Exagen Inc. Secures Conditional NY State Approval for New Lupus and Rheumatoid Arthritis Biomarkers and Announces Select Preliminary 2024 Financial Results
Exagen has received conditional approval from NY State for new lupus (SLE) and rheumatoid arthritis (RA) biomarker assays, planned for commercial launch in January 2025. The company announced preliminary unaudited financial results for Q4 and full year 2024, achieving:
- Record full-year revenue of $55.3-$55.8 million
- AVISE CTD trailing 12-month average selling price of $408-$412
- Net loss of ($14.8) to ($15.8) million
- Adjusted EBITDA of ($9.8) to ($10.8) million
- Cash position of $22.2 million
The new biomarkers include T-Cell Lupus profile (TC4d, TIgG, TIgM) for enhanced SLE diagnosis and RA profile with anti-RA33 biomarkers (IgA, IgG, IgM) for improved RA diagnosis. The company reached a milestone of testing its 1,000,000th patient with AVISE CTD and showed significant improvement in adjusted EBITDA by 37-43% compared to 2023.
Exagen ha ricevuto l'approvazione condizionata dallo Stato di New York per i nuovi assay biomarker per lupus (SLE) e artrite reumatoide (RA), previsti per il lancio commerciale a gennaio 2025. L'azienda ha annunciato risultati finanziari preliminari non verificati per il quarto trimestre e per l'intero anno 2024, ottenendo:
- Ricavi record per l'anno intero tra $55.3 e $55.8 milioni
- Prezzo medio di vendita dell'AVISE CTD negli ultimi 12 mesi tra $408 e $412
- Perdita netta compresa tra ($14.8) e ($15.8) milioni
- EBITDA rettificato compreso tra ($9.8) e ($10.8) milioni
- Posizione di cassa di $22.2 milioni
I nuovi biomarcatori includono il profilo T-Cell Lupus (TC4d, TIgG, TIgM) per una diagnosi migliorata del SLE e il profilo RA con biomarcatori anti-RA33 (IgA, IgG, IgM) per una diagnosi migliore dell'RA. L'azienda ha raggiunto un traguardo testando il milionesimo paziente con AVISE CTD e ha mostrato un significativo miglioramento dell'EBITDA rettificato dal 37 al 43% rispetto al 2023.
Exagen ha recibido la aprobación condicional del Estado de Nueva York para nuevos ensayos de biomarcadores de lupus (SLE) y artritis reumatoide (RA), que está previsto lanzar comercialmente en enero de 2025. La compañía anunció resultados financieros preliminares no auditados para el cuarto trimestre y el año completo 2024, logrando:
- Ingresos récord de $55.3 a $55.8 millones durante todo el año
- Precio promedio de venta de AVISE CTD de $408 a $412 en los últimos 12 meses
- Pérdida neta de entre ($14.8) y ($15.8) millones
- EBITDA ajustado de entre ($9.8) y ($10.8) millones
- Posición de efectivo de $22.2 millones
Los nuevos biomarcadores incluyen el perfil T-Cell Lupus (TC4d, TIgG, TIgM) para un diagnóstico mejorado de SLE y el perfil RA con biomarcadores anti-RA33 (IgA, IgG, IgM) para mejorar el diagnóstico de RA. La compañía alcanzó un hito al testear a su paciente número 1,000,000 con AVISE CTD y mostró una mejora significativa en EBITDA ajustado del 37 al 43% en comparación con 2023.
엑사겐(Exagen)은 뉴욕주로부터 새로운 루푸스(SLE) 및 류마치스 관절염(RA) 바이오마커 검사에 대한 조건부 승인을 받았으며, 상업적 출시를 2025년 1월로 예정하고 있습니다. 회사는 2024년 4분기 및 연간 예비 감사 결과를 발표했으며, 다음과 같은 성과를 달성했습니다:
- 연간 기록적인 매출 5530만 달러에서 5580만 달러 사이
- AVISE CTD의 12개월 평균 판매 가격이 408달러에서 412달러 사이
- 순손실이 ($1480만)에서 ($1580만) 사이
- 조정된 EBITDA가 ($980만)에서 ($1080만) 사이
- 현금 보유액 2220만 달러
새로운 바이오마커는 SLE 진단을 향상시키기 위한 T-Cell 루푸스 프로필(TC4d, TIgG, TIgM)과 RA 진단 개선을 위한 항-RA33 바이오마커(IgA, IgG, IgM)를 포함하고 있습니다. 회사는 AVISE CTD로 1,000,000번째 환자를 검사하는 이정표를 세웠으며, 2023년 대비 조정 EBITDA가 37-43% 개선된 결과를 보였습니다.
