Workflow
AVISE CTD
icon
Search documents
Exagen Inc. Reports Strong Fourth Quarter and Full-Year 2025 Results
Globenewswire· 2026-03-10 12:00
Core Insights - Exagen Inc. reported record total revenue of $66.6 million for the year ended December 31, 2025, representing a 20% increase compared to 2024 [6][4] - The company achieved over 11% growth in test volume for its AVISE CTD product, supported by new biomarkers and an expanded sales force [1][6] - The average selling price (ASP) for AVISE CTD increased to $441 per test, up by $30 or 7% from the previous year [6][4] Financial Performance - For Q4 2025, revenue was $16.6 million, compared to $13.7 million in Q4 2024 [2][17] - Gross margin for the year was 58.3%, with operating expenses totaling $52.9 million [2][17] - The net loss for the year was $19.9 million, compared to a net loss of $15.1 million in 2024 [2][17] Business Highlights - The company supported the diagnosis and management of care for over 137,000 patients tested by AVISE CTD [6] - Exagen launched novel biomarkers for T-Cell and seronegative rheumatoid arthritis, enhancing its AVISE CTD platform [6][4] - The leadership team was strengthened with the appointment of Michael Mahler, PhD, as Chief Scientific Officer [6] Financial Outlook - Exagen expects full-year 2026 revenue to be in the range of $70 million to $73 million [5]
Exagen Inc. to Announce Fourth Quarter and Full Year 2025 Financial Results on March 10, 2026
Globenewswire· 2026-02-24 14:00
Core Insights - Exagen Inc. will release its financial results for Q4 2025 on March 10, 2026, before market opening [1] - The conference call to discuss the results will be hosted by the CEO and CFO at 8:30 a.m. ET [1] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [2] - The company's flagship product, AVISE CTD, aids in the early and accurate diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [2] - Exagen operates a CLIA-certified, CAP-accredited laboratory specializing in rheumatic disease testing, providing precise and timely results [2] - The company emphasizes research, innovation, education, and patient-centered care to address challenges in autoimmune disease management [2]
Exagen Inc. to Participate in Fourth Quarter Investor Conferences
Globenewswire· 2025-11-11 14:00
Core Insights - Exagen Inc. is a leading provider of autoimmune diagnostics, focusing on transforming care for patients with chronic autoimmune conditions [2] - The company will participate in two upcoming investor conferences in November 2025, indicating active engagement with the investment community [1] Company Overview - Exagen Inc. is based in San Diego County, California, and is dedicated to improving clinical outcomes through its innovative testing portfolio [2] - The flagship product, AVISE CTD, aids clinicians in diagnosing complex autoimmune conditions such as lupus, rheumatoid arthritis, and Sjögren's disease with greater accuracy [2] - Exagen operates a CLIA-certified, CAP-accredited laboratory that specializes in testing for rheumatic diseases, providing precise and timely results [2] - The company emphasizes research, innovation, education, and patient-centered care to address challenges in autoimmune disease management [2]
Exagen Inc. Reports Strong Q3 2025 Results
Globenewswire· 2025-11-04 13:00
Core Insights - Exagen Inc. reported a record revenue of $17.2 million for Q3 2025, marking a 38% increase compared to Q3 2024, or a 26% increase when excluding one-time adjustments from 2024 [8] - The company anticipates full-year revenue for 2025 to be between $65 million and $70 million, with expectations of achieving positive adjusted EBITDA in Q4 2025 [4] Financial Performance - Revenue for Q3 2025 was $17,244 thousand, compared to $12,507 thousand in Q3 2024, and for the nine months ended September 30, 2025, revenue was $49,944 thousand, up from $41,986 thousand in the same period of 2024 [2][18] - Gross margin improved to 58.4% in Q3 2025 from 55.8% in Q3 2024, and for the nine months, it was 59.3% compared to 58.7% [2] - Operating expenses increased to $13,175 thousand in Q3 2025 from $11,644 thousand in Q3 2024, and for the nine months, they rose to $38,688 thousand from $34,888 thousand [2][18] - The net loss for Q3 2025 was $7,087 thousand, compared to a net loss of $5,028 thousand in Q3 2024, with a nine-month net loss of $15,278 thousand versus $11,354 thousand in the prior year [2][18] Operational Highlights - The volume of AVISE CTD tests grew by 16% compared to Q3 2024, and the average selling price (ASP) for AVISE CTD tests increased to $441, up by $37 from Q3 2024 [8] - The company ended Q3 2025 with cash and cash equivalents of $35,652 thousand, an increase from $22,035 thousand at the end of Q3 2024 [2][18] - Exagen launched seronegative RA markers for anti-PAD4, enhancing the AVISE CTD panel, and presented six abstracts at the American College of Rheumatology Conference [8] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focusing on improving clinical outcomes for patients with chronic autoimmune conditions through innovative testing solutions [13] - The company's flagship product, AVISE CTD, aids in the diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [13]
