QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended | |||||
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | ||||||||||||||||||||||
(Address of Principal Executive Offices) | (Zip Code) |
(Registrant's Telephone Number, Including Area Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||
☒ | Smaller reporting company | |||||||||||||
Emerging growth company |
Page | ||||||||
Part I. | Financial Information | |||||||
Item 1. | ||||||||
Item 2. | ||||||||
Item 3. | ||||||||
Item 4. | ||||||||
Part II. | Other Information | |||||||
Item 1. | ||||||||
Item 1A. | ||||||||
Item 5. | ||||||||
Item 6. | ||||||||
March 31, 2024 | December 31, 2023 | |||||||||||||
Assets | ||||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | $ | ||||||||||||
Accounts receivable, net | ||||||||||||||
Prepaid expenses and other current assets | ||||||||||||||
Total current assets | ||||||||||||||
Property and equipment, net | ||||||||||||||
Operating lease right-of-use assets | ||||||||||||||
Other assets | ||||||||||||||
Total assets | $ | $ | ||||||||||||
Liabilities and Stockholders' Equity | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ | $ | ||||||||||||
Accrued and other current liabilities | ||||||||||||||
Operating lease liabilities | ||||||||||||||
Borrowings-current portion | ||||||||||||||
Total current liabilities | ||||||||||||||
Borrowings-non-current portion, net of discounts and debt issuance costs | ||||||||||||||
Non-current operating lease liabilities | ||||||||||||||
Other non-current liabilities | ||||||||||||||
Total liabilities | ||||||||||||||
Commitments and contingencies (Note 5) | ||||||||||||||
Stockholders' equity: | ||||||||||||||
Preferred stock, $ | ||||||||||||||
Common stock, $ | ||||||||||||||
Additional paid-in capital | ||||||||||||||
Accumulated deficit | ( | ( | ||||||||||||
Total stockholders' equity | ||||||||||||||
Total liabilities and stockholders' equity | $ | $ | ||||||||||||
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Revenue | $ | $ | ||||||||||||
Operating expenses: | ||||||||||||||
Costs of revenue | ||||||||||||||
Selling, general and administrative expenses | ||||||||||||||
Research and development expenses | ||||||||||||||
Total operating expenses | ||||||||||||||
Loss from operations | ( | ( | ||||||||||||
Interest expense | ( | ( | ||||||||||||
Interest income | ||||||||||||||
Net loss | $ | ( | $ | ( | ||||||||||
Net loss per share, basic and diluted | $ | ( | $ | ( | ||||||||||
Weighted-average number of shares used to compute net loss per share, basic and diluted | ||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | |||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||
Balances as of December 31, 2023 | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Issuance of stock from vested restricted stock units | — | — | — | — | ||||||||||||||||||||||||||||
Issuance of stock under Employee Stock Purchase Plan | — | — | ||||||||||||||||||||||||||||||
Exercise of stock options | — | — | — | — | ||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | |||||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | |||||||||||||||||||||||||||
Balances as of March 31, 2024 | $ | $ | $ | ( | $ |
Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | |||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||
Balances as of December 31, 2022 | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Issuance of stock from vested restricted stock units | — | — | — | — | ||||||||||||||||||||||||||||
Exercise of stock options | ||||||||||||||||||||||||||||||||
Issuance of stock under Employee Stock Purchase Plan | — | — | ||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | |||||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | |||||||||||||||||||||||||||
Balances as of March 31, 2023 | $ | $ | $ | ( | $ |
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Cash flows from operating activities: | ||||||||||||||
Net loss | $ | ( | $ | ( | ||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
Depreciation and amortization | ||||||||||||||
Amortization of debt discount and debt issuance costs | ||||||||||||||
Non-cash interest expense | ||||||||||||||
Loss on disposal of assets | ||||||||||||||
Non-cash lease expense | ||||||||||||||
Stock-based compensation | ||||||||||||||
Changes in assets and liabilities: | ||||||||||||||
Accounts receivable, net | ( | ( | ||||||||||||
Prepaid expenses and other current assets | ( | |||||||||||||
Other assets | ( | |||||||||||||
Operating lease liabilities | ( | ( | ||||||||||||
Accounts payable | ( | ( | ||||||||||||
Accrued and other current liabilities | ( | |||||||||||||
Net cash used in operating activities | ( | ( | ||||||||||||
Cash flows from investing activities: | ||||||||||||||
Purchases of property and equipment | ( | ( | ||||||||||||
Net cash used in investing activities | ( | ( | ||||||||||||
Cash flows from financing activities: | ||||||||||||||
Proceeds from exercise of stock options | ||||||||||||||
Proceeds from common stock issued under Employee Stock Purchase Plan | ||||||||||||||
Principal payments on finance lease obligations | ( | ( | ||||||||||||
Principal payment on note payable obligations | ( | ( | ||||||||||||
Net cash used in financing activities | ( | ( | ||||||||||||
Net change in cash, cash equivalents and restricted cash | ( | ( | ||||||||||||
Cash, cash equivalents and restricted cash, beginning of period | ||||||||||||||
Cash, cash equivalents and restricted cash, end of period | $ | $ | ||||||||||||
Supplemental disclosure of cash flow information: | ||||||||||||||
Cash paid for interest | $ | $ | ||||||||||||
Supplemental disclosure of non-cash items: | ||||||||||||||
Equipment purchased under notes payable obligations | $ | $ | ||||||||||||
Costs incurred, but not paid, in connection with capital expenditures | $ | $ | ||||||||||||
Revenue | ||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Medicare | % | % | ||||||||||||
Medicare Advantage | % | % | ||||||||||||
United Healthcare | % | * | ||||||||||||
Accounts Receivable, Net | ||||||||||||||
March 31, 2024 | December 31, 2023 | |||||||||||||
Medicare | % | % | ||||||||||||
Medicare Advantage | % | % |
* | Less than 10%. |
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Revenue: | ||||||||||||||
Commercial | $ | $ | ||||||||||||
Government | ||||||||||||||
Client(1) | ||||||||||||||
Other(2) | ||||||||||||||
Total revenue | $ | $ |
March 31, 2024 | December 31, 2023 | |||||||||||||
Cash and cash equivalents | $ | $ | ||||||||||||
Restricted cash | ||||||||||||||
$ | $ |
March 31, 2024 | March 31, 2023 | |||||||||||||
Warrants to purchase common stock | ||||||||||||||
Common stock options | ||||||||||||||
Restricted stock units | ||||||||||||||
Employee stock purchase plan | ||||||||||||||
Total |
March 31, 2024 | December 31, 2023 | |||||||||||||
Diagnostic testing supplies | $ | $ | ||||||||||||
Prepaid product royalties | ||||||||||||||
Prepaid maintenance and insurance contracts | ||||||||||||||
Other prepaid expenses and other current assets | ||||||||||||||
Prepaid expenses and other current assets | $ | $ |
March 31, 2024 | December 31, 2023 | |||||||||||||
Furniture and fixtures | $ | $ | ||||||||||||
Laboratory equipment | ||||||||||||||
Computer equipment and software | ||||||||||||||
Leasehold improvements | ||||||||||||||
Construction in progress | ||||||||||||||
Total property and equipment | ||||||||||||||
Less: accumulated depreciation and amortization | ( | ( | ||||||||||||
Property and equipment, net | $ | $ |
March 31, 2024 | December 31, 2023 | |||||||||||||
Accrued payroll and related expenses | $ | $ | ||||||||||||
Accrued interest | ||||||||||||||
Accrued purchases of goods and services | ||||||||||||||
Accrued royalties | ||||||||||||||
Accrued clinical study activity | ||||||||||||||
Finance lease obligations, current portion | ||||||||||||||
Refund liability | ||||||||||||||
Other accrued liabilities | ||||||||||||||
Accrued and other current liabilities | $ | $ |
2024 (remaining) | $ | |||||||
2025 | ||||||||
2026 | ||||||||
Total | ||||||||
Less: | ||||||||
Unamortized debt discount and issuance costs | ( | |||||||
Interest | ( | |||||||
Total borrowings, net of discounts and debt issuance costs | ||||||||