Exagen a reçu une approbation conditionnelle de l'État de New York pour de nouveaux tests de biomarqueurs de lupus (SLE) et d'arthrite rhumatoïde (RA), prévus pour un lancement commercial en janvier 2025. L'entreprise a annoncé des résultats financiers préliminaires non audités pour le quatrième trimestre et l'année entière 2024, atteignant :
- Un chiffre d'affaires record de 55,3 à 55,8 millions de dollars
- Prix de vente moyen de l'AVISE CTD sur 12 mois de 408 à 412 dollars
- Perte nette de ($14,8) à ($15,8) millions
- EBITDA ajusté de ($9,8) à ($10,8) millions
- Position de trésorerie de 22,2 millions de dollars
Les nouveaux biomarqueurs comprennent le profil T-Cell Lupus (TC4d, TIgG, TIgM) pour un diagnostic amélioré du SLE et le profil RA avec des biomarqueurs anti-RA33 (IgA, IgG, IgM) pour un diagnostic amélioré de la RA. L'entreprise a atteint un jalon en testant son millionième patient avec AVISE CTD et a montré une amélioration significative de l'EBITDA ajusté de 37 à 43 % par rapport à 2023.
Exagen hat die bedingte Genehmigung des Bundesstaates New York für neue Biomarker-Assays für Lupus (SLE) und rheumatoide Arthritis (RA) erhalten, die für die kommerzielle Einführung im Januar 2025 geplant sind. Das Unternehmen gab vorläufige, unprüfte Finanzzahlen für das 4. Quartal und das Gesamtjahr 2024 bekannt und erzielte:
- Rekordjahresumsatz zwischen $55,3 und $55,8 Millionen
- Durchschnittlicher Verkaufspreis von AVISE CTD über die letzten 12 Monate zwischen $408 und $412
- Nettverlust zwischen ($14,8) und ($15,8) Millionen
- Angepasstes EBITDA zwischen ($9,8) und ($10,8) Millionen
- Bargeldposition von $22,2 Millionen
Die neuen Biomarker umfassen das T-Cell Lupus-Profil (TC4d, TIgG, TIgM) für eine verbesserte SLE-Diagnose und das RA-Profil mit Anti-RA33-Biomarkern (IgA, IgG, IgM) für eine verbesserte RA-Diagnose. Das Unternehmen hat einen Meilenstein erreicht, indem es seinen millionsten Patienten mit AVISE CTD getestet hat, und zeigte eine signifikante Verbesserung des angepassten EBITDA um 37-43% im Vergleich zu 2023.
- Record full-year 2024 revenue of $55.3-$55.8 million
- AVISE CTD trailing 12-month ASP improved by $72-$76 compared to Q4 2023
- 37-43% improvement in adjusted EBITDA compared to 2023
- Net neutral cash usage in Q4 2024
- Milestone achievement of 1,000,000 patients tested with AVISE CTD
- Net loss of ($14.8) to ($15.8) million for full-year 2024
- Negative adjusted EBITDA of ($9.8) to ($10.8) million
Insights
The NY State approval for new lupus and RA biomarkers represents a significant advancement in autoimmune diagnostics. The T-Cell Lupus profile (TC4d, TIgG and TIgM) enhances diagnostic accuracy for SLE cases that are typically challenging to identify. The expanded RA profile with anti-RA33 biomarkers addresses a critical gap in seronegative RA diagnosis, where traditional markers often fail to detect the disease. The timing of this approval, enabling a January 2025 commercial launch, positions Exagen to capture immediate market share in the
The preliminary financials reveal strong operational execution with record-setting metrics. Notable highlights include:
- Full-year revenue of
$55.3-55.8 million - AVISE CTD pricing strength with
$408-412 trailing 12-month ASP, representing a$72-76 improvement YoY - Significant adjusted EBITDA improvement of
37-43% compared to 2023 - Cash preservation with net neutral Q4 usage and
$22.2 million balance
The milestone of testing 1 million patients with AVISE CTD demonstrates significant market penetration and validates the platform's clinical utility. The combination of NY State approval and strong financial metrics creates multiple growth catalysts for 2025. The improved reimbursement metrics and ASP growth indicate strong payer acceptance and market demand. With autoimmune diseases affecting over 24 million Americans and diagnostic challenges persisting, Exagen's enhanced testing capabilities address a substantial unmet need while strengthening their competitive moat in the specialized diagnostics sector.
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 to adjusted EBITDA and cash burn
CARLSBAD, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today announced it has received conditional approval from the New York State Department of Health for its new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays, with a planned commercial launch in January 2025. The company also announced preliminary unaudited select financial results for the fourth quarter and full year ended December 31, 2024, in line with prior financial guidance.
New AVISE CTD Biomarkers
The company’s new SLE and RA biomarkers will be incorporated into the AVISE CTD platform. Collectively, the company expects these new biomarkers will further improve the clinical utility of 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 comprises 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, particularly in clinically ambiguous cases.
