EXAGEN INC. 10-K

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and financial performance, includes forward-looking statements that are based on current beliefs, plans and expectations and involve risks, uncertainties and assumptions. You should read the "Special note regarding forward-looking statements" and "Risk Factors" section of this Annual Report on Form 10-K for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Overview We are dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases by enabling timely differential diagnosis and optimizing therapeutic intervention. We have developed and are commercializing a portfolio of innovative testing products under our AVISE ® brand, several of which incorporate CB-CAPs technology. Our goal is to enable healthcare providers to improve care for patients through the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases, including SLE and RA. We market our testing products under our AVISE ® brand that allow for the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases. Our lead testing product, AVISE ® CTD, enables differential diagnosis for patients presenting with symptoms indicative of a wide variety of CTDs and other related diseases with overlapping symptoms. We commercially launched AVISE ® CTD in 2012 and revenue from this product comprised 84% and 81% of our revenue for the years ended December 31, 2022 and 2021, respectively. There is an unmet need for rheumatologists to add clarity in their CTD clinical evaluation, and we believe there is a significant opportunity for our tests that enable the differential diagnosis of these diseases, particularly for potentially life-threatening diseases such as SLE. We perform all of our AVISE ® tests in our approximately 13,000 square foot laboratory, which is certified by CLIA and accredited by CAP, and located in Vista, California. Our laboratory is certified for performance of high-complexity testing by CMS in accordance with CLIA and is licensed by all states requiring out-of-state licensure. Our clinical laboratory typically reports all AVISE ® testing product results within five business days. We market our AVISE ® testing products using our specialized sales force covering 40 territories in the United States. Unlike many diagnostic sales forces that are trained only to understand the comparative benefits of their tests, the specialized backgrounds of our sales force coupled with our comprehensive training enables our sales representatives to interpret results from our de-identified patient test reports and provide unique insights in a highly tailored discussion with rheumatologists. Reimbursement for our testing services comes from several sources, including commercial payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid, and patients. Reimbursement rates vary by product and payor. Since inception we have devoted substantially all of our efforts developing and marketing products for the diagnosis, prognosis and monitoring of autoimmune diseases. We have never been profitable and, as of December 31, 2022 we had an accumulated deficit of $255.5 million. We have funded our operations primarily through equity and debt financings and revenue from sales of our products. We incurred net losses of $47.4 million and $26.9 million for the years ended December 31, 2022 and 2021, respectively and we expect to continue to incur operating losses in the near term. We completed our initial public offering (IPO) in September 2019, raising net proceeds from the offering of approximately $50.4 million. In March 2021, we completed a public offering of shares of our common stock for net proceeds of approximately $64.7 million. As of December 31, 2022, we had $62.4 million of cash and cash equivalents. Management Change In October 2022, we appointed a new President and Chief Executive Officer of the Company (the Change in Management). In connection with the Change in Management, in the fourth quarter of 2022, we began to update our strategy and implement cost savings and other initiatives. We are continuing the process of evaluating our operations, test offerings, research and development pursuits and facilities footprint, among other aspects of our business strategy. 72 Factors Affecting Our Performance We believe there are several important factors that have impacted, and that we expect will impact, our operating performance and results of operations, including: ▪ Reimbursement for Our Testing Products . Our revenue depends on achieving broad coverage and reimbursement for our tests from third-party payors, including both commercial and government payors, such as Medicare and Medicaid. Payment from third-party payors differs depending on whether we have entered into a contract with the payors as a "participating provider" or do not have a contract and are considered a "non-participating provider." Payors will often reimburse non-participating providers, if at all, at a lower amount than participating providers. We have received a substantial portion of our revenue from a limited number of commercial payors, most of which have not contracted with us to be a participating provider. In addition to the challenges described under the heading "Financial Overview" below, historically, we have experienced situations where commercial payors proactively reduced the amounts they were willing to reimburse for our tests, and in other situations, commercial payors have determined that the amounts they previously paid were too high and have sought to recover those perceived excess payments by deducting such amounts from payments otherwise being