Less: Borrowings-current portion | ( | |||||||
Borrowings-non-current portion, net of discounts and debt issuance costs | $ |
March 31, 2024 | ||||||||||||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||
Money market funds, included in cash and cash equivalents | $ | $ | $ | $ |
December 31, 2023 | ||||||||||||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||
Money market funds, included in cash and cash equivalents | $ | $ | $ | $ |
Shares | Exercise Price | Issuance date | Expiration date | ||||||||||||||||||||
Common stock warrants | $ | January 19, 2016 | January 19, 2026 | ||||||||||||||||||||
Common stock warrants | $ | March 31, 2016 | March 31, 2026 | ||||||||||||||||||||
Common stock warrants | $ | April 1, 2016 | April 1, 2026 | ||||||||||||||||||||
Common stock warrants | $ | September 7, 2017 | September 7, 2024 | ||||||||||||||||||||
Common stock warrants | $ | December 7, 2018 | December 7, 2025 | ||||||||||||||||||||
Common stock warrants | $ | June 22, 2021 | None | ||||||||||||||||||||
Number of Shares | Weighted- Average Grant Date Fair Value | |||||||||||||
Outstanding, December 31, 2023 | $ | |||||||||||||
Awards granted | $ | |||||||||||||
Awards released | ( | $ | ||||||||||||
Awards canceled | ( | $ | ||||||||||||
Outstanding, March 31, 2024 | $ |
Number of Options | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||||||||||||
Outstanding, December 31, 2023 | $ | $ | ||||||||||||||||||||||||
Granted | $ | |||||||||||||||||||||||||
Exercised | ( | $ | ||||||||||||||||||||||||
Forfeited | ( | $ | ||||||||||||||||||||||||
Expired | ( | $ | ||||||||||||||||||||||||
Outstanding, March 31, 2024 | $ | $ | ||||||||||||||||||||||||
Vested and expected to vest, March 31, 2024 | $ | $ | ||||||||||||||||||||||||
Options exercisable, March 31, 2024 | $ | $ |
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Costs of revenue | $ | $ | ||||||||||||
Selling, general and administrative | ||||||||||||||
Research and development | ||||||||||||||
Total | $ | $ |
Three Months Ended March 31, | ||||||||||||||||||||
2024 | 2023 | Change | ||||||||||||||||||
Revenue | $ | 14,415 | $ | 11,230 | $ | 3,185 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||
Costs of revenue | 5,817 | 5,926 | (109) | |||||||||||||||||
Selling, general and administrative expenses | 10,542 | 11,884 | (1,342) | |||||||||||||||||
Research and development expenses | 1,059 | 1,126 | (67) | |||||||||||||||||
Total operating expenses | 17,418 | 18,936 | (1,518) | |||||||||||||||||
Loss from operations | (3,003) | (7,706) | 4,703 | |||||||||||||||||
Interest expense | (549) | (638) | 89 | |||||||||||||||||
Interest income | 192 | 656 | (464) | |||||||||||||||||
Net loss | $ | (3,360) | $ | (7,688) | $ | 4,328 |
Three Months Ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
(in thousands) | ||||||||||||||
Net cash used in: | ||||||||||||||
Operating activities | $ | (9,040) | $ | (9,749) | ||||||||||
Investing activities | (86) | (396) | ||||||||||||
Financing activities | (100) | (62) | ||||||||||||
Net change in cash, cash equivalents and restricted cash | $ | (9,226) | $ | (10,207) |
Incorporated by Reference | ||||||||||||||||||||
Exhibit Number | Exhibit Description | Form | File No. | Exhibit | Exhibit Filing Date | Filed/Furnished Herewith | ||||||||||||||
3.1 | 8-K | 001-39049 | 3.1 | 9/23/2019 | ||||||||||||||||
3.2 | 8-K | 001-39049 | 3.1 | 3/22/2021 | ||||||||||||||||
3.3 | 8-K | 001-39049 | 3.1 | 1/23/2023 | ||||||||||||||||
4.1 | S-1/A | 333-233446 | 4.1 | 9/9/2019 | ||||||||||||||||
4.2 | S-1/A | 333-233446 | 4.2 | 9/9/2019 | ||||||||||||||||
4.3 | S-1/A | 333-233446 | 4.3 | 9/9/2019 | ||||||||||||||||
4.4 | S-1/A | 333-233446 | 4.4 | 9/9/2019 | ||||||||||||||||
4.5 | S-1/A | 333-233446 | 4.8 | 9/9/2019 | ||||||||||||||||
4.6 | 10-Q | 001-39049 | 4.5 | 8/9/2021 | ||||||||||||||||
10.1 | X | |||||||||||||||||||
31.1 | X | |||||||||||||||||||
31.2 | X | |||||||||||||||||||
32.1* | X | |||||||||||||||||||
101.INS | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | X | ||||||||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document. | X | ||||||||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | X | ||||||||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | X | ||||||||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document. | X | ||||||||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | X | ||||||||||||||||||
104 | The cover page from the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, has been formatted in Inline XBRL. | X |
EXAGEN INC. | ||||||||
Date: May 13, 2024 | by: | /s/ John Aballi | ||||||
John Aballi | ||||||||
President and Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: May 13, 2024 | by: | /s/ Kamal Adawi | ||||||
Kamal Adawi | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) |
Date: May 13, 2024 | /s/ John Aballi | ||||
John Aballi | |||||
President and Chief Executive Officer | |||||
(Principal Executive Officer) |
Date: May 13, 2024 | /s/ Kamal Adawi | ||||
Kamal Adawi | |||||
Chief Financial Officer | |||||
(Principal Financial and Accounting Officer) |
/s/ John Aballi | ||
John Aballi | ||
President and Chief Executive Officer (Principal Executive Officer) |
/s/ Kamal Adawi | ||
Kamal Adawi | ||
Chief Financial Officer (Principal Financial and Accounting Officer) |
Unaudited Condensed Balance Sheets (Parenthetical) - $ / shares |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Preferred stock | ||
Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Shares authorized (in shares) | 10,000,000 | 10,000,000 |
Shares outstanding (in shares) | 0 | 0 |
Shares issued (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) | 17,317,941 | 17,045,954 |
Shares outstanding (in shares) | 17,317,941 | 17,045,954 |
Unaudited Condensed Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Income Statement [Abstract] | ||
Revenue | $ 14,415 | $ 11,230 |
Operating expenses: | ||
Costs of revenue | 5,817 | 5,926 |
Selling, general and administrative expenses | 10,542 | 11,884 |
Research and development expenses | 1,059 | 1,126 |
Total operating expenses | 17,418 | 18,936 |
Loss from operations | (3,003) | (7,706) |
Interest expense | (549) | (638) |
Interest income | 192 | 656 |
Net loss | $ (3,360) | $ (7,688) |
Net loss per share, basic (in dollars per share) | $ (0.19) | $ (0.44) |
Net loss per share, diluted (in dollars per share) | $ (0.19) | $ (0.44) |
Weighted-average number of shares used to compute net loss per share, basic (in shares) | 17,944,438 | 17,526,763 |
Weighted-average number of shares used to compute net loss per share, diluted (in shares) | 17,944,438 | 17,526,763 |
Organization |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Exagen Inc. (the Company) is a commercial-stage diagnostics company which exists to provide clarity in autoimmune disease decision making with the goal of improving patients' clinical outcomes. 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. As of March 31, 2024, the Company had cash and cash equivalents of $27.3 million and had an accumulated deficit of $282.6 million. Since inception, the Company has financed its operations primarily through a combination of equity financings, debt financing arrangements, and revenue from sales of the Company's products. Based on the Company's current business plan, management believes that its existing capital resources will be sufficient to fund the Company's obligations for at least twelve months following the issuance of these 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.
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Summary of Significant Accounting Policies |
