Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 16, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-39049 | ||
Entity Registrant Name | EXAGEN INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-0434866 | ||
Entity Address, Address Line One | 1261 Liberty Way | ||
Entity Address, City or Town | Vista | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92081 | ||
City Area Code | (760) | ||
Local Phone Number | 560-1501 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | XGN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 61.5 | ||
Entity Common Stock, Shares Outstanding | 16,825,696 | ||
Documents Incorporated by Reference | Certain information required to be disclosed in Part III of this report is incorporated by reference from the registrant's definitive Proxy Statement for the 2023 Annual Meeting of Stockholders, which proxy statement will be filed not later than 120 days after the end of the fiscal year covered by this Form 10-K. | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001274737 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | BDO USA, LLP |
Auditor Location | San Diego, California |
Auditor Firm ID | 243 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 62,391 | $ 99,442 |
Accounts receivable, net | 6,077 | 9,654 |
Prepaid expenses and other current assets | 4,143 | 3,638 |
Total current assets | 72,611 | 112,734 |
Property and equipment, net | 8,197 | 4,772 |
Operating lease right-of-use assets | 4,885 | 0 |
Goodwill | 0 | 5,506 |
Other assets | 528 | 433 |
Total assets | 86,221 | 123,445 |
Current liabilities: | ||
Accounts payable | 3,046 | 2,492 |
Operating lease liabilities | 1,040 | 0 |
Borrowings-current portion | 190 | 0 |
Accrued and other current liabilities | 5,347 | 6,826 |
Total current liabilities | 9,623 | 9,318 |
Borrowings-non-current portion, net of discounts and debt issuance costs | 28,778 | 27,478 |
Non-current operating lease liabilities | 4,493 | 0 |
Deferred tax liabilities | 0 | 306 |
Other non-current liabilities | 867 | 1,407 |
Total liabilities | 43,761 | 38,509 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding at December 31, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2022 and December 31, 2021; 16,549,984 and 16,164,994 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 17 | 16 |
Additional paid-in capital | 297,970 | 293,060 |
Accumulated deficit | (255,527) | (208,140) |
Total stockholders' equity | 42,460 | 84,936 |
Total liabilities and stockholders' equity | $ 86,221 | $ 123,445 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 10,000,000 | 10,000,000 |
Shares issued (in shares) | 0 | |
Shares outstanding (in shares) | 0 | |
Common stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 200,000,000 | 200,000,000 |
Shares issued (in shares) | 16,549,984 | 16,164,994 |
Shares outstanding (in shares) | 16,549,984 | 16,164,994 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Revenue | $ 45,563 | $ 48,299 |
Operating expenses: | ||
Costs of revenue | 24,214 | 20,588 |
Selling, general and administrative expenses | 52,018 | 44,541 |
Research and development expenses | 9,876 | 7,237 |
Goodwill Impairment | 5,506 | 0 |
Total operating expenses | 91,614 | 72,366 |
Loss from operations | (46,051) | (24,067) |
Interest expense | (2,448) | (2,625) |
Interest income | 830 | 16 |
Loss before income taxes | (47,669) | (26,676) |
Income tax expense | 282 | (175) |
Net loss | $ (47,387) | $ (26,851) |
Net loss per share, basic (in dollars per share) | $ (2.77) | $ (1.68) |
Net loss per share, diluted (in dollars per share) | $ (2.77) | $ (1.68) |
Weighted-average number of shares used to compute net loss per share, basic (in shares) | 17,082,348 | 15,972,256 |
Weighted-average number of shares used to compute net loss per share, diluted (in shares) | 17,082,348 | 15,972,256 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 12,652,308 | |||
Beginning balance at Dec. 31, 2020 | $ 41,839 | $ 13 | $ 223,115 | $ (181,289) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of stock in public offering, net of issuance costs of $4,435 (in shares) | 4,255,000 | |||
Issuance of stock in public offering, net of issuance costs of $4,435 | 64,709 | $ 4 | 64,705 | |
Retirement of common stock in exchange for common stock warrant (in shares) | (804,951) | |||
Retirement of common stock in exchange for common stock warrant | (12,775) | $ (1) | (12,774) | |
Issuance of common stock warrant in exchange for retirement of common stock | 12,775 | 12,775 | ||
Exercise of stock options (in shares) | 11,950 | |||
Exercise of stock options | 89 | 89 | ||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 32,968 | |||
Issuance of stock under Employee Stock Purchase Plan | 390 | 390 | ||
Stock-based compensation | 4,728 | 4,728 | ||
Exercise of common stock warrants (in shares) | 17,719 | |||
Exercise of common stock warrants | 32 | 32 | ||
Net loss | $ (26,851) | (26,851) | ||
Ending balance (in shares) at Dec. 31, 2021 | 16,164,994 | 16,164,994 | ||
Ending balance at Dec. 31, 2021 | $ 84,936 | $ 16 | 293,060 | (208,140) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of stock from vested restricted stock units and payment of employees' taxes (in shares) | 64,064 | |||
Issuance of stock from vested restricted stock units and payment of employees' taxes | $ (239) | (239) | ||
Exercise of stock options (in shares) | 245,186 | 245,186 | ||
Exercise of stock options | $ 61 | $ 1 | 60 | |
Issuance of stock under Employee Stock Purchase Plan (in shares) | 75,740 | |||
Issuance of stock under Employee Stock Purchase Plan | 385 | 385 | ||
Stock-based compensation | $ 4,704 | 4,704 | ||
Exercise of common stock warrants (in shares) | 0 | |||
Net loss | $ (47,387) | (47,387) | ||
Ending balance (in shares) at Dec. 31, 2022 | 16,549,984 | 16,549,984 | ||
Ending balance at Dec. 31, 2022 | $ 42,460 | $ 17 | $ 297,970 | $ (255,527) |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Parenthetical) $ in Thousands | Dec. 31, 2021 USD ($) |
Statement of Financial Position [Abstract] | |
Stock issuance costs | $ 4,435 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (47,387) | $ (26,851) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,557 | 948 |
Amortization of debt discount and debt issuance costs | 161 | 279 |
Non-cash interest expense | 551 | 540 |
Deferred income taxes | (306) | 148 |
Non-cash lease expense | 967 | 0 |
Long-lived assets impairment | 397 | 0 |
Goodwill Impairment | 5,506 | 0 |
Stock-based compensation | 4,704 | 4,728 |
Other | 36 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable, net | 3,577 | (744) |
Prepaid expenses and other current assets | (505) | 521 |
Other assets | (47) | (167) |
Operating lease liabilities | (854) | 0 |
Accounts payable | 901 | (655) |
Accrued and other current liabilities | (1,402) | 984 |
Net cash used in operating activities | (32,144) | (20,269) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (4,318) | (2,370) |
Purchase of other assets | 0 | (50) |
Net cash used in investing activities | (4,318) | (2,420) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 61 | 89 |
Payments of taxes withheld on vested restricted stock units | (239) | 0 |
Proceeds from common stock issued under Employee Stock Purchase Plan | 385 | 390 |
Proceeds from exercise of common stock warrants | 0 | 32 |
Principal payment on finance lease obligations | (667) | (525) |
Principal payment on note payable obligations | (29) | 0 |
Proceeds from the issuance of common stock in public offering, gross | 0 | 69,144 |
Net cash (used in) provided by financing activities | (489) | 64,683 |
Net change in cash, cash equivalents and restricted cash | (36,951) | 41,994 |
Cash, cash equivalents and restricted cash, beginning of year | 99,542 | 57,548 |
Cash, cash equivalents and restricted cash, end of year | 62,591 | 99,542 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest expense | 1,732 | 1,815 |
Supplemental disclosure of non-cash items: | ||
Equipment purchased under finance lease obligations | 741 | 1,111 |
Equipment purchased under notes payable obligations | 807 | 0 |
Costs incurred, but not paid, in connection with capital expenditures | 182 | 685 |
Deferred offering costs reclassified to equity | 0 | 28 |
Public Offering | ||
Cash flows from financing activities: | ||
Payment of issuance costs related to public offering | 0 | (4,407) |
Other Offering | ||
Cash flows from financing activities: | ||
Payment of issuance costs related to public offering | $ 0 | $ (40) |
Organization
Organization | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Exagen Inc. (the Company) is a commercial-stage diagnostics company dedicated to helping patients suffering from debilitating and chronic autoimmune diseases by enabling timely differential diagnosis and optimizing therapeutic intervention. Liquidity The Company has incurred recurring losses and negative cash flows from operating activities since inception. The Company anticipates that it will continue to incur net losses into the foreseeable future. At December 31, 2022, the Company had cash and cash equivalents of $62.4 million and had an accumulated deficit of $255.5 million. Since inception, the Company has financed its operations primarily through a combination of equity financings, debt financing arrangements, and revenue from sales of the Company's products. Based on the Company's current business plan, management believes that its existing capital resources will be sufficient to fund the Company's obligations for at least twelve months following the issuance of these financial statements. To execute its business plans, the Company may need additional funding to support its continuing operations and pursue its growth strategy. Until such time as the Company can achieve significant cash flows from operations, if ever, it expects to finance its operations through the sale of its stock, debt financings or other strategic transactions. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. The terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its programs, product portfolio expansion plans or commercialization efforts, which could have a material adverse effect on the Company's business, operating results and financial condition and the Company's ability to achieve its intended business objectives. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The Company's financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the accompanying financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could materially differ from those estimates. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to revenue recognition, the estimated incremental borrowing rate for the determination of the Company's operating lease right-of-use (ROU) assets, the recoverability of its long-lived assets and the goodwill impairment test. 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. Concentration of Credit Risk and Other Risk and Uncertainties Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents and accounts receivable. Substantially all the Company's cash and 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. We have not experienced any losses on our cash or cash equivalents. Significant payors and customers are those which represent more than 10% of the Company's total revenue or accounts receivable balance at each respective balance sheet date. For each significant payor and customer, revenue as a percentage of total revenue and accounts receivable as a percentage of total accounts receivable are as follows: Revenue Year Ended December 31, 2022 2021 Medicare 39 % 19 % Medicare Advantage 15 % 13 % Blue Shield * 12 % * Less than 10%. Accounts Receivable December 31, 2022 2021 Medicare 21 % * Medicare Advantage 13 % * Blue Shield * 19 % United Healthcare * 18 % * Less than 10%. For the years ended December 31, 2022 and 2021, approximately 84% and 81% of the Company's revenue was related to the AVISE ® CTD test, respectively. The Company is dependent on key suppliers for certain laboratory materials. For each of the years ended December 31, 2022 and 2021, approximately 96% of the Company's diagnostic testing supplies were purchased from two suppliers. An interruption in the supply of these materials would impact the Company's ability to perform testing services. Disaggregation of Revenue The following table includes the Company's revenues as disaggregated by payor and customer category (in thousands): Year Ended December 31, 2022 2021 Revenue: Commercial $ 18,975 $ 27,499 Government 17,687 9,221 Client(1) 7,928 9,288 Other(2) 973 1,091 Janssen (SIMPONI ® ) — 1,200 Total revenue $ 45,563 $ 48,299 (1) Includes hospitals, other laboratories, etc. (2) Includes patient self-pay. Cash, Cash Equivalents and Restricted Cash The Company considers all 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. The Company has an arrangement with a financial institution with which it has an existing banking relationship whereby in exchange for the issuance of corporate credit cards, the Company agreed to obtain a certificate of deposit with this financial institution as collateral for the balances borrowed on these credit cards ($0.2 million and $0.1 million at December 31, 2022 and 2021, respectively). The Company has classified the value of this certificate of deposit (including all interest earned thereon) within other assets in the accompanying balance sheets. The Company has the right to terminate the credit card program at any time. Upon termination of the credit card program and repayment of all outstanding balances owed, the Company may redeem the certificate of deposit (and all interest earned thereon). Cash, cash equivalents and restricted cash presented in the accompanying statements of cash flows consist of the following (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 62,391 $ 99,442 Restricted cash 200 100 $ 62,591 $ 99,542 Property and Equipment Property and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three Long-lived Assets The Company’s long-lived assets are comprised principally of its property and equipment and operating lease assets (see Note 5). We amortize all finite lived intangible assets over their respective estimated useful lives. Operating lease assets are amortized over the term of the leases. In considering whether long-lived assets are impaired, we combine our intangible assets and other long-lived assets (excluding goodwill), into groupings, a determination which we principally make on the basis of whether the assets are specific to a particular test offered by us or technology we are developing. If the Company identifies a change in the circumstances related to its long-lived assets, such as property and equipment and intangible assets (other than goodwill), that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset (other than goodwill) is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Management’s estimates of future cash flows are impacted by projected test volume and levels of reimbursement, as well as expectations related to the future cost structure of the entity. