Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 06, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 $0.001 per share | |
Trading Symbol | XGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 12,652,138 | |
Entity Central Index Key | 0001274737 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 61,434 | $ 72,084 |
Accounts receivable, net | 9,297 | 5,715 |
Prepaid expenses and other current assets | 1,824 | 3,451 |
Total current assets | 72,555 | 81,250 |
Property and equipment, net | 1,758 | 1,380 |
Goodwill | 5,506 | 5,506 |
Other assets | 174 | 174 |
Total assets | 79,993 | 88,310 |
Current liabilities: | ||
Accounts payable | 2,454 | 1,476 |
Accrued and other current liabilities | 5,820 | 4,419 |
Total current liabilities | 8,274 | 5,895 |
Borrowings-non-current portion, net of discounts and debt issuance costs | 26,453 | 25,854 |
Deferred tax liabilities | 147 | 264 |
Other non-current liabilities | 645 | 638 |
Total liabilities | 35,519 | 32,651 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2020 and December 31, 2019; 12,652,113 and 12,560,990 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 13 | 13 |
Additional paid-in capital | 222,297 | 220,248 |
Accumulated deficit | (177,836) | (164,602) |
Total stockholders' equity | 44,474 | 55,659 |
Total liabilities and stockholders' equity | $ 79,993 | $ 88,310 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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) | 12,652,113 | 12,560,990 |
Shares outstanding (in shares) | 12,652,113 | 12,560,990 |
Unaudited Condensed Statements
Unaudited Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenue | $ 10,775 | $ 10,439 | $ 29,307 | $ 30,173 |
Operating expenses: | ||||
Costs of revenue | 4,341 | 4,783 | 12,224 | 14,217 |
Selling, general and administrative expenses | 9,202 | 7,306 | 27,104 | 20,787 |
Research and development expenses | 1,018 | 507 | 2,403 | 1,610 |
Total operating expenses | 14,561 | 12,596 | 41,731 | 36,614 |
Loss from operations | (3,786) | (2,157) | (12,424) | (6,441) |
Interest expense | (647) | (909) | (1,913) | (2,720) |
Change in fair value of financial instruments | 0 | (200) | 0 | 267 |
Other income, net | 125 | 125 | 985 | 264 |
Loss before income taxes | (4,308) | (3,141) | (13,352) | (8,630) |
Income tax benefit | 0 | 0 | 118 | 0 |
Net loss | (4,308) | (3,141) | (13,234) | (8,630) |
Accretion of redeemable convertible preferred stock | 0 | (338) | 0 | (4,640) |
Deemed dividend recorded in connection with financing transactions | 0 | (13,601) | 0 | (13,601) |
Net loss attributable to common stockholders (Note 2) | $ (4,308) | $ (17,080) | $ (13,234) | $ (26,871) |
Net loss per share, basic and diluted (USD per share) | $ (0.34) | $ (11.29) | $ (1.05) | $ (48.70) |
Weighted-average number of shares used to compute net loss per share, basic and diluted (in shares) | 12,644,348 | 1,513,189 | 12,626,259 | 551,730 |
Unaudited Condensed Statement_2
Unaudited Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series H redeemable convertible preferred stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 63,005 | ||||
Beginning balance at Dec. 31, 2018 | $ (111,966) | $ 0 | $ 40,598 | $ (152,564) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | (2,114) | (2,114) | |||
Exercise of stock options (in shares) | 24 | ||||
Stock-based compensation | 12 | 12 | |||
Net loss | (2,704) | (2,704) | |||
Ending balance (in shares) at Mar. 31, 2019 | 63,029 | ||||
Ending balance at Mar. 31, 2019 | $ (116,772) | $ 0 | 38,496 | (155,268) | |
Beginning balance (in shares) at Dec. 31, 2018 | 532,606,084 | ||||
Beginning balance at Dec. 31, 2018 | $ 105,232 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | $ 2,114 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs (in shares) | 97,646,289 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs | $ 7,520 | ||||
Ending balance (in shares) at Mar. 31, 2019 | 630,252,373 | ||||
Ending balance at Mar. 31, 2019 | $ 114,866 | ||||
Beginning balance (in shares) at Dec. 31, 2018 | 63,005 | ||||
Beginning balance at Dec. 31, 2018 | (111,966) | $ 0 | 40,598 | (152,564) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (8,630) | ||||
Ending balance (in shares) at Sep. 30, 2019 | 12,559,492 | ||||
Ending balance at Sep. 30, 2019 | $ 58,650 | $ 13 | 219,831 | (161,194) | |
Beginning balance (in shares) at Dec. 31, 2018 | 532,606,084 | ||||
Beginning balance at Dec. 31, 2018 | $ 105,232 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | $ 4,640 | ||||
Deemed dividend recognized on beneficial conversion features of Series H redeemable convertible preferred stock (Note 7) | $ 6,741 | ||||
Ending balance (in shares) at Sep. 30, 2019 | 0 | ||||
Ending balance at Sep. 30, 2019 | $ 0 | ||||
Beginning balance (in shares) at Mar. 31, 2019 | 63,029 | ||||
Beginning balance at Mar. 31, 2019 | (116,772) | $ 0 | 38,496 | (155,268) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | (2,188) | (2,188) | |||
Exercise of stock options (in shares) | 26 | ||||
Stock-based compensation | 11 | 11 | |||
Net loss | (2,785) | (2,785) | |||
Ending balance (in shares) at Jun. 30, 2019 | 63,055 | ||||
Ending balance at Jun. 30, 2019 | $ (121,734) | $ 0 | 36,319 | (158,053) | |
Beginning balance (in shares) at Mar. 31, 2019 | 630,252,373 | ||||
Beginning balance at Mar. 31, 2019 | $ 114,866 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | $ 2,188 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs (in shares) | 51,282,048 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs | $ 3,972 | ||||
Ending balance (in shares) at Jun. 30, 2019 | 681,534,421 | ||||
Ending balance at Jun. 30, 2019 | $ 121,026 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | (338) | (338) | |||
Stock-based compensation | 62 | 62 | |||
Issuance of Series H redeemable convertible preferred stock for aggregate proceeds of $0.047 per share, net of issuance costs of $318 (Note 7) | 6,741 | 6,741 | |||
Deemed dividend recognized on beneficial conversion features of Series H redeemable convertible preferred stock | (6,741) | (6,741) | |||
Deemed dividend from conversion of Series G to Series H redeemable convertible preferred stock | (6,860) | (6,860) | |||
Stock issued upon conversion of redeemable convertible preferred shares (in shares) | 7,816,643 | ||||
Conversion of preferred stock to common stock in connection with initial public offering | 138,906 | $ 8 | 138,898 | ||
Issuance of common stock in initial public offering, net of underwriting discount, commissions and issuance costs (Note 8) (in shares) | 4,140,000 | ||||
Issuance of common stock in initial public offering, net of underwriting discount, commissions and issuance costs (Note 8) | 50,518 | $ 4 | 50,514 | ||
Net exercise of common and preferred stock warrants (in shares) | 539,794 | ||||
Net exercise of common and preferred stock warrants | 511 | $ 1 | 510 | ||
Reclassification of redeemable convertible preferred stock warrant liabilities as equity | 726 | 726 | |||
Net loss | (3,141) | (3,141) | |||
Ending balance (in shares) at Sep. 30, 2019 | 12,559,492 | ||||
Ending balance at Sep. 30, 2019 | 58,650 | $ 13 | 219,831 | (161,194) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | 338 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs (in shares) | 233,446,519 | ||||
Issuance of Series redeemable convertible preferred stock for aggregate proceeds, net of issuance costs | $ 3,941 | ||||
Deemed dividend recognized on beneficial conversion features of Series H redeemable convertible preferred stock (Note 7) | $ 6,741 | 6,700 | |||
Deemed dividend from conversion of Series G to Series H redeemable convertible preferred stock (Note 7) (in shares) | 97,592,739 | ||||
Deemed dividend from conversion of Series G to Series H redeemable convertible preferred stock (Note 7) | $ 6,860 | ||||
Conversion of preferred stock to common stock in connection with initial public offering (in shares) | (1,012,573,679) | ||||
Conversion of preferred stock to common stock in connection with initial public offering (Note 7) | $ (138,906) | ||||