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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 March 31, 2024, condensed statements of operations and stockholders' equity for the three months ended March 31, 2024 and 2023, cash flows for the three months ended March 31, 2024 and 2023 and the related footnote disclosures 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. These unaudited condensed financial statements and related footnote disclosures should be read in conjunction with the Company’s audited financial statements for the fiscal year ended December 31, 2023, included in its Annual Report on Form 10-K filed with the SEC on March 18, 2024. 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 March 31, 2024 and its results of operations for the periods presented. The results for the three months ended March 31, 2024 are not necessarily indicative of the results expected for the full fiscal year or any other interim period. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. 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 recoverability of its long-lived assets and net deferred tax assets (and related valuation allowance). The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. Concentration of Credit Risk and Other Risk and Uncertainties Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents and accounts receivable. Substantially all the Company's cash and cash equivalents are held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company has not experienced any losses on its cash or cash equivalents. Significant payors and customers are those which represent more than 10% of the Company's total revenue or accounts receivable balance at each respective balance sheet date. For each significant payor and customer, revenue as a percentage of total revenue and accounts receivable as a percentage of total accounts receivable are as follows:
For the three months ended March 31, 2024 and 2023, approximately 90% and 87%, 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 March 31, 2024 and 2023, approximately 92% and 97%, respectively, of the Company's diagnostic testing supplies were purchased from two suppliers. An interruption in the supply of these materials would impact the Company's ability to perform testing services. Disaggregation of Revenue The following table includes the Company's revenues as disaggregated by payor and customer category (in thousands):
(1)Includes hospitals, other laboratories, etc. (2)Includes patient self-pay. Cash, Cash Equivalents and Restricted Cash The Company considers all highly-liquid investments purchased with a remaining maturity date of three months or less upon acquisition to be cash equivalents. These investments are stated at cost, which approximates fair value. The Company has an arrangement with a financial institution with which it has an existing banking relationship, whereby in exchange for the issuance of corporate credit cards, the Company agreed to obtain a certificate of deposit with this financial institution in the amount of $0.2 million as collateral for the balances borrowed on these 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 statements of cash flows consist of the following (in thousands):
Long-lived Assets The Company’s long-lived assets are comprised principally of its property and equipment and operating lease assets. The Company amortizes all finite lived intangible assets over their respective estimated useful lives. Operating lease assets are amortized over the term of the leases. In considering whether long-lived assets are impaired, the Company combines its intangible assets and other long-lived assets, into groupings, a determination which is made principally on the basis of whether the assets are specific to a particular test offered or technology being developed. If the Company identifies a change in the circumstances related to its long-lived assets that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Management’s estimates of future cash flows are impacted by projected test volume and levels of reimbursement, as well as expectations related to the future cost structure of the entity. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value, and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. Revenue Recognition Substantially all of the Company's revenue has been derived from sales of its testing products and is primarily comprised of a high volume of relatively low-dollar transactions. The Company primarily markets its testing products to rheumatologists and their physician assistants in the United States. The healthcare professionals who order the Company's testing products and to whom test results are reported are generally not responsible for payment for these products. The parties that pay for these services (each, a payor) consist of commercial payors (healthcare insurers), government payors (primarily Medicare and Medicaid), client payors (hospitals, other laboratories, etc.) and patient self-pay. The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606) and follows a five-step process to determine the amount and timing of revenue recognized: (1) identify the contract with the customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to performance obligations in the contract, and (5) recognize revenue when (or as) the performance obligation is satisfied. The Company's service is a single performance obligation that is completed upon the delivery of test results to the prescribing physician which triggers revenue recognition. Payors are generally billed at the Company's list price, unless a separate pricing contract is in place. Net revenues recognized consist of amounts billed net of allowances for differences between amounts billed and the estimated consideration the Company expects to receive from such payors. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. The Company follows a standard process, which considers historical denial and collection experience, insurance reimbursement policies and other factors, to estimate allowances and implicit price concessions. Adjustments are recorded in the current period as changes in estimates occur. Further adjustments to the allowances, based on actual receipts, are recorded upon settlement. Included in revenues for the three months ended March 31, 2024 and 2023 was a $2.5 million net revenue increase and a $0.3 million net revenue increase, respectively, associated with changes in estimated variable consideration related to performance obligations satisfied in previous periods. The transaction price is estimated using an expected value method on a portfolio basis. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. The Company's portfolios are grouped per payor (i.e. each individual commercial payor, Medicare, Medicaid, client payors, patient self-pay, etc.) and per test. Consideration may be constrained and excluded from the transaction price in situations where there is no contractually agreed upon reimbursement coverage or in absence of a predictable pattern and history of collectability with a payor. Accordingly, in such situations revenues are recognized on the basis of actual cash collections. Additionally, from time to time, the Company may issue refunds to payors for overpayments or amounts billed in error. Any refunds are accounted for as reductions in revenues in the statement of operations as an element of variable consideration. The estimated expected refunds are accrued as a liability on the Company’s balance sheet. Collection of the Company's net revenues from payors is normally a function of providing complete and correct billing information, along with any requested medical or other claims-related information to the healthcare insurers. This generally occurs within 30 to 90 days of billing, however, the amount and timing of any reimbursements or collections for our billed tests may vary by payor and other circumstances. Contracts do not contain significant financing components based on the typical period of time between performance of services and collection of consideration. Accounts Receivable and Allowance for Credit Losses We accrue an allowance for credit losses against our accounts receivable based on management’s current estimate of amounts that will not be collected. Management’s estimates are typically based on historical loss information adjusted for current conditions. We generally do not perform evaluations of the financial condition of our customers and generally do not require collateral. The allowance for credit losses was zero as of March 31, 2024 and 2023. Adjustments for implicit price concessions attributable to variable consideration, as discussed above, are incorporated into the measurement of the accounts receivable balances and are not part of the allowance for credit losses. 