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value, and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. During the year ended December 31, 2022, the Company recorded an impairment charge to fixed assets totaling $0.4 million (see Note 3). The impairment charge was classified within research and development expenses in the accompanying statements of operations. Goodwill Goodwill is reviewed for impairment annually (during the fourth quarter) or more frequently if indicators of impairment exist. As the Company operates in a single operating segment and reporting unit, the Company first assesses qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative assessment. If, after assessing qualitative factors, the Company determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing a quantitative assessment is unnecessary. If deemed necessary, a quantitative assessment compares the fair value of the reporting unit with its carrying amount, including goodwill. If the fair value of the reporting unit exceeds its carrying amount, goodwill is not considered impaired; otherwise, an impairment loss is recorded. During the year ended December 31, 2022, the Company recorded an impairment charge to goodwill totaling $5.5 million (see Note 3). Leases The Company categorizes leases at their commencement as either operating or finance leases. Effective January 1, 2022 upon the adoption of Accounting Standards Codification (ASC) 842, the Company recognizes operating lease ROU assets and operating lease liabilities for each lease arrangement identified. Lease liabilities are recorded at the present value of future lease payments discounted using the Company's incremental borrowing rate for the lease established at the commencement date. ROU assets are measured at the amount of the lease liability plus any initial direct costs, less any lease incentives received before commencement. Lease expense is recognized as a single lease cost over the lease term on a straight-line basis. The Company has elected not to apply the recognition requirements to short-term leases and not to separate non-lease components from lease components for its leases. Clinical Studies From time to time, the Company engages in efforts to scientifically measure and document the application and efficacy of its various testing products. These arrangements typically require the Company to pay a fee to a third-party scientific investigator (usually a physician or research institution) for each subject enrolled in a clinical study, and the Company accrues expenses based on estimated progress of services performed, including actual level of subjects enrolled and progress of the clinical studies. Payments made prior to the completion of clinical study services are capitalized as a prepaid expense. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered. Expenses associated with clinical study activities are recorded in research and development expenses in the accompanying statement of operations. Revenue Recognition Substantially all of the Company's revenue has been derived from sales of its testing products and is primarily comprised of a high volume of relatively low-dollar transactions. The Company primarily markets its testing products to rheumatologists and their physician assistants in the United States. The healthcare professionals who order the Company's testing products and to whom test results are reported are generally not responsible for payment for these products. The parties that pay for these services (each, a payor) consist of commercial payors (healthcare insurers), government payors (primarily Medicare and Medicaid), client payors (i.e., hospitals, other laboratories, etc.) and patient self-pay. The Company's service is a single performance obligation that is completed upon the delivery of test results to the prescribing physician which triggers revenue recognition. Payors are billed at the Company's list price. Net revenues recognized consist of amounts billed net of allowances for differences between amounts billed and the estimated consideration the Company expects to receive from such payors. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. The Company follows a standard process, which considers historical denial and collection experience, insurance reimbursement policies and other factors, to estimate allowances and implicit price concessions, recording adjustments in the current period as changes in estimates occur. Further adjustments to the allowances, based on actual receipts, are recorded upon settlement. Included in revenues for the years ended December 31, 2022 and 2021 was a net revenue decrease of $2.4 million and a net revenue increase of $0.7 million, respectively, associated with changes in estimated variable consideration related to performance obligations satisfied in previous periods. The transaction price is estimated using an expected value method on a portfolio basis. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. The Company's portfolios are grouped per payor (i.e. each individual commercial payor, Medicare, Medicaid, client payors, patient self-pay, etc.) and per test. Consideration may be constrained and excluded from the transaction price in situations where there is no contractually agreed upon reimbursement coverage or in absence of a predictable pattern and history of collectability with a payor. Accordingly, in such situations revenues are recognized on the basis of actual cash collections. Additionally, from time to time, the Company may issue refunds to payors for overpayments or amounts billed in error. Any refunds are accounted for as reductions in revenues in the statement of operations as an element of variable consideration. The estimated expected refunds are accrued as a liability on the Company’s balance sheet. Collection of the Company's net revenues from payors is normally a function of providing complete and correct billing information to the healthcare insurers and generally occurs within 30 to 90 days of billing. Contracts do not contain significant financing components based on the typical period of time between performance of services and collection of consideration. Janssen Promotion Agreement In December 2018, the Company entered into a co-promotion agreement (as amended from time to time, the Janssen Agreement) with Janssen Biotech, Inc. (Janssen) to co-promote SIMPONI ® in the United States. In August 2021, the Company and Janssen mutually agreed to terminate the Janssen Agreement, effective August 31, 2021. Pursuant to the Janssen Agreement, as amended, the Company was responsible for the costs associated with its sales force over the course of such co-promotion. Janssen was responsible for all other aspects of the commercialization of SIMPONI ® under the Janssen Agreement. In exchange for the Company's sales and co-promotional services, the Company was entitled to a quarterly tiered promotion fee based on the incremental increase in total prescribed units of SIMPONI ® for that quarter over a predetermined baseline. The Company's obligations relating to sales and co-promotion services for SIMPONI ® were a series of single performance obligations since Janssen simultaneously received and consumed benefits provided by the Company's sales and co-promotional services. The method for measuring progress towards satisfying the performance obligations was based on prescribed units in excess of the contractual baseline at the contractual rate earned per unit. The Company recognized no co-promotion revenue and $1.2 million in co-promotion revenue during the years ended December 31, 2022 and December 31, 2021, respectively. The related expenses for marketing SIMPONI ® were included in selling, general and administrative expenses and were expensed as incurred. Pursuant to the terms of the termination, the Company received $0.6 million in consideration (which was earned in the year ended December 31, 2021) and the Company was restricted until May 31, 2022 from promoting any other biologic or Janus kinase inhibitor used for the treatment of indications covered by the Janssen Agreement without first obtaining Janssen's written consent. The restriction no longer applies. 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. Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were approximately $3.0 million and $1.7 million for the years ended December 31, 2022 and 2021, respectively, and are included in selling, general and administrative expenses in the accompanying statements of operations. Shipping and Handling Costs Costs incurred for shipping and handling are included in costs of revenue in the accompanying statements of operations and totaled approximately $2.7 million and $2.1 million, for the years ended December 31, 2022 and 2021, respectively. Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards to employees and directors based on the grant-date estimated fair values over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The fair value of stock options and purchases under the Company's 2019 Employee Stock Purchase Plan (ESPP) rights is determined using the Black-Scholes-Merton (BSM) option pricing model, which requires management to make certain assumptions regarding a number of complex and subjective variables. Equity award forfeitures are recorded as they occur. The BSM option pricing model incorporates various inputs, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. Volatility is based on the Company's historical calculated volatility since being publicly traded. The weighted-average expected term of options was calculated using the simplified method. The risk-free interest rate for periods within the contractual term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is zero, as the Company has never declared or paid dividends and has no plans to do so in the foreseeable future. The fair value of each restricted stock unit is determined on the grant date using the closing price of the Company's common stock on that date. The Company's restricted stock units generally vest in equal annual installments over four years from the date of grant or, for grants to new hires, date of hire. Vesting of restricted stock units is subject to the holder's continued service with the Company. The Company issues new shares to satisfy restricted stock units upon vesting. Comprehensive Loss Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from transactions from nonowner sources. There have been no items qualifying as other comprehensive loss and, therefore, for all periods presented, the Company's comprehensive loss was the same as its reported net loss. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would adjust the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares used to compute basic and diluted shares includes shares issuable upon the exercise of pre-funded warrants at a nominal price. Potentially dilutive common stock equivalents are comprised of warrants for the purchase of common stock, options and restricted stock units outstanding under the Company's 2019 Incentive Award Plan (the 2019 Plan) and shares of the Company's common stock pursuant to the ESPP. For the years ended December 31, 2022 and 2021, there is 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 antidilutive. 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): Years Ended December 31, 2022 2021 Warrants to purchase common stock 409,108 409,108 Common stock options 1,421,235 2,014,330 Restricted stock units 1,036,208 415,325 Employee stock purchase plan 58,711 20,193 Total 2,925,262 2,858,956 Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations as, and manages its business in, one operating segment. Recent Accounting Pronouncements From time to time, new accounting pronouncements 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. Under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), the Company meets the definition of an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. 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. Recently Adopted Accounting Standards In February 2016, the FASB issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842). The new topic supersedes Topic 840, Leases , and increases transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and requires disclosures of key information about leasing arrangements. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842 , which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU 2018-11, Leases: Targeted Improvements , which was issued to provide relief to companies from restating comparative periods. On January 1, 2022, the Company adopted ASU 2016-12, using the modified retrospective transition method. Periods prior to January 1, 2022 have not been restated for the adoption of ASC 842 and continue to reflect the accounting treatment of leases in accordance with the prior lease accounting guidance, ASC 840, Leases . The Company adopted the new lease standard using a cumulative effect to accumulated deficit and there was no impact to accumulated deficit upon adoption. The Company elected the package of practical expedients, which among other things allowed the Company to carry forward its historical lease classification. As part of the adoption, the Company recorded operating lease liabilities of $6.4 million, operating lease ROU assets of $5.9 million, adjusted for deferred rent and lease incentive obligations of $0.5 million previously included in other non-current liabilities and accrued and other current liabilities, pertaining to its office and laboratory space operating leases. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of expected credit losses for financial instruments carried at amortized cost, such as accounts receivable, held at the reporting date based on historical experience, current conditions and reasonable forecasts. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. In November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financing Instruments-Credit Losses , which included an amendment of the effective date for nonpublic entities. For non-emerging growth companies, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019. For emerging growth companies, ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted this pronouncement on January 1, 2023 and the impact of the provisions of this standard on its Consolidated Financial Statements is expected to be immaterial. In August 2020, the FASB issued ASU 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 the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Specifically, ASU 2020-06 simplifies accounting for the issuance of convertible instruments by removing major separation models required under current GAAP. In addition, the ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share (EPS) calculation in certain areas. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, beginning in fiscal years which begin after December 15, 2020, including interim periods within those fiscal years. The FASB has specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The amendment is to be adopted through either a modified retrospective or fully retrospective method of transition. The Company is currently evaluating the potential impact that the adoption of ASU 2020-06 may have on its consolidated financial statements and related disclosures. |
