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]

Delivered record full-year total revenue and AVISE CTD average selling priceImproved full-year adjusted EBITDA loss and cash use by over 40%Commercialized new biomarkers to enhance clinical utility of AVISE CTD CARLSBAD, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today reported financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights.   Three Months Ended December 31, Year Ended Decembe ...

Core Viewpoint - Exagen Inc. is set to release its financial results for the quarter and year ended December 31, 2024, on March 11, 2025, with a conference call scheduled 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, rheumatoid arthritis, and Sjögren's syndrome 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 to tackle challenges in autoimmune disease management [4]. Conference Call Details - The conference call will be hosted by John Aballi, President and CEO, and Jeff Black, CFO, at 8:30 AM ET on March 11, 2025 [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 April 14, 2025, with specific access details provided [3].

Company Overview - Exagen Inc. (XGN) shares increased by 29.4% to close at $5.02, with trading volume significantly higher than usual [1] - The stock has gained 14.5% over the past four weeks, indicating a positive trend [1] Recent Developments - The surge in Exagen shares is linked to the announcement of solid preliminary fourth quarter and full year 2024 results in January [2] - Exagen received conditional approval from the New York State Department of Health for new biomarker assays related to systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) [2] - Earnings estimates for 2025 improved from a loss of $0.70 to $0.58 over the past 30 days, suggesting positive investor sentiment regarding future growth [2] Earnings Expectations - The company is expected to report a quarterly loss of $0.27 per share, reflecting a year-over-year increase of 12.9% [3] - Projected revenues for the upcoming quarter are $13.5 million, which is a 2% decrease from the same quarter last year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating stability in earnings expectations [4] Industry Context - Exagen operates within the Zacks Medical - Products industry, where Capricor Therapeutics (CAPR) is another player, closing at $15.07 with a 0.7% decline in the last trading session [4] - Capricor's consensus EPS estimate for the upcoming report is -$0.31, representing a significant year-over-year change of -1450% [5]

Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [4] - 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 syndrome [4] - Exagen specializes in testing for rheumatic diseases, offering a comprehensive suite of AVISE-branded tests for diagnosis, prognosis, and monitoring [4] Upcoming Events - Management will participate in the BTIG at Snowbird conference on February 11, 2025, with one-on-one investor meetings scheduled [1] - At the TD Cowen's 45th Annual Health Care Conference, management will engage in a fireside chat on March 5, 2025, and will also hold one-on-one investor meetings [2] - The 5th Annual KeyBanc Capital Markets Healthcare Forum will see management participating virtually in a fireside chat and one-on-one meetings on March 18, 2025 [3]

Core Insights - Exagen Inc. has received conditional approval for new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays, with a commercial launch planned for January 2025 [1][2] - The company reported preliminary financial results indicating record full-year revenue and improvements in adjusted EBITDA and cash burn for the year ended December 31, 2024 [1][4] Financial Performance - Preliminary revenue for Q4 2024 is estimated between $13.3 million and $13.8 million, while full-year revenue is projected between $55.3 million and $55.8 million [2] - The net loss for Q4 2024 is expected to be between $3.4 million and $4.4 million, with a full-year net loss between $14.8 million and $15.8 million [2] - Adjusted EBITDA for Q4 2024 is projected to be between ($2.2 million) and ($3.2 million), with full-year adjusted EBITDA between ($9.8 million) and ($10.8 million) [2][8] - The trailing twelve-month average selling price (ASP) for AVISE CTD is expected to be between $408 and $412 [2][4] Product Development - The new SLE and RA biomarkers will enhance the AVISE CTD platform, improving clinical utility and aiding in the diagnosis of autoimmune conditions [2][3] - The T-Cell Lupus profile includes new biomarkers (TC4d, TIgG, TIgM) that offer superior sensitivity for SLE compared to conventional biomarkers [3] - The RA profile will feature additional anti-RA33 biomarkers (IgA, IgG, IgM) to assist clinicians in identifying patients with RA [3] Operational Milestones - The company achieved a significant milestone by testing its 1,000,000th patient with AVISE CTD in 2024, marking a notable achievement in the field of autoimmune diagnostics [2] - Exagen's CEO highlighted the company's progress towards profitability and record reimbursement per test, indicating strong operational optimization [2]

