Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 05, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
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 $0.001 per share | |
Trading Symbol | XGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 16,164,232 | |
Entity Central Index Key | 0001274737 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 106,766 | $ 57,448 |
Accounts receivable, net | 9,210 | 8,910 |
Prepaid expenses and other current assets | 2,405 | 4,159 |
Total current assets | 118,381 | 70,517 |
Property and equipment, net | 3,446 | 2,102 |
Goodwill | 5,506 | 5,506 |
Other assets | 439 | 250 |
Total assets | 127,772 | 78,375 |
Current liabilities: | ||
Accounts payable | 1,512 | 3,014 |
Accrued and other current liabilities | 6,584 | 5,757 |
Total current liabilities | 8,096 | 8,771 |
Borrowings-non-current portion, net of discounts and debt issuance costs | 27,288 | 26,659 |
Deferred tax liabilities | 158 | 158 |
Other non-current liabilities | 1,427 | 948 |
Total liabilities | 36,969 | 36,536 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2021 and December 31, 2020; 16,164,232 and 12,652,308 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 16 | 13 |
Additional paid-in capital | 291,874 | 223,115 |
Accumulated deficit | (201,087) | (181,289) |
Total stockholders' equity | 90,803 | 41,839 |
Total liabilities and stockholders' equity | $ 127,772 | $ 78,375 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 0 |
Shares outstanding (in shares) | 0 | 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) | 16,164,232 | 12,652,308 |
Shares outstanding (in shares) | 16,164,232 | 12,652,308 |
Unaudited Condensed Statements
Unaudited Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenue | $ 12,251 | $ 10,775 | $ 35,610 | $ 29,307 |
Operating expenses: | ||||
Costs of revenue | 5,487 | 4,341 | 15,649 | 12,224 |
Selling, general and administrative expenses | 11,528 | 9,202 | 32,739 | 27,104 |
Research and development expenses | 1,740 | 1,018 | 5,035 | 2,403 |
Total operating expenses | 18,755 | 14,561 | 53,423 | 41,731 |
Loss from operations | (6,504) | (3,786) | (17,813) | (12,424) |
Interest expense | (678) | (647) | (1,986) | (1,913) |
Other income, net | 3 | 125 | 1 | 985 |
Loss before income taxes | (7,179) | (4,308) | (19,798) | (13,352) |
Income tax benefit | 0 | 0 | 0 | 118 |
Net loss | $ (7,179) | $ (4,308) | $ (19,798) | $ (13,234) |
Net loss per share, basic (in dollars per share) | $ (0.42) | $ (0.34) | $ (1.27) | $ (1.05) |
Net loss per share, diluted (in dollars per share) | $ (0.42) | $ (0.34) | $ (1.27) | $ (1.05) |
Weighted-average number of shares used to compute net loss per share, basic (in shares) | 16,945,591 | 12,644,348 | 15,636,150 | 12,626,259 |
Weighted-average number of shares used to compute net loss per share, diluted (in shares) | 16,945,591 | 12,644,348 | 15,636,150 | 12,626,259 |
Unaudited Condensed Statement_2
Unaudited Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 12,560,990 | |||
Beginning balance at Dec. 31, 2019 | $ 55,659 | $ 13 | $ 220,248 | $ (164,602) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of stock options (in shares) | 43,700 | |||
Exercise of stock options | 10 | 10 | ||
Stock-based compensation | 431 | 431 | ||
Net exercise of common stock warrants (in shares) | 22,366 | |||
Net exercise of common stock warrants | 0 | |||
Net loss | (5,563) | (5,563) | ||
Ending balance (in shares) at Mar. 31, 2020 | 12,627,056 | |||
Ending balance at Mar. 31, 2020 | 50,537 | $ 13 | 220,689 | (170,165) |
Beginning balance (in shares) at Dec. 31, 2019 | 12,560,990 | |||
Beginning balance at Dec. 31, 2019 | 55,659 | $ 13 | 220,248 | (164,602) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (13,234) | |||
Ending balance (in shares) at Sep. 30, 2020 | 12,652,113 | |||
Ending balance at Sep. 30, 2020 | 44,474 | $ 13 | 222,297 | (177,836) |
Beginning balance (in shares) at Mar. 31, 2020 | 12,627,056 | |||
Beginning balance at Mar. 31, 2020 | 50,537 | $ 13 | 220,689 | (170,165) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of stock options (in shares) | 3,599 | |||
Exercise of stock options | 2 | 2 | ||
Stock-based compensation | 647 | 647 | ||
Net exercise of common stock warrants (in shares) | 9,754 | |||
Net exercise of common stock warrants | 18 | 18 | ||
Net loss | (3,363) | (3,363) | ||
Ending balance (in shares) at Jun. 30, 2020 | 12,640,409 | |||
Ending balance at Jun. 30, 2020 | 47,841 | $ 13 | 221,356 | (173,528) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of stock options (in shares) | 55 | |||
Exercise of stock options | 0 | |||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 11,649 | |||
Issuance of stock under Employee Stock Purchase Plan | 142 | 142 | ||
Stock-based compensation | 799 | 799 | ||
Net loss | (4,308) | (4,308) | ||
Ending balance (in shares) at Sep. 30, 2020 | 12,652,113 | |||
Ending balance at Sep. 30, 2020 | $ 44,474 | $ 13 | 222,297 | (177,836) |
Beginning balance (in shares) at Dec. 31, 2020 | 12,652,308 | 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 | |
Exercise of stock options (in shares) | 3,381 | |||
Exercise of stock options | 44 | 44 | ||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 14,991 | |||
Issuance of stock under Employee Stock Purchase Plan | 175 | 175 | ||
Stock-based compensation | 912 | 912 | ||
Net loss | (6,209) | (6,209) | ||
Ending balance (in shares) at Mar. 31, 2021 | 16,925,680 | |||
Ending balance at Mar. 31, 2021 | $ 101,470 | $ 17 | 288,951 | (187,498) |
Beginning balance (in shares) at Dec. 31, 2020 | 12,652,308 | 12,652,308 | ||
Beginning balance at Dec. 31, 2020 | $ 41,839 | $ 13 | 223,115 | (181,289) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net exercise of common stock warrants (in shares) | 17,719 | |||
Net loss | $ (19,798) | |||
Ending balance (in shares) at Sep. 30, 2021 | 16,164,232 | 16,164,232 | ||
Ending balance at Sep. 30, 2021 | $ 90,803 | $ 16 | 291,874 | (201,087) |
Beginning balance (in shares) at Mar. 31, 2021 | 16,925,680 | |||
Beginning balance at Mar. 31, 2021 | 101,470 | $ 17 | 288,951 | (187,498) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
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) | 6,055 | |||
Exercise of stock options | 35 | 35 | ||
Stock-based compensation | 1,285 | 1,285 | ||
Net loss | (6,410) | (6,410) | ||
Ending balance (in shares) at Jun. 30, 2021 | 16,126,784 | |||
Ending balance at Jun. 30, 2021 | 96,380 | $ 16 | 290,272 | (193,908) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of stock options (in shares) | 1,752 | |||
Exercise of stock options | 1 | 1 | ||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 17,977 | |||
Issuance of stock under Employee Stock Purchase Plan | 215 | 215 | ||
Stock-based compensation | 1,354 | 1,354 | ||
Net exercise of common stock warrants (in shares) | 17,719 | |||
Net exercise of common stock warrants | 32 | 32 | ||
Net loss | $ (7,179) | (7,179) | ||
Ending balance (in shares) at Sep. 30, 2021 | 16,164,232 | 16,164,232 | ||
Ending balance at Sep. 30, 2021 | $ 90,803 | $ 16 | $ 291,874 | $ (201,087) |
Unaudited Condensed Statement_3
Unaudited Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | Mar. 31, 2021USD ($) |
Statement of Financial Position [Abstract] | |
Stock issuance costs | $ 4,435 |
Unaudited Statements of Cash Fl
Unaudited Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (19,798) | $ (13,234) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 656 | 392 |
Amortization of debt discount and debt issuance costs | 226 | 202 |
Non-cash interest expense | 403 | 397 |
Deferred income taxes | 0 | (117) |
Stock-based compensation | 3,551 | 1,877 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (300) | (3,582) |
Prepaid expenses and other current assets | 1,754 | 1,627 |
Other assets | (167) | 0 |
Accounts payable | (1,085) | 781 |
Accrued and other current liabilities | 538 | 1,472 |
Net cash used in operating activities | (14,222) | (10,185) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,306) | (450) |
Purchase of other assets | (50) | 0 |
Net cash used in investing activities | (1,356) | (450) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 80 | 12 |
Proceeds from common stock issued under Employee Stock Purchase Plan | 390 | 142 |
Proceeds from exercise of common stock warrants | 32 | 18 |
Principal payment on capital lease obligations | (343) | (187) |
Proceeds from Paycheck Protection Program loan | 0 | 2,865 |