Other Financial Information
Other Financial Information | 12 Months Ended |
Dec. 31, 2022 | |
Other Financial Information [Abstract] | |
Other Financial Information | Other Financial Information Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2022 2021 Diagnostic testing supplies $ 1,795 $ 1,091 Prepaid product royalties 40 49 Prepaid maintenance and insurance contracts 2,072 2,008 Other prepaid and other current assets 236 490 Prepaid and other current assets $ 4,143 $ 3,638 Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2022 2021 Furniture and fixtures $ 98 $ 83 Laboratory equipment 5,136 4,361 Computer equipment and software 1,482 1,206 Leasehold improvements 5,223 1,151 Construction in progress 1,382 1,855 Total property and equipment 13,321 8,656 Less: accumulated depreciation and amortization (5,124) (3,884) Property and equipment, net $ 8,197 $ 4,772 Depreciation and amortization expense for the years ended December 31, 2022 and 2021, was approximately $1.6 million and $0.9 million, respectively. At December 31, 2022 and 2021, the gross book value of assets under finance leases was $2.8 million and $2.5 million, respectively, and is classified in "Laboratory equipment" in the table above. Impairment of Long-Lived Assets and Goodwill During the year ended December 31, 2022, the Company recorded an impairment charge of $0.4 million related to previously capitalized equipment used in research and development activities that were halted in the fourth quarter of 2022. The Company based the fair values of these assets on their anticipated disposal values, which is considered a Level 3 measurement. The impairment charge was classified within research and development expenses The Company determined that the sustained decrease in its market capitalization constituted an indicator of impairment and as a result, instead of performing a qualitative test, the Company chose to proceed directly to performing a quantitative test during the fourth quarter. The Company determined the fair value of the reporting unit using the discounted cash flow (DCF) method, which is considered a Level 3 measurement. In applying the DCF method, cash flows are estimated for a five-year financial forecast developed by management. A terminal value, which represents the value of additional cash flows into perpetuity, is also calculated. Cash flows are then discounted to present value at a discount rate commensurate with their risk. Based on this analysis, the carrying value of the reporting unit was in excess of the fair value and the goodwill was fully impaired. During the year ended December 31, 2022, the Company recorded an impairment charge of $5.5 million. The following table presents details of the Company's goodwill for the year ended December 31, 2022 (in thousands): Total Balance as of December 31, 2021 $ 5,506 Goodwill impairment (5,506) Balance as of December 31, 2022 $ — Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands): December 31, 2022 2021 Accrued payroll and related expenses $ 2,355 $ 4,048 Accrued interest 142 139 Accrued purchases of goods and services 803 510 Accrued royalties 514 180 Accrued clinical study activity 162 254 Finance lease obligations, current portion 700 587 Refund liability 445 — Other accrued liabilities 226 1,108 Accrued and other current liabilities $ 5,347 $ 6,826 |
Borrowings
Borrowings | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Borrowings | Borrowings 2017 Term Loan In September 2017, the Company executed a term loan agreement (the 2017 Term Loan) with Innovatus Life Sciences Lending Fund I, LP (Innovatus), as amended, pursuant to which the Company has borrowed $25 million. At December 31, 2022, no additional amounts remain available to borrow under the 2017 Term Loan. In November 2021, the Company executed the Second Amendment to the Loan and Security Agreement (the 2017 Loan Amendment). The interest rate on all borrowings under the 2017 Loan Amendment is 8.0%, of which 2.0% is paid in-kind in the form of additional term loans (PIK Loans) until December of 2024, after which interest accrues at an annual rate of 8.0%. The Company has estimated the effective interest rate of this loan to be approximately 8.5%. Accrued interest is due and payable monthly, unless the Company elects to pay paid-in-kind interest. The outstanding principal and accrued interest on the 2017 Loan Amendment will be repaid in twenty-four equal monthly installments commencing in December 2024. Upon repayment of the final installment under the 2017 Loan Amendment, the Company is required to pay an additional fee of $1.0 million. This obligation is being accreted into interest expense over the term of Loan Amendment using the effective interest method. For the years ended December 31, 2022 and 2021, the Company issued PIK Loans totaling $0.6 million and $0.5 million, respectively. The 2017 Loan Amendment requires a prepayment premium of 2% of the aggregate outstanding principal. The prepayment premium decreases by 1% on each of November 1, 2023 and 2024. The 2017 Loan Amendment is collateralized by a first priority security interest in substantially all of the Company's assets, including intellectual property. The affirmative covenants of the 2017 Loan Amendment require that the Company timely file taxes, maintain good standing and government compliance, maintain liability and other insurance, provide prompt notification of significant corporate events, and furnish audited financial statements within 150 days of fiscal year end without qualification as to the scope of the audit or as to going concern and without any other similar qualification. The affirmative covenants require that the Company achieve a specified level of revenue, as measured quarterly on a rolling twelve-month basis, commencing with the quarter ending December 31, 2022. The consequences of failing to achieve the performance covenant may be cured if, within sixty days of failing to achieve the performance covenant, the Company issues additional equity securities or subordinated debt with net proceeds sufficient to fund any cash flow deficiency generated from operations, as defined. The 2017 Loan Amendment requires that the Company maintain certain levels of minimum liquidity and maintains an unrestricted cash balance of $2.0 million. The negative covenants provide, among other things, that without the prior consent of Innovatus subject to certain exceptions, the Company may not dispose of certain assets, engage in certain business combinations or acquisitions, incur additional indebtedness or encumber any of the Company's property, pay dividends on the Company's capital stock or make prohibited investments. The Loan Amendment agreement provides that an event of default will occur if, among other triggers, (i) the Company defaults in the payment of any amount payable under the agreement when due, (ii) there occurs any circumstance(s) that could reasonably be expected to result in a material adverse effect on the Company's business, operations or condition, or on the Company's ability to perform its obligations under the agreement, (iii) the Company becomes insolvent, (iv) the Company undergoes a change in control or (v) the Company breaches any negative covenants or certain affirmative covenants in the agreement or, subject to a cure period, otherwise neglects to perform or observe any material item in the agreement. At December 31, 2022, the Company was in compliance with all covenants of the 2017 Loan Amendment. Upon an event of default in any of the 2017 Loan Amendment covenants, the repayment of the 2017 Loan Amendment may be accelerated, and the applicable interest rate will be increased by 4.0% until the default is cured. Although repayment of the 2017 Loan Amendment can be accelerated under certain circumstances, the Company believes acceleration of this loan is not probable as of the date of these financial statements. Accordingly, the Company has reflected the amounts of the 2017 Loan Amendment due beyond twelve months of the balance sheet date as non-current. 2022 Equipment Notes Payable In May 2022, the Company purchased laboratory equipment using notes payable. At December 31, 2022, the total notes payable balance related to this financed equipment was $0.8 million, with $0.2 million classified within borrowings-current portion and $0.6 million within borrowings-non-current portion, net of discounts and debt issuance costs in the accompanying balance sheets. The financed equipment is subject to a 5.28% effective interest rate and will mature on October 1, 2026. Future Minimum Payments on the Outstanding Borrowings As of December 31, 2022, future minimum aggregate payments, including interest, for outstanding borrowings are as follows (in thousands): Years Ending December 31, 2023 $ 1,911 2024 3,205 2025 16,377 2026 14,973 Total 36,466 Less: Unamortized debt discount and issuance costs (158) Interest (7,340) Total borrowings, net of discounts and debt issuance costs 28,968 Less: Borrowings-current portion (190) Borrowings-non-current portion, net of discounts and debt issuance costs $ 28,778 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases The Company adopted ASC 842, Leases , as of January 1, 2022. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company's historic accounting under ASC 840, Leases . Operating Leases The Company leases office and laboratory spaces in Vista, California, under leases that expire in April 2027, with an option to extend portions of the leases for additional 5-year periods. The Company has not included the optional renewal periods in the measurement of the lease liabilities because it is not reasonably certain that the Company will exercise these renewal options. The Company's lease payments under each of these leases are subject to escalation clauses. Effective on August 23, 2021, the Company entered into a sub-lease agreement for an additional office space in Carlsbad, California. The sub-lease commenced in October 2021 and expires in April 2027. The sub-lease agreement provides for monthly base rent of $66,021 which began on October 1, 2021, and such amount increases by approximately 3% annually beginning October 1, 2022. The Company determines if a contract contains a lease at inception or modification of a contract. The Company discounts their lease obligations using its incremental borrowing rate at the commencement date. The incremental borrowing rate is the rate of interest the Company would have to pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic environment. The Company primarily considers industry data, its credit rating and the lease term to determine its incremental borrowing rate. Finance Leases The Company has entered into various finance lease agreements to obtain laboratory equipment. The terms of the Company's finance leases generally range from three Operating and Finance Leases Balances and Costs Operating and finance leases consist of the following (in thousands): Lease Balance Classification December 31, 2022 Lease Assets Operating Operating lease right-of-use assets $ 4,885 Finance Property and equipment, net $ 1,427 Lease Liabilities Current Operating Operating lease liabilities $ 1,040 Finance Accrued and other current liabilities $ 700 Non-current Operating Non-current operating lease liabilities $ 4,493 Finance Other non-current liabilities $ 848 Costs associated with the Company's leases were included in the statements of operations as follows (in thousands): Lease Cost Year Ended December 31, 2022 Operating leases Operating lease cost (1) $ 1,540 Finance lease cost Amortization of lease assets 679 Interest on finance lease liabilities 80 Total lease cost $ 2,299 (1) Includes variable lease cost of $165,000 for the year ended December 31, 2022. Supplemental cash flow information on leases is as follows (in thousands): Cash paid for amounts included in the measurement of lease liabilities Year Ended December 31, 2022 Operating cash out flows from operating leases $ 1,262 Operating cash out flows from interest paid on finance leases $ 80 Financing cash out flows from finance leases $ 667 Information regarding the weighted-average lease term and weighted average discount rate are as follows: December 31, 2022 Weighted-average remaining lease term (years) Operating leases 4.3 Finance leases 1.94 Weighted-average discount rate Operating leases 8.0 % Finance leases 4.8 % Future payments under operating and finance leases as of December 31, 2022 are as follows (in thousands): Operating Leases Finance Leases 2023 $ 1,446 $ 828 2024 1,489 574 2025 1,533 248 2026 1,584 147 Thereafter 539 29 Total minimum lease payments 6,591 1,826 Less: imputed interest (1,058) (278) Total lease liabilities 5,533 1,548 Less: current portion (1,040) (700) Lease obligations, net of current portion $ 4,493 $ 848 Disclosures Under ASC 840 Minimum annual lease payments under non-cancelable operating lease arrangements as of December 31, 2021 are as follows (in thousands): Years Ending December 31, Operating Leases 2022 $ 1,337 2023 1,445 2024 1,489 2025 1,533 2026 1,584 Thereafter 539 Total minimum lease payments $ 7,927 For the year ended December 31, 2021, rent expense was $0.9 million. Acquisition-related liabilities In connection with the acquisition of the medical diagnostics division of Royalty Pharma Collection Trust (Royalty Pharma) (formerly known as Cypress Bioscience, Inc.) in 2010, the Company was required to pay certain amounts in the event that certain revenue milestones were achieved and upon the first commercial sale of a product associated with this acquisition, for which the obligations no longer exist at December 31, 2022. In addition, the Company has ongoing royalty payment obligations with Royalty Pharma of 2.5% on net sales of products which incorporate certain acquired technologies. Future royalties payable under these arrangements are limited to the lesser of (i) an aggregate of $1.2 million (including an upfront payment of $0.1 million) and (ii) the total royalties earned through January 1, 2024. Licensing Agreements The Company has licensed technology for use in its diagnostic tests. In addition to the milestone payments required by these agreements, individual license agreements generally provide for ongoing royalty payments ranging from 1.5% to 7.0% on net sales of products which incorporate licensed technology, as defined in such agreements. Royalties are accrued when earned and recorded in costs of revenue in the accompanying statement of operations. In May 2021, the Company entered into an exclusive license agreement with Allegheny Health Network Research Institute (AHN) to obtain an exclusive license to AHN's patent rights in certain inventions, pursuant to which the Company paid AHN an initial license fee of $0.4 million. In addition, under the terms of the exclusive license agreement, the Company is required to pay the greater of royalties in the low single digits on net sales of diagnostic tests using the assigned patents or a flat annual minimum royalty amount, pending approvals and commercialization. In November 2021, the Company entered into an exclusive license agreement with Queen Mary University of London (QMUL) to obtain an exclusive license to QMUL's patent rights in certain inventions, pursuant to which the Company paid QMUL an initial license fee of $0.4 million. The Company is obligated to make a one-time payment of $0.1 million relating to the first commercial sale of the licensed products. In addition, after the first 18 months of commercial sales under the terms of the exclusive license agreement, the Company is required to pay royalties in the high single-digits on net sales of testing products using the assigned patents, pending approvals and commercialization. Supply Agreement In December 2021, the Company entered into an amended supply agreement with one supplier for reagents which includes minimum annual purchase commitments of $6.0 million and $6.9 million for the years ended December 31, 2022 and 2023, respectively, with a 15% annual increase thereafter for unconditional minimum purchase commitments through the year ending December 31, 2025. Collaboration Obligations In May 2021, the Company entered into a master research collaboration agreement with AHN, pursuant to which the Company is required to pay AHN a collaboration fee of $0.4 million for each year during the initial term of the agreement. Collaboration expenses under the master research collaboration agreement were $0.4 million for the year ended December 31, 2022. Collaboration expenses under the AHN collaboration are included in research and development expenses. Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications; including for subpoenas and other civil investigative demands, from governmental agencies, Medicare or Medicaid and managed care organizations reviewing billing practices or requesting comment on allegations of billing irregularities that are brought to their attention through billing audits or third parties. 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 or that the Company believes to be immaterial. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. Litigation From time to time, the Company may be subject to various legal proceedings that arise in the ordinary course of business activities. The Company does not believe the outcome of any such matters will have a material effect on its financial position or results of operations. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company's cash, cash equivalents and restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued and other current liabilities approximate their fair values due to their short-term nature, which are determined to be a Level 1 measurement. The estimated fair values of the Company's long-term borrowings are determined by Level 2 inputs and are based primarily on quoted market prices for the same or similar issues. As of December 31, 2022, the 2017 Term Loan had a carrying value of $28.3 million and a fair value of $26.9 million. The estimated fair value of the 2017 Term Loan, which uses Level 2 fair value inputs, was determined based on a discounted cash flow approach using available market information on discount and borrowing rates with similar terms, maturities, and credit ratings. The recorded value of the Company's long-term borrowings as of December 31, 2021 approximated their fair values as the interest rate and other terms were that which were available to the Company at the time. See footnote 3 for discussion of recorded impairment charges related to long-lived assets and goodwill. 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 I that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 - Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The following table sets forth the Company's financial instruments that were measured at fair value on a recurring basis within the fair value hierarchy (in thousands): December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 29,438 $ 29,438 $ — $ — Certificate of deposit, included in cash and cash equivalents 30,100 30,100 — — Total $ 59,538 $ 59,538 $ — $ — December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 95,761 $ 95,761 $ — $ — |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock Shelf Registration Statement On November 10, 2020, the Company filed a registration statement on Form S-3 (the Shelf Registration Statement), covering the offering, from time to time, of up to $150.0 million of common stock, preferred stock, debt securities, warrants and units, which Shelf Registration Statement became effective on November 19, 2020. On March 25, 2021, the Company completed a public offering of 4,255,000 shares of its common stock at a public offering price of $16.25 per share. Net proceeds from the offering were approximately $64.7 million, after deducting underwriting discounts, commissions and other offering expenses of $4.4 million. The shares were registered pursuant to the Company's Shelf Registration Statement discussed above. At The Market Sales Agreement On September 15, 2022, the Company entered into a sales agreement (the Sales Agreement) with Cowen and Company, LLC, as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of Company common stock having an aggregate offering price of up to $50.0 million. The Company is not obligated to sell any shares of Company common stock in the offering. As of December 31, 2022, the Company has not sold any shares of its common stock pursuant to the Sales Agreement . Exchange Agreement On June 22, 2021, the Company entered into an exchange agreement (the Exchange Agreement) with an investor and its affiliates (the Exchanging Stockholders), pursuant to which the Company exchanged an aggregate of 804,951 shares of the Company's common stock owned by the Exchanging Stockholders for pre-funded warrants (the Exchange Warrants) to purchase an aggregate of 804,951 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Exchange Warrants), with an exercise price of $0.001 per share. The Exchange Warrants do not expire and are exercisable at any time except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 4.99% of the Company's common stock, which percentage may change at the Exchanging Stockholder's election to any other percentage upon 61 days' notice to the Company. The Company recorded the retirement of common stock exchanged as a reduction of common shares outstanding and additional paid-in-capital at the fair value of the Exchange Warrants on the issuance date. The Exchange Warrants are classified as equity and the fair value of the Exchange Warrants was recorded as an increase to additional paid-in-capital and is not subject to remeasurement. The Company determined that the fair value of the Exchange Warrants is substantially similar to the fair value of the retired shares on the issuance date due to the negligible exercise price for the Exchange Warrants. As of December 31, 2022, none of the Exchange Warrants have been exercised. Outstanding Warrants The following equity classified warrants to purchase common stock were outstanding as of December 31, 2022: Shares Exercise Price Issuance date Expiration date Common stock warrants 237,169 $ 1.84 January 19, 2016 January 19, 2026 Common stock warrants 67,086 1.84 March 31, 2016 March 31, 2026 Common stock warrants 131 1.84 April 1, 2016 April 1, 2026 Common stock warrants 83,778 14.32 September 7, 2017 September 7, 2024 Common stock warrants 20,944 14.32 December 7, 2018 December 7, 2025 Common stock warrants (Exchange Warrants) 804,951 0.001 June 22, 2021 None 1,214,059 During the year ended December 31, 2022, no warrants to purchase common stock were exercised. |
Stock Option Plan
Stock Option Plan | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Option Plan | Stock Option Plan 2019 Incentive Award Plan In September 2019, the Company's Board of Directors adopted, and the Company's stockholders approved, the 2019 Plan. Under the 2019 Plan, which expires in September 2029, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. The options generally expire ten years after the date of grant and are exercisable to the extent vested. Vesting is established by the Board of Directors and is generally four years from the date of grant or, for grants to new hires, date of hire. The 2019 Plan contains an "evergreen provision" that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2029 in an amount equal to the lesser of: (i) 4% of the outstanding capital stock on each December 31st, or (ii) such lesser amount determined by the Board of Directors. As of December 31, 2022, 1,452,435 shares remained available for future awards. Under the evergreen provision, on January 1, 2023, an additional 661,999 shares became available for issuance under the 2019 Plan. 2019 Employee Stock Purchase Plan In September 2019, the Board of Directors adopted, and the Company's stockholders approved, the ESPP. The ESPP became effective on the day the ESPP was adopted by the Company's Board of Directors. The ESPP permits participants to purchase common stock through payroll deductions of up to 20% of their eligible compensation. The number of shares of common stock available for issuance under the ESPP will be annually increased on the first day of each calendar year during the term of the ESPP through January 1, 2029 in an amount equal to the lesser of (i) 1% of the outstanding capital stock on each December 31st, or (ii) such lesser amount determined by the Board of Directors. As of December 31, 2022, 413,425 shares of common stock remained available for issuance under the ESPP. Under the evergreen provision, on January 1, 2023, an additional 165,500 shares became available for issuances under the ESPP. Stock Options Stock option activity under the Company's 2019 Plan is set forth below: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2021 2,014,330 $ 12.10 7.87 $ 5,428 Granted 63,000 $ 5.25 Exercised (245,186) $ 0.26 Forfeited (257,982) $ 16.09 Expired (152,927) $ 13.73 Outstanding, December 31, 2022 1,421,235 $ 12.94 7.09 $ 483 Vested and expected to vest, December 31, 2022 1,421,235 $ 12.94 7.09 $ 483 Options exercisable, December 31, 2022 1,129,333 $ 12.94 6.89 $ 483 The weighted-average grant date fair value per share of employee options granted to employees during the years ended December 31, 2022 and 2021 was $2.74 and $8.83, respectively. The intrinsic value is calculated as the difference between the fair value of the Company's common stock and the exercise price of the stock options. The fair value of the Company's common stock was $2.40 and $11.63 per share at December 31, 2022 and 2021, respectively. The intrinsic value of options exercised for the years ended December 31, 2022 and 2021 was $0.6 million and $0.1 million, respectively. As of December 31, 2022, total unrecognized compensation cost related to option awards was $1.8 million, which is expected to be recognized over a remaining weighted-average vesting period of 1.1 years. Restricted Stock Units Restricted stock unit activity under the Company's 2019 Plan is set forth below: Number of Weighted- Aggregate Outstanding, December 31, 2021 415,325 $ 16.54 $ 4,830 Awards granted 1,076,725 $ 5.89 Awards released (100,586) $ 16.55 Awards canceled (355,256) $ 11.29 Outstanding, December 31, 2022 1,036,208 $ 7.28 $ 2,487 As of December 31, 2022, all of the outstanding restricted stock units are unvested. The fair value of restricted stock units vested in the year ended December 31, 2022 was $0.7 million. No restricted stock units vested in the year ended December 31, 2021. The weighted average grant date fair value for restricted stock units granted during the years ended December 31, 2022 and 2021 was $5.89 and $16.53, respectively. As of December 31, 2022, total unrecognized compensation cost related to restricted stock units was $6.0 million, which is expected to be recognized over a remaining weighted-average vesting period of 3.3 years. Stock-Based Compensation Expense Stock Options The fair value of employee stock options was estimated using the following assumptions in the Black-Scholes options pricing model to determine the fair value of stock options granted: Year Ended December 31, 2022 2021 Expected volatility 54% 56%-60% Risk-free interest rate 3.4% 0.8%-1.1% Dividend yield — — Expected term (in years) 5.5 5.5-6.1 Employee Stock Purchase Plan The following assumptions were used to calculate the stock-based compensation for each stock purchase right granted under the ESPP: Year Ended December 31, 2022 2021 Expected volatility 45%-57% 45%-60% Risk-free interest rate 0.6%-3.3% 0.1% Dividend yield — — Expected term (in years) 0.5 0.5 Stock-based compensation expense related to the ESPP for the years ended December 31, 2022 and 2021 was less than $0.1 million and $0.2 million, respectively. As of December 31, 2022, total unrecognized compensation cost related to stock purchase rights granted under the ESPP was less than $0.1 million, which is expected to be recognized over a remaining weighted-average vesting period of 0.2 years. Total non-cash stock-based compensation expense recorded related to options granted, restricted stock units granted and stock purchase rights granted under the ESPP in the statement of operations is as follows (in thousands): Year Ended December 31, 2022 2021 Cost of revenue $ 213 $ 164 Selling, general and administrative 3,860 3,943 Research and development 631 621 Total $ 4,704 $ 4,728 Common stock reserved for future issuance consists of the following at December 31, 2022: Warrants to purchase common stock 1,214,059 Common stock option grants issued and outstanding 1,421,235 Common stock reserved for issuance upon vesting of outstanding restricted stock units 1,036,370 Common shares available for grant under the 2019 Plan 1,452,435 Common shares available for future issuance under ESPP 413,425 Total 5,537,524 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2022 2021 Current: Federal $ — $ — State 24 27 Total current 24 27 Deferred: Federal (137) 137 State (169) 11 Total deferred (306) 148 Provision (benefit) for income tax $ (282) $ 175 The effective tax rate of our provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 Federal statutory tax rate (21.0) % (21.0) % State income taxes, net of federal tax benefits (4.3) % (3.8) % Research and development tax credits (1.5) % (1.2) % Stock compensation 1.4 % 0.9 % Non-deductible expenses 0.9 % 1.1 % Change in valuation allowance 23.9 % 24.6 % Effective tax rate (0.6) % 0.6 % Significant components of the Company’s deferred tax assets at December 31, 2022 and 2021 are shown below (in thousands). A valuation allowance has been established as realization of the Company’s deferred tax assets has not met the more likely-than-not threshold requirement. If the Company’s judgment changes and it is determined that the Company will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation allowance on deferred tax assets will be accounted for as a reduction to income tax expense. December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 29,789 $ 22,365 Research and