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]

Group 1 - Exagen Inc. (XGN) shares increased by 5.5% to close at $7.32, supported by higher trading volume compared to normal sessions, contrasting with a 1.7% loss over the past four weeks [1] - The rise in XGN shares is linked to positive market sentiment driven by bullish analyst coverage, particularly from Craig-Hallum, which initiated coverage with a Buy rating and a $12 price target, indicating over 70% upside potential [2] - Exagen's AVISE CTD test has demonstrated significantly improved diagnostic accuracy for autoimmune diseases, contributing to growing investor confidence and optimism regarding the company's test expansion and leadership enhancements [2] Group 2 - The company is projected to report a quarterly loss of $0.18 per share, reflecting a year-over-year decline of 12.5%, while revenues are expected to reach $15.4 million, a 2.3% increase from the previous year [3] - The consensus EPS estimate for Exagen has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [4] - Exagen holds a Zacks Rank of 3 (Hold), indicating a neutral outlook within the Zacks Medical - Products industry [5]

Core Insights - Exagen Inc. has appointed Chas McKhann to its Board of Directors, effective July 17, 2025, enhancing its leadership team with his extensive experience in the life sciences industry [1][2]. Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions. The company aims to improve clinical outcomes through its innovative testing portfolio, including its flagship product, AVISE® CTD, which aids in the diagnosis of complex autoimmune diseases [5]. Leadership Appointment - Chas McKhann brings over 25 years of experience in the life sciences sector, having held significant leadership roles in various medical technology companies. His previous positions include Board member, President, and CEO of Silk Road Medical and Apollo Endosurgery, both of which were acquired by Boston Scientific [2]. - The President and CEO of Exagen, John Aballi, expressed enthusiasm about McKhann's appointment, highlighting his leadership and commercial expertise as vital for driving growth and advancing patient care [3]. Strategic Vision - McKhann expressed his honor in joining Exagen's Board, emphasizing the company's commitment to innovation in autoimmune diagnostics and his eagerness to contribute to strategic growth and long-term value creation for all stakeholders [4].

Core Viewpoint - Exagen Inc. is set to release its financial results for Q2 2025 on July 29, 2025, with a conference call scheduled for the same day to discuss the results [1]. Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on improving care for patients with chronic autoimmune conditions [4]. - The company's flagship product, AVISE® CTD, aids clinicians in diagnosing complex autoimmune diseases such as lupus and rheumatoid arthritis with greater accuracy [4]. - Exagen specializes in testing for rheumatic diseases, offering a comprehensive suite of AVISE-branded tests for diagnosis, prognosis, and monitoring [4]. - The company emphasizes research, innovation, education, and patient-centered care in addressing autoimmune disease management challenges [4]. Conference Call Details - The conference call will be hosted by John Aballi, President and CEO, and Jeff Black, CFO, at 8:30 a.m. ET [1]. - Interested parties can access the call via phone or webcast through the Exagen investor relations website [2]. - A replay of the conference call will be available until August 12, 2025, with access details provided [3].

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 Insights - Exagen Inc. has completed the sale of an additional 502,500 shares of common stock at a public offering price of $5.25 per share, resulting in gross proceeds of approximately $20.2 million [1][2] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions. The company aims to improve clinical outcomes through its innovative testing portfolio, including its flagship product AVISE® CTD, which aids in the diagnosis of complex autoimmune conditions [5] Offering Details - The public offering was conducted under a shelf registration statement on Form S-3, which was declared effective by the SEC on November 29, 2023. The offering included a final prospectus supplement that describes the terms of the offering [3] Underwriter Information - Canaccord Genuity acted as the sole bookrunner for the offering, facilitating the sale of all shares in the public offering [2]