Repayment of Paycheck Protection Program loan | 0 | (2,865) |
Proceeds from the issuance of common stock in public offering, gross | 69,144 | 0 |
Payment of issuance costs related to public offering | (4,407) | 0 |
Net cash provided by (used in) financing activities | 64,896 | (15) |
Net change in cash, cash equivalents and restricted cash | 49,318 | (10,650) |
Cash, cash equivalents and restricted cash, beginning of period | 57,548 | 72,184 |
Cash, cash equivalents and restricted cash, end of period | 106,866 | 61,534 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest expense | 1,362 | 1,312 |
Supplemental disclosure of non-cash items: | ||
Equipment purchased under capital lease obligations | 1,111 | 123 |
Costs incurred, but not paid, in connection with capital expenditures | 135 | 197 |
Deferred offering costs reclassified to equity | $ 28 | $ 0 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Exagen Inc. (the Company) is dedicated to transforming the care continuum for 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 September 30, 2021, the Company had cash and cash equivalents of $106.8 million and had an accumulated deficit of $201.1 million. Since inception, the Company has financed its operations primarily through a combination of equity financings of common stock and private placements of preferred securities, 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 condensed 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 | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying interim condensed balance sheet as of September 30, 2021, the condensed statements of operations and the condensed statements of stockholders' equity for the three and nine months ended September 30, 2021 and 2020 and cash flows for the nine months ended September 30, 2021 and 2020 and the related footnote disclosure are unaudited and have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and with accounting principles generally accepted in the United States (GAAP) applicable to interim financial statements. In management's opinion, the unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and include all normal adjustments, necessary for the fair presentation of the Company's financial position as of September 30, 2021 and its results of operations for the three and nine month periods presented. The results for the nine months ended September 30, 2021 are not necessarily indicative of the results expected for the full fiscal year or any other interim period. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020, included in its Annual Report on Form 10-K filed with the SEC on March 16, 2021. The preparation of the accompanying condensed 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 condensed 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 condensed financial statements include, but are not limited to revenue recognition, the fair value of financial instruments measured at fair value, the recoverability of its long-lived assets (including goodwill) and net deferred tax assets (and related valuation allowance). 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. 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 Three Months Ended Nine Months Ended 2021 2020 2021 2020 Medicare 19 % 20 % 19 % 21 % Medicare Advantage 13 % 11 % 13 % 11 % Blue Shield 12 % 12 % 12 % 12 % Janssen (SIMPONI ® ) * 13 % * 12 % * Less than 10%. Accounts Receivable September 30, 2021 December 31, 2020 Blue Shield 17 % 11 % United Healthcare 16 % * Janssen (SIMPONI ® ) 11 % 35 % * Less than 10%. For the three months ended September 30, 2021 and 2020, approximately 81% and 68%, respectively, of the Company's revenue was related to the AVISE ® CTD test. For the nine months ended September 30, 2021 and 2020, approximately 81% and 71%, respectively, of the Company's revenue was related to the AVISE ® CTD test. The Company is dependent on key suppliers for certain laboratory materials. For the three months ended September 30, 2021 and 2020, approximately 95% and 98%, respectively, of the Company's diagnostic testing supplies were purchased from two suppliers. For the nine months ended September 30, 2021 and 2020, approximately 96% and 97%, respectively, 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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Revenue: Healthcare insurers $ 6,910 $ 5,749 $ 20,318 $ 15,949 Government 2,330 2,184 6,733 6,236 Client(1) 2,346 1,260 6,738 3,088 Other(2) 265 235 821 636 Janssen (SIMPONI ® ) 400 1,347 1,000 3,398 Total revenue $ 12,251 $ 10,775 $ 35,610 $ 29,307 (1) Includes hospitals, other laboratories, etc. (2) Includes patient self-pay . Fair Value Measurements The carrying value of the Company's cash and cash equivalents approximate fair value due to the short-term nature of these items. Based on the borrowing rates currently available to the Company for debt with similar terms and consideration of default and credit risk, the carrying value of the Company's long-term borrowings approximates its fair value, which is considered a Level 2 input. 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. 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. In 2016, the Company entered into 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 $0.1 million certificate of deposit with this financial institution as collateral for the balances borrowed on these credit cards. 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 condensed statements of cash flows consist of the following (in thousands): September 30, 2021 December 31, 2020 Cash and cash equivalents $ 106,766 $ 57,448 Restricted cash 100 100 $ 106,866 $ 57,548 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 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. The transaction price is estimated using an expected value method on a portfolio basis. The Company's portfolios are grouped per payor (i.e. each individual third-party insurance, Medicare, client payors, patient self-pay, etc.) and per test basis. 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 on August 31, 2021. Pursuant to the Janssen Agreement, 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. For the first and second quarters of 2020, the tiered promotion fee ranged from $750 to $1,250 per prescription over a predetermined baseline. Due in part to COVID-19, in June 2020, the Janssen Agreement was amended to adjust the predetermined average baseline for the third and fourth quarters of 2020. The Janssen Agreement was further amended in June 2020 and December 2020 to adjust the predetermined average baseline for prescribed units for the quarters ending December 31, 2020 and March 31, 2021 and was subject to further adjustment under certain circumstances. In June 2021, the Janssen Agreement was again amended to proportionally increase the baseline for prescribed units for the quarter ended June 30, 2021 to reflect the addition of certain geographies to the sales territories covered by the Janssen Agreement. For the first and second quarters of 2021, the Company was entitled to an amended tiered promotion fee ranging from $500 to $1,000 per prescription based on the incremental increase in total prescribed units, and the Company was entitled to receive a promotion fee of at least $0.3 million, but capped at 10% above the adjusted predetermined baseline. Upon the termination of the Janssen Agreement on August 31, 2021, the Company became entitled to receive an aggregate of $0.6 million in consideration. Pursuant to the terms of the termination, the Company is restricted from promoting any other biologic or Janus kinase inhibitor used for treatment of indications covered by the Janssen Agreement without first obtaining Janssen's written consent until May 31, 2022. 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 since the Amended Janssen Agreement is cancelable. The Company recognized co-promotion revenue of approximately $0.4 million and $1.3 million during the three months ended September 30, 2021 and 2020, respectively. The Company recognized co-promotion revenue of approximately $1.0 million and $3.4 million during the nine months ended September 30, 2021 and 2020, respectively. The related expenses for marketing SIMPONI ® are included in selling, general and administrative expenses and are expensed as incurred. 