Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 07, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
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 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 $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 40,598,954 |
CONDENSED BALANCE SHEETS (Unaud
CONDENSED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | ||
Current assets: | ||||
Cash and cash equivalents | $ 39,774 | $ 105,982 | [1] | |
Accounts receivable, net | 14,392 | 27,245 | [1] | |
Inventory | 55,625 | 50,776 | [1] | |
Other receivable | 4,824 | 8,188 | [1] | |
Prepaid expenses | 2,506 | 10,274 | [1] | |
Other current assets | 3,350 | 3,817 | [1] | |
Total current assets | 120,471 | 206,282 | [1] | |
Property and equipment, net | 48,295 | 30,974 | [1] | |
Operating lease right-of-use assets | 17,704 | 2,714 | [1] | |
Restricted cash equivalents | 1,943 | |||
Other assets | 772 | 384 | [1] | |
Total assets | 189,185 | 240,354 | [1] | |
Current liabilities: | ||||
Accounts payable | 25,173 | 19,371 | [1] | |
Accrued liabilities | 55,032 | 29,162 | [1] | |
Operating lease liabilities, current | 2,316 | 1,609 | [1] | |
Customer deposits | [1] | 189 | ||
Total current liabilities | 82,521 | 50,331 | [1] | |
Term loan payable, net | 29,408 | |||
Operating lease liabilities, net of current portion | 16,367 | 1,220 | [1] | |
Total liabilities | 128,296 | 51,551 | [1] | |
Commitments and contingencies (See Note 16) | [1] | |||
Stockholders’ equity: | ||||
Preferred stock $0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | [1] | |||
Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 40,448,703 and 39,663,645 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 40 | 40 | [1] | |
Additional paid-in capital | 324,851 | 317,304 | [1] | |
Accumulated deficit | (264,002) | (128,541) | [1] | |
Total stockholders’ equity | 60,889 | 188,803 | [1] | |
Total liabilities and stockholders’ equity | $ 189,185 | $ 240,354 | [1] | |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
CONDENSED BALANCE SHEETS (Una_2
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 | [1] |
Statement of Financial Position [Abstract] | |||
Preferred stock par value | $ 0.001 | $ 0.001 | |
Preferred stock shares authorized | 10,000,000 | 10,000,000 | |
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 | 200,000,000 | |
Common stock shares issued | 40,448,703 | 39,663,645 | |
Common stock shares outstanding | 40,448,703 | 39,663,645 | |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Net sales | $ 34,390,000 | $ 14,976,000 | $ 151,010,000 | $ 31,931,000 |
Cost of products sold | 133,945,000 | 14,837,000 | 202,657,000 | 32,710,000 |
Impairment of long-lived assets | 1,622,000 | 1,622,000 | ||
Gross loss | (99,555,000) | (1,483,000) | (51,647,000) | (2,401,000) |
Operating expenses: | ||||
Research and development | 9,141,000 | 14,342,000 | 32,089,000 | 30,741,000 |
Selling, general and administrative | 17,596,000 | 11,788,000 | 50,133,000 | 23,988,000 |
Total operating expenses | 26,737,000 | 26,130,000 | 82,222,000 | 54,729,000 |
Loss from operations | (126,292,000) | (27,613,000) | (133,869,000) | (57,130,000) |
Other income (expense), net: | ||||
Interest income and other (expense), net | 393,000 | 117,000 | 736,000 | 399,000 |
Interest expense, net | (949,000) | (2,312,000) | (281,000) | |
Total other income (expense), net | (556,000) | 117,000 | (1,576,000) | 118,000 |
Loss before provision for income taxes | (126,848,000) | (27,496,000) | (135,445,000) | (57,012,000) |
Provision for income taxes | 14,000 | 16,000 | ||
Net loss | $ (126,862,000) | $ (27,496,000) | $ (135,461,000) | $ (57,012,000) |
Net loss per share of common stock, | ||||
Basic | $ (3.15) | $ (0.71) | $ (3.39) | $ (1.71) |
Diluted | $ (3.15) | $ (0.71) | $ (3.39) | $ (1.71) |
Weighted-average number of shares used in net loss per share of common stock, | ||||
Basic | 40,216,244 | 38,667,615 | 39,974,997 | 33,348,104 |
Diluted | 40,216,244 | 38,667,615 | 39,974,997 | 33,348,104 |
CONDENSED STATEMENTS OF REDEEMA
CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | |
Beginning balance at Dec. 31, 2020 | $ (62,308) | $ 3 | $ 1,403 | $ (63,714) | ||
Beginning balance, shares at Dec. 31, 2020 | 23,978,747 | |||||
Beginning balance at Dec. 31, 2020 | $ 121,080 | |||||
Beginning 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 issuance costs | 159,898 | $ 10 | 159,888 | |||
Issuance of common stock upon IPO, net of issuance costs, shares | 10,350,000 | |||||
Issuance of common stock upon exercise of stock options | 516 | 516 | ||||
Issuance of common stock upon exercise of stock options, shares | 440,055 | |||||
Issuance of common stock under ESPP | 332 | 332 | ||||
Issuance of common stock under ESPP, shares | 39,811 | |||||
Issuance of common stock for settlement of restricted stock units, Shares | 11,250 | |||||
Stock-based compensation | 6,500 | 6,500 | ||||
Net loss | (57,012) | (57,012) | ||||
Ending balance at Sep. 30, 2021 | 193,988 | $ 39 | 314,675 | (120,726) | ||
Ending balance, Shares at Sep. 30, 2021 | 39,003,504 | |||||
Beginning balance at Jun. 30, 2021 | 215,800 | $ 39 | 308,991 | (93,230) | ||
Beginning balance, Shares at Jun. 30, 2021 | 38,684,546 | |||||
Issuance of common stock upon exercise of stock options | 324 | 324 | ||||
Issuance of common stock upon exercise of stock options, shares | 267,897 | |||||
Issuance of common stock under ESPP | 332 | 332 | ||||
Issuance of common stock under ESPP, shares | 39,811 | |||||
Issuance of common stock for settlement of restricted stock units, Shares | 11,250 | |||||
Stock-based compensation | 5,028 | 5,028 | ||||
Net loss | (27,496) | (27,496) | ||||
Ending balance at Sep. 30, 2021 | 193,988 | $ 39 | 314,675 | (120,726) | ||
Ending balance, Shares at Sep. 30, 2021 | 39,003,504 | |||||
Beginning balance at Dec. 31, 2021 | 188,803 | [1] | $ 40 | 317,304 | (128,541) | |
Beginning balance, Shares at Dec. 31, 2021 | 39,663,645 | |||||
Issuance of common stock warrants in connection with the term loan | 494 | 494 | ||||
Issuance of common stock upon exercise of stock options | $ 154 | 154 | ||||
Issuance of common stock upon exercise of stock options, shares | 73,940 | 73,940 | ||||
Issuance of common stock under ESPP | $ 519 | 519 | ||||
Issuance of common stock under ESPP, shares | 199,820 | |||||
Issuance of common stock for settlement of restricted stock units, Shares | 511,298 | |||||
Stock-based compensation | 6,380 | 6,380 | ||||
Net loss | (135,461) | (135,461) | ||||
Ending balance at Sep. 30, 2022 | 60,889 | $ 40 | 324,851 | (264,002) | ||
Ending balance, Shares at Sep. 30, 2022 | 40,448,703 | |||||
Beginning balance at Jun. 30, 2022 | 185,067 | $ 40 | 322,167 | (137,140) | ||
Beginning balance, Shares at Jun. 30, 2022 | 40,081,464 | |||||
Issuance of common stock upon exercise of stock options | 33 | 33 | ||||
Issuance of common stock upon exercise of stock options, shares | 13,446 | |||||
Issuance of common stock under ESPP | 220 | 220 | ||||
Issuance of common stock under ESPP, shares | 122,009 | |||||
Issuance of common stock for settlement of restricted stock units, Shares | 231,784 | |||||
Stock-based compensation | 2,431 | 2,431 | ||||
Net loss | (126,862) | (126,862) | ||||
Ending balance at Sep. 30, 2022 | $ 60,889 | $ 40 | $ 324,851 | $ (264,002) | ||
Ending balance, Shares at Sep. 30, 2022 | 40,448,703 | |||||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (135,461) | $ (57,012) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,796 | 6,500 |
Allowance for doubtful accounts (recoveries) | (67) | 259 |
Depreciation and amortization | 5,015 | 2,158 |
Long-lived asset impairment | 1,622 | |
Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory | 107,159 | 1,284 |
Accretion and amortization of term loans discount | 503 | |
Remeasurement of derivative liabilities and convertible notes | 281 | |
Noncash interest expense | 3 | |
Noncash lease expense | 864 | (1) |
Changes in assets and liabilities: | ||
Inventory | (74,100) | (39,383) |
Accounts receivable | 12,920 | (11,870) |
Other receivable | 3,364 | 58 |
Prepaid expenses and other current assets | 885 | (4,669) |
Other assets | 181 | (7,165) |
Accounts payable | 4,051 | 6,472 |
Customer deposits | (189) | 365 |
Accrued liabilities | (3,236) | 10,255 |
Net cash used in operating activities | (72,315) | (90,843) |
Cash flows from investing activities: | ||
Acquisition of property and equipment | (21,401) | (10,777) |
Net cash used in investing activities | (21,401) | (10,777) |
Cash flows from financing activities: | ||
Proceeds for issuance of term loans, net of discount | 29,570 | |
Third-party issuance costs related to term loans | (740) | |
Proceeds from issuance of common stock on IPO, net of issuance costs | 159,898 | |
Proceeds from exercise of stock options | 102 | 464 |
Proceeds from the issuance of common stock under ESPP | 519 | 332 |
Net cash provided by financing activities | 29,451 | 160,694 |
Net increase (decrease) in cash and restricted cash equivalents | (64,265) | 59,074 |
Cash, cash equivalents and restricted cash equivalents, beginning of period | 105,982 | 60,550 |
Cash, cash equivalents and restricted cash equivalents, end of period | 41,717 | 119,624 |
Reconciliation to amounts on the condensed balance sheets: | ||
Cash and cash equivalents | 39,774 | 117,286 |
Restricted cash equivalents | 1,943 | 2,338 |
Total cash, cash equivalents and restricted cash equivalents | 41,717 | 119,624 |
Supplemental disclosures of cash flow information | ||
Cash paid for taxes | 16 | |
Cash paid for interest, net of amounts capitalized | 1,529 | |
Supplemental disclosures of noncash financing and investing activities: | ||
Purchase of property and equipment included in accounts payable and accrued liabilities | 2,220 | 550 |
Net acquisition of right-of-use asset through operating lease obligation | 16,443 | 2,362 |
Issuance of warrants in connection with term loan | 494 | |
Vesting of early exercise options | 52 | 52 |
Stock-based compensation expense adjustments to inventory | $ 584 | 360 |
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | 24,982 | |
Conversion of convertible redeemable preferred shares into common stock on IPO | $ 121,080 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2022 | |
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 with a mission to bring central laboratory quality testing for infectious diseases in the home and point of care settings. 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. Liquidity and Going Concern Net loss for the three and nine months ended September 30, 2022 was $ 126.9 million and $ 135.5 million , respectively, as compared to net loss of $ 27.5 million and $ 57.0 million , for the three and nine months ended September 30, 2021, respectivel y. The Company had net income of $ 13.1 million for the three months ended March 31, 2022, which was the first period the Company achieved net income since its inception. The Company incurred recurring losses and negative cash flow from all other periods of its operating activities. The Company may continue to incur additional losses in future periods and the net losses that the Company incurs may fluctuate significantly from period to period due to the seasonality of its product portfolio. As of September 30, 2022, the Company had $ 39.8 million in cash and cash equivalents and an accumulated deficit of $ 264.0 million . The Company generated net sales of $ 34.4 million and $ 151.0 million in the three and nine months ended September 30, 2022 , respectively. 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 10. Term Loans. Based on the Company’s current planned operations, and in the absence of additional sources of liquidity, management anticipates that its existing cash and cash equivalents and anticipated cash flows from operations will not be sufficient to meet its operating and liquidity needs for at least twelve months from the issuance of the accompanying unaudited condensed financial statements. On November 1, 2022, the Food and Drug Administration (“FDA”) recommended moving forward with the review and Emergency Use Authorization (“EUA”) authorization of the Lucira COVID-19 and influenza test for a point-of-care (“POC”) indication. On November 4, 2022, the Company submitted an amendment to the FDA to limit the indication at this time only to POC use. The FDA has agreed to allow the Company to further amend this POC EUA to include over-the-counter (“OTC”) use once additional prospective clinical data has been obtained through ongoing clinical trials. The Company believes the delay in receiving the EUA for OTC use will materially adversely impact its ability to generate revenue during this upcoming flu season. The ability to continue as a going concern is dependent upon the Company 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 securities, or other sources of capital in order to further implement its business plan. However, if other 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, or curtail current operations and business plans. The Company’s board of directors (the “Board”) has initiated a review of strategic alternatives, including a potential sale, merger or other strategic transaction, and of our financing strategy. The Company is in the early stages of this strategic review and has not set a timetable for completion of the review process. There can be no assurance that the process will result in any transaction or strategic change at this time. Taken together, the Company believes the conditions and events described above raise substantial doubt about the Company’s ability to continue as a going concern within the next twelve months from the date of the issuance of the accompanying unaudited condensed financial statements. While the accompanying unaudited condensed financial statements have been prepared under the going concern basis of accounting, the Company continues to evaluate plans to resolve its risks to continue to operate as a going concern. These plans, however, have not yet been finalized and are not fully within the Company’s control. As a result, management has concluded that its plans at this stage do not alleviate substantial doubt about the Company’s ability to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