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; depreciation; amortization 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 for each of the three months ended March 31, 2024 and 2023. These costs 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 were approximately $0.8 million and $0.7 million for the three months ended March 31, 2024 and 2023, respectively. Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards to employees and directors based on the grant-date estimated fair values over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The fair value of stock options and purchases under the Company's 2019 Employee Stock Purchase Plan (ESPP) rights is determined using the Black-Scholes-Merton (BSM) option pricing model, which requires management to make certain assumptions regarding a number of complex and subjective variables. Equity award forfeitures are recorded as they occur. The BSM option pricing model incorporates various inputs, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. Volatility is based on the Company's historical calculated volatility since being publicly traded. The weighted-average expected term of options was calculated using the simplified method, as we have concluded that our stock option exercise history does not provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate for periods within the contractual term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is zero, as the Company has never declared or paid dividends and has no plans to do so in the foreseeable future. The fair value of each restricted stock unit (RSU) is determined on the grant date using the closing price of the Company's common stock on that date. The Company's RSUs generally vest in equal annual installments over four years from the date of grant or, for grants to new hires, date of hire. Vesting of the RSU is subject to the holder's continued service with the Company. The Company issues new shares of common stock to satisfy the RSUs upon vesting. Comprehensive Loss Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from transactions from nonowner sources. There have been no items qualifying as other comprehensive loss and, therefore, for all periods presented, the Company's comprehensive loss was the same as its reported net loss. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares used to compute basic and diluted shares includes shares issuable upon the exercise of pre-funded warrants at a nominal price. Potentially dilutive common stock equivalents are comprised of warrants for the purchase of common stock, stock options, RSUs outstanding under the Company's 2019 Incentive Award Plan (the 2019 Plan) and shares of the Company's common stock pursuant to the ESPP. For the three months ended March 31, 2024 and 2023, 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):
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, Accounting Standards Updates (ASU) not included in the Company’s disclosures were assessed and determined to be either not applicable or are not expected to have a material impact on the Company's financial statements or disclosures. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires public entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and details of how the CODM uses financial reporting to assess the performance of a segment. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. This ASU will likely result in additional required disclosure when adopted. The Company is currently evaluating the provisions of this ASU and the impact on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which requires additional income tax disclosures in the rate reconciliation table for federal, state and foreign income taxes, in addition to more details about the reconciling items in some categories when items meet a certain quantitative threshold. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect that it will have a material impact on its financial statements.
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Other Financial Information | Other Financial Information Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands):
Property and Equipment Property and equipment consist of the following (in thousands):
Depreciation and amortization expense for the three months ended March 31, 2024 and 2023 was approximately $0.5 million and $0.6 million, respectively. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands):
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Borrowings |
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Borrowings | Borrowings 2017 Term Loan In September 2017, the Company executed a term loan agreement (the 2017 Term Loan) with Innovatus Life Sciences Lending Fund I, LP (Innovatus), as amended (the Amended Loan Agreement), pursuant to which the Company borrowed $25.0 million. As of March 31, 2024, no additional amounts remained available to borrow under the Amended Loan Agreement. On April 28, 2023, the Company entered into the Amended Loan Agreement. The Amended Loan Agreement was treated as a modification. In connection with the Amended Loan Agreement, the Company repaid $10.0 million of the principal balance outstanding, for which the prepayment premium was waived. Pursuant to the Amended Loan Agreement, the interest rate on all borrowings under the Amended Loan Agreement is the sum (the Basic Rate) of (a) the greater of 8.0% or The Wall Street Journal prime rate (the Prime Rate), plus (b) 2.0%, which is paid-in-kind in the form of additional term loans (PIK Loans). Under the Amended Loan Agreement, an amount equal to 1.5% of the Basic Rate will be payable in-kind and capitalized to the principal amount of the outstanding term loan on a monthly basis until April 1, 2026, after which interest is scheduled to accrue at the Basic Rate. The maturity date of the loan was extended to December 31, 2026. The Company estimated the effective interest rate of this loan to be approximately 11.0% as of March 31, 2024. Accrued interest is due and payable monthly, unless the Company elects to pay paid-in-kind interest. The outstanding principal and accrued interest under the Amended Loan Agreement is to be repaid in ten equal monthly installments commencing in April 2026. Upon repayment of the final installment under the Amended Loan Agreement, the Company is required to pay an additional fee of $1.0 million. This obligation is being accreted into interest expense over the term of the loan using the effective interest method. For each of the three months ended March 31, 2024 and 2023, the Company issued PIK Loans totaling $0.1 million, all of which is included in borrowings-non-current portion on the accompanying balance sheet. The Amended Loan Agreement currently requires a prepayment premium of 1% of the aggregate outstanding principal for any prepayments made prior to November 1, 2024. The Amended Loan Agreement is collateralized by a first priority security interest in substantially all of the Company's assets, including intellectual property. The affirmative covenants of the Amended Loan Agreement 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, however the Company is not required to comply with the revenue covenant for any quarter during which it maintains a minimum aggregate cash balance equal to fifty percent of the aggregate principal amount of the Amended Loan Agreement (excluding any capitalized interest paid-in-kind) at all times during such quarter. The consequences of failing to achieve the performance covenants, when applicable, will be cured if, (i) within thirty days of failing to achieve the performance covenant, the Company submits a new financial plan approved by the Company's board of directors (the Board) to Innovatus under which the Company is expected to break even on a cash flow basis prior to the maturity date, and (ii) within thirty days of the submission of such financial plan, the Company issues additional equity securities or subordinated debt with net proceeds sufficient to fund any cash flow deficiency generated from operations, as defined in the Amended Loan Agreement. The Amended Loan Agreement requires that the Company maintain certain levels of minimum liquidity and