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].

Financial Data and Key Metrics Changes - The company reported record revenue of $15.5 million for Q1 2025, representing an approximately 8% increase compared to Q1 2024 [21] - The average selling price (ASP) for the advised CTD tests increased to $419 per test, driven by the addition of new biomarkers [21] - Gross margin for Q1 2025 was 58.9%, slightly down from 59.6% in 2024, with expectations for improvement throughout the year [23] - The net loss for Q1 2025 was $3.8 million, compared to $3.4 million in the same period last year [26] Business Line Data and Key Metrics Changes - The company achieved a 6% increase in testing volume over Q4 2024, attributed to the successful launch of new biomarkers [9] - The ASP is expected to receive an incremental boost of approximately $90 by the end of 2025 from the new markers [8] Market Data and Key Metrics Changes - The company has secured positive medical policy with TRICARE, which will enhance reimbursement for its tests [7] - The company is focusing on expanding its presence in the rheumatology market, currently servicing about one-third of the community [36] 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 [9][30] - Future innovations include the launch of seronegative markers expected by the end of 2025, which are anticipated to improve sensitivity for identifying rheumatoid arthritis patients [14][15] - The company is exploring strategic transactions related to autoimmune disease diagnostics, with a focus on biomarker development [67] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about meeting profitability goals, citing the successful launch of new biomarkers and improved reimbursement efforts [20][30] - The company is encouraged by the momentum gained from recent ALJ hearing wins and positive medical policy changes [7][88] Other Important Information - The company has refinanced its debt with a new credit facility from Perceptive Advisors, extending maturity and providing additional borrowing capacity [13][29] - The company ended Q1 2025 with cash and cash equivalents of over $11 million and an accounts receivable balance of just under $15 million [27] Q&A Session Summary Question: Expectations for volume growth throughout the year - Management indicated that they expect volume to grow throughout 2025, with a focus on increasing tests per physician and expanding their reach in the rheumatology market [36][38] Question: Details on the impact of new markers on volume growth - Management noted that the stability of the sales team and the excitement around new markers are key drivers for volume growth, with expectations for continued improvement [44] Question: Update on the launch of the second wave of RA markers - The company expects to launch the second wave of RA markers by the end of 2025 or early 2026, pending regulatory approvals [55] Question: Insights on market awareness of new tests - Management acknowledged that while awareness is reasonable among existing users, further education efforts will be necessary to fully inform the broader physician community [60][61] Question: Strategic transactions and their potential focus - Management indicated that potential strategic transactions would likely relate to existing business in the autoimmune space, particularly in biomarker development [67] Question: Update on ALJ hearings and their impact - Management shared that they have several ALJ hearings scheduled and are learning from past experiences to improve their appeal processes [81][83] Question: Learnings from TRICARE's positive medical policy - Management highlighted that the positive determination from TRICARE validates their evidence and can be leveraged in discussions with other payers [88][90]

Financial Performance - Exagen reported record Q1 2025 revenue of $15.5 million, an increase from $14.4 million in Q1 2024, representing a growth of 7.5% year-over-year[2] - The net loss for Q1 2025 was $3.8 million, compared to a net loss of $3.4 million in Q1 2024, indicating a 11.6% increase in losses[2] - Adjusted EBITDA for Q1 2025 was $(2.5) million, worsening from $(2.0) million in Q1 2024[25] - Exagen expects full-year 2025 revenue to be at least $65 million and aims to achieve positive adjusted EBITDA in Q4 2025[4] Operating Expenses - Operating expenses for Q1 2025 were $12.5 million, compared to $11.6 million in Q1 2024, reflecting an increase of 7.6%[2] Product Development - The trailing twelve-month average selling price (ASP) for AVISE CTD tests increased to $419, up $42 per test compared to Q1 2024[3] - Exagen launched new biomarkers for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), with expected reimbursement of $90 per test[3] Cash and Financing - The company ended Q1 2025 with cash, cash equivalents, and restricted cash totaling $11.2 million, with accounts receivable of $14.7 million[3] - The company closed a $25 million senior secured credit facility to refinance existing debt and extend maturity, with potential for additional borrowing capacity[9] Business Expansion - Exagen initiated commercial expansion with the identification of new sales territories[9]

Core Insights - Exagen Inc. reported a record revenue of $15.5 million for Q1 2025, reflecting a growth from $14.4 million in Q1 2024, driven by increased average selling price (ASP) and test volume growth [2][5] - The company anticipates full-year revenue of at least $65 million for 2025 and aims to achieve positive adjusted EBITDA by Q4 2025 [4][5] Financial Performance - Revenue for Q1 2025 was $15,498,000, up from $14,415,000 in Q1 2024, marking an increase of approximately 7.5% [2] - Gross margin decreased slightly to 58.9% in Q1 2025 from 59.6% in Q1 2024 [2] - Operating expenses rose to $12,488,000 in Q1 2025 from $11,601,000 in Q1 2024, leading to an operating loss of $3,365,000 compared to a loss of $3,003,000 in the previous year [2][5] - Net loss for Q1 2025 was $3,752,000, compared to a net loss of $3,360,000 in Q1 2024 [2][5] - Adjusted EBITDA for Q1 2025 was $(2,508,000), worsening from $(1,992,000) in Q1 2024 [2][20] Cash Position and Funding - As of March 31, 2025, the company had cash and cash equivalents of $11,194,000, down from $27,267,000 a year earlier [2][5] - The company closed a senior secured credit facility with Perceptive Advisors, securing $25 million to refinance existing debt and extend maturity [5] Product and Market Developments - The ASP for the AVISE CTD test increased to $419, a rise of $42 per test compared to Q1 2024 [5] - Exagen launched new biomarkers for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), with expected reimbursement around $90 per test [5] - The company is expanding its commercial reach with new sales territories identified [5] Research and Innovation - Exagen published a manuscript on T-cell research in a peer-reviewed journal, highlighting the clinical benefits of new SLE biomarkers [5] - Research on biomarkers for early kidney damage detection was presented at a significant industry summit [5]

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].

Core Viewpoint - Exagen (NASDAQ: XGN) is initiated with a Buy rating, indicating a positive outlook on the company's performance and growth potential [1] Company Performance - Exagen's turnaround is gaining traction, suggesting improvements in operational efficiency and market positioning [1] - The core AVISE diagnostics franchise is experiencing growth, which is a key driver for the company's revenue [1] - Margins are improving, indicating better cost management and profitability [1] Product Development - The company has recently added new biomarker tests for lupus and rheumatoid arthritis (RA), expanding its product offerings and addressing additional market needs [1]

CARLSBAD, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, will release financial results for the quarter ended March 31, 2025, before the market opens on Monday, May 5, 2025. John Aballi, Exagen’s President and Chief Executive Officer, and Jeff Black, Chief Financial Officer, will host a conference call to review the company’s results at 8:30 a.m. ET (5:30 a.m. PT). Interested parties may access the conference call by dialing 201-389-0918 (U.S. ...

Exagen (XGN) Q4 2024 Earnings Call March 11, 2025 04:51 PM ET Company Participants Ryan Douglas - IRJohn Aballi - CEO, President & DirectorJeff Black - CFOMatthew Parisi - Equity Research Associate Conference Call Participants Kyle Mikson - Managing Director & Senior Research AnalystRoss Osborn - AnalystMark Massaro - Managing Director - Senior Equity Research AnalystDan Brennan - AnalystAndrew Brackmann - Equity Research Analyst Operator Greetings, and welcome to ExoGen, Inc. Fourth Quarter twenty twenty f ...

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]