preferred stock. Liquidation Preference and Redemption In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or a deemed liquidation event, the holders of shares of Series C then outstanding were entitled to be paid before any payment was made to the holders of the Series B, Series A or common stock, the Series C liquidation preference, which is equal to the greater of (i) one times the Series C original issue price, plus any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series C been converted into common stock. Upon satisfaction of Series C liquidation preference, the Series B liquidation preference, which is equal to the greater of (i) the per share liquidation preference plus all declared but unpaid dividends or (ii) the amount per share as would be payable had all shares of Series B been converted into common stock, is paid prior to any other preferences. Upon the satisfaction of the Series B liquidation preference, the Series A liquidation preference, which was equal to the greater of (i) the per share liquidation preference plus all declared but unpaid dividends or (ii) the amount per share as would be payable had all shares of Series A been converted into common stock, wa s paid prior to any additional preferences. Following the satisfaction of the liquidation preferences, all holders of shares of common stock participate in any remaining distribution on a pro rata basis based on the number of shares of common stock then held. As of December 31, 2020, the liquidation preference per share for Series A, Series B, and Series C was $ 5.1185 , $ 4.6616 and $ 5.3905 respectively. Each of the following events was considered a “Deemed Liquidation Event” unless the holders of at least a majority of the outstanding shares of redeemable convertible preferred stock on an as-converted basis elect otherwise by written notice sent to the Company at least five (5) days prior to the effective date of any such event: (a) a merger or consolidation in which (i) the Company is a constituent party or (ii) a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation, except any such merger or consolidation involving the Company or a subsidiary in which the shares of capital stock of the Company outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediately following such merger or consolidation, at least a majority, by voting power, of the capital stock of (1) the surviving or resulting corporation; or (2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation of such surviving or resulting corporation; (b) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by the Company or any subsidiary of the Company of all or substantially all the assets of the Company and its subsidiaries taken as a whole, or the sale or disposition (whether by merger, consolidation or otherwise) of one or more subsidiaries of the Company if substantially all of the assets of the Company and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusive license or other disposition is to a wholly owned subsidiary of the Company; or (c) a share purchase, share exchange or tender offer in which at least a majority, by voting power, of the shares of capital stock of the Company are transferred to another person. Conversion Each share of redeemable convertible preferred stock would be automatically convertible into common stock at its then-effective conversion price (discussed below) (i) upon the vote or written consent of the holders of at least a majority of the then outstanding shares of redeemable convertible preferred stock on an as-converted basis, or (ii) upon the completion of a firm underwritten public offering of the Company’s common stock with gross proceeds of at least $50.0 million. In addition, each share of the Company’s redeemable convertible preferred stock would be convertible, at the option of the holder, into shares of common stock by dividing the initial conversion prices by the conversion price in effect at the time of conversion. The following table summarizes the number of shares of common stock into which each share of redeemable convertible preferred stock could have been converted as of December 31, 2020: Initial Conversion Conversion Conversion Price as of Ratio to Price December 31, 2020 Common Stock Series A $ 5.1185 $ 5.1185 1 Series B $ 4.6616 $ 4.6616 1 Series C $ 5.3905 $ 5.3905 1 The conversion price of Series A, Series B, and Series C was subject to adjustment for recapitalization (i.e. stock dividends, stock splits, reorganization, reclassification, combination of shares), or upon the issuance of shares at a price less than the then current conversion price. Voting The holder of each share of redeemable convertible preferred stock was entitled to one vote for each share of common stock into which it would convert. The holders of Series A, exclusively and as a separate class, were entitled to elect one director. In addition, the holders of record of the shares of Series B, exclusively and as a separate class, were entitled to elect two directors. The holders of Series C, exclusively and as a separate class on an as-converted basis, were entitled to elect one director. Redemption The convertible preferred stock was not redeemable at the option of the holders. Initial Public Offering The following is a description of the changes to stockholders’ equity (deficit) following the initial public offering. On February 9, 2021, in connection with the closing of the IPO, all shares of Series A, Series B and Series C redeemable convertible preferred stock converted into 23,978,747 shares of common stock. As a result of the IPO, the Company has no redeemable convertible preferred stock outstanding as of December 31, 2021. Upon the closing of the IPO, the Company amended and restated its certificate of incorporation to authorize two classes of stock, respectively, common stock and preferred stock. The total number of shares which the Company is authorized to issue is 210,000,000 shares. 200,000,000 shares of which is common stock, having a par value per share of $0.001. 10,000,000 shares of which is preferred stock, having a par value per share of $0.001. Preferred Stock Under the amended and restated certificate of incorporation, the Board may, without further action by the Company’s stockholders, fix the rights, preferences, privileges and restrictions of up to an aggregate of 10,000,000 shares of preferred stock in one or more series and authorize their issuance. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. Any issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders would receive dividend payments and payments on liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deterring or preventing a change of control or other corporate action. No shares of preferred stock were issued or outstanding as of December 31, 2021. Common Stock In January 2020, the number of authorized shares of common stock was increased to 75,000,000. Similarly, in August 2020, the certificate of incorporation was amended to increase the number of shares authorized for issuance to 150,000,000 shares of common stock. On February 9, 2021, the Company amended and restated its certificate of incorporation to authorize two classes of stock, respectively, common stock and preferred stock. The total number of shares which the Company is authorized to issue is 210,000,000 shares. 200,000,000 shares of which shall be common stock, having a par value per share of $0.001. 10,000,000 shares of which shall be preferred stock, having a par value per share of $0.001. Common stockholders are entitled to dividends as and when declared by the Board, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. The holder of each share of common stock is entitled to one vote. The Company had shares of common stock reserved for future issuance upon the exercise or conversion of the following: December 31, 2021 2020 Redeemable convertible preferred stock — 23,978,747 Common stock option grants issued and outstanding under 2014 Plan 3,245,250 4,587,700 Common shares issuable on conversion of convertible notes payable — 1,470,947 Common stock reserved for issuance under 2021 Plan 1,578,216 — Common shares available for grant under the 2014 stock option plan — 206,012 Common stock option grants issued and outstanding under 2021 Plan 467,024 — Restricted stock units issued and outstanding 3,387,505 — Common stock reserved for issuance under ESPP 710,189 — Total shares of common stock reserved for future issuance 9,388,184 30,243,406 |
Equity Incentive Plan
Equity Incentive Plan | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity Incentive Plan | Note 9. Equity Incentive Plan In 2014, the Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”) to permit the grant of share-based awards, such as stock grants and incentives and non-qualified stock options to employees, directors, consultants and advisors. The Board has the authority to determine to whom awards will be granted, the number of shares, the term and the exercise price. Awards granted under the 2014 Plan have a term of 10 years and generally vest over a four-year In January 2021, the Board adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The stockholders approved the 2021 Plan in January 2021, and it became effective upon the execution of the underwriting agreement for the IPO on February 4, 2021. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. A total of 5,200,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Plan. In addition, the number of shares of common stock available for issuance under the 2021 Plan will be automatically increased on the first day of each calendar year during the ten-year term of the 2021 Plan, beginning with January 1, 2022 and ending with January 1, 2031, by an amount equal to 5 % of the outstanding number of shares of common stock on December 31 of the preceding calendar year or such lesser amount as determined by the Board. No further grants will be made under the 2014 Equity Incentive Plan. Restricted Stock Units Restricted stock units (“RSUs”) are generally subject to a 4-year vesting period, with 25% of the shares vesting approximately one year from the vesting commencement date and quarterly thereafter over the remaining vesting term. The Company had the following activity for RSUs for the year ended December 31, 2021: Underlying Shares Weighted- Average Grant Date Fair Value Balance as of January 1, 2020 — $ — Granted 3,522,015 7.71 Vested (11,250 ) 13.77 Canceled or forfeited (123,260 ) 11.08 Balance as of December 31, 2021 3,387,505 $ 7.57 During the year ended December 31, 2021, the Company cancelled or forfeited 123,260 RSUs primarily consisting of 100,000 RSUs, which were not yet vested, upon the departure of a former executive officer. Additionally, during the year ended December 31, 2021, the Company settled and vested 11,250 RSUs upon the departure of a different executive officer pursuant to their separation agreement. The Company recognized $0.1 million of stock-based compensation expense related to the acceleration of vesting in conjunction with such separation agreement. Total compensation costs as of December 31, 2021 related to RSUs to be recognized in future periods was $29.2 million and is expected to be recognized over the weighted average period of 3.7 years. Stock Options A summary of stock option activity for the years ended December 31, 2021 and 2020 are as follows: Weighted- Average Weighted- Remaining Average Contractual Aggregate Number of Options Exercise Price Term (years) Intrinsic Value Balance as of January 1, 2020 4,587,700 $ 1.51 9.2 $ 3,152 Granted 691,758 15.99 Exercised (1,100,196 ) 1.34 Cancelled (466,988 ) 8.61 Balance as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Options vested and expected to vest as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Options vested and exercisable as of December 31, 2021 1,469,107 $ 1.68 7.6 $ 10,459 Total options vested during the years ended December 31, 2021 and 2020, were 1,921,793 and 680,258 respectively, with an aggregate fair value of $5.4 million and $0.3 million, respectively. During the year December 31, 2021, the Company accelerated the vesting of 604,642 stock options related to the departure of an executive officer as part of their separation agreement. The Company recognized $4.1 million of stock-based compensation expense related to the acceleration of vesting in conjunction with such separation agreement. The aggregate intrinsic value of options exercised was $6.5 million and $0.1 million for the years ended December 31, 2021 and 2020, respectively. Total compensation costs as of December 31, 2021 related to option awards to be recognized in future periods was $4.7 million and is expected to be recognized over the weighted average period of 2.4 years for the options The fair value of each option grant was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for the years ended: December 31, 2021 2020 Estimated fair value of common stock $ 16.45 $ 1.93 Expected term (in years) 5.9 6.0 Risk-free interest rate 0.7 % 0.4 % Dividend yield — — Volatility 47.1 % 44.8 % Common stock fair value —Prior to the Company’s