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 $0.6 million and $0.3 million for the three months ended September 30, 2021 and 2020, respectively, and $1.3 million and $0.9 million for the nine months ended September 30, 2021 and 2020, respectively, and are included in selling, general and administrative expenses in the accompanying condensed statements of operations. Shipping and Handling Costs Costs incurred for shipping and handling are included in costs of revenue in the accompanying condensed statements of operations and totaled approximately $0.6 million and $0.4 million for the three months ended September 30, 2021 and 2020, respectively, and $1.6 million and $1.1 million for the nine months ended September 30, 2021 and 2020, 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 estimates, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. 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 was 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 the grant date and generally vest from the grant date in four equal annual installments subject to the holder's continued service with the Company. The Company issues new shares to satisfy restricted stock units upon vesting. The fair value of the Company's common stock is determined by using the closing price of its common stock on the corresponding date. 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. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares in 2021 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 three and nine months ended September 30, 2021 and 2020, 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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Warrants to purchase common stock 409,108 426,827 409,108 426,827 Common stock options 2,067,057 1,975,250 2,067,057 1,975,250 Restricted stock units 403,100 — 403,100 — Employee stock purchase plan 4,130 3,144 4,130 3,144 Total 2,883,395 2,405,221 2,883,395 2,405,221 Government Assistance Grant Income Government assistance grants which are unconditional when received and intended to compensate for expenses incurred or replace lost revenue are recognized when those expenses are incurred or during the period that lost revenue is experienced, and the net amount is included in other income in the accompanying condensed statements of operations. 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 Not Yet Adopted 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. 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. Pursuant to this ASU, in the period of adoption the Company will not restate comparative periods presented in its condensed financial statements. The effective date of this guidance for public companies is for reporting periods beginning after December 15, 2018. In June 2020, the FASB issued ASU 2020-05, which delays the adoption of ASU 2016-02 for non-public entities to fiscal years beginning after December 15, 2021, and interim periods beginning after December 15, 2022. As an emerging growth company as defined in the JOBS Act, the Company has elected to early adopt this ASU as of January 1, 2022. Topic 842 mandates a modified retrospective transition method. The Company intends to adopt the new lease standard using a cumulative effect to accumulated deficit and will elect the package of practical expedients, which among other things will allow the Company to carry forward its historical lease classification. The Company is currently evaluating the impact of Topic 842 on its condensed financial statements. Recently Adopted Accounting Standards In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes . The new guidance removes certain exceptions to the general principles of ASC 740 in order to simplify the complexities of its application. These changes include eliminations to the exceptions for intraperiod tax allocation, recognizing deferred tax liabilities related to outside basis differences, and year-to-date losses in interim periods, among others. The effective date of this guidance for public companies is for fiscal years, and interim period within those fiscal years, beginning after December 15, 2020. The Company adopted this guidance on January 1, 2021, and the adoption did not have a material impact on its condensed financial statements. |
Other Financial Information
Other Financial Information | 9 Months Ended |
Sep. 30, 2021 | |
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): September 30, 2021 December 31, 2020 Diagnostic testing supplies $ 1,010 $ 1,203 Prepaid product royalties 54 68 Prepaid maintenance and insurance contracts 1,040 2,229 Other prepaid and other current assets 301 659 Prepaid and other current assets $ 2,405 $ 4,159 Property and Equipment Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Furniture and fixtures $ 83 $ 64 Laboratory equipment 4,100 2,679 Computer equipment and software 1,106 927 Leasehold improvements 1,141 1,072 Construction in progress 613 301 Total property and equipment 7,043 5,043 Less: accumulated depreciation and amortization (3,597) (2,941) Property and equipment, net $ 3,446 $ 2,102 Depreciation and amortization expense for the three months ended September 30, 2021 and 2020 was approximately $0.3 million and $0.1 million, and for the nine months ended September 30, 2021 and 2020, was approximately $0.7 million and $0.4 million, respectively. At September 30, 2021 and December 31, 2020, the gross book value of assets under capital lease was $2.5 million and $1.2 million, respectively, and is classified in "Laboratory equipment" in the table above. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands): September 30, 2021 December 31, 2020 Accrued payroll and related expenses $ 3,793 $ 3,589 Accrued interest 145 147 Accrued purchases of goods and services 765 311 Accrued royalties 342 221 Accrued clinical study activity 337 228 Capital lease obligations, current portion 586 308 Other accrued liabilities 616 953 Accrued and other current liabilities $ 6,584 $ 5,757 |
Borrowings
Borrowings | 9 Months Ended |
Sep. 30, 2021 | |
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) and borrowed $20.0 million, $17.8 million of which was immediately used to repay the Company's existing loan with Capital Royalty Partners II L.P. and its affiliates. On December 7, 2018, the Company borrowed an additional $5.0 million under the 2017 Term Loan. At September 30, 2021, no additional amounts remain available to borrow under the 2017 Term Loan. In November 2019, the Company executed the First Amendment to the Loan and Security Agreement (the 2017 Loan Amendment). The interest rate on all borrowings under the 2017 Loan Amendment is 8.5%, of which 2.0% is paid in-kind in the form of additional term loans (PIK Loans) until December of 2022, after which interest accrues at an annual rate of 8.5%. The Company has estimated the effective interest rate of this loan to be approximately 10%. 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 of the nine months ended September 30, 2021 and 2020, the Company issued PIK Loans totaling $0.4 million. In October 2021, the Company executed the Second Amendment to the Loan and Security Agreement (the Second Loan Amendment), discussed in Note 10 to these financial statements, below. The 2017 Loan Amendment requires a prepayment premium of 2% of the aggregate outstanding principal. The prepayment premium decreases by 1% on November 19, 2021 and 2022. 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. 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 September 30, 2021, 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 condensed 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. Future Minimum Payments on the Outstanding Borrowings As of September 30, 2021, future minimum aggregate payments, including interest, for outstanding borrowings under the Loan Amendment are as follows (in thousands): September 30, 2021 2021 (remaining) $ 446 2022 2,996 2023 15,619 2024 14,280 Total 33,341 Less: Unamortized debt discount and issuance costs (224) Interest (5,829) Total borrowings, net of discounts and debt issuance costs $ 27,288 |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases As of September 30, 2021, the Company leases office and laboratory space in Vista, California, under leases that expire in January 2026, with an option to extend a portion of the lease for an additional 5-year period. In addition, the Company also leases additional office space in Vista, California, under a lease that expires in January 2026 with an option to extend the lease for an additional 5-year period. 