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 (“GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and pursuant to the instructions of the SEC on Form 10-Q and Article 10 of Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the management’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. The accompanying unaudited condensed balance sheet as of September 30, 2022, the unaudited condensed statements of operations for the three and nine months ended September 30, 2022 and 2021, the statements of redeemable convertible preferred stock and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021, and the unaudited condensed statements of cash flows for the nine months ended September 30, 2022 and 2021 are unaudited. The unaudited interim unaudited condensed financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2022 and the results of its operations and cash flows for the nine months ended September 30, 2022 and 2021. The financial data and other information disclosed in these notes as of September 30, 2022 and 2021 and for the three and nine months ended September 30, 2022 and 2021 are unaudited. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. These unaudited condensed financial statements and accompanying notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 , as filed with the SEC on March 31, 2022. Risks and Uncertainties The Company’s ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the conflicts in Ukraine and potential resurgence related to the COVID-19 pandemic and actions taken to slow its spread, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If the Company is not able to secure adequate additional funding when needed, the Company will need to re-evaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, limit, suspend or curtail planned test kit development programs and commercialization efforts, and cease operations entirely. Having insufficient funds may also require the Company to relinquish rights to technology that it would otherwise prefer to develop and market itself, or on less favorable terms than the Company would otherwise choose. The foregoing actions and circumstances could materially adversely impact the Company's business, results of operations and future prospects. Use of Estimates Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to recognition of stock-based compensation, incremental borrowing rate, revenue recognition, inventory valuation, sales returns, warranty reserves, allowance for doubtful accounts, accrued research and development costs, uncertain tax positions, the recoverability of its long-lived assets and the valuation of deferred tax assets. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. Reclassifications Certain prior period amounts have been reclassified to conform to the current period presentation. The impact of these reclassifications did not have an impact to the current assets and liabilities, the statements of operations or net operating cash flows. Cash, Cash Equivalents 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 September 30, 2022 and December 31, 2021, the Company held cash and cash equivalents of $ 39.8 million and $ 106.0 million , respectively, primarily consisting of short-term, highly liquid instruments, which consists of money market accounts and high-quality debt securities issued by the U.S. government via cash sweep accounts. All cash and cash equivalents are maintained with major financial institutions. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits; however, these deposits typically may be redeemed upon demand and, therefore, bear minimal risk. As of September 30, 2022, the Company held a restricted cash equivalents balance of $ 1.9 million which was used to secure standby letters of credit in relation to the Company’s operating lease agreement entered into in March 2022 for a facility in Vista, California, and the lease agreement entered into in June 2022 for a facility in Berkeley, California. The cash was deposited in a money market account with maturities of three months or less, with automatic renewal. The standby letters of credit are subject to annual automatic renewal over the term of the associated lease. The restricted cash equivalents are recorded as a long-term asset on the unaudited condensed balance sheets as of September 30, 2022 , due to the long-term nature of the underlying obligation. Fair Value Measurements The carrying value of the Company’s cash, cash equivalents, restricted cash equivalents, accounts receivable, other receivable, prepaid expenses, other current assets, accounts payable and accrued liabilities approximate fair value due to the short-term nature of these items. The Company has not elected to apply fair value accounting related to its Term Loans. 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. 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. 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, remaining shelf life, excessive levels of inventory, deterioration, salvage value and other factors. Inventory held as of September 30, 2022 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. See Note 6 Inventory. Warranty The Company offers a standard product warranty that its 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, costs incurred for replacement materials in correcting product failures, and warranty policies. The Company regularly reviews these estimates to assess the appropriateness of the Company’s recorded warranty liabilities and adjust the amounts as necessary. As of September 30, 2022 and December 31, 2021 , the accrued liability for warranty returns was not significant. Property and Equipment, Net Property and equipment are stated at cost, net of accumulated 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. Construction in progress consists of multiple projects, primarily related to new equipment to expand our manufacturing capability as our product demand grows. Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. 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 unaudited condensed balance sheets and any resulting gain or loss is reflected in other income or expense in the unaudited condensed statements of operations in the period realized. Website Development Costs Website development costs are recorded at cost and amortized on a straight-line basis over their estimated useful lives. Website development costs consist of capitalized software costs incurred in the development of the Lucira Connect website and the Company's e-commerce platform and web based tools (the "websites"). The Company determined that costs incurred during the website development stage of its website development programs that are directly related to the actual development of the respective software application are capitalized, while costs incurred in the preliminary project and post implementation stages are expensed as incurred. Additionally, indirect costs related to the software development during the website development stages are expensed as incurred. As the websites are constantly updated to the next version once they have reached technological feasibility, the Company separates costs on a reasonable basis between maintenance and upgrades that extend the functionality and useful life of the websites. The maintenance costs are expensed as incurred. The Company has concluded that given the rapid changes in technology, the internally developed website software has a useful life of three years and is amortized on a straight-line basis. Amortization expense related to the websites is recorded in cost of products sold in the accompanying unaudited condensed statements of operations. 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 unaudited condensed balance sheets. The Company did not have any finance leases as of September 30, 2022 and December 31, 2021 . 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. 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. For the nine months ended September 30, 2022 , the Company determined that there were no impairments of its long-lived assets. For the three and nine months ended September 30, 2021, a $ 1.6 million impairment of long-lived assets was recorded. See additional discussion in Note 7. Property and Equipment, Net. Debt Issuance Costs, Debt Discount and Detachable Debt-Related Warrants As described in Note 10. Term Loans, the Company entered into a term loan credit facility with Silicon Valley Bank. (“SVB”) and Hercules Capital, Inc. (“Hercules”) during the nine months ended September 30, 2022 . Costs incurred to issue debt are deferred and recorded as a reduction of the debt balance in the accompanying unaudited condensed balance sheets. Debt discounts related to the relative fair value of warrants issued in conjunction with the debt are also recorded as a reduction of the debt balance and accreted over the expected term of the debt to interest expense using the effective interest method. 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 Company's initial public offering (the “IPO”) on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. 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, the Company will recognize revenue for arrangements once the performance obligations are satisfied and control of the product has transferred to the customer. This usually occurs 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/or customer acceptance of products depending on obligations written in the contract. Revenue is measured based on the amount of consideration that the Company expects to be entitled to, which considers both fixed and variable consideration. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal of revenue will not occur. Transaction price is impacted by variable consideration such as discounts, allowances and constraints placed on revenue due to uncertainty. 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. Collection of the Company’s net revenue generally occurs within 30 - 45 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. Some customers, particularly in certain countries outside of the United States, pay in advance of product delivery. Costs to obtain or fulfill a contract are expensed when incurred because the Company’s performance obligation is satisfied at a point in time. Costs to obtain a contract, commissions, are included in selling, general and administrative expenses and costs to fulfill a contract are included in cost of products sold in the unaudited condensed 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 to customers or upon customer acceptance of products 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. Shipping and Handling Costs Shipping and handling costs are included in cost of products sold. 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 unaudited condensed balance sheets and within research and development expenses in the unaudited condensed 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 $ 1.1 million and $ 1.9 million for the three and nine months ended September 30, 2022 , respectively, compared to less than $ 0.1 million and $ 1.3 million for the three and nine months ended September 30, 2021 , respectively, and are included in selling, general and administrative expenses in the accompanying unaudited condensed statements of operations. Stock-Based Compensation The Company’s stock-based awards consist of stock options issued to employees and non-employees, restricted stock units issued to employees and shares of the Company’s common stock purchased by employee participants in the ESPP. 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 fair value of the common stock is based on the closing price of the common stock on the date of grant as reported on the Nasdaq Global Select Market. The Company classifies stock-based compensation expense in its unaudited condensed statements of operations 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. The Company determines the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options over a similar time period, 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 . Provision for 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 earnings 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. 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 operating and reportable segment, which is the business of designing, manufacturing and selling of disposable test kits. 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 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 |
Net Sales
Net Sales | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Net Sales | Note 3. Net Sales All of the Company’s net sales have been derived from sales of its test kits through its healthcare, business-to-business, international and direct-to-consumer channels. Since receiving the initial EUA in the fourth quarter of 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. The following table sets forth the Company’s net sales by channel: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Healthcare $ 2,967 $ 1,647 $ 11,425 $ 4,269 Business-to-business 13,554 8,712 69,098 15,484 International 7,571 4,543 32,737 6,709 Direct-to-consumer 10,298 74 37,750 5,469 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 The following table sets forth the Company’s net sales, gross loss and gross margin: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 Cost of products sold 133,945 14,837 202,657 32,710 Impairment of long-lived assets — 1,622 — 1,622 Gross loss $ ( 99,555 ) $ ( 1,483 ) $ ( 51,647 ) $ ( 2,401 ) Gross margin ( 289 )% ( 10 )% ( 34 )% ( 8 )% During the three and nine months ended September 30, 2022, the Company recorded a charge of $ 107.2 million related to excess inventory and non-cancellable purchase commitments that is reflected within cost of products sold on the unaudited condensed statements of operations. This charge includes $ 69.8 million of excess inventories of COVID-19 test kits, $ 7.4 million of advanced payments related to procurement of sub-assembly components and $ 30.0 million related to an accrual of excess non-cancellable purchase commitments for raw materials and non-cancelable purchase commitments with Jabil Inc. (“Jabil”). The charge primarily resulted from the Company's assessment of current inventory levels and non-cancellable purchase commitments for raw materials as compared to current net sales forecasts of its COVID-19 test kit and its combination COVID-19 and influenza test kit, for which the Company determined that a charge for excess inventory was necessary to adjust the carrying value of the test kits units on hand as of September 30, 2022 to their estimated net realizable value and to record the liability for the non-cancellable portion of raw materials purchase commitments. During the three and nine months ended September 30, 2021, certain facts and circumstances indicated that the costs of certain assets, primarily those associated with dry room facilities affixed to the Auburn Hills Michigan manufacturing facility, may not be recoverable before the end of their previously estimated useful life. Based on these facts and circumstances, the Company conducted an impairment analysis, which resulted in recording an impairment charge of $ 1.6 million related to these assets. The following table sets forth the Company’s net sales by geographic area based on the customers’ locations: Three Months Ended Nine Months Ended 2022 2021 2022 2021 United States $ 26,819 $ 10,433 $ 118,273 $ 25,222 Canada 7,058 2,683 30,982 2,683 Rest of World 513 1,860 1,755 4,026 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 |
Concentration of Credit Risk an
Concentration of Credit Risk and Significant Suppliers | 9 Months Ended |
Sep. 30, 2022 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk and Significant Suppliers | Note 4. Concentration of Credit Risk and Significant Suppliers Financial instruments that potentially subject the Company to credit risk consist principally of cash and restricted cash equivalents held by financial institutions, other receivables and account receivables. Substantially all of the Company’s cash and restricted cash equivalents are held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. The following customers had outstanding accounts receivable due of 10% or greater of the Company’s total accounts receivable. September 30, December 31, Customer A 22 % 19 % Customer B 48 % 12 % Customer C — % 18 % For the three and nine months ended September 30, 2022 and 2021, the following customers represented 10% or more of the Company’s net sales: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Customer A — % — % 11 % — % Customer B 17 % 14 % * * Customer C — % 15 % — % * Customer D * 11 % * * ________________________________ * Denotes that the customer accounted for less than 10% of net sales for the period presented. As of September 30, 2022, the Company had non-cancellable purchase commitments of $ 36.2 million , consisting primarily of $ 19.9 million of raw material purchase commitments, $ 5.8 million related to asset and equipment related to expanding the Company’s manufacturing capacity and automation, $ 2.2 million related to non-commercial services, $ 15.1 million pursuant to the manufacturing services agreement (the “Jabil MSA”), with Jabil, and technical services agreement with Jabil (the “Jabil TSA”). Under the Jabil MSA, 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. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 5. Fair Value Measurements The Company’s cash equivalents and restricted cash equivalents are measured at fair value on recurring basis and is classified as Level 1 input. Cash equivalents and restricted cash equivalents are a money market account that the Company opened in August 2020. 