Core Viewpoint - Exagen Inc. has announced a public offering of 3,350,000 shares of its common stock at a price of $5.25 per share, aiming to raise approximately $17.59 million before expenses [1]. Group 1: Offering Details - The offering consists of 3,350,000 shares, with gross proceeds expected to be $17,587,500 before deducting underwriting discounts and commissions [1]. - Exagen has granted underwriters a 30-day option to purchase an additional 502,500 shares under the same terms [1]. - The offering is expected to close on May 9, 2025, pending customary closing conditions [1]. Group 2: Underwriting and Registration - Canaccord Genuity is acting as the sole bookrunner for the offering [2]. - The public offering is made under a shelf registration statement on Form S-3, which was filed with the SEC on November 17, 2023, and declared effective on November 29, 2023 [3]. Group 3: Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on improving care for patients with chronic autoimmune conditions [5]. - The company's flagship product, AVISE® CTD, aids in the diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [5]. - Exagen emphasizes research, innovation, and patient-centered care in addressing autoimmune disease management challenges [5].

Core Insights - Exagen Inc. reported a quarterly loss of $0.20 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.19 per share a year ago [1] - The company achieved revenues of $15.5 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 8.38% and up from $14.42 million year-over-year [2] - Exagen shares have increased approximately 46.8% since the beginning of the year, contrasting with a -3.3% decline in the S&P 500 [3] Financial Performance - The company has surpassed consensus EPS estimates three times over the last four quarters [1] - Exagen has also topped consensus revenue estimates three times in the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $15.5 million, and for the current fiscal year, it is -$0.57 on revenues of $64.4 million [7] Market Outlook - The sustainability of Exagen's stock price movement will largely depend on management's commentary during the earnings call [3] - The estimate revisions trend for Exagen is currently mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] - The Medical - Products industry, to which Exagen belongs, is currently ranked in the bottom 32% of over 250 Zacks industries, which may impact stock performance [8]

Financial Data and Key Metrics Changes - The company achieved record revenue of $15,500,000 for Q1 2025, representing an approximately 8% increase compared to Q1 2024 [23] - The average selling price (ASP) for advised CTD tests increased to $419 per test, driven by the addition of new biomarkers [24] - Gross margin for Q1 was 58.9%, slightly down from 59.6% in 2024, with expectations for improvement throughout 2025 [26][27] - The net loss for Q1 was $3,800,000 compared to $3,400,000 in the same period last year, with an adjusted EBITDA loss of $2,500,000 versus $2,000,000 in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company reported a 6% increase in testing volume over Q4 performance, attributed to the successful launch of new biomarkers [11] - The ASP is expected to receive an incremental boost of approximately $90 by the end of the year from the new markers [10] Market Data and Key Metrics Changes - The company has secured positive medical policy with TRICARE, which will enhance reimbursement for active duty service members and their families [9] - The company is focusing on expanding its presence in the rheumatology market, currently servicing about one-third of the community [40] Company Strategy and Development Direction - The company aims to achieve positive adjusted EBITDA by the end of 2025, with a focus on expanding ASP and volume [11][34] - Future innovations include the launch of seronegative markers expected by the end of the year, which are anticipated to improve sensitivity for identifying rheumatoid arthritis patients [16][17] - The company is exploring strategic transactions related to autoimmune disease diagnostics, with a focus on novel biomarker development [70] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about meeting profitability goals, citing strong early traction from new biomarkers and improved sales team stability [22][34] - The company is well-positioned from a balance sheet perspective, with nearly $80,000,000 in combined cash, accounts receivable, and available future credit capacity as of April 30 [34] Other Important Information - The company has successfully won its first ALJ hearing, which is expected to set a precedent for future appeals [8] - The new credit facility with Perceptive Advisors extends the maturity of prior term debt, providing flexibility for growth initiatives [31][32] Q&A Session Summary Question: Expectations for volume growth throughout the year - Management is pleased with Q1 volume growth and expects it to continue, focusing on existing physician bases and expanding into the rheumatology market [40][42] Question: Update on the launch of the second wave of RIM markers - The launch is expected around year-end, with preparations underway for regulatory approvals [58][60] Question: Market awareness of new enhanced tests - Awareness varies regionally, with ongoing educational efforts to inform physicians about new markers [61][64] Question: Types of strategic transactions considered - The company is likely to pursue opportunities related to existing business in the autoimmune space, particularly in biomarker development [70] Question: Progress in kidney disease diagnostics - The company is committed to advancing early markers for kidney disease, with promising science and significant patient need [76][79] Question: Impact of ALJ hearing wins - Management has several hearings scheduled and expects to learn from each to improve future appeals [85]