Ending balance (in shares) at Sep. 30, 2019 | 0 | ||||
Ending balance at Sep. 30, 2019 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2019 | 12,560,990 | 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 and preferred stock warrants (in shares) | 22,366 | ||||
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 | 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) | 47,354 | ||||
Net loss | $ (13,234) | ||||
Ending balance (in shares) at Sep. 30, 2020 | 12,652,113 | 12,652,113 | |||
Ending balance at Sep. 30, 2020 | $ 44,474 | $ 13 | 222,297 | (177,836) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Accretion of redeemable convertible preferred stock | 0 | ||||
Deemed dividend recognized on beneficial conversion features of Series H redeemable convertible preferred stock (Note 7) | $ 0 | ||||
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 and preferred stock warrants (in shares) | 9,754 | ||||
Net exercise of common and preferred 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 | ||||
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 | 12,652,113 | |||
Ending balance at Sep. 30, 2020 | $ 44,474 | $ 13 | $ 222,297 | $ (177,836) |
Unaudited Condensed Statement_3
Unaudited Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | |
Series G redeemable convertible preferred stock | |||
Sale of temporary equity, price per share (in dollars per share) | $ 0.078 | $ 0.078 | |
Issuance costs | $ 28 | $ 96 | |
Series H redeemable convertible preferred stock | |||
Sale of temporary equity, price per share (in dollars per share) | $ 0.047 | ||
Issuance costs | $ 318 |
Unaudited Statements of Cash Fl
Unaudited Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (13,234) | $ (8,630) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 392 | 480 |
Amortization of debt discount and debt issuance costs | 202 | 575 |
Non-cash interest expense | 397 | 484 |
Revaluation of warrant liabilities | 0 | (267) |
Deferred income taxes | (117) | 0 |
Loss on disposal of assets | 0 | 20 |
Stock-based compensation | 1,877 | 85 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (3,582) | (286) |
Prepaid expenses and other current assets | 1,627 | 510 |
Other assets | 0 | (24) |
Accounts payable | 781 | 174 |
Accrued and other liabilities | 1,472 | 1,095 |
Net cash used in operating activities | (10,185) | (5,784) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (450) | (377) |
Proceeds from sale of property and equipment | 0 | 300 |
Net cash used in investing activities | (450) | (77) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 12 | 0 |
Proceeds from common stock issued under Employee Stock Purchase Pan | 142 | 0 |
Proceeds from exercise of common stock warrants | 18 | 0 |
Principal payment on capital lease obligations | (187) | (94) |
Proceeds from Paycheck Protection Program loan | 2,865 | 0 |
Repayment of Paycheck Protection Program loan | (2,865) | 0 |
Proceeds from initial public offering, net of issuance costs and offering costs | 0 | 52,195 |
Net cash (used in) provided by financing activities | (15) | 70,525 |
Net change in cash, cash equivalents and restricted cash | (10,650) | 64,664 |
Cash, cash equivalents and restricted cash, beginning of period | 72,184 | 13,264 |
Cash, cash equivalents and restricted cash, end of period | 61,534 | 77,928 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest expense | 1,312 | 1,661 |
Supplemental disclosure of non-cash items: | ||
Accretion to redemption value of redeemable convertible preferred stock | 0 | 4,640 |
Equipment purchased under capital lease obligations | 123 | 412 |
Costs incurred, but not paid, in connection with capital expenditures | 197 | 71 |
Conversion of redeemable convertible preferred stock | 0 | 138,906 |
Net exercise of common and preferred stock warrants | 0 | 511 |
Issuance costs included in accounts payable and accrued liabilities | 0 | 1,677 |
Reclassification of redeemable convertible preferred stock warrant liabilities as equity | 0 | 726 |
Series G redeemable convertible preferred stock | ||
Cash flows from financing activities: | ||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 0 | 7,742 |
Supplemental disclosure of non-cash items: | ||
Deemed dividend from conversion of Series G to Series H redeemable convertible preferred stock | 0 | 6,860 |
Conversion of Series G to Series H redeemable convertible preferred stock | 0 | 11,875 |
Series H redeemable convertible preferred stock | ||
Cash flows from financing activities: | ||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 0 | 10,682 |
Supplemental disclosure of non-cash items: | ||
Deemed dividend recognized for beneficial conversion features of Series H redeemable convertible preferred stock | $ 0 | $ 6,741 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Exagen Inc. (the Company) was incorporated under the laws of the state of New Mexico in 2002, under the name Exagen Corporation. In 2003, Exagen Corporation changed its state of incorporation from New Mexico to Delaware by merging with and into Exagen Diagnostics, Inc., pursuant to which the Company changed its name to Exagen Diagnostics, Inc. In January 2019, the Company changed its name to 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, 2020, the Company had cash and cash equivalents of $61.4 million and had an accumulated deficit of $177.8 million. Since inception, the Company has financed its operations primarily through private placements of preferred securities, the sale of common stock through its initial public offering (IPO) and debt financing arrangements. 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, 2020 | |
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, 2020, the condensed statements of operations and the condensed statements of redeemable convertible preferred stock and stockholders' equity (deficit) for the three and nine months ended September 30, 2020 and 2019 and cash flows for the nine months ended September 30, 2020 and 2019 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, 2020 and its results of operations for the three and nine months ended September 30, 2020 and 2019, statements of redeemable convertible preferred stock and stockholders' equity (deficit) for the three and nine months ended September 30, 2020 and 2019 and cash flows for the nine months ended September 30, 2020 and 2019 in accordance with GAAP. The results for the nine months ended September 30, 2020 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 accounting principles generally accepted in the United States of America. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2019, included in its Annual Report on Form 10-K filed with the SEC on March 25, 2020. 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), net deferred tax assets (and related valuation allowance), and for periods prior to the IPO, the fair value of the Company's common stock and redeemable convertible preferred stock. 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 payers 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 payer 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 2020 2019 2020 2019 Medicare 20 % 25 % 21 % 26 % Janssen (SIMPONI ® ) 13 % * 12 % * Blue Shield 12 % 13 % 12 % 13 % Medicare Advantage 11 % 12 % 11 % 11 % United Healthcare * 10 % * 10 % Accounts Receivable September 30, 2020 December 31, 2019 Janssen (SIMPONI ® ) 37 % 19 % Anthem Blue Cross Blue Shield 12 % * Blue Shield 10 % 15 % United Healthcare * 22 % * Less than 10%. For the three months ended September 30, 2020 and 2019, approximately 68%, and 83%, respectively, of the Company's revenue was related to the AVISE ® CTD test. For the nine months ended September 30, 2020 and 2019, approximately 71% and 83%, 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, 2020 and 2019, approximately 98% and 97%, respectively, of the Company's diagnostic testing supplies were purchased from two suppliers. For the nine months ended September 30, 2020 and 2019, approximately 97% and 96%, 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 payer and customer category (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Revenue: Healthcare insurers $ 5,749 $ 6,188 $ 15,949 $ 17,716 Government 2,184 2,665 6,236 7,964 Client 1,260 1,007 3,088 3,200 Other(1) 235 148 636 458 Janssen (SIMPONI ® ) 1,347 431 3,398 835 Total revenue $ 10,775 $ 10,439 $ 29,307 $ 30,173 (1) Includes patient self-pay that is immaterial . Fair Value Measurements The carrying value of the Company's cash and cash equivalents, other assets and accrued liabilities 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, 2020 December 31, 2019 Cash and cash equivalents $ 61,434 $ 72,084 Restricted cash 100 100 $ 61,534 $ 72,184 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 (the Payers) consist of healthcare insurers, government payers (primarily Medicare and Medicaid), client payers (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. Payers 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 payers. 