IPO in February 2021, the fair value of the Company’s common stock was determined by the Board with assistance from management. The Board determined the fair value of common stock by considering independent valuation reports and a number of objective and subjective factors, including valuations of comparable companies, sales of redeemable convertible preferred stock, operating and financial performance, the lack of liquidity of the Company’s common stock and the general and industry-specific economic outlook. Following the closing of the IPO, the fair value of the Company’s common stock is the closing price of the common stock as reported on the Nasdaq Global Select Market. Expected dividend yield —The Company has not paid nor does it anticipate paying any dividends on its common stock in the foreseeable future. Risk-free interest rates —The Company applies the risk-free interest rate based on the US Treasury yield for the expected term of the option. Expected term —The Company calculated the expected term as the average of the contractual term of the option and the vesting period for its employee stock options. Expected volatility —Since the Company does not have sufficient stock price history to estimate the expected volatility of its shares, the expected volatility is calculated based on the average volatility for a peer group in the industry in which the Company does business. The weighted-average grant date fair value of the options granted under the 2014 and the 2021 Plan as calculated using the Black-Scholes option-pricing model was $7.09 and $0.82 per share for the years ended December 31, 2021 and 2020, respectively. Total compensation cost for share-based payment arrangements included in the Company’s Statements of Operations for all stock-based compensation arrangements for the years ended was as follows: December 31, 2021 2020 Cost of products sold $ 736 $ 17 Research and development 1,066 162 Selling, general and administrative 6,303 258 Total $ 8,105 $ 437 Employee Stock Purchase Plan In January 2021, the Company adopted the Employee Stock Purchase Plan (“ESPP”). The Company initially reserved 750,000 shares of the Company’s common stock for purchase under the ESPP. In addition, the number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years, which commenced on January 1, 2022, in an amount equal to 1% of the total number of shares of the Company’s common stock outstanding on the last day of the preceding year, or a lesser number of shares determined by the Board. The ESPP allows for qualified participants to purchase shares of the Company’s common stock at a price equal to the lower of 85% of the closing price at the beginning of the offering period or 85% of the closing price at the end of each six-month purchase period. In February 2021, the Company’s employees enrolled in the offering period (“first offering”) to purchase a variable number of shares of its common stock under the ESPP at the purchase date. In August 2021, the employees purchased 39,811 shares from the first offering at $8.33 per share In August 2021, the Company’s employees enrolled in the offering period (“second offering”) to purchase a variable number of shares of its common stock under the ESPP at the purchase date. The shares were measured at grant date using a weighted-average fair value of $5.16 per share under a Black Scholes valuation model. During the year ended December 31, 2021, the Company recorded $0.3 million of stock-based compensation related to its ESPP. There was $0.1 million of unrecognized stock-based compensation expense for the year ended December 31, 2021, related to the ESPP that is expected to be recognized over an average vesting period of 0.1 years. The fair value of shares to be issued under the Company’s ESPP was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for the year ended December 31, 2021 and 2020: December 31, 2021 2020 Fair value of common stock $ 12.45 $ — Expected term (in years) 0.5 — Risk-free interest rate 0.1 % 0.0 % Dividend yield — — Volatility 108.7 % 0.0 % |
Provision for Income Taxes
Provision for Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Provision for Income Taxes | Note 10. Provision for Income Taxes The components of the current provision for income taxes for the years ended were as follows: December 31, 2021 2020 Current: Federal $ — $ — State 17 1 Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards. The effective tax rate of the Company’s provision (benefit) for income taxes differs from the federal statutory rate as follows: Years Ending December 31, 2021 2020 Income tax computed at federal statutory rate 21.00 % 21.00 % 162(m) limitation (0.90 )% 0.00 % Remeasurement of derivative liabilities and convertible notes (0.09 )% (4.23 )% Section 383 limitations on federal R&D tax credits 0.00 % (4.14 )% Section 382 limitations on California NOLs 0.00 % (4.50 )% Other permanent adjustments (0.67 )% (0.22 )% State taxes, net of federal benefit 5.21 % 6.96 % R&D credit carryovers 4.26 % 3.26 % Change in valuation allowance (28.84 )% (18.13 )% Total (0.03 )% 0.00 % Temporary differences and carryforwards that give rise to a significant portion of deferred tax assets and liabilities are as follows: December 31, 2021 2020 Deferred tax assets: Federal net operating loss carryforwards $ 24,270 $ 11,189 State net operating loss carryforwards 3,890 1,784 Research and development credits 5,281 1,368 Operating lease liabilities 709 227 Intangible assets 454 283 Inventory valuation adjustment 49 739 Allowance for doubtful accounts 116 — Accrued compensation 875 115 Non-qualified stock options 805 — Other 3 31 36,452 15,736 Valuation allowance (33,427 ) (14,733 ) Net deferred tax assets 3,025 1,003 Deferred tax liabilities: Property and equipment (2,345 ) (793 ) Operating lease right-of-use asset (680 ) (210 ) Total deferred tax liabilities (3,025 ) (1,003 ) Total deferred income taxes — — ASC 740 requires that the tax benefit of net operating losses (“NOLs”), temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Management believes that realization of the deferred tax assets arising from the above-mentioned future tax benefits from operating loss carryforwards is currently not more likely than not and, accordingly, has provided a valuation allowance. The valuation allowance increased by $18.7 million and $6.8 million for the years ended December 31, 2021 and 2020. As of December 31, 2021, the Company had federal and state NOL carryforwards of approximately $115.6 million and $56.2 million, respectively. The federal NOLs include $11.0 million that may be used to offset up to 100% of future taxable income and the federal and state NOLs will begin to expire in the calendar year 2034, unless previously utilized. The NOL carryforwards subject to expiration could expire unused and be unavailable to offset future income tax liabilities. Under the Tax Cuts and Jobs Act, or the Tax Act, as modified by the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, federal NOLs incurred in taxable years beginning after December 31, 2017 and in future taxable years may be carried forward indefinitely. There is variation in how states will respond to the Tax Act and CARES Act. In addition, for state income tax purposes, there may be periods during which the use of NOLs is suspended or otherwise limited, such as recent California legislation limiting the usability of NOLs for tax years beginning in 2020 and before 2022. Separately, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50%, by value, in its equity ownership over a 3-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. We determined that an ownership change occurred on October 9, 2015, but that all federal NOL carryforwards can be utilized prior to the expiration. As of August 7, 2020, we experienced an ownership change, which resulted in limitations in our ability to utilize federal research and development credits of $1.6 million and state NOLs of $24.5 million. In addition, we may in the future experience ownership changes, as a result of other changes in our stock ownership (some of which are not in our control). For these reasons, our ability to utilize our NOL carryforwards and other tax attributes to reduce future tax liabilities may be limited. In the ordinary course of its business the Company incurs costs that, for tax purposes, are determined to be qualified research expenditures within the meaning of IRC §41 and are, therefore, eligible for the Increasing Research Activities credit under IRC §41. The federal R&D credit carryforward as of December 31, 2021 is $3.0 million which begins to expire in the calendar year 2040 and a California R&D credit carryforward of $2.2 million has no expiration date. As of December 31, 2021, the Company has total uncertain tax benefit of $647 thousand related to R&D Credit, which is recorded as a reduction of the deferred tax asset related credit carryforward. If the uncertain tax benefits were to be recognized, there would be no impact to the effective tax rate, due to the Company’s full valuation allowance position. It is the Company’s policy to account for interest and penalties related to uncertain tax positions as Interest expense and General and administrative expense, respectively in its Statements of Operations. No interest or penalties have been recorded related to the uncertain tax positions. A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: Years Ending December 31, 2021 2020 Balance at the beginning of the year $ 187 $ 160 Additions based on tax positions related to prior years 491 127 Subtractions based on tax positions related to prior years (31 ) (100 ) Total $ 647 $ 187 It is not expected that there will be a significant change in uncertain tax positions in the next 12 months. The Company is subject to U.S. federal and state income tax as well as to income tax in multiple state jurisdictions. In the normal course of business, the Company is subject to examination by tax authorities. As of the date of the financial statements, there are no tax examinations in progress. The statute of limitations for tax years ended after December 31, 2014 are open for federal and state tax purposes. In response to the COVID-19 pandemic, the CARES Act was signed into law in March 2020. The CARES Act lifts certain deduction limitations originally imposed by the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act”). Corporate taxpayers may carryback NOLs originating during 2018 through 2020 for up to five years, which was not previously allowed under the 2017 Tax Act. The CARES Act also eliminates the 80% of taxable income limitations by allowing corporate entities to fully utilize NOL carryforwards to offset taxable income in 2018, 2019 or 2020. Taxpayers may generally deduct interest up to the sum of 50% of adjusted taxable income plus business interest income (30% limit under the 2017 Tax Act) for tax years beginning January 1, 2019 and 2020. The CARES Act allows taxpayers with alternative minimum tax credits to claim a refund in 2020 for the entire amount of the credits instead of recovering the credits through refunds over a period of years, as originally enacted by the 2017 Tax Act. The impact on the Company’s income taxes is minimal. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan | Note 11. Retirement Plan In December 2017, the Company adopted the Lucira Health, Inc. 401(k) Plan which allows eligible employees to contribute pre-tax and Roth contributions to the plan, as allowed by law. The Company currently does not match employee contributions. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 12. Related Parties The Company issued Convertible Notes to related parties for a total of $11.5 million during the year ended December 31, 2020, and carried the same terms as those disclosed in Note 7. The Convertible Notes interest expense was immaterial during the years ended December 31, 2021, and 2020. The Company recorded charges relating to the remeasurement of derivative liabilities and convertible notes of $0.3 million and $2.8 million for the years ended December 31, 2021 and 2020, respectively, in connection with 2020 Notes held by related parties, which were subsequently converted into Series C preferred stock. The Company held $8.7 million in 2020B Notes to related parties as of December 31, 2020. On February 9, 2021, upon the closing of the IPO all outstanding shares of preferred Stock and the 2020B Notes automatically converted into shares of common stock. The Company incurred $0.1 million in consulting expenses with individuals related to a former executive officer or its Board during the year ended December 31, 2021. Additionally, the Company recorded revenue of less than $0.1 million from individuals or companies related to an executive officer or its Board during the year ended December 31, 2021. The Company incurred $0.2 million in consulting expenses with a person related to an executive officer of the Company during the year ended December 31, 2020, of which less than $0.1 million remained payable to such party as of December 31, 2020. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13. Subsequent Events Loan and Security Agreement In February 2022, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), in its capacity as administrative agent and collateral agent (in such capacity, the “Agent”), and Hercules and Silicon Valley Bank (“SVB”) as lenders (collectively, the “Lenders”). The Loan Agreement provides for term loans in an aggregate principal amount of up to $80.0 million, \available in four tranches. The first tranche consists of term loans in an aggregate principal amount of $30.0 million, all of which were funded to the Company on the closing date. The remaining tranches are available to the Company upon request at certain dates and amounts, depending on specified conditions being achieved at specified dates. The Company intends to use the proceeds of the term loans for working capital and general corporate purposes. The term loans will mature on February 1, 2026 and bear interest at an annual rate the greater of 5.50% plus the prime rate (as reported in the Wall Street Journal) and 8.75%. The term loans are interest only for a specified period, subject to extension under specified conditions. After the interest only period, monthly principal and interest payments are required over the remaining term of the loans to the maturity date. The term loans may be prepaid, subject to specified prepayment premiums. An end of term charge of 5.25% of the term loans advanced will be due upon prepayment or repayment. The Loan Agreement contains customary events of default, representations and warranties and covenants, including financial covenants requiring the Company to maintain certain minimum cash and revenue levels upon the occurrence of specified events as more fully set forth in the Loan Agreement. Lenders have participation and notice rights in an amount up to $5.0 million for the future sale and issuance of the Company’s capital stock that is broadly marketed to multiple investors. The Company has granted a senior security interest in all of the Company’s right, title, and interest in, to and under substantially all of Company’s personal property and other assets, excluding intellectual property. In connection with the entry into the Loan Agreement, the Company issued a warrant for 59,642 shares of common stock to each of Hercules and SVB. Each warrant is exercisable for a period of seven years from issuance at a per-share exercise price equal to $5.03. Termination of the Eiken Agreement On March 8, 2022, the Company provided notice of termination of the Eiken Agreement. Termination will be effective May 12, 2022. The Company terminated the Eiken Agreement because certain Eiken Licensed Patents have expired, all of which are locations in which the Company operates. Following termination of the Eiken Agreement, the Company will not be required to make any future royalty payments under the Eiken Agreement. Leased Facility On March 15, 2022, the Company executed a lease for an 82,000 square foot facility in Vista, California. The term of the lease is 126 months with options to extend 5 years and includes lease incentives of an initial rent-free period. The Company will make monthly rent payments, which will approximate $1.3 million per year over the term of the lease. The Company expects to take possession of the facility in April 2022 to begin tenant improvements and expects completion and assumption of full occupancy by August 2022. The Company will account for the lease as an operating lease as of the commencement date under ASC Topic 842, Leases |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company performed an evaluation of its activities through the date of filing this Annual Report and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing of this Annual Report, except for the transactions disclosed in Note 13 Subsequent Events. |
Use of Estimates | Use of Estimates The preparation of the accompanying financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, income and expenses as well as the related disclosure of contingent assets and liabilities. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Company’s Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results. The full extent to which the COVID-19 pandemic could continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing and distribution will depend on future developments that remain uncertain at this time, particularly as virus variants continue to spread. |
Reclassifications | Reclassifications Certain prior-period amounts have been reclassified to conform to the current presentation. Such reclassifications had no impact on previously reported net loss, total assets, total liabilities, or stockholders’ equity. |
Concentration of Credit Risk and Significant Suppliers and Distributors | Concentration of Credit Risk and Significant Suppliers and Distributors Financial instruments that potentially subject the Company to credit risk consist principally of cash held by financial institutions, grant income receivables and account receivables. Substantially all of the Company’s cash is held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. As of and during the year ended December 31, 2021 , Customers A, B and C represented 18 % , 17 % and 12 % , respectively, of the Company’s accounts receivable , and Customers C and A accounted for % and 10 %, respectively, of the Company’s revenue . As of and during the year ended December 31, 2020, there was only one customer which represented 100% of the Company’s accounts receivable and revenue. The Company is dependent on one contract manufacturer for commercial manufacturing of the Company’s test kits, key suppliers for certain laboratory materials and inventory items and certain key partners for distribution and fulfillment of customer orders. An interruption in the supply of these materials or disruption of the fulfillment and distribution operations, could temporarily impact the Company’s ability to manufacture its commercial inventory and perform development, testing and clinical trials related to its products. On July 14, 2021, the Company entered into a Distribution Agreement with Switch Health Solutions Inc. (“Switch”), which agreement was subsequently amended on December 21, 2021 (such agreement as amended, the “Distribution Agreement”). Under the Distribution Agreement, the Company appointed Switch as a non-exclusive distributor for the Company’s CHECK IT COVID-19 Test Kits (the “Test Kits”) in Canada. Under the Distribution Agreement, Switch is required to provide the Company with forecasts of the quantity of Test Kits that Switch expects to order for each of the coming 12 calendar months through December 2022 and each six-month period following December 2022 (each, a “Rolling Forecast”). For each calendar month in the Rolling Forecast, Switch is required to purchase at least the quantity of Test Kits set forth in the Rolling Forecast for such month. If the Company fails to fulfill the quantity of Test Kits set forth in any part of the Rolling Forecast for which Switch submits a purchase order(s), then Switch will not be required to purchase the remaining quantity of Test Kits set forth in the Rolling Forecast. If Switch fails to purchase the quantity of Test Kits in any month, or in the aggregate for the 12 month period, in each case as set forth in the Rolling Forecast, then Switch is liable to the Company for a low double-digit percentage of the total price applicable to the quantity of Test Kits set forth in the Rolling Forecast for the two months following such failure by Switch. The Distribution Agreement is for a one-year term and either party has the right to renew the Distribution Agreement for successive periods of one-year each by providing written notice to the other party prior to the expiration of the current term. Either party may terminate the Distribution Agreement (a) for uncured material breach by the other party, (b) if the other party enters into insolvency or bankruptcy or a trustee or receiver or the equivalent is appointed for the other party or proceedings are instituted against the other party relating to dissolution, liquidation, winding up, bankruptcy, insolvency, etc. or (c) for convenience upon 30 days’ notice to the other party. Additionally, either party may terminate immediately upon written notice if a regulatory or governmental agency or court takes action the result of which would prohibit or significantly restrict the sale, distribution, use or manufacture of the Test Kits in accordance with the Distribution Agreement. |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company’s cash, accounts receivable, prepaid expenses, other current assets and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s derivative liabilities and convertible notes were measured at fair value on a recurring basis and were classified as Level 3 liabilities. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable consist primarily of amounts due to the Company related to product sales. It is the practice of the Company to provide for uncollectible accounts in the year the accounts are determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: Years Ended December 31, 2021 2020 Beginning balance $ — $ — Amounts charged to costs and expenses 358 — Write-offs (259 ) — Ending balance $ 99 $ — |
Cash, and Restricted Cash Equivalents | Cash and Restricted Cash Equivalents The Company considers highly liquid investments purchased with a remaining maturity date upon acquisition of three months or less to be cash equivalents and are stated at cost, which approximates fair value. As of December 31, 2021 and 2020, there were no cash equivalents. As of December 31, 2020, the Company held a restricted cash balance of $2.3 million which was used to secure a letter of credit in relation to the Company’s contract manufacturer to secure certain purchases made on the Company’s behalf. The cash was deposited in a money market account with maturities of three months or less and classified as restricted cash equivalents on the Company’s Balance Sheets. The letter of credit matured in November 2021 and as of December 31, 2021, the Company held no restricted cash. |
Inventories Produced in Preparation for Product Launches | Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company determines are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive clinical test results for the underlying product, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the submission of the regulatory application. The Company closely monitors the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. As of December 31, 2020, the Company held $1.3 million that met criteria for capitalization. As of December 31, 2021, the Company utilized all of the preapproval inventory write-offs for cost of sales of $1.0 million and for selling, general and administrative and research and development activities of $0.3 million. |
Inventories | Inventories The Company values its inventory at the lower of cost or net realizable value and determines the cost of inventory using standard costs which closely resembles the first-in, first-out method. Lower of cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. Inventory held as of December 31, 2021 is in the form of raw materials, work in process and finished goods. In order to assess the ultimate realization of inventories, the Company is required to make judgments as to future demand requirements compared to current or committed inventory levels. The Company periodically reviews its inventories for shelf life, excess or obsolescence and writes-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Amounts written-down due to unmarketable inventory are recorded in cost of revenue and a new lower-cost basis for the inventory is established. The Company recorded $6.5 million of inventory obsolescence charges during the year ended December 31, 2021 related to an issue during transit and quality control exceptions related to one of the key raw material components of its product. |
Warranty | Warranty The Company offers a standard product warranty that our products will perform as intended upon the date of original delivery for a reasonable period of time, which typically coincides with product shelf life. The Company has the obligation, at its option, to either refund, repair or replace a defective product. At the time revenue is recognized, an estimate of future warranty costs is recorded as a component of cost of products sold. The estimate of future warranty costs is based on historical as well as current product failure rates, service delivery costs incurred in correcting product failures, and warranty policies. The Company regularly reviews these estimates to assess the appropriateness of our recorded warranty liabilities and adjust the amounts as necessary. As of December 31, 2021 and 2020, the accrued liability for warranty returns was not significant. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and seven years. Leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining term of the related lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the Balance Sheets and any resulting gain or loss is reflected in Other income (expense), net in the Statements of Operations in the period realized. |
