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]

Revenue and Financial Performance - Revenue from the AVISE CTD product comprised 91% and 88% of total revenue for the nine months ended September 30, 2024 and 2023, respectively[89]. - The company incurred net losses of $11.4 million and $18.1 million for the nine months ended September 30, 2024 and 2023, respectively, and expects to continue incurring operating losses in the near term[89]. - Revenue decreased by $0.9 million, or 6.8%, for the three months ended September 30, 2024, primarily due to a $1.2 million decrease related to revenue adjustments[114]. - Revenue increased by $3.2 million, or 8.3%, for the nine months ended September 30, 2024, primarily due to improved average selling price (ASP)[122]. - The number of AVISE CTD tests delivered declined by approximately 6% year-over-year for the three months ended September 30, 2024, accounting for 93% of revenue[114]. - The number of AVISE CTD tests delivered declined by approximately 13% year-over-year for the nine months ended September 30, 2024, accounting for 91% of revenue[122]. - Gross margin as a percentage of revenue decreased to 55.8% for the three months ended September 30, 2024, compared to 57.4% for the same period in 2023[115]. Cash and Liquidity - As of September 30, 2024, the company had $22.0 million in cash and cash equivalents and an accumulated deficit of $290.6 million[89]. - The company anticipates that existing cash and cash equivalents, along with anticipated future revenue, will be sufficient to meet cash requirements for at least the next 12 months[136]. - The company expects to incur operating losses in the near term, with net cash used in operating activities for the nine months ended September 30, 2024, amounting to $13.6 million, compared to $22.8 million for the same period in 2023[140][141]. - Cash used in investing activities for the nine months ended September 30, 2024, was $0.4 million, compared to $0.7 million for the same period in 2023[142]. - Net cash used in financing activities for the nine months ended September 30, 2024, was $0.4 million, significantly lower than $10.4 million for the same period in 2023, which included a Term Loan Prepayment of $10.0 million[143]. - The company has not sold any shares of its common stock under the Sales Agreement as of September 30, 2024[134]. Operational Insights - The company has delivered approximately 980,714 AVISE CTD tests since its launch in 2012[96]. - The company has sufficient laboratory capacity to support increased test volume as it continues to grow its business[135]. - The company’s cash flow from operating activities was impacted by delays in claim submission and processing, affecting accounts receivable[140][141]. - Reimbursement for testing products is critical, with a significant portion of revenue coming from a limited number of commercial payors, many of which are not contracted as participating providers[96]. Research and Development - The company plans to incorporate three new biomarkers (TC4d, TIgG, and TIgM) into the AVISE CTD test by the end of 2024, which are expected to enhance diagnostic sensitivity for lupus beyond the current 80%[93]. - The addition of new biomarkers is anticipated to positively impact the average sales price of AVISE CTD and overall revenue, with expectations of achieving positive cash flows within a year of their launch[94]. - Research and development expenses increased by $0.1 million, or 5.8%, for the three months ended September 30, 2024, mainly due to higher employee-related expenses[118]. Compliance and Future Financing - As of September 30, 2024, the company was in compliance with all covenants of the Amended Loan Agreement with Innovatus[132]. - The company has filed a registration statement covering the offering of up to $150.0 million of various securities, which remained unsold as of September 30, 2024[133]. - The company expects to finance operations through equity offerings, debt financings, or other capital sources if additional funding is required[137].

Financial Performance - Total revenue for Q3 2024 was $12.5 million, reflecting a net negative impact of $1.2 million from one-time adjustments[2] - Gross margin for Q3 2024 was 55.8%, down from 57.4% in Q3 2023, with approximately 400 bps impact from one-time adjustments[6] - Net loss for Q3 2024 improved to $5.0 million, compared to a net loss of $5.4 million in Q3 2023[8] - Adjusted EBITDA loss for Q3 2024 was $4.0 million, compared to a loss of $3.6 million in Q3 2023[9] - The company expects full-year 2024 revenue to be between $55 million and $56 million, with adjusted EBITDA loss expectations of better than $12 million[10] Cash and Assets - Cash and cash equivalents as of September 30, 2024, were $22.0 million, with a net cash burn of $2.5 million for the quarter[4] - Total current assets decreased from $47,841,000 in December 2023 to $35,557,000 in September 2024, a decline of approximately 25.7%[21] - Cash and cash equivalents dropped from $36,493,000 in December 2023 to $22,035,000 in September 2024, representing a decrease of about 39.6%[21] - Accounts receivable increased from $6,551,000 in December 2023 to $9,387,000 in September 2024, an increase of approximately 43.3%[21] Operating Expenses - Operating expenses for Q3 2024 were $17.2 million, down from $18.5 million in Q3 2023[7] - Stock-based compensation expense decreased from $891,000 in the three months ended September 30, 2023, to $217,000 in the same period of 2024, a reduction of approximately 75.6%[22] Liabilities and Equity - Total liabilities decreased from $34,250,000 in December 2023 to $30,737,000 in September 2024, a reduction of approximately 10.5%[21] - Stockholders' equity fell from $22,694,000 in December 2023 to $12,868,000 in September 2024, a decline of about 43.3%[21] - Non-current operating lease liabilities decreased from $2,760,000 in December 2023 to $1,952,000 in September 2024, a decline of about 29.2%[21] Other Metrics - Trailing twelve-month average selling price (ASP) for AVISE® CTD was $404, a 26% increase from $320 in Q3 2023[3] - Net loss for the first three quarters of 2024 improved by $6.8 million or 37% compared to the same period in 2023[3] - Net loss for the three months ended September 30, 2024, was $5,028,000 compared to a net loss of $5,415,000 for the same period in 2023, showing an improvement of approximately 7.1%[22] - Adjusted EBITDA for the three months ended September 30, 2024, was $(4,024,000), compared to $(3,574,000) for the same period in 2023, indicating a decline of about 12.5%[22] - Interest expense for the three months ended September 30, 2024, was $562,000, slightly up from $557,000 in the same period of 2023[22] Product Development - The company completed analytical validation for novel biomarkers to enhance AVISE® CTD and submitted for approval to NY State Department of Health[4]

CARLSBAD, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, announced today the acceptance of five abstracts at the 2024 American College of Rheumatology’s (ACR) annual meeting, ACR Convergence 2024, being held November 14-19, 2024, at the Walter E. Washington Convention Center in Washington, D.C. Exagen’s featured plenary presentation, in collaboration with Johns Hopkins University, will highlight a urinary biomarker panel that holds the potentia ...

Core Insights - Exagen Inc. is participating in the 2024 Cantor Global Healthcare Conference scheduled for September 17-19, 2024, in New York City [1] - The company's President and CEO, John Aballi, along with CFO Jeff Black, will engage in a fireside chat on September 18th at 9:45 AM ET [1] Company Overview - Exagen Inc. is a prominent provider of autoimmune testing solutions, aiming to enhance decision-making in autoimmune disease management to improve clinical outcomes for patients [2] - The company is based in San Diego County, California [2]