Management View - Exagen Inc. aims to address diagnostic delays in autoimmune diseases, with CEO John Aballi stating the company's commitment to owning the entire space and providing comprehensive care [2] - The company has set a revenue target of $70 million to $73 million for 2026, indicating a strategic focus on growth and expansion [2] - Exagen plans to expand its sales force and innovation cadence to support its growth objectives [2]

Core Insights - Exagen reported record revenue of $66.6 million for full-year 2025, marking a nearly 20% increase from 2024, driven by higher testing volume and ASP expansion [1] - The company has implemented operational changes since 2022, including customer service upgrades, clinical record collection improvements, and a streamlined R&D portfolio [2][3] - Exagen's strategy focuses on enhancing diagnostic precision for autoimmune diseases, contrasting with longer diagnostic timelines in conditions like lupus and rheumatoid arthritis [3] Financial Performance - For 2026, Exagen guided revenue between $70 million and $73 million, anticipating high single-digit volume growth and low single-digit ASP growth [5][16] - The trailing 12-month ASP increased to approximately $441, up about 7% from $411, despite experiencing ASP pressure in the second half of 2025 due to a client billing disruption [6][7] - The company reported a gross margin of just over 58% for 2025, down from about 60% in 2024, attributed to ASP pressure [13] Operational Developments - Exagen expanded its sales organization to 45 territories, up from about 40, and reported a testing volume of 137,000 AVISE CTD tests in 2025 [6][10] - The company has launched three sets of innovative biomarkers in the clinic within an 18-month period and is working on additional clinical offerings [2][18] - Management highlighted ongoing efforts to improve market access, including advocacy from the American College of Rheumatology [11] Cash Position and Expenses - Exagen ended 2025 with over $32 million in cash and cash equivalents, with a total of more than $43 million in cash plus accounts receivable [15] - Operating expenses for 2025 were $53 million, reflecting a 13% year-over-year increase, with SG&A at $47 million and R&D at just over $6 million [14] Future Outlook - The company aims to reach breakeven Adjusted EBITDA and positive cash generation at an ~$80 million revenue run rate, with a focus on ASP expansion and cost optimization [5][17] - Exagen plans to formalize a product launch cadence, intending to introduce one new product each year, with a focus on myositis and other autoimmune conditions [18]

分组1 - Exagen Inc. reported a quarterly loss of $0.2 per share, consistent with the Zacks Consensus Estimate, and the same loss as the previous year [1] - The company posted revenues of $16.63 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 1.62% and showing an increase from $13.65 million year-over-year [2] - Exagen shares have declined approximately 44.4% since the beginning of the year, contrasting with the S&P 500's decline of 0.7% [3] 分组2 - The earnings outlook for Exagen is uncertain, with current consensus EPS estimates at -$0.15 for the coming quarter and -$0.48 for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Products sector is in the bottom 38% of over 250 Zacks industries, suggesting potential underperformance compared to higher-ranked industries [8] 分组3 - The estimate revisions trend for Exagen was unfavorable prior to the earnings release, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $66.6 million, a nearly 20% increase over 2024, with testing volume up over 11% and trailing 12-month ASP up over 7% [21][27][29] - Gross margin for 2025 was just over 58%, down from about 60% in 2024, reflecting ASP pressure experienced in the second half of the year [23][24] - Operating expenses for 2025 were $53 million, up about 13% compared to 2024, indicating early signs of scale in the business as revenue growth outpaced expense growth [24][25] Business Line Data and Key Metrics Changes - The company reset the volume run rate from approximately 30,000 tests in Q1 to over 35,000 tests in subsequent quarters, marking the highest Q4 testing volume in Exagen's history [11][21] - The ASP at the end of 2025 was approximately $441, up from $411 at the start of the year, driven by new product enhancements and improved revenue cycle management [12][21] Market Data and Key Metrics Changes - The company expanded its sales force from 40 to 45 territories in 2025, with expectations for improved productivity from new sales representatives over time [12][21] - The Pharma Services segment generated $1.7 million in revenue in 2025, significantly up from roughly $100,000 in 2024, with a backlog value of over $4 million expected to be realized over the next 2-3 years [23] Company Strategy and Development Direction - The company aims to own the entire autoimmune diagnostics space, focusing on comprehensive care and innovation to address significant unmet needs in the market [6][19] - The strategy includes advancing adoption through an upgraded sales force, expanding ASP through revenue cycle optimizations, and driving innovation with a structured product cadence [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable, profitable growth, guiding revenue expectations for 2026 to be between $70 million and $73 million [18][27] - The management highlighted the importance of achieving cash flow positivity and durable profitability, emphasizing the need for continued investment in commercial and R&D efforts [32][29] Other Important Information - The company is developing a solution for myositis, with plans to have it ready for commercialization by 2027, reflecting a strong demand from clinicians [36][16] - The American College of Rheumatology (ACR) has begun advocating for the company's AVISE platform, which is expected to enhance market access and support ASP growth [14][50] Q&A Session Summary Question: Why is it the right time to make investments despite profitability targets? - Management indicated that investments are necessary for durable cash flow positivity and to support long-term growth, with a focus on enhancing the commercial organization and R&D pipeline [32][35] Question: What is the commercialization target for myositis? - The company aims to have the myositis offering ready for the clinic by 2027, with ongoing internal feasibility studies and validation of assays [36] Question: What is the expected ASP for Q4 2026? - Management noted that while they have not disclosed the expected trailing twelve-month ASP, they anticipate stabilization and incremental gains in the second half of the year [38][39] Question: How is the Northwell Health situation impacting volume? - Management clarified that the Northwell situation was a one-time setback and that growth initiatives have compensated for any lost volume [39][40] Question: What is the status of the local coverage determination for rheumatologic diseases? - The company maintains regular contact with the team at MolDX regarding the draft LCD, which is expected to cover broader testing in rheumatologic conditions [71][72]