made. When we contract to serve as a participating provider, reimbursements are made pursuant to a negotiated fee schedule and are limited to only covered indications. If we are not able to obtain or maintain coverage and adequate reimbursement from third-party payors, we may not be able to effectively increase our testing volume and revenue as expected. Additionally, retrospective reimbursement adjustments can negatively impact our revenue and cause our financial results to fluctuate. ▪ Continued Growth of Our Testing Products. Since the launch of AVISE ® CTD in 2012 and through December 31, 2022, we have delivered approximately 750,000 of these tests. For the year ended December 31, 2022, 135,210 AVISE ® CTD tests were delivered, representing approximately 5% growth over the same period in 2021. The number of ordering healthcare providers in the fourth quarter of 2022 was a record 2,419, representing an approximate 14% increase over the same period in 2021. Revenue growth for our testing products will depend on our ability to continue to expand our base of ordering healthcare providers and increase our penetration with existing healthcare providers. ▪ Synergistic Partnerships . In August 2021, we mutually agreed to terminate the Janssen Agreement regarding our promotion efforts with SIMPONI ® effective August 31, 2021. Our SIMPONI ® promotion efforts contributed no revenue and $1.2 million in revenue for the years ended December 31, 2022 and 2021, respectively. We will continue to rely on our existing testing products to drive revenue growth. ▪ Development of Additional Testing Products. We rely on sales of our AVISE ® CTD test to generate the significant majority of our revenue. We expect to continue to invest in research and development in order to develop additional testing products. Our success in developing new testing products will be important in our efforts to grow our business by expanding the potential market for our testing products and diversifying our sources of revenue. ▪ Maintain Meaningful Margin . We seek to maintain meaningful margin through a continued focus on increasing operating leverage through the implementation of certain internal initiatives, such as leveraging validation, utility and reimbursement oriented clinical studies to facilitate payor coverage of our testing products. We plan to increase focus on long-term reimbursement and ASP growth and seek to improve our per test costs by focusing on profitable, core test offerings and reducing fixed costs and overhead. ▪ Timing of Our Research and Development Expenses . Our spending on experiments and clinical studies may vary substantially from quarter to quarter. We also expend funds to secure clinical samples that can be used in discovery, product development, clinical validation, utility and outcome studies. The timing of these research and development activities is difficult to predict. If a substantial number of clinical samples are obtained in a given quarter or if a high-cost experiment is conducted in one quarter versus the next, the timing of these expenses will affect our financial results. We conduct clinical studies to validate our new testing products, as well as ongoing clinical and outcome studies to further expand the published evidence to support our commercialized AVISE ® testing products. Spending on research and development for both experiments and studies may vary significantly by quarter depending on the timing of these various expenses. ▪ How We Recognize Revenue . We record revenue on an accrual basis, using an estimate of the amount we will ultimately realize, as determined based on a historical analysis of amounts collected by test and by payor, among other factors. Changes to such estimates may increase or decrease revenue recognized in future periods. 73 While each of these areas present significant opportunities for us, they also pose significant risks and challenges that we must address. We discuss many of these risks, uncertainties and other factors in the section entitled "Risk Factors." Impact of COVID-19 In January 2023, the Biden administration announced plans to end the national emergencies for addressing COVID-19 on May 11, 2023. The full extent to which the COVID-19 pandemic may directly or indirectly continue to impact our business, results of operations and financial condition remains dependent on future developments that are highly uncertain. We have implemented business continuity plans designed to address the COVID-19 pandemic and minimize disruptions to ongoing operations. Janssen Promotion Agreement In December 2018, we entered into the Janssen Agreement, under which we were responsible for the costs associated with our sales force in promoting SIMPONI ® in the United States. In August 2021, we and Janssen mutually agreed to terminate the Janssen Agreement effective August 31, 2021. Pursuant to the terms of the termination, we were restricted from promoting any other biologic or Janus kinase inhibitor used for treatment of indications covered by the Janssen Agreement without first obtaining Janssen's written consent until May 31, 2022. For the year ended December 31, 2021, we recognized approximately $1.2 million in revenue for our promotional efforts under the Janssen Agreement. No revenue from the Janssen Agreement was recognized for the year ended December 31, 2022. Seasonality Based on our experience to date, we expect some seasonal variations in our financial results due to a variety of factors. Some of these factors include the year-end holiday period and other major holidays, vacation patterns of both patients