Leases | Leases The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as operating or finance. Operating leases are included in Operating lease right-of-use (“ROU”) assets and Operating lease liabilities on the Balance Sheets. The Company did not have any finance leases as of December 31, 2021 and 2020. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and exclude lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company’s long-lived assets are comprised principally of its property and equipment, including leasehold improvements and ROU assets. The Company reviews long-lived assets whenever events or changes in circumstances indicate that the carrying amount of the asset group may not be fully recoverable. The Company identifies impairments related to long-lived assets when management determines that the remaining carrying value will not be realized through future use. The Company evaluates events or circumstances, including competition in the markets where it operates, that would indicate the carrying value of assets may not be fully recoverable. If an event or circumstance is identified indicating carrying value may not be recoverable, the sum of future undiscounted cash flows is compared to the carrying value. If the carrying value exceeds the future undiscounted cash flows, the carrying value of the asset is reduced to fair value, with the difference recorded as an impairment charge. Assets are evaluated for impairment on an individual basis, which management believes is the lowest level for which there are identifiable cash flows. The Company evaluates assets for impairment by assessing if long-lived assets will be sold or otherwise disposed of significantly before the end of their previously estimated useful life as its primary indicator of potential impairment. The fair value of assets is determined as the present value of the estimated future cash flows, adjusted as necessary for market participant factors. Any required impairment loss would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. During the year ended December 31, 2021, a $1.4 million impairment of long-lived assets charge was recorded, there was no impairment charge recorded during the same period in 2020. See additional discussion in Note 4, Other Financial Information. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock The Company’s shares of preferred stock were assessed at issuance for classification and redemption features requiring bifurcation. The Company’s preferred stock was not mandatorily redeemable. The Company presents as temporary equity any stock which (i) the Company undertakes to redeem at a fixed or determinable price on the fixed or determinable date or dates; (ii) is redeemable at the option of the holders, or (iii) has conditions for redemption which are not solely within the control of the Company. The Company’s preferred stock was redeemable if the Company had not been dissolved within 90 days following the occurrence of certain deemed liquidation events, which the Company determined was not solely within its control and thus had classified shares of redeemable convertible preferred stock as temporary equity until such time as the conditions were removed or lapse. The Company initially recorded redeemable convertible preferred stock at fair value, net of issuance costs. In connection with the IPO on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock . |
Deferred Offering Costs | Deferred Offering Costs The Company capitalized certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are recorded as a reduction of the proceeds received from the equity financing. There was $2.2 million of deferred offering costs related to the Company’s IPO recorded as Other assets on the Company’s Balance Sheet as of December 31, 2020. The Company recorded additional offering costs between December 31, 2020 and February 9, 2021 and recorded $3.7 million as an offset to the IPO proceeds. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”), “Revenue from Contracts with Customers” when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Under ASC 606, assuming all other revenue recognition criteria have been met, the Company will recognize revenue for arrangements upon the transfer of risk and title of the Company’s products and upon customer obtaining control of the product, which occurs at a point in time and is generally upon shipment to the customer, unless terms of contractual arrangements with customers state otherwise in which case the control is transferred upon completion of delivery and customer acceptance of products. Upon transfer of risk and title to the customer, no further performance obligations by the Company to the customer after shipment of the product are present. Revenue is measured based on the amount of consideration that the Company expects to receive as reduced by estimated discounts and allowances. The Company's performance obligations relate to contracts with a duration of less than one year. The Company elected to apply the practical expedient provided in ASC 606, therefore, the Company is not required to disclose the aggregate amount of transaction price allocated to performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period. All of the Company’s revenue has been derived from sales of its test kits through its healthcare, business-to-business, international and direct-to-consumer (e-commerce) channels. Since receiving the initial EUA in the fourth quarter 2020, the Company marketed its test products to physicians and licensed healthcare providers through its healthcare channel in the United States. On April 9, 2021, the Company received its first FDA EUA authorization for OTC non-prescription use and expanded its marketing to include domestic testing providers, distributors, businesses within its business-to-business channel, and direct-to-consumer through its partnerships with e-commerce sales and distribution platforms. In 2021, the Company also sold tests internationally through international distributors in Canada, Taiwan, Singapore, and Israel through its international channel. The following table sets forth the Company’s net sales by channel: Years Ended December 31, 2021 2020 Healthcare $ 27,205 $ 269 Business-to-business 41,439 — International 18,262 — Direct-to-consumer (e-commerce) 6,149 — Net sales $ 93,055 $ 269 Collection of the Company’s net revenue generally occurs within 30 days of billing. Contracts do not contain significant financing components based on the typical period of time between delivery of products and collection of consideration. Collections of revenue from customers in the Company’s e-commerce channel generally occurs instantaneously or within a few days as customers pay using credit cards. Customers in certain countries outside of the United States pay in advance of product delivery. In those instances, payment and delivery typically occur in the same month. Costs to obtain or fulfill a contract are currently expensed when incurred because our performance obligation is satisfied at a point in time. These costs are recorded as Cost of products sold in the Statements of Operations. The Company invoices its customers upon shipment of product and records its sales upon shipment in accordance with its standard terms and conditions, unless underlying customer contracts specify otherwise. In those instances, the Company records revenue upon delivery and upon customer acceptance of products to customers when control of products is transferred to customers. When necessary, the Company invoices and collects sales tax from its customers for sales of products. The Company has elected to exclude sales tax from the measurement of the transaction price. The following table sets forth the Company’s net sales by geographic area based on the customers’ locations: Years Ended December 31, 2021 2020 United States $ 74,793 $ 269 Canada 13,066 — All other countries 5,196 — Net sales $ 93,055 $ 269 |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs are included in cost of goods sold. |
Research and Development Grants | Research and Development Grants In July 2018, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), a division within the U.S. Department of Health and Human Services (“HHS”), for an award of up to $10 million to demonstrate the feasibility of a novel in-home, disposable, point-of-care rapid diagnostic assay for the detection of Influenza A and B for work performed through July 2020. In September 2019, the Company amended its agreement with BARDA to increase the award to $21.5 million and extend the reporting period through July 2022. The Company earns grant income for performing tasks under research and development agreements with governmental agencies. Grant income derived from reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with government contracts and grants are recorded at the gross amount within grant income. The costs associated with these reimbursements are reflected as a component of research and development expense in the Company’s S tatements of O perations. The Company recognized grant income from BARDA of $0.0 million and $1.8 million during the years ended December 31, 2021 and 2020, respectively. In July 2021, BARDA terminated the influenza contract for convenience. The Company recognized grant income from other governmental agencies of $0.6 million and $0.3 million during the years ended December 31, 2021 and 2020, respectively. The Company records a receivable included in Other current assets on the Balance Sheets, which consists of billed and unbilled amounts earned from various government grants for costs incurred prior to the period end under reimbursement contracts. The amounts are billed to the respective government agencies. As collection is deemed probable, no allowance for doubtful accounts has been established. If amounts become uncollectible, they are recorded as operating expense in the Company’s Statements of Operations. As of December 31, 2021 and 2020, $0.2 million and $0.2 million were unbilled, respectively. |
Research and Development | Research and Development Costs associated with research and development activities are expensed as incurred and include, but are not limited to, personnel-related expenses including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. The Company records accrued expenses for estimated costs of its research and development activities conducted by third-party service providers, which include clinical trial activities. The Company records the estimated costs of research and development activities based upon the estimated value of services or supplies provided but not yet invoiced and include these costs in accrued liabilities in the Balance Sheets and within research and development expense in the Statements of Operations. The Company records accrued expenses for these costs based on factors such as estimates of the work completed or supplies received and in accordance with agreements established with these vendors. Any payments made in advance of services or supplies provided are recorded as prepaid assets, which are expensed as the services or supplies are received. The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. Such estimates in determining the accrued balance in each reporting period are subject to management judgment. As actual costs become known, the Company adjusts its accrued estimates. |
Advertising and Marketing Costs | Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were $1.7 million and immaterial for the years ended December 31, 2021 and 2020, respectively, and are included in Selling, general and administrative expenses in the accompanying Statements of Operations. |
Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based awards consist of stock options issued to employees and non-employees and restricted stock units issued to employees. The Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur. The Company classifies stock-based compensation expense in its S tatements of O perations in the same manner in which the award recipient’s cash compensation costs are classified. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of complex assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option. Prior to the Company’s initial public offering, the Company was a private company and lacked company-specific historical and implied fair value information. Therefore, the Board of Directors (the “Board”) of the Company considered numerous objective and subjective factors to determine the fair value of the Company’s common stock options at each meeting in which awards were approved. The factors considered include, but are not limited to (i) the results of contemporaneous independent third-party valuations of the Company’s common stock and the prices, rights, preferences and privileges of the Company’s redeemable convertible preferred stock relative to those of its common stock; (ii) the lack of marketability of the Company’s common stock; (iii) actual operating and financial results;(iv) current business conditions and projections; (v) the likelihood of achieving a liquidity event, such as an IPO or sale of the Company, given prevailing market conditions, and (vi) precedent transactions involving the Company’s shares. The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The expected term was estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise data to estimate the expected term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would adjust the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents of potentially diluted securities outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of redeemable convertible preferred stock, and options outstanding under the Company’s stock option plan. For the years ended December 31, 202 1 and 20 20 , there was no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive securities would be anti-dilutive. The following table summarizes the Company’s net loss per share: Years Ended December 31, 2021 2020 Numerator Net loss attributable to common stockholders basic and diluted $ (64,827 ) $ (37,348 ) Denominator Weighted-average number of common shares outstanding, basic and diluted 34,768,542 2,396,798 Net loss per share attributable to common stockholders, basic and diluted $ (1.86 ) $ (15.58 ) Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): December 31, 2021 2020 Redeemable convertible preferred stock — 23,978,747 Common shares issuable upon conversion of convertible note — 1,470,947 Options to purchase common stock 3,712,274 4,470,249 Unvested restricted stock units 3,387,505 — Employee stock purchase plan 45,275 — Early exercised options subject to future vesting 86,131 117,451 Total 7,231,185 30,037,394 |
Segment Reporting | Segment Reporting The Company has determined that the Chief Executive Officer is its Chief Operating Decision Maker. The Company’s Chief Executive Officer reviews financial information presented on an aggregate basis for the purposes of assessing the performance and making decisions on how to allocate resources. Accordingly, the Company has determined that it operates in a single |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements, or Accounting Standard Updates (“ASU”) are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. The Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with those standards. This means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company has the option to adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards unless the Company otherwise early adopts select standards. Recently Adopted Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13 , Measurement of Credit Losses on Financial Instruments (Topic 326): Measurement of Credit Losses on Financial Instruments In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Activity in Allowance for Doubtful Accounts | The following table summarizes the activity in the allowance for doubtful accounts: Years Ended December 31, 2021 2020 Beginning balance $ — $ — Amounts charged to costs and expenses 358 — Write-offs (259 ) — Ending balance $ 99 $ — |
Summary of Net Sales by Channel and Geographic Area Based on Customers' Locations | The following table sets forth the Company’s net sales by channel: Years Ended December 31, 2021 2020 Healthcare $ 27,205 $ 269 Business-to-business 41,439 — International 18,262 — Direct-to-consumer (e-commerce) 6,149 — Net sales $ 93,055 $ 269 The following table sets forth the Company’s net sales by geographic area based on the customers’ locations: Years Ended December 31, 2021 2020 United States $ 74,793 $ 269 Canada 13,066 — All other countries 5,196 — Net sales $ 93,055 $ 269 |
Summary of Net Loss per Share | The following table summarizes the Company’s net loss per share: Years Ended December 31, 2021 2020 Numerator Net loss attributable to common stockholders basic and diluted $ (64,827 ) $ (37,348 ) Denominator Weighted-average number of common shares outstanding, basic and diluted 34,768,542 2,396,798 Net loss per share attributable to common stockholders, basic and diluted $ (1.86 ) $ (15.58 ) |
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): December 31, 2021 2020 Redeemable convertible preferred stock — 23,978,747 Common shares issuable upon conversion of convertible note — 1,470,947 Options to purchase common stock 3,712,274 4,470,249 Unvested restricted stock units 3,387,505 — Employee stock purchase plan 45,275 — Early exercised options subject to future vesting 86,131 117,451 Total 7,231,185 30,037,394 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — 2,338 — — Liabilities Convertible notes payable $ — $ — $ 24,694 — — 24,694 |
Schedule of Change in Fair Value of Derivative Liabilities and Convertible Notes | The change in the fair value of the derivative liabilities and convertible notes accounted for at fair value is summarized below for the years ended December 31: Year ended December 31 2021 2020 Fair value at beginning of the year $ 24,694 $ — Initial fair value of instruments issued — 31,139 Change in fair value of instruments and accrued interest, net 288 7,533 Extinguishment of instruments held at fair value (24,982 ) (13,978 ) Fair value at end of the year $ — $ 24,694 |
Other Financial Information (Ta
Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Other Financial Information [Abstract] | |
Schedule of Inventory | December 31, 2021 2020 Raw materials $ 35,923 $ 4,725 Work in process 10,539 140 Finished goods 4,314 — Total $ 50,776 $ 4,865 |
Schedule of Other Receivables | December 31, 2021 2020 Other receivable $ 8,188 $ 798 |
Schedule of Prepaid Expenses | December 31, 2021 2020 Prepaid expenses $ 10,274 $ 3,496 |
Schedule of Property and Equipment, Net | December 31, 2021 2020 Construction in progress $ 3,466 $ 15,308 Machinery and equipment 29,333 4,679 Website development costs 1,110 — Furniture and fixtures 200 88 Leasehold improvements 1,702 501 Total, at cost 35,811 20,576 Accumulated depreciation and amortization (4,837 ) (1,168 ) Property and equipment, net $ 30,974 $ 19,408 |
Schedule of Long-Lived Assets Including Right-of-Use Assets by Geographic Area | The following table sets forth the Company’s long-lived assets, including right-of-use assets by geographic area: December 31, 2021 2020 United States $ 16,730 $ 7,528 Dominican Republic 15,753 12,432 All other countries 1,205 196 Total long-lived assets $ 33,688 $ 20,156 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: December 31, 2021 2020 Professional fees $ 612 $ 1,577 Accrued manufacturing and inventory purchases 17,200 1,165 Canada Importation Taxes 1,551 — Payroll liabilities 4,466 604 Royalty liabilities 1,662 — Accrued sales tax 2,215 204 Early exercise liability 189 263 Accrued deferred offering costs — 487 Other 1,267 145 Total $ 29,162 $ 4,445 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of December 31, 2021, are as follows: Operating Leases Year ending December 31: 2022 $ 1,659 2023 1,205 2024 147 2025 — 2026 — Total 3,011 Less: imputed interest (182 ) Operating lease liabilities $ 2,829 |
Summary of Additional Information Related to Leases | Additional information related to the Company’s leases was as follows for the years ended December 31: 2021 2020 Operating lease cost $ 943 $ 435 Short-term lease cost $ 1,663 $ 536 Weighted-average remaining lease term (years) 1.82 2.36 Weighted-average discount rate 7.15 % 13.14 % |
Capital Stock (Tables)
Capital Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Redeemable Convertible Preferred Stock | As of December 31, 2020, the Company’s redeemable convertible preferred stock consisted of the following: Shares Shares Issued and Net Carrying Liquidation Authorized Outstanding Value Value Series A 14,115,898 3,274,913 $ 15,020 $ 16,763 Series B 30,996,574 7,191,256 33,406 33,523 Series C 58,243,355 13,512,578 72,654 72,840 Total 103,355,827 23,978,747 $ 121,080 $ 123,126 |
Summary of Number of Shares of Common Stock into Which Redeemable Convertible Preferred Stock Shares Converted | The following table summarizes the number of shares of common stock into which each share of redeemable convertible preferred stock could have been converted as of December 31, 2020: Initial Conversion Conversion Conversion Price as of Ratio to Price December 31, 2020 Common Stock Series A $ 5.1185 $ 5.1185 1 Series B $ 4.6616 $ 4.6616 1 Series C $ 5.3905 $ 5.3905 1 |
Summary of Shares of Common Stock Reserved for Future Issuance | The Company had shares of common stock reserved for future issuance upon the exercise or conversion of the following: December 31, 2021 2020 Redeemable convertible preferred stock — 23,978,747 Common stock option grants issued and outstanding under 2014 Plan 3,245,250 4,587,700 Common shares issuable on conversion of convertible notes payable — 1,470,947 Common stock reserved for issuance under 2021 Plan 1,578,216 — Common shares available for grant under the 2014 stock option plan — 206,012 Common stock option grants issued and outstanding under 2021 Plan 467,024 — Restricted stock units issued and outstanding 3,387,505 — Common stock reserved for issuance under ESPP 710,189 — Total shares of common stock reserved for future issuance 9,388,184 30,243,406 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Restricted Stock Units Activity | The Company had the following activity for RSUs for the year ended December 31, 2021: Underlying Shares Weighted- Average Grant Date Fair Value Balance as of January 1, 2020 — $ — Granted 3,522,015 7.71 Vested (11,250 ) 13.77 Canceled or forfeited (123,260 ) 11.08 Balance as of December 31, 2021 3,387,505 $ 7.57 |
Summary of Stock Option Activity | A summary of stock option activity for the years ended December 31, 2021 and 2020 are as follows: Weighted- Average Weighted- Remaining Average Contractual Aggregate Number of Options Exercise Price Term (years) Intrinsic Value Balance as of January 1, 2020 4,587,700 $ 1.51 9.2 $ 3,152 Granted 691,758 15.99 Exercised (1,100,196 ) 1.34 Cancelled (466,988 ) 8.61 Balance as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Options vested and expected to vest as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Options vested and exercisable as of December 31, 2021 1,469,107 $ 1.68 7.6 $ 10,459 |
Summary of Assumptions Used to Estimate Fair Value of Stock Options | The fair value of each option grant was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for the years ended: December 31, 2021 2020 Estimated fair value of common stock $ 16.45 $ 1.93 Expected term (in years) 5.9 6.0 Risk-free interest rate 0.7 % 0.4 % Dividend yield — — Volatility 47.1 % 44.8 % |
Summary of Compensation Cost for Share-Based Payment Arrangements | Total compensation cost for share-based payment arrangements included in the Company’s Statements of Operations for all stock-based compensation arrangements for the years ended was as follows: December 31, 2021 2020 Cost of products sold $ 736 $ 17 Research and development 1,066 162 Selling, general and administrative 6,303 258 Total $ 8,105 $ 437 |
Summary of Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plans | The fair value of shares to be issued under the Company’s ESPP was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for the year ended December 31, 2021 and 2020: December 31, 2021 2020 Fair value of common stock $ 12.45 $ — Expected term (in years) 0.5 — Risk-free interest rate 0.1 % 0.0 % Dividend yield — — Volatility 108.7 % 0.0 % |
Provision for Income Taxes (Tab
Provision for Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Components of Current Provision for Income Taxes | The components of the current provision for income taxes for the years ended were as follows: December 31, 2021 2020 Current: Federal $ — $ — State 17 1 |
Schedule of Effective Tax Rate of Provision (Benefit) for Income Taxes | The effective tax rate of the Company’s provision (benefit) for income taxes differs from the federal statutory rate as follows: Years Ending December 31, 2021 2020 Income tax computed at federal statutory rate 21.00 % 21.00 % 162(m) limitation (0.90 )% 0.00 % Remeasurement of derivative liabilities and convertible notes (0.09 )% (4.23 )% Section 383 limitations on federal R&D tax credits 0.00 % (4.14 )% Section 382 limitations on California NOLs 0.00 % (4.50 )% Other permanent adjustments (0.67 )% (0.22 )% State taxes, net of federal benefit 5.21 % 6.96 % R&D credit carryovers 4.26 % 3.26 % Change in valuation allowance (28.84 )% (18.13 )% Total (0.03 )% 0.00 % |
Significant Portion of Deferred Tax Assets and Liabilities | Temporary differences and carryforwards that give rise to a significant portion of deferred tax assets and liabilities are as follows: December 31, 2021 2020 Deferred tax assets: Federal net operating loss carryforwards $ 24,270 $ 11,189 State net operating loss carryforwards 3,890 1,784 Research and development credits 5,281 1,368 Operating lease liabilities 709 227 Intangible assets 454 283 Inventory valuation adjustment 49 739 Allowance for doubtful accounts 116 — Accrued compensation 875 115 Non-qualified stock options 805 — Other 3 31 36,452 15,736 Valuation allowance (33,427 ) (14,733 ) Net deferred tax assets 3,025 1,003 Deferred tax liabilities: Property and equipment (2,345 ) (793 ) Operating lease right-of-use asset (680 ) (210 ) Total deferred tax liabilities (3,025 ) (1,003 ) Total deferred income taxes — — |
