Revenue Performance - Revenue from the AVISE® CTD product comprised 92% and 90% of total revenue for the three months ended March 31, 2025, and 2024, respectively [104]. - Revenue increased by $1.1 million, or 7.5%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to ASP expansion driven by new biomarkers [132]. - The number of AVISE CTD tests delivered in the three months ended March 31, 2025, increased by approximately 2% compared to the same period in 2024 [132]. Product Development - The company plans to commercially launch the PAD4 biomarker by the end of 2025, expecting an 8% increase in overall sensitivity for identifying RA patients [111]. - The company is developing a test for Lupus Nephritis using licensed intellectual property from Johns Hopkins University, with results expected in Q3 2025 [111]. - The company continues to invest in research and development to create new testing products with superior clinical utility for rheumatic conditions [109]. Financial Position - As of March 31, 2025, the company had an accumulated deficit of $298.1 million and cash and cash equivalents of $11.2 million [141]. - Net cash used in operating activities for the three months ended March 31, 2025 was $10.7 million, compared to $9.0 million for the same period in 2024 [152][153]. - Cash and cash equivalents, along with anticipated future revenue, are expected to be sufficient to meet cash requirements for at least the next 12 months [148]. Expenses and Losses - The company incurred a net loss of $3.8 million for the three months ended March 31, 2025, compared to a net loss of $3.4 million for the same period in 2024 [140]. - Cost of revenue increased by $0.6 million, or 9.6%, for the three months ended March 31, 2025, primarily due to increases in materials and employee-related expenses [132]. - Selling, general and administrative expenses increased by $0.7 million, or 6.3%, for the three months ended March 31, 2025, primarily due to increased employee-related expenses [134]. - Research and development expenses increased by $0.2 million, or 21.2%, for the three months ended March 31, 2025, primarily due to increased employee-related expenses and outside services [136]. Financing and Debt - The company entered into a Perceptive Term Loan Facility on April 25, 2025, with an initial term loan of $25 million, of which $19.7 million was used to repay a previous term loan [107]. - The Perceptive Term Loan Facility provides a senior secured delayed draw term loan facility of up to $75.0 million, with an initial tranche of $25.0 million funded [144]. - Interest expense is expected to increase by approximately $1.0 million annually in the year ending December 31, 2025, compared to the year ended December 31, 2024 [128]. Operational Strategy - The company aims to enhance gross margins and improve operating expense efficiencies through internal initiatives focused on reimbursement and clinical utility [112]. - The company is focused on expanding its base of healthcare providers and increasing penetration with existing providers to drive revenue growth [112]. - The company is pursuing partnerships with pharmaceutical companies and academic research centers to leverage its testing products and de-identified data [105]. Cash Management - The company implemented several revenue cycle management initiatives during the year ended December 31, 2023, to optimize cash collections [122]. - The net change in cash, cash equivalents, and restricted cash for the three months ended March 31, 2025 was a decrease of $10.8 million [151]. - The company expects to finance operations through equity offerings, debt financings, or other capital sources until it can generate sufficient revenue [149]. Compliance and Governance - As of March 31, 2025, the company maintained compliance with all covenants of the Amended Loan Agreement with Innovatus [143]. - The company has not sold any shares of its common stock under the Sales Agreement with TD Securities as of March 31, 2025 [145].
Exagen(XGN) - 2025 Q1 - Quarterly Report