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 shall increase by approximately 3% annually beginning October 1, 2022. The Company is entitled to base rent abatement for a specified period of time which began on November 1, 2021. For the three months ended September 30, 2021 and 2020, rent expense was $0.2 million and $0.3 million, respectively. For the nine months ended September 30, 2021 and 2020, rent expense was $0.5 million. Acquisition-related liabilities In connection with the acquisition of the medical diagnostics division of 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. The acquisition also included amounts that may be due under several licensing agreements. One such license agreement, the license agreement, dated September 13, 2007, between the Company and Prometheus Laboratories, Inc. (the Prometheus License), was terminated by mutual agreement on September 28, 2021. In consideration for terminating the Prometheus License, including with respect to the remaining potential milestone payments thereunder, the Company agreed to pay Prometheus Laboratories, Inc. a fee of approximately $0.1 million and acquired the intellectual property previously licensed to the Company pursuant to the Prometheus Agreement. The Company has ongoing royalty payment obligations 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 $100,000) 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 as described above, individual license agreements generally provide for ongoing royalty payments ranging from 1.5% to 3.0% 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 condensed statement of operations. In May 2021, the Company entered into an exclusive license agreement with Allegheny Health Network Research Institute, or 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. Supply Agreement In September 2020, the Company entered into an amended supply agreement with one supplier for reagents which includes minimum annual purchase commitments of $4.1 million and $6.0 million for the years ended December 31, 2021 and 2022, respectively, with a 15% annual increase thereafter through the year ended 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 $0.1 and $0.2 for the three and nine months ended September 30, 2021, respectively. 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 subpoenas and other civil investigative demands, from governmental agencies, Medicare or Medicaid payors 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. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements 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): September 30, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 105,679 $ 105,679 $ — $ — December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 34,507 $ 34,507 $ — $ — |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock 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 and commissions and offering expenses of $4.4 million. The shares were registered pursuant to the Company's Shelf Registration Statement discussed above. 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 the 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 September 30, 2021, none of the Exchange Warrants have been exercised. Outstanding Warrants The following equity classified warrants to purchase common stock were outstanding as of September 30, 2021: 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 nine months ended September 30, 2021, warrants to purchase common stock were exercised resulting in the issuance of 17,719 shares of the Company's common stock and cash proceeds of an immaterial amount. |
Stock Option Plan
Stock Option Plan | 9 Months Ended |
Sep. 30, 2021 | |
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. As of September 30, 2021, 1,139,831 shares of common stock remained available for future awards. 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. As of September 30, 2021, 327,516 shares of common stock remained available for issuance 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, 2020 1,975,761 $ 11.81 8.71 $ 6,750 Granted 229,850 $ 16.79 Exercised (11,188) $ 7.13 Forfeited (122,435) $ 14.49 Expired (4,931) $ 21.50 Outstanding, September 30, 2021 2,067,057 $ 12.20 8.14 $ 6,956 Vested and expected to vest, September 30, 2021 2,067,057 $ 12.20 8.14 $ 6,956 Options exercisable, September 30, 2021 979,111 $ 10.30 7.77 $ 4,794 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. As of September 30, 2021, total unrecognized compensation cost related to option awards was $7.7 million, which is expected to be recognized over a remaining weighted-average vesting period of 2.2 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, 2020 — $ — $ — Awards granted 422,150 $ 16.81 Awards released — $ — Awards canceled (19,050) $ 16.28 Outstanding, September 30, 2021 403,100 $ 16.84 $ 5,482 As of September 30, 2021, all of the outstanding restricted stock units are unvested. As of September 30, 2021, total unrecognized compensation cost related to restricted stock units was $5.9 million, which is expected to be recognized over a remaining weighted-average vesting period of 3.5 years. Stock-Based Compensation Expense Stock Options The fair value of employee stock options was estimated using the following assumptions to determine the fair value of stock options granted: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 86% 52% 83%-86% 47%-52% Risk-free interest rate 0.9% 0.4% 0.8%-1.1% 0.4%-1.7% Dividend yield — — — — Expected term (in years) 5.77 6.08 5.50-6.08 5.50-6.08 Employee Stock Purchase Plan The following assumptions were used to calculate the stock-based compensation for each stock purchase right granted under the ESPP: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 45% 83% 45%-60% 58%-83% Risk-free interest rate 0.1% 0.1% 0.1% 0.1%-1.1% Dividend yield — — — — Expected term (in years) 0.50 0.50 0.50 0.50 Stock-based compensation expense for the ESPP was immaterial for the three and nine months ended September 30, 2021 and 2020. As of September 30, 2021, total unrecognized compensation cost related to stock purchase rights granted under the ESPP was an immaterial amount, which is expected to be recognized over a remaining weighted-average vesting period of 0.4 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 condensed statement of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of revenue $ 64 $ 9 $ 136 $ 21 Selling, general and administrative 1,115 710 2,955 1,696 Research and development 175 80 460 160 Total $ 1,354 $ 799 $ 3,551 $ 1,877 |
Covid-19
Covid-19 | 9 Months Ended |
Sep. 30, 2021 | |
Reorganizations [Abstract] | |
Covid-19 | COVID-19 During 2020, due to the worldwide COVID-19 pandemic, the Company experienced a reduction in patient test volumes, delays in patient enrollment in ongoing and planned clinical studies, and delays in the procurement of its testing supplies. In response to the pandemic, the Company has curtailed non-essential employee travel, equipped employees with the ability to work remotely with the exception of clinical laboratory employees, and reduced marketing spend and employee headcount. The full extent to which the COVID-19 pandemic will directly or indirectly continue to impact the Company's business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19, including, the success of ongoing vaccination efforts, the emergence and prevalence of variant strains of COVID-19, the institution or reinstitution of shutdowns, "stay-at-home-orders" and other public health measures as well as the related economic impact of these matters on local, regional and international markets. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits net operating loss (NOL) carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. The CARES Act did not have a material impact on the Company's effective tax rate or income tax provision for the three months ended March 31, 2020. Under the Tax Cuts and Jobs Act (TCJA), NOLs generated post TCJA were allowed to be carried forward indefinitely but were only allowed to offset 80% of taxable income. As a result of the CARES Act and the change to permit NOLs generated in taxable years 2018, 2019 and 2020 to offset 100% of taxable income, the Company released valuation allowance against its deferred tax assets in the amount of $0.1 million. The release of valuation allowance resulted in a discrete tax benefit of $0.1 million in the first quarter of 2020. In April 2020, the Company received $0.7 million of funding under the CARES Act Provider Relief Fund, subject to the Company's agreement to comply with the Department of Health & Human Services' standard terms and conditions. The CARES Act Provider Relief Fund is a federal fund allocated for general distributions to Medicare facilities and providers impacted by the COVID-19 pandemic and is intended to support COVID-related expenses or lost revenue attributable to COVID-19. The funding received is considered a government grant, which is recognized when there is reasonable assurance that the grant will be received and that conditions attached to the grant have been met. During the three and nine months ended September 30, 2020, the Company recognized $0 and $0.7 million, respectively, due to lost revenue attributable to COVID-19, which is reflected in other income, net, on its condensed statements of operations. On April 16, 2020, the Company entered into a promissory note (the Note) with BOKF, NA dba Bank of Oklahoma (BofO), the lender, evidencing an unsecured loan pursuant to the U.S. Small Business Administration (SBA) Paycheck Protection Program (PPP) of the CARES Act of approximately $2.9 million (the PPP Loan). The Company applied for and received the PPP Loan pursuant to the then published PPP qualification and certification requirements. On April 23, 2020, the SBA, in consultation with the Department of Treasury, issued new guidance that created uncertainty regarding the qualification requirements for the PPP Loan (the New Guidance). In light of the New Guidance, on May 11, 2020, the Company paid off in full the principal and interest on the PPP Loan, resulting in the termination of the Note. On December 27, 2020, the Consolidated Appropriations Act, 2021 was signed into law. It provides additional COVID-19 focused relief and extends certain provisions of the CARES Act. At this time, the Company does not believe that the Consolidated Appropriations Act, 2021 has a material impact on its financial statements. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In October 2021, the Company entered into a lease amendment relating to its existing office space located adjacent to the Company's headquarters. The lease amendment extends the term of such lease from January 2026 to April 2027. The lease amendment provides that the base monthly rent for the leased space shall be $22,470 for the 12-month period beginning February 2026 and $23,594 for the period beginning February 2027 through April 2027. In October 2021, the Company entered into a fifth addendum to the lease relating to its headquarters. The fifth addendum extends to the term of such lease from January 2026 to April 2027. The fifth addendum provides that the base monthly rent for the leased space shall be $20,084 for the period between February 2026 and April 2027. In October 2021, the Company entered into a first addendum to the lease related to its office and laboratory space in the building attached to the Company's existing headquarters. The first addendum extends the term of such lease from January 2026 to April 2027. The first addendum provides that the base monthly rent for the leased space shall be $14,751 for the period between February 2026 and April 2027. In October 2021, the Company and Innovatus entered into the Second Loan Amendment to the 2017 Term Loan, which became effective on November 1, 2021. The Second Loan Amendment amends the 2017 Term Loan by, among other things, (i) decreasing the interest rate on all borrowings to 8.0%, of which 2.0% will be paid-in-kind and capitalized to the principal amount of the outstanding term loan on a monthly basis until December 2024; after which interest will accrue at an annual rate of 8.0%; (ii) extending the interest-only period through December 2024 and the maturity date to November 19, 2026; and (iii) changing the specified level of revenue, as measured quarterly on a rolling twelve-month basis, commencing with the quarter ending December 31, 2022, the Company must achieve to satisfy the related financial covenant in the 2017 Loan Amendment, subject to exceptions based on achievement of performance milestones and the ability to cure any default thereof with the issuance of equity securities or subordinated indebtedness. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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. |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company's cash and cash equivalents approximate fair value due to the short-term nature of these items. Based on the borrowing rates currently available to the Company for debt with similar terms and consideration of default and credit risk, the carrying value of the Company's long-term borrowings approximates its fair value, which is considered a Level 2 input. 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. |
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. |
Revenue Recognition | 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 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. The transaction price is estimated using an expected value method on a portfolio basis. The Company's portfolios are grouped per payor (i.e. each individual third-party insurance, Medicare, client payors, patient self-pay, etc.) and per test basis. 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. |
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 $0.6 million and $0.3 million for the three months ended September 30, 2021 and 2020, respectively, and $1.3 million and $0.9 million for the nine months ended September 30, 2021 and 2020, respectively, and are included in selling, general and administrative expenses in the accompanying condensed statements of operations. |
Shipping and Handling Costs | Shipping and Handling Costs Costs incurred for shipping and handling are included in costs of revenue in the accompanying condensed statements of operations and totaled approximately $0.6 million and $0.4 million for the three months ended September 30, 2021 and 2020, respectively, and $1.6 million and $1.1 million for the nine months ended September 30, 2021 and 2020, respectively. |
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 estimates, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. 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 was 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 the grant date and generally vest from the grant date in four equal annual installments subject to the holder's continued service with the Company. The Company issues new shares to satisfy restricted stock units upon vesting. The fair value of the Company's common stock is determined by using the closing price of its common stock on the corresponding date. |
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. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares in 2021 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 three and nine months ended September 30, 2021 and 2020, 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 Not Yet Adopted, Recently Adopted Accounting Standards | Recent Accounting Pronouncements Not Yet Adopted 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. 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. Pursuant to this ASU, in the period of adoption the Company will not restate comparative periods presented in its condensed financial statements. The effective date of this guidance for public companies is for reporting periods beginning after December 15, 2018. In June 2020, the FASB issued ASU 2020-05, which delays the adoption of ASU 2016-02 for non-public entities to fiscal years beginning after December 15, 2021, and interim periods beginning after December 15, 2022. As an emerging growth company as defined in the JOBS Act, the Company has elected to early adopt this ASU as of January 1, 2022. Topic 842 mandates a modified retrospective transition method. The Company intends to adopt the new lease standard using a cumulative effect to accumulated deficit and will elect the package of practical expedients, which among other things will allow the Company to carry forward its historical lease classification. The Company is currently evaluating the impact of Topic 842 on its condensed financial statements. Recently Adopted Accounting Standards In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes . The new guidance removes certain exceptions to the general principles of ASC 740 in order to simplify the complexities of its application. These changes include eliminations to the exceptions for intraperiod tax allocation, recognizing deferred tax liabilities related to outside basis differences, and year-to-date losses in interim periods, among others. The effective date of this guidance for public companies is for fiscal years, and interim period within those fiscal years, beginning after December 15, 2020. The Company adopted this guidance on January 1, 2021, and the adoption did not have a material impact on its condensed financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 Three Months Ended Nine Months Ended 2021 2020 2021 2020 Medicare 19 % 20 % 19 % 21 % Medicare Advantage 13 % 11 % 13 % 11 % Blue Shield 12 % 12 % 12 % 12 % Janssen (SIMPONI ® ) * 13 % * 12 % * Less than 10%. Accounts Receivable September 30, 2021 December 31, 2020 Blue Shield 17 % 11 % United Healthcare 16 % * Janssen (SIMPONI ® ) 11 % 35 % * Less than 10%. |