and healthcare providers (including medical conferences), climate and weather conditions in our markets (for example, excess sun exposure can cause flares in SLE), seasonal conditions that may affect medical practices and provider activity (for example influenza outbreaks that may reduce the percentage of patients that can be seen) and other factors relating to the timing of patient benefit changes, as well as patient deductibles and co-insurance limits. Inflationary Environment The current inflationary environment has resulted in higher prices, which have impacted our costs incurred to generate revenue from our laboratory testing services, costs to attract and retain personnel, and other operating costs. The severity and duration of the current inflationary environment remains uncertain and may continue to impact our financial condition and results of operations. Financial Overview Revenue We recognize revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers. We record revenue on an accrual basis, using an estimate of the amount we will ultimately receive, as determined based on a historical analysis of amounts collected by test and by payor, among other factors. These assessments require significant judgment by management. To date, we have derived nearly all of our revenue from the sale of our testing products, most of which is attributable to our AVISE ® CTD test. We primarily market our testing products to rheumatologists in the United States. The rheumatologists who order our testing products and to whom results are reported are generally not responsible for payment for these products. The parties that pay for these services (payors) consist of commercial payors (e.g. insurance companies, health maintenance organizations, etc.), government payors (primarily Medicare and Medicaid), client payors (e.g. hospitals, other laboratories, etc.), and patient self-pay. Our service is completed upon the delivery of test results to the prescribing rheumatologists which triggers billing for the service. Our ability to increase our revenue will depend on our ability to further penetrate the market for our current and future testing products, and increase our reimbursement and collection rates for tests delivered. In the quarter ended March 31, 2022, CMS agreed, effective April 1, 2022, to recognize a new PLA code for our protein-based test, AVISE ® Lupus. Noridian, our MAC, priced this PLA code at $1,085 per test. To determine pricing 74 beyond 2022, CMS recommended crosswalking AVISE ® Lupus (0312U) to Vectra (81490) at a rate of $840.65 per test. This pricing was finalized on the 2023 CLFS and is effective from January 1, 2023 through December 31, 2025. The process for obtaining and maintaining consistent reimbursement for new tests can be uncertain, lengthy and time consuming. A pricing determination is not synonymous with a coverage determination. Having a price associated with the PLA code for any particular test does not secure coverage or reimbursement for that PLA code from Medicare or any other third-party payor. In an effort to improve transparency regarding Medicare support of AVISE ® Lupus, on July 29, 2022, we submitted a formal request to Noridian for coverage of our AVISE ® Lupus test under the new PLA Code. On September 27, 2022, we received notice that Noridian has deemed our application for an LCD to be valid. Ultimately receiving a favorable LCD is uncertain and may be time-consuming, resource intensive and require multiple quarterly or annual periods to complete. In the meantime, we will continue to submit Medicare claims for AVISE ® Lupus, appeal denials and respond to requests for additional information. We face challenges relating to commercial payor claim processing and revenue. Now that we are billing under our PLA code, we are experiencing an increase in denials due to unfavorable medical policy with certain plans, and we expect this situation to persist. Operating Expenses Costs of Revenue Costs of revenue represents the expenses associated with obtaining and testing patient specimens. The components of our costs of revenue include materials costs, direct labor, equipment and infrastructure expenses associated with testing specimens, shipping charges to transport specimens, blood specimen collections fees, royalties, depreciation and allocated overhead, including rent and utilities. Each payor, whether commercial, government, or individual, reimburses us at different amounts. These differences can be significant. As a result, our costs of revenue as a percentage of revenue may vary significantly from period to period due to the composition of payors for each period's billings. We expect that our costs of revenue will increase in the near-term as test volume increases. Selling, General and Administrative Expenses Selling, general and administrative expenses consist of personnel costs, including stock-based compensation expense, direct marketing expenses, accounting and legal expenses, consulting costs, and allocated overhead including rent, information technology, depreciation and utilities. We expect that our selling, general and administrative expenses will decrease in the near-term as a result of cost saving initiatives which began in the fourth quarter of 2022. Research and Development Expenses Research and development expenses include costs incurred to develop our technology, test products and product candidates, in addition to costs incurred to collect clinical specimens and conduct clinical studies to develop and support those products and product candidates. These costs consist of personnel costs, including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. We expense all research and development costs in the periods in which they are incurred. We expect that our research and development expenses will decrease in the near-term as a result of cost saving initiatives which began in the fourth quarter of 2022. Interest Expense Interest expense consists of cash and non-cash interest expense associated with our financing arrangements, including the borrowings under our amended loan and security agreement with Innovatus. We expect interest expense to remain consistent in 2023 as compared to 2022. Interest Income Interest income consists of interest income earned on our cash and cash equivalents. 