Exagen(US:XGN)2025-11-04 14:16Revenue and Growth - Revenue from the AVISE® CTD product comprised 89% and 91% of total revenue for the nine months ended September 30, 2025 and 2024, respectively [110]. - The number of AVISE CTD tests delivered increased by approximately 16% year-over-year for the three months ended September 30, 2025, and increased sequentially by approximately 2% over the second quarter of 2025 [118]. - Revenue increased by $4.7 million, or 37.9%, for the three months ended September 30, 2025, compared to the same period in 2024, driven by a 16% increase in AVISE CTD tests delivered and ASP expansion to $441 per test [138]. - For the nine months ended September 30, 2025, revenue was $49.9 million, an increase of $7.9 million compared to $42.0 million for the same period in 2024 [149]. - Revenue increased by $8.0 million, or 19.0%, for the nine months ended September 30, 2025, driven by ASP expansion and an 8% increase in AVISE CTD tests delivered [150]. Product Development and Launches - The company expects to launch a new customized array for Lupus Nephritis biomarkers in the fourth quarter of 2025, initially through Pharma collaborations for research use [113]. - The new PAD4 biomarker assays launched in January 2025 have shown 35% sensitivity and 95% specificity for RA, addressing a critical diagnostic gap [115]. - The company has delivered over one million AVISE CTD tests since its launch in 2012 [118]. - The company plans to continue pursuing partnerships with leading pharmaceutical companies and academic research centers to enhance its testing product portfolio [111]. Financial Performance and Expenses - Cost of revenue increased by $1.6 million, or 29.7%, for the three months ended September 30, 2025, primarily due to increases in materials and employee-related expenses [140]. - Gross margin as a percentage of revenue improved to 58.4% for the three months ended September 30, 2025, compared to 55.8% for the same period in 2024, attributed to ASP expansion and better overhead absorption [141]. - Selling, general and administrative expenses rose by $1.3 million, or 12.6%, for the three months ended September 30, 2025, mainly due to increased employee-related expenses [142]. - Research and development expenses increased by $0.2 million, or 16.8%, for the three months ended September 30, 2025, primarily due to higher employee-related costs [144]. - Interest expense increased by $0.8 million for the three months ended September 30, 2025, primarily due to the Perceptive Term Loan Facility [146]. - The net loss for the three months ended September 30, 2025, was $7.1 million, compared to a net loss of $5.0 million for the same period in 2024 [138]. - Cost of revenue rose by $3.0 million, or 17.3%, primarily due to increased materials and employee-related expenses [151]. - Gross margin improved to 59.3% for the nine months ended September 30, 2025, compared to 58.7% in the same period of 2024, attributed to ASP expansion [152]. - Selling, general and administrative expenses increased by $3.0 million, or 9.7%, mainly due to higher employee-related expenses and travel costs [153]. - Research and development expenses grew by $0.8 million, or 20.9%, primarily due to increased employee-related expenses and outside services [155]. - Net loss for the nine months ended September 30, 2025, was $15.3 million, compared to a net loss of $11.4 million in the same period of 2024 [161]. Cash Flow and Financial Position - Cash and cash equivalents as of September 30, 2025, were $35.7 million, with an accumulated deficit of $309.6 million [161]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $24.8 million, primarily from debt issuance and common stock offerings [176]. Accounting and Reporting - The management's discussion and analysis is based on condensed financial statements prepared in accordance with GAAP, with year-end balance sheets derived from audited financial statements [178]. - There have been no significant changes in critical accounting policies and estimates during the nine months ended September 30, 2025, compared to those disclosed in the 2024 Annual Report [179]. - Recent accounting pronouncements are summarized in "Note 2. Summary of Significant Accounting Policies" in the unaudited condensed financial statements included in the Quarterly Report [180].