Disaggregation of Revenue | The following table includes the Company's revenues as disaggregated by payor and customer category (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Revenue: Healthcare insurers $ 6,910 $ 5,749 $ 20,318 $ 15,949 Government 2,330 2,184 6,733 6,236 Client(1) 2,346 1,260 6,738 3,088 Other(2) 265 235 821 636 Janssen (SIMPONI ® ) 400 1,347 1,000 3,398 Total revenue $ 12,251 $ 10,775 $ 35,610 $ 29,307 (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 condensed statements of cash flows consist of the following (in thousands): September 30, 2021 December 31, 2020 Cash and cash equivalents $ 106,766 $ 57,448 Restricted cash 100 100 $ 106,866 $ 57,548 |
Schedule of Cash and Cash Equivalents | Cash, cash equivalents and restricted cash presented in the accompanying condensed statements of cash flows consist of the following (in thousands): September 30, 2021 December 31, 2020 Cash and cash equivalents $ 106,766 $ 57,448 Restricted cash 100 100 $ 106,866 $ 57,548 |
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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Warrants to purchase common stock 409,108 426,827 409,108 426,827 Common stock options 2,067,057 1,975,250 2,067,057 1,975,250 Restricted stock units 403,100 — 403,100 — Employee stock purchase plan 4,130 3,144 4,130 3,144 Total 2,883,395 2,405,221 2,883,395 2,405,221 |
Other Financial Information - (
Other Financial Information - (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Other Financial Information [Abstract] | |
Prepaid expenses table | Prepaid expenses and other current assets consist of the following (in thousands): September 30, 2021 December 31, 2020 Diagnostic testing supplies $ 1,010 $ 1,203 Prepaid product royalties 54 68 Prepaid maintenance and insurance contracts 1,040 2,229 Other prepaid and other current assets 301 659 Prepaid and other current assets $ 2,405 $ 4,159 |
Property and equipment | Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Furniture and fixtures $ 83 $ 64 Laboratory equipment 4,100 2,679 Computer equipment and software 1,106 927 Leasehold improvements 1,141 1,072 Construction in progress 613 301 Total property and equipment 7,043 5,043 Less: accumulated depreciation and amortization (3,597) (2,941) Property and equipment, net $ 3,446 $ 2,102 |
Accrued and other current liabilities | Accrued and other current liabilities consist of the following (in thousands): September 30, 2021 December 31, 2020 Accrued payroll and related expenses $ 3,793 $ 3,589 Accrued interest 145 147 Accrued purchases of goods and services 765 311 Accrued royalties 342 221 Accrued clinical study activity 337 228 Capital lease obligations, current portion 586 308 Other accrued liabilities 616 953 Accrued and other current liabilities $ 6,584 $ 5,757 |
Borrowings - (Tables)
Borrowings - (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Future Minimum Aggregate Payments for Outstanding Borrowings | As of September 30, 2021, future minimum aggregate payments, including interest, for outstanding borrowings under the Loan Amendment are as follows (in thousands): September 30, 2021 2021 (remaining) $ 446 2022 2,996 2023 15,619 2024 14,280 Total 33,341 Less: Unamortized debt discount and issuance costs (224) Interest (5,829) Total borrowings, net of discounts and debt issuance costs $ 27,288 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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): September 30, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 105,679 $ 105,679 $ — $ — December 31, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds, included in cash and cash equivalents $ 34,507 $ 34,507 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Schedule of Outstanding Warrants | The following equity classified warrants to purchase common stock were outstanding as of September 30, 2021: 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 nine months ended September 30, 2021, warrants to purchase common stock were exercised resulting in the issuance of 17,719 shares of the Company's common stock and cash proceeds of an immaterial amount. |
Stock Option Plan (Tables)
Stock Option Plan (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020 1,975,761 $ 11.81 8.71 $ 6,750 Granted 229,850 $ 16.79 Exercised (11,188) $ 7.13 Forfeited (122,435) $ 14.49 Expired (4,931) $ 21.50 Outstanding, September 30, 2021 2,067,057 $ 12.20 8.14 $ 6,956 Vested and expected to vest, September 30, 2021 2,067,057 $ 12.20 8.14 $ 6,956 Options exercisable, September 30, 2021 979,111 $ 10.30 7.77 $ 4,794 |
Schedule of 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, 2020 — $ — $ — Awards granted 422,150 $ 16.81 Awards released — $ — Awards canceled (19,050) $ 16.28 Outstanding, September 30, 2021 403,100 $ 16.84 $ 5,482 |
Schedule of Fair Value Assumptions, Stock Options | The fair value of employee stock options was estimated using the following assumptions to determine the fair value of stock options granted: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 86% 52% 83%-86% 47%-52% Risk-free interest rate 0.9% 0.4% 0.8%-1.1% 0.4%-1.7% Dividend yield — — — — Expected term (in years) 5.77 6.08 5.50-6.08 5.50-6.08 |
Schedule of Fair Value Assumptions, Employee Stock Purchase Plan | The following assumptions were used to calculate the stock-based compensation for each stock purchase right granted under the ESPP: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 45% 83% 45%-60% 58%-83% Risk-free interest rate 0.1% 0.1% 0.1% 0.1%-1.1% Dividend yield — — — — Expected term (in years) 0.50 0.50 0.50 0.50 |
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 condensed statement of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of revenue $ 64 $ 9 $ 136 $ 21 Selling, general and administrative 1,115 710 2,955 1,696 Research and development 175 80 460 160 Total $ 1,354 $ 799 $ 3,551 $ 1,877 |
Organization - (Details)
Organization - (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 106,766 | $ 57,448 |
Accumulated deficit | $ 201,087 | $ 181,289 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Revenue by Major Payers (Details) - Customer Concentration Risk | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Medicare | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 19.00% | 20.00% | 19.00% | 21.00% | |
Medicare Advantage | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 13.00% | 11.00% | 13.00% | 11.00% | |
Blue Shield | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 12.00% | 12.00% | 12.00% | 12.00% | |
Blue Shield | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 17.00% | 11.00% | |||
United Healthcare | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 16.00% | ||||
Janssen (SIMPONI) | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 13.00% | 12.00% | |||
Janssen (SIMPONI) | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 11.00% | 35.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)segmentinstallment | Sep. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2016USD ($) | |
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Restricted cash | $ 100,000 | $ 100,000 | $ 100,000 | |||||||
Joint venture quarterly promotion fee cap | 10.00% | 10.00% | ||||||||
Revenue | 12,251,000 | $ 10,775,000 | 35,610,000 | $ 29,307,000 | ||||||
Advertising expense | 600,000 | 300,000 | $ 1,300,000 | 900,000 | ||||||
Dividend yield | 0.00% | |||||||||
Number of operating segments | segment | 1 | |||||||||