development tax credits 2,216 1,102 Accruals, reserves and other 349 1,055 Interest expense 2,236 1,953 Indefinite lived assets 362 — Stock compensation 1,606 1,407 Lease liability 1,374 — Capitalization of research and experimentation costs 2,047 — Total gross deferred tax assets 39,979 27,882 Less: valuation allowance (38,567) (27,158) Deferred tax assets, net 1,412 724 Deferred tax liabilities: Financing and acquisition-related liabilities — (335) Indefinite lived assets — (521) Right of use assets (1,206) — Basis differences in fixed and intangible assets (206) (175) Deferred tax liabilities, net (1,412) (1,031) Net deferred tax liabilities $ — $ (307) Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022 and 2021, which related primarily to increases in net operating loss (NOL) carryforwards, research and development tax credits, capitalization of research and experimentation costs, and impairment of goodwill were as follows (in thousands): December 31, 2022 2021 Valuation allowance at the beginning of the year $ 27,158 $ 20,596 Increases recorded to income tax provision 11,409 6,562 Valuation allowance at the end of the year $ 38,567 $ 27,158 At December 31, 2022 and 2021, the Company had federal NOL carryforwards of approximately $118.4 million and $89.4 million, respectively. At December 31, 2022 and 2021, the Company had state NOL carryforwards of $87.0 million and $61.0 million, respectively. Approximately $43.5 million of the federal tax loss carryforwards will begin to expire in 2023, unless previously utilized. The federal NOL carryforwards generated in after December 31, 2017 of $74.9 million will carryforward indefinitely. The Company’s state tax loss carryforwards will expire in 2030, unless previously utilized. At December 31, 2022, the Company's deferred tax assets are primarily comprised of federal and state tax NOL carryforwards. The Company completed a formal study through the year ended December 31, 2019 and determined ownership changes within the meaning of Internal Revenue Code (IRC), Section 382 had occurred in 2003, 2008, 2012, 2017 and 2019. The Company is subject to taxation in the United States and in various state jurisdictions. The Company’s tax years for 2003 and forward are subject to examination by the U.S. and state tax authorities due to the carryforward of unutilized net operating losses and research and development credits. The Company recognizes interest and/or penalties related to income tax matters in its provision for income taxes. The Company does not have any material accruals for, and did not recognize any, material interest or penalties in these financial statements in any period presented. Uncertain Tax Positions At December 31, 2022 and 2021, the Company had no unrecognized tax benefits. The Company does not believe that the balance of unrecognized tax benefits will materially change within the next twelve months. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
401(k) Plan | 401(k) PlanThe Company sponsors an employee savings plan that qualifies as a deferred salary arrangement under Section 401(k) of the Code. Participating employees may defer up to the Internal Revenue Service annual contribution limit. Additionally, the Company may elect to make contributions into the savings plan at its sole discretion. For the years ended December 31, 2022 and 2021, the Company made contributions to the Plan at 4% and 3% of qualified employee compensation, respectively. For the years ended December 31, 2022 and 2021, these contributions totaled approximately $0.9 million and $0.5 million, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Concentration of Credit Risk and Other Risk and Uncertainties | Concentration of Credit Risk and Other Risk and Uncertainties Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents and accounts receivable. Substantially all the Company's cash and 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. We have not experienced any losses on our cash or cash equivalents. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all 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. |
Property and Equipment | Property and EquipmentProperty and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three |
Long-lived Assets | Long-lived Assets The Company’s long-lived assets are comprised principally of its property and equipment and operating lease assets (see Note 5). We amortize all finite lived intangible assets over their respective estimated useful lives. Operating lease assets are amortized over the term of the leases. In considering whether long-lived assets are impaired, we combine our intangible assets and other long-lived assets (excluding goodwill), into groupings, a determination which we principally make on the basis of whether the assets are specific to a particular test offered by us or technology we are developing. If the Company identifies a change in the circumstances related to its long-lived assets, such as property and equipment and intangible assets (other than goodwill), that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset (other than goodwill) is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Management’s estimates of future cash flows are impacted by projected test volume and levels of reimbursement, as well as expectations related to the future cost structure of the entity. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value, and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. During the year ended December 31, 2022, the Company recorded an impairment charge to fixed assets totaling $0.4 million (see Note 3). The impairment charge was classified within research and development expenses in the accompanying statements of operations. Goodwill Goodwill is reviewed for impairment annually (during the fourth quarter) or more frequently if indicators of impairment exist. As the Company operates in a single operating segment and reporting unit, the Company first assesses qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative assessment. If, after assessing qualitative factors, the Company determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing a quantitative assessment is unnecessary. If deemed necessary, a quantitative assessment compares the fair value of the reporting unit with its carrying amount, including goodwill. If the fair value of the reporting unit exceeds its carrying amount, goodwill is not considered impaired; otherwise, an impairment loss is recorded. |
Leases | Leases The Company categorizes leases at their commencement as either operating or finance leases. Effective January 1, 2022 upon the adoption of Accounting Standards Codification (ASC) 842, the Company recognizes operating lease ROU assets and operating lease liabilities for each lease arrangement identified. Lease liabilities are recorded at the present value of future lease payments discounted using the Company's incremental borrowing rate for the lease established at the commencement date. ROU assets are measured at the amount of the lease liability plus any initial direct costs, less any lease incentives received before commencement. Lease expense is recognized as a single lease cost over the lease term on a straight-line basis. The Company has elected not to apply the recognition requirements to short-term leases and not to separate non-lease components from lease components for its leases. |
Clinical Studies | Clinical Studies From time to time, the Company engages in efforts to scientifically measure and document the application and efficacy of its various testing products. These arrangements typically require the Company to pay a fee to a third-party scientific investigator (usually a physician or research institution) for each subject enrolled in a clinical study, and the Company accrues expenses based on estimated progress of services performed, including actual level of subjects enrolled and progress of the clinical studies. Payments made prior to the completion of clinical study services are capitalized as a prepaid expense. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered. Expenses associated with clinical study activities are recorded in research and development expenses in the accompanying statement of operations. |
Revenue Recognition and Shipping and Handling Costs | Revenue Recognition Substantially all of the Company's revenue has been derived from sales of its testing products and is primarily comprised of a high volume of relatively low-dollar transactions. The Company primarily markets its testing products to rheumatologists and their physician assistants in the United States. The healthcare professionals who order the Company's testing products and to whom test results are reported are generally not responsible for payment for these products. The parties that pay for these services (each, a payor) consist of commercial payors (healthcare insurers), government payors (primarily Medicare and Medicaid), client payors (i.e., hospitals, other laboratories, etc.) and patient self-pay. The Company's service is a single performance obligation that is completed upon the delivery of test results to the prescribing physician which triggers revenue recognition. Payors are billed at the Company's list price. Net revenues recognized consist of amounts billed net of allowances for differences between amounts billed and the estimated consideration the Company expects to receive from such payors. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. The Company follows a standard process, which considers historical denial and collection experience, insurance reimbursement policies and other factors, to estimate allowances and implicit price concessions, recording adjustments in the current period as changes in estimates occur. Further adjustments to the allowances, based on actual receipts, are recorded upon settlement. Included in revenues for the years ended December 31, 2022 and 2021 was a net revenue decrease of $2.4 million and a net revenue increase of $0.7 million, respectively, associated with changes in estimated variable consideration related to performance obligations satisfied in previous periods. The transaction price is estimated using an expected value method on a portfolio basis. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. The Company's portfolios are grouped per payor (i.e. each individual commercial payor, Medicare, Medicaid, client payors, patient self-pay, etc.) and per test. Consideration may be constrained and excluded from the transaction price in situations where there is no contractually agreed upon reimbursement coverage or in absence of a predictable pattern and history of collectability with a payor. Accordingly, in such situations revenues are recognized on the basis of actual cash collections. Additionally, from time to time, the Company may issue refunds to payors for overpayments or amounts billed in error. Any refunds are accounted for as reductions in revenues in the statement of operations as an element of variable consideration. The estimated expected refunds are accrued as a liability on the Company’s balance sheet. Collection of the Company's net revenues from payors is normally a function of providing complete and correct billing information to the healthcare insurers and generally occurs within 30 to 90 days of billing. Contracts do not contain significant financing components based on the typical period of time between performance of services and collection of consideration. Janssen Promotion Agreement In December 2018, the Company entered into a co-promotion agreement (as amended from time to time, the Janssen Agreement) with Janssen Biotech, Inc. (Janssen) to co-promote SIMPONI ® in the United States. In August 2021, the Company and Janssen mutually agreed to terminate the Janssen Agreement, effective August 31, 2021. Pursuant to the Janssen Agreement, as amended, the Company was responsible for the costs associated with its sales force over the course of such co-promotion. Janssen was responsible for all other aspects of the commercialization of SIMPONI ® under the Janssen Agreement. In exchange for the Company's sales and co-promotional services, the Company was entitled to a quarterly tiered promotion fee based on the incremental increase in total prescribed units of SIMPONI ® for that quarter over a predetermined baseline. The Company's obligations relating to sales and co-promotion services for SIMPONI ® were a series of single performance obligations since Janssen simultaneously received and consumed benefits provided by the Company's sales and co-promotional services. The method for measuring progress towards satisfying the performance obligations was based on prescribed units in excess of the contractual baseline at the contractual rate earned per unit. The Company recognized no co-promotion revenue and $1.2 million in co-promotion revenue during the years ended December 31, 2022 and December 31, 2021, respectively. The related expenses for marketing SIMPONI ® were included in selling, general and administrative expenses and were expensed as incurred. Pursuant to the terms of the termination, the Company received $0.6 million in consideration (which was earned in the year ended December 31, 2021) and the Company was restricted until May 31, 2022 from promoting any other biologic or Janus kinase inhibitor used for the treatment of indications covered by the Janssen Agreement without first obtaining Janssen's written consent. The restriction no longer applies. Shipping and Handling Costs Costs incurred for shipping and handling are included in costs of revenue in the accompanying statements of operations and totaled approximately $2.7 million and $2.1 million, for the years ended December 31, 2022 and 2021, respectively. |
Research and Development | Research and Development Costs associated with research and development activities are expensed as incurred and include, but are not limited to, personnel-related expenses, including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. |