Core Insights - Exagen Inc. has completed its 1,000,000th AVISE CTD test, highlighting its commitment to aiding patients and clinicians in managing connective tissue diseases and autoimmune conditions [1][3][4] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [6] - The company's flagship product, AVISE CTD, enhances the accuracy of diagnosing complex autoimmune diseases such as lupus, rheumatoid arthritis, and Sjögren's disease [6] Product Significance - AVISE CTD offers critical information for the accurate diagnosis of autoimmune and connective tissue diseases, addressing the limitations of traditional screening methods [2] - The test has been supported by extensive peer-reviewed literature, demonstrating its clinical validity and utility in patient care [4] Market Context - The incidence of autoimmune diseases has significantly increased in recent years, creating a growing need for reliable diagnostic tools like AVISE CTD [2]

Core Insights - Exagen Inc. has announced the validation and regulatory submission for new biomarkers related to Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis (RA) to enhance the AVISE CTD platform, aiming to improve diagnostic accuracy and reduce the time for autoimmune disease diagnosis [1][2][3] Group 1: Product Enhancements - The new biomarkers include a T Cell Lupus profile with three new T Cell biomarkers (TC4d, TIgG, TIgM) that enhance sensitivity for SLE compared to conventional biomarkers [3][4] - The RA profile will be improved with the addition of four biomarkers (anti-CarP and anti-RA33 biomarkers IgA, IgG, IgM), providing more data for accurate RA diagnosis [4][5] Group 2: Clinical Impact - The enhancements to the AVISE CTD test are expected to provide clinicians with clearer insights into individual patient health, potentially leading to more definitive diagnoses for suspected autoimmune patients [5][6] - The AVISE CTD test has been instrumental in delivering diagnostic clarity for various connective tissue diseases (CTDs) since its launch in 2012, addressing challenges posed by overlapping symptoms and ambiguous disease states [2][5] Group 3: Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions through innovative testing solutions [6][7] - The company's flagship product, AVISE CTD, is designed to assist clinicians in diagnosing complex autoimmune conditions with greater accuracy and timeliness [6][7]

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $12.5 million, down 7% compared to Q3 2023, primarily due to one-time adjustments [17][18] - Excluding these adjustments, revenue was $13.7 million, up about 2% over 2023, and year-to-date revenue was $42 million, up 8% over 2023 [17] - Adjusted EBITDA loss for Q3 2024 was approximately $4 million, compared to $3.6 million in 2023, while year-to-date adjusted EBITDA loss improved to $7.6 million from $13.2 million in 2023 [21][24] Business Line Data and Key Metrics Changes - AVISE testing volume was slightly down quarter-over-quarter due to seasonal factors, but the average selling price (ASP) improved for the seventh consecutive quarter, reaching $404 per CTD test [8] - The adjusted EBITDA loss was approximately $4 million for the quarter, with a 30% improvement expected for the full year [8][21] Market Data and Key Metrics Changes - The company experienced a significant impact from hurricanes, resulting in a 50% loss of testing volume out of Florida for two and a half weeks at the end of Q3 and into Q4 [34] - The ASP expansion and expense management have contributed to narrowing losses, with a net loss of $5 million for Q3 2024, an improvement of nearly 40% over the same period in 2023 [21] Company Strategy and Development Direction - The company is focused on delivering profitable growth and aims to achieve cash flow positivity by the end of next year [7][23] - New proprietary markers are being developed for the AVISE CTD platform, with a commercial launch expected by year-end [11][13] - The company is enhancing its marketing efforts and has revised its test reports to improve clinician experience and streamline workflow [61][70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of the business despite short-term challenges, emphasizing the importance of the upcoming product launches [7][24] - The company anticipates substantial impact from new marker enhancements, with expectations for significant revenue growth in 2025 [31][32] Other Important Information - The company ended Q3 2024 with cash and cash equivalents of $22 million, representing a net cash burn of $2.5 million for the quarter [22] - Full-year 2024 revenue is now expected to be between $55 million and $56 million, reflecting the impact of one-time adjustments [24] Q&A Session Summary Question: Can you elaborate on the one-time adjustments and their implications? - The $1.2 million in adjustments included a $300,000 reversal of revenue due to a coding discrepancy and a $900,000 reserve for at-risk accounts receivable [28][29] Question: What impact do you expect from the new biomarker launch in 2025? - The company anticipates a substantial impact from the new markers, with established CPT codes expected to facilitate coverage [31][32] Question: How did the hurricanes affect testing volume? - The company lost approximately 50% of testing volume out of Florida for two and a half weeks due to the hurricanes [34] Question: What feedback have you received from clinicians regarding the new test report? - Clinicians have expressed positive feedback on the revised test report, which enhances usability and clarity [70] Question: What are the company's plans for capacity expansion? - The company has the potential to double its lab capacity with the addition of a night shift and has already made capital upgrades to support this [63]