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, is recorded upon settlement. The transaction price is estimated using an expected value method on a portfolio basis. The Company's portfolios are grouped per payer (i.e. each individual third-party insurance, Medicare, client payers, patient self-pay, etc.) and per test basis. Collection of the Company's net revenues from payers 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 with Janssen Biotech, Inc. (Janssen) to co-promote SIMPONI ® in the United States (the Janssen Agreement). The Company is responsible for the costs associated with its salesforce over the course of such co-promotion. Janssen is 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 is 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 all periods presented, 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 (Amended Janssen Agreement). In accordance with the Amended Janssen Agreement, the predetermined baseline for prescribed units for each remaining quarter in 2020 was adjusted and is subject to further adjustment, and for each of the third and fourth quarters of 2020, the Company will receive a minimum promotion fee of $0.3 million and the fee will be capped at 5% above the adjusted predetermined baseline. The predetermined baseline for 2021 will be agreed upon by the Company and Janssen no later than November 30, 2020. In addition, during the term of the Janssen agreement, the Company is restricted from promoting any other biologic or Janus kinase inhibitor, or JAK inhibitor, used for treatment of indications covered by the agreement without first obtaining Janssen's written consent. The Amended Janssen Agreement expires on December 31, 2021, unless extended by the Company for an additional 12 months upon 180 days written notice prior to the end of the current term. If the Company elects to extend the term, the predetermined baseline for 2022 will be subject to future agreement by the Company and Janssen. Janssen may terminate the Amended Janssen Agreement at any time for any reason upon 30 days' notice to the Company, and the Company may terminate the Amended Janssen Agreement for any reason at the end of any calendar quarter upon 30 days' notice to Janssen. Either party may terminate the Amended Janssen Agreement in the event of the other party's default of any of its material obligations under the agreement if such default remains uncured for a specified period of time following receipt of written notice of such default. The Company's obligations relating to sales and co-promotion services for SIMPONI ® is a series of single performance obligations since Janssen simultaneously receives and consumes benefits provided by the Company's sales and co-promotional services. The method for measuring progress towards satisfying the performance obligations is based on prescribed units in excess of the contractual baseline at the contractual rate earned per unit since the agreement is cancelable. The Company recognized co-promotional revenue of approximately $1.3 million and $0.4 million during the three months ended September 30, 2020 and 2019, respectively. The Company recognized co-promotional revenue of approximately $3.4 million and $0.8 million during the nine months ended September 30, 2020 and 2019, 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 $0.3 million and $0.4 million for the three months ended September 30, 2020 and 2019, respectively, and $0.9 million and $1.1 million for the nine months ended September 30, 2020 and 2019, 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 $0.4 million for each of the three months ended September 30, 2020 and 2019, and $1.1 million for each of the nine months ended September 30, 2020 and 2019. 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 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. This decision was based on the lack of relevant historical data due to the Company's limited historical experience. In addition, due to the Company's limited historical data, the estimated volatility incorporates the historical volatility over the expected term of the award of comparable companies whose share prices are publicly available. 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. Upon the effective date of the IPO, the Company began using the closing price of its common stock as the fair value 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. Potentially dilutive common stock equivalents are comprised of redeemable convertible preferred stock, warrants for the purchase of redeemable convertible preferred and common stock and options outstanding under the Company's stock option plans. For the three and nine months ended September 30, 2020 and 2019, 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, 2020 2019 2020 2019 Warrants to purchase common stock 426,827 461,273 426,827 461,273 Common stock options 1,975,250 1,475,006 1,975,250 1,475,006 Total 2,402,077 1,936,279 2,402,077 1,936,279 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 are included in other income, net. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations as, and manages its business in, one operating segment. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB), or other standard setting bodies and adopted by the Company as of the specified effective date. Under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), the Company meets the definition of an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company's financial position or results of operations upon adoption. 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 for 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 delay adoption of this ASU until 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 August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework--Changes to the Disclosure Requirements for Fair Value Measurement , which adds and modifies certain disclosure requirements for fair value measurements. Under the new guidance, entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3 fair value measurements. However, public companies will be required to disclose the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive income. The narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all period presented upon their effective date. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods, and early adoption is permitted. The Company adopted this guidance on January 1, 2020, 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, 2020 | |