Reconciliation of Beginning and Ending Balances of Unrecognized Tax Benefits | A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: Years Ending December 31, 2021 2020 Balance at the beginning of the year $ 187 $ 160 Additions based on tax positions related to prior years 491 127 Subtractions based on tax positions related to prior years (31 ) (100 ) Total $ 647 $ 187 |
Organization - Additional Infor
Organization - Additional Information (Details) $ / shares in Units, $ in Thousands | Feb. 09, 2021USD ($)$ / sharesshares | Jan. 28, 2021 | Dec. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Feb. 04, 2022USD ($) | Dec. 31, 2020USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Entity incorporation, date of incorporation | Feb. 20, 2013 | |||||
Reverse stock split, description | On January 28, 2021, the Company’s board of directors approved a 1-for-4.3103 reverse stock split (the “Reverse Stock Split”) of the Company’s common stock and each series of its redeemable convertible preferred stock to be consummated prior to the effectiveness of the Company’s initial public offering (“IPO”) on February 4, 2021. | |||||
Stock split conversion ratio | 0.2320 | |||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 159,898 | |||||
Conversion of stock | shares | 23,978,747 | |||||
Cash | 105,982 | $ 105,982 | $ 58,212 | |||
Accumulated deficit | $ (128,541) | (128,541) | $ (63,714) | |||
Revenue from sale of test kits | $ 93,300 | |||||
First Tranche | Subsequent Event | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Debt instrument principal amount | $ 30,000 | |||||
Maximum | Subsequent Event | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Debt finance costs | $ 80,000 | |||||
IPO | Common Stock | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares issued in transaction | shares | 10,350,000 | |||||
Shares issued price per share | $ / shares | $ 17 | |||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 159,900 | |||||
Underwriting discounts and commissions | 12,300 | |||||
Offering expenses | $ 3,700 | |||||
Conversion of stock | shares | 25,449,694 | |||||
Underwriters' Option to Purchase Additional Shares | Common Stock | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares issued in transaction | shares | 1,350,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | Feb. 09, 2021USD ($)shares | Jul. 31, 2021 | Sep. 30, 2019USD ($) | Jul. 31, 2018USD ($) | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) |
Significant Accounting Policies [Line Items] | ||||||
Restricted cash balance | $ 0 | $ 2,300,000 | ||||
Capitalized pre-launch production costs | 1,300,000 | |||||
Inventory write-offs and obsolescence charges | $ 6,508,000 | |||||
Operating lease existence of option to extend [true false] | true | |||||
Operating lease option to extend | 3 years | options to extend | ||||
Long-lived asset impairment | $ 1,439,000 | 0 | ||||
Redeemable convertible preferred stock redemption period after occurrence of certain liquidation events | 90 days | |||||
Convertible preferred stock converted into common stock | shares | 23,978,747 | |||||
Net revenues collection period | 30 days | |||||
Grant income | $ 597,000 | 2,145,000 | ||||
Grant income from other governmental agencies | 600,000 | 300,000 | ||||
Allowance for doubtful accounts receivable, current | 99,000 | |||||
Unbilled receivables, current | $ 200,000 | 200,000 | ||||
Expected dividend yield | 0.00% | |||||
Number of operating segments | Segment | 1 | |||||
Number of reportable segments | Segment | 1 | |||||
ASU 2019-12 | ||||||
Significant Accounting Policies [Line Items] | ||||||
Change in accounting principle, accounting standards update, adopted | true | |||||
Change in accounting principle, accounting standards update, early adoption | true | |||||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | |||||
Change in accounting principle, accounting standards update, immaterial effect | true | |||||
Biomedical Advanced Research And Development Authority | ||||||
Significant Accounting Policies [Line Items] | ||||||
Maximum amount of award to demonstrate feasibility | $ 10,000,000 | |||||
Demonstrate feasibility period | 2020-07 | |||||
Amount of increase in award to demonstrate feasibility | $ 21,500,000 | |||||
Demonstrate feasibility period extended | 2022-07 | |||||
Grant income | $ 0 | 1,800,000 | ||||
IPO | ||||||
Significant Accounting Policies [Line Items] | ||||||
Additional offering costs | $ 3,700,000 | |||||
Other Assets | IPO | ||||||
Significant Accounting Policies [Line Items] | ||||||
Deferred offering costs | 2,200,000 | |||||
Maximum | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment estimated useful lives | 7 years | |||||
Performance obligation expected period | 1 year | |||||
Minimum | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment estimated useful lives | 3 years | |||||
Cost of Sales | ||||||
Significant Accounting Policies [Line Items] | ||||||
Capitalized pre-launch production costs expensed within year | $ 1,000,000 | |||||
SellingGeneralAndAdministrativeAndResearchAndDevelopmentActivitiesMember | ||||||
Significant Accounting Policies [Line Items] | ||||||
Capitalized pre-launch production costs expensed within year | 300,000 | |||||
Research and Development Grants | ||||||
Significant Accounting Policies [Line Items] | ||||||
Allowance for doubtful accounts receivable, current | 0 | |||||
Selling, General and Administrative Expenses | ||||||
Significant Accounting Policies [Line Items] | ||||||
Advertising and marketing costs | $ 1,700,000 | $ 1,700,000 | ||||
Accounts Receivable | Credit Concentration Risk | Customer A | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 18.00% | |||||
Accounts Receivable | Credit Concentration Risk | Customer B | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 17.00% | |||||
Accounts Receivable | Credit Concentration Risk | Customer C | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 12.00% | |||||
Revenue Benchmark | Customer Concentration Risk | Customer A | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 10.00% | |||||
Revenue Benchmark | Customer Concentration Risk | Customer C | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 11.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Activity in Allowance for Doubtful Accounts (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Accounting Policies [Abstract] | |
Amounts charged to costs and expenses | $ 358 |
Write-offs | (259) |
Ending balance | $ 99 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Net Sales by Channel (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Net sales | $ 93,055 | $ 269 |
Healthcare | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | 27,205 | $ 269 |
Business-to-Business | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | 41,439 | |
International | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | 18,262 | |
Direct-to-Consumer (E-Commerce) | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | $ 6,149 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Net Sales by Geographic Area Based on Customers' Locations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Net sales | $ 93,055 | $ 269 |
United States | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | 74,793 | $ 269 |
Canada | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | 13,066 | |
All Other Countries | ||
Disaggregation Of Revenue [Line Items] | ||
Net sales | $ 5,196 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | ||
Net loss | $ (64,827) | $ (37,348) |
Denominator | ||
Weighted-average number of shares used in net loss per share of common stock, basic and diluted | 34,768,542 | 2,396,798 |
Net loss per share of common stock, basic and diluted | $ (1.86) | $ (15.58) |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 7,231,185 | 30,037,394 |
Redeemable Convertible Preferred Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 23,978,747 | |
Common Shares Issuable Upon Conversion of Convertible Note | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 1,470,947 | |
Options To Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 3,712,274 | 4,470,249 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 3,387,505 | |
Employee Stock Purchase Plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 45,275 | |
Early Exercised Options Subject to Future Vesting | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 86,131 | 117,451 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Recurring $ in Thousands | Dec. 31, 2020USD ($) |
Level 1 | |
Assets | |
Restricted cash equivalents | $ 2,338 |
Total assets, fair value | 2,338 |
Level 3 | |
Liabilities | |
Convertible notes payable | 24,694 |
Total liabilities, fair value | $ 24,694 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Change in Fair Value of Derivative Liabilities and Convertible Notes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | ||
Fair value at beginning of the year | $ 24,694 | |
Initial fair value of instruments issued | $ 31,139 | |
Change in fair value of instruments and accrued interest, net | 288 | 7,533 |
Extinguishment of instruments held at fair value | $ (24,982) | (13,978) |
Fair value at end of the year | $ 24,694 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 1 Months Ended | |
Jul. 31, 2020 | Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | ||
Percentage of price paid per share for equity securities by the investors | 80.00% | 80.00% |
Other Financial Information - S
Other Financial Information - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Raw materials | $ 35,923 | $ 4,725 |
Work in process | 10,539 | 140 |
Finished goods | 4,314 | |
Total | $ 50,776 | $ 4,865 |
Other Financial Information -_2
Other Financial Information - Schedule of Other Receivables (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Other receivable | $ 8,188 | $ 798 |
Other Financial Information -_3
Other Financial Information - Schedule of Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Prepaid expenses | $ 10,274 | $ 3,496 |
Other Financial Information - A
Other Financial Information - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Other Financial Information [Abstract] | ||
Advanced payments related to procurement of inventories of components | $ 9,400 | |
Depreciation and amortization expense | 3,671 | $ 280 |
Impairment charge | $ 1,400 |
Other Financial Information -_4
Other Financial Information - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Total, at cost | $ 35,811 | $ 20,576 |
Accumulated depreciation and amortization | (4,837) | (1,168) |
Property and equipment, net | 30,974 | 19,408 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Total, at cost | 3,466 | 15,308 |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total, at cost | 29,333 | 4,679 |
Website Development Costs | ||
Property Plant And Equipment [Line Items] | ||
Total, at cost | 1,110 | |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total, at cost | 200 | 88 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total, at cost | $ 1,702 | $ 501 |
Other Financial Information -_5
Other Financial Information - Schedule of Long-Lived Assets Including Right-of-Use Assets by Geographic Area (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | $ 33,688 | $ 20,156 |
United States | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | 16,730 | 7,528 |
Dominican Republic | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | 15,753 | 12,432 |
All Other Countries | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | $ 1,205 | $ 196 |
Other Financial Information -_6
Other Financial Information - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Professional fees | $ 612 | $ 1,577 |
Accrued manufacturing and inventory purchases | 17,200 | 1,165 |
Canada Importation Taxes | 1,551 | |
Payroll liabilities | 4,466 | 604 |
Royalty liabilities | 1,662 | |
Accrued sales tax | 2,215 | 204 |
Early exercise liability | 189 | 263 |
Accrued deferred offering costs | 487 | |
Other | 1,267 | 145 |
Total | $ 29,162 | $ 4,445 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2021 | Apr. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Line Items] | ||||
Additional outstanding, other non-cancellable purchase commitment | $ 68,500 | |||
Eiken Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Payment for partial consideration of rights granted | 24 | $ 24 | ||
Payment for license fee | $ 9 | $ 9 | ||
Eiken Agreement | Cost of Sales | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Royalty expense | $ 2,700 | |||
Technology Services Agreement with Jabil | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Services agreement initial term | three years | |||
Service agreement expiration period | 180 days | |||
Service agreement material breach other party period | 60 days | |||
Manufacturing Services Agreement with Jabil | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Services agreement initial term | three years | |||
