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]

Financial Performance - The company incurred net losses of $15.1 million and $23.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $294.3 million as of December 31, 2024[179]. - The company may require substantial additional capital to finance operations, which may not be available on acceptable terms[181]. - The company may require substantial additional capital to finance planned operations, which may not be available on acceptable terms[259]. - Medicare revenue accounted for 25% of total revenue in 2024, down from 34% in 2023[213]. - Revenue from the sale of AVISE CTD tests comprised 91% of total revenue in 2024, up from 88% in 2023[213]. - The company maintains cash deposits exceeding the FDIC insurance limit of $250,000, which poses a risk to liquidity if financial institutions face adverse developments[254]. - As of December 31, 2024, the company had $15.0 million in principal outstanding under a term loan, with an additional $3.5 million in interest payable in-kind[257]. - The company is required to maintain a minimum liquidity of at least $2.0 million and achieve certain minimum annual revenue amounts under its loan agreement[257]. Product Development and Market Strategy - The company expects its financial results to depend primarily on sales of its testing products, particularly the AVISE CTD testing product, which has been a significant revenue source since its launch in 2012[190]. - The company is planning to launch AVISE CTD incorporating new T-Cell Biomarkers and RA Sub-Profile Biomarkers in January 2025[190]. - Market acceptance of the company's testing products is crucial for commercial success, influenced by factors such as perceived accuracy, competitive advantages, and reimbursement availability[196][200]. - The company must educate healthcare providers and patients to generate demand for testing products, with efforts including scientific presentations and one-on-one education[198]. - The company may need to expand its specialized sales force to effectively market and sell testing products as it grows[215]. Regulatory and Compliance Risks - The company is subject to CLIA regulations, which require specific standards for clinical laboratories, and must maintain accreditation to perform high complexity testing[269]. - Failure to comply with CLIA requirements could lead to significant penalties, including revocation of accreditation, which would severely impact the company's ability to operate and generate revenue[271]. - The regulatory environment is complex and subject to change, with numerous federal and state laws affecting operations, including FDA regulations and HIPAA compliance[275]. - The company has faced litigation and governmental investigations, incurring costs such as a $0.7 million settlement in October 2023 related to a qui tam action[281]. - Compliance with export control and anti-corruption laws is critical, as violations could result in severe penalties and reputational harm[283]. - The potential for regulatory changes poses ongoing risks to the company's operations and financial performance[274]. - The FDA's final rule to regulate laboratory-developed tests (LDTs) will phase out enforcement discretion over four years, with high-risk tests requiring premarket approval by the 3.5-year mark[286]. - Noncompliance with FDA requirements could lead to severe enforcement actions, including civil penalties and operational restrictions[290]. - Compliance failures with data protection laws, such as HIPAA and the GDPR, could result in significant penalties and damage to reputation[293][300]. Operational Challenges - The company has faced challenges with third-party payors, including non-coverage policies for AVISE Lupus, which could materially affect revenue[186]. - The company relies on sole suppliers for some reagents and materials, which poses a risk to its ability to meet demand for testing products[178]. - The billing process for testing products is complex and resource-intensive, with risks of errors and delays in claims processing that could adversely affect revenue[207][212]. - The company faces risks related to information technology systems, including potential disruptions that could affect operations and financial condition[243]. - Business disruptions from natural or manmade disasters could significantly harm the company's revenue and financial condition[192]. - The company’s sole fulfillment center is vulnerable to disruptions from disasters, which could hinder the supply of testing products and harm customer relationships[204]. - The company may need to scale operations and enhance quality assurance to meet increased demand for testing products, which could strain resources and affect service quality[205][206]. Competition and Market Dynamics - Competition includes traditional testing methods and commercial laboratories, which may have greater resources and brand recognition[217][220]. - The annual total addressable market estimates for testing products may be inaccurate, which could impair sales growth if actual market conditions differ from projections[201]. - The company faces risks in developing new testing products, which may take several years and involve significant investment[222][226]. Intellectual Property and Innovation - The company holds an exclusive license to two issued U.S. patents and five issued U.S. patents relevant to its AVISE testing products, but faces challenges in maintaining intellectual property protection[305][307]. - The company relies on trade secret protection and confidentiality agreements to safeguard proprietary know-how, but faces risks of unintentional disclosure[308]. - Changes in U.S. patent law could diminish the value of patents, impacting the company's ability to protect its AVISE testing products[310]. - The company may struggle to protect intellectual property rights globally due to high costs and varying patent laws in different jurisdictions[313]. - The company faces risks of third-party claims alleging intellectual property infringement, which could delay development efforts and result in loss of patent rights[323]. Management and Governance - The company has identified material weaknesses in internal controls that have been remediated, but future weaknesses may still occur, potentially impacting financial reporting accuracy and investor confidence[194]. - The loss of senior management or key personnel could hinder the company's ability to execute its business strategy effectively[234]. - The stock price of the company may be volatile, influenced by various factors including financial performance, market conditions, and strategic announcements[330]. - The company may face securities class action litigation following periods of market volatility, which could divert management's attention and resources[331]. - The company has never paid dividends and does not anticipate doing so in the foreseeable future, relying on capital appreciation for returns[340].

Financial Performance - Preliminary revenue for Q4 2024 is projected between $13.3 million and $13.8 million, while full-year revenue is expected to be between $55.3 million and $55.8 million[3] - The net loss for Q4 2024 is estimated between $3.4 million and $4.4 million, with a full-year net loss projected between $14.8 million and $15.8 million[3] - Adjusted EBITDA for Q4 2024 is expected to range from ($2.2) million to ($3.2) million, with full-year adjusted EBITDA between ($9.8) million and ($10.8) million[3] - Exagen's cash, cash equivalents, and restricted cash stood at $22.2 million as of December 31, 2024[3] Product Development - Exagen received conditional approval for new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays, with a planned commercial launch in January 2025[1] - The new SLE and RA biomarkers are expected to enhance the clinical utility of the AVISE CTD platform, aiding in more accurate diagnoses[2] - Exagen tested its 1,000,000th patient with AVISE CTD in 2024, marking a significant milestone in the company's history[3] Operational Achievements - The AVISE CTD trailing twelve-month average selling price (ASP) is projected to be between $408 and $412, reflecting an improvement of $72 to $76 compared to Q4 2023[5] - The company achieved record reimbursement per test and overall revenue performance in 2024[3] - Exagen's management emphasizes that achieving profitability is now firmly within reach, supported by operational optimizations[3]