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, 2020 December 31, 2019 Diagnostic testing supplies $ 841 $ 1,427 Prepaid product royalties 72 123 Prepaid maintenance and insurance contracts 897 1,768 Other prepaid and other current assets 14 133 Prepaid and other current assets $ 1,824 $ 3,451 Property and Equipment Property and equipment consist of the following (in thousands): September 30, 2020 December 31, 2019 Furniture and fixtures $ 44 $ 25 Laboratory equipment 2,663 2,228 Computer equipment and software 927 851 Leasehold improvements 473 424 Construction in progress 438 247 Total property and equipment 4,545 3,775 Less: accumulated depreciation and amortization (2,787) (2,395) Property and equipment, net $ 1,758 $ 1,380 Depreciation and amortization expense for the three months ended September 30, 2020 and 2019 was approximately $0.1 million, and for the nine months ended September 30, 2020 and 2019, was approximately $0.4 million and $0.5 million, respectively. At September 30, 2020 and December 31, 2019, the gross book value of assets under capital lease was $1.2 million and $0.8 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, 2020 December 31, 2019 Accrued payroll and related expenses $ 3,818 $ 2,362 Accrued interest 142 145 Accrued purchases of goods and services 542 319 Accrued royalties 178 727 Accrued clinical study activity 139 40 Capital lease obligations, current portion 272 238 Other accrued liabilities 729 588 Accrued and other current liabilities $ 5,820 $ 4,419 |
Borrowings
Borrowings | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020, 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 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 Loan Amendment will be repaid in twenty-four If the Loan Amendment is prepaid before November 19, 2020, the Loan Amendment requires a prepayment premium of 3% of the aggregate outstanding principal. The prepayment premium decreases by 1% during each subsequent twelve-month period after November 19, 2020. The Loan Amendment is collateralized by a first priority security interest on substantially all of the Company's assets, including intellectual property. The affirmative covenants of the 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, and commencing with the quarter ending December 31, 2019. 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 Company's revenues for the twelve-month period ended September 30, 2020 were lower than the specified targets, and as a result, subsequent to September 30, 2020, the Company and Innovatus agreed on a new management plan and target to bring the Company back into compliance with the Loan Amendment. The Loan Amendment requires that the Company maintain certain levels of minimum liquidity. The Company is required to maintain 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, 2020, the Company was in compliance with all covenants of the Loan Amendment, other than as described above. Upon an event of default in any of the Loan Amendment covenants, the repayment of the 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 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 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, 2020, future minimum aggregate payments, including interest, for outstanding borrowings under the Loan Amendment are as follows (in thousands): September 30, 2020 2020 (remaining) $ 437 2021 1,755 2022 2,996 2023 15,619 2024 14,280 Total 35,087 Less: Unamortized debt discount and issuance costs (320) Interest (8,314) Total borrowings, net of discounts and debt issuance costs $ 26,453 |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases As of September 30, 2020, 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. For the three months ended September 30, 2020 and 2019, rent expense was $0.3 million and $0.1 million, respectively. For the nine months ended September 30, 2020 and 2019, rent expense was $0.5 million and $0.3 million, respectively. 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. All milestone payments other than one have been paid as of December 31, 2017. The remaining milestone obligation is for an additional $2.0 million payment due to Prometheus Laboratories, Inc. (Prometheus) for which the fair value was determined to be zero at September 30, 2020 and December 31, 2019. In addition, the Company has ongoing royalty payment obligations on net sales of products which incorporate certain acquired technologies ranging from 2.5% to 7.5%. Future royalties payable under these arrangements are limited to the lesser of an aggregate of $4.2 million (including an upfront payment of $100,000) or 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 on net sales of products which incorporate licensed technology, as defined, ranging from 2.0% to 20.0%. Royalties are accrued when earned and recorded in costs of revenue in the accompanying condensed statement of operations. 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 $2.8 million, $4.1 million and $6.0 million for the years ended December 31, 2020, 2021 and 2022, respectively, with a 15% annual increase thereafter through the year ended December 31, 2025. 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 payers 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 of which of 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 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 4,009 $ 4,009 $ — $ — December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 70,760 $ 70,760 $ — $ — |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2020 | |
Temporary Equity Disclosure [Abstract] | |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock Series G Financing In January 2019, the Company entered into an agreement with new and certain existing preferred stockholders to issue shares of Series G redeemable convertible preferred stock in multiple separate closings at a per share price of $0.078 in each closing. In conjunction with the issuance of the Series H redeemable convertible preferred stock, each share of issued and outstanding Series G redeemable convertible preferred stock was converted into shares of Series H redeemable convertible preferred stock. Series H Financing In July 2019, the Company entered into an agreement with a new investor to issue shares of Series H redeemable convertible preferred stock at a per share price of $0.04712. The Company accounted for the difference between the effective conversion price of $0.04712 and the fair value of the underlying common stock at the commitment date as a beneficial conversion feature, which was immediately accreted as a deemed dividend. As a result, the Company recognized a beneficial conversion feature in the amount of $6.7 million in the third quarter of 2019, that was recorded as additional paid-in capital (in the absence of retained earnings) in the accompanying condensed statement of redeemable convertible preferred stock and stockholders’ equity (deficit). Additionally, the Company concluded that the conversion of shares of Series G into shares of Series H redeemable convertible preferred stock in connection with the issuance of Series H redeemable convertible preferred stock represented an extinguishment of the Series G shares. As a result, the Company recognized a deemed dividend for the extinguishment charge in the amount of $6.9 million in the third quarter of 2019, that was recorded as additional paid-in capital (in the absence of retained earnings) in the accompanying condensed statement of redeemable convertible preferred stock and stockholders' equity (deficit). Initial Public Offering Upon completion of the Company's IPO in September 2019, an aggregate of 7,816,643 shares of common stock, excluding warrant conversions, were issued to the holders of the Company's Series A-3, Series B-3, Series C, Series D, Series E, Series F and Series H redeemable convertible preferred stockholders upon the automatic conversion of all shares of redeemable convertible preferred stock to common stock. As a result, no shares of redeemable convertible preferred stock remain outstanding at December 31, 2019. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock On September 23, 2019, the Company closed its IPO of 4,140,000 shares of its common stock at a price to the public of $14.00 per share, including the exercise in full by the underwriters of their option to purchase 540,000 additional shares of the Company's common stock. Including the exercise of the option to purchase additional shares, the aggregate net proceeds to the Company from the offering was approximately $50.4 million, net of underwriting discounts, commissions and other estimated offering expenses, for aggregate expenses of approximately $7.5 million. In addition, an aggregate of 7,816,643 shares of common stock, excluding warrant conversions, were issued to the holders of the Company's Series A-3, Series B-3, Series C, Series D, Series E, Series F and Series H redeemable convertible preferred stockholders upon the automatic conversion of all shares of redeemable convertible preferred stock to common stock. Outstanding Warrants The following equity classified warrants to purchase common stock were outstanding as of September 30, 2020: Shares Exercise Price Issuance date Expiration date Common stock warrants 252,798 $ 1.84 January 19, 2016 January 19, 2026 Common stock warrants 69,176 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 8, 2017 September 8, 2024 Common stock warrants 20,944 14.32 December 7, 2018 December 7, 2025 426,827 During the nine months ended September 30, 2020, warrants to purchase common stock were exercised resulting in the issuance of 32,120 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, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Plan | Stock Option Plan In September 2019, the Company's Board of Directors adopted, and the Company's stockholders approved, the 2019 Incentive Award Plan (the 2019 Plan). A total of (i) 2,011,832 shares of common stock plus (ii) shares subject to awards granted under the 2013 Plan on or before the effective date of the 2019 Plan became available for issuance under the 2019 Plan and was initially reserved for issuance under the 2019 Plan. Under the 2019 Plan, 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, 2020, 1,140,029 shares remained available for future awards. Activity under the Company's stock option plans is set forth below: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2019 1,375,542 $ 8.33 9.16 $ 23,654 Granted 901,531 $ 16.14 Exercised (47,354) $ 0.27 Forfeited (244,749) $ 10.05 Expired (9,720) $ 29.11 Outstanding, September 30, 2020 1,975,250 $ 11.77 8.94 $ 5,064 Vested and expected to vest, September 30, 2020 1,975,250 $ 11.77 8.94 $ 5,064 Options exercisable, September 30, 2020 394,739 $ 6.51 8.25 $ 2,430 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. Stock-Based Compensation Expense 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, 2020 2019 2020 2019 Expected volatility 52% 59% 47%-52% 59% Risk-free interest rate 0.4% 2.0% 0.4%-1.7% 2.0%-2.6% Dividend yield — — — — Expected term (in years) 6.08 5.75-6.08 5.50-6.08 5.75-6.08 Total non-cash stock-based compensation expense recorded related to options granted in the condensed statement of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Cost of revenue $ 9 $ 4 $ 21 $ 6 Selling, general and administrative 710 55 1,696 73 Research and development 80 3 160 6 Total $ 799 $ 62 $ 1,877 $ 85 Stock-based compensation expense for the ESPP was immaterial for the three and nine months ended September 30, 2020. As of September 30, 2020, total unrecognized compensation cost was $9.3 million, which is expected to be recognized over a remaining weighted-average vesting period of 3.0 years. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Parties | Related PartiesThe closings of the Series G financing described in Note 7 were issued to existing holders of the Company's redeemable convertible preferred stock, including certain members of our Board of Directors. |
Covid-19
Covid-19 | 9 Months Ended |
Sep. 30, 2020 | |
Reorganizations [Abstract] | |
Covid-19 | COVID-19 The current COVID-19 worldwide pandemic has presented substantial public health challenges and is affecting the Company's employees, patients, physicians and other healthcare providers, communities and business operations, as well as the U.S. and global economies and financial markets. International and U.S. governmental authorities in impacted regions are taking actions in an effort to slow the spread of COVID-19, including issuing varying forms of "stay-at-home" orders, and restricting business functions outside of one's home. As a result of these limitations and reordering of priorities across the U.S. healthcare system, which have resulted in a reduction in patient flow, the Company's test volumes began to decrease in the second half of March 2020. During the third quarter of 2020, the Company's AVISE ® CTD volumes substantially recovered to pre-COVID-19 AVISE ® CTD volumes in the first quarter. For the three months ended September 30, 2020 and for the nine months ended September 30, 2020 as compared to the same period a year ago, the Company has experienced AVISE ® CTD test volumes decreases of approximately 4% and 8%, respectively. However, the continued spread of COVID-19 may adversely affect testing volumes in future periods, the extent of which is highly uncertain. In addition, the Company believes there are several other important factors that have impacted, and that it expects will impact its operating performance and results of operations, including shutdowns of its facilities and operations as well as those of its suppliers and courier services, disruptions to the supply chain of material needed for its tests, its sales and commercialization activities and its ability to receive specimens and perform or deliver the results from its tests, delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, as well its inability to achieve volume-based pricing discounts with its key suppliers and absorb fixed laboratory expenses. In addition, the Company has experienced delays in patient enrollment for ongoing and planned clinical studies involving its tests. The Company may also face increased competition for laboratory employees due to the increased demand in the industry for such personnel. While the full impact COVID-19 will have on the Company's future business is unpredictable at this time, the Company expects it to have a material impact on its financial results for at least the next quarter and potentially beyond, depending upon the timing of any lifting or re-imposition of COVID-19 limitations on the U.S. healthcare system and general economic recovery. In response to the COVID-19 pandemic, the Company has curtailed non-essential employee travel and equipped most of its employees with the ability to work remotely with the exception of its clinical laboratory employees, and implemented measures to protect the health of its employees and to support the functionality of its clinical laboratory. In addition, in the second quarter of 2020 the Company's salesforce recommenced certain field-based interactions and scaled marketing spend, although access to healthcare providers remains limited and the use of virtual sales tools has increased. From March 2020 through September 30, 2020, as a result of the COVID-19 pandemic, the Company terminated temporary employees and 18 full-time employees, which included three employees at the vice president level. The termination of full-time employees resulted in the recognition of a restructuring charge for termination benefits of $0.3 million which has been paid as of September 30, 2020. The restructuring charges were included in selling, general and administrative expenses in the condensed statements of operations. 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 it or treat COVID-19, as well as the economic impact on local, regional, national 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 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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, other assets and accrued liabilities 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 (the Payers) consist of healthcare insurers, government payers (primarily Medicare and Medicaid), client payers (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. Payers 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 payers. 