Exagen Announces Acceptance of Six Abstracts at 2025 American College of Rheumatology Convergence
Globenewswire· 2025-10-23 13:15
Core Insights - Exagen Inc. announced the acceptance of six abstracts at the 2025 American College of Rheumatology's annual meeting, highlighting advancements in autoimmune testing [1][2][3] Group 1: Research and Presentations - A plenary presentation in collaboration with Johns Hopkins University will focus on a urinary biomarker panel for guiding precision management of Lupus Nephritis [2][3] - Additional abstracts will cover innovative research on anti-RA33, anti-PAD4, and traditional biomarkers to improve rheumatoid arthritis diagnostic accuracy, as well as T Cell biomarkers to differentiate systemic lupus erythematosus from other conditions [2][3] - Exagen will present preliminary data on a novel kidney damage biomarker panel aimed at transforming early kidney disease management [3] Group 2: Abstract Details - The accepted abstracts include a plenary talk on "Urinary Tenascin C Predicts Kidney Function Loss in Lupus Nephritis" scheduled for October 27, 2025 [4] - Other presentations will feature a machine learning classifier for rheumatoid arthritis and a kidney-specific biomarker panel that differentiates Lupus Nephritis from diabetic kidney disease [4][5] - A poster presentation will discuss the clinical utility of a multianalyte lupus risk score incorporating cell-bound complement activation products [6] Group 3: Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on improving patient care for chronic autoimmune conditions [7] - The company's flagship product, AVISE CTD, enhances the diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [7] - Exagen operates a CLIA-certified, CAP-accredited laboratory specializing in rheumatic disease testing, emphasizing research, innovation, and patient-centered care [7]
Exagen Inc. to Announce Third Quarter 2025 Financial Results on November 4, 2025
Globenewswire· 2025-10-21 20:05
Core Insights - Exagen Inc. will release its financial results for Q3 2025 on November 4, 2025, before market opening [1] - The conference call to discuss the results will be hosted by the President and CEO, John Aballi, along with CFO Jeff Black at 8:30 a.m. ET [1] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [2] - The company's flagship product, AVISE CTD, aids in the early and accurate diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [2] - Exagen operates a CLIA-certified, CAP-accredited laboratory specializing in rheumatic disease testing, providing precise and timely results [2] - The company emphasizes research, innovation, education, and patient-centered care to address challenges in autoimmune disease management [2]
Exagen Inc. to Participate in Third Quarter Investor Conferences
Globenewswire· 2025-08-06 20:05
Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [2] - The company's flagship product, AVISE CTD, aids in the early and accurate diagnosis of complex autoimmune diseases such as lupus, rheumatoid arthritis, and Sjögren's disease [2] - Exagen specializes in testing for rheumatic diseases, offering a comprehensive suite of AVISE-branded tests for diagnosis, prognosis, and monitoring [2] Upcoming Events - Exagen management will participate in the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025, in Boston, MA, featuring a fireside chat and 1X1 meetings [1] - The company will also attend the Cantor Global Healthcare Conference 2025 on September 3, 2025, in New York, NY, with similar participation formats [1]
Exagen Q2 Revenue Jumps 14 Percent
The Motley Fool· 2025-07-29 15:51