75 Income Tax (Expense) Benefit Income taxes include federal and state income taxes in the United States. Results of Operations Comparison of the Years Ended December 31, 2022 and 2021: Years Ended December 31, Change 2022 2021 (in thousands) Revenue $ 45,563 $ 48,299 $ (2,736) Operating expenses: Costs of revenue 24,214 20,588 3,626 Selling, general and administrative expenses 52,018 44,541 7,477 Research and development expenses 9,876 7,237 2,639 Goodwill impairment 5,506 — 5,506 Total operating expenses 91,614 72,366 19,248 Loss from operations (46,051) (24,067) (21,984) Interest expense (2,448) (2,625) 177 Interest income 830 16 814 Loss before income taxes (47,669) (26,676) (20,993) Income tax expense 282 (175) 457 Net loss $ (47,387) $ (26,851) $ (20,536) Revenue Revenue decreased $2.7 million, or 5.7%, for the year ended December 31, 2022 compared to the year ended December 31, 2021, primarily due to the $1.2 million reduction of revenue from the Janssen Agreement and a decrease in ASP, partially offset by increases in volume. The number of AVISE ® CTD tests delivered increased to 135,210 in the year ended December 31, 2022 compared to 128,246 tests delivered in the same 2021 period. The AVISE ® CTD test accounted for 84% and 81% of revenue for the years ended December 31, 2022 and 2021, respectively. The number of ordering healthcare providers increased to 2,419 for the three months ended December 31, 2022 compared to 2,126 in the same 2021 period. Costs of Revenue Costs of revenue increased $3.6 million, or 17.6%, for the year ended December 31, 2022 compared to the year ended December 31, 2021. This increase was primarily due to increases of $1.4 million in labor costs, $0.8 million in materials and supplies expenses, $0.6 million in shipping and handling costs associated with the increase in test volume and inflationary pressures in 2022 compared to 2021, and $0.6 million in overhead costs related to our expanded clinical laboratory. Gross margin as a percentage of revenue decreased to 46.9% for the year ended December 31, 2022, compared to 57.4% for the year ended December 31, 2021. This was primarily attributable to decreases in revenue and increased costs, as described above. Selling, General and Administrative Expenses Selling, general and administrative expenses increased $7.5 million, or 16.8%, for the year ended December 31, 2022 compared to the year ended December 31, 2021. This increase was primarily due to an increase of $4.5 million of personnel costs, including salaries, benefits, other reimbursable employee expenses and severance expenses, in addition to increases related to marketing expenses of $1.3 million, facilities and allocated overhead of $0.7 million, legal expenses of $0.6 million, professional service fees of $0.6 million, public company expenses of $0.2 million and third-party billing expenses of $0.2 million. These increases were partially offset by decreases in expenses related to employee bonuses of $1.0 million. Research and Development Expenses 76 Research and development expenses increased $2.6 million, or 36.5%, for the year ended December 31, 2022 compared to the year ended December 31, 2021. The increase was primarily due to an increase of $1.8 million of personnel costs, including salaries, benefits and severance expenses, increases related to lab supplies of $0.8 million, facilities and allocated overhead of 0.6 million and a long-lived assets impairment charge of $0.4 million. These increases were partially offset by decreases in expenses related to clinical studies of $0.6 million, collaboration expenses of $0.3 million and employee bonuses of $0.2 million. Goodwill Impairment As part of our annual goodwill impairment assessment in the fourth quarter of 2022, we determined that the sustained decrease in our market capitalization constituted an indicator of impairment and as a result, a quantitative goodwill impairment test was completed as of December 31, 2022. This analysis identified an impairment of $5.5 million related to our goodwill. Interest Expense Interest expense decreased $0.2 million for the year ended December 31, 2022 compared to the year ended December 31, 2021 due to lower interest rates on the company's 2017 Term Loan. Interest Income Interest income increased $0.8 million for the year ended December 31, 2022 compared to the year ended December 31, 2021 due to higher money market interest rates in 2022 compared to 2021. Income Tax (Expense) Benefit Income tax expense increased $0.5 million for the year ended December 31, 2022 compared to the year ended December 31, 2021 due to a change from a deferred tax liability position to a deferred tax asset position related to indefinite-lived intangibles resulting from our goodwill. Liquidity and Capital Resources We have incurred net losses since our inception. For the years ended December 31, 2022 and 2021, we incurred a net loss of $47.4 million and $26.9 million, respectively, and we expect to incur additional losses and increased operating expenses in future periods. As of December 31, 2022, we had an accumulated deficit of $255.5 million. To date, we have generated only limited revenue, and we may never achieve revenue sufficient to offset our expenses. Since becoming public, our primary sources of capital have been cash inflows from product sales, sales of our common stock and, to a lesser extent, borrowings under our 2017 Term Loan. On November 10, 2020, we filed a registration statement on Form S-3 (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. In March 2021, we completed a public offering of shares of our common stock, which shares were sold under the Shelf Registration Statement. Net proceeds from the offering were approximately $64.7 million. On September 15, 2022, the Company entered into a sales agreement (the Sales Agreement) with Cowen and Company, LLC, as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of Company common stock having an aggregate offering price of up to $50.0 million. The Company is not obligated to sell any shares of Company common stock in the offering and, as of December 31, 2022, the Company had not sold any shares of its common stock pursuant to the Sales Agreement. As of December 31, 2022, we had $62.4 million of cash and cash equivalents. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our funds are held in cash, money market funds and certificates of deposit. In September 2017, we entered into the loan and security agreement with Innovatus under which we immediately drew down $20.0 million. In December 2018, we borrowed an additional $5.0 million under the loan agreement. In each of November 2019 and November 2021, we amended the loan and security agreement with Innovatus, which we collectively refer to as the Amended Loan Agreement. Pursuant to the Amended Loan Agreement, the loan term is for nine years with a final maturity date of November 2026. The Amended Loan Agreement accrues interest at an annual rate of 8.0%, of which 2.0% will be payable in-kind. Paid in-kind interest is added to the principal balance each period. After December 1, 2024, the entire 8.0% will be paid in cash at the end of each period. On or after November 1, 2022, we may, at our option, prepay the term loan borrowings by paying the lender a prepayment 77 premium. The prepayment premium was 2% as of December 31, 2022 and decreases by 1% on each of November 1, 2023 and November 1, 2024. Our obligations under the Amended Loan Agreement are secured by a security interest in substantially all of our assets, including our intellectual property. The Amended Loan Agreement contains customary conditions to borrowing, events of default, and covenants, including covenants requiring us to maintain minimum liquidity of $2.0 million, covenants to achieve certain minimum amounts of revenue (the performance covenant), and covenants limiting our ability to dispose of assets, undergo a change in control, merge with or acquire other entities, incur debt, incur liens, pay dividends or other distributions to holders of our capital stock, repurchase stock and make investments, in each case subject to certain exceptions. The consequences of failing to achieve the performance covenant will be cured if, within sixty days of failing to achieve the performance covenant, we issue 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. At December 31, 2022, we were in compliance with all covenants of the Amended Loan Agreement. In addition, upon the occurrence of an event of default, Innovatus, among other things, can declare all indebtedness due and payable immediately, which would adversely impact our liquidity and reduce the availability of our cash flows to fund working capital needs, capital expenditures and other general corporate purposes. Funding Requirements Our primary use of cash is to fund our operations as we continue to grow our business. We expect to continue to incur operating losses in the near term. In the short-term, we expect costs of revenue to increase as test volume increases. We expect selling, general and administrative expenses, and research and development expenses to decrease in the short-term as a result of cost saving initiatives which began in the fourth quarter of 2022. We believe we have sufficient laboratory capacity to support increased test volume. Cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. We expect that our near- and longer-term liquidity requirements will continue to consist of working capital and general corporate expenses associated with the growth of our business, including payments we may be required to make upon the achievement of previously negotiated milestones associated with intellectual property we have licensed, payments related to non-cancelable purchase obligations with one supplier for reagents, payments related to our principal and interest under our long term borrowing arrangements, payments for operating leases related to our office and laboratory space in Vista, California and our office space in Carlsbad, California, and payments for finance leases related to our laboratory equipment (see Note 4 and Note 5 to our audited financial statements included in this Annual Report on Form 10-K). Based on our current business plan, we believe that our existing cash and cash equivalents and our anticipated future revenue, will be sufficient to meet our anticipated cash requirements for at least the next 12 months from the date of this filing. Our estimate of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including: • our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for our testing products; • our ability to maintain and grow sales of our AVISE ® testing products, as well as the costs associated with conducting clinical studies to demonstrate the utility of our products and support reimbursement efforts; ▪ fluctuations in working capital; ▪ the costs of developing our product pipeline, including the costs associated with conducting our ongoing and future validation, utility and outcome studies as well as the success of our development efforts; and ▪ the extent to which we establish additional partnerships or in-license, acquire or invest in complementary businesses or products as well as the success of our existing partnerships and/or in-licenses. Until such time, if ever, as we can generate revenue to support our costs structure, we expect to finance our operations through equity offerings, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders may be diluted, and the terms of these 78 securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. If additional funding is required or desired, there can be no assurance that additional funds will be available to us on acceptable terms on a timely basis, if at all, or that we will generate sufficient cash from operations to adequately fund our operating needs or achieve or sustain profitability. If we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion plans or commercialization efforts. Doing so will likely have an unfavorable effect on our ability to execute on our business plan and could have a negative impact on our commercial and strategic relationships. If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition, and results of operations could be adversely affected. Cash Flows The following table summarizes our cash flows for the periods indicated: Years Ended December 31, 2022 2021 (in thousands) Net cash provided by (used in): Operating activities $ (32,144) $ (20,269) Investing activities (4,318) (2,420) Financing activities (489) 64,683 Net change in cash, cash equivalents and restricted cash $ (36,951) $ 41,994 Cash Flows from Operating Activities Net cash used in operating activities for the year ended December 31, 2022 was $32.1 million and primarily resulted from (i) our net loss of $47.4 million adjusted for non-cash charges of $13.5 million primarily related to impairment of our goodwill, stock-based compensation, depreciation, amortization, non-cash lease expenses, non-cash interest and deferred income taxes and (ii) changes in our net operating assets of $1.7 million primarily related to net increases in accounts receivable and net decreases in accounts payable, partially offset by net decreases in prepaid expenses and other current assets and net increases in accrued liabilities and other current liabilities. Net cash used in operating activities for the year ended December 31, 2021 was $20.3 million and primarily resulted from (i) our net loss of $26.9 million adjusted for non-cash charges of $6.6 million related to stock-based compensation, depreciation, amortization, non-cash interest and deferred income taxes and (ii) changes in our net operating assets of $0.1 million primarily related to net increases in accounts receivable and net decreases in accounts payable, partially offset by net decreases in prepaid expenses and other current assets and net increases in accrued liabilities and other current liabilities. Cash Flows from Investing Activities Net cash used in investing activities for the year ended December 31, 2022 and 2021 was $4.3 million and $2.4 million, respectively, and was primarily due to net purchases of property and equipment. Cash Flows from Financing Activities Net cash used in financing activities for the year ended December 31, 2022 was $0.5 million, primarily consisting of principal payments on finance lease obligations and payment of taxes on vested restricted stock units, partially offset by the proceeds from the Exagen Inc. 2019 Employee Stock Purchase Plan (the ESPP) purchases. Net cash provided by financing activities for the year ended December 31, 2021 was $64.7 million and primarily resulted from the net proceeds received from our public offering in March 2021 of $64.7 million and proceeds from the ESPP purchases, partially offset by principal payments on finance lease obligations. Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our audited financial statements, which have been prepared in accordance with accounting principles generally accepted in United States of America (GAAP). The preparation of these audited financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the audited financial statements, as well as the reported revenue 79 generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe the following accounting policies are the most critical to us, in that they require our most difficult, subjective or complex judgments in the preparation of our financial statements. For further information, see Note 2, Summary of Significant Accounting Policies, to our Financial Statements, which outlines our application of significant accounting policies. Revenue Recognition To date, substantially all of our revenue has been derived from sales of our testing products. We primarily market our testing products to rheumatologists and their physician assistants in the United States. The healthcare professionals who order our services and to whom test results are reported are generally not responsible for payment for these services. The parties that pay for these services consist of commercial payors, government payors (primarily Medicare and Medicaid), client payors (e.g. hospitals, other laboratories, etc.) and patient self-pays. Payors are billed at our list price. Net revenues recognized consist of amounts billed net of allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors. We follow a standard process, which considers historical denial and collection experience, insurance reimbursement policies and other factors, to estimate allowances and implicit price concessions, recording adjustments in the current period as changes in estimates. Further adjustments to the allowances, based on actual receipts, are recorded upon settlement. The transaction price is estimated using an expected value method on a portfolio basis. Our portfolios are grouped per payor (e.g. each individual third-party insurance, Medicare, Medicaid, client payors, patient self-pay, etc.) and per test basis. Collection of our net revenues from payors is normally a function of providing complete and correct billing information to the healthcare insurers and generally occurs within 30 to 90 days of billing. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation by management. We continually assess the state of our cash collections in order to identify areas of risk and opportunity that allow us to appropriately estimate receivables and revenue. Should we later determine the judgements underlying estimated collections change, our financial results could be impacted in future periods. Included in revenues for the years ended December 31, 2022 and 2021 was a net revenue decrease of $2.4 million and a net revenue increase of $0.7 million, respectively, associated with changes in estimated variable consideration related to performance obligations satisfied in previous periods. Goodwill Goodwill is not amortized but is tested for impairment at least annually or more frequently whenever a triggering event or change in circumstances occurs at the reporting unit level. For our goodwill impairment analysis, we operate in a single reporting unit, and allocate all goodwill to this reporting unit. Management first assesses qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying amount as a basis for determining whether it is necessary to perform a quantitative assessment. If a quantitative assessment is deemed necessary, management uses all available information to make this fair value determination, including the present values of expected future cash flows, driven by our forecast of future revenue, using discount rates commensurate with the risks involved in the assets and observed market multiples of operating cash flows. Our stock price and associated market capitalization is also considered in the determination of reporting unit fair value. A prolonged or significant decline in our share price could provide evidence of a need to record a material impairment to goodwill. We are required to recognize an impairment charge if the carrying amount of the reporting unit exceeds its fair value. The judgments and estimates involved in identifying and quantifying the impairment of goodwill involve inherent uncertainties, and the measurement of the fair value is dependent on the accuracy of the assumptions used in making the estimates and how those estimates compare to our future operating performance. Stock-Based Compensation We recorded stock-based compensation expense of approximately $4.7 million for each of the years ended December 31, 2022 and 2021, respectively. We expect to continue to grant stock options, restricted stock units and other equity-based awards in the future and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase. For stock options and purchase rights granted under the ESPP, we 80 estimate the grant date fair value using the Black-Scholes option-pricing valuation model. For RSUs, we use the closing price of our common stock on the date of grant to determine the fair value. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based awards. If we had made different assumptions, our stock-based compensation expense, net loss and net loss per share attributable to common stockholders could have been significantly different. See Note 2 and Note 8 to our audited financial statements in this Annual Report on Form 10-K for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted and purchases under our ESPP rights in the years ended December 31, 2022 and 2021. Recent Accounting Pronouncements See "Notes to the Financial Statements-Note 2-Recent Accounting Pronouncements" of our annual financial statements. JOBS Act Accounting Election The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an "emerging growth company." The JOBS Act permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have elected to use this extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our audited financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We will remain an emerging growth company until the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act, which will occur in 2024. However, if certain events occur prior to the end of this five-year period, including if we become a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, our annual gross revenues exceed $1.07 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to this anniversary. 81 Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not applicable. Item 8. Financial Statements and Supplementary Data. The financial statements and supplemental data required by this item are set forth at the pages indicated in Part IV, Item 15(a)(1) of this Annual Report on Form 10-K. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.