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, is recorded upon settlement. The transaction price is estimated using an expected value method on a portfolio basis. The Company's portfolios are grouped per payer (i.e. each individual third-party insurance, Medicare, client payers, patient self-pay, etc.) and per test basis. Collection of the Company's net revenues from payers 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 $0.3 million and $0.4 million for the three months ended September 30, 2020 and 2019, respectively, and $0.9 million and $1.1 million for the nine months ended September 30, 2020 and 2019, respectively, and are included in selling, general and administrative expenses in the accompanying condensed statements of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards to employees and directors based on the grant-date estimated fair values over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The fair value of stock options and purchases under the 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. This decision was based on the lack of relevant historical data due to the Company's limited historical experience. In addition, due to the Company's limited historical data, the estimated volatility incorporates the historical volatility over the expected term of the award of comparable companies whose share prices are publicly available. The risk-free interest rate for periods within the contractual term of the option is |
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. Potentially dilutive common stock equivalents are comprised of redeemable convertible preferred stock, warrants for the purchase of redeemable convertible preferred and common stock and options outstanding under the Company's stock option plans. For the three and nine months ended September 30, 2020 and 2019, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive securities would be antidilutive. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations as, and manages its business in, one operating segment. |
Recent Accounting Pronouncements; Recently Adopted Accounting Standards | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB), or other standard setting bodies and adopted by the Company as of the specified effective date. Under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), the Company meets the definition of an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company's financial position or results of operations upon adoption. 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 for 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 delay adoption of this ASU until 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 August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework--Changes to the Disclosure Requirements for Fair Value Measurement , which adds and modifies certain disclosure requirements for fair value measurements. Under the new guidance, entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3 fair value measurements. However, public companies will be required to disclose the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive income. The narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all period presented upon their effective date. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods, and early adoption is permitted. The Company adopted this guidance on January 1, 2020, 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, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Concentration of Risk, by Risk Factor and Significant Payer | For each significant payer 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 2020 2019 2020 2019 Medicare 20 % 25 % 21 % 26 % Janssen (SIMPONI ® ) 13 % * 12 % * Blue Shield 12 % 13 % 12 % 13 % Medicare Advantage 11 % 12 % 11 % 11 % United Healthcare * 10 % * 10 % Accounts Receivable September 30, 2020 December 31, 2019 Janssen (SIMPONI ® ) 37 % 19 % Anthem Blue Cross Blue Shield 12 % * Blue Shield 10 % 15 % United Healthcare * 22 % * Less than 10%. |
Disaggregation of Revenue | The following table includes the Company's revenues as disaggregated by payer and customer category (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Revenue: Healthcare insurers $ 5,749 $ 6,188 $ 15,949 $ 17,716 Government 2,184 2,665 6,236 7,964 Client 1,260 1,007 3,088 3,200 Other(1) 235 148 636 458 Janssen (SIMPONI ® ) 1,347 431 3,398 835 Total revenue $ 10,775 $ 10,439 $ 29,307 $ 30,173 (1) Includes patient self-pay that is immaterial . |
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, 2020 December 31, 2019 Cash and cash equivalents $ 61,434 $ 72,084 Restricted cash 100 100 $ 61,534 $ 72,184 |
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, 2020 December 31, 2019 Cash and cash equivalents $ 61,434 $ 72,084 Restricted cash 100 100 $ 61,534 $ 72,184 |
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, 2020 2019 2020 2019 Warrants to purchase common stock 426,827 461,273 426,827 461,273 Common stock options 1,975,250 1,475,006 1,975,250 1,475,006 Total 2,402,077 1,936,279 2,402,077 1,936,279 |
Other Financial Information - (
Other Financial Information - (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Other Financial Information [Abstract] | |
Prepaid expenses table | Prepaid expenses and other current assets consist of the following (in thousands): September 30, 2020 December 31, 2019 Diagnostic testing supplies $ 841 $ 1,427 Prepaid product royalties 72 123 Prepaid maintenance and insurance contracts 897 1,768 Other prepaid and other current assets 14 133 Prepaid and other current assets $ 1,824 $ 3,451 |
Property and equipment | Property and equipment consist of the following (in thousands): September 30, 2020 December 31, 2019 Furniture and fixtures $ 44 $ 25 Laboratory equipment 2,663 2,228 Computer equipment and software 927 851 Leasehold improvements 473 424 Construction in progress 438 247 Total property and equipment 4,545 3,775 Less: accumulated depreciation and amortization (2,787) (2,395) Property and equipment, net $ 1,758 $ 1,380 |
Accrued and other current liabilities | Accrued and other current liabilities consist of the following (in thousands): September 30, 2020 December 31, 2019 Accrued payroll and related expenses $ 3,818 $ 2,362 Accrued interest 142 145 Accrued purchases of goods and services 542 319 Accrued royalties 178 727 Accrued clinical study activity 139 40 Capital lease obligations, current portion 272 238 Other accrued liabilities 729 588 Accrued and other current liabilities $ 5,820 $ 4,419 |
Borrowings - (Tables)
Borrowings - (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Future Minimum Aggregate Payments for Outstanding Borrowings | As of September 30, 2020, future minimum aggregate payments, including interest, for outstanding borrowings under the Loan Amendment are as follows (in thousands): September 30, 2020 2020 (remaining) $ 437 2021 1,755 2022 2,996 2023 15,619 2024 14,280 Total 35,087 Less: Unamortized debt discount and issuance costs (320) Interest (8,314) Total borrowings, net of discounts and debt issuance costs $ 26,453 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 4,009 $ 4,009 $ — $ — December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 70,760 $ 70,760 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Schedule of Outstanding Warrants | The following equity classified warrants to purchase common stock were outstanding as of September 30, 2020: Shares Exercise Price Issuance date Expiration date Common stock warrants 252,798 $ 1.84 January 19, 2016 January 19, 2026 Common stock warrants 69,176 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 8, 2017 September 8, 2024 Common stock warrants 20,944 14.32 December 7, 2018 December 7, 2025 426,827 |
Stock Option Plan (Tables)
Stock Option Plan (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | Activity under the Company's stock option plans is set forth below: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2019 1,375,542 $ 8.33 9.16 $ 23,654 Granted 901,531 $ 16.14 Exercised (47,354) $ 0.27 Forfeited (244,749) $ 10.05 Expired (9,720) $ 29.11 Outstanding, September 30, 2020 1,975,250 $ 11.77 8.94 $ 5,064 Vested and expected to vest, September 30, 2020 1,975,250 $ 11.77 8.94 $ 5,064 Options exercisable, September 30, 2020 394,739 $ 6.51 8.25 $ 2,430 |