maintains an unrestricted cash balance of $2.0 million. The negative covenants provide, among other things, that without the prior consent of Innovatus, subject to certain exceptions, the Company may not dispose of certain assets, engage in certain business combinations or acquisitions, incur additional indebtedness or encumber any of the Company's property, pay dividends on the Company's capital stock or make prohibited investments. The Amended Loan 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. As of March 31, 2024, the Company was in compliance with all covenants of the Amended Loan Agreement. Upon an event of default in any of the Amended Loan Agreement covenants, the repayment of the 2017 Term Loan may be accelerated, and the applicable interest rate will be increased by 4.0% until the default is cured. Although repayment of the 2017 Term Loan 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 Amended Loan Agreement due beyond twelve months of the balance sheet date as non-current. Equipment Notes Payable In May 2022, the Company purchased laboratory equipment using notes payable. At March 31, 2024, the total notes payable balance related to this financed equipment was $0.8 million, with $0.3 million classified within borrowings-current portion and $0.5 million within borrowings-non-current portion, net of discounts and debt issuance costs in the accompanying balance sheets. The financed equipment is subject to a 5.28% effective interest rate and will mature on October 1, 2026. In April 2024, the Company purchased additional laboratory equipment using notes payable in the amount of $0.7 million. Future Minimum Payments on the Outstanding Borrowings As of March 31, 2024, future minimum aggregate payments, including interest, for outstanding borrowings are as follows (in thousands):
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Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Licensing Agreements The Company has licensed technology for use in its diagnostic tests. In addition to the milestone payments required by these agreements, individual license agreements generally provide for ongoing royalty payments ranging from 1.5% to 7.0% on net sales of products which incorporate licensed technology, as defined in such agreements. Royalties are accrued when incurred and recorded in costs of revenue in the accompanying condensed statements of operations. Collaboration Obligations In May 2021, the Company entered into a master research collaboration agreement with Allegheny Health Network Research Institute (AHN), pursuant to which the Company is required to pay AHN a collaboration fee of $0.4 million per year. Collaboration expenses under the master research collaboration agreement were $0.1 million for each of the three months ended March 31, 2024 and 2023. Collaboration expenses under the AHN collaboration are included in research and development expenses. Supply Agreements In December 2021, the Company amended a supply agreement with one supplier for reagents which includes minimum annual purchase commitments of $8.0 million and $9.2 million for the years ending December 31, 2024 and 2025, respectively. Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications; including for subpoenas and other civil investigative demands, from governmental agencies, Medicare or Medicaid and managed care organizations reviewing billing practices or requesting comment on allegations of billing irregularities that are brought to their attention through billing audits or third parties. The Company's exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made or that the Company believes to be immaterial. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. Litigation From time to time, the Company may be subject to various legal proceedings that arise in the ordinary course of business activities. The Company does not believe the outcome of any such matters will have a material effect on its financial position or results of operations. In October 2023, the Company resolved an investigation with the U.S. Attorney’s Office for the District of Massachusetts that was initiated by a qui tam lawsuit. Pursuant to a settlement agreement entered into by and between the Company and the U.S. Department of Justice (the Settlement Agreement), the Company made a single lump-sum remittance to the government in the amount of $0.7 million in connection with specimen processing arrangements that Exagen historically had with physicians. The U.S. Attorney’s Office dismissed this “covered conduct” in the qui tam lawsuit with prejudice, while non-covered conduct was dismissed without prejudice. In November 2023 the complaint was unsealed and served on Exagen. Exagen filed a motion to dismiss the complaint. In December 2023, the Company's insurance carrier provided reimbursement for certain defense costs the Company incurred in the October 2023 qui tam lawsuit. In February 2024, the relator filed a motion for leave to amend the complaint. Exagen opposed this motion, and all motions are still pending. The Company intends to vigorously defend against the claims being asserted in the complaint. The Company's participation in federal healthcare programs is not affected by the Settlement Agreement.
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements The carrying value of the Company's cash, cash equivalents and restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued and other current liabilities approximate their fair values due to their short-term nature, which are determined to be a Level 1 measurement. The estimated fair value of the Company's long-term borrowings is determined by Level 2 inputs and based primarily on quoted market prices for the same or similar issues. As of March 31, 2024, the 2017 Term Loan had a carrying value of $18.8 million and a fair value of $19.3 million. As of December 31, 2023, the 2017 Term Loan had a carrying value of $18.7 million and a fair value of $19.7 million. The estimated fair value of the 2017 Term Loan was determined based on a discounted cash flow approach using available market information on discount and borrowing rates with similar terms, maturities, and credit ratings. The carrying value of the Company's other long-term borrowing at each of March 31, 2024 and December 31, 2023 was $0.8 million, and approximated its fair value. 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. Techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-levels of the valuation hierarchy for disclosure of fair value measurements are defined as follows: Level 1 - Unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 - Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 - Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The 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):
The fair value of the Company's money market funds is based on quoted market prices.
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Stockholders' Equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity | Stockholders' Equity Common Stock Shelf Registration Statement On November 17, 2023, the Company filed a registration statement on Form S-3, as amended (the 2023 Shelf Registration Statement), covering the offering, from time to time, of up to $150.0 million of common stock, preferred stock, debt securities, warrants and units. The 2023 Shelf Registration Statement became effective on November 29, 2023, and all $150.0 million remain available for sale as of March 31, 2024. At The Market Sales Agreement On September 15, 2022, the Company entered into a sales agreement, as amended on November 17, 2023 (the Sales Agreement) with Cowen and Company, LLC, as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of Company common stock having an aggregate offering price of up to $50.0 million. The Company is not obligated to sell any shares of Company common stock in the offering. As of March 31, 2024, the Company has not sold any shares of its common stock pursuant to the Sales Agreement. Outstanding Warrants The following equity classified warrants to purchase common stock were outstanding as of March 31, 2024:
During the three months ended March 31, 2024, no warrants to purchase common stock were exercised.
