Exagen Inc. Secures Conditional NY State Approval for New Lupus and Rheumatoid Arthritis Biomarkers and Announces Select Preliminary 2024 Financial Results

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]