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, 2020 2019 2020 2019 Expected volatility 52% 59% 47%-52% 59% Risk-free interest rate 0.4% 2.0% 0.4%-1.7% 2.0%-2.6% Dividend yield — — — — Expected term (in years) 6.08 5.75-6.08 5.50-6.08 5.75-6.08 |
Schedule of Non-cash Stock-based Compensation Expense | Total non-cash stock-based compensation expense recorded related to options granted in the condensed statement of operations is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Cost of revenue $ 9 $ 4 $ 21 $ 6 Selling, general and administrative 710 55 1,696 73 Research and development 80 3 160 6 Total $ 799 $ 62 $ 1,877 $ 85 |
Organization - (Details)
Organization - (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 61,434 | $ 72,084 |
Accumulated deficit | $ 177,836 | $ 164,602 |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Medicare | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 20.00% | 25.00% | 21.00% | 26.00% | |
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 | 37.00% | 19.00% | |||
Blue Shield | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 12.00% | 13.00% | 12.00% | 13.00% | |
Blue Shield | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 10.00% | 15.00% | |||
Medicare Advantage | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 11.00% | 12.00% | 11.00% | 11.00% | |
United Healthcare | Revenue Benchmark | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 10.00% | 10.00% | |||
United Healthcare | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 22.00% | ||||
Anthem Blue Cross Blue Shield | Accounts Receivable | |||||
Disaggregation of Revenue [Line Items] | |||||
Percent of total revenue | 12.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)segment | Sep. 30, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2016USD ($) | |
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Restricted cash | $ 100,000 | $ 100,000 | $ 100,000 | |||||
Joint venture quarterly promotion fee cap | 5.00% | 5.00% | ||||||
Revenue | $ 10,775,000 | $ 10,439,000 | $ 29,307,000 | $ 30,173,000 | ||||
Advertising Expense | 300,000 | 400,000 | $ 900,000 | 1,100,000 | ||||
Cost of revenue | 400,000 | 1,100,000 | ||||||
Number of operating segments | segment | 1 | |||||||
Janssen (SIMPONI) | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Revenue | 1,300,000 | $ 400,000 | $ 3,400,000 | $ 800,000 | ||||
Forecast | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Joint venture quarterly promotion fee cap | 5.00% | |||||||
Minimum | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Joint venture, quarterly promotion fee per prescription | $ 750 | |||||||
Joint venture, quarterly promotion fee | 300,000 | 300,000 | ||||||
Minimum | Forecast | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Joint venture, quarterly promotion fee | $ 300,000 | |||||||
Maximum | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Joint venture, quarterly promotion fee per prescription | $ 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 | $ 400,000 | $ 1,100,000 | ||||||
Revenue Benchmark | Product Concentration Risk | AVISE CTD Test | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Percent of total revenue | 68.00% | 83.00% | 71.00% | 83.00% | ||||
Revenue Benchmark | Supplier Concentration Risk | Two Suppliers | ||||||||
New Accounting Pronouncement, Early Adoption [Line Items] | ||||||||
Percent of total revenue | 98.00% | 97.00% | 97.00% | 96.00% |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 10,775 | $ 10,439 | $ 29,307 | $ 30,173 |
Healthcare insurers | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 5,749 | 6,188 | 15,949 | 17,716 |
Government | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 2,184 | 2,665 | 6,236 | 7,964 |
Client | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 1,260 | 1,007 | 3,088 | 3,200 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 235 | 148 | 636 | 458 |
Janssen (SIMPONI) | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 1,347 | $ 431 | $ 3,398 | $ 835 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 61,434 | $ 72,084 | ||
Restricted cash | 100 | 100 | ||
Total Cash, Cash Equivalents and Restricted Cash | $ 61,534 | $ 72,184 | $ 77,928 | $ 13,264 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 2,402,077 | 1,936,279 | 2,402,077 | 1,936,279 |
Warrants to purchase common stock | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 426,827 | 461,273 | 426,827 | 461,273 |
Common stock options | ||||
Class of Stock [Line Items] | ||||
Anti-dilutive securities excluded from computation (in shares) | 1,975,250 | 1,475,006 | 1,975,250 | 1,475,006 |
Other Financial Information - P
Other Financial Information - Prepaid expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other Financial Information [Abstract] | ||
Diagnostic testing supplies | $ 841 | $ 1,427 |
Prepaid product royalties | 72 | 123 |
Prepaid maintenance and insurance contracts | 897 | 1,768 |
Other prepaid and other current assets | 14 | 133 |
Prepaid and other current assets | $ 1,824 | $ 3,451 |
Other Financial Information -_2
Other Financial Information - Property and equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 4,545 | $ 3,775 |
Less: accumulated depreciation and amortization | (2,787) | (2,395) |
Property and equipment, net | 1,758 | 1,380 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 44 | 25 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,663 | 2,228 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 927 | 851 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 473 | 424 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 438 | $ 247 |
Other Financial Information - N
Other Financial Information - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation and amortization | $ 100 | $ 100 | $ 400 | $ 500 | |
Property and equipment, gross | 4,545 | 4,545 | $ 3,775 | ||
Assets under capital lease | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 1,200 | $ 1,200 | $ 800 |
Other Financial Information - A
Other Financial Information - Accrued and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other Financial Information [Abstract] | ||
Accrued payroll and related expenses | $ 3,818 | $ 2,362 |
Accrued interest | 142 | 145 |
Accrued purchases of goods and services | 542 | 319 |
Accrued royalties | 178 | 727 |
Accrued clinical study activity | 139 | 40 |
Capital lease obligations, current portion | 272 | 238 |
Other accrued liabilities | 729 | 588 |
Accrued and other current liabilities | $ 5,820 | $ 4,419 |
Borrowings - Narrative (Details
Borrowings - Narrative (Details) - USD ($) | Dec. 07, 2018 | Nov. 30, 2019 | Sep. 30, 2017 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
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 | 3.00% | ||||||
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 | $ 200,000 | $ 400,000 | $ 500,000 |
Borrowings - Future minimum pay
Borrowings - Future minimum payments (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Debt Disclosure [Abstract] | |
2020 (remaining) | $ 437 |
2021 | 1,755 |
2022 | 2,996 |
2023 | 15,619 |
2024 | 14,280 |
Total | 35,087 |
Unamortized debt discount and issuance costs | (320) |
Interest | (8,314) |
Total borrowings, net of discounts and debt issuance costs | $ 26,453 |
Commitment and Contingencies -
Commitment and Contingencies - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Loss Contingencies [Line Items] | |||||
Operating lease, rent expense | $ 300,000 | $ 100,000 | $ 500,000 | $ 300,000 | |
Purchase obligation, due in next twelve months | $ 2,800,000 | ||||
Purchase obligation, due in second year | 4,100,000 | ||||
Purchase obligation, due in third year | 6,000,000 | ||||
Annual increase in purchase commitments | 15.00% | 15.00% | |||
Minimum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 2.00% | 2.00% | |||
Maximum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 20.00% | 20.00% | |||
Prometheus Laboratories | |||||
Loss Contingencies [Line Items] | |||||
Remaining milestone obligation | $ 2,000,000 | $ 2,000,000 | |||