Revenue Performance - Revenue from the AVISE® CTD product comprised 92% and 90% of total revenue for the three months ended March 31, 2025, and 2024, respectively [104]. - Revenue increased by $1.1 million, or 7.5%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to ASP expansion driven by new biomarkers [132]. - The number of AVISE CTD tests delivered in the three months ended March 31, 2025, increased by approximately 2% compared to the same period in 2024 [132]. Product Development - The company plans to commercially launch the PAD4 biomarker by the end of 2025, expecting an 8% increase in overall sensitivity for identifying RA patients [111]. - The company is developing a test for Lupus Nephritis using licensed intellectual property from Johns Hopkins University, with results expected in Q3 2025 [111]. - The company continues to invest in research and development to create new testing products with superior clinical utility for rheumatic conditions [109]. Financial Position - As of March 31, 2025, the company had an accumulated deficit of $298.1 million and cash and cash equivalents of $11.2 million [141]. - Net cash used in operating activities for the three months ended March 31, 2025 was $10.7 million, compared to $9.0 million for the same period in 2024 [152][153]. - Cash and cash equivalents, along with anticipated future revenue, are expected to be sufficient to meet cash requirements for at least the next 12 months [148]. Expenses and Losses - The company incurred a net loss of $3.8 million for the three months ended March 31, 2025, compared to a net loss of $3.4 million for the same period in 2024 [140]. - Cost of revenue increased by $0.6 million, or 9.6%, for the three months ended March 31, 2025, primarily due to increases in materials and employee-related expenses [132]. - Selling, general and administrative expenses increased by $0.7 million, or 6.3%, for the three months ended March 31, 2025, primarily due to increased employee-related expenses [134]. - Research and development expenses increased by $0.2 million, or 21.2%, for the three months ended March 31, 2025, primarily due to increased employee-related expenses and outside services [136]. Financing and Debt - The company entered into a Perceptive Term Loan Facility on April 25, 2025, with an initial term loan of $25 million, of which $19.7 million was used to repay a previous term loan [107]. - The Perceptive Term Loan Facility provides a senior secured delayed draw term loan facility of up to $75.0 million, with an initial tranche of $25.0 million funded [144]. - Interest expense is expected to increase by approximately $1.0 million annually in the year ending December 31, 2025, compared to the year ended December 31, 2024 [128]. Operational Strategy - The company aims to enhance gross margins and improve operating expense efficiencies through internal initiatives focused on reimbursement and clinical utility [112]. - The company is focused on expanding its base of healthcare providers and increasing penetration with existing providers to drive revenue growth [112]. - The company is pursuing partnerships with pharmaceutical companies and academic research centers to leverage its testing products and de-identified data [105]. Cash Management - The company implemented several revenue cycle management initiatives during the year ended December 31, 2023, to optimize cash collections [122]. - The net change in cash, cash equivalents, and restricted cash for the three months ended March 31, 2025 was a decrease of $10.8 million [151]. - The company expects to finance operations through equity offerings, debt financings, or other capital sources until it can generate sufficient revenue [149]. Compliance and Governance - As of March 31, 2025, the company maintained compliance with all covenants of the Amended Loan Agreement with Innovatus [143]. - The company has not sold any shares of its common stock under the Sales Agreement with TD Securities as of March 31, 2025 [145].