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 September 30, 2022 Level 1 Level 2 Level 3 Assets Cash equivalents $ 38,920 $ — $ — Restricted cash equivalents 1,943 — — Total $ 40,863 $ — $ — The Company did not have any financial instruments measured at fair value on a recurring basis as of September 30, 2022 . |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 6. Inventory Inventory consist of the following: September 30, December 31, Raw materials $ 16,477 $ 35,923 Work in process 28,579 10,539 Finished goods 10,569 4,314 Total $ 55,625 $ 50,776 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. During the three and nine months ended September 30, 2022, the Company recorded a charge of $ 69.8 million related to excess inventory. This charge primarily resulted from a significant reduction in sales forecast as a result of an unanticipated delay in the FDA’s approval of the Company's combination COVID-19 and influenza test kit and a decline in COVID-19 test kit demand. Accordingly, the Company determined that a write off adjustment was needed for excess inventory to adjust the carrying value of the inventory to their estimated net realizable value. In addition to such write off adjustments for the existing inventory, the Company recorded a charge of $ 7.4 million related to the balance of advanced payments for component parts. The Company also evaluated its non-cancellable commitments for the purchase of additional raw materials and accrued $ 30.0 million of which $ 27.3 million related to excess non-cancellable purchase commitments for raw materials and non-cancelable purchase commitments with Jabil and $ 2.7 million primarily related to materials purchased by Jabil on the Company's behalf for which the Company has not been billed as of September 30, 2022 as a component of cost of sales as such raw materials are also determined to be excess in relation to the anticipated sales volume with the Company’s normal operating cycle (see Note 3). Determination of the write off adjustment for the inventory on hand as well as non-cancellable purchase commitments is subject to significant uncertainty regarding the impact of future prevalence and severity of COVID-19 and influenza. In addition, management's estimates and assumptions including, but not limited to, future product demand, ability to renegotiate with various vendors, potential salvage value, and disposition costs are subject to additional adjustments, which can be material, if such estimates change in the future. Inventory as of September 30, 2022, and December 31, 2021 included $ 3.8 million and $ 0.0 million , respectively, of raw materials purchases for use in the U.S. pre-launch manufacturing campaign of its combination COVID-19 and influenza test kits. Stock-based compensation of $ 1.3 million and $ 0.4 million was capitalized into inventory for the nine months ended September 30, 2022 and 2021 , respectively. Capitalized stock-based compensation is recognized in cost of product sales when the related product is sold. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Note 7. Property and Equipment, Net September 30, December 31, 2022 2021 Construction in progress $ 23,317 $ 3,466 Machinery and equipment 30,332 29,333 Website development costs 1,457 1,110 Furniture and fixtures 784 200 Leasehold improvements 2,256 1,702 Total, at cost 58,146 35,811 Accumulated depreciation and amortization ( 9,851 ) ( 4,837 ) Property and equipment, net $ 48,295 $ 30,974 Depreciation and amortization expense was $ 1.7 million and $ 5.0 million for the three and nine months ended September 30, 2022, respectively, compared to $ 1.3 million and $ 2.2 million for the three and nine months ended September 30, 2021, respectively. During the nine months ended September 30, 2022, the Company deployed $ 1.0 million of assets into production from construction-in-progress. Construction-in-progress is related to the setup of manufacturing infrastructure and the purchase of long lead time manufacturing equipment. Construction-in-progress amounts recorded are not subject to depreciation as such assets are not yet available for their intended use. During the three and nine months ended September 30, 2021, certain facts and circumstances indicated that costs of certain assets, primarily those associated with dry room facilities affixed to the Auburn Hills Michigan manufacturing facility, may not be recoverable before the end of their previously estimated useful life. Based on these facts and circumstances, the Company conducted an impairment analysis, which resulted in recording an impairment charge of $ 1.6 million related to these assets. During the three and nine months ended September 30, 2022, there have been no facts or circumstances identified by the Company that would indicate the carrying value of the Company's long-lived assets may not be recoverable over their useful lives. The following table sets forth the Company’s long-lived assets, including ROU assets by geographic area: September 30, December 31, 2022 2021 United States $ 47,320 $ 16,730 Dominican Republic 15,760 15,753 All other countries 2,919 1,205 Total long-lived assets $ 65,999 $ 33,688 Substantially all of the Company's long-lived assets at locations outside of the United States, includes production related equipment located at certain vendor facilities. |
Other Financial Information
Other Financial Information | 9 Months Ended |
Sep. 30, 2022 | |
Other Financial Information [Abstract] | |
Other Financial Information | Note 8. Other Financial Information 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 period the accounts are determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: September 30, December 31, Beginning balance $ 99 $ — Amounts charged to costs and expenses ( 133 ) 358 Write-offs ( 153 ) ( 259 ) Recovery of previous write-offs 200 — Ending balance $ 13 $ 99 Other Receivable September 30, December 31, Other receivable $ 4,824 $ 8,188 The other receivable balance as of September 30, 2022 and 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 The following table summarizes the components of prepaid expenses: September 30, December 31, Prepaid expenses $ 871 $ 307 Prepaid insurance 1,635 588 Prepaid inventory — 9,379 Total $ 2,506 $ 10,274 As of September 30, 2022 and December 31, 2021, prepaid inventory includes $ 0.0 million and $ 9.4 million , respectively, of advanced payments related to procurement of inventories of components to be used in assembling test kits. For the three and nine months ended September 30, 2022, the Company recorded a charge for excess inventory of $ 7.4 million related to the balance of advanced payments for these component parts, which primarily resulted from the Company's assessment of current levels of inventory and related component parts as compared to current net sales forecasts related primarily to its combination COVID-19 and influenza test kit, for which the Company determined that a charge for excess inventory was necessary to adjust the carrying value of COVID-19 test kits and combination COVID-19 and influenza test kit units on hand and component parts as of September 30, 2022 to their estimated net realizable value. The charge for excess inventory is included in cost of products sold on the unaudited condensed statements of operations for the three and nine months ended September 30, 2022. Accrued Liabilities Accrued liabilities consist of the following: September 30, December 31, Professional fees $ 1,423 $ 612 Accrued manufacturing and inventory purchases 16,400 17,200 Accrued non-cancellable purchase orders 29,974 — Canada importation taxes 2,376 1,551 Payroll liabilities 2,098 4,466 Royalty liabilities — 1,662 Accrued sales tax 1,496 2,215 Early exercise liability 138 189 Accrued interest 281 — Insurance premium liability 421 — Other 425 1,267 Total $ 55,032 $ 29,162 Accrued liabilities as of September 30, 2022 include $ 30.0 million of accrued open non-cancellable purchase commitments related to raw materials for future inventory production. For the three and nine months ended September 30, 2022, the Company recorded a charge for excess inventory of the same amount, which primarily resulted from the Company's assessment of current levels of inventory and related non-cancellable raw materials purchase commitments as compared to current net sales forecasts of its combination COVID-19 and influenza test kit and COVID-19 test kits. The charge for excess inventory is included in cost of products sold on the unaudited condensed statements of operations for the three and nine months ended September 30, 2022 . |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | Note 9. Leases The Company has operating leases for corporate offices, operations and research and development facilities. These leases have remaining lease terms of 1 to 10 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. 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 for 60 months and includes lease incentives of an initial rent-free period. The Company is obligated to make monthly rent payments of approximately $ 1.3 million per year over the term of the lease. The Company took possession of the facility on April 1, 2022 to begin tenant improvements and expects completion and assumption of full occupancy by the end of June 2023. Under the terms of the operating lease, the Company has been provided tenant improvement allowances of up to $ 0.8 million. In conjunction with and under the terms of the operating lease agreement, the Company entered into a $ 1.2 million Standby Letter of Credit as guarantee of the Company’s payment of the tenant improvements and on-going rent payments over the term of the lease. The Company has accounted for the lease as an operating lease as of April 1, 2022, the commencement date under ASC Topic 842, Leases , and has recorded a ROU asset in the amount of $ 8.1 million, representing the Company’s right to use the underlying asset over the lease term and an offsetting lease liability of the same amount, representing the Company’s obligation to make lease payments arising from the lease. On June 15, 2022, the Company executed a lease for a 20,400 square foot facility in Berkeley, California. The term of the lease is 99 months with an option to extend 84 months and includes lease incentives of an initial rent-free period. The Company took possession of the facility on June 15, 2022 to begin tenant improvements and expects completion and assumption of full occupancy by March 2023. Under the terms of the operating lease, the Company has been provided tenant improvement allowances of up to $ 4.1 million. In conjunction with and under the terms of the operating lease agreement, the Company entered into a $ 0.7 million Standby Letter of Credit as guarantee of the Company’s payment of the tenant improvements and on-going rent payments over the term of the lease. The average annual rent over the term of the lease is approximately $ 1.8 million per year. The Company has accounted for the lease as an operating lease as of June 15, 2022, the commencement date under ASC Topic 842, Leases , and has recorded a ROU asset in the amount of $ 8.6 million, representing the Company’s right to use the underlying asset over the lease term and an offsetting lease liability, representing the Company’s obligation to make lease payments arising from the lease. Leases with an initial term of 12 months or less or those with an estimated lease liability less than a specified amount, are not recorded on the unaudited condensed 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 unaudited condensed balance sheets as of September 30, 2022 and December 31, 2021. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Maturities of lease liabilities as of September 30, 2022, are as follows: Operating Leases Year ending December 31: 2022 $ 434 2023 2,726 2024 2,922 2025 2,899 2026 2,994 Thereafter 17,010 Total 28,985 Less: imputed interest ( 10,302 ) Present value of operating lease liabilities 18,683 Less: current portion ( 2,316 ) Operating lease liabilities, net of current portion $ 16,367 The Company made operating lease payments of $ 1.4 million and $ 0.3 million during the nine months ended September 30, 2022 and 2021, respectively, which are included as cash flow from operating activities on the unaudited condensed statements of cash flows. Additional information related to the Company’s leases was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating lease cost $ 1,126 $ 253 $ 2,450 $ 471 Short-term lease cost $ 467 $ 312 $ 790 $ 939 September 30, December 31, Weighted-average remaining lease term (years) 8.81 1.82 Weighted-average discount rate 9.49 % 7.15 % In addition to the Vista and Berkley California leases, the Company has executed certain amendments to lease facilities in Emeryville and San Jose California. These amendments are the result of the Company's consolidation of certain of its locations and departments. Upon the execution of each of the amendments, which were deemed to be lease modifications, the Company remeasured the respective lease liabilities and corresponding ROU assets as of the effective date of each amendment and recorded a net reduction of $ 0.1 million during the nine months ended September 30, 2022 of the lease liabilities and respective ROU assets. |
Term Loans
Term Loans | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Term Loans | Note 10. Term Loans On February 4, 2022, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules in its capacity as administrative agent and collateral agent, and Hercules and SVB as lenders. The Loan Agreement was subsequently amended on March 17, 2022 and June 15, 2022 (the "Amended Loan Agreement"). The Amended Loan Agreement provides for up to $ 80.0 million in borrowing capacity (the “Term Loans”) available in four tranches. The first tranche consists of a Term Loan in an aggregate principal amount of $ 30.0 million, all of which was funded to the Company on the closing date. The Company intends to use the proceeds of the Term Loans for working capital and general corporate purposes. The second tranche, not to exceed $ 20.0 million, is available for draw at the Company’s option beginning September 1, 2022, and on or prior to March 31, 2023, subject to the terms of the Amended Loan Agreement and the tranche two draw test, defined as the achievement by the Company of net product revenue of at least $ 75.0 million, measured on a trailing six-month basis as of the Company’s most recent financial statements provided to the lenders. Loan advances under tranche two will be made in increments of $ 5.0 million. The third tranche of up to $ 15.0 million will be available for draw on or prior to June 15, 2023, subject to the terms of the Amended Loan Agreement and the tranche three draw test, defined as the achievement by the Company of net product revenue of at least $ 250.0 million, measured on a trailing twelve-month basis as of the Company’s most recent financial statements provided to the lenders. Loan advances under the third tranche will be made in increments of $ 5.0 million. The fourth tranche of up to $ 15.0 million will be available for draw on or prior to March 15, 2024, subject to the terms and conditions of the Amended Loan Agreement and approval by the investment committees of each of the lenders. 