Core Viewpoint - Exagen reported strong revenue growth driven by its AVISE CTD test, but continued to face widening net losses due to increased operating expenses and ongoing investments in sales and research efforts [1][5][7]. Financial Performance - Q2 2025 GAAP revenue reached $17.2 million, exceeding analyst expectations of $16.31 million, and representing a 14.2% increase from $15.1 million in Q2 2024 [2][5]. - GAAP EPS was $(0.21), worse than the expected $(0.15) and a decline from $(0.16) in Q2 2024, marking a 31.3% year-over-year deterioration [2][5]. - Gross margin improved slightly to 60.4%, up from 60.1% in the previous year, with management targeting mid-60% range in the long term [2][6]. - Cash and cash equivalents increased to $30.0 million, a 22.6% rise from $24.5 million in Q2 2024, bolstered by a recent equity offering [2][9]. Product and Market Dynamics - The AVISE CTD test, which accounts for approximately 90% of revenue, saw a 14% sequential increase in test volumes and a 7% year-over-year rise, reflecting growing clinical adoption [3][5]. - The average selling price (ASP) for AVISE CTD improved to $428, a $27 increase from the previous year, attributed to reimbursement progress and higher pricing on new biomarkers [5][6]. Operational Insights - Operating expenses rose due to increased hiring for sales and R&D, with R&D costs climbing to $1.5 million from $1.2 million in Q2 2024 [7]. - The net loss widened to $4.4 million from $3.0 million in Q2 2024, driven by higher spending and the need to scale revenue [7]. Reimbursement and Legal Developments - Exagen achieved a significant legal victory regarding a denied Medicare Advantage claim, which may set a precedent for future appeals [8]. - Positive policy decisions for AVISE CTD with TRICARE were secured, expanding coverage for military families after a two-year review [8]. Future Outlook - For fiscal 2025, management projects GAAP revenue between $65 million and $70 million, relying on continued momentum from AVISE CTD and reimbursement efforts [11]. - The company aims to reach break-even on adjusted EBITDA by Q4 2025, contingent on sales acceleration and expense management [11].
Exagen Inc. Reports Strong Q2 2025 Results
Globenewswire· 2025-07-29 12:00
Core Insights - Exagen Inc. reported a record revenue of $17.2 million for Q2 2025, reflecting an 11% increase from Q1 2025 and a 14% increase from Q2 2024 [7] - The company expects full-year revenue for 2025 to be between $65 million and $70 million, with a potential for positive adjusted EBITDA in Q4 2025 [4] Financial Performance - Revenue for Q2 2025 was $17,202 thousand, compared to $15,064 thousand in Q2 2024, marking a year-over-year growth [2] - Gross margin for Q2 2025 was 60.4%, slightly up from 60.1% in Q2 2024 [2] - Operating expenses increased to $13,025 thousand in Q2 2025 from $11,643 thousand in Q2 2024 [2] - The net loss for Q2 2025 was $4,439 thousand, compared to a net loss of $2,966 thousand in Q2 2024 [2] Operational Highlights - The volume of AVISE CTD tests grew by 14% compared to Q1 2025 and by 7% compared to Q2 2024 [7] - The average selling price (ASP) for AVISE CTD tests increased to $428, up by $27 from Q2 2024 [7] - The company strengthened its balance sheet with a $20.2 million public offering and a new loan credit facility, ending Q2 2025 with cash and equivalents of $30.2 million [7] Corporate Developments - Dr. Michael Mahler was appointed as Chief Scientific Officer, bringing over 20 years of experience in autoimmune diagnostic research [7] - Chas McKhann joined the Board of Directors, contributing 25 years of experience in the life sciences sector [7]
Michael Mahler, PhD Joins Exagen as Chief Scientific Officer to Enhance Leadership in Autoimmune Diagnostics
Globenewswire· 2025-06-23 13:00
Core Insights - Exagen Inc. has appointed Dr. Michael Mahler as Chief Scientific Officer, enhancing its expertise in autoimmune testing [1][4] - Dr. Mahler has over 20 years of experience in immunology and autoimmune research, with a strong background in developing diagnostic solutions [3][5] - Exagen aims to improve the diagnosis and treatment of autoimmune diseases through innovative testing and strategic initiatives under Dr. Mahler's leadership [4][5] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [5] - The company's flagship product, AVISE CTD, aids in the accurate diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [5] - Exagen's laboratory specializes in rheumatic disease testing, offering a comprehensive suite of AVISE-branded tests for diagnosis, prognosis, and monitoring [5] Dr. Mahler's Background - Dr. Mahler holds a Ph.D. from the University of Heidelberg and has collaborated with prominent figures in autoimmune research [2] - He has held significant roles in various diagnostic companies, most recently as Senior Vice President at Werfen, contributing to the discovery of novel autoantigens [3] - His scientific work includes over 300 peer-reviewed publications and numerous patents, advancing the field of autoimmune diagnostics [3]