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Stock Option Plan |
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Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Option Plan | Stock Option Plan 2019 Incentive Award Plan In September 2019, the Board adopted, and the Company's stockholders approved, the 2019 Plan. Under the 2019 Plan, which expires in September 2029, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs 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 and is generally four years from the date of grant or, for grants to new hires, date of hire. The 2019 Plan contains an "evergreen provision" that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2029 in an amount equal to the lesser of: (i) 4% of the outstanding capital stock on each December 31st, or (ii) such lesser amount determined by the Board. As of March 31, 2024, 1,959,901 shares of common stock remained available for future awards under the 2019 Plan. Restricted Stock Units RSU activity under the Company's 2019 Plan is set forth below:
As of March 31, 2024, all of the outstanding RSUs were unvested. The fair value of RSUs vested in the three months ended March 31, 2024 and 2023 was $0.4 million and $0.3 million, respectively. The weighted average grant date fair value for RSUs granted in the three months ended March 31, 2024 and 2023 was $1.95 and $2.30, respectively. As of March 31, 2024, total unrecognized compensation cost related to RSUs was $4.6 million, which is expected to be recognized over a remaining weighted-average vesting period of 3.2 years. Stock Options Stock option activity under the 2019 Plan is set forth below:
There were no stock options granted in each of the three months ended March 31, 2024 and 2023. The intrinsic value is calculated as the difference between the fair value of the Company's common stock and the exercise price of the stock options. The aggregate intrinsic value of options exercised during the three months ended March 31, 2024 was negligible. The aggregate intrinsic value of options exercised during the three months ended March 31, 2023 was $0.2 million. As of March 31, 2024, total unrecognized compensation cost related to option awards was $0.1 million, which is expected to be recognized over a remaining weighted-average vesting period of 0.53 years. 2019 Employee Stock Purchase Plan In September 2019, the Board adopted, and the Company's stockholders approved, the ESPP. The ESPP became effective on the day the ESPP was adopted by the Board. The ESPP permits participants to purchase common stock through payroll deductions of up to 20% of their eligible compensation. The number of shares of common stock available for issuance under the ESPP will be annually increased on the first day of each calendar year during the term of the ESPP through January 1, 2029 in an amount equal to the lesser of (i) 1% of the outstanding capital stock on each December 31st, or (ii) such lesser amount determined by the Board. As of March 31, 2024, 565,187 shares of common stock remained available for issuance under the ESPP. Stock-Based Compensation Expense Total non-cash stock-based compensation expense recorded related to options granted, RSUs granted and stock purchase rights granted under the ESPP in the condensed statements of operations is as follows (in thousands):
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Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | |
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Mar. 31, 2024 |
Mar. 31, 2023 |
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Pay vs Performance Disclosure | ||
Net loss | $ (3,360) | $ (7,688) |
Insider Trading Arrangements |
3 Months Ended |
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Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
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Mar. 31, 2024 | |
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. The Company has not experienced any losses on its cash or cash equivalents.
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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 of three months or less upon acquisition to be cash equivalents. These investments are stated at cost, which approximates fair value.
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Long-lived Assets | Long-lived Assets The Company’s long-lived assets are comprised principally of its property and equipment and operating lease assets. The Company amortizes all finite lived intangible assets over their respective estimated useful lives. Operating lease assets are amortized over the term of the leases. In considering whether long-lived assets are impaired, the Company combines its intangible assets and other long-lived assets, into groupings, a determination which is made principally on the basis of whether the assets are specific to a particular test offered or technology being developed. If the Company identifies a change in the circumstances related to its long-lived assets that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Management’s estimates of future cash flows are impacted by projected test volume and levels of reimbursement, as well as expectations related to the future cost structure of the entity. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value, and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense.
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Revenue Recognition | Revenue Recognition Substantially all of the Company's revenue has been derived from sales of its testing products and is primarily comprised of a high volume of relatively low-dollar transactions. The Company primarily markets its testing products to rheumatologists and their physician assistants in the United States. The healthcare professionals who order the Company's testing products and to whom test results are reported are generally not responsible for payment for these products. The parties that pay for these services (each, a payor) consist of commercial payors (healthcare insurers), government payors (primarily Medicare and Medicaid), client payors (hospitals, other laboratories, etc.) and patient self-pay. The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606) and follows a five-step process to determine the amount and timing of revenue recognized: (1) identify the contract with the customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to performance obligations in the contract, and (5) recognize revenue when (or as) the performance obligation is satisfied. The Company's service is a single performance obligation that is completed upon the delivery of test results to the prescribing physician which triggers revenue recognition. Payors are generally billed at the Company's list price, unless a separate pricing contract is in place. Net revenues recognized consist of amounts billed net of allowances for differences between amounts billed and the estimated consideration the Company expects to receive from such payors. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. The Company follows a standard process, which considers historical denial and collection experience, insurance reimbursement policies and other factors, to estimate allowances and implicit price concessions. Adjustments are recorded in the current period as changes in estimates occur. Further adjustments to the allowances, based on actual receipts, are recorded upon settlement. Included in revenues for the three months ended March 31, 2024 and 2023 was a $2.5 million net revenue increase and a $0.3 million net revenue increase, respectively, associated with changes in estimated variable consideration related to performance obligations satisfied in previous periods. The transaction price is estimated using an expected value method on a portfolio basis. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. The Company's portfolios are grouped per payor (i.e. each individual commercial payor, Medicare, Medicaid, client payors, patient self-pay, etc.) and per test. Consideration may be constrained and excluded from the transaction price in situations where there is no contractually agreed upon reimbursement coverage or in absence of a predictable pattern and history of collectability with a payor. Accordingly, in such situations revenues are recognized on the basis of actual cash collections. Additionally, from time to time, the Company may issue refunds to payors for overpayments or amounts billed in error. Any refunds are accounted for as reductions in revenues in the statement of operations as an element of variable consideration. The estimated expected refunds are accrued as a liability on the Company’s balance sheet. Collection of the Company's net revenues from payors is normally a function of providing complete and correct billing information, along with any requested medical or other claims-related information to the healthcare insurers. This generally occurs within 30 to 90 days of billing, however, the amount and timing of any reimbursements or collections for our billed tests may vary by payor and other circumstances. Contracts do not contain significant financing components based on the typical period of time between performance of services and collection of consideration.