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 %. As of September 30, 2022, the interest rate was 11.75 % . For the three and nine months ended September 30, 2022, the Company recorded $ 1.0 million and $ 2.5 million , respectively, of interest expense related to the Term Loans, which included $ 0.2 million and $ 0.5 million , respectively, of non-cash interest related to the amortization of the loan discount. The Term Loans are interest only, paid monthly, up to September 1, 2024, after which the interest-only period may be extended, provided there has been no event of default or a continuing event of default and the Company has submitted sufficient evidence, satisfactory to the lenders, that the Company has achieved the tranche three draw test. After the interest only period, monthly principal and interest payments are required over the remaining term of the loans to the maturity date. The Company may prepay all or a portion of the outstanding term loan advances including principal and accrued and unpaid interest, subject to a prepayment fee of 3 % of the principal advance being prepaid if within 12 months of the initial advance closing date, 2 % if within 24 months of the advance closing date and 1 % if within 36 months of the advance closing date. An end of term charge of 5.25 % of the Term Loans advanced will be due upon prepayment or repayment. The Amended 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 of September 30, 2022 , the Company was in compliance with the financial covenants of the Amended 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. Notwithstanding the foregoing, the Company’s intellectual property will automatically be included within the assets securing the Term Loans to the extent necessary to permit perfection of the Lender’s security interests for rights to payment and proceeds from the sale, licensing or disposition of the Company’s intellectual property (the “Rights to Payment”) if a judicial authority holds that a security interest in the Rights to Payment requires a security interest in the underlying intellectual property. In connection with entering into the Loan Agreement, the Company issued warrants to Hercules (the “Hercules Warrant”) and to SVB (the “SVB Warrant” and together with the Hercules Warrant, the “Warrants”). The number of shares of the Company’s common stock subject to the Hercules Warrant is equal to the quotient derived by dividing the amount equal to 1.00 % times the aggregate principal amount of term loan advances made and funded under the Loan Agreement by the exercise price of $ 5.03 per share. The number of shares of the Company’s common stock subject to the SVB Warrant is equal to 1.00% multiplied by the aggregate amount of the term loan advances made and funded under the Loan Agreement divided by the $5.03 per share. In conjunction with the first tranche advance of $ 30.0 million, SVB and Hercules each hold Warrants to purchase 59,642 shares of the Company’s common stock. Each warrant is exercisable for a period of seven years from issuance at a per-share exercise price equal to $5.03. The Warrants, which met equity classification, were recognized as a component of permanent stockholders’ equity within additional paid-in-capital on the unaudited condensed balance sheets and were recorded at the issuance date using a relative fair value allocation method. The Company valued the Warrants at issuance, which resulted in a discount on the Term Loan, and allocated the proceeds from the loan proportionately to the Term Loan and to the Warrants, of which $ 0.5 million was allocated to the Warrants. The Company determined the fair value of the Warrants as of February 4, 2022 using the Black-Scholes option pricing model and applying the following assumptions: Fair value of common stock $ 5.15 Expected term (in years) 7.0 Risk-free interest rate 1.9 % Dividend yield — Volatility 92.6 % Because the Company does not have sufficient trading price history of its common stock, the volatility was based on historical trading price of a select peer group of publicly traded companies. In connection with entering into the Loan Agreement, the Company incurred $ 1.2 million of debt issuance costs, including commitment and legal fees in connection with the Loan Agreement, fees paid directly to the lenders and other direct third-party costs. Total issuance costs also include the fair value allocated to the Warrants and the end of term fee of $ 1.6 million, for $ 3.3 million of issuance costs. The Company allocated $ 2.7 million of the total issuance costs to the first term loan advance and recorded the issuance costs as unamortized discount, which is being amortized to non-cash interest expense over the term of the loan using the effective interest method. The remaining $ 0.6 million of issuance costs associated with unfunded loan advances are recorded as other assets on the unaudited condensed balance sheets and will be allocated to debt discount as the future tranche is funded. If future available tranches are not funded, these debt issuance costs will be charged to interest expense in the period. The $ 1.6 million end of term fee is included in the contractual cash flows and is accreted to interest expense using the effective interest method over the term of the loan. The effective interest rate on the Term Loans, including the discount and the accretion of the final end of term payment, was 13.7 % as of September 30, 2022. Balance sheet information related to the Term Loans is as follows: September 30, 2022 Tranche 1 of Term Loans (1) $ 31,575 Less: Unamortized debt discount and issuance costs ( 2,167 ) Carrying value of Term Loans, non-current $ 29,408 (1) Balance includes $ 1.6 million final end of term fee, which represents 5.25 % of the principal loan advance. The Company has not elected to apply fair value accounting to the Term Loans as the Company believes the carrying value of the Term Loans approximates fair value based on the variable coupon rate, subject to adjustments to the prime rate as published by the Wall Street Journal. The Term Loans are considered a Level 2 in the fair value measurement hierarchy. Interest expense, net of amounts capitalized is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Contractual coupon $ 832 $ — $ 1,959 $ — Amortization of debt discount and issuance costs 195 — 502 — Total interest expense on the Term Loan 1,027 — 2,461 — Other interest expense 12 — 50 — Capitalized interest ( 90 ) — ( 199 ) — Interest expense, net $ 949 $ — $ 2,312 $ — The Annual principal payments on the Term Loans are as follows: Year ending December 31, 2022 $ — 2023 — 2024 7,059 2025 21,176 2026 3,340 Total principal payments $ 31,575 |
Convertible Notes Payable
Convertible Notes Payable | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Convertible Notes Payable | Note 11. Convertible Notes Payable IPO and Conversion of Convertible Notes Payable On February 9, 2021, upon the closing of the IPO, certain then-outstanding convertible notes payable and accrued interest automatically converted into shares of common stock at a conversion price equal to 80 % of the IPO price per share, which resulted in the issuance of 1,470,947 shares of common stock. |
Capital Stock
Capital Stock | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Capital Stock | Note 12. Capital Stock Preferred Stock Under its 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 September 30, 2022. Common Stock Under its amended and restated certificate of incorporation, the Company is authorized to issue 200,000,000 shares of common 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. Under the Loan Agreement, as amended, the Company is precluded from declaring or paying cash dividends, subject to certain exceptions. 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: September 30, December 31, 2022 2021 Common stock option grants issued and outstanding under 2014 Equity Incentive Plan 2,905,756 3,245,250 Common stock reserved for issuance under the 2022 Inducement Plan 2,445,550 — Common stock reserved for issuance under the 2021 Equity Incentive Plan 3,102,956 1,578,216 Common stock option grants issued and outstanding under the 2021 Equity Incentive Plan 819,837 467,024 Restricted common stock units issued and outstanding 4,301,840 3,387,505 Warrants to purchase common stock 119,284 — Common stock reserved for issuance under ESPP 907,005 710,189 Total shares of common stock reserved for future issuance 14,602,228 9,388,184 |
Equity Incentive Plan
Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plan | Note 13. Equity Incentive Plan 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. On January 1, 2022, the number of shares available for issuance under the 2021 Plan was automatically increased by 1,983,182 shares. In April 2022, the Board approved the 2022 Inducement Plan, (the “Inducement Plan”) a non-stockholder approved stock plan, in order to award stock options, restricted stock units and other awards as allowed under the Inducement Plan as an inducement to potential new employees and directors of the Company. Under the Inducement Plan, 3,500,000 shares were approved and available for future issuance. As of September 30, 2022, 2,445,550 awards had been granted or were outstanding. The stock-based compensation expense for the Company’s equity incentive plans was allocated as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Cost of products sold $ 377 $ 91 $ 767 $ 351 Research and development 700 274 1,797 695 Selling, general and administrative 1,295 4,663 3,232 5,454 Total $ 2,372 $ 5,028 $ 5,796 $ 6,500 Stock-based compensation expense excludes amounts capitalized to inventory. During the three and nine months ended September 30, 2022, the Company capitalized stock-based compensation expense of $ 0.4 million and $ 1.3 million to inventory, respectively, and during the three and nine months ended September 30, 2021, the Company capitalized $ 0.1 million and $ 0.4 million of stock-based compensation expense to inventory, respectively. For the three and nine months ended September 30, 2022, cost of products sold includes $ 0.3 million of stock-based compensation included in the cost per unit of inventories written down to net realizable value. Total stock-based compensation expense by type of award was as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options $ 460 $ 4,678 $ 1,185 $ 5,642 Restricted stock units 1,875 252 4,932 $ 627 ESPP 96 98 263 $ 231 Total $ 2,431 $ 5,028 $ 6,380 $ 6,500 Total compensation costs as of September 30, 2022 related to non-vested awards to be recognized in future periods was $ 24.7 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 nine months ended September 30, 2022 is as follows: Number of Weighted- Weighted- Aggregate Balance as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Granted 431,213 $ 1.88 — — Exercised ( 73,940 ) $ 1.38 — — Cancelled ( 343,954 ) $ 5.05 — — Balance as of September 30, 2022 3,725,593 $ 3.01 7.3 $ 337,947 Options vested and expected to vest as of September 30, 2022 3,725,593 $ 3.01 7.3 $ 337,947 Options vested and exercisable as of September 30, 2022 2,154,038 $ 2.48 6.5 $ 288,503 Total options vested during the nine months ended September 30, 2022 was 842,371 , with an aggregate fair value of $ 1.6 million . The aggregate intrinsic value of options exercised was $ 0.1 million for the nine months ended September 30, 2022. Total compensation costs as of September 30, 2022 related to option awards to be recognized in future periods was $ 2.6 million and is expected to be recognized over the weighted average period of 2.1 years. The weighted-average grant date fair value of the options granted during the nine months ended September 30, 2022 and 2021 was $ 1.27 and $ 7.52 per share, respectively, as calculated using the Black-Scholes option-pricing model with the following assumptions on a weighted-average basis: Nine Months Ended September 30, 2022 2021 Fair value of common stock $ 1.88 $ 17.00 Expected term (in years) 5.5 5.9 Risk-free interest rate 3.0 % 0.6 % Dividend yield — — Volatility 79.6 % 46.9 % Common stock fair value —Prior to the IPO 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 on the date of grant is the closing price of the common stock as reported on the Nasdaq Global Select Market. Dividend yield of zero —The Company has not declared or paid dividends. Risk-free interest rates —The Company applied the risk-free interest rate based on the U.S. 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. Restricted Stock Units Restricted stock units (“RSUs”) are generally subject to a four 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 nine months ended September 30, 2022: Underlying Weighted- Balance as of December 31, 2021 3,387,505 $ 7.57 Granted 1,803,604 $ 3.33 Vested ( 511,298 ) $ 6.85 Canceled or forfeited ( 377,971 ) $ 7.78 Balance as of September 30, 2022 4,301,840 $ 5.86 Total compensation costs as of September 30, 2022 related to RSUs to be recognized in future periods was $ 22.1 million and is expected to be recognized over the weighted average period of 3.7 years. Employee Stock Purchase Plan The ESPP provides eligible employees with an opportunity to purchase common stock from the Company at a discount through accumulated payroll deductions. Under the ESPP, the Board may specify offerings but generally provides for a duration of six months, currently for which each six-month offering periods are February and August. In February 2021, the Company’s employees enrolled in the offering period (the “first offering”) to purchase a variable number of shares of its common stock under the ESPP at the purchase date. The purchase price is specified pursuant to each offering, but cannot, under the terms of the ESPP, be less than 85 % of the lower of the fair market value per share of the Company's common stock on either the offering date or on the purchase date. The ESPP also includes a six month look-back provision for the purchase price of the stock price on the purchase date is less than the stock price on the offering date. In January 2022, the number of shares available for issuance under the ESPP was automatically increased by 396,636 shares. As of September 30, 2022, the Company had 907,005 shares available for issuance under the ESPP. Pursuant to the ESPP, the Company issued 199,820 shares of common stock at a weighted average price per share of $ 2.60 during the nine months ended September 30, 2022. Cash received from purchases under the ESPP for the nine months ended September 30, 2022 was $ 0.5 million . 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 nine months ended September 30, 2022 and 2021: Fair value of shares to be issued under ESPP Nine Months Ended September 30, 2022 2021 Fair value of common stock $ 2.11 $ 9.80 Expected term (in years) 0.5 0.5 Risk-free interest rate 3.2 % 0.1 % Dividend yield — — Volatility 113.4 % 139.1 % |
Provision for Income Taxes
Provision for Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Provision for Income Taxes | Note 14. Provision for Income Taxes The Company recorded income tax expense of $ 14.0 thousand and $ 16.0 million for the three and nine months ended September 30, 2022, respectively, which primarily consisted of state taxes. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the carrying amounts of existing assets and liabilities in the financial statements and their respective tax bases using tax rates expected to be in effect during the years in which the basis differences reverse. The Company believes it is more likely than not that its federal and state net deferred tax assets will not be fully realized. In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of its deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. A valuation allowance is recorded for loss carryforwards and other deferred tax assets where it is more likely than not that such deferred tax assets will not be realized. Accordingly, the Company continues to maintain a valuation allowance against all of its U.S. net deferred tax assets as of September 30, 2022. The Company will continue to maintain a full valuation allowance against its net federal and state deferred tax assets until there is sufficient evidence to support recoverability of its deferred tax assets. As of September 30, 2022, the Company had total uncertain tax benefits of $ 1.1 million related to research and development credits, which is recorded as a reduction of the deferred tax assets-related credit carryforwards. The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months. It is the Company's policy to account for interest and penalties related to uncertain tax positions as interest expenses and selling, general and administrative expense, respectively, in its unaudited condensed statements of operations. No interest or penalty have been recorded related to the uncertain tax positions. 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 examination in progress. The statute of limitations for tax years ended after December 31, 2014 is open for federal and state tax purposes. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 15. Net Loss Per Share Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common stock outstanding during the period. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the net income (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 options and restricted stock units outstanding under the Company’s stock option plan, as well as warrants outstanding to purchase shares of the Company's common stock. In each of the periods of the three and nine months ended September 30, 2022 and 2021, 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: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Numerator Net loss attributable to common stockholders, basic and diluted $ ( 126,862 ) $ ( 27,496 ) $ ( 135,461 ) $ ( 57,012 ) Denominator Weighted-average number of shares of common stock outstanding: Basic and diluted 40,216,244 38,667,615 39,974,997 33,348,104 Net loss per share attributable to common stockholders: Basic and diluted $ ( 3.15 ) $ ( 0.71 ) $ ( 3.39 ) $ ( 1.71 ) 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): As of September 30, 2022 2021 Warrants to purchase common stock 119,284 - Options to purchase common stock 3,725,593 4,713,028 Unvested restricted stock units 4,301,840 1,763,445 Total 8,146,717 6,476,473 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 16. Commitments and Contingencies Commitments License Agreement with Eiken Chemical Co., Ltd. In July 2020, the Company entered into a patent license agreement (the “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 referred 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 referred to as the Initial Licensed Products, in the United States. The Company also had limited have-made rights with respect to the Eiken Licensed Patents. On March 8, 2022, the Company provided notice of termination of the Eiken Agreement, which became 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. As a result of the termination, the Company is no longer required to make any future royalty payments under the Eiken Agreement. The Company was obligated to pay a royalty in the low single-digit percentage on total net sales of all Licensed Products, which was recorded as a cost of products sold. Royalty expense for the three and nine months ended September 30, 2022 was $ 0.0 million and $ 4.0 million , respectively, and for the three and nine months ended September 30, 2021 was $ 0.5 million and $ 1.0 million , respectively. Technology Services Agreement with Jabil On September 10, 2020, the Company entered into the Jabil TSA, 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. Manufacturing Services Agreement with Jabil On September 10, 2020, the Company entered into the Jabil MSA, 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 September 30, 2022, the Company had $ 15.1 million of non-cancellable purchase commitments pursuant to the manufacturing services agreement with Jabil, and technical services agreement with Jabil. Other Commitments As of September 30, 2022, the Company had non-cancellable purchase commitments of $ 27.9 million , consisting primarily of $ 19.9 million of raw material purchase commitments, and $ 5.8 million asset and equipment related to expanding its manufacturing capacity and automation, and $ 2.2 million related to non-commercial services. Of the $ 27.9 million non-cancellable purchase commitments, the Company accrued for $ 19.9 million of accrued open non-cancellable purchase commitments related to raw materials for future inventory production (see Note 3). 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 would be expected to have a material adverse effect on the financial position, results of operations or cash flows of the Company. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 17. Related Parties The Company incurred less than $ 0.1 million and $ 0.1 million in expenses with individuals related to a former executive officer and the Board during both the three and nine months ended September 30, 2022 and 2021 , respectively. Additionally, the Company recorded revenues of less than $ 0.1 million and less than $ 0.1 million from individuals or companies related to an executive officer and the Board during the three and nine months ended September 30, 2022 and 2021 , respectively. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 18. Subsequent Events Reduction in Force On October 20, 2022, the Board approved a reduction in force involving 56 employees, representing approximately 25.0 % of the Company’s workforce. On October 31, 2022, the Company notified such employees of this reduction in force. The Company expects that this reduction in force will be completed by December 30, 2022 . On November 14, 2022, the Company notified an additional 97 employees of a second reduction in force, representing approximately 43.0 % of its workforce. The Company expects that this reduction in force will be completed by January 15, 2023 . The Company does not expect to incur material charges in connection with these reductions in force. These actions are part of the Company’s initiatives to re-balance its cost structure. Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer On November 10, 2022, Daniel George, Chief Financial Officer, notified the Company of his decision to resign, effective November 15, 2022. We expect Mr. George will remain as a consultant to the Company. Effective upon Mr. George’s resignation, the Board appointed Richard Narido to serve as Chief Financial Officer on an interim basis. Mr. Narido, is currently the Company's Vice President of Finance, a role he has held since March 2021. While acting as interim Chief Financial Officer, Mr. Narido will serve as the Company's principal financial officer and principal accounting officer. Departure of Board Member and Chief Technology Officer On November 14, 2022, Debkishore Mitra, Ph.D., Chief Technology Officer and a member of the Board, notified the Company of his decision to resign from both positions, effective November 18, 2022. We expect Dr. Mitra will remain as a consultant to the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 (“GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and pursuant to the instructions of the SEC on Form 10-Q and Article 10 of Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the management’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. The accompanying unaudited condensed balance sheet as of September 30, 2022, the unaudited condensed statements of operations for the three and nine months ended September 30, 2022 and 2021, the statements of redeemable convertible preferred stock and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021, and the unaudited condensed statements of cash flows for the nine months ended September 30, 2022 and 2021 are unaudited. The unaudited interim unaudited condensed financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2022 and the results of its operations and cash flows for the nine months ended September 30, 2022 and 2021. The financial data and other information disclosed in these notes as of September 30, 2022 and 2021 and for the three and nine months ended September 30, 2022 and 2021 are unaudited. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. These unaudited condensed financial statements and accompanying notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 , as filed with the SEC on March 31, 2022. |
Risks and Uncertainties | Risks and Uncertainties The Company’s ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the conflicts in Ukraine and potential resurgence related to the COVID-19 pandemic and actions taken to slow its spread, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If the Company is not able to secure adequate additional funding when needed, the Company will need to re-evaluate its operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, limit, suspend or curtail planned test kit development programs and commercialization efforts, and cease operations entirely. Having insufficient funds may also require the Company to relinquish rights to technology that it would otherwise prefer to develop and market itself, or on less favorable terms than the Company would otherwise choose. The foregoing actions and circumstances could materially adversely impact the Company's business, results of operations and future prospects. |
Use of Estimates | Use of Estimates Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to recognition of stock-based compensation, incremental borrowing rate, revenue recognition, inventory valuation, sales returns, warranty reserves, allowance for doubtful accounts, accrued research and development costs, uncertain tax positions, the recoverability of its long-lived assets and the valuation of deferred tax assets. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. |
Reclassifications | Reclassifications Certain prior period amounts have been reclassified to conform to the current period presentation. The impact of these reclassifications did not have an impact to the current assets and liabilities, the statements of operations or net operating cash flows. |
Cash, Cash Equivalents and Restricted Cash Equivalents | Cash, Cash Equivalents 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 September 30, 2022 and December 31, 2021, the Company held cash and cash equivalents of $ 39.8 million and $ 106.0 million , respectively, primarily consisting of short-term, highly liquid instruments, which consists of money market accounts and high-quality debt securities issued by the U.S. government via cash sweep accounts. All cash and cash equivalents are maintained with major financial institutions. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits; however, these deposits typically may be redeemed upon demand and, therefore, bear minimal risk. As of September 30, 2022, the Company held a restricted cash equivalents balance of $ 1.9 million which was used to secure standby letters of credit in relation to the Company’s operating lease agreement entered into in March 2022 for a facility in Vista, California, and the lease agreement entered into in June 2022 for a facility in Berkeley, California. The cash was deposited in a money market account with maturities of three months or less, with automatic renewal. The standby letters of credit are subject to annual automatic renewal over the term of the associated lease. The restricted cash equivalents are recorded as a long-term asset on the unaudited condensed balance sheets as of September 30, 2022 , due to the long-term nature of the underlying obligation. |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company’s cash, cash equivalents, restricted cash equivalents, accounts receivable, other receivable, prepaid expenses, other current assets, accounts payable and accrued liabilities approximate fair value due to the short-term nature of these items. The Company has not elected to apply fair value accounting related to its Term Loans. 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. |
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. |
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, remaining shelf life, excessive levels of inventory, deterioration, salvage value and other factors. Inventory held as of September 30, 2022 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. See Note 6 Inventory. |
Warranty | Warranty The Company offers a standard product warranty that its 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, costs incurred for replacement materials in correcting product failures, and warranty policies. The Company regularly reviews these estimates to assess the appropriateness of the Company’s recorded warranty liabilities and adjust the amounts as necessary. As of September 30, 2022 and December 31, 2021 , 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 accumulated 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. Construction in progress consists of multiple projects, primarily related to new equipment to expand our manufacturing capability as our product demand grows. Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. 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 unaudited condensed balance sheets and any resulting gain or loss is reflected in other income or expense in the unaudited condensed statements of operations in the period realized. |
Website Development Costs | Website Development Costs Website development costs are recorded at cost and amortized on a straight-line basis over their estimated useful lives. Website development costs consist of capitalized software costs incurred in the development of the Lucira Connect website and the Company's e-commerce platform and web based tools (the "websites"). The Company determined that costs incurred during the website development stage of its website development programs that are directly related to the actual development of the respective software application are capitalized, while costs incurred in the preliminary project and post implementation stages are expensed as incurred. Additionally, indirect costs related to the software development during the website development stages are expensed as incurred. As the websites are constantly updated to the next version once they have reached technological feasibility, the Company separates costs on a reasonable basis between maintenance and upgrades that extend the functionality and useful life of the websites. The maintenance costs are expensed as incurred. The Company has concluded that given the rapid changes in technology, the internally developed website software has a useful life of three years and is amortized on a straight-line basis. Amortization expense related to the websites is recorded in cost of products sold in the accompanying unaudited condensed statements of operations. |
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 unaudited condensed balance sheets. The Company did not have any finance leases as of September 30, 2022 and December 31, 2021 . 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. 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. For the nine months ended September 30, 2022 , the Company determined that there were no impairments of its long-lived assets. For the three and nine months ended September 30, 2021, a $ 1.6 million impairment of long-lived assets was recorded. See additional discussion in Note 7. Property and Equipment, Net. |
Debt Issuance Costs, Debt Discount and Detachable Debt-Related Warrants | Debt Issuance Costs, Debt Discount and Detachable Debt-Related Warrants As described in Note 10. Term Loans, the Company entered into a term loan credit facility with Silicon Valley Bank. (“SVB”) and Hercules Capital, Inc. (“Hercules”) during the nine months ended September 30, 2022 . Costs incurred to issue debt are deferred and recorded as a reduction of the debt balance in the accompanying unaudited condensed balance sheets. Debt discounts related to the relative fair value of warrants issued in conjunction with the debt are also recorded as a reduction of the debt balance and accreted over the expected term of the debt to interest expense using the effective interest method. |
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 Company's initial public offering (the “IPO”) on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. |
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, the Company will recognize revenue for arrangements once the performance obligations are satisfied and control of the product has transferred to the customer. This usually occurs 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/or customer acceptance of products depending on obligations written in the contract. Revenue is measured based on the amount of consideration that the Company expects to be entitled to, which considers both fixed and variable consideration. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal of revenue will not occur. Transaction price is impacted by variable consideration such as discounts, allowances and constraints placed on revenue due to uncertainty. 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. Collection of the Company’s net revenue generally occurs within 30 - 45 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. Some customers, particularly in certain countries outside of the United States, pay in advance of product delivery. Costs to obtain or fulfill a contract are expensed when incurred because the Company’s performance obligation is satisfied at a point in time. Costs to obtain a contract, commissions, are included in selling, general and administrative expenses and costs to fulfill a contract are included in cost of products sold in the unaudited condensed 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 to customers or upon customer acceptance of products 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. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs are included in cost of products sold. |