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $66.6 million, a nearly 20% increase over 2024, with testing volume up over 11% and trailing 12-month ASP up over 7% [21][27][29] - Gross margin for 2025 was just over 58%, down from about 60% in 2024, reflecting ASP pressure experienced in the second half of the year [23][24] - Operating expenses for 2025 were $53 million, up about 13% compared to 2024, indicating early signs of scale in the business as revenue growth outpaced expense growth [24][25] Business Line Data and Key Metrics Changes - The company reset the volume run rate from approximately 30,000 tests in Q1 to over 35,000 tests in subsequent quarters, marking the highest Q4 testing volume in Exagen's history [11][21] - ASP at the end of 2025 was approximately $441, up from $411 at the start of the year, driven by new product enhancements and improved revenue cycle management [12][22] Market Data and Key Metrics Changes - The company expanded its sales force from 40 to 45 territories in 2025, with expectations for improved productivity from new sales representatives over time [12][21] - The Pharma Services segment generated $1.7 million in revenue in 2025, significantly up from roughly $100,000 in 2024, with a backlog value of over $4 million expected to be realized over the next 2-3 years [23] Company Strategy and Development Direction - The company aims to own the entire autoimmune diagnostics space, focusing on comprehensive care and innovation to address significant unmet needs in the market [6][18] - The strategy includes advancing adoption through an upgraded sales force, expanding ASP through revenue cycle optimizations, and driving innovation with a structured product cadence [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable, profitable growth, with revenue expectations for 2026 set between $70 million to $73 million [18][27] - The company is focused on creating a foundation for innovation and evaluating select inorganic opportunities to support long-term growth [19][20] Other Important Information - The company has five promising assets in development and plans to launch one product each year to expand its addressable market opportunity [15][16] - The American College of Rheumatology has begun advocating for the company's products, which is expected to drive medical policy progress with payers [14][50] Q&A Session Summary Question: Why is it the right time to make investments despite profitability targets? - Management indicated that investments in the commercial organization and R&D are necessary for durable cash flow positivity, emphasizing the importance of achieving sustainable growth [32][35] Question: What is the commercialization target for the myositis product? - The company aims to have the myositis offering ready for the clinic by 2027, with ongoing internal feasibility studies and validation of assays [36][37] Question: What is the expected ASP for Q4 2026? - Management did not disclose specific ASP figures but indicated that they expect stabilization and incremental gains in the second half of 2026 [39][40] Question: How is the Northwell Health situation affecting volume growth? - Management views the Northwell situation as a one-time setback and has seen growth initiatives compensate for any lost volume [40][41] Question: What is the status of the local coverage determination for rheumatologic disease? - The company maintains regular contact with the team at MolDX regarding the draft LCD, which is expected to cover broader testing in rheumatologic conditions [76][77] Question: What are medical directors asking about during discussions? - Medical directors are interested in understanding the clinical impact of the company's tests on patient outcomes and are looking for contemporary data to support their decisions [80][81]