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Accounts Receivable and Allowance for Credit Losses | Accounts Receivable and Allowance for Credit Losses We accrue an allowance for credit losses against our accounts receivable based on management’s current estimate of amounts that will not be collected. Management’s estimates are typically based on historical loss information adjusted for current conditions. We generally do not perform evaluations of the financial condition of our customers and generally do not require collateral. The allowance for credit losses was zero as of March 31, 2024 and 2023. Adjustments for implicit price concessions attributable to variable consideration, as discussed above, are incorporated into the measurement of the accounts receivable balances and are not part of the allowance for credit losses.
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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; depreciation; amortization and allocated overhead, including rent and utilities.
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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 for each of the three months ended March 31, 2024 and 2023. These costs are included in selling, general and administrative expenses in the accompanying condensed statements of operations.
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Shipping and Handling Costs | Shipping and Handling Costs Costs incurred for shipping and handling are included in costs of revenue in the accompanying condensed statements of operations
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Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards to employees and directors based on the grant-date estimated fair values over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The fair value of stock options and purchases under the Company's 2019 Employee Stock Purchase Plan (ESPP) rights is determined using the Black-Scholes-Merton (BSM) option pricing model, which requires management to make certain assumptions regarding a number of complex and subjective variables. Equity award forfeitures are recorded as they occur. The BSM option pricing model incorporates various inputs, including the fair value of the Company's common stock, expected volatility, expected term and risk-free interest rates. Volatility is based on the Company's historical calculated volatility since being publicly traded. The weighted-average expected term of options was calculated using the simplified method, as we have concluded that our stock option exercise history does not provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate for periods within the contractual term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is zero, as the Company has never declared or paid dividends and has no plans to do so in the foreseeable future. The fair value of each restricted stock unit (RSU) is determined on the grant date using the closing price of the Company's common stock on that date. The Company's RSUs generally vest in equal annual installments over four years from the date of grant or, for grants to new hires, date of hire. Vesting of the RSU is subject to the holder's continued service with the Company. The Company issues new shares of common stock to satisfy the RSUs upon vesting.
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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.
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Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. The weighted-average number of shares used to compute basic and diluted shares includes shares issuable upon the exercise of pre-funded warrants at a nominal price. Potentially dilutive common stock equivalents are comprised of warrants for the purchase of common stock, stock options, RSUs outstanding under the Company's 2019 Incentive Award Plan (the 2019 Plan) and shares of the Company's common stock pursuant to the ESPP. For the three months ended March 31, 2024 and 2023, 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.
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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.
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Recent Accounting Pronouncements and 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, Accounting Standards Updates (ASU) not included in the Company’s disclosures were assessed and determined to be either not applicable or are not expected to have a material impact on the Company's financial statements or disclosures. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires public entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and details of how the CODM uses financial reporting to assess the performance of a segment. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. This ASU will likely result in additional required disclosure when adopted. The Company is currently evaluating the provisions of this ASU and the impact on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which requires additional income tax disclosures in the rate reconciliation table for federal, state and foreign income taxes, in addition to more details about the reconciling items in some categories when items meet a certain quantitative threshold. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect that it will have a material impact on its financial statements.
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Fair Value Measurements | The carrying value of the Company's cash, cash equivalents and restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued and other current liabilities approximate their fair values due to their short-term nature, which are determined to be a Level 1 measurement. The estimated fair value of the Company's long-term borrowings is determined by Level 2 inputs and based primarily on quoted market prices for the same or similar issues. As of March 31, 2024, the 2017 Term Loan had a carrying value of $18.8 million and a fair value of $19.3 million. As of December 31, 2023, the 2017 Term Loan had a carrying value of $18.7 million and a fair value of $19.7 million. The estimated fair value of the 2017 Term Loan was determined based on a discounted cash flow approach using available market information on discount and borrowing rates with similar terms, maturities, and credit ratings. The carrying value of the Company's other long-term borrowing at each of March 31, 2024 and December 31, 2023 was $0.8 million, and approximated its fair value. 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. Techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-levels of the valuation hierarchy for disclosure of fair value measurements are defined as follows: Level 1 - Unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 - Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 - Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
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Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Concentration of Risk, by Risk Factor and Significant Payer | For each significant payor and customer, revenue as a percentage of total revenue and accounts receivable as a percentage of total accounts receivable are as follows:
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Disaggregation of Revenue | The following table includes the Company's revenues as disaggregated by payor and customer category (in thousands):
(1)Includes hospitals, other laboratories, etc. (2)Includes patient self-pay.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents | Cash, cash equivalents, and restricted cash presented in the accompanying statements of cash flows consist of the following (in thousands):
|
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Schedule of Restricted Cash and Cash Equivalents | Cash, cash equivalents, and restricted cash presented in the accompanying statements of cash flows consist of the following (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
|
Other Financial Information (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Financial Information [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands):
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Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following (in thousands):
|
Borrowings (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Aggregate Payments for Outstanding Borrowings | As of March 31, 2024, future minimum aggregate payments, including interest, for outstanding borrowings are as follows (in thousands):
|
Fair Value Measurements (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
|
