Exagen Inc. secures NY State Conditional Approval for New Lupus and Rheumatoid Arthritis Biomarkers and Releases Selected Preliminary 2024 Financial Results.
New biomarkers on track for commercial launch in January 2025
Preliminary financial results indicate record full-year revenue and AVISE CTD trailing twelve-month ASP, with improvements in adjusted EBITDA and cash spend
CARLSBAD, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) — Exagen Inc . (Nasdaq: NASDAQ: ), a leading provider of autoimmune testing, today announced that it has received conditional approval from the New York State Department of Health for its new biomarker tests for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), with planned commercial launch in January 2025. The company also released preliminary unaudited select financial results for the fourth quarter and full year ended December 31, 2024, consistent with prior financial guidance.
New AVISE CTD biomarkers
The company’s new SLE and RA biomarkers will be incorporated into the AVISE CTD platform. Together, the company expects these new biomarkers to further improve the clinical utility of the AVISE CTD and provide clinicians with the information they need to definitively diagnose patients and shorten their autoimmune diagnostic journeys.
The new biomarkers are as follows:
- T-Cell Lupus Profile Includes New Biomarkers; TC4d, TIgG and TIgM. These markers provide superior sensitivity for SLE compared to conventional SLE biomarkers, further enhancing our industry-leading AVISE Lupus Profile for a more comprehensive diagnosis, especially in clinically equivocal cases.
- The RA profile includes additional anti-RA33 biomarkers; IgA, IgG and IgM. These markers provide clinicians with more data to reliably identify patients with RA and support the diagnosis of seronegative RA.
Preliminary unaudited selected financial results
Three months over December 31, 2024 |
Twelve months are over December 31, 2024 |
|||||
(in millions, except for the last 12-month average sales price) | ||||||
Income | $13.3 to $13.8 | $55.3 to $55.8 | ||||
Net loss | ($3.4) to ($4.4) | ($14.8) to ($15.8) | ||||
Adjusted EBITDA | ($2.2) to ($3.2) | ($9.8) to ($10.8) | ||||
AVISE CTD Average sales price for 12 months | 408 to 412 dollars | 408 to 412 dollars | ||||
Cash, cash equivalents and restricted cash | 22.2 dollars | 22.2 dollars | ||||
The preliminary unaudited selected financial results released today represent:
- Record revenue for the whole of 2024 and AVISE CTD ASP
- AVISE CTD trails trailing twelve-month ASP improvement of $72 to $76 compared to Q4 2023.
- Full-year 2024 adjusted EBITDA improvement of 37% to 43% compared to full-year 2023
- Net neutral use of cash in the fourth quarter of 2024
2024 was, according to many, an exceptional year for Exagen. We have reached a significant milestone testing our 1,000,000th patient with AVISE CTD, an impressive achievement for any proprietary test, especially one in a field that has not seen robust biomarker innovation in decades, said John Aballi, CEO. We also made great strides in optimizing our company’s operations and continued to move towards profitability – a goal that is now firmly in place, all with record fee-per-test and record total revenue performance.”
Mr. Aballi continued, Kicking off 2025 with New York State approval of our new tests is another significant milestone, and we now sit in the midst of several growth catalysts with strong momentum to start the year. I am very grateful for the dedicated team we have and could not be more excited for what lies ahead.
Warning regarding selected preliminary unaudited financial results
The Company provides the above preliminary unaudited selected financial information and results of operations as of and for the three months and year ended December 31, 2024, based on currently available information. The financial closing procedures of the company with regard to the above estimated financial data have not yet been completed. These procedures often result in changes to accounts. Our independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to the preliminary unaudited selected financial information and, accordingly, our independent registered public accounting firm expresses no opinion or any other form of assurance with respect thereto. As a result, the Company’s final results may differ from the above preliminary results. Management undertakes no obligation to update or supplement the above information until it issues its audited financial statements prepared in accordance with US Generally Accepted Accounting Principles (GAAP) for the year ended December 31, 2024.
Use of unaudited non-GAAP financial measures
In addition to financial results prepared in accordance with GAAP, this press release contains the metric Adjusted EBITDA, which is not calculated in accordance with GAAP and is a non-GAAP financial measure. Adjusted EBITDA excludes from net loss interest income (expense), income tax expense (benefit), depreciation expense, stock-based compensation expense and other expenses or income that management believes are not representative of the company’s operations. Such items could have a material impact on the calculation of GAAP net loss.