Financial Data and Key Metrics Changes - In 2025, Exagen achieved record revenue of $66.6 million, a nearly 20% increase over 2024, driven by over 11% growth in testing volume and over 7% increase in trailing 12-month ASP [21][24] - The gross margin for 2025 was just over 58%, down from about 60% in 2024, reflecting ASP pressure in the second half of the year [23][24] - Operating expenses for 2025 were $53 million, up about 13% compared to 2024, indicating early signs of scale in the business as revenue growth outpaced expense growth [24][25] Business Line Data and Key Metrics Changes - The volume run rate increased from approximately 30,000 tests in Q1 2025 to over 35,000 tests in subsequent quarters, marking the highest Q4 testing volume in Exagen's history [12][21] - The ASP at the end of 2025 was approximately $441, up from $411 at the start of the year, reflecting successful execution in revenue cycle management and product enhancements [13][21] Market Data and Key Metrics Changes - The Pharma Services segment generated $1.7 million in revenue in 2025, significantly up from roughly $100,000 in 2024, with a backlog value of over $4 million expected to grow [23] - The company anticipates revenue for 2026 to be between $70 million and $73 million, with both volume and ASP growth contributing [19][27] Company Strategy and Development Direction - Exagen aims to own the entire autoimmune diagnostics space, focusing on comprehensive care and innovative solutions to address significant unmet needs in autoimmune disease diagnosis [6][19] - The company is prioritizing three objectives: advancing adoption through an upgraded sales force, expanding ASP through revenue cycle optimizations, and driving innovation with a structured product development cadence [20][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term opportunity for ASP growth, driven by strategic initiatives that have improved ASP from $280 to $441 over the past three years [27][28] - The company is focused on achieving positive adjusted EBITDA and sustainable cash flow, with a breakeven revenue run rate now expected to be around $80 million [28][30] Other Important Information - Exagen has launched three sets of innovative markers into the clinic within an 18-month period, with ongoing efforts to streamline R&D and focus on high-potential projects [10][18] - The company is actively engaging with medical directors and has secured advocacy from the American College of Rheumatology, which is expected to enhance market access and support ASP growth [14][51] Q&A Session Summary Question: What is the rationale behind the recent investments and the adjusted profitability target? - Management indicated that the investments are aimed at ensuring durable cash flow positivity and enhancing the commercial organization, which is critical for long-term growth [32][34] Question: What is the status of the myositis product development? - The company is on track to have the myositis offering ready for commercialization by 2027, following internal feasibility studies and validation of assays [36] Question: How is the ASP expected to trend in 2026? - Management expects low single-digit ASP growth relative to Q4 2025 levels, with a focus on stabilizing and gradually increasing ASP throughout the year [37][60] Question: Can you provide an update on the Northwell Health situation and its impact on volume? - Management clarified that the Northwell situation was a one-time setback, and growth initiatives have compensated for any lost volume, with positive trends observed in Q4 [39][46] Question: What is the current status of the local coverage determination for rheumatologic diseases? - The local coverage determination is still in progress, and its outcome could significantly impact the company's future product offerings and market positioning [74][75]

