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]

Financial Performance - Exagen Inc. reported a quarterly loss of $0.28 per share, which was better than the Zacks Consensus Estimate of a loss of $0.30, and an improvement from a loss of $0.31 per share a year ago, representing an earnings surprise of 6.67% [1] - The company posted revenues of $12.51 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 7.70%, and down from $13.42 million in the same quarter last year [2] - Over the last four quarters, Exagen has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Exagen shares have increased approximately 49.3% since the beginning of the year, outperforming the S&P 500's gain of 25.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $14 million, and for the current fiscal year, it is -$1.03 on revenues of $57.05 million [7] Industry Outlook - The Medical - Products industry, to which Exagen belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Exagen's stock may be influenced by the overall outlook for the industry [8]