Service agreement expiration period | 180 days | |||
Service agreement material breach other party period | 30 days | |||
Outstanding non-cancellable purchase commitment | $ 26,500 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2021 | Jul. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | ||||
Operating lease, commencement month and year | 2021-08 | 2021-07 | ||
Operating lease, expired month and year | 2024-06 | |||
Operating lease option to extend | 3 years | options to extend | ||
Operating lease, lease term | 2 years | |||
Operating lease, renewal term | 2 years | |||
Operating lease payments | $ 0.9 | $ 0.4 | ||
Minimum | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease remaining lease term | 1 year | |||
Maximum | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease remaining lease term | 3 years |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 1,659 |
2023 | 1,205 |
2024 | 147 |
Total | 3,011 |
Less: imputed interest | (182) |
Operating lease liabilities | $ 2,829 |
Leases - Summary of Additional
Leases - Summary of Additional Information Related to Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Operating lease cost | $ 943 | $ 435 |
Short-term lease cost | $ 1,663 | $ 536 |
Weighted-average remaining lease term (years) | 1 year 9 months 25 days | 2 years 4 months 9 days |
Weighted-average discount rate | 7.15% | 13.14% |
Convertible Notes Payable - Add
Convertible Notes Payable - Additional Information (Details) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020 | Aug. 31, 2020 | Jul. 31, 2020 | Jun. 30, 2020 | Jul. 31, 2020 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | ||||||||
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | $ 24,982,000 | |||||||
Percentage of price paid per share for equity securities by the investors | 80.00% | 80.00% | ||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | 159,898,000 | |||||||
Remeasurement of derivative liabilities and convertible notes | $ 281,000 | $ 7,515,000 | ||||||
Series C | ||||||||
Debt Instrument [Line Items] | ||||||||
Conversion of stock | 2,593,110 | |||||||
Conversion price | $ 5.3905 | $ 5.3905 | ||||||
2020A Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Aggregate cash consideration | $ 11,100,000 | |||||||
Accrued interest rate per annum | 4.00% | 4.00% | ||||||
Debt instrument, maturity date | Jun. 12, 2021 | |||||||
Debt conversion, description | Pursuant to the 2020A Notes, the outstanding principal balance and unpaid accrued interest was automatically convertible into equity shares in the next equity financing round of at least $10 million (“2020A Qualified Financing”) at a price per share equal to the lower of (i) 80% of the price paid per share for equity securities by the investors in the 2020A Qualified Financing | |||||||
Accrued interest | $ 44,000 | |||||||
2020A Notes | Other Income (Expense), Net | ||||||||
Debt Instrument [Line Items] | ||||||||
Remeasurement of derivative liabilities and convertible notes | $ 2,800,000 | |||||||
2020A Notes | Series C | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of share issuance price | 80.00% | |||||||
Share issuance price | $ 5.3905 | |||||||
Conversion price | $ 5.3905 | |||||||
2020A Notes | 2020A Qualified Financing | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of price paid per share for equity securities by the investors | 80.00% | |||||||
Amount of common shares outstanding on diluted basis immediately prior to closing of qualified financing | $ 95,000,000 | $ 95,000,000 | ||||||
Accrued and unpaid interest | $ 11,200,000 | |||||||
2020A Notes | 2020A Qualified Financing | Series C | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from issuance of temporary equity | $ 58,700,000 | |||||||
Conversion of stock | 2,593,110 | |||||||
Conversion price | $ 4.3124 | |||||||
2020A Notes | 2020A Qualified Financing | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | $ 10,000,000 | |||||||
2020B Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Aggregate cash consideration | $ 20,000,000 | |||||||
Accrued interest rate per annum | 0.15% | 0.15% | ||||||
Debt instrument, maturity date | Dec. 11, 2022 | |||||||
Debt conversion, description | The outstanding principal and unpaid accrued interest of each Note is convertible upon occurrence of one of the following events: Maturity or Change in Control. In the event of an equity financing including an IPO with proceeds of not less than $10 million (“2020B Qualified Financing”), 2020B notes automatically convert into equity securities sold in the 2020B Qualified Financing at 80% of the price paid for securities sold in the 2020B Qualified Financing. In the event of an equity financing or IPO of less than $10 million, the majority holders of the 2020B Notes have the option to treat the offering as a 2020B Qualified Financing at 80% of the price paid for securities sold in the round (“2020B Non-Qualified Financing”). | |||||||
2020B Notes | Other Income (Expense), Net | ||||||||
Debt Instrument [Line Items] | ||||||||
Remeasurement of derivative liabilities and convertible notes | $ 300,000 | $ 4,700,000 | ||||||
2020B Notes | Series C | ||||||||
Debt Instrument [Line Items] | ||||||||
Original issue price | $ 5.3905 | |||||||
2020B Notes | Common Stock | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of price paid for securities sold from conversion | 70.00% | |||||||
2020B Notes | 2020B Qualified Financing | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of price paid for securities sold from conversion | 80.00% | |||||||
2020B Notes | 2020B Qualified Financing | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 10,000,000 | |||||||
2020B Notes | Two Thousand Twenty B Non Qualified Financing | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 10,000,000 | |||||||
Percentage of price paid for securities sold from conversion | 80.00% |
Capital Stock - Redeemable Conv
Capital Stock - Redeemable Convertible Preferred Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 09, 2021 | Aug. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2021 | Aug. 06, 2020 | Jan. 31, 2020 | Jan. 09, 2020 | Dec. 31, 2019 |
Class Of Stock [Line Items] | ||||||||
Temporary equity shares issued | 23,978,747 | 0 | ||||||
Redeemable convertible preferred stock shares outstanding | 23,978,747 | 0 | ||||||
Temporary equity shares authorized | 103,355,827 | 0 | ||||||
Gross proceeds from issuance of redeemable convertible preferred stock | $ 76,142 | |||||||
Conversion of stock | 23,978,747 | |||||||
Total number of shares authorized | 210,000,000 | |||||||
Common stock, shares authorized | 200,000,000 | 150,000,000 | 150,000,000 | 200,000,000 | 75,000,000 | |||
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | 10,000,000 | 0 | 10,000,000 | |||||
Preferred stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Redeemable Convertible Preferred Stock | ||||||||
Class Of Stock [Line Items] | ||||||||
Temporary equity shares issued | 0 | |||||||
Redeemable convertible preferred stock shares outstanding | 23,978,747 | 0 | 6,712,085 | |||||
Temporary equity shares authorized | 103,355,827 | 45,389,864 | ||||||
Series B | ||||||||
Class Of Stock [Line Items] | ||||||||
Temporary equity shares authorized | 30,996,574 | 30,996,574 | 31,273,966 | |||||
Series C | ||||||||
Class Of Stock [Line Items] | ||||||||
Temporary equity shares issued | 13,512,578 | |||||||
Temporary equity shares authorized | 58,243,355 | 58,243,355 | ||||||
Gross proceeds from issuance of redeemable convertible preferred stock | $ 69,800 | |||||||
Conversion of stock | 2,593,110 |
Capital Stock - Summary of Rede
Capital Stock - Summary of Redeemable Convertible Preferred Stock (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 06, 2020 | Jan. 09, 2020 |
Temporary Equity [Line Items] | ||||
Shares Authorized | 0 | 103,355,827 | ||
Shares Issued and Outstanding | 23,978,747 | |||
Net Carrying Value | $ 121,080 | |||
Liquidation Value | $ 0 | $ 123,126 | ||
Series A Redeemable Convertible Preferred Stock | ||||
Temporary Equity [Line Items] | ||||
Shares Authorized | 14,115,898 | |||
Shares Issued and Outstanding | 3,274,913 | |||
Net Carrying Value | $ 15,020 | |||
Liquidation Value | $ 16,763 | |||
Series B | ||||
Temporary Equity [Line Items] | ||||
Shares Authorized | 30,996,574 | 30,996,574 | 31,273,966 | |
Shares Issued and Outstanding | 7,191,256 | |||
Net Carrying Value | $ 33,406 | |||
Liquidation Value | $ 33,523 | |||
Series C | ||||
Temporary Equity [Line Items] | ||||
Shares Authorized | 58,243,355 | 58,243,355 | ||
Shares Issued and Outstanding | 13,512,578 | |||
Net Carrying Value | $ 72,654 | |||
Liquidation Value | $ 72,840 |
Capital Stock - Dividends - Add
Capital Stock - Dividends - Additional Information (Details) | Feb. 09, 2021USD ($) |
Redeemable Convertible Preferred Stock | |
Class Of Stock [Line Items] | |
Temporary equity, dividends declared | $ 0 |
Capital Stock - Liquidation Pre
Capital Stock - Liquidation Preference and Redemption - Additional Information (Details) | Dec. 31, 2020$ / shares |
Series A Redeemable Convertible Preferred Stock | |
Class Of Stock [Line Items] | |
Liquidation preference per share | $ 5.1185 |
Series B | |
Class Of Stock [Line Items] | |
Liquidation preference per share | 4.6616 |
Series C | |
Class Of Stock [Line Items] | |
Liquidation preference per share | $ 5.3905 |
Capital Stock - Conversion - Ad
Capital Stock - Conversion - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Minimum | |
Class Of Stock [Line Items] | |
Gross proceeds from underwritten public offering of common stock. | $ 50,000 |
Capital Stock - Summary of Numb
Capital Stock - Summary of Number of Shares of Common Stock into Which Redeemable Convertible Preferred Stock Shares Converted (Details) | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Series A Redeemable Convertible Preferred Stock | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 5.1185 |
Conversion price | $ 5.1185 |
Conversion Ratio to Common Stock | 1 |
Series B | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 4.6616 |
Conversion price | $ 4.6616 |
Conversion Ratio to Common Stock | 1 |
Series C | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 5.3905 |
Conversion price | $ 5.3905 |
Conversion Ratio to Common Stock | 1 |
Capital Stock - Initial Public
Capital Stock - Initial Public Offering - Additional Information (Details) - $ / shares | Feb. 09, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Jan. 31, 2020 | Dec. 31, 2019 |
Class Of Stock [Line Items] | ||||||
Conversion of stock | 23,978,747 | |||||
Redeemable convertible preferred stock shares outstanding | 0 | 23,978,747 | ||||
Total number of shares authorized | 210,000,000 | |||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 150,000,000 | 150,000,000 | 75,000,000 | |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 0 | |||
Preferred stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |||
Redeemable Convertible Preferred Stock | ||||||
Class Of Stock [Line Items] | ||||||
Redeemable convertible preferred stock shares outstanding | 0 | 23,978,747 | 6,712,085 |
Capital Stock - Preferred Stock
Capital Stock - Preferred Stock - Additional Information (Details) - shares | Dec. 31, 2021 | Feb. 09, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | |||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 0 |
Preferred stock shares issued | 0 | 0 | |
Preferred stock shares outstanding | 0 | 0 | |
Preferred Stock | |||
Class Of Stock [Line Items] | |||
Preferred stock, shares authorized | 10,000,000 | ||
Preferred stock shares issued | 0 | ||
Preferred stock shares outstanding | 0 |
Capital Stock - Common Stock -
Capital Stock - Common Stock - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2021 | Feb. 09, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Jan. 31, 2020 | |
Equity [Abstract] | |||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 150,000,000 | 150,000,000 | 75,000,000 |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | ||
Dividends declared | $ 0 | ||||
Common stock, voting rights | The holder of each share of common stock is entitled to one vote. |
Capital Stock - Summary of Shar
Capital Stock - Summary of Shares of Common Stock Reserved for Future Issuance (Details) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 9,388,184 | 30,243,406 |
Redeemable Convertible Preferred Stock | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 23,978,747 | |
Common Stock Option Grants Issued and Outstanding under 2014 Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 3,245,250 | 4,587,700 |
Common Shares Issuable on Conversion of Convertible Notes Payable | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 1,470,947 | |
Common Stock Reserved for Issuance under 2021 Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 1,578,216 | |
Common Shares Available for Grant under 2014 Stock Option Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 206,012 | |
Common Stock Option Grants Issued and Outstanding under 2021 Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 467,024 | |
