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].

Exagen Inc. Reports Third Quarter 2024 Results Expanded AVISE® CTD trailing twelve-month average selling price Reduced Adjusted EBITDA loss for first three quarters of 2024 Revenue in line with expectations, excluding one-time adjustments November 12, 2024 Carlsbad, Calif., – Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today reported financial results for the quarter ended September 30, 2024 and recent corporate updates. | --- | --- | --- | --- | --- | --- | --- | --- | -- ...

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 ...

CARLSBAD, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today announced its participation in the 2024 Cantor Global Healthcare Conference, which takes place September 17-19, 2024, at the InterContinental Barclay Hotel in New York City. John Aballi, Exagen's President and Chief Executive Officer and Jeff Black, Exagen's Chief Financial Officer, will participate in a fireside chat on Wednesday, September 18th, at 9:45 AM ET. About Exa ...

Shares of Exagen Inc. (XGN) have been struggling lately and have lost 5.9% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case for the ...

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Have you been paying attention to shares of Exagen Inc. (XGN) ? Shares have been on the move with the stock up 42.6% over the past month. The stock hit a new 52-week high of $2.78 in the previous session. Exagen Inc. has gained 38.7% since the start of the year compared to the 6.6% move for the Zacks Medical sector and the 5.9% return for the Zacks Medical - Products industry. What's Driving the Outperformance? The stock has a great record of positive earnings surprises, as it hasn't missed our earnings con ...