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]

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]

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]

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]

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]

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].

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]

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]

Core Viewpoint - Exagen Inc. has secured a term loan credit facility of up to $75 million from Perceptive Advisors, with an initial funding of $25 million aimed at refinancing existing debt and enhancing the company's balance sheet [1][3]. Financing Details - The first tranche of $25 million was utilized to retire Exagen's existing term debt with Innovatus Capital Partners [3]. - Additional tranches include $10 million available through March 31, 2026, and another $10 million through December 31, 2026, both contingent on achieving specific revenue milestones [8]. - A business development tranche of $30 million is also available through March 31, 2027, at Perceptive's discretion [8]. Loan Terms - The interest rate for the credit agreement is set at Term SOFR + 7%, with a SOFR floor of 4.75% [5]. - Exagen will make interest-only payments for the first 60 months, with the total principal and interest due at maturity [5]. - The loan is secured by substantially all of Exagen's assets [5]. Equity Component - Exagen issued a warrant to Perceptive for 400,000 shares of common stock, with specific exercise prices based on the 10-day VWAP prior to the closing [6]. - Up to an additional 750,000 warrants may be issued, with exercise prices tied to the 10-day VWAP preceding each tranche's funding date [6]. Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on improving patient care through innovative testing solutions [10]. - The company's flagship product, AVISE CTD, aids in the diagnosis of complex autoimmune conditions such as lupus and rheumatoid arthritis [10]. - Exagen is committed to addressing challenges in autoimmune disease management through research, innovation, and patient-centered care [10].

Financial Data and Key Metrics Changes - Total revenue for 2024 reached a record $55.6 million, marking a 6% increase from 2023, primarily driven by ASP expansion [31][32] - Adjusted EBITDA loss narrowed to approximately $10 million, showcasing a 40% improvement over 2023 [39] - Gross margin expanded to just under 60% in 2024 compared to 56% in 2023, with Q4 gross margin at about 62% [35][36] Business Line Data and Key Metrics Changes - The average selling price (ASP) for AVISE CTD increased to $411, up $75 from 2023 and $126 since 2022 [32][8] - Testing volume for 2024 was 123,000 AVISE CTD units, down 11% relative to 2023 [136] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in rheumatoid arthritis (RA), estimating an annual rate of connective tissue disease evaluations at around 2.5 million tests, with a conservative penetration estimate of about 5% [104] Company Strategy and Development Direction - The company is focused on enhancing its value proposition in the RA market with the launch of new biomarkers, which are expected to broaden the utility for clinicians [79][81] - Plans to expand sales territories from 40 to potentially mid-40s during 2025 to drive profitable growth [127] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, expecting strong revenue growth driven by both ASP expansion and volume [24] - The company aims to achieve positive adjusted EBITDA by Q4 2025, marking a key milestone in its turnaround strategy [40] Other Important Information - The company has made significant investments in capacity and technology to meet expected demand, including a $1.2 million investment in flow cytometry equipment [70] - The launch of new biomarkers is seen as a catalyst for both patient care and competitive differentiation in the market [20][22] Q&A Session Summary Question: Can you help us think about modeling for ASP going forward based on the new markers? - Management indicated that while they cannot provide precise guidance for 2025, the $90 incremental revenue from new markers is a reasonable approximation, with potential for ASP to trend upwards [48][49] Question: What is the adjusted EBITDA profitability target for Q4? - Management confirmed that adjusted EBITDA is a good proxy for free cash flow, with expectations for positive adjusted EBITDA in Q4 2025 [54] Question: What is the sensitivity improvement from the RA33 launch? - The new T cell biomarkers improve sensitivity for lupus diagnosis, capturing roughly 51% of previously undiagnosed patients, while RA markers are expected to capture 15-16% of seronegative patients [65][68] Question: How does the company plan to recover lost volume from physicians? - Management believes the business is recoverable and is focused on optimizing processes to facilitate smoother interactions with physicians [94] Question: What is the opportunity for the test to penetrate the RA market? - The company estimates the RA market opportunity at around 2.5 million tests annually, with a conservative penetration estimate of about 5% [104] Question: How will the company balance volume growth with profitability? - Management expects to see volume growth improve in 2025, with plans for sales expansion and a focus on enhancing the quality of the sales team [111][113]