Remaining milestone obligation, fair value | 0 | 0 | $ 0 | ||
Advance royalties payment | $ 100,000 | $ 100,000 | |||
Prometheus Laboratories | Minimum | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 2.50% | 2.50% | |||
Prometheus Laboratories | Maximum | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 7.50% | 7.50% | |||
Future minimum royalty commitment | $ 4,200,000 | $ 4,200,000 | |||
Office and Laboratory | |||||
Loss Contingencies [Line Items] | |||||
Operating lease, renewal term | 5 years | ||||
Office | |||||
Loss Contingencies [Line Items] | |||||
Operating lease, renewal term | 5 years |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - Money market funds - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Money market funds | $ 4,009 | $ 70,760 |
Level 1 | ||
Assets: | ||
Money market funds | 4,009 | 70,760 |
Level 2 | ||
Assets: | ||
Money market funds | 0 | 0 |
Level 3 | ||
Assets: | ||
Money market funds | $ 0 | $ 0 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 23, 2019 | Jul. 31, 2019 | Jan. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Temporary Equity [Line Items] | ||||||||||
Deemed dividend recognized for beneficial conversion features of Series H redeemable convertible preferred stock | $ 6,741 | |||||||||
Temporary equity, deemed dividend | $ (6,860) | |||||||||
Redeemable convertible preferred stock outstanding (in shares) | 0 | 681,534,421 | 630,252,373 | 0 | 532,606,084 | |||||
Common Stock | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Stock issued upon conversion of redeemable convertible preferred shares (in shares) | 7,816,643 | |||||||||
Common Stock | IPO | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Stock issued upon conversion of redeemable convertible preferred shares (in shares) | 7,816,643 | |||||||||
Series G redeemable convertible preferred stock | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Sale of temporary equity, price per share (in dollars per share) | $ 0.078 | $ 0.078 | $ 0.078 | |||||||
Series H redeemable convertible preferred stock | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Sale of temporary equity, price per share (in dollars per share) | $ 0.04712 | $ 0.047 | ||||||||
Deemed dividend recognized for beneficial conversion features of Series H redeemable convertible preferred stock | $ 6,700 | $ 0 | $ 6,741 | |||||||
Redeemable Convertible Preferred Stock | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Redeemable convertible preferred stock outstanding (in shares) | 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) - Common Stock - USD ($) $ / shares in Units, $ in Millions | Sep. 23, 2019 | Sep. 30, 2019 |
Class of Stock [Line Items] | ||
Stock issued upon conversion of redeemable convertible preferred shares (in shares) | 7,816,643 | |
IPO | ||
Class of Stock [Line Items] | ||
Initial public offering (in shares) | 4,140,000 | |
Shares issued in public offering, price per share (in dollars per share) | $ 14 | |
Sale of Stock, Consideration Received on Transaction | $ 50.4 | |
Estimated offering expenses for aggregate expenses | $ 7.5 | |
Stock issued upon conversion of redeemable convertible preferred shares (in shares) | 7,816,643 | |
Over-Allotment Option | ||
Class of Stock [Line Items] | ||
Initial public offering (in shares) | 540,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | Sep. 30, 2020$ / sharesshares |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 426,827 |
Number of warrants exercised common stock (in shares) | 32,120 |
Warrant expiration January 19, 2026 | |
Class of Stock [Line Items] | |
Warrants issued to purchase redeemable convertible preferred stock (in shares) | 252,798 |
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) | 69,176 |
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 8, 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 |
Stock Option Plan - Narrative (
Stock Option Plan - Narrative (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options, unrecognized compensation cost | $ 9.3 | |
Stock options, cost not yet recognized, remaining weighted average vesting period | 3 years | |
2019 Incentive Award Plan | Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for issuance under stock option plan (in shares) | 2,011,832 | |
Stock options, expiration period | 10 years | |
Stock options, vesting period | 4 years | |
Shares that remain available for future awards (in shares) | 1,140,029 |
Stock Option Plan - Stock Optio
Stock Option Plan - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Outstanding, December 31, 2019 (in shares) | shares | 1,375,542 | |
Granted (in shares) | shares | 901,531 | |
Exercised (in shares) | shares | (47,354) | |
Forfeited (in shares) | shares | (244,749) | |
Expired (in shares) | shares | (9,720) | |
Outstanding, September 30, 2020 (in shares) | shares | 1,975,250 | 1,375,542 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||
Outstanding, December 31, 2019, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 8.33 | |
Granted, Weighted Average Exercise Price (in dollars per share) | $ / shares | 16.14 | |
Exercised, Weighted Average Exercise Price (in dollars per share) | $ / shares | 0.27 | |
Forfeited, Weighted Average Exercise Price (in dollars per share) | $ / shares | 10.05 | |
Expired, Weighted Average Exercise Price (in dollars per share) | $ / shares | 29.11 | |
Outstanding, September 30, 2020, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 11.77 | $ 8.33 |
Stock Options, Additional Disclosures [Abstract] | ||
Outstanding, Weighted Average Remaining Contractual Term | 8 years 11 months 8 days | 9 years 1 month 28 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term | 8 years 11 months 8 days | |
Options exercisable, Weighted Average Remaining Contractual Term | 8 years 3 months | |
Outstanding, Aggregate Intrinsic Value | $ | $ 5,064 | $ 23,654 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 5,064 | |
Options exercisable, Aggregate Intrinsic Value | $ | $ 2,430 | |
Vested and expected to vest, September 30, 2020 (in shares) | shares | 1,975,250 | |
Options exercisable, September 30, 2020 (in Shares) | shares | 394,739 | |
Vested and expected to vest, September 30, 2020, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 11.77 | |
Options exercised, September 30, 2020, Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 6.51 |
Stock Option Plan - Fair Value
Stock Option Plan - Fair Value Assumptions (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 52.00% | 59.00% | 59.00% | |
Expected volatility rate, minimum | 47.00% | |||
Expected volatility rate, maximum | 52.00% | |||
Risk-free interest rate | 0.40% | 2.00% | ||
Risk-free interest rate, minimum | 0.40% | 2.00% | ||
Risk-free interest rate, maximum | 1.70% | 2.60% | ||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 29 days | 5 years 9 months | 5 years 6 months | 5 years 9 months |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Stock Option Plan - Stock-Based
Stock Option Plan - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 799 | $ 62 | $ 1,877 | $ 85 |
Cost of revenue | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 9 | 4 | 21 | 6 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 710 | 55 | 1,696 | 73 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 80 | $ 3 | $ 160 | $ 6 |
Covid-19 (Details)
Covid-19 (Details) - USD ($) $ in Thousands | Apr. 16, 2020 | Apr. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2020 |
Restructuring Cost and Reserve [Line Items] | ||||||
AVISE CTD test volume, percentage | 4.00% | 8.00% | ||||
Coronavirus, Aid, Relief, And Economic Securities (CARES) Act, deferred tax assets, valuation allowance | $ 100 | $ 100 | ||||
Coronavirus, Aid, Relief, And Economic Securities (CARES) Act, deferred tax assets, income tax benefit | $ 100 | |||||
Coronavirus, Aid, Relief, and Economic Securities (CARES) Act, proceeds from loan | $ 2,900 | $ 700 | ||||
Revenues | $ 0 | $ 700 | ||||
One-time Termination Benefits | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring charges | $ 300 |