Janssen Promotion Agreement | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Termination of agreement | 600,000 | $ 600,000 | ||||||||
Restricted stock units | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Vesting Period, Number Of Annual Installments | installment | 4 | |||||||||
Janssen (SIMPONI) | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Revenue | 400,000 | 1,300,000 | $ 1,000,000 | 3,400,000 | ||||||
Minimum | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Joint venture, quarterly promotion fee per prescription | $ 500 | $ 500 | $ 750 | $ 750 | ||||||
Joint venture, quarterly promotion fee | 300,000 | 300,000 | ||||||||
Maximum | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Joint venture, quarterly promotion fee per prescription | $ 1,000 | $ 1,000 | $ 1,250 | $ 1,250 | ||||||
Other assets | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Restricted cash | $ 100,000 | |||||||||
Shipping and Handling | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Cost of revenue | $ 600,000 | $ 400,000 | $ 1,600,000 | $ 1,100,000 | ||||||
Revenue Benchmark | Product Concentration Risk | AVISE CTD Test | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Percent of total revenue | 81.00% | 68.00% | 81.00% | 71.00% | ||||||
Revenue Benchmark | Supplier Concentration Risk | Two Major Suppliers | ||||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||||
Percent of total revenue | 95.00% | 98.00% | 96.00% | 97.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 12,251 | $ 10,775 | $ 35,610 | $ 29,307 |
Healthcare insurers | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 6,910 | 5,749 | 20,318 | 15,949 |
Government | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 2,330 | 2,184 | 6,733 | 6,236 |
Client | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 2,346 | 1,260 | 6,738 | 3,088 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 265 | 235 | 821 | 636 |
Janssen (SIMPONI) | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 400 | $ 1,347 | $ 1,000 | $ 3,398 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 106,766 | $ 57,448 | ||
Restricted cash | 100 | 100 | ||
Total Cash, Cash Equivalents and Restricted Cash | $ 106,866 | $ 57,548 | $ 61,534 | $ 72,184 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 2,883,395 | 2,405,221 | 2,883,395 | 2,405,221 |
Warrants to purchase common stock | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 409,108 | 426,827 | 409,108 | 426,827 |
Common stock options | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 2,067,057 | 1,975,250 | 2,067,057 | 1,975,250 |
Restricted stock units | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 403,100 | 0 | 403,100 | 0 |
Employee stock purchase plan | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 4,130 | 3,144 | 4,130 | 3,144 |
Other Financial Information - P
Other Financial Information - Prepaid expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Diagnostic testing supplies | $ 1,010 | $ 1,203 |
Prepaid product royalties | 54 | 68 |
Prepaid maintenance and insurance contracts | 1,040 | 2,229 |
Other prepaid and other current assets | 301 | 659 |
Prepaid and other current assets | $ 2,405 | $ 4,159 |
Other Financial Information -_2
Other Financial Information - Property and equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 7,043 | $ 5,043 |
Less: accumulated depreciation and amortization | (3,597) | (2,941) |
Property and equipment, net | 3,446 | 2,102 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 83 | 64 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 4,100 | 2,679 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,106 | 927 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,141 | 1,072 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 613 | $ 301 |
Other Financial Information - N
Other Financial Information - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation and amortization | $ 300 | $ 100 | $ 700 | $ 400 | |
Property and equipment, gross | 7,043 | 7,043 | $ 5,043 | ||
Assets under capital lease | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 2,500 | $ 2,500 | $ 1,200 |
Other Financial Information - A
Other Financial Information - Accrued and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Other Financial Information [Abstract] | ||
Accrued payroll and related expenses | $ 3,793 | $ 3,589 |
Accrued interest | 145 | 147 |
Accrued purchases of goods and services | 765 | 311 |
Accrued royalties | 342 | 221 |
Accrued clinical study activity | 337 | 228 |
Capital lease obligations, current portion | 586 | 308 |
Other accrued liabilities | 616 | 953 |
Accrued and other current liabilities | $ 6,584 | $ 5,757 |
Borrowings - Narrative (Details
Borrowings - Narrative (Details) - USD ($) | Dec. 07, 2018 | Nov. 30, 2019 | Sep. 30, 2017 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Loan payable | Capital Royalty Partners II LP | |||||||
Debt Instrument [Line Items] | |||||||
Loan repayment | $ 17,800,000 | ||||||
2017 Term loan | Loan payable | Innovatus Life Sciences Lending Fund | |||||||
Debt Instrument [Line Items] | |||||||
Term loan borrowings | $ 5,000,000 | $ 20,000,000 | $ 0 | ||||
Term loan, interest rate | 8.50% | ||||||
Term loan, paid in-kind, interest rate | 2.00% | ||||||
Term loan, effective interest rate | 10.00% | ||||||
Debt instrument, term | 24 months | ||||||
Term loan, fee incurred upon payment of final installment | $ 1,000,000 | ||||||
Term loan, prepayment premium percentage | 2.00% | ||||||
Term loan, annual reduction in prepayment penalty percentage | 1.00% | ||||||
Term loan covenant, minimum unrestricted cash balance | $ 2,000,000 | ||||||
Term loan covenant, increase to interest rate | 4.00% | ||||||
2017 Term loan | Paid in-kind note | Innovatus Life Sciences Lending Fund | |||||||
Debt Instrument [Line Items] | |||||||
Term loan, paid in-kind loans issued | $ 100,000 | $ 100,000 | $ 400,000 | $ 400,000 |
Borrowings - Future minimum pay
Borrowings - Future minimum payments (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Debt Disclosure [Abstract] | |
2021 (remaining) | $ 446 |
2022 | 2,996 |
2023 | 15,619 |
2024 | 14,280 |
Total | 33,341 |
Unamortized debt discount and issuance costs | (224) |
Interest | (5,829) |
Total borrowings, net of discounts and debt issuance costs | $ 27,288 |
Commitment and Contingencies -
Commitment and Contingencies - Narrative (Details) - USD ($) | Aug. 23, 2021 | May 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Loss Contingencies [Line Items] | ||||||
Operating lease, rent expense | $ 200,000 | $ 300,000 | $ 500,000 | $ 500,000 | ||
Purchase obligation, to be paid remainder of fiscal year | 4,100,000 | 4,100,000 | ||||
Purchase obligation, due in year one | $ 6,000,000 | $ 6,000,000 | ||||
Annual increase in purchase commitments | 15.00% | 15.00% | ||||
AHN Collaboration | ||||||
Loss Contingencies [Line Items] | ||||||
Collaboration agreement, collaboration expenses | $ 100,000 | $ 200,000 | ||||
Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Initial license fee | $ 400,000 | |||||
Minimum | Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty obligation, percent of net sales | 1.50% | 1.50% | ||||
Maximum | Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty obligation, percent of net sales | 3.00% | 3.00% | ||||
Prometheus Laboratories | ||||||
Loss Contingencies [Line Items] | ||||||
Payments to acquire intellectual property | $ 100,000 | |||||
Future minimum royalty commitment | $ 1,200,000 | 1,200,000 | ||||
Advance royalties payment | $ 100,000 | $ 100,000 | ||||
Prometheus Laboratories | Minimum | ||||||
Loss Contingencies [Line Items] | ||||||
Royalty obligation, percent of net sales | 2.50% | 2.50% | ||||
Allegheny Health Network Research Institute | ||||||
Loss Contingencies [Line Items] | ||||||
Collaboration fee | $ 400,000 | |||||
Office and Laboratory | ||||||
Loss Contingencies [Line Items] | ||||||
Operating lease, renewal term | 5 years | |||||
Office | ||||||
Loss Contingencies [Line Items] | ||||||
Operating lease, renewal term | 5 years | |||||
Operating lease monthly base rent | $ 66,021 | |||||
Operating lease annual increase in base rent payment percent | 3.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - Money market funds, included in cash and cash equivalents - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Money market funds, included in cash and cash equivalents | $ 105,679 | $ 34,507 |