Stockholders' Equity (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Outstanding Warrants | The following equity classified warrants to purchase common stock were outstanding as of March 31, 2024:
|
Stock Option Plan (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restricted Stock Unit Activity | RSU activity under the Company's 2019 Plan is set forth below:
|
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Schedule of Stock Option Activity | Stock option activity under the 2019 Plan is set forth below:
|
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Schedule of Non-Cash Stock-Based Compensation Expense | Total non-cash stock-based compensation expense recorded related to options granted, RSUs granted and stock purchase rights granted under the ESPP in the condensed statements of operations is as follows (in thousands):
|
Organization (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 27,267 | $ 36,493 |
Accumulated deficit | $ 282,576 | $ 279,216 |
Summary of Significant Accounting Policies - Revenue by Major Payers (Details) - Customer Concentration Risk |
3 Months Ended | 12 Months Ended | |
---|---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
|
Medicare | Revenue | |||
Disaggregation of Revenue [Line Items] | |||
Percent of total revenue | 29.00% | 39.00% | |
Medicare | Accounts Receivable, Net | |||
Disaggregation of Revenue [Line Items] | |||
Percent of total revenue | 33.00% | 42.00% | |
Medicare Advantage | Revenue | |||
Disaggregation of Revenue [Line Items] | |||
Percent of total revenue | 17.00% | 16.00% | |
Medicare Advantage | Accounts Receivable, Net | |||
Disaggregation of Revenue [Line Items] | |||
Percent of total revenue | 23.00% | 16.00% | |
United Healthcare | Revenue | |||
Disaggregation of Revenue [Line Items] | |||
Percent of total revenue | 10.00% |
Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2024
USD ($)
segment
|
Mar. 31, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
|
New Accounting Pronouncement, Early Adoption [Line Items] | |||
Restricted cash | $ 200 | $ 200 | |
Revenue recognized in previous periods | 2,500 | $ 300 | |
Advertising expense | $ 300 | 300 | |
Number of operating segments | segment | 1 | ||
Restricted stock units | |||
New Accounting Pronouncement, Early Adoption [Line Items] | |||
Stock options, vesting period | 4 years | ||
Shipping and Handling | |||
New Accounting Pronouncement, Early Adoption [Line Items] | |||
Cost of revenue | $ 800 | $ 700 | |
Revenue | Product Concentration Risk | AVISE CTD Test | |||
New Accounting Pronouncement, Early Adoption [Line Items] | |||
Percent of total revenue | 90.00% | 87.00% | |
Revenue | Supplier Concentration Risk | Two Major Suppliers | |||
New Accounting Pronouncement, Early Adoption [Line Items] | |||
Percent of total revenue | 92.00% | 97.00% |
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 14,415 | $ 11,230 |
Commercial | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 6,863 | 4,215 |
Government | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 4,186 | 4,426 |
Client | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 3,284 | 2,407 |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 82 | $ 182 |
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|---|---|
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 27,267 | $ 36,493 | ||
Restricted cash | 200 | 200 | ||
Total cash, cash equivalents and restricted cash | $ 27,467 | $ 36,693 | $ 52,384 | $ 62,591 |
Summary of Significant Accounting Policies - Securities (Details) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 3,130,071 | 2,937,005 |
Warrants to purchase common stock | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 409,108 | 409,108 |
Common stock options | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 928,900 | 1,019,076 |
Restricted stock units | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 1,781,040 | 1,494,085 |
Employee stock purchase plan | ||
Class of Stock [Line Items] | ||
Anti-dilutive securities excluded from computation (in shares) | 11,023 | 14,736 |
Other Financial Information - Prepaid Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Other Financial Information [Abstract] | ||
Diagnostic testing supplies | $ 2,100 | $ 2,871 |
Prepaid product royalties | 34 | 35 |
Prepaid maintenance and insurance contracts | 2,077 | 1,860 |
Other prepaid expenses and other current assets | 21 | 31 |
Prepaid expenses and other current assets | $ 4,232 | $ 4,797 |
Other Financial Information - Property and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 10,444 | $ 10,970 |
Less: accumulated depreciation and amortization | (5,669) | (5,769) |
Property and equipment, net | 4,775 | 5,201 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 98 | 98 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 4,901 | 5,312 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,073 | 2,185 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 3,316 | 3,316 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 56 | $ 59 |
Other Financial Information - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Other Financial Information [Abstract] | ||
Depreciation and amortization | $ 0.5 | $ 0.6 |
Other Financial Information - Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Other Financial Information [Abstract] | ||
Accrued payroll and related expenses | $ 3,711 | $ 4,738 |
Accrued interest | 140 | 139 |
Accrued purchases of goods and services | 634 | 720 |
Accrued royalties | 219 | 463 |
Accrued clinical study activity | 0 | 118 |
Finance lease obligations, current portion | 438 | 490 |
Refund liability | 311 | 302 |
Other accrued liabilities | 587 | 561 |
Accrued and other current liabilities | $ 6,040 | $ 7,531 |
Borrowings - Future Minimum Payments (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Debt Disclosure [Abstract] | ||
2024 (remaining) | $ 1,466 | |
2025 | 1,974 | |
2026 | 21,243 | |
Total | 24,683 | |
Unamortized debt discount and issuance costs | (103) | |
Interest | (5,043) | |
Total borrowings, net of discounts and debt issuance costs | 19,537 | |
Less: Borrowings-current portion | (268) | $ (264) |
Borrowings-non-current portion, net of discounts and debt issuance costs | $ 19,269 | $ 19,231 |
Commitment and Contingencies (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |||
---|---|---|---|---|---|
Oct. 31, 2023 |
May 31, 2021 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2021 |
|
Loss Contingencies [Line Items] | |||||
Purchase obligation, due in third year | $ 8,000 | ||||
Purchase obligation, due in fourth year | $ 9,200 | ||||
U.S. Department Of Justice Case | Settled Litigation | |||||
Loss Contingencies [Line Items] | |||||
Settlement payment | $ 700 | ||||
AHN Collaboration | |||||
Loss Contingencies [Line Items] | |||||
Collaboration agreement, collaboration expenses | $ 100 | $ 100 | |||
Allegheny Health Network Research Institute | |||||
Loss Contingencies [Line Items] | |||||
Collaboration fee | $ 400 | ||||
Minimum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 1.50% | ||||
Maximum | Licensing Agreements | |||||
Loss Contingencies [Line Items] | |||||
Royalty obligation, percent of net sales | 7.00% |
Stockholders' Equity - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Sep. 15, 2022 |
Mar. 31, 2024 |
Nov. 17, 2023 |
|
Class of Stock [Line Items] | |||
Exercise of common stock warrants (in shares) | 0 | ||
Cowen Equity Distribution Agreement | |||
Class of Stock [Line Items] | |||
Proceeds from sale of stock | $ 50,000 | ||
Shelf Registration Statement | |||
Class of Stock [Line Items] | |||
Common stock offering, authorized amount | $ 150,000 | ||
Common stock offering, remaining authorized amount | $ 150,000 |
Stock Option Plan - Restricted Stock Units (Details) - Restricted stock units - $ / shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Number of Shares | ||
Outstanding, beginning of period (in shares) | 1,387,459 | |
Awards granted (in shares) | 781,875 | |
Awards released (in shares) | (217,056) | |
Awards canceled (in shares) | (171,238) | |
Outstanding, end of period (in shares) | 1,781,040 | |
Weighted- Average Grant Date Fair Value | ||
Outstanding, beginning of period (in dollars per share) | $ 4.24 | |
Awards granted (in dollars per share) | 1.95 | $ 2.30 |
Awards released (in dollars per share) | 5.76 | |
Awards canceled (in dollars per share) | 5.05 | |
Outstanding, end of period (in dollars per share) | $ 2.97 |
Stock Option Plan - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 553 | $ 986 |
Costs of revenue | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 17 | 53 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 479 | 831 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 57 | $ 102 |
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