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 unaudited condensed balance sheets and within research and development expenses in the unaudited condensed 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 $ 1.1 million and $ 1.9 million for the three and nine months ended September 30, 2022 , respectively, compared to less than $ 0.1 million and $ 1.3 million for the three and nine months ended September 30, 2021 , respectively, and are included in selling, general and administrative expenses in the accompanying unaudited condensed 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, restricted stock units issued to employees and shares of the Company’s common stock purchased by employee participants in the ESPP. 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 fair value of the common stock is based on the closing price of the common stock on the date of grant as reported on the Nasdaq Global Select Market. The Company classifies stock-based compensation expense in its unaudited condensed statements of operations 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. The Company determines the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options over a similar time period, 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 . |
Provision for Income Taxes | Provision for 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 earnings 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. |
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 operating and reportable segment, which is the business of designing, manufacturing and selling of disposable test kits. |
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 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 August 2020, the FASB issued ASU No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. The Company early adopted the ASU on January 1, 2022 . Adoption of the ASU did not impact the Company’s financial position, results of operations or cash flows. 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 , which requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The standard is effective for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company expects to adopt this ASU beginning January 1, 2023. The Company is evaluating the potential impact of this standard on its financial statements, but does not expect the adoption to have a material impact on the Company's financial statements. |
Net Sales (Tables)
Net Sales (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
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: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Healthcare $ 2,967 $ 1,647 $ 11,425 $ 4,269 Business-to-business 13,554 8,712 69,098 15,484 International 7,571 4,543 32,737 6,709 Direct-to-consumer 10,298 74 37,750 5,469 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 The following table sets forth the Company’s net sales by geographic area based on the customers’ locations: Three Months Ended Nine Months Ended 2022 2021 2022 2021 United States $ 26,819 $ 10,433 $ 118,273 $ 25,222 Canada 7,058 2,683 30,982 2,683 Rest of World 513 1,860 1,755 4,026 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 |
Summary of Net Sales, Gross Loss and Gross Margin | The following table sets forth the Company’s net sales, gross loss and gross margin: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Net sales $ 34,390 $ 14,976 $ 151,010 $ 31,931 Cost of products sold 133,945 14,837 202,657 32,710 Impairment of long-lived assets — 1,622 — 1,622 Gross loss $ ( 99,555 ) $ ( 1,483 ) $ ( 51,647 ) $ ( 2,401 ) Gross margin ( 289 )% ( 10 )% ( 34 )% ( 8 )% |
Concentration of Credit Risk _2
Concentration of Credit Risk and Significant Suppliers (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Risks and Uncertainties [Abstract] | |
Schedules of Concentration of Risk, by Risk Factor | The following customers had outstanding accounts receivable due of 10% or greater of the Company’s total accounts receivable. September 30, December 31, Customer A 22 % 19 % Customer B 48 % 12 % Customer C — % 18 % For the three and nine months ended September 30, 2022 and 2021, the following customers represented 10% or more of the Company’s net sales: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Customer A — % — % 11 % — % Customer B 17 % 14 % * * Customer C — % 15 % — % * Customer D * 11 % * * ________________________________ * Denotes that the customer accounted for less than 10% of net sales for the period presented. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 Level 1 Level 2 Level 3 Assets Cash equivalents $ 38,920 $ — $ — Restricted cash equivalents 1,943 — — Total $ 40,863 $ — $ — |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consist of the following: September 30, December 31, Raw materials $ 16,477 $ 35,923 Work in process 28,579 10,539 Finished goods 10,569 4,314 Total $ 55,625 $ 50,776 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | September 30, December 31, 2022 2021 Construction in progress $ 23,317 $ 3,466 Machinery and equipment 30,332 29,333 Website development costs 1,457 1,110 Furniture and fixtures 784 200 Leasehold improvements 2,256 1,702 Total, at cost 58,146 35,811 Accumulated depreciation and amortization ( 9,851 ) ( 4,837 ) Property and equipment, net $ 48,295 $ 30,974 |
Schedule of Long-Lived Assets Including ROU Assets by Geographic Area | The following table sets forth the Company’s long-lived assets, including ROU assets by geographic area: September 30, December 31, 2022 2021 United States $ 47,320 $ 16,730 Dominican Republic 15,760 15,753 All other countries 2,919 1,205 Total long-lived assets $ 65,999 $ 33,688 |
Other Financial Information (Ta
Other Financial Information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Financial Information [Abstract] | |
Summary of Activity in Allowance for Doubtful Accounts | The following table summarizes the activity in the allowance for doubtful accounts: September 30, December 31, Beginning balance $ 99 $ — Amounts charged to costs and expenses ( 133 ) 358 Write-offs ( 153 ) ( 259 ) Recovery of previous write-offs 200 — Ending balance $ 13 $ 99 |
Schedule of Other Receivables | Other Receivable September 30, December 31, Other receivable $ 4,824 $ 8,188 |
Schedule of Prepaid Expenses | The following table summarizes the components of prepaid expenses: September 30, December 31, Prepaid expenses $ 871 $ 307 Prepaid insurance 1,635 588 Prepaid inventory — 9,379 Total $ 2,506 $ 10,274 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: September 30, December 31, Professional fees $ 1,423 $ 612 Accrued manufacturing and inventory purchases 16,400 17,200 Accrued non-cancellable purchase orders 29,974 — Canada importation taxes 2,376 1,551 Payroll liabilities 2,098 4,466 Royalty liabilities — 1,662 Accrued sales tax 1,496 2,215 Early exercise liability 138 189 Accrued interest 281 — Insurance premium liability 421 — Other 425 1,267 Total $ 55,032 $ 29,162 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of September 30, 2022, are as follows: Operating Leases Year ending December 31: 2022 $ 434 2023 2,726 2024 2,922 2025 2,899 2026 2,994 Thereafter 17,010 Total 28,985 Less: imputed interest ( 10,302 ) Present value of operating lease liabilities 18,683 Less: current portion ( 2,316 ) Operating lease liabilities, net of current portion $ 16,367 |
Summary of Additional Information Related to Leases | Additional information related to the Company’s leases was as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating lease cost $ 1,126 $ 253 $ 2,450 $ 471 Short-term lease cost $ 467 $ 312 $ 790 $ 939 September 30, December 31, Weighted-average remaining lease term (years) 8.81 1.82 Weighted-average discount rate 9.49 % 7.15 % |
Term Loans (Tables)
Term Loans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Assumptions Used to Estimate Fair Value of Warrants | The Company determined the fair value of the Warrants as of February 4, 2022 using the Black-Scholes option pricing model and applying the following assumptions: Fair value of common stock $ 5.15 Expected term (in years) 7.0 Risk-free interest rate 1.9 % Dividend yield — Volatility 92.6 % The weighted-average grant date fair value of the options granted during the nine months ended September 30, 2022 and 2021 was $ 1.27 and $ 7.52 per share, respectively, as calculated using the Black-Scholes option-pricing model with the following assumptions on a weighted-average basis: Nine Months Ended September 30, 2022 2021 Fair value of common stock $ 1.88 $ 17.00 Expected term (in years) 5.5 5.9 Risk-free interest rate 3.0 % 0.6 % Dividend yield — — Volatility 79.6 % 46.9 % |
Schedule of Balance Sheet Information Related to Term Loans | Balance sheet information related to the Term Loans is as follows: September 30, 2022 Tranche 1 of Term Loans (1) $ 31,575 Less: Unamortized debt discount and issuance costs ( 2,167 ) Carrying value of Term Loans, non-current $ 29,408 (1) Balance includes $ 1.6 million final end of term fee, which represents 5.25 % of the principal loan advance. |
Schedule of Interest Expense, Net of Amounts Capitalized | Interest expense, net of amounts capitalized is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Contractual coupon $ 832 $ — $ 1,959 $ — Amortization of debt discount and issuance costs 195 — 502 — Total interest expense on the Term Loan 1,027 — 2,461 — Other interest expense 12 — 50 — Capitalized interest ( 90 ) — ( 199 ) — Interest expense, net $ 949 $ — $ 2,312 $ — |
Schedule of Annual Principal Payments | The Annual principal payments on the Term Loans are as follows: Year ending December 31, 2022 $ — 2023 — 2024 7,059 2025 21,176 2026 3,340 Total principal payments $ 31,575 |
Capital Stock (Tables)
Capital Stock (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
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: September 30, December 31, 2022 2021 Common stock option grants issued and outstanding under 2014 Equity Incentive Plan 2,905,756 3,245,250 Common stock reserved for issuance under the 2022 Inducement Plan 2,445,550 — Common stock reserved for issuance under the 2021 Equity Incentive Plan 3,102,956 1,578,216 Common stock option grants issued and outstanding under the 2021 Equity Incentive Plan 819,837 467,024 Restricted common stock units issued and outstanding 4,301,840 3,387,505 Warrants to purchase common stock 119,284 — Common stock reserved for issuance under ESPP 907,005 710,189 Total shares of common stock reserved for future issuance 14,602,228 9,388,184 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Expense for Equity Incentive Plans | The stock-based compensation expense for the Company’s equity incentive plans was allocated as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Cost of products sold $ 377 $ 91 $ 767 $ 351 Research and development 700 274 1,797 695 Selling, general and administrative 1,295 4,663 3,232 5,454 Total $ 2,372 $ 5,028 $ 5,796 $ 6,500 Stock-based compensation expense excludes amounts capitalized to inventory. During the three and nine months ended September 30, 2022, the Company capitalized stock-based compensation expense of $ 0.4 million and $ 1.3 million to inventory, respectively, and during the three and nine months ended September 30, 2021, the Company capitalized $ 0.1 million and $ 0.4 million of stock-based compensation expense to inventory, respectively. For the three and nine months ended September 30, 2022, cost of products sold includes $ 0.3 million of stock-based compensation included in the cost per unit of inventories written down to net realizable value. Total stock-based compensation expense by type of award was as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options $ 460 $ 4,678 $ 1,185 $ 5,642 Restricted stock units 1,875 252 4,932 $ 627 ESPP 96 98 263 $ 231 Total $ 2,431 $ 5,028 $ 6,380 $ 6,500 |
Summary of Stock Option Activity | A summary of stock option activity for the nine months ended September 30, 2022 is as follows: Number of Weighted- Weighted- Aggregate Balance as of December 31, 2021 3,712,274 $ 3.30 8.1 $ 23,150 Granted 431,213 $ 1.88 — — Exercised ( 73,940 ) $ 1.38 — — Cancelled ( 343,954 ) $ 5.05 — — Balance as of September 30, 2022 3,725,593 $ 3.01 7.3 $ 337,947 Options vested and expected to vest as of September 30, 2022 3,725,593 $ 3.01 7.3 $ 337,947 Options vested and exercisable as of September 30, 2022 2,154,038 $ 2.48 6.5 $ 288,503 |
Summary of Assumptions Used to Estimate Fair Value of Warrants | The Company determined the fair value of the Warrants as of February 4, 2022 using the Black-Scholes option pricing model and applying the following assumptions: Fair value of common stock $ 5.15 Expected term (in years) 7.0 Risk-free interest rate 1.9 % Dividend yield — Volatility 92.6 % The weighted-average grant date fair value of the options granted during the nine months ended September 30, 2022 and 2021 was $ 1.27 and $ 7.52 per share, respectively, as calculated using the Black-Scholes option-pricing model with the following assumptions on a weighted-average basis: Nine Months Ended September 30, 2022 2021 Fair value of common stock $ 1.88 $ 17.00 Expected term (in years) 5.5 5.9 Risk-free interest rate 3.0 % 0.6 % Dividend yield — — Volatility 79.6 % 46.9 % |
Summary of Restricted Stock Units Activity | The Company had the following activity for RSUs for the nine months ended September 30, 2022: Underlying Weighted- Balance as of December 31, 2021 3,387,505 $ 7.57 Granted 1,803,604 $ 3.33 Vested ( 511,298 ) $ 6.85 Canceled or forfeited ( 377,971 ) $ 7.78 Balance as of September 30, 2022 4,301,840 $ 5.86 |
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 nine months ended September 30, 2022 and 2021: Fair value of shares to be issued under ESPP Nine Months Ended September 30, 2022 2021 Fair value of common stock $ 2.11 $ 9.80 Expected term (in years) 0.5 0.5 Risk-free interest rate 3.2 % 0.1 % Dividend yield — — Volatility 113.4 % 139.1 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Net Loss Per Share | The following table summarizes the Company’s net loss per share: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Numerator Net loss attributable to common stockholders, basic and diluted $ ( 126,862 ) $ ( 27,496 ) $ ( 135,461 ) $ ( 57,012 ) Denominator Weighted-average number of shares of common stock outstanding: Basic and diluted 40,216,244 38,667,615 39,974,997 33,348,104 Net loss per share attributable to common stockholders: Basic and diluted $ ( 3.15 ) $ ( 0.71 ) $ ( 3.39 ) $ ( 1.71 ) |
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): As of September 30, 2022 2021 Warrants to purchase common stock 119,284 - Options to purchase common stock 3,725,593 4,713,028 Unvested restricted stock units 4,301,840 1,763,445 Total 8,146,717 6,476,473 |
Organization - Additional Infor
Organization - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Feb. 04, 2022 | Dec. 31, 2021 | [1] | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||
Entity incorporation, date of incorporation | Feb. 20, 2013 | |||||||
Net income (loss) | $ (126,862) | $ 13,100 | $ (27,496) | $ (135,461) | $ (57,012) | |||
Cash and cash equivalents | 39,774 | $ 117,286 | 39,774 | $ 117,286 | $ 105,982 | |||
Accumulated deficit | (264,002) | (264,002) | $ (128,541) | |||||
Net sales | $ 34,400 | $ 151,000 | ||||||
First Tranche | ||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||
Debt instrument principal amount | $ 30,000 | |||||||
Maximum | ||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||
Debt finance costs | $ 80,000 | |||||||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | [1] | Feb. 09, 2021 shares | |
Significant Accounting Policies [Line Items] | |||||||
Cash and cash equivalents | $ 39,774,000 | $ 117,286,000 | $ 39,774,000 | $ 117,286,000 | $ 105,982,000 | ||
Restricted cash equivalents balance | $ 1,943,000 | 2,338,000 | $ 1,943,000 | 2,338,000 | |||