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 approximately $3.0 million and $1.7 million for the years ended December 31, 2022 and 2021, respectively, and are included in selling, general and administrative expenses in the accompanying statements of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards to employees and directors based on the grant-date estimated fair values over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The fair value of stock options and purchases under the Company's 2019 Employee Stock Purchase Plan (ESPP) rights is determined using the Black-Scholes-Merton (BSM) option pricing model, which requires management to make certain assumptions regarding a number of complex and subjective variables. Equity award forfeitures are recorded as they occur. The BSM option pricing model incorporates various inputs, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. Volatility is based on the Company's historical calculated volatility since being publicly traded. The weighted-average expected term of options was calculated using the simplified method. The risk-free interest rate for periods within the contractual term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is zero, as the Company has never declared or paid dividends and has no plans to do so in the foreseeable future. The fair value of each restricted stock unit is determined on the grant date using the closing price of the Company's common stock on that date. The Company's restricted stock units generally vest in equal annual installments over four years from the date of grant or, for grants to new hires, date of hire. Vesting of restricted stock units is subject to the holder's continued service with the Company. The Company issues new shares to satisfy restricted stock units upon vesting. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from transactions from nonowner sources. There have been no items qualifying as other comprehensive loss and, therefore, for all periods presented, the Company's comprehensive loss was the same as its reported net loss. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would adjust the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares used to compute basic and diluted shares includes shares issuable upon the exercise of pre-funded warrants at a nominal price. Potentially dilutive common stock equivalents are comprised of warrants for the purchase of common stock, options and restricted stock units outstanding under the Company's 2019 Incentive Award Plan (the 2019 Plan) and shares of the Company's common stock pursuant to the ESPP. For the years ended December 31, 2022 and 2021, there is 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 antidilutive. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations as, and manages its business in, one operating segment. |
Recent Accounting Pronouncements Recently Adopted Accounting Standards Not Yet Adopted | Recent Accounting Pronouncements From time to time, new accounting pronouncements 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. Under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), the Company meets the definition of an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. 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. Recently Adopted Accounting Standards In February 2016, the FASB issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842). The new topic supersedes Topic 840, Leases , and increases transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and requires disclosures of key information about leasing arrangements. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842 , which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU 2018-11, Leases: Targeted Improvements , which was issued to provide relief to companies from restating comparative periods. On January 1, 2022, the Company adopted ASU 2016-12, using the modified retrospective transition method. Periods prior to January 1, 2022 have not been restated for the adoption of ASC 842 and continue to reflect the accounting treatment of leases in accordance with the prior lease accounting guidance, ASC 840, Leases . The Company adopted the new lease standard using a cumulative effect to accumulated deficit and there was no impact to accumulated deficit upon adoption. The Company elected the package of practical expedients, which among other things allowed the Company to carry forward its historical lease classification. As part of the adoption, the Company recorded operating lease liabilities of $6.4 million, operating lease ROU assets of $5.9 million, adjusted for deferred rent and lease incentive obligations of $0.5 million previously included in other non-current liabilities and accrued and other current liabilities, pertaining to its office and laboratory space operating leases. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of expected credit losses for financial instruments carried at amortized cost, such as accounts receivable, held at the reporting date based on historical experience, current conditions and reasonable forecasts. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. In November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financing Instruments-Credit Losses , which included an amendment of the effective date for nonpublic entities. For non-emerging growth companies, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019. For emerging growth companies, ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted this pronouncement on January 1, 2023 and the impact of the provisions of this standard on its Consolidated Financial Statements is expected to be immaterial. In August 2020, the FASB issued ASU 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 the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Specifically, ASU 2020-06 simplifies accounting for the issuance of convertible instruments by removing major separation models required under current GAAP. In addition, the ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share (EPS) calculation in certain areas. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, beginning in fiscal years which begin after December 15, 2020, including interim periods within those fiscal years. The FASB has specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The amendment is to be adopted through either a modified retrospective or fully retrospective method of transition. The Company is currently evaluating the potential impact that the adoption of ASU 2020-06 may have on its consolidated financial statements and related disclosures. |
Fair Value Measurements | The carrying value of the Company's cash, cash equivalents and restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued and other current liabilities approximate their fair values due to their short-term nature, which are determined to be a Level 1 measurement. The estimated fair values of the Company's long-term borrowings are determined by Level 2 inputs and are based primarily on quoted market prices for the same or similar issues. As of December 31, 2022, the 2017 Term Loan had a carrying value of $28.3 million and a fair value of $26.9 million. The estimated fair value of the 2017 Term Loan, which uses Level 2 fair value inputs, was determined based on a discounted cash flow approach using available market information on discount and borrowing rates with similar terms, maturities, and credit ratings. The recorded value of the Company's long-term borrowings as of December 31, 2021 approximated their fair values as the interest rate and other terms were that which were available to the Company at the time. See footnote 3 for discussion of recorded impairment charges related to long-lived assets and goodwill. 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 I 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Concentration of Risk, by Risk Factor and Significant Payer | For each significant payor and customer, revenue as a percentage of total revenue and accounts receivable as a percentage of total accounts receivable are as follows: Revenue Year Ended December 31, 2022 2021 Medicare 39 % 19 % Medicare Advantage 15 % 13 % Blue Shield * 12 % * Less than 10%. Accounts Receivable December 31, 2022 2021 Medicare 21 % * Medicare Advantage 13 % * Blue Shield * 19 % United Healthcare * 18 % * Less than 10%. |
Disaggregation of Revenue | The following table includes the Company's revenues as disaggregated by payor and customer category (in thousands): Year Ended December 31, 2022 2021 Revenue: Commercial $ 18,975 $ 27,499 Government 17,687 9,221 Client(1) 7,928 9,288 Other(2) 973 1,091 Janssen (SIMPONI ® ) — 1,200 Total revenue $ 45,563 $ 48,299 (1) Includes hospitals, other laboratories, etc. (2) Includes patient self-pay. |
Schedule of Restricted Cash and Cash Equivalents | Cash, cash equivalents and restricted cash presented in the accompanying statements of cash flows consist of the following (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 62,391 $ 99,442 Restricted cash 200 100 $ 62,591 $ 99,542 |
Schedule of Cash and Cash Equivalents | Cash, cash equivalents and restricted cash presented in the accompanying statements of cash flows consist of the following (in thousands): December 31, 2022 2021 Cash and cash equivalents $ 62,391 $ 99,442 Restricted cash 200 100 $ 62,591 $ 99,542 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings 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): Years Ended December 31, 2022 2021 Warrants to purchase common stock 409,108 409,108 Common stock options 1,421,235 2,014,330 Restricted stock units 1,036,208 415,325 Employee stock purchase plan 58,711 20,193 Total 2,925,262 2,858,956 |
Other Financial Information (Ta
Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Financial Information [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2022 2021 Diagnostic testing supplies $ 1,795 $ 1,091 Prepaid product royalties 40 49 Prepaid maintenance and insurance contracts 2,072 2,008 Other prepaid and other current assets 236 490 Prepaid and other current assets $ 4,143 $ 3,638 |
Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2022 2021 Furniture and fixtures $ 98 $ 83 Laboratory equipment 5,136 4,361 Computer equipment and software 1,482 1,206 Leasehold improvements 5,223 1,151 Construction in progress 1,382 1,855 Total property and equipment 13,321 8,656 Less: accumulated depreciation and amortization (5,124) (3,884) Property and equipment, net $ 8,197 $ 4,772 |
Schedule of Goodwill | The following table presents details of the Company's goodwill for the year ended December 31, 2022 (in thousands): Total Balance as of December 31, 2021 $ 5,506 Goodwill impairment (5,506) Balance as of December 31, 2022 $ — |
Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following (in thousands): December 31, 2022 2021 Accrued payroll and related expenses $ 2,355 $ 4,048 Accrued interest 142 139 Accrued purchases of goods and services 803 510 Accrued royalties 514 180 Accrued clinical study activity 162 254 Finance lease obligations, current portion 700 587 Refund liability 445 — Other accrued liabilities 226 1,108 Accrued and other current liabilities $ 5,347 $ 6,826 |
Borrowings (Tables)
Borrowings (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Future Minimum Aggregate Payments for Outstanding Borrowings | As of December 31, 2022, future minimum aggregate payments, including interest, for outstanding borrowings are as follows (in thousands): Years Ending December 31, 2023 $ 1,911 2024 3,205 2025 16,377 2026 14,973 Total 36,466 Less: Unamortized debt discount and issuance costs (158) Interest (7,340) Total borrowings, net of discounts and debt issuance costs 28,968 Less: Borrowings-current portion (190) Borrowings-non-current portion, net of discounts and debt issuance costs $ 28,778 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Lease Costs | Operating and finance leases consist of the following (in thousands): Lease Balance Classification December 31, 2022 Lease Assets Operating Operating lease right-of-use assets $ 4,885 Finance Property and equipment, net $ 1,427 Lease Liabilities Current Operating Operating lease liabilities $ 1,040 Finance Accrued and other current liabilities $ 700 Non-current Operating Non-current operating lease liabilities $ 4,493 Finance Other non-current liabilities $ 848 Costs associated with the Company's leases were included in the statements of operations as follows (in thousands): Lease Cost Year Ended December 31, 2022 Operating leases Operating lease cost (1) $ 1,540 Finance lease cost Amortization of lease assets 679 Interest on finance lease liabilities 80 Total lease cost $ 2,299 (1) Includes variable lease cost of $165,000 for the year ended December 31, 2022. Supplemental cash flow information on leases is as follows (in thousands): Cash paid for amounts included in the measurement of lease liabilities Year Ended December 31, 2022 Operating cash out flows from operating leases $ 1,262 Operating cash out flows from interest paid on finance leases $ 80 Financing cash out flows from finance leases $ 667 Information regarding the weighted-average lease term and weighted average discount rate are as follows: December 31, 2022 Weighted-average remaining lease term (years) Operating leases 4.3 Finance leases 1.94 Weighted-average discount rate Operating leases 8.0 % Finance leases 4.8 % |
Summary of Lessee, Operating Lease, Liability, Maturity | Future payments under operating and finance leases as of December 31, 2022 are as follows (in thousands): Operating Leases Finance Leases 2023 $ 1,446 $ 828 2024 1,489 574 2025 1,533 248 2026 1,584 147 Thereafter 539 29 Total minimum lease payments 6,591 1,826 Less: imputed interest (1,058) (278) Total lease liabilities 5,533 1,548 Less: current portion (1,040) (700) Lease obligations, net of current portion $ 4,493 $ 848 |
Summary of Finance Lease, Liability, Maturity | Future payments under operating and finance leases as of December 31, 2022 are as follows (in thousands): Operating Leases Finance Leases 2023 $ 1,446 $ 828 2024 1,489 574 2025 1,533 248 2026 1,584 147 Thereafter 539 29 Total minimum lease payments 6,591 1,826 Less: imputed interest (1,058) (278) Total lease liabilities 5,533 1,548 Less: current portion (1,040) (700) Lease obligations, net of current portion $ 4,493 $ 848 |
Schedule of Future Minimum Rental Payments for Operating Leases | Minimum annual lease payments under non-cancelable operating lease arrangements as of December 31, 2021 are as follows (in thousands): Years Ending December 31, Operating Leases 2022 $ 1,337 2023 1,445 2024 1,489 2025 1,533 2026 1,584 Thereafter 539 Total minimum lease payments $ 7,927 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Financial Instrument Measured on a Recurring Basis | The following table sets forth the Company's financial instruments that were measured at fair value on a recurring basis within the fair value hierarchy (in thousands): December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 29,438 $ 29,438 $ — $ — Certificate of deposit, included in cash and cash equivalents 30,100 30,100 — — Total $ 59,538 $ 59,538 $ — $ — December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 95,761 $ 95,761 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Outstanding Warrants | The following equity classified warrants to purchase common stock were outstanding as of December 31, 2022: Shares Exercise Price Issuance date Expiration date Common stock warrants 237,169 $ 1.84 January 19, 2016 January 19, 2026 Common stock warrants 67,086 1.84 March 31, 2016 March 31, 2026 Common stock warrants 131 1.84 April 1, 2016 April 1, 2026 Common stock warrants 83,778 14.32 September 7, 2017 September 7, 2024 Common stock warrants 20,944 14.32 December 7, 2018 December 7, 2025 Common stock warrants (Exchange Warrants) 804,951 0.001 June 22, 2021 None 1,214,059 |
Stock Option Plan (Tables)
Stock Option Plan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | Stock option activity under the Company's 2019 Plan is set forth below: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2021 2,014,330 $ 12.10 7.87 $ 5,428 Granted 63,000 $ 5.25 Exercised (245,186) $ 0.26 Forfeited (257,982) $ 16.09 Expired (152,927) $ 13.73 Outstanding, December 31, 2022 1,421,235 $ 12.94 7.09 $ 483 Vested and expected to vest, December 31, 2022 1,421,235 $ 12.94 7.09 $ 483 Options exercisable, December 31, 2022 1,129,333 $ 12.94 6.89 $ 483 |