Level 1 | ||
Assets: | ||
Money market funds, included in cash and cash equivalents | 105,679 | 34,507 |
Level 2 | ||
Assets: | ||
Money market funds, included in cash and cash equivalents | 0 | 0 |
Level 3 | ||
Assets: | ||
Money market funds, included in cash and cash equivalents | $ 0 | $ 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 22, 2021 | Mar. 25, 2021 | Nov. 10, 2020 | Sep. 30, 2021 | Mar. 31, 2021 |
Class of Stock [Line Items] | |||||
Estimated offering expenses for aggregate expenses | $ 4,435 | ||||
Number of warrants exercised (in shares) | 0 | ||||
Exchanging Stockholders | |||||
Class of Stock [Line Items] | |||||
Number of shares exchanged for warrants (in shares) | 804,951 | ||||
Number of common shares to be called upon exercise of 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% | ||||
Common Stock | |||||
Class of Stock [Line Items] | |||||
Sale of stock, number shares issued (in shares) | 4,255,000 | ||||
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 | ||||
Common Stock | IPO | |||||
Class of Stock [Line Items] | |||||
Sale of stock, number shares issued (in shares) | 150,000,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 1,214,059 |
Net exercise of common stock warrants (in shares) | 17,719 |
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) $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($)shares | |
Stock options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock options, unrecognized compensation cost | $ | $ 7.7 |
Stock options, cost not yet recognized, remaining weighted average vesting period | 2 years 2 months 12 days |
Employee stock purchase plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares that remain available for future awards (in shares) | shares | 327,516 |
Maximum employee payroll deduction percentage | 20.00% |
Stock options, cost not yet recognized, remaining weighted average vesting period | 4 months 24 days |
Restricted stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock options, unrecognized compensation cost | $ | $ 5.9 |
Stock options, cost not yet recognized, remaining weighted average vesting period | 3 years 6 months |
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 |
Shares that remain available for future awards (in shares) | shares | 1,139,831 |
Stock Option Plan - Stock Optio
Stock Option Plan - Stock Option Activity (Details) - Stock options $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Outstanding, December 31, 2020 (in shares) | shares | 1,975,761 | |
Granted (in shares) | shares | 229,850 | |
Exercised (in shares) | shares | (11,188) | |
Forfeited (in shares) | shares | (122,435) | |
Expired (in shares) | shares | (4,931) | |
Outstanding, June 30, 2021 (in shares) | shares | 2,067,057 | 1,975,761 |
Vested and expected to vest, June 30, 2021 (in shares) | shares | 2,067,057 | |
Options exercisable, June 30, 2021 (in Shares) | shares | 979,111 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||
Outstanding, December 31, 2020, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 11.81 | |
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares | 16.79 | |
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares | 7.13 | |
Forfeited, Weighted Average Exercise Price (in dollars per share) | $ / shares | 14.49 | |
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares | 21.50 | |
Outstanding, June 30, 2021, Weighted Average Exercise Price (in dollars per share) | $ / shares | 12.20 | $ 11.81 |
Vested and expected to vest, June 30, 2021, Weighted Average Exercise Price (in dollars per share) | $ / shares | 12.20 | |
Options exercised, June 30, 2021, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 10.30 | |
Stock Options, Additional Disclosures [Abstract] | ||
Outstanding, Weighted Average Remaining Contractual Term | 8 years 1 month 20 days | 8 years 8 months 15 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term | 8 years 1 month 20 days | |
Options exercisable, Weighted Average Remaining Contractual Term | 7 years 9 months 7 days | |
Outstanding, Aggregate Intrinsic Value | $ | $ 6,956 | $ 6,750 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 6,956 | |
Options exercisable, Aggregate Intrinsic Value | $ | $ 4,794 |
Stock Option Plan - Restricted
Stock Option Plan - Restricted Stock Units (Details) - Restricted stock units - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Outstanding, December 31, 2020 (in shares) | 0 | |
Awards granted (in shares) | 422,150 | |
Awards released (in shares) | 0 | |
Awards canceled (in shares) | (19,050) | |
Outstanding, September 30, 2021 (in shares) | 403,100 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Outstanding, December 31, 2020 (in dollars per share) | $ 0 | |
Awards granted, Weighted-Average Grant Date Fair Value (in dollars per share) | 16.81 | |
Awards released, Weighted-Average Grant Date Fair Value (in dollars per share) | 0 | |
Awards canceled, Weighted-Average Grant Date Fair Value (in dollars per share) | 16.28 | |
Outstanding, September 30, 2021 (in dollars per share) | $ 16.84 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value [Abstract] | ||
Outstanding, Aggregate Intrinsic Value | $ 5,482 | $ 0 |
Stock Option Plan - Fair Value
Stock Option Plan - Fair Value Assumptions (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility rate, minimum | 45.00% | 58.00% | ||
Expected volatility rate, maximum | 60.00% | 83.00% | ||
Risk-free interest rate, minimum | 0.10% | |||
Risk-free interest rate, maximum | 1.10% | |||
Dividend yield | 0.00% | |||
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 86.00% | 52.00% | ||
Expected volatility rate, minimum | 83.00% | 47.00% | ||
Expected volatility rate, maximum | 86.00% | 52.00% | ||
Risk-free interest rate | 0.90% | 0.40% | ||
Risk-free interest rate, minimum | 0.80% | 0.40% | ||
Risk-free interest rate, maximum | 1.10% | 1.70% | ||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock options | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 9 months 7 days | 6 years 29 days | 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 29 days | 6 years 29 days | ||
Employee stock purchase plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 45.00% | 83.00% | ||
Risk-free interest rate | 0.10% | 0.10% | 0.10% | |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
Stock Option Plan - Stock-Based
Stock Option Plan - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,354 | $ 799 | $ 3,551 | $ 1,877 |
Cost of revenue | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 64 | 9 | 136 | 21 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 1,115 | 710 | 2,955 | 1,696 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 175 | $ 80 | $ 460 | $ 160 |
Covid-19 (Details)
Covid-19 (Details) - USD ($) $ in Thousands | Apr. 16, 2020 | Apr. 30, 2020 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Restructuring Cost and Reserve [Line Items] | ||||||
Coronavirus, Aid, Relief, And Economic Securities (CARES) Act, deferred tax assets, valuation allowance | $ 100 | |||||
Coronavirus, Aid, Relief, And Economic Securities (CARES) Act, deferred tax assets, income tax benefit | $ 100 | |||||
Proceeds from government assistance | $ 700 | $ 0 | $ 700 | |||
Proceeds from Paycheck Protection Program loan | $ 0 | $ 2,865 | ||||
Paycheck Protection Program, CARES Act | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Proceeds from Paycheck Protection Program loan | $ 2,900 |
Subsequent Events - Narrative (
Subsequent Events - Narrative (Details) - USD ($) | 1 Months Ended | |
Oct. 31, 2021 | Nov. 30, 2019 | |
2017 Term loan | Innovatus Life Sciences Lending Fund | Loan payable | ||
Subsequent Event [Line Items] | ||
Interest rate | 8.50% | |
Term loan, paid in-kind, interest rate | 2.00% | |
Subsequent Event | 2017 Term loan | Innovatus Life Sciences Lending Fund | Loan payable | ||
Subsequent Event [Line Items] | ||
Interest rate | 8.00% | |
Term loan, paid in-kind, interest rate | 2.00% | |
Subsequent Event | Office Space | ||
Subsequent Event [Line Items] | ||
Operating lease monthly base rent | $ 22,470 | |
Lease term | 12 months | |
Operating lease, monthly base rent after first increase | $ 23,594 | |
Subsequent Event | Headquarters | ||
Subsequent Event [Line Items] | ||
Operating lease monthly base rent | 20,084 | |
Subsequent Event | Office and Laboratory | ||
Subsequent Event [Line Items] | ||
Operating lease monthly base rent | $ 14,751 |