Financial Performance - The company incurred net losses of $20.0 million and $15.1 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $314.3 million as of December 31, 2025[177]. - The company anticipates that its financial results will primarily depend on sales of testing products, necessitating sufficient revenue generation to support business growth[189]. - The company has experienced fluctuations in operating results, making future predictions difficult and potentially leading to results falling below expectations[186]. - Revenue from Medicare accounted for 24% and 25% of total revenue for the years ended December 31, 2025 and 2024, respectively[213]. - The AVISE CTD test generated 91% of the company's revenue for both years ended December 31, 2025 and 2024[213]. Operational Risks - The company faces risks related to third-party payors not providing adequate coverage and reimbursement for testing products, which could materially compromise commercial success[178]. - The company may require substantial additional capital to finance planned operations, which may not be available on acceptable terms[176]. - The company relies on sole suppliers for some materials used in testing products, which poses a risk if replacements cannot be funded or sourced[176]. - The company may face business disruptions from various factors, including natural disasters and geopolitical tensions, which could harm operations and financial condition[190]. - The company has previously identified material weaknesses in internal controls, which could impair the accuracy of financial reporting and investor confidence[193]. Market and Competitive Landscape - The company faces competition from traditional diagnostic methods and established commercial laboratories, which may hinder revenue growth and market acceptance[218]. - Key competitive factors include the quality of clinical validation data, confidence in diagnostic results, and cost-effectiveness of testing products[219]. - The annual total addressable market estimates for testing products may be smaller than anticipated, affecting sales growth[201]. - The company must maintain a specialized sales force to effectively market its testing products in a concentrated specialty market[216]. Regulatory Compliance - The company is subject to a heavily regulated industry, and compliance with numerous statutes and regulations is both expensive and time-consuming[176]. - Compliance with numerous regulations, including CLIA, is essential for maintaining operations and could result in penalties if not adhered to[280]. - The company must maintain CLIA compliance and certification to bill for tests provided to Medicare beneficiaries, with potential sanctions leading to significant revenue loss[283]. - The company is required to hold licenses for testing in California and New York, with non-compliance risking withdrawal of product approvals and limiting revenue[284]. - The company operates in a heavily regulated industry, facing substantial penalties for non-compliance with various federal and state laws[286]. Intellectual Property - The company has exclusive licenses to two issued U.S. patents and owns seven issued U.S. patents relevant to AVISE testing products, but faces risks in maintaining intellectual property protection[311]. - The termination of licenses related to CB-CAPs technology may increase competition for previously protected testing products[312]. - The company cannot assure that its current or future testing products will not infringe existing or future patents, potentially impacting marketability[331]. - Legal proceedings to protect or enforce patents could be expensive and time-consuming, with uncertain outcomes that may adversely affect the business[334]. Financial Obligations and Capital Structure - The company has a senior secured delayed draw term loan facility with an aggregate principal amount of up to $65.0 million, with an initial tranche of $25.0 million funded[265]. - The term loan facility matures on April 25, 2030, and includes an interest-only period through maturity, accruing interest at a rate of the greater of Term SOFR or 4.75%, plus a margin of 7.0%[265]. - The company filed a shelf registration statement for aggregate offerings of up to $150.0 million, including a prospectus supplement for sales of common stock not exceeding $50.0 million[270]. - The company may need to seek additional capital due to potential lower demand for testing products or lower-than-expected reimbursement rates, which could force delays or reductions in product development[268]. Economic and External Factors - Inflation has led to increased costs for laboratory services, personnel, and operations, potentially impacting financial results[256]. - Changes in U.S. trade policy and tariffs could materially increase costs and adversely affect business operations and financial condition[257]. - The company faces economic challenges including inflation and geopolitical instability, which may increase operating expenses and reduce revenue[313]. Corporate Governance and Shareholder Matters - The company has never declared or paid any cash dividends on its common stock and does not intend to do so in the foreseeable future[355]. - The average daily trading volume of the company's common stock during 2025 was approximately 256,838 shares[356]. - The company may face delisting from Nasdaq if it fails to meet continued listing requirements, which could negatively affect the stock price[357]. - Greater than 5% stockholders collectively own approximately 31% of the outstanding capital stock, while directors and executive officers collectively own about 33% as of February 17, 2026[354].

Patient Focused. Discovery Driven. Accelerating personalized medicine in autoimmune disease Q4 & FY 2025 UPD ATE | MARCH 10, 20 26 Disclaimer 2 Identifying autoimmune disease is a challenge… Ambiguous symptoms Manifestations overlap Tests lack specificity, sensitivity Outdated tech, testing delays High rate of misdiagnosis With rheumatoid arthritis2 ~1M Americans diagnosed with lupus1 ~2M >41M A M E R I C A N S A N A + ANA+: antinuclear antibody positive, first-line screen for autoimmune disease 3 3 1. lupu ...

Core Insights - Exagen Inc. reported record total revenue of $66.6 million for the year ended December 31, 2025, representing a 20% increase compared to 2024 [6][4] - The company achieved over 11% growth in test volume for its AVISE CTD product, supported by new biomarkers and an expanded sales force [1][6] - The average selling price (ASP) for AVISE CTD increased to $441 per test, up by $30 or 7% from the previous year [6][4] Financial Performance - For Q4 2025, revenue was $16.6 million, compared to $13.7 million in Q4 2024 [2][17] - Gross margin for the year was 58.3%, with operating expenses totaling $52.9 million [2][17] - The net loss for the year was $19.9 million, compared to a net loss of $15.1 million in 2024 [2][17] Business Highlights - The company supported the diagnosis and management of care for over 137,000 patients tested by AVISE CTD [6] - Exagen launched novel biomarkers for T-Cell and seronegative rheumatoid arthritis, enhancing its AVISE CTD platform [6][4] - The leadership team was strengthened with the appointment of Michael Mahler, PhD, as Chief Scientific Officer [6] Financial Outlook - Exagen expects full-year 2026 revenue to be in the range of $70 million to $73 million [5]

Core Insights - Exagen Inc. will release its financial results for Q4 2025 on March 10, 2026, before market opening [1] - The conference call to discuss the results will be hosted by the CEO and CFO 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]