Schedule of Share-based Payment Arrangement, Restricted Stock Unit, Activity | Restricted stock unit activity under the Company's 2019 Plan is set forth below: Number of Weighted- Aggregate Outstanding, December 31, 2021 415,325 $ 16.54 $ 4,830 Awards granted 1,076,725 $ 5.89 Awards released (100,586) $ 16.55 Awards canceled (355,256) $ 11.29 Outstanding, December 31, 2022 1,036,208 $ 7.28 $ 2,487 |
Schedule of Fair Value Assumptions, Stock Options | The fair value of employee stock options was estimated using the following assumptions in the Black-Scholes options pricing model to determine the fair value of stock options granted: Year Ended December 31, 2022 2021 Expected volatility 54% 56%-60% Risk-free interest rate 3.4% 0.8%-1.1% Dividend yield — — Expected term (in years) 5.5 5.5-6.1 The following assumptions were used to calculate the stock-based compensation for each stock purchase right granted under the ESPP: Year Ended December 31, 2022 2021 Expected volatility 45%-57% 45%-60% Risk-free interest rate 0.6%-3.3% 0.1% Dividend yield — — Expected term (in years) 0.5 0.5 |
Schedule of Non-cash Stock-based Compensation Expense | Total non-cash stock-based compensation expense recorded related to options granted, restricted stock units granted and stock purchase rights granted under the ESPP in the statement of operations is as follows (in thousands): Year Ended December 31, 2022 2021 Cost of revenue $ 213 $ 164 Selling, general and administrative 3,860 3,943 Research and development 631 621 Total $ 4,704 $ 4,728 |
Schedule of Common Stock Reserved For Future Issuance | Common stock reserved for future issuance consists of the following at December 31, 2022: Warrants to purchase common stock 1,214,059 Common stock option grants issued and outstanding 1,421,235 Common stock reserved for issuance upon vesting of outstanding restricted stock units 1,036,370 Common shares available for grant under the 2019 Plan 1,452,435 Common shares available for future issuance under ESPP 413,425 Total 5,537,524 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2022 2021 Current: Federal $ — $ — State 24 27 Total current 24 27 Deferred: Federal (137) 137 State (169) 11 Total deferred (306) 148 Provision (benefit) for income tax $ (282) $ 175 |
Schedule of Effective Income Tax Rate Reconciliation | The effective tax rate of our provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 Federal statutory tax rate (21.0) % (21.0) % State income taxes, net of federal tax benefits (4.3) % (3.8) % Research and development tax credits (1.5) % (1.2) % Stock compensation 1.4 % 0.9 % Non-deductible expenses 0.9 % 1.1 % Change in valuation allowance 23.9 % 24.6 % Effective tax rate (0.6) % 0.6 % |
Schedule of Deferred Tax Assets and Liabilities | If the Company’s judgment changes and it is determined that the Company will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation allowance on deferred tax assets will be accounted for as a reduction to income tax expense. December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 29,789 $ 22,365 Research and development tax credits 2,216 1,102 Accruals, reserves and other 349 1,055 Interest expense 2,236 1,953 Indefinite lived assets 362 — Stock compensation 1,606 1,407 Lease liability 1,374 — Capitalization of research and experimentation costs 2,047 — Total gross deferred tax assets 39,979 27,882 Less: valuation allowance (38,567) (27,158) Deferred tax assets, net 1,412 724 Deferred tax liabilities: Financing and acquisition-related liabilities — (335) Indefinite lived assets — (521) Right of use assets (1,206) — Basis differences in fixed and intangible assets (206) (175) Deferred tax liabilities, net (1,412) (1,031) Net deferred tax liabilities $ — $ (307) |
Summary of Valuation Allowance | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022 and 2021, which related primarily to increases in net operating loss (NOL) carryforwards, research and development tax credits, capitalization of research and experimentation costs, and impairment of goodwill were as follows (in thousands): December 31, 2022 2021 Valuation allowance at the beginning of the year $ 27,158 $ 20,596 Increases recorded to income tax provision 11,409 6,562 Valuation allowance at the end of the year $ 38,567 $ 27,158 |
Organization (Details)
Organization (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 62,391 | $ 99,442 |
Accumulated deficit | $ 255,527 | $ 208,140 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Revenue by Major Payers (Details) - Customer Concentration Risk | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Medicare | Revenue Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 39% | 19% |
Medicare | Receivable Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 21% | |
Medicare Advantage | Revenue Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 15% | 13% |
Medicare Advantage | Receivable Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 13% | |
Blue Shield | Revenue Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 12% | |
Blue Shield | Receivable Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 19% | |
United Healthcare | Receivable Benchmark | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 18% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) segment installment | Dec. 31, 2021 USD ($) | Jan. 01, 2022 USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Restricted cash | $ 200 | $ 100 | |
Long-lived assets impairment | 397 | 0 | |
Goodwill Impairment | 5,506 | 0 | |
Revenue recognized | (2,400) | 700 | |
Revenue | 45,563 | 48,299 | |
Advertising and marketing costs | $ 3,000 | 1,700 | |
Dividend yield | 0% | ||
Number of annual vesting installments | installment | 4 | ||
Number of operating segments | segment | 1 | ||
Operating lease liabilities | $ 5,533 | ||
Operating lease right-of-use assets | $ 4,885 | 0 | |
Accounting Standards Update 2016-02 | Cumulative Effect, Period of Adoption, Adjustment | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease liabilities | $ 6,400 | ||
Operating lease right-of-use assets | 5,900 | ||
Deferred rent credit | $ 500 | ||
Janssen Promotion Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Termination of agreement | 600 | ||
Minimum | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property, plant and equipment, useful life | 3 years | ||
Maximum | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property, plant and equipment, useful life | 5 years | ||
Shipping and Handling | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cost of revenue | $ 2,700 | $ 2,100 | |
Revenue Benchmark | Supplier Concentration Risk | Two Suppliers | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Concentration risk percentage | 96% | 96% | |
Revenue Benchmark | AVISE CTD Test | Product Concentration Risk | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Concentration risk percentage | 84% | 81% | |
Blue Shield | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Revenue | $ 1,200 | $ 1,200 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 45,563 | $ 48,299 |
Commercial | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 18,975 | 27,499 |
Government | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 17,687 | 9,221 |
Client | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 7,928 | 9,288 |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 973 | 1,091 |
Blue Shield | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 0 | $ 1,200 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 62,391 | $ 99,442 | |
Restricted cash | 200 | 100 | |
Total cash, cash equivalents and restricted cash | $ 62,591 | $ 99,542 | $ 57,548 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 2,925,262 | 2,858,956 |
Warrants to purchase common stock | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 409,108 | 409,108 |
Common stock options | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 1,421,235 | 2,014,330 |
Restricted stock units | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 1,036,208 | 415,325 |
Employee stock purchase plan | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 58,711 | 20,193 |
Other Financial Information - P
Other Financial Information - Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Financial Information [Abstract] | ||
Diagnostic testing supplies | $ 1,795 | $ 1,091 |
Prepaid product royalties | 40 | 49 |
Prepaid maintenance and insurance contracts | 2,072 | 2,008 |
Other prepaid and other current assets | 236 | 490 |
Prepaid and other current assets | $ 4,143 | $ 3,638 |
Other Financial Information -_2
Other Financial Information - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 13,321 | $ 8,656 |
Less: accumulated depreciation and amortization | (5,124) | (3,884) |
Property and equipment, net | 8,197 | 4,772 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 98 | 83 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 5,136 | 4,361 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,482 | 1,206 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 5,223 | 1,151 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,382 | $ 1,855 |
Other Financial Information - N
Other Financial Information - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization | $ 1,600 | $ 900 |
Long-lived assets impairment | $ 397 | 0 |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Selling, general and administrative expenses | |
Goodwill Impairment | $ 5,506 | 0 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Gross book value of assets under finance leases | $ 2,800 | $ 2,500 |
Other Financial Information - G
Other Financial Information - Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill [Roll Forward] | ||
Beginning balance | $ 5,506 | |
Goodwill impairment | (5,506) | $ 0 |
Ending balance | $ 0 | $ 5,506 |
Other Financial Information - A
Other Financial Information - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Financial Information [Abstract] | ||
Accrued payroll and related expenses | $ 2,355 | $ 4,048 |
Accrued interest | 142 | 139 |
Accrued purchases of goods and services | 803 | 510 |
Accrued royalties | 514 | 180 |
Accrued clinical study activity | 162 | 254 |
Finance lease obligations, current portion | 700 | 587 |
Refund liability | 445 | 0 |
Other accrued liabilities | 226 | 1,108 |
Accrued and other current liabilities | $ 5,347 | $ 6,826 |
Borrowings - Narrative (Details
Borrowings - Narrative (Details) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2021 USD ($) installment | Sep. 30, 2017 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | May 31, 2022 USD ($) | |
2017 Term loan | Loan payable | Innovatus Life Sciences Lending Fund | |||||
Debt Instrument [Line Items] | |||||
Term loan borrowings | $ 25,000,000 | $ 0 | |||
Interest rate (as a percent) | 8% | ||||
Term loan, paid in-kind, interest rate | 2% | ||||
Term loan, effective interest rate | 8.50% | ||||
Number of monthly installments | installment | 24 | ||||
Term loan, fee incurred upon payment of final installment | $ 1,000,000 | ||||
Term loan, prepayment premium percentage | 2% | ||||
Term loan, annual reduction in prepayment penalty percentage | 1% | ||||
Term loan, covenant, revenue performance period | 12 months | ||||
Term loan, covenant, number of days to cure covenant if performance measure is not met | 60 days | ||||
Term loan covenant, minimum unrestricted cash balance | $ 2,000,000 | ||||
Term loan covenant, increase to interest rate | 4% | ||||
2017 Term loan | Paid in-kind note | Innovatus Life Sciences Lending Fund | |||||
Debt Instrument [Line Items] | |||||
Term loan, paid in-kind loans issued | $ 600,000 | $ 500,000 | |||
Equipment Notes Payable | |||||
Debt Instrument [Line Items] | |||||
Term loan, effective interest rate | 5.28% | ||||
Notes payable | $ 800,000 | ||||
Notes payable current | 200,000 | ||||
Notes payable noncurrnet | $ 600,000 |
Borrowings - Future Minimum Pay
Borrowings - Future Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2023 | $ 1,911 | |
2024 | 3,205 | |
2025 | 16,377 | |
2026 | 14,973 | |
Total | 36,466 | |
Unamortized debt discount and issuance costs | (158) | |
Interest | (7,340) | |
Total borrowings, net of discounts and debt issuance costs | 28,968 | |
Borrowings-current portion | (190) | $ 0 |
Borrowings-non-current portion, net of discounts and debt issuance costs | $ 28,778 | $ 27,478 |
Commitment and Contingencies -
Commitment and Contingencies - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Aug. 23, 2021 | Nov. 30, 2021 | May 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | |||||
Rent expense | $ 900,000 | ||||
Period for royalties to begin | 18 months | ||||
Purchase obligation, due in next twelve months | 6,000,000 | ||||
Purchase obligation, due in second year | $ 6,900,000 | ||||
Annual increase in purchase commitments | 15% | ||||
Office and Laboratory | |||||
Loss Contingencies [Line Items] | |||||
Operating lease, renewal term | 5 years | ||||
Office | |||||
Loss Contingencies [Line Items] | |||||
Operating lease, monthly base rent | $ 66,021 | ||||
Operating lease, annual increase in base rent payment percentage | 3% | ||||
AHN Collaboration | |||||
Loss Contingencies [Line Items] | |||||
Collaboration agreement, collaboration expenses | $ 400,000 | ||||
Minimum | |||||
Loss Contingencies [Line Items] | |||||
Finance lease, term of contract | 3 years | ||||
Minimum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 1.50% | ||||
Maximum | |||||
Loss Contingencies [Line Items] | |||||
Finance lease, term of contract | 5 years | ||||
Maximum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 7% | ||||
Prometheus Laboratories | |||||
Loss Contingencies [Line Items] | |||||
Future minimum royalty commitment | $ 1,200,000 | ||||
Advance royalties payment | $ 100,000 | ||||
Prometheus Laboratories | Minimum | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 2.50% | ||||
Allegheny Health Network Research Institute | |||||
Loss Contingencies [Line Items] | |||||
Collaboration fee | $ 400,000 | ||||
Allegheny Health Network Research Institute | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Initial license fee | $ 400,000 | ||||
Queen Mary University Of London | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Initial license fee | $ 400,000 | ||||
One time payment | $ 100,000 |
Commitment and Contingencies _2
Commitment and Contingencies - Lease Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 4,885 | $ 0 |
Finance lease, right-of-use asset, after accumulated amortization | $ 1,427 | |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property and equipment, net | |
Operating lease liabilities | $ 1,040 | 0 |
Finance lease obligations, current portion | $ 700 | $ 587 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued and other current liabilities | Accrued and other current liabilities |
Non-current operating lease liabilities | $ 4,493 | $ 0 |