Operating lease existence of option to extend [true false] | true | ||||||
Operating lease option to extend | options to extend | ||||||
Redeemable convertible preferred stock redemption period after occurrence of certain liquidation events | 90 days | ||||||
Impairments of long-lived assets | 1,600,000 | $ 0 | 1,600,000 | ||||
Expected dividend yield | 0% | ||||||
Number of operating segments | Segment | 1 | ||||||
Number of reportable segments | Segment | 1 | ||||||
ASU 2020-06 | |||||||
Significant Accounting Policies [Line Items] | |||||||
Change in accounting principle, accounting standards update, adopted | true | true | |||||
Change in accounting principle, accounting standards update, early adoption | true | true | |||||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 | Jan. 01, 2022 | |||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||||
Selling, General and Administrative Expenses | |||||||
Significant Accounting Policies [Line Items] | |||||||
Advertising and marketing costs | $ 1,100,000 | $ 1,900,000 | $ 1,300,000 | ||||
Common Stock | Redeemable Convertible Preferred Stock | IPO | |||||||
Significant Accounting Policies [Line Items] | |||||||
Convertible preferred stock converted into common stock | shares | 23,978,747 | ||||||
Website Development Costs | |||||||
Significant Accounting Policies [Line Items] | |||||||
Property and equipment estimated useful lives | 3 years | ||||||
Minimum | |||||||
Significant Accounting Policies [Line Items] | |||||||
Property and equipment estimated useful lives | 3 years | ||||||
Net revenues collection period | 30 days | ||||||
Maximum | |||||||
Significant Accounting Policies [Line Items] | |||||||
Property and equipment estimated useful lives | 7 years | ||||||
Performance obligation expected period | 1 year | 1 year | |||||
Net revenues collection period | 45 days | ||||||
Maximum | Selling, General and Administrative Expenses | |||||||
Significant Accounting Policies [Line Items] | |||||||
Advertising and marketing costs | $ 100,000 | ||||||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Net Sales - Summary of Net Sale
Net Sales - Summary of Net Sales by Channel (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Net sales | $ 34,390 | $ 14,976 | $ 151,010 | $ 31,931 |
Healthcare | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | 2,967 | 1,647 | 11,425 | 4,269 |
Business-to-Business | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | 13,554 | 8,712 | 69,098 | 15,484 |
International | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | 7,571 | 4,543 | 32,737 | 6,709 |
Direct-to-Consumer (E-Commerce) | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | $ 10,298 | $ 74 | $ 37,750 | $ 5,469 |
Net Sales - Summary of Net Sa_2
Net Sales - Summary of Net Sales, Gross Loss and Gross Margin (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | ||||
Net sales | $ 34,390 | $ 14,976 | $ 151,010 | $ 31,931 |
Cost of products sold | 133,945 | 14,837 | 202,657 | 32,710 |
Impairment of long-lived assets | 1,622 | 1,622 | ||
Gross loss | $ (99,555) | $ (1,483) | $ (51,647) | $ (2,401) |
Gross margin | (289.00%) | (10.00%) | (34.00%) | (8.00%) |
Net Sales - Additional Informat
Net Sales - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Charge for excess inventory and non-cancellable purchase commitments | $ 107,159,000 | $ 1,284,000 | ||
Impairment charge | $ 1,600,000 | 0 | $ 1,600,000 | |
Cost of Products Sold | ||||
Disaggregation of Revenue [Line Items] | ||||
Charge for excess inventory and non-cancellable purchase commitments | $ 107,200,000 | 107,200,000 | ||
COVID-19 Test Kits | ||||
Disaggregation of Revenue [Line Items] | ||||
Charge for excess inventory and non-cancellable purchase commitments | 69,800,000 | 69,800,000 | ||
Procurement of Sub-Assembly Components | ||||
Disaggregation of Revenue [Line Items] | ||||
Charge for excess inventory and non-cancellable purchase commitments | 7,400,000 | 7,400,000 | ||
Non-cancellable Purchase Commitments for Raw Materials | ||||
Disaggregation of Revenue [Line Items] | ||||
Charge for excess inventory and non-cancellable purchase commitments | $ 30,000,000 | $ 30,000,000 |
Net Sales - Summary of Net Sa_3
Net Sales - Summary of Net Sales by Geographic Area Based on Customers' Locations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Net sales | $ 34,390 | $ 14,976 | $ 151,010 | $ 31,931 |
United States | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | 26,819 | 10,433 | 118,273 | 25,222 |
Canada | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | 7,058 | 2,683 | 30,982 | 2,683 |
Rest of World | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net sales | $ 513 | $ 1,860 | $ 1,755 | $ 4,026 |
Concentration of Credit Risk _3
Concentration of Credit Risk and Significant Suppliers - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Concentration Risk [Line Items] | |
Non-cancellable purchase commitments | $ 36.2 |
Forecast rolling period | 12 months |
Each forecast required period | 4 months |
Raw Material Purchase Commitments | |
Concentration Risk [Line Items] | |
Non-cancellable purchase commitments | $ 19.9 |
Asset & Equipment Related to Expanding Manufacturing Capacity & Automation | |
Concentration Risk [Line Items] | |
Non-cancellable purchase commitments | 5.8 |
Non-commercial Services | |
Concentration Risk [Line Items] | |
Non-cancellable purchase commitments | 2.2 |
Manufacturing Services Agreement | |
Concentration Risk [Line Items] | |
Non-cancellable purchase commitments | $ 15.1 |
Concentration of Credit Risk _4
Concentration of Credit Risk and Significant Suppliers - Schedules of Concentration of Risk, Accounts Receivable (Details) - Credit Concentration Risk - Accounts Receivable | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 22% | 19% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 48% | 12% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 18% |
Concentration of Credit Risk _5
Concentration of Credit Risk and Significant Suppliers - Schedules of Concentration of Risk, Net Sales (Details) - Customer Concentration Risk - Net Sales | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | |
Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 11% | ||
Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 17% | 14% | |
Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 15% | ||
Customer D | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 11% |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - Level 1 $ in Thousands | Sep. 30, 2022 USD ($) |
Assets | |
Cash equivalents | $ 38,920 |
Restricted cash equivalents | 1,943 |
Total assets, fair value | $ 40,863 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 16,477 | $ 35,923 | |
Work in process | 28,579 | 10,539 | |
Finished goods | 10,569 | 4,314 | |
Total | $ 55,625 | $ 50,776 | [1] |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Inventory [Line Items] | |||||
Charge for excess inventory and non-cancellable purchase commitments | $ 107,159 | $ 1,284 | |||
Accrued inventory related to excess non-cancellable purchase commitments for raw materials | $ 30,000 | 30,000 | |||
Raw materials purchases for use in the pre-launch manufacturing campaign | 3,800 | 3,800 | $ 0 | ||
Stock-based compensation capitalized into inventory | 400 | $ 100 | 1,300 | $ 400 | |
COVID-19 | |||||
Inventory [Line Items] | |||||
Charge for excess inventory and non-cancellable purchase commitments | 69,800 | 69,800 | |||
Accrual of Excess Non-Cancellable Purchase Commitments for Raw Materials and Non-Cancelable Purchase Commitments with Jabil Inc. | |||||
Inventory [Line Items] | |||||
Accrued inventory related to excess non-cancellable purchase commitments for raw materials | 27,300 | 27,300 | |||
Materials Purchased by Jabil | |||||
Inventory [Line Items] | |||||
Accrued inventory related to excess non-cancellable purchase commitments for raw materials | 2,700 | 2,700 | |||
Procurement of Sub-Assembly Components | |||||
Inventory [Line Items] | |||||
Charge for excess inventory and non-cancellable purchase commitments | $ 7,400 | $ 7,400 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment [Line Items] | |||
Construction in progress | $ 58,146 | $ 35,811 | |
Accumulated depreciation and amortization | (9,851) | (4,837) | |
Property and equipment, net | 48,295 | 30,974 | [1] |
Construction In Progress | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress | 23,317 | 3,466 | |
Machinery And Equipment | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress | 30,332 | 29,333 | |
Website Development Costs | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress | 1,457 | 1,110 | |
Furniture And Fixtures | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress | 784 | 200 | |
Leasehold Improvements | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress | $ 2,256 | $ 1,702 | |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization | $ 1,700,000 | $ 1,300,000 | $ 5,015,000 | $ 2,158,000 |
Deployed of assets into production from construction-in-progress | 1,000,000 | |||
Impairment charge | $ 1,600,000 | $ 0 | $ 1,600,000 |
Property and Equipment, Net -_2
Property and Equipment, Net - Schedule of Long-Lived Assets Including ROU Assets by Geographic Area (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | $ 65,999 | $ 33,688 |
United States | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | 47,320 | 16,730 |
Dominican Republic | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | 15,760 | 15,753 |
All Other Countries | ||
Revenues From External Customers And Long Lived Assets [Line Items] | ||
Total long-lived assets | $ 2,919 | $ 1,205 |
Other Financial Information - S
Other Financial Information - Summary of Activity in Allowance for Doubtful Accounts (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Other Financial Information [Abstract] | ||
Beginning balance | $ 99 | |
Amounts charged to costs and expenses | (133) | $ 358 |
Write-offs | (153) | (259) |
Recovery of previous write-offs | 200 | |
Ending balance | $ 13 | $ 99 |
Other Financial Information -_2
Other Financial Information - Schedule of Other Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Other Financial Information [Abstract] | |||
Other receivable | $ 4,824 | $ 8,188 | [1] |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Other Financial Information -_3
Other Financial Information - Schedule of Prepaid Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Other Financial Information [Abstract] | |||
Prepaid expenses | $ 871 | $ 307 | |
Prepaid insurance | 1,635 | 588 | |
Prepaid inventory | 9,379 | ||
Total | $ 2,506 | $ 10,274 | [1] |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Other Financial Information - A
Other Financial Information - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Advanced payments related to procurement of inventories of components | $ 0 | $ 0 | $ 9,400 | |
Charge for excess inventory and non-cancellable purchase commitments | 107,159 | $ 1,284 | ||
Accrued open non-cancellable purchase commitments | 29,974 | 29,974 | ||
Procurement of Sub-Assembly Components | ||||
Charge for excess inventory and non-cancellable purchase commitments | 7,400 | 7,400 | ||
Non-cancellable Purchase Commitments for Raw Materials | ||||
Charge for excess inventory and non-cancellable purchase commitments | 30,000 | 30,000 | ||
Accrued open non-cancellable purchase commitments | $ 30,000 | $ 30,000 |
Other Financial Information -_4
Other Financial Information - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Other Financial Information [Abstract] | |||
Professional fees | $ 1,423 | $ 612 | |
Accrued manufacturing and inventory purchases | 16,400 | 17,200 | |
Accrued non-cancellable purchase orders | 29,974 | ||
Canada importation taxes | 2,376 | 1,551 | |
Payroll liabilities | 2,098 | 4,466 | |
Royalty liabilities | 1,662 | ||
Accrued sales tax | 1,496 | 2,215 | |
Early exercise liability | 138 | 189 | |
Accrued interest | 281 | ||
Insurance premium liability | 421 | ||
Other | 425 | 1,267 | |
Total | $ 55,032 | $ 29,162 | [1] |
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | |||||
Jun. 15, 2022 USD ($) ft² | Mar. 15, 2022 USD ($) ft² | Mar. 31, 2022 | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | [1] | |
Lessee Lease Description [Line Items] | |||||||
Operating lease option to extend | options to extend | ||||||
Operating lease existence of option to extend [true false] | true | ||||||
Operating lease payments | $ 1,400 | $ 300 | |||||
Proceeds from letter of credit | $ 700 | $ 1,200 | |||||
Operating lease ROU assets | 8,600 | 8,100 | 17,704 | $ 2,714 | |||
Offsetting lease liability | $ 8,600 | $ 8,100 | 18,683 | ||||
Lessor facility leases amendment description | In addition to the Vista and Berkley California leases, the Company has executed certain amendments to lease facilities in Emeryville and San Jose California. These amendments are the result of the Company's consolidation of certain of its locations and departments. Upon the execution of each of the amendments, which were deemed to be lease modifications, the Company remeasured the respective lease liabilities and corresponding ROU assets as of the effective date of each amendment and recorded a net reduction of $0.1 million during the nine months ended September 30, 2022 of the lease liabilities and respective ROU assets. | ||||||
Facility lease reduction of ROU assets | 100 | ||||||
Facility lease reduction of lease liabilities | $ 100 | ||||||
California | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease option to extend | option to extend | options to extend | |||||
Operating lease, lease term | 99 months | 126 months | |||||
Operating lease, renewal term | 84 months | 60 months | |||||
Area of lease facility | ft² | 20,400 | 82,000 | |||||
Operating lease existence of option to extend [true false] | true | true | |||||
Operating lease payments | $ 1,800 | $ 1,300 | |||||
Minimum | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease remaining lease term | 1 year | ||||||
Maximum | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease remaining lease term | 10 years | ||||||
Operating lease tenant improvement allowance | $ 4,100 | $ 800 | |||||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jun. 15, 2022 | Mar. 15, 2022 | Dec. 31, 2021 | [1] |
Leases [Abstract] | |||||
2022 | $ 434 | ||||
2023 | 2,726 | ||||
2024 | 2,922 | ||||
2025 | 2,899 | ||||
2026 | 2,994 | ||||
Thereafter | 17,010 | ||||
Total | 28,985 | ||||
Less: imputed interest | (10,302) | ||||
Present value of operating lease liabilities | 18,683 | $ 8,600 | $ 8,100 | ||
Less: current portion | (2,316) | $ (1,609) | |||
Operating lease liabilities, net of current portion | $ 16,367 | $ 1,220 | |||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Leases - Summary of Additional
Leases - Summary of Additional Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Leases [Abstract] | |||||
Operating lease cost | $ 1,126 | $ 253 | $ 2,450 | $ 471 | |
Short-term lease cost | $ 467 | $ 312 | $ 790 | $ 939 | |
Weighted-average remaining lease term (years) | 8 years 9 months 21 days | 8 years 9 months 21 days | 1 year 9 months 25 days | ||
Weighted-average discount rate | 9.49% | 9.49% | 7.15% |
Term Loans - Additional Informa
Term Loans - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 15, 2022 | Feb. 04, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | |
Warrant | ||||
Debt Instrument [Line Items] | ||||
Percentage aggregate principal amount of term loan advances | 1% | |||
Warrant, exercise price per share | $ 5.03 | |||
Warrants advance | $ 30,000,000 | |||
Warrants to purchase | 59,642 | |||
Warrants and rights outstanding, term | 7 years | |||
Warrants and rights outstanding | $ 500,000 | |||
Payment of debt issuance costs | 1,200,000 | |||
Fair value allocated to warrants and end of term fee | 1,600,000 | |||
Debt issuance costs | 3,300,000 | |||
End of term fee | 1,600,000 | |||
Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument future sale and issuance of capital stock | $ 5,000,000 | |||
Debt issuance costs | 80,000,000 | |||
Term Loans | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 80,000,000 | |||
Debt instrument, maturity date | Feb. 01, 2026 | |||