The table below shows a reconciliation of preliminary net loss to Adjusted EBITDA, which is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures (UNAUDITED)” above for additional information on the Company’s use of non-GAAP financial measures.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
Three months over December 31, 2024 |
Twelve months are over December 31, 2024 |
|||||||
(in millions) | ||||||||
Adjusted EBITDA | ||||||||
Net loss | ($3.4) to ($4.4) | ($14.8) to ($15.8) | ||||||
Other (income) expenses | ($0.2) | ($0.8) | ||||||
Interest expenses | 0.6 dollars | 2.3 dollars | ||||||
Depreciation costs | 0.4 dollars | 1.7 dollars | ||||||
Stock-based compensation expense | 0.4 dollars | 1.8 dollars | ||||||
Adjusted EBITDA (non-GAAP) | ($2.2) to ($3.2) | ($9.8) to ($10.8) | ||||||
Management believes that this non-GAAP financial measure, taken in combination with GAAP financial measures, provides useful information to both management and investors excluding certain non-cash and other charges that are not indicative of the company’s underlying operating results. Management uses non-GAAP measures to compare the company’s performance against forecasts and strategic plans and to compare the company’s external performance against competitors. However, this non-GAAP financial measure may differ from non-GAAP financial measures used by other companies, even when the same or similar names are used to identify such measures, limiting their usefulness for comparative purposes. The non-GAAP information is not prepared under a comprehensive set of accounting rules and should be used only to supplement an understanding of the company’s US GAAP operating results
This non-GAAP financial measure is not intended to be considered in isolation or to be used as a substitute for net loss presented in accordance with GAAP, it should be considered in conjunction with the financial information presented in accordance with GAAP, it has no standardized meaning prescribed by GAAP, is unaudited and not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that management may exclude for purposes of this non-GAAP financial measure, and may in the future cease to exclude items that have historically been excluded for purposes of this non-GAAP GAAP financial measure. measure. Likewise, management may choose to change the nature of the adjustments to arrive at this non-GAAP financial measure.
About Exagen
Exagen Inc. (Nasdaq: XGN) is a leading provider of autoimmune diagnostics, committed to transforming care for patients with chronic and debilitating autoimmune conditions. Based in San Diego County, California, Exagen’s mission is to provide clarity in autoimmune disease decision-making and improve clinical outcomes through its innovative testing portfolio. The main product of the company, AVISE ® CTD allows clinicians to more effectively diagnose complex autoimmune conditions such as lupus, rheumatoid arthritis and Sjøgren’s syndrome earlier and with greater accuracy. The Exagena laboratory specializes in the testing of rheumatic diseases, providing precise and timely results, supported by a complete package of AVISE brand tests for disease diagnosis, prognosis and monitoring. With a focus on research, innovation, education and patient-centered care, Exagen is dedicated to meeting the ongoing challenges of autoimmune disease management.
For more information, visit Exagen.com or follow @ExagenInc on X (formerly known as Twitter).
Forward-looking statements
Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Exagen’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Exagen’s goals, strategies and ambitions; the potential utility and effectiveness of Exagen’s services and testing solutions, including newly approved SLE and RA biomarkers; potential shareholder value and growth and profitability; preliminary financial information as of December 31, 2024; and routing. The inclusion of forward-looking statements should not be considered a representation by Exagen that any of its plans will be achieved. Actual results may differ from those stated in this press release due to risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions by Medicare and third-party payers and in interactions with regulatory authorities and delays in ongoing and planned clinical trials involving its tests; Exagen’s commercial success depends on achieving and maintaining significant market acceptance of its test products among rheumatologists, patients, third-party payers and others in the medical community; Exagen’s ability to successfully implement its business strategies; third party payors not providing coverage and adequate reimbursement for Exagen’s test products, including Exagen’s ability to collect past due funds; Exagen’s ability to obtain and maintain intellectual property protection for its test products; regulatory developments affecting Exagen’s operations; and other risks described in Exagen’s previous press releases and Exagen’s filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in Exagen’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC -on March 18, 2024 and all subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events occurring or circumstances existing after the date hereof . All forward-looking statements are qualified in their entirety by this cautionary statement, which is made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Ryan Douglas
Exagen Inc.
ir@exagen.com
760.560.1525