Lease obligations, net of current portion | $ 848 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other non-current liabilities |
Commitment and Contingencies _3
Commitment and Contingencies - Costs Associated with the Company's Leases (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 1,540 |
Amortization of lease assets | 679 |
Interest on finance lease liabilities | 80 |
Total lease cost | 2,299 |
Variable lease cost | $ 165 |
Commitment and Contingencies _4
Commitment and Contingencies - Supplemental Cash Flow Information On Leases And Weighted-Average Lease Term (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash paid for amounts included in the measurement of lease liabilities | ||
Operating cash out flows from operating leases | $ 1,262 | |
Operating cash out flows from interest paid on finance leases | 80 | |
Financing cash out flows from finance leases | $ 667 | $ 525 |
Weighted-average remaining lease term (years) | ||
Operating leases | 4 years 3 months 18 days | |
Finance leases | 1 year 11 months 8 days | |
Weighted-average discount rate | ||
Operating leases | 8% | |
Finance leases | 4.80% |
Commitment and Contingencies _5
Commitment and Contingencies - Future Payments Under Operating And Finance Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2023 | $ 1,446 | |
2024 | 1,489 | |
2025 | 1,533 | |
2026 | 1,584 | |
Thereafter | 539 | |
Total minimum lease payments | 6,591 | |
Less: imputed interest | (1,058) | |
Total lease liabilities | 5,533 | |
Less: current portion | (1,040) | $ 0 |
Lease obligations, net of current portion | 4,493 | 0 |
Finance Leases | ||
2023 | 828 | |
2024 | 574 | |
2025 | 248 | |
2026 | 147 | |
Thereafter | 29 | |
Total minimum lease payments | 1,826 | |
Less: imputed interest | (278) | |
Total lease liabilities | 1,548 | |
Less: current portion | (700) | $ (587) |
Lease obligations, net of current portion | $ 848 |
Commitment and Contingencies _6
Commitment and Contingencies - Minimum Annual Lease Payments Under Non-cancelable Lease Arrangements (Details) $ in Thousands | Dec. 31, 2021 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ 1,337 |
2023 | 1,445 |
2024 | 1,489 |
2025 | 1,533 |
2026 | 1,584 |
Thereafter | 539 |
Total minimum lease payments | $ 7,927 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Total borrowings, net of discounts and debt issuance costs | $ 28,968 | |
Recurring | ||
Assets: | ||
Total | 59,538 | |
Recurring | Money market funds, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 29,438 | $ 95,761 |
Recurring | Certificate of deposit, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 30,100 | |
Recurring | Level 1 | ||
Assets: | ||
Total | 59,538 | |
Recurring | Level 1 | Money market funds, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 29,438 | 95,761 |
Recurring | Level 1 | Certificate of deposit, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 30,100 | |
Recurring | Level 2 | ||
Assets: | ||
Total | 0 | |
Recurring | Level 2 | 2017 Term loan | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Total borrowings, net of discounts and debt issuance costs | 28,300 | |
Debt Instrument, Fair Value Disclosure | 26,900 | |
Recurring | Level 2 | Money market funds, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Recurring | Level 2 | Certificate of deposit, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 0 | |
Recurring | Level 3 | ||
Assets: | ||
Total | 0 | |
Recurring | Level 3 | Money market funds, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 0 | $ 0 |
Recurring | Level 3 | Certificate of deposit, included in cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | $ 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Sep. 15, 2022 | Jun. 22, 2021 | Mar. 25, 2021 | Nov. 10, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||||||
Estimated offering expenses for aggregate expenses | $ 4,435 | |||||
Exercise of common stock warrants (in shares) | 0 | |||||
Cowen Equity Distribution Agreement | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from public offering, net | $ 50,000 | |||||
Exchanging Stockholders | ||||||
Class of Stock [Line Items] | ||||||
Number of shares exchanged for warrants (in shares) | 804,951 | |||||
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ 0.001 | |||||
Sale of stock, percentage of ownership after transaction | 4.99% | |||||
Number of warrants exercised (in shares) | 0 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock, number shares issued (in shares) | 4,255,000 | 150,000,000 | ||||
Shares issued in public offering, price per share (in dollars per share) | $ 16.25 | |||||
Proceeds from public offering, net | $ 64,700 | |||||
Estimated offering expenses for aggregate expenses | $ 4,400 | |||||
Exercise of common stock warrants (in shares) | 17,719 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Common Stock Outstanding (Details) | Dec. 31, 2022 $ / shares shares |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 1,214,059 |
Warrant expiration January 19, 2026 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 237,169 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1.84 |
Warrant expiration March 31, 2026 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 67,086 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1.84 |
Warrant expiration April 1, 2026 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 131 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 1.84 |
Warrant expiration September 7, 2024 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 83,778 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 14.32 |
Warrant expiration December 7, 2025 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 20,944 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 14.32 |
No expiration | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 804,951 |
Class of warrant or right, exercise price of warrants or rights (in dollars per share) | $ / shares | $ 0.001 |
Stock Option Plan - Narrative (
Stock Option Plan - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Employee options, weighted-average grant date fair value per share (in dollars per share) | $ 2.74 | $ 8.83 | |
Common stock, fair value per share (in dollars per share) | $ 2.40 | $ 11.63 | |
Intrinsic value of options exercised | $ 600 | $ 100 | |
Stock options, unrecognized compensation cost | $ 1,800 | ||
Stock options, cost not yet recognized, remaining weighted average vesting period | 1 year 1 month 6 days | ||
Stock-based compensation expense | $ 4,704 | 4,728 | |
Employee stock purchase plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Annual percentage increase in shares available for issuance under the Plan | 1% | ||
Maximum Employee payroll deduction percentage | 20% | ||
Stock options, cost not yet recognized, remaining weighted average vesting period | 2 months 12 days | ||
Stock-based compensation expense | $ 100 | $ 200 | |
Unrecognized compensation cost related to stock purchase | $ 100 | ||
Employee stock purchase plan | Subsequent Event | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Increase (decrease) in number of shares authorized (in shares) | 165,500 | ||
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, fair value per share (in dollars per share) | $ 7.28 | $ 16.54 | |
Grant date fair value of RSUs vested | $ 700 | ||
Vested (in shares) | 0 | ||
Awards granted (in dollars per share) | $ 5.89 | $ 16.53 | |
Stock options, unrecognized compensation cost | $ 6,000 | ||
Stock options, cost not yet recognized, remaining weighted average vesting period | 3 years 3 months 18 days | ||
2019 Incentive Award Plan | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options, expiration period | 10 years | ||
Stock options, vesting period | 4 years | ||
Annual percentage increase in shares available for issuance under the Plan | 4% | ||
Shares that remain available for future awards | 1,452,435 | ||
2019 Incentive Award Plan | Stock options | Subsequent Event | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Increase (decrease) in number of shares authorized (in shares) | 661,999 |
Stock Option Plan - Stock Optio
Stock Option Plan - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Options | ||
Outstanding, Beginning balance (in shares) | 2,014,330 | |
Granted (in shares) | 63,000 | |
Exercised (in shares) | (245,186) | |
Forfeited (in shares) | (257,982) | |
Expired (in shares) | (152,927) | |
Outstanding, Ending balance (in shares) | 1,421,235 | 2,014,330 |
Vested and expected to vest (in shares) | 1,421,235 | |
Options exercisable (in Shares) | 1,129,333 | |
Weighted- Average Exercise Price | ||
Outstanding, Beginning balance (in dollars per share) | $ 12.10 | |
Granted (in dollars per share) | 5.25 | |
Exercised (in dollars per share) | 0.26 | |
Forfeited (in dollars per share) | 16.09 | |
Expired (in dollars per share) | 13.73 | |
Outstanding, Ending balance (in dollars per share) | 12.94 | $ 12.10 |
Vested and expected to vest (in dollars per share) | 12.94 | |
Options exercisable (in dollars per share) | $ 12.94 | |
Weighted-Average Remaining Contractual Term (Years) and Aggregate Instrinsic Value | ||
Outstanding, Weighted Average Remaining Contractual Term | 7 years 1 month 2 days | 7 years 10 months 13 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term | 7 years 1 month 2 days | |
Options exercisable, Weighted Average Remaining Contractual Term | 6 years 10 months 20 days | |
Outstanding, Aggregate Intrinsic Value | $ 483 | $ 5,428 |
Vested and Expected to Vest, Aggregate Intrinsic Value | 483 | |
Options Exercisable, Aggregate Intrinsic Value | $ 483 |
Stock Option Plan - Restricted
Stock Option Plan - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted- Average Grant Date Fair Value | ||
Outstanding, Beginning balance (in dollars per share) | $ 11.63 | |
Outstanding, Ending balance (in dollars per share) | $ 2.40 | $ 11.63 |
Restricted stock units | ||
Number of Shares | ||
Outstanding, Beginning balance (in shares) | 415,325 | |
Awards granted (in shares) | 1,076,725 | |
Awards released (in shares) | (100,586) | |
Awards canceled (in shares) | (355,256) | |
Outstanding, Ending balance (in shares) | 1,036,208 | 415,325 |
Weighted- Average Grant Date Fair Value | ||
Outstanding, Beginning balance (in dollars per share) | $ 16.54 | |
Awards granted (in dollars per share) | 5.89 | $ 16.53 |
Awards released (in dollars per share) | 16.55 | |
Awards canceled (in dollars per share) | 11.29 | |
Outstanding, Ending balance (in dollars per share) | $ 7.28 | $ 16.54 |
Aggregate Intrinsic Value | ||
Outstanding, Aggregate Intrinsic Value | $ 2,487 | $ 4,830 |
Stock Option Plan - Fair Value
Stock Option Plan - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0% | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility rate, minimum | 54% | 56% |
Expected volatility rate, maximum | 60% | |
Risk-free interest rate, minimum | 3.40% | 0.80% |
Risk-free interest rate, maximum | 1.10% | |
Dividend yield | 0% | 0% |
Stock options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 6 months |
Stock options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | |
Employee stock purchase plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility rate, minimum | 45% | 45% |
Expected volatility rate, maximum | 57% | 60% |
Risk-free interest rate, minimum | 0.60% | 0.10% |
Risk-free interest rate, maximum | 3.30% | |
Dividend yield | 0% | 0% |
Expected term (in years) | 6 months | 6 months |
Stock Option Plan - Stock-Based
Stock Option Plan - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 4,704 | $ 4,728 |
Cost of revenue | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 213 | 164 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 3,860 | 3,943 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 631 | $ 621 |
Stock Option Plan - Common Stoc
Stock Option Plan - Common Stock Reserved For Future Issuance (Details) | Dec. 31, 2022 shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 5,537,524 |
Warrants to purchase common stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 1,214,059 |
Common stock option grants issued and outstanding | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 1,421,235 |
Common stock reserved for issuance upon vesting of outstanding restricted stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 1,036,370 |
Common shares available for grant under the 2019 Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 1,452,435 |
Common shares available for future issuance under ESPP | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock reserved for future issuance (in shares) | 413,425 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
Federal | $ 0 | $ 0 |
State | 24 | 27 |
Total current | 24 | 27 |
Deferred: | ||
Federal | (137) | 137 |
State | (169) | 11 |
Total deferred | (306) | 148 |
Provision (benefit) for income tax | $ (282) | $ 175 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory tax rate | (21.00%) | (21.00%) |
State income taxes, net of federal tax benefits | (4.30%) | (3.80%) |
Research and development tax credits | (1.50%) | (1.20%) |
Stock compensation | 1.40% | 0.90% |
Non-deductible expenses | 0.90% | 1.10% |
Change in valuation allowance | 23.90% | 24.60% |
Effective tax rate | (0.60%) | 0.60% |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 29,789 | $ 22,365 | |
Research and development tax credits | 2,216 | 1,102 | |
Accruals, reserves and other | 349 | 1,055 | |
Interest expense | 2,236 | 1,953 | |
Indefinite lived assets | 362 | 0 | |
Stock compensation | 1,606 | 1,407 | |
Lease liability | 1,374 | 0 | |
Capitalization of research and experimentation costs | 2,047 | 0 | |
Total gross deferred tax assets | 39,979 | 27,882 | |
Less: valuation allowance | (38,567) | (27,158) | $ (20,596) |
Deferred tax assets, net | 1,412 | 724 | |
Deferred tax liabilities: | |||
Financing and acquisition-related liabilities | 0 | (335) | |
Indefinite lived assets | 0 | (521) | |
Right of use assets | (1,206) | 0 | |
Basis differences in fixed and intangible assets | (206) | (175) | |
Deferred tax liabilities, net | (1,412) | (1,031) | |
Net deferred tax liabilities | $ 0 | $ (307) |
Income Taxes - Change In Valuat
Income Taxes - Change In Valuation Allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Changes In The Valuation Allowance For Deferred Tax Assets [Roll Forward] | ||
Valuation allowance at the beginning of the year | $ 27,158 | $ 20,596 |
Increases recorded to income tax provision | 11,409 | 6,562 |
Valuation allowance at the end of the year | $ 38,567 | $ 27,158 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Federal net operating loss carryforwards | $ 118,400,000 | $ 89,400,000 |
State net operating loss carryforwards | 87,000,000 | 61,000,000 |
Federal tax loss carryforwards, subject to expiration | 43,500,000 | |
Federal net operating loss carryforwards, carryforward indefinitely | 74,900,000 | |
Unrecognized tax benefits | $ 0 | $ 0 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Qualified employee compensation, employer matching contribution, percent of employees' gross pay | 4% | 3% |
Qualified employee compensation contribution, amount | $ 0.9 | $ 0.5 |