- RA profile includes additional anti-RA33 biomarkers; IgA, IgG, and IgM. These markers provide clinicians with more data to confidently identify patients with RA and substantiate a seronegative RA diagnosis.
Preliminary Unaudited Select Financial Results
| Three Months Ended December 31, 2024 | Twelve Months Ended December 31, 2024 | |||||
| (in millions, except trailing 12-month average selling price) | ||||||
| Revenue | ||||||
| Net Loss | ( | ( | ||||
| Adjusted EBITDA | ( | ( | ||||
| AVISE CTD Trailing 12-month average selling price | ||||||
| Cash, cash equivalents and restricted cash | ||||||
The preliminary unaudited select financial results reported today represent:
- Record full-year 2024 revenue and AVISE CTD ASP
- AVISE CTD trailing twelve-month ASP improvement of
$72 t o$76 compared to Q4 2023 - Full-year 2024 adjusted EBITDA improvement of to
37% to43% compared to full-year 2023 - Net neutral cash usage in the fourth quarter of 2024
“2024 was a remarkable year for Exagen by many accounts. We reached a significant milestone by testing our 1,000,000th patient with AVISE CTD, an impressive achievement for any proprietary test, but especially one in a field that hasn’t seen robust biomarker innovation for many decades,” said John Aballi, CEO. “We’ve also made great strides in optimizing our company’s operations and continued our progress toward profitability - a goal which is now firmly within reach, all while delivering record reimbursement per test and record overall revenue performance."
Mr. Aballi continued, “To start 2025 with New York State’s approval of our new assays is another significant milestone, and we now sit in the midst of several growth catalysts with strong momentum to start the year. I’m very grateful to the dedicated team we have, and couldn’t be more excited about what lies ahead.”
Cautionary Note Regarding Select Preliminary Unaudited Financial Results
The company is providing the above preliminary unaudited select 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 company’s financial closing procedures with respect to the estimated financial data provided above are not yet complete. 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 select financial information and, accordingly, our independent registered public accounting firm does not express an opinion or any other form of assurance with respect thereto. As a result, the company’s final results may vary from the preliminary results presented above. Management undertakes no obligation to update or supplement the information provided above until it releases its audited financial statements prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP) for the year ended December 31, 2024.
Use of Unaudited Non-GAAP Financial Measures
In addition to the 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 and amortization 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 significant impact on the calculation of GAAP net loss.
The table below presents the 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 further information regarding the company's use of non-GAAP financial measures.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
| Three Months Ended December 31, 2024 | Twelve Months Ended December 31, 2024 | |||||||
| (in millions) | ||||||||
| Adjusted EBITDA | ||||||||
| Net loss | ( | ( | ||||||
| Other (Income) Expense | ( | ( | ||||||
| Interest Expense | ||||||||
| Depreciation and amortization expense | ||||||||
| Stock-based compensation expense | ||||||||
| Adjusted EBITDA (Non-GAAP) | ( | ( | ||||||
Management believes that this non-GAAP financial measure, taken in conjunction with GAAP financial measures, provides useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the company’s core operating results. Management uses non-GAAP measures to compare the company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. However, this non-GAAP financial measure may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP
This non-GAAP financial measure is not meant to be considered in isolation or used as a substitute for net loss reported in accordance with GAAP, should be considered in conjunction with financial information presented in accordance with GAAP, has no standardized meaning prescribed by GAAP, is unaudited, and is 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 historically have been excluded for purposes of this non-GAAP financial measure. Likewise, management may determine to modify the nature of 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 company’s flagship product, AVISE® CTD, enables clinicians to more effectively diagnose complex autoimmune conditions such as lupus, rheumatoid arthritis, and Sjögren’s syndrome earlier and with greater accuracy. Exagen’s laboratory specializes in the testing of rheumatic diseases, delivering precise and timely results, supported by a full suite of AVISE-branded tests for disease diagnosis, prognosis, and monitoring. With a focus on research, innovation, education, and patient-centered care, Exagen is dedicated to addressing the ongoing challenges of autoimmune disease management.
For more information, please 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 the newly approved SLE and RA biomarkers; potential shareholder value and growth and profitability; preliminary financial information as of and for December 31, 2024; and guidance. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, and delays in ongoing and planned clinical trials involving its tests; Exagen’s commercial success depends upon attaining and maintaining significant market acceptance of its testing products among rheumatologists, patients, third-party payors and others in the medical community; Exagen’s ability to successfully execute on its business strategies; third-party payors not providing coverage and adequate reimbursement for Exagen’s testing products, including Exagen’s ability to collect on funds due; Exagen’s ability to obtain and maintain intellectual property protection for its testing products; regulatory developments affecting Exagen’s business; and other risks described in Exagen’s prior 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 any 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 that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Ryan Douglas
Exagen Inc.
ir@exagen.com
760.560.1525
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