Stated interest rate | 8.75% | 11.75% | 11.75% | |
Interest expense | $ 1,000,000 | $ 2,500,000 | ||
Non-cash interest of amortization of loan discount | $ 200,000 | $ 500,000 | ||
Debt instrument term loan prepayment percentage | 5.25% | |||
Effective interest rate | 13.70% | 13.70% | ||
Term Loans | Within 12 Months of the Initial Advance Closing Date | ||||
Debt Instrument [Line Items] | ||||
Debt instrument term loan prepayment percentage | 3% | |||
Term Loans | Within 24 Months of the Initial Advance Closing Date | ||||
Debt Instrument [Line Items] | ||||
Debt instrument term loan prepayment percentage | 2% | |||
Term Loans | Within 36 Months of the Initial Advance Closing Date | ||||
Debt Instrument [Line Items] | ||||
Debt instrument term loan prepayment percentage | 1% | |||
Term Loans | Prime Rate | ||||
Debt Instrument [Line Items] | ||||
Interest rate | 5.50% | |||
First Tranche | ||||
Debt Instrument [Line Items] | ||||
Debt instrument principal amount | $ 30,000,000 | |||
Second Tranche | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | 20,000,000 | |||
Minimum net product revenue threshold for loan advances | 75,000,000 | |||
Loan advances incremental amount | 5,000,000 | |||
Third Tranche | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | 15,000,000 | |||
Minimum net product revenue threshold for loan advances | 250,000,000 | |||
Loan advances incremental amount | 5,000,000 | |||
Fourth Tranche | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 15,000,000 | |||
First Term Loan Advance | Warrant | ||||
Debt Instrument [Line Items] | ||||
Debt issuance costs | 2,700,000 | |||
Unfunded Loan Advances | Warrant | ||||
Debt Instrument [Line Items] | ||||
Debt issuance costs | $ 600,000 |
Term Loans - Summary of Assumpt
Term Loans - Summary of Assumptions Used to Estimate Fair Value of Warrants (Details) - $ / shares | 9 Months Ended | |
Feb. 04, 2022 | Sep. 30, 2022 | |
Debt Instrument [Line Items] | ||
Expected dividend yield | 0% | |
Warrant | ||
Debt Instrument [Line Items] | ||
Fair value of common stock | $ 5.15 | |
Expected term (in years) | 7 years | |
Risk-free interest rate | 1.90% | |
Volatility | 92.60% |
Term Loans - Schedule of Balanc
Term Loans - Schedule of Balance Sheet Information Related to Term Loans (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Instrument [Line Items] | |
Tranche 1 of Term Loans | $ 31,575 |
Less: Unamortized debt discount and issuance costs | (2,167) |
Carrying value of Term Loans, non-current | $ 29,408 |
Term Loans - Schedule of Bala_2
Term Loans - Schedule of Balance Sheet Information Related to Term Loans (Parenthetical) (Details) - Term Loans $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | |
Debt Instrument final term fee | $ 1.6 |
Debt instrument principal loan advance percentage | 5.25% |
Term Loans - Schedule of Intere
Term Loans - Schedule of Interest Expense, Net of Amounts Capitalized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Instruments [Abstract] | |||
Contractual coupon | $ 832 | $ 1,959 | |
Amortization of debt discount and issuance costs | 195 | 502 | |
Total interest expense on the Term Loan | 1,027 | 2,461 | |
Other interest expense | 12 | 50 | |
Capitalized interest | (90) | (199) | |
Interest expense, net | $ 949 | $ 2,312 | $ 281 |
Term Loans - Schedule of Annual
Term Loans - Schedule of Annual Principal Payments (Details) - Term Loans $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Instrument [Line Items] | |
2024 | $ 7,059 |
2025 | 21,176 |
2026 | 3,340 |
Total principal payments | $ 31,575 |
Convertible Notes Payable - Add
Convertible Notes Payable - Additional Information (Details) - shares | 9 Months Ended | |
Feb. 09, 2021 | Sep. 30, 2021 | |
Common Stock | ||
Debt Instrument [Line Items] | ||
Issuance of common stock | 10,350,000 | |
2020B Notes | IPO | ||
Debt Instrument [Line Items] | ||
Percentage of price paid for securities sold from conversion | 80% | |
2020B Notes | Common Stock | ||
Debt Instrument [Line Items] | ||
Issuance of common stock | 1,470,947 |
Capital Stock - Preferred Stock
Capital Stock - Preferred Stock - Additional Information (Details) - shares | Sep. 30, 2022 | Dec. 31, 2021 | [1] | Feb. 09, 2021 |
Class Of Stock [Line Items] | ||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
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 | |||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Capital Stock - Common Stock -
Capital Stock - Common Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |||
Sep. 30, 2022 | Dec. 31, 2021 | [1] | Feb. 09, 2021 | |
Equity [Abstract] | ||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |
Dividends declared | $ 0 | |||
Common stock, voting rights | Under the Loan Agreement, as amended, the Company is precluded from declaring or paying cash dividends, subject to certain exceptions. The holder of each share of common stock is entitled to one vote. | |||
[1] The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date |
Capital Stock - Summary of Shar
Capital Stock - Summary of Shares of Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 14,602,228 | 9,388,184 |
Common Stock Option Grants Issued and Outstanding under 2014 Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 2,905,756 | 3,245,250 |
Common Stock Reserved For Issuance Under 2022 Inducement Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 2,445,550 | |
Common Stock Reserved for Issuance under 2021 Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 3,102,956 | 1,578,216 |
Common Stock Option Grants Issued and Outstanding under 2021 Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 819,837 | 467,024 |
Restricted Common Stock Units Issued and Outstanding | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 4,301,840 | 3,387,505 |
Common Stock Reserved for Issuance under ESPP | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 907,005 | 710,189 |
Warrants to Purchase Common Stock | ||
Class Of Stock [Line Items] | ||
Total shares of common stock reserved for future issuance | 119,284 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Jan. 31, 2022 | Jan. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Apr. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares approved | 14,602,228 | 14,602,228 | 9,388,184 | ||||||
Awards granted or outstanding | 431,213 | ||||||||
Compensation cost to be recognized related to non-vested awards | $ 24,700 | $ 24,700 | |||||||
Compensation cost to be recognized related to non-vested awards over weighted average period | 3 years 8 months 12 days | ||||||||
Options vested number of shares | 842,371 | ||||||||
Options vested in period fair value | $ 1,600 | ||||||||
Aggregate intrinsic value of options exercised | 100 | ||||||||
Proceeds from the issuance of common stock under employee stock purchase plan | 519 | $ 332 | |||||||
Stock-based compensation capitalized into inventory | 400 | $ 100 | 1,300 | 400 | |||||
Stock-based compensation expense | 2,372 | $ 5,028 | 5,796 | $ 6,500 | |||||
Inventories Written Down | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock-based compensation expense | $ 300 | $ 300 | |||||||
Employee Stock Purchase Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares available for issuance | 907,005 | 907,005 | |||||||
Weighted average grant date fair value | $ 2.60 | ||||||||
Maximum percentage of purchase price is specified pursuant to each offering | 85% | ||||||||
Number of shares available for issuance increased | 396,636 | ||||||||
Number of shares issued | 199,820 | ||||||||
Proceeds from the issuance of common stock under employee stock purchase plan | $ 500 | ||||||||
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 1 month 6 days | ||||||||
Compensation cost to be recognized related to awards | $ 2,600 | $ 2,600 | |||||||
Weighted average grant date fair value | $ 1.27 | $ 7.52 | |||||||
Restricted Stock Units (RSUs) | Vesting in One-year Cliff | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Compensation cost to be recognized related to non-vested awards | $ 22,100 | $ 22,100 | |||||||
Compensation cost to be recognized related to non-vested awards over weighted average period | 3 years 8 months 12 days | ||||||||
Award vesting period | 4 years | ||||||||
Award vesting rights,percentage | 25% | ||||||||
2021 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares approved | 5,200,000 | ||||||||
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 | 5% | ||||||||
Number of shares available for issuance | 1,983,182 | ||||||||
2022 Inducement Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares available for issuance | 3,500,000 | ||||||||
Awards granted or outstanding | 2,445,550 |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Stock-based Compensation Expense for Equity Incentive Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 2,372 | $ 5,028 | $ 5,796 | $ 6,500 |
Stock-based compensation expense, net of capitalized amounts | 2,431 | 5,028 | 6,380 | 6,500 |
Cost of Products Sold | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 377 | 91 | 767 | 351 |
Research and Development Grants | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 700 | 274 | 1,797 | 695 |
Selling, General and Administrative Expenses | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 1,295 | 4,663 | 3,232 | 5,454 |
Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense, net of capitalized amounts | 460 | 4,678 | 1,185 | 5,642 |
Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense, net of capitalized amounts | 1,875 | 252 | 4,932 | 627 |
ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense, net of capitalized amounts | $ 96 | $ 98 | $ 263 | $ 231 |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | ||
Number of Options, Beginning Balance | shares | 3,712,274 | |
Number of Options, Granted | shares | 431,213 | |
Number of Options, Exercised | shares | (73,940) | |
Number of Options, Cancelled | shares | (343,954) | |
Number of Options, Ending Balance | shares | 3,725,593 | 3,712,274 |
Number of Options vested and expected to vest as of September 30, 2022 | shares | 3,725,593 | |
Number of Options vested and exercisable as of September 30, 2022 | shares | 2,154,038 | |
Weighted-Average Exercise Price, Beginning Balance | $ / shares | $ 3.30 | |
Weighted-Average Exercise Price, Granted | $ / shares | 1.88 | |
Weighted-Average Exercise Price, Exercised | $ / shares | 1.38 | |
Weighted-Average Exercise Price, Cancelled | $ / shares | 5.05 | |
Weighted-Average Exercise Price, Ending Balance | $ / shares | 3.01 | $ 3.30 |
Weighted-Average Exercise Price, Options vested and expected to vest as of September 30, 2022 | $ / shares | 3.01 | |
Weighted-Average Exercise Price, Options vested and exercisable as of September 30, 2022 | $ / shares | $ 2.48 | |
Weighted-Average Remaining Contractual Term, Balance | 7 years 3 months 18 days | 8 years 1 month 6 days |
Weighted-Average Remaining Contractual Term, Options vested and expected to vest as of September 30, 2022 | 7 years 3 months 18 days | |
Weighted-Average Remaining Contractual Term, Options vested and exercisable as of September 30, 2022 | 6 years 6 months | |
Aggregate Intrinsic Value | $ | $ 337,947 | $ 23,150 |
Aggregate Intrinsic Value, Options vested and expected to vest as of September 30, 2022 | $ | 337,947 | |
Aggregate Intrinsic Value, Options vested and exercisable as of September 30, 2022 | $ | $ 288,503 |
Equity Incentive Plan - Summa_3
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Stock Options (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock | $ 1.88 | $ 17 |
Expected term (in years) | 5 years 6 months | 5 years 10 months 24 days |
Risk-free interest rate | 3% | 0.60% |
Volatility | 79.60% | 46.90% |
Equity Incentive Plan - Summa_4
Equity Incentive Plan - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Underlying Shares, Beginning Balance | shares | 3,387,505 |
Underlying Shares, Granted | shares | 1,803,604 |
Underlying Shares, Vested | shares | (511,298) |
Underlying Shares, Canceled or forfeited | shares | (377,971) |
Underlying Shares, Ending Balance | shares | 4,301,840 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 7.57 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 3.33 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 6.85 |
Weighted-Average Grant Date Fair Value, Canceled and forfeited | $ / shares | 7.78 |
Weighted-Average Grant Date Fair Value, Ending Balance | $ / shares | $ 5.86 |
Equity Incentive Plan - Summa_5
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plans (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock | $ 2.11 | $ 9.80 |
Expected term (in years) | 6 months | 6 months |
Risk-free interest rate | 3.20% | 0.10% |
Volatility | 113.40% | 139.10% |
Provision for Income Taxes - Ad
Provision for Income Taxes - Additional Information (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Income Tax Disclosure [Abstract] | ||
Benefit from income taxes | $ 14,000 | $ 16,000 |
Uncertain tax benefit, related to research and development credits | $ 1,100,000 | 1,100,000 |
Interest or penalties related to uncertain tax positions | $ 0 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator | |||||
Net loss attributable to common stockholders, basic and diluted | $ (126,862) | $ 13,100 | $ (27,496) | $ (135,461) | $ (57,012) |
Weighted-average number of shares of common stock outstanding: | |||||
Basic | 40,216,244 | 38,667,615 | 39,974,997 | 33,348,104 | |
Diluted | 40,216,244 | 38,667,615 | 39,974,997 | 33,348,104 | |
Net loss per share attributable to common stockholders: | |||||
Basic | $ (3.15) | $ (0.71) | $ (3.39) | $ (1.71) | |
Diluted | $ (3.15) | $ (0.71) | $ (3.39) | $ (1.71) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 8,146,717 | 6,476,473 |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 119,284 | |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 3,725,593 | 4,713,028 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 4,301,840 | 1,763,445 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | $ 36.2 | $ 36.2 | ||
Non-cancellable Purchase Commitments excluding Jabil MSA | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 27.9 | 27.9 | ||
Eiken Agreement | Cost of Products Sold | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Royalty expense | 0 | $ 0.5 | 4 | $ 1 |
Manufacturing Services Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Outstanding non-cancellable purchase commitment | 15.1 | |||
Non-cancellable purchase commitments | 15.1 | 15.1 | ||
Raw Material Purchase Commitments | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 19.9 | 19.9 | ||
Raw Material Purchase Commitments | Non-cancellable Purchase Commitments excluding Jabil MSA | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 19.9 | 19.9 | ||
Raw Materials for Future Inventory Production | Non-cancellable Purchase Commitments excluding Jabil MSA | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 19.9 | 19.9 | ||
Asset And Equipment Related To Manufacturing Capacity And Automation | Non-cancellable Purchase Commitments excluding Jabil MSA | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 5.8 | 5.8 | ||
Non-commercial Services | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | 2.2 | 2.2 | ||
Non-commercial Services | Non-cancellable Purchase Commitments excluding Jabil MSA | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Non-cancellable purchase commitments | $ 2.2 | $ 2.2 |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related Party Transaction [Line Items] | ||||
Related party transaction consulting expenses | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 |
Maximum | ||||
Related Party Transaction [Line Items] | ||||
Revenue recorded related party transaction | $ 100 | $ 100,000 | $ 100 | $ 100,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - Employee | Nov. 14, 2022 | Oct. 20, 2022 |
Subsequent Event [Line Items] | ||
Percentage of workforce reduced | 43% | |
Number of additional employees approved to second reduction in force | 97 | |
Reduction in force expected date of completion | Jan. 15, 2023 | Dec. 30, 2022 |
Board of Directors | ||
Subsequent Event [Line Items] | ||
Number of employees approved to reduction in force | 56 | |
Percentage of workforce reduced | 25% |