Restricted Stock Units Issued And Outstanding | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 3,387,505 | |
Common Stock Reserved for Issuance under ESPP | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 710,189 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2021 | Jan. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for issuance | 9,388,184 | 30,243,406 | ||
Options vested number of shares | 1,921,793 | 680,258 | ||
Options vested in period fair value | $ 5,400 | $ 300 | ||
Number of Options vested and expected to vest | 3,712,274 | |||
Aggregate intrinsic value of options exercised | $ 6,500 | 100 | ||
Stock-based compensation | 8,105 | $ 437 | ||
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for issuance | 750,000 | |||
Share-based compensation arrangement increase in shares available for issuance period | 10 years | |||
Percentage of increase in common stock available for issuance amount equal to outstanding number of shares of common stock | 1.00% | |||
Compensation cost to be recognized related to non-vested awards | $ 100 | |||
Compensation cost to be recognized related to non-vested awards over weighted average period | 1 month 6 days | |||
Weighted average grant date fair value | $ 8.33 | $ 5.16 | ||
Number of shares employee purchased | 39,811 | |||
Stock-based compensation | $ 300 | |||
Executive Officer | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,100 | |||
Number of Options vested and expected to vest | 604,642 | |||
Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Underlying Shares, Canceled or forfeited | 123,260 | |||
Underlying shares not vested | 3,387,505 | |||
Underlying Shares, Vested | 11,250 | |||
Compensation cost to be recognized related to non-vested awards | $ 29,200 | |||
Compensation cost to be recognized related to non-vested awards over weighted average period | 3 years 8 months 12 days | |||
Restricted Stock Units (RSUs) | Executive Officer | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Underlying shares not vested | 100,000 | |||
Underlying Shares, Vested | 11,250 | |||
Stock-based compensation expense | $ 100 | |||
Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost to be recognized related to non-vested awards over weighted average period | 2 years 4 months 24 days | |||
Compensation cost to be recognized related to awards | $ 4,700 | |||
Vesting at Beginning of Offering Period | Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share based compensation qualified participants to purchase shares price | 85.00% | |||
Vesting at Beginning of Offering Period | Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Award vesting period | 4 years | |||
Award vesting rights, percentage | 25.00% | |||
Closing Price at End of Each Six Month Purchase Period | Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share based compensation qualified participants to purchase shares price | 85.00% | |||
2014 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Award, expiration period | 10 years | |||
Award vesting period | 4 years | |||
Common stock reserved for issuance | 5,512,742 | |||
Number of shares available for grant | 206,012 | 0 | ||
Weighted average grant date fair value | $ 7.09 | $ 0.82 | ||
2014 Plan | Vesting at Beginning of Offering Period | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Award vesting rights, percentage | 25.00% | |||
2021 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for issuance | 5,200,000 | |||
Number of shares available for grant | 0 | |||
Share-based compensation arrangement increase in shares available for issuance period | 10 years | |||
Percentage of increase in common stock available for issuance amount equal to outstanding number of shares of common stock | 5.00% | |||
Weighted average grant date fair value | $ 7.09 | $ 0.82 |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Underlying Shares, Granted | shares | 3,522,015 |
Underlying Shares, Vested | shares | (11,250) |
Underlying Shares, Canceled or forfeited | shares | (123,260) |
Underlying Shares, Ending Balance | shares | 3,387,505 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | $ 7.71 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 13.77 |
Weighted-Average Grant Date Fair Value, Canceled and forfeited | $ / shares | 11.08 |
Weighted-Average Grant Date Fair Value, Ending Balance | $ / shares | $ 7.57 |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of Options, Beginning Balance | 4,587,700 | |
Number of Options, Granted | 691,758 | |
Number of Options, Exercised | (1,100,196) | |
Number of Options, Cancelled | (466,988) | |
Number of Options, Ending Balance | 3,712,274 | 4,587,700 |
Number of Options vested and expected to vest as of December 31, 2021 | 3,712,274 | |
Number of Options vested and exercisable as of December 31, 2021 | 1,469,107 | |
Weighted-Average Exercise Price, Beginning Balance | $ 1.51 | |
Weighted-Average Exercise Price, Granted | 15.99 | |
Weighted-Average Exercise Price, Exercised | 1.34 | |
Weighted-Average Exercise Price, Cancelled | 8.61 | |
Weighted-Average Exercise Price, Ending Balance | 3.30 | $ 1.51 |
Weighted-Average Exercise Price, Options vested and expected to vest as of December 31, 2021 | 3.30 | |
Weighted-Average Exercise Price, Options vested and exercisable as of December 31, 2021 | $ 1.68 | |
Weighted-Average Remaining Contractual Term, Balance | 9 years 2 months 12 days | 9 years 1 month 6 days |
Weighted-Average Remaining Contractual Term, Options vested and expected to vest as of December 31, 2021 | 8 years 1 month 6 days | |
Weighted-Average Remaining Contractual Term, Options vested and exercisable as of December 31, 2021 | 7 years 7 months 6 days | |
Aggregate Intrinsic Value, Balance | $ 23,150 | $ 3,152 |
Aggregate Intrinsic Value, Options vested and expected to vest as of December 31, 2021 | 23,150 | |
Aggregate Intrinsic Value, Options vested and exercisable as of December 31, 2021 | $ 10,459 |
Equity Incentive Plan - Summa_3
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | |
Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Estimated fair value of common stock | $ 16.45 | $ 1.93 |
Expected term (in years) | 5 years 10 months 24 days | 6 years |
Risk-free interest rate | 0.70% | 0.40% |
Volatility | 47.10% | 44.80% |
Equity Incentive Plan - Summa_4
Equity Incentive Plan - Summary of Compensation Cost for Share-Based Payment Arrangements (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total compensation cost | $ 8,105 | $ 437 |
Cost of Sales | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total compensation cost | 736 | 17 |
Research and Development Grants | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total compensation cost | 1,066 | 162 |
Selling, General and Administrative Expenses | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total compensation cost | $ 6,303 | $ 258 |
Equity Incentive Plan - Summa_5
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plans (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock | $ 12.45 | |
Expected term (in years) | 6 months | |
Risk-free interest rate | 0.10% | 0.00% |
Volatility | 108.70% | 0.00% |
Provision for Income Taxes - Co
Provision for Income Taxes - Components of Current Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
State | $ 17 | $ 1 |
Provision for Income Taxes - Sc
Provision for Income Taxes - Schedule of Effective Tax Rate of Provision (Benefit) for Income Taxes (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income tax computed at federal statutory rate | 21.00% | 21.00% |
162(m) limitation | (0.90%) | 0.00% |
Remeasurement of derivative liabilities and convertible notes | (0.09%) | (4.23%) |
Section 383 limitations on federal R&D tax credits | 0.00% | (4.14%) |
Section 382 limitations on California NOLs | 0.00% | (4.50%) |
Other permanent adjustments | (0.67%) | (0.22%) |
State taxes, net of federal benefit | 5.21% | 6.96% |
R&D credit carryovers | 4.26% | 3.26% |
Change in valuation allowance | (28.84%) | (18.13%) |
Total | (0.03%) | 0.00% |
Provision for Income Taxes - Si
Provision for Income Taxes - Significant Portion of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Federal net operating loss carryforwards | $ 24,270 | $ 11,189 |
State net operating loss carryforwards | 3,890 | 1,784 |
Research and development credits | 5,281 | 1,368 |
Operating lease liabilities | 709 | 227 |
Intangible assets | 454 | 283 |
Inventory valuation adjustment | 49 | 739 |
Allowance for doubtful accounts | 116 | |
Accrued compensation | 875 | 115 |
Non-qualified stock options | 805 | |
Other | 3 | 31 |
Deferred tax assets, gross | 36,452 | 15,736 |
Valuation allowance | (33,427) | (14,733) |
Net deferred tax assets | 3,025 | 1,003 |
Deferred tax liabilities: | ||
Property and equipment | (2,345) | (793) |
Operating lease right-of-use asset | (680) | (210) |
Total deferred tax liabilities | $ (3,025) | $ (1,003) |
Provision for Income Taxes - Ad
Provision for Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | Aug. 07, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||||
Valuation allowance increased amount | $ 18,700 | $ 6,800 | ||
Tax cuts and jobs act deferred tax assets operating loss carryforwards foreign | 115,600 | |||
Tax cuts and jobs act deferred tax assets operating loss carryforwards state and local | 56,200 | |||
Tax cuts and jobs act deferred tax assets operating loss carryforwards federal | $ 11,000 | |||
Operating loss carryforwards, offset | 100 | |||
Change in aggregate ownership percentage | 50.00% | |||
Aggregate ownership period | 3 years | |||
Deferred tax assets R&D credits | $ 1,600 | $ 3,000 | ||
Deferred tax assets California net operating loss | $ 24,500 | 2,200 | ||
Deferred tax assets R&D credits | 647 | $ 187 | $ 160 | |
Interest or penalties related to uncertain tax positions | $ 0 | |||
Corporate taxpayers net operating loss carryforwards term | 5 years | |||
Percentage of tax cuts and jobs act taxable income limitations allowing corporate entities | 80.00% | |||
Percentage of tax cuts and jobs act adjusted taxable income | 50.00% | |||
Percentage of tax cuts and jobs act limit interest income | 30.00% |
Provision for Income Taxes - Re
Provision for Income Taxes - Reconciliation of Beginning and Ending Balances of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Balance at the beginning of the year | $ 187 | $ 160 |
Additions based on tax positions related to prior years | 491 | 127 |
Subtractions based on tax positions related to prior years | (31) | (100) |
Total | $ 647 | $ 187 |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | ||
Remeasurement of derivative liabilities and convertible notes payable | $ 281 | $ 7,515 |
Related party transaction consulting expenses | 100 | 200 |
Maximum | ||
Related Party Transaction [Line Items] | ||
Revenue recorded related party transaction | 100 | 100 |
Convertible notes | ||
Related Party Transaction [Line Items] | ||
Notes issued related parties | 11,500 | |
Convertible notes 2020B | ||
Related Party Transaction [Line Items] | ||
Notes to related parties | 8,700 | |
2020 Notes | ||
Related Party Transaction [Line Items] | ||
Remeasurement of derivative liabilities and convertible notes payable | $ 300 | $ 2,800 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ / shares in Units, $ in Millions | Mar. 15, 2022USD ($)ft² | Mar. 08, 2022 | Feb. 28, 2022USD ($)$ / sharesshares | Jul. 31, 2021 | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Aug. 31, 2021 |
Subsequent Event [Line Items] | |||||||
Operating lease, lease term | 2 years | ||||||
Operating lease option to extend | 3 years | options to extend | |||||
Monthly rent payments | $ 0.9 | $ 0.4 | |||||
Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Area of facility lease | ft² | 82,000 | ||||||
Operating lease, lease term | 126 months | ||||||
Operating lease option to extend | 5 years | ||||||
Monthly rent payments | $ 1.3 | ||||||
Subsequent Event | Eiken Agreement | |||||||
Subsequent Event [Line Items] | |||||||
License termination effective date | May 12, 2022 | ||||||
Subsequent Event | Hercules | |||||||
Subsequent Event [Line Items] | |||||||
Warrants issued for common stock | shares | 59,642 | ||||||
Warrants exercisable period | 7 years | ||||||
Exercise price of warrant | $ / shares | $ 5.03 | ||||||
Subsequent Event | Silicon Valley Bank | |||||||
Subsequent Event [Line Items] | |||||||
Warrants issued for common stock | shares | 59,642 | ||||||
Warrants exercisable period | 7 years | ||||||
Exercise price of warrant | $ / shares | $ 5.03 | ||||||
Subsequent Event | Maximum | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument future sale and issuance of capital stock | $ 5 | ||||||
Term Loan | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument principal amount | $ 80 | ||||||
Debt instrument, maturity date | Feb. 1, 2026 | ||||||
Accrued interest rate per annum | 8.75% | ||||||
Debt instrument term loan prepayment percentage | 5.25% | ||||||
Term Loan | Subsequent Event | Prime Rate | |||||||
Subsequent Event [Line Items] | |||||||
Interest rate | 5.